,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342837,Effect of Mass Treatment with Azithromycin on Causes of Death in Children in Malawi: Secondary Analysis from the MORDOR Trial.,"Recent evidence indicates mass drug administration with azithromycin may reduce child mortality. This study uses verbal autopsy (VA) to investigate the causes of individual deaths during the Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial in Malawi. Cluster randomization was performed as part of MORDOR. Biannual household visits were conducted to distribute azithromycin or placebo to children aged 1-59 months and update the census to identify deaths for VA. MORDOR was not powered to investigate mortality effects at individual sites, but the available evidence is presented here for hypothesis generation regarding the mechanism through which azithromycin may reduce child mortality. Automated VA analysis was performed to infer the likely cause of death using two major analysis programs, InterVA and SmartVA. A total of 334 communities were randomized to azithromycin or placebo, with more than 130,000 person-years of follow-up. During the study, there were 1,184 deaths, of which 1,131 were followed up with VA. Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20). The intention-to-treat analysis by cause using InterVA suggested fewer HIV/AIDS deaths in azithromycin-treated communities (rate ratio 0.70 [95% CI: 0.50-0.97];  P  = 0.03) and fewer pneumonia deaths (rate ratio 0.82 [95% CI: 0.60-1.12];  P  = 0.22). The use of the SmartVA algorithm suggested fewer diarrhea deaths (rate ratio 0.71 [95% CI: 0.51-1.00];  P  = 0.05) and fewer pneumonia deaths (rate ratio 0.58 [95% CI: 0.33-1.00];  P  = 0.05). Although this study is not able to provide strong evidence, the data suggest that the mortality reduction during MORDOR in Malawi may have been due to effects on pneumonia and diarrhea or HIV/AIDS mortality.",2020,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"['A total of 334 communities', 'Children in Malawi']","['azithromycin', 'Azithromycin', 'azithromycin or placebo']","['child mortality', 'pneumonia deaths', 'Causes of Death', 'Mortality', 'diarrhea deaths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",334.0,0.538584,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0613']
1,32342840,Cost-Effectiveness of Mass Treatment with Azithromycin for Reducing Child Mortality in Malawi: Secondary Analysis from the MORDOR Trial.,"The recent Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin mass drug administration (MDA). Here, we investigate the financial costs and cost-effectiveness from the health provider perspective of azithromycin MDA at the MORDOR-Malawi study site. During MORDOR, a cluster-randomized trial involving biannual azithromycin MDA or placebo to children aged 1-59 months, fieldwork-related costs were collected, including personnel, transport, consumables, overheads, training, and supervision. Mortality rates in azithromycin- and placebo-treated clusters were calculated overall and for the five health zones of Mangochi district. These were used to estimate the number needed to treat to avert one death and the costs per death and disability-adjusted life year (DALY) averted. The cost per dose of MDA was $0.74 overall, varying between $0.63 and $0.94 in the five zones. Overall, the number needed to treat to avert one death was 1,213 children; the cost per death averted was $898.47, and the cost per DALY averted was $9.98. In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows: 3,070, $2,899.24, and $32.31 in Monkey Bay zone; 1,530, $1,214.42, and $13.49 in Chilipa zone; and 344, $217.98, and $2.42 in Namwera zone. This study is a preliminary cost-effectiveness analysis that indicates azithromycin MDA for reducing child mortality has the potential to be highly cost-effective in some settings in Malawi, but the reasons for geographical variation in effectiveness require further investigation.",2020,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:",['Malawi'],"['biannual azithromycin MDA or placebo', 'azithromycin- and placebo', 'Azithromycin', 'azithromycin MDA', 'azithromycin']","['cost per death averted', 'child mortality', 'cost per dose of MDA', 'Child Mortality', 'financial costs and cost-effectiveness', 'mortality', 'Mortality rates']","[{'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0794041,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0622']
2,32342841,Effects of Biannual Azithromycin Mass Drug Administration on Malaria in Malawian Children: A Cluster-Randomized Trial.,"Reductions in malaria morbidity have been reported following azithromycin mass drug administration (MDA) for trachoma. The recent MORDOR trial reported a reduction in child mortality following biannual azithromycin MDA. Here, we investigate the effects of azithromycin MDA on malaria at the MORDOR-Malawi study site. A cluster-randomized double-blind placebo-controlled trial, with 15 clusters per arm, was conducted. House-to-house census was updated biannually, and azithromycin or placebo syrup was distributed to children aged 1-59 months for a total of four biannual distributions. At baseline, 12-month, and 24-month follow-up visits, a random sample of 1,200 children was assessed for malaria with thick and thin blood smears and hemoglobin measurement. In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities; 95% CI: -2.8 to 1.5), or anemia (1.7% lower in azithromycin-treated communities; 95% CI: -8.1 to 4.6) between placebo and azithromycin communities. Further interrogation of the data at the individual level per-protocol, including only those who received treatment 6 months previously, and by intention-to-treat did not identify differences in parasitemia between treatment arms. In contrast to several previous reports, this study did not show an effect of azithromycin MDA on malaria parasitemia at the community or individual levels.",2020,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities",['Malaria in Malawian Children'],"['azithromycin or placebo syrup', 'azithromycin MDA', 'azithromycin', 'Biannual Azithromycin Mass Drug Administration', 'azithromycin-treated communities', 'placebo']","['child mortality', 'malaria parasitemia', 'anemia', 'prevalence of parasitemia', 'gametocytemia', 'malaria morbidity', 'malaria with thick and thin blood smears and hemoglobin measurement']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",1200.0,0.469202,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Lyson', 'Initials': 'L', 'LastName': 'Samikwa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Feston', 'Initials': 'F', 'LastName': 'Sikina', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Burr', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0619']
3,32342846,Impact of Intermittent Mass Testing and Treatment on Incidence of Malaria Infection in a High Transmission Area of Western Kenya.,"Progress with malaria control in western Kenya has stagnated since 2007. Additional interventions to reduce the high burden of malaria in this region are urgently needed. We conducted a two-arm, community-based, cluster-randomized, controlled trial of active case detection and treatment of malaria infections in all residents mass testing and treatment (MTaT) of 10 village clusters (intervention clusters) for two consecutive years to measure differences in the incidence of clinical malaria disease and malaria infections compared with 20 control clusters where MTaT was not implemented. All residents of intervention clusters, irrespective of history of fever or other malaria-related symptoms, were tested three times per year before the peak malaria season using malaria rapid diagnostic tests. All positive cases were treated with dihydroartemisinin-piperaquine. The incidence of clinical malaria was measured through passive surveillance, whereas the cumulative incidence of malaria infection was measured using active surveillance in a cohort comprising randomly selected residents. The incidence of clinical malaria was 0.19 cases/person-year (p-y, 95% CI: 0.13-0.28) in the intervention arm and 0.24 cases/p-y (95% CI: 0.15-0.39) in the control arm (incidence rate ratio [IRR] 0.79, 95% CI: 0.61-1.02). The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04). Six rounds of MTaT over 2 years did not have a significant impact on the incidence of clinical malaria or the cumulative incidence of malaria infection in this area of high malaria transmission.",2020,"The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04).","['All residents of intervention clusters, irrespective of history of fever or other malaria-related symptoms', 'in a High Transmission Area of Western Kenya']",['dihydroartemisinin-piperaquine'],"['incidence of clinical malaria or the cumulative incidence of malaria infection', 'incidence rate ratio [IRR', 'Incidence of Malaria Infection', 'incidence of clinical malaria', 'cumulative incidence of malaria infection', 'cumulative incidence of malaria infections', 'incidence of clinical malaria disease and malaria infections']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.204021,"The cumulative incidence of malaria infections was similar between the intervention (2.08 infections/p-y, 95% CI: 1.93-2.26) and control arms (2.19 infections/p-y, 95% CI: 2.02-2.37) with a crude IRR of 0.95 (95% CI: 0.87-1.04).","[{'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Samuels', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Wycliffe', 'Initials': 'W', 'LastName': 'Odongo', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Nobert Awino', 'Initials': 'NA', 'LastName': 'Odero', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Kephas', 'Initials': 'K', 'LastName': 'Otieno', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Ya Ping', 'Initials': 'YP', 'LastName': 'Shi', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Stephen Patrick', 'Initials': 'SP', 'LastName': 'Kachur', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Hamel', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Lindblade', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0735']
4,32342848,Safety and Immunogenicity of an AS03 B -Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study.,"Dengue disease and its causative agents, the dengue viruses (DENV-1-4), cause high morbidity in tropical and subtropical regions. We evaluated three dosing regimens of the investigational tetravalent AS03 B -adjuvanted dengue-purified inactivated vaccine (DPIV + AS03 B ). In this phase 1/2, observer-blind, placebo-controlled study (NCT02421367), 140 healthy adults were randomized 1:1:2 to receive DPIV + AS03 B  according to the following regimens: 0-1 month (M), 0-1-6 M, or 0-3 M. Participants received DPIV + AS03 B  or placebo at M0, M1, M3, and M6 according to their dosing schedule. Primary objectives were 1) to evaluate the safety of DPIV + AS03 B  for 28 days (D) after each dose; 2) to demonstrate the added value of a booster dose (0-1-6 M versus 0-1 M) based on neutralizing antibody titers to each DENV type (DENV-1-4) at 28 D after the last dose; and, if this objective was met, 3) to demonstrate the benefit of a longer interval between the first and second doses (0-1 M versus 0-3 M). Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups. Within 28 D following each dose, the frequency of unsolicited AEs after DPIV + AS03 B  appeared higher for three-dose (0-1-6 M) than two-dose (0-1 M and 0-3 M) regimens. No serious AEs were considered related to vaccination, and no potential immune-mediated diseases were reported during the study. All three schedules were well tolerated. Both primary immunogenicity objectives were demonstrated. The 0-3 M and 0-1-6 M regimens were more immunogenic than the 0-1 M regimen.",2020,"Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups.","['140 healthy adults', 'Healthy U.S. Adults']","['adjuvanted dengue-purified inactivated vaccine (DPIV + AS03 B ', 'DPIV + AS03', 'investigational tetravalent AS03 B', 'AS03 B -Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine', 'DPIV + AS03 B  or placebo at M0, M1, M3, and M6 according to their dosing schedule', 'placebo']","['safety of DPIV + AS03 B  for 28 days (D', 'Adverse events (AEs', 'tolerated', 'Safety and Immunogenicity']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.149575,"Adverse events (AEs) within 7 D after vaccination tended to be more frequent after DPIV + AS03 B  doses than placebo; the number of grade 3 AEs was low (≤ 4.5% after DPIV + AS03 B ; ≤ 2.9% after placebo), with no obvious differences across groups.","[{'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'McArthur', 'Affiliation': 'Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Currier', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moris', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Keiser', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0738']
5,32343308,"Dexmedetomidine with sufentanil in intravenous patient-controlled analgesia for relief from postoperative pain, inflammation and delirium after esophageal cancer surgery.","BACKGROUND AND AIMS


Postoperative pain can cause serious adverse reactions that severely affect postoperative outcome. The present study evaluated the effect of dexmedetomidine (DEX) added to sufentanil in intravenous patient-controlled analgesia (PCA) on the relief of pain and inflammatory responses during postoperative recovery of patients undergoing a combined thoracoscopic-laparoscopic esophagectomy (TLE).
METHODS


Sixty patients undergoing TLE were randomly allocated to receive 1 μg/ml of sufentanil alone (Group S) or 1 μg/ml of sufentanil plus 2.5 μg/ml of DEX (Group D) for postoperative intravenous (IV) PCA. Postoperative pain relief, cumulative PCA requirements, inflammatory marker levels, delirium and recovery were assessed.
RESULTS


A joint DEX and sufentanil regimen significantly reduced the area under the curve of numerical rating scores for pain at rest (NRSR) and coughing (NRSC) at 1-48 h postoperatively (P = 0.000) that were associated with lower PCA-delivered cumulative sufentanil consumption and less PCA frequency until 48 h postoperatively (P < 0.05 and P < 0.0001, respectively). The simultaneous administration of DEX and sufentanil significantly reduced plasma IL-6 and TNF-α concentrations and increased IL-10 level (P < 0.0001, P = 0.0003 and P = 0.0345, respectively), accompanied by better postoperative delirium categories and health statuses of patients (P = 0.024 and P < 0.05, respectively). There was no hypotension, bradycardia, respiratory depression or oversedation in Group D.
CONCLUSION


Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses and lower postoperative delirium categories and better health statuses.",2020,"Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses.","['patients undergoing a', 'after Esophageal Cancer Surgery', 'Sixty patients undergoing TLE']","['Dexmedetomidine with Sufentanil', 'postoperative intravenous (IV) PCA', 'sufentanil alone (Group S) or 1 μg/ml of sufentanil plus 2.5 μg', 'DEX', 'dexmedetomidine (DEX', 'sufentanil', 'DEX and sufentanil', 'combined thoracoscopic-laparoscopic esophagectomy (TLE', 'IV PCA sufentanil', 'intravenous patient-controlled analgesia (PCA']","['cumulative sufentanil consumption and less PCA frequency', 'Postoperative Pain, Inflammation, and Delirium', 'postoperative delirium categories and health statuses', 'hypotension, bradycardia, respiratory depression, or oversedation', 'area under the curve of numerical rating scores for pain at rest (NRSR) and coughing (NRSC', 'Postoperative pain relief, cumulative PCA requirements, inflammatory marker levels, delirium, and recovery', 'postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses', 'plasma IL-6 and TNF-α concentrations and increased IL-10 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0542127', 'cui_str': 'Oversedation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",60.0,0.453352,"Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses.","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Zhetao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Zeyuan', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}]",Bioscience reports,['10.1042/BSR20193410']
6,32276071,Acute alcohol intoxication and expectations reshape the spatiotemporal functional architecture of executive control.,"While the deleterious effects of acute ethyl alcohol intoxication on executive control are well-established, the underlying spatiotemporal brain mechanisms remain largely unresolved. In addition, since the effects of alcohol are noticeable to participants, isolating the effects of the substance from those related to expectations represents a major challenge. We addressed these issues using a double-blind, randomized, parallel, placebo-controlled experimental design comparing the behavioral and electrical neuroimaging acute effects of 0.6 vs 0.02 ​g/kg alcohol intake recorded in 65 healthy adults during an inhibitory control Go/NoGo task. Topographic ERP analyses of covariance with self-reported dose expectations allowed to dissociate their neurophysiological effects from those of the substance. While alcohol intoxication increased response time variability and post-error slowing, bayesian analyses indicated that it did not modify commission error rates. Functionally, alcohol induced topographic ERP modulations over the periods of the stimulus-locked N2 and P3 components, arising from pre-supplementary motor and anterior cingulate areas. In contrast, alcohol decreased the strength of the response-locked anterior cingulate error-related component but not its topography. This pattern indicates that alcohol had a locally specific influence within the executive control network, but disrupted performance monitoring processes via global strength-based mechanisms. We further revealed that alcohol-related expectations induced temporally specific functional modulations of the early N2 stimulus-locked medio-lateral prefrontal activity, a processing phase preceding those influenced by the actual alcohol intake. Our collective findings thus not only reveal the mechanisms underlying alcohol-induced impairments in impulse control and error processing, but also dissociate substance- from expectations- related functional effects.",2020,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.",['65 healthy adults during an inhibitory control Go/NoGo task'],['placebo'],['strength of the response-locked anterior cingulate error'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",65.0,0.0365488,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.","[{'ForeName': 'Farfalla', 'Initials': 'F', 'LastName': 'Ribordy Lambert', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Corentin A', 'Initials': 'CA', 'LastName': 'Wicht', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Spierer', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland. Electronic address: lucas.spierer@unifr.ch.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116811']
7,32339768,Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events.,"Decades of research demonstrate that childhood exposure to traumatic events, particularly interpersonal violence experiences (IPV; sexual abuse, physical abuse, witnessing violence), increases risk for negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD). Despite this well-established link-including empirical support for shared etiological and functional connections between SUP and PTSD -the field has been void of a gold standard treatment for adolescent populations. To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events. The purpose of this paper is to provide a detailed description of the design and methods of this RCT designed to reduce SUP, PTSD symptoms, and related risk behaviors, with outcomes measured from pre-treatment through 18 months post-entry. Specifically, the recruitment and sampling procedures, assessment measures and methods, description of the intervention, and planned statistical approaches to evaluating the full range of outcomes are detailed. Clinical and research implications of this work are also discussed.",2020,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","['adolescents who have experienced IPV and other traumatic events', 'adolescents who have experienced interpersonal violence and other traumatic events']","['integrative treatment', 'Risk Reduction through Family Therapy (RRFT']","['SUP, PTSD symptoms, and related risk behaviors', 'negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.0401951,"To address this gap, our team recently completed a large randomized controlled trial to evaluate the efficacy of Risk Reduction through Family Therapy (RRFT), an integrative and exposure-based risk-reduction and treatment approach for adolescents who have experienced IPV and other traumatic events.","[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene, Oregon, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: danielso@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106012']
8,32339933,"""A multicentre prospective randomized controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents"".",,2020,,['nursing home residents'],['static air mattress and alternating air pressure mattress'],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0001876', 'cui_str': 'Air pressure'}]",[],,0.0890545,,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fagart', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France. Electronic address: willy.fagart@chu-nimes.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De La Bachelerie', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blot', 'Affiliation': ""Centre d'Evaluation des Dispositif Médicaux-Handicap (CEDM-H), CHU de Nîmes, 30029 Nîmes, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupeyron', 'Affiliation': 'Département de Médecine Physique et de Réadaptation, CHU de Nîmes, 30029 Nîmes, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chevalier', 'Affiliation': 'Laboratoire De Biostatistique, Épidémiologie, Santé Publique, Informatique Médicale, CHU de Nîmes, 30029 Nîmes, France.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103547']
9,32339943,Effect of increased relative stiffness of the lumbar spine on hamstring muscle stretching in individuals with a history of low back pain suspected to have a clinical lumbar instability: A randomized crossover design.,"BACKGROUND


Theoretically, lumbopelvic stabilization techniques during hamstring muscle stretching could increase lumbar stiffness relative to hamstring muscle in individuals with a history of low back pain and suspected clinical lumbar instability. However, evidence to support this theory is limited. This study aimed to 1) determine changes in lumbopelvic, lumbar, and hip motions, and hamstring muscle length after stretching exercises with lumbopelvic stiffening or relaxing techniques, and 2) compare those changes between techniques.
METHODS


This study used a randomized crossover design. Thirty-two participants with a history of low back pain and bilateral hamstring muscle tightness were recruited. The order of the first technique was randomly assigned. After a 2-day washout, participants were crossed over to the second technique. Motion data during active forward trunk bending and bilateral hamstring muscle length during passive knee extension were collected pre- and post-intervention.
FINDINGS


Significant increases (P < 0.05) were found in bilateral hamstring muscle length for both techniques. However, stiffening technique demonstrated a significant decrease in lumbar motion (P < 0.05) and increase in hip motion (P < 0.05), while relaxing technique demonstrated trends showing increases in lumbar and hip motions (P = 0.134 and 0.115, respectively). The findings showed significantly greater improvement (P < 0.05) in lumbar and hip motions with stiffening technique.
INTERPRETATION


The findings suggest increased relative stiffness of the lumbar spine during hamstring muscle stretching can specifically lengthen bilateral hamstring muscle and decrease excessive lumbar motion. This stiffening technique may prevent excessive movement of the lumbar spine, thereby reducing the risk of recurrent low back pain.",2020,"However, stiffening technique demonstrated a significant decrease in lumbar motion (P < 0.05) and increase in hip motion (P < 0.05), while relaxing technique demonstrated trends showing increases in lumbar and hip motions (P = 0.134 and 0.115, respectively).","['Thirty-two participants with a history of low back pain and bilateral hamstring muscle tightness were recruited', 'individuals with a history of low back pain suspected to have a clinical lumbar instability', 'individuals with a history of low back pain and suspected clinical lumbar instability']","['lumbar spine', 'hamstring muscle stretching']","['lumbar motion', 'excessive lumbar motion', 'hip motion', 'lumbopelvic, lumbar, and hip motions, and hamstring muscle length', 'bilateral hamstring muscle length', 'lumbar and hip motions']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]",32.0,0.0268945,"However, stiffening technique demonstrated a significant decrease in lumbar motion (P < 0.05) and increase in hip motion (P < 0.05), while relaxing technique demonstrated trends showing increases in lumbar and hip motions (P = 0.134 and 0.115, respectively).","[{'ForeName': 'Peemongkon', 'Initials': 'P', 'LastName': 'Wattananon', 'Affiliation': 'Motor Control and Neural Plasticity Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170, Thailand. Electronic address: peemongkon.wat@mahidol.ac.th.'}, {'ForeName': 'Wallika', 'Initials': 'W', 'LastName': 'Prasertkul', 'Affiliation': 'Physical Therapy Clinic, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170, Thailand.. Electronic address: wallika.pra@mahidol.ac.th.'}, {'ForeName': 'Prasert', 'Initials': 'P', 'LastName': 'Sakulsriprasert', 'Affiliation': 'Biomechanics and Sport Lab, Faculty of Physical Therapy, Mahidol University, 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170, Thailand. Electronic address: prasert.sak@mahido.ac.th.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy and Rehabilitation Science, University of Montana, 135 Skaggs Building, Missoula, MT 59812, USA. Electronic address: james.laskin@umontana.edu.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.104996']
10,32339953,Effects of cardiopulmonary resuscitation training for Mozambican nursing students in a low-resource setting: An intervention study.,"BACKGROUND


There is an increasing incidence of cardiovascular diseases in Africa. Nurses' ability to undertake cardiopulmonary resuscitation (CPR) can significantly impact the survival of patients who experience cardiac arrest.
OBJECTIVES


We aimed to identify the effects of CPR training among Registered Nurse-Bachelor of Science in Nursing (RN-BSN) students in Mozambique.
DESIGN


A one-group pretest-posttest repeated-measures quasi-experimental design.
SETTING


Auditorium of a general hospital and 2 Anne manikins, but no automatic external defibrillator.
PARTICIPANTS


Thirty-two RN-BSN students.
METHODS


Students' attitudes and self-efficacy on CPR were measured by self-reported questionnaires three times (before, immediately after, and 20 weeks post intervention). Data were analyzed by the paired t-test and repeated-measures analysis of variance.
RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001). Sociodemographic characteristics did not significantly differ throughout the measurements of attitude or self-efficacy.
CONCLUSIONS


CPR manikin training positively affected attitude and self-efficacy in CPR among RN-BSN nursing students immediately, but not at 20 weeks, after the training. There is a need for research to repeatedly quantify parameters in a controlled study at different intervals and develop an instructor-training course customized to Mozambique.",2020,"RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001).","['patients who experience cardiac arrest', 'Registered Nurse-Bachelor of Science in Nursing (RN-BSN) students in Mozambique', 'Africa', 'Students', 'Auditorium of a general hospital and 2 Anne manikins, but no automatic external defibrillator.\nPARTICIPANTS\n\n\nThirty-two RN-BSN students', 'Mozambican nursing students in a low-resource setting']","['CPR training', 'CPR manikin training', 'cardiopulmonary resuscitation (CPR', 'cardiopulmonary resuscitation training']","['attitude or self-efficacy', 'Attitude and self-efficacy scores', 'attitude and self-efficacy', 'attitudes and self-efficacy on CPR', 'Sociodemographic characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",,0.0139191,"RESULTS


Attitude and self-efficacy scores of students on CPR significantly increased immediately after CPR training, but decreased 20 weeks after the intervention (p < .001).","[{'ForeName': 'Jeonghui', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'Department of Nursing, Bucheon University, 56 Sosa-Ro, Bucheon City 14774, Gyeonggi Province, Republic of Korea.'}, {'ForeName': 'Ogcheol', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, 84 Heukseok-Ro, Dongjak-Gu 06974, Seoul, Republic of Korea. Electronic address: leeoc@cau.ac.kr.'}]",Nurse education today,['10.1016/j.nedt.2020.104433']
11,31469815,"Aquatic Exercise Program for Individuals With Osteoarthritis: Pain, Stiffness, Physical Function, Self-Efficacy.",,2019,,['Individuals With Osteoarthritis'],['Aquatic Exercise Program'],"['Pain, Stiffness, Physical Function, Self-Efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0131561,,[],Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/RNJ.0000000000000239']
12,32390164,"Thiamidol containing treatment regimens in facial hyperpigmentation: An international multi-center approach consisting of a double-blind, controlled, split-face study and of an open label, real-world study.","OBJECTIVE


Tyrosinase is the rate-limiting enzyme in melanogenesis. Thiamidol is the most potent inhibitor of human tyrosinase out of 50,000 tested compounds. In clinical studies, it was shown to improve facial hyperpigmentation, post-inflammatory hyperpigmentation, and age spots significantly. To identify the optimal number of daily Thiamidol applications, we conducted a split-face study comparing the efficacy and tolerability of four-times with two-times daily application. Subsequently, we evaluated the efficacy and tolerability of a typical face care regimen containing Thiamidol in a real-world study.
METHODS


The split-face study was double-blind, randomized, controlled, including two Thiamidol containing products (serum and day care SPF 30). The serum was applied twice-daily on one half of the face, and the day care SPF30 twice-daily on the whole face. The real-world study was open-label, observational, including three Thiamidol containing products (day care SPF 30 in the morning, serum and night care in the evening). In both studies, subjects with mild-to-moderate facial hyperpigmentation applied the products over 12 weeks. Assessments included clinical and subjective grading of hyperpigmentation, skin condition, hemi-/modified MASI, chromameter, and clinical photography.
RESULTS


In the split-face study (n=34), hyperpigmentation, skin roughness, and hMASI improved all significantly (p<0.001) versus baseline, with first visible results after two weeks of twice-daily application. The four-times daily application led to significant improvement versus the two-times daily application. In the real-world study (n=83), all evaluated parameters, including skin condition and chromametry (n=30), improved significantly (p<0.001) in comparison to baseline and the corresponding preceding visits. The subjects judged the cosmetic properties of the products positively. In both studies the products were well tolerated.
CONCLUSION


Four-times daily Thiamidol improves facial hyperpigmentation significantly more than two-times daily application and is well tolerated by the subjects. The real-world study with a typical face care regimen containing Thiamidol shows improvement of facial hyperpigmentation and confirms tolerability. Furthermore, the data provide evidence for the suitability of this three-product Thiamidol regimen for day-to-day life.",2020,"In clinical studies, it was shown to improve facial hyperpigmentation, post-inflammatory hyperpigmentation, and age spots significantly.","['subjects with mild-to-moderate facial hyperpigmentation', 'facial hyperpigmentation']",['Thiamidol'],"['tolerated', 'facial hyperpigmentation', 'facial hyperpigmentation, post-inflammatory hyperpigmentation', 'efficacy and tolerability', 'facial hyperpigmentation and confirms tolerability', 'clinical and subjective grading of hyperpigmentation, skin condition, hemi-/modified MASI, chromameter, and clinical photography', 'hyperpigmentation, skin roughness, and hMASI']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}]",[],"[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0431056', 'cui_str': 'Photography of patient'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}]",50000.0,0.0212795,"In clinical studies, it was shown to improve facial hyperpigmentation, post-inflammatory hyperpigmentation, and age spots significantly.","[{'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Philipp-Dormston', 'Affiliation': 'Hautzentrum Köln, Schillingsrotter Str. 39-41, 50996, Köln, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vila Echagüe', 'Affiliation': 'Centro de referencia en tratamiento laser, Av. Del Libertador 662, Piso 17, depto, Buenos Aires, Argentina.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Pérez Damonte', 'Affiliation': 'CLAIM, José Bonifacio 717, Buenos Aires, Argentina.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Riedel', 'Affiliation': 'Beiersdorf AG, Unnastrasse 48, 20245, Hamburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Filbry', 'Affiliation': 'Beiersdorf AG, Unnastrasse 48, 20245, Hamburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Warnke', 'Affiliation': 'Beiersdorf AG, Unnastrasse 48, 20245, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lofrano', 'Affiliation': 'BDF Argentina, Av Triunvirato 2902, C1427 AAP CABA, Argentina, Buenos Aires.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Roggenkamp', 'Affiliation': 'Beiersdorf AG, Unnastrasse 48, 20245, Hamburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nippel', 'Affiliation': 'Beiersdorf AG, Unnastrasse 48, 20245, Hamburg, Germany.'}]",International journal of cosmetic science,['10.1111/ics.12626']
13,32342118,[Reducing the risk of ipsilateral breast tumor relapse: external beam accelerated partial breast irradiation vs. whole breast irradiation following breast-conserving surgery in patients with ductal carcinoma in situ and node-negative breast cancer : The multicentric randomised RAPID trial].,,2020,,['patients with ductal carcinoma in situ and node-negative breast cancer '],['external beam accelerated partial breast irradiation vs. whole breast irradiation following breast-conserving surgery'],['risk of ipsilateral breast tumor relapse'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0433685,,"[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Souchon', 'Affiliation': ', Paul-Lincke-Ufer 8b, 10999, Berlin, Deutschland. r.souchon@t-online.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01609-9']
14,32345077,Efficacy and safety of active vitamin D supplementation in chronic spontaneous urticaria patients.,"Background:  Chronic spontaneous urticaria (CSU) is a common skin disorder affecting negatively patients' lives. Vitamin D deficiency has been reported to be associated to many allergic skin disorders. Objective:  This study aimed to evaluate the association between the serum level of 25 hydroxy vitamin D and CSU and to assess the efficacy and safety of active vitamin D in management of CSU. Methods:  The study was conducted on 77 patients with CSU and 67 healthy controls, then the 77 CSU patients were randomized to either the study group that received 0.25 µg alfacalcidol daily or the placebo group that received oral placebo for 12 weeks. Results:  Serum 25(OH) D was significantly lower in CSU as compared to healthy controls and was negatively correlated to the urticarial severity. After alfacalcidol administration, the study group showed significant higher level of 25(OH) D compared to the placebo group. In addition, the mean serum level of IL6, hsCRP and TNFα significantly decreased in the study group in comparison to the placebo group and as compared to their baseline results. Conclusion:  Vitamin D deficiency is more common in CSU patients as compared to healthy people and hence, alfacalcidol might have a beneficial role as add on therapy in CSU management with no reported side effects.",2020,"In addition, mean serum level of IL6, hsCRP and TNFα significantly decreased in the study group in comparison to placebo group and as compared to their baseline results.  ","['Chronic Spontaneous Urticaria Patients', '77 patients with CSU and 67 healthy controls, then the 77 CSU patients']","['25 hydroxy vitamin D and CSU', 'oral placebo', 'Vitamin D deficiency', 'active vitamin D', '0.25ug alfacalcidol daily or the placebo', 'Active Vitamin D Supplementation', 'placebo']","['Efficacy and Safety', 'urticarial severity', 'level of 25(OH', 'Serum 25(OH', 'mean serum level of IL6, hsCRP and TNFα']","[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",77.0,0.257238,"In addition, mean serum level of IL6, hsCRP and TNFα significantly decreased in the study group in comparison to placebo group and as compared to their baseline results.  ","[{'ForeName': 'Amal Ahmed', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Biochemistry, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.'}, {'ForeName': 'Maha S', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Dermatology and Andrology, National Research Centre, Cairo, Egypt.'}, {'ForeName': 'Eman Mohamed', 'Initials': 'EM', 'LastName': 'Salah', 'Affiliation': 'Department of Dermatology, Andrology, Sexual Medicine and STDs, Faculty of Medicine, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Eldemery', 'Affiliation': 'Medical Biochemistry, Faculty of medicine October 6 University, Cairo, Egypt.'}, {'ForeName': 'Mona Mohamed', 'Initials': 'MM', 'LastName': 'Darwish', 'Affiliation': 'Department of Dermatology, EL Sahel Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Doaa M', 'Initials': 'DM', 'LastName': 'Ghaith', 'Affiliation': 'Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rasha A', 'Initials': 'RA', 'LastName': 'Attala', 'Affiliation': 'Department of Dermatology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.'}, {'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'El Borolossy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1762838']
15,32347137,Study of cervical precancerous lesions detection by spectroscopy and support vector machine.,"Background and objective:  Diffuse reflectance spectroscopy (DRS) offers a fast, non-invasive, and low-cost alternative for cervical cancer diagnosis. We aim to develop a method for screening precancerous lesions based on DRS. Material and methods:  Characteristic parameters of cervical tissue were extracted from spectra, including optical characteristic parameters such as absorption and scattering coefficients, and some slope and area parameters of the spectrum. Data were randomly divided into training (60%) and test (40%) sets. Of the 210 included patients, 166 were healthy, 22 had erosion of the cervix, and 31 had cervical intraepithelial neoplasia (CIN). The support vector machine (SVM) algorithm was used to classify normal and abnormal cervical tissue based on 11 characteristic parameters. Results:  The SVM with linear kernel function, applied on the training data, could distinguish tissue with lesions from healthy tissue with an accuracy of 1.00. When the classifiers were applied to the test set, erosion of cervix and CIN could be discriminated from healthy tissue with an accuracy of 0.95 ([Formula: see text]0.03). Conclusions:  This research shows that the diagnostic algorithm can be valuable for non-invasive diagnosis of cervical cancer. This is a significant step toward the development of a tool for tissue assessment of cervical cancer.",2020,"When the classifiers were applied to the test set, erosion of cervix and CIN could be discriminated from healthy tissue with an accuracy of 0.95 (","['210 included patients, 166 were healthy, 22 had erosion of the cervix, and 31 had cervical intraepithelial neoplasia (CIN']","['support vector machine (SVM) algorithm', 'Diffuse reflectance spectroscopy (DRS', 'spectroscopy and support vector machine']",[],"[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0007869', 'cui_str': 'Erosion of cervix'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}]","[{'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}]",[],210.0,0.0162398,"When the classifiers were applied to the test set, erosion of cervix and CIN could be discriminated from healthy tissue with an accuracy of 0.95 (","[{'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Yanbai', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Weitao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Biomedical Engineering, College of Automation Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Gynecology, Nanjing BenQ Hospital Co Ltd, Nanjing, China.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2020.1723111']
16,32348038,Comparative biomechanical testing of customized three-dimensional printing acetabular-wing plates for complex acetabular fractures.,"BACKGROUND


Three-dimensional (3D) printing of an acetabular wing-plate is a new minimally invasive surgical technique for complex acetabular fractures.
OBJECTIVES


To investigate the biomechanical stability of 3D printing acetabular wing-plates. The results were compared with 2 conventional fixation systems.
MATERIAL AND METHODS


Eighteen fresh frozen cadaveric pelvises with both column fractures were randomly divided to 3 groups: A - iliosciatic plates fixation system; B - 3D printing plates; C - 2 parallel reconstruction plates fixation system. These constructions were loaded onto a biomechanical testing machine. Longitudinal displacement and stiffness values of the constructs were measured to estimate their stability.
RESULTS


When the load force reached 700 N, Group A was superior to Group B in the longitudinal displacement of point 1 (p > 0.05). The longitudinal displacement of point 2 showed no significant differences among Groups A, B and C, and the displacement of the fracture line over point 3 showed no significant differences between Groups A and B (p > 0.05). The axial stiffness of Groups A, B and C were 122.4800 ±8.8480 N/mm, 168.4830 ±14.8091 N/mm and 83.1300 ±3.8091 N/mm, respectively. Group B was significantly stiffer than A and C (p < 0.05). Loads at failure of internal fixation were 1378.83 ±34.383 N, 1516.83 ±30.896 N and 1351.00 ±26.046 N for Groups A, B and C, respectively. Group B was significantly superior to Groups A and C (p > 0.05).
CONCLUSIONS


Customized 3D printing acetabular-wing plates provide stability for acetabular fractures compared to intraspecific buttressing fixation.",2020,"The axial stiffness of Groups A, B and C were 122.4800 ±8.8480 N/mm, 168.4830 ±14.8091 N/mm and 83.1300 ±3.8091 N/mm, respectively.",['Eighteen fresh frozen cadaveric pelvises with both column fractures'],"[' iliosciatic plates fixation system; B - 3D printing plates; C - 2 parallel reconstruction plates fixation system', 'customized three-dimensional printing acetabular-wing plates']",['displacement of the fracture line'],"[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0559867', 'cui_str': 'Fracture of both columns'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0050322', 'cui_str': 'A(2)C'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",18.0,0.0174596,"The axial stiffness of Groups A, B and C were 122.4800 ±8.8480 N/mm, 168.4830 ±14.8091 N/mm and 83.1300 ±3.8091 N/mm, respectively.","[{'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Canbin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'UniSA Clinical & Health Sciences, UniSA Cancer Research Institute, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Fuming', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'UniSA Clinical & Health Sciences, UniSA Cancer Research Institute, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Shicai', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'The Third Affiliated Hospital, Southern Medical University, Guangzhou, China.'}]",Advances in clinical and experimental medicine : official organ Wroclaw Medical University,['10.17219/acem/116749']
17,32344198,Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.,"BACKGROUND


The bile acid (BA) pathway plays a role in regulation of food intake and glucose metabolism, based mainly on findings in animal models. Our aim was to determine whether the BA pathway is altered and correctable in human obesity and diabetes.
METHODS


We conducted 3 investigations: 1) BA receptor pathways were studied in NCI-H716 enteroendocrine cell (EEC) line, whole human colonic mucosal tissue and in human colonic EEC isolated by Fluorescence-activated Cell Sorting (ex vivo) from endoscopically-obtained biopsies colon mucosa; 2) We characterized the BA pathway in 307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a placebo-controlled, double-blind, randomised, 28-day trial, we studied the effect of ileo-colonic delivery of conjugated BAs (IC-CBAS) on glucose metabolism, incretins, and lipids, in participants with obesity and diabetes.
FINDINGS


Human colonic GLP-1-producing EECs express TGR5, and upon treatment with bile acids in vitro, human EEC differentially expressed GLP-1 at the protein and mRNA level. In Ussing Chamber, GLP-1 release was stimulated by Taurocholic acid in either the apical or basolateral compartment. FGF19 was decreased in obesity and diabetes compared to controls. When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide. Increase in faecal BA was associated with weight loss and with decreased fructosamine.
INTERPRETATIONS


In humans, BA signalling machinery is expressed in colonic EECs, deficient in obesity and diabetes, and when stimulated with IC-CBAS, improved glucose homeostasis. ClinicalTrials.gov number, NCT02871882, NCT02033876.
FUNDING


Research support and drug was provided by Satiogen Pharmaceuticals (San Diego, CA). AA, MC, and NFL report grants (AA- C-Sig P30DK84567, K23 DK114460; MC- NIH R01 DK67071; NFL- R01 DK057993) from the NIH. JR was supported by an Early Career Grant from Society for Endocrinology.",2020,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","['human obesity and diabetes', 'participants with obesity and diabetes', '307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a']","['placebo, IC-CBAS', 'conjugated bile acids', 'ileo-colonic delivery of conjugated BAs (IC-CBAS', 'FGF19', 'placebo']","['glucose homeostasis', 'weight loss', 'faecal BA', 'obesity and diabetes', 'postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0443599', 'cui_str': 'Conjugated bile acids'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",307.0,0.064704,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Calderon', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McRae', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Rievaj', 'Affiliation': 'University of Cambridge, UK; Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Inuk', 'Initials': 'I', 'LastName': 'Zandvakili', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Linker-Nord', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Gedulin', 'Affiliation': 'Satiogen Pharmaceuticals, San Diego, CA, United States.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Vella', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Acosta', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States. Electronic address: acosta.andres@mayo.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102759']
18,32344201,Continuous postoperative pericardial flushing method versus standard care for wound drainage after adult cardiac surgery: A randomized controlled trial.,"BACKGROUND


Excessive bleeding, incomplete wound drainage, and subsequent accumulation of blood and clots in the pericardium have been associated with a broad spectrum of bleeding-related complications after cardiac surgery. We developed and studied the continuous postoperative pericardial flushing (CPPF) method to improve wound drainage and reduce blood loss and bleeding-related complications.
METHODS


We conducted a single-center, open-label, ITT, randomized controlled trial at the Academic Medical Center Amstserdam. Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD) were randomly assigned (1:1) to receive CPPF method or standard care. The primary outcome was actual blood loss after 12-hour stay in the intensive care unit (ICU). Secondary outcomes included bleeding-related complications and clinical outcome after six months follow-up.
FINDINGS


Between May 2013 and February 2016, 170 patients were randomly allocated to CPPF method (study group; n = 80) or to standard care (control group; n = 90). CPPF significantly reduced blood loss after 12-hour stay in the ICU (-41%) when compared to standard care (median differences -155 ml, 95% confidence interval (CI) -310 to 0; p=≤0·001). Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively. At discharge from hospital, patients in the study group were less likely to have pleural effusion in a surgically opened pleural cavity (22% vs. 36%; p = 0·043).
INTERPRETATION


Our study results indicate that CPPF is a safe and effective method to improve chest tube patency and reduce blood loss after cardiac surgery. Larger trials are needed to draw final conclusions concerning the effectiveness of CPPF on clinically relevant outcomes.",2020,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","['wound drainage after adult cardiac surgery', 'Between May 2013 and February 2016, 170 patients', 'Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD']","['CPPF', 'CPPF method or standard care', 'Continuous postoperative pericardial flushing method versus standard care', 'CPPF method (study group; n\u202f=\u202f80) or to standard care (control group; n\u202f=\u202f90']","['actual blood loss after 12-hour stay in the intensive care unit (ICU', 'Cardiac tamponade and reoperation for bleeding', 'pleural effusion', 'bleeding-related complications and clinical outcome after six months follow-up', 'blood loss']","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0553700', 'cui_str': 'Actual blood loss'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007177', 'cui_str': 'Cardiac tamponade'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",170.0,0.171937,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Diephuis', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Electronic address: e.c.diephuis@amsterdamumc.nl.'}, {'ForeName': 'Corianne', 'Initials': 'C', 'LastName': 'de Borgie', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tomšič', 'Affiliation': 'Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Winkelman', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Wim Jan', 'Initials': 'WJ', 'LastName': 'van Boven', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Berto', 'Initials': 'B', 'LastName': 'Bouma', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Department of Anesthesiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Juffermans', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koolbergen', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102744']
19,32345650,Using the BRAVO Risk Engine to Predict Cardiovascular Outcomes in Clinical Trials With Sodium-Glucose Transporter 2 Inhibitors.,"OBJECTIVE


This study evaluated the ability of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) risk engine to accurately project cardiovascular outcomes in three major clinical trials-BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction (DECLARE-TIMI 58) trial-on sodium-glucose cotransporter 2 inhibitors (SGLT2is) to treat patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS


Baseline data from the publications of the three trials were obtained and entered into the BRAVO model to predict cardiovascular outcomes. Projected benefits of reducing risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events were evaluated, and simulated outcomes were compared with those observed in each trial.
RESULTS


BRAVO achieved the best prediction accuracy when simulating outcomes of the CANVAS and DECLARE-TIMI 58 trials. For the EMPA-REG OUTCOME trial, a mild bias was observed (∼20%) in the prediction of mortality and angina. The effect of risk reduction on outcomes in treatment versus placebo groups predicted by the BRAVO model strongly correlated with the observed effect of risk reduction on the trial outcomes as published. Finally, the BRAVO engine revealed that most of the clinical benefits associated with SGLT2i treatment are through A1C control, although reductions in SBP and BMI explain a proportion of the observed decline in cardiovascular events.
CONCLUSIONS


The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI. Since these benefits are individually small, the use of the complex, dynamic BRAVO model is ideal to explain the cardiovascular outcome trial results.",2020,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","['patients with type 2 diabetes', 'Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME']","['BI 10773 (Empagliflozin', 'placebo', 'sodium-glucose cotransporter 2 inhibitors (SGLT2is']","['mortality and angina', 'Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction', 'A1C, SBP, and BMI', 'risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3490349', 'cui_str': 'BI 10773'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0433696,"The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, Gainesville, FL.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Vivian A', 'Initials': 'VA', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA vfonseca@tulane.edu.'}]",Diabetes care,['10.2337/dc20-0227']
20,32345653,Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study.,"OBJECTIVE


To describe celiac disease (CD) screening rates and glycemic outcomes of a gluten-free diet (GFD) in patients with type 1 diabetes who are asymptomatic for CD.
RESEARCH DESIGN AND METHODS


Asymptomatic patients (8-45 years) were screened for CD. Biopsy-confirmed CD participants were randomized to GFD or gluten-containing diet (GCD) to assess changes in HbA 1c  and continuous glucose monitoring over 12 months.
RESULTS


Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%,  N  = 1,298] vs. 4.7% [95% CI 3.4-5.9%,  N  = 1,089],  P  = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%,  P  < 0.0001). Fifty-one participants were randomized to a GFD ( N  = 27) or GCD ( N  = 24). No HbA 1c  differences were seen between the groups (+0.14%, 1.5 mmol/mol; 95% CI -0.79 to 1.08;  P  = 0.76), although greater postprandial glucose increases (4-h +1.5 mmol/L; 95% CI 0.4-2.7;  P  = 0.014) emerged with a GFD.
CONCLUSIONS


CD is frequently observed in asymptomatic patients with type 1 diabetes, and clinical vigilance is warranted with initiation of a GFD.",2020,"RESULTS


Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%,  N  = 1,298] vs. 4.7% [95% CI 3.4-5.9%,  N  = 1,089],  P  = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%,  P  < 0.0001).","['patients with type 1 diabetes who are asymptomatic for CD', 'asymptomatic patients with type 1 diabetes', 'Biopsy-confirmed CD participants', 'Asymptomatic patients (8-45 years) were screened for CD', 'Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease']","['GCD', 'GFD or gluten-containing diet (GCD', 'GFD', 'gluten-free diet (GFD']","['rates of prior CD screening', 'postprandial glucose increases', 'CD-seropositivity rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272312', 'cui_str': 'Celiac disease screen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}]",51.0,0.0463207,"RESULTS


Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9-8.2%,  N  = 1,298] vs. 4.7% [95% CI 3.4-5.9%,  N  = 1,089],  P  = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%,  P  < 0.0001).","[{'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada farid.mahmud@sickkids.ca.'}, {'ForeName': 'Antoine B M', 'Initials': 'ABM', 'LastName': 'Clarke', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kariym C', 'Initials': 'KC', 'LastName': 'Joachim', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Assor', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': ""Division of Endocrinology and Metabolism, St. Joseph's Health Care, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saibil', 'Affiliation': 'Division of Gastroenterology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lochnan', 'Affiliation': 'Department of Endocrinology, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Zubin', 'Initials': 'Z', 'LastName': 'Punthakee', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amish', 'Initials': 'A', 'LastName': 'Parikh', 'Affiliation': 'Division of Endocrinology, Trillium Health Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Advani', 'Affiliation': ""Division of Endocrinology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Baiju R', 'Initials': 'BR', 'LastName': 'Shah', 'Affiliation': 'Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'Division of Endocrinology and Metabolism, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Zuijdwijk', 'Affiliation': ""Division of Endocrinology and Metabolism, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mack', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Koltin', 'Affiliation': 'Division of Endocrinology, Trillium Health Partners, Toronto, Ontario, Canada.'}, {'ForeName': 'Emilia N', 'Initials': 'EN', 'LastName': 'De Melo', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Mukerji', 'Affiliation': ""Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Division of Endocrinology and Metabolism, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bax', 'Affiliation': ""Pediatric Gastroenterology, Department of Pediatrics, Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Lawson', 'Affiliation': ""Division of Endocrinology and Metabolism, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cino', 'Affiliation': 'Division of Gastroenterology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Beaton', 'Affiliation': 'Division of Gastroenterology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Navaaz A', 'Initials': 'NA', 'LastName': 'Saloojee', 'Affiliation': 'Department of Gastroenterology, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Lou', 'Affiliation': 'JDRF, New York, NY.'}, {'ForeName': 'Patricia H', 'Initials': 'PH', 'LastName': 'Gallego', 'Affiliation': ""Division of Endocrinology, Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada.""}, {'ForeName': 'Premysl', 'Initials': 'P', 'LastName': 'Bercik', 'Affiliation': 'Department of Gastroenterology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Houlden', 'Affiliation': 'Department of Endocrinology, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirsch', 'Affiliation': 'Division of Endocrinology, Markham-Stouffville Hospital, Markham, Ontario, Canada.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Paterson', 'Affiliation': 'Department of Gastroenterology, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Marcon', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}]",Diabetes care,['10.2337/dc19-1944']
21,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625']
22,32344285,"Non-thyroidal illness syndrome, the hidden player in the septic shock induced myocardial contractile depression.","Septic shock causes high mortality in hospitalized patients, especially in those that develop myocardial dysfunction as an early complication. The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction). Most patients with septic shock have low serum thyroid hormone levels, a condition known as non-thyroidal illness syndrome. Thyroid hormones sustain myocardial contractility and energy metabolism. Septic shock non-thyroidal illness syndrome causes myocardial hypothyroidism, and hypothyroidism causes myocardial dysfunction that resembles the myocardial depression of septic shock. We hypothesize that the myocardial hypothyroidism that occurs during septic shock has a causal role in the pathogenesis of septic shock-induced myocardial dysfunction. Thyroid hormones regulate the calcium cycle, the phenotype of contractile proteins, adrenergic response, and fatty acid transport and oxidation in the cardiomyocytes. Therefore, the administration of levothyroxine and liothyronine to normalize thyroid hormones level within the myocardium will improve the myocardial function. The hypothesis will be tested in humans with septic shock by performing a prospective, randomized, placebo-controlled study to compare the effect of thyroid hormone administration with placebo on myocardial function. The proposed hypothesis challenges the idea that non-thyroidal illness syndrome is a beneficial response of the thyroid hormone axis to illness and that thyroid hormone replacement is detrimental. The administration of thyroid hormone in order to prevent and reverse myocardial hypothyroidism during septic shock is a new theoretical concept on thyroid hormone metabolism and action at the tissue level during non-thyroidal illness syndrome. If the hypothesis is correct, clinicians should consider cardiac hypothyroidism as a central player in myocardial dysfunction caused by sepsis. Thyroid hormone replacement should be incorporated into the armamentarium of septic shock treatment.",2020,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"['hospitalized patients', 'humans with septic shock']","['Thyroid hormone replacement', 'levothyroxine and liothyronine', 'thyroid hormone', 'placebo']","['low serum thyroid hormone levels', 'ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction', 'myocardial function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.205492,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Lado-Abeal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, Truman Medical Centers and University of Missouri Kansas City, MO, USA. Electronic address: joaquin.lado@tmcmed.org.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109775']
23,32344324,"Cognitive Restructuring vs. Defusion: Impact on craving, healthy and unhealthy food intake.","Coping with food cravings is crucial for weight management. Individuals tend to use avoidance strategies to resist food cravings and prevent overeating, but such strategies may not result in the benefits sought. This study compared the effects of two cognitive techniques (Restructuring vs. Defusion) for dealing with food cravings in terms of their impact on healthy vs. unhealthy eating behavior (i.e., consumption of chocolate and/or carrots following the intervention). Sixty-five participants (M age  = 19.65 years) received either a 30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15 min of practice, or 45 min of obesity education and discussion (control). To examine craving and eating choices following the intervention, participants received bags of chocolate and carrots and were asked to carry these with them at all times over the next week, exchanging the bags every 2 days. Participants in the CD group ate fewer chocolates (M = 11.74) compared to CR (M = 17.06) and Control groups (M = 29.18) during the experimental week. The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates. CD resulted in fewer self-reported cravings compared to CR and CO groups. At a final taste test, both CD and CR groups ate significantly fewer chocolates compared to the CO group. CD appears to be an effective technique in managing food craving and to present some advantages over CR.",2020,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.",['Sixty-five participants (M age \xa0'],"['bags of chocolate and carrots', '30-minute face-to-face instruction on cognitive restructuring (CR) or cognitive defusion (CD) along with 15\xa0min of practice, or 45\xa0min of obesity education and discussion (control', 'CD', 'cognitive techniques (Restructuring vs. Defusion', 'Cognitive Restructuring vs. Defusion']",[],"[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],65.0,0.020642,"The groups did not differ in number of carrot pieces eaten, though the CD group ate more carrots than chocolates.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'University of Cyprus, Cyprus. Electronic address: mkarekla@ucy.ac.cy.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Georgiou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Panayiotou', 'Affiliation': 'University of Cyprus, Cyprus.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Sandoz', 'Affiliation': 'University of Louisiana at Lafayette, United States of America.'}, {'ForeName': 'A Solomon', 'Initials': 'AS', 'LastName': 'Kurz', 'Affiliation': 'VISN 17 Center of Excellence for Research on Returning War Veterans, Central Texas Veterans Health Care System, United States of America.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'University of Nicosia, Cyprus.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101385']
24,32348638,Utilization trends of respiratory medication in premature infants discharged on home oxygen therapy.,"BACKGROUND


Roughly half of all extremely preterm infants will be diagnosed with bronchopulmonary dysplasia (BPD), and a third will be discharged on home oxygen therapy (HOT). To date, there have been no studies that have examined the relationship between respiratory medication utilization in infants with BPD on HOT.
METHODS


The recorded home oximetry trial was a multicenter, randomized trial comparing two home oxygen management strategies in premature infants. Infants were enrolled at first outpatient pulmonary or neonatal intensive care unit (NICU) follow-up visit with a pulmonary component. Respiratory medication prescriptions and dosage were collected from time of enrollment through 6 months after HOT discontinuation. Patients were seen monthly while on HOT and at 1, 3, and 6 months after successful discontinuation.
RESULTS


During protocol visits, 174 (89%) infants had respiratory medications documented. Respiratory medication use was higher at initial follow-up visit compared with NICU discharge and decreased at the final 6-month follow-up visit. Infants who received inhaled steroids (IS) before weaning had mean HOT duration of 138 days (range: 24-562 days); infants who received IS after weaning had shorter mean HOT duration (55 days, range: 21-264). In time-to-event analysis the no IS group and the postwean group differed significantly (χ 2   1   = 8.1; P = .004). NICU clinics gave a total of 35 prescriptions to 43 patients, an average of 0.8 per patient, while the pulmonary clinics gave 837 prescriptions to 153 patients, or 5.5 per patient (P < .0001).
CONCLUSION


Respiratory prescribing patterns for infants on HOT are highly variable. Utilization of IS was not associated with shorter duration of HOT.",2020,In time-to-event analysis the no IS group and the postwean group differed significantly (χ 2   1   = 8.1; P = .004).,"['infants with BPD', 'Infants were enrolled at first outpatient pulmonary or neonatal intensive care unit (NICU) follow-up visit with a pulmonary component', 'premature infants', 'premature infants discharged on home oxygen therapy']",['inhaled steroids (IS'],"['mean HOT duration', 'shorter duration of HOT']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}]",,0.10114,In time-to-event analysis the no IS group and the postwean group differed significantly (χ 2   1   = 8.1; P = .004).,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'White', 'Affiliation': 'Division of Neonatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Berenson', 'Affiliation': 'School of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Mannan', 'Affiliation': 'Division of Neonatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Division of Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Rhein', 'Affiliation': 'Division of Neonatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric pulmonology,['10.1002/ppul.24735']
25,32350931,Effect of a tailored home-based exercise program in patients with systemic sclerosis: A randomized controlled trial.,"OBJECTIVE


The aim was to evaluate the effect of a home-based exercise program on functional capacity, health-related quality of life (HRQoL), and disability, in patients with systemic sclerosis (SSc).
METHODS


A 6-month randomized controlled trial was conducted on SSc patients by comparing a home-based minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care. At baseline and after 3 and 6 months, the patients underwent: 6 minutes walking test; hand mobility in scleroderma test; maximal exercise test on an ergocycle; strength measures (handgrip, quadriceps, and biceps). HRQoL (short-form 36 [SF-36]) and disability (health assessment questionnaire disability index [HAQ-DI]) were measured at the same time.
RESULTS


Forty-four patients participated in the study. Twenty-two were randomly assigned to the intervention group (IG, mean age 63.60 ± 10.40 years) and 22 to the control group (CG, 61.80 ± 14.40 years). At 6 months, the distance walked in 6 minutes increased by 46 m (baseline 486, 95% CI 458-513 m; 6 months 532, 95% CI 504-561 m) in IG, whereas it decreased by 5 m (baseline 464, 95% CI 431-497 m; 6 months 459, 95% CI 427-490 m) in CG with a significantly different temporal trend at the between-groups comparison (P < .001). An improvement was also observed for strength measures (handgrip, P = .003; quadriceps, P < .001; biceps, P < .001), for the SF-36 physical component score (P < .001) and for the HAQ-DI (P = .011).
CONCLUSIONS


This study indicates that in SSc patients, a minimally supervised home-based exercise program improves physical performance, quality of life, and disability in comparison with usual care.",2020,"An improvement was also observed for strength measures (handgrip, p=0.003; quadriceps, p <0.001; biceps, p <0.001), for the SF-36 physical component score (p<0.001) and for the HAQ-DI (p=0.011).
","['Twenty-two were randomly assigned to the intervention group (IG, mean age', 'patients with systemic sclerosis (SSc', 'patients with Systemic Sclerosis', 'SSc patients by comparing a home-based', 'Forty-four patients participated in the study']","['home-based exercise program', 'tailored home-based exercise program', 'minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care']","['mobility in scleroderma-test (HAMIS-test); maximal exercise test on an ergo-cycle; strength measures (handgrip, quadriceps and biceps', 'functional capacity, health-related quality of life (HRQoL) and disability', 'distance walked in six minutes', 'HRQoL [short form-36 (SF-36)] and disability [health assessment questionnaire disability index (HAQ-DI', 'SF-36 physical component score', 'strength measures', 'physical performance, quality of life and disability']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.147349,"An improvement was also observed for strength measures (handgrip, p=0.003; quadriceps, p <0.001; biceps, p <0.001), for the SF-36 physical component score (p<0.001) and for the HAQ-DI (p=0.011).
","[{'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Cazzoletti', 'Affiliation': 'Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zamboni', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Caimmi', 'Affiliation': 'Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tardivo', 'Affiliation': 'Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Unit of Respiratory Disease and Sports Medicine, Department of Medicine, University of Verona, Verona, Italy.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13702']
26,32350999,Evaluation of a novel telemedicine-based intervention to manage body image disturbance in head and neck cancer survivors.,"OBJECTIVES


The study aimed to evaluate the feasibility, acceptability, and preliminary clinical impact of BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a novel telemedicine-based cognitive-behavioral intervention to manage body image disturbance (BID) in head and neck cancer (HNC) survivors.
METHODS


Head and neck cancer survivors with BID were enrolled into a single-arm pilot trial. Participants completed study measures at baseline, 1- and 3-months post-BRIGHT to assess its acceptability and clinical impact. Participants completed semi-structured interviews to evaluate the feasibility and acceptability of BRIGHT and refine the intervention.
RESULTS


Ten HNC survivors with BID were enrolled into the trial of tablet-based BRIGHT. BRIGHT was feasible, as judged by low dropout (n = 1), high session completion rates (100%; 45/45) and low rates of technical issues with the tablet-based delivery (11% minor; 0% major). Ninety percent of participants were highly likely to recommend BRIGHT, reflecting its acceptability. BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15-5.96). Program evaluation revealed high levels of satisfaction with BRIGHT, particularly the delivery platform. During the qualitative evaluation, participants highlighted that BRIGHT improved image-related coping behavior.
CONCLUSIONS


BRIGHT is feasible, acceptable to HNC survivors, and has significant potential as a novel approach to manage BID in HNC survivors. Additional research is necessary to refine BRIGHT and evaluate its clinical efficacy and scalability.",2020,"BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15 to 5.96).","['Head and Neck Cancer Survivors', 'Ten HNC survivors with BID', 'head and neck cancer (HNC) survivors', 'HNC survivors with BID']","['Novel Telemedicine-Based Intervention', 'telemedicine-based cognitive-behavioral intervention']",['mean Body Image Scale scores'],"[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0558116', 'cui_str': 'Distorted body image'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0951576,"BRIGHT was associated with a 34.5% reduction in mean Body Image Scale scores at 1-month post-BRIGHT (mean difference from baseline = 4.56; 95% CI 1.55, 7.56), an effect that was durable at 3-months post-BRIGHT (mean decrease from baseline = 3.56; 95% CI 1.15 to 5.96).","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Graboyes', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Maurer', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Courtney H', 'Initials': 'CH', 'LastName': 'Marsh', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McElligott', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Day', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Hornig', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Sterba', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina (MUSC), Charleston, South Carolina, USA.'}]",Psycho-oncology,['10.1002/pon.5399']
27,32353816,Effects of a Mindfulness-based Intervention on diurnal cortisol pattern in disadvantaged families: A randomized controlled trial.,"OBJECTIVE


The present study examined the psychophysiological effects of Family-based Mindfulness Intervention (FBMI) on children and parents from disadvantaged families.
METHODS


This randomized controlled trial recruited parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n = 26) and waitlist control (n = 25) groups. The parent intervention included 6 sessions and the child intervention included 8 sessions with 2 half-hour joint programs. Both interventions lasted 9 hours in total each. All participants completed four salivary cortisol measures after wakeup, before lunchtime, late-afternoon, and before sleep at baseline and end of the intervention. The diurnal cortisol pattern was summarized by the morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope.
RESULTS


Compared to the control group, children in the FBMI group showed significant increases in morning cortisol (d = 0.50, p =  0.03) and significant decreases in diurnal cortisol slopes (d = 0.50, p =  0.04) at the end of intervention. Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention. No significant treatment effects were found on the mean cortisol.
DISCUSSION


The present findings suggest that FBMI could improve the diurnal cortisol slope and cortisol levels of the children and parents from disadvantaged families, respectively. Future studies should elucidate its potential benefits on neuroendocrine functioning.",2020,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","['children and parents from disadvantaged families', 'parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n\u202f=\u202f26) and waitlist control (n\u202f=\u202f25) groups', 'disadvantaged families']","['Mindfulness-based Intervention', 'FBMI', 'Family-based Mindfulness Intervention (FBMI', 'child intervention included 8 sessions with 2 half-hour joint programs']","['morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope', 'diurnal cortisol slopes', 'morning cortisol', 'evening cortisol', 'diurnal cortisol slope and cortisol levels', 'salivary cortisol measures', 'mean cortisol', 'diurnal cortisol pattern']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",51.0,0.0257721,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herman H M', 'Initials': 'HHM', 'LastName': 'Lo', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: herman.lo@polyu.edu.hk.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104696']
28,32353822,Effects of sugammadex on postoperative respiratory management in children with congenital heart disease: a randomized controlled study.,"BACKGROUND


Early extubation can reduce pulmonary complications in children undergoing cardiac surgery. The aim of this study is to evaluate the effects of sugammadex for postoperative respiratory management in children with congenital heart disease.
METHODS


Sixty children with congenital heart disease undergoing elective cardiac surgery were divided into group S and group C (30 children in each group). When post tetanic twitches count (PTC) = 1-2 and train-of-four (TOF) = 0, the children in group S received sugammadex4 mg/kg for reversal of neuromuscular block at the end of surgery, and the children in group C received the same volume of normal saline. The recovery time to TOF of 0.9, the mechanical ventilation and extubation times were recorded. On the other side, the hemodynamic parameters before and 5 min after administration, and side effects were also recorded. The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
RESULTS


The recovery time to TOF of 0.9 and extubation time were significantly shorter in the group S than in the group C (4.2 ± 1.4 vs 108.2 ± 26.7 min, 66.3 ± 6.5 vs 171.6 ± 23.1 min, respectively, P <  0.01). The CRP and PCT levels were found to be increased in both groups at postoperative 24 h than before surgery. Further, the levels of PCT and CRP at postoperative 24 h were lower in group S when compared to group C (median, 7 vs 17.5 mg/ml, 1.76 vs 5.22 ng/ml, respectively, P <  0.05). There were no statistical differences observed between the two groups (P> 0.05) with respect to side effects.
CONCLUSION


Sugammadex is rapid and effective in reversing rocuronium-induced neuromuscular block, and significantly reduces the extubation time and the release of postoperative CRP and PCT in children with congenital heart diseases.",2020,"The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
","['children undergoing cardiac surgery', 'children with congenital heart diseases', 'Sixty children with congenital heart disease undergoing elective cardiac surgery', 'children with congenital heart disease']","['sugammadex', 'Sugammadex']","['levels of PCT and CRP', 'postoperative respiratory management', 'levels of C-reactive protein (CRP) and procalcitonin (PCT', 'CRP and PCT levels', 'pulmonary complications', 'extubation time', 'recovery time to TOF of 0.9 and extubation time', 'recovery time to TOF of 0.9, the mechanical ventilation and extubation times']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",60.0,0.104172,"The levels of C-reactive protein (CRP) and procalcitonin (PCT) before and 24 h after surgery were measured.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiaobing', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Wangping', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, Jiaxing 314000, China. Electronic address: zhang650679@163.com.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Rufang', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China. Electronic address: zhangrf398@163.com.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""Department of Cardiothoracic Surgery, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Rong', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai JiaoTong University, Shanghai 200062, China.""}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110180']
29,32356559,Physical activity and markers of glycation in older individuals: data from a combined cross-sectional and randomized controlled trial (EXAMIN AGE).,"BACKGROUND


Advanced glycation end products (AGEs) are protein modifications that are predominantly formed from dicarbonyl compounds that arise from glucose and lipid metabolism. AGEs and sedentary behavior have been identified as a driver of accelerated (vascular) aging. The effect of physical activity on AGE accumulation is unknown. Therefore, we investigated whether plasma AGEs and dicarbonyl levels are different across older individuals that were active or sedentary and whether plasma AGEs are affected by high-intensity interval training (HIIT).
METHODS


We included healthy older active (HA, n=38, 44.7% female, 60.1 ± 7.7 years old) and healthy older sedentary (HS, n=36, 72.2% female, 60.0 ± 7.3 years old) individuals as well as older sedentary individuals with increased cardiovascular risk (SR, n=84, 50% female, 58.7 ± 6.6 years old). The SR group was randomized into a 12-week walking-based HIIT program or control group. We measured protein-bound and free plasma AGEs and dicarbonyls by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) at baseline and after the HIIT intervention.
RESULTS


Protein-bound AGE Nε-(carboxymethyl)lysine (CML) was lower in SR (2.6 ± 0.5 μmol/l) and HS (3.1 ± 0.5 μmol/l) than in HA (3.6 ± 0.6 μmol/l; P<0.05) and remained significantly lower after adjustment for several potential confounders. None of the other glycation markers were different between HS and HA. HIIT did not change plasma AGEs and dicarbonyls in SR.
DISCUSSION


Although lifestyle interventions may act as important modulators of cardiovascular risk, HIIT is not a potent short-term intervention to reduce glycation in older individuals, underlining the need for other approaches, such as pharmacological agents, to reduce AGEs and lower cardiovascular risk in this population.",2020,"HIIT did not change plasma AGEs and dicarbonyls in SR.
","['older individuals that were active or sedentary and whether plasma AGEs are affected by high intensity interval training (HIIT', 'older individuals', 'healthy older active (HA,\xa0n=38, 44.7% female, 60.1±7.7 years old) and healthy older sedentary (HS,\xa0n=36, 72.2% female, 60.0±7.3 years old) individuals as well as older sedentary individuals with increased cardiovascular risk (SR,\xa0n=84, 50% female, 58.7±6.6 years old']",['walking-based HIIT program or control group'],"['plasma AGEs and dicarbonyl levels', 'Physical activity and markers of glycation', 'protein-bound and free plasma AGEs and dicarbonyls by UPLC-MS/MS']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033618', 'cui_str': 'Protein binding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}]",,0.0486955,"HIIT did not change plasma AGEs and dicarbonyls in SR.
","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'D G Van den Eynde', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Streese', 'Affiliation': 'Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'J H M Houben', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Coen', 'Initials': 'C', 'LastName': 'D A Stehouwer', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'L J M Scheijen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'G Schalkwijk', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Nordin', 'Initials': 'N', 'LastName': 'M J Hanssen', 'Affiliation': 'Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Henner', 'Initials': 'H', 'LastName': 'Hanssen', 'Affiliation': 'Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}]","Clinical science (London, England : 1979)",['10.1042/CS20200255']
30,32359042,"Efficacy of the eCHECKUP TO GO for High School Seniors: Sex Differences in Risk Factors, Protective Behavioral Strategies, and Alcohol Use.","OBJECTIVE


The purpose of this randomized controlled study was to examine sex as a moderator of the efficacy of a brief, web-based personalized feedback intervention (eCHECKUP TO GO) on decreasing cognitive risk factors for alcohol use, increasing protective behavioral strategies, and reducing alcohol use among high school seniors.
METHOD


Participants (n = 311) were high school seniors randomized by class period to the eCHECKUP TO GO intervention or assessment-only control group. Participants completed online surveys at baseline and 30-day follow-up (91.0%; n = 283).
RESULTS


Students in the intervention group reported a significant reduction in normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative to those in the control group. Intervention effects for perceptions of frequency of peer drunkenness and frequency of alcohol use were moderated by sex, with results favoring females. In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity. Further, we did not find significant intervention or moderator effects for protective behavioral strategies.
CONCLUSIONS


Results of this study extend the literature by demonstrating the efficacy of the eCHECKUP TO GO for both males and females on reducing cognitive risk factors and alcohol use, although results were significant for a broader range of variables for females. Results also indicate that program content regarding normative feedback and protective behavioral strategies may need modification to be more effective for this age group.",2020,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","['High School Seniors', 'Participants (n = 311) were high school seniors randomized by class period to the', 'high school seniors']","['eCHECKUP TO GO intervention or assessment-only control group', 'web-based personalized feedback intervention (eCHECKUP TO GO', 'eCHECKUP TO GO']","['normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",311.0,0.0172365,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Doumas', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Esp', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Biomolecular Research Center, Boise State University, Boise, Idaho.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flay', 'Affiliation': 'Initiative for Healthy Schools, Boise State University, Boise, Idaho.'}]",Journal of studies on alcohol and drugs,[]
31,32347216,Grinding the intaglio surface of yttria partially- and fully-stabilized zirconia polycrystals restorations: Effect on their fatigue behavior.,"This study evaluated the effects of diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ) adhesively cemented to dentin analogue substrate on the fatigue failure load, cycle number until failure, surface micromorphology and phase transformation. Disc-shaped specimens were produced from second (Katana ML-HT, Kuraray) and third-generation zirconia (Katana STML, Kuraray) and randomly allocated (n = 15) into two groups according to the intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface). The ceramic discs were adhesively cemented (Multilink Automix System) onto dentin analogue discs. Fatigue tests were executed by the step-stress method. The obtained data were analyzed by Kaplan Meier and Mantel-Cox tests. In addition, surface topography, roughness, phase transformation and fractography analyses were performed. SEM analysis showed that grinding increased the surface roughness and introduced defects in zirconia from both generations. Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 N < grinding: 1600 N), while these same outcomes were reduced by grinding for the third-generation zirconia significantly (control: 766.67 N > grinding: 620 N). Thus, clinical adjustments with diamond burs damage the fatigue behavior of adhesively cemented third-generation zirconia.",2020,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ",[],"['intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface', 'diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ']","['surface roughness and introduced defects in zirconia', 'Fatigue tests', 'fatigue failure load, number of cycles to failure and survival rates', 'fatigue behavior']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215012,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Bruna Dias', 'Initials': 'BD', 'LastName': 'Ilha', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: brunailha2@hotmail.com.'}, {'ForeName': 'Michele Mirian', 'Initials': 'MM', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: mmayodontologia@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103800']
32,32278029,"Addition of Chinese herbal remedy, Tongguan Capsules, to the standard treatment in patients with myocardial infarction improve the ventricular reperfusion and remodeling: Proteomic analysis of possible signaling pathways.","ETHNOPHARMACOLOGICAL RELEVANCE


Tongguan Capsules (TGC), a patented Chinese herbal remedy containing Salvia miltiorrhiza, Astragalus membranaceus, Borneolum syntheticum and Grasshopper, has been previously tested in the experimental model of animal hearts subjected to ischemia/reperfusion injury and its cardioprotective effect has been described.
AIM OF THE STUDY


This clinical trial was aimed at investigation whether the administration of TGC to patients suffered myocardial infarction (MI), would diminish dilation of the left ventricular (LV) and reduce development of the adverse clinical consequences.
METHODS


Eligible patients were enrolled and randomized 1:1 to TGC (4.5 g/d for 6 months) superimposed on standard treatment for MI, or the control group receiving the standard protocol alone. The outcomes of this trial were valued after 6 months and reported as a mean change from the baseline in LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia that required the additional therapy within 6 months. In addition, arrays with a panel of specific antibodies were used to assess levels of major cytokines and other pathophysiologic markers, that prompted conclusions about the mechanisms of the ultimate clinical outcomes in both patient's subgroups.
RESULTS


Meaningfully, obtained results indicated that MI patients randomly assigned to the TGC treatment, demonstrated a significant reduction of LVESVI (-4.03 ± 0.73 vs. 1.59 ± 0.43 mL/m 2 , P < 0.001) and a lower incidence of the major adverse cardiovascular events (5.45% vs. 11.44%, P = 0.033). Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis.
CONCLUSION


Addition of TGC to the current conventional treatment of MI patients, significantly reduced their adverse LV remodeling and contributed to the more positive clinical outcome.
TRIAL REGISTRATION


ChiCTR-IPR-17011618.",2020,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","['Eligible patients', 'patients with myocardial infarction', 'patients suffered myocardial infarction (MI']","['TGC', 'Chinese herbal remedy, Tongguan Capsules', 'standard treatment for MI, or the control group receiving the standard protocol alone']","['levels of markers of myocardial apoptosis and fibrosis', 'LVESVI', 'major adverse cardiovascular events', 'LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia', 'adverse LV remodeling', 'serum levels of major inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.109447,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Yuanshen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Qubo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Biological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112794']
33,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389']
34,32350810,Correction to: Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,In Methods section under Study Design and Patients.,2020,In Methods section under Study Design and Patients.,['Indian Men'],['Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions'],['Androgenetic Alopecia'],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",,0.0800492,In Methods section under Study Design and Patients.,"[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00381-z']
35,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
36,32354671,"HPV vaccine uptake among daughters of Latinx immigrant mothers: Findings from a cluster randomized controlled trial of a community-based, culturally relevant intervention.","OBJECTIVE


We examined the efficacy of a culturally relevant, community-based HPV vaccination intervention among Latinx immigrant mothers with daughters aged 9-12 in Alabama.
METHODS


We conducted a cluster-randomized controlled trial with ""place of residence"" (e.g., apartment complexes, trailer parks) as the unit of randomization that evaluated two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating and appropriate nutrition label interpretation. Identical baseline/post/7-month follow up questionnaires were completed by all participants and both interventions consisted of four group sessions and one individual session. A total of 40 locations were randomized with 317 mother-daughter dyads enrolled in the study between May 2013 and October 2017.
RESULTS


A total of 278 mother-daughter dyads met full eligibility and initiated the intervention/control participation. Retention rate overall was 93.2% (92.6% for the intervention arm and 93.7% for the control arm). Daughters in the intervention arm were significantly more likely to receive one, two, and three doses of HPV vaccine than daughters in the control arm p < 0.001). In multivariate analyses, mothers in the intervention arm had a six times greater odds of vaccinating daughters with the first dose (OR = 5.96, 95% CI: 3.38, 10.49), eight times greater odds of vaccinating daughters with the second dose (OR = 8.09, 95% CI: 4.0, 16.35), and more than 16 times greater odds of completing the three-dose HPV vaccine series than mothers in the control arm after adjusting for mother's age, time in the U.S., income, and daughter's health insurance status (OR = 16.5, 95% CI: 5.73, 47.48). Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1).
CONCLUSIONS


A theory-driven, culturally-relevant intervention developed through extensive formative assessments in collaboration with community members can effectively promote HPV vaccination among 9-12 years of age daughters of Latina immigrants.",2020,"Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1).
","['9-12\xa0years of age daughters of Latina immigrants', 'Latinx immigrant mothers with daughters aged 9-12 in Alabama', 'A total of 40 locations were randomized with 317 mother-daughter dyads enrolled in the study between May 2013 and October 2017', 'daughters of Latinx immigrant mothers', '278 mother-daughter dyads met full eligibility and initiated the intervention/control participation']","['HPV vaccination and 2) promotion of healthy eating and appropriate nutrition label interpretation', 'culturally relevant, community-based HPV vaccination intervention', 'HPV vaccine']","['Retention rate overall', 'HPV vaccine uptake']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]",40.0,0.112342,"Only perceived risk of their daughters' future HPV infection remained significant as a predictor of three-dose HPV vaccination completion (OR = 0.69, 95% CI: 0.23, 2.1).
","[{'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Scarinci', 'Affiliation': 'University of Alabama at Birmingham, Division of Preventive Medicine, 1717 11th Ave South, Birmingham, AL 35205, United States. Electronic address: scarinci@uab.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'University of Alabama at Birmingham, Division of Preventive Medicine, 1717 11th Ave South, Birmingham, AL 35205, United States. Electronic address: barbarahansen@uabmc.edu.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'University of Alabama at Birmingham, Division of Preventive Medicine, 1717 11th Ave South, Birmingham, AL 35205, United States. Electronic address: youngkim@uabmc.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.03.052']
37,32361220,Clinical impact of lung ultrasound monitoring for diagnosis of ventilator associated pneumonia: A diagnostic randomized controlled trial.,"PURPOSE


Studies have shown that lung-ultrasound may be superior to chest x-ray (CXR) in diagnosing ventilator-associated pneumonia (VAP). This study investigated whether the use of lung-ultrasound monitoring could detect VAP earlier and improve patient outcome.
METHODS


This was a single-center diagnostic randomized controlled trial. In the control group, VAP was diagnosed using a combination of CXR and clinical findings. In the intervention group, VAP was diagnosed using a combination of lung-ultrasound and clinical findings. The primary outcome measured was ventilator free days (VFD). Secondary outcomes were ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days.
RESULTS


We randomized intubated patients until 44 VAP diagnosis was made in each group. VFD was higher in the intervention group than in the control group (7.80+/- 9.7 days versus 3.7+/- 6.4 days, p = .044). There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
CONCLUSION


The use of lung-ultrasound monitoring for diagnosis of VAP improves patient outcome when compared to the standard diagnostic strategy that relies on CXR.",2020,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
",['diagnosis of ventilator associated pneumonia'],"['VAP', 'lung ultrasound monitoring', 'lung-ultrasound monitoring']","['ICU length of stay', 'delta SOFA', 'ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days', 'ICU mortality', 'antibiotic duration', 'ventilator free days (VFD', 'VFD']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.170703,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70).
","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal. Electronic address: saurabh_44@hotmail.com.'}, {'ForeName': 'Pramesh Sunder', 'Initials': 'PS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Gentle Sunder', 'Initials': 'GS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Moda Nath', 'Initials': 'MN', 'LastName': 'Marhatta', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.012']
38,32361223,Comparison of programmed intermittent epidural bolus and continuous epidural infusion for post-operative analgesia after major abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Few studies have compared continuous epidural infusion (CEI) against programmed intermittent epidural bolus (PIEB) epidural analgesia after major abdominal surgery. It has not been established whether the modality of epidural medication administration affects postoperative pain and other patient outcomes. The goal of this study was to compare the efficacy of PIEB against CEI in postoperative pain management after a broad range of surgeries with abdominal incisions, all managed in the context of an established enhanced recovery after surgery (ERAS) pathway.
DESIGN


Prospective, randomized, controlled trial.
SETTING


Postoperative acute care.
PATIENTS


120 patients scheduled for major surgery involving abdominal incisions with planned postoperative epidural analgesia were enrolled as study participants.
INTERVENTIONS


All subjects received a standardized epidural solution containing ropivacaine 0.0625% and fentanyl 2 μg/ml. The CEI group received this solution as a continuous infusion, while the PIEB group received this solution as programmed intermittent boluses.
MEASUREMENTS


The primary study outcome was the total local anesthetic used over the first 24 h post-operatively. Secondary outcomes included pain severity, pain interference, total opioid consumption, patient satisfaction, and adverse effects at 24, 48, and 72 h postoperatively.
MAIN RESULTS


There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB: 123 mg [Interquartile Range (IQR): 114-136]; CEI: 126 mg [IQR: 120-134]). There were also no differences in average pain severity, total opioid consumption, patient satisfaction, number of PCEA requests and incidence of adverse events at 24, 48, and 72 h postoperatively.
CONCLUSIONS


Our study suggests that within the context of an established ERAS program, PIEB and CEI modes of epidural analgesia can be equally efficacious and safe in providing postoperative analgesia after major abdominal surgery.",2020,There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB:,"['post-operative analgesia after major abdominal surgery', '120 patients scheduled for major surgery involving abdominal incisions with planned postoperative epidural analgesia were enrolled as study participants']","['PIEB against CEI', 'standardized epidural solution containing ropivacaine', 'continuous epidural infusion', 'CEI']","['total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB', 'total local anesthetic used over the first 24\xa0h post-operatively', 'average pain severity, total opioid consumption, patient satisfaction, number of PCEA requests and incidence of adverse events', 'pain severity, pain interference, total opioid consumption, patient satisfaction, and adverse effects']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0198488', 'cui_str': 'Abdomen incision'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",120.0,0.371242,There was no difference in the primary outcome of total amount of local anesthetic administered in the first 24-hour postoperative period (PIEB:,"[{'ForeName': 'Po-Yi Paul', 'Initials': 'PP', 'LastName': 'Su', 'Affiliation': 'University of California San Francisco, United States of America. Electronic address: paul.su@ucsf.edu.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Peniche', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Elle', 'Initials': 'E', 'LastName': 'Clelland', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ladd', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Lee-Lynn', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Siegmueller', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Latronica', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Naidu', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Aleshi', 'Affiliation': 'University of California San Francisco, United States of America.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Behrends', 'Affiliation': 'University of California San Francisco, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109850']
39,32361265,Randomised phase II trial of gemcitabine and nab-paclitaxel with necuparanib or placebo in untreated metastatic pancreas ductal adenocarcinoma.,"BACKGROUND


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


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


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


The addition of necuparanib to standard of care treatment for advanced PDAC did not improve OS. Safety was acceptable. No further development of necuparanib is planned although targeting the coagulation cascade pathway remains relevant in PDAC. NCT01621243.",2020,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","['One-hundred ten patients were randomised, 62 to necuparanib arm and 58 to', 'untreated metastatic pancreatic ductal adenocarcinoma (PDAC', 'Eligibility included 18 years, histologically or cytologically confirmed metastatic PDAC, measurable disease and Eastern Co-Operative Oncology Group performance status of 0-1', 'untreated metastatic pancreas ductal adenocarcinoma']","['gemcitabine/nab-paclitaxel', 'gemcitabine and nab-paclitaxel with necuparanib or placebo', 'necuparanib (5\xa0mg/kg subcutaneous injection once daily) or placebo (subcutaneous injection once daily) and gemcitabine/nab-paclitaxel', 'necuparanib or placebo to gemcitabine/nab-paclitaxel', 'placebo']","['median OS', 'haematologic toxicity', 'median overall survival (OS), and secondary end-points included median progression-free survival, response rates and safety', 'safety and oncologic signal']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",110.0,0.686627,"The necuparanib arm had a higher incidence of haematologic toxicity relative to placebo patients (83% and 70%).
","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. Electronic address: oreillye@mskcc.org.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barone', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Devalingam', 'Initials': 'D', 'LastName': 'Mahalingam', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic Cancer Center, Scottsdale, AZ, USA; ACCRU Research Consortium, Rochester, MN, USA.'}, {'ForeName': 'Spencer H', 'Initials': 'SH', 'LastName': 'Shao', 'Affiliation': 'Compass Oncology, Rose Quarter Cancer Center, Portland, OR, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Rosano', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology, US Oncology Research, 910 East Houston Street, Tyler, TX 71702, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roach', 'Affiliation': 'Momenta Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Ryan', 'Affiliation': 'Massachussetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.005']
40,32361279,Radial versus femoral access for percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: Trial sequential analysis.,"BACKGROUND


Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI).
METHODS


We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications.
RESULTS


A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm.
CONCLUSIONS


In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.",2020,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","['A total of 17 studies with 11,992 patients were included in the current TSA', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with ST-segment elevation myocardial infarction']","['TRA', 'transradial access (TRA) versus transfemoral access (TFA', 'percutaneous coronary intervention', 'Radial versus femoral access']","['MI and stroke', '30-day mortality, major bleeding, MACE and access site complication rates', '30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications', 'major bleeding', '30-day mortality', 'access site complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",11992.0,0.316525,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA. Electronic address: Mohammed.Osman@hsc.wvu.edu.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Khansa', 'Initials': 'K', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Babikir', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Regner', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Qais', 'Initials': 'Q', 'LastName': 'Radaideh', 'Affiliation': 'Division of Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Moreland', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Department of Cardiovascular Medicine, Cleveland Clinic, OH, USA.'}]",American heart journal,['10.1016/j.ahj.2020.03.014']
41,32299086,Young adults born preterm below 30 weeks of gestation and risk of QT tract prolongation.,,2020,,['Young adults born preterm below 30 weeks of gestation and risk of QT tract prolongation'],[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],[],,0.0253211,,"[{'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Bassareo', 'Affiliation': ""University College of Dublin, Mater Misericordiae University Hospital and Our Lady's Children's Hospital Crumlin, Dublin, Ireland. piercard@inwind.it.""}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Fanos', 'Affiliation': 'Neonatal Intensive Care Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mercuro', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}]",Pediatric research,['10.1038/s41390-020-0904-8']
42,32305659,The impact of state and dispositional mindfulness on prospective memory: A virtual reality study.,"Prospective memory (PM) consists of remembering to perform an action that was previously planned. The recovery and execution of these actions require attentional resources. Mindfulness, as a state or a dispositional trait, has been associated with better attentional abilities while mind wandering is linked with attentional failures. In this study, we investigated the impact of mindfulness on PM. Eighty participants learned 15 cue-action associations. They were, then, asked to recall the actions at certain moments (time-based items) or places (event-based items) during a walk in a virtual town. Before the PM task, participants were randomly assigned to a mindfulness or mind wandering (control condition) session. Dispositional mindfulness was measured via the Five Facets Mindfulness Questionnaire (FFMQ). Although considered as two opposite states, we did not report any difference between the two groups on PM abilities. Nevertheless, the natural tendency to describe one's own sensations (the Describing facet of the FFMQ) predicted time-based performance in both groups. We discuss different hypotheses to explain this finding in light of recent findings on the impact of mind wandering on future oriented cognition. Our main observation is a positive link between the Describing facet and time-based PM performances. We propose that this link could be due to the common association of this mindfulness facets and PM with attentional and interoceptive abilities. Additional studies are needed to explore this hypothesis.",2020,"Mindfulness, as a state or a dispositional trait, has been associated with better attentional abilities while mind wandering is linked with attentional failures.",['Eighty participants learned 15 cue-action associations'],['mindfulness or mind wandering (control condition) session'],"['Dispositional mindfulness', 'Five Facets Mindfulness Questionnaire (FFMQ', 'PM abilities']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",80.0,0.0266846,"Mindfulness, as a state or a dispositional trait, has been associated with better attentional abilities while mind wandering is linked with attentional failures.","[{'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Girardeau', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France. Electronic address: jean-charles.girardeau@parisdescartes.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Blondé', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Makowski', 'Affiliation': 'School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Abram', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Piolino', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France; Institut Universitaire de France (IUF), France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sperduti', 'Affiliation': 'Laboratoire Mémoire, Cerveau & Cognition (MC(2)Lab, EA7536), Institut de Psychologie, Université de Paris, Paris, France.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102920']
43,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
44,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
45,32352320,IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation.,"Hepatocellular carcinoma recurs in 70-80% of cases following potentially curative resection or ablation and the immune component of the liver microenvironment plays a key role in recurrence. Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1. Atezolizumab (PD-L1 inhibitor) plus bevacizumab (VEGF inhibitor) has been shown to significantly improve overall survival, progression-free survival and overall response rate in unresectable HCC. Dual PD-L1/VEGF blockade may be effective in reducing HCC recurrence by creating a more immune-favorable microenvironment. We describe the rationale and design of IMbrave 050 (NCT04102098), a randomized, open-label, Phase III study comparing atezolizumab plus bevacizumab versus active surveillance in HCC patients at high-risk of recurrence following curative resection or ablation. The primary end point is recurrence-free survival.  Clinical Trial Registration:  NCT04102098.",2020,Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1.,"['HCC patients at high-risk of recurrence following curative resection or ablation', 'high-risk hepatocellular carcinoma after curative resection or ablation']","['Dual PD-L1/VEGF blockade', 'Atezolizumab (PD-L1 inhibitor) plus bevacizumab (VEGF inhibitor', 'atezolizumab plus bevacizumab']","['overall survival, progression-free survival and overall response rate', 'HCC recurrence', 'recurrence-free survival']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",,0.0781475,Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1.,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Minshan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Cancer Center & National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kaseb', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology & Hepatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Han Chu', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Yopp', 'Affiliation': 'Department of Surgery, Division of Surgical Oncology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Pierce', 'Initials': 'P', 'LastName': 'Chow', 'Affiliation': 'Division of Surgical Oncology, National Cancer Centre, Singapore.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""PLA Cancer Center, People's Liberation Army (PLA) 81 Hospital, Nanjing 210016, PR China.""}]","Future oncology (London, England)",['10.2217/fon-2020-0162']
46,32353645,Effectiveness of simulation learning program for mastering public health nursing skills to enhance strength of community: A quasi-experimental design.,"PURPOSE


The purpose of this study is to develop a simulation learning program for mastering public health nursing skills to enhance strength of community, and to verify its effectiveness.
METHODS


The program is one-day session to master the skills from three exercises. This study adopts a quasi-experimental design. We selected unbiased 34 participants in intervention group and 30 participants in control group, and conducted self-administered questionnaire surveys at three points in time: pre, post 1 and post 2. Three tools were used to measure the required outcome. For the outcome evaluation, we calculated the changes in the mean value of each tool between pre and post 1 and between pre and post 2, and compared them between the two groups.
RESULTS


The change of intervention group in the total score at the post 1 stage from the pre stage was significantly higher than control group regarding each of the scales (P < .05).
CONCLUSIONS


The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.",2020,The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.,"['mastering public health nursing skills to enhance strength of community', '34 participants in intervention group and 30 participants in control group, and conducted self-administered questionnaire surveys at three points in time: pre, post 1 and post 2']",['simulation learning program'],['total score'],"[{'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0034023', 'cui_str': 'Nursing, Public Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439547', 'cui_str': 'Points in time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0086858', 'cui_str': 'Programmed Learning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.015403,The program was found to be effective in upgrading the skills of less-experienced public health nurses to enhance strength of community.,"[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Okamoto', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan. Electronic address: reiko@sahs.med.osaka-u.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Gouda', 'Affiliation': ""Faculty of Nursing and Rehabilitation, Konan Women's University, Japan.""}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Koide', 'Affiliation': 'Faculty of Nursing, Shitennouji University, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Tokimasa', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Kageyama', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Iwamoto', 'Affiliation': 'Faculty of Nursing, Kobe City College of Nursing, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Shiomi', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Kusano', 'Affiliation': 'Faculty of Nursing, Osaka Medical College, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Misaki', 'Initials': 'M', 'LastName': 'Kiya', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Aoki', 'Initials': 'A', 'LastName': 'Tada', 'Affiliation': 'Osaka University, Graduate School of Medicine, Division of Health Sciences, Japan.'}, {'ForeName': 'Hanayo', 'Initials': 'H', 'LastName': 'Koetaka', 'Affiliation': ""Faculty of Nursing and Rehabilitation, Konan Women's University, Japan.""}]",Nurse education today,['10.1016/j.nedt.2020.104432']
47,32353714,Music during image-guided breast biopsy reduces patient anxiety levels.,"PURPOSE


Interventions to decrease anxiety associated with image-guided breast biopsy are needed. Music intervention has been shown to be helpful in other outpatient procedural settings but data are limited regarding its effectiveness in the setting of breast biopsy. The purpose of this study was to determine whether listening to self-selected music during image-guided breast biopsy lowers anxiety.
MATERIALS AND METHODS


This randomized controlled trial was approved by the institutional review board and was HIPAA-compliant. 157 women between 18 and 75 (mean, 49.7 years) years of age, undergoing stereotactic or ultrasound-guided core biopsy, were enrolled in the study and were prospectively randomized to music or usual care. Patients in the music group listened to music of their choice during the biopsy. All patients completed the State Trait Anxiety Inventory (STAI) before and after the biopsy. Differences in pre-biopsy and post-biopsy anxiety levels were compared between the two groups using the Mann-Whitney U test.
RESULTS


Baseline trait anxiety scores in the two groups were similar (34.0 music, 31.5 control, p = .11). Patients in both groups showed lower state anxiety levels after the biopsy (45.6 to 34.3 music, 41.0 to 33.8 control, p < .001 for both). Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03). Post-biopsy anxiety levels were similar to normative values for working women in the same age group.
CONCLUSION


Listening to self-selected music reduces anxiety in patients undergoing breast biopsy.",2020,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","['patients undergoing breast biopsy', '157 women between 18 and 75 (mean, 49.7\xa0years) years of age, undergoing stereotactic or ultrasound-guided core biopsy']","['Music intervention', 'music or usual care', 'Listening to self-selected music', 'music group listened to music of their choice during the biopsy', 'Music during image-guided breast biopsy', 'listening to self-selected music during image-guided breast biopsy']","['anxiety', 'pre-biopsy and post-biopsy anxiety levels', 'state anxiety levels', 'Post-biopsy anxiety levels', 'Baseline trait anxiety scores', 'State Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",157.0,0.0640536,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","[{'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Bennett', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America. Electronic address: Debbie.bennett@health.slu.edu.'}, {'ForeName': 'J Shannon', 'Initials': 'JS', 'LastName': 'Swan', 'Affiliation': 'MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Gazelle', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America; MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saksena', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.018']
48,32353805,"Sugammadex versus neostigmine for reversal of rocuronium-induced neuromuscular blockade: A randomized, double-blinded study of thoracic surgical patients evaluating hypoxic episodes in the early postoperative period.","STUDY OBJECTIVE


This objective of this study was to determine if reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine results in a decreased number of hypoxic episodes in the early postoperative period in patients undergoing thoracic surgery with single lung ventilation.
DESIGN


Single-center, randomized, double-blind, two-arm clinical trial.
SETTING


Operating room and postanesthesia care unit.
PATIENTS


92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation.
INTERVENTIONS


Subjects received either 2 mg/kg sugammadex or 50 μg/kg neostigmine with 8 μg/kg glycopyrrolate for reversal of moderate neuromuscular blockade.
MEASUREMENTS


For the first 90 min postoperatively, all episodes of hypoxia were recorded. Neuromuscular monitoring was performed with acceleromyography (TOF-Watch® SX) and the train of four (TOF) was recorded at 2, 5, 10, and 15 min after administration of the neuromuscular reversal agent.
MAIN RESULTS


Subjects who received neostigmine had a median of 1 episode (interquartile range IQR: 0-2.2) of hypoxia versus subjects who received sugammadex who had a median of 0 episodes (IQR: 0-1) (p = 0.009). The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
CONCLUSIONS


In thoracic surgical patients necessitating single lung ventilation, sugammadex provides faster reversal of moderate neuromuscular blockade and results in a decreased number of postoperative hypoxic episodes compared with neostigmine.",2020,"The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
","['Operating room and postanesthesia care unit', 'patients undergoing thoracic surgery with single lung ventilation', '92 subjects aged ≥18, American Society of Anesthesiologists physical status II-IV, and undergoing a thoracic operation necessitating single lung ventilation', 'thoracic surgical patients evaluating hypoxic episodes in the early postoperative period', 'induced neuromuscular blockade']","['Sugammadex versus neostigmine', 'rocuronium', 'acceleromyography (TOF-Watch® SX', 'neostigmine', '2\xa0mg/kg sugammadex or 50\xa0μg/kg neostigmine with 8\xa0μg/kg glycopyrrolate', 'sugammadex versus neostigmine']","['episodes of hypoxia', 'hypoxic episodes', 'median of 1 episode', 'postoperative hypoxic episodes', 'mean time to recovery of TOF\xa0≥']","[{'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0524832', 'cui_str': 'Surgical procedure on thorax'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C3805242', 'cui_str': 'Acceleromyography'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",92.0,0.706447,"The mean time to recovery of TOF ≥ 0.9 was significantly faster with sugammadex at 10 min (95% confidence interval CI: 5-15) compared with neostigmine at 40 min (95% CI: 15-53) (p < 0.001).
","[{'ForeName': 'Tiffany S', 'Initials': 'TS', 'LastName': 'Moon', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA. Electronic address: Tiffany.Moon@UTSouthwestern.edu.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reznik', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Cardiovascular and Thoracic Surgery, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Pak', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Jan', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pruszynski', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Cardiovascular and Thoracic Surgery, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Katelynn M', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Lu', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gasanova', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Fox', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Ogunnaike', 'Affiliation': 'University of Texas Southwestern Medical Center, Department of Anesthesiology and Pain, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109804']
49,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION


Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users.
METHODS


ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms.
RESULTS


We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups.
CONCLUSIONS


A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434']
50,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
51,32361689,PECS II may reduce chronic pain after breast surgery: A propensity score based secondary analysis of the BREAST trial.,,2020,,['after breast surgery'],['PECS'],['chronic pain'],"[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0055065', 'cui_str': 'CEP combination'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.250447,,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Cassai', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy. Electronic address: alessandro.decassai@aopd.veneto.it.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bonanno', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Andreatta', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marchet', 'Affiliation': 'Day Surgery Multidisciplinare, Surgical Department, Azienda Ospedaliera Padova, Padova, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Feltracco', 'Affiliation': 'UOC Anesthesia and Intensive Care Unit, University Hospital of Padova, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Carron', 'Affiliation': 'Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, University of Padova, Padova, Italy.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109851']
52,32371183,Optimization of CT windowing for diagnosing invasiveness of adenocarcinoma presenting as sub-solid nodules.,"PURPOSE


To evaluate the optimal window setting to diagnose the invasiveness of lung adenocarcinoma in sub-solid nodules (SSNs).
METHODS


We retrospectively included 437 SSNs and randomly divided them 3:1 into a training group (327) and a testing group (110). The presence of a solid component was regarded as indicator of invasiveness. At fixed window level (WL) of 35 Hounsfield Units (HU), two readers adjusted the window width (WW) in the training group and recorded once a solid component appeared or disappeared on CT images acquired at 120 kVp. The optimal WW cut-off value to differentiate between invasive and pre-invasive lesions, based on the receiver operating characteristic (ROC) curve, was defined as ""core"" WW. The diagnostic performances of the mediastinal window setting (WW/WL, 350/35 HU) and core window setting were then compared in the testing group.
RESULTS


Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS)], 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA)]. In training group, the core WW of 1175 HU was the optimal cut-off to detect solid components of SSNs (AUC:0.79). In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
CONCLUSION


At 120 kVp, core window setting (WW/WL, 1175/35 HU) outperformed the traditional mediastinal window setting to diagnose the invasiveness of SSNs.",2020,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","['lung adenocarcinoma in sub-solid nodules (SSNs', 'Of the 437 SSNs, 88 were pre-invasive [17 atypical adenomatous hyperplasia (AAH) and 71 adenocarcinoma in situ (AIS', '437 SSNs', ' 349 were invasive [233 minimally invasive adenocarcinoma (MIA), 116 invasive adenocarcinoma (IA']",['CT'],"['sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness']","[{'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0334001', 'cui_str': 'Atypical glandular hyperplasia'}, {'cui': 'C0334000', 'cui_str': 'Glandular hyperplasia'}, {'cui': 'C0334276', 'cui_str': 'Adenocarcinoma in situ'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1301821', 'cui_str': 'Social security number'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}]",233.0,0.0224966,"In testing group, the sensitivity, specificity, positive, negative predictive value, and diagnostic accuracy for SSN invasiveness were 49.4%, 90.5%, 95.7%, 29.7%, and 57.3% for mediastinal window setting, and 87.6%, 76.2%, 91.6%, 76.2%, and 85.5% for core window setting.
","[{'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China; University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.""}, {'ForeName': 'Shuxuan', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Marjolein A', 'Initials': 'MA', 'LastName': 'Heuvelmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands; Medisch Spectrum Twente, Department of Pulmonology, Enschede, the Netherlands.'}, {'ForeName': 'Daiwei', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Yingru', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China.""}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands.'}, {'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dorrius', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Institute for Diagnostic Accuracy (iDNA) BV, Groningen, the Netherlands; University of Groningen, Faculty of Medical Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Geertruida H', 'Initials': 'GH', 'LastName': 'de Bock', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Vliegenthart', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Radiology, Groningen, the Netherlands.'}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre of Cancer, Key Laboratory of Cancer Prevention and Therapy, Department of Radiology, Tianjin, People's Republic of China. Electronic address: yezhaoxiang@163.com.""}]",European journal of radiology,['10.1016/j.ejrad.2020.108981']
53,32371199,Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.,"BACKGROUND


Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes.
DESIGN


The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed.
RESULTS


There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
CONCLUSIONS


Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation.
TRIAL REGISTRATION


ClinicalTrials.govNCT01913522.",2020,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
",['346 patients enrolled in'],"['implantable cardiac monitor', 'CIRCA-DOSE']","['AF burden, and post-ablation arrhythmia outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3879681', 'cui_str': 'Implantable cardiac monitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",346.0,0.0501133,"Patients objectively classified as ""Low Burden"" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as ""High Burden"" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence).
","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada; Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': 'Robert R J', 'Initials': 'RRJ', 'LastName': 'Yao', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada; Center for Cardiovascular Innovation, Vancouver, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Umjeet', 'Initials': 'U', 'LastName': 'Jolly', 'Affiliation': ""St. Mary's Hospital, Kitchener, Canada.""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'St. Boniface Hospital, Winnipeg, Canada.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Raymond', 'Affiliation': 'Centre Hospitalier Universitaire de Montreal, Université de Montréal, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Department of Medicine, Université Laval, Quebec, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Toronto General Hospital, University of Toronto, Toront006F, Canada.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Luong', 'Affiliation': 'Department of Medicine, University of British Columbia, Canada.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Glover', 'Affiliation': 'Sunnybrook Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.008']
54,32375676,Pacemaker detected active minutes are superior to pedometer-based step counts in measuring the response to physical activity counseling in sedentary older adults.,"BACKGROUND


In patients with permanent pacemakers (PPM), physical activity (PA) can be monitored using embedded accelerometers to measure pacemaker detected active hours (PDAH), a strong predictor of mortality. We examined the impact of a PA Counseling (PAC) intervention on increasing activity as measured by PDAH and daily step counts.
METHODS


Thirteen patients (average age 80 ± 6 years, 84.6% women) with implanted Medtronic PPMs with a ≤ 2 PDAH daily average were included in this study. Patients were randomized to Usual Care (UC, N = 6) or a Physical Activity Counseling Intervention (PACI, N = 7) groups. Step count and PDAH data were obtained at baseline, following a 12-week intervention, then 12 weeks after intervention completion. Data were analyzed using independent t-tests, Pearson's r, chi-square, and general linear models for repeated measures.
RESULTS


PDAH significantly differed by time point for all subject combined (P = 0.01) but not by study group. Subjects with baseline gait speeds of > 0.8 m/sec were responsible for the increases in PDAH observed. Step counts did not differ over time in the entire cohort or by study group. Step count and PDAH significantly correlated at baseline (r = 0.60, P = 0.03). This correlation disappeared by week 12.
CONCLUSION(S)


PDAH can be used to monitor PA and PA interventions and may be superior to hip-worn pedometers in detecting activity. A significant increase in PA, regardless of treatment group, suggests that patient awareness of the ability to monitor PA through a PPM increases PA in these patients, particularly in patients with gait speeds of < 0.8 m/sec.
TRIAL REGISTRATION


ClincalTrials.gov NCT03052829. Date of Registration: 2/14/2017.",2020,"RESULTS


PDAH significantly differed by time point for all subject combined (P = 0.01) but not by study group.","['Thirteen patients (average age 80\u2009±\u20096\u2009years, 84.6% women) with implanted Medtronic PPMs with a\u2009≤\u20092 PDAH daily average were included in this study', 'sedentary older adults', 'patients with permanent pacemakers (PPM), physical activity (PA']","['Usual Care (UC, N\xa0=\u20096) or a Physical Activity Counseling Intervention (PACI, N\xa0=\u20097) groups', 'physical activity counseling', 'PA Counseling (PAC) intervention']","['Step count and PDAH data', 'Step count and PDAH', 'PA']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0294036,"RESULTS


PDAH significantly differed by time point for all subject combined (P = 0.01) but not by study group.","[{'ForeName': 'Venkata K', 'Initials': 'VK', 'LastName': 'Puppala', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Hofeld', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Amberly', 'Initials': 'A', 'LastName': 'Anger', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Sudhi', 'Initials': 'S', 'LastName': 'Tyagi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': 'College of Health Sciences Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Marcie G', 'Initials': 'MG', 'LastName': 'Berger', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Kwang Woo', 'Initials': 'KW', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Widlansky', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA. mwidlans@mcw.edu.'}]",BMC geriatrics,['10.1186/s12877-020-01559-y']
55,32390201,Promoting positive development: Coaches as trainers in sports-based resilience programs.,"OBJECTIVE


To assess the efficacy of a train-the-trainer model for sporting coaches delivering a youth sports-based resilience program.
DESIGN


A quasi-experimental design was applied, with a pre-post comparison, utilising purposive sampling to take advantage of an existing naturally formed group.
SETTING AND PARTICIPANTS


A total of 11 coaches and 86 athletes involved in a community rowing program.
MAIN OUTCOME MEASURE(S)


Coaches responded to paper-based measures of resilience and knowledge/attitudes pre- and post-completion of a training workshop. Athletes responded to online measures of stress, efficacy and life satisfaction pre- and post-completion of a resilience program.
RESULTS


Following the completion of the train-the-trainer workshop, coaches reported significant increases in general knowledge and confidence in teaching resilience skills. Following the delivery of the resilience program, athlete self-efficacy and satisfaction with life scores were significantly higher, with significant reductions in reported stress for athletes trained by the varsity-level coaches.
CONCLUSION


There is support for investing in a train-the-trainer model for the delivery of a resilience skills program within a sports context. Caution is given to investing in the training and support of the coaches, particularly coaches with less coaching experience. These results are consistent with previous research and demonstrate support for coach-led resilience programs being effective in community settings, with implications for rural and remote locations.",2020,"Following the completion of the train-the-trainer workshop, coaches reported significant increases in general knowledge and confidence in teaching resilience skills.","['sporting coaches delivering a youth sports-based resilience program', 'A total of 11 coaches and 86 athletes involved in a community rowing program']",['train-the-trainer model'],"['general knowledge and confidence in teaching resilience skills', 'athlete self-efficacy and satisfaction with life scores']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0236552,"Following the completion of the train-the-trainer workshop, coaches reported significant increases in general knowledge and confidence in teaching resilience skills.","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Varela', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Hanrahan', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Policarpio', 'Initials': 'P', 'LastName': 'DeCano', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Clayton R', 'Initials': 'CR', 'LastName': 'Cook', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Barrett', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}]",The Australian journal of rural health,['10.1111/ajr.12626']
56,32382556,Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Dental Patients under General Anesthesia: A Randomised Clinical Trial.,"The aim of this study was to compare the effects of preoperative intranasal dexmedetomidine and oral midazolam on preoperative sedation and postoperative agitation in pediatric dentistry. A total of 60 children (ASA grade I, aged 3-6 years) scheduled for elective pediatric dental treatment were randomly divided into the dexmedetomidine (DEX) and midazolam (MID) groups. Ramsay sedation score, parental separation anxiety scale, mask acceptance scale, pediatric anesthesia emergence delirium scale, and hemodynamic parameters were recorded. The Ramsay sedation scale and hemodynamic parameters of the children were observed and recorded immediately before administration and 10, 20, and 30 min after administration. A satisfactory mask acceptance scale rate was 93.33% in both MID and DEX groups, and there was no significant difference between the two groups ( p  > 0.05). The proportions of children that ""successfully separated from their parents"" were 93.33% (MID) and 96.67% (DEX). No significant difference was found between the two groups ( p  > 0.05). The incidence of agitation was 20% in the MID group and 0% in the DEX group, and the difference was statistically significant ( p  < 0.05). Intranasal dexmedetomidine and oral midazolam provided satisfactory sedation. No significant difference between the two groups was found in terms of parental separation anxiety and mask acceptance ( p  > 0.05). The incidence of postoperative pediatrics emergence delirium was significantly lower in the DEX group ( p  < 0.05).",2020,No significant difference between the two groups was found in terms of parental separation anxiety and mask acceptance ( p  > 0.05).,"['pediatric dentistry', '60 children (ASA grade I, aged 3-6 years) scheduled for elective pediatric dental treatment', 'Pediatric Dental Patients under General Anesthesia']","['DEX', 'Intranasal Dexmedetomidine and Oral Midazolam', 'Intranasal dexmedetomidine', 'midazolam', 'dexmedetomidine', 'dexmedetomidine (DEX) and midazolam (MID']","['incidence of postoperative pediatrics emergence delirium', 'satisfactory sedation', 'incidence of agitation', 'Ramsay sedation scale and hemodynamic parameters', 'satisfactory mask acceptance scale rate', 'parental separation anxiety and mask acceptance', 'Ramsay sedation score, parental separation anxiety scale, mask acceptance scale, pediatric anesthesia emergence delirium scale, and hemodynamic parameters', 'preoperative sedation and postoperative agitation']","[{'cui': 'C0030763', 'cui_str': 'Pediatric dentistry'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003477', 'cui_str': 'Separation anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",60.0,0.0341515,No significant difference between the two groups was found in terms of parental separation anxiety and mask acceptance ( p  > 0.05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laoratory of Oral Biomedicine Ministry of Education, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laoratory of Oral Biomedicine Ministry of Education, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Tiejun', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laoratory of Oral Biomedicine Ministry of Education, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laoratory of Oral Biomedicine Ministry of Education, Wuhan University, Wuhan, Hubei 430079, China.'}]",BioMed research international,['10.1155/2020/5142913']
57,32382584,A Clinical Comparison of Failure Rates of Metallic and Ceramic Brackets: A Twelve-Month Study.,"Objective


Clinical comparison of the survival rates between stainless steel and ceramic brackets over a 12-month period.
Materials and Methods


The study involved 20 consecutive patients with diagnosed malocclusion that required two-arch fixed appliance treatment. The participants were randomly divided into two 10-member groups. Group 1 was treated with Abzil Agile (3M Unitek) stainless steel brackets; group 2 was treated with Radiance (American Orthodontics) monocrystalline ceramic brackets. All the brackets were bonded by the same operator. Over the next 12 months, all bracket failures were recorded with each appointment. The received data were processed statistically using the Mantel-Cox test, Kaplan-Meier method, and Cox hazard model.
Results


A total of 381 brackets were bonded, 195 of which were metallic brackets and 186 were ceramic ones. In the 12-month observation period, there were 14 metal (7.2%) and 2 ceramic bracket (1.1%) failures. The overall failure rate was 4.2% ( n  = 16). The majority of failures (14 brackets; 87.5%) occurred during the first 6 months of the experiment, 12 (83%) of which were metal brackets and 2 (100%) were ceramic brackets. The statistical analysis revealed significant differences between the groups ( p  < 0.05).
Conclusions


Metal brackets demonstrated significantly higher failure rates than ceramic brackets for both 6- and 12-month observation periods ( p  < 0.05). The 6% difference between the brackets is clinically significant as it corresponds to one additional failure within 12 months.",2020,"Conclusions


Metal brackets demonstrated significantly higher failure rates than ceramic brackets for both 6- and 12-month observation periods ( p  < 0.05).","['A total of 381 brackets were bonded, 195 of which were metallic brackets and 186 were ceramic ones', '20 consecutive patients with diagnosed malocclusion that required two-arch fixed appliance treatment']","['Abzil Agile (3M Unitek) stainless steel brackets', 'stainless steel and ceramic brackets', 'Radiance (American Orthodontics) monocrystalline ceramic brackets', 'Metallic and Ceramic Brackets']","['failure rates', 'overall failure rate', 'survival rates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",20.0,0.0499491,"Conclusions


Metal brackets demonstrated significantly higher failure rates than ceramic brackets for both 6- and 12-month observation periods ( p  < 0.05).","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Ogiński', 'Affiliation': 'Department of Maxillofacial Orthopaedics and Orthodontics, Division of Facial Abnormalities, Wrocław Medical University, Wrocław 50-425, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Kawala', 'Affiliation': 'Department of Maxillofacial Orthopaedics and Orthodontics, Wrocław Medical University, Wrocław 50-425, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Mikulewicz', 'Affiliation': 'Department of Maxillofacial Orthopaedics and Orthodontics, Division of Facial Abnormalities, Wrocław Medical University, Wrocław 50-425, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Antoszewska-Smith', 'Affiliation': 'Department of Maxillofacial Orthopaedics and Orthodontics, Wrocław Medical University, Wrocław 50-425, Poland.'}]",BioMed research international,['10.1155/2020/9725101']
58,32382685,Effectiveness and safety of intermittent preventive treatment for malaria using either dihydroartemisinin-piperaquine or artesunate-amodiaquine in reducing malaria related morbidities and improving cognitive ability in school-aged children in Tanzania: A study protocol for a controlled randomised trial.,"Background


In high transmission settings, up to 70% of school-aged children harbour malaria parasites without showing any clinical symptoms. Thus, epidemiologically, school aged children act as a substantial reservoir for malaria transmission. Asymptomatic  Plasmodium  infections induce inflammation leading to iron deficiency anaemia. Consequently, anaemia retards child growth, predisposes children to other diseases and reduces cognitive potential that could lead to poor academic performance. School aged children become increasingly more vulnerable as compared to those aged less than five years due to delayed acquisition of protective immunity. None of the existing Intermittent Preventive Treatment (IPT) strategies is targeting school-aged children. Here, we describe the study protocol of a clinical trial conducted in north-eastern Tanzania to expand the IPT by assessing the effectiveness and safety of two antimalarial drugs, Dihydroartemisinin-Piperaquine (DP) and Artesunate-Amodiaquine (ASAQ) in preventing malaria related morbidities in school-aged children (IPTsc) living in a high endemic area.
Methods/design


The trial is a phase IIIb, individual randomized, open label, controlled trial enrolling school children aged 5-15 years, who receive either DP or ASAQ or control (no drug), using a ""balanced block design"" with the ""standard of care"" arm as reference. The interventional treatments are given three times a year for the first year. A second non-interventional year will assess possible rebound effects. Sample size was estimated to 1602 school children (534 per group) from selected primary schools in an area with high malaria endemicity. Thick and thin blood smears (to measure malaria parasitaemia using microscope) were obtained prior to treatment at baseline, and will be obtained again at month 12 and 20 from all participants. Haemoglobin concentration using a haemoglobinometer (HemoCue AB, Sweden) will be measured four monthly. Finger-prick blood (dried bloodspot-DBS) prepared on Whatman 3 M filter paper, will be used for sub-microscopic malaria parasite detection usingPCR, detect markers of drug resistance (using next generation sequencing (NGS) technology), and malaria serological assays (using enzyme-linked immunosorbent assay, ELISA). To determine the benefit of IPTsc on cognitive and psychomotor ability test of everyday attention for children (TEA-Ch) and a '20 m Shuttle run' respectively, will be conducted at baseline, month 12 and 20. The primary endpoints are change in mean haemoglobin from baseline concentration and reduction in clinical malaria incidence at month 12 and 20 of follow up. Mixed design methods are used to assess the acceptability, cost-effectiveness and feasibility of IPTsc as part of a more comprehensive school children health package. Statistical analysis will be in the form of multilevel modelling, owing to repeated measurements and clustering effect of participants.
Discussion


Malaria intervention using IPTsc strategy may be integrated in the existing national school health programme. However, there is limited systematic evidence to assess the effectiveness and operational feasibility of this approach. School-aged children are easily accessible in most endemic malaria settings. The evidence from this study will guide the implementation of the strategy to provide complementary approach to reduce malaria related morbidity, anaemia and contribute to the overall burden reduction.
Trial registration


Clinicaltrials.gov: NCT03640403, registered on Aug 21, 2018, prospectively registered.Url https://www.clinicaltrials.gov/ct2/show/NCT03640403?term=NCT03640403&rank=1.",2020,School aged children become increasingly more vulnerable as compared to those aged less than five years due to delayed acquisition of protective immunity.,"['school-aged children', 'school-aged children (IPTsc) living in a high endemic area', 'school-aged children in Tanzania', 'children (TEA-Ch', 'school children aged 5-15 years, who receive either DP or ASAQ or control (no drug), using a ""balanced block design"" with the ""standard of care"" arm as reference', 'School-aged children', 'School aged children', '1602 school children (534 per group) from selected primary schools in an area with high malaria endemicity']","['existing Intermittent Preventive Treatment (IPT) strategies', 'antimalarial drugs, Dihydroartemisinin-Piperaquine (DP) and Artesunate-Amodiaquine (ASAQ', 'dihydroartemisinin-piperaquine or artesunate-amodiaquine', 'Finger-prick blood (dried bloodspot-DBS']","['Haemoglobin concentration', 'change in mean haemoglobin from baseline concentration and reduction in clinical malaria incidence', 'acceptability, cost-effectiveness and feasibility of IPTsc', 'cognitive ability']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0585653', 'cui_str': 'Test of everyday attention'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.233735,School aged children become increasingly more vulnerable as compared to those aged less than five years due to delayed acquisition of protective immunity.,"[{'ForeName': 'Geofrey', 'Initials': 'G', 'LastName': 'Makenga', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Baraka', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'Filbert', 'Initials': 'F', 'LastName': 'Francis', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'Swabra', 'Initials': 'S', 'LastName': 'Nakato', 'Affiliation': 'Global Health Institute, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Gesase', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Mtove', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'Rashid', 'Initials': 'R', 'LastName': 'Madebe', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Kyaruzi', 'Affiliation': 'College of Education (DUCE), University of Dar Es Salaam, Dar Es Salaam, Tanzania.'}, {'ForeName': 'Daniel T R', 'Initials': 'DTR', 'LastName': 'Minja', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'John P A', 'Initials': 'JPA', 'LastName': 'Lusingu', 'Affiliation': 'National Institute for Medical Research, Tanga Centre, Tanga, Tanzania.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Van Geertruyden', 'Affiliation': 'Global Health Institute, University of Antwerp, Antwerp, Belgium.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100546']
59,32382714,"A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in  Mycobacterium tuberculosis -uninfected adolescents in Cape Town, South Africa.","Background


Tuberculosis (TB) remains the leading cause of infectious disease-related death. Recently, a trial of BCG revaccination and vaccination with H4:IC31, a recombinant protein vaccine, in South African adolescents (Aeras C-040-404) showed efficacy in preventing sustained QuantiFERON (QFT) conversion, a proxy for  Mycobacterium tuberculosis  ( M.tb ) infection. A phase 1b trial of 84 South African adolescents was conducted, concurrent with Aeras C-040-404, to assess the safety and immunogenicity of H4:IC31, H56:IC31 and BCG revaccination, and to identify and optimize immune assays for identification of candidate correlates of protection in efficacy trials.
Methods


Two doses of H4:IC31 and H56:IC31 vaccines were administered intramuscularly (IM) 56 days apart, and a single dose of BCG (2-8 × 10 5  CFU) was administered intradermally (ID). T-cell and antibody responses were measured using intracellular cytokine staining and binding antibody assays, respectively. Binding antibodies and CD4+/CD8+ T-cell responses to H4- and H56-matched antigens were measured in samples from all participants. The study was designed to characterize safety and immunogenicity and was not powered for group comparisons. (Clinicaltrials.gov NCT02378207).
Findings


In total, 481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female). The vaccines were generally safe and well-tolerated, with no reported severe adverse events related to the study vaccines. H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies. The highest vaccine-induced CD4+ T-cell response rates were for those recognizing Ag85B in the H4:IC31 and H56:IC31 vaccinated groups. BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells, with no increase in H4- or H56-specific IgG binding antibodies. There were few antigen-specific CD8+ T-cell responses detected in any group.
Interpretation


BCG revaccination administered as a single dose ID and both H4:IC31 and H56:IC31 administered as 2 doses IM had acceptable safety profiles in healthy, QFT-negative, previously BCG-vaccinated adolescents. Characterization of the assays and the immunogenicity of these vaccines may help to identify valuable markers of protection for upcoming immune correlates analyses of C-040-404 and future TB vaccine efficacy trials.
Funding


NIAID and Aeras.",2020,H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies.,"['Mycobacterium tuberculosis -uninfected adolescents in Cape Town, South Africa', '84 South African adolescents', 'South African adolescents', '481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female']","['H4:IC31, H56:IC31, and BCG revaccination', 'H4:IC31 and H56:IC31 vaccines', 'H4:IC31 and H56:IC31', 'H4:IC31, a recombinant protein vaccine']","['antigen-specific CD8+ T-cell responses', 'severe adverse events', 'highest vaccine-induced CD4+ T-cell response rates', 'T-cell and antibody responses', 'BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells', 'safety and immunogenicity', 'safe and well-tolerated', 'H4- or H56-specific']","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034861', 'cui_str': 'Recombinant protein'}]","[{'cui': 'C0456981', 'cui_str': 'Specific antigen'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",84.0,0.0974093,H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies.,"[{'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'One', 'Initials': 'O', 'LastName': 'Dintwe', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Middelkoop', 'Affiliation': 'The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Randhawa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Ruhwald', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kromann', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Andersen', 'Affiliation': 'Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, United States.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Rutkowski', 'Affiliation': 'Aeras, Rockville, MD, United States.'}, {'ForeName': 'Dereck', 'Initials': 'D', 'LastName': 'Tait', 'Affiliation': 'Aeras, Cape Town, South Africa.'}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Seaton', 'Affiliation': 'Duke Human Vaccine Institute, Departments of Surgery, Immunology, and Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Departments of Surgery, Immunology, and Molecular Genetics and Microbiology, Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Ginsberg', 'Affiliation': 'Aeras, Rockville, MD, United States.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100313']
60,32380239,Effects of Partial Sleep Deprivation on Braking Response of Drivers in Hazard Scenarios.,"This study aimed at modeling the Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD). Fifty male participants drove the driving simulator in three experimental conditions: two test sessions and a baseline. The two test sessions were conducted after one and two nights of PSD (sleep = 4.25 ± 0.5 h), respectively. Sleep reduction was recorded using a wrist-worn Actiwatch. The baseline session was conducted after full rest (7-8 h sleep/day for a week). The order of test sessions and baseline was randomized. Each test included two hazard events: 1) pedestrians crossing a road and 2) parked vehicles merging into a roadway. Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings were also recorded during each drive. Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events. The models were chosen with clustered heterogeneity to account for intra-group heterogeneity due to repeated measures across tests. In the case of pedestrians crossing event, RT increased by 10% in the first test session and no significant effect observed on RT in the second test session. The overall TBT reduced by 25% and 28% during the first and second PSD sessions, respectively. In the case of vehicle merging event, both response time and total braking time delayed by 44% and 17% respectively after PSD. Other factors such as age, experience, work-rest hours, KSS and SSQ rating, often exercising, approaching speed and braking force were also found significant in the analysis. The parametric AFT approach adopted in this study showed the change in 'response time' and 'total braking time' concerning the type of hazard scenario and partial sleep-deprivation.",2020,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"['Fifty male participants', 'Drivers in Hazard Scenarios']",['Partial Sleep Deprivation'],"['Sleep reduction', 'response time and total braking time delayed', 'pedestrians crossing a road and 2) parked vehicles merging into a roadway', 'Karolinska Sleepiness Scale (KSS) and Sleepiness Symptoms Questionnaire (SSQ) ratings', 'overall TBT', 'Response Time (RT) and Total Braking Time (TBT) of drivers under Partial Sleep Deprivation (PSD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",50.0,0.023591,Four separate models using parametric accelerated failure time (AFT) with Weibull distribution were developed for RT and TBT in the two events.,"[{'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Mahajan', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India.'}, {'ForeName': 'Nagendra R', 'Initials': 'NR', 'LastName': 'Velaga', 'Affiliation': 'Transportation Systems Engineering, Department of Civil Engineering, Indian Institute of Technology (IIT) Bombay, Powai, Mumbai 400 076, India. Electronic address: n.r.velaga@iitb.ac.in.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105545']
61,32380260,Methodological and reporting issues in a randomised controlled trial: Comment on de la Fuente et al (2020).,,2020,,[],[],[],[],[],[],,0.0693986,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast BT9 7BL, United Kingdom. Electronic address: p.ohalloran@qub.ac.uk.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103585']
62,32380427,Differences in disease status between patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer: Exploratory analysis of the randomized phase III TRICS trial.,"BACKGROUND


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


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


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


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


UMIN 000002571.",2020,ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020).,"['advanced gastric cancer (AGC', 'patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer', '163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n\xa0=\xa055) or the early relapse (ER) group (n\xa0=\xa0108']",['Second-line chemotherapy (SLC'],"['adjusted median PFS', 'survival', 'ORR', 'performance status (PS) 0', 'adjusted median OS', 'incidence of adverse events', 'PFS and better ORR', 'overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",163.0,0.100949,ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020).,"[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006 Japan. Electronic address: kazuno13@hotmail.co.jp.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Graduate School of Medicine, Kurume University, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. Electronic address: kmurotani@med.kurume-u.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka, 558-0056 Japan. Electronic address: fujitani@gh.opho.jp.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Inagaki', 'Affiliation': 'Department of Surgery, Inagaki Clinic, 1-2-9, Nenohanacho, Owariasahi, 488-0002 Japan. Electronic address: h.inagaki@ina-cl.com.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, 563-8510 Japan. Electronic address: akamaru@ka3.so-net.ne.jp.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, 2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 Japan. Electronic address: t-shinya@d7.dion.ne.jp.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Surgery, Shizuoka General Hospital, 4-27-1, Kitaando, Aoi-ku, Shizuoka, 420-0881 Japan. Electronic address: masakazu-takagi@i.shizuoka-pho.jp.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryugecho, Yao, 581-0069 Japan. Electronic address: shigeyuki.tamura@hosp-yao.osaka.jp.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567 Japan. Electronic address: sugimoto-na2@mc.pref.osaka.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Gastroenterology, Saiseikai Shiga Prefectural Hospital, 2-4-1, Ohashi Ritto, 520-3046 Japan. Electronic address: bssjh242@yahoo.co.jp.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastric Surgery, The National Hospital Organization National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan. Electronic address: tayoshik@ncc.go.jp.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center,1981, Kamoda, Kawagoe, 350-0844 Japan. Electronic address: itoru@saitama-med.ac.jp.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Comprehensive Cancer Center, Aizawa Hospital, 2-5-1, Honjo, Matsumoto, 390-0814 Japan. Electronic address: geka-dr7@ai-hosp.or.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006 Japan. Electronic address: hasegawa.hiroko.yr@mail.hosp.go.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54, Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8397 Japan. Electronic address: smorita@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Miyashita', 'Affiliation': 'Data Center, Epidemiological & Clinical Research Information Network, 21-7, Shogoinsannocho, Sakyo-ku, Kyoto, 606-8392 Japan. Electronic address: miya@ecrin.or.jp.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuburaya', 'Affiliation': 'Department of Surgery, Ozawa Hospital, 1-1-17, Honcho, Odawara, 250-0012 Japan. Electronic address: tuburayaa@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, 4-6-2, Sohara Higashijimacho, Kakamigahara, 504-8601 Japan. Electronic address: sakamjun@tokaihp.jp.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Kaizuka City Hospital, 3-10-20, Hori, Kaizuka, 597-0015 Japan. Electronic address: tsujinaka@hosp.kaizuka.osaka.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.027']
63,32347804,Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.,"BACKGROUND


Mobile messaging is often used in behavioral weight loss interventions, yet little is known as to the extent to which they contribute to weight loss when part of a multicomponent treatment package. The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
OBJECTIVE


This study describes the use of MOST to develop a messaging intervention as a component to test as part of a weight loss treatment package in a subsequent optimization trial.
METHODS


On the basis of our conceptual model, a text message intervention was created to support self-regulation of weight-related behaviors. We tested the messages in the ENLIGHTEN feasibility pilot study. Adults with overweight and obesity were recruited to participate in an 8-week weight loss program. Participants received a commercially available self-monitoring smartphone app, coaching calls, and text messages. The number and frequency of text messages sent were determined by individual preferences, and weight was assessed at 8 weeks.
RESULTS


Participants (n=9) in the feasibility pilot study lost 3.2% of their initial body weight over the 8-week intervention and preferred to receive 1.8 texts per day for 4.3 days per week. Researcher burden in manually sending messages was high, and the cost of receiving text messages was a concern. Therefore, a fully automated push notification system was developed to facilitate sending tailored daily messages to participants to support weight loss.
CONCLUSIONS


Following the completion of specifying the conceptual model and the feasibility pilot study, the message intervention went through a final iteration. Theory and feasibility pilot study results during the preparation phase informed critical decisions about automation, frequency, triggers, and content before inclusion as a treatment component in a factorial optimization trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01814072; https://clinicaltrials.gov/ct2/show/NCT01814072.",2020,"The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
",['Adults with overweight and obesity were recruited to participate in an 8-week weight loss program'],"['commercially available self-monitoring smartphone app, coaching calls, and text messages']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0318916,"The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints.
","[{'ForeName': 'Angela Fidler', 'Initials': 'AF', 'LastName': 'Pfammatter', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Sara Hoffman', 'Initials': 'SH', 'LastName': 'Marchese', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}]",JMIR formative research,['10.2196/16297']
64,32348796,Food-based social comparisons influence liking and consumption.,"This study examined the effects of food-based social comparisons on hedonic ratings and consumption of a meal. Participants were randomly assigned to one of three experimental conditions in which they were led to believe that they got a worse meal, a better meal, or the same meal as another participant. They then tasted and rated their own meal. Subsequent liking and ad lib food consumption were measured. Participants who were told that another person got a better meal than they did (upward comparison) liked their meal less than if they were told that another person received either the same meal as they did or a worse meal (downward comparison). Similarly, participants who were in the upward comparison condition ate less food than if they were in the control or downward comparison conditions. Consumption was mediated by liking. The results suggest that being told that someone else is eating a meal that is higher or lower in hedonic value than one's own meal induces hedonic contrast and influences liking and consumption.",2020,"Participants were randomly assigned to one of three experimental conditions in which they were led to believe that they got a worse meal, a better meal, or the same meal as another participant.",['Participants who were told that another person got a better meal than they did (upward comparison) liked their meal less than if they were told that another person'],['food-based social comparisons'],"['hedonic contrast and influences liking and consumption', 'hedonic ratings and consumption of a meal', 'Subsequent liking and ad lib food consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",,0.0296622,"Participants were randomly assigned to one of three experimental conditions in which they were led to believe that they got a worse meal, a better meal, or the same meal as another participant.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Mills', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, M3J 1P3, Canada. Electronic address: jsmills@yorku.ca.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Polivy', 'Affiliation': 'Department of Psychology, University of Toronto, Toronto, ON, M3J 1P3, Canada.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Psychology, York University, Toronto, ON, M3J 1P3, Canada.'}]",Appetite,['10.1016/j.appet.2020.104720']
65,32348815,Addressing Chemophobia: Informational versus affect-based approaches.,"This study investigated the effect of two communication strategies (informational and affect-based) in reducing chemophobia, the irrational fear of chemicals. In an online experiment, participants (N = 448) were randomly assigned to one of three groups (""control"", ""knowledge"", or ""affect"" group). The following dependent variables were assessed: chemophobia, knowledge of basic toxicological principles, affect towards chemicals, benefit perception of the use of chemicals, and preference for natural substitutes in consumer products. The results showed that only the informational approach, which conveys knowledge of basic toxicological principles, significantly decreased chemophobia and the preference for natural substitutes in consumer products. The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia. This suggested that the provision of relevant information about basic toxicological principles is a more effective strategy than merely addressing laypeople's affect towards chemicals to reduce chemophobia. Relevant knowledge could be taught in schools or disseminated by toxicologists and scientists who are trusted by the public.",2020,"The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia.",['participants (N\u202f=\u202f448'],[],"['chemophobia, knowledge of basic toxicological principles, affect towards chemicals, benefit perception of the use of chemicals, and preference for natural substitutes in consumer products']",[],[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205472', 'cui_str': 'Toxicologic'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0596381', 'cui_str': 'Consumer product'}]",448.0,0.0278971,"The affect-based approach significantly increased positive affect towards chemicals and the benefit perception of their use, but did not decrease chemophobia.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Saleh', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland. Electronic address: rita.saleh@hest.ethz.ch.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bearth', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siegrist', 'Affiliation': 'Consumer Behavior, Institute for Environmental Decisions, ETH Zurich, Universitaetstrasse 22, 8092, Zurich, Switzerland.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111390']
66,32360392,A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder.,"BACKGROUND


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


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


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


These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.",2020,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"['children with fetal alcohol spectrum disorder', 'children with Fetal Alcohol Spectrum Disorders (FASD', 'children with FASD', '44 children with FASD']","['CT with either active or sham tDCS', 'transcranial direct current stimulation (tDCS) augmented cognitive training (CT', 'transcranial direct-current stimulation and cognitive training', 'tDCS', 'tDCS-augmented CT', 'CT', 'TDCS-augmented CT']","['feasibility and efficacy', 'trail making task', 'attention scores and decrease in parent-reported attention deficits', 'attention on a continuous performance test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.0938664,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Krueger', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'University of Maryland, USA.'}, {'ForeName': 'Mariah J', 'Initials': 'MJ', 'LastName': 'Schumacher', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Abhrajeet V', 'Initials': 'AV', 'LastName': 'Roy', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota, Twin Cities, USA. Electronic address: jwozniak@umn.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.04.015']
67,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS


People with type 2 diabetes (T2D) have a greater prevalence of musculoskeletal and neuropathic pain. This exploratory analysis investigated whether exercise of different intensities leads to changes in self-reported musculoskeletal pain or symptoms of diabetic neuropathy in inactive individuals with type 2 diabetes.
METHODS


Thirty-two inactive adults with T2D (59% male, mean age 58.7 ± 9.1yrs, median HbA 1c  7.8%) were randomised to usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT). At baseline and 8-weeks, musculoskeletal and neuropathic pain were evaluated using a modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively. Quantitative sensory testing was used to determine thermal, mechanical and vibration detection thresholds, as well as pain pressure thresholds. Adverse events were recorded throughout the intervention.
RESULTS


Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [-10.6 to -0.2], p = 0.04) and non-significantly greater for C-MICT (MD -5.9 [-12.4 to 0.7], p = 0.08). Changes in neuropathy symptoms were not different between C-HIIT and CON (MD 1.0 [-0.9 to 2.8], p = 0.31), or C-MICT and CON (MD 0.2 [-3.1 to 3.6], p = 0.89). No differences in sensory function were observed between groups. Similar rates of adverse events were seen in both exercise interventions (19 C-HIIT; 17 C-MICT), all but one of which were mild.
CONCLUSIONS


Preliminary data suggests 8-weeks of high-intensity combined aerobic and resistance exercise may be safely prescribed for inactive individuals with T2D and may reduce musculoskeletal pain but not neuropathic symptoms.
TRIAL REGISTRATION


ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c  7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168']
68,32311655,Randomized sketches for kernel CCA.,"Kernel canonical correlation analysis (KCCA) is a popular tool as a nonlinear extension of canonical correlation analysis. Consistency and optimal convergence rate have been established in the literature. However, the time complexity of KCCA scales as O(n 3 ) and is thus prohibitive when n is large. We propose an m-dimensional randomized sketches approach for KCCA with m<<n, based on the recent work on randomized sketches for kernel ridge regression (KRR). Technically we establish our theoretical results relying on an interesting connection between KCCA and KRR by utilizing a novel ""duality tracking"" device that alternates between the infinite-dimensional operator-theory-based view of KCCA and the finite-dimensional kernel-matrix-based view.",2020,"However, the time complexity of KCCA scales as O(n 3 ) and is thus prohibitive when n is large.",[],['Kernel canonical correlation analysis (KCCA'],[],[],"[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],,0.045723,"However, the time complexity of KCCA scales as O(n 3 ) and is thus prohibitive when n is large.","[{'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Lian', 'Affiliation': 'Department of Mathematics, City University of Hong Kong, Hong Kong; City University of Hong Kong Shenzhen Research Institute, Shenzhen, China. Electronic address: henglian@cityu.edu.hk.'}, {'ForeName': 'Fode', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Center of Statistical Research and School of Statistics, Southwestern University of Finance and Economics, Chengdu, 611130, China.'}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'School of Management, Fudan University, Shanghai, China; Department of Mathematics, City University of Hong Kong, Hong Kong.'}]",Neural networks : the official journal of the International Neural Network Society,['10.1016/j.neunet.2020.04.006']
69,32375104,Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial.,"BACKGROUND


Adverse cardiac remodeling is a major risk factor for the development of post myocardial infarction (MI) heart failure (HF). This study investigates the effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute ST-segment-elevation myocardial infarction (STEMI).
METHODS


In this double-blind, randomized, placebo-controlled trial patients with first STEMI were eligible. To preferentially enrich patients at high risk of adverse remodeling, main inclusion criteria were a left-ventricular ejection fraction (LVEF) ≤45% and an infarct size >10% on day 5 to 9 post MI as measured by cardiac MRI. Patients were then randomized to 6 months treatment with either 25 mg fulacimstat (n = 54) or placebo (n = 53) twice daily on top of standard of care starting day 6 to 12 post MI. The changes in LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI) from baseline to 6 months were analyzed by a central blinded cardiac MRI core laboratory.
RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity. Comparable changes in LVEF (fulacimstat: 3.5% ± 5.4%, placebo: 4.0% ± 5.0%, P = .69), LVEDVI (fulacimstat: 7.3 ± 13.3 mL/m 2 , placebo: 5.1 ± 18.9 mL/m 2 , P = .54), and LVESVI (fulacimstat: 2.3 ± 11.2 mL/m 2 , placebo: 0.6 ± 14.8 mL/m 2 , P = .56) were observed in both treatment arms.
CONCLUSION


Fulacimstat was safe and well tolerated in patients with left-ventricular dysfunction (LVD) after first STEMI but had no effect on cardiac remodeling.",2020,"RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.",['controlled trial patients with first STEMI were eligible'],"['chymase inhibitor fulacimstat', '25 mg fulacimstat (n\u202f=\u202f54) or placebo', 'placebo']","['safe and well tolerated and achieved mean total trough concentrations', 'safe and well tolerated', 'cardiac remodeling', 'adverse cardiac remodeling', 'LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.55485,"RESULTS


Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.","[{'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine, Cardiology, Charité-Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center, Durham, United States.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'Hadassah Hebrew University Hospital Ein Kerem, Heart Institute, Jerusalem, Israel.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Kettner', 'Affiliation': 'Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Shimony', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Experimental Medicine Cardiovascular, Bayer AG, Wuppertal, Germany. Electronic address: christiane.otto@bayer.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becka', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andres Iniguez', 'Initials': 'AI', 'LastName': 'Romo', 'Affiliation': 'Hospital Alvaro Cunqueiro, Servicio de la Cardiologia, Vigo, Spain.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Hasin', 'Affiliation': 'Shaare Zedek Medical Center, Department of Cardiology, Jerusalem, Israel.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': 'Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Gonzalo Calvo', 'Initials': 'GC', 'LastName': 'Rojas', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Division of Cardiology, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.012']
70,32375843,Effect of continuous nursing interventions on valve noise-related anxiety and quality of life in patients who underwent mechanical mitral valve replacement.,"OBJECTIVE


The purpose of this study was to evaluate the effect of continuous nursing interventions on valve noise-related anxiety in patients undergoing mechanical mitral valve replacement (MVR) and to analyze its impact on patient quality of life.
METHODS


Ninety patients who underwent mechanical MVR were divided into two groups. All patients in group A received routine nursing care. In addition to this intervention, an assigned nurse periodically provided patients in group B with continuous nursing interventions and ongoing health consultations during a 1-year follow-up. A hospital anxiety and depression (HAD) scale, a customized questionnaire and a Short Form Health Status 36 (SF-36) score questionnaire were used as the research tools.
RESULTS


The postoperative HAD scores were better in group B than in group A, but the differences in most of the data were not statistically significant between the groups, except for HA sections 0-7 and 11-21. Based on the customized questionnaire, the subjective disturbance level was significantly lower in group B than in group A (the results of Q1 and Q4 were statistically significant). With regard to the SF-36 scores, group B was superior to group A in general health, emotional function and mental health, while the other dimensions had no significant difference.
CONCLUSIONS


Compared with routine care, patients who received continuous care intervention after mechanical MVR had fewer anxiety symptoms and better quality of life.",2020,"With regard to the SF-36 scores, group B was superior to group A in general health, emotional function and mental health, while the other dimensions had no significant difference.
","['Ninety patients who underwent mechanical MVR', 'patients undergoing mechanical mitral valve replacement (MVR', 'patients who underwent mechanical mitral valve replacement']","['continuous nursing interventions', 'routine nursing care', 'continuous nursing interventions and ongoing health consultations']","['postoperative HAD scores', 'subjective disturbance level', 'general health, emotional function and mental health', 'anxiety symptoms and better quality of life', 'SF-36 scores', 'SF-36) score questionnaire', 'hospital anxiety and depression (HAD) scale', 'valve noise-related anxiety and quality of life']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]",90.0,0.0229273,"With regard to the SF-36 scores, group B was superior to group A in general health, emotional function and mental health, while the other dimensions had no significant difference.
","[{'ForeName': 'Qiu-Yu', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01117-y']
71,32381843,Adjunctive Effect of Doxycycline with Conventional Periodontal Therapy on Glycemic Level for Chronic Periodontitis with Type 2 Diabetes Mellitus Subjects.,"AIMS


This study aimed to assess the use of doxycycline in adjunct to periodontal therapy on the glycemic levels for chronic periodontitis patients with type 2 diabetes mellitus (DM).
MATERIALS AND METHODS


Fifty-one diabetic subjects with chronic periodontitis were selected and randomly assigned into 3 groups with 17 subjects each. Scaling and root planing (SRP) was done in group I, SRP and doxycycline was given in group II, and group III did not receive any periodontal treatment till 3 months. Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters were evaluated at baseline (day 0) and after 3 months (day 90). The statistical analysis was carried out using SPSS 17.0 software with significance fixed at 95% CI ( p  < 0.05).
RESULTS


The mean difference between baseline and day 90 for all periodontal parameters was significantly higher ( p  < 0.01) in group I and group II compared to control (group III). The metabolic parameters such as fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), and glycated hemoglobin (HbA1c%) level were reduced in groups I and II compared to group III; however, only HbA1c% values were found significantly reduced ( p  < 0.01) at day 90. Group II showed significantly better metabolic parameters than group I at day 90.
CONCLUSION


The adjunct of doxycycline to conventional periodontal therapy provides additional benefit in reducing glycemic level and improves periodontal health.
CLINICAL SIGNIFICANCE


The prevalence of diabetes as well as periodontitis is increasing nowadays in the world. With treatment of periodontitis, it is found that there is reduction of glycemic level in diabetes. So it is an alert to health professionals about the relation of diabetes and periodontitis and so that they conduct a multidisciplinary treatment.",2019,"Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters were evaluated at baseline (day 0) and after 3 months (day 90).","['Chronic Periodontitis with Type 2 Diabetes Mellitus Subjects', 'chronic periodontitis patients with type 2 diabetes mellitus (DM', 'Fifty-one diabetic subjects with chronic periodontitis']","['doxycycline', 'Scaling and root planing (SRP', 'SRP and doxycycline', 'Doxycycline with Conventional Periodontal Therapy', 'periodontal therapy']","['glycemic levels', 'fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), and glycated hemoglobin (HbA1c%) level', 'Glycemic Level', 'metabolic parameters', 'Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters', 'glycemic level and improves periodontal health']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",51.0,0.0174445,"Probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and metabolic parameters were evaluated at baseline (day 0) and after 3 months (day 90).","[{'ForeName': 'Abhaya C', 'Initials': 'AC', 'LastName': 'Das', 'Affiliation': ""Department of Periodontics and Oral Implantology, Institute of Dental Sciences, Siksha 'O' Anusandhan (Deemed to be university), Bhubaneswar, Odisha, India, Phone: +91 9437088379, e-mail: drabhaya2011@gmail.com.""}, {'ForeName': 'Swarga J', 'Initials': 'SJ', 'LastName': 'Das', 'Affiliation': 'Department of Periodontics and Oral Implantology, Regional Dental College, Guwahati, Assam, India.'}, {'ForeName': 'Saurav', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': ""Department of Periodontics and Oral Implantology, Institute of Dental Sciences, Siksha 'O' Anusandhan (Deemed to be university), Bhubaneswar, Odisha, India.""}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Endocrinology, Gauhati Medical College, Guwahati, Assam, India.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Taschieri', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, IRCCS Galeazzi Orthopedic Institute, Milan, Lombardia, Italy.'}, {'ForeName': 'Massimo D', 'Initials': 'MD', 'LastName': 'Fabbro', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences, IRCCS Galeazzi Orthopedic Institute, Milan, Lombardia, Italy.'}]",The journal of contemporary dental practice,[]
72,32381845,Effect of Vitamin D on Canine Distalization and Alveolar Bone Density Using Multi-slice Spiral CT: A Randomized Controlled Trial.,"AIM


The aim of this split-mouth, blinded randomized controlled trial was to evaluate the clinical and radiographic effects of locally delivered 1,25 dihydroxycholecalciferol (1,25 DHC) on the amount of canine distalization.
MATERIALS AND METHODS


Fifteen patients between age groups of 15 years to 30 years willing to undergo orthodontic treatment in a dental college participated in the study. A computer-generated randomization list was generated to divide the maxillary arch into experimental side and control side. Allocation concealment was applied. Canine distalization was initiated using nickel-titanium (NiTi) closed coil springs delivering a force of 150 g per side, which was attached to the maxillary first molar tube and canine hook. Local periodontal gel injection of 1,25 DHC was given on the experimental side and placebo gel on the control side at distal side of the maxillary canine at monthly interval, respectively. Patients were evaluated from beginning (T 0 ), 4 weeks (T 1 ), 8 weeks (T 2 ), and 12 weeks (T 3 ). CT scans were taken at T 0  and T 3  to measure the changes in bone density. The difference in amount of canine distalization and the changes in bone density were assessed on the experimental and control sides, respectively. Descriptive statistics and paired  t  test were used to determine any differences.
RESULTS


The results showed statistically significant increase in the amount of canine distalization and decrease in cancellous bone density on the experimental side when compared to control side.
CONCLUSION


The active form of vitamin D can be an effective agent to accelerate orthodontic tooth movement (OTM).
CLINICAL SIGNIFICANCE


This study provides a new insight into the scope of vitamin D in clinical orthodontics and its innovative method of application to accelerate tooth movement in patients will revolutionize treatment as well as open newer boundaries in orthodontic research at a biomolecular level.",2019,"The results showed statistically significant increase in the amount of canine distalization and decrease in cancellous bone density on the experimental side when compared to control side.
",['Fifteen patients between age groups of 15 years to 30 years willing to undergo orthodontic treatment in a dental college participated in the study'],"['vitamin D', 'Vitamin D', '1,25 dihydroxycholecalciferol (1,25 DHC', 'placebo gel']","['bone density', 'Canine Distalization and Alveolar Bone Density', 'amount of canine distalization', 'cancellous bone density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",15.0,0.0640305,"The results showed statistically significant increase in the amount of canine distalization and decrease in cancellous bone density on the experimental side when compared to control side.
","[{'ForeName': 'Sanju T', 'Initials': 'ST', 'LastName': 'Varughese', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Malabar Dental College and Research Centre, Edappal, Kerala, India, Phone: +91 9847372051, e-mail: santhoms18@gmail.com.'}, {'ForeName': 'Pavithra U', 'Initials': 'PU', 'LastName': 'Shamanna', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Sri Hasanamba Dental College and Hospital, Hassan, Karnataka, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Goyal', 'Affiliation': 'Dental Department, Panchkula Welfare Trust, Panchkula, Haryana, India.'}, {'ForeName': 'Beenu S', 'Initials': 'BS', 'LastName': 'Thomas', 'Affiliation': 'Department of Prosthodontics, Malabar Dental College and Research Centre, Edappal, Kerala, India.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Lakshmanan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Malabar Dental College and Research Centre, Edappal, Kerala, India.'}, {'ForeName': 'Venith J', 'Initials': 'VJ', 'LastName': 'Pulikkottil', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Malabar Dental College and Research Centre, Edappal, Kerala, India.'}, {'ForeName': 'Mohammed G', 'Initials': 'MG', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pharmacology, Yenepoya College of Pharmacy and Research Centre, Yenepoya University, Mangaluru, Karnataka, India.'}]",The journal of contemporary dental practice,[]
73,32381847,Evaluation of Different Pretreatment Efficacy with Fluoride-releasing Material on Shear Bond Strength of Orthodontic Bracket: An  In Vitro  Study.,"AIM


The aim of this study was to assess the efficacy of different pretreatments with fluoride-releasing material on shear bond strength (SBS) of orthodontic bracket.
MATERIALS AND METHODS


A total of 60 human mandibular premolars were taken in this study. These samples were stored in periodically changed distilled water at room temperature so as to stop bacterial growth. All samples were randomized to three pretreatment groups: group I, acid etching; group II, fluoride varnish; group III, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste. Later, Transbond XT was applied on brackets made of stainless steel and brackets were centered buccally and then light-cured. The INSTRON universal machine was used to measure SBS. Based on the values, the adhesive remnant index (ARI) was estimated.
RESULTS


The maximum SBS was seen in group III (18.84 μ 1.04), followed by group II (14.18 μ 0.23), and the minimum bond strength was found in group I (13.90 μ 1.22). The one-way analysis of variance (ANOVA) showed high statistically significant difference within the pretreatment groups. The pretreatment group comparisons showed statistically significant difference between group I vs group III and group II vs group III. Score 0 was more in group III [8 (40%)] followed by group II [4 (20%)] and group I [2 (10%)]. The lowest number of score 3 was found in CPP-ACP paste group. After comparing the ARI scores within the groups, the Chi-square test showed a probability of 0.001 which was statistically significant.
CONCLUSION


Our study established that the CPP-ACP paste pretreatment improves the SBS of orthodontic bracket significantly followed by fluoride varnish and acid etching.
CLINICAL SIGNIFICANCE


The bond strength of orthodontic brackets that were bonded should be adequate to resist orthodontic forces applied during treatment. The effect of the adhesive material to improve the adequate bond strength depends on the efficient pretreatment methods.",2019,"The maximum SBS was seen in group III (18.84 μ 1.04), followed by group II (14.18 μ 0.23), and the minimum bond strength was found in group","['60 human mandibular premolars', 'Orthodontic Bracket']","['fluoride-releasing material', 'CPP-ACP paste', 'fluoride varnish; group III, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste', 'Fluoride-releasing Material', 'acid etching']","['SBS of orthodontic bracket', 'minimum bond strength', 'ARI scores', 'adhesive remnant index (ARI', 'shear bond strength (SBS', 'maximum SBS']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",60.0,0.0181436,"The maximum SBS was seen in group III (18.84 μ 1.04), followed by group II (14.18 μ 0.23), and the minimum bond strength was found in group","[{'ForeName': 'Nitin R', 'Initials': 'NR', 'LastName': 'Khargekar', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, NSVK Sri Venkateshwara Dental College and Hospital, Bengaluru, Karnataka, India, Phone: +91 9448647970, e-mail: nkhargekar@yahoo.co.in.'}, {'ForeName': 'Jubin H', 'Initials': 'JH', 'LastName': 'Kalathingal', 'Affiliation': 'Kings Dental Center, Qatar.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sam', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, Prince Sattam Bin Abdul Aziz University, Al-Kharj, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Elpatal', 'Affiliation': 'Department of Pedodontics and Oral Health, College of Dentistry, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Sadananda', 'Initials': 'S', 'LastName': 'Hota', 'Affiliation': 'Department of Prosthodontics, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Purnendu', 'Initials': 'P', 'LastName': 'Bhushan', 'Affiliation': 'Department of Prosthodontics, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Bhubaneswar, Odisha, India.'}]",The journal of contemporary dental practice,[]
74,32383125,Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial.,"BACKGROUND


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


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


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


clinicaltrials.gov (NCT04308668); registered 16 March, 2020.",2020,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'symptomatic outpatients with COVID-19 showing symptoms for less than four days', '1,500 patients each for the PEP and PET trials']","['hydroxychloroquine or placebo', 'Post-exposure prophylaxis or pre-emptive therapy', 'hydroxychloroquine', 'hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET', 'placebo']","['incidence of symptomatic COVID-19', 'ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1500.0,0.697151,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"[{'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada. slother@manitoba-physicians.ca.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Agostinis', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases & Medical Microbiology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics and Child Health, Department of Pharmacology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'Critical Care Research, St-Boniface Hospital, Winnipeg, MB, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Schwartz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Centre, Population Health and Optimal Health Practices Research Unit Trauma - Emergency - Critical Care Medicine, Université Laval, Quebec, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01684-7']
75,32379637,Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study.,"BACKGROUND


Different degrees of disorders are reported in respiratory function, physical function and psychological function in patients with corona virus disease 2019 (COVID-19), especially in elderly patients. With the experience of improved and discharged COVID-19 patients, timely respiratory rehabilitation intervention may improve prognosis, maximize functional preservation and improve quality of life (QoL), but there lacks of studies worldwide exploring the outcome of this intervention.
OBJECTIVE


To investigate the effects of 6-week respiratory rehabilitation training on respiratory function, QoL, mobility and psychological function in elderly patients with COVID-19.
METHODS


This paper reported the findings of an observational, prospective, quasi-experimental study, which totally recruited 72 participants, of which 36 patients underwent respiratory rehabilitation and the rest without any rehabilitation intervention. The following outcomes were measured: pulmonary function tests including plethysmography and diffusing lung capacity for carbon monoxide (DLCO), functional tests (6-min walk distance test), Quality of life (QoL) assessments (SF-36 scores), activities of daily living (Functional Independence Measure, FIM scores), and mental status tests (SAS anxiety and SDS depression scores).
RESULTS


After 6 weeks of respiratory rehabilitation in the intervention group, there disclosed significant differences in FEV1(L), FVC(L), FEV1/FVC%, DLCO% and 6-min walk test. The SF-36 scores, in 8 dimensions, were statistically significant within the intervention group and between the two groups. SAS and SDS scores in the intervention group decreased after the intervention, but only anxiety had significant statistical significance within and between the two groups.
CONCLUSIONS


Six-week respiratory rehabilitation can improve respiratory function, QoL and anxiety of elderly patients with COVID-19, but it has little significant improvement on depression in the elderly.",2020,"CONCLUSIONS


Six-week respiratory rehabilitation can improve respiratory function, QoL and anxiety of elderly patients with COVID-19, but it has little significant improvement on depression in the elderly.","['elderly patients with COVID-19', '72 participants, of which 36 patients underwent respiratory rehabilitation and the rest without any rehabilitation intervention', 'patients with corona virus disease 2019 (COVID-19), especially in elderly patients']",['respiratory rehabilitation training'],"['SAS and SDS scores', 'quality of life (QoL', 'respiratory function, QoL, mobility and psychological function', 'respiratory function, QoL and anxiety', 'SF-36 scores', 'pulmonary function tests including plethysmography and diffusing lung capacity for carbon monoxide (DLCO), functional tests (6-min walk distance test), Quality of life (QoL) assessments (SF-36 scores), activities of daily living (Functional Independence Measure, FIM scores), and mental status tests (SAS anxiety and SDS depression scores', 'FEV1(L), FVC(L), FEV1/FVC%, DLCO% and 6-min walk test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3160837', 'cui_str': 'Walking distance test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",36.0,0.0321073,"CONCLUSIONS


Six-week respiratory rehabilitation can improve respiratory function, QoL and anxiety of elderly patients with COVID-19, but it has little significant improvement on depression in the elderly.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Geriatric Center, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, PR China.'}, {'ForeName': 'Weitong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, PR China.'}, {'ForeName': 'Yadong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medcine, Huanggang Central Hospital, Hubei Province. Huanggang, 438000, PR China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medcine, Huanggang Central Hospital, Hubei Province. Huanggang, 438000, PR China.'}, {'ForeName': 'Yunqian', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Geriatric Center, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Laboratory, Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University), Haikou, 570311, China. Electronic address: hkchenying@126.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101166']
76,32381037,Correction to: Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden.,"Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.",2020,"Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.",[],['fluoxetine'],[],[],"[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]",[],,0.0426855,"Following publication of the original article [1], we were notified that one of the corresponding author's affiliations was omitted.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lundström', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Akademiska, Sjukhuset, SE-751 85, Uppsala, Sweden. erik.lundstrom@neuro.uu.se.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Isaksson', 'Affiliation': 'Department of Clinical Neuroscience, Neurology, Karolinska Institutet, Nobels väg 6, SE-171 76, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Näsman', 'Affiliation': 'Centre for Safety Research, KTH Royal Institute of Technology, TR10 B, SE-100 44, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Wester', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Mårtensson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences, Lund, Neurology, Skåne University Hospital, Lund University, SE-221 85, Lund, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Wallén', 'Affiliation': 'Department of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Borg', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'Royal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': 'Royal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Sunnerhagen', 'Affiliation': 'Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04327-w']
77,32384122,Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.,"BACKGROUND


In the primary analysis of a 12-month double-blind randomized active placebo-controlled trial, treatment of children with cystic fibrosis (CF) and pancreatic insufficiency (PI) with a readily absorbable structured lipid (Encala™, Envara Health, Wayne, PA) was safe, well-tolerated and improved dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA).
OBJECTIVE


To determine if the Encala™ treatment effect varied by severity of baseline fat malabsorption.
METHODS


Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a calorie and macronutrient-matched placebo were included in this subgroup analysis. Subjects were categorized by median baseline CFA: low CFA (<88%) and high CFA (≥88%). At baseline and 3-month evaluations, CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores were calculated. Fasting plasma fatty acid (FA) concentrations were also measured.
RESULTS


Subjects in the low CFA subgroup had significantly improved CFA (+7.5±7.2%, mean 86.3±6.7, p = 0.002), and reduced stool fat loss (-5.7±7.2 g/24 hours) following three months of EncalaTM treatment. These subjects also had increased plasma linoleic acid (+20%), α-linolenic acid (+56%), and total FA (+20%) (p≤0.005 for all) concentrations and improvements in HAZ (0.06±0.08), WAZ (0.17±0.16), and BMIZ (0.20±0.25) (p≤0.002 for all). CFA and FA were unchanged with placebo in the low CFA group, with some WAZ increases (0.14±0.24, p = 0.02). High CFA subjects (both placebo and Encala™ groups) had improvements in WAZ and some FA.
CONCLUSIONS


Subjects with CF, PI and more severe fat malabsorption experienced greater improvements in CFA, FA and growth after three months of Encala™ treatment. Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.",2020,"Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.","['children with cystic fibrosis', 'children with cystic fibrosis (CF) and pancreatic insufficiency (PI', 'Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a']","['calorie and macronutrient-matched placebo', 'WAZ', 'placebo']","['residual fat malabsorption and growth', 'plasma linoleic acid', 'safe, well-tolerated and efficacious', 'Fasting plasma fatty acid (FA) concentrations', 'CFA', 'total FA', 'CFA and FA', 'CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores', 'concentrations and improvements in HAZ', 'dietary energy absorption, weight gain and FA status', 'stool fat loss', 'dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA', 'CFA, FA and growth', 'α-linolenic acid']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030293', 'cui_str': 'Pancreatic insufficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0554103', 'cui_str': 'Intestinal malabsorption of fat'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0443214', 'cui_str': 'Fat absorption'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}]",,0.119462,"Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Mascarenhas', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232685']
78,32384676,"A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy.","Leber hereditary optic neuropathy (LHON) is an intractable disease associated with mitochondrial DNA (mtDNA) mutations. In this preliminary, single-arm, prospective, open-label exploratory trial, we investigated the effectiveness and safety of skin electrical stimulation (SES) for cases of LHON harboring the mtDNA 11,778 mutation. Of the 11 enrolled patients, 10 completed six sessions of SES once every two weeks over a 10-week period. The primary outcome measure was the change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA) at one week after the last session of SES. The main secondary outcome measures were the logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities at one, four, and eight weeks. At all follow-up points, the logMAR BCVA had improved significantly from baseline (1.74 ± 0.13 at baseline, 1.66 ± 0.20 at one week, 1.65 ± 0.21 at four weeks, and 1.66 ± 0.20 at eight weeks;  p  < 0.05). At eight weeks of follow-up, five patients showed >2-fold increase in the summed sensitivity at 52 measurement points from baseline. No adverse effects were observed. In conclusion, SES could be a viable treatment option for patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation.",2020,No adverse effects were observed.,"['11 enrolled patients', 'Leber Hereditary Optic Neuropathy', 'cases of LHON harboring the mtDNA 11,778 mutation', 'patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation']","['SES', 'Skin Electrical Stimulation', 'skin electrical stimulation (SES']","['logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities', 'summed sensitivity', 'change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA', 'logMAR BCVA', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917796', 'cui_str': ""Leber's optic atrophy""}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0430866', 'cui_str': 'Humphrey perimeter plot'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",11.0,0.0623657,No adverse effects were observed.,"[{'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Kurimoto', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Seiko', 'Initials': 'S', 'LastName': 'Kamada', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yamada-Nakanishi', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Matsumiya', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051359']
79,32384719,"A Low-Glycemic Index, High-Fiber, Pulse-Based Diet Improves Lipid Profile, but Does Not Affect Performance in Soccer Players.","Pulses (i.e., lentils, chickpeas, beans, peas) are low-glycemic index, high-fiber foods that are beneficial for improving blood lipids. Young soccer players typically have low dietary fiber intake, perhaps because of concerns regarding gastro-intestinal problems during exercise performance. Twenty-seven (17 females) soccer players were randomized to receive a pulse-based diet or their regular diet for four weeks in a cross-over study and evaluated for changes in blood lipids and athletic performance, with 19 (22 ± 6y; 12 females) completing the study (eight participants withdrew because of lack of time). Women increased high density lipoproteins (+0.5 ± 0.7 vs. -0.6 ± 0.3 mmol/L;  p  < 0.01) and reduced total cholesterol to high density lipoprotein ratio (-2.4 ± 2.9 vs. +2.6 ± 2.2;  p  < 0.01) on the pulse-based vs. regular diet, respectively, while there were no differences between diet phases in men. Athletic performance assessed by distance covered during games by a global positioning system was not significantly different during the pulse-based vs. regular diet (9180 ± 1618 vs. 8987 ± 1808 m per game;  p  = 0.35). It is concluded that a pulse-based diet can improve blood lipid profile without affecting athletic performance in soccer players.",2020,Athletic performance assessed by distance covered during games by a global positioning system was not significantly different during the pulse-based vs. regular diet (9180 ± 1618 vs. 8987 ± 1808 m per game;  ,"['Young soccer players', 'Twenty-seven (17 females) soccer players', 'soccer players', 'Soccer Players']",['pulse-based diet or their regular diet'],"['high density lipoproteins', 'blood lipid profile', 'total cholesterol to high density lipoprotein ratio']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0192598,Athletic performance assessed by distance covered during games by a global positioning system was not significantly different during the pulse-based vs. regular diet (9180 ± 1618 vs. 8987 ± 1808 m per game;  ,"[{'ForeName': 'Eliran', 'Initials': 'E', 'LastName': 'Mizelman', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Hanifi', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5A2, Canada.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brenna', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5A2, Canada.'}]",Nutrients,['10.3390/nu12051324']
80,32384727,Benefits of a Three-Day Bamboo Forest Therapy Session on the Physiological Responses of University Students.,"Studies have indicated that natural environments have the potential to improve the relationship between a stressful life and psychological well-being and physical health. Forest therapy has recently received widespread attention as a novel solution for stress recovery and health promotion. Bamboo is an important forest type in many countries, especially in East and Southeast Asia and in African countries. Bamboo is widespread throughout southwestern China. Empirical field research on the physiological effects of bamboo forest therapy is currently lacking. To explore the benefits of bamboo forest therapy on the physiological responses of university students, 120 university volunteers between the ages of 19 and 24 participated in this study (60 males and 60 females) and were randomly divided into four groups of equal size (15 males and 15 females in each). Four sites were selected for the experiment, including two natural bamboo forests (YA and YB), a bamboo forest park (DJY), and an urban environment (CS). During the testing period, all participants were asked to view the landscape for 15 min in the morning and then walk in the testing area for 15 min in the afternoon. Blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2) were measured as the physiological indexes, and the semantic differential method (SDM) questionnaire was completed for the environmental satisfaction evaluation. The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites. The three-day bamboo forest therapy session improved the physiological well-being of university students. First, the blood pressure and heart rate of the university students decreased, and the SpO2 increased, after the three-day viewing and walking activities of the three-day bamboo forest therapy session. The viewing activities had a more pronounced effect on decreased heart rate in university students. Additionally, three-day bamboo forest therapy had a positive impact on decreased systolic blood pressure and heart rate in the university students, and it was significantly decreased in females, while peripheral oxygen saturation (SpO2) remained relatively low. Finally, compared with the urban site (CS), the bamboo forest sites effectively improved the university students' physiological state of health, decreased their physical pressure, and stabilized their physiological indicators. These findings provide scientific evidence that a three-day bamboo forest therapy session can increase positive physiological responses. The potential for a longer-term effect on human physiological health requires further investigation.",2020,"The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites.","['university students, 120 university volunteers between the ages of 19 and 24 participated in this study (60 males and 60 females) and were randomly divided into four groups of equal size (15 males and 15 females in each', 'Four sites were selected for the experiment, including two natural bamboo forests (YA and YB), a bamboo forest park (DJY), and an urban environment (CS', 'University Students', 'university students']",['bamboo forest therapy'],"['Blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2', ""university students' physiological state of health, decreased their physical pressure, and stabilized their physiological indicators"", 'semantic differential method (SDM) questionnaire', 'heart rate', 'blood pressure and heart rate of the university students', 'peripheral oxygen saturation (SpO2', 'systolic blood pressure and heart rate', 'positive physiological responses']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",120.0,0.0259646,"The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites.","[{'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Bingyang', 'Initials': 'B', 'LastName': 'Lyu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Songyuan', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Qibing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17093238']
81,32384874,Serum level of IL-1ra was associated with the treatment of latent tuberculosis infection in a Chinese population.,"BACKGROUND


Dynamically changed levels of serum cytokines might predict the development of active TB from latent tuberculosis infection (LTBI) and monitor preventive treatment effectiveness. The aim of the study was to identify potential serum cytokines associated with LTBI treatment which might predict active disease development in a Chinese population.
METHODS


Based on a randomized controlled trial aiming to explore short-course regimens for LTBI treatment, the dynamic changes of serum cytokines determined by bead-based multiplex assays were investigated for the participants who developed active TB during follow-up and age and gender matched controls stayed healthy.
RESULTS


Totally, 21 patients diagnosed with active tuberculosis (TB) during the 2-year follow-up (12 from treated groups and 9 from untreated controls) and 42 age and gender matched healthy controls (24 from treated groups and 18 from untreated controls) were included in the study. Before treatment, serum IL-1ra was statistically higher among those who developed active disease during follow-up as compared with those stayed healthy. As for treated participants, the levels of IL-1ra were significantly lower after treatment in comparison with those before treatment both in active TB group (p = 0.002) and non-TB group (p = 0.009). For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
CONCLUSION


Our results suggested that declined serum level of IL-1ra was associated with LTBI treatment. Further studies are needed to verify whether it could be used to evaluate LTBI treatment and to predict active disease development.",2020,"For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
","['participants who developed active TB during follow-up and age and gender matched controls stayed healthy', '21 patients diagnosed with active tuberculosis (TB) during the 2-year follow-up (12 from treated groups and 9 from untreated controls) and 42 age and gender matched healthy controls (24 from treated groups and 18 from untreated controls) were included in the study']",[],"['serum level of IL-1ra', 'levels of IL-1ra', 'Serum level of IL-1ra', 'serum IL-1ra']","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}]",21.0,0.136814,"For untreated participants, the levels of IL-1ra were not statistically different between different time points both in active TB group (p = 0.078) and non-TB group (p = 0.265).
","[{'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Henan', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Zisen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Dakuan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Xueling', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""The Sixth People's Hospital of Zhengzhou, Zhengzhou, 450061, China.""}, {'ForeName': 'Jiaoxia', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'The Center for Disease Prevention and Control of Zhongmu County, Zhengzhou, 451470, China.'}, {'ForeName': 'Boxuan', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Gastroenterology Department, PLA Rocket Force Characteristic Medical Center, Beijing, 100088, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens, Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dong Dan San Tiao, Dongcheng District, Beijing, 100730, China. gaolei@ipbcams.ac.cn.'}]",BMC infectious diseases,['10.1186/s12879-020-05047-x']
82,32385061,"Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial.","INTRODUCTION


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


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


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


NCT04000958.",2020,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","['patients with chronic obstructive pulmonary disease (COPD', 'Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment', '416 hospitalised patients just recovering from AECOPD', 'patients recovering from acute exacerbation of chronic obstructive pulmonary disease']","['PIFR-based optimised inhalation therapy and training', 'PIFR-based optimised inhalation therapy']","['30-day treatment failure rate', 'risk of early treatment failure', 'PIFR', 'peak inhalation flow rate (PIFR', 'PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021455', 'cui_str': 'Inhalation Devices'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",416.0,0.260112,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","[{'ForeName': 'Jianlan', 'Initials': 'J', 'LastName': 'Hua', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University, Shanghai, China.'}, {'ForeName': 'Hui-Fang', 'Initials': 'HF', 'LastName': 'Cao', 'Affiliation': ""Department of Pulmonary, Shanghai Jing'an District Central Hospital, Shanghai, China, Shanghai, China.""}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Du', 'Affiliation': 'Department of Pulmonary, Shanghai Qingpu District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Ma', 'Affiliation': ""Department of Pulmonary, North Branch of Shanghai Ninth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Zuo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China jingatlas@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-034804']
83,32385063,Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity.,"INTRODUCTION


Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1% or 2%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimises excess adiposity and optimises child nutrition and growth.
METHODS AND ANALYSIS


Cow's Milk Fat Obesity pRevention Trial will be a pragmatic, superiority, parallel group randomised controlled trial involving children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids! practice-based research network in Toronto, Canada. Children (n=534) will be randomised to receive one of two interventions: (1) a recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk. The primary outcome is adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness. Outcomes will be measured 24 months postrandomisation and compared using analysis of covariance (ANCOVA), adjusting for baseline measures.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from Unity Health Toronto and The Hospital for Sick Children. Results will be presented locally, nationally and internationally and published in a peer-reviewed journal. The findings may be helpful to nutrition guidelines for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention.
TRIAL REGISTRATION NUMBER


NCT03914807; pre-results.",2020,"vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness.","['Children (n=534', 'children in North America', 'children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids', 'child adiposity']","[""cow's milk fat"", 'recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk']","['adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire', 'vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3256606', 'cui_str': 'milk fat, cow'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",534.0,0.221937,"vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness.","[{'ForeName': 'Shelley M', 'Initials': 'SM', 'LastName': 'Vanderhout', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Aglipay', 'Affiliation': ""Pediatrics, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Birken', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thorpe', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Constantin', 'Affiliation': 'Department of Pediatrics, Mcgill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Adele', 'Initials': 'MA', 'LastName': 'Davis', 'Affiliation': 'Canadian Paediatric Society, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Feldman', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Geoff D C', 'Initials': 'GDC', 'LastName': 'Ball', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Janus', 'Affiliation': 'Offord Centre for Child Studies, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Junker', 'Affiliation': 'Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Manson', 'Affiliation': 'Health Promotion, Chronic Disease and Injury Prevention, Public Health Ontario, Ottawa, Ontario, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Clinical Trials Unit, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nav', 'Initials': 'N', 'LastName': 'Persaud', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Omand', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Relton', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Yamashiro', 'Affiliation': 'Ontario Medical Association, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Tavares', 'Affiliation': 'Patient Partner, Toronto, Ontario, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Weir', 'Affiliation': 'Patient Partner, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathon L', 'Initials': 'JL', 'LastName': 'Maguire', 'Affiliation': 'Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada jonathon.maguire@utoronto.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035241']
84,32320558,"Finally, a Successful Randomized Trial for GVHD.",,2020,,[],[],[],[],[],[],,0.0496384,,"[{'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Chao', 'Affiliation': 'From the Duke University School of Medicine, Durham, NC.'}]",The New England journal of medicine,['10.1056/NEJMe2003331']
85,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
86,32386407,Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice?,"The stepped-wedge cluster randomized trial (SW-CRT) involves the sequential transition of clusters (such as hospitals, public health units or communities) from control to intervention conditions in a randomized order. The use of the SW-CRT is growing rapidly. Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT). For this reason, the CONSORT extension for SW-CRTs requires that investigators provide a clear justification for the choice of study design. In this paper, we argue that all other things being equal, the SW-CRT is at greater risk of bias due to misspecification of the secular trends at the analysis stage. This is particularly problematic for studies randomizing a small number of heterogeneous clusters. We outline the potential conditions under which an SW-CRT might be an appropriate choice. Potentially appropriate and often overlapping justifications for conducting an SW-CRT include: (i) the SW-CRT provides a means to conduct a randomized evaluation which otherwise would not be possible; (ii) the SW-CRT facilitates cluster recruitment as it enhances the acceptability of a randomized evaluation either to cluster gatekeepers or other stakeholders; (iii) the SW-CRT is the only feasible design due to pragmatic and logistical constraints (for example the roll-out of a scare resource); and (iv) the SW-CRT has increased statistical power over other study designs (which will include situations with a limited number of clusters). As the number of arguments in favour of an SW-CRT increases, the likelihood that the benefits of using the SW-CRT, as opposed to a parallel-CRT, outweigh its risks also increases. We argue that the mere popularity and novelty of the SW-CRT should not be a factor in its adoption. In situations when a conventional parallel-CRT is feasible, it is likely to be the preferred design.",2020,Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT).,[],[],[],[],[],[],,0.0694736,Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT).,"[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",International journal of epidemiology,['10.1093/ije/dyaa077']
87,32386418,Influence of Provider Communication on Emerging Adults' Medication Cognitions and Provider Satisfaction.,"OBJECTIVE


This study examined how the content of medical provider communication related to medication prescriptions influenced emerging adults' (EA) medication-related cognitions and satisfaction with care.
METHODS


In total, 257 EA (ages 18-25) were randomized to one of three audio vignettes depicting a medical appointment in which the EA imagined him/herself as the recipient of an oral antibiotic prescription. Provider communication content varied by vignette as follows: the positive outcome expectancy (POE) vignette focused on enhancing patient POE related to antibiotic use; the negative outcome expectancy (NOE) vignette focused on reducing patient NOE; and the standard care vignette focused on providing factual medication information. Following the vignette, participants self-reported on demographics, select medication-related cognitions, and provider satisfaction from vignette.
RESULTS


Those in the NOE vignette condition reported higher provider satisfaction, perceived the provider to have given more information, and evidenced lower NOE and higher POE about the antibiotic compared with those in the other conditions. Intent to adhere did not vary by vignette condition.
CONCLUSIONS


Brief, provider-initiated communication focused on reducing patient NOE may have unique value in altering EA's medication-related cognitions. Given that medication-related beliefs are known correlates of adherence, future research should replicate and expand these findings in the context of real-world medical encounters and through the utilization of objective indices of medication adherence to more fully understand the potential significance of provider language emphasizing reduction of NOE on medication adherence.",2020,"Intent to adhere did not vary by vignette condition.
","['In total, 257 EA (ages 18-25']","['Provider Communication', 'audio vignettes depicting a medical appointment in which the EA imagined him/herself as the recipient of an oral antibiotic prescription']",['provider satisfaction'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",257.0,0.0202149,"Intent to adhere did not vary by vignette condition.
","[{'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Carreon', 'Affiliation': ""Texas Children's Hospital/Baylor College of Medicine.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Durkin', 'Affiliation': 'Rosalind Franklin University of Medicine and Science.'}, {'ForeName': 'W Hobart', 'Initials': 'WH', 'LastName': 'Davies', 'Affiliation': 'University of Wisconsin-Milwaukee.'}, {'ForeName': 'Rachel Neff', 'Initials': 'RN', 'LastName': 'Greenley', 'Affiliation': 'Rosalind Franklin University of Medicine and Science.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa022']
88,32386466,Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial.,"INTRODUCTION


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


Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible. The primary outcome measure was change in the mean pelvic pain intensity from baseline to 12 months, measured using the numeric rating scale (0-10). Secondary outcomes were changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation. The differences between the groups regarding change in scores were analyzed using the independent t-test and Mann-Whitney U-test. Sensitivity analysis of the primary outcome was performed with a linear regression model adjusted for the baseline value. A p-value <0.05 was considered statistically significant.
RESULTS


Of the 62 women included, 26 in the intervention group and 25 in the comparator group were available after 12 months for data collection and analysis. The difference between the groups for change in the mean pain intensity score was -1.2 (95% confidence interval, -2.3 to -0.2; P=0.027), favoring the intervention group. The intervention group showed greater improvements in respiratory patterns (mean difference 0.9; 95% confidence interval, 0.2-1.6; P=0.015) and pain-related fear of movements (mean difference 2.9; 95% confidence interval, -5.5 to -0.3; P=0.032), and no significant differences were observed between the groups for the other secondary outcomes.
CONCLUSIONS


Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.",2020,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","['women with chronic pelvic pain', 'Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible']","['multimodal physical therapy', 'primary care physical therapy (comparator group', 'structured group-based multimodal physical therapy']","['mean pain intensity score', 'respiratory patterns', 'pain-related fear of movements', 'numeric rating scale', 'changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation', 'mean pelvic pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.107811,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","[{'ForeName': 'Ane Sigrid', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona Birgitte', 'Initials': 'MB', 'LastName': 'Rydningen', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Wojniusz', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Marthe', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Clinical Research Department, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Rolv-Ole', 'Initials': 'RO', 'LastName': 'Lindsetmo', 'Affiliation': 'Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro Killi', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13896']
89,32386476,The relationship between postoperative opioid consumption and the incidence of hypoxemic events following total hip arthroplasty: a post hoc analysis.,"Background


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


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


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


Following total hip arthroplasty, a greater than 70% reduction in morphine consumption may be necessary to translate into a corresponding reduction in hypoxemic events.",2020,"A significantly smaller proportion of patients who received the combined treatment with parecoxib and propacetamol had hypoxemia versus placebo (2.8% v. 13.2%, p < 0.05), and the mean number of hypoxemic events was significantly smaller for parecoxib (0.12), propacetamol (0.06) and parecoxib plus propacetamol (0.03) versus placebo (0.36; all p < 0.05).",['total hip arthroplasty'],"['parecoxib plus propacetamol', 'morphine', 'intravenous parecoxib', 'total hip arthroplasty, placebo', 'parecoxib', 'placebo']","['peripheral oxygen saturation less', 'mean number of hypoxemic events', 'hypoxemia', 'cumulative morphine consumption', 'morphine consumption', 'Hypoxemia', 'times and oximeter readings of hypoxemic events', 'hypoxemic events', 'peripheral blood oxygenation']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0084186', 'cui_str': 'propacetamol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0182117', 'cui_str': 'Oxygen analyzer'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.254389,"A significantly smaller proportion of patients who received the combined treatment with parecoxib and propacetamol had hypoxemia versus placebo (2.8% v. 13.2%, p < 0.05), and the mean number of hypoxemic events was significantly smaller for parecoxib (0.12), propacetamol (0.06) and parecoxib plus propacetamol (0.03) versus placebo (0.36; all p < 0.05).","[{'ForeName': 'Margaret Noyes', 'Initials': 'MN', 'LastName': 'Essex', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Camu', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Borgeat', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'P Arline', 'Initials': 'PA', 'LastName': 'Salomon', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Cheung', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.010519']
90,32390475,Mid-term results of a prospective randomised controlled trial comparing large-head metal-on-metal hip replacement to hip resurfacing using patient-reported outcome measures and objective functional task-based outcomes.,"BACKGROUND


The early outcomes of large head-metal-on-metal total hip arthroplasty (MoM THA) are compromised by adverse local tissue reaction to metal debris. This study is the mid-term follow-up of a prospective randomised control trial (pRCT) comparing MoM THA to MoM HR. We sought to answer whether there was a difference between MoM THA and MoM HR at mid-term follow-up in the implant survival; patient-reported outcome measures (PROMs); and when performing objective functional tasks?
METHODS


A total of 104 patients were studied. Of these 56 had MoM THA (50 male) and 48 had HR (43 male). Mean age at surgery was 52 years in both groups. We reviewed this cohort at mid-term follow-up [minimum 8 years (mean 9 years; range 8-10; SD 0.7)]. PROMs that were completed were OHS, WOMAC, SF-12, and the UCLA. For objective functional task-based outcomes, gait parameters for operated legs were assessed in a subgroup of 17 patients with high UCLA.
RESULTS


Revision rate in MoM THA group was 7/56 (12.5%) and in the HR group was 1/48 (2.1%). Overall revision rate at minimum 8-year follow-up was 7.7% (8 of 104 patients). PROMs data comparing MoM THA versus HR showed no difference between the groups. 4 (8.5%) of the non-revised (47) HR patients had WOMAC function or pain score below 70. 3 (6.4%) patients had both pain and function scores <70. In the THA group, 5 (10.2%) of the non-revised (49) patients had WOMAC pain or function scores <70. 3 (6.1%) patients had both pain and function scores <70. The comparison of HA versus THA showed several gait parameters in the HR group to be better but not statistically significant ( p  > 0.05 Mann-Whitney U-test).
CONCLUSIONS


At mid-term follow-up, the revision rate of MoM articulation for THA is high (7.7%), being higher in large head MoM total hips versus resurfacing. Overall probability of 10-year survival is 92.3% (KM analysis, 95% for MoM THA and 98% for HR). The HR group had better functional parameters on gait-based tasks compared to THA group but this difference did not reach statistical significance.",2020,The HR group had better functional parameters on gait-based tasks compared to THA group but this difference did not reach statistical significance.,"['104 patients were studied', 'Mean age at surgery was 52\u2009years in both groups', '17 patients with high UCLA', 'Of these 56 had MoM THA (50 male) and 48 had HR (43 male']","['MoM', 'large-head metal-on-metal hip replacement to hip resurfacing']","['revision rate of MoM articulation', 'functional parameters on gait-based tasks', 'pain and function scores', 'WOMAC pain or function scores', 'Revision rate', 'Overall probability of 10-year survival', 'MoM THA and MoM HR', 'several gait parameters', 'Overall revision rate', 'WOMAC function or pain score']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C2243051', 'cui_str': 'Large head'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}]","[{'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",104.0,0.127936,The HR group had better functional parameters on gait-based tasks compared to THA group but this difference did not reach statistical significance.,"[{'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Konan', 'Affiliation': 'Department of Trauma and Orthopaedics, University College London Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Waugh', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver General Hospital, Vancouver, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Ohly', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver General Hospital, Vancouver, Canada.'}, {'ForeName': 'Clive P', 'Initials': 'CP', 'LastName': 'Duncan', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver General Hospital, Vancouver, Canada.'}, {'ForeName': 'Bassam A', 'Initials': 'BA', 'LastName': 'Masri', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver General Hospital, Vancouver, Canada.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Garbuz', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver General Hospital, Vancouver, Canada.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020919671']
91,32390503,Handling missing data in modelling quality of clinician-prescribed routine care: Sensitivity analysis of departure from missing at random assumption.,"Missing information is a major drawback in analyzing data collected in many routine health care settings. Multiple imputation assuming a missing at random mechanism is a popular method to handle missing data. The missing at random assumption cannot be confirmed from the observed data alone, hence the need for sensitivity analysis to assess robustness of inference. However, sensitivity analysis is rarely conducted and reported in practice. We analyzed routine paediatric data collected during a cluster randomized trial conducted in Kenyan hospitals. We imputed missing patient and clinician-level variables assuming the missing at random mechanism. We also imputed missing clinician-level variables assuming a missing not at random mechanism. We incorporated opinions from 15 clinical experts in the form of prior distributions and shift parameters in the delta adjustment method. An interaction between trial intervention arm and follow-up time, hospital, clinician and patient-level factors were included in a proportional odds random-effects analysis model. We performed these analyses using R functions derived from the  jomo  package. Parameter estimates from multiple imputation under the missing at random mechanism were similar to multiple imputation estimates assuming the missing not at random mechanism. Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.",2020,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,['Kenyan hospitals'],[],[],"[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.0221474,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gachau', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Quartagno', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Edmund Njeru', 'Initials': 'EN', 'LastName': 'Njagi', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Owuor', 'Affiliation': 'School of Mathematics, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'English', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ayieko', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}]",Statistical methods in medical research,['10.1177/0962280220918279']
92,32390559,Analysis of internal spermatic vein embolization through catheter versus laparoscopic high ligation in treatment of left varicocele.,"OBJECTIVE


Varicocele is a common disease in young and middle-aged men. This study aims to compare the efficacy of internal spermatic vein embolization of left varicocele versus laparoscopic high ligation.
METHODS


From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option. Among these, 26 patients were treated with sclerosing agent injection, while 43 patients underwent laparoscopic surgery. They were followed up for 12 months after surgery, and the technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time with regard to these two methods were analyzed.
RESULTS


All patients completed the medical procedures. There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%. Furthermore, the operative time, hospitalization time, and cost of treatment were 31.1 ± 11.1 min, 1.2 ± 0.49 days, and 9613.11 ± 895.97 Yuan, respectively. In the laparoscopic group, 9 patients underwent laparoscopic bilateral high ligation, while 34 patients received treatment on the left side alone. The recurrence rate of left varicocele was 4.7% and the complication rate was 44.2%. Furthermore, the operative time, hospitalization time, and treatment cost were 50.4 ± 14.48 min, 4.0 ± 2.02 days, and 10,948.29 ± 2547.00 Yuan, respectively. Moreover, there were statistically significant differences ( P  <   0.05) in operative time, hospitalization time, and treatment cost. Patients in the sclerotherapy group had an advantage with respect to the overall complication rate when compared with patients from the laparoscopic group ( X 2  = 4.448,  P  <   0.05), and there was a statistically significant difference in hydrocele ( X 2  = 4.555,  P  <   0.05). However, there was no significant difference in the recurrence rate between these two groups ( X 2  = 1.245,  P  >   0.05).
CONCLUSION


Patients who underwent sclerotherapy showed a higher technical success rate, a lower recurrence rate, fewer complications, and shorter hospitalization time compared to those treated with laparoscopic ligation. Transcatheter sclerosing agent injection may be a preferable treatment option for patients with unilateral varicocele.",2020,"There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%.","['patients with unilateral varicocele', 'young and middle-aged men', 'left varicocele', '26 patients were treated with sclerosing agent injection, while 43 patients underwent', 'From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option']","['Transcatheter sclerosing agent injection', 'laparoscopic bilateral high ligation', 'internal spermatic vein embolization through catheter versus laparoscopic high ligation', 'internal spermatic vein embolization of left varicocele versus laparoscopic high ligation', 'sclerotherapy', 'laparoscopic surgery']","['recurrence rate, fewer complications, and shorter hospitalization time', 'operative time, hospitalization time, and cost of treatment', 'recurrence rate of left varicocele', 'overall complication rate', 'technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time', 'technical success rate', 'complication rate', 'recurrence rate', 'operative time, hospitalization time, and treatment cost', 'hydrocele']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226718', 'cui_str': 'Structure of testicular vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1720771', 'cui_str': 'Hydrocele'}]",69.0,0.0594976,"There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%.","[{'ForeName': 'Ye-Xiang', 'Initials': 'YX', 'LastName': 'Jing', 'Affiliation': 'Department of Graduate School, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Zhao-Xuan', 'Initials': 'ZX', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Qing-Yi', 'Initials': 'QY', 'LastName': 'Meng', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}]",Vascular,['10.1177/1708538120923548']
93,32390563,"Liraglutide accelerates colonic transit in people with type 1 diabetes and polyneuropathy: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


Glucagon-like peptide-1 receptor agonists, such as liraglutide, reduce hyperglycaemia and induce weight loss and are used as a treatment in diabetes. However, common adverse effects include nausea, loss of appetite and prolonged gastric emptying. It is not known whether these changes are centrally generated or if liraglutide alters the enteric motility.
OBJECTIVE


To investigate the effects of liraglutide on gastrointestinal function and symptoms.
METHODS


A total of 48 adults with type 1 diabetes and confirmed distal symmetric polyneuropathy were randomised to receive liraglutide 1.8 mg/day or placebo for 26 weeks. Regional transit times and motility indexes were assessed with a wireless motility capsule, whereas symptoms were evaluated using the validated gastroparesis cardinal symptom index.
RESULTS


Liraglutide treatment reduced large bowel transit time (31.7%,  p  = 0.04) and decreased motility index (6.1%,  p  = 0.04) compared to placebo, whereas the groups did not differ in gastric emptying or small-bowel transit times. Liraglutide increased postprandial fullness with 29% ( p  = 0.01). Increased small bowel transit time was associated with decreased bloating ( p  = 0.008).
CONCLUSION


Liraglutide accelerates large bowel transit and decreases motility index, which may indicate better coordination of propulsive motility. This potentially improves the function of the enteric nervous system, leading to normalised colonic function and positive effects in type 1 diabetes.",2020,"RESULTS


Liraglutide treatment reduced large bowel transit time (31.7%,  p  = 0.04) and decreased motility index (6.1%,  p  = 0.04) compared to placebo, whereas the groups did not differ in gastric emptying or small-bowel transit times.","['people with type 1 diabetes and polyneuropathy', '48 adults with type 1 diabetes and confirmed distal symmetric polyneuropathy']","['placebo', 'liraglutide 1.8 mg/day or placebo', 'liraglutide', 'Liraglutide']","['gastroparesis cardinal symptom index', 'gastrointestinal function and symptoms', 'Regional transit times and motility indexes', 'motility index', 'large bowel transit time', 'nausea, loss of appetite and prolonged gastric emptying', 'colonic transit', 'gastric emptying or small-bowel transit times', 'bloating', 'postprandial fullness', 'small bowel transit time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0232688', 'cui_str': 'Large bowel transit time'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",48.0,0.196728,"RESULTS


Liraglutide treatment reduced large bowel transit time (31.7%,  p  = 0.04) and decreased motility index (6.1%,  p  = 0.04) compared to placebo, whereas the groups did not differ in gastric emptying or small-bowel transit times.","[{'ForeName': 'Anne-Marie Langmach', 'Initials': 'AL', 'LastName': 'Wegeberg', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christian Stevns', 'Initials': 'CS', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Region Hovedstaden, Gentofte, Denmark.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Farmer', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jesper Scott', 'Initials': 'JS', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Asbjorn M', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Poul Erik', 'Initials': 'PE', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brock', 'Affiliation': 'Steno Diabetes Center Copenhagen, Region Hovedstaden, Gentofte, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}]",United European gastroenterology journal,['10.1177/2050640620925968']
94,32390583,Comparing Training Techniques in Personal Protective Equipment Use.,"INTRODUCTION


Physicians' management of hazardous material (HAZMAT) incidents requires personal protective equipment (PPE) utilization to ensure the safety of victims, facilities, and providers; therefore, providing effective and accessible training in its use is crucial. While an emphasis has been placed on the importance of PPE, there is debate about the most effective training methods. Circumstances may not allow for a traditional in-person demonstration; an accessible video training may provide a useful alternative.
HYPOTHESIS


Video training of Emergency Medicine (EM) residents in the donning and doffing of Level C PPE is more effective than in-person training.
NULL HYPOTHESIS


Video training of EM residents in the donning and doffing of Level C PPE is equally effective compared with in-person training.
METHODS


A randomized, controlled pilot trial was performed with 20 EM residents as part of their annual Emergency Preparedness training. Residents were divided into four groups, with Group 1 and Group 2 viewing a demonstration video developed by the Emergency Preparedness Team (EPT) and Group 3 and Group 4 receiving the standard in-person demonstration training by an EPT member. The groups then separately performed a donning and doffing simulation while blinded evaluators assessed critical tasks utilizing a prepared evaluation tool. At the drill's conclusion, all participants also completed a self-evaluation survey about their subjective interpretations of their respective trainings.
RESULTS


Both video and in-person training modalities showed significant overall improvement in participants' confidence in doffing and donning PPE equipment (P <.05). However, no statistically significant difference was found in the number of failed critical tasks in donning or doffing between the training modalities (P >.05). Based on these results, the null hypothesis cannot be rejected. However, these results were limited by the small sample size and the study was not sufficiently powered to show a difference between training modalities.
CONCLUSION


In this pilot study, video and in-person training were equally effective in training for donning and doffing Level C PPE, with similar error rates in both modalities. Further research into this subject with an appropriately powered study is warranted to determine whether this equivalence persists using a larger sample size.",2020,Both video and in-person training modalities showed significant overall improvement in participants' confidence in doffing and donning PPE equipment (P <.05).,['20 EM residents as part of their annual Emergency Preparedness training'],['Group 1 and Group 2 viewing a demonstration video developed by the Emergency Preparedness Team (EPT) and Group 3 and Group 4 receiving the standard in-person demonstration training by an EPT member'],['number of failed critical tasks'],"[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1956344', 'cui_str': 'Emergency Preparedness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1956344', 'cui_str': 'Emergency Preparedness'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0356448,Both video and in-person training modalities showed significant overall improvement in participants' confidence in doffing and donning PPE equipment (P <.05).,"[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Salway', 'Affiliation': 'New York Health and Hospitals, Office of Quality and Safety, New York, New York, USA.'}, {'ForeName': 'Trenika', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New HampshireUSA.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Londono', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, New YorkUSA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Roblin', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, New YorkUSA.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Koenig', 'Affiliation': 'Center for Disaster Medical Sciences, University of California - Irvine School of Medicine, Irvine, CaliforniaUSA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Arquilla', 'Affiliation': 'SUNY Downstate College of Medicine, Brooklyn, New YorkUSA.'}]",Prehospital and disaster medicine,['10.1017/S1049023X20000564']
95,32390591,A Smartphone App-Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app-based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience.
OBJECTIVE


The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors.
METHODS


This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users' engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology.
RESULTS


The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques.
CONCLUSIONS


Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today's digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15178.",2020,"The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes).","['Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors', 'cancer survivors', 'Cancer Survivors', 'cancer survivors who have completed all their cancer treatments']","['tailored mindfulness app intervention', 'app-based mindfulness intervention', 'Smartphone App-Based Mindfulness Intervention', 'Smartphone app-based MBIs', 'tailored app-based mindfulness intervention', 'SEAMLESS (Smartphone App-Based Mindfulness Intervention', 'Am MBCS', 'Mindfulness-based interventions (MBIs']","['well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4275029', 'cui_str': 'Maternal uniparental disomy of chromosome 20'}]","[{'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.129973,"The SEAMLESS (Smartphone App-Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship-MBCS-Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes).","[{'ForeName': 'Utkarsh B', 'Initials': 'UB', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Norman As', 'Initials': 'NA', 'LastName': 'Farb', 'Affiliation': 'Department of Psychology, University of Toronto Mississauga, Mississauga, ON, Canada.'}, {'ForeName': 'Katherine-Ann Laura', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Speca', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Lupichuk', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Tang', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Faris', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Thoburn', 'Affiliation': 'Mobio Interactive, Toronto, ON, Canada.'}, {'ForeName': 'Bechara J', 'Initials': 'BJ', 'LastName': 'Saab', 'Affiliation': 'Mobio Interactive, Toronto, ON, Canada.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology, University of Calgary, Calgary, AB, Canada.'}]",JMIR research protocols,['10.2196/15178']
96,32390706,Retrograde inspection  vs  standard forward view for the detection of colorectal adenomas during colonoscopy: A back-to-back randomized clinical trial.,"BACKGROUND


The adenoma detection rate (ADR) is inversely associated with the incidence of interval colorectal cancer and serves as a benchmark quality criterion during screening colonoscopy. However, adenoma miss rates reach up to 26% and studies have shown that a second inspection of the right colon in retroflected view (RFV) can increase ADR.
AIM


To assess whether inspection of the whole colon in RFV compared to standard forward view (SFV) can increase ADR.
METHODS


Patients presenting for screening or surveillance colonoscopy were invited to participate in this randomized controlled trial and randomized into two arms. In RFV arm colonoscopy was initially performed with SFV, followed by a second inspection of the whole colon in RFV. In the SFV arm first withdrawal was performed with SFV, followed by a second inspection of the whole colon again with SFV. Number, size and morphology of polyps found during first and second inspection in each colonic segment were recorded and all polyps were removed and sent for histopathology in separate containers.
RESULTS


Two hundred and five patients were randomly assigned to the RFV ( n  = 101) and SFV ( n  = 104) arm. In the RFV arm, both polyp detection rate (PDR) and ADR were increased under second inspection in RFV (PDR 1 st  SFV: 39.8%, PDR 2 nd  RFV: 46.6%; ADR 1 st  SFV: 35.2%, ADR 2 nd  RFV: 42%). Likewise, in the SFV arm, PDR and ADR were increased under second inspection (PDR 1 st  SFV: 37.5%, PDR 2 nd  SFV: 46.6%; ADR 1 st  SFV: 34.1%, ADR 2 nd  SFV: 44.3%) with no significant differences in ADR and PDR between the SFV and RFV arm. Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1 st  SFV: 1.71; 2 nd  RFV: 2.38; APP SFV arm: 1 st  SFV: 1.83, 2 nd  SFV:2.2). The majority of adenomas additionally found during second inspection in RFV or in SFV were located in the transverse and left-sided colon and were > 5 mm in size.
CONCLUSION


Second inspection of the whole colon leads to increased adenoma detection with no differences between SFV and RFV. Hence, increased detection is most likely a feature of the second inspection itself but not of the inspection mode.",2020,"Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1 st  SFV: 1.71; 2 nd  RFV: 2.38; APP SFV arm: 1 st  SFV: 1.83, 2 nd  SFV:2.2).","['Two hundred and five patients', 'Patients presenting for screening or surveillance colonoscopy']","['standard forward view (SFV', 'RFV', 'SFV', 'Retrograde inspection  vs  standard forward view']","['polyp detection rate (PDR) and ADR', 'Mean number of adenomas per patient (APP', 'ADR and PDR', 'PDR and ADR', 'adenoma detection', 'Number, size and morphology of polyps']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",205.0,0.041914,"Mean number of adenomas per patient (APP) was increased in the RFV and SFV (APP RFV arm: 1 st  SFV: 1.71; 2 nd  RFV: 2.38; APP SFV arm: 1 st  SFV: 1.83, 2 nd  SFV:2.2).","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rath', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany. timo.rath@uk-erlangen.de.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Neufert', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kremer', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Leppkes', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Klinikum Aschaffenburg, Aschaffenburg 63739, Germany.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Department of Internal Medicine 1, Division of Gastroenterology, Ludwig Demling Endoscopy Center of Excellence, Friedrich-Alexander-University, Erlangen Nuernberg, Erlangen 91054, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Zopf', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Klinikum Fürth, Fürth 90766, Germany.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i16.1962']
97,32390713,Reversion of vegetation following the cessation of fertilizer application.,"Tadham Moor in Somerset, England, is an exceptionally rich wetland site which has been mown for hay for many years, with stock grazing the aftermath, but with no history of any fertilizer use. A randomized blocks field experiment (1986-1989) was used to study the effects of five levels of nitrogen input treatments: 0 = control, 25, 50, 100 and 200 kg of N fertilizer per ha per yr. In Phase II of the experiment (1990-1993), each plot was split into two subplots. The allocated fertilizer treatment for the plot was continued in one, randomly selected, subplot but the treatment was discontinued in the other subplot. The experiment not only identified and quantified the changes occurring in the vegetation of hay meadows under different levels of N input, it also provided valuable insight into the dynamics of the sward upon the discontinuance of the treatments. The data for Phase II were used to estimate the time required by the changed vegetation (under different nitrogen treatments) to revert to a state comparable to that prevailing in the control plots. A method for estimating reversion times is described. The main difficulties in estimating the reversion times are identified, the choice of robust vegetation variables being critical. Reversion time estimation methods are presented and used to obtain working estimates for the four nitrogen treatments, applied for 5 yr. These estimates are 3, 5, 7 and 9 yr respectively. The validity of the estimates of 3 yr for the lowest nitrogen input treatment (25 kg /ha/yr) was checked using the available post cessation data.",1996,"The experiment not only identified and quantified the changes occurring in the vegetation of hay meadows under different levels of N input, it also provided valuable insight into the dynamics of the sward upon the discontinuance of the treatments.",[],[],[],[],[],[],,0.0180231,"The experiment not only identified and quantified the changes occurring in the vegetation of hay meadows under different levels of N input, it also provided valuable insight into the dynamics of the sward upon the discontinuance of the treatments.","[{'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Mountford', 'Affiliation': 'Natural Environmental Research Council, Institute of Terrestrial Ecology, Monks Wood, Abbots Ripton, Huntingdon, Cambs PE17 2LS, United Kingdom; Tel. + 44 1487 773381; Fax + 44 1487 773467; E-mail om@wpo.nerc.ac.uk.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Lakhani', 'Affiliation': 'Natural Environmental Research Council, Institute of Terrestrial Ecology, Monks Wood, Abbots Ripton, Huntingdon, Cambs PE17 2LS, United Kingdom; Tel. + 44 1487 773381; Fax + 44 1487 773467; E-mail om@wpo.nerc.ac.uk.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Holland', 'Affiliation': 'Natural Environmental Research Council, Institute of Terrestrial Ecology, Monks Wood, Abbots Ripton, Huntingdon, Cambs PE17 2LS, United Kingdom; Tel. + 44 1487 773381; Fax + 44 1487 773467; E-mail om@wpo.nerc.ac.uk.'}]",Journal of vegetation science : official organ of the International Association for Vegetation Science,['10.2307/3236322']
98,32390720,Effects of an Impulse Frequency Dependent 10-Week Whole-body Electromyostimulation Training Program on Specific Sport Performance Parameters.,"The difference in the efficacy of altered stimulation parameters in whole-body-electromyostimulation (WB-EMS) training remains largely unexplored. However, higher impulse frequencies (>50 Hz) might be most adequate for strength gain. The aim of this study was to analyze potential differences in sports-related performance parameters after a 10-week WB-EMS training with different frequencies. A total of 51 untrained participants (24.9 ± 3.9 years, 174 ± 9 cm, 72.4 ± 16.4 kg, BMI 23.8 ± 4.1, body fat 24.7 ± 8.1 %) was randomly divided into three groups: one inactive control group (CON) and two training groups. They completed a 10-week WB-EMS program of 1.5 sessions/week, equal content but different stimulation frequencies (training with 20 Hz (T20) vs. training with 85 Hz (T85)). Before and after intervention, all participants completed jumping (Counter Movement Jump (CMJ), Squat Jump (SJ), Drop Jump (DJ)), sprinting (5m, 10m, 30m), and strength tests (isometric trunk flexion/extension). One-way ANOVA was applied to calculate parameter changes. Post-hoc least significant difference tests were performed to identify group differences. Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85). A 10-week WB-EMS training leads to significant improvements of jump and strength parameters in untrained participants. No differences could be detected between the frequencies. Therefore, both stimulation frequencies can be regarded as adequate for increasing specific sport performance parameters. Further aspects as regeneration or long term effects by the use of different frequencies still need to be clarified.",2020,"Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85).","['51 untrained participants (24.9 ± 3.9 years, 174 ± 9 cm, 72.4 ± 16.4 kg, BMI 23.8 ± 4.1, body fat 24.7 ± 8.1 ', 'untrained participants']","['inactive control group (CON', 'Impulse Frequency Dependent 10-Week Whole-body Electromyostimulation Training Program', 'jumping (Counter Movement Jump (CMJ), Squat Jump (SJ), Drop Jump (DJ']","['trunk flexion', 'Specific Sport Performance Parameters', 'jump and strength parameters']","[{'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517875', 'cui_str': '8.1'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",51.0,0.012783,"Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85).","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ludwig', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Backfisch', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}]",Journal of sports science & medicine,[]
99,32390721,Acute Maltodextrin Supplementation During Resistance Exercise.,"Most of the research investigating the ergogenic enhancing mechanisms of carbohydrate have been conducted using aerobic based exercise. Therefore, the purpose of this study was to investigate the effects of pre-exercise maltodextrin ingestion on resistance exercise performance, serum insulin, epinephrine, glucose, and muscle glycogen concentrations. In a double blind, cross over, repeated measures design, participants completed four sets to failure at 70% of 1-RM with 45s rest on the angled leg press with or without pre-exercise maltodextrin (2g/kg) after a 3hr fast. Serum glucose, epinephrine, and insulin were assessed at baseline, 30 min post-ingestion, immediately after, and 1hr post-exercise with or without carbohydrate supplementation. Muscle glycogen was assessed from biopsy specimens sampled from the vastus lateralis before supplementation, immediately after exercise, and 1hr post exercise under both conditions. There was no main effect of supplement on resistance exercise performance (p = 0.18). Muscle glycogen concentration decreased across time for both groups (p < 0.001). There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026). An interaction occurred showing insulin decreased during exercise in the carbohydrate condition (p = 0.003). Also, there was a main effect of insulin being elevated with carbohydrate consumption (p = 0.027). Epinephrine was decreased across all time points after carbohydrate ingestion (p = 0.023). Carbohydrate supplementation before resistance exercise did not improve leg press performance to fatigue despite increased metabolic substrate availability. These results indicate that pre-exercise dietary carbohydrate will be utilized preferentially during exercise due to decreased epinephrine, decreased serum glucose, and increased insulin concentrations. However, the increases in glycolytic substrate availability will not increase exercise performance or glycogen content following 1hr of recovery.",2020,There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026).,[],"['Epinephrine', 'Carbohydrate supplementation before resistance exercise', '1-RM with 45s rest on the angled leg press with or without pre-exercise maltodextrin', 'pre-exercise maltodextrin ingestion', 'Acute Maltodextrin Supplementation']","['resistance exercise performance', 'Muscle glycogen', 'serum glucose', 'resistance exercise performance, serum insulin, epinephrine, glucose, and muscle glycogen concentrations', 'exercise performance or glycogen content', 'serum glucose, and increased insulin concentrations', 'Muscle glycogen concentration', 'Serum glucose, epinephrine, and insulin']",[],"[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.109494,There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Hwang', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}]",Journal of sports science & medicine,[]
100,32390724,One Session of Extracorporeal Shockwave Therapy-Induced Modulation on Tendon Shear Modulus is Associated with Reduction in Pain.,"The aim of the study was to examine the immediate effect of 1 session of extracorporeal shockwave therapy (ESWT) on patellar tendon stiffness and to explore the relationship between the change in tendon stiffness and the pain intensity. Thirty-four male athletes aged 22.2 ± 3.8 with patellar tendinopathy were recruited. The participants were randomized into ESWT and sham groups. The ESWT group received 1500 impulses of ESWT at 4 Hz with maximal tolerable pain intensity and the sham group received intensities below 0.08 mJ/mm 2 . Supersonic Shearwave Imaging (SSI) was used to measure tendon shear modulus (an index of tissue stiffness), and a visual analogue scale was used to quantify the pain intensity during compression with 10 lb (4.535 kg) pressure directed on the most tender part and then during a single-leg declined-squat test. A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06). In the ESWT group, the change in tendon shear modulus was associated with the change in the intensity of pain during single-legged declined-squat test (ρ = 0.55; p = 0.023) but not pressure pain (p > 0.05). These findings suggest that one session of ESWT induces reduction of tendon stiffness in volleyball and basketball players with patellar tendinopathy. The reduction in tendon stiffness is associated with reduction in pain during single-legged declined-squat test.",2020,"A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06).","['Thirty-four male athletes aged 22.2 ± 3.8 with patellar tendinopathy were recruited', 'volleyball and basketball players with patellar tendinopathy']","['ESWT', 'extracorporeal shockwave therapy (ESWT', 'Extracorporeal Shockwave Therapy-Induced Modulation', 'Supersonic Shearwave Imaging (SSI']","['pressure pain', 'patellar tendon stiffness', 'tendon shear modulus', 'change in tendon shear modulus', 'intensity of pain', 'pain', 'tendon stiffness', 'tendon stiffness and the pain intensity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",34.0,0.0444846,"A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06).","[{'ForeName': 'Zhi Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Wai Chun', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Siu Ngor', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Sciences, the Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of sports science & medicine,[]
101,32390725,Impact of Duration of Eccentric Movement in the One-Repetition Maximum Test Result in the Bench Press among Women.,"Scientific studies related to resistance training have considered many variables; however, the tempo of movement of particular repetitions is often neglected or not reported in resistance training practice and research. The aim of the study was to determine the effect of different duration of the eccentric (ECC) phase of movement on one-repetition maximum test (1RM) results during the bench press exercise (BP). Twenty-one strength trained females (age = 23.4 ± 2.2 years, body mass = 52.3 ± 6.7 kg), with a minimum one year of strength training experience took part in the study. The experiment was conducted following a randomized crossover design, where each participant completed the 1RM test in the BP with three different duration times of the ECC movement: 2/0/X, 4/0/X, 6/0/X. Concentric (CON) movement was performed with maximal velocity (X). The ANOVA with repeated measures were used to compare the differences between the analyzed variables. The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01). Therefore, the results indicated that the longer the duration of the ECC phase of movement, the greater the decrease in the result of the 1RM test. The 1RM test procedure should include information about the movement tempo used during the test protocol.",2020,The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01).,"['Women', 'Twenty-one strength trained females (age = 23.4 ± 2.2 years, body mass = 52.3 ± 6.7 kg), with a minimum one year of strength training experience took part in the study']",[],['maximal load in the 1RM test'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",21.0,0.0242881,The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01).,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mostowik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Hajduk', 'Affiliation': 'Galen-Orthopaedics, 43-150 Bierun, ul Jerzego 6, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}]",Journal of sports science & medicine,[]
102,32390729,The Achilles Tendon Response to a Bout of Running is not affected by Triceps Surae Stretch Training in Runners.,"An acute bout of distance running decreases Achilles tendon CSA. The purpose of this study was to examine if three-week stretch training of the Achilles tendon alters the Achilles tendon thinning response to running. Thirty-three recreational runners were divided into a control group (n = 17) and an intervention group (n = 16). The intervention included a three-week soleus stretch (knee flexed) and gastrocnemius stretch (knee extended). Three gastrocnemius stretches and three soleus stretches were performed each day, six days per week. Stretches were held for 30 s per repetition for a total duration of 180 s per leg per day. Achilles tendon CSA and range of motion measures were completed pre and post-run before and after the three-week stretching intervention. The runs prior to and following the three-week stretch training intervention both resulted in a 6% decrease in Achilles tendon CSA (p < 0.0001). There was no interaction across time between control and intervention groups in CSA (p = 0.446). Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009). We therefore conclude that even when an increased dorsiflexion range of motion occurs, three weeks of triceps surae stretching does not alter the response of the Achilles tendon CSA.",2020,Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009).,"['Thirty-three recreational runners', 'Runners']",['distance running'],"['dorsiflexion range of motion', 'Achilles tendon CSA', 'Achilles tendon CSA and range of motion measures']","[{'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0210059,Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009).,"[{'ForeName': 'Coulter D', 'Initials': 'CD', 'LastName': 'Neves', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Sponbeck', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Katy Andrews', 'Initials': 'KA', 'LastName': 'Neves', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Ulrike H', 'Initials': 'UH', 'LastName': 'Mitchell', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Hunter', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Aaron Wayne', 'Initials': 'AW', 'LastName': 'Johnson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}]",Journal of sports science & medicine,[]
103,32390731,Occlusion Training During Specific Futsal Training Improves Aspects of Physiological and Physical Performance.,"This study aimed to examine the effects of lower limb blood flow restriction (BFR) performed during 3-a-side futsal game training on aerobic and anaerobic performance of futsal players. Twelve male futsal players were randomized into two groups (n = 6); both groups performed ten sessions of the 3-a-side game every other day in half of a futsal court; but one group trained under BFR conditions. Pneumatic cuffs used for the BFR group were inflated to 110% leg systolic blood pressure and increased by 10% after each two completed sessions. Before and after the training sessions subjects completed a series of tests to assess aerobic and anaerobic performances along with changes in blood lactate and anabolic and catabolic hormones. All aerobic and anaerobic performance variables improved in both group after training, however improvements in mean power (12.2%, p = 0.03), run time to fatigue (TTF), (7.1%, p = 0.02) and running economy (RE), (-22.7%, p = 0.01) were significantly greater in the BFR group. There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group. Small-sided game (SSG) training with the addition of BFR because of accumulated metabolites and hormonal changed leads to substantially greater increases in performance than SSGs training alone.",2020,"There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group.","['futsal players', 'Twelve male futsal players']","['Occlusion Training During Specific Futsal Training', 'lower limb blood flow restriction (BFR) performed during 3-a-side futsal game training', 'Small-sided game']","['mean power', 'All aerobic and anaerobic performance variables', 'growth hormone', 'blood lactate and anabolic and catabolic hormones', 'Physiological and Physical Performance', 'run time to fatigue (TTF', 'rate of lactate removal', 'running economy (RE', 'leg systolic blood pressure', 'testosterone to cortisol ratio']","[{'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",12.0,0.0159885,"There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group.","[{'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sarikhani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Paton', 'Affiliation': 'Faculty of Health and Sport Science, the Eastern Institute of Technology, Napier, New Zealand.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Bayati', 'Affiliation': 'Department of Exercise Physiology, Sports Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, Nikaia, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Medbase St. Gallen Am Vadianplatz, St. Gallen, Switzerland.'}]",Journal of sports science & medicine,[]
104,32390736,Acute Effects of Dynamic Stretching Followed by Vibration Foam Rolling on Sports Performance of Badminton Athletes.,"Dynamic stretching (DS) is performed to increase sports performance and is also used primarily for transiently increasing range of motion (ROM). Recently, vibration foam rolling (VFR) has emerged. Its underlying concept is that it combines foam rolling techniques with local vibration to improve ROM and muscular activation concurrently. This crossover study investigated the effects of DS or DS followed by VFR (DS + VFR) during warm-ups on flexibility, muscle stiffness, power, and agility of the lower limbs in badminton athletes. Forty badminton players performed DS or DS + VFR as warm-up exercises on two occasions in a randomized order. The target muscle groups were the bilateral shoulder, anterior and posterior thigh, posterior calf, and lower back. Main outcome measures: The primary outcome was knee range of motion (ROM), and the secondary outcomes were muscle stiffness, lower limb power (countermovement jump [CMJ]), and agility. Results indicated that the protocols improved performance. DS increased knee flexion ROM (% change = 1.92, ES = 0.3, p = 0.033), CMJ height (% change = 5.04, ES = 0.2, p = 0.004), and agility (% change = -4.97, ES = 0.4, p < 0.001) but increased quadriceps muscle stiffness (% change = 3.74, ES = 0.3, p = 0.001) and increased gastrocnemius muscle stiffness (% change = 10.39, ES = 0.5, p = 0.001). DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001). DS + VFR was not significantly superior to DS, except for muscle stiffness reduction. Taken together, we suggest that practitioners consider DS as a first line of warm-up exercise to increase ROM, CMJ height, and agility in athletes. Moreover, the addition of VFR to DS results in a large reduction of muscle stiffness, potentially reducing the risk of sports injury. Athletes, coaches and athletic professionals may consider them when selecting effective warm-up practices to augment athletic performance.",2020,"DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001).","['badminton athletes', 'Sports Performance of Badminton Athletes']","['Dynamic Stretching Followed by Vibration Foam Rolling', 'DS or DS followed by VFR (DS + VFR', 'DS + VFR', 'Dynamic stretching (DS']","['reduced quadriceps muscle stiffness', 'quadriceps muscle stiffness', 'performance', 'flexibility, muscle stiffness, power, and agility of the lower limbs', 'CMJ height', 'gastrocnemius muscle stiffness', 'DS or DS + VFR', 'knee extension ROM', 'DS increased knee flexion ROM', 'DS + VFR', 'knee range of motion (ROM), and the secondary outcomes were muscle stiffness, lower limb power (countermovement jump [CMJ]), and agility', 'ROM, CMJ height, and agility in athletes']","[{'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.0380452,"DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001).","[{'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-sen University, Kaohsiung 804, Taiwan.'}, {'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",Journal of sports science & medicine,[]
105,32390905,Insensitivity to Success and Failure: An Experimental Study of Performance-Based Feedback in Depression.,"Objective


This experimental study set out to examine the effects of performance feedback (success or failure) on depressed emotions and self-serving attribution bias in inpatients suffering from major depressive disorder (MDD).
Methods


The study was based on a 2 × 2 experimental design in which 71 MDD patients and 59 healthy controls participated. Both groups (MDD and controls) were randomly assigned to two conditions: success or failure in the performance feedback. A section of Raven's Standard Progressive Matrices (SPM) was used as a bogus test of the participants' reasoning abilities, and the Core Depressive Factor of the Zung Self-Rating Depression Scale was used to measure changes in depressed emotion in the subjects following the performance feedback. Participants then rated the accuracy of the SPM as a measure of their reasoning capacity.
Results


The levels of depressed emotions in patients with MDD did not differ significantly under the two feedback conditions. In contrast, depressed emotion levels increased significantly in healthy individuals in response to failure feedback but did not change in response to success feedback. With regard to the ratings of SPM accuracy, there was no significant difference across the two feedback conditions for depressed patients; however, the accuracy ratings were higher in the success condition than in the failure condition for the controls.
Conclusion


Individuals with MDD exhibit blunted emotional reactivity when experiencing new positive or negative social stimuli, supporting the theory of Emotion Context Insensitivity. In addition, self-serving attribution bias does not occur in MDD, which is consistent with the theory of learned helplessness in depression.",2020,"With regard to the ratings of SPM accuracy, there was no significant difference across the two feedback conditions for depressed patients; however, the accuracy ratings were higher in the success condition than in the failure condition for the controls.
","['inpatients suffering from major depressive disorder (MDD', '71 MDD patients and 59 healthy controls participated']",['performance feedback (success or failure'],"['SPM accuracy', 'accuracy ratings', 'depressed emotion levels', 'Insensitivity to Success and Failure', 'levels of depressed emotions']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",71.0,0.0255518,"With regard to the ratings of SPM accuracy, there was no significant difference across the two feedback conditions for depressed patients; however, the accuracy ratings were higher in the success condition than in the failure condition for the controls.
","[{'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Che', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Dailin', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yinxia', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xingwei', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Taisheng', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Medical Psychological Center, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00670']
106,32390910,Longitudinal Effects of Mediums of Word Explanation on L2 Vocabulary Learning Strategies Among Chinese Grade-7 Students.,"This longitudinal study investigated how different mediums of word explanation affected the use of English vocabulary strategies among Chinese Grade-7 students. 170 students were tested on their English receptive vocabulary size and vocabulary strategy application before and after an 8.33-month intervention. Students were divided into three experimental groups and one control group. The three experimental groups were provided with learning materials that explained the target vocabulary in three mediums, respectively: English-only, English-and-Chinese, and Chinese-only. Results showed that, after the intervention, receptive vocabulary size did not have any direct significant impact on vocabulary strategy development, whereas mediums of word explanation materials impacted students' application of vocabulary learning strategies (VLS) in different ways. Our findings showed that the English-only mediums significantly enhanced students' use of metacognition, cognition, and memorization strategies, but decreased social strategy development. Chinese-only mediums significantly facilitated cognition and memorization strategy development. Implications for L2 vocabulary education are discussed.",2020,"Results showed that, after the intervention, receptive vocabulary size did not have any direct significant impact on vocabulary strategy development, whereas mediums of word explanation materials impacted students' application of vocabulary learning strategies (VLS) in different ways.","['Chinese Grade-7 students', '170 students', 'Chinese Grade-7 Students']","['Mediums of Word Explanation on L2 Vocabulary Learning Strategies', 'learning materials that explained the target vocabulary in three mediums, respectively: English-only, English-and-Chinese, and Chinese-only']","[""students' use of metacognition, cognition, and memorization strategies""]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",170.0,0.0119818,"Results showed that, after the intervention, receptive vocabulary size did not have any direct significant impact on vocabulary strategy development, whereas mediums of word explanation materials impacted students' application of vocabulary learning strategies (VLS) in different ways.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon, Hong Kong.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'School of Economics and Management, China University of Petroleum, Qingdao, China.'}, {'ForeName': 'Sammy Xiao-Ying', 'Initials': 'SX', 'LastName': 'Wu', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Wei-Yang', 'Initials': 'WY', 'LastName': 'Dong', 'Affiliation': 'Department of Asian Policy Studies, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Chinese Language Studies, The Education University of Hong Kong, Tai Po, Hong Kong.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00702']
107,32390925,Selection of the Better Dual-Timed Up and Go Cognitive Task to Be Used in Patients With Stroke Characterized by Subtraction Operation Difficulties.,"Background:  The Timed Up and Go Test (TUG) with serial subtraction is commonly used to assess cognitive-dual task performance during walking for fall prediction. Some stroke patients cannot perform number subtraction and it is unclear which cognitive task can be used to substitute for the subtraction task in the TUG test. The aim of this study was to determine the type of cognitive task that produced the highest decrease on both motor and cognitive performances during TUG-dual in stroke patients.  Methods:  A total of 23 persons with stroke but capable of completing subtraction (ST) and 19 persons with subtraction operation difficulties (SOD) participated. Both groups have a similar age range (ST: 59.3 ± 10.4 years and SOD: 62.0 ± 6.8 years) and stroke onset duration (ST: 44.13 ± 62.29 months and SOD: 42.34 ± 39.69 months). The participants performed TUG without a cognitive task (TUG-single) followed by a cognitive task when seated (cognitive-single). In addition, TUG with a cognitive task (TUG-dual) was performed, with the activity randomly selected from four cognitive tasks, including alternate reciting, auditory working memory, clock task, and phonologic fluency. The main outcome variables-TUG duration measured by OPAL accelerometer and cognitive-dual task effect (DTE)-were analyzed using repeated-measures analyses of variance (ANOVA).  Results:  The number of correct responses when seated were significantly lower in the SOD as compared to the ST ( p  < 0.05) during all cognitive tasks, except the phonologic fluency. During TUG-cognitive, TUG duration in the ST was significantly longer for all cognitive tasks compared with TUG-single ( p  < 0.0001), whereas TUG duration in the SOD was significantly increased only during the phonologic fluency task ( p  < 0.01). In the ST, there was a significant difference in cognitive DTE between the subtraction and the phonologic fluency tasks ( p  < 0.01). The highest cognitive cost was found in the subtraction task, whereas the highest cognitive benefit was shown in the phonologic fluency task. No significant cognitive DTE was found among the cognitive tasks in the SOD.  Conclusion:  For stroke persons with SOD, phonologic fluency is suitable to be used in the TUG-cognitive assessment. In contrast, subtraction (by 3s) is recommended for the assessment of TUG-cognitive in stroke persons who can perform subtraction.",2020,"During TUG-cognitive, TUG duration in the ST was significantly longer for all cognitive tasks compared with TUG-single ( p  < 0.0001), whereas TUG duration in the SOD was significantly increased only during the phonologic fluency task ( p  < 0.01).","['stroke persons with SOD, phonologic fluency', 'Both groups have a similar age range (ST: 59.3 ± 10.4 years and SOD: 62.0 ± 6.8 years) and stroke onset duration (ST: 44.13 ± 62.29 months and SOD: 42.34 ± 39.69 months', 'stroke patients', '23 persons with stroke but capable of completing subtraction (ST) and 19 persons with subtraction operation difficulties (SOD) participated', 'Patients With Stroke Characterized by Subtraction Operation Difficulties']","['TUG with a cognitive task (TUG-dual', 'TUG without a cognitive task (TUG-single) followed by a cognitive task when seated (cognitive-single']","['motor and cognitive performances', 'highest cognitive cost', 'TUG duration measured by OPAL accelerometer and cognitive-dual task effect (DTE)-were analyzed using repeated-measures analyses of variance (ANOVA', 'cognitive DTE', 'phonologic fluency', 'cognitive-dual task performance', 'phonologic fluency tasks', 'TUG duration in the SOD', 'number of correct responses']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",23.0,0.0144992,"During TUG-cognitive, TUG duration in the ST was significantly longer for all cognitive tasks compared with TUG-single ( p  < 0.0001), whereas TUG duration in the SOD was significantly increased only during the phonologic fluency task ( p  < 0.01).","[{'ForeName': 'Ampha', 'Initials': 'A', 'LastName': 'Pumpho', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhonnayok, Thailand.'}, {'ForeName': 'Nithinun', 'Initials': 'N', 'LastName': 'Chaikeeree', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhonnayok, Thailand.'}, {'ForeName': 'Vitoon', 'Initials': 'V', 'LastName': 'Saengsirisuwan', 'Affiliation': 'Department of Physiology, Faculty of Science, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rumpa', 'Initials': 'R', 'LastName': 'Boonsinsukh', 'Affiliation': 'Faculty of Physical Therapy, Srinakharinwirot University, Nakhonnayok, Thailand.'}]",Frontiers in neurology,['10.3389/fneur.2020.00262']
108,32391068,Effects of six month personalized endurance training on work ability in middle-aged sedentary women: a secondary analysis of a randomized controlled trial.,"Background


To test the effects of guided endurance training on work ability in middle-aged female hospital workers of various occupations.
Methods


We randomized 265 healthy, sedentary, middle-aged women (45-65 years) to an endurance training group (EG 210 min/week) or a wait-list control group (CG). At baseline and at 6-month follow-up, we assessed work ability (Work Ability Index [WAI]), physical activity (Freiburger activity questionnaire) and peak oxygen uptake (VO 2peak ) by cardiopulmonary exercise testing. To examine the influence of baseline work ability, participants were divided into poor-moderate (WAI 1, 7-36 points,  n  = 83), good (WAI 2, 37-43 points,  n  = 136) and excellent (WAI 3, 44-49 points,  n  = 46) WAI subgroups.
Results


Cardiorespiratory fitness improved significantly after 6 months in the EG but not in the CG. The WAI total score increased significantly in the EG (38.3 ± 5.0 to 39.8 ± 4.9 points) but not in the CG (39.4 ± 4.7 to 39.3 ± 4.9 points), with a significant difference between groups ( p  < 0.01). In the EG, only the poor-moderate subgroup (WAI 1, 33.0 ± 2.9 to 36.6 ± 4.8 points,  p  < 0.05) increased the WAI total score, with this increase being significantly higher compared to the good (WAI 2, 40.2 ± 2.1 to, 40.4 ± 3.7 points) and excellent (WAI 3, 45.6 ± 1.5 to 45.7 ± 1.8 points) subgroup.
Conclusions


A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees. Women with low baseline work ability seem to particularly benefit from the intervention, which implies that similar interventions may be particularly beneficial for this group of individuals.
Trial registration


German Clinical Trails Register Identifier: DRKS00005159. Registered 25 September 2013.",2020,"Conclusions


A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees.","['middle-aged sedentary women', 'middle-aged previously sedentary hospital employees', 'middle-aged female hospital workers of various occupations', '265 healthy, sedentary, middle-aged women (45-65\u2009years) to an']","['endurance training group (EG 210\u2009min/week) or a wait-list control group (CG', 'guided endurance training', 'guided exercise training intervention', 'personalized endurance training']","['work ability (Work Ability Index [WAI]), physical activity (Freiburger activity questionnaire) and peak oxygen uptake (VO 2peak ', 'cardiorespiratory fitness', 'WAI total score', 'Cardiorespiratory fitness']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",265.0,0.047855,"Conclusions


A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees.","[{'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Eigendorf', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Kerling', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kueck', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Boyen', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Nelius', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Melk', 'Affiliation': '2Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Boethig', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Hilfiker', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Berliner', 'Affiliation': '4Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': '4Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hilfiker-Kleiner', 'Affiliation': '4Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Eberhard', 'Affiliation': '5Department of Prosthetic Dentistry and Biomedical Material Sciences, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': '5Department of Prosthetic Dentistry and Biomedical Material Sciences, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Schippert', 'Affiliation': '6Department of Obstetrics and Gynecology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haverich', 'Affiliation': '3Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Haufe', 'Affiliation': '1Institute of Sports Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}]","Journal of occupational medicine and toxicology (London, England)",['10.1186/s12995-020-00261-4']
109,32391109,Decreased biochemical progression in patients with castration-resistant prostate cancer using a novel mefenamic acid anti-inflammatory therapy: A randomized controlled trial.,"Prostate cancer (PCa) is the second most common non-dermatological cancer in men and is a growing public health problem. Castration-resistant disease (CRD) is the most advanced stage of the disease and is difficult to control. Patients with CRD may no longer accept conventional therapies as they are not in appropriate clinical conditions or they refuse to receive it. Given that inflammation is an essential component of CRD origin and progression, anti-inflammatory agents could be a therapeutic option with fenamates as one of the proposed choices. A prospective, randomized, double-blinded, 2-arm, parallel group, phase II-III clinical trial was performed involving 20 patients with CRD-PCa (with a prostate specific antigen level <100 ng/ml) that were undergoing androgen deprivation therapy (ADT) and did not accept any established treatment for that disease stage. In addition to ADT, 10 patients received placebo and 10 received mefenamic acid (500 mg orally every 12 h) for 6 months. The primary endpoint was the change in serum prostate-specific antigen (PSA) at 6 months. The PSA levels decreased significantly with mefenamic acid (an average 42% decrease), whereas there was an average 55% increase in the placebo group (P=0.024). In the patients treated with the placebo, 70% had biochemical disease progression (an increase of ≥25% in PSA levels), which did not occur in any of the patients treated with mefenamic acid (relative risk=0.12; 95% confidence interval, 0.01-0.85; P=0.033). There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment. In conclusion, mefenamic acid administration decreased biochemical progression in patients with castration resistant PCa, improved their quality of life and increased their BMI. Future studies are required in order to strengthen the findings of the present clinical trial. Trial registration, Cuban Public Registry of Clinical Trials Database RPCEC00000248, August 2017.",2020,There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment.,"['Patients with CRD', '20 patients with CRD-PCa (with a prostate specific antigen level <100 ng/ml) that were undergoing androgen deprivation therapy (ADT) and did not accept any established treatment for that disease stage', 'patients with castration resistant PCa', 'patients with castration-resistant prostate cancer']","['Castration-resistant disease (CRD', 'mefenamic acid anti-inflammatory therapy', 'mefenamic acid', 'placebo']","['biochemical progression', 'biochemical disease progression', 'quality of life (EQ-5D-5L score) and body mass index (BMI', 'PSA levels', 'change in serum prostate-specific antigen (PSA', 'quality of life and increased their BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033575', 'cui_str': 'Disorder of prostate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0231254', 'cui_str': 'Increased body mass index'}]",20.0,0.285137,There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment.,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guzman-Esquivel', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Mendoza-Hernandez', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tiburcio-Jimenez', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Oscar N', 'Initials': 'ON', 'LastName': 'Avila-Zamora', 'Affiliation': 'Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.'}, {'ForeName': 'Josuel', 'Initials': 'J', 'LastName': 'Delgado-Enciso', 'Affiliation': 'Department of Research, Foundation for Cancer Ethics, Education and Research of The Cancerology State Institute, Colima 28085, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'De-Leon-Zaragoza', 'Affiliation': 'Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Casarez-Price', 'Affiliation': 'Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.'}, {'ForeName': 'Iram P', 'Initials': 'IP', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Molecular and Structural Physiology Laboratory, School of Biological Sciences, Autonomous University of Nuevo León, Monterrey, Nuevo León 64460, Mexico.'}, {'ForeName': 'Margarita L', 'Initials': 'ML', 'LastName': 'Martinez-Fierro', 'Affiliation': 'Molecular Medicine Laboratory, Academic Unit of Human Medicine and Health Sciences, Autonomous University of Zacatecas, Zacatecas, Zacatecas 98160, Mexico.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Meza-Robles', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Barocio-Acosta', 'Affiliation': 'Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Baltazar-Rodriguez', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Zaizar-Fregoso', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Plata-Florenzano', 'Affiliation': 'Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Delgado-Enciso', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.'}]",Oncology letters,['10.3892/ol.2020.11509']
110,32391134,Are physical therapy pain levels affected by surgical approach in total hip arthroplasty? A randomized controlled trial.,"The main objective of this study was to evaluate the difference in pain levels during postoperative physical therapy pathways in patients who underwent a cement less total hip replacement either through a muscle sparing direct anterior approach (DAA), or the classic trans-gluteal lateral approach (LA). One hundred and twelve (112) patients were randomized into two equal groups. Baseline values of myoglobin levels were acquired prior to surgery and repeated at 6 hours postoperatively as a biomarker for muscle damage. Pain levels during the first passive and consecutive 3 active physical therapy sessions were noted using a visual analogue-numeric scale (VAS). Pain levels were also acquired at 6 weeks, 3 months, 6 months and 1 year, following a 20-meter (65.6 feet) walking test. Postoperative myoglobin (ng/mL) levels were significantly higher (p< 0.05) in the LA group (335.05±83.54) then the DAA group (237.71±57.54). Pain levels were significantly lower (p<0.001) in the DAA group for both passive (2.5±1.45 vs. 4.28±2.19) and active physical therapy sessions and there was a positive correlation between postoperative myoglobin levels and pain levels until 6 postoperative weeks. There was no significant difference in demographics between the two groups except for gender distribution. The direct anterior approach's main advantage of being a minimally invasive muscle sparing technique is showing a better rehabilitation experience with lower pain levels during passive and active physical therapy when compared to the classic trans-gluteal lateral approach.",2020,Postoperative myoglobin (ng/mL) levels were significantly higher (p< 0.05) in the LA group (335.05±83.54) then the DAA group (237.71±57.54).,"['patients who underwent a cement less total hip replacement either through a', 'One hundred and twelve (112) patients']","['muscle sparing direct anterior approach (DAA), or the classic trans-gluteal lateral approach (LA']","['Baseline values of myoglobin levels', 'Postoperative myoglobin (ng/mL) levels', 'visual analogue-numeric scale (VAS', 'pain levels', 'Pain levels', 'postoperative myoglobin levels and pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202142', 'cui_str': 'Myoglobin measurement, urine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",112.0,0.035969,Postoperative myoglobin (ng/mL) levels were significantly higher (p< 0.05) in the LA group (335.05±83.54) then the DAA group (237.71±57.54).,"[{'ForeName': 'Dan-Viorel', 'Initials': 'DV', 'LastName': 'Nistor', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Nicolae Ciprian', 'Initials': 'NC', 'LastName': 'Bota', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Sergiu', 'Initials': 'S', 'LastName': 'Caterev', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Todor', 'Affiliation': 'Department of Orthopedics, Traumatology and Pediatric Orthopedics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",Orthopedic reviews,['10.4081/or.2020.8399']
111,32391156,Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial.,"Background


Recent reports have demonstrated that among patients with subarachnoid hemorrhage (SAH) treated with hypertonic NaCl, resultant hyperchloremia has been associated with the development of acute kidney injury (AKI). We report a trial comparing the effect of two hypertonic solutions with different chloride contents on the resultant serum chloride concentrations in SAH patients, with a primary outcome aimed at limiting chloride elevation.
Methods


A low ChloridE hyperTonic solution for brain Edema (ACETatE) trial is a single-center, double-blinded, double-dummy, randomized pilot trial comparing bolus infusions of 23.4% NaCl and 16.4% NaCl/Na-acetate for the treatment of cerebral edema in patients with SAH. Randomization occurred when patients developed hyperchloremia (serum Cl -  ≥ 109 mmol/L) and required hyperosmolar treatment.
Results


We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment. 15 patients were randomized to the 23.4% NaCl group, and 17 patients were randomized to the 16.4% NaCl/Na-acetate group. Although serum chloride levels increased similarly in both groups, the NaCl/Acetate group showed a significantly lower Cl -  load at the end of the study period (978mEq vs. 2,464mEq,  p  < 0.01). Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01). Both solutions had similar effects on ICP reduction, but NaCl/Acetate treatment had a more prominent effect on immediate post-infusion Na +  concentrations (increase of 2.2 ± 2.8 vs. 1.4 ± 2.6, ( p  < 0.01)). Proximal tubule renal biomarkers differed in concentration between the two groups.
Conclusions


Our pilot trial showed the feasibility and safety of replacing 23.4% NaCl infusions with 16.4% NaCl/Na-acetate infusions to treat cerebral edema in patients with SAH. The degree of hyperchloremia was similar in the two groups. 16.4% NaCl/Na-acetate infusions led to lower Cl -  load and AKI rates than 23.4% NaCl infusions. Further multi-center studies are needed to corroborate these results.
Trial registration


clinicaltrials.gov # NCT03204955, registered on 6/28/2017.",2020,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01).","['subarachnoid hemorrhage-related complications', 'We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment', 'SAH patients', '15 patients were randomized to the 23.4% NaCl group, and 17 patients', 'patients with SAH', 'patients with subarachnoid hemorrhage (SAH) treated with']","['hypertonic NaCl', 'low ChloridE hyperTonic solution', 'NaCl and 16.4% NaCl/Na-acetate', 'NaCl/Na-acetate group', 'NaCl infusions with 16.4% NaCl/Na-acetate infusions', 'Low-chloride- versus high-chloride-containing hypertonic solution', 'hypertonic solutions']","['degree of hyperchloremia', 'cerebral edema', 'ICP reduction', 'serum chloride levels', 'reduced rate of AKI', 'Cl -  load', 'feasibility and safety', 'immediate post-infusion Na +  concentrations', 'lower Cl -  load and AKI rates']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0860861', 'cui_str': 'Cl- decreased'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1317978', 'cui_str': 'Serum chloride measurement'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",59.0,0.317213,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01).","[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Sadan', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': '2Department of Critical Care Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ 85054 USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Joao McONeil', 'Initials': 'JM', 'LastName': 'Plancher', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander C M', 'Initials': 'ACM', 'LastName': 'Greven', 'Affiliation': '3School of Medicine, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Kandiah', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Cederic', 'Initials': 'C', 'LastName': 'Pimentel', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Papangelou', 'Affiliation': '4Department of Anesthesiology, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Asbury', 'Affiliation': '5Department of Pharmacy, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': '6Department of Biostatistics and Bioinformatics, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Samuels', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}]",Journal of intensive care,['10.1186/s40560-020-00449-0']
112,32391158,Fear-avoidance beliefs are associated with exercise adherence: secondary analysis of a randomised controlled trial (RCT) among female healthcare workers with recurrent low back pain.,"Background


Exercise is recommended for the treatment and management of low back pain (LBP) and the prevention of chronicity. Exercise adherence has been only modest in intervention studies among people with musculoskeletal pain. Fear-avoidance beliefs (FABs) are known to affect exercise adherence. The purpose  was twofold: to examine which bio-psycho-social factors contributed to exercise adherence during a 6-month neuromuscular exercise intervention among female healthcare workers with recurrent LBP, and to investigate how exercising affects FABs at 6 and 12 months' follow-up.
Methods


Some 219 healthcare workers aged 30-55 years with mild-to-moderate re-current non-specific LBP were originally allocated into: 1) exercise, 2) counselling, 3) combined exercise and counselling, and 4) control groups. In the present secondary analysis, groups 1 and 3 (exercise only and exercise+counselling) were merged to be exercisers and groups 2 and 4 were merged to be non-exercisers. Baseline variables of the exercise compliers (≥24 times over 24 weeks;  n  = 58) were compared to those of the non-compliers (< 1 time/week, 0-23 times;  n  = 52). The effects of the exercise programme on FABs were analysed by a generalised linear mixed model according to the intention-to-treat principle (exercisers;  n  = 110 vs non-exercisers;  n  = 109) at three measurement points (baseline, 6, and 12 months). A per-protocol analysis compared the more exercised to the less exercised and non-exercisers.
Results


A low education level ( p  = 0.026), shift work ( p  = 0.023), low aerobic  (p  = 0.048) and musculoskeletal ( p  = 0.043) fitness, and high baseline physical activity-related FABs ( p  = 0.019) were related to low exercise adherence. The exercise programme reduced levels of both physical activity- and work-related FABs, and there was a dose response: FABs reduced more in persons who exercised ≥24 times compared to those who exercised 0-23 times.
Conclusion


Healthcare workers who had lower education and fitness levels, worked shifts, and had high physical activity-related FABs had a lower adherence to the 6-month neuromuscular exercise programme. Exercising with good adherence reduced levels of FABs, which have been shown to be linked with prolonged LBP. Motivational strategies should be targeted at persons with low education and fitness levels and high FABs in order to achieve better exercise adherence.",2020,"The exercise programme reduced levels of both physical activity- and work-related FABs, and there was a dose response: FABs reduced more in persons who exercised ≥24 times compared to those who exercised 0-23 times.
","['people with musculoskeletal pain', '219 healthcare workers aged 30-55\u2009years with mild-to-moderate re-current non-specific LBP', 'female healthcare workers with recurrent low back pain', 'female healthcare workers with recurrent LBP']","['neuromuscular exercise intervention', '\n\n\nExercise', 'exercise programme', 'exercise, 2) counselling, 3) combined exercise and counselling, and 4) control groups']","['low aerobic', 'high baseline physical activity-related FABs', 'FABs', 'musculoskeletal', 'levels of both physical activity- and work-related FABs', 'Fear-avoidance beliefs (FABs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0751648', 'cui_str': 'Recurrent Low Back Pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",219.0,0.0379503,"The exercise programme reduced levels of both physical activity- and work-related FABs, and there was a dose response: FABs reduced more in persons who exercised ≥24 times compared to those who exercised 0-23 times.
","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Taulaniemi', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Kankaanpää', 'Affiliation': '2Department of Physical and Rehabilitation Medicine, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Rinne', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Tokola', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Parkkari', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}, {'ForeName': 'Jaana H', 'Initials': 'JH', 'LastName': 'Suni', 'Affiliation': '1UKK Institute for Health Promotion Research, Tampere, Finland.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00177-w']
113,32391167,"Body, Soul and Spirit, an adaptation of two evidence-based interventions to promote physical activity and healthy eating among adults in churches in Lagos Nigeria: a three-arm cluster randomized controlled pilot trial.","Background


Physical inactivity and unhealthy eating are two leading behavioral risk factors contributing to preventable non-communicable diseases (NCDs). Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries. Comparatively, evidence of such interventions is sparse in low- and middle-income countries, where NCD mortality is greater. This paper describes the protocol for the development of the cultural adaptation and pilot testing of a combination of two EBI (i.e., Body and Soul and the Healthy Body Healthy Spirit), in church-based settings in Lagos, Nigeria. In addition, we describe the development of the inclusion of an additional component, i.e., faith-based text messages, into one of the treatment arms. Our objective is to assess the feasibility of developing and implementing the adapted interventions with the ultimate aim of developing a fully powered trial.
Methods


This pilot study will assess the design and implementation of a three-arm cluster-randomized pilot trial in 12 randomly selected Anglican churches (4 in each arm). First, we will design a cultural adaptation of the two EBI's to form a multifaceted combined intervention known as the  Body Soul and Spirit . The second treatment arm, i.e.,  Body Soul and Spirit Plus , will retain all the components of  Body Soul and Spirit  with the inclusion of faith-based text messages using mobile phones. Participants in the control arm will receive information leaflets designed to increase physical activity and healthy food consumption. The outcome measures include participant recruitment and retention, program participation and satisfaction, and data collection completion rates. The outcomes for the proposed definitive trial will be the number of servings of fruit and vegetables and minutes of moderate to vigorous physical activity per day will be assessed at baseline, 3 and 6-month follow-up. Implementation outcomes will be assessed using qualitative and quantitative methods.
Discussion


The study will enhance the understanding of how best to design and implement behavioral interventions in church-based settings using community-based participatory approaches. It will also inform the development of a definitive randomized controlled trial.
Trial registration


Pan African Clinical Trials Registry on 12th July 2018. PACTR201807136835945. Available at https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3481.",2020,Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries.,"['Healthy Body Healthy Spirit), in church-based settings in Lagos, Nigeria', 'adults in churches in Lagos Nigeria', '12 randomly selected Anglican churches (4 in each arm']",['Body Soul and Spirit'],"['participant recruitment and retention, program participation and satisfaction, and data collection completion rates', 'physical activity and healthy food consumption']","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337726', 'cui_str': 'Anglican Church'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",12.0,0.111384,Evidence-based interventions (EBI) using community-engaged approaches to address these risks abound in high-income countries.,"[{'ForeName': 'Oluwakemi Ololade', 'Initials': 'OO', 'LastName': 'Odukoya', 'Affiliation': '1Department of Community Health and Primary Care, College of Medicine, University of Lagos, State, Lagos, Nigeria.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Manortey', 'Affiliation': 'ENSIGN School of Public Health, Kpong, Ghana.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': '3Department of Family Medicine and Public Health, School of Medicine, UC San Diego, San Diego, CA USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Alder', 'Affiliation': 'ENSIGN School of Public Health, Kpong, Ghana.'}, {'ForeName': 'Kolawole S', 'Initials': 'KS', 'LastName': 'Okuyemi', 'Affiliation': '5Department of Family and Preventive Medicine, University of Utah School Of Medicine, Salt Lake City, UT USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00600-6']
114,32391263,A Retrospective Exploration of Targeted Maintenance Therapy in Advanced Colorectal Cancer: Based on the Background of Chinese Patient Assistance Program.,"Background:  Maintenance therapy with bevacizumab (Bev) in patients with colorectal cancer (CRC) provides progression-free survival (PFS) benefits. However, the role of maintenance therapy with an anti-EGFR monoclonal antibody has not been established.  Methods:  Eligible CRC patients were assigned to maintenance therapy with cetuximab (Cet; Cet group) or Bev (Bev group). PFS, the duration of maintenance therapy, and safety were analyzed. Cox multivariate regression analyses were performed to determine independent prognostic factors.  Results:  A total of 143 eligible patients were assigned to the Cet ( n  = 79) or Bev ( n  = 64) groups. In the Cet group, all patients had KRAS wild-type. The baseline characteristics were well-balanced between the two groups, except for a higher percentage of patients with a left-sided primary tumor in the Cet group than in the Bev group (86.1 vs. 62.5%,  P  < 0.0001). The median PFS was not significantly different between the Cet group and the Bev group: 5.9 months (95% CI 2.30-9.50) vs. 7.0 months (95% CI 3.69-10.31) (HR 1.17, 95% CI 0.77-1.79,  P  = 0.45). The median duration of maintenance therapy in the Cet group was shorter than that in the Bev group: 4.0 months (95% CI 1.94-5.99) vs. 4.8 months (95% CI 2.68-6.98) (HR 0.90, 95% CI 0.61-1.33;  P  = 0.59). The subgroup analyses showed that the median PFS for the first maintenance therapy and the second maintenance therapy were 3.2 months (95% CI 1.69-4.78) and 5.2 months (95% CI 1.58-8.83), respectively (HR 0.89, 95% CI 0.44-1.81;  P  = 0.75).  Conclusions:  This study suggests that maintenance therapy with Cet or Bev can be considered an appropriate option following induction chemotherapy for selected patients with advanced CRC. Multiple maintenance therapy seems to confer survival benefits in advanced CRC. Maintenance therapy with Cet after first-line induction chemotherapy seems to be associated with greater survival benefits.",2020,"The median PFS was not significantly different between the Cet group and the Bev group: 5.9 months (95% CI 2.30-9.50) vs. 7.0 months (95% CI 3.69-10.31) (HR 1.17, 95% CI 0.77-1.79,  P  = 0.45).","['selected patients with advanced CRC', 'patients with colorectal cancer (CRC', 'Advanced Colorectal Cancer', 'Eligible CRC patients', '143 eligible patients were assigned to the Cet ( n  = 79) or Bev ( n  = 64) groups']","['maintenance therapy with cetuximab (Cet; Cet group) or Bev (Bev group', 'bevacizumab (Bev']","['median duration of maintenance therapy', 'PFS, the duration of maintenance therapy, and safety', 'survival benefits', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",143.0,0.0515908,"The median PFS was not significantly different between the Cet group and the Bev group: 5.9 months (95% CI 2.30-9.50) vs. 7.0 months (95% CI 3.69-10.31) (HR 1.17, 95% CI 0.77-1.79,  P  = 0.45).","[{'ForeName': 'Hanguang', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dehao', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Cancer Institute (Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education), The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Junxi', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Departments of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.00522']
115,32391304,Effects of a Participatory School-Based Intervention on Students' Health-Related Knowledge and Understanding.,"Introduction:  The development of knowledge and understanding in relation to movement and health is a basic requirement to facilitate lifelong engagement in physical activity with its accompanying possible health benefits. To train teachers in applying adequate strategies, implementation studies have often shown little acceptance of traditional top-down approaches. Thus, the purpose of the Health.edu project was to develop, implement and evaluate effective and feasible measures addressing students' health-related knowledge and understanding (HKU) in physical education (PE) via a participatory approach.  Materials and Methods:  For evaluation, a controlled pre-post-test study with 233 students from eight different secondary schools in Germany was carried out. Four schools (with two PE teachers at each school) comprised the intervention group and they participated in a 1-year participatory planning process to conceptualize and implement evidence-based PE lessons addressing students' HKU. Control schools carried out their regular PE lessons. Evaluation followed a mixed-methods research design, assessing program implementation via written documentary technique as well as program effectiveness using a standardized questionnaire.  Results:  Results show a significant intervention effect on students' HKU with a medium effect size. However, due to the participatory process, there were considerable differences between the intervention schools that were involved. Student's HKU improved most in schools where program implementation corresponded to relevant principles of fostering HKU.  Discussion:  The present study purposefully dispensed with any structured intervention programs for PE teachers to follow. The results show the potential effects of this participatory approach to strengthen student's HKU. However, the participatory planning does not always work in the intended manner, emphasizing that numerous contextual factors influence the implementation process.",2020,Results show a significant intervention effect on students' HKU with a medium effect size.,"['Four schools (with two PE teachers at each school', '233 students from eight different secondary schools in Germany was carried out', ""Students' Health-Related Knowledge and Understanding""]","[""1-year participatory planning process to conceptualize and implement evidence-based PE lessons addressing students' HKU"", 'Participatory School-Based Intervention']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],233.0,0.0189003,Results show a significant intervention effect on students' HKU with a medium effect size.,"[{'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Strobl', 'Affiliation': 'Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Ptack', 'Affiliation': 'Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Töpfer', 'Affiliation': 'Department of Sport Science and Sport, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sygusch', 'Affiliation': 'Department of Sport Science and Sport, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Tittlbach', 'Affiliation': 'Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.'}]",Frontiers in public health,['10.3389/fpubh.2020.00122']
116,32391374,An Acute Reduction in Habitual Protein Intake Attenuates Post Exercise Anabolism and May Bias Oxidation-Derived Protein Requirements in Resistance Trained Men.,"Protein recommendations for resistance-trained athletes are generally lower than their habitual intakes. Excess protein consumption increases the capacity to oxidize amino acids, which can attenuate post-exercise anabolism and may impact protein requirements determined by stable isotope techniques predicated on amino acid tracer oxidation. We aimed to determine the impact of an acute (5d) reduction in dietary protein intake on post-exercise anabolism in high habitual consumers using the indicator amino acid oxidation (IAAO) technique. Resistance trained men [ n  = 5; 25 ± 7 y; 73.0 ± 5.7 kg; 9.9 ± 2.9% body fat; 2.69 ± 0.38 g·kg -1 ·d -1  habitual protein intake) consumed a high (H; 2.2 g·kg -1 ·d -1 ) and moderate (M; 1.2 g·kg -1 ·d -1 ) protein diet while training every other day. During the High protein phase, participants consumed a 2d controlled diet prior to determining whole body phenylalanine turnover, net balance (NB), and  13 CO 2  excretion (F 13 CO 2 ) after exercise via oral [ 13 C]phenylalanine. During the Moderate phase, participants consumed 2.2 g protein·kg -1 ·d -1  for 2d prior to consuming 1.2 g protein·kg -1 ·d -1  for 5d. Phenylalanine metabolism was measured on days 1, 3, and 5 (M1, M3, and M5, respectively) of the moderate intake. F 13 CO 2 , the primary outcome for IAAO, was ~72 and ~55% greater on the 1st day (M1,  P  < 0.05) and the third day of the moderate protein diet (M3,  P  = 0.07), respectively, compared to the High protein trial. Compared to the High protein trial, NB was ~25% lower on the 1st day (M1,  P  < 0.01) and 15% lower on the third day of the moderate protein diet (M3,  P  = 0.09). High habitual protein consumption may bias protein requirements determined by traditional IAAO methods that use only a 2d pre-trial controlled diet. Post-exercise whole body anabolism is attenuated following a reduction in protein intake in resistance trained men and may require ~3-5d to adapt. This trial is registered at clinicaltrials.gov as NCT03845569.",2020,Post-exercise whole body anabolism is attenuated following a reduction in protein intake in resistance trained men and may require ~3-5d to adapt.,"['Resistance Trained Men', 'Resistance trained men [ n  = 5; 25 ± 7 y; 73.0 ± 5.7 kg; 9.9 ± 2.9% body fat; 2.69 ± 0.38 g·kg -1 ·d -1  habitual protein intake) consumed a high (H; 2.2 g·kg -1 ·d -1 ) and moderate (M; 1.2 g·kg -1 ·d -1 ) protein diet while training every other day', 'high habitual consumers']",[],"['Phenylalanine metabolism', 'IAAO']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517456', 'cui_str': '0.38'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0452269', 'cui_str': 'Protein diet'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}]",[],"[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0298941,Post-exercise whole body anabolism is attenuated following a reduction in protein intake in resistance trained men and may require ~3-5d to adapt.,"[{'ForeName': 'Cassidy T', 'Initials': 'CT', 'LastName': 'Tinline-Goodfellow', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel W D', 'Initials': 'DWD', 'LastName': 'West', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Malowany', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00055']
117,32391524,Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS).,"Background


Implementing and sustaining evidence-based programs with fidelity may require multiple implementation strategies tailored to address multi-level, context-specific barriers and facilitators. Ideally, selecting and tailoring implementation strategies should be guided by theory, evidence, and input from relevant stakeholders; however, methods to guide the selection and tailoring of strategies are not well-developed. There is a need for more rigorous methods for assessing and prioritizing implementation determinants (barriers and facilitators) and linking implementation strategies to determinants. The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment. COAST-IS will enable organizational leaders and clinicians to use Intervention Mapping to select and tailor implementation strategies to address their site-specific needs. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change.
Methods


COAST-IS will be piloted with community mental health organizations that are working to address the needs of children and youth who experience trauma-related emotional or behavioral difficulties by engaging in a learning collaborative to implement an evidence-based psychosocial intervention (trauma-focused cognitive behavioral therapy). Organizations will be matched and then randomized to participate in the learning collaborative only (control) or to receive additional support through COAST-IS. The primary aims of this study are to (1) assess the acceptability, appropriateness, feasibility, and perceived utility of COAST-IS; (2) evaluate the organizational stakeholders' fidelity to the core elements of COAST-IS; and (3) demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial.
Discussion


COAST-IS is a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. If effective, COAST-IS has the potential to improve the implementation and sustainment of a wide range of evidence-based practices in mental health and other sectors.
Trial registration


This study was registered in ClinicalTrials.gov (NCT03799432) on January 10, 2019 (last updated August 5, 2019).",2020,The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment.,"['community mental health organizations', 'January 10, 2019 (last updated August 5, 2019']",[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]",[],[],,0.0998777,The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment.,"[{'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Haley', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sheila V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Amaya-Jackson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Glienke', 'Affiliation': 'North Carolina Child Treatment Program, Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Mellicent', 'Initials': 'M', 'LastName': 'Blythe', 'Affiliation': 'North Carolina Child Treatment Program, Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lengnick-Hall', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'McCrary', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Lewis', 'Affiliation': 'MacColl Center for Health Care Innovation, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, Child and Adolescent Services Research Center, University of California San Diego School of Medicine, San Diego, CA, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Implementation science communications,['10.1186/s43058-020-00009-5']
118,32391555,Differences in smoking topography and subjective responses to smoking among African American and White menthol and non-menthol smokers.,"INTRODUCTION


It has been suggested that menthol increases exposure to harmful elements of smoking and makes smoking more rewarding, easier to initiate, and harder to quit. Isolating the direct effects of menthol is challenging as African American (AA) race and menthol preference are highly overlapping. This study evaluated smoking behavior and subjective responses among a balanced sample of AA and White menthol and non-menthol smokers. In addition, smoking topography (ST) was compared to naturalistic smoking (NS) and interactions with menthol and race were explored.
METHODS


Smokers (N = 100) smoked and rated their preferred brand of cigarette via ST or NS during two laboratory visits (counterbalanced).
RESULTS


Controlling for baseline differences among the groups (e.g., nicotine dependence), menthol smokers took shorter and smaller puffs and AA smokers took longer puffs, but there were no differences in total puff volume, carbon monoxide, or other ST parameters. Menthol smokers reported greater urge reduction and lower sensory stimulation. Smoking method (ST vs NS) had no effects on smoking behavior or exposure. Cigarettes smoked via ST were rated stronger. Differences in satisfaction based on smoking method interacted with race and menthol status. Ratings of aversion differed by race and menthol status.
CONCLUSIONS


Menthol was not associated with increased smoke exposure or reward (except for urge reduction). ST caused minimal experimental reactivity relative to NS. Additional research that isolates the effects of menthol and examines potential interactive effects with race and other variables is needed to better understand its role in smoking-related health disparities.",2020,Smoking method (ST vs NS) had no effects on smoking behavior or exposure.,"['Smokers (N = 100) smoked and rated their preferred brand of cigarette via ST or NS during two laboratory visits (counterbalanced', 'balanced sample of AA and White menthol and non-menthol smokers', 'African American and White menthol and non-menthol smokers']","['ST', 'menthol']","['total puff volume, carbon monoxide, or other ST parameters', 'smoking behavior and subjective responses', 'urge reduction and lower sensory stimulation', 'smoking behavior or exposure', 'smoke exposure or reward']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",100.0,0.0108914,Smoking method (ST vs NS) had no effects on smoking behavior or exposure.,"[{'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Gunawan', 'Affiliation': 'Behavior, Cognition, & Neuroscience, Department of Psychology, American University, NW, Washington, DC.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Juliano', 'Affiliation': 'Department of Psychology, American University, NW, Washington DC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa079']
119,32391584,Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: a randomised clinical study.,"AIM


To compare efficacy of an anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control) for dentine hypersensitivity relief after 8 weeks' twice-daily use.
MATERIALS AND METHODS


In this randomised, examiner-blind, stratified, parallel study, primary and secondary efficacy variables were mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe), respectively, from baseline to Week 8 between Test (n=62) and Negative control (n=62). Test and Positive control (n=61) comparisons were exploratory objectives.
RESULTS


All groups significantly improved from baseline on both dentine hypersensitivity measures (p<0.0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p=0.0476; 12.57% difference). Difference in tactile threshold was -7.20g (95% CI -16.376, 1.975), this was not statistically significant (p=0.3715; -21.83% difference). Test group showed no significant difference versus Positive Control for either measure. Toothpastes were generally well tolerated.
CONCLUSION


Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls.
STUDY REGISTRATION


Clinicaltrials.gov; NCT03310268.",2020,"Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls.
",[],"['anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control', 'anhydrous stannous fluoride toothpaste']","['dentine hypersensitivity', 'tolerated', 'mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe', 'dentine hypersensitivity relief', 'dentine hypersensitivity measures', 'Schiff sensitivity scores']",[],"[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C1247980', 'cui_str': 'Sodium Fluoride Toothpaste'}, {'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1253019', 'cui_str': 'Stannous Fluoride Toothpaste'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0429399', 'cui_str': 'Tactile threshold'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.132493,"Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls.
","[{'ForeName': 'Danying', 'Initials': 'D', 'LastName': 'Tao', 'Affiliation': ""Department of Preventative Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University, School of Medicine, National Clinical Research Center for Oral Disease, Shanghai Key Laboratory of Stomatology &, Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Ling', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}, {'ForeName': 'Xi-Ping', 'Initials': 'XP', 'LastName': 'Feng', 'Affiliation': ""Department of Preventative Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University, School of Medicine, National Clinical Research Center for Oral Disease, Shanghai Key Laboratory of Stomatology &, Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gallob', 'Affiliation': 'Consumer Research Consulting, LLC, Las Vegas, NV, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Souverain', 'Affiliation': 'GSK Consumer Healthcare, Nyon, Switzerland.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Preventative Dentistry, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University, School of Medicine, National Clinical Research Center for Oral Disease, Shanghai Key Laboratory of Stomatology &, Shanghai Research Institute of Stomatology, Shanghai, China.""}, {'ForeName': 'Anousheh', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}]",Journal of clinical periodontology,['10.1111/jcpe.13305']
120,32305578,"Response to ""Effect of Aromatherapy Massage on Quality of Sleep in the Palliative Care Ward: Randomized Controlled Trial"".",,2020,,[],['Aromatherapy Massage'],['Quality of Sleep'],[],"[{'cui': 'C2585844', 'cui_str': 'Aromatherapy massage'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0879721,,"[{'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Nursing, National Defense Medical College, Tokorozawa, Japan. Electronic address: masamitsu4k26@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kako', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Japanese Red Cross Kyushu International College of Nursing, Fukuoka, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Oosono', 'Affiliation': 'Faculty of Nursing, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Noto', 'Affiliation': 'Department of Health Sciences, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.007']
121,32371830,Effects of intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement on oxygenation and respiratory mechanics during laparoscopic gynaecological surgery: A randomised controlled trial.,"BACKGROUND


The creation of pneumoperitoneum during laparoscopic surgery can lead to adverse effects on the respiratory system. Positive end-expiratory pressure (PEEP) plays an important role in mechanical ventilation during laparoscopic surgery.
OBJECTIVE


To evaluate whether PEEP setting guided by oesophageal pressure (Poeso) measurement would affect oxygenation and respiratory mechanics during laparoscopic gynaecological surgery.
DESIGN


A randomised controlled study.
SETTING


A single-centre trial from March 2018 to June 2018.
PATIENTS


Forty-four adult patients undergoing laparoscopic gynaecological surgery with anticipated duration of surgery more than 2 h.
INTERVENTION


PEEP set according to Poeso measurement (intervention group) versus PEEP constantly set at 5 cmH2O (control group).
MAIN OUTCOME MEASURES


Gas exchange and respiratory mechanics after induction and intubation (T0) and at 15 and 60 min after initiation of pneumoperitoneum (T1 and T2, respectively).
RESULTS


PEEP during pneumoperitoneum was significantly higher in the intervention group than in the control group (T1, 12.5 ± 1.9 vs. 5.0 ± 0.0 cmH2O and T2, 12.4 ± 1.9 vs. 5.0 ± 0.0 cmH2O, both P < 0.001). Partial pressures of oxygen decreased significantly from baseline during pneumoperitoneum in the control group but not in the intervention group. Nevertheless, the changes in partial pressures of oxygen did not differ between groups. Compliance of the respiratory system (CRS) significantly decreased and driving pressure significantly increased during pneumoperitoneum in both groups. However, the changes in CRS and driving pressure were significantly less in the intervention group. Transpulmonary pressure during expiration was maintained in the intervention group while it decreased significantly in the control group.
CONCLUSION


PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03256396.",2020,"PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
","['laparoscopic gynaecological surgery', 'A single-centre trial from March 2018 to June 2018', 'Forty-four adult patients undergoing laparoscopic gynaecological surgery with anticipated duration of surgery more than 2\u200ah']","['intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement', 'PEEP set according to Poeso measurement (intervention group) versus PEEP constantly set at 5\u200acmH2O (control group', 'PEEP setting guided by oesophageal pressure (Poeso) measurement']","['oxygenation and respiratory mechanics', 'CRS and driving pressure', 'driving pressure', 'partial pressures of oxygen', 'Partial pressures of oxygen', 'Positive end-expiratory pressure (PEEP', 'Gas exchange and respiratory mechanics after induction and intubation (T0) and at 15 and 60\u200amin after initiation of pneumoperitoneum (T1 and T2, respectively', 'Transpulmonary pressure during expiration']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0807495', 'cui_str': 'Positive end expiratory pressure setting'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",44.0,0.183262,"PEEP setting guided by Poeso measurement showed no beneficial effects in terms of oxygenation but respiratory mechanics were better during laparoscopic gynaecological surgery.
","[{'ForeName': 'Annop', 'Initials': 'A', 'LastName': 'Piriyapatsom', 'Affiliation': 'From the Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand (AP, SP).'}, {'ForeName': 'Sanchai', 'Initials': 'S', 'LastName': 'Phetkampang', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001204']
122,32375684,Health management committee strengthening and community mobilisation through women's groups to improve trained health worker attendance at birth in rural Nepal: a cluster randomised controlled trial.,"BACKGROUND


Engaging citizens and communities to make services accountable is vital to achieving health development goals. Community participation in health management committees can increase public accountability of health services. We conducted a cluster randomised controlled trial to test the impact of strengthened health management committees (HMCs) and community mobilisation through women's groups on institutional deliveries and deliveries by trained health workers in rural Nepal.
METHODS


The study was conducted in all Village Development Committee clusters in the hills district of Makwanpur (population of 420,500). In 21 intervention clusters, we conducted three-day workshops with HMCs to improve their capacity for planning and action and supported female community health volunteers to run women's groups. These groups met once a month and mobilised communities to address barriers to institutional delivery through participatory learning and action cycles. We compared this intervention with 22 control clusters. Prospective surveillance from October 2010 to the end of September 2012 captured complete data on 13,721 deliveries in intervention and control areas. Analysis was by intention to treat.
RESULTS


The women's group intervention was implemented as intended, but we were unable to support HMCs as planned because many did not meet regularly. The activities of community based organisations were systematically targeted at control clusters, which meant that there were no true 'control' clusters. 39% (5403) of deliveries were in health institutions and trained health workers attended most of them. There were no differences between trial arms in institutional delivery uptake (1.45, 0.76-2.78) or attendance by trained health workers (OR 1.43, 95% CI 0.74-2.74).
CONCLUSIONS


The absence of a true counterfactual and inadequate coverage of the HMC strengthening intervention impedes our ability to draw conclusions. Further research is needed to test the effectiveness of strengthening public accountability mechanisms on increased utilisation of services at delivery.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN99834806. Date of registration:28/09/10.",2020,"There were no differences between trial arms in institutional delivery uptake (1.45, 0.76-2.78) or attendance by trained health workers (OR 1.43, 95% CI 0.74-2.74).
","[""through women's groups on institutional deliveries and deliveries by trained health workers in rural Nepal"", 'Prospective surveillance from October 2010 to the end of September 2012 captured complete data on 13,721 deliveries in intervention and control areas', ""female community health volunteers to run women's groups"", 'all Village Development Committee clusters in the hills district of Makwanpur (population of 420,500', ""women's groups to improve trained health worker attendance at birth in rural Nepal""]","['HMC strengthening intervention', 'strengthened health management committees (HMCs) and community mobilisation', 'registration:28/09/10']",['institutional delivery uptake'],"[{'cui': 'C0242543', 'cui_str': ""Women's Groups""}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0442532', 'cui_str': 'Hill'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",420500.0,0.114859,"There were no differences between trial arms in institutional delivery uptake (1.45, 0.76-2.78) or attendance by trained health workers (OR 1.43, 95% CI 0.74-2.74).
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK. Joanna.morrison@ucl.ac.uk.'}, {'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Tumbahangphe', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gram', 'Affiliation': 'Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Budhathoki', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Neupane', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Thapa', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Kunta', 'Initials': 'K', 'LastName': 'Dahal', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Bidur', 'Initials': 'B', 'LastName': 'Thapa', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Dharma', 'Initials': 'D', 'LastName': 'Manandhar', 'Affiliation': 'Mother and Infant Research Activities, PO Box 921, Thapathali, Kathmandu, Nepal.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Costello', 'Affiliation': 'Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osrin', 'Affiliation': 'Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02960-6']
123,32377523,"Carrageenan-Free Diet Shows Improved Glucose Tolerance and Insulin Signaling in Prediabetes: A Randomized, Pilot Clinical Trial.","Objectives


Carrageenan is well known to cause inflammation and is used in laboratory experiments to study mediators and treatments of inflammation. However, carrageenan is added to hundreds of processed foods to improve texture. Previous work indicated that low concentrations of carrageenan in drinking water caused marked glucose intolerance and insulin resistance in a mouse model. This exploratory, clinical study tested the impact of the no-carrageenan diet in prediabetes.  Research Design and Methods . Participants with prediabetes ( n  = 13), defined as HbA1c of 5.7%-6.4%, enrolled in a 12-week, randomized, parallel-arm, feeding trial. One group ( n  = 8) was provided all meals and snacks with no carrageenan. A second group ( n  = 5) received a similar diet with equivalent content of protein, fat, and carbohydrate, but with carrageenan. Blood samples were collected at baseline and during oral glucose tolerance tests at 6 and 12 weeks. The primary outcome measure was changed in %HbA1c between baseline and 12 weeks. Statistical analysis included paired and unpaired  t -tests, correlations, and 2 × 2 ANOVAs.
Results


Subjects on no carrageenan had declines in HbA1c and HOMA-IR ( p  = 0.006,  p  = 0.026; paired  t -test, two tailed). They had increases in C-peptide ( p  = 0.029) and Matsuda Index (2.1 ± 0.7 to 4.8 ± 2.3;  p  = 0.052) and declines in serum IL-8, serum galectin-3, and neutrophil phospho-(Ser307/312)-IRS1 ( p  = 0.049,  p  = 0.003, and  p  = 0.006; paired  t -tests, two tailed). Subjects on the diet with carrageenan had no significant changes in these parameters. Significant differences between no-carrageenan and carrageenan-containing diet groups for changes from baseline to 12 weeks occurred in C-peptide, phospho-Ser-IRS1, phospho-AKT1, and mononuclear cell arylsulfatase B ( p  = 0.007,  p  = 0.038,  p  = 0.0012, and  p  = 0.0008; 2 × 2 ANOVA). Significant correlations were evident between several of the variables.
Conclusions


Findings indicate improvement in HbA1c and HOMA-IR in participants on no-carrageenan diets, but not in participants on carrageenan-containing diets. Significant differences between groups suggest that removing carrageenan may improve insulin signaling and glucose tolerance. Larger studies are needed to further consider the impact of carrageenan on development of diabetes.",2020,"They had increases in C-peptide ( p  = 0.029) and Matsuda Index (2.1 ± 0.7 to 4.8 ± 2.3;  p  = 0.052) and declines in serum IL-8, serum galectin-3, and neutrophil phospho-(Ser307/312)-IRS1 ( p  = 0.049,  p  = 0.003, and  p  = 0.006; paired  t -tests, two tailed).","['in Prediabetes', 'prediabetes', 'Participants with prediabetes ( n  = 13), defined as HbA1c of 5.7%-6.4']","['Carrageenan-Free Diet', 'similar diet with equivalent content of protein, fat, and carbohydrate, but with carrageenan']","['HbA1c and HOMA-IR', 'Blood samples', 'insulin signaling and glucose tolerance', 'Glucose Tolerance and Insulin Signaling', 'Matsuda Index', 'C-peptide', 'glucose intolerance and insulin resistance', 'serum IL-8, serum galectin-3, and neutrophil phospho-(Ser307/312)-IRS1']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0007289', 'cui_str': 'Carrageenan'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0123658', 'cui_str': 'Insulin Receptor Substrate-1'}]",,0.0310569,"They had increases in C-peptide ( p  = 0.029) and Matsuda Index (2.1 ± 0.7 to 4.8 ± 2.3;  p  = 0.052) and declines in serum IL-8, serum galectin-3, and neutrophil phospho-(Ser307/312)-IRS1 ( p  = 0.049,  p  = 0.003, and  p  = 0.006; paired  t -tests, two tailed).","[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Feferman', 'Affiliation': 'Department of Medicine, College of Medicine, University of Illinois at Chicago and Jesse Brown VA Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Medicine, College of Medicine, University of Illinois at Chicago and Jesse Brown VA Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Oates', 'Affiliation': 'Department of Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Haggerty', 'Affiliation': 'Department of Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Tianxiu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Varady', 'Affiliation': 'Department of Nutrition, College of Applied Health Sciences, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Joanne K', 'Initials': 'JK', 'LastName': 'Tobacman', 'Affiliation': 'Department of Medicine, College of Medicine, University of Illinois at Chicago and Jesse Brown VA Medical Center, Chicago, IL, USA.'}]",Journal of diabetes research,['10.1155/2020/8267980']
124,32382082,High-risk additional chromosomal abnormalities at low blast counts herald death by CML.,"Blast crisis is one of the remaining challenges in chronic myeloid leukemia (CML). Whether additional chromosomal abnormalities (ACAs) enable an earlier recognition of imminent blastic proliferation and a timelier change of treatment is unknown. One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV were analyzed for ACA/Ph+ and blast increase. By impact on survival, ACAs were grouped into high risk (+8, +Ph, i(17q), +17, +19, +21, 3q26.2, 11q23, -7/7q abnormalities; complex) and low risk (all other). The presence of high- and low-risk ACAs was linked to six cohorts with different blast levels (1%, 5%, 10%, 15%, 20%, and 30%) in a Cox model. One hundred and twenty-three patients displayed ACA/Ph+ (8.1%), 91 were high risk. At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA. No effect was observed at blast levels of 20-30%. Sixty-three patients with high-risk ACA (69%) died (n = 37) or were alive after progression or progression-related transplantation (n = 26). High-risk ACA at low blast counts identify end-phase CML earlier than current diagnostic systems. Mortality was lower with earlier treatment. Cytogenetic monitoring is indicated when signs of progression surface or response to therapy is unsatisfactory.",2020,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","['chronic myeloid leukemia (CML', 'Sixty-three patients with high-risk ACA (69%) died (n\u2009=\u200937) or were alive after progression or progression-related transplantation (n\u2009=\u200926', 'One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV']",[],"['Mortality', 'survival, ACAs']","[{'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0450407', 'cui_str': 'ph+'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}]",63.0,0.0438058,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'ELN Foundation, Weinheim, Germany. hehlmann.eln@gmail.com.'}, {'ForeName': 'Astghik', 'Initials': 'A', 'LastName': 'Voskanyan', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Kalmanti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Rinaldetti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kohlbrenner', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': 'MLL, München, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schlegelberger', 'Affiliation': 'Institut für Humangenetik, MHH, Hannover, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fabarius', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Seifarth', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Spieß', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wuchter', 'Affiliation': 'Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg und DRK-Blutspendedienst, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.'}, {'ForeName': 'Hans-Jochem', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': 'Medizinische Klinik III, Universitätsklinikum Großhadern, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Dieter K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': '2. Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': 'Klinikum Schwabing, München, Germany.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': 'Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Baerlocher', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Uniklinik RWTH, Aachen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum, Jena, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saußele', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'Department of Hematology-Oncology, Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0826-9']
125,32382172,Impact of brief psychosocial intervention on key relatives of patients with schizophrenia: A randomized controlled trial.,"Background


Caregivers of patients with schizophrenia often experience high burden of care and have deterioration in the quality of their life. This study attempted to assess the efficacy of a brief psychosocial intervention (BPI) on the burden of care and quality of life (QOL) of key relatives of patients with schizophrenia and its subsequent effect on QOL of their patients (if any).
Methods


A total of 66 patients and their key relatives were included in the study. Patients were assessed for psychopathology (by applying Positive and Negative Syndrome Scale and World Health Organization QOL scale [WHOQOL-BREF]) and relatives were assessed on Burden Assessment Schedule and WHOQOL scale (WHOQOL-100). Thirty-three patients and their key relatives were randomly allocated to BPI group and nonspecific control intervention group.
Results


There was a statistically significant reduction in burden of care ( P  = 0.004) and improvement in QOL of relatives ( P  = 0.024) as well as in QOL scores of patients ( P  = 0.0028) in the BPI group.
Conclusion


BPI is associated with a significant improvement in QOL as well as burden of care of key relatives of patients with schizophrenia, which, in turn, results in improvement in QOL of their patients.",2020,"There was a statistically significant reduction in burden of care ( P  = 0.004) and improvement in QOL of relatives ( P  = 0.024) as well as in QOL scores of patients ( P  = 0.0028) in the BPI group.
","['patients with schizophrenia', '66 patients and their key relatives were included in the study', 'Thirty-three patients and their key relatives', 'patients with schizophrenia and its subsequent effect on QOL of their patients (if any']","['BPI group and nonspecific control intervention group', 'psychosocial intervention', 'brief psychosocial intervention (BPI']","['QOL scores', 'QOL', 'burden of care', 'psychopathology (by applying Positive and Negative Syndrome Scale and World Health Organization QOL scale [WHOQOL-BREF', 'burden of care and quality of life (QOL', 'QOL of relatives', 'Burden Assessment Schedule and WHOQOL scale (WHOQOL-100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704407', 'cui_str': '100'}]",66.0,0.0521096,"There was a statistically significant reduction in burden of care ( P  = 0.004) and improvement in QOL of relatives ( P  = 0.024) as well as in QOL scores of patients ( P  = 0.0028) in the BPI group.
","[{'ForeName': 'Rajneesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychiatry, Indira Gandhi ESIC Hospital, Delhi, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Nischal', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Pronob Kumar', 'Initials': 'PK', 'LastName': 'Dalal', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Sannidhya', 'Initials': 'S', 'LastName': 'Varma', 'Affiliation': 'Department of Consultant Psychiatrist, Helios Psychiatry Clinic, Sector 33-D, Chandigarh, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Tripathi', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Sujita Kumar', 'Initials': 'SK', 'LastName': 'Kar', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Bandna', 'Initials': 'B', 'LastName': 'Gupta', 'Affiliation': ""Department of Psychiatry, King George's Medical University, Lucknow, Uttar Pradesh, India.""}]",Indian journal of psychiatry,['10.4103/psychiatry.IndianJPsychiatry_138_19']
126,32383680,"Efficacy and Impact of Digital HIV Care Navigation in Young People Living With HIV in San Francisco, California: Prospective Study.","BACKGROUND


Young people are disproportionately impacted by HIV infection and exhibit poor HIV care continuum outcomes. Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV. Youth-focused interventions are needed to improve HIV care continuum outcomes.
OBJECTIVE


This study assessed the preliminary efficacy and impact of a digital HIV care navigation intervention among young people living with HIV in San Francisco. Health electronic navigation (eNavigation or eNav) is a 6-month, text message-based, digital HIV care navigation intervention, in which young people living with HIV are connected to their own HIV care navigator through text messaging to improve engagement in HIV primary care.
METHODS


This study had a single-arm, prospective, pre-post design. The analysis included 120 young men who have sex with men or transwomen living with HIV aged between 18 and 34 years. We analyzed self-reported sociobehavioral information pre- and postintervention at baseline and 6 months, which was collected using computer-assisted self-interviewing surveys. We characterized the sample and built generalized estimating equation (GEE) models to assess differences in HIV care continuum outcomes at baseline and 6 months.
RESULTS


The characteristics according to the intervention completion status were not different from those of the overall sample. The mean age of the participants was 27.75 years (SD 4.07). Most participants (103/120, 85.8%) identified as men, and the sample was racially/ethnically diverse. At baseline, majority (99/120, 82.5%) of the participants had recently received primary HIV care, yet this was more likely in those who completed the intervention than in those who did not (54/60, 90% vs 45/60, 75%; χ 2 1 =4.68, P=.03). More than half of the sample reported taking antiretroviral therapy (92/120, 76.7%) and having an undetectable viral load (65/120, 54.2%). The 6-month follow-up surveys were completed by 73.3% (88/120) of participants, and these participants were not characteristically different from the overall sample at baseline. GEE models indicated that participants had increased odds of viral suppression at 6 months as compared with baseline. No relevant additive or multiplicative interactions were noted on comparing outcome effects over time according to intervention completion.
CONCLUSIONS


Digital HIV care navigation fills a critical gap in public health and HIV care systems, making these systems more responsive and accountable to the needs of the most vulnerable individuals. Our intervention bridges the time between primary care visits with interactive, tailored, personalized, and peer-delivered social support; information; and motivational interviewing to scaffold behavioral change. This study is part of the next wave of system-informed mHealth intervention research that will offer potentially disruptive solutions to traditional in-person delivered interventions and improve the health of the most vulnerable individuals.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/16406.",2020,Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV.,"['young people living with HIV in San Francisco', 'young people living with HIV', 'Young People Living With HIV in San Francisco, California', '120 young men who have sex with men or transwomen living with HIV aged between 18 and 34 years', 'Most participants (103/120, 85.8%) identified as men, and the sample was racially/ethnically diverse']","['Health electronic navigation (eNavigation or eNav', 'Digital HIV Care Navigation', 'Mobile health (mHealth) interventions', 'digital HIV care navigation intervention']",['viral suppression'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",120.0,0.0756441,Mobile health (mHealth) interventions are promising approaches to meet the unique needs of young people living with HIV.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Arayasirikul', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Trujillo', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Victory', 'Initials': 'V', 'LastName': 'Le', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Wilson', 'Affiliation': 'San Francisco Department of Public Health, Center for Public Health Research, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18597']
127,32383682,Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention for Adult Smokers Seeking Online Help: Double-Blind Randomized Controlled Trial.,"BACKGROUND


Automatically activated cognitive motivational processes such as the tendency to attend to or approach smoking-related stimuli (ie, attentional and approach bias) have been related to smoking behaviors. Therefore, these cognitive biases are thought to play a role in maintaining smoking behaviors. Cognitive biases can be modified with cognitive bias modification (CBM), which holds promise as an easy-access and low-cost online intervention. However, little is known about the effectiveness of online interventions combining two varieties of CBM. Targeting multiple cognitive biases may improve treatment outcomes because these biases have been shown to be relatively independent.
OBJECTIVE


This study aimed to test the individual and combined effects of two web-based CBM varieties-attentional bias modification (AtBM) and approach bias modification (ApBM)-in a double-blind randomized controlled trial (RCT) with a 2 (AtBM: active versus sham) × 2 (ApBM: active versus sham) factorial design.
METHODS


A total of 504 adult smokers seeking online help to quit smoking were randomly assigned to 1 of 4 experimental conditions to receive 11 fully automated CBM training sessions. To increase participants' intrinsic motivation to change their smoking behaviors, all participants first received brief, automated, tailored feedback. The primary outcome was point prevalence abstinence during the study period. Secondary outcomes included daily cigarette use and attentional and approach bias. All outcomes were repeatedly self-assessed online from baseline to the 3-month follow-up. For the examination of training effects on outcome changes, an intention-to-treat analysis with a multilevel modeling (MLM) approach was adopted.
RESULTS


Only 10.7% (54/504) of the participants completed all 11 training sessions, and 8.3% (42/504) of the participants reached the 3-month follow-up assessment. MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).
CONCLUSIONS


This RCT provides no support for the effectiveness of combining AtBM and ApBM in a self-help web-based smoking cessation intervention. However, this study had a very high dropout rate and a very low frequency of training usage, indicating an overall low acceptability of the intervention, which precludes any definite conclusion on its efficacy. We discuss how this study can inform future designs and settings of online CBM interventions.
TRIAL REGISTRATION


Netherlands Trial Register NTR4678; https://www.trialregister.nl/trial/4678.",2020,"MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).
","['504 adult smokers seeking online help to quit smoking', 'Adult Smokers Seeking Online Help']","['two web-based CBM varieties-attentional bias modification (AtBM) and approach bias modification (ApBM)-in', 'MLM', '2 (AtBM: active versus sham', '11 fully automated CBM training sessions', 'Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention']","['daily cigarette use and attentional and approach bias', 'prevalence abstinence', 'prevalence abstinence rates', 'AtBM or ApBM', 'changes in daily cigarette use', 'attentional bias']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",504.0,0.312757,"MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).
","[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Larsen', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Boffo', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Raoul P P P', 'Initials': 'RPPP', 'LastName': 'Grasman', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pronk', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joeri B G', 'Initials': 'JBG', 'LastName': 'van Wijngaarden', 'Affiliation': 'Max Planck Institute for Brain Research, Frankfurt, Germany.'}, {'ForeName': 'Reinout W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",JMIR mental health,['10.2196/16342']
128,32380428,Indirect treatment comparison of nivolumab versus placebo for the adjuvant treatment of melanoma.,"INTRODUCTION


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


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


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


Nivolumab was associated with significantly improved efficacy outcomes versus placebo, whereas maintaining patient's overall HRQoL. Across the different analysis and populations, there was a high level of consistency in the effect size.",2020,"HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
","['patients with resected stage IIIA-IIIC melanoma (AJCC, 6th edition', 'patients with stage IIIB/C or IV disease (American Joint Committee on Cancer [AJCC], 7th edition) versus', 'melanoma']","['nivolumab versus placebo', 'nivolumab', 'ipilimumab with placebo', 'ipilimumab', 'placebo']","['relative efficacy, safety and health-related quality of life (HRQoL', 'hazard of experiencing a serious AE', 'distant metastases-free survival', 'hazard of experiencing an adverse event (AE) and AEs leading to treatment discontinuation', 'safety and efficacy', 'recurrence-free survival (hazard ratio [HR', 'efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.626136,"HRQoL ITCs showed comparable time to deterioration in 14 of the 15 QLQ-C30 domains; only the dyspnoea domain significantly favoured placebo.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hemstock', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK. Electronic address: mhemstock@bresmed.com.'}, {'ForeName': 'Adenike', 'Initials': 'A', 'LastName': 'Amadi', 'Affiliation': 'Bristol-Myers Squibb, Uxbridge, UK.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kupas', 'Affiliation': 'Bristol-Myers Squibb GmbH & Co. KGaA, Munich, Germany.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Roskell', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Srividya', 'Initials': 'S', 'LastName': 'Kotapati', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Kyna', 'Initials': 'K', 'LastName': 'Gooden', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'University of Oxford, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen and German Cancer Consortium, Heidelberg, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.011']
129,32380445,Intermittent theta-burst stimulation moderates interaction between increment of N-Acetyl-Aspartate in anterior cingulate and improvement of unipolar depression.,"BACKGROUND


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


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


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


Our findings suggest a potential neurochemical pathway and mechanisms of antidepressant action of iTBS, which may moderate the improvement of metabolic markers of neuronal viability. iTBS might increase neuroplasticity, thus facilitating normalization of neuronal circuit function.",2020,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,[],"['Intermittent theta-burst stimulation (iTBS', '20 iTBS or sham stimulations applied over left DLPFC', 'repetitive transcranial magnetic stimulation (rTMS) technique', 'Proton magnetic resonance spectroscopy ( 1 H-MRS']","['Cho/NAA ratio', 'NAA change and depression improvement', 'depressive symptoms', 'unipolar depression']",[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.0453926,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,"[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Zavorotnyy', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Department of Psychiatry and Psychotherapy, Psychiatric Services Aargau, Academic Hospital of the University of Zurich, Brugg, Switzerland; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany. Electronic address: maxim.zavorotnyy@staff.uni-marburg.de.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zöllner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Health Protection Authority, Frankfurt, Main, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Rekate', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dietsche', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bopp', 'Affiliation': 'Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany; Department of Neurosurgery, University of Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Krug', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nenadić', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.03.015']
130,32380449,Effects of high-frequency repetitive transcranial magnetic stimulation over the contralesional motor cortex on motor recovery in severe hemiplegic stroke: A randomized clinical trial.,"BACKGROUND


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


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


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


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


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


Clinical trial registered with the Chinese Clinical Trial Registry at http://www.chictr.org.cn/showproj.aspx?proj=23264 (ChiCTR-IPR-17013580).",2020,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","['severe hemiplegic stroke', 'Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory', 'patients with severe hemiplegic stroke', 'severe stroke patients']","['high-frequency repetitive transcranial magnetic stimulation', 'HF-rTMS', 'high-frequency rTMS (HF-rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\xa0Hz rTMS (HF group), 1\xa0Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks']","['FMA score', 'root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability', 'change in the Fugl-Meyer Motor Assessment (FMA) Scale score', 'cortical conductivity of the uninjured hemisphere and recovery of motor impairment', 'contralesional hemisphere cortical excitability and conductivity', 'RMS-SEMG of the key muscles']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",45.0,0.537609,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ying-Yu', 'Initials': 'YY', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Hai', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yue-Wen', 'Initials': 'YW', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China. Electronic address: mayw@cmu1h.com.'}]",Brain stimulation,['10.1016/j.brs.2020.03.020']
131,32384364,Effectiveness of the virtual reality on cognitive function of children with hemiplegic cerebral palsy: a single-blind randomized controlled trial - Erratum.,,2020,,['children with hemiplegic cerebral palsy'],['virtual reality'],['cognitive function'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.130281,,[],International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000414']
132,32384502,Comparison of high tone therapy and transcutaneous electrical nerve stimulation therapy in chemotherapy-induced polyneuropathy.,"INTRODUCTION


Chemotherapy-induced peripheral neuropathy (CIPN) is a worldwide concern in patients receiving neurotoxic agents for cancer therapy. High tone external muscle stimulation is a promising therapeutic approach to alleviate symptoms of CIPN.
METHODS


This pilot study aims to investigate whether the application of home-based high-tone external muscle stimulation therapy (HTEMS) improves symptoms of CIPN. The trial is planned as a therapist- and assessor-blinded, 1:1 randomized controlled study. A total of 50 patients with chemotherapy-induced peripheral polyneuropathy will be included. All patients will perform therapy at home. Study participants will be allocated randomly to the HTEMS therapy (intervention group) or to the transcutaneous electrical nerve stimulation (TENS, control group), respectively, following a standardized therapy schedule. Compliance of participants can be verified by reading out the tool box. Outcomes will be evaluated at baseline and after 8 weeks of home-based therapy. The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire. Secondary outcomes are the patient-reported change in health-related quality of life and clinician-reported changes of vibration sensibility, tendon reflexes, temperature sensibility, perception of touch, and strength of the lower leg muscles. Further a safety- and process evaluation will be performed.
DISCUSSION


This pilot RCT aims to evaluate the impact of home-based HTEMS as compared to TENS in CIPN. There is a need for an effective treatment for CIPN and the results of this study are expected to possibly identify a novel and effective treatment strategy in the future.",2020,The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire.,"['chemotherapy-induced polyneuropathy', '50 patients with chemotherapy-induced peripheral polyneuropathy', 'patients receiving neurotoxic agents for cancer therapy']","['HTEMS therapy (intervention group) or to the transcutaneous electrical nerve stimulation (TENS, control group', 'home-based high-tone external muscle stimulation therapy (HTEMS', 'Chemotherapy-induced peripheral neuropathy (CIPN', 'high tone therapy and transcutaneous electrical nerve stimulation therapy', 'High tone external muscle stimulation']","['improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire', 'patient-reported change in health-related quality of life and clinician-reported changes of vibration sensibility, tendon reflexes, temperature sensibility, perception of touch, and strength of the lower leg muscles']","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0034943', 'cui_str': 'Peripheral reflex'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C2350522', 'cui_str': 'Touch perception'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",50.0,0.0546638,The primary outcome includes improvement of CIPN according to the patient-reported EORTC QLQ-CIPN 20 questionnaire.,"[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schaffler-Schaden', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sassmann', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Johansson', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Gampenrieder', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rinnerthaler', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Lampl', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Herfert', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lenzhofer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Yvonne T', 'Initials': 'YT', 'LastName': 'Landkammer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rieder', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation.'}]",Medicine,['10.1097/MD.0000000000020149']
133,32384504,Efficacy of baby shampoo and commercial eyelid cleanser in patients with meibomian gland dysfunction: A randomized controlled trial.,"BACKGROUND


To compare the efficacy between Johnson's baby shampoo top-to-toe (No More Tears formula) and OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser (OSO) in patients with grade 2 meibomian gland dysfunction (MGD).
METHODS


Sixty participants with grade 2 MGD were enrolled and analyzed based on intention to treat basis in a prospective, randomized, single-blind trial for eye scrub using either diluted baby shampoo or OSO. The data collection included the Ocular Surface Disease Index (OSDI) questionnaire, compliance, and complications. The eye examinations were according to the Tear Film and Ocular Surface Society at baseline and at post-treatment weeks 4 and 12.
RESULTS


The mean (±SD) age of the 60 patients who presented with grade 2 MGD was 48.0 ± 13.8 years and 75.0% were females. The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001). The mean (±SD) differences of the improvement of OSDI score from baseline were not statistically significantly different between the baby shampoo and OSO groups at post-treatment weeks 4 and 12 (P = .57 and P = .54, respectively). The compliance and complications were also not statistically significant between the 2 groups.
CONCLUSIONS


Eyelid scrub using either baby shampoo or OSO and warm compresses could significantly reduce eye irritability and uncomfortable symptoms in grade 2 MGD patients. In this study, the efficacy, compliance, and complications between the 2 groups were not statistically significantly different.",2020,The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001).,"['patients with meibomian gland dysfunction', '60 patients who presented with grade 2 MGD was 48.0\u200a±\u200a13.8 years and 75.0% were females', 'grade 2 MGD patients', 'patients with grade 2 meibomian gland dysfunction (MGD', 'Sixty participants with grade 2 MGD']","['baby shampoo and commercial eyelid cleanser', 'OCuSOFT Lid Scrub Original Foaming Eyelid Cleanser (OSO', 'diluted baby shampoo or OSO']","['OSDI scores', 'eye irritability and uncomfortable symptoms', 'OSDI score', 'Ocular Surface Disease Index (OSDI) questionnaire, compliance, and complications', 'compliance and complications', 'efficacy, compliance, and complications', 'Tear Film and Ocular Surface Society']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0150765', 'cui_str': 'Shampoo'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0722230', 'cui_str': 'Ocusoft'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",60.0,0.0646905,The OSDI scores of these participants between pre-treatment and post-treatment weeks 4 and 12 improved significantly in both groups (all P < .001).,"[{'ForeName': 'Orapan', 'Initials': 'O', 'LastName': 'Aryasit', 'Affiliation': ''}, {'ForeName': 'Yuwarat', 'Initials': 'Y', 'LastName': 'Uthairat', 'Affiliation': ''}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Singha', 'Affiliation': ''}, {'ForeName': 'Orasa', 'Initials': 'O', 'LastName': 'Horatanaruang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020155']
134,32384509,To explore the clinical efficacy of Traditional Chinese Medicine bath in the treatment of psoriasis vulgaris with blood-heat syndrome and its effect on related cytokines based on different temperature and different concentration.,"BACKGROUND


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


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


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


ChiCTR1900027468.",2020,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","['288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years', 'psoriasis vulgaris with blood-heat syndrome']","['Traditional Chinese Medicine bath', 'glycyrrhizin tablet, po 75\u200amg tid; AA Skincare jojoba Oil, us.ext qd', 'ozone hydrotherapy', 'various Chinese herbal bath conditions (water temperatures and herbal concentrations']","['efficacy and safety', 'serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17', 'psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0064161', 'cui_str': 'jojoba wax'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",36.0,0.0598044,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","[{'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yuesi', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Mingling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020172']
135,32384527,Standardized Hospital Discharge Communication for Patients With Pressure Injury: A Quasi-experimental Trial.,"PURPOSE


To determine if improved communication between certified wound care nurses and home health nurses, through use of standardized electronic wound care order sets and discharge instructions, decreased delay in treatment and 30-day readmission rates and improved wound healing for patients discharged to home with pressure injuries.
DESIGN


Quasi-experimental, nonequivalent group trial.
SUBJECTS AND SETTING


Cognitively intact adult patients hospitalized in the Midwestern United States with a stage 2 or higher pressure injury discharged to home care services.
METHODS


We revised the electronic medical record to include an adapted, standardized version of the Project Re-Engineered Discharge wound care order set that included specific wound care instructions for use following discharge to home care. Medical records of 12 patients were reviewed prior to the change and 9 records were reviewed postchange for information about initiation of care, wound healing, and 30-day readmission. The Pressure Ulcer Scale of Healing tool was used to evaluate wound healing.
RESULTS


Time to initiation of treatment was 2.4 days for the control group and 1.6 days for the intervention group. Missing documentation made it difficult to evaluate the control group, as 73% of all wound measurements were missing from the electronic medical record. Use of the standardized wound care order set resulted in 100% of wound care orders and 92% of discharge instructions being present in the intervention group's electronic medical record at the time of hospital discharge. There was no statistically significant difference between control and intervention group's Pressure Ulcer Scale of Healing scores for any postdischarge measurement or in 30-day readmission rates.
CONCLUSIONS


The new standardized wound care order sets at the time of discharge did increase adherence to time to implementation and documentation of executing wound care orders by home care nurses. Further research of standardized order sets is needed to determine the impact on improving patient outcomes.",2020,"There was no statistically significant difference between control and intervention group's Pressure Ulcer Scale of Healing scores for any postdischarge measurement or in 30-day readmission rates.
","['patients discharged to home with pressure injuries', 'Medical records of 12 patients were reviewed prior to the change and 9 records were reviewed', 'Patients With Pressure Injury', 'Cognitively intact adult patients hospitalized in the Midwestern United States with a stage 2 or higher pressure injury discharged to home care services']",[],"['Pressure Ulcer Scale of Healing tool', 'Pressure Ulcer Scale of Healing scores', 'postchange for information about initiation of care, wound healing, and 30-day readmission', 'Standardized Hospital Discharge Communication', '30-day readmission rates']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184713', 'cui_str': 'Discharge to home'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",12.0,0.0435111,"There was no statistically significant difference between control and intervention group's Pressure Ulcer Scale of Healing scores for any postdischarge measurement or in 30-day readmission rates.
","[{'ForeName': 'Teresa K', 'Initials': 'TK', 'LastName': 'Novy', 'Affiliation': 'Teresa K. Novy, DNP, RN-BC, CWON, Nursing Department, Mennonite College of Nursing, Illinois State University, Normal. Wendy M. Woith, PhD, RN, FAAN, Nursing Department, Mennonite College of Nursing, Illinois State University, Normal.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Woith', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000644']
136,32391709,"Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents.","BACKGROUND


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


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


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


This is the first report that a brief, computerized SSI may reduce depressive symptoms in adolescents in sub-Saharan Africa. Replication trials with extended follow-ups will help gauge the strength and durability of these effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","['Kenyan adolescents', 'High school students (N = 103, age 13-18', 'adolescents in sub-Saharan Africa']","['computerized SSI', 'digital SSI Shamiri-Digital (Shamiri means ""thrive"" in Kiswahili) or a study-skills control intervention', 'Single-session digital intervention', 'computerized single-session interventions (SSIs']","['severe depression symptoms', 'anxiety symptoms, well-being, or happiness', 'depressive symptoms', 'adolescent depressive symptoms']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0872907,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","[{'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, University of Pennsylvania.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Rediet G', 'Initials': 'RG', 'LastName': 'Alemu', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Roe', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Arango G', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Benny H', 'Initials': 'BH', 'LastName': 'Otieno', 'Affiliation': 'Shamiri Institute.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wasanga', 'Affiliation': 'Department of Psychology, Kenyatta University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shingleton', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000505']
137,32391740,Effects of Early and Systematic Integration of Specialist Palliative Care in Patients with Advanced Cancer: Randomized Controlled Trial PALINT.,"Background:  A broad consensus on the optimal structure, intensity, and timing of early specialist palliative care (SPC) intervention is lacking.  Objective:  To evaluate the benefit of an early and systematic palliative intervention alongside standard oncology care compared with standard oncology care alone in patients with advanced solid tumors.  Design:  PALINT, a single-center RCT, conducted at the Masaryk Memorial Cancer Institute, the largest comprehensive cancer center in the Czech Republic (CR).  Setting/Subjects/Measurements:  Patients with newly diagnosed advanced cancer within six weeks from the start of the palliative systemic therapy were randomly assigned to the integration of SPC (intervention; a consultation with a PC physician every six to eight weeks) or to the standard oncology care (control). The primary endpoint was the quality of life (QOL) assessed by EORTC QLQ C30 and Hospital Anxiety and Depression Scale (HADS) at three and six months.  Results:  From 2015 to 2017, a total of 126 patients were randomly assigned to intervention (60) or to control (66) arm. At baseline, at three and six months, the global QOL scores (mean, 95% CI) in the intervention and control arm were 58.6 (53.9-63.3), 61.9 (56.4-67.4) and 66.7 (60.2-73.2) versus 54.2 (49.4-58.9), 59.0 (53.7-64.3), and 62.8 (56.7-68.9), respectively. The prevalence of anxiety (HADS-A; value >7) was 36.7%, 27.5%, and 18.9% versus 34.8%, 23.5%, and 16.3% and the prevalence of depression (HADS-D; value >7) was 28.3%, 25.4%, and 29.7% versus 28.8%, 29.4%, and 27.9%, respectively. There was no significant difference between the two arms. The overall survival was similar in both arms (347 vs. 310 days;  p  = 0.203).  Conclusions:  A model of early integration of SPC consisting of a consultation with a PC physician alone every six to eight weeks did not increase the QOL of patients with advanced cancer compared with routine oncology care in a center with widely available supportive services. These negative results underline the importance of the multidisciplinary patient centered approach in the early SPC.",2020,"The prevalence of anxiety (HADS-A; value >7) was 36.7%, 27.5%, and 18.9% versus 34.8%, 23.5%, and 16.3% and the prevalence of depression (HADS-D; value >7) was 28.3%, 25.4%, and 29.7% versus 28.8%, 29.4%, and 27.9%, respectively.","['patients with advanced solid tumors', 'patients with advanced cancer', 'Patients with newly diagnosed advanced cancer within six weeks from the start of the palliative systemic therapy', 'Results:  From 2015 to 2017, a total of 126 patients', 'Patients with Advanced Cancer', 'single-center RCT, conducted at the Masaryk Memorial Cancer Institute, the largest comprehensive cancer center in the Czech Republic (CR']","['systematic palliative intervention alongside standard oncology care', 'early specialist palliative care (SPC) intervention', 'Specialist Palliative Care', 'SPC (intervention; a consultation with a PC physician every six to eight weeks) or to the standard oncology care (control', 'standard oncology care alone']","['global QOL scores', 'QOL', 'overall survival', 'prevalence of depression', 'quality of life (QOL) assessed by EORTC QLQ C30 and Hospital Anxiety and Depression Scale (HADS', 'prevalence of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",126.0,0.14543,"The prevalence of anxiety (HADS-A; value >7) was 36.7%, 27.5%, and 18.9% versus 34.8%, 23.5%, and 16.3% and the prevalence of depression (HADS-D; value >7) was 28.3%, 25.4%, and 29.7% versus 28.8%, 29.4%, and 27.9%, respectively.","[{'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Slama', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Pochop', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Sedo', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Svancara', 'Affiliation': 'Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Sedova', 'Affiliation': 'Department of Hematology and Oncology, The University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Svetlakova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Demlova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Rostislav', 'Initials': 'R', 'LastName': 'Vyzula', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0697']
138,32391862,A Multifaceted Antimicrobial Stewardship Program for the Treatment of Uncomplicated Cystitis in Nursing Home Residents.,"Importance


Urinary tract infections are the most common infections in nursing home residents. However, most antibiotic use is for unlikely cystitis (ie, nonspecific symptoms and positive culture results secondary to asymptomatic bacteriuria or a urine sample improperly collected for culture) that is unnecessary and inappropriate. This antibiotic use is associated with an increased risk of antimicrobial resistance, adverse drug events, and Clostridioides difficile (formerly Clostridium difficile) infections.
Objective


To determine the association of a multifaceted antimicrobial stewardship and quality improvement intervention with the reduction in unnecessary antimicrobial use for unlikely cystitis among noncatheterized nursing home residents.
Design, Setting, and Participants


A quality improvement intervention evaluation was conducted to target antimicrobial use among residents with unlikely cystitis in 25 nursing homes across the United States. Baseline data were collected between February 1, 2017, and April 30, 2017. The intervention was conducted from May 1, 2017, to April 30, 2018.
Interventions


Intervention nursing homes (n = 12) were randomized to receive a 1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis. Monthly web-based coaching calls were held for staff of intervention nursing homes. All facilities received quarterly feedback reports regarding the management of uncomplicated cystitis. Control group nursing homes (n = 13) received usual care.
Main Outcomes and Measures


The primary outcome was the incidence of antibiotic treatment for unlikely cystitis cases, defined using published criteria. Secondary outcomes included overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death.
Results


Among the 25 nursing homes participating in this quality improvement study, including 512 408 intervention facility resident-days and 443 912 control facility resident-days, fewer unlikely cystitis cases were treated with antibiotics in intervention facilities compared with control facilities (adjusted incident rate ratio [AIRR], 0.73 [95% CI, 0.59-0.91]); C difficile infection rates were also lower in intervention nursing homes vs control nursing homes (AIRR, 0.35 [95% CI, 0.19-0.64]). Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83 [95% CI, 0.70-0.99]; P = .04). There was no increase in all-cause hospitalizations or deaths due to the intervention (all-cause hospitalizations: AIRR, 0.95 [95% CI, 0.75-1.19]; all-cause death: AIRR, 0.92 [95% CI, 0.73-1.16]).
Conclusions and Relevance


This study suggests that a low-intensity, multifaceted intervention was associated with improved antibiotic prescribing for uncomplicated cystitis in a cohort of nursing homes without an adverse association with other safety outcomes. Although promising, further study is needed to determine whether the intervention could be widely implemented to assist facilities in meeting new federal nursing home requirements for antimicrobial stewardship and quality assurance performance improvement programs.",2020,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","['25 nursing homes participating', 'noncatheterized nursing home residents', 'residents with unlikely cystitis in 25 nursing homes across the United States', 'Interventions\n\n\nIntervention nursing homes (n\u2009=\u200912', 'nursing home residents', 'Uncomplicated Cystitis in Nursing Home Residents']","['Multifaceted Antimicrobial Stewardship Program', '1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis', 'usual care']","['Overall antibiotic use', 'incidence of antibiotic treatment for unlikely cystitis cases', 'overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death', 'urinary tract infection', 'C difficile infection rates']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0698375,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hanlon', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Drinka', 'Affiliation': 'Division of Internal Medicine and Geriatrics, University of Wisconsin, Madison.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schweon', 'Affiliation': 'Infection Prevention Consultant, Saylorsburg, Pennsylvania.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1256']
139,32391894,Effect of Viewing Disney Movies During Chemotherapy on Self-Reported Quality of Life Among Patients With Gynecologic Cancer: A Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT03863912.",2020,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","['Inclusion criteria included age older than 18 years, written informed consent, and planned 6 cycles of chemotherapy with either', 'December 2017 to December 2018 at a cancer referral center in Vienna, Austria', 'women with gynecologic cancers was recruited through July 2018', 'Patients With Gynecologic Cancer', 'patients with gynecologic cancers', 'Fifty-six women entered the study, and 50 completed it, including 25 women in the Disney group (mean [SD] age, 59 [12] years) and 25 women in the control group (mean [SD] age, 62 [8] years']","['Viewing Disney Movies', 'carboplatin and paclitaxel or carboplatin and pegylated liposomal doxorubicin']","['Perceived global health status', 'Quality of Life', 'change of quality of life, as defined by the EORTC Core-30 (version 3) questionnaire, and fatigue, as defined by the EORTC Quality of Life Questionnaire Fatigue', 'emotional functioning, social functioning, and fatigue status', 'fatigue symptoms', ""patients' family life and social activities"", 'social functioning questions']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.15327,"Furthermore, watching Disney movies was associated with less encroachment on patients' family life and social activities, as evaluated by the social functioning questions (mean [SD] score, 86.1 [23.0] vs 63.6 [33.6]; maximum test P = .01).","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pils', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Enikoe', 'Initials': 'E', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, General Hospital of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ristl', 'Affiliation': 'Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4568']
140,32386761,Renal function and coronary bypass surgery in patients with ischemic heart failure.,"OBJECTIVE


Chronic kidney disease is a known risk factor in cardiovascular disease, but its influence on treatment effect of bypass surgery remains unclear. We assessed the influence of chronic kidney disease on 10-year mortality and cardiovascular outcomes in patients with ischemic heart failure treated with medical therapy (medical treatment) with or without coronary artery bypass grafting.
METHODS


We calculated the baseline estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration formula, chronic kidney disease stages 1-5) from 1209 patients randomized to medical treatment or coronary artery bypass grafting in the Surgical Treatment for IsChemic Heart failure trial and assessed its effect on outcome.
RESULTS


In the overall Surgical Treatment for IsChemic Heart failure cohort, patients with chronic kidney disease stages 3 to 5 were older than those with stages 1 and 2 (66-71 years vs 54-59 years) and had more comorbidities. Multivariable modeling revealed an inverse association between estimated glomerular filtration rate and risk of death, cardiovascular death, or cardiovascular rehospitalization (all P < .001, but not for stroke, P = .697). Baseline characteristics of the 2 treatment arms were equal for each chronic kidney disease stage. There were significant improvements in death or cardiovascular rehospitalization with coronary artery bypass grafting (stage 1: hazard ratio, 0.71; confidence interval, 0.53-0.96, P = .02; stage 2: hazard ratio, 0.71; confidence interval, 0.59-0.84, P < .0001; stage 3: hazard ratio, 0.76; confidence interval, 0.53-0.96, P = .03). These data were inconclusive in stages 4 and 5 for insufficient patient numbers (N = 28). There was no significant interaction of estimated glomerular filtration rate with the treatment effect of coronary artery bypass grafting (P = .25 for death and P = .54 for death or cardiovascular rehospitalization).
CONCLUSIONS


Chronic kidney disease is an independent risk factor for mortality in patients with ischemic heart failure with or without coronary artery bypass grafting. However, mild to moderate chronic kidney disease does not appear to influence long-term treatment effects of coronary artery bypass grafting.",2020,"There were significant improvements in death or cardiovascular rehospitalization with coronary artery bypass grafting (stage 1: hazard ratio, 0.71; confidence interval, 0.53-0.96, P = .02; stage 2: hazard ratio, 0.71; confidence interval, 0.59-0.84, P ","['patients with ischemic heart failure', 'patients with ischemic heart failure treated with medical therapy (medical treatment) with or without coronary artery bypass grafting', '1209 patients randomized to', 'patients with chronic kidney disease stages 3 to 5 were older than those with stages 1 and 2 (66-71\xa0years vs 54-59\xa0years) and had more comorbidities', 'patients with ischemic heart failure with or without coronary artery bypass grafting']","['coronary artery bypass grafting', 'medical treatment or coronary artery bypass grafting', 'coronary bypass surgery']","['chronic kidney disease stage', 'Renal function', 'glomerular filtration rate and risk of death, cardiovascular death, or cardiovascular rehospitalization', 'death or cardiovascular rehospitalization', 'glomerular filtration rate', '10-year mortality and cardiovascular outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1209.0,0.0554792,"There were significant improvements in death or cardiovascular rehospitalization with coronary artery bypass grafting (stage 1: hazard ratio, 0.71; confidence interval, 0.53-0.96, P = .02; stage 2: hazard ratio, 0.71; confidence interval, 0.59-0.84, P ","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany. Electronic address: doenst@med.uni-jena.de.'}, {'ForeName': 'Haissam', 'Initials': 'H', 'LastName': 'Haddad', 'Affiliation': 'Department of Medicine, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hill', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Malcom Randal VAMC, Gainesville, Fla.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Conn.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Farsky', 'Affiliation': 'Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil; Department of Cardiology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.02.136']
141,32386772,Underrepresentation of Women in Cardiovascular Randomized Clinical Trials.,,2020,,[],[],[],[],[],[],,0.29109,,"[{'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Sepehrvand', 'Affiliation': ''}, {'ForeName': 'Wendimagegn', 'Initials': 'W', 'LastName': 'Alemayehu', 'Affiliation': ''}, {'ForeName': 'Debraj', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'Pishoy', 'Initials': 'P', 'LastName': 'Gouda', 'Affiliation': ''}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': ''}]",The Canadian journal of cardiology,['10.1016/j.cjca.2019.12.030']
142,32386810,Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial.,"PURPOSE


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


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


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


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


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


Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.",2020,"There were no significant differences between arms for any secondary outcome.
","['Seven hundred eighty-five patients with age-related cataract', '785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS', '3 hospitals in the UK National Health Service (NHS']","['standard phacoemulsification cataract surgery (PCS', 'Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT', 'Femtosecond Laser-Assisted Cataract Trial [FACT', 'femtosecond laser-assisted cataract surgery (FLACS', 'Femtosecond laser-assisted cataract surgery']","['clinical effectiveness and cost-effectiveness', 'unaided distance visual acuity (UDVA', 'mean UDVA difference', 'corrected distance visual acuity, complications, and patient-reported outcomes measures', 'mean corrected distance visual acuity difference']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",785.0,0.436528,"There were no significant differences between arms for any secondary outcome.
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Day', 'Affiliation': 'The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: alex.day@ucl.ac.uk.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': 'School of Medicine, University of St. Andrews, Fife, Scotland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, United Kingdom.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Department of Primary Care & Public Health Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, United Kingdom.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Rubin', 'Affiliation': 'UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Mayank A', 'Initials': 'MA', 'LastName': 'Nanavaty', 'Affiliation': 'Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, United Kingdom.'}, {'ForeName': 'Kamaljit S', 'Initials': 'KS', 'LastName': 'Balaggan', 'Affiliation': 'Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, West Midlands, United Kingdom.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wilkins', 'Affiliation': 'The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.02.028']
143,32386811,Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial.,"PURPOSE


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


Prospective, multicenter randomized controlled trial.
PARTICIPANTS


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


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


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


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


Descemet membrane endothelial keratoplasty and UT-DSAEK did not differ significantly in mean BSCVA, but the percentage of eyes achieving 20/25 Snellen vision was significantly higher with DMEK. Endothelial cell loss did not differ significantly between the treatment groups, and both techniques induced a minimal hyperopic shift.",2020,Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR],"['Six corneal surgeons participated in this study', 'Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands', 'Participants were allocated to DMEK (n\xa0= 29) or']","['UT-DSAEK', 'Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty']","['Endothelial cell loss', 'mild hyperopic shift', 'Best spectacle-corrected visual acuity', 'BSCVA at 12 months after surgery', 'percentage of eyes achieving 20/25 Snellen vision', 'percentage of eyes reaching 20/25 Snellen BSCVA', 'spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK', 'Endothelial cell density']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}]",54.0,0.324218,Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR],"[{'ForeName': 'Suryan L', 'Initials': 'SL', 'LastName': 'Dunker', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address: suryan.dunker@mumc.nl.'}, {'ForeName': 'Mor M', 'Initials': 'MM', 'LastName': 'Dickman', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Robert P L', 'Initials': 'RPL', 'LastName': 'Wisse', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Nobacht', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert H J', 'Initials': 'RHJ', 'LastName': 'Wijdh', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marjolijn C', 'Initials': 'MC', 'LastName': 'Bartels', 'Affiliation': 'Department of Ophthalmology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Mei L', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology, Gelre Hospitals, Apeldoorn, The Netherlands.'}, {'ForeName': 'Frank J H M', 'Initials': 'FJHM', 'LastName': 'van den Biggelaar', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Kruit', 'Affiliation': 'Euro Tissue Bank - Bio Implant Service (ETB-BISLIFE), Leiden, The Netherlands.'}, {'ForeName': 'Rudy M M A', 'Initials': 'RMMA', 'LastName': 'Nuijts', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands.'}]",Ophthalmology,['10.1016/j.ophtha.2020.02.029']
144,32360236,"Evaluation of the Efficacy of Hilotherapy for Postoperative Edema, Ecchymosis, and Pain After Rhinoplasty.","PURPOSE


Edema and ecchymosis are among the most important morbidities after rhinoplasty. The aim of the present study was to investigate the effects of hilotherapy application compared with traditional ice applications after rhinoplasty in terms of periorbital edema, ecchymosis, and pain.
PATIENTS AND METHODS


A total of 60 patients (35 women and 25 men) had undergone primary rhinoplasty with the same surgeon. In the postoperative period, 30 patients in the study group received continuous cooling at 15°C using Hilotherm (Hilotherm GmbH, Argenbühl-Eisenharz, Germany), and 30 patients in the control group were treated with conventional cryotherapy with ice packs. Both treatments started within 45 minutes after the end of the surgery and were maintained for 24 hours. For the following 1 week, the patients were examined for edema, ecchymosis, and pain.
RESULTS


When the postoperative periorbital region was evaluated for mean edema and mean ecchymosis for 7 days, less edema and less ecchymosis were detected in the Hilotherm group compared with that observed in the ice pack group (P < .001). When the mean pain scores were compared both morning and evening for 7 days, less pain had been recorded with Hilotherm application compared with ice application (P < .001).
CONCLUSIONS


Hilotherapy is a useful method to prevent postoperative edema, ecchymosis, and pain compared with traditional ice application.",2020,"When the mean pain scores were compared both morning and evening for 7 days, less pain had been recorded with Hilotherm application compared with ice application (P < .001).
",['60 patients (35 women and 25 men) had undergone primary rhinoplasty with the same surgeon'],"['conventional cryotherapy with ice packs', 'continuous cooling at 15°C using Hilotherm (Hilotherm GmbH, Argenbühl-Eisenharz, Germany', 'hilotherapy application', 'Hilotherapy']","['edema, ecchymosis, and pain', 'postoperative edema, ecchymosis, and pain', 'mean edema and mean ecchymosis', 'mean pain scores', 'pain', 'periorbital edema, ecchymosis, and pain', 'edema and less ecchymosis', 'Postoperative Edema, Ecchymosis, and Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}]",60.0,0.0248466,"When the mean pain scores were compared both morning and evening for 7 days, less pain had been recorded with Hilotherm application compared with ice application (P < .001).
","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Hanci', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey. Electronic address: dhanci007@hotmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Üstün', 'Affiliation': 'Specialist, Department of Otorhinolaryngology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ayça Başkadem', 'Initials': 'AB', 'LastName': 'Yılmazer', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ayşe Enise', 'Initials': 'AE', 'LastName': 'Göker', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Karaketir', 'Affiliation': 'Specialist, Department of Otorhinolaryngology Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Uyar', 'Affiliation': 'Professor Doctor and Department Head, Department of Otorhinolaryngology, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.03.032']
145,32375773,"The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia six months after surgical treatment and the influence of social support, recurrence, and age: a secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO II.","BACKGROUND


Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated.
METHODS


The aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) 6 months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model.
RESULTS


Thirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = -.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses.
CONCLUSION


The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.
TRIAL REGISTRATION


The WOMAN-PRO II program was registered in ClinicalTrials.gov NCT01986725 on 18 November 2013.",2020,The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery.,"['women with vulvar neoplasia (n\u2009=\u200949) 6 months after surgical treatment in four Swiss hospitals and one Austrian hospital', 'Age ', 'women with vulvar neoplasia six months after surgical treatment', 'Thirty-six women (intervention', 'women with vulvar neoplasia', '13 women (26.5%) dropped out of the trial', 'Women with vulvar neoplasia often complain about physical and psychological distress after surgical treatment']",['written information and counselling by an advanced practice nurse'],"['local recurrence', 'resilience score', 'counselling time', 'social support', 'resilience scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",13.0,0.105192,The results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery.,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kofler', 'Affiliation': 'Institute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland. sa.kofler@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kobleder', 'Affiliation': 'Institute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ott', 'Affiliation': 'Lecturer for Business Mathematics and Statistics, University of Applied Sciences FHS St. Gallen, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Senn', 'Affiliation': 'Institute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.'}]",BMC women's health,['10.1186/s12905-020-00965-z']
146,32381793,Consequences of 660 nm Diode Laser Following Postsurgical Exodontia in Patients under Contraceptive Pills: A Randomized Double-blinded Clinical Trial.,"AIM


The photobiomodulation (PBM) effect of 660 nm diode laser in reducing pain, edema, trismus and promote healing subsequently to the transalveolar extraction of mandibular third molars in female patients taking contraceptive pills were evaluated.
MATERIALS AND METHODS


Fifty female patients participated in our study. The 660 nm diode laser was applied immediately on randomly selected patients of the study group ( n  = 25) over the surgical site for 1 minute with continuous laser beam application. For the control group ( n  = 25), the same extraction procedure was performed without the application of 660 nm diode laser. Pain intensity, swelling, trismus, and healing was evaluated before extraction and during recall visits 24 hours, 48 hours, and 7 days postoperatively.
RESULTS


The values of pain, swelling, and trismus were significantly inferior in the study group compared to the control group ( p  < 0.05) at T2 and T3; while the values of the healing index were significantly superior in the study group compared to the control group ( p  < 0.001) at T1, T2, and T3.
CONCLUSION


Using 660 nm diode laser reduced the postsurgical discomforts (pain, edema, and trismus) and promote healing associated following transalveolar extraction of the lower third molar.
CLINICAL SIGNIFICANCE


To develop a framework based on the results regarding the PBM effect of 660 nm diode laser following transalveolar extraction of lower third molar in a female patient taking oral contraceptive pills, which may help to improve the treatment services provided to the community.",2020,"The values of pain, swelling, and trismus were significantly inferior in the study group compared to the control group ( p  < 0.05) at T2 and T3; while the values of the healing index were significantly superior in the study group compared to the control group ( p  < 0.001) at T1, T2, and T3.
","['Fifty female patients participated in our study', 'Patients under Contraceptive Pills', 'female patients taking contraceptive pills']","['660 nm Diode Laser Following Postsurgical Exodontia', '660 nm diode laser']","['healing index', 'Pain intensity, swelling, trismus, and healing', 'postsurgical discomforts (pain, edema, and trismus) and promote healing associated following transalveolar extraction of the lower third molar', 'pain, edema, trismus and promote healing', 'values of pain, swelling, and trismus']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0904853,"The values of pain, swelling, and trismus were significantly inferior in the study group compared to the control group ( p  < 0.05) at T2 and T3; while the values of the healing index were significantly superior in the study group compared to the control group ( p  < 0.001) at T1, T2, and T3.
","[{'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Salem', 'Affiliation': 'Department of Oral Surgery, Maxillofacial and Diagnostic Science, College of Dentistry, Qassim University, Buraydah, Al Qassim, Kingdom of Saudi Arabia, Phone: +966 531017409, e-mail: Dr.suzan.salem@qudent.org.'}]",The journal of contemporary dental practice,[]
147,32381794,"Efficacy of Erbium, Chromium-doped Yttrium, Scandium, Gallium and Garnet Laser-activated Irrigation Compared with Passive Ultrasonic Irrigation, Conventional Irrigation, and Photodynamic Therapy against  Enterococcus faecalis .","AIM


To compare the antimicrobial effects of two different irrigation solutions activated with erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) laser or an ultrasonic system and a photodynamic therapy (PDT) on  Enterococcus faecalis  ( E. faecalis ).
MATERIALS AND METHODS


The root canals of 72 single-rooted human permanent incisors were prepared with ProTaper Universal rotary instruments and incubated with  E. faecalis  (ATCC 29212) for 4 weeks. Then the teeth were randomly divided into seven experimental groups with 10 specimens for canal disinfection procedures. Group I, standard needle irrigation (SNI) with 2.5% sodium hypochlorite (NaOCl); group II, SNI with 2% chlorhexidine gluconate (CHX); group III, laser-activated irrigation (LAI) by Er,Cr:YSGG of NaOCl; group IV, LAI of CHX; and group V, passive ultrasonic irrigation (PUI) of NaOCl; group VI, PUI of CHX; group VII, PDT. The remaining two teeth were used as the control group. After the disinfection procedures were completed, the root canals were filled with phosphate-buffered saline and bacterial samples were taken with sterile paper cones. The cultivation was performed on Mueller-Hinton agar (MHA) plates. The live bacteria were calculated by counting the colonies on these plaques. The statistical analysis was performed using Kruskal-Wallis  H  test and Miller's multiple comparison technique.
RESULTS


Both LAI and PUI of NaOCl and PUI of CHX were more successful than the PDT on root canal disinfection ( p  < 0.05).
CONCLUSION


Within the limitation of the present study, the activation of NaOCl solution by Er,Cr:YSGG laser or an ultrasonic system can be useful in the elimination of the  E. faecalis  from the canal. The PUI of CHX also has similar results. Photodynamic therapy showed a lower performance compared to these methods.
CLINICAL SIGNIFICANCE


The activation of the sodium hypochlorite with Er,Cr:YSGG laser or PUI may be useful for removal of the  E. faecalis  biofilm layer in the root canal.",2020,"Both LAI and PUI of NaOCl and PUI of CHX were more successful than the PDT on root canal disinfection ( p  < 0.05).
",['72 single-rooted human permanent incisors'],"['NaOCl solution by Er,Cr:YSGG laser', 'ProTaper Universal rotary instruments and incubated with  E. faecalis  (ATCC 29212', 'erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) laser or an ultrasonic system and a photodynamic therapy (PDT', 'Passive Ultrasonic Irrigation, Conventional Irrigation, and Photodynamic Therapy', 'canal disinfection procedures', 'Photodynamic therapy', 'standard needle irrigation (SNI) with 2.5% sodium hypochlorite (NaOCl); group II, SNI with 2% chlorhexidine gluconate (CHX); group III, laser-activated irrigation (LAI) by Er,Cr:YSGG of NaOCl; group IV, LAI of CHX; and group V, passive ultrasonic irrigation (PUI) of NaOCl; group VI, PUI of CHX; group VII, PDT', 'Erbium, Chromium-doped Yttrium, Scandium, Gallium and Garnet Laser-activated Irrigation', 'sodium hypochlorite with Er,Cr:YSGG laser or PUI']","['root canal disinfection', 'live bacteria']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C0441855', 'cui_str': 'Group V'}, {'cui': 'C0445385', 'cui_str': 'VII'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",,0.0189239,"Both LAI and PUI of NaOCl and PUI of CHX were more successful than the PDT on root canal disinfection ( p  < 0.05).
","[{'ForeName': 'Saime A', 'Initials': 'SA', 'LastName': 'Aydin', 'Affiliation': 'Department of Dental Prosthesis Technology, Vocational School of Health Services, Avrasya University, Trabzon, Turkey.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Taşdemir', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Karadeniz Technical University, Trabzon, Turkey, Phone: +90 462 377 4701, e-mail: tamertd72@yahoo.com.'}, {'ForeName': 'Celal K', 'Initials': 'CK', 'LastName': 'Buruk', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Davut', 'Initials': 'D', 'LastName': 'Çelik', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Karadeniz Technical University, Trabzon, Turkey.'}]",The journal of contemporary dental practice,[]
148,32381795,Effectiveness of Bubble Breath Play Therapy in the Dental Management of Anxious Children: A Pilot Study.,"Play is an inseparable part of childhood and can act as a mode through which children can be desensitized toward dental treatment.
AIM


To assess and compare the efficacy of bubble breath play therapy (BBPT) and tell-show-do (TSD) technique in the dental management of anxious/fearful children.
MATERIALS AND METHODS


Forty-eight children aged 6-8 years were randomly divided into group I: BBPT and group II: TSD. The effectiveness of the BBPT and TSD technique in reducing anxiety/fear in children was assessed pretreatment, during, and posttreatment evaluation of the child's anxiety levels using finger pulse oximeter and Venham's anxiety and behavior rating scale. All children underwent rotary restorative treatment.
RESULTS


The mean pulse rate in the BBPT and TSD group was 106.96 mm Hg and 102.25 mm Hg, respectively, at baseline. A decrease in the pulse rate was observed in both the groups after the application of behavior modification strategies. However, after the dental treatment, the mean pulse rate slightly increased in the BBPT group, while it showed a further improvement in the TSD group.
CONCLUSION


The BBPT acts as a distraction and can be considered to enhance rapport between the dentist and children during dental treatment.
CLINICAL SIGNIFICANCE


Application of appropriate strategies to allay dental fear in children is essential to provide quality dental treatment and build a positive attitude toward oral health.",2020,A decrease in the pulse rate was observed in both the groups after the application of behavior modification strategies.,"['anxious/fearful children', 'Anxious Children', 'Forty-eight children aged 6-8 years']","['bubble breath play therapy (BBPT) and tell-show-do (TSD) technique', 'rotary restorative treatment', 'Bubble Breath Play Therapy', 'BBPT', 'BBPT and TSD technique']","['pulse rate', ""child's anxiety levels using finger pulse oximeter and Venham's anxiety and behavior rating scale"", 'mean pulse rate slightly', 'mean pulse rate']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0032216', 'cui_str': 'Play therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}]",48.0,0.0195124,A decrease in the pulse rate was observed in both the groups after the application of behavior modification strategies.,"[{'ForeName': 'Umme', 'Initials': 'U', 'LastName': 'Azher', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Bengaluru, Karnataka, India, Phone: +91 9945352984, e-mail: drummeazher@yahoo.com.'}, {'ForeName': 'Sarakanuru K', 'Initials': 'SK', 'LastName': 'Srinath', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Government Dental College and Research Institute, Victoria Hospital, Bengaluru, Karnataka, India.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Nayak', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Bengaluru, Karnataka, India.'}]",The journal of contemporary dental practice,[]
149,32382720,Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: An analysis from the randomised non-inferiority THREE-D trial.,"Background


Although repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD), treatment selection is still mainly a process of trial-and-error. The present study aimed to identify clinical predictors of remission after a course of rTMS delivered to the left DLPFC to improve patient selection.
Methods


Data from a large randomised non-inferiority trial comparing standard 10 Hz and intermittent theta burst stimulation (iTBS) for the treatment of MDD were used for the exploratory analyses. Individual variables were assessed for their association with remission and then included in a logistic regression model to determine odds ratios (OR) and corresponding 95% confidence intervals. Model discrimination (internal validation) was carried out to assess model optimism using the c-index. ClinicalTrials.gov identifier: NCT01887782.
Findings


388 subjects were included in the analysis (199-iTBS and 189-10 Hz, respectively). Higher baseline severity of both depressive and anxiety symptoms were associated with a lower chance of achieving remission (OR=0.64, 95% CI 0.46-0.88; and 0.78, 95% CI 0·60-0.98, respectively). Current employment was a positive predictor for remission (OR=1.69, 95% CI 1.06-2.7), while greater number of treatment failures was associated with lower odds of achieving remission (OR=0.51, 95% CI 0.27-0.98). A non-linear effect of age and remission was observed. An analysis to allow an estimate of the probability of remission using all variables was assessed. The c-index for the fitted model was 0.687.
Interpretation


Our results suggest that measuring depression symptom severity, employment status, and refractoriness are important in prognosticating outcome to a course of rTMS in MDD.
Funding


Canadian Institutes of Health Research MOP-136801.",2020,"Current employment was a positive predictor for remission (OR=1.69, 95% CI 1.06-2.7), while greater number of treatment failures was associated with lower odds of achieving remission (OR=0.51, 95% CI 0.27-0.98).","['Findings\n\n\n388 subjects were included in the analysis (199-iTBS and 189-10 Hz, respectively', 'major depressive disorder']","['repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'rTMS', 'standard 10\xa0Hz and intermittent theta burst stimulation (iTBS']","['achieving remission', 'depressive and anxiety symptoms']","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",388.0,0.211351,"Current employment was a positive predictor for remission (OR=1.69, 95% CI 1.06-2.7), while greater number of treatment failures was associated with lower odds of achieving remission (OR=0.51, 95% CI 0.27-0.98).","[{'ForeName': 'Alisson P', 'Initials': 'AP', 'LastName': 'Trevizol', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, 1001 Queen St. W., Unit 4-115, Toronto, ON M6J1H4, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Institute of Medical Science, University of Toronto, Canada.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vila-Rodriguez', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, 1001 Queen St. W., Unit 4-115, Toronto, ON M6J1H4, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, 1001 Queen St. W., Unit 4-115, Toronto, ON M6J1H4, Canada.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100349']
150,32383271,Acute effects of cannabinoids on symptoms of obsessive-compulsive disorder: A human laboratory study.,"BACKGROUND


Preclinical data implicate the endocannabinoid system in the pathology underlying obsessive-compulsive disorder (OCD), while survey data have linked OCD symptoms to increased cannabis use. Cannabis products are increasingly marketed as treatments for anxiety and other OCD-related symptoms. Yet, few studies have tested the acute effects of cannabis on psychiatric symptoms in humans.
METHODS


We recruited 14 adults with OCD and prior experience using cannabis to enter a randomized, placebo-controlled, human laboratory study to compare the effects on OCD symptoms of cannabis containing varying concentrations of Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on OCD symptoms to placebo. We used a within-subjects design to increase statistical power. Across three laboratory sessions, participants smoked three cannabis varietals in random order: placebo (0% THC/0% CBD); THC (7.0% THC/0.18% CBD); and CBD (0.4% THC/10.4% CBD). We analyzed acute changes in OCD symptoms, state anxiety, cardiovascular measures, and drug-related effects (e.g., euphoria) as a function of varietal.
RESULTS


Twelve participants completed the study. THC increased heart rate, blood pressure, and intoxication compared with CBD and placebo. Self-reported OCD symptoms and anxiety decreased over time in all three conditions. Although OCD symptoms did not vary as a function of cannabis varietal, state anxiety was significantly lower immediately after placebo administration relative to both THC and CBD.
CONCLUSIONS


This is the first placebo-controlled investigation of cannabis in adults with OCD. The data suggest that smoked cannabis, whether containing primarily THC or CBD, has little acute impact on OCD symptoms and yields smaller reductions in anxiety compared to placebo.",2020,"Although OCD symptoms did not vary as a function of cannabis varietal, state anxiety was significantly lower immediately after placebo administration relative to both THC and CBD.
","['Twelve participants completed the study', 'adults with OCD', '14 adults with OCD and prior experience using cannabis to enter a randomized']","['cannabinoids', 'placebo']","['symptoms of obsessive-compulsive disorder', 'Self-reported OCD symptoms and anxiety', 'heart rate, blood pressure, and intoxication', 'OCD symptoms of cannabis containing varying concentrations of Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on OCD symptoms', 'CBD', 'function of cannabis varietal, state anxiety', 'OCD symptoms, state anxiety, cardiovascular measures, and drug-related effects (e.g., euphoria']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}]",14.0,0.24613,"Although OCD symptoms did not vary as a function of cannabis varietal, state anxiety was significantly lower immediately after placebo administration relative to both THC and CBD.
","[{'ForeName': 'Reilly R', 'Initials': 'RR', 'LastName': 'Kayser', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Raskin', 'Affiliation': 'Office of Mental Health, Research Foundation for Mental Hygiene, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arout', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Helen Blair', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}]",Depression and anxiety,['10.1002/da.23032']
151,32379608,The Impact of Childhood Maltreatment on Long-Term Outcomes in Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression.,"BACKGROUND


Childhood maltreatment (CM) predicted poorer outcomes in acute depression treatment with CBT, IPT and Supportive Psychotherapy (SP). The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) fared well in patients with chronic depression and CM during acute treatment, yet there is a considerable lack of empirical evidence for long-term outcomes.
METHODS


We analyzed one and two-year follow-up data of 268 patients randomized to 24 sessions (20 weeks) of acute and 8 sessions (28 weeks) of extended treatment with CBASP or SP. Primary outcome was the number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE). Secondary outcomes included self- and clinician-rated depression symptoms. We investigated this moderating effect for any CM and for specific subtypes of CM.
RESULTS


Intent-to-treat analyses revealed that the presence of CM did not significantly moderate long-term effects of CBASP compared to SP. The analysis of trauma subtypes revealed that patients with childhood emotional abuse had statistically significant worse outcomes than patients without (main effect, p=.015) and that the advantage of CBASP over SP was larger in patients with childhood emotional abuse than in patients without (interaction effect, p=.045) after 1 year. No significant effects were found for other trauma subtypes.
LIMITATIONS


The measurement of CM was limited to retrospective self-assessment.
CONCLUSIONS


The presence of CM did not significantly moderate long-term treatment effects of CBASP compared to SP. When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.",2020,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","['Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression', 'patients with chronic depression and CM during acute treatment']","['CBT, IPT and Supportive Psychotherapy (SP', 'Psychotherapy (CBASP', 'CBASP', 'CBASP or SP']","['number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE', 'self- and clinician-rated depression symptoms']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",268.0,0.144678,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bausch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: paul.bausch@gmx.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Elsaeßer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.164']
152,32379660,A sleep hygiene and yoga intervention conducted in affordable housing communities: Pilot study results and lessons for a future trial.,"BACKGROUND


and purpose: Inadequate sleep is highly prevalent among socioeconomically disadvantaged and racial/ethnic minority communities and is often related to maladaptive sleep behaviors and stress. There is scant research investigating the delivery of these interventions in underserved communities. The purpose of this study was to develop and test the feasibility and acceptability of a sleep education and yoga intervention for socioeconomically disadvantaged and racial/ethnic diverse adults.
MATERIALS AND METHODS


We present quantitative and qualitative data from a single-arm sleep education and yoga pilot study (n = 17) conducted in two affordable housing communities, and the multi-modal process we employed to refine the intervention for a future trial.
RESULTS


Participants were age 43.6 years on average (±19.3 years) and 88.2% were female. Nearly 56% identified as non-Hispanic Black and 19% as Hispanic/Latino. Results showed significant pre/post-intervention improvements in sleep duration (5.4 ± 1.2 h/night vs 6.9 ± 1.7 h/night; p < 0.01), sleep-related impairment (-8.15; p < 0.01), sleep disturbance (-5.95; p < 0.01), and sleep hygiene behaviors (-5.50; p < 0.01).
CONCLUSION


This study indicates intervention acceptability and improvements in sleep and sleep hygiene. Future randomized controlled trials are needed to assess efficacy.",2020,Results showed significant pre/post-intervention improvements in sleep duration (5.4 ± 1.2 h/night vs 6.9 ± 1.7 h/night; p < 0.01),"['Participants were age 43.6 years on average (±19.3 years) and 88.2% were female', 'underserved communities', 'socioeconomically disadvantaged and racial/ethnic diverse adults', 'We present quantitative and qualitative data from a single-arm sleep education and yoga pilot study (n\xa0=\xa017']",['sleep education and yoga intervention'],"[' sleep-related impairment ', 'sleep duration', 'sleep disturbance', 'sleep and sleep hygiene', 'sleep hygiene behaviors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0607289,Results showed significant pre/post-intervention improvements in sleep duration (5.4 ± 1.2 h/night vs 6.9 ± 1.7 h/night; p < 0.01),"[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Spadola', 'Affiliation': 'Sandler School of Social Work, Florida Atlantic University, Boca Raton, FL, USA. Electronic address: cspadola@fau.edu.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Rottapel', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jarvis T', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Department of Social and Behavioral Sciences, Boston, MA, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Bertisch', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine Harvard Medical School, Boston, MA, USA.""}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101121']
153,32379667,Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19.,"BACKGROUND


Patients with Coronavirus Disease 2019(COVID-19) will experience high levels of anxiety and low sleep quality due to isolation treatment. Some sleep-improving drugs may inhibit the respiratory system and worsen the condition. Prolonged bedside instruction may increase the risk of medical infections.
OBJECTIVE


To investigate the effect of progressive muscle relaxation on anxiety and sleep quality of COVID-19.
METHODS


In this randomized controlled clinical trial, a total of 51 patients who entered the isolation ward were included in the study and randomly divided into experimental and control groups. The experimental group used progressive muscle relaxation (PMR) technology for 30 min per day for 5 consecutive days. During this period, the control group received only routine care and treatment. Before and after the intervention, the Spielberger State-Trait Anxiety Scale (STAI) and Sleep State Self-Rating Scale (SRSS) were used to measure and record patient anxiety and sleep quality. Finally, data analysis was performed using SPSS 25.0 software.
RESULTS


The average anxiety score (STAI) before intervention was not statistically significant (P = 0.730), and the average anxiety score after intervention was statistically significant (P < 0.001). The average sleep quality score (SRSS) of the two groups before intervention was not statistically significant (P = 0.838), and it was statistically significant after intervention (P < 0.001).
CONCLUSION


Progressive muscle relaxation as an auxiliary method can reduce anxiety and improve sleep quality in patients with COVID-19.",2020,"The average anxiety score (STAI) before intervention was not statistically significant (P = 0.730), and the average anxiety score after intervention was statistically significant (P < 0.001).","['patients with COVID-19', '51 patients who entered the isolation ward', 'Patients with Coronavirus Disease 2019(COVID-19']","['progressive muscle relaxation (PMR) technology', 'progressive muscle relaxation', 'Prolonged bedside instruction']","['anxiety and sleep quality', 'average sleep quality score (SRSS', 'average anxiety score (STAI', 'anxiety and sleep quality of COVID-19', 'patient anxiety and sleep quality', 'Spielberger State-Trait Anxiety Scale (STAI) and Sleep State Self-Rating Scale (SRSS', 'sleep quality', 'average anxiety score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",51.0,0.0217776,"The average anxiety score (STAI) before intervention was not statistically significant (P = 0.730), and the average anxiety score after intervention was statistically significant (P < 0.001).","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Health Care Center, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China. Electronic address: hmliukai@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Duozhi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Health Care Center, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Ruzheng', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of General Practice, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Zaisheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of General Practice, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}, {'ForeName': 'Liqing', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Department of General Practice, Hainan Hospital of Hainan Medical College (Hainan General Hospital), Haikou, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101132']
154,32380950,Perturbation-based gait training to improve daily life gait stability in older adults at risk of falling: protocol for the REACT randomized controlled trial.,"BACKGROUND


The European population is rapidly ageing. There is an urgent need for innovative solutions to reduce fall risk in older adults. Perturbation-based gait training is a promising new method to improve reactive balance responses. Whereas positive effects on task-specific dynamic balance recovery during gait have been shown in clinical or laboratory settings, translation of these effects to daily life gait function and fall risk is limited. We aim to evaluate the effect of a 4-week perturbation-based treadmill training on daily-life dynamic gait stability, assessed with inertial sensor data. Secondary outcomes are balance recovery performance, clinical balance and gait assessment scores, the amount of physical activity in daily life and falls incidence during 6 months follow-up.
METHODS


The study is a monocenter assessor-blinded randomized controlled trial. The target study sample consists of 70 older adults of 65 years and older, living in the community and with an elevated risk of falling. A block-randomization to avoid seasonal effects will be used to allocate the participants into two groups. The experimental group receives a 4-week, two times per week perturbation-based gait training programme on a treadmill, with simulated slips and trips, in combination with cognitive dual tasks. The control group receives a 4-week, two times per week treadmill training programme under cognitive dual-task conditions without perturbations. Participants will be assessed at baseline and after the 4-weeks intervention period on their daily-life gait stability by wearing an inertial sensor on the lower back for seven consecutive days. In addition, clinical balance and gait assessments as well as questionnaires on falls- and gait-efficacy will be taken. Daily life falls will be followed up over 6 months by a fall calendar.
DISCUSSION


Whereas perturbation-based training has shown positive effects in improving balance recovery strategies and in reducing laboratory falls, this study will contribute to investigate the translation of perturbation-based treadmill training effects in a clinical setting towards improving daily life gait stability and reducing fall risk and falls.
TRIAL REGISTRATION


NTR7703 / NL66322.028.18, Registered: January 8, 2019; Enrolment of the first participant April 8, 2019.",2020,"The experimental group receives a 4-week, two times per week perturbation-based gait training programme on a treadmill, with simulated slips and trips, in combination with cognitive dual tasks.","['older adults at risk of falling', 'older adults', '70 older adults of 65\u2009years and older, living in the community and with an elevated risk of falling', ' January 8, 2019; Enrolment of the first participant April 8, 2019']","['gait training programme on a treadmill, with simulated slips and trips, in combination with cognitive dual tasks', 'Perturbation-based gait training', '4-week perturbation-based treadmill training', 'treadmill training programme under cognitive dual-task conditions without perturbations']","['Daily life falls', 'falls- and gait-efficacy', 'reactive balance responses', 'balance recovery performance, clinical balance and gait assessment scores, the amount of physical activity in daily life and falls incidence', 'daily-life dynamic gait stability', 'daily life gait stability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0179199', 'cui_str': 'Balance'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.121924,"The experimental group receives a 4-week, two times per week perturbation-based gait training programme on a treadmill, with simulated slips and trips, in combination with cognitive dual tasks.","[{'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Rieger', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Papegaaij', 'Affiliation': 'Motek Medical BV, Hogehilweg 18C, 1101 CD, Amsterdam, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Steenbrink', 'Affiliation': 'Motek Medical BV, Hogehilweg 18C, 1101 CD, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap H', 'Initials': 'JH', 'LastName': 'van Dieën', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pijnappels', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. m.pijnappels@vu.nl.'}]",BMC geriatrics,['10.1186/s12877-020-01566-z']
155,32383701,[CLINICAL DIAGNOSTIC VALUE OF OXIDATIVE STRESS MARKERS IN PATIENTS WITH CHRONIC HEART FAILURE. OPPORTUNITIES OF THEIR PHARMACOLOGICAL CORRECTION BY ETOXIDOL].,"Purpose - to evaluate the effectiveness of a fundamentally new antioxidant drug Amoxidal malate in patients with chronic heart failure (CHF) and its effect on marker of oxidative stress 2,3-diphosphoglycerate -2,3-DPG regulating the dissociation of oxyhemoglobin into hemoglobin and oxygen depending on the partial pressure of oxygen in the lungs and effect on other markers of oxidative stress. Clinical study of etoxazole was conducted in the city hospital N 23. 32 people were examined. At the age of 55 to 76 years (men and women) with coronary heart disease, stable angina, who had a myocardial infarction with a diagnosis of chronic heart failure II-IU FC according to the NYHA classification. Hypertension was diagnosed in 15 patients and type 2 diabetes mellitus in 8 patients. The study included patients with an ejection fraction of less than 40%. Permanent atrial fibrillation was diagnosed in 6 patients. Patients were divided into 2 groups: 1 main group, 22 patients who were added to the standard therapy with intravenous infusions of Ethylmethylhydroxypyridine malate, 2 group - control group, 10 people who received standard pharmacotherapy of CHF. Indicators of oxidative status, especially 2,3-DPH, were evaluated. and also, the voltage of oxygen (pO2), pCO2, pH, concentration of superoxide dismutase (SOD), malondialdehyde (MDA), the concentration of total peroxides in the blood of these patients. Etilmetilgidroksipiridinamaalat restores oxygenation of the blood in patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK. Analysis comparative assessment of treatment results shows that the addition of Ethoxide to standard therapy is most beneficial effect on patients› IU F. K. the Inclusion of the new Patriotic antioxidant drug Amoxidal in standard therapy of patients with CHF is pathogenetically justified and promising.",2020,Etilmetilgidroksipiridinamaalat restores oxygenation of the blood in patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK.,"['city hospital N 23', 'patients with an ejection fraction of less than 40', '15 patients and type 2 diabetes mellitus in 8 patients', 'patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK', '32 people', 'At the age of 55 to 76 years (men and women) with coronary heart disease, stable angina, who had a myocardial infarction with a diagnosis of chronic heart failure II-IU FC according to the NYHA classification', 'patients with chronic heart failure (CHF']","['standard therapy with intravenous infusions of Ethylmethylhydroxypyridine malate, 2 group - control group, 10 people who received standard pharmacotherapy of CHF', 'etoxazole', 'fundamentally new antioxidant drug Amoxidal malate']","['Etilmetilgidroksipiridinamaalat restores oxygenation', 'Hypertension', 'voltage of oxygen (pO2), pCO2, pH, concentration of superoxide dismutase (SOD), malondialdehyde (MDA), the concentration of total peroxides', 'Permanent atrial fibrillation']","[{'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0024546', 'cui_str': 'Malates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1702038', 'cui_str': 'etoxazole'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0201931', 'cui_str': 'Carbon dioxide measurement, partial pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}]",32.0,0.0236632,Etilmetilgidroksipiridinamaalat restores oxygenation of the blood in patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pavlova', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kukes', 'Affiliation': '1First Moscow State Medical University named after Sechenov; 2Scientific Center for Expert Evaluation of Medical Products. Moscow, Russia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shih', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Badridinova', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Berechikidze', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Degtyarevskaya', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}]",Georgian medical news,[]
156,32383748,Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT01934803.",2020,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","['participants recruited from 2013 to 2015', 'Participants were adults (aged 18-70 years) with documented HIV infection who were antiretroviral therapy-naive at baseline and had past 30-day heavy alcohol consumption', 'HIV-Positive Adults With Heavy Alcohol Use', 'Participants were recruited from HIV and addiction clinical and nonclinical care sites in St Petersburg, Russia', 'A total of 254 participants (184 men [72%]; mean [SD] age, 34 [6] years) were enrolled in the trial; 126', 'people with heavy alcohol use who are living with HIV/AIDS']","['Zinc supplementation', 'zinc supplementation', 'Zinc Supplementation vs Placebo', 'Intervention\n\n\nPharmacy-grade zinc gluconate supplementation', 'placebo']","['Mortality Risk and HIV Disease Progression', 'mortality risk', 'cardiovascular disease risk (Reynolds Risk Score', 'change in CD4 cell count', 'high CD4 cell counts', 'VACS Index score', 'changes in inflammatory or microbial translocation biomarkers', 'soluble CD14 level', 'mortality risk measured as a change in Veterans Aging Cohort Study (VACS', 'VACS Index scores range', 'interleukin-6 level', 'adherence rate to zinc supplementation', 'lipopolysaccharide binding protein level', 'mortality and risk of cardiovascular disease, reduces levels of inflammation and microbial translocation, and slows HIV disease progression', 'Index score', 'intestinal fatty acid binding protein level', 'heavy drinking', 'dimerized plasmin fragment D level', 'mortality risk, CD4 cell counts, cardiovascular disease risk, and levels of inflammation or microbial translocation', 'Reynolds Risk Score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}]",126.0,0.736847,"In the per-protocol analyses, zinc supplementation statistically significantly affected changes in the VACS Index score at 18 months (AMD, -7.49; 95% CI, -13.74 to -1.23; P = .02); however, the adherence rate to zinc supplementation was 51%.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE), Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Blokhina', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Coleman', 'Affiliation': 'Biostatistics and Epidemiology Data Analytics Center (BEDAC), Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Yaroslavtseva', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'So-Armah', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Larner College of Medicine, Department of Pathology and Laboratory Medicine, The University of Vermont, Colchester.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.4330']
157,32384612,Effects of 12 Weeks of Resistance Training on Cardiovascular Risk Factors in School Adolescents.,"Background and objectives:  The practice of physical exercise, especially resistance exercise, is important for the treatment and/or prevention of cardiovascular risk factors in adult individuals. However, there are few studies on its effects on adolescent individuals. Therefore, the aim of the present study was to evaluate the effects of applying a 12-week resistance training program on cardiovascular risk factors in adolescents.  Materials and Methods:  Thus, 122 adolescents aged 13-16 years of both genders participated in the study from school in the city of Lagarto, Sergipe (SE), Brazil, divided into two groups: Control Group (CG) and Group undergoing resistance training (RTG). Blood collection and anthropometric measurements were performed before and after the 12-week resistance training program (RTP).  Results:  After 12 weeks of the RTP in the adolescents, there was a reduction in the triglyceride variables (9.55%,  p  = 0.0286), Low-Density Lipoproteins (LDL) (5.42%,  p  = 0.0244), non-High-Density Lipoproteins (HDL) (5.40%,  p  = 0.0019), blood glucose (6.71%,  p  = 0.0040), systolic blood pressure (10.13%,  p  < 0.0001), as well as an increase in the body weight variable (1.73%,  p  = 0.0003).  Conclusions:  It was concluded that a 12-week RTP can prevent and/or alleviate the development of several chronic degenerative diseases in adulthood and that resistance training is important for maintaining the health of adolescents.",2020,It was concluded that a 12-week RTP can prevent and/or alleviate the development of several chronic degenerative diseases in adulthood and that resistance training is important for maintaining the health of adolescents.,"['adult individuals', 'School Adolescents', '122 adolescents aged 13-16 years of both genders participated in the study from school in the city of Lagarto, Sergipe (SE), Brazil, divided into two groups', 'adolescent individuals', 'adolescents']","['resistance training program', 'RTP', 'Control Group (CG) and Group undergoing resistance training (RTG', 'physical exercise, especially resistance exercise', 'Resistance Training']","['triglyceride variables', 'blood glucose', 'Blood collection and anthropometric measurements', 'cardiovascular risk factors', 'non-High-Density Lipoproteins (HDL', 'systolic blood pressure', 'Cardiovascular Risk Factors', 'Low-Density Lipoproteins (LDL', 'body weight variable']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0916139', 'cui_str': 'Stk38 protein, mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0530684', 'cui_str': 'ezogabine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1535899', 'cui_str': 'Non-high-density lipoprotein cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",122.0,0.0161412,It was concluded that a 12-week RTP can prevent and/or alleviate the development of several chronic degenerative diseases in adulthood and that resistance training is important for maintaining the health of adolescents.,"[{'ForeName': 'Lorrany da', 'Initials': 'LD', 'LastName': 'Rosa Santos', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Silvan Silva de', 'Initials': 'SS', 'LastName': 'Araujo', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Erlânyo Francisco Dos Santos', 'Initials': 'EFDS', 'LastName': 'Vieira', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Charles Dos Santos', 'Initials': 'CDS', 'LastName': 'Estevam', 'Affiliation': 'Departamento de Fisiologia, Universidade Federal de Sergipe, São Cristóvão 49100-000, Brazil.'}, {'ForeName': 'Jymmys Lopes Dos', 'Initials': 'JLD', 'LastName': 'Santos', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Rogério Brandão', 'Initials': 'RB', 'LastName': 'Wichi', 'Affiliation': 'Departamento de Educação Física, Universidade Federal de Sergipe, São Cristóvão 49040-780, Brazil.'}, {'ForeName': 'Fábio Bessa', 'Initials': 'FB', 'LastName': 'Lima', 'Affiliation': 'Departamento de Fisiologia e Biofísica, Instituto de Ciências Biomédicas I (ICB I), Universidade de São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Carla Roberta Oliveira', 'Initials': 'CRO', 'LastName': 'Carvalho', 'Affiliation': 'Departamento de Fisiologia e Biofísica, Instituto de Ciências Biomédicas I (ICB I), Universidade de São Paulo, São Paulo 05508-000, Brazil.'}, {'ForeName': 'Felipe José', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Physical Education Department and Group of Studies and Research of Performance, Sport, Health and Paralympic Sports-GEPEPS, Universidade Federal de Sergipe, São Cristóvão 49100-000, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Departamento de Morfologia, Universidade Federal de Sergipe, São Cristóvão 49100-000, Brazil.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56050220']
158,32384663,"Efficacy of Commercially Available Nutritional Supplements: Analysis of Serum Uptake, Macular Pigment Optical Density and Visual Functional Response.","Purpose:  To compare the change in serum carotenoids, macular pigment optical density (MPOD) and visual function with the intake of two commercially available nutritional supplements.  Methods:  Participants were given a 24-week supply of a lipid-based micronized liquid medical food, Lumega-Z™ (LM), containing 28 mg of the macular carotenoids lutein (L), zeaxanthin (Z) and  meso -zeaxanthin (MZ), or given PreserVision™ AREDS 2 Formula (gel-caps; PV) containing 12 mg of the macular carotenoids L and Z, but no reported MZ. Serum levels of L, Z and MZ were obtained at baseline and after 12 weeks. Macular pigment optical densities (MPOD) and visual function were assessed at baseline and after 24 weeks.  Results:  Average blood serum concentrations of L, Z and MZ in the two groups at baseline were similar. The increases in L, Z and MZ were 0.434, 0.063 and 0.086 mol/L vs. 0.100, 0.043 and 0.001 mol/L, respectively, in the LM vs. PV group. From baseline to week 24, average MPOD in the LM-group increased by 0.064 from 0.418 to 0.482, whereas in the PV-group, it was essentially unchanged (0.461 to 0.459;). Although log-contrast sensitivity was improved in all groups under three conditions (photopic, mesopic and mesopic with glare), the change in log-contrast sensitivity was not statistically significant . Conclusion:  Despite only a 2.3-fold higher carotenoid concentration than PV, LM supplementation provides approximately 3-4-fold higher absorption, which leads to a significant elevation of MPOD levels.",2020,"The increases in L, Z and MZ were 0.434, 0.063 and 0.086 mol/L vs. 0.100, 0.043 and 0.001 mol/L, respectively, in the LM vs. PV group.",[],"['lipid-based micronized liquid medical food, Lumega-Z™ (LM), containing 28 mg of the macular carotenoids lutein (L), zeaxanthin (Z) and  meso -zeaxanthin (MZ), or given PreserVision™ AREDS 2 Formula (gel-caps; PV) containing 12 mg of the macular carotenoids L and Z, but no reported MZ', 'Commercially Available Nutritional Supplements']","['Average blood serum concentrations of L, Z and MZ', 'Serum Uptake, Macular Pigment Optical Density and Visual Functional Response', 'Serum levels of L, Z and MZ', 'MPOD levels', 'average MPOD', 'carotenoid concentration', 'serum carotenoids, macular pigment optical density (MPOD) and visual function', 'Macular pigment optical densities (MPOD) and visual function', 'log-contrast sensitivity']",[],"[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C2927194', 'cui_str': 'Medical food'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0303444', 'cui_str': 'Magnesium-28'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2586580', 'cui_str': 'PreserVision'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0398595', 'cui_str': 'Myeloperoxidase deficiency'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}]",,0.0553229,"The increases in L, Z and MZ were 0.434, 0.063 and 0.086 mol/L vs. 0.100, 0.043 and 0.001 mol/L, respectively, in the LM vs. PV group.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bone', 'Affiliation': 'College of Arts, Science and Education, Florida International University, Miami, FL 33199, USA.'}, {'ForeName': 'Pinakin Gunvant', 'Initials': 'PG', 'LastName': 'Davey', 'Affiliation': 'College of Optometry, Western University of Health Sciences, Pomona, CA 91766, USA.'}, {'ForeName': 'Betzabe O', 'Initials': 'BO', 'LastName': 'Roman', 'Affiliation': 'College of Arts, Science and Education, Florida International University, Miami, FL 33199, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Evans', 'Affiliation': 'Guardion Health Sciences Inc, San Diego, CA 92128, USA.'}]",Nutrients,['10.3390/nu12051321']
159,32387014,[Repurposing of chlorpromazine in COVID-19 treatment: the reCoVery study].,"OBJECTIVES


The ongoing COVID-19 pandemic comprises a total of more than 2,350,000 cases and 160,000 deaths. The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking. Urgent action is needed to fight this fatal coronavirus infection by reducing the number of infected people along with the infection contagiousness and severity. Since the beginning of the COVID-19 outbreak several weeks ago, we observe in GHU PARIS Psychiatrie & Neurosciences (Sainte-Anne hospital, Paris, France) a lower prevalence of symptomatic and severe forms of COVID-19 infections in psychiatric patients (∼4%) compared to health care professionals (∼14%). Similar observations have been noted in other psychiatric units in France and abroad. Our hypothesis is that psychiatric patients could be protected from severe forms of COVID-19 by their psychotropic treatments. Chlorpromazine (CPZ) is a phenothiazine derivative widely used in clinical routine in the treatment of acute and chronic psychoses. This first antipsychotic medication has been discovered in 1952 by Jean Delay and Pierre Deniker at Sainte-Anne hospital. In addition, to its antipsychotic effects, several in vitro studies have also demonstrated a CPZ antiviral activity via the inhibition of clathrin-mediated endocytosis. Recently, independent studies revealed that CPZ is an anti-MERS-CoV and an anti-SARS-CoV-1 drug. In comparison to other antiviral drugs, the main advantages of CPZ lie in its biodistribution: (i) preclinical and clinical studies have reported a high CPZ concentration in the lungs (20-200 times higher than in plasma), which is critical because of the respiratory tropism of SARS-CoV-2; (ii) CPZ is highly concentrated in saliva (30-100 times higher than in plasma) and could therefore reduce the contagiousness of COVID-19; (iii) CPZ can cross the blood-brain barrier and could therefore prevent the neurological forms of COVID-19.
METHODS


Our hypothesis is that CPZ could decrease the unfavorable evolution of COVID-19 infection in oxygen-requiring patients without the need for intensive care, but also reduce the contagiousness of SARS-CoV-2. At this end, we designed a pilot, phase III, multicenter, single blind, randomized controlled clinical trial. Efficacy of CPZ will be assessed according to clinical, biological and radiological criteria. The main objective is to demonstrate a shorter time to response (TTR) to treatment in the CPZ+standard-of-care (CPZ+SOC) group, compared to the SOC group. Response to treatment is defined by a reduction of at least one level of severity on the WHO-Ordinal Scale for Clinical Improvement (WHO-OSCI). The secondary objectives are to demonstrate in the CPZ+SOC group, compared to the SOC group: (A) superior clinical improvement; (B) a greater decrease in the biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia); (D) a greater decrease in parenchymal involvement (chest CT) on the seventh day post-randomization; (E) to define the optimal dosage of CPZ and its tolerance; (F) to evaluate the biological parameters of response to treatment, in particular the involvement of inflammatory cytokines. Patient recruitment along with the main and secondary objectives are in line with WHO 2020 COVID-19 guidelines.
CONCLUSION


This repositioning of CPZ as an anti-SARS-CoV-2 drug offers an alternative and rapid strategy to alleviate the virus propagation and the infection severity and lethality. This CPZ repositioning strategy also avoids numerous developmental and experimental steps and can save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easy to manage side effects. Indeed, CPZ is an FDA-approved drug with an excellent tolerance profile, prescribed for around 70 years in psychiatry but also in clinical routine in nausea and vomiting of pregnancy, in advanced cancer and also to treat headaches in various neurological conditions. The broad spectrum of CPZ treatment - including antipsychotic, anxiolytic, antiemetic, antiviral, immunomodulatory effects along with inhibition of clathrin-mediated endocytosis and modulation of blood-brain barrier - is in line with the historical French commercial name for CPZ, i.e. LARGACTIL, chosen as a reference to its ""LARGe ACTion"" properties. The discovery of those CPZ properties, as for many other molecules in psychiatry, is both the result of serendipity and careful clinical observations. Using this approach, the field of mental illness could provide innovative therapeutic approaches to fight SARS-CoV-2.",2020,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,['psychiatric patients'],"['Chlorpromazine (CPZ', 'CPZ', 'chlorpromazine', 'phenothiazine derivative']","['biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia', 'parenchymal involvement (chest CT', 'shorter time to response (TTR']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0622901,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research university, université Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 evolutionary genomics of RNA viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France; GHU PARIS Psychiatrie et Neurosciences, site Sainte-Anne, service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.04.010']
160,32387042,"Anti-inflammatory effects of lenabasum, a cannabinoid receptor type 2 agonist, on macrophages from cystic fibrosis.","BACKGROUND


Lenabasum is an oral synthetic cannabinoid receptor type 2 agonist previously shown to reduce the production of key airway pro-inflammatory cytokines known to play a role in cystic fibrosis (CF). In a double-blinded, randomized, placebo-control phase 2 study, lenabasum lowered the rate of pulmonary exacerbation among patients with CF. The present study was undertaken to investigate anti-inflammatory mechanisms of lenabasum exhibits in CF macrophages.
METHODS


We used monocyte-derived macrophages (MDMs) from healthy donors (n = 15), MDMs with CFTR inhibited with C-172 (n = 5) and MDMs from patients with CF (n = 4). Monocytes were differentiated to macrophages and polarized into classically activated (M1) macrophages by LPS or alternatively activated (M2) macrophages by IL-13 in presence or absence of lenabasum.
RESULTS


Lenabasum had no effect on differentiation, polarization and function of macrophages from healthy individuals. However, in CF macrophages lenabasum downregulated macrophage polarization into the pro-inflammatory M1 phenotype and secretion of the pro-inflammatory cytokines IL-8 and TNF-α in a dose-dependent manner. An improvement in phagocytic activity was also observed following lenabasum treatment. Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs. The effects of lenabasum on MDMs with CFTR inhibited by C-172 were not as obvious.
CONCLUSION


In CF macrophages lenabasum modulates macrophage polarization and function in vitro in a way that would reduce inflammation in vivo. Further studies are warranted to determine the link between activating the CBR2 receptor and CFTR.",2020,"Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs.","['healthy donors (n\xa0=\xa015), MDMs with CFTR inhibited with', 'patients with CF']","['C-172', 'placebo']","['rate of pulmonary exacerbation', 'differentiation, polarization and function of macrophages', 'phagocytic activity']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0429742,"Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs.","[{'ForeName': 'Abdullah A', 'Initials': 'AA', 'LastName': 'Tarique', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Tama', 'Initials': 'T', 'LastName': 'Evron', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Tepper', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Morshed', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isabella S G', 'Initials': 'ISG', 'LastName': 'Andersen', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nelufa', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sly', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia. Electronic address: p.sly@uq.edu.au.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fantino', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.03.015']
161,32387055,Timing of Peak Vision Gains in Patients with Neovascular Age-Related Macular Degeneration Treated with Ranibizumab.,"PURPOSE


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


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


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


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


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


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


In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab. These findings suggest that continued treatment may result in greater vision improvements when consistent anti-vascular endothelial growth factor therapy is maintained over a longer period.",2020,"In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab.","['Patients with Neovascular Age-Related Macular Degeneration Treated with', 'patients with neovascular age-related macular degeneration (nAMD) who received', 'Treatment-naïve patients 50 years of age or older with subfoveal nAMD']","['Ranibizumab', 'ranibizumab']","['baseline demographic and clinical characteristics, presence of persistent subretinal fluid (SRF) or intraretinal fluid (IRF), and on-study events (atrophy status, fibrosis, retinal pigment epithelium\xa0tears', 'time to peak best-corrected visual acuity (BCVA', 'peak BCVA', 'Time to peak BCVA and its predictive value for magnitude of BCVA changes and BCVA', 'average lost vision', 'vision outcomes', 'vision gains', 'patient characteristics, persistent SRF or IRF', 'vision improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.134321,"In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab.","[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Bann-Mo', 'Initials': 'BM', 'LastName': 'Day', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoilov', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.011']
162,32387091,The Clinical Utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND


The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB.
OBJECTIVE


To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician.
METHODS AND RESULTS


We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs.
CONCLUSION


We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, New York, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001']
163,32387123,Re: Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery in Patients with High Grade Upper Tract Urothelial Carcinoma.,,2020,,['Patients with High Grade Upper Tract Urothelial Carcinoma'],['Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.0194814,,"[{'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Califano', 'Affiliation': 'Department of Urology, Bichat-Claude Bernard Hospital Paris Descartes University, Paris, France; Urology Unit, Department of Neurosciences, Reproductive Sciences and Odontostomatology, Federico II University of Naples, Naples, Italy. Electronic address: gianl.califano2@gmail.com.'}, {'ForeName': 'Evanguelos', 'Initials': 'E', 'LastName': 'Xylinas', 'Affiliation': 'Department of Urology, Bichat-Claude Bernard Hospital Paris Descartes University, Paris, France. Electronic address: evanguelosxylinas@hotmail.com.'}]",European urology,['10.1016/j.eururo.2020.04.008']
164,32387140,Religious Coping in Cancer: A quantitative analysis of expressive writing samples from patients with renal cell carcinoma.,"CONTEXT


Past religiosity/spirituality (R/S) research has mainly relied on self-report instruments which may result in self-presentation and defensive biases.
OBJECTIVES


To address these limitations, we reviewed the writing samples that were generated as part of an expressive writing trial, coded the samples for R/S content, and examined cross-sectional and prospective associations between R/S content and symptom and psychosocial outcomes.
METHODS


Participants diagnosed with renal cell carcinoma who were randomized to the expressive writing arm completed a standard writing protocol. Prior to randomization, they completed validated measures of R/S, depressive symptoms, social support, fatigue, and sleep disturbances and 1, 4 and 10 months after completing the intervention. Writing samples were coded for positive and negative religious coping (RC), and personal (e.g., private prayer) and collective (e.g., church attendance) religious engagement (RE).
RESULTS


Of the 138 patients, 117 provided at least one writing sample, and 89% of participants made at least one R/S reference with 70% including at least one positive RC statement and 45.3% revealed personal and 42.3% collective religious engagement. Negative RC was rare (8%). Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not. In prospective analyses, RE was associated with reduced cancer-related symptoms over time (P=.04) and negative RC was associated with increased psychological distress over time (P=.004).
CONCLUSION


Behavioral coding of expressive writing samples supported the literature suggesting that positive RC is common among cancer patients. Although negative RC may be relatively rare, it may be associated with psychological distress.",2020,"Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not.","['Cancer', 'Participants diagnosed with renal cell carcinoma', 'cancer patients', 'patients with renal cell carcinoma']",['expressive writing arm completed a standard writing protocol'],"['psychological distress', 'R/S, depressive symptoms, social support, fatigue, and sleep disturbances', 'positive and negative religious coping (RC), and personal (e.g., private prayer) and collective (e.g., church attendance) religious engagement (RE']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0681189', 'cui_str': 'Religiosity'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0392356', 'cui_str': 'Prayer'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",138.0,0.0481885,"Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not.","[{'ForeName': 'Santhosshi', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: snarayanan2@mdanderson.org.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.029']
165,32387209,"Invited commentary on ""The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"".",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0620143,,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Critical Care Medicine, Qinpu Branch of Zhongshan Hospital, Fufan University, Shanghai, China, 201700.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Wuhan Hospital of Traditional Chinese Medicine, Hubei, China, 430014. Electronic address: chenmingaini1232@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.073']
166,32387453,"Clinical and molecular characteristics and treatment outcomes of advanced right-colon, left-colon and rectal cancers: data from 1180 patients in a phase III trial of panitumumab with an extended biomarker panel.","BACKGROUND


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


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


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


RAS-wt patients with left-PTL are more likely to have panitumumab PFS advantage than those with right-PTL or rectal-PTL. However, an extended biomarker panel demonstrated significant heterogeneity in panitumumab PFS effect within a tumor location. AREG/EREG and HER3 mRNA expression identifies patients with right-PTL or rectal-PTL who achieve similar PFS effect with panitumumab as left-colon patients. Testing could provide a more reliable basis for clinical decision-making. Further validation and development of these biomarkers is required to optimise routine patient care.",2020,"IrPan PFS improvement compared with irinotecan was seen in left-PTL (HR=0.61,p=0.002) but not right-PTL (HR=0.98,p=0.90)(interaction p=0.05; RAS/BRAF-wt interaction p=0.10), or in rectal-PTL (HR=0.82,p=0.20)(interaction p=0.14 compared with left-PTL; RAS/BRAF-wt interaction p=0.04).","['advanced colorectal cancer (aCRC', 'advanced right-colon, left-colon and rectal cancers', '1180 patients in a phase III trial of panitumumab with an extended biomarker panel', 'aCRC patients from the second-line PICCOLO trial of']","['irinotecan /panitumumab', 'irinotecan versus irinotecan/panitumumab', 'panitumumab', 'irinotecan']","['IrPan PFS improvement', 'High HER3 expression', 'EREG/AREG or HER3 expression, had IrPan PFS improvement']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0072460', 'cui_str': 'Proto-Oncogene Protein erbB-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C3884279', 'cui_str': 'EREG protein, human'}, {'cui': 'C3884535', 'cui_str': 'AREG protein, human'}]",558.0,0.0774107,"IrPan PFS improvement compared with irinotecan was seen in left-PTL (HR=0.61,p=0.002) but not right-PTL (HR=0.98,p=0.90)(interaction p=0.05; RAS/BRAF-wt interaction p=0.10), or in rectal-PTL (HR=0.82,p=0.20)(interaction p=0.14 compared with left-PTL; RAS/BRAF-wt interaction p=0.04).","[{'ForeName': 'Jenny F', 'Initials': 'JF', 'LastName': 'Seligmann', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Elliott', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Richman', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Hemmings', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Jacobs', 'Affiliation': 'Molecular Digestive Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Molecular Digestive Oncology Unit, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Barrett', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Seymour', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.476']
167,32387472,Folinic acid improves the score of Autism in the EFFET placebo-controlled randomized trial.,"Autism spectrum disorders (ASD) are influenced by interacting maternal and environmental risk factors. High-dose folinic acid has shown improvement in verbal communication in ASD children. The EFFET randomized placebo-controlled trial (NCT02551380) aimed to evaluate the efficacy of folinic acid (FOLINORAL®) at a lower dose of 5 mg twice daily. Nineteen children were included in the EFFET trial. The primary efficacy outcome was improvement of Autism Diagnostic Observation Schedule (ADOS) score. The secondary outcomes were the improvement in ADOS sub scores communication, social interactions, Social Responsiveness Score (SRS) and treatment safety. The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively). We observed a greater change of ADOS global score (-2.78 vs. -0.4 points) and (-1.78 vs. 0.20 points) in the folinic acid group, compared to the placebo group. No serious adverse events were observed. This pilot study showed significant efficacy of folinic acid with an oral formulation that is readily available. It opens a perspective of therapeutic intervention with folinic acid but needs to be confirmed by a multi-center trial on a larger number of children.",2020,"The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively).","['Nineteen children were included in the EFFET trial', 'Autism spectrum disorders (ASD', 'ASD children']","['High-dose folinic acid', 'placebo', 'folinic acid (FOLINORAL®', 'Folinic acid', 'folinic acid']","['verbal communication', 'Autism Diagnostic Observation Schedule (ADOS) score', 'improvement in ADOS sub scores communication, social interactions, Social Responsiveness Score (SRS) and treatment safety', 'ADOS global score', 'serious adverse events', 'global ADOS score and social interaction and communication sub scores']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.384112,"The global ADOS score and social interaction and communication sub scores were significantly improved at week 12 compared to baseline in the folinic acid group (P = 0.003, P = 0.004 and P = 0.022, respectively), but not in the placebo group (P = 0.574, P = 0.780, P = 0.269, respectively).","[{'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Leheup', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Rosa-Maria', 'Initials': 'RM', 'LastName': 'Guéant-Rodriguez', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Oussalah', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Quadros', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France; Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Guéant', 'Affiliation': 'Inserm UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), Regional University Hospital of Nancy and University of Lorraine, BP 184, 54511, Nancy (Vandoeuvre), France. Electronic address: jean-louis.gueant@univ-lorraine.fr.'}]",Biochimie,['10.1016/j.biochi.2020.04.019']
168,32387499,Deep-learning-based pancreas segmentation and station recognition system in EUS: development and validation of a useful training tool (with video).,"BACKGROUND & AIMS


Endoscopic ultrasonography (EUS) is considered one of the most sensitive modalities for pancreatic cancer detection, but it is highly operator-dependent and the learning curve is steep. In this study, we constructed a system named Pancreaticobiliary (BP) master for EUS training and quality control.
METHODS


The standard procedure of pancreatic EUS was divided into 6 stations. We developed a station classification model and a pancreas/abdominal aorta/portal confluence segmentation model with 19486 images and 2207 images, respectively. Then, we used 1920 images and 700 images for classification and segmentation internal validation, respectively. 396 videos clips were used to test station recognition. An independent data set contained 180 images was applied for comparing the performance between models and EUS experts. 768 images from other two hospitals were used for external validation. A crossover study was conducted to test the system effect on reducing difficulty in ultrasnographics interpretation among trainees.
RESULTS


The models achieved 94.2% accuracy in station classification and 0.836 dice in segmentation at internal validation. At external validation, the models achieved 82.4% accuracy in station classification and 0.715 dice in segmentation. In video test, the station classification model achieved each-frame-accuracy of 86.2%. Comparing with the EUS experts, the models achieved 90.0% accuracy in classification and 0.77 and 0.813 dice in blood vessel and pancreas segmentation, which is comparable to that of expert. In the crossover study, trainees station recognition accuracy improved from 67.2% to 78.4% (95% CI, 0.058-1.663; P ＜ 0.01).
CONCLUSIONS


This system has potential to play an important role in shortening the pancreatic EUS learning curve and improving EUS quality control in the future.",2020,The models achieved 94.2% accuracy in station classification and 0.836 dice in segmentation at internal validation.,"['trainees', '396 videos clips']","['Endoscopic ultrasonography (EUS', 'system named Pancreaticobiliary (BP) master for EUS training', 'Deep-learning-based pancreas segmentation and station recognition system']",['trainees station recognition accuracy'],"[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0172156,The models achieved 94.2% accuracy in station classification and 0.836 dice in segmentation at internal validation.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Liangru', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Wuhan Union Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiangwu', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Wuhan Puai Hospital, Wuhan, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zihua', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'An', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Wuhan Puai Hospital, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Wuhan EndoAngel Medical Technology Company, Wuhan, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'Department of Surgery, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China. Electronic address: yuhonggang@whu.edu.cn.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.04.071']
169,32387531,The effect of presenting relative calorie information on calories ordered.,"In this research, we tested the effect of a novel method of presenting calorie information-highlighting relative differences in calories among ingredients. We conducted an online hypothetical food choice experiment where 633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables. Each participant was randomly assigned to one of four calorie information conditions: 1) a condition in which no information about calories was provided, 2) a condition in which calorie information was provided for each ingredient, 3) a condition in which calorie information was presented relative to the highest calorie item, and 4) a condition in which calorie information was presented relative to the lowest calorie item. Participants in the high- and low-calorie reference conditions ordered between 32 and 36 fewer calories per sandwich than participants in the no-calorie information control condition (p ≤ 0.04). Calories ordered by participants in the per-item calorie condition were not significantly different than the control. Presenting relative calorie or other nutritional information to make health-related trade-offs more salient may guide consumers to make healthier choices.",2020,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"['633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables']","['condition in which no information about calories was provided, 2) a condition in which calorie information']",[],"[{'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",[],633.0,0.0417974,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, University of Nebraska-Lincoln, 314A Filley Hall, Lincoln, NE, 68583, USA. Electronic address: cgustafson6@unl.edu.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Zeballos', 'Affiliation': 'USDA Economic Research Service, Food Economic Division, Washington, D.C, USA. Electronic address: eliana.zeballos@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104727']
170,32387659,Dupilumab prevents flares in adults with moderate-to-severe atopic dermatitis in a 52-week randomized controlled phase 3 trial.,,2020,,['adults with moderate-to-severe atopic dermatitis'],['Dupilumab'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}]",[],,0.102047,,"[{'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sidbury', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Ludwig-Maximilian University, Munich, Germany.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA. Electronic address: Ana.Rossi@sanofi.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.05.003']
171,32387690,Vein conduits used to enhance arterial microsurgical end-to-end suture repair: a randomized comparative study.,"Wrapping microsurgical sutures with a vein conduit is a well-described procedure for microsurgical nerve repair. While this has rarely been described in the context of vascular repair, this technique could increase the permeability of the sutured vessels. As part of a University Diploma in Microsurgery, 9 junior surgeons performed a comparative study of 18 microsurgical repairs on rats with and without vein sleeve. The vessels used were an external jugular vein sleeve on the end-to-end anastomosis of the common carotid artery and comparing it to this same anastomosis without a sleeve. The data analyzed were rat weight, suture time with carotid clamping time, number of stitches used, complications as well as vascular leakage and permeability of the repair at 0 and 5 minutes evaluated with a patency test. The average rat body weight was 255 g. Mean suture time was 52 minutes in group A (sleeved repairs) and 41 minutes in group B (standard repairs). The number of stitches placed was 5.1 points on average in group A and 5.6 points in group B. The time to perform the repair and the number of stitches was not statistically different between groups. The patency test was positive in 100% of cases in group A and in 78% of cases in group B. There was a significant difference between the permeability rate of the repairs, with better results in group A (p=0.03). There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01). The addition of a vein sleeve around an end-to-end arterial suture repair seems to improve its permeability and therefore its reliability.",2020,"There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01).",[],"['18 microsurgical repairs on rats with and without vein sleeve', 'Vein conduits used to enhance arterial microsurgical end-to-end suture repair', 'external jugular vein sleeve', 'Wrapping microsurgical sutures with a vein conduit']","['average rat body weight', 'rat weight, suture time with carotid clamping time, number of stitches used, complications as well as vascular leakage and permeability of the repair at 0 and 5 minutes evaluated with a patency test', 'permeability rate', 'number of stitches placed', 'patency test', 'time to perform the repair and the number of stitches', 'Mean suture time', 'anastomotic leaks']",[],"[{'cui': 'C0567345', 'cui_str': 'Microsurgical repair'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0226543', 'cui_str': 'Structure of external jugular vein'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}]",,0.0395513,"There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lancien', 'Affiliation': 'Department of Plastic, Reconstructive Surgery, Burns Centre, University Hospital Nantes,1, place Alexis Ricordeau, 44000 Nantes, France. Electronic address: ulancien@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Delaveau', 'Affiliation': 'Department of Orthopedic and Traumatology surgery, University Hospital Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pouedras', 'Affiliation': 'Department of Orthopedic and Traumatology surgery, University Hospital Nantes, 1, place Alexis Ricordeau, 44000 Nantes, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fortier', 'Affiliation': 'Department of Urology, University Hospital Angers, 4, rue Larrey, 49100 Angers, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bin', 'Affiliation': 'Department of Orthopedic pediatric surgery, Angers University Hospital, 4, rue Larrey, 49100 Angers, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ghersallah', 'Affiliation': 'Department of Stomatology and Maxillofacial Surgery, Hospital of Le Mans, 194, avenue Rubillard, 72037 Le Mans, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jeudy', 'Affiliation': 'Centre de la Main - Angers assistance- main, 47, rue de la Foucaudière, 49000 Trélazé, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saint Cast', 'Affiliation': 'Centre de la Main - Angers assistance- main, 47, rue de la Foucaudière, 49000 Trélazé, France.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Fournier', 'Affiliation': 'Department of Neurosurgery, Laboratory of Anatomy, rue Haute de Reculée, 49000 Angers, France.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.04.009']
172,32387716,Hypertension During Diabetic Ketoacidosis in Children.,"OBJECTIVES


To characterize hemodynamic alterations occurring during diabetic ketoacidosis (DKA) in a large cohort of children and to identify clinical and biochemical factors associated with hypertension.
STUDY DESIGN


This was a planned secondary analysis of data from the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation in DKA (FLUID) Study, a randomized clinical trial of fluid resuscitation protocols for children in DKA. Hemodynamic data (heart rate, blood pressure) from children with DKA were assessed in comparison with normal values for age and sex. Multivariable statistical modeling was used to explore clinical and laboratory predictors of hypertension.
RESULTS


Among 1258 DKA episodes, hypertension was documented at presentation in 154 (12.2%) and developed during DKA treatment in an additional 196 (15.6%), resulting in a total of 350 DKA episodes (27.8%) in which hypertension occurred at some time. Factors associated with hypertension at presentation included more severe acidosis, (lower pH and lower PCO 2 ), and stage 2 or 3 Acute Kidney Injury (AKI). More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
CONCLUSIONS


Despite dehydration, hypertension occurs in a substantial number of children with DKA. Factors associated with hypertension include greater severity of acidosis, lower PCO 2  and lower GCS scores during DKA treatment, suggesting that hypertension might be centrally mediated.",2020,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","['children with DKA', 'children in DKA', 'Hypertension During Diabetic Ketoacidosis in Children']",[],"['severity of acidosis, lower PCO 2  and lower GCS scores', 'Hemodynamic data (heart rate, blood pressure', 'severe acidosis and lower Glasgow Coma Scale (GCS) scores', 'hypertension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.0665684,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Nemours/A.I. DuPont Hospital for Children, Sidney Kimmel Medical College at Thomas Jefferson University.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine; Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The George Washington School of Medicine and Health Sciences.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine.""}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Colorado Children's Hospital, University of Colorado-Denver School of Medicine.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University School of Medicine.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania.""}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Columbia University College of Physicians and Surgeons.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School.""}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California Davis.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': 'Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine. Electronic address: nsglaser@ucdavis.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.066']
173,32387962,"Long-term treatment of chronic orofacial, pudendal, and central neuropathic limb pain with repetitive transcranial magnetic stimulation of the motor cortex.","OBJECTIVE


To assess the long-term analgesic effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) of the motor cortex in patients with chronic pain syndrome.
METHODS


The study included 57 patients (orofacial pain, n = 26, pudendal neuralgia, n = 18, and neuropathic limb pain, n = 13) with an ""induction phase"" of 12 daily rTMS sessions for 3 weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months.
RESULTS


All pain measures significantly decreased from baseline to the end of the induction phase. Analgesic response, defined as pain intensity decrease ≥ 30% compared to baseline, was observed in 39 patients (68%), who could be differentiated from non-responders from the 7th rTMS session. At the end of the maintenance phase (D180), 27 patients (47%) were still responders. Anxio-depressive symptoms and quality of life also improved. The analgesic response at the end of the induction phase was associated with lower pain score at baseline, and the response at the end of the maintenance phase was associated with lower anxio-depressive score at baseline.
CONCLUSION


The analgesic efficacy of motor cortex rTMS can be maintained in the long term in various chronic pain conditions. Patients with high pain level and severe anxio-depressive symptoms may have a less favorable profile to respond to the procedure.
SIGNIFICANCE


The overall impact of rTMS treatment on daily life requires a multidimensional evaluation that goes beyond the analgesic effect that can be achieved.",2020,All pain measures significantly decreased from baseline to the end of the induction phase.,"['patients with chronic pain syndrome', '57 patients (orofacial pain, n\xa0=\xa026, pudendal neuralgia, n\xa0=\xa018, and neuropathic limb pain, n\xa0=\xa013) with an ""induction phase"" of 12 daily rTMS sessions for 3\xa0weeks, followed by a ""maintenance phase"" of bi-monthly sessions for the next five months', 'Patients with high pain level and severe anxio-depressive symptoms']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'rTMS', 'motor cortex rTMS']","['pain intensity decrease\xa0≥', 'anxio-depressive score', 'Anxio-depressive symptoms and quality of life', 'analgesic response', 'lower pain score', 'Analgesic response', 'All pain measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1298685', 'cui_str': 'Chronic pain syndrome'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C1997249', 'cui_str': 'Pudendal neuralgia'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",57.0,0.0662332,All pain measures significantly decreased from baseline to the end of the induction phase.,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Hodaj', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France. Electronic address: HHodaj@chu-grenoble.fr.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Enkelejda', 'Initials': 'E', 'LastName': 'Hodaj', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dumolard', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Maindet', 'Affiliation': 'Centre de la Douleur, Pôle Anesthésie Réanimation, CHU Grenoble Alpes, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': ""Centre d'Investigation Clinique, CHU Grenoble Alpes, F-38000 Grenoble, France.""}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Delon-Martin', 'Affiliation': 'Grenoble Alpes University, Grenoble Institut Neurosciences, GIN, F-38000 Grenoble, France.'}, {'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Lefaucheur', 'Affiliation': 'EA 4391, Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor, Université Paris Est Créteil, Créteil, France.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.03.022']
174,32361126,Kinetic parameters during land and water walking performed by individuals with Down Syndrome.,"BACKGROUND


Down Syndrome (DS) is a genetic condition presenting delay in acquisition of main motor milestones, such as walking. Although studies have been investigating the biomechanical parameters during land walking performed by individual with DS, the literature is scarce regarding kinetic parameters analysis in this population, specially during water walking.
RESEARCH QUESTION


This study sought to assess the vertical ground reaction force (Fz) of walking performed in water and on land at different speeds by individuals with DS.
METHODS


Fourteen adults with DS (age: 27.9 ± 7.9 years; body mass: 58.4 ± 12.9 kg; height: 1.4 ± 0.1 m, body mass index: 29.2 ± 5.4 kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment. The protocol consisted of walking performed at three self-selected speeds (slow, comfortable and fast) in randomized order. The Fz was assessed with a waterproof force plate in each condition. Two-way repeated-measures ANOVA (environment and speed), with Bonferroni's post hoc tests, were used for analysis. A significance level was set as α = 0.05.
RESULTS


Significant differences were observed between environments (p < 0.001), with reduced first peak of Fz (68-73%), second peak of Fz (66-70%), loading rate (75-78%) and impulse (40-41%) in the water walking for all speeds analyzed. In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking. Moreover, the loading rate significantly increased (p = 0.019) as the impulse significantly reduced (p < 0.001) in the higher speeds.
SIGNIFICANCE


Individuals with DS present reduced Fz outcomes during water walking in comparison to land. Therefore, water walking may be performed by individuals with DS with safe vertical loads on lower limbs regardless the self-selected speed for rehabilitation, correction of gait and training purposes.",2020,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","['individuals with DS', 'individuals with Down Syndrome', 'Individuals with DS present', 'Fourteen adults with DS (age: 27.9\u2009±\u20097.9 years; body mass: 58.4\u2009±\u200912.9\u2009kg; height: 1.4\u2009±\u20090.1\u2009m, body mass index: 29.2\u2009±\u20095.4\u2009kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment']",['vertical ground reaction force (Fz) of walking performed in water and on land'],"['speed of walking', 'second peak of Fz', 'reduced Fz outcomes', 'loading rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0563034', 'cui_str': 'Aquatic environment'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0231467,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","[{'ForeName': 'Gabriela Neves', 'Initials': 'GN', 'LastName': 'Nunes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Gabriele Randuz', 'Initials': 'GR', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Exercise Research Laboratory, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Vitor de Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Rochele Barboza', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Alexandre Carriconde', 'Initials': 'AC', 'LastName': 'Marques', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil. Electronic address: tinialberton@yahoo.com.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.017']
175,32382289,Tai Chi Improves Coronary Heart Disease Risk by Inactivating MAPK/ERK Pathway through Serum miR-126.,"Background


Tai Chi is effective in preventing heart disease (CHD) risk, but the molecular mechanism remains unclear. Mitogen-activated protein kinase (MAPK) signaling plays a critical role in the pathogenesis of CHD and can be activated by miR-126. Tai Chi may exert its protective function through the miR-126-modulated MAPK pathway.
Methods


The CHD patients after PCI were randomized into the CG group (CG) (n = 19, normal care) and Tai Chi group (TG) (Tai Chi intervention, n = 17). Epicardial adipose tissue volume (EATV) (one main adverse cardiovascular event of CHD), HR (heart rate), QoL (quality of life) scores, and balance performance were measured in the two groups. The body fat content, abdominal subcutaneous fat, and visceral fat were measured to reflect the improvement of adipose tissue dysfunction. The levels of miR-126 and MAPK-associated molecules were measured in peripheral blood leukocytes. Meanwhile, the effects of miR-126 silence and mimic on MAPK-associated molecules were also explored in cardiac cell H9C2.
Results


After the 3-month intervention, Tai Chi reduced EATV and HR and increased QoL scores and balance performance, respectively ( P  < 0.05). The fat percentage, body fat mass, and BMI were also significantly reduced after Tai Chi intervention ( P  < 0.05). The levels of miR-126, MAPK, JNK, and ERK in the TG group were lower than those in the CG group ( P  < 0.05). The miR-126 levels had a strong relationship with the values of EATV, HR, and QoL scores ( P  < 0.05). miR-126 silence or mimic inactivated or activated MAPK-associated molecules in the cardiac cell lines.
Conclusions


Tai Chi improved CHD risk by inactivating the MAPK/ERK pathway via serum miR-126.",2020,"After the 3-month intervention, Tai Chi reduced EATV and HR and increased QoL scores and balance performance, respectively ( P  < 0.05).",['CHD patients after PCI'],"['Tai Chi group (TG) (Tai Chi intervention', 'Mitogen-activated protein kinase (MAPK', 'CG']","['Tai Chi reduced EATV and HR and increased QoL scores and balance performance', 'levels of miR-126, MAPK, JNK, and ERK', 'values of EATV, HR, and QoL scores', 'Epicardial adipose tissue volume (EATV) (one main adverse cardiovascular event of CHD), HR (heart rate), QoL (quality of life) scores, and balance performance', 'body fat content, abdominal subcutaneous fat, and visceral fat', 'levels of miR-126 and MAPK-associated molecules', 'adipose tissue dysfunction', 'CHD risk', 'fat percentage, body fat mass, and BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1563741', 'cui_str': 'Fat, Abdominal Subcutaneous'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1282512', 'cui_str': 'At risk of coronary heart disease'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0230156,"After the 3-month intervention, Tai Chi reduced EATV and HR and increased QoL scores and balance performance, respectively ( P  < 0.05).","[{'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Shui', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Xiaoxing', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun 130021, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/4565438']
176,32382296,Comparison of the Effect of Inhalation Aromatherapy with 10% and 30% Peppermint Essential Oils on the Severity of Nausea in Abdominal Surgery Patients.,"Background


One of the most common surgical complications is nausea. Regarding the contradictory findings on the effect of aromatherapy with peppermint on the severity of nausea, in the present study, we aimed at comparing the effect of aromatherapy with 10% and 30% peppermint essential oils on the severity of nausea in surgical patients.
Methods


This single-blind randomized controlled trial was conducted at the surgical ward of Imam Reza Hospital in Kermanshah, Iran. A total of 120 patients undergoing abdominal surgery were randomly divided into three groups of 10% peppermint, 30% peppermint, and control (40 patients in each group) using a random number table. In each of the intervention groups, 0.2 ml of 10% and 30% peppermint essential oil was inhaled. In the control group, the same amount of distilled water colored with green food coloring was inhaled. The severity of nausea was measured by nausea visual analog scale (NVAS) before and 10 minutes after the intervention.
Results


In the 10% peppermint group, the mean severity of nausea before the intervention was 52.3 ± 13.7 out of 100, which reduced to 40.5 ± 13.5 after the intervention ( p  < 0.001). In the 30% peppermint group, the mean severity scores of nausea before and after the intervention were 60.2 ± 15.0 and 39.7 ± 12.4, respectively ( p  < 0.001). In the control group, the mean severity scores of nausea before and after the intervention was not statistically significant. There was no significant difference between the two intervention groups in terms of the mean severity of nausea after the intervention.
Conclusions


It can be concluded that 10% and 30% peppermint essential oils are equally effective on the severity of nausea.",2020,"In the control group, the mean severity scores of nausea before and after the intervention was not statistically significant.","['Abdominal Surgery Patients', 'surgical ward of Imam Reza Hospital in Kermanshah, Iran', 'surgical patients', '120 patients undergoing abdominal surgery']","['aromatherapy', 'Inhalation Aromatherapy with 10% and 30% Peppermint Essential Oils', 'aromatherapy with peppermint', 'peppermint, 30% peppermint, and control']","['severity of nausea', 'Severity of Nausea', 'nausea visual analog scale (NVAS', 'mean severity scores of nausea', 'nausea', 'mean severity of nausea']","[{'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",120.0,0.0223965,"In the control group, the mean severity scores of nausea before and after the intervention was not statistically significant.","[{'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Ahmadi', 'Affiliation': 'Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Jahangir', 'Initials': 'J', 'LastName': 'Rezaei', 'Affiliation': 'Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Health Institute, Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khatony', 'Affiliation': 'Health Institute, Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5897465']
177,32382387,RT-qPCR study of COX-1 and -2 genes in oral surgical model comparing single-dose preemptive ibuprofen and etoricoxib: A randomized clinical trialy.,"Background


This study aimed to evaluate the gene expression of cyclooxygenases (COXs) in an oral model of preemptive analgesia.
Material and Methods


Gingival tissue was collected during extraction of lower third molars from a randomized, triple-blind, split-mouth and placebo-controlled study. The eligible patients were randomly sorted to receive a single dose either of ibuprofen 400mg, or etoricoxib 120 mg or a placebo, one hour prior to surgery. The temporal course of RNAm was evaluated for COX-1 and -2 by means of a quantitative polymerase chain reaction in real time (RT-qPCR) at time zero and 30 minutes after the surgical procedure began, and it was correlated with clinical parameters (pain and maximum mouth opening).
Results


There was a significant increase in COX-1 expression between T0 and T30 in ibuprofen ( p =0.004) and etoricoxib ( p =0.010) groups. As regards COX-2, there were increases from T0 to T30 in all groups (placebo,  p =0.012; ibuprofen,  p <0.001; etoricoxib,  p <0.001). All groups showed a significant decrease in COX-2:COX-1 ratio from T0 to T30 (placebo,  p =0.013; ibuprofen,  p <0.001; etoricoxib,  p =0.047). Experimental groups showed a significant correlation between COX-1 and COX-2 levels and clinical pain parameters.
Conclusions


The present preemptive analgesia study concludes that COX-2 RNAm induction was directly linked to third molar-related tissue inflammation and that the relation between COX-1 and COX-2 levels were inversely proportional to the preemptively administered nonsteroidal anti-inflammatory drugs COX-2 selectivity.  Key words: Preemptive analgesia, dental extraction, cyclooxygenases, real-time polymerase chain reaction.",2020,"All groups showed a significant decrease in COX-2:COX-1 ratio from T0 to T30 (placebo,  p =0.013; ibuprofen,  p <0.001; etoricoxib,  p =0.047).",[],"['cyclooxygenases (COXs', 'ibuprofen', 'etoricoxib', 'ibuprofen 400mg, or etoricoxib 120 mg or a placebo', 'ibuprofen and etoricoxib']","['COX-1 expression', 'COX-2:COX-1 ratio', 'COX-1 and COX-2 levels', 'COX-1 and COX-2 levels and clinical pain parameters']",[],"[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C1306284', 'cui_str': 'etoricoxib 120 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1565830', 'cui_str': 'PTGS1 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0974223,"All groups showed a significant decrease in COX-2:COX-1 ratio from T0 to T30 (placebo,  p =0.013; ibuprofen,  p <0.001; etoricoxib,  p =0.047).","[{'ForeName': 'Assis-Filipe', 'Initials': 'AF', 'LastName': 'Medeiros-Albuquerque', 'Affiliation': 'DDS, MSc, PhD, Division of Oral Surgery, School of Dentistry, Fortaleza University (UNIFOR), Fortaleza, Brazil.'}, {'ForeName': 'Cristiane-Sá', 'Initials': 'CS', 'LastName': 'Roriz-Fonteles', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'José-Jackson', 'Initials': 'JJ', 'LastName': 'do Nascimento-Costa', 'Affiliation': 'MSc, PhD, Biotechnology Nucleus of Sobral - NUBIS, School of Medicine, Federal University of Ceará, Sobral, Brazil.'}, {'ForeName': 'José-Roberto', 'Initials': 'JR', 'LastName': 'Viana-Silva', 'Affiliation': 'MSc, PhD, Biotechnology Nucleus of Sobral - NUBIS, School of Medicine, Federal University of Ceará, Sobral, Brazil.'}, {'ForeName': 'Paulo-Goberlânio', 'Initials': 'PG', 'LastName': 'de Barros-Silva', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Eduardo-Costa', 'Initials': 'EC', 'LastName': 'Studart-Soares', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Filipe-Nobre', 'Initials': 'FN', 'LastName': 'Chaves', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Karuza-Maria', 'Initials': 'KM', 'LastName': 'Alves-Pereira', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Thyciana-Rodrigues', 'Initials': 'TR', 'LastName': 'Ribeiro', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Fábio-Wildson', 'Initials': 'FW', 'LastName': 'Gurgel-Costa', 'Affiliation': 'DDS, MSc, PhD, Division of Clinical Dentistry, Postgraduate Program in Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56447']
178,32382415,Effect of procalcitonin on the prognosis of patients with COPD.,"The aim of the present study was to investigate the effect of procalcitonin levels on the prognosis of chronic obstructive pulmonary disease (COPD), and its relationship with other indices of infection. Inpatients diagnosed with acute aggravation of COPD between January 2017 and June 2018 were enrolled in the present study. Troponin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), white blood cell (WBC) count, percentage of neutrophils (NE%), hospitalization days and hospitalization expenses were collected and followed up for half a year to observe the survival rate in patients with COPD and the risk of acute aggravation. There were 246 patients with procalcitonin (PCT) levels <0.1 ng/ml, among whom 55 were randomly selected and assigned to a PCT negative group; and another 55 patients with PCT levels ≥0.1 ng/ml were assigned to a PCT positive group. The serum CRP, ESR, WBC count, NE% and hospitalization expenses in the PCT positive group were significantly higher compared with the PCT negative group (P<0.05). There was a positive association between PCT levels and CRP, WBC, NE% and hospitalization expenses, but not between PCT and ESR. The number of AECOPD events occurring within half a year between the two groups was statistically significant (χ²=5.923; P<0.05), and there was no significant correlation between PCT and recurrence frequency. Together, the results of the present study suggest that the levels of PCT in patients with acute aggravation may reflect the severity of COPD and may be used as a reference value for prognostic risk assessment. Serum PCT levels may be used as an indicator to predict duration and cost of hospitalization.",2020,"The serum CRP, ESR, WBC count, NE% and hospitalization expenses in the PCT positive group were significantly higher compared with the PCT negative group (P<0.05).","['Inpatients diagnosed with acute aggravation of COPD between January 2017 and June 2018 were enrolled in the present study', '246 patients with procalcitonin (PCT) levels <0.1 ng/ml, among whom 55 were randomly selected and assigned to a PCT negative group; and another 55 patients with PCT levels', 'patients with COPD']",['procalcitonin'],"['number of AECOPD events', 'PCT levels and CRP, WBC, NE% and hospitalization expenses', 'Troponin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), white blood cell (WBC) count, percentage of neutrophils (NE%), hospitalization days and hospitalization expenses', 'survival rate', 'Serum PCT levels', 'chronic obstructive pulmonary disease (COPD', 'serum CRP, ESR, WBC count, NE% and hospitalization expenses']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",246.0,0.0257163,"The serum CRP, ESR, WBC count, NE% and hospitalization expenses in the PCT positive group were significantly higher compared with the PCT negative group (P<0.05).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}, {'ForeName': 'Minli', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}, {'ForeName': 'Zhengfu', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Geriatrics Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China.'}]",Biomedical reports,['10.3892/br.2020.1298']
179,32380977,"Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial.","BACKGROUND


Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS.
METHODS


A pilot clinical trial using 140 mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change.
RESULTS


Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was - 0.679% for the AP group and - 1.069% for the placebo group (mean difference: -0.39; 95% CI [- 0.836-0.055], p = 0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200-1.777], p = 0.06). The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (mean difference: 0.63, p = 0.042). Adverse events related to AP were mild rash and dysgeusia.
CONCLUSIONS


AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02273635 retrospectively registered on October 24th, 2014.",2020,The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (,"['Forty-four patients were randomized: 23', 'not active progressive multiple sclerosis', 'patients with not active primary or secondary progressive MS was conducted']","['140\u2009mg oral AP or placebo', 'andrographolide (AP', 'Andrographolide', 'andrographolide', 'placebo']","['3-month confirmed disability progression (3-CDP) and mean EDSS change', 'mean percentage brain volume change (mPBVC', '3-CDP', 'brain atrophy and disability progression', 'efficacy and safety', 'mild rash and dysgeusia', 'median baseline EDSS', 'Annualized mPBVC', 'mean EDSS change']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051821', 'cui_str': 'andrographolide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",44.0,0.386963,The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (,"[{'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Ciampi', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile. ethelciampi@gmail.com.'}, {'ForeName': 'Reinaldo', 'Initials': 'R', 'LastName': 'Uribe-San-Martin', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cárcamo', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile. ccarcamo@med.puc.cl.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Cruz', 'Affiliation': 'Radiology, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Reyes', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Vásquez', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Burgos', 'Affiliation': 'Pharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, Independencia, 613, Valdivia, Chile.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hancke', 'Affiliation': 'Pharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, Independencia, 613, Valdivia, Chile.'}]",BMC neurology,['10.1186/s12883-020-01745-w']
180,32384465,Study on prevention of hypercapnia by Nasal High Flow in patients with endoscopic submucosal dissection during intravenous anesthesia.,"BACKGROUND


For relatively invasive upper gastrointestinal endoscopy procedures, such as an endoscopic submucosal dissection (ESD), intravenous anesthesia is routinely used to reduce patient anxiety. However, with the use of intravenous sedation, even at mild to moderate depth of anesthesia, there is always a risk of upper airway obstruction due to a relaxation of the upper airway muscles.With the advent of Nasal High Flow (NHF) devices that allow humidified high flow air through the nasal cavity, can be used as a respiratory management method in the context of anesthesia. AIRVO is commonly used for patients with obstructive sleep apnea and other respiratory disorders. This device uses a mild positive pressure load (several cmH2O) that improves carbon dioxide (CO2) washout and reduces rebreathing to improve respiratory function and therefore is widely used to prevent hypoxemia and hypercapnia.This study aims to maintain upper airway patency by applying NHF with air (AIRVO) as a respiratory management method during intravenous anesthesia for patients undergoing an ESD. In addition, this study investigates whether the use of an NHF device in this context can prevent intraoperative hypercapnia and hypoxemia.
METHODS/DESIGN


This study design employed 2 groups of subjects. Both received intravenous anesthesia while undergoing an ESD, and 1 group also used a concurrent nasal cannula NHF device. Here we examine if the use of an NHF device during intravenous anesthesia can prevent hypoxemia and hypercapnia, which could translate to improved anesthesia management.Efficacy endpoints were assessed using a transcutaneous CO2 monitor. This device measured the changes in CO2 concentration during treatment. Transcutaneous CO2 (PtcCO2) concentrations of 60 mmHg or more (PaCO2 > 55 mmHg) were considered marked hypercapnia. PtcCO2 concentrations of 50 to 60 mmHg or more (equivalent to PaCO2 > 45 mmHg) were considered moderate hypercapnia.Furthermore, the incidence of hypoxemia with a transcutaneous oxygen saturation value of 90% or less, and whether the use of NHF was effective in preventing this adverse clinical event were evaluated.
DISCUSSION


The purpose of this study was to obtain evidence for the utility of NHF as a potential therapeutic device for patients undergoing an ESD under anesthesia, assessed by determining if the incidence rates of hypercapnia and hypoxemia decreased in the NHF device group, compared to the control group that did not use of this device.
TRIAL REGISTRATION


The study was registered the jRCTs 072190022.URL https://jrct.niph.go.jp/en-latest-detail/jRCTs072190022.",2020,PtcCO2 concentrations of 50 to 60 mmHg or more (equivalent to PaCO2 > 45 mmHg) were considered moderate hypercapnia.,"['2 groups of subjects', 'patients with endoscopic submucosal dissection during intravenous anesthesia', 'patients with obstructive sleep apnea and other respiratory disorders', 'patients undergoing an ESD', 'patients undergoing an ESD under anesthesia']","['NHF with air (AIRVO', 'NHF device', 'Nasal High Flow (NHF) devices', 'intravenous anesthesia', 'NHF', 'carbon dioxide (CO2) washout and reduces rebreathing']","['CO2 concentration', 'PtcCO2 concentrations', 'Transcutaneous CO2 (PtcCO2) concentrations', 'hypercapnia and hypoxemia']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",,0.0532691,PtcCO2 concentrations of 50 to 60 mmHg or more (equivalent to PaCO2 > 45 mmHg) were considered moderate hypercapnia.,"[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Yamguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hosogaya', 'Affiliation': 'Nagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Nakashima', 'Affiliation': 'Nagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}]",Medicine,['10.1097/MD.0000000000020038']
181,32384478,Clinical study of XiangShaLiuJunZi decoction combined with S-1 as maintenance therapy for stage III or IV gastric carcinoma and colorectal carcinoma.,"INTRODUCTION


S-1, a new oral fluorouracil chemotherapeutical drug, has been increasingly used in clinical maintenance after first-line chemotherapy for stage III or IV gastric carcinoma (GC) and colorectal carcinoma (CRC) for its own advantages. XiangshaLiujunzi Decoction (XSLJZD), a classic traditional Chinese medicine (TCM) formula with effects of alleviating the adverse reactions of chemotherapy and improving the quality of life of cancer patients has been gradually confirmed, with no more reports about the maintenance therapy mode of combination of chemotherapeutic drugs and TCM. We designed the study of XSLJZD combined with S-1 in the maintenance therapy of Stage III or IV GC and CRC, and hoped that this research program will go further and comprehensively evaluate its efficacy and safety.
OBJECTIVES


The aim of this study was to determine the efficacy and safety of XSLJZD combined with S-1 in the maintenance therapy of stage III or IV GC and CRC.
METHODS


This study is an open, single-center, randomized study. Patients with stage III or stage IV GC and CRC will be randomized (1:1) into S-1group, S-1 combined with XSLJZD group for 5 years of maintenance therapy. The primary endpoint was progression-free survival, and secondary end point was overall survival and Quality of Life Assessment (QOLA), which include an improvement in symptoms before and after treatment, Karnofsky Performance Status, and adverse events assessment.
DISCUSSION


This study will provide meaningful clinical information about the combination of chemotherapeutic drugs S-1 with TCM in the maintenance therapy of stage III or IV GC and CRC.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR-INR-16008575.",2020,"formula with effects of alleviating the adverse reactions of chemotherapy and improving the quality of life of cancer patients has been gradually confirmed, with no more reports about the maintenance therapy mode of combination of chemotherapeutic drugs and TCM.","['stage III or IV gastric carcinoma (GC) and colorectal carcinoma (CRC', 'Patients with stage III or stage IV GC and CRC', 'cancer patients', 'stage III or IV gastric carcinoma and colorectal carcinoma']","['XSLJZD combined with S-1', 'TCM', 'XiangShaLiuJunZi decoction combined with S-1', 'S-1group, S-1 combined with XSLJZD', 'XiangshaLiujunzi Decoction (XSLJZD), a classic traditional Chinese medicine (TCM']","['quality of life', 'efficacy and safety', 'progression-free survival', 'overall survival and Quality of Life Assessment (QOLA), which include an improvement in symptoms before and after treatment, Karnofsky Performance Status, and adverse events assessment']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3884575', 'cui_str': 'Xiangshaliujunzi decoction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0439658', 'cui_str': 'Classic'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0857071,"formula with effects of alleviating the adverse reactions of chemotherapy and improving the quality of life of cancer patients has been gradually confirmed, with no more reports about the maintenance therapy mode of combination of chemotherapeutic drugs and TCM.","[{'ForeName': 'Xiao-Cui', 'Initials': 'XC', 'LastName': 'Hong', 'Affiliation': 'Oncology Center, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.'}, {'ForeName': 'Qi-Lian', 'Initials': 'QL', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Xing-Bo', 'Initials': 'XB', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Ke-Hui', 'Initials': 'KH', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Ou', 'Affiliation': ''}, {'ForeName': 'Hui-Jie', 'Initials': 'HJ', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020081']
182,32384495,"A simple, efficient, and safe way of finding recurrent laryngeal nerve beneficial for PTC patients.","BACKGROUND


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


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


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


The improved method of finding RLN is a simple, efficient and safe way, and easy to implement.",2020,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
",['One hundred fifty-eight patients'],[],"['metastatic LN and recurrent laryngeal nerve palsy', 'parathyroid hormone level', 'lower ratio of auto-transplantation and less operative time']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",158.0,0.0184314,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
","[{'ForeName': 'Shouyi', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}]",Medicine,['10.1097/MD.0000000000020138']
183,32384500,Multiple versus single doses of dexamethasone in total hip arthroplasty: A protocol of randomized controlled trial.,"BACKGROUND


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


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


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


This study protocol was registered in Research Registry (researchregistry5460).",2020,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","['Two hundred patients undergoing', 'early postoperative pain treatment after THA', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['dexamethasone', 'normal saline', 'intravenous dexamethasone', 'THA']","['postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion', 'visual analog scale pain scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",200.0,0.478323,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","[{'ForeName': 'Bangjian', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Shaoqiong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Operation room, Panzhihua Central Hospital.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sheng', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Sichuan Province, China.'}]",Medicine,['10.1097/MD.0000000000020147']
184,32385307,Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients.,"Medium cut-off (MCO) dialyzers help remove larger middle molecules associated with symptoms related to the accumulation of uremic retention solutes. We investigated the effect of an MCO dialyzer on the improvement of quality of life (QOL) in maintenance hemodialysis (HD) patients. Forty-nine HD patients with high-flux dialysis were randomly assigned to either an MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer and completed the study. QOL was assessed at baseline and after 12 weeks of treatment using the Kidney Disease Quality of Life Short Form-36, and pruritus was assessed using a questionnaire and visual analog scale. The reduction ratios of middle molecules were also evaluated. Laboratory markers, including serum albumin, did not differ between the two groups after 12 weeks. Removals of kappa and lambda free light chains were greater for MCO dialyzer than high-flux dialyzer. The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively). MCO dialyzers may improve patient-reported outcomes, particularly the physical components of QOL and uremic pruritus, in patients with high-flux dialyzers.",2020,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","['maintenance hemodialysis (HD) patients', 'maintenance hemodialysis patients', 'patients with high-flux dialyzers', 'Forty-nine HD patients with high-flux dialysis']","['Medium cut-off (MCO) dialyzers', 'MCO dialyzer', 'MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer', 'medium cut-off versus high-flux dialyzers', 'MCO dialyzers', 'MCO']","['reduction ratios of middle molecules', 'serum albumin', 'Removals of kappa and lambda free light chains', 'QOL', 'quality of life (QOL', 'questionnaire and visual analog scale', 'Kidney Disease Quality of Life Short Form-36, and pruritus', 'quality of life outcomes', 'frequency of scratching during sleep']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",49.0,0.0435656,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yeongwoo', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ju-Min', 'Initials': 'JM', 'LastName': 'Yook', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Soon-Youn', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. jh-cho@knu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-64622-z']
185,32385730,CARGEL Bioscaffold improves cartilage repair tissue after bone marrow stimulation in a minipig model.,"PURPOSE


To gain knowledge of the repair tissue in critically sized cartilage defects using bone marrow stimulation combined with CARGEL Bioscaffold (CB) compared with bone marrow stimulation (BMS) alone in a validated animal model.
METHODS


Six adult Göttingen minipigs received two chondral defects in each knee. The knees were randomized to either BMS combined with CB or BMS alone. The animals were euthanized after 6 months. Follow-up consisted of histomorphometry, immunohistochemistry, semiquantitative scoring of the repair tissue (ICRS II), and μCT of the trabecular bone beneath the defect.
RESULTS


There was significantly more fibrocartilage (80% vs 64%, p = 0.04) and a trend towards less fibrous tissue (15% vs 30%, p = 0.05) in the defects treated with CB. Hyaline cartilage was only seen in one defect treated with CB and none treated with BMS alone. For histological semiquantitative score (ICRS II), defects treated with CB scored lower on subchondral bone (69 vs. 44, p = 0.04). No significant differences were seen on the other parameters of the ICRS II. Immunohistochemistry revealed a trend towards more positive staining for collagen type II in the CB group (p = 0.08). μCT demonstrated thicker trabeculae (p = 0.029) and a higher bone material density (p = 0.028) in defects treated with CB.
CONCLUSION


Treatment of cartilage injuries with CARGEL Bioscaffold seems to lead to an improved repair tissue and a more pronounced subchondral bone response compared with bone marrow stimulation alone. However, the CARGEL Bioscaffold treatment did not lead to formation of hyaline cartilage.",2020,Immunohistochemistry revealed a trend towards more positive staining for collagen type II in the CB group (p = 0.08).,['Six adult Göttingen minipigs received two chondral defects in each knee'],"['CARGEL Bioscaffold', 'BMS', 'BMS combined with CB or BMS alone', 'bone marrow stimulation combined with CARGEL Bioscaffold (CB', 'bone marrow stimulation (BMS', 'μCT']","['subchondral bone response', 'histological semiquantitative score (ICRS II), defects treated with CB scored lower on subchondral bone', 'fibrous tissue', 'cartilage repair tissue', 'positive staining for collagen type', 'bone material density', 'fibrocartilage', 'Hyaline cartilage']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0410334', 'cui_str': 'Defect of articular cartilage'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0225331', 'cui_str': 'Fibrous tissue'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0684077', 'cui_str': 'Fibrocartilage'}, {'cui': 'C0225362', 'cui_str': 'Hyaline cartilage'}]",6.0,0.0454569,Immunohistochemistry revealed a trend towards more positive staining for collagen type II in the CB group (p = 0.08).,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hede', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark. kch@clin.au.dk.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Christensen', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Olesen', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Biomedicine, Aarhus University, Wilhelm Meyers Allé 3, 8000, Aarhus C, Denmark.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Foldager', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Lind', 'Affiliation': 'Orthopedic Research Laboratory, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Section J, Level 1, 8200, Aarhus N, Denmark.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00245-7']
186,32320997,Erratum.,[This corrects the article doi: https://doi.org/10.1590/S1984-29612019096].,2020,[This corrects the article doi: https://doi.org/10.1590/S1984-29612019096].,[],[],[],[],[],[],,0.0144103,[This corrects the article doi: https://doi.org/10.1590/S1984-29612019096].,[],Revista brasileira de parasitologia veterinaria = Brazilian journal of veterinary parasitology : Orgao Oficial do Colegio Brasileiro de Parasitologia Veterinaria,['10.1590/S1984-29612019108']
187,31810064,High-Intensity Interval Versus Moderate-Intensity Continuous Training in Individuals With Parkinson's Disease: Hemodynamic and Functional Adaptation.,"PURPOSE


To investigate the effect of high-intensity interval training (HIIT) versus moderate-intensity continuous exercise training (MICE) on hemodynamic and functional variables in individuals with Parkinson's disease.
METHODS


Twenty participants (13 men) were randomly assigned to a thrice-weekly HIIT (n = 12) or MICE (n = 8) for 12 weeks. Hemodynamic (resting heart rate and blood pressure, carotid femoral pulse wave velocity, endothelial reactivity, and heart rate variability) and functional variables (5-time sit-to-stand, timed up and go, and 6-min walking tests) assessed before and after training.
RESULTS


Demographic, hemodynamic and functional variables were similar between groups at baseline. Endothelial reactivity tended to increase after HIIT, but not after MICE, resulting in improved level (∼8%, P < .01) of this variable in HIIT versus MICE during follow-up. Six-minute walking test improved after HIIT (10.4 ± 3.8%, P < .05), but did not change after MICE. Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05). No significant changes were found after HIIT or MICE in any other variable assessed.
CONCLUSION


These results suggest that exercise intensity may influence training-induced adaptation on endothelial reactivity and aerobic capacity in individuals with Parkinson's disease.",2020,"Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05).","['Twenty participants (13 men', ""individuals with Parkinson's disease"", ""Individuals With Parkinson's Disease""]","['Moderate-Intensity Continuous Training', 'high-intensity interval training (HIIT) versus moderate-intensity continuous exercise training (MICE', 'MICE']","['Endothelial reactivity', 'Hemodynamic (resting heart rate and blood pressure, carotid femoral pulse wave velocity, endothelial reactivity, and heart rate variability) and functional variables (5-time sit-to-stand, timed up and go, and 6-min walking tests', 'hemodynamic and functional variables', 'endothelial reactivity and aerobic capacity', 'Hemodynamic and Functional Adaptation', 'High-Intensity Interval']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",20.0,0.0402688,"Sit to stand improved similarly after HIIT (27.2 ± 6.1%, P < .05) and MICE (21.5 ± 5.4%, P < .05).","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'Barbieri', 'Affiliation': ''}, {'ForeName': 'Fernanda Zane', 'Initials': 'FZ', 'LastName': 'Arthuso', 'Affiliation': ''}, {'ForeName': 'Fabiana Araújo', 'Initials': 'FA', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Gabriel Felipe', 'Initials': 'GF', 'LastName': 'Moretto', 'Affiliation': ''}, {'ForeName': 'Luis Felipe Itikawa', 'Initials': 'LFI', 'LastName': 'Imaizumi', 'Affiliation': ''}, {'ForeName': 'Awassi Yophiwa', 'Initials': 'AY', 'LastName': 'Ngomane', 'Affiliation': ''}, {'ForeName': 'Guilherme Veiga', 'Initials': 'GV', 'LastName': 'Guimarães', 'Affiliation': ''}, {'ForeName': 'Emmanuel Gomes', 'Initials': 'EG', 'LastName': 'Ciolac', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0588']
188,31810065,Acute Effects of Water-Based Concurrent Training Intrasession Exercise Sequences on Energy Expenditure in Young Women.,"BACKGROUND


To compare the acute effects of water-based aerobic-resistance and resistance-aerobic concurrent training (CT) sessions on energy expenditure (EE) during and postexercise in young women.
METHODS


Nine active women (24 [3] y; 60 [5] kg) completed 4 sessions: (1) familiarization, (2) aquatic maximal test to determine the heart rate corresponding to the anaerobic threshold, (3) CT protocol with aerobic-resistance sequence, and (4) CT protocol with resistance-aerobic sequence. Both protocols started and ended with the participants in the supine position for 30 minutes to perform resting and postexercise oxygen consumption measurements. The water-based resistance protocol comprised 4 sets of 15 seconds at maximal velocity, and the water-based aerobic protocol was performed at a continuous intensity (heart rate corresponding to the anaerobic threshold). EE measurements were calculated based on oxygen consumption and the corresponding caloric equivalent. Paired t test was used to compare the EE values between the water-based CT intrasession exercise sequences (α = .05).
RESULTS


There was no difference between the water-based aerobic-resistance and resistance-aerobic in total EE (330.78 vs 329.56 kcal; P = .96), EE per minute (7.35 vs 7.32 kcal·min-1; P = .96), and postexercise EE (63.65 vs 59.92 kcal; P = .50).
CONCLUSIONS


The intrasession exercise sequence during water-based CT had no influence on the EE in young women.",2020,"There was no difference between the water-based aerobic-resistance and resistance-aerobic in total EE (330.78 vs 329.56 kcal; P = .96), EE per minute (7.35 vs 7.32 kcal·min-1; P = .96), and postexercise EE (63.65 vs 59.92 kcal; P = .50).
","['Nine active women (24 [3', 'Young Women', 'young women']","['water-based aerobic-resistance and resistance-aerobic concurrent training (CT) sessions', '4 sessions: (1)\xa0familiarization, (2)\xa0aquatic maximal test to determine the heart rate corresponding to the anaerobic threshold, (3)\xa0CT protocol with aerobic-resistance sequence, and (4)\xa0CT protocol with resistance-aerobic sequence', 'Water-Based Concurrent Training Intrasession Exercise Sequences']","['energy expenditure (EE', 'postexercise EE', 'Energy Expenditure', 'EE values', 'water-based aerobic-resistance and resistance-aerobic in total EE']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",9.0,0.0264676,"There was no difference between the water-based aerobic-resistance and resistance-aerobic in total EE (330.78 vs 329.56 kcal; P = .96), EE per minute (7.35 vs 7.32 kcal·min-1; P = .96), and postexercise EE (63.65 vs 59.92 kcal; P = .50).
","[{'ForeName': 'Mariana R', 'Initials': 'MR', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Cristine L', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': ''}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Braga', 'Affiliation': ''}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0246']
189,32386308,Preoperative topical estrogen treatment versus placebo in 244 children with midshaft and posterior hypospadias.,"PURPOSE


Urethral fistula and dehiscence are common after hypospadias surgery. Preoperative androgens have been considered to reduce these complications although not evidence-based. Dermatologists have reported the benefits of topical Estrogens on skin healing. We investigated whether the preoperative use of topical Promestriene could reduce healing complications in hypospadias surgery. Our primary objective was to demonstrate a reduction of healing complications with Promestriene versus placebo. Impact on reoperations and other complications, clinical tolerance, bone growth and biological systemic effects of the treatment were also considered.
METHODS


We conducted a prospective, randomized, placebo-controlled, double-blind, parallel group trial, between 2011 and 2015, in 4 French centers. One-stage Transverse Preputial Island Flap Urethroplasty (Onlay urethroplasty) was selected for severe hypospadias. Promestriene or placebo was applied on the penis for 2 months prior to surgery. The primary outcome was the presence of postoperative urethral fistula or dehiscence in the first year post-surgery. For safety reasons, hormonal and anatomical screenings were performed.
RESULTS


Out of 241 patients who received surgery, 122 patients were randomized to receive placebo and 119 Promestriene. The primary outcome was unavailable for 11 patients. Healing complications were assessed at 16.4% (19/116) in the placebo versus 14.9% (17/114) in the Promestriene arm and the odds ratio adjusted on centre was 0.93 [0.45; 1.94] (p=0.86).
CONCLUSIONS AND RELEVANCE


Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.",2020,"Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.","['hypospadias surgery', '241 patients who received surgery', '2011 and 2015, in 4 French centers', '122 patients', '244 children with midshaft and posterior hypospadias']","['topical Estrogens', 'topical Promestriene', 'Promestriene or placebo', 'placebo']","['healing complications', 'reoperations and other complications, clinical tolerance, bone growth and biological systemic effects', 'presence of postoperative urethral fistula or dehiscence in the first year post-surgery', 'skin healing', 'Healing complications']","[{'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0072151', 'cui_str': 'promestriene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041970', 'cui_str': 'Urethral fistula'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",241.0,0.658829,"Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Gorduza', 'Affiliation': ""Centre de Référence Maladies Rares\xa0Développement Génital\xa0: du Fœtus à l'Adulte.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Plotton', 'Affiliation': ""Centre de Référence Maladies Rares\xa0Développement Génital\xa0: du Fœtus à l'Adulte.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Remontet', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1\xa0; CNRS, UMR, Laboratoire de Biométrie et Biologie Evolutive, Villeurbanne, France.'}, {'ForeName': 'Claire-Lise', 'Initials': 'CL', 'LastName': 'Gay', 'Affiliation': ""Centre de Référence Maladies Rares\xa0Développement Génital\xa0: du Fœtus à l'Adulte.""}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'El Jani', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of clinical epidemiology, CHU-Lyon, Bron, France.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Cheikhelard', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France ; Université Sorbonne Paris cité, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blanc', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France ; Université Sorbonne Paris cité, Paris, France.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Elghoneimi', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, Centre de Référence des Maladies Endocriniennes Rares de la Croissance, Hôpital Robert Debré, APHP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Marc-David', 'Initials': 'MD', 'LastName': 'Leclair', 'Affiliation': 'Service de chirurgie pédiatrique, CHU de Nantes, 38 boulevard Jean Monnet, Nantes, Loire Atlantique, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roy', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1\xa0; CNRS, UMR, Laboratoire de Biométrie et Biologie Evolutive, Villeurbanne, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Pirot', 'Affiliation': ""Service pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Edouard Herriot, Place d'Arsonval, Lyon Cedex, France.""}, {'ForeName': 'Yanis', 'Initials': 'Y', 'LastName': 'Mimouni', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of clinical epidemiology, CHU-Lyon, Bron, France.'}, {'ForeName': 'Segolene', 'Initials': 'S', 'LastName': 'Gaillard', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of clinical epidemiology, CHU-Lyon, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chatelain', 'Affiliation': ""Centre de Référence Maladies Rares\xa0Développement Génital\xa0: du Fœtus à l'Adulte.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Morel', 'Affiliation': ""Centre de Référence Maladies Rares\xa0Développement Génital\xa0: du Fœtus à l'Adulte.""}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Kassai', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of clinical epidemiology, CHU-Lyon, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mouriquand', 'Affiliation': ""Centre de Référence Maladies Rares\xa0Développement Génital\xa0: du Fœtus à l'Adulte.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa231']
190,32386324,Hyperoncotic Albumin is not effective in the treatment of Peripheral Oedema.,It is somewhat bemusing that Hahn et al (1) choose the example of using hyperoncotic albumin to reduce peripheral oedema as an example of a clinical application that should not be abandoned on the basis of the Revised Starling Principle. Hyperoncotic albumin has never been proven in robust clinical trials to reduce peripheral oedema. A recent Randomised Controlled Trial (RCT) showed no change in clinical outcomes (2) in patients whilst receiving hyperoncotic albumin in conjunction with standard diuretic therapy.,2020,(1) choose the example of using hyperoncotic albumin to reduce peripheral oedema as an example of a clinical application that should not be abandoned on the basis of the Revised Starling Principle.,['patients whilst receiving hyperoncotic albumin in conjunction with standard diuretic therapy'],"['Hyperoncotic Albumin', 'Hyperoncotic albumin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0063222', 'cui_str': 'hyperoncotic albumin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0063222', 'cui_str': 'hyperoncotic albumin'}]",[],,0.0696144,(1) choose the example of using hyperoncotic albumin to reduce peripheral oedema as an example of a clinical application that should not be abandoned on the basis of the Revised Starling Principle.,"[{'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Muggleton', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13619']
191,32388538,Serotonin differentially modulates the temporal dynamics of the limbic response to facial emotions in male adults with and without autism spectrum disorder (ASD): a randomised placebo-controlled single-dose crossover trial.,"Emotion processing-including signals from facial expressions-is often altered in individuals with autism spectrum disorder (ASD). The biological basis of this is poorly understood but may include neurochemically mediated differences in the responsivity of key 'limbic' regions (including amygdala, ventromedial prefrontal cortex (vmPFC) and nucleus accumbens (NAc)). Emerging evidence also suggests that ASD may be a disorder of brain temporal dynamics. Moreover, serotonin (5-HT) has been shown to be a key regulator of both facial-emotion processing and brain dynamics, and 5-HT abnormalities have been consistently implicated in ASD. To date, however, no one has examined how 5-HT influences the dynamics of facial-emotion processing in ASD. Therefore, we compared the influence of 5-HT on the responsivity of brain dynamics during facial-emotion processing in individuals with and without ASD. Participants completed a facial-emotion processing fMRI task at least 8 days apart using a randomised double-blind crossover design. At each visit they received either a single 20-mg oral dose of the selective serotonin reuptake inhibitor (SSRI) citalopram or placebo. We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults. The neurotypical adults' limbic response reverted more rapidly to baseline following a 5-HT-challenge. Our results suggest that serotonergic homoeostatic control of the temporal dynamics in limbic regions is altered in adults with ASD, and provide a fresh perspective on the biology of ASD.",2020,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"['individuals with autism spectrum disorder (ASD', 'individuals with and without ASD', 'male adults with and without autism spectrum disorder (ASD', 'adults with ASD']","['serotonin (5-HT', 'citalopram', 'Serotonin', 'selective serotonin reuptake inhibitor (SSRI) citalopram or placebo', 'Emotion processing-including signals from facial expressions', '5-HT', 'placebo']",['facial-emotion processing fMRI task'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.311869,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"[{'ForeName': 'Nichol M L', 'Initials': 'NML', 'LastName': 'Wong', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. nichol.wong@kcl.ac.uk.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Findon', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vladimira', 'Initials': 'V', 'LastName': 'Stoencheva', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blainey', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Grainne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0693-0']
192,32388584,Enteric-coated sodium bicarbonate supplementation improves high-intensity cycling performance in trained cyclists.,"PURPOSE


Enteric-coated sodium bicarbonate (NaHCO 3 ) can attenuate gastrointestinal (GI) symptoms following acute bicarbonate loading, although the subsequent effects on exercise performance have not been investigated. The purpose of this study was to examine the effects of enteric-coated NaHCO 3  supplementation on high-intensity exercise performance and GI symptoms.
METHODS


Eleven trained male cyclists completed three 4 km time trials after consuming; a placebo or 0.3 g∙kg -1  body mass NaHCO 3  in enteric-coated or gelatin capsules. Exercise trials were timed with individual peak blood bicarbonate ion concentration ([HCO 3 - ]). Blood acid-base balance was measured pre-ingestion, pre-exercise, and post-exercise, whereas GI symptoms were recorded pre-ingestion and immediately pre-exercise.
RESULTS


Pre-exercise blood [HCO3 - ] and potential hydrogen (pH) were greater for both NaHCO 3  conditions (P < 0.0005) when compared to placebo. Performance time was faster with enteric-coated (- 8.5 ± 9.6 s, P = 0.044) and gelatin (- 9.6 ± 7.2 s, P = 0.004) NaHCO 3  compared to placebo, with no significant difference between conditions (mean difference = 1.1 ± 5.3 s, P = 1.000). Physiological responses were similar between conditions, although blood lactate ion concentration was higher with gelatin NaHCO 3  (2.4 ± 1.7 mmol∙L -1 , P = 0.003) compared with placebo. Furthermore, fewer participants experienced GI symptoms with enteric-coated (n = 3) compared to gelatin (n = 7) NaHCO 3 .
DISCUSSION


Acute enteric-coated NaHCO 3  consumption mitigates GI symptoms at the onset of exercise and improves subsequent 4 km cycling TT performance. Athletes who experience GI side-effects after acute bicarbonate loading may, therefore, benefit from enteric-coated NaHCO 3  supplementation prior to exercise performance.",2020,"NaHCO 3  compared to placebo, with no significant difference between conditions (mean difference = 1.1 ± 5.3 s, P = 1.000).","['trained cyclists', 'Eleven trained male cyclists completed three 4\xa0km time trials after consuming; a']","['placebo or 0.3\xa0g∙kg -1  body mass NaHCO 3  in enteric-coated or gelatin capsules', 'enteric-coated NaHCO 3  supplementation', 'sodium bicarbonate (NaHCO 3 ', 'gelatin', 'Enteric-coated sodium bicarbonate supplementation', 'placebo']","['Blood acid-base balance', 'Pre-exercise blood [HCO3 - ] and potential hydrogen (pH', 'high-intensity exercise performance and GI symptoms', 'high-intensity cycling performance', 'Performance time', 'GI symptoms', 'Physiological responses', 'blood lactate ion concentration']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",11.0,0.268481,"NaHCO 3  compared to placebo, with no significant difference between conditions (mean difference = 1.1 ± 5.3 s, P = 1.000).","[{'ForeName': 'Nathan Philip', 'Initials': 'NP', 'LastName': 'Hilton', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK. hiltonn@edgehill.ac.uk.'}, {'ForeName': 'Nicholas Keith', 'Initials': 'NK', 'LastName': 'Leach', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK.'}, {'ForeName': 'Melissa May', 'Initials': 'MM', 'LastName': 'Hilton', 'Affiliation': 'Therapies Department, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'S Andy', 'Initials': 'SA', 'LastName': 'Sparks', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK.'}, {'ForeName': 'Lars Robert', 'Initials': 'LR', 'LastName': 'McNaughton', 'Affiliation': 'Department of Sport and Physical Activity, Sports Nutrition and Performance Research Group, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04387-5']
193,32388622,"The effect of oxytocin, gender, and ovarian hormones on stress reactivity in individuals with cocaine use disorder.","RATIONALE


Cocaine use disorder (CUD) is associated with dysregulation of the hypothalamic-pituitary-adrenal axis, which plays a critical role in the human stress response. Men and women with CUD differ in reactivity to social stressors. The hypothalamic neuropeptide oxytocin is involved in anxiolytic and natural reward processes, and has shown therapeutic potential for addictive disorders and stress reduction.
OBJECTIVES


To examine the impact of oxytocin (oxytocin (OXY) vs. placebo (PBO)) and gender (female (F) vs. male (M)) on response to a social stress task in individuals with CUD. To explore whether ovarian hormones moderate this stress response.
METHODS


One hundred twelve adults with CUD were randomized to receive 40 IU intranasal oxytocin (n = 56) or matching placebo (n = 56). Forty minutes after drug administration, participants were exposed to a social stressor. Generalized linear mixed models were used to examine neuroendocrine (cortisol) and subjective (craving, stress) response at pre-stressor, stressor + 0, + 10, + 30, + 60 min.
RESULTS


Gender moderated the effect of oxytocin on neuroendocrine response (p = 0.048); women receiving oxytocin (F + OXY) showed blunted cortisol response compared to the other three groups (F + PBO; M + OXY; M + PBO). There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016). Oxytocin had no significant effect on craving or stress, and gender did not moderate the effect of oxytocin on either measure. Higher endogenous progesterone was associated with lower craving response in women (p = 0.033).
CONCLUSIONS


Oxytocin may have differential effects in men and women with CUD. Women may be at greater risk for relapse in response to social stressors, but ovarian hormones may attenuate this effect.",2020,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"['individuals with cocaine use disorder', 'Men and women with CUD differ in reactivity to social stressors', 'One hundred twelve adults with CUD', 'individuals with CUD', 'men and women with CUD', 'gender (female (F) vs. male (M']","['oxytocin', 'oxytocin (oxytocin (OXY) vs. placebo (PBO', 'Oxytocin', '40 IU intranasal oxytocin (n\u2009=\u200956) or matching placebo']","['subjective stress response', 'blunted cortisol response', 'craving or stress', 'neuroendocrine response', 'craving response', 'neuroendocrine (cortisol) and subjective (craving, stress) response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}]",112.0,0.0816261,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA. shermanb@musc.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Nunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05516-w']
194,32389013,mRNA expression disturbance of complement system related genes in acute arterial thrombotic and paroxysmal atrial fibrillation patients.,"BACKGROUND


This study aimed to compare the characteristics of mRNA expression of genes in complement system between acute arterial thrombotic patients and paroxysmal atrial fibrillation (PAF) patients.
METHODS


Twenty acute myocardial infarction (AMI) patients and 20 PAF patients were assigned into the experiment groups, and 20 stable angina pectoris (SAP) patients were enrolled in the control group.
RESULTS


When compared with the control group, mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes was significantly upregulated, and CR2 gene significantly downregulated in the AMI group (P<0.05); while mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes was significantly downregulated in PAF patients (P<0.05). Results of the comparison between the AMI and PAF group showed that mRNA expression of C1QA, C1QB, C1QC, C1R, CFB, CFD, CFP, MBL2, MASP2, C5, C6, C8B, C9, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CFI, CFHR1, CD46, CD55, CLU, VTN and CD59 genes was significantly upregulated in the AMI group (P<0.05).
CONCLUSIONS


Taken SAP patients as controls, the complement system is in a high-intensive disturbance with simultaneous activation and inhibition in AMI patients, indicating that the cascade response of complement system is disturbed, and then the membrane attack complex (MAC) cannot form finally. The mRNA expression of related genes in the complement system is under a status of downregulation in PAF patients, indicating that the functions of cascade response in the complement system decreased significantly in PAF patients, leading to significantly decreased MAC functions.",2020,"When compared with the control group, mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes was significantly upregulated, and CR2 gene significantly downregulated in the AMI group (P<0.05); while mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes was significantly downregulated in PAF patients (P<0.05).","['acute arterial thrombotic patients and paroxysmal atrial fibrillation (PAF) patients', 'Twenty acute myocardial infarction (AMI) patients and 20 PAF patients were assigned into the experiment groups, and 20 stable angina pectoris (SAP) patients were enrolled in the control group', 'acute arterial thrombotic and paroxysmal atrial fibrillation patients']",[],"['CR2 gene', 'mRNA expression of C1QA, C1QB, C1QC, C1R, CFB, CFD, CFP, MBL2, MASP2, C5, C6, C8B, C9, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CFI, CFHR1, CD46, CD55, CLU, VTN and CD59 genes', 'mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes', 'mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes', 'MAC functions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0056184', 'cui_str': 'Lymphocyte antigen CD21'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C1562113', 'cui_str': 'Fleck corneal dystrophy'}, {'cui': 'C0055162', 'cui_str': 'CFP protocol'}, {'cui': 'C0056182', 'cui_str': 'Complement receptor CRI'}, {'cui': 'C1701032', 'cui_str': 'ITGAM protein, human'}, {'cui': 'C0055288', 'cui_str': 'Chemotaxis factor inhibitor'}, {'cui': 'C0285488', 'cui_str': 'Lymphocyte antigen CD46'}, {'cui': 'C0108793', 'cui_str': 'Decay accelerating factor'}, {'cui': 'C0054966', 'cui_str': 'Lymphocyte antigen CD59'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",20.0,0.0171834,"When compared with the control group, mRNA expression of C1QA, C1QB, C1QC, C1R, CFP, C5, CR1, ITGAM, ITGAX, ITGB2, C5AR1, CD46, CD55 and CD59 genes was significantly upregulated, and CR2 gene significantly downregulated in the AMI group (P<0.05); while mRNA expression of CFD, MBL2, MASP2, C5, C6, C8B, C9, C5AR1, CR2, CFI, CFHR1, CD46, CD55, VTN and CD59 genes was significantly downregulated in PAF patients (P<0.05).","[{'ForeName': 'Siwan', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Cardiology, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China.'}, {'ForeName': 'Lemin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Tongji Hospital, Tongji University School of Medicine, Shanghai 200065, China. wanglemin2003@163.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.18']
195,32389019,Effects of auricular acupuncture on appetite in patients with advanced cancer: a pilot randomized controlled trial.,"BACKGROUND


Over half of patients with advanced cancer report appetite loss or anorexia. Previous studies have shown the benefit of acupuncture for cancer-related nausea and vomiting, but limited evidence exists for its role in appetite improvement. Our study aimed to evaluate the feasibility and safety of auricular acupuncture to improve appetite for cancer patients with advanced disease.
METHODS


We performed a two-arm parallel, pilot randomized controlled trial (RCT) of auricular acupuncture versus usual care control in patients with stage III or IV cancer who experienced appetite loss. The primary outcome was changed in the Simplified Nutritional Appetite Questionnaire (SNAQ; score range, 4-20) between two groups from baseline to weeks 2 and 4, with secondary outcomes including change in weight, as well as an additional evaluation at week 8 for durability of treatment effects. We used independent two-sample t-test for the change in mean score for each outcome during or after treatment. We assessed the interaction between time and treatment from baseline to weeks 2, 4, and 8 using mixed-effects models by ANOVA test.
RESULTS


We randomized 55 patients to auricular acupuncture (N=27) or control group (N=28). By week 4, the auricular acupuncture group had a significantly higher escalation in the SNAQ score than the control group compared with baseline [mean difference 3.69; 95% confidential interval (95% CI): 2.5, 4.8; P<0.001] and experienced a 51.4% improvement in appetite. From baseline to weeks 2 and 4, patients lost a little weight in the control group but gained weight in the auricular acupuncture group. Between baseline and week 4, change in the SNAQ score was significantly associated with change in weight (P=0.001). No adverse events (AEs) were reported during the study.
CONCLUSIONS


Compared to usual care, auricular acupuncture is feasible and safe to improve appetite and help patients with advanced cancer gain weight.",2020,"By week 4, the auricular acupuncture group had a significantly higher escalation in the SNAQ score than the control group compared with baseline [mean difference 3.69; 95% confidential interval (95% CI): 2.5, 4.8; P<0.001] and experienced a 51.4% improvement in appetite.","['patients with advanced cancer', 'N=27) or control group (N=28', 'patients with advanced cancer gain weight', 'patients with stage III or IV cancer who experienced appetite loss', 'cancer patients with advanced disease', 'patients with advanced cancer report appetite loss or anorexia']","['usual care, auricular acupuncture', 'acupuncture', 'auricular acupuncture']","['Simplified Nutritional Appetite Questionnaire (SNAQ; score range, 4-20', 'SNAQ score', 'appetite', 'change in weight, as well as an additional evaluation at week 8 for durability of treatment effects', 'feasibility and safety', 'gained weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",55.0,0.345349,"By week 4, the auricular acupuncture group had a significantly higher escalation in the SNAQ score than the control group compared with baseline [mean difference 3.69; 95% confidential interval (95% CI): 2.5, 4.8; P<0.001] and experienced a 51.4% improvement in appetite.","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Bendheim Integrative Medicine Center, New York, NY, USA.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Integrative Chinese and Western Medicine, Cancer Hospital of Peking University, Beijing 100142, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China. hebinbj68@163.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.24']
196,32389050,Necessity of Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation for Supination-External Rotation Lateral Malleolar Fractures.,"BACKGROUND


Interfragmentary lag screws, protected by a plate, have been applied for many years in the treatment of supination-external rotation (SER) ankle fractures. Recently, similar biomechanical stability was found between fixation completed with a plate and lag screw and a plate alone. The aim of this study was to determine whether interfragmentary lag screws are necessary during precontoured lateral locking plate fixation for SER lateral malleolar fractures.
METHODS


A prospective randomized controlled trial of 76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures was conducted. The patients were randomly treated either with or without the use of interfragmentary lag screws with precontoured lateral locking plate fixation. Clinical outcomes were assessed using the Olerud-Molander Ankle Score and a visual analog scale for pain. Radiologic outcomes were assessed based on the Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing. Sixty-nine patients completed 12 months of follow-up.
RESULTS


There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery. All patients in both groups achieved primary bone healing.
CONCLUSION


The results of this study suggest that with precontoured lateral locking plate fixation, the use of interfragmentary lag screw is not essential in the treatment SER lateral malleolar fractures.
LEVEL OF EVIDENCE


Level I, prospective randomized study.",2020,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"['76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures', 'Sixty-nine patients completed 12 months of follow-up', 'Supination-External Rotation Lateral Malleolar Fractures']","['precontoured lateral locking plate fixation', 'Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation', 'interfragmentary lag screws with precontoured lateral locking plate fixation']","['Radiologic outcomes', 'biomechanical stability', 'Olerud-Molander Ankle Score and a visual analog scale for pain', 'Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing', 'primary bone healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}]",76.0,0.0331161,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Gi Won', 'Initials': 'GW', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Ansan Hospital, Seoul, Korea.'}, {'ForeName': 'Hak Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}]",Foot & ankle international,['10.1177/1071100720917645']
197,32389076,Biomechanical responses of young adults with unilateral transfemoral amputation using two types of mechanical stance control prosthetic knee joints.,"BACKGROUND


Prosthetic knee joint function is important in the rehabilitation of individuals with transfemoral amputation.
OBJECTIVES


The objective of this study was to assess the gait patterns associated with two types of mechanical stance control prosthetic knee joints-weight-activated braking knee and automatic stance-phase lock knee. It was hypothesized that biomechanical differences exist between the two knee types, including a prolonged swing-phase duration and exaggerated pelvic movements for the weight-activated braking knee during gait.
STUDY DESIGN


Prospective crossover study.
METHODS


Spatiotemporal, kinematic, and kinetic parameters were obtained via instrumented gait analysis for 10 young adults with a unilateral transfemoral amputation. Discrete gait parameters were extracted based on their magnitudes and timing.
RESULTS


A 1.01% ± 1.14% longer swing-phase was found for the weight-activated braking knee (p < 0.05). The prosthetic ankle push-off also occurred earlier in the gait cycle for the weight-activated braking knee. Anterior pelvic tilt was 3.3 ± 3.0 degrees greater for the weight-activated braking knee. This range of motion was also higher (p < 0.05) and associated with greater hip flexion angles.
CONCLUSIONS


Stance control affects biomechanics primarily in the early and late stance associated with prosthetic limb loading and unloading. The prolonged swing-phase time for the weight-activated braking knee may be associated with the need for knee unloading to initiate knee flexion during gait. The differences in pelvic tilt may be related to knee stability and possibly the different knee joint stance control mechanisms.
CLINICAL RELEVANCE


Understanding the influence of knee function on gait biomechanics is important in selecting and improving treatments and outcomes for individuals with lower-limb amputations. Weight-activated knee joints may result in undesired gait deviations associated with stability in early stance-phase, and swing-phase initiation in the late stance-phase of gait.",2020,A 1.01% ± 1.14% longer swing-phase was found for the weight-activated braking knee (p < 0.05).,"['individuals with lower-limb amputations', 'individuals with transfemoral amputation', '10 young adults with a unilateral transfemoral amputation', 'young adults with unilateral transfemoral amputation using two types of mechanical stance control prosthetic knee joints']",['mechanical stance control prosthetic knee joints-weight-activated braking knee and automatic stance-phase lock knee'],"['prolonged swing-phase duration and exaggerated pelvic movements', 'hip flexion angles', 'Biomechanical responses', 'weight-activated braking knee']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0231753', 'cui_str': 'Knee locking'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",10.0,0.0173578,A 1.01% ± 1.14% longer swing-phase was found for the weight-activated braking knee (p < 0.05).,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Andrysek', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital and Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'García', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rozbaczylo', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alvarez-Mitchell', 'Affiliation': 'Escuela de Kinesiologia, Universidad Andres Bello, Santiago, Chile.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Valdebenito', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Rotter', 'Affiliation': 'Instituto Teleton, Santiago, Chile.'}, {'ForeName': 'F Virginia', 'Initials': 'FV', 'LastName': 'Wright', 'Affiliation': 'Holland Bloorview Kids Rehabilitation Hospital and Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.'}]",Prosthetics and orthotics international,['10.1177/0309364620916385']
198,32389377,Evaluation of the accuracy of implant placement by using fully guided versus partially guided tissue-supported surgical guides with cylindrical versus C-shaped guiding holes: A split-mouth clinical study.,"STATEMENT OF PROBLEM


The accuracy of partially guided implant placement protocols in comparison with fully guided protocols is still unclear. C-shaped guide holes have become popular; however, their effect on drilling and implant position accuracy has not been thoroughly investigated.
PURPOSE


The purpose of this split-mouth clinical study was to evaluate the accuracy of implant placement by using fully guided versus partially guided surgical guides with cylindrical versus C-shaped guiding holes.
MATERIAL AND METHODS


Adopting 80% power of the study in calculating sample size, a total of 48 implants were placed in the mandibular interforaminal area of 12 edentulous participants, who were randomly divided into 2 groups: a fully guided group, comprising 24 implants placed on 1 side by using a fully guided protocol and a partially guided group, comprising 24 implants placed on the other side in a partially guided protocol. Each group was further subdivided into 2 subgroups: cylindrical, including 12 implants placed through cylindrical guide holes, and C-shaped (12 implants) placed through C-shaped guiding holes. Postoperative cone beam computed tomography scans were made, and based on image fusion, the total deviations between the virtually preplanned and actual implant positions were determined and compared between both groups and subgroups. The linear horizontal deviation of the implant hexagon and apex, together with apical depth deviation and angular deviations between the position of the actually placed and virtually planned implants, were analyzed in 3 dimensions. The Kolmogorov-Smirnov test of normality was used. Comparisons were carried out by using the Kruskal-Wallis test. Post hoc pair-wise comparisons when the Kruskal-Wallis test was significant were carried out by using the Dunn-Sidak test (α=.05).
RESULTS


No statistically significant differences were found in coronal linear deviation (P>.05), apical linear deviation (P>.05), apical depth deviation (P=.086), or angular deviation (P=.247), between the fully guided protocol and the partially guided protocol.
CONCLUSIONS


The accuracy of partially guided implant placement was clinically comparable with that of fully guided placement whether the guiding holes were cylindrical or C-shaped.",2020,"No statistically significant differences were found in coronal linear deviation (P>.05), apical linear deviation (P>.05), apical depth deviation (P=.086), or angular deviation (P=.247), between the fully guided protocol and the partially guided protocol.
","['Adopting 80% power of the study in calculating sample size, a total of 48 implants were placed in the mandibular interforaminal area of 12 edentulous participants']","['Postoperative cone beam computed tomography\xa0scans', '24 implants placed on 1 side by using a fully guided protocol and a partially guided group, comprising 24 implants placed on the other side in a partially guided protocol', 'implant placement by using fully guided versus partially guided tissue-supported surgical guides with cylindrical versus C-shaped guiding holes', '12 implants placed through cylindrical guide holes, and C-shaped (12 implants) placed through C-shaped guiding holes', 'implant placement by using fully guided versus partially guided surgical guides with cylindrical versus C-shaped guiding holes']","['coronal linear deviation (P>.05), apical linear deviation (P>.05), apical depth deviation']","[{'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",48.0,0.0279397,"No statistically significant differences were found in coronal linear deviation (P>.05), apical linear deviation (P>.05), apical depth deviation (P=.086), or angular deviation (P=.247), between the fully guided protocol and the partially guided protocol.
","[{'ForeName': 'Moamen M', 'Initials': 'MM', 'LastName': 'Sarhan', 'Affiliation': 'Demonstrator of Prosthodontics, Faculty of Dentistry, Damanhour University, Damanhour, Egypt. Electronic address: moamen.sarhan@yahoo.com.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Khamis', 'Affiliation': 'Professor and Chairman, Prosthodontic Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Ahlam M', 'Initials': 'AM', 'LastName': 'El-Sharkawy', 'Affiliation': 'Professor of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.02.025']
199,32389383,Influence of an Audiovisual Resource on the Preoperative Anxiety of Adult Endodontic Patients: A Randomized Controlled Clinical Trial.,"INTRODUCTION


The expectation of undergoing endodontic treatment can cause anxiety in patients. Anxiety is described as a transient emotional state closely related to pain, fear, and imbalance of the organism. The clinician commonly must use some type of tool to alleviate the patient's preoperative anxiety before treatment can be applied. The aim of this study was to evaluate the influence of an audiovisual resource on the preoperative anxiety of adult patients undergoing endodontic treatment.
METHODS


One hundred sixty endodontic patients were randomly divided into experimental and control groups (n = 80) and then assessed at 2 preoperative time points separated by a 10-minute interval. After the first assessment, the patients in the experimental group watched a video of their own choice obtained from the Internet to provide them with a relaxing experience. In both groups and at both time points, the assessments consisted of collecting the patients' vital signs (diastolic blood pressure, systolic blood pressure, and heart rate) and data regarding their subjective perception of anxiety using a visual analog scale.
RESULTS


There were no significant differences between the groups regarding the vital sign variation observed between the 2 assessment time points. However, the variation in the scores obtained on the visual analog scale was significantly greater in the experimental group (P < .05), indicating a greater reduction in the level of preoperative anxiety in this group.
CONCLUSIONS


The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.",2020,The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.,"['patients undergoing endodontic treatment', 'adult patients undergoing endodontic treatment', 'Adult Endodontic Patients', 'patients', 'One hundred sixty endodontic patients']","['audiovisual resource', 'Audiovisual Resource']","['level of preoperative anxiety', 'visual analog scale', 'vital sign variation', 'vital signs (diastolic blood pressure, systolic blood pressure, and heart rate) and data regarding their subjective perception of anxiety using a visual analog scale', 'perception of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",160.0,0.0247464,The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.,"[{'ForeName': 'Marco André', 'Initials': 'MA', 'LastName': 'Craveiro', 'Affiliation': 'Discipline of Endodontics, Department of Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: andre.craveiro@usp.br.'}, {'ForeName': 'Celso Luiz', 'Initials': 'CL', 'LastName': 'Caldeira', 'Affiliation': 'Discipline of Endodontics, Department of Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.03.024']
200,32389434,"Emergency Department Stopping Elderly Accidents, Deaths and Injuries (ED STEADI) Program.","BACKGROUND


Falls are among the leading cause of emergency department (ED) visits.
OBJECTIVE


We set out to determine whether using a bedside decision aid could decrease falls.
METHODS


This randomized controlled trial was conducted on those aged ≥ 65 years who were being discharged home and screened positive for a Centers for Disease Control and Prevention (CDC) fall risk factor. Control-arm subjects were given a CDC brochure about falls. The active-arm subjects received a personalized decision aid intervention. Both groups were followed up via telephone.
RESULTS


A total of 200 subjects were enrolled and, after exclusions, 184 patients were analyzed. There were 76 male (41.3%) and 108 female (58.7%) subjects; 14% of the subjects chose to have their medications reviewed, 13.6% chose to have an eye examination, 22.8% chose to begin an exercise program, and the majority (44.6%) chose to have a home safety evaluation. Patients in the intervention arm chose more interventions to complete compared to control-arm subjects (p < 0.0001), but did not complete more interventions (p = 0.3387) and did not experience fewer falls compared to the control arm (p = 0.5675). At study conclusion, 73 subjects reported at least one fall during the study.
CONCLUSIONS


Overall, in this study, subjects who had their fall-risk interventions facilitated by a decision tool chose to participate in interventions more than control subjects. However, they did not complete the interventions or fall less often than their counterparts in the control arm. Future study is needed to determine the effect of CDC screening guidelines and interventions facilitated by a decision aid on fall outcomes and their application in the ED population.",2020,"Patients in the intervention arm chose more interventions to complete compared to control-arm subjects (p < 0.0001), but did not complete more interventions (p = 0.3387) and did not experience fewer falls compared to the control arm (p = 0.5675).","['those aged ≥', '73 subjects reported at least one fall during the study', '200 subjects were enrolled and, after exclusions, 184 patients were analyzed', '76 male (41.3%) and 108 female (58.7%) subjects; 14% of the subjects chose to have their medications reviewed, 13.6% chose to have an eye examination, 22.8% chose to begin an exercise program, and the majority (44.6%) chose to have a home safety evaluation', '65\xa0years who were being discharged home and screened positive for a Centers for Disease Control and Prevention (CDC) fall risk factor', 'subjects who had their fall-risk interventions facilitated by a decision tool chose to participate in interventions more than control subjects']","['personalized decision aid intervention', 'CDC brochure about falls']",[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",[],200.0,0.0287967,"Patients in the intervention arm chose more interventions to complete compared to control-arm subjects (p < 0.0001), but did not complete more interventions (p = 0.3387) and did not experience fewer falls compared to the control arm (p = 0.5675).","[{'ForeName': 'Marna Rayl', 'Initials': 'MR', 'LastName': 'Greenberg', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Goodheart', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Jacoby', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Barraco', 'Affiliation': 'Department of Surgery, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Crowley', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Day', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Youngdahl', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Surmaitis', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Macfarlan', 'Affiliation': 'Network Office of Research and Innovation, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Bryan G', 'Initials': 'BG', 'LastName': 'Kane', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.019']
201,32389453,A Comparison of Different Remifentanil Effect-Site Concentrations to Allow for Early Extubation After Cardiac Surgery.,"OBJECTIVES


Assess different remifentanil effect-site concentrations (Ce) for readiness for extubation time after cardiac surgery.
DESIGN


Prospective, randomized, blinded, controlled study.
DESIGN


Single university hospital.
PARTICIPANTS


Seventy-three patients scheduled for cardiac surgery.
INTERVENTIONS


After ethical approval, patients scheduled for cardiac surgery with target-controlled propofol infusion were randomly assigned to receive remifentanil effect-site concentrations (Ce) of 1, 2, or 3 ng/mL (n = 25, 25, and 23, respectively).
MEASUREMENTS AND MAIN RESULTS


The primary endpoint was readiness for extubation. Secondary outcomes were also recorded, including the cumulative doses and number of changes of propofol and remifentanil, hemodynamic variables, time to spontaneous eye opening and breathing, actual extubation, incidences of light anesthesia and myocardial ischemia, need for vasopressors and inotropes, and intensive care unit (ICU) and hospital stays. There was no difference in the time to readiness for extubation in any of the groups (0.1 ng/mL: 11.5 min (5-37); 0.2 ng/mL: 22 min (10-35); and 0.3 ng/mL: 21 min (10-49), p < 0.532); however, there was a significant difference among the 3 groups regarding the cumulative remifentanil doses (p < 0.001). Time to spontaneous eye opening and breathing, actual extubation, use of vasopressors and inotropes, incidences of light anesthesia and myocardial ischemia, and length of ICU and hospital stay were similar for all groups. Forty-six of the 73 patients were extubated on-table.
CONCLUSION


Remifentanil Ce 1, 2, and 3 ng/mL produced comparative effects on time to extubation and hemodynamic responses to cardiac surgery. The 3 Ce resulted in immediate on-table extubation in 50% of patients.",2020,"Remifentanil Ce 1, 2, and 3 ng/mL produced comparative effects on time to extubation and hemodynamic responses to cardiac surgery.","['Single university hospital', 'patients scheduled for cardiac surgery with target-controlled propofol infusion', 'Early Extubation', 'Forty-six of the 73 patients were extubated on-table', 'Seventy-three patients scheduled for cardiac surgery']","['remifentanil effect-site concentrations (Ce', 'remifentanil effect-site concentrations (Ce) of 1, 2, or 3 ng/mL', 'Remifentanil Ce']","['readiness for extubation', 'cumulative doses and number of changes of propofol and remifentanil, hemodynamic variables, time to spontaneous eye opening and breathing, actual extubation, incidences of light anesthesia and myocardial ischemia, need for vasopressors and inotropes, and intensive care unit (ICU) and hospital stays', 'cumulative remifentanil doses', 'Time to spontaneous eye opening and breathing, actual extubation, use of vasopressors and inotropes, incidences of light anesthesia and myocardial ischemia, and length of ICU and hospital stay', 'immediate on-table extubation', 'time to readiness for extubation']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475746', 'cui_str': 'Light anesthesia'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039224', 'cui_str': 'Table'}]",73.0,0.132438,"Remifentanil Ce 1, 2, and 3 ng/mL produced comparative effects on time to extubation and hemodynamic responses to cardiac surgery.","[{'ForeName': 'Alaa M', 'Initials': 'AM', 'LastName': 'Khidr', 'Affiliation': 'King Fahd Hospital of the University, College of Medicine, Imam Abdulrahman Bin Faisal University, Al Khobar, Saudi Arabia.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Khalil', 'Affiliation': 'King Fahd Hospital of the Imam Abdulrahman Bin Faisal University, Al Khobar, Saudi Arabia; Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Abdulfattah', 'Affiliation': 'Clinical Nursing Supervisor Operating Room, Day Surgery, CSSD, Hemodialysis, and PDU, King Fahd Hospital of the Imam Abdulrahman Bin Faisal University, Al Khobar, Saudi Arabia.'}, {'ForeName': 'Mohamed R', 'Initials': 'MR', 'LastName': 'El Tahan', 'Affiliation': 'King Fahd Hospital of the University, College of Medicine, Imam Abdulrahman Bin Faisal University, Al Khobar, Saudi Arabia. Electronic address: mohamedrefaateltahan@yahoo.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.03.049']
202,32389457,Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi.,"PURPOSE


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


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


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


With evidence of potential higher impact on continuation and no safety concerns, we recommend self-injection be added to the contraception options available to young women in low-resource settings.",2020,", there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women.","[""Young Women's Experiences With"", '731 women', 'young (18-24\xa0years) versus older (≥25\xa0years) women', 'young women versus older women']","['self-injected and provider-administered injectable contraception', 'subcutaneous depot medroxyprogesterone acetate (DMPA-SC', 'Subcutaneous Depot Medroxyprogesterone Acetate', 'medroxyprogesterone acetate']","['continuation rates', 'Continuation rates', 'distribution of reasons for discontinuation', 'adverse events', 'continuation, pregnancy, safety, and side effects', 'pregnancy or safety']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1262153', 'cui_str': 'Injectable contraception'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",731.0,0.15831,", there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women.","[{'ForeName': 'Holly M', 'Initials': 'HM', 'LastName': 'Burke', 'Affiliation': 'FHI 360, Reproductive, Maternal, Newborn, and Child Health, Durham, North Carolina. Electronic address: hburke@fhi360.org.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'FHI 360, Biostatistics, Durham, North Carolina.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Packer', 'Affiliation': 'FHI 360, Reproductive, Maternal, Newborn, and Child Health, Durham, North Carolina.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'FHI 360, Biostatistics, Durham, North Carolina.'}, {'ForeName': 'Bagrey', 'Initials': 'B', 'LastName': 'Ngwira', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.03.038']
203,32389532,"The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7.","INTRODUCTION


Rural women have higher rates of cardiovascular disease than their nonrural counterparts, partially because of their social and environmental contexts. The study objective is to test a refined version of the multilevel Strong Hearts, Healthy Communities intervention, which used extensive process and outcome evaluation data from the original randomized trial to optimize effectiveness as measured by improved Simple 7 score, a composite measure of cardiovascular disease risk.
STUDY DESIGN


The intervention was implemented in a 6-month, delayed intervention, community-randomized trial; control participants received the program following 24-week outcome assessment. The study was conducted in 2017-2018; data analysis occurred in 2018-2019.
SETTING/PARTICIPANTS


The study was conducted in 11 rural, medically underserved towns in New York. Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary.
INTERVENTION


The intervention group received 24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments.
MAIN OUTCOME MEASURES


Measures included weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors. Individual Simple 7 components were examined, and mixed linear regression analyses were used to examine change in Simple 7 score.
RESULTS


A total of 182 participants were randomized. Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI).
CONCLUSIONS


These findings highlight the importance of rigorously evaluating programs in real-world community settings and, when appropriate, revising and retesting interventions to optimize dissemination potential.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03059472.",2020,"Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI).
","['2017-2018; data analysis occurred in 2018-2019', '11 rural, medically underserved towns in New York', 'Rural women', '182 participants were randomized', 'Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary']","['24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments']","['Simple 7 components (physical activity, healthy diet score, and BMI', 'weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",182.0,0.0779213,"Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI).
","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University System, College Station, Texas; Department of Nutrition, Texas A&M University, College Station, Texas. Electronic address: r.seguin-fowler@ag.tamu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Center for Rural Community Health, Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York.'}, {'ForeName': 'Galen D', 'Initials': 'GD', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University System, College Station, Texas.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Marshall', 'Affiliation': 'Master of Public Health Program, Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, New York.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pullyblank', 'Affiliation': 'Center for Rural Community Health, Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Friedman School of Nutrition, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'Montana State University Extension, Bozeman, Montana.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.01.027']
204,32389574,"Pharmacokinetics and pharmacodynamics of JR-051, a biosimilar of agalsidase beta, in healthy adults and patients with Fabry disease: Phase I and II/III clinical studies.","Fabry disease is a rare X-linked lysosomal disease, in which mutations in the gene encoding α-galactosidase A result in progressive cellular accumulation of globotriaosylceramide (GL-3) in various organs including the skin, kidney, and heart, often leading to life-threatening conditions. Enzyme replacement therapy is currently the standard therapy for the disease, to which two α-galactosidase A formulations have been approved: agalsidase α (Replagal®, Shire) and agalsidase β (Fabrazyme®, Sanofi). We have recently developed a biosimilar of agalsidase β, JR-051, and investigated its pharmacokinetics and pharmacodynamics to assess its bioequivalence to agalsidase β. In a randomized phase I study, healthy adult male volunteers were treated with JR-051 or agalsidase β and the pharmacokinetics of the drugs were compared. The ratio of geometric means (90% confidence interval [CI]) of the AUC 0 - 24  and C max  for JR-051 over agalsidase β were 0.91 (0.8294, 1.0082) and 0.90 (0.7992, 1.0125), respectively. In a 52-week, single-arm, phase II/III study, patients with Fabry disease switched therapy from agalsidase β to JR-051 to evaluate its pharmacodynamics. The mean (95% CI) plasma GL-3 concentrations at weeks 26 and 52 relative to pre-JR-051 administration were 1.03 (0.91, 1.15) and 0.96 (0.86, 1.06), respectively, which were within the pre-determined bioequivalence acceptance range (0.70, 1.43). The mean (95% CI) plasma globotriaosylsphingosine (lyso-GL-3) concentrations at weeks 26 and 52 relative to pre-JR-051 administration were 1.07 (0.92, 1.23) and 1.13 (1.03, 1.22), respectively. Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified. In conclusion, these studies demonstrated bioequivalence of JR-051 to agalsidase β in terms of its pharmacokinetics and pharmacodynamics. JR-051 offers a potential new treatment option for patients with Fabry disease.",2020,"Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified.","['patients with Fabry disease', 'healthy adult male volunteers', 'healthy adults and patients with Fabry disease']","['JR-051', 'Enzyme replacement therapy', 'JR-051 or agalsidase β']","['ratio of geometric means', 'plasma globotriaosylsphingosine (lyso-GL-3) concentrations', 'Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators', 'plasma GL-3 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002986', 'cui_str': ""Fabry's disease""}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0082711', 'cui_str': 'globotriaosyl lysosphingolipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0337138,"Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified.","[{'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Life Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan. Electronic address: nakamura@kumamoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Tozawa', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Yamaoka', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Tatsuyoshi', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Research Division, JCR Pharmaceuticals, 2-2-9 Murotani, Nishi-ku, Kobe, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Research Division, JCR Pharmaceuticals, 2-2-9 Murotani, Nishi-ku, Kobe, Japan.'}, {'ForeName': 'Torayuki', 'Initials': 'T', 'LastName': 'Okuyama', 'Affiliation': 'National Centre for Child Health and Development, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Eto', 'Affiliation': 'Advanced Clinical Research Centre & Asian Lysosome Storage Disorder Centre, Institute of Neurological Disorders, Japan.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.04.003']
205,32389606,Patient-reported receipt of goal-concordant care among seriously ill outpatients - prevalence and associated factors.,"CONTEXT


Goal-concordant care is an important indicator of high-quality care in serious illness.
OBJECTIVES


To estimate the prevalence of patient-reported receipt of goal-concordant care among seriously ill outpatients and identify factors associated with absence of patient-reported goal-concordance.
METHODS


Analysis of enrollment surveys from a multi-center cluster-randomized trial of outpatients with serious illness. Patients reported their prioritized healthcare goal and the focus of their current medical care; these items were matched to define receipt of goal-concordant care.
RESULTS


Of 405 patients with a prioritized healthcare goal, 58% reported receipt of goal-concordant care, 17% goal-discordant care, and 25% were uncertain of the focus of their care. Patient-reported receipt of goal-concordance differed by patient goal. For patients who prioritized extending life, 86% reported goal-concordant care, 2% goal-discordant care, and 12% were uncertain of the focus of their care. For patients who prioritized relief of pain and discomfort, 51% reported goal-concordant care, 21% goal-discordant care, and 28% were uncertain of the focus of their care. Patients who prioritized a goal of relief of pain and discomfort were more likely to report goal-discordant care than patients who prioritized a goal of extending life (RRR 22.20; 95%CI 4.59, 107.38).
CONCLUSION


Seriously ill outpatients who prioritize a goal of relief of pain and discomfort are less likely to report receipt of goal-concordant care than patients who prioritize extending life. Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.",2020,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"['patients who prioritize relief of pain and discomfort and promoting care aligned with that goal', 'Analysis of enrollment surveys from a multi-center cluster-randomized trial of outpatients with serious illness', '405 patients with a prioritized healthcare goal']",[],['pain and discomfort'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",405.0,0.0464339,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Modes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington. Electronic address: modes@uw.edu.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Heckbert', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nielsen', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington; Department of Bioethics and Humanities, University of Washington, Seattle, Washington.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Kross', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.026']
206,32389633,Decreasing Cesarean Delivery Rates Using a Trial of Labour After Cesarean (TOLAC) Bundle.,"OBJECTIVE


To develop and implement a trial of labour after cesarean delivery (TOLAC) bundle-a group of interventions aimed at decreasing cesarean delivery (CD) for women who have had a prior CD (Robson group 5).
METHODS


A TOLAC bundle was developed that included: (1) educational rounds for health care providers, (2) a physician-patient TOLAC discussion aid, and (3) patient-centred educational resources. A before-and-after study design was employed. A one-year chart review determined baseline CD rates in Robson group 5 patients at a tertiary care academic centre. Following this, from February 1, 2018 until May 31, 2019, each bundle intervention was sequentially introduced every four to six months and modified based on provider feedback. Obstetricians were provided with their individual CD rates using an audit-and-feedback approach prior to the introduction of the next intervention.
RESULTS


The baseline CD rate for Robson group 5 patients was 71% (175/247 eligible patients). Following the introduction of the bundle, the CD rate decreased to 61% (131/214 eligible patients). This was a 10% decrease in the CD rate (P = 0.029). A significant increase in rate of induction was noted, from 5% pre-intervention to 11% post-intervention (p = 0.017). There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission.
CONCLUSIONS


A TOLAC bundle, consisting of provider education, a TOLAC discussion aid, and patient resources, combined with audit and feedback, decreased CD for Robson group 5 patients.",2020,"There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission.
","['women who have had a prior CD (Robson group 5', 'Robson group 5 patients at a tertiary care academic centre']","['labour after cesarean delivery (TOLAC) bundle-a group of interventions aimed at decreasing cesarean delivery (CD', 'Labour']","['baseline CD rate', 'CD rate', 'rate of induction', 'Decreasing Cesarean Delivery Rates', 'rates of uterine rupture or NICU admission', 'rate of vaginal birth', 'baseline CD rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042143', 'cui_str': 'Rupture of uterus'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",,0.0265818,"There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miazga', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON. Electronic address: elizabeth.miazga@mail.utoronto.ca.'}, {'ForeName': 'Cheyanne', 'Initials': 'C', 'LastName': 'Reed', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON.'}, {'ForeName': 'Modupe', 'Initials': 'M', 'LastName': 'Tunde-Byass', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, North York General Hospital, North York, ON.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cipolla', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, Trillium Health Partners, Mississauga, ON.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynecology, Mount Sinai Hospital, Toronto, ON.'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Shore', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, St. Michael's Hospital, Toronto, ON.""}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.02.113']
207,32389658,Comparison of Dabigatran Plus a P2Y 12  Inhibitor with Warfarin-Based Triple Therapy across Body Mass Index in RE-DUAL PCI.,"BACKGROUND


Body mass index (BMI) affects drug levels of nonvitamin K antagonist oral anticoagulants. We sought to assess whether BMI affected outcomes in the RE-DUAL PCI trial.
METHODS


RE-DUAL PCI (NCT02164864) evaluated the safety and efficacy of a dual antithrombotic therapy regimen using dabigatran (110 or 150 mg twice daily [BID] and a P2Y 12  platelet antagonist), in comparison with ""triple therapy"" with warfarin, aspirin, and a P2Y 12  platelet inhibitor, in 2725 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI). We compared the risk of first ISTH-defined major or clinically relevant nonmajor bleeding events (primary endpoint), and the composite of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization (main efficacy endpoint), in relation to baseline BMI.
RESULTS


Median (range) BMI was 28.1 (14-66) kg/m 2 . Dabigatran dual therapy versus warfarin triple therapy had relevantly and similarly lower rates of bleeding at both 110 and 150 mg BID doses, irrespective of BMI. Thromboembolic event rates appeared consistent across categories of BMI, including those <25 and ≥35 kg/m 2  (P for interaction: .806 and .279, respectively).
CONCLUSIONS


The reduction in bleeding with dabigatran dual therapy compared with warfarin triple therapy in patients here evaluated appears consistent across BMI categories.",2020,"Dabigatran dual therapy versus warfarin triple therapy had relevantly and similarly lower rates of bleeding at both 110 and 150 mg BID doses, irrespective of BMI.",['2725 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI'],"['triple therapy"" with warfarin, aspirin, and a P2Y 12  platelet inhibitor', 'warfarin triple therapy', 'Dabigatran', 'Warfarin-Based Triple Therapy', 'dabigatran']","['rates of bleeding', 'composite of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization (main efficacy endpoint), in relation to baseline BMI', 'BMI', 'safety and efficacy', 'Thromboembolic event rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032188', 'cui_str': 'Platelet Inhibitors'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",2725.0,0.0837822,"Dabigatran dual therapy versus warfarin triple therapy had relevantly and similarly lower rates of bleeding at both 110 and 150 mg BID doses, irrespective of BMI.","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Department of Cardiology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Procopio', 'Affiliation': ""Department of Cardiology and Center of Excellence on Aging, G. d'Annunzio University, Chieti, Italy.""}, {'ForeName': 'José-Luis Lopez', 'Initials': 'JL', 'LastName': 'Sendon', 'Affiliation': 'Cardiology, University Hospital La Paz, UAM, CIBER-CV, IdiPaz, Madrid, Spain.'}, {'ForeName': 'Dimitar', 'Initials': 'D', 'LastName': 'Raev', 'Affiliation': 'Clinic of Internal Medicine, University Hospital ""St. Anna"", Sofia, Bulgari.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Department of Cardiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Opolski', 'Affiliation': 'Department of Cardiology, Medical University of Warsaw, Poland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148 and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jurriën M Ten', 'Initials': 'JMT', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center, Boston and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'Mainanalytics ma GmbH, Weimar (Lahn), Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center, Boston and Harvard Medical School, Boston, MA;. Electronic address: cpcannon@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of medicine,['10.1016/j.amjmed.2020.03.045']
208,32389679,Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools.,"Solar ultraviolet radiation (UV) exposure is the primary risk factor for skin cancer and children receive about one-quarter of lifetime UV exposure before age 18. Thus, skin cancer prevention is essential for children. The objective of this study was to test an intervention to facilitate implementation of district sun safety policies. Elementary schools (N = 118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school. Elementary schools were randomly assigned to receive the 20-month Sun Safe Schools intervention (N = 58) or to a minimal informational control condition (N = 60). Principals were 47.8 and teachers 44.3 years of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2%). The 20-month Sun Safe Schools intervention was delivered to principals and included a coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program. The principal (N = 118) and a teacher (N = 113) at each school reported on school sun protection practices 20-months post-baseline. The schools were diverse in student characteristics (M = 64.1% free/reduced price meals; M = 54.5% Hispanic). Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control M = 0.4, intervention M = 0.9, p = .005). Principals and teachers combined replicated these findings and also reported implementing more practices present in the district policy (control M = 0.9, intervention M = 1.3, p = .005). In sum, the intervention increased sun safety practices in public elementary schools. Trial Registration. This study is registered in ClinicalTrials.gov, www.clinicaltrials.gov, with the identification number of NCT03243929.",2020,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","['Principals were 47.8 and teachers 44.3\u202fyears of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2', 'California public elementary schools', 'Elementary schools (N\u202f=\u202f118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school', 'Elementary schools']","['Solar ultraviolet radiation (UV) exposure', '20-month Sun Safe Schools intervention (N\u202f=\u202f58) or to a minimal informational control condition', 'coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program']","['sun safety practices', 'sun safety practices overall']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0636129,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA. Electronic address: Kim.Reynolds@cgu.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, 2625 W. Alameda Ave., Suite 517, Burbank, CA 91505, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR 97227, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106125']
209,32389735,PREOPERATIVE GABAPENTIN FOR MINIMALLY INVASIVE HYSTERECTOMY: A RANDOMIZED CONTROLLED TRIAL.,"STUDY OBJECTIVE


To evaluate whether single dose gabapentin given preoperatively reduces narcotic use 24 hours after minimally invasive hysterectomy (MIH).
DESIGN


Randomized controlled trial.
SETTING


Single academic-affiliated community hospital.
PATIENTS


Women undergoing MIH for benign indications between June 2016 and June 2017.
INTERVENTIONS


Subjects were randomized to receive a preoperative regimen of acetaminophen, celecoxib, and gabapentin versus acetaminophen and celecoxib alone.
MEASUREMENTS


The primary outcome assessed was the total amount of narcotic used at 24 hours after surgery. Secondary outcomes included adverse effects from gabapentin use, total narcotic use, and pain scores at 2 weeks postoperative.
MAIN RESULTS


A total of 129 women were randomized and eligible for analysis in the gabapentin study arm (n=68) or the control arm (n=61). Demographic characteristics and surgical details were similar between groups. Narcotic use totaling 168 versus 161 oral morphine milliequivalents in the gabapentin and control groups, respectively, at 24 hours postoperative did not significantly differ between groups (P=.60). Total narcotic use and pain scores at 2 weeks postoperative and the rates of adverse effects from gabapentin also were similar between study arms.
CONCLUSION


Single-dose, preoperative gabapentin for women undergoing benign minimally invasive hysterectomy does not reduce total opioid use 24 hours after surgery.",2020,"Single-dose, preoperative gabapentin for women undergoing benign minimally invasive hysterectomy does not reduce total opioid use 24 hours after surgery.","['A total of 129 women were randomized and eligible for analysis in the gabapentin study arm (n=68) or the control arm (n=61', 'Single academic-affiliated community hospital', 'Women undergoing MIH for benign indications between June 2016 and June 2017', 'women undergoing benign minimally invasive hysterectomy', 'minimally invasive hysterectomy (MIH']","['morphine milliequivalents', 'gabapentin', 'acetaminophen, celecoxib, and gabapentin versus acetaminophen and celecoxib alone', 'preoperative gabapentin']","['total amount of narcotic', 'Total narcotic use and pain scores', 'Demographic characteristics and surgical details', 'adverse effects from gabapentin use, total narcotic use, and pain scores', 'rates of adverse effects']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]",129.0,0.29268,"Single-dose, preoperative gabapentin for women undergoing benign minimally invasive hysterectomy does not reduce total opioid use 24 hours after surgery.","[{'ForeName': 'Terri Q', 'Initials': 'TQ', 'LastName': 'Huynh', 'Affiliation': 'Department of Obstetrics & Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, DE, USA. Electronic address: terri.huynh@christianacare.org.'}, {'ForeName': 'Nima R', 'Initials': 'NR', 'LastName': 'Patel', 'Affiliation': 'Department of Obstetrics & Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, DE, USA.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Goldstein', 'Affiliation': 'Department of Epidemiology & Biostatistics, Drexel University Dornsife School of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Makai', 'Affiliation': 'Department of Obstetrics & Gynecology, Division of Minimally Invasive Gynecology, Christiana Care Health Systems, Newark, DE, USA.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.04.040']
210,32381800,Effect of Different Intracanal Medicaments on Apical Sealing Ability of BioRoot RCS.,"AIMS AND OBJECTIVES


The aim of the present study was to determine the effect of different intracanal medicaments on the apical seal of BioRoot root canal sealer (RCS).
MATERIALS AND METHODS


One hundred permanent single-rooted teeth were used in this study. All the samples were decoronated at the cementoenamel junction and instrumented in a sequential order from 15 to 50 number k-file. The specimens were randomly divided into five groups containing 20 teeth each. Intracanal medicaments used in this study were Metapex, triple antibiotic paste, Metrogyl DG gel forte (metronidazole gel 1.5% w/w), and curenext gel. For control group following instrumentation, the roots were obturated with laterally compacted gutta-percha with BioRoot RCS. In medicament groups after the period of 14 days, the medicaments were removed. All the four groups were obturated with BioRoot RCS and gutta-percha cones using lateral compaction technique. All the specimens were coated with nail varnish and immersed in 2% methylene blue. Then the specimens were demineralized and diphanized. The cleared teeth were analyzed by means of a stereomicroscope under 10× magnification. All the data were analyzed in SPSS version 18 software (IBM, Chicago, IL, USA).
RESULT


Among all the intracanal medicaments, triple antibiotic paste showed the highest microleakage. When Metpaex and Metrogyl DG gel forte were compared with  Curcuma longa , differences were not statistically significant.
CONCLUSION


Among all the intracanal medicaments, triple antibiotic paste showed the highest microleakage and least was Metapex.
CLINICAL SIGNIFICANCE


Incomplete removal of medicaments prevents the penetration of sealer into the dentinal tubules and interferes with the normal setting reaction, thus affecting the seal of obturating material leading to microleakage and subsequent treatment failure. Hence, while placing an intracanal medicament, it is important to consider its effect on leakage of the root canal system.",2020,"Among all the intracanal medicaments, triple antibiotic paste showed the highest microleakage and least was Metapex.
",['One hundred permanent single-rooted teeth'],"['Metapex, triple antibiotic paste, Metrogyl DG gel forte (metronidazole gel 1.5% w/w), and curenext gel', 'intracanal medicaments', 'Intracanal Medicaments', 'Metpaex and Metrogyl DG gel forte', 'nail varnish and immersed in 2% methylene blue', 'BioRoot RCS and gutta-percha cones using lateral compaction technique']",['highest microleakage'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C1567041', 'cui_str': 'Metapex'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0699683', 'cui_str': 'Metrogyl'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205250', 'cui_str': 'High'}]",100.0,0.0214066,"Among all the intracanal medicaments, triple antibiotic paste showed the highest microleakage and least was Metapex.
","[{'ForeName': 'Prasanti Kumari', 'Initials': 'PK', 'LastName': 'Pradhan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Kalinga Institute of Dental Sciences, Kalinga Institute of Industrial Technology University, Bhubaneswar, Odisha, India, Phone: +91 8763613044, e-mail: drprasanti@rediffmail.com.'}, {'ForeName': 'Kanhu Charan', 'Initials': 'KC', 'LastName': 'Sahoo', 'Affiliation': 'Department of Dentistry, Sahid Laxman Nayak Medical College, Koraput, Odisha, India.'}, {'ForeName': 'Sradhashree', 'Initials': 'S', 'LastName': 'Dipallini', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Kalinga Institute of Dental Sciences, Kalinga Institute of Industrial Technology University, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Swagata', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Kalinga Institute of Dental Sciences, Kalinga Institute of Industrial Technology University, Bhubaneswar, Odisha, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lata', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Kalinga Institute of Dental Sciences, Kalinga Institute of Industrial Technology University, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Patri', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Kalinga Institute of Dental Sciences, Kalinga Institute of Industrial Technology University, Bhubaneswar, Odisha, India.'}]",The journal of contemporary dental practice,[]
211,32381804,Effect of Two Implant-supported Partial Overdenture Attachment Design on the Periodontal Health.,"OBJECTIVE


This study aimed to evaluate and compare the effect of locator attachment and ball and socket (BS) attachment on the peri-implant and periabutment supporting structures on clinical pocket depth and gingival index in cases of limited interarch spaces in mandibular Kennedy class I implant-supported removable partial overdentures.
MATERIALS AND METHODS


A comparative clinical trial was conducted among twenty partially edentulous patients aged 30-60 years. The study participants were randomly divided into two study groups based on the attachment system used: group I - locator attachment, and group II - BS attachment. Two implants were positioned in the 1st or 2nd molar area following the two-stage surgical protocol. Evaluation of the peri-implant and periabutment supporting structures was done at the time of overdenture insertion and after 6, 12, and 18 months by measuring the pocket depth and gingival index. Inter- and intragroup comparisons were done using independent-samples  t  test and paired-sample  t  test respectively.  p  < 0.05 was considered statistically significant.
RESULTS


It was observed that there was a statistically significant increase in the pocket depth around the implant as well as the abutment in both groups at 6, 12, and 18 months when compared to baseline. Intergroup comparison for pocket depth and gingival index revealed nonsignificant results. However, the values were higher in the BS group.
CONCLUSION


The locator attachment group had lower, though statistically not significant, pocket depth and gingival index scores around both the dental implant and the natural abutment as compared with the BS attachment.
CLINICAL SIGNIFICANCE


Gingival health surrounding dental implant attachments is very crucial for the long-term success of dental implant, this could help the clinician to select the proper design for implant attachment underneath the over denture prosthesis.",2020,"The locator attachment group had lower, though statistically not significant, pocket depth and gingival index scores around both the dental implant and the natural abutment as compared with the BS attachment.
","['cases of limited interarch spaces in mandibular Kennedy class I implant-supported removable partial overdentures', 'twenty partially edentulous patients aged 30-60 years']","['locator attachment and ball and socket (BS) attachment', 'Two Implant-supported Partial Overdenture Attachment Design']","['pocket depth and gingival index', 'pocket depth and gingival index scores', 'pocket depth']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0204414', 'cui_str': 'Partial overdenture'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0204414', 'cui_str': 'Partial overdenture'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.0601962,"The locator attachment group had lower, though statistically not significant, pocket depth and gingival index scores around both the dental implant and the natural abutment as compared with the BS attachment.
","[{'ForeName': 'Hisham A', 'Initials': 'HA', 'LastName': 'Mously', 'Affiliation': 'Department of Oral and Maxillofacial Prosthodontics, King Abdul-aziz University, Faculty of Dentistry, Jeddah, Kingdom of Saudi Arabia, Phone: +966 557388777, e-mail: dr.mously@gmail.com.'}]",The journal of contemporary dental practice,[]
212,32381807,Comparison of Efficacy of Topical Curcumin Gel with Triamcinolone-hyaluronidase Gel Individually and in Combination in the Treatment of Oral Submucous Fibrosis.,"AIM


To study the efficacy of topical curcumin mucoadhesive semisolid gel, triamcinolone acetonide/hyaluronidase mucoadhesive semisolid gel, and a combination of both in the treatment of oral submucous fibrosis (OSMF).
MATERIALS AND METHODS


One hundred and twenty patients diagnosed with OSMF were randomly divided into groups I, II, and III. Each patients in groups I, II, and III was given professionally prepared mucoadhesive semisolid gel of curcumin, a combination of triamcinolone acetonide and hyaluronidase mucoadhesive semisolid gel, and a combination of all three, respectively. Patients were instructed to apply the gel thrice daily for 6 weeks on buccal mucosa bilaterally using the tip of index finger. Three parameters were evaluated at the end of each week, namely, mouth opening, burning on visual analog scale (VAS), and the color of oral mucosa on the binary scale. The results were subjected to statistical analysis.
RESULTS


It was observed that the group administered the three drug combinations achieved the greatest mouth opening (mean increase 4.05 mm) as compared to the other two groups. It was observed that triamcinolone and hyaluronidase group reported reduction in burning sensation on VAS (mean difference 6) as compared to the other two groups. It was observed that group III (1% curcumin, 1% hyaluronidase and 0.1% triamcinolone acetonide combined) drug therapy showed better change in mucosa color as compared to groups I (1% curcumin) and II.
CONCLUSION


Thus, we can conclude that curcumin has a therapeutic effect on patients diagnosed with OSMF. Maximum utilization and enhanced drug delivery were achieved with the help of a combination other two active drugs, namely, triamcinolone and hyaluronidase.
CLINICAL SIGNIFICANCE


Curcumin role in the treatment of oral cancers and the precancer lesion is very promising.",2020,It was observed that triamcinolone and hyaluronidase group reported reduction in burning sensation on VAS (mean difference 6) as compared to the other two groups.,"['patients diagnosed with OSMF', 'Oral Submucous Fibrosis', 'One hundred and twenty patients diagnosed with OSMF', 'oral submucous fibrosis (OSMF']","['triamcinolone acetonide and hyaluronidase mucoadhesive semisolid gel', 'topical curcumin mucoadhesive semisolid gel, triamcinolone acetonide/hyaluronidase mucoadhesive semisolid gel', 'triamcinolone', 'Topical Curcumin Gel with Triamcinolone-hyaluronidase Gel', 'triamcinolone acetonide']","['Maximum utilization and enhanced drug delivery', 'greatest mouth opening ', 'change in mucosa color', 'namely, mouth opening, burning on visual analog scale (VAS), and the color of oral mucosa on the binary scale', 'burning sensation on VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C1720454', 'cui_str': 'Semi-solid dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0474492', 'cui_str': 'Color of oral mucosa'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}]",120.0,0.0124886,It was observed that triamcinolone and hyaluronidase group reported reduction in burning sensation on VAS (mean difference 6) as compared to the other two groups.,"[{'ForeName': 'Ashish B', 'Initials': 'AB', 'LastName': 'Lanjekar', 'Affiliation': 'Department of Oral Medicine and Radiology, Swargiya Dadasaheb Kalmegh Smruti Dental College, Nagpur, Maharashtra, India, Phone: +91 9595052481, e-mail: Ashishlanjekar2007@gmail.com.'}, {'ForeName': 'Rahul R', 'Initials': 'RR', 'LastName': 'Bhowate', 'Affiliation': 'Department of Oral Medicine and Radiology, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Bakhle', 'Affiliation': 'Department of Pharmaceutic, Priyadarshini JL College of Pharmacy, Nagpur, Maharashtra, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Narayane', 'Affiliation': 'Department of Prosthodontics and Crown and Bridge, Dr Hedgewar Smruti Rugna Seva Mandal Dental College and Hospital, Hingoli, Maharashtra, India.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Pawar', 'Affiliation': 'Department of Oral Pathology, Dr Hedgewar Smruti Rugna Seva Mandal Dental College and Hospital, Washim, Maharashtra, India.'}, {'ForeName': 'Ranjeet', 'Initials': 'R', 'LastName': 'Gandagule', 'Affiliation': 'Department of Prosthodontics, Dr Hedgewar Smruti Rugna Seva Mandal Dental College and Hospital, Hingoli, Maharashtra, India.'}]",The journal of contemporary dental practice,[]
213,32381820,Placement of Sticky Bone™ in Patients with Generalized Periodontitis Previously Treated with Coenzyme Q10.,"AIM


The aim of this study was to observe the effects of coenzyme Q10 (CoQ10) in patients with localized periodontitis and place Sticky Bone™ in defects not resolved in the test or control group.
MATERIALS AND METHODS


A total of 30 patients with periodontitis of pocket depth ≥5 mm were randomly divided into test and control groups, each comprising 25 sites, where CoQ10 was placed in the test group and methyl cellulose in the control group; all the parameters were recorded, and patients were followed up for 12 months. At the end of 12 months, patients who did not respond to subgingival placement of CoQ10 were treated surgically where Sticky Bone™ was placed and further followed up for 6 months.
RESULTS


There was significant difference between plaque index (PI), gingival index (GI), and probing pocket depth (PPD) at baseline and 1 month, and there was an increase in values of PI and PPD seen at 6 months and significant increase in values of GI, PI, and PPD seen at 12 months, and no significant difference in values was seen at 12 months and baseline.
CONCLUSION


Coenzyme Q10 does not aid in the treatment of periodontitis.
CLINICAL SIGNIFICANCE


Clinically, it shows that CoQ10 has no role to play in the cases of periodontitis. In such cases, without delay patients should be taken up for periodontal flap surgery after complete scaling and root planning (SRP), if the pocket does not resolve.",2020,"There was significant difference between plaque index (PI), gingival index (GI), and probing pocket depth (PPD) at baseline and 1 month, and there was an increase in values of PI and PPD seen at 6 months and significant increase in values of GI, PI, and PPD seen at 12 months, and no significant difference in values was seen at 12 months and baseline.
","['30 patients with periodontitis of pocket depth ≥5 mm', 'patients with localized periodontitis and place Sticky Bone™ in defects not resolved in the test or control group', 'Patients with Generalized Periodontitis']","['Coenzyme Q10', 'coenzyme Q10 (CoQ10']","['values of GI, PI, and PPD seen', 'values of PI and PPD', 'plaque index (PI), gingival index (GI), and probing pocket depth (PPD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",30.0,0.0394424,"There was significant difference between plaque index (PI), gingival index (GI), and probing pocket depth (PPD) at baseline and 1 month, and there was an increase in values of PI and PPD seen at 6 months and significant increase in values of GI, PI, and PPD seen at 12 months, and no significant difference in values was seen at 12 months and baseline.
","[{'ForeName': 'Ashi', 'Initials': 'A', 'LastName': 'Chug', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Sagrika', 'Initials': 'S', 'LastName': 'Shukla', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India, Phone: +91 9873090671, e-mail: shukla.sagrika@gmail.com.'}]",The journal of contemporary dental practice,[]
214,32383615,Effect of Aminophylline in Preventing Renal Dysfunction among Neonates with Prenatal Asphyxia: A Clinical Trial.,"BACKGROUND


As there are different views on the effects of aminophylline on neonatal renal function, we intended to observe the effects of aminophylline on renal dysfunction in neonates with prenatal asphyxia.
METHODS


This randomized trial was conducted in the Obstetrics and Gynecology Hospital, Tehran, Iran, from June 2016 to May 2017, in neonates with moderate to severe asphyxia during birth. Fifty-six neonates were divided randomly into two groups. The intervention group received one dose of 5mg/kg slow intravenous aminophylline injection and the placebo group received 2 mL/kg of intravenous 10% solution of dextrose saline during the first hour of life. They were monitored and compared for renal functional indices, electrolytes, and complications of asphyxia during the three days of life.
RESULTS


The mean of Cr (37.9 ± 8.8 vs 38.5 ± 9.4 and 20.8 ± 4.8 vs 30.1 ± 5.2 μmol/L), GFR (21.55 ± 4.7 vs 20.25 ± 4.4 and 30.8 ± 7.1 vs 20.1 ± 6.5 mL/minute/1.73 m 2 ), Na (135.1 ± 12.4 vs134.5 ± 11.2 and 128.9 ± 11.5 vs 134.2 ± 10.9 mEq/L), and urine output (98.2 ± 25 vs 96.8 ± 23 and 148.7 ± 35 vs 108.8 ± 20 cc) were in the aminophylline treated and placebo group on the 1st and 3rd days, respectively. The mean difference of Cr (-9.3 (-8.9; -9.7) μmol/L); ( P  = 0.02), GFR (10.7 (10.1; 11.3) mL/minute/1.73 m 2 ) ( P  = 0.009), Na (-5.3 (-5.9; -4.7) mEq/L) ( P  = 0.002), and urine volume (39.9 (24.9; 54.9) cc) ( P  = 0.001) presented statistically significant differences on the third day between the intervention and placebo group.
CONCLUSION


Aminophylline was effective in preventing renal dysfunction in neonates with asphyxia. Neonates who received aminophylline indicated a significant improvement in GFR and urine output on the first day of life.",2020,"They were monitored and compared for renal functional indices, electrolytes, and complications of asphyxia during the three days of life.
","['Obstetrics and Gynecology Hospital, Tehran, Iran, from June 2016 to May 2017, in neonates with moderate to severe asphyxia during birth', 'Neonates with Prenatal Asphyxia', 'neonates with asphyxia', 'Fifty-six neonates', 'neonates with prenatal asphyxia']","['aminophylline', '4.7) mEq/L', 'aminophylline injection and the placebo group received 2 mL/kg of intravenous 10% solution of dextrose saline', 'Aminophylline', 'placebo']","['GFR', 'Renal Dysfunction', 'GFR and urine output', 'renal dysfunction', 'renal functional indices, electrolytes, and complications of asphyxia', 'urine volume']","[{'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004044', 'cui_str': 'Asphyxiation'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0002575', 'cui_str': 'Aminophylline'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C4049912', 'cui_str': 'Aminophylline Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0004044', 'cui_str': 'Asphyxiation'}]",56.0,0.303683,"They were monitored and compared for renal functional indices, electrolytes, and complications of asphyxia during the three days of life.
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saboute', 'Affiliation': 'Department of Neonatology, Akbar Abadi Hospital, Iran University of Medical Sciences, (IUMS), Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Balasi', 'Affiliation': 'Department of Neonatology, Ali Asghar Hospital, Iran University of Medical Sciences, (IUMS), Tehran, Iran.'}, {'ForeName': 'Saleheh', 'Initials': 'S', 'LastName': 'Tajalli', 'Affiliation': 'School of Nursing and Midwifery, Iran University of Medical Sciences, (IUMS), Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Hajipour', 'Affiliation': 'Student Research Committee, Epidemiology Department, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Heshmat', 'Affiliation': 'Department of Neonatology, Ali Asghar Hospital, Iran University of Medical Sciences, (IUMS), Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Khalesi', 'Affiliation': 'Department of Neonatology, Ali Asghar Hospital, Iran University of Medical Sciences, (IUMS), Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Archives of Iranian medicine,['10.34172/aim.2020.20']
215,32381098,Improvement cues of lesion absorption using the adjuvant therapy of traditional Chinese medicine Qinbudan tablet for retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen.,"BACKGROUND


China is the second highest pulmonary tuberculosis (PTB) burden country worldwide. However, retreatment of PTB has often developed resistance to at least one of the four first-line anti-TB drugs. The cure rate (approximately 50.0-73.3%) and management of retreatment of PTB in China needs to be improved. Qinbudan decoction has been widely used to treat PTB in China since the 1960s. Previously clinical studies have shown that the Qinbudan tablet (QBDT) promoted sputum-culture negative conversion and lesion absorption. However, powerful evidence from a randomized controlled clinical trial is lacking. Therefore, the aim of this study was to compare the efficacy and safety of QBDT as an adjunct therapy for retreatment of PTB.
METHODS


We conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial in China. People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013. The treatment group received an anti-TB regimen and QBDT, and the control group was administered an anti-TB regimen plus placebo. Anti-TB treatment options included isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin for 2 months (2HRZES), followed by isoniazid, rifampicin, ethambutol for 6 months (6HRE), daily for 8 months. Primary outcome was sputum-culture conversion using the MGIT 960 liquid medium method. Secondary outcomes included lung lesion absorption and cavity closure. Adverse events and reactions were observed after treatment. A structured questionnaire was used to record demographic information and clinical symptoms of all subjects. Data analysis was performed by SPSS 25.0 software in the full analysis set (FAS) population.
RESULTS


One hundred eighty-one cases of retreatment PTB were randomly divided into two groups: the placebo group (88 cases) and the QBDT group (93 cases). A total of 166 patients completed the trial and 15 patients lost to follow-up. The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment. A significant 16.6% increase in lesion absorption was observed in the QBDT group when compared with the placebo group (67.7% vs 51.1%; rate difference = 0.17, 95% CI: 0.02-0.31; χ 2  = 5.56, P = 0.02). The intervention and placebo group did not differ in terms of cavity closure (25.5% vs 21.1%; rate difference = 0.04, 95% CI: - 0.21-0.12; χ 2  = 0.27, P = 0.60). Two patients who received chemotherapy and combined QBDT reported pruritus/nausea and vomiting.
CONCLUSIONS


No significant improvement in culture conversion was observed for retreatment PTB with traditional Chinese medicine plus standard anti-TB regimen. However, QBDT as an adjunct therapy significantly promoted lesion absorption, thereby reducing lung injury due to Mycobacterium tuberculosis infection.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov, NCT02313610.",2020,"The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment.","['One hundred eighty-one cases of retreatment PTB', '166 patients completed the trial and 15 patients lost to follow-up', 'retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen', 'People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013']","['chemotherapy and combined QBDT', 'anti-TB regimen and QBDT, and the control group was administered an anti-TB regimen plus placebo', 'QBDT', 'Qinbudan decoction', 'traditional Chinese medicine Qinbudan tablet', 'isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin for 2 months (2HRZES), followed by isoniazid, rifampicin, ethambutol for 6 months (6HRE', 'placebo']","['cure rate', 'Adverse events and reactions', 'culture conversion', 'lesion absorption', 'culture conversion rate', 'efficacy and safety', 'sputum-culture conversion', 'lung lesion absorption and cavity closure', 'pruritus/nausea and vomiting', 'cavity closure']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",166.0,0.583189,"The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment.","[{'ForeName': 'Shao-Yan', 'Initials': 'SY', 'LastName': 'Zhang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Ji-You', 'Initials': 'JY', 'LastName': 'Fu', 'Affiliation': ""Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Ding-Zhong', 'Initials': 'DZ', 'LastName': 'Wu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Chang-Rong', 'Initials': 'CR', 'LastName': 'Shao', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'He-Ping', 'Initials': 'HP', 'LastName': 'Xiao', 'Affiliation': ""Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Nai-Hui', 'Initials': 'NH', 'LastName': 'Chu', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing, 101149, People's Republic of China.""}, {'ForeName': 'Qun-Yi', 'Initials': 'QY', 'LastName': 'Deng', 'Affiliation': ""Department of Tuberculosis, Shenzhen Third People's Hospital, Shenzhen University School of Medicine, Shenzhen, 518000, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Tuberculosis, The Second Hospital of Nanjing, Nanjing, 210003, People's Republic of China.""}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Yan', 'Affiliation': ""Department of Tuberculosis, Chongqing Public Health Medical Center, Chongqing, 400036, People's Republic of China.""}, {'ForeName': 'Zhao-Long', 'Initials': 'ZL', 'LastName': 'Wang', 'Affiliation': ""Jinghua Pharmaceutical Group Co., Ltd, Nantong, 226005, People's Republic of China.""}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Biostatistics and Department of Epidemiology, School of Public Health, Fudan University, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Immunology and Microbiology, School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Yue-Juan', 'Initials': 'YJ', 'LastName': 'Zheng', 'Affiliation': ""Department of Immunology and Microbiology, School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Zheng', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Hui-Yong', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Zhen-Hui', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China. tcmdoctorlu@163.com.""}]",Infectious diseases of poverty,['10.1186/s40249-020-00660-z']
216,32384457,Randomized cross-over trial of demand oxygen delivery system.,"INTRODUCTION


Long-term oxygen therapy is reported to improve hypoxemia and survival in patients with respiratory failure. The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder 2- to 3-fold. A portable oxygen concentrator with an auto-DODS has been developed to switch its sensitivity among 3 levels (standard, high, and extra high) and to supply pulsed-flow oxygen when it detects apnea. The aim of this study is to evaluate the efficacy of this newly developed portable oxygen concentrator with auto-DODS compared to the efficacy of conventional DODS in oxygenation.
METHODS AND ANALYSIS


Twenty-six patients with chronic obstructive pulmonary disease or interstitial pneumonia will be randomized to use auto-DODS or conventional DODS at rest and during a 6-minute walk test. Primary endpoints are mean oxygen saturation (SpO2) at rest and during the 6-minute walk test. Secondary endpoints are the ratios of the times during which the oxygen concentrator operates at each sensitivity mode (standard, high, and extra high) and at a constant pulse rate to the examination time, the ratio of the times during which SpO2 fall below 90% to the examination time, the lowest value of SpO2 during the examination time, the mean and highest pulse rates during the examination time, 6-minute walking distance, recovery time, Borg scale, comfort, and reliability, which are measured by a numerical rating scale and a questionnaire, respectively.
ETHICS AND DISSEMINATION


The study was conducted in accordance with the Declaration of Helsinki and was registered on Aug 23, 2019 (https://jrct.niph.go.jp/en-latest-detail/jRCTs052190041). The results of the study will be presented at academic conferences and submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


jRCTs052190041.",2020,The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder,"['Twenty-six patients with chronic obstructive pulmonary disease or interstitial pneumonia', 'accordance with the Declaration of Helsinki and was registered on Aug 23, 2019 (https://jrct.niph.go.jp/en-latest-detail/jRCTs052190041', 'patients with respiratory failure']","['conventional DODS', 'auto-DODS or conventional DODS']","['hypoxemia and survival', 'mean oxygen saturation (SpO2) at rest and during the 6-minute walk test', 'ratios of the times during which the oxygen concentrator operates at each sensitivity mode (standard, high, and extra high) and at a constant pulse rate to the examination time, the ratio of the times during which SpO2 fall below 90% to the examination time, the lowest value of SpO2 during the examination time, the mean and highest pulse rates during the examination time, 6-minute walking distance, recovery time, Borg scale, comfort, and reliability, which are measured by a numerical rating scale and a questionnaire, respectively']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.0386822,The demand oxygen delivery system (DODS) saves oxygen and extends the usable time of an oxygen cylinder,"[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Otoshi', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Kanoko', 'Initials': 'K', 'LastName': 'Umezawa', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Katsurada', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Department of Internal Medicine, Division of Respiratory Medicine.'}]",Medicine,['10.1097/MD.0000000000020010']
217,32384461,Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement: A randomized controlled study.,"This study aimed to assess the efficacy of needle-knife (NK) combined with etanercept (NKCE) in attenuating pain, inflammation, disease activity, and improving hip joint function in ankylosing spondylitis (AS) patients with hip joint involvement.Totally, 90 patients with active AS involving unilateral hip joint were enrolled and randomly assigned in 1:1:1 ratio to receive NKCE, NK or conventional drugs (control). The ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint were assessed at baseline (W0), after 1-week treatment (W1) and after 24-week treatment (W24).ESR and CRP were decreased in NKCE group compared with NK and control groups, while was not attenuated in NK group compared with control group. Regrading pain and disease activity, NKCE group presented a reduction in hip pain VAS score and BASDAI compared with NK and control groups, and NK group showed a decrease in hip pain VAS score and BASDAI compared with control group. Besides, BASFI was lowered in NKCE and NK groups compared with control group, but similar between NKCE and NK groups. mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.NKCE decreases hip pain, inflammation, disease activity and improves hip joint function in AS patients with hip joint involvement.",2020,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","['90 patients with active AS involving unilateral hip joint', 'ankylosing spondylitis (AS) patients with hip joint involvement', 'AS patients with hip joint involvement', 'ankylosing spondylitis patients with hip joint involvement']","['needle-knife combined with etanercept', 'needle-knife (NK) combined with etanercept (NKCE', 'NKCE, NK or conventional drugs (control', 'NKCE']","['pain, inflammation, disease activity', 'BASFI', 'mHHS and hip ROM', 'Regrading pain and disease activity', 'disease activity and hip joint function', 'hip pain, inflammation, disease activity and improves hip joint function', 'hip pain VAS score and BASDAI', 'ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]","[{'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C2363836', 'cui_str': 'Natural killer cell count'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",90.0,0.0265861,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","[{'ForeName': 'Yuquan', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Meimei', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Lianqun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Changxian', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}]",Medicine,['10.1097/MD.0000000000020019']
218,32384462,Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia.,"BACKGROUND


It has not been determined that demand valve oxygen therapy is effective for nocturnal hypoxia. A portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS; standard, high, and extra high) has recently been developed to improve oxygenation and comfort. This oxygen concentrator can supply a pulsed flow when it detects apnoea. The aim of this study is to demonstrate that this newly developed portable oxygen concentrator with an auto-demand function is non-inferior to a continuous-flow oxygen concentrator for nocturnal hypoxemia.
METHODS


Twenty patients with chronic obstructive pulmonary disease or interstitial pneumonia will be randomized to receive a portable oxygen concentrator with an auto-DODS or a continuous-flow oxygen concentrator during sleep. The primary endpoint is mean oxygen saturation (SpO2) during the total sleep time. The secondary endpoints are the ratios of time that the oxygen concentrator spends in each sensitivity mode (standard, high, and extra-high) and at a constant pulse rate to the total sleep time, the total time and ratio of time for which SpO2 is less than 90% during the total sleep time, the lowest value of SpO2 during the total sleep time, the mean and highest pulse rate during the total sleep time, the apnoea index during the total sleep time, the total sleep duration itself, and comfort and reliability as measured by numerical rating scale and questionnaires.
DISCUSSION


If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
TRIAL REGISTRATION


The study was registered on Aug 23, 2019 (jRCTs052190042).",2020,"If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
","['nocturnal hypoxemia', 'Twenty patients with chronic obstructive pulmonary disease or interstitial pneumonia']","['demand oxygen delivery system', 'portable oxygen concentrator with an auto-DODS or a continuous-flow oxygen concentrator during sleep']","['mean oxygen saturation (SpO2) during the total sleep time', 'total sleep time, the lowest value of SpO2 during the total sleep time, the mean and highest pulse rate during the total sleep time, the apnoea index during the total sleep time, the total sleep duration itself, and comfort and reliability as measured by numerical rating scale and questionnaires', 'ratios of time that the oxygen concentrator spends in each sensitivity mode (standard, high, and extra-high) and at a constant pulse rate to the total sleep time, the total time and ratio of time for which SpO2']","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}]","[{'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1618343', 'cui_str': 'Portable oxygen concentrator'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0182123', 'cui_str': 'Oxygen concentrator'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",20.0,0.0357811,"If the auto-DODS demonstrates non-inferiority to continuous flow in oxygenation during sleep, the auto-DODS can be used even at night, and the patient will need only 1 device.
","[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Otoshi', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kanoko', 'Initials': 'K', 'LastName': 'Umezawa', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Katsurada', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}]",Medicine,['10.1097/MD.0000000000020031']
219,32384464,Study on prevention of hypercapnia by nasal high flow in patients undergoing endoscopic retrograde cholangiopancreatography during intravenous anesthesia.,"BACKGROUND


For relatively invasive upper gastrointestinal endoscopy procedures, such as an endoscopic retrograde cholangiopancreatography (ERCP), and also lower gastrointestinal endoscopy procedures, intravenous anesthesia is routinely used to reduce patient anxiety. However, with the use of intravenous anesthesia, even at mild to moderate depth of anesthesia, there is always a risk of upper airway obstruction due to a relaxation of the upper airway muscles.With the advent of nasal high flow (NHF) devices that allow humidified high flow air through the nasal cavity, can be used as a respiratory management method in the context of anesthesia. AIRVO is commonly used for patients with obstructive sleep apnea and other respiratory disorders. This device uses a mild positive pressure load (several cmH2O) that improves carbon dioxide (CO2) washout and reduces rebreathing to improve respiratory function and therefore is widely used to prevent hypoxemia and hypercapnia.This study aims to maintain upper airway patency by applying NHF with air (AIRVO) as a respiratory management method during intravenous anesthesia for patients undergoing an ERCP. In addition, this study investigates whether the use of an NHF device in this context can prevent intraoperative hypercapnia and hypoxemia.
METHODS/DESIGN


This study design employed 2 groups of subjects. Both received intravenous anesthesia while undergoing an ERCP, and 1 group also used a concurrent nasal cannula NHF device. Here we examine if the use of an NHF device during intravenous anesthesia can prevent hypoxemia and hypercapnia, which could translate to improved anesthesia management.Efficacy endpoints were assessed using a transcutaneous CO2 monitor (TCM). This device measured the changes in CO2 concentration during treatment. Transcutaneous CO2 (PtcCO2) concentrations of 60 mm Hg or more (PaCO2 > 55 mm Hg) were considered marked hypercapnia. PtcCO2 concentrations of 50 to 60 mm Hg or more (equivalent to PaCO2 > 45 mm Hg) were considered moderate hypercapnia.Furthermore, the incidence of hypoxemia with a transcutaneous oxygen saturation value of 90% or less, and whether the use of NHF was effective in preventing this adverse clinical event were evaluated.
DISCUSSION


The purpose of this study was to obtain evidence for the utility of NHF as a potential therapeutic device for patients undergoing an ERCP under sedation, assessed by determining if the incidence rates of hypercapnia and hypoxemia decreased in the NHF device group, compared to the control group that did not use this device.
TRIAL REGISTRATION


The study was registered in the jRCTs 072190021.URL https://jrct.niph.go.jp/en-latest-detail/jRCTs072190021.",2020,PtcCO2 concentrations of 50 to 60 mm Hg or more (equivalent to PaCO2 > 45 mm Hg) were considered moderate hypercapnia.,"['2 groups of subjects', 'patients with obstructive sleep apnea and other respiratory disorders', 'patients undergoing an ERCP', 'patients undergoing endoscopic retrograde cholangiopancreatography during intravenous anesthesia', 'patients undergoing an ERCP under sedation']","['NHF with air (AIRVO', 'nasal high flow (NHF) devices', 'endoscopic retrograde cholangiopancreatography (ERCP', 'NHF device', 'NHF', 'intravenous anesthesia while undergoing an ERCP', 'carbon dioxide (CO2) washout and reduces rebreathing']","['CO2 concentration', 'hypercapnia and hypoxemia', 'transcutaneous CO2 monitor (TCM', 'marked hypercapnia', 'PtcCO2 concentrations', 'Transcutaneous CO2 (PtcCO2) concentrations']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C2964661', 'cui_str': 'Transcutaneous CO2 monitor'}, {'cui': 'C0522501', 'cui_str': 'Massive'}]",,0.0820981,PtcCO2 concentrations of 50 to 60 mm Hg or more (equivalent to PaCO2 > 45 mm Hg) were considered moderate hypercapnia.,"[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Sawase', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ozawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Komatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hosogaya', 'Affiliation': 'Nagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Nakashima', 'Affiliation': 'Nagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Kazuhiko', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences.'}]",Medicine,['10.1097/MD.0000000000020036']
220,32323429,Evaluating the efficacy of ursodeoxycholic acid plus methotrexate vs methotrexate alone in the treatment of moderate to severe plaque-type psoriasis: A randomized clinical trial.,,2020,,['moderate to severe plaque-type psoriasis'],['Ursodeoxycholic acid plus Methotrexate versus Methotrexate alone'],[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]",[],,0.0291496,,"[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Lajevardi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Kashiri', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghiasi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Darya', 'Initials': 'D', 'LastName': 'Khosravi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Fazlolahi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ifa', 'Initials': 'I', 'LastName': 'Etesami', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Dermatologic therapy,['10.1111/dth.13455']
221,32384947,Analysis of Clinical Efficacy of Nano-Albumin Paclitaxel Treatment for Advanced Cell Lung Cancer.,"To compare the clinical efficacy and adverse reactions associated with nano-albumin paclitaxel combined with cisplatin and traditional paclitaxel combined with cisplatin for the treatment of non-small cell lung cancer. From December 2016 to August 2019, 78 patients with non-small cell lung cancer in our hospital were randomly allocated into either the observation group ( n  = 39) or the control group ( n  = 39). The observation group was treated with nano-albumin combined with cisplatin, and the control group was treated with traditional paclitaxel combined with platinum chemotherapy. After four cycles of treatment, the clinical efficacy and adverse reactions for the two groups were statistically analyzed. Before treatment, there was no statistically significant difference in age, sex, tumor type, and ECOG score between the two groups. After four cycles of treatment, the disease control rate in the observation group was 79.49%, which was significantly higher than that in the control group (38.46%,  P  <0.05), and the occurrence of myelosuppression, nausea, vomiting, and hyperglycemia in the observation group was significantly lower than that in the control group ( P  <0.05). Compared with the traditional paclitaxel combined with platinum chemotherapy regimen, the nanoalbumin combined with paclitaxel regimen had significant clinical effect and the adverse reactions were significantly reduced. Thus, it can be considered effective and safe and is suitable for clinical promotion.",2020,"After four cycles of treatment, the disease control rate in the observation group was 79.49%, which was significantly higher than that in the control group (38.46%,  P  <0.05), and the occurrence of myelosuppression, nausea, vomiting, and hyperglycemia in the observation group was significantly lower than that in the control group ( P  <0.05).","['From December 2016 to August 2019, 78 patients with non-small cell lung cancer in our hospital', 'Advanced Cell Lung Cancer', 'non-small cell lung cancer']","['traditional paclitaxel combined with platinum chemotherapy', 'nano-albumin paclitaxel combined with cisplatin and traditional paclitaxel combined with cisplatin', 'nano-albumin combined with cisplatin', 'Nano-Albumin Paclitaxel Treatment']","['disease control rate', 'age, sex, tumor type, and ECOG score', 'clinical efficacy and adverse reactions', 'adverse reactions', 'occurrence of myelosuppression, nausea, vomiting, and hyperglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",78.0,0.0226385,"After four cycles of treatment, the disease control rate in the observation group was 79.49%, which was significantly higher than that in the control group (38.46%,  P  <0.05), and the occurrence of myelosuppression, nausea, vomiting, and hyperglycemia in the observation group was significantly lower than that in the control group ( P  <0.05).","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing 100053, PR China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing 100053, PR China.'}, {'ForeName': 'Xiuyi', 'Initials': 'X', 'LastName': 'Zhi', 'Affiliation': 'Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing 100053, PR China.'}, {'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing 100053, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing 100053, PR China.'}]",Journal of nanoscience and nanotechnology,['10.1166/jnn.2020.18556']
222,32385016,The Clinical Effect of Psychological Nursing on Patients Undergoing Coronary Angiography Based on Gold Nanoparticle Contrast Agents.,"To study the clinical effect of psychological nursing on cardiovascular patients undergoing coronary angiography. Sixty cardiovascular patients in our hospital who needed coronary angiography were randomly divided into two groups (30 in each group); contrast agents based on gold nanoparticles were used for all patients. The experimental group received psychological nursing alongside conventional nursing care, and the control group received only conventional nursing care. The two groups were compared for ease of receiving coronary angiography, medical imaging, anxiety, depression, blood pressure, heart rate, efficacy, and patient satisfaction. A gold nanoparticle contrast agent has very low toxicity to cardiovascular endothelial cells, good biocompatibility, and a metabolic effect in vivo. Compared to the control group, the coronary angiography in the experimental group was easier; the medical images were clearer; patients' anxiety, depression, blood pressure, and heart rate decreased; and curative effect and patient satisfaction were higher. Psychological nursing may significantly improve the psychological and physical condition of cardiovascular patients undergoing coronary angiography, effectively improve the efficacy as well as satisfaction of patients, and has obvious application value in clinical treatment. Similarly, gold nanoparticle contrast agents have important value in the clinical application of coronary angiography.",2020,"Compared to the control group, the coronary angiography in the experimental group was easier; the medical images were clearer; patients' anxiety, depression, blood pressure, and heart rate decreased; and curative effect and patient satisfaction were higher.","['cardiovascular patients undergoing coronary angiography', 'cardiovascular patients undergoing', 'Sixty cardiovascular patients in our hospital who needed coronary angiography', 'Patients Undergoing Coronary Angiography Based on Gold Nanoparticle Contrast Agents']","['psychological nursing', 'coronary angiography', 'psychological nursing alongside conventional nursing care, and the control group received only conventional nursing care', 'Psychological Nursing']","['anxiety, depression, blood pressure, and heart rate decreased; and curative effect and patient satisfaction', 'ease of receiving coronary angiography, medical imaging, anxiety, depression, blood pressure, heart rate, efficacy, and patient satisfaction']","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0113791,"Compared to the control group, the coronary angiography in the experimental group was easier; the medical images were clearer; patients' anxiety, depression, blood pressure, and heart rate decreased; and curative effect and patient satisfaction were higher.","[{'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Cardiology, College of Medical Sciences, Bethune Hospital, Taiyuan 030000, Shanxi, PR China.'}, {'ForeName': 'Xiushan', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, College of Medical Sciences, Bethune Hospital, Taiyuan 030000, Shanxi, PR China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, College of Medical Sciences, Bethune Hospital, Taiyuan 030000, Shanxi, PR China.'}]",Journal of nanoscience and nanotechnology,['10.1166/jnn.2020.18601']
223,32385058,Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.,"INTRODUCTION


Salt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.
METHODS AND ANALYSIS


A cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
ETHICS AND DISSEMINATION


The study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.
TRIAL REGISTRATION NUMBER


ChiCTR1800016804.",2020,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","['For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member', 'China', 'six provinces covering northern, central and southern China', 'In total, 780 home cooks and 780 adult family members will be recruited']","['intervention package, including community-based standardised offline and online health education and salt intake monitoring', 'home cook intervention']","['change in salt intake', 'change in salt-related knowledge, attitude and practice and blood pressure (BP']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.101015,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","[{'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Beijing Center for Diseases Prevention and Control, Beijing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-033842']
224,32386127,Early child development in children who are HIV-exposed uninfected compared to children who are HIV-unexposed: observational sub-study of a cluster-randomized trial in rural Zimbabwe.,"INTRODUCTION


Exposure to maternal HIV may affect early child development (ECD), although previous studies have reported heterogeneous findings. We evaluated ECD among children who were HIV-exposed uninfected (CHEU) and children who were HIV-unexposed (CHU) recruited to the SHINE trial in rural Zimbabwe.
METHODS


SHINE was a community-based cluster-randomized trial of improved infant feeding and/or improved water, sanitation and hygiene. Pregnant women were enrolled between 2012 and 2015. We assessed ECD in a sub-study at 24 months of age, between 2016 and 2017, using the Malawi Developmental Assessment Tool (MDAT; assessing motor, cognitive, language and social development); MacArthur-Bates Communicative Development Inventory (CDI) (assessing vocabulary and grammar); A-not-B test (assessing object permanence); and a self-control task. Mothers and infants were tested longitudinally for HIV. We used generalized estimating equations to compare ECD scores between CHEU and CHU, accounting for the cluster-randomized design. Primary results were adjusted for trial-related factors that could affect measurement reliability of ECD: study nurse, age of child, calendar month of birth, sex and randomized arm.
RESULTS


A total of 205 CHEU and 1175 CHU were evaluated. Mean total MDAT score was 90.6 (SD 8.7) in CHEU compared to 92.4 (9.1) in CHU (adjusted mean difference -1.3, 95% CI: -2.3, -0.3), driven mostly by differences in gross motor (-0.5, 95% CI: -0.9, -0.2) and language scores (-0.6, 95% CI: -1.1, -0.1). There was evidence that fine motor scores were lower in CHEU (adjusted mean difference -0.4, 95% CI: -0.8, 0.0) but no evidence of a difference in social scores (0.1, 95% CI: -0.2, 0.4). Mean MacArthur-Bates CDI vocabulary score was 57.9 (SD 19.2) in CHEU compared to 61.3 (18.8) in CHU (adjusted mean difference -2.9 words, 95% CI: -5.7, -0.1). Object permanence and self-control scores were similar between groups.
CONCLUSIONS


CHEU in rural Zimbabwe had total child development and vocabulary scores that were approximately 0.15 standard deviations lower than CHU at two years of age. More detailed and specific studies are now needed to unravel the reasons for developmental delay in CHEU and the likelihood that these delays persist in the longer term.",2020,"There was evidence that fine motor scores were lower in CHEU (adjusted mean difference -0.4, 95% CI: -0.8, 0.0) but no evidence of a difference in social scores (0.1, 95% CI: -0.2, 0.4).","['SHINE was a community-based cluster-randomized trial of improved infant feeding and/or improved water, sanitation and hygiene', 'children who are HIV-exposed uninfected compared to children who are HIV-unexposed: observational sub-study of a cluster-randomized trial in rural Zimbabwe', 'children who were HIV-exposed uninfected (CHEU) and children who were HIV-unexposed (CHU) recruited to the SHINE trial in rural Zimbabwe', 'Pregnant women were enrolled between 2012 and 2015']",[],"['language scores', 'total child development and vocabulary scores', 'Malawi Developmental Assessment Tool (MDAT; assessing motor, cognitive, language and social development); MacArthur-Bates Communicative Development Inventory (CDI) (assessing vocabulary and grammar); A-not-B test (assessing object permanence', 'Mean MacArthur-Bates CDI vocabulary score', 'fine motor scores', 'Object permanence and self-control scores', 'Mean total MDAT score', 'social scores']","[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589514', 'cui_str': 'Object constancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.212219,"There was evidence that fine motor scores were lower in CHEU (adjusted mean difference -0.4, 95% CI: -0.8, 0.0) but no evidence of a difference in social scores (0.1, 95% CI: -0.2, 0.4).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandna', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Florence D', 'Initials': 'FD', 'LastName': 'Majo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Gwendoline', 'Initials': 'G', 'LastName': 'Kandawasvika', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Naume V', 'Initials': 'NV', 'LastName': 'Tavengwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Gladstone', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25456']
225,32390092,"A randomized, controlled, two-month pilot trial of stannous fluoride dentifrice versus sodium fluoride dentifrice after oxalate treatment for dentinal hypersensitivity.","OBJECTIVES


To compare the effects of a stannous fluoride dentifrice and a sodium fluoride dentifrice on dentinal hypersensitivity when used with an oxalate-based regimen combining in-office and at-home treatment.
MATERIALS AND METHODS


In this single-center, randomized, controlled, double-blind, pilot clinical trial, 30 subjects were professionally treated at baseline with a 3% oxalate/potassium salt solution on up to two target teeth, then randomized 1:1 to either 0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice. Both groups were given 6 sensitivity strips (3.14% potassium oxalate gel) and a soft, manual toothbrush. Subjects were permitted to apply strips on up to two teeth, up to three times per tooth, at home as desired throughout the study. Dentinal sensitivity (cold air blast challenge) was assessed at baseline, immediately after post-professional treatment, and at day 60 using the Schiff scale and a Visual Analog Scale (VAS).
RESULTS


Immediately after professional oxalate treatment, the overall mean Schiff and VAS score decreased 25.6% and 22.4% from baseline, respectively (p ≤ 0.001 for both). At day 60, further reductions in both mean scores were seen in both groups. There were no significant differences between the groups at day 60. All treatments were well tolerated.
CONCLUSIONS


In subjects treated with oxalates for dentinal hypersensitivity, both stannous fluoride and sodium fluoride dentifrices are well tolerated, are feasible for routine use, and do not detract from the desensitizing effects of an in-office and at-home oxalate combination treatment regimen.
CLINICAL RELEVANCE


Either stannous fluoride or sodium fluoride dentifrices can be recommended to dentinal hypersensitivity patients who undergo professional oxalate treatment.",2020,There were no significant differences between the groups at day 60.,"['dentinal hypersensitivity patients who undergo professional oxalate treatment', 'dentinal hypersensitivity', '30 subjects were professionally treated at baseline with a 3']","['stannous fluoride dentifrice', 'stannous fluoride or sodium fluoride dentifrices', 'stannous fluoride dentifrice versus sodium fluoride dentifrice', '0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice', 'sodium fluoride dentifrice', 'stannous fluoride and sodium fluoride dentifrices', 'oxalate/potassium salt solution']","['Dentinal sensitivity (cold air blast challenge', 'tolerated', 'overall mean Schiff and VAS score', 'Visual Analog Scale (VAS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",30.0,0.0592205,There were no significant differences between the groups at day 60.,"[{'ForeName': 'Chad J', 'Initials': 'CJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy. chadjanderson@sbcglobal.net.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Kugel', 'Affiliation': 'Department of Comprehensive Care, School of Dental Medicine, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Yuanshu', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferrari', 'Affiliation': 'Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerlach', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03275-8']
226,32390099,"Reply to: Commentary to Josef Tacke, et al. The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.",,2020,,[],['Drug-Eluting Balloons Outperform Standard Balloon Angioplasty'],[],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]",[],,0.0218828,,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lammer', 'Affiliation': 'Department of Cardiovascular and Interventional Radiology, Medical University Vienna, Gebirgsgasse 26, 1230, Vienna, Austria. johannes.lammer@meduniwien.ac.at.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02464-y']
227,32390102,"Yes, I can - maybe … Effects of placebo-related instructions on neuroregulation in children with ADHD.","Neurofeedback training (NFT) provides strategies for children with ADHD to achieve changes on the neurophysiological and behavioral level to attenuate ADHD symptoms. We assume self-efficacy (an ""active attitude""), a core variable in successful NFT. In a randomized, double-blind controlled study, we investigated the impact of a ""placebo instruction"" on the EEG-regulation performance during two sessions of Theta-Beta-NFT in children with ADHD (age 8-12 years). Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12). Results of our pilot study are discussed in view of factors necessary for a valid training (ensuring maximal self-efficacy in the participants) and the fidelity of placebo-controlled trials in NFT-research.",2020,"Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12).","['children with ADHD', 'children with ADHD (age 8-12\xa0years']","['Theta-Beta-NFT', 'standard instruction', 'placebo instruction', 'Neurofeedback training (NFT', 'placebo-related instructions']",['EEG-regulation performance'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.224866,"Children receiving the information ""this might be a placebo-training"" showed inferior neuroregulation (n = 10) compared to children receiving a standard instruction (n = 12).","[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Gevensleben', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany. hgevens@gwdg.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schmiedeke', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'NeuroCare Group, Munich, Germany.'}, {'ForeName': 'Aribert', 'Initials': 'A', 'LastName': 'Rothenberger', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, von-Siebold-Str. 5, D37075, Goettingen, Germany.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02193-z']
228,32390120,Concurrent arthroscopic meniscal repair during open-wedge high tibial osteotomy is not clinically beneficial for medial meniscus posterior root tears.,"PURPOSE


This prospective study aimed to investigate the clinical benefits of meniscal repair during open-wedge high tibial osteotomies (OWHTOs) in patients with medial meniscus posterior root tears (MMPRTs) and to identify potential risk factors for meniscal healing.
METHODS


Ninety patients with degenerative MMPRTs were included in the final cohort and randomized into three groups. The patients in Group A (n = 30) underwent OWHTO and arthroscopic all-inside meniscal repair concurrently, those in Group B (n = 34) underwent OWHTO only, and those in Group C (n = 26) underwent arthroscopic partial meniscectomy. Clinical and radiological outcomes were recorded, and meniscal healing was evaluated during second-look arthroscopy. Logistic regression analysis was performed to identify risk factors for meniscal healing.
RESULTS


After a minimum follow-up of 24 months, no significant differences between Groups A and B regarding the final Lysholm (p = 0.689) or Hospital for Special Surgery (HSS) scores (p = 0.256) were observed. There were significant differences among the three groups regarding the hip-knee-ankle angle (HKA), weight-bearing line (WBL) ratio, medial proximal tibial angle (MPTA), and joint line convergence angle (JLCA) (p < 0.001, respectively), but the differences between Groups A and B were not significant. During second-look arthroscopy, the healing rate of the MMPRTs was significantly higher in Group A (63.3%) than in Group B (35.3%). Concurrent meniscal repair and changes in the HKA, and MPTA were risk factors for meniscal healing.
CONCLUSION


Concurrent arthroscopic meniscal repair during OWHTO did not lead to significant clinical benefits in the treatment of MMPRTs, except for an increased rate of meniscal healing, which was not associated with clinical outcomes.
LEVEL OF EVIDENCE


II, prospective comparative study.",2020,"After a minimum follow-up of 24 months, no significant differences between Groups A and B regarding the final Lysholm (p = 0.689) or Hospital for Special Surgery (HSS) scores (p = 0.256) were observed.","['patients with medial meniscus posterior root tears (MMPRTs', 'medial meniscus posterior root tears', 'Ninety patients with degenerative MMPRTs']","['Concurrent arthroscopic meniscal repair during open-wedge high tibial osteotomy', 'meniscal repair during open-wedge high tibial osteotomies', 'arthroscopic partial meniscectomy']","['rate of meniscal healing', 'meniscal healing', 'Hospital for Special Surgery (HSS) scores', 'hip-knee-ankle angle (HKA), weight-bearing line (WBL) ratio, medial proximal tibial angle (MPTA), and joint line convergence angle (JLCA', 'healing rate of the MMPRTs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0407887', 'cui_str': 'Repair of meniscus'}, {'cui': 'C0445153', 'cui_str': 'Opening wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0443193', 'cui_str': 'Convergence'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]",90.0,0.0346142,"After a minimum follow-up of 24 months, no significant differences between Groups A and B regarding the final Lysholm (p = 0.689) or Hospital for Special Surgery (HSS) scores (p = 0.256) were observed.","[{'ForeName': 'Xiurong', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': 'Department of Sports Medicine, The Third Affiliated Hospital of Wenzhou Medical University, No. 108, Wansong Road, Ruian, Wenzhou, 325200, Zhejiang, China.'}, {'ForeName': 'Jiandi', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Sports Medicine, The Third Affiliated Hospital of Wenzhou Medical University, No. 108, Wansong Road, Ruian, Wenzhou, 325200, Zhejiang, China.'}, {'ForeName': 'Shanxi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The Third Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325200, Zhejiang, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Sports Medicine, The Third Affiliated Hospital of Wenzhou Medical University, No. 108, Wansong Road, Ruian, Wenzhou, 325200, Zhejiang, China.'}, {'ForeName': 'Fanghui', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Sports Medicine, The Third Affiliated Hospital of Wenzhou Medical University, No. 108, Wansong Road, Ruian, Wenzhou, 325200, Zhejiang, China.'}, {'ForeName': 'Guojing', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Sports Medicine, The Third Affiliated Hospital of Wenzhou Medical University, No. 108, Wansong Road, Ruian, Wenzhou, 325200, Zhejiang, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Sports Medicine, The Third Affiliated Hospital of Wenzhou Medical University, No. 108, Wansong Road, Ruian, Wenzhou, 325200, Zhejiang, China. zhanglei@wmu.edu.cn.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06055-9']
229,32390123,"Vitamin D and the hepatitis B vaccine response: a prospective cohort study and a randomized, placebo-controlled oral vitamin D 3  and simulated sunlight supplementation trial in healthy adults.","PURPOSE


To determine serum 25(OH)D and 1,25(OH) 2 D relationship with hepatitis B vaccination (study 1). Then, to investigate the effects on hepatitis B vaccination of achieving vitamin D sufficiency (serum 25(OH)D ≥ 50 nmol/L) by a unique comparison of simulated sunlight and oral vitamin D 3  supplementation in wintertime (study 2).
METHODS


Study 1 involved 447 adults. In study 2, 3 days after the initial hepatitis B vaccination, 119 men received either placebo, simulated sunlight (1.3 × standard-erythema dose, 3 × /week for 4 weeks and then 1 × /week for 8 weeks) or oral vitamin D 3  (1000 IU/day for 4 weeks and 400 IU/day for 8 weeks). We measured hepatitis B vaccination efficacy as percentage of responders with anti-hepatitis B surface antigen immunoglobulin G ≥ 10 mIU/mL.
RESULTS


In study 1, vaccine response was poorer in persons with low vitamin D status (25(OH)D ≤ 40 vs 41-71 nmol/L mean difference [95% confidence interval] - 15% [- 26, - 3%]; 1,25(OH) 2 D ≤ 120 vs ≥ 157 pmol/L - 12% [- 24%, - 1%]). Vaccine response was also poorer in winter than summer (- 18% [- 31%, - 3%]), when serum 25(OH)D and 1,25(OH) 2 D were at seasonal nadirs, and 81% of persons had serum 25(OH)D < 50 nmol/L. In study 2, vitamin D supplementation strategies were similarly effective in achieving vitamin D sufficiency from the winter vitamin D nadir in almost all (~ 95%); however, the supplementation beginning 3 days after the initial vaccination did not effect the vaccine response (vitamin D vs placebo 4% [- 21%, 14%]).
CONCLUSION


Low vitamin D status at initial vaccination was associated with poorer hepatitis B vaccine response (study 1); however, vitamin D supplementation commencing 3 days after vaccination (study 2) did not influence the vaccination response.
CLINICAL TRIAL REGISTRY NUMBER


Study 1 NCT02416895; https://clinicaltrials.gov/ct2/show/study/NCT02416895; Study 2 NCT03132103; https://clinicaltrials.gov/ct2/show/NCT03132103.",2020,Vaccine response was also poorer in winter than summer,"['119 men received either', '10', 'wintertime (study 2', 'healthy adults', 'Study 1 involved 447 adults']","['Vitamin D', 'oral vitamin D 3', 'placebo-controlled oral vitamin D 3  and simulated sunlight supplementation', 'placebo, simulated sunlight', 'vitamin D supplementation']","['achieving vitamin D sufficiency', 'Vaccine response', 'poorer hepatitis B vaccine response', 'hepatitis B vaccination efficacy']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0474232', 'cui_str': 'Hepatitis B vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.418231,Vaccine response was also poorer in winter than summer,"[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Kashi', 'Affiliation': 'College of Human Sciences, Bangor University, Bangor, LL57 2PZ, UK.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Oliver', 'Affiliation': 'College of Human Sciences, Bangor University, Bangor, LL57 2PZ, UK. s.j.oliver@bangor.ac.uk.'}, {'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Wentz', 'Affiliation': 'Beaver College of Health Sciences, Appalachian State University, Boone, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'College of Human Sciences, Bangor University, Bangor, LL57 2PZ, UK.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Carswell', 'Affiliation': 'College of Human Sciences, Bangor University, Bangor, LL57 2PZ, UK.'}, {'ForeName': 'Jonathan C Y', 'Initials': 'JCY', 'LastName': 'Tang', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Department of Army Health and Physical Performance Research, Army HQ, Andover, UK.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Izard', 'Affiliation': 'Occupational Medicine, HQ Army Recruiting and Initial Training Command, Upavon, UK.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Allan', 'Affiliation': 'Medical Physics Department, Salford Royal NHS Foundation Trust, and University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Lesley E', 'Initials': 'LE', 'LastName': 'Rhodes', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, and Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Fraser', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Julie P', 'Initials': 'JP', 'LastName': 'Greeves', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Science, Liverpool John Moores University, Liverpool, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02261-w']
230,32392700,Evaluation of the Stomatognathic System before and after Osteopathic Manipulative Treatment in 120 Healthy People by Using Surface Electromyography.,"Objective:  To investigate the action of osteopathic manipulative treatment on the muscular activity of the stomatognathic apparatus by using surface electromyography (sEMG).  Material and Methods:  Surface electromyography (sEMG) was performed on the masseter and anterior temporalis muscles of 120 subjects (73 F; 47 M), both at time T0 and T2. The sample was divided into three randomized groups of 40 subjects each: control, placebo, and osteopathic manipulative treatment (OMT). In the T1 interval between the two evaluations, the control group was not treated, the placebo group underwent a placebo treatment, and the OMT group underwent manipulative treatment. The mean value of each measurement and its coefficient of variation, between time T0 and T2, were calculated for both the intragroup (OMT, placebo, control) and the intergroup (OMT-placebo, OMT-control).  Outcomes:  In 40% of the subjects, statistically significant improvements were highlighted in the OMT. Whereas, the statistically significant results of the placebo and control groups were 7.5% and 17.5%, respectively, of which more than 75% moved away from the physiological range, showing a worsening of the muscular activity. This analysis showed statistically significant variations ( p  ≤ 0.05) in the OMT group compared to the placebo and the control groups.  Conclusions:  OMT determines variations of the activity of masticatory muscles.",2020,This analysis showed statistically significant variations ( p  ≤ 0.05) in the OMT group compared to the placebo and the control groups.  ,"['120 Healthy People by Using Surface Electromyography', '40 subjects each']","['control, placebo, and osteopathic manipulative treatment (OMT', 'Surface electromyography (sEMG', 'OMT', 'osteopathic manipulative treatment', 'placebo']",['OMT'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}]",[],120.0,0.05336,This analysis showed statistically significant variations ( p  ≤ 0.05) in the OMT group compared to the placebo and the control groups.  ,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manzotti', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Viganoni', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Lauritano', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bernasconi', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Paparo', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Rachele', 'Initials': 'R', 'LastName': 'Risso', 'Affiliation': 'SOMA-osteopathic Institute of Milan, 20126 Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nanussi', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milano-Bicocca, 20126 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17093250']
231,32392715,"Impact of Intensive Lifestyle Treatment (Diet Plus Exercise) on Endothelial and Vascular Function, Arterial Stiffness and Blood Pressure in Stage 1 Hypertension: Results of the HINTreat Randomized Controlled Trial.","Lifestyle modification is an important component of essential hypertension (EH) therapy. The aim of the Hypertension Intensive Nutrition Treatment (HINTreat) parallel, randomized controlled trial was to examine the effect of a 6-month intensive lifestyle treatment (ILT) (diet plus exercise with monthly visits) compared to the usual care. A total of 76 adults with stage 1 EH were randomized (38 in each group). Dietary analysis, anthropometry, physical activity, biochemical and urine profile, blood pressure (BP), asymmetric dimethylarginine (ADMA), central hemodynamics, β-stiffness index and carotid intima media-thickness were evaluated. The dietary inflammatory index (DII) was calculated for each participant from the intake of 29 nutrients/food components. At the end of the trial, participants in the ILT group reduced their 24h urinary Na excretion ( p  ≤ 0.001), daytime systolic BP ( p  ≤ 0.048) and mean carotid β-stiffness index ( p  ≤ 0.005) and ameliorated their lipidemic profile compared to the standard care. Univariate analysis for the total sample showed a strong association between DII and ADMA levels (β = 0.089,  p  ≤ 0.01). ILT is effective in improving the inflammatory components of the diet and selected cardiometabolic parameters, including arterial stiffness.",2020,"At the end of the trial, participants in the ILT group reduced their 24h urinary Na excretion ( p  ≤ 0.001), daytime systolic BP ( p  ≤ 0.048) and mean carotid β-stiffness index ( p  ≤ 0.005) and ameliorated their lipidemic profile compared to the standard care.","['Stage 1 Hypertension', '76 adults with stage 1 EH']","['ILT', 'intensive lifestyle treatment (ILT) (diet plus exercise with monthly visits', 'Intensive Lifestyle Treatment (Diet Plus Exercise']","['Endothelial and Vascular Function, Arterial Stiffness and Blood Pressure', 'lipidemic profile', '24h urinary Na excretion', 'dietary inflammatory index (DII', 'Dietary analysis, anthropometry, physical activity, biochemical and urine profile, blood pressure (BP), asymmetric dimethylarginine (ADMA), central hemodynamics, β-stiffness index and carotid intima media-thickness', 'DII and ADMA levels', 'mean carotid β-stiffness index', 'daytime systolic BP']","[{'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",76.0,0.0675404,"At the end of the trial, participants in the ILT group reduced their 24h urinary Na excretion ( p  ≤ 0.001), daytime systolic BP ( p  ≤ 0.048) and mean carotid β-stiffness index ( p  ≤ 0.005) and ameliorated their lipidemic profile compared to the standard care.","[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Vamvakis', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Gkaliagkousi', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Lazaridis', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Grammatikopoulou', 'Affiliation': 'Department of Nutritional Sciences & Dietetics, Faculty of Health Sciences, International Hellenic University, Alexander Campus, Sindos, PO Box 141, GR57400 Thessaloniki, Greece.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Triantafyllou', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Nikolaidou', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Koletsos', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Anyfanti', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Tzimos', 'Affiliation': 'Northern Greece Statistics Directorate, Hellenic Statistical Authority, 218 Delfon Str, GR54646 Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Division of Endocrinology and Metabolism and Diabetes Center, First Department of Internal Medicine, Medical School, AHEPA University Hospital, Aristotle University of Thessaloniki, GR54621 Thessaloniki, Greece.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Douma', 'Affiliation': 'Third Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, GR56403 Thessaloniki, Greece.'}]",Nutrients,['10.3390/nu12051326']
232,32392796,"Clinical Utility of Extracorporeal Shock Wave Therapy on Hypertrophic Scars of the Hand Caused by Burn Injury: A Prospective, Randomized, Double-Blinded Study.","Postburn hypertrophic scarring is a common complication in burn injuries to the hands, often associated with impaired hand function. We evaluated the effects of extracorporeal shock wave therapy (ESWT), compared to a sham stimulation therapy, on hypertrophic scars of the hand caused by burn injury and investigated its effects on hand function. This was a double-blinded, randomized, controlled trial of 48 patients with a burn to their dominant right hand. The parameters of ESWT were as follows: energy flux density, 0.05-0.30 mJ/mm 2 ; frequency, 4 Hz; 1000 to 2000 impulses per treatment; four treatments, once a week for four weeks. The outcomes measured were as follows: a 10-point visual analogue scale pain score; Vancouver scar scale for scar vascularity, height, pliability and pigmentation; ultrasound measurement of scar thickness; Jebsen-Taylor hand function test; grip strength; Perdue pegboard test; and the Michigan hand outcomes questionnaire. The change in the score from baseline to post-treatment was compared between the two groups. ESWT improved the pain score ( p  = 0.001), scar thickness ( p  = 0.018), scar vascularity ( p  = 0.0015), and improved hand function (simulated card-turning,  p  = 0.02; picking up small objects,  p  = 0.004). The other measured outcomes were not different between the two groups. ESWT is effective in decreasing pain, suppressing hypertrophic scarring, and improving hand function.",2020,"ESWT improved the pain score ( p  = 0.001), scar thickness ( p  = 0.018), scar vascularity ( p  = 0.0015), and improved hand function (simulated card-turning,  p  = 0.02; picking up small objects,  p  = 0.004).","['Hypertrophic Scars of the Hand Caused by Burn Injury', '48 patients with a burn to their dominant right hand']","['ESWT', 'Extracorporeal Shock Wave Therapy', 'extracorporeal shock wave therapy (ESWT']","['scar vascularity', 'hand function', 'scar thickness', '10-point visual analogue scale pain score; Vancouver scar scale for scar vascularity, height, pliability and pigmentation; ultrasound measurement of scar thickness; Jebsen-Taylor hand function test; grip strength; Perdue pegboard test; and the Michigan hand outcomes questionnaire', 'pain score', 'pain, suppressing hypertrophic scarring']","[{'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}]",48.0,0.0594385,"ESWT improved the pain score ( p  = 0.001), scar thickness ( p  = 0.018), scar vascularity ( p  = 0.0015), and improved hand function (simulated card-turning,  p  = 0.02; picking up small objects,  p  = 0.004).","[{'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine Hallym University, Seoul 07247, Korea.'}, {'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon 14584, Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine Hallym University, Seoul 07247, Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine Hallym University, Seoul 07247, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9051376']
233,32392952,[Efficacy of minimally invasive pulmonary surfactant administration in preterm infants with neonatal respiratory distress syndrome: a multicenter clinical trial].,"Objective:  To explore the feasibility and safety of minimally invasive surfactant administration (MISA) in preterm neonates with respiratory distress syndrome (NRDS).  Methods:  In this multicenter prospective randomized controlled trial, 92 preterm infants with gestation age ≤30 weeks and diagnosed with NRDS were enrolled in 8 level Ⅲ neonatal intensive care units (NICU) in Beijing-Tianjin-Hebei Region from 1(st) July 2017 to 31(st) December 2018. They were randomly assigned to minimally invasive surfactant administration (MISA) group or endotracheal intubation surfactant administration (EISA) group according to random number generated by computer. Infants in both groups received calf pulmonary surfactant preparation at a dose of 70-100 mg/kg. The data of demography, perinatal situation, medication administration, complications, clinical outcomes in the two groups were compared with Chi-square test, Student's  t -test, Mann-Whitney  U  test or Fisher's exact test.  Results:  Among the 92 preterm infants, 53 were males, 39 were females; 47 were in the MISA group (25 males), and 45 were in the EISA group (28 males). The gestational age and birth weight were (29.5±1.2) weeks and (1 271±242) g in all patients, (29.5±1.4) weeks and (1 285±256) g in the MISA group, and (29.6±0.9) weeks and (1 255±227) g in the EISA group. The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s  vs.  50 (30, 60) s,  Z= 3.009,  P= 0.003; 90 (60, 300) s  vs.  60 (44, 270) s,  Z= 3.365,  P= 0.001). For the outcomes, the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and bronchopulmonary dysplasia (BPD) were lower in the MISA group than in the EISA group (36% (17/47)  vs.  67% (30/45), χ(2)=8.556,  P= 0.003; 26% (12/47)  vs.  47% (21/45), χ(2)=4.464,  P= 0.035).  Conclusions:  Minimally invasive surfactant administration is applicable in preterm infants ≤30 weeks gestational age with NRDS. Although the length of whole procedure is longer than route endotracheal administration, the benefit of decreasing the incidences of hsPDA and BPD outweighs this demerit.",2020,"The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s  vs.  50 (30, 60) s,  Z= 3.009,  P= 0.003; 90 (60, 300) s  vs.  60 (44, 270) s,  Z= 3.365,  P= 0.001).","['92 preterm infants with gestation age ≤30 weeks and diagnosed with NRDS were enrolled in 8 level Ⅲ neonatal intensive care units (NICU) in Beijing-Tianjin-Hebei Region from 1(st', 'preterm infants ≤30 weeks gestational age with NRDS', 'July 2017 to 31(st) December 2018', '92 preterm infants, 53 were males, 39 were females; 47 were in the MISA group (25 males), and 45 were in the EISA group (28 males', 'preterm neonates with respiratory distress syndrome (NRDS', 'preterm infants with neonatal respiratory distress syndrome']","['Minimally invasive surfactant administration', 'minimally invasive surfactant administration (MISA', 'EISA', 'calf pulmonary surfactant preparation', 'minimally invasive pulmonary surfactant administration', 'minimally invasive surfactant administration (MISA) group or endotracheal intubation surfactant administration (EISA']","['incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and bronchopulmonary dysplasia (BPD', 'duration of surfactant infusion and the length of whole procedure', 'gestational age and birth weight', 'feasibility and safety']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.148513,"The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s  vs.  50 (30, 60) s,  Z= 3.009,  P= 0.003; 90 (60, 300) s  vs.  60 (44, 270) s,  Z= 3.365,  P= 0.001).","[{'ForeName': 'H Q', 'Initials': 'HQ', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Tong', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'T Y', 'Initials': 'TY', 'LastName': 'Han', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Neonatology, Fifth Medical Center, General Hospital of the Chinese People's Liberation Army, Beijing 100039, China.""}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Fifth Medical Center, General Hospital of the Chinese People's Liberation Army, Beijing 100039, China.""}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Central Hospital of China National Petroleum Corporation, Langfang 065000, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Central Hospital of China National Petroleum Corporation, Langfang 065000, China.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Central Hospital of China National Petroleum Corporation, Langfang 065000, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Neonatology, 980 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Shijiazhuang 050082, China.""}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Bao', 'Affiliation': ""Department of Neonatology, 980 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Shijiazhuang 050082, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Tian', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'W X', 'Initials': 'WX', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Neonatology, Second Hospital of Tianjin Medical University, Tianjin 300211, China.'}, {'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Sun', 'Affiliation': 'Department of Neonatology, Second Hospital of Tianjin Medical University, Tianjin 300211, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Neonatology, Xingtai People's Hospital, Xingtai 054001, China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Xingtai People's Hospital, Xingtai 054001, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital, Cangzhou 061001, China.'}, {'ForeName': 'W L', 'Initials': 'WL', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital, Cangzhou 061001, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital, Cangzhou 061001, China.'}]",Zhonghua er ke za zhi = Chinese journal of pediatrics,['10.3760/cma.j.cn112140-20191018-00658']
234,32392996,[Efficacy and safety of low-intensity pulsed ultrasound at different intervals by mechanical force in treating erectile dysfunction: a preliminary study].,"Objective:  To study the efficacy and safety of low-intensity pulsed ultrasound (LIPUS) at different intervals by mechanical force in treating erectile dysfunction (ED).  Method:  Forty patients with mild to moderate ED were randomized in a 1∶1 ratio to receive 16-treatment sessions of LIPUS in group A and group B, applied 3 times per week and 2 times per week, respectively. End-point assessments were made at 8th week after treatment. Efficacy were evaluated using International Index of Erectile Function-Erectile Function domain score (IIEF-EF), Erectile Hardness Score (EHS), Self-Esteem and Relationship Questionnaire (SEAR), Sexual Encounter Profile (SEP), Global Assessment Question (GAQ), and pain were assessed by Visual Analogue Score (VAS).Treatment response was confirmed by a minimal clinically importance difference (MCID) at 8th week.  Results:  Compared with baseline, IIEF-EF score [(17.1±5.48 vs 23.4±3.75,  P< 0.05) and (18.9±4.34 vs 24.1±4.32,  P< 0.05)], proportion of EHS 4 [(0 vs 40%,  P< 0.05) and (16.7% vs 55.6%,  P< 0.05)], and Overall Relationship score [(50.6 vs 67.5,  P< 0.05) and (44.4 vs 70.1,  P< 0.05)] were significantly improved at 8th week in two groups, respectively. Compared with baseline, the positive responses to SEP-3 increased significantly at 8th week in two groups (50.0% vs 80.0%, P< 0.05) and (44.4% vs 88.9%,  P< 0.05), respectively. The positive responses to GAQ-2 were 90.0% and 88.9% at 8th week in two groups, respectively. There were no significant differences in IIEF-EF, EHS, SEAR, SEP and GAQ at 8th week between two groups. There was no significant difference in treatment response using MCID between two groups at end-point (80.5% vs 77.5%). The treatment duration for full sessions were 2.5 weeks less in group A than group B. No adverse effects were reported in all cases.  Conclusion:  LIPUS at two different intervals is effective and safe for mild to moderate ED, and the regimen at 3 times per week can achieve quite good effect in relatively short duration,while the long-term effects is still be clarified in further study.",2020,"There were no significant differences in IIEF-EF, EHS, SEAR, SEP and GAQ at 8th week between two groups.","['treating erectile dysfunction', 'Forty patients with mild to moderate ED']","['low-intensity pulsed ultrasound (LIPUS', 'low-intensity pulsed ultrasound', 'LIPUS']","['positive responses to GAQ-2', 'IIEF-EF score', 'treatment response using MCID', 'proportion of EHS', 'positive responses to SEP-3', 'International Index of Erectile Function-Erectile Function domain score (IIEF-EF), Erectile Hardness Score (EHS), Self-Esteem and Relationship Questionnaire (SEAR), Sexual Encounter Profile (SEP), Global Assessment Question (GAQ), and pain were assessed by Visual Analogue Score', 'Overall Relationship score', 'IIEF-EF, EHS, SEAR, SEP and GAQ', 'adverse effects']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C4042796', 'cui_str': 'LIPUS'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",40.0,0.039409,"There were no significant differences in IIEF-EF, EHS, SEAR, SEP and GAQ at 8th week between two groups.","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Xia', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Chen', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'X C', 'Initials': 'XC', 'LastName': 'Li', 'Affiliation': 'Clinical Research Center, Shanghai General Hospital, Shanghai 200080, China.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Zhi', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Tian', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Hu', 'Affiliation': 'Urologic Medical Center, Institute of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Clinical Research Center, Shanghai General Hospital, Shanghai 200080, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191207-02679']
235,32393092,Laughter Yoga reduces the cortisol response to acute stress in healthy individuals.,"Stress is one of the foremost contributors to the development of psychiatric diseases. Since the prevalence of stress-related complaints is increasing, we are in need for affordable and effective treatment alternatives. Laughter yoga (LY), a popular method encouraging participants to simulate laughter and participate in yogic breathing exercises, is hypothesized to buffer negative effects of stress. Although widely practiced, empirical evidence for beneficial effects of LY is scarce. We investigated the acute effects of a single 30-minute LY session on the autonomic, endocrine and psychological response to a standardized psychosocial stressor. Thirty-five healthy subjects (51% female) were randomly assigned to experience either a LY ( n  = 11), a relaxation breathing ( n  = 12) or a (non-intervention) control ( n  = 12) session prior to their exposure to the Trier Social Stress Test for Groups (TSST-G). Salivary cortisol, salivary alpha amylase, and subjective stress were assessed repeatedly throughout the experiment.We expected that LY and relaxation breathing groupshow a downregulating of stress response indices compared to the control group. Further, we expected that LY has beneficial effects compared to relaxation breathing.The groups did not differ in salivary cortisol, alpha amylase or subjective stress reactivity during the 30-minute intervention. However, in response to the TSST-G, the LY, but neither the relaxation breathing, nor the control condition, showed an attenuated cortisol stress response. These findings highlight the potential of LY tobuffer the endocrine stress response. Therefore, LY could be used as a cheap and easily-to-implement add-on to more traditional stress interventions. Lay summary:  In recent years, more and more people have reported to feel stressed. Although our body is well equipped to deal with acute stress, stress that lasts too long can tire our system and contribute to illness in the long run. Therefore, we need affordable and effective measures to reduce stress. In this study we have investigated whether a single laughter yoga session can help us to deal with acute stress. Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation. As such, laughter yoga mightbe a cheap and easily-to-implement add-on to more traditional stress reduction interventions.",2020,"Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation.","['Thirty-five healthy subjects (51% female', 'healthy individuals']","['Laughter yoga (LY', 'single laughter yoga session', 'Laughter Yoga', 'relaxation breathing ( n \u2009=\u200912) or a (non-intervention) control ( n \u2009=\u200912) session prior to their exposure to the Trier Social Stress Test for Groups (TSST-G']","['cortisol stress response', 'Salivary cortisol, salivary alpha amylase, and subjective stress', 'cortisol response', 'salivary cortisol, alpha amylase or subjective stress reactivity', 'autonomic, endocrine and psychological response']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4045984', 'cui_str': 'Laughter Yoga'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",35.0,0.0113006,"Although laughter yoga did not change how stressful a situation was perceived, it reduced the amount of stress hormones that were released in response to the situation.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'University of Constance, Constance, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wirz', 'Affiliation': 'University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Dickinson', 'Affiliation': ""Centre de recherche de l'Institutuniversitaire de gériatrie de Montréal, Quebec, Canada.""}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'University of Constance, Constance, Germany.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2020.1766018']
236,32393099,Budesonide vs Saline Nasal Irrigation in Allergic Rhinitis: A Randomized Placebo-Controlled Trial.,"OBJECTIVES


Budesonide nasal irrigation is currently widely used in the treatment of chronic sinusitis typically following endoscopic sinus surgery to improve inflammatory control. Its application in treatment of allergic rhinitis has not been previously studied. This study assesses the subjective and clinical response to budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation in patients with allergic rhinitis.
STUDY DESIGN


This is a prospective, single-center, double-blind, randomized placebo-controlled trial.
SETTING


Tertiary care hospital.
SUBJECTS AND METHODS


Fifty-two patients diagnosed with allergic rhinitis were randomized into 2 groups to receive either buffered hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule. Patients were assessed at baseline and 4 weeks subjectively using the Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS). Clinical assessment was done using the modified Lund-Kennedy score.
RESULTS


The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P  < .001). The budesonide irrigation group was found to have significantly better improvement than the saline nasal irrigation group with the SNOT-22 scores ( P  = .012) and VAS scores ( P  = .007). However, the difference in the clinical response between the 2 groups was not significant ( P  = .268).
CONCLUSION


This study adds evidence to the use of saline nasal irrigation in allergic rhinitis but also demonstrates efficacy of the addition of budesonide to irrigations. Budesonide nasal irrigation thus appears to be a viable treatment option for allergic rhinitis.",2020,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P  < .001).","['Allergic Rhinitis', 'Fifty-two patients diagnosed with allergic rhinitis', 'Tertiary care hospital', 'patients with allergic rhinitis']","['Placebo', 'budesonide irrigation', 'budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation', 'hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule', 'Budesonide', 'Saline Nasal Irrigation', 'saline nasal irrigation', 'Budesonide nasal irrigation', 'placebo']","['Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS', 'clinical response', 'average SNOT-22, VAS, and modified Lund-Kennedy scores', 'SNOT-22 scores', 'VAS scores']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",52.0,0.0682754,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P  < .001).","[{'ForeName': 'Nikitha', 'Initials': 'N', 'LastName': 'Periasamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Kailesh', 'Initials': 'K', 'LastName': 'Pujary', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ajay M', 'Initials': 'AM', 'LastName': 'Bhandarkar', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Naveen D', 'Initials': 'ND', 'LastName': 'Bhandarkar', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.'}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820919363']
237,32393193,Neuroprotective effects of exercise in people with progressive multiple sclerosis (Exercise PRO-MS): study protocol of a phase II trial.,"BACKGROUND


Neurodegeneration, rather than inflammation, plays a key role in the progressive phase of multiple sclerosis (MS). Current disease modifying treatment options for people with progressive MS (PMS) do not specifically target neurodegeneration. Preliminary evidence suggests that exercise therapy might have neuroprotective effects. However, neuroprotective effect studies of exercise interventions in PMS are scarce and the possible mode of action underlying neuroprotective effects of exercise are unknown and need to be elucidated. The main aim of this phase II trial is to assess whether progressive resistance training (PRT) and high intensity interval training (HIIT), can slow down neurodegeneration in people with PMS.
METHODS


In a single-blinded phase II clinical trial with an extended baseline period, 60 people with PMS will be randomly assigned to PRT or HIIT. The participants should have had a relapse onset of MS with confirmed disease progression, however still ambulatory. The duration of the study is 48 weeks, consisting of 16 weeks baseline period (no intervention), 16 weeks intervention and 16 weeks follow-up. Patient-tailored training will be performed 3 times per week for one hour in groups, led by an experienced physiotherapist. The primary outcome measure is neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI). Secondary outcome parameters will include other biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors.
DISCUSSION


Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention. Combining outcome parameters may help to elucidate the mode of action underlying neuroprotective effects of exercise.
TRIAL REGISTRATION


This trial is prospectively registered at the Dutch Trial Registry (number NL8265, date 06-01-2020).",2020,"Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention.","['people with PMS', '60 people with PMS', 'people with progressive multiple sclerosis (Exercise PRO-MS', 'people with progressive MS (PMS']","['exercise therapy', 'progressive resistance training (PRT) and high intensity interval training (HIIT', 'exercise']","['neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI', 'biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027746', 'cui_str': 'Nerve degeneration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",60.0,0.173043,"Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Gravesteijn', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands. a.gravesteijn@amsterdamumc.nl.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Beckerman', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'de Jong', 'Affiliation': 'Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hulst', 'Affiliation': 'Department of Anatomy and Neurosciences, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'de Groot', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}]",BMC neurology,['10.1186/s12883-020-01765-6']
238,32393194,Experiences of maternity care in New South Wales among women with mental health conditions.,"BACKGROUND


High quality maternity care is increasingly understood to represent a continuum of care. As well as ensuring a positive experience for mothers and families, integrated maternity care is responsive to mental health needs of mothers. The aim of this paper is to summarize differences in women's experiences of maternity care between women with and without a self-reported mental health condition.
METHODS


Secondary analyses of a randomized, stratified sample patient experience survey of 4787 women who gave birth in a New South Wales public hospital in 2017. We focused on 64 measures of experiences of antenatal care, hospital care during and following birth and follow up at home. Experiences covered eight dimensions: overall impressions, emotional support, respect for preferences, information, involvement, physical comfort and continuity. Multivariable logistic regression was used to compare experiences of women with and without a self-reported longstanding mental health condition.
RESULTS


Compared to women without a condition, women with a longstanding mental health condition (n = 353) reported significantly less positive experiences by eight percentage points on average, with significant differences on 41 out of 64 measures after adjusting for age, education, language, parity, type of birth and region. Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care. Most women with mental health conditions (75% or more) reported positive experiences for measures related to guidelines for maternity care for women with mental illness (discussion of emotional health, healthy behaviours, weight gain). Their experiences were not significantly different from those of women with no reported conditions.
CONCLUSIONS


Women with a mental health condition had significantly less positive experiences of maternity care across all stages of care compared to women with no condition. However, for some measures, including those related to guidelines for maternity care for women with mental illness, there were highly positive ratings and no significant differences between groups. This suggests disparities in experiences of care for women with mental health conditions are not inevitable. More can be done to improve experiences of maternity care for women with mental health conditions.",2020,"Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care.","[""women's experiences of maternity care between women with and without a self-reported mental health condition"", 'women with mental health conditions', '4787 women who gave birth in a New South Wales public hospital in 2017', '64 measures of experiences of antenatal care, hospital care during and following birth and follow up at home', 'Women with a mental health condition']",['maternity care'],"['emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care', 'impressions, emotional support, respect for preferences, information, involvement, physical comfort and continuity', 'positive experiences of maternity care']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]",4787.0,0.0883294,"Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Corscadden', 'Affiliation': 'Australian Institute of Tropical Health and Medicine, James Cook University, 1 James Cook Dr, Douglas, Queensland, 4811, Australia. lisa.corscadden@health.nsw.gov.au.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Callander', 'Affiliation': 'School of Medicine, Griffiths University, 170 Kessels Rd, Nathan, QLD, 4111, Australia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Topp', 'Affiliation': 'College of Public Health, Medical & Veterinary Sciences, James Cook University, 1 James Cook Dr, Douglas, Queensland, 4811, Australia.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Watson', 'Affiliation': 'Bureau of Health Information, Level 11, 67 Albert Avenue, Chatswood, NSW, 2067, Australia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02972-2']
239,32393214,The transtheoretical model is an effective weight management intervention: a randomized controlled trial.,"BACKGROUND


Given the current worldwide epidemic of obesity, there is a demand for interventions with higher impact, such as those carried out in the primary health care (PHC) setting. Here we evaluate the effect of intervention performed according to the stages of change of the transtheoretical model (TTM) for weight management.
METHODS


This randomized controlled trial in Brazilian PHC offered free physical exercise and nutrition education. The participants were women, aged 20 years or older who were obese or overweight, users in PHC service. The intervention group (IG, n = 51) received the same orientation as the comparison group (CG, n = 35) plus individual health counseling based on the TTM aimed at weight loss, which lasted 6 months. The outcome measures were anthropometric, food, and nutrient profiles. Inflammatory parameters were evaluated in a random subsample. The inter-group and intra-group differences were evaluated using interntion-to-treat analysis, and analysis of covariance (ANCOVA) used to assess intervention effectiveness.
RESULTS


There was a difference between groups of - 1.4 kg (CI95%: - 2.5; - 0.3) in body weight after the intervention. About 97% of women in the IG reported benefits of the intervention and presented positive changes in diet, biochemical markers, and anthropometry. The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
CONCLUSION


The individualized TTM-based intervention, combined with usual care, was an effective strategy in PHC. These results should encourage the use of interdisciplinary practices; nevertheless, research to identify additional strategies is needed to address barriers to weight maintenance among obese low-income women.
TRIAL REGISTRATION


The trial is registered with Brazilian clinical trials under the code: RBR-8t7ssv, Registration date: 12/12/2017 (retrospectively registered).",2020,"The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
","['participants were women, aged 20\u2009years or older who were obese or overweight, users\xa0in PHC service', 'obese low-income women']","['same orientation as the comparison group (CG, n\u2009=\u200935) plus individual health counseling based on the TTM', 'physical exercise and nutrition education']","['anthropometric, food, and nutrient profiles', 'body weight', 'body mass index, resistine, and blood glucose results']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose level - finding'}]",,0.0888361,"The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up.
","[{'ForeName': 'Patrícia Pinheiro', 'Initials': 'PP', 'LastName': 'de Freitas', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Mariana Carvalho', 'Initials': 'MC', 'LastName': 'de Menezes', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Luana Caroline', 'Initials': 'LC', 'LastName': 'Dos Santos', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adriano Marçal', 'Initials': 'AM', 'LastName': 'Pimenta', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adaliene Versiani Matos', 'Initials': 'AVM', 'LastName': 'Ferreira', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Research Group in Nutrition Interventions, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. alinelopesenf@gmail.com.'}]",BMC public health,['10.1186/s12889-020-08796-1']
240,32393215,"Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis.","BACKGROUND


Revefenacin, a once-daily, long-acting muscarinic antagonist delivered via standard jet nebulizer, increased trough forced expiratory volume in 1 s (FEV 1 ) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in prior phase 3 trials. We evaluated the efficacy of revefenacin in patients with markers of more severe COPD.
METHODS


A post hoc subgroup analysis of two replicate, randomized, phase 3 trials was conducted over 12 weeks. Endpoints included least squares change from baseline in trough FEV 1 , St. George's Respiratory Questionnaire (SGRQ) responders, and transition dyspnea index (TDI) responders at Day 85. This analysis included patient subgroups at high risk for COPD exacerbations and compared patients who received revefenacin 175 μg and placebo: severe and very severe airflow limitation (percent predicted FEV 1  30%-< 50% and < 30%), 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) D, reversibility (≥ 12% and ≥ 200 mL increase in FEV 1 ) to short-acting bronchodilators, concurrent use of long-acting β agonists and/or inhaled corticosteroids, older age (> 65 and > 75 years), and comorbidity risk factors.
RESULTS


Revefenacin demonstrated significant improvements in FEV 1  versus placebo at Day 85 among the intention-to-treat (ITT) population and all subgroups. Additionally, there was a greater number of SGRQ and TDI responders in the ITT population and the majority of subgroups analyzed among patients who received revefenacin versus placebo. For the SGRQ responders, the odds of response (odds ratio > 2.0) were significantly greater in the revefenacin arm versus the placebo arm among the severe airflow obstruction, very severe airflow obstruction and 2011 GOLD D subgroups. For the TDI responders, the odds of response (odds ratio > 2.0) were significantly greater among the severe airflow obstruction subgroup and patients aged > 75 years.
CONCLUSIONS


Revefenacin showed significantly greater improvements in FEV 1  versus placebo in the ITT population and all subgroups. Furthermore, there were a greater number of SGRQ and TDI responders in the ITT population, and in the majority of patient subgroups among patients who received revefenacin versus placebo. Based on the data presented, revefenacin could be a therapeutic option among patients with markers of more severe COPD.
TRIAL REGISTRATION


Clinical trials registered with www.clinicaltrials.gov (Studies 0126 [NCT02459080; prospectively registered 22 May 2015] and 0127 [NCT02512510; prospectively registered 28 July 2015]).",2020,"For the SGRQ responders, the odds of response (odds ratio > 2.0) were significantly greater in the revefenacin arm versus the placebo arm among the severe airflow obstruction, very severe airflow obstruction and 2011 GOLD D subgroups.","['www.clinicaltrials.gov (Studies 0126 [NCT02459080; prospectively registered 22 May 2015] and 0127', 'patients with markers of more severe COPD', 'patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in prior phase 3 trials', 'patient subgroups at high risk for COPD exacerbations and compared patients who received', 'and/or inhaled corticosteroids, older age (>\u200965 and\u2009>\u200975\u2009years), and comorbidity risk factors']","['revefenacin', 'revefenacin versus placebo', 'revefenacin 175\u2009μg and placebo', 'placebo']","['FEV', 'number of SGRQ and TDI responders', ""least squares change from baseline in trough FEV 1 , St. George's Respiratory Questionnaire (SGRQ) responders, and transition dyspnea index (TDI) responders"", 'severe airflow limitation', '2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) D, reversibility ']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C4519232', 'cui_str': 'revefenacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}]",,0.403189,"For the SGRQ responders, the odds of response (odds ratio > 2.0) were significantly greater in the revefenacin arm versus the placebo arm among the severe airflow obstruction, very severe airflow obstruction and 2011 GOLD D subgroups.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Donohue', 'Affiliation': 'Pulmonary Medicine, UNC School of Medicine, 321 S Columbia St, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, LLC, 3860 Crater Lake Ave, Medford, OR, 97504, USA.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Edmund J', 'Initials': 'EJ', 'LastName': 'Moran', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Haumann', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., 901 Gateway Blvd, South San Francisco, CA, 94080, USA. gcrater@theravance.com.'}]",BMC pulmonary medicine,['10.1186/s12890-020-1156-4']
241,32393279,Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR).,"BACKGROUND


Narcolepsy is a rare chronic sleep disorder that typically begins in youth. Excessive daytime sleepiness is the main disabling symptom, but the disease is often associated with severe endocrine-metabolic and psychosocial issues, worsened by a long diagnostic delay, requiring a multidisciplinary approach. The scarcity of reference Sleep Centres forces the patient and family to travel for seeking medical consultations, increasing the economic and psychosocial burden of the disease. Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders. However, Telemedicine clinical and economic benefits for patients with narcolepsy are still unknown.
METHODS


TENAR is a two-part project, including: 1. a cross-sectional study (involving 250 children and adults with suspected narcolepsy) evaluating the accuracy of Teletriage (i.e., a synchronous live interactive sleep assessment through a Televisit) for narcolepsy diagnosis compared to the reference standard; and 2. a two-arm, parallel, open randomized controlled trial (RCT) to demonstrate the non-inferiority of the multidisciplinary care of narcolepsy through Televisits versus standard care. In this RCT, 202 adolescents (> 14 y.o.) and adults with narcolepsy will be randomly allocated (1:1 ratio) either to Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm). The primary outcome is sleepiness control (according to the Epworth Sleepiness Scale). Secondary outcomes are other symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs. At baseline and at 12 months, patients will undergo neurologic, metabolic, and psychosocial assessments and we will measure primary and secondary outcomes. Primary outcomes will be also measured at 6 months (remotely or in person, according to the arm).
DISCUSSION


TENAR project will assess, for the first time, the feasibility, accuracy, efficacy and safety of Telemedicine procedures applied to the diagnosis and the multidisciplinary care of children and adults with narcolepsy. The study may be a model for the remote management of other rare disorders, offering care access for patients living in areas lacking medical centres with specific expertise.
TRIAL REGISTRATION


Number of the Tele-multidisciplinary care study NCT04316286. Registered 20 March 2020.",2020,"Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders.","['person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR', '202 adolescents (>\u200914 y.o.) and adults with narcolepsy', 'children and adults with narcolepsy', 'patients with narcolepsy', '250 children and adults with suspected narcolepsy', 'patients living in areas lacking medical centres with specific expertise']","['Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm', 'synchronous live interactive sleep assessment through a Televisit', 'Telemedicine']","['6\u2009months (remotely or in person, according to the arm', 'symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs', 'sleepiness control (according to the Epworth Sleepiness Scale', 'Excessive daytime sleepiness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]",250.0,0.120184,"Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ingravallo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Vignatelli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy. l.vignatelli@ausl.bologna.it.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Pagotto', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vandi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Moresco', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Mangiaruga', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Oriolo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Zenesini', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}]",BMC neurology,['10.1186/s12883-020-01762-9']
242,32393300,"The effect of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.","OBJECTIVE


The purpose of this study was to explore the effects of music therapy on pain, anxiety and depression in patients after coronary artery bypass grafting.
METHODS


A retrospective study of 99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China. According to the different interventions, all the participants were divided into 3 groups: group A: music therapy; group B: rest without music therapy; and group C: conventional treatment. The Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were used to measure the patient's pain, anxiety and depression before and after 30 min of the intervention.
RESULTS


There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention. After 30 min of music therapy, the NRS, SDS and SAS scores of patients in group A were significantly lower than those before music therapy, and the differences were statistically significant. However, before and after the intervention in groups B and C, the NRS, SDS and SAS scores were not statistically significant. By comparison among the three groups after 30 min of intervention, the NRS, SDS and SAS scores in patients in group A were significantly lower than those in groups B and C, and the differences were statistically significant. The scores were not significantly different between groups B and C.
CONCLUSION


Music therapy can effectively alleviate the pain, anxiety and depression of patients after coronary artery bypass grafting.",2020,"There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention.","['99 patients after coronary artery bypass from January 2017 to January 2019 was conducted in a cardiac center in China', 'patients after coronary artery bypass grafting']","['music therapy', 'music therapy; group B: rest without music therapy; and group C: conventional treatment', 'Music therapy']","[""patient's pain, anxiety and depression"", 'pain, anxiety and depression', 'Numerical Rating Scale (NRS), Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS', 'NRS, SDS and SAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.0155104,"There were no significant differences in the NRS, SDS and SAS scores between the three groups of patients before the intervention.","[{'ForeName': 'Wang-Sheng', 'Initials': 'WS', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. caohua0791@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01141-y']
243,32393320,"Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial.","BACKGROUND


Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain.
METHODS


Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
DISCUSSION


Despite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.",2020,"The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
","['Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3\u2009months and scores for pain greater than 40\u2009mm on a visual analogue scale (VAS', 'chronic low back pain']","['Usual care including home exercise with versus without spa therapy', 'Spa therapy', 'UCHE alone, or UCHE plus spa therapy', 'usual care including home exercise (UCHE) versus UCHE alone']","['VAS score for pain', 'presence/absence of a clinically relevant change', 'VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5\u2009L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",358.0,0.216203,"The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
","[{'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Forestier', 'Affiliation': 'Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France. romain.forestier@wanadoo.fr.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Suehs', 'Affiliation': 'Departments of Medical Information and Respiratory Diseases, Univ Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Françon', 'Affiliation': 'Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Marty', 'Affiliation': 'Department of Rheumatology, APHP - Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Genevay', 'Affiliation': 'Department of Rheumatology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Sellam', 'Affiliation': 'Department of Rheumatology, APHP - Hôpital Saint-Antoine, Sorbonne Université, Inserm URMS_938, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chauveton', 'Affiliation': 'Delegation for Clinical Research and Innovation, Univ Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Fatma Begüm', 'Initials': 'FB', 'LastName': 'Erol Forestier', 'Affiliation': 'Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.'}]",Trials,['10.1186/s13063-020-04271-9']
244,32393370,Comparing the effects of ketorolac and Paracetamol on postoperative pain relief after coronary artery bypass graft surgery. A randomized clinical trial.,"INTRODUCTION


Pain management after coronary artery bypass graft (CABG) surgery remains challenging.
OBJECTIVE


This study aimed to compare the effects of Ketorolac and Paracetamol on postoperative CABG pain relief.
METHOD


This double-blind randomized clinical trial study was conducted in Ahvaz, Iran, from September 2018-December 2019. Two consecutive groups of 60 patients undergoing elective on-pump coronary artery bypass graft surgery.
INTERVENTION


The patients were divided into 0.5 mg/kg of ketorolac mg/dl and 10 mg/kg of Paracetamol after surgery for pain management. Primary outcomes were: visual analog pain scale (VAS) at the time point immediately after extubation (baseline) and at 6, 12, 24 and 48 h and the total dose of morphine consumption. Secondary outcomes included the hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction.
STATISTICAL ANALYSIS


The data were analyzed using SPSS version 22(SPSS, Chicago, IL). The Mann-Whitney U-test was used to compare demographic data, VAS scores, vital signs, and side effects. Repeated measurements were tested within groups using Friedman's ANOVA and the Wilcoxon rank-sum test. Values were expressed as means ± standard deviations. Statistical significance was defined as a p-value < 0.05.
RESULTS


Compared with baseline scores, there were significant declines in VAS scores in both groups throughout the time sequence (P< 0.05). The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h. However, at 24 and 48 h, the VAS score in group Paracetamol was significantly higher than in group Ketorolac. There were no significant differences between groups about hemodynamic variables.
CONCLUSION


The efficacy of ketorolac is comparable to that of Paracetamol in postoperative CABG pain relief.
TRIAL REGISTRY


IRCT20150216021098N5. Registered at 2019-09-12.",2020,"The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h.","['60 patients undergoing elective on-pump coronary artery bypass graft surgery', 'Ahvaz, Iran, from September 2018-December 2019', 'after coronary artery bypass graft surgery']","['Ketorolac and Paracetamol', 'coronary artery bypass graft (CABG) surgery', 'ketorolac mg/dl and 10\u2009mg/kg of Paracetamol', 'Paracetamol', 'ketorolac', 'ketorolac and Paracetamol']","['VAS score', 'statistical VAS score', 'demographic data, VAS scores, vital signs, and side effects', 'postoperative CABG pain relief', 'hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction', 'visual analog pain scale (VAS', 'postoperative pain relief', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",60.0,0.1372,"The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforooshzadeh', 'Affiliation': 'Department of Cardiac Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. f_javaherforoosh@yahoo.com.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Abdalbeygi', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farahzad', 'Initials': 'F', 'LastName': 'Janatmakan', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Gholizadeh', 'Affiliation': 'Atherosclerosis Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01125-y']
245,32393387,The impact of glutamate infusion on postoperative NT-proBNP in patients undergoing coronary artery bypass surgery: a randomized study.,"BACKGROUND


Glutamate, a key intermediate in myocardial metabolism, may enhance myocardial recovery after ischemia and possibly reduce the incidence and severity of postoperative heart failure in coronary artery bypass surgery (CABG). N-terminal pro-B-type natriuretic peptide (NT-proBNP) can be used to assess postoperative heart failure (PHF) after CABG. Our hypothesis was that glutamate enhances myocardial recovery in post-ischemic heart failure and, therefore, will be accompanied by a mitigated postoperative increase of NT-proBNP.
METHODS


Substudy of the GLUTAmate for Metabolic Intervention in Coronary Surgery (GLUTAMICS) trial (ClinicalTrials.gov Identifier: NCT00489827) a prospective triple-center double-blind randomized clinical trial on 399 patients undergoing CABG with or without concomitant procedure for acute coronary syndrome at three Swedish Cardiac Surgery centres (Linköping, Örebro, and Karlskrona) from May 30, 2007 to November 12, 2009. Patients were randomly assigned to intravenous infusion of 0.125 M L-glutamic acid or saline (1.65 mL/kg of body weight per hour) intraoperatively and postoperatively. Plasma NT-proBNP was measured preoperatively, the first (POD1) and third postoperative morning (POD3). A Clinical Endpoints Committee, blinded to both intervention and NT-proBNP used prespecified criteria to diagnose PHF. The primary endpoints were the absolute levels of postoperative NT-proBNP and the difference between preoperative and postoperative levels of NT-proBNP.
RESULTS


Overall no significant difference was detected in postoperative NT-proBNP levels between groups. However, in high-risk patients (upper quartile of EuroSCORE II ≥ 4.15; glutamate group n = 56; control group n = 45) glutamate was associated with significantly lower postoperative increase of NT-proBNP (POD3-Pre: 3900 [2995-6260] vs. 6745 [3455-12,687] ng•L -1 , p = 0.012) and lower NT-proBNP POD3 (POD3: 4845 [3426-7423] vs. 8430 [5370-14,100] ng•L -1 , p = 0.001). After adjusting for significant differences in preoperative demographics, NT-proBNP POD3 in the glutamate group was 0.62 times of that in the control group (p = 0.002). Patients in the glutamate group also had shorter ICU stay (21 [19-26] vs. 25 [22-46] h, p = 0.025) and less signs of myocardial injury (Troponin T POD3 (300 [170-500] vs. 560 [210-910] ng•L -1 , p = 0.025).
CONCLUSIONS


Post hoc analysis of postoperative NT-proBNP suggests that intravenous infusion of glutamate may prevent or mitigate myocardial dysfunction in high-risk patients undergoing CABG. Further studies are necessary to confirm these findings. Trial registration Swedish Medical Products Agency 151:2003/70403 (prospectively registered with amendment about this substudy filed March 17, 2007). ClinicalTrials.gov Identifier: NCT00489827 (retrospectively registered) https://clinicaltrials.gov/ct2/show/NCT00489827?term=glutamics&draw=1&rank=1.",2020,"After adjusting for significant differences in preoperative demographics, NT-proBNP POD3 in the glutamate group was 0.62 times of that in the control group (p = 0.002).","['coronary artery bypass surgery (CABG', 'for acute coronary syndrome at three Swedish Cardiac Surgery centres (Linköping, Örebro, and Karlskrona) from May 30, 2007 to November 12, 2009', 'patients undergoing coronary artery bypass surgery', 'high-risk patients undergoing CABG', '399 patients undergoing']","['CABG with or without concomitant procedure', 'glutamate infusion', 'intravenous infusion of 0.125\xa0M\xa0L-glutamic acid or saline', 'N-terminal pro-B-type natriuretic peptide (NT-proBNP']","['signs of myocardial injury (Troponin T POD3', 'postoperative NT-proBNP', 'myocardial dysfunction', 'preoperative demographics, NT-proBNP POD3', 'postoperative NT-proBNP levels', 'Plasma NT-proBNP', 'shorter ICU stay', 'lower NT-proBNP POD3', 'postoperative increase of NT-proBNP', 'absolute levels of postoperative NT-proBNP and the difference between preoperative and postoperative levels of NT-proBNP']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0061472', 'cui_str': 'Glutamic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",399.0,0.384104,"After adjusting for significant differences in preoperative demographics, NT-proBNP POD3 in the glutamate group was 0.62 times of that in the control group (p = 0.002).","[{'ForeName': 'Huiqi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Vidlund', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Farkas', 'Initials': 'F', 'LastName': 'Vanky', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Friberg', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Yanqi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Svedjeholm', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine and Health Sciences, Unit of Cardiovascular Sciences, Linköping University, Linköping, Sweden. rolf.svedjeholm@regionostergotland.se.'}]",Journal of translational medicine,['10.1186/s12967-020-02351-7']
246,32393405,Experimental manipulation of beliefs about the importance of thoughts and the effect on an aggressive impulse.,"BACKGROUND


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


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


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


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


Some beliefs can be modified through a single session in which information similar to what could be obtained in quotidian life is provided.",2020,"However, experimentally induced changes in beliefs did not yield differences in the intrusiveness of the aggressive impulse.
","['Eighty-five participants completed a battery of self-report instruments assessing obsession symptoms, thought control, affectivity and obsessive beliefs']",[],[],"[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006122', 'cui_str': 'Brainwashing'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",[],[],85.0,0.0437257,"However, experimentally induced changes in beliefs did not yield differences in the intrusiveness of the aggressive impulse.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jiménez-Ros', 'Affiliation': 'Psychology Research Centre (CIP/UAL) and Universidade do Algarve, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Faísca', 'Affiliation': 'Centre for Biomedical Research (CBMR) and Universidade do Algarve, Portugal.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Martins', 'Affiliation': 'Universidade do Algarve.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Janeiro', 'Affiliation': 'Psychology Research Centre (CIP/UAL) and Universidade do Algarve, Portugal.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Martins', 'Affiliation': 'Centre for Biomedical Research (CBMR) and Universidade do Algarve, Portugal.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000120']
247,32393479,"Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial.","INTRODUCTION


The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices.  Orthèse diabète  is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of  this device  in DFU healing.
RESEARCH, DESIGN AND METHODS


The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either  Orthèse Diabète (experimental device ), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.
RESULTS


Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%)  Orthèse Diabète  users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the  Orthèse Diabète  group than in the control group (15% vs 4%).  Orthèse Diabète  was less frequently worn than conventional devices (46% vs 66%, p=0.04).
CONCLUSIONS


Orthèse Diabète , a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.
TRIAL REGISTRATION NUMBER


NCT01956162.",2020,Adverse events believed to be related to the device were higher in the  Orthèse Diabète  group than in the control group (15% vs 4%).  ,"['112 randomized patients (men 78%, age 62±10 years', 'Adults with neuropathic DFU', 'patients with neuropathic diabetic foot ulcers']","['new versus standard removable offloading device', 'Orthèse Diabète (experimental device ), or any type of conventional (usually used in France) removable offloading devices (control group']","['occurrence of new DFU', 'Adverse events', 'sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer', '3-month proportion of patients with fully healed DFU', 'infectious complications', 'ipsilateral lower-limb amputation']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406526', 'cui_str': 'Neuropathic ulcer of foot due to diabetes mellitus'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0237568', 'cui_str': 'Experimental device'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]",112.0,0.174542,Adverse events believed to be related to the device were higher in the  Orthèse Diabète  group than in the control group (15% vs 4%).  ,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Potier', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France louis.potier@gmail.com.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'François', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.'}, {'ForeName': 'Dured', 'Initials': 'D', 'LastName': 'Dardari', 'Affiliation': 'Diabetology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, Paris, France.'}, {'ForeName': 'Marilyne', 'Initials': 'M', 'LastName': 'Feron', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Narimene', 'Initials': 'N', 'LastName': 'Belhatem', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Nobecourt-Dupuy', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Universitaire de la Réunion, Saint Denis de la Réunion, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dolz', 'Affiliation': 'Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.'}, {'ForeName': 'Lyse', 'Initials': 'L', 'LastName': 'Bordier', 'Affiliation': 'Endocrinology Department, Hôpital Bégin, Saint-Mandé, France.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Ducloux', 'Affiliation': 'APHP, Hôpital Corentin-Celton, Centre de Cicatrisation du Pied du Diabétique, Issy les Moulineaux, France.'}, {'ForeName': 'Abdelkader', 'Initials': 'A', 'LastName': 'Chibani', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Gonesse, Gonesse, France.'}, {'ForeName': 'Dominique-François', 'Initials': 'DF', 'LastName': 'Eveno', 'Affiliation': 'Department of Functional Rehabilitation, Centre Hospitalier La Tourmaline, La Tourmaline, France.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Crea Avila', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition, Centre Hospitalier Régional de Metz-Thionville, Thionville, France.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHRU Montpellier, Montpellier, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Baillet-Blanco', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rigalleau', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gand', 'Affiliation': 'INSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Saulnier', 'Affiliation': 'INSERM CIC 1402, University of Poitiers, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Velho', 'Affiliation': 'INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Roussel', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Pellenc', 'Affiliation': 'Vascular Surgery Department, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Dupré', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Malgrange', 'Affiliation': 'Endocrinology, Diabetology and Nutrition, Centre Hospitalier Universitaire de Reims, Reims, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Mohammedi', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, CHU Bordeaux, Haut Lévèque Hospital, Pessac, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000954']
248,32393496,"A phase 2 randomized, double-blind, placebo-controlled trial of MHAA4549A, a monoclonal antibody, plus oseltamivir in patients hospitalized with severe influenza A infection.","Background.  For patients hospitalized with severe influenza A, morbidity and mortality remain high. MHAA4549A, a human monoclonal antibody targeting the influenza A hemagglutinin stalk, has demonstrated pharmacological activity in animal studies and in a human influenza A challenge study. We evaluated the safety and efficacy of MHAA4549A plus oseltamivir against influenza A infection in hospitalized patients. Methods.  The CRANE trial was a phase 2b, randomized, double-blind, placebo-controlled study of single intravenous (IV) doses of placebo, 3600-mg, or 8400-mg MHAA4549A together with oral oseltamivir (+OTV), in patients hospitalized with severe influenza A. Patients, enrolled across 68 clinical sites in 18 countries, were randomized 1:1:1. The primary outcome was the median time to normalization of respiratory function defined as the time to removal of supplemental oxygen support to maintain a stable SpO 2  ≥ 95%. Safety, pharmacokinetics, and effects on influenza viral load were also assessed. Results.  166 patients were randomized and analyzed during a preplanned interim analysis. Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes. Adverse event frequency was balanced across cohorts. MHAA4549A+OTV did not further reduce viral load versus placebo+OTV. Conclusions.  In hospitalized patients with influenza A, MHAA4549A did not improve clinical outcomes over OTV alone. Variability in patient removal from oxygen supplementation limited the utility of the primary endpoint. Validated endpoints are needed to assess novel treatments for severe influenza A.",2020,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","['patients hospitalized with severe influenza A. Patients, enrolled across 68 clinical sites in 18 countries', 'patients hospitalized with severe influenza A infection', 'hospitalized patients', '166 patients']","['MHAA4549A plus oseltamivir', 'placebo, 3600-mg, or 8400-mg MHAA4549A together with oral oseltamivir (+OTV', 'MHAA4549A', 'MHAA4549A+OTV', 'placebo+OTV, MHAA4549A+OTV', 'placebo']","['median time to normalization of respiratory function defined as the time to removal of supplemental oxygen support to maintain a stable SpO 2  ≥ 95', 'time to normalization of respiratory function', 'Safety, pharmacokinetics, and effects on influenza viral load', 'safety and efficacy', 'Adverse event frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C5191361', 'cui_str': '166'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",166.0,0.65193,"Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function (placebo+OTV: 4.28 days; 3600-mg MHAA4549A+OTV: 2.78 days; 8400-mg MHAA4549A+OTV: 2.65 days), nor did it improve other secondary clinical outcomes.","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA lim.jeremy@gene.com.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Nimer', 'Initials': 'N', 'LastName': 'Assy', 'Affiliation': 'Galilee Medical Center, Department of Internal Med A, The Azrieli Faculty of Medicine, Nahariya, Israel.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Chu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00352-20']
249,32384426,A phase I/IIa double blind single institute trial of low dose sirolimus for Pendred syndrome/DFNB4.,"INTRODUCTION


Pendred syndrome (PDS)/DFNB 4 is a disorder with fluctuating and progressive hearing loss, vertigo, and thyroid goiter. We identified pathophysiology of a neurodegenerative disorder in PDS patient derived cochlear cells that were induced via induced pluripotent stem cells and found sirolimus, an mTOR inhibitor, as an inhibitor of cell death with the minimum effective concentration less than 1/10 of the approved dose for other diseases. Given that there is no rational standard therapy for PDS, we planned a study to examine effects of low dose oral administration of sirolimus for the fluctuating and progressive hearing loss, and the balance disorder of PDS by daily monitor of their audio-vestibular symptoms.
METHODS AND ANALYSIS


This is a phase I/IIa double blind parallel-group single institute trial in patient with PDS/DFNB4. Sixteen of outpatients with fluctuating hearing diagnosed as PDS in SLC26A4 genetic testing aged in between 7 and 50 years old at the time of consent are given either placebo or sirolimus tablet (NPC-12T). In NPC-12T placebo arm, placebo will be given for 36 weeks; in active substance arm, placebo will be given for 12 weeks and the NPC-12T for 24 weeks. Primary endpoints are safety and tolerability. The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results. A 2-sided 95% confidence interval of the incidence rate by respective dosing arms will be calculated using the Clopper-Pearson method. Clinical effects on audio-vestibular tests performed daily and precise physiological test at each visit will also be examined as secondary and expiratory endpoints.
TRIAL REGISTRATION NUMBER


JMA-IIA00361; Pre-results.",2020,The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results.,"['patient with PDS/DFNB4', 'Sixteen of outpatients with fluctuating hearing diagnosed as PDS in SLC26A4 genetic testing aged in between 7 and 50 years old at the time of consent are given either', 'Pendred syndrome/DFNB4']","['placebo or sirolimus tablet (NPC-12T', 'placebo', 'NPC-12T placebo', 'sirolimus']","['number of occurrences and types of adverse events', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3538946', 'cui_str': 'Dilated Vestibular Aqueduct'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}]","[{'cui': 'C0449789', 'cui_str': 'Number of occurrences'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.43163,The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Akiyama', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hosoya', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Fujiki', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yoshihama', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ozawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Tsukada', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shin-Ya', 'Initials': 'SY', 'LastName': 'Nishio', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Usami', 'Affiliation': 'Department of Otorhinolaryngology, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tomonobu', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Pediatrics, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",Medicine,['10.1097/MD.0000000000019763']
250,32384434,In vivo investigation on bio-markers of perimenopausal panic disorder and catgut embedding acupoints mechanism.,"BACKGROUND


Panic disorder (PD), defined by repeated and unexpected panic attacks, severely affects patients' living quality and social function. Perimenopausal women are high-risk group of PD and suffer greatly from it. Modern medicine therapies for this disorder have many side reactions and poor effects, so nonpharmacological modality is an urgent need. Although acupoint catgut embedding is widely used in clinical practice, there is no persuasive evidence of its effect for perimenopausal PD. The aim of this study is to investigate the effectiveness and safety of acupoint catgut embedding for perimenopausal PD and to elucidate the correlations among brain neural activation, bio-markers (amino acids) and clinical outcomes with radiographic evidence, thus to explore its neural mechanism.
METHODS


The parallel designed, exploratory randomized controlled trial will include 70 outpatients with perimenopausal PD recruited from two hospitals of Chinese Medicine. These subjects will be randomly allocated to an intervention group (Group Embedding) and a control group (Group Medication) in a 1:1 ratio. The subjects in the intervention group will receive acupoint catgut embedding treatment two weeks a time in the following predefined acupuncture points: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Zusanli (ST36) and Pishu (BL20). The included women of the control group will take 0.4 mg Alprazolam tablet orally, 1 tablet a time, 3 times a day. There is a study period of 3 months and a follow-up period of 1 month for each group. The primary outcomes will be the following therapeutic indexes: the frequency of panic attack, Panic Disorder Severity Score (PDSS), and Panic-associated Symptoms Score (PASS) during the observation period and follow-up period. The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups. Additionally, functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (1H-MRS) scans will be done before and after the observation period to show cranial neuroimaging changes.
DISCUSSION


We present a study design and rationale to explore the effectiveness and neural mechanism of acupoint catgut embedding for perimenopausal PD. There are still several factors restrict our research such as no unified standard of diagnostic criteria and curative effect evaluation.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-INR-16009724, registered in November 2016.",2020,The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups.,"['70 outpatients with perimenopausal PD recruited from two hospitals of Chinese Medicine', 'perimenopausal PD', 'Perimenopausal women']","['Alprazolam', 'acupoint catgut embedding treatment two weeks a time in the following predefined acupuncture points: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Zusanli (ST36) and Pishu (BL20', 'control group (Group Medication', 'functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (1H-MRS) scans', 'acupoint catgut embedding']","['frequency of panic attack, Panic Disorder Severity Score (PDSS), and Panic-associated Symptoms Score (PASS', 'Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0450614', 'cui_str': 'BL20'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0086769', 'cui_str': 'Panic attack'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}]",70.0,0.0811251,The changes in Hamilton Anxiety Scale (HAMA) Score and Symptom Checklist 90 (SCL-90) Score will also be compared between these two groups.,"[{'ForeName': 'Guizhen', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""The Bao'an District TCM Hospital, The Affiliated Hospital of Guangzhou University of Chinese Medicine, Shenzhen.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junquan', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yunxiang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Medicine,['10.1097/MD.0000000000019909']
251,32384437,Extracorporeal shock wave therapy versus corticosteroid injection for chronic plantar fasciitis: A protocol of randomized controlled trial.,"BACKGROUND


The outcomes of corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT) as primary treatment of plantar fasciitis have been debated. This study was conducted to compare and evaluate the therapeutic effects of ultrasound-guided CSI versus medium frequency ESWT in the treatment of plantar fasciitis among Chinese population.
METHODS


This study was a single-center, randomized, and double-blinded trial. The study protocol was approved by local ethics committee board and subsequently registered in Research Registry. Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40). The primary outcome measures were visual analog scale and Foot Function Index scores. Secondary outcome measures included the heel tenderness index score and plantar fascia thickness as obtained by ultrasound examination. All of the assessments were performed at baseline and 1, 3, and 6 months after treatment.
RESULTS


This is a randomized controlled trial evaluating the efficacy of CSI versus ESWT in the treatment of plantar fasciitis. This study has limited inclusion and exclusion criteria and a well-controlled intervention.
CONCLUSIONS


The results of this trial will provide more evidence on which method can better treat plantar fasciitis.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5428).",2020,Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40).,"['chronic plantar fasciitis', 'plantar fasciitis among Chinese population', 'plantar fasciitis', 'Eighty patients with unilateral plantar fasciitis']","['corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT', 'ultrasound-guided CSI versus medium frequency ESWT', 'betamethasone sodium plus 0.5\u200amL of prilocaine', 'Extracorporeal shock wave therapy versus corticosteroid injection', 'CSI treatment', 'ESWT', 'CSI versus ESWT']","['visual analog scale and Foot Function Index scores', 'heel tenderness index score and plantar fascia thickness as obtained by ultrasound examination']","[{'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]",80.0,0.206775,Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Traumatic Orthopedics, Weifang People's Hospital, Weifang, Shandong, 261041.""}, {'ForeName': 'Wen Ming', 'Initials': 'WM', 'LastName': 'Luo', 'Affiliation': ""Department of Traumatic Orthopedics, Weifang People's Hospital, Weifang, Shandong, 261041.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, Weifang Maternal and Child health Hospital, Weifang, Shandong, 261000, China.'}]",Medicine,['10.1097/MD.0000000000019920']
252,32384885,Effects of reflection and immediate feedback to improve clinical reasoning of medical students in the assessment of dermatologic conditions: a randomised controlled trial.,"BACKGROUND


There are few studies that directly compared different interventions to improve medical students' clinical reasoning for dermatologic conditions.
OBJECTIVE


To investigate the effectiveness of adding practice with reflection and immediate feedback on traditional dermatology electives in improving medical students' ability in evaluating skin lesions.
METHODS


The participants were fourth-year medical students of Seoul National University College of Medicine, Korea, who were enrolled to take a 2-week dermatology elective course (n = 87). Students were assigned to one of the three educational interventions: 2-h training involving 10 written clinical cases (experimental); 1-h lecture and 1-h outpatient clinic (lecture); and 2-h outpatient clinic (no intervention). Before and at the end of rotation, diagnostic accuracy was estimated using 20 written clinical cases with photographs (10 novel cases presented in diagnostic training [training set], 10 cases with diagnoses not included in training [control set]).
RESULTS


There was a significant interaction effect of intervention×set×time. A post hoc analysis indicated that the students in the experimental group outperformed students in the other two groups only in the training set of the final tests; after completing the 2-week rotation, for the training set, the mean score was higher in the experimental group (7.5 ± 1.3) than in the lecture (5.7 ± 1.6) and no intervention (5.6 ± 1.3) groups, producing an effect size of 1.2 standard deviation (SD) and 1.5 SD, respectively.
CONCLUSION


Practicing written clinical cases with reflection and feedback is superior to a lecture-based approach and yields additional benefits to a dermatology elective, thereby enhancing medical students' ability to accurately diagnose skin lesions.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03472001. Registered 21 March 2018.",2020,"A post hoc analysis indicated that the students in the experimental group outperformed students in the other two groups only in the training set of the final tests; after completing the 2-week rotation, for the training set, the mean score was higher in the experimental group (7.5 ± 1.3) than in the lecture (5.7 ± 1.6) and no intervention (5.6 ± 1.3) groups, producing an effect size of 1.2 standard deviation (SD) and 1.5 SD, respectively.
","['participants were fourth-year medical students of Seoul National University College of Medicine, Korea, who were enrolled to take a 2-week dermatology elective course (n\u2009=\u200987', 'medical students in the assessment of dermatologic conditions']","['educational interventions: 2-h training involving 10 written clinical cases (experimental); 1-h lecture and 1-h outpatient clinic (lecture); and 2-h outpatient clinic (no intervention', 'practice with reflection and immediate feedback', 'reflection and immediate feedback']",['mean score'],"[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",10.0,0.0374438,"A post hoc analysis indicated that the students in the experimental group outperformed students in the other two groups only in the training set of the final tests; after completing the 2-week rotation, for the training set, the mean score was higher in the experimental group (7.5 ± 1.3) than in the lecture (5.7 ± 1.6) and no intervention (5.6 ± 1.3) groups, producing an effect size of 1.2 standard deviation (SD) and 1.5 SD, respectively.
","[{'ForeName': 'Sungjun', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Dong Hun', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyun-Sun', 'Initials': 'HS', 'LastName': 'Yoon', 'Affiliation': 'Department of Dermatology, SMG-SNU Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, South Korea. hsyoon79@gmail.com.'}]",BMC medical education,['10.1186/s12909-020-02063-y']
253,32384905,Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study.,"BACKGROUND


Plantar heel pain (PHP) is present in a wide range of individuals and creates significant burden to quality of life and participation in physical activity. The high recurrence rates and persistence of PHP suggests current management options may not address all potentially modifiable factors associated with the condition. Reports of intrinsic foot muscle (IFM) atrophy in individuals with PHP, together with biomechanical evidence of their important contribution to optimal foot function, suggests that an intervention focused on IFM training may be beneficial in managing PHP. We will test the feasibility of a prospective, assessor-blinded, parallel-group, randomised clinical trial that compares foot exercise plus education to brief advice in individuals with PHP.
METHODS


Twenty participants with PHP will be randomly allocated to one of two groups for a 12-week intervention period: (i) foot exercise plus education, or (ii) brief advice. The foot exercise plus education group will attend eight sessions with a physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs. The brief advice group will attend one session with a physiotherapist and receive brief information about self-management strategies and reassurance. Outcome measures will be obtained at baseline and the primary end-point of 12 weeks. Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention. Secondary outcomes will explore treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance.
DISCUSSION


To reduce the burden of PHP on individuals and society, there is a need to establish effective treatments that are feasible and accepted by patients and health professionals. This trial will be the first to evaluate the feasibility of conducting a full-scale RCT, as well as the credibility, acceptability, and treatment effects, of education and foot exercise for PHP. The findings of this study will inform the development of a full-scale RCT.
TRIAL REGISTRATION


The trial protocol was prospectively registered with the Australia and New Zealand Clinical Trial Registry (ACTRN12619000987167) on 11th July 2019.",2020,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","['individuals with PHP', 'Twenty participants with PHP']","['foot exercise plus education', 'Foot exercise plus education versus wait and see', 'IFM training', 'physiotherapist and receive detailed education on self-management strategies as well as a progressive exercise program for the IFMs', 'foot exercise plus education, or (ii) brief advice']","['treatment effects, which will consist of pain, physical function, physical activity level, pain self-efficacy, perceived treatment effect, magnetic resonance and ultrasound image measurement of IFM morphology, ultrasound imaging measurement of plantar fascia thickness, IFM motor performance, foot posture, foot mobility, ankle dorsiflexion range of motion, toe flexor and plantar flexor strength/endurance', 'feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}]","[{'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C1286219', 'cui_str': 'Mobility of foot'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",20.0,0.0820667,"Primary outcomes will be the feasibility of conducting a full-scale randomised clinical trial (RCT), and the credibility and acceptability of the foot exercise plus education intervention.","[{'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Franettovich Smith', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia. melinda.smith@uq.edu.au.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mellor', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Medicine and Health and The Kolling Research Institute, The University of Sydney, Sydney, New South Wales, 2006, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hoggarth', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, 4072, Australia.'}]",Journal of foot and ankle research,['10.1186/s13047-020-00384-1']
254,32384914,"Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA).","BACKGROUND


One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA).
METHODS


ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement. Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022. A sample of 542 patients is needed. The neonate is randomized to the intervention (propofol) or control placebo group. Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6. To guide drug administration, FANS is scored before attempting laryngoscopy. Once an adequate score has been obtained, LISA is performed according to a standardized protocol. The primary outcome is the need for mechanical ventilation within 72 h of life. Secondary outcomes are tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2 years of age.
DISCUSSION


This paper describes the first multicenter, double-blind, randomized, placebo-controlled trial on this topic and will provide crucial information to support implementation of the LISA procedure.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04016246. Registered 06 June 2019, N°EUDRACT: 2018-002876-41.",2020,Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6.,"['Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022', '542 patients', 'preterm neonates born before 32\u2009weeks gestational age (wGA']","['Propofol versus placebo', 'intervention (propofol) or control placebo', 'ketamine', 'invasive surfactant administration (LISA', 'propofol, versus placebo (rescue with ketamine', 'placebo']","['need for mechanical ventilation within 72\u2009h of life', 'tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2\u2009years of age']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.721645,Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Chevallier', 'Affiliation': 'UMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps University, Grenoble, France. mchevallier3@chu-grenoble.fr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Durrmeyer', 'Affiliation': 'Neonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ego', 'Affiliation': 'Neonatal Intensive Care Unit, Grenoble Alps University Hospital, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Debillon', 'Affiliation': 'UMR 5525 ThEMAS, CNRS, TIMC-IMAG, Grenoble Alps University, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02112-x']
255,32384922,Logbooks alone are not enough: initial experience with implementing a logbook for medical students in a clinical internship in gynecology and obstetrics.,"BACKGROUND


Logbooks are being increasingly widely used as a means of improving medical education and further training. They will in all probability continue to be mandatory in the Practical Year (PJ) in Germany even after the upcoming amendment of the Medical Licensing Regulations (ÄAppO). However, there are different approaches to their design and use, and these are also currently undergoing considerable change. This study for the first time examines and discusses the influence of logbooks on students' evaluation of a gynecology internship.
METHODS


The study was based on a well-established two-part 1-week internship course, with initially unstructured morning classes on wards and duty areas, along with precisely planned afternoon classes with skills training by peer teachers and seminars supervised by duty-exempted physicians. The postgraduate lecturers were prepared for the introduction of the logbook in a special course, and the aim was to optimize morning classes by introducing learning objectives adapted to the respective locations. The effects over 38 weeks of practical training were examined in evaluations by 235 prospectively group-randomized students with and without logbooks (n = 166 and n = 66, respectively; three datasets were not evaluable).
RESULTS


In the cohort comparison, the logbook group responded significantly more positively toward the internship at the start of the course (P = 0.046). In the final evaluation, however, medical supervision during the entire internship was rated significantly more poorly (P = 0.007). The logbook cohort also considered that guidance based on learning objectives was significantly worse, as was the extent to which wards and duty areas were prepared for the students (P = 0.001 and P = 0.029).
CONCLUSIONS


Introducing a logbook to optimize clinical teaching in internships may raise expectations that cannot always be met. In addition to adapting the learning objectives to a general framework that is less favorable in comparison with the Practical Year, the least that is required appears to be simultaneous and continuous mentoring of the lecturers, as well as an increase in staffing resources.",2020,"In the final evaluation, however, medical supervision during the entire internship was rated significantly more poorly (P = 0.007).","['235 prospectively group-randomized students with and without logbooks (n\u2009=\u2009166 and n\u2009=\u200966, respectively; three datasets were not evaluable']",['skills training by peer teachers and seminars supervised by duty-exempted physicians'],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",[],,0.0224506,"In the final evaluation, however, medical supervision during the entire internship was rated significantly more poorly (P = 0.007).","[{'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Jud', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany. Sebastian.jud@uk-erlangen.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cupisti', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Frobenius', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Benn', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Winkler', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Heindl', 'Affiliation': 'Department of Gynecology, Erlangen University Hospital, Universitätsstrasse 21-23, 91054, Erlangen, Germany.'}]",European journal of medical research,['10.1186/s40001-020-00413-6']
256,32384945,Effect of Carbon Nanoparticle Tracer Combined with Laparoscopy in the Treatment of Colon Cancer.,"In this study, our aim was to compare the clinical effects of laparoscopic surgery and open surgery for the treatment of colon cancer. From January 2018 to December 2018, a random sample of 398 colon cancer patients was collected. The open abdominal surgery group underwent open surgery, while the laparoscopic surgery group underwent laparoscopic surgery. The success rate of the two groups, total intraoperative blood loss, length of incision, postoperative bedtime, times of lymph node dissection, and incidence of postoperative complications were compared. Both groups were provided carbon nanotracers for staining. The intraoperative blood loss of the laparoscopic group was significantly lower than that of the open abdominal group (this difference was statistically significant,  P  < 0.01). However, the operation time and lymph node dissection were similar for the laparoscopic group and the open abdominal group (the difference was not statistically significant,  P  > 0.05). The gastrointestinal function recovery time, hospital stay, and lung infection rate of patients in the laparoscopic group were significantly lower than those of patients in the open abdominal group. Postoperative bleeding, anastomotic leakage, and wound infection were also observed, but differences between the groups were not statistically significant. The incidence of postoperative complications in the laparoscopic surgery group was lower than that in the open surgery group (statistically significantly,  P  < 0.05). Laparoscopic surgery in patients with colon cancer is effective and offers patients improved health, shortened recovery time, and better quality of life. Carbon nanotracers can be used to stain lymph nodes and to make distinguishing between diseased and normal tissue easier.",2020,"Postoperative bleeding, anastomotic leakage, and wound infection were also observed, but differences between the groups were not statistically significant.","['patients with colon cancer', 'colon cancer', 'From January 2018 to December 2018, a random sample of 398 colon cancer patients was collected', 'Colon Cancer']","['laparoscopic surgery and open surgery', 'Carbon Nanoparticle Tracer Combined with Laparoscopy', 'open abdominal surgery group underwent open surgery', 'Laparoscopic surgery', 'laparoscopic surgery group underwent laparoscopic surgery']","['operation time and lymph node dissection', 'incidence of postoperative complications', 'gastrointestinal function recovery time, hospital stay, and lung infection rate', 'health, shortened recovery time, and better quality of life', 'total intraoperative blood loss, length of incision, postoperative bedtime, times of lymph node dissection, and incidence of postoperative complications', 'intraoperative blood loss', 'success rate', 'Postoperative bleeding, anastomotic leakage, and wound infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}]",398.0,0.0386433,"Postoperative bleeding, anastomotic leakage, and wound infection were also observed, but differences between the groups were not statistically significant.","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, PR China.'}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, PR China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, PR China.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, PR China.'}, {'ForeName': 'Lianghui', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gastrointestinal Surgery, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, PR China.'}, {'ForeName': 'Minghai', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui, PR China.'}]",Journal of nanoscience and nanotechnology,['10.1166/jnn.2020.18598']
257,32386000,[Effect of proprotein convertase subtilisin/kexin type 9 inhibitor on blood lipid profile in patients with extremely high risk atherosclerotic cardiovascular disease].,"OBJECTIVE


To investigate the lowering effect on lipid and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in patients with extremely high risk atherosclerotic cardiovascular disease (ASCVD).
METHODS


The outpatients and in-patients with extremely high risk ASCVD admitted to the Second Affiliated Hospital of Chongqing Medical University from April to October in 2019 were enrolled. The enrolled patients were divided into two groups by random number table method. The patients in the atorvastatin group were given only 20 mg atorvastatin orally every night for 4 weeks. In the combined group, oral atorvastatin was administered with subcutaneous injection of 140 mg evolocumab, a PCSK9 inhibitor, once every 2 weeks, and the course of treatment was 4 weeks. Serum lipid profile was measured before and 4 weeks after treatment, including triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and lipoprotein-a (Lp-a). Adverse events were recorded.
RESULTS


During the study period, a total of 40 patients were enrolled, with 20 patients in the atorvastatin group and 20 in the combined group. There was no significant difference in blood lipid profile before treatment between the two groups. After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant. Further analysis showed that the differences in TC, LDL-C and Lp-a between before and after treatment in the combined group were significantly higher than those in the atorvastatin group [TC difference (mmol/L): 2.78±1.98 vs. 0.54±0.83, LDL-C difference (mmol/L): 1.91±1.38 vs. 0.39±0.72, Lp-a difference (mg/L): 115.87±138.93 vs. -84.19±251.85, all P < 0.05]. Only 1 patient in the combined group developed allergic reaction, mainly manifested as skin rash, who alleviated after anti-allergic treatment. No other adverse reactions such as abnormal liver function and increased myozyme occurred in the two groups.
CONCLUSIONS


PCSK9 inhibitor could rapidly and effectively reduced the levels of TC, LDL-C and Lp-a in extremely high risk ASCVD patients, while had little effect on the levels of TG and HDL-C. It is safe to some extent.",2020,"After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant.","['patients with extremely high risk atherosclerotic cardiovascular disease', '40 patients were enrolled, with 20 patients in the atorvastatin group and 20 in the combined group', 'patients with extremely high risk atherosclerotic cardiovascular disease (ASCVD', 'outpatients and in-patients with extremely high risk ASCVD admitted to the Second Affiliated Hospital of Chongqing Medical University from April to October in 2019 were enrolled']","['atorvastatin', 'proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor', 'oral atorvastatin', 'proprotein convertase subtilisin/kexin type 9 inhibitor']","['blood lipid profile', 'Adverse events', 'skin rash', 'triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and lipoprotein-a (Lp-a', 'Serum lipid profile', 'allergic reaction', 'TC, LDL-C and Lp-a', 'abnormal liver function and increased myozyme', 'levels of TC and LDL-C', 'levels of TG and HDL-C', 'levels of TC, LDL-C and Lp']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1703294', 'cui_str': 'Myozyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.0184988,"After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China. Corresponding author: Du Jianlin, Email: jianlindunev@cqmu.edu.cn.'}, {'ForeName': 'Songbai', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'She', 'Affiliation': ''}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200129-00053']
258,32386001,[Clinical research of early goal directed sedation applying in acute brain injury].,"OBJECTIVE


To investigate the value and feasibility of early goal directed sedation (EGDS) in patients with acute brain injury.
METHODS


A total of 110 patients with acute brain injury who were admitted to intensive care unit (ICU) of the Third Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to March 2019 were included and randomly divided into EGDS group and standard sedation group (STD) using the random number table. Patients in the EGDS group were sedated by continuous intravenous infusion of dexmedetomidine (initial dose of 0.2 μg×kg -1 ×min -1 ) for 72 consecutive hours. Patients in the STD group received intravenous bolus of propofol as appropriate clinically. Richmond agitation-sedation score (RASS) and electroencephalogram bispectral index (BIS) were used to continuously monitor the level of sedation. All patients were given sufentanil for analgesia. Routine treatments such as dehydration and reduction of intracranial pressure with mannitol, hemostasis or antiplatelet therapy were given according to the patients' condition. Vital signs, acute physiology and chronic health evaluation II (APACHE II) score, Glasgow coma scale (GCS) score, BIS value, artery blood gas analysis, duration of mechanical ventilation, analgesic dosage and adverse events were recorded in two groups before and 24, 48, and 72 hours after sedation.
RESULTS


(1) Among the 110 patients, patients who received the second surgery due to cerebral hemorrhage, had worsening of cerebral hernia, withdrew during the course of the study, or whose family members abandoned treatment were excluded from the study. Finally, 105 patients were enrolled in the study, including 56 patients in the EGDS group and 49 in the STD group. There was no significant difference in gender, age, types of brain injury, baseline APACHE II or GCS score or rate of mechanical ventilation between the two groups. (2) Compared with before sedation, heart rate (HR) significantly decreased till 72 hours after sedation in both groups, and the decrease in the EGDS groups was more obvious as compared with the STD group (bpm: 70.49±7.53 vs. 79.83±9.48, P < 0.05). Besides HR, significant improvement was found in the APACHE II and GCS scores in the STD group at 72 hours of sedation as compared with before sedation, and no significant difference was found in other indicators. Compared with before sedation, arterial partial pressure of carbon dioxide (PaCO 2 ) was significantly increased from the 24th hour of sedation, mean artery pressure (MAP) was decreased significantly and GCS score, BIS value were increased significantly from the 48th hour of sedation, till 72 hours, which were all improved significantly as compared with the STD group [72-hour PaCO 2  (mmHg, 1 mmHg = 0.133 kPa): 40.30±5.98 vs. 31.57±8.20, 72-hour MAP (mmHg): 85.01±8.26 vs. 89.54±9.41, 72-hour GCS score: 8.62±3.34 vs. 7.89±2.74, 72-hour BIS: 60.87±24.79 vs. 56.68±33.43, all P < 0.05]. APACHE II score was significantly lower only at the 72nd hour of sedation as compared with before sedation in the EGDS group, and no significant difference was found as compared with the STD group (17.10±7.05 vs. 18.90±3.32, P > 0.05). Oxygenation index (PaO 2 /FiO 2 ) was significantly increased only at the 24th hour of sedation in the EGDS group as compared with the STD group (mmHg: 261.05±118.45 vs. 226.45±96.54, P < 0.05). (3) The duration of mechanical ventilation was significantly shorter in the EGDS group than that in the STD group (hours: 20.56±9.03 vs. 27.75±11.23, P < 0.05), and the total administered dose of sufentanil was significantly lower in the EGDS group than that in the STD group (μg: 79.16±26.76 vs. 102.46±35.48, P < 0.05). (4) Compared with the STD group, the incidence of bradycardia in the EGDS group was increased significantly [10.71% (6/56) vs. 6.12% (3/49), P < 0.05], while the incidence of tachycardia was decreased significantly [14.29% (8/56) vs. 38.78% (19/49), P < 0.05], but no significant difference was found in the incidence of hypotension [5.36% (3/56) vs. 4.08% (2/49), P > 0.05]. The incidence of unexpected extubation in the STD group was 4.08% (2/49), which did not occurre in the EGDS group.
CONCLUSIONS


EGDS can improve the GCS score and BIS value of patients with acute brain injury, suggesting that the EGDS is safe and feasible, which can help improve neurological function in patients with acute brain injury.",2020,"Besides HR, significant improvement was found in the APACHE II and GCS scores in the STD group at 72 hours of sedation as compared with before sedation, and no significant difference was found in other indicators.","['acute brain injury', '105 patients were enrolled in the study, including 56 patients in the EGDS group and 49 in the STD group', 'patients with acute brain injury', ""110 patients with acute brain injury who were admitted to intensive care unit (ICU) of the Third Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to March 2019"", '110 patients, patients who received the second surgery due to cerebral hemorrhage, had worsening of cerebral hernia, withdrew during the course of the study, or whose family members abandoned treatment were excluded from the study']","['mannitol, hemostasis or antiplatelet therapy', 'sufentanil', 'EGDS', 'early goal directed sedation (EGDS', 'EGDS group and standard sedation group (STD', 'propofol', 'dexmedetomidine']","['incidence of tachycardia', 'mean artery pressure (MAP', 'GCS score, BIS value', 'Vital signs, acute physiology and chronic health evaluation II (APACHE II) score, Glasgow coma scale (GCS) score, BIS value, artery blood gas analysis, duration of mechanical ventilation, analgesic dosage and adverse events', 'neurological function', 'heart rate (HR', 'Richmond agitation-sedation score (RASS) and electroencephalogram bispectral index (BIS', 'APACHE II and GCS scores', 'APACHE II score', 'Oxygenation index (PaO 2 /FiO 2 ', 'duration of mechanical ventilation', 'incidence of bradycardia', 'gender, age, types of brain injury, baseline APACHE II or GCS score or rate of mechanical ventilation', 'incidence of hypotension', 'GCS score and BIS value', 'arterial partial pressure of carbon dioxide (PaCO 2 ', 'incidence of unexpected extubation']","[{'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0014065', 'cui_str': 'Congenital cerebral hernia'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1272694', 'cui_str': 'Abandoned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]",110.0,0.0369951,"Besides HR, significant improvement was found in the APACHE II and GCS scores in the STD group at 72 hours of sedation as compared with before sedation, and no significant difference was found in other indicators.","[{'ForeName': 'Guirong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Gengsheng', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': ""Department of Neurosurgery, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': ""Ya'nan"", 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Department of Geriatrics, the Third Medical Center of the Chinese People's Liberation Army General Hospital, Beijing 100039, China. Corresponding author: Yang Changchun, Email: yangchangchun99@sina.com.""}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200106-00092']
259,32386039,Short term efficacy of EX-PRESS filtration shunt implantation for open angle glaucoma.,"OBJECTIVES


To observe the short-term efficacy of EX-PRESS filtration shunt implantation in the treatment of open angle glaucoma, and to analyze the safety and effectiveness of the surgical method.
METHODS


From April 2017 to January 2018, a total of 28 eyes of 17 open angle glaucoma patients in Xiangya Hospital of Central South University were screened. Among them, 16 eyes in the experimental group were treated with EX-PRESS filtration shunt (P200)implantation, and 12 eyes in the control group underwent trabeculectomy. Related examinations were performed in 1 day before operation, 1 day after operation, 1 week after operation, 1 month after operation and 3 months after operation, which included intraocular pressure (IOP), uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA), central anterior chamber depth (ACD), trabecular iris angle (TIA), the long axis of drainage nail and corneal endothelium angle (ACA), intraoperative and postoperative complications. Visual-related quality of life questionnaire was conducted and scored in 3 months after operation.
RESULTS


In the experimental group, the IOP in 1 day after operation, 1 week after operation and 1 month after operation was decreased significantly compared with that in 1 day before operation (all  P <0.05), but the IOP in 3 months after operation was not significantly decreased compared with that in 1 day before operation ( P >0.05). In the control group, the IOP in 1 week after operation, 1 month and 3 months after operation was decreased significantly with that of pre-operation (all  P <0.05), but the IOP in 1 day after operation was not significantly decreased compared with that in 1 day before operation ( P >0.05).The BCVA between the 2 groups was significantly different in 1 week after operation, 1 month and 3 months after operation compared with that in 1 day before operation ( P >0.05). The ACD in 1 day after operation, 1 week after operation, 1 month after operation and 3 months after operation was not significantly different compared with that in 1 day before operation (all  P >0.05). However, the ACD in 1 week after operation and 1 month after operation was significantly different in the control group compared with that in 1 day before operation (both  P <0.05). There was no significant change in the TIA in the 2 group compared with that in 1 day before operation (all  P >0.05). At different observed time after operation, there was no significant difference in the ACA (all  P >0.05). The correlation analysis of Pearson showed that there was a weak correlation between the ACA and the IOP ( r =0.286,  P <0.05). According to the standard of surgical success defined in this study, the success rate of experimental group was 81.25%, and the control group was 83.33%. There was no significant difference in the visual-related quality of life score between the experimental group and the control group ( P >0.05), but the mean value in the former was higher.
CONCLUSIONS


As a new type of anti-glaucoma surgery, the success rate of EX-PRESS filtration shunt implantation for 3-month follow-up is equivalent to that of classic trabeculectomy. The operation process is simple, and there is no significant change in the ACD before and after the operation in the period of 3-month follow-up. The stability of the anterior chamber is better. There is no significant correlation between the relative position of the shunt in the anterior chamber and the IOP. Compared with trabeculectomy, there is no significant difference in the visual-related quality of life.",2020,"At different observed time after operation, there was no significant difference in the ACA (all  P >0.05).","['From April 2017 to January 2018, a total of 28 eyes of 17 open angle glaucoma patients in Xiangya Hospital of Central South University were screened', 'open angle glaucoma']","['EX-PRESS filtration shunt implantation', 'trabeculectomy', 'EX-PRESS filtration shunt (P200)implantation']","['safety and effectiveness', 'intraocular pressure (IOP), uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA), central anterior chamber depth (ACD), trabecular iris angle (TIA), the long axis of drainage nail and corneal endothelium angle (ACA), intraoperative and postoperative complications', 'Visual-related quality of life questionnaire', 'visual-related quality of life', 'IOP', 'TIA', 'success rate', 'visual-related quality of life score']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0014259', 'cui_str': 'Structure of corneal endothelium'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0156499,"At different observed time after operation, there was no significant difference in the ACA (all  P >0.05).","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha 410008, China 381955476@qq.com.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha 410008, China tanqianxy99@163.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Weitao', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Yuheng', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Ophthalmology, Xiangya Hospital, Central South University, Changsha 410008, China.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.180461']
260,32386040,Therapeutic effect of myofascial trigger point electroacupuncture technology on the treatment of overactive bladder syndrome in female.,"OBJECTIVES


To explore the therapeutic effect of myofascial trigger point electroacupuncture technology on treating female overactive bladder syndrome.
METHODS


Forty female patients with overactive bladder were randomly divided into 2 groups: an experimental group and a control group. The experimental group was treated with myofascial trigger point electroacupuncture therapy combined with solifenacin succinate while the control group was only treated with solifenacin succinate. Patients in both groups were treated for 12 weeks. The overactive bladder symptom score (OABSS), urinary urgency score and urination frequency of 24 h in the 2 groups were compared to analyze the therapeutic effect.
RESULTS


Before the comprehensive treatment, there was no significant difference between the experimental group and the control group ( P >0.05). After 2 and 12 weeks of continuous treatment, the OABSS, urinary urgency symptoms score and 24 h urination frequency in the experimental group and the control group were lower than those before the treatment, and the degree of decline in the experimental group was more obvious, with significant difference ( P <0.05).
CONCLUSIONS


Treating overactive bladder syndrome in women with myofascial trigger point electroacupuncture combined with solifenacin succinate can significantly improve the OABSS and improve the life quality of the patients.",2020,"After 2 and 12 weeks of continuous treatment, the OABSS, urinary urgency symptoms score and 24 h urination frequency in the experimental group and the control group were lower than those before the treatment, and the degree of decline in the experimental group was more obvious, with significant difference ( P <0.05).
","['Forty female patients with overactive bladder', 'women with myofascial trigger point', 'overactive bladder syndrome in female']","['myofascial trigger point electroacupuncture technology', 'myofascial trigger point electroacupuncture therapy combined with solifenacin succinate', 'electroacupuncture', 'solifenacin succinate']","['life quality', 'OABSS, urinary urgency symptoms score and 24 h urination frequency', 'OABSS', 'overactive bladder symptom score (OABSS), urinary urgency score and urination frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1509436', 'cui_str': 'Solifenacin succinate'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}]",40.0,0.0130924,"After 2 and 12 weeks of continuous treatment, the OABSS, urinary urgency symptoms score and 24 h urination frequency in the experimental group and the control group were lower than those before the treatment, and the degree of decline in the experimental group was more obvious, with significant difference ( P <0.05).
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China 547732876@qq.com.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Ruting', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Shaodan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Department of Health Management, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Qianyu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China.'}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Third Xiangya Hospital, Central South University, Changsha 410013, China lixh0901@csu.edu.cn.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.180790']
261,32390248,An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine.,"WHAT IS KNOWN AND OBJECTIVE


Tolperisone is a centrally acting muscle relaxant under development in the United States as a treatment for acute and painful symptoms of muscle spasms. The objective of this three-way, randomized, blinded, three-period crossover study was to assess the safety and cognitive effects of tolperisone compared to placebo and the widely used muscle relaxant cyclobenzaprine in healthy volunteers.
METHODS


Subjects were randomized to 1 of 3 treatment arms to receive tolperisone (150 mg), cyclobenzaprine (10 mg) or placebo 3 times per day (TID) in 3 separate study periods. Subjects completed a driving test on the Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim), a validated driving simulator, on day 1 at time to maximum plasma concentration, on day 2 before the morning dose of study drug and on day 3 at steady state following the morning dose. Subjects were assessed on various driving parameters and on a computer-administered digit-symbol substitution test (CogScreen symbol digit coding test). The driving scenario is a monotonous 100 km highway route on which subjects are instructed to maintain speed and lane position.
RESULTS AND DISCUSSION


The performance of subjects who had received tolperisone was not significantly different from those who had received placebo in terms of the primary end point: standard deviation of lateral position, a measure of weaving. Subjects who had received tolperisone also performed comparably to those who had received placebo on a range of secondary measures assessing driving ability, cognition and psychomotor performance. In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability. Despite their markedly poorer driving performance after receiving cyclobenzaprine, few subjects reported feeling unsafe to drive on day 1 (10.3%) and day 2 (3.4%). The incidence of adverse events was similar for tolperisone (36.4%) and placebo (29.0%) and was greater for cyclobenzaprine (45.4%).
WHAT IS NEW AND CONCLUSION


Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID).",2020,"In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability.","['Subjects who had received tolperisone also performed comparably to those who had received', 'healthy volunteers', 'Subjects']","['cyclobenzaprine', 'muscle relaxant cyclobenzaprine', 'relaxant cyclobenzaprine', 'tolperisone', 'placebo and cyclobenzaprine', 'placebo']","['safety and cognitive effects', 'driving ability and cognitive effects', 'driving ability, cognition and psychomotor performance', 'incidence of adverse events', 'standard deviation of lateral position, a measure of weaving']","[{'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0056732', 'cui_str': 'cyclobenzaprine'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0895344,"In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability.","[{'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Caron', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Kaye', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wessel', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Halseth', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Drug Development, Cognitive Research Corporation, St. Petersburg, FL, USA.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13165']
262,32390309,"A retrospective assessment and comparison of the effectiveness of benzoyl peroxide, the combination of topical niacinamide, gallic acid and lauric acid and the combination of benzoyl peroxide and erythromycin in acne vulgaris.","Acne vulgaris is a chronic inflammatory skin disease that mostly develops during adolescence and continues throughout adulthood. It affects the face, the main location of cosmetic appearance. Despite many developments in acne treatment, various combination therapies are needed to create the best option. Ninety patients were included in this study. We used the global acne grading system (GAGS) and the lesion counting and photographic standards that were used by Hayashi et al., to assess acne severity. The patients were randomly divided into 3 groups as Group 1 (using only 5% BPO, twice a day), Group 2 (using only the combination of 5% BPO + 3% erythromycin, twice a day) and Group 3 (using only the combination of 4% niacinamide +1% gallic acid +1% lauric acid, twice a day). 30 patients were included in each group. The scores were evaluated at weeks 0, 2, 4 and 8, and compared with each other. As a result of the study, all three treatment types were found to be effective. The combination of 4% niacinamide +1% gallic acid +1% lauric acid can be used as an alternative topical treatment for acne vulgaris to prevent resistance against topical antibiotics and the side effects of some other treatments. This article is protected by copyright. All rights reserved.",2020,"As a result of the study, all three treatment types were found to be effective.","['30 patients were included in each group', 'Ninety patients were included in this study', 'acne vulgaris']","['benzoyl peroxide', 'BPO\u2009+\u20093% erythromycin, twice a day) and Group 3 (using only the combination of 4% niacinamide +1% gallic acid +1% lauric acid', 'niacinamide +1% gallic acid +1% lauric acid', 'topical niacinamide, gallic acid and lauric acid and the combination of benzoyl peroxide and erythromycin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]",[],90.0,0.0201762,"As a result of the study, all three treatment types were found to be effective.","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kozan', 'Affiliation': 'Amasya University Sabuncuoglu Serefeddin Training and Research Hospital - Dermatology, Amasya, Turkey.'}, {'ForeName': 'Rukiye', 'Initials': 'R', 'LastName': 'Yasak Guner', 'Affiliation': 'Dermatology Department, Cumhuriyet University School of Medicine, Sivas, Turkey.'}, {'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Dermatology Department, Cumhuriyet University School of Medicine, Sivas, Turkey.'}]",Dermatologic therapy,['10.1111/dth.13534']
263,32390339,The effect of a self-management program on renal function control in patients with hemodialysis in Taiwan: A longitudinal randomized controlled trial.,"AIM


This study was designed to investigate the longitudinal effect of participating in a self-management program (SMP) on renal function control in patients receiving hemodialysis.
METHODS


This randomized controlled trial enrolled a total of 58 patients at the hemodialysis center of a teaching hospital in Taiwan. The control group (n = 30) received the usual care and the experimental group (n = 28) received a 4-week SMP intervention. The results of the follow-up on the longitudinal data at 3, 6, and 9 months showed that the renal function indices, potassium and phosphorus levels, and interdialytic weight gain were significantly better than at the pre-test for the experimental group.
RESULTS


In terms of the interaction between group and time, the potassium level dropped significantly below the pre-test value only after 3 months (B = -0.31, SE = 0.15, p = .044), suggesting that the post-test potassium level had significantly decreased after 3 months. In terms of the interaction between group and time, the phosphorus level dropped significantly below the pre-test value only after 6 months (B = -0.53, SE = 0.28, p = .050), suggesting that the post-test phosphorus level significantly decreased after 6 months. Finally, the intervention could effectively control the weight change between dialysis sessions for up to 9 months (B = -1.34, SE = 0.30, p < .001).
CONCLUSIONS


The SMP intervention decreased potassium and phosphorus levels and helped control interdialytic weight gain in patients undergoing hemodialysis.",2020,"In terms of the interaction between group and time, the phosphorus level dropped significantly below the pre-test value only after 6 months (B = -0.53, SE = 0.28, p = .050), suggesting that the post-test phosphorus level significantly decreased after 6 months.","['patients receiving hemodialysis', 'patients undergoing hemodialysis', 'patients with hemodialysis in Taiwan', '58 patients at the hemodialysis center of a teaching hospital in Taiwan']","['SMP intervention', 'self-management program', '4-week SMP intervention', 'self-management program (SMP']","['phosphorus level', 'renal function control', 'potassium and phosphorus levels', 'potassium level', 'renal function indices, potassium and phosphorus levels, and interdialytic weight gain', 'control interdialytic weight gain', 'post-test phosphorus level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",58.0,0.0151549,"In terms of the interaction between group and time, the phosphorus level dropped significantly below the pre-test value only after 6 months (B = -0.53, SE = 0.28, p = .050), suggesting that the post-test phosphorus level significantly decreased after 6 months.","[{'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Shu-Fang V', 'Initials': 'SV', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Cheng', 'Initials': 'KC', 'LastName': 'Lu', 'Affiliation': 'Division of Nephrology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan.'}, {'ForeName': 'Chief-Yu', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Speech Language Pathology and Audiology, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Wen-I', 'Initials': 'WI', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Ju-Han', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'Department of Gerontological Health Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12345']
264,32390389,Ghrelin Levels and Hunger Sensation after Laparoscopic Sleeve Gastrectomy Compared with Laparoscopic Greater Curvature Plication in Obese Patients.,"BACKGROUND


The aims of our study were to compare serum acylated ghrelin (the active form of ghrelin) concentrations before and after the surgery of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic greater curvature plication (LGCP) and to correlate these levels with excess weight loss and hunger sensations on a short-term basis.
METHODS


The patients included in the study had either (1) a body mass index (BMI) over 35 kg/m2 and one comorbidity or (2) a BMI over 40 kg/m2. Ghrelin levels were measured on the day of the surgery, 1 month after the procedure, and 3 months after the procedure. A questionnaire about hunger sensation was administered to the patients, and changes in the patients' weights were evaluated on the same timeline as the measurement of the ghrelin levels.
RESULTS


Eighteen obese patients were included in the study, including 10 patients in the LSG group and 8 patients in the LGCP group. All the procedures were performed laparoscopically. The average level of preoperative ghrelin in the LSG group was 212.21 pg/mL ± 140.57 SD. After 1 month, the average ghrelin level in the LSG group was 74.47 pg/mL ± 29.55 SD (p = 0.01), and it was 41.47 pg/mL ± 15.19 SD (p = 0.002) after 3 months. The average level of preoperative ghrelin in the LGCP group was 318.08 pg/mL ± 161.70 SD. It decreased to 190.58 pg/mL ± 116.75 SD (p = 0.01) after 1 month and to 91.57 pg/mL ± 56.70 SD (p = 0.004) after 3 months. Comparing the two groups, hunger sensation had decreased more in the LSG group (p = 0.03) 3 months after the surgery.
CONCLUSIONS


Laparoscopic sleeve gastrectomy (LSG) and laparoscopic greater curvature plication (LGCP) produced the same weight loss and diminished hunger sensation in the short term on the selected patients. LSG had an increased effect on ghrelin levels when compared with LGCP at 1 month after the procedure and 3 months after the procedure.",2020,"Comparing the two groups, hunger sensation had decreased more in the LSG group (p = 0.03) 3 months after the surgery.
","['patients undergoing', 'Obese Patients', 'patients included in the study had either (1) a body mass index (BMI) over 35 kg/m2 and one comorbidity or (2', 'Eighteen obese patients were included in the study, including 10 patients in the LSG group and 8 patients in the LGCP group']","['LGCP', 'laparoscopic sleeve gastrectomy (LSG) or laparoscopic greater curvature plication (LGCP', 'Laparoscopic Sleeve Gastrectomy', 'Laparoscopic sleeve gastrectomy (LSG) and laparoscopic greater curvature plication (LGCP', 'Laparoscopic Greater Curvature Plication', 'LSG']","['hunger sensation', 'ghrelin levels', 'average level of preoperative ghrelin', 'average ghrelin level', 'Ghrelin levels', 'Ghrelin Levels and Hunger Sensation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0227223', 'cui_str': 'Structure of greater curvature of stomach'}, {'cui': 'C0185026', 'cui_str': 'Plication'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0227223', 'cui_str': 'Structure of greater curvature of stomach'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",18.0,0.0437715,"Comparing the two groups, hunger sensation had decreased more in the LSG group (p = 0.03) 3 months after the surgery.
","[{'ForeName': 'Amadeus', 'Initials': 'A', 'LastName': 'Dobrescu', 'Affiliation': ''}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Copaescu', 'Affiliation': ''}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Zmeu', 'Affiliation': ''}, {'ForeName': 'Ciprian', 'Initials': 'C', 'LastName': 'Duta', 'Affiliation': ''}, {'ForeName': 'Ovidiu H', 'Initials': 'OH', 'LastName': 'Bedreag', 'Affiliation': ''}, {'ForeName': 'Laurian', 'Initials': 'L', 'LastName': 'Stoica', 'Affiliation': ''}, {'ForeName': 'Cristi', 'Initials': 'C', 'LastName': 'Tarta', 'Affiliation': ''}, {'ForeName': 'Alexandru F', 'Initials': 'AF', 'LastName': 'Rogobete', 'Affiliation': ''}, {'ForeName': 'Fulger', 'Initials': 'F', 'LastName': 'Lazar', 'Affiliation': ''}]",Clinical laboratory,['10.7754/Clin.Lab.2019.191012']
265,32393614,Can a teacher-led mindfulness intervention for new school entrants improve child outcomes? Protocol for a school cluster randomised controlled trial.,"INTRODUCTION


The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes.
METHODS AND ANALYSIS


This cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months post-randomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted.
ETHICS AND DISSEMINATION


Ethics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peer-review publications, national and international conference presentations and research snapshots directly provided to participating schools and families.
PRE-RESULTS TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12619000326190).",2020,"The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes.","[""826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up"", '22 primary schools in disadvantaged areas of Melbourne, Australia']","['mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions']","['child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",826.0,0.172604,"The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes.","[{'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Quach', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia jon.quach@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Deery', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Clinton', 'Affiliation': 'Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gold', 'Affiliation': 'Deakin Health Economics, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'Centre for Community Child Health, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036523']
266,32393616,Correction: Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,,2020,,['insomnia with short sleep duration'],['Correction: Acupuncture'],[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.208285,,[],BMJ open,['10.1136/bmjopen-2019-033731corr1']
267,32084218,Catecholaminergic modulation of the cost of cognitive control in healthy older adults.,"Catecholamines have long been associated with cognitive control and value-based decision-making. More recently, we have shown that catecholamines also modulate value-based decision-making about whether or not to engage in cognitive control. Yet it is unclear whether catecholamines influence these decisions by altering the subjective value of control. Thus, we tested whether tyrosine, a catecholamine precursor altered the subjective value of performing a demanding working memory task among healthy older adults (60-75 years). Contrary to our prediction, tyrosine administration did not significantly increase the subjective value of conducting an N-back task for reward, as a main effect. Instead, in line with our previous study, exploratory analyses indicated that drug effects varied as a function of participants' trait impulsivity scores. Specifically, tyrosine increased the subjective value of conducting an N-back task in low impulsive participants, while reducing its value in more impulsive participants. One implication of these findings is that the over-the-counter tyrosine supplements may be accompanied by an undermining effect on the motivation to perform demanding cognitive tasks, at least in certain older adults. Taken together, these findings indicate that catecholamines can alter cognitive control by modulating motivation (rather than just the ability) to exert cognitive control.",2020,"Contrary to our prediction, tyrosine administration did not significantly increase the subjective value of conducting an N-back task for reward, as a main effect.","['healthy older adults (60-75 years', 'healthy older adults']","['catecholamines', 'Catecholamines']","['subjective value of conducting an N-back task for reward', 'trait impulsivity scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0143666,"Contrary to our prediction, tyrosine administration did not significantly increase the subjective value of conducting an N-back task for reward, as a main effect.","[{'ForeName': 'Monja I', 'Initials': 'MI', 'LastName': 'Froböse', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Westbrook', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Bloemendaal', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Aarts', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0229294']
268,31324520,"rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) in real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres.","BACKGROUND


This is a Phase IV, national, multicentre, retrospective study to observe the real-world use of rhBMP-2 in France.
HYPOTHESIS


There was no statistical hypothesis, the statistical analyses were descriptive in nature.
PATIENTS AND METHODS


Data was collected from patient medical files in 10 French spinal centres. Primary objectives were to understand which patients were treated with rhBMP-2, commercialised in Europe as InductOs™ and how rhBMP-2 was used during spinal fusion surgery in France between 2011 and 2012.
RESULTS


Four hundred patients (634 levels) treated with rhBMP-2 were included in the analysis. The most frequent primary diagnostic indication for rhBMP-2 use was degenerative disc disease (DDD; 129/400; 32.3% of patients) followed by spondylolisthesis (119/400; 29.8%), deformity (59/400; 14.8%) and pseudoarthrosis (29/400; 7.3%). The most frequently treated level was L4-L5 (33.8% of levels in 53.5% of patients); followed by L5-S1 (29.8%, 47.3%), L3-L4 (16.7%, 26.5%), and L2-L3 (7.3%, 11.5%), all other levels (less than 5% of patients). No interbody fusion device was used in 42.7% of levels. Wetted matrix of rhBMP-2 was placed in the interbody space in 58.4% of levels (370/634). The most common procedure for rhBMP-2 treatment was posterior lumbar fusion (PLF) (221/634; 34.9% of levels), followed by anterior lumbar interbody fusion (ALIF) (188/634; 29.7%), posterior lumbar interbody fusion (PLIF) (111/634; 17.5%), lateral lumbar interbody fusion (LLIF) (106/634; 16.7%), transforaminal lumbar interbody fusion (TLIF) (4/634; 0.6%) and 'other' (4/634; 0.6%). Thirty-one adverse events of Interest (AEI) were recorded in 27 patients. One AEI was considered related to rhBMP-2. Unplanned secondary spine interventions at index level treated with rhBMP-2 were required in 4 patients.
DISCUSSION


In years 2011 and 2012 when the surgeries captured in this retrospective study were done, rhBMP-2 was indicated for single level (L4-S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with DDD. The most common procedure for the treatment with rhBMP-2 was PLF (off-label use), followed by ALIF (on-label use). The safety findings confirm a predictable and manageable safety profile.
LEVEL OF EVIDENCE


IV.",2019,Wetted matrix of rhBMP-2 was placed in the interbody space in 58.4% of levels (370/634).,"['patient medical files in French spinal centres', 'Four hundred patients (634 levels) treated with rhBMP-2 were included in the analysis', 'Data was collected from patient medical files in 10 French spinal centres']","['L4-L5', 'rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2', 'rhBMP-2, commercialised in Europe as InductOs™ and how rhBMP-2']","['posterior lumbar fusion (PLF', 'lateral lumbar interbody fusion (LLIF', 'posterior lumbar interbody fusion (PLIF', 'L3-L4', 'adverse events of Interest (AEI', 'transforaminal lumbar interbody fusion (TLIF', 'L2-L3']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1445578', 'cui_str': 'dibotermin alfa'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1445578', 'cui_str': 'dibotermin alfa'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",,0.0417833,Wetted matrix of rhBMP-2 was placed in the interbody space in 58.4% of levels (370/634).,"[{'ForeName': 'Ange François', 'Initials': 'AF', 'LastName': 'Vincentelli', 'Affiliation': 'Neurochirurgie, Générale de Santé - Hôpital Privé Clairval, Serarl Neuro Val Redon, 317, boulevard du Redon, Marseille 13009, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Szadkowski', 'Affiliation': 'Chirurgie Orthopedique et Traumatologie, Hôpital Privé Jean-Mermoz, Ramsay Générale de Santé, 24, avenue Paul-Santy, Lyon 69008, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vardon', 'Affiliation': 'Chirurgie Orthopedique et Traumatologie, Clinique Médipole Garonne, 45, rue de Gironis, CS 13624, Toulouse 311036, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Litrico', 'Affiliation': 'Neurochirurgie, CHU Nice - Hôpital Pasteur, BP 69, Nice 06002, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Fuentès', 'Affiliation': 'Neurochirurgie, Service de Neurochirurgie la Timone, PR Dufour, 264, rue Saint Pierre, 13385 Marseille, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Steib', 'Affiliation': ""Service de Chirurgie du rachis, Hôpitaux Universitaires de Strasbourg - Hautepierre, 2, avenue Molière, Strasbourg 67200, France; Hôpital Civil, Pavillon chirurgical B, 1, place de l'hôpital, BP 426, Strasbourg 67091200, France.""}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Le Huec', 'Affiliation': 'Polyclinique bordeaux nord aquitaine, lab deterca univ bordeaux, 15-35, rue Boucher, Bordeaux 33000, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Huppert', 'Affiliation': 'Ortho-rachis 2, CHU Pellegrin tripode, Bordeaux 33076, France; Neurochirurgie, Clinique Du Parc, 9bis, rue de la Piot, Saint-Priest en Jarez 42270, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Dubois', 'Affiliation': ""Neurochirurgie, Nouvelle Clinique de l'Union, boulevard de Ratalens-Saint-Jean, BP 36, Saint-Jean 31240, France.""}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Lenoir', 'Affiliation': 'Neurochirurgie, Clinique Ambroise-Paré, 25-27 boulevard Victor Hugo, Neuilly-sur-seine 92200, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Sailhan', 'Affiliation': 'Neurochirurgie, Hôpital Cochin, 27, rue du Faubourg Saint-Jacques, Paris 75014, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Passuti', 'Affiliation': 'Chirurgie Orthopedique et Traumatologie, CHU Nantes - Hôpital Saint-Jacques, 85, rue Saint-Jacques, Nantes Cedex 44093, France. Electronic address: norbert.passuti@chu-nantes.fr.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2019.04.023']
269,32330670,Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study.,"BACKGROUND


Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external facilitation to support local champions and their implementation teams in enacting changes. This paper describes the rationale for and design of a study that will evaluate whether TACTICS can increase implementation of PE for PTSD and improve patient outcomes in military BH clinics relative to provider training in PE alone.
METHODS


The study is a multi-site, cluster randomized, stepped-wedge trial, with the military treatment facility as the unit of analysis. Eight facilities undergo a provider-training phase, followed by 5 months of TACTICS implementation. The timing of TACTICS at each facility is randomly assigned to begin 9, 14, or 19 months after beginning the provider-training phase. Primary analyses will compare the proportion of PTSD patients receiving PE and patients' mean improvement in PTSD symptoms before and after the onset of TACTICS.
DISCUSSION


TACTICS endeavors to balance standardization of empirically-supported implementation strategies with the flexibility of application necessary for success across varied clinical settings. If successful, TACTICS may represent a systematic and scalable method of promoting and supporting EBP implementation.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03663452.",2020,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"['military BH clinics relative to provider training in PE alone', 'military behavioral health clinics']",[],['PTSD symptoms'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0549177,A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities.,"[{'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Rosen', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: craig.rosen@va.gov.'}, {'ForeName': 'C Adrian', 'Initials': 'CA', 'LastName': 'Davis', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: carrie.davis6@va.gov.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Riggs', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: driggs@deploymentpsych.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Center for Deployment Psychology, Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, United States of America. Electronic address: jcook@deploymentpsych.org.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America; Department of Psychology, University of Texas at San Antonio, One UTSA Circle, San Antonio, TX 78249, United States of America. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Katherine Anne', 'Initials': 'KA', 'LastName': 'Comtois', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, United States of America. Electronic address: kcomtois@uw.edu.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Haddock', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: keithhaddock@hopehri.com.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'University of Texas at Austin, Steve Hicks School of Social Work, 1925 San Jacinto Blvd, Austin, TX 78712, United States of America. Electronic address: Elisa.Borah@austin.utexas.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Finley', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Department of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States of America; Veterans Evidence-based Research Dissemination and Implementation Center (VERDICT), South Texas Veterans Health Care System, 7400 Merton Minter Blvd, San Antonio, TX 78229, United States of America. Electronic address: finleye@uthscsa.edu.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Jahnke', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: sara@hopehri.com.'}, {'ForeName': 'Walker S C', 'Initials': 'WSC', 'LastName': 'Poston', 'Affiliation': 'Social Sciences Innovations Corporation, 71 W 23rd St 4th Floor, New York, NY 10010, United States of America. Electronic address: carlosposton@hopehri.com.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wiltsey-Stirman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: sws1@stanford.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neitzer', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America. Electronic address: andrea.neitzer@va.gov.'}, {'ForeName': 'Capt Rachel', 'Initials': 'CR', 'LastName': 'Broussard', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: rachel.a.broussard2.mil@mail.mil.'}, {'ForeName': 'Maj Amy', 'Initials': 'MA', 'LastName': 'Brzuchalski', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: amy.e.brzuchalski.mil@mail.mil.'}, {'ForeName': 'Maj Spencer P', 'Initials': 'MSP', 'LastName': 'Clayton', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: spencer.p.clayton.mil@mail.mil.'}, {'ForeName': 'Lt Allison M', 'Initials': 'LAM', 'LastName': 'Conforte', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: allison.m.conforte.mil@mail.mil.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Flores', 'Affiliation': 'William Beaumont Army Medical Center, Ft. Bliss, 5005 N Piedras St, El Paso, TX 79920, United States of America. Electronic address: araceli.flores8.civ@mail.mil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hein', 'Affiliation': 'Blanchfield Army Community Hospital, Ft. Campbell, 650 Joel Dr, Fort Campbell, KY 42223, United States of America. Electronic address: jessica.l.hein.civ@mail.mil.'}, {'ForeName': 'Capt Felicia', 'Initials': 'CF', 'LastName': 'Keith', 'Affiliation': 'David Grant United States Air Force Medical Center, Travis Air Force Base, 101 Bodin Cir, Fairfield, CA, 94533, United States of America. Electronic address: felicia.a.keith.mil@mail.mil.'}, {'ForeName': 'Capt Jeremy', 'Initials': 'CJ', 'LastName': 'Jinkerson', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: jeremy.d.jinkerson.mil@mail.mil.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Letendre', 'Affiliation': 'Bassett Army Community Hospital, Ft. Wainwright, 4076 Neely Rd, Fairbanks, AK 99703, United States of America. Electronic address: margaret.a.letendre.civ@mail.mil.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Nofziger', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: debra.l.nofziger.ctr@mail.mil.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Pollick', 'Affiliation': 'Naval Hospital Jacksonville, Naval Air Station Jacksonville, 2080 Child St, Jacksonville, FL 32214, United States of America. Electronic address: kirsten.m.pollick2.civ@mail.mil.'}, {'ForeName': 'Capt Kyra', 'Initials': 'CK', 'LastName': 'Santiago', 'Affiliation': '49th Medical Group, Holloman Air Force Base, 280 1st St, Alamogordo, NM 88330, United States of America. Electronic address: kyra.t.santiago.mil@mail.mil.'}, {'ForeName': 'Lt Col John', 'Initials': 'LCJ', 'LastName': 'Waggoner', 'Affiliation': '81st Medical Group, Keesler Air Force Base, 500 Fisher St, Biloxi, MS 39534, United States of America. Electronic address: john.w.waggoner6.mil@mail.mil.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Ft. Sam Houston, 3551 Roger Brooke Dr, San Antonio, TX, 78234, United States of America. Electronic address: craig.a.woodworth.civ@mail.mil.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, 795 Willow Rd, Menlo Park, CA, United States of America; Department of Psychiatry and Behavioral Sciences, Stanford University, 401 Quarry Rd, Palo Alto, CA 94305, United States of America. Electronic address: carmen.mclean4@va.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106008']
270,32391627,Cost-effectiveness of multi-layered silicone foam dressings for prevention of sacral and heel pressure ulcers in high-risk intensive care unit patients: An economic analysis of a randomised controlled trial.,"Pressure ulcer incidence is high in intensive care units. This causes a serious financial burden to healthcare systems. We evaluated the cost-effectiveness of multi-layered silicone foam dressings for prevention of sacral and heel pressure ulcers in addition to standard prevention in high-risk intensive care units patients. A randomised controlled trial to assess the efficacy of multi-layered silicone foam dressings to prevent the development of pressure ulcers on heels and sacrum among 422 intensive care unit patients was conducted. Direct costs for preventive dressings in the intervention group and costs for treatment of incident pressure ulcers in both groups were measured using a bottom-up approach. A cost-effectiveness analysis by calculating the incremental cost-effectiveness ratio using different assumptions was performed. Additional dressing and labour costs of €150.81 (€116.45 heels; €34.36 sacrum) per patient occurred in the intervention group. Treatment costs were €569.49 in the control group and €134.88 in the intervention group. The incremental cost-effectiveness ratio was €1945.30 per PU avoided (€8144.72 on heels; €701.54 sacrum) in the intervention group. We conclude that application of preventive dressings is cost-effective for the sacral area, but only marginal on heels for critically ill patients.",2020,A randomised controlled trial to assess the efficacy of multi-layered silicone foam dressings to prevent the development of pressure ulcers on heels and sacrum among 422 intensive care unit patients was conducted.,"['critically ill patients', 'high-risk intensive care unit patients', 'high-risk intensive care units patients', '422 intensive care unit patients']",['multi-layered silicone foam dressings'],"['Additional dressing and labour costs', 'sacral and heel pressure ulcers', 'incident pressure ulcers', 'incremental cost-effectiveness ratio', 'Treatment costs', 'Pressure ulcer incidence']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}]","[{'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0558158', 'cui_str': 'Pressure ulcer of heel'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0795923,A randomised controlled trial to assess the efficacy of multi-layered silicone foam dressings to prevent the development of pressure ulcers on heels and sacrum among 422 intensive care unit patients was conducted.,"[{'ForeName': 'Monira', 'Initials': 'M', 'LastName': 'El Genedy', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hahnel', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Tsenka', 'Initials': 'T', 'LastName': 'Tomova-Simitchieva', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Padula', 'Affiliation': 'Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hauß', 'Affiliation': 'Nursing Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Löber', 'Affiliation': 'Department of Clinical Quality and Risk Management, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Blume-Peytavi', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kottner', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",International wound journal,['10.1111/iwj.13390']
271,32391656,Long-term outcomes after perioperative treatment with omega-3 fatty acid supplements in colorectal cancer.,"BACKGROUND


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


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


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


Perioperative supplementation with n-3 FA did not confer a survival benefit in patients undergoing colorectal cancer surgery. n-3 FA did not benefit the subgroup of patients treated with adjuvant chemotherapy or decrease the risk of disease recurrence.",2020,"The risk of disease recurrence at 3 years was similar (relative risk 1·66, 95 per cent c.i.","['Patients scheduled for elective resection of colorectal cancer between 2007 and 2010', '148 patients enrolled in the study, 125 (65 patients receiving', 'colorectal cancer', 'patients undergoing colorectal cancer surgery']","['adjuvant chemotherapy', 'omega-3 fatty acids (n-3 FA', 'n-3 FA', 'n-3 FA-enriched ONS and 60 receiving standard ONS', 'omega-3 fatty acid supplements', 'n-3 FA-enriched oral nutrition supplement (ONS) twice daily or a standard ONS (control', 'n-3 FA and adjuvant chemotherapy']","['5-year survival rate', 'survival benefit', 'postoperative complications, 3-year cumulative incidence of local or metastatic colorectal cancer recurrence and 5-year overall survival', 'postoperative complications', 'risk of disease recurrence', 'perioperative outcomes and survival', 'higher mortality']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",148.0,0.24371,"The risk of disease recurrence at 3 years was similar (relative risk 1·66, 95 per cent c.i.","[{'ForeName': 'L Schmidt', 'Initials': 'LS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Gastrointestinal Surgery, Aalborg, Denmark.'}, {'ForeName': 'S Ladefoged', 'Initials': 'SL', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Gastrointestinal Surgery, Aalborg, Denmark.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'M Nytoft', 'Initials': 'MN', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Oncology, Aalborg, Denmark.'}, {'ForeName': 'E Berg', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg, Denmark.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Thorlacius-Ussing', 'Affiliation': 'Department of Gastrointestinal Surgery, Aalborg, Denmark.'}]",BJS open,['10.1002/bjs5.50295']
272,32391667,[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].,"OBJECTIVE


To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19).
METHODS


We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1：1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of SARS-CoV-2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online (NCT04261517).
RESULTS


One patient in HCQ group developed to severe during the treatment. On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group ( P >0.05). The median duration from hospitalization to virus nucleic acid negative conservation was 4 (1,9) days in HCQ group, which is comparable to that in the control group [2 (1,4) days, Z=1.27,  P >0.05]. The median time for body temperature normalization in HCQ group was 1 (0,2) day after hospitalization, which was also comparable to that in the control group [1 (0,3) day]. Radiological progression was shown on CT images in 5 cases (33.3%) of the HCQ group and 7 cases (46.7%) of the control group, and all patients showed improvement in follow-up examinations. Four cases (26.7%) of the HCQ group and 3 cases (20%) of the control group had transient diarrhea and abnormal liver function ( P >0.05).
CONCLUSIONS


The prognosis of COVID-19 moderate patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.",2020,"On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group ( P >0.05).","['patients with moderate COVID-19', 'patients with moderate coronavirus disease 2019 (COVID-19', 'enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center']","['HCQ', 'hydroxychloroquine (HCQ', 'hydroxychloroquine']","['Radiological progression', 'transient diarrhea and abnormal liver function', 'efficacy and safety', 'median duration from hospitalization to virus nucleic acid negative conservation', 'negative conversion rate of SARS-CoV-2 nucleic acid', 'median time for body temperature normalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",30.0,0.0309209,"On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group ( P >0.05).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Qingnian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}]",Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences,[]
273,32391695,Ultrafast Excitation Transfer in Cy5 DNA Photonic Wires Displays Dye Conjugation and Excitation Energy Dependency.,"DNA scaffolds enable base-pair-specific positioning of fluorescent molecules, allowing for nanometer-scale precision in controlling multidye interactions. Expanding on this concept, DNA-based molecular photonic wires (MPWs) allow for light harvesting and directional propagation of photonic energy on the nanometer scale. The most common MPW examples exploit Förster resonance energy transfer (FRET), and FRET between the same dye species (HomoFRET) was recently shown to increase the distance and efficiency at which MPWs can function. Although increased proximity between adjacent fluorophores can be used to increase the energy transfer efficiency, FRET assumptions break down as the distance between the dye molecules becomes comparable to their size (∼2 nm). Here we compare dye conjugation with single versus dimer Cy5 dye repeats as HomoFRET MPW components on a double-crossover DNA scaffold. At room temperature (RT) under low-light conditions, end-labeled uncoupled dye molecules provide optimal transfer, while the Cy5 dimers show ultrafast (<100 ps) nonradiative decay that severely limits their functionality. Of particular interest is the observation that through increased excitation fluence as well as cryogenic temperatures, the dimeric MPW shows suppression of the ultrafast decay, demonstrating fluorescence lifetimes similar to the single Cy5 MPWs. This work points to the complex dynamic capabilities of dye-based nanophotonic networks, where dye positioning and interactions can become critical, and could be used to extend the lengths and complexities of such dye-DNA devices, enabling multiparameter nanophotonic circuitry.",2020,"DNA scaffolds enable base-pair-specific positioning of fluorescent molecules, allowing for nanometer-scale precision in controlling multidye interactions.",[],[],['excitation fluence'],[],[],[],,0.0251721,"DNA scaffolds enable base-pair-specific positioning of fluorescent molecules, allowing for nanometer-scale precision in controlling multidye interactions.","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Mazuski', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'Sebastián A', 'Initials': 'SA', 'LastName': 'Díaz', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wood', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'Lawson T', 'Initials': 'LT', 'LastName': 'Lloyd', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Klein', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Divita', 'Initials': 'D', 'LastName': 'Mathur', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Melinger', 'Affiliation': 'Electronic Science and Technology Division, Code 6800, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Engel', 'Affiliation': 'Department of Chemistry, Institute for Biophysical Dynamics, and James Franck Institute, University of Chicago, Chicago, Illinois 60637, United States.'}, {'ForeName': 'Igor L', 'Initials': 'IL', 'LastName': 'Medintz', 'Affiliation': 'Center for Bio/Molecular Science and Engineering, Code 6900, U.S. Naval Research Laboratory, Washington, D.C. 20375, United States.'}]",The journal of physical chemistry letters,['10.1021/acs.jpclett.0c01020']
274,32391919,Intravenous itraconazole compared with liposomal amphotericin B as empirical antifungal therapy in patients with neutropaenia and persistent fever.,"BACKGROUND


Fungal infections are a major complication of neutropaenia following chemotherapy. Their early diagnosis is difficult and empirical antifungal treatment is widely used, use of less toxic drugs that reduce breakthrough infection are required.
OBJECTIVE


We conducted a multicentre, open-label, randomised, non-inferiority trial to compare the safety and efficacy of intravenous itraconazole (ivITCZ) and liposomal amphotericin B (LAmB) as empirical antifungal therapy in patients with haematological malignancies with neutropaenia and persistent fever.
METHODS


Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled. Patients were randomised for treatment with LAmB (3.0 mg /kg /day) or ivITCZ (induction: 400 mg /day, maintenance: 200 mg /day).
RESULTS


Observed overall favourable response rates of 17/52 (32.7%) and 18/50 (36.0%) in the LAmB and ivITCZ groups, with a model-based estimate of a 4% difference (90% CI, -12% to 20%), did not fulfil the statistical non-inferiority criterion. In the LAmB group, there were two cases of breakthrough infection and five cases of probable invasive fungal disease, whereas in the itraconazole group, neither breakthrough infection nor probable invasive fungal disease occurred. Patients in the ivITCZ group had significantly fewer grade 3-4 hypokalaemia-related events than LAmB group patients (P <0.01). The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07).
CONCLUSION


ivITCZ showed similar efficacy and safety as LAmB as empirical antifungal therapy in haematological malignancy patients with febrile neutropaenia, although the small sample size and various limitations prevented demonstration of its non-inferiority.",2020,"The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07).
","['patients with neutropaenia and persistent fever', 'haematological malignancy patients with febrile neutropaenia', 'Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled', 'patients with haematological malignancies with neutropaenia and persistent fever']","['itraconazole', 'itraconazole (ivITCZ) and liposomal amphotericin B (LAmB', 'Intravenous itraconazole', 'ivITCZ', 'LAmB', 'liposomal amphotericin B']","['breakthrough infection nor probable invasive fungal disease', 'overall incidence of adverse events', 'grade 3-4 hypokalaemia-related events', 'efficacy and safety', 'safety and efficacy', 'overall favourable response rates', 'breakthrough infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0476474', 'cui_str': 'Persistent fever'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}]","[{'cui': 'C3666010', 'cui_str': 'Breakthrough infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.107165,"The overall incidence of adverse events tended to be lower in the ivITCZ group (P = 0.07).
","[{'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Akiko M', 'Initials': 'AM', 'LastName': 'Saito', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Ilseung', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hidaka', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Kagoo', 'Affiliation': 'Department of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroatsu', 'Initials': 'H', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Niimi', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Komeno', 'Affiliation': 'Department of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.'}, {'ForeName': 'Chikamasa', 'Initials': 'C', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Minami-Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Tajima', 'Affiliation': 'Stem Cell Transplantation Center, National Hospital Organization Yonago Medical Center, Yonago, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': 'Department of Hematology and Internal Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Shimomura', 'Affiliation': 'Department of Internal Medicine, National Hospital Organization Hiroshima-Nishi Medical Center, Otake, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nakashima', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Chikashi', 'Initials': 'C', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Mito Medical Center, Higashiibarakigun, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Kubonishi', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Sakurai', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Department of Bacteriology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",Mycoses,['10.1111/myc.13100']
275,32391945,Effectiveness of an oral health education programme for older adults using a workbook.,"OBJECTIVE


This study investigated the effects of an oral health education programme utilising a workbook for people aged 65 years or older.
MATERIALS AND METHODS


A pre-post quasi-experimental design was used to verify the effectiveness of an oral health education programme using a workbook. Oral health education was provided once a week for 5 weeks from May to June 2019. Intervention group I only received lectures on oral health education, while intervention group II reviewed the content using the workbook immediately after the lecture. Chi-square test, Fisher's exact test and a one-way analysis of variance (ANOVA) were conducted to compare differences among the three groups; a paired t test was also carried out to identify the changes before and after the programme.
RESULTS


Intervention group I showed a significant increase of 3.52 on oral health knowledge and 3.47 on oral health recognition, while exhibiting a significant decrease of 0.21 on the O'Leary index and 0.69 on the tongue coating index. Intervention group II depicted a significant increase of 4.48 on oral health knowledge and 3.97 on oral health recognition and a significant decrease of 0.32 on the O'Leary index and 2.10 on the tongue coating index.
CONCLUSIONS


The oral health education programme using the workbook increased knowledge and recognition of oral health and lowered the O'Leary and tongue coating indexes. Hence, the use of a workbook may facilitate the effectiveness of oral health education for older people.",2020,The oral health education programme using the workbook increased knowledge and recognition of oral health and lowered the O'Leary and tongue coating indexes.,"['people aged 65\xa0years or older', 'older people', 'older adults using a workbook']","['lectures on oral health education', 'oral health education programme']","[""O'Leary index"", 'oral health knowledge', 'tongue coating index', 'oral health recognition', ""knowledge and recognition of oral health and lowered the O'Leary and tongue coating indexes""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009144', 'cui_str': 'Furred tongue'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",,0.0212376,The oral health education programme using the workbook increased knowledge and recognition of oral health and lowered the O'Leary and tongue coating indexes.,"[{'ForeName': 'Kyeong Hee', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Dental Hygiene, College of Bioecological Health, Shinhan University, Uijeongbu, Korea.'}, {'ForeName': 'Yoon Young', 'Initials': 'YY', 'LastName': 'Choi', 'Affiliation': 'Artificial Intelligence Big Data Medical Center, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Eun Seo', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'Department of Dental Hygiene, College of Bioecological Health, Shinhan University, Uijeongbu, Korea.'}]",Gerodontology,['10.1111/ger.12472']
276,32392019,Financial Toxicity After Acute Respiratory Distress Syndrome: A National Qualitative Cohort Study.,"OBJECTIVES


The financial burdens and subsequent related distress of medical care, referred to as financial toxicity, may limit access to beneficial treatments. However, financial toxicity after acute care is less described-and may be an important but underexplored mechanism preventing full recovery after critical illnesses such as acute respiratory distress syndrome. We sought to identify the mechanisms by which financial toxicity manifested in patients with acute respiratory distress syndrome, protective factors against such toxicity, and the consequences of financial toxicity to survivors' lives following acute respiratory distress syndrome.
DESIGN


We conducted semistructured interviews following patients' hospitalization and during recovery as an ancillary study to a multicenter randomized clinical trial in acute respiratory distress syndrome. Patients were 9-16 months post randomization at the time of interview.
SETTING AND PARTICIPANTS


The Reevaluation Of Systemic Early Neuromuscular Blockade trial examined the use of early neuromuscular blockade in mechanically ventilated patients with moderate/severe acute respiratory distress syndrome. We recruited consecutive surviving patients who were English speaking, consented to follow-up, and were randomized between December 11, 2017, and May 4, 2018 (n = 79) from 29 U.S. sites.
MEASUREMENTS AND MAIN RESULTS


We asked about patients' perceptions of financial burden(s) that they associated with their acute respiratory distress syndrome hospitalization. Forty-six of 79 eligible acute respiratory distress syndrome survivors (58%) participated (from 22 sites); their median age was 56 (interquartile range 47-62). Thirty-one of 46 reported at least one acute respiratory distress syndrome-related financial impact. Financial toxicity manifested via medical bills, changes in insurance coverage, and loss of employment income. Respondents reported not working prior to acute respiratory distress syndrome, using Medicaid or Medicare, or, conversely, generous work benefits as factors which may have limited financial burdens. Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
CONCLUSIONS


Financial toxicity related to critical illness is common and may limit patients' emotional, physical, and social recovery after acute respiratory distress syndrome hospitalization for at least a year.",2020,"Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
","['patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome', 'consecutive surviving patients who were English speaking, consented to follow-up, and were randomized between December 11, 2017, and May 4, 2018 (n = 79) from 29 U.S. sites', 'Forty-six of 79 eligible acute respiratory distress syndrome survivors (58%) participated (from 22 sites); their median age was 56 (interquartile range 47-62', 'mechanically ventilated patients with moderate/severe acute respiratory distress syndrome', 'Thirty-one of 46 reported at least one acute respiratory distress syndrome-related financial impact', 'After Acute Respiratory Distress Syndrome']",[],"['Financial toxicity manifested via medical bills, changes in insurance coverage, and loss of employment income', 'acute respiratory distress syndrome hospitalization', 'financial toxicity', 'Financial Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004895', 'cui_str': 'Beak'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0425083', 'cui_str': 'Loss of job'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.13736,"Patients reported multiple consequences of acute respiratory distress syndrome-related financial toxicity, including harms to their mental and physical health, increased reliance on others, and specific material hardships.
","[{'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Hauschildt', 'Affiliation': 'Department of Sociology, College of Literature, Science, and Arts, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Seigworth', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, HSR&D Center of Innovation, Ann Arbor, MI.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Kamphuis', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, HSR&D Center of Innovation, Ann Arbor, MI.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McPeake', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004378']
277,32386593,"Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial.","BACKGROUND


Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response.
METHODS


This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080.
FINDINGS


Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator.
INTERPRETATION


Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis.
FUNDING


Novartis Pharma.",2020,"INTERPRETATION


Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52.","['26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis', 'Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive', '709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50', 'patients with psoriatic arthritis', '61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101', 'Eligible patients', 'patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response']","['adalimumab', 'interactive response technology to receive secukinumab or adalimumab', 'secukinumab (n=426) or adalimumab', 'secukinumab and adalimumab', 'Secukinumab versus adalimumab', 'Adalimumab', 'secukinumab', 'secukinumab versus adalimumab', 'mL citrate free subcutaneous injection']","['superiority of secukinumab versus adalimumab for ACR20 response', 'proportion of patients with at least 20% improvement in the ACR response criteria (ACR20', 'efficacy and safety', 'serious infections', 'ACR20 response']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",853.0,0.314879,"INTERPRETATION


Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52.","[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. Electronic address: iain.mcinnes@glasgow.ac.uk.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'Rheumatology University Hospital and Fraunhofer Institute for Molecular Biology and Applied Ecology, Branch for Translational Medicine and Pharmacology and Fraunhofer Cluster of Excellence for Immune-Mediated Diseases, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Centre, Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'Rheumatology, Allergy, Immunology Division, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ritchlin', 'Affiliation': 'Allergy, Immunology and Rheumatology Division, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'Jordi Gratacós', 'Initials': 'JG', 'LastName': 'Masmitja', 'Affiliation': 'Rheumatology Department, University Hospital Parc Taulí, Sabadell, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology and INSERM-CIC1415, University Hospital of Tours, EA 7501 GICC, University of Tours, Tours, France.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Korotaeva', 'Affiliation': 'Research Institute of Rheumatology n.a. V A Nasonova, Moscow, Russia.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ruvie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Pellet', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Shephard', 'Initials': 'S', 'LastName': 'Mpofu', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30564-X']
278,32386720,"Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.","BACKGROUND


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


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


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


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


Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases.",2020,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
","['non-pregnant adults', 'women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria', '19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA', 'Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV', 'antiretroviral-naive pregnant women living with HIV (NICHD P1081', 'From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz', 'pregnant women living with HIV', '144']","['lamivudine 150 mg and zidovudine', 'raltegravir', 'raltegravir or efavirenz', 'efavirenz', 'Raltegravir versus efavirenz']","['Frequencies of severe or life-threatening adverse events', 'safety and efficacy', 'plasma HIV viral load below 200 copies per mL at (or near) delivery']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0987069', 'cui_str': 'Lamivudine 150 MG'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",408.0,0.357245,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
","[{'ForeName': 'Esaú C', 'Initials': 'EC', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil. Electronic address: esaujoao@gmail.com.'}, {'ForeName': 'R Leavitt', 'Initials': 'RL', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Maria Isabel S', 'Initials': 'MIS', 'LastName': 'Gouvèa', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Lourdes B Teixeira', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Trevon L', 'Initials': 'TL', 'LastName': 'Fuller', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Ngocho', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Boniface N', 'Initials': 'BN', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Mathiba', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Essack', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Jose Henrique S', 'Initials': 'JHS', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Moreira', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Rolon', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Sinart', 'Initials': 'S', 'LastName': 'Prommas', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University and Chiangrai Prachanukroh Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Peerawong', 'Initials': 'P', 'LastName': 'Werarak', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Laimon', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Hennessy', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Frenkel', 'Affiliation': ""University of Washington and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Anthony', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'US Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30038-2']
279,32386721,"Dolutegravir versus efavirenz in women starting HIV therapy in late pregnancy (DolPHIN-2): an open-label, randomised controlled trial.","BACKGROUND


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


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


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


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


Unitaid.",2020,"89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06).","['Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or', 'All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses', 'women starting HIV therapy in late pregnancy (DolPHIN-2', 'recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester']","['efavirenz', 'Dolutegravir versus efavirenz', 'dolutegravir-based or efavirenz-based therapy', 'HIV antiretroviral therapy (ART']","['virological suppression', 'viral loads', 'occurrence of drug-related adverse events', 'viral load of less than 50 copies per mL at the first post-partum visit', 'serious adverse events', 'HIV viral load', 'median duration of maternal therapy']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",268.0,0.259954,"89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06).","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kintu', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Thokozile R', 'Initials': 'TR', 'LastName': 'Malaba', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jesca', 'Initials': 'J', 'LastName': 'Nakibuka', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Papamichael', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Seden', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Hodel', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Adelline', 'Initials': 'A', 'LastName': 'Twimukye', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; Department of Gynaecology and Obstetrics School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Reynolds', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burger', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Waitt', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Taegtmeyer', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'School of Public Health & Family Medicine, and Desmond Tutu HIV Centre, Department of Medicine, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Lamorde', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa; Centre for Infectious Diseases Epidemiology and Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. Electronic address: khoo@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30050-3']
280,32386747,Effect of immune regulatory pathways after immunization with GMZ2 malaria vaccine candidate in healthy lifelong malaria-exposed adults.,"BACKGROUND


Despite appreciable immunogenicity in malaria-naive populations, many candidate malaria vaccines are considerably less immunogenic in malaria-exposed populations. This could reflect induction of immune regulatory mechanisms involving Human Leukocyte Antigen G (HLA-G), regulatory T (Treg), and regulatory B (Breg) cells. Here, we addressed the question whether there is correlation between these immune regulatory pathways and both plasmablast frequencies and vaccine-specific IgG concentrations.
METHODS


Fifty Gabonese adults with lifelong exposure to Plasmodium spp were randomized to receive three doses of either 30 µg or 100 µg GMZ2-CAF01, or 100 µg GMZ2-alum, or control vaccine (rabies vaccine) at 4-week intervals. Only plasma and peripheral blood mononuclear cells isolated from blood samples collected before (D0) and 28 days after the third vaccination (D84) of 35 participants were used to measure sHLA-G levels and anti-GMZ2 IgG concentrations, and to quantify Treg, Breg and plasmablast cells. Vaccine efficacy was assessed using controlled human malaria infection (CHMI) by direct venous inoculation of Plasmodium falciparum sporozoites (PfSPZ Challenge).
RESULTS


The sHLA-G concentration increased from D0 to D84 in all GMZ2 vaccinated participants and in the control group, whereas Treg frequencies increased only in those receiving 30 µg or 100 µg GMZ2-CAF01. The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies. Importantly, having a D84:D0 ratio of sHLA-G above the median was associated with an increased risk of P. falciparum infection after sporozoites injection.
CONCLUSION


Regulatory immune responses are induced following immunization. Stronger sHLA-G and Treg immune responses may suppress vaccine induced immune responses, and the magnitude of the sHLA-G response increased the risk of Plasmodium falciparum infection after CHMI. These findings could have implications for the design and testing of malaria vaccine candidates in semi-immune individuals.",2020,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","['Fifty Gabonese adults with lifelong exposure to Plasmodium spp', 'healthy lifelong malaria-exposed adults']","['30\xa0µg or 100\xa0µg GMZ2-CAF01, or 100\xa0µg GMZ2-alum, or control vaccine (rabies vaccine', 'GMZ2 malaria vaccine candidate']","['Vaccine efficacy', 'sHLA-G levels and anti-GMZ2 IgG concentrations', 'anti-GMZ2 IgG concentration', 'Only plasma and peripheral blood mononuclear cells', 'sHLA-G concentration', 'risk of P. falciparum infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",35.0,0.0706217,"The sHLA-G level on D84 was associated with a decrease of the anti-GMZ2 IgG concentration, whereas Treg frequencies on D0 or on D84, and Breg frequency on D84 were associated with lower plasmablast frequencies.","[{'ForeName': 'Odilon', 'Initials': 'O', 'LastName': 'Nouatin', 'Affiliation': ""Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: paterneodilon@gmail.com.""}, {'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Ateba Ngoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon. Electronic address: ulyssus7000@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: benjamin.mordmueller@uni-tuebingen.de.'}, {'ForeName': 'Jean Ronald', 'Initials': 'JR', 'LastName': 'Edoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: j.ronaldedoa@cermel.org.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Mougeni', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Brückner', 'Affiliation': 'Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany. Electronic address: sinab@gmx.net.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Bouyoukou Hounkpatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: meral.esen@uni-tuebingen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Theisen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark and Centre for Medical Parasitology at Department of International Health, Immunology and Microbiology, University of Copenhagen, and Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark. Electronic address: mth@ssi.dk.'}, {'ForeName': 'Kabirou', 'Initials': 'K', 'LastName': 'Moutairou', 'Affiliation': ""Département de Biochimie et de Biologie Cellulaire, Faculté des Sciences et Techniques, Université d'Abomey-Calavi, Cotonou, Benin. Electronic address: kamoutairo@yahoo.fr.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, MD 20850, USA. Electronic address: slhoffman@sanaria.com.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique, 72 BP45 Cotonou, Benin. Electronic address: isaadou2002@yahoo.fr.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': ""Centre d'Etude et de Recherche sur le Paludisme Associé à la Grossesse et à l'Enfance, Faculté des Sciences de la Santé, Université d'Abomey-Calavi, Cotonou, MERIT UMR D216, Benin; Université de Paris, MERIT, IRD, Paris, France. Electronic address: adrian.luty@ird.fr.""}, {'ForeName': 'Marguerite M', 'Initials': 'MM', 'LastName': 'Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: mmassingaloembe@cermel.org.'}, {'ForeName': 'Selidji Todagbé', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: agnandjis@cermel.org.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: bertrand.lell@cermel.org.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Ayôla Akim', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, BP: 242 Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tubingen, Wilhelmstraβe 27, D-72074 Tübingen, Germany; Germany; German Centre for Infection Research (DZIF), Partner Site Tübingen, Germany; Leiden University Medical Centre (LUMC), 2333 ZA Leiden, the Netherlands. Electronic address: aadegnika@cermel.org.'}]",Vaccine,['10.1016/j.vaccine.2020.04.046']
281,32393732,"Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT).","SWOG S0777, a randomized phase III trial, compared bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd). This updated analysis includes 460 patients evaluable for survival endpoints: 225 eligible and analyzable patients were randomized to Rd and 235 to VRd. The 6-month induction was six 28-day cycles of Rd and eight 21-day cycles of VRd followed by Rd maintenance for all patients. Median follow up is 84 months. Median PFS is 41 months for VRd and 29 months for Rd: stratified hazard ratio (96% Wald Confidence Interval) was 0.742 (0.594, 0.928) and one-sided stratified log-rank P-value 0.003. Median OS for VRd is still not reached with median OS for Rd being 69 months: stratified hazard ratio (96% Wald Confidence Interval) was 0.709 (0.543, 0.926) and stratified two-sided P-value was 0.0114. Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])). Median duration of Rd maintenance was 17.1 months. The addition of bortezomib to lenalidomide dexamethasone for induction therapy results in a statistically significant and clinically meaningful improvement in PFS as well as better OS. VRd continues to represent an appropriate standard of care irrespective of age.",2020,Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])).,"['460 patients evaluable for survival endpoints: 225 eligible and analyzable patients', 'patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT']","['bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone', 'bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd', 'bortezomib to lenalidomide dexamethasone']","['Median PFS', 'Median OS for VRd', 'Median duration of Rd maintenance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.128355,Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])).,"[{'ForeName': 'Brian G M', 'Initials': 'BGM', 'LastName': 'Durie', 'Affiliation': 'Cedars Sinai Cancer Center, Los Angeles, CA, USA. BDurie@myeloma.org.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hoering', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Sexton', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Muneer H', 'Initials': 'MH', 'LastName': 'Abidi', 'Affiliation': 'Michigan State University/Spectrum Health Cancer Center, Grand Rapids, MI, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Epstein', 'Affiliation': 'Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dispenzieri', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Kahanic', 'Affiliation': 'Sanford NCORP of the North Central Plains/ Siouxland Regional Cancer Center, Sioux City, IA, USA.'}, {'ForeName': 'Mohan C', 'Initials': 'MC', 'LastName': 'Thakuri', 'Affiliation': 'Cancer Care Western NC, Asheville, NC, USA.'}, {'ForeName': 'Frederic J', 'Initials': 'FJ', 'LastName': 'Reu', 'Affiliation': 'Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reynolds', 'Affiliation': 'Michigan Cancer Research Consortium NCORP, St. Joseph Mercy Hospital, Ann Arbor, MI, USA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Barlogie', 'Affiliation': ''}]",Blood cancer journal,['10.1038/s41408-020-0311-8']
282,32393741,Randomized resonant metamaterials for single-sensor identification of elastic vibrations.,"Vibrations carry a wealth of useful physical information in various fields. Identifying the multi-source vibration information generally requires a large number of sensors and complex hardware. Compressive sensing has been shown to be able to bypass the traditional sensing requirements by encoding spatial physical fields, but how to encode vibration information remains unexplored. Here we propose a randomized resonant metamaterial with randomly coupled local resonators for single-sensor compressed identification of elastic vibrations. The disordered effective masses of local resonators lead to highly uncorrelated vibration transmissions, and the spatial vibration information can thus be physically encoded. We demonstrate that the spatial vibration information can be reconstructed via a compressive sensing framework, and this metamaterial can be reconfigured while maintaining desirable performance. This randomized resonant metamaterial presents a new perspective for single-sensor vibration sensing via vibration transmission encoding, and potentially offers an approach to simpler sensing devices for many other physical information.",2020,"This randomized resonant metamaterial presents a new perspective for single-sensor vibration sensing via vibration transmission encoding, and potentially offers an approach to simpler sensing devices for many other physical information.",[],[],[],[],[],[],,0.0256581,"This randomized resonant metamaterial presents a new perspective for single-sensor vibration sensing via vibration transmission encoding, and potentially offers an approach to simpler sensing devices for many other physical information.","[{'ForeName': 'Tianxi', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China.""}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China. qbhe@sjtu.edu.cn.""}, {'ForeName': 'Zhi-Ke', 'Initials': 'ZK', 'LastName': 'Peng', 'Affiliation': ""State Key Laboratory of Mechanical System and Vibration, Shanghai Jiao Tong University, 200240, Shanghai, People's Republic of China.""}]",Nature communications,['10.1038/s41467-020-15950-1']
283,32393793,Persistent cannabis use as an independent risk factor for violent behaviors in patients with schizophrenia.,"Although recent studies have shown a moderately strong association between cannabis use and violence among people with severe mental disorders, the direction of this association has not been investigated prospectively in a population with schizophrenia. Therefore, this study aims to determine, using cross-lag models, whether a temporal relationship between cumulative cannabis use and violence exists in a population with schizophrenia. The authors reported findings covering an 18-month period from a randomized, double-blind clinical trial of antipsychotic medications for schizophrenia treatment. Among the 1460 patients enrolled in the trial, 965 were followed longitudinally. Although persistent cannabis use predicted subsequent violence, violence did not predict cannabis use. The relationship was therefore unidirectional and persisted when controlling for stimulants and alcohol use. Finally, a significant body of evidence suggests a link between persistent cannabis use and violence among people with mental illnesses. Studies to further investigate the mechanisms underlying this association should be conducted.",2020,"Although persistent cannabis use predicted subsequent violence, violence did not predict cannabis use.","['people with severe mental disorders', '1460 patients enrolled in the trial, 965 were followed longitudinally', 'population with schizophrenia', 'people with mental illnesses', 'patients with schizophrenia']",['antipsychotic medications'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],1460.0,0.267235,"Although persistent cannabis use predicted subsequent violence, violence did not predict cannabis use.","[{'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Beaudoin', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada. Melissa.Beaudoin.1@UMontreal.ca.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Potvin', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Charles-Edouard', 'Initials': 'CE', 'LastName': 'Giguère', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Sophie-Lena', 'Initials': 'SL', 'LastName': 'Discepola', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumais', 'Affiliation': ""Centre de recherche de l'Institut universitaire en santé mentale de Montréal, Montreal, QC, Canada. Alexandre.Dumais@UMontreal.ca.""}]",NPJ schizophrenia,['10.1038/s41537-020-0104-x']
284,32393964,Validation of diffusion MRI phenotypes for predicting response to bevacizumab in recurrent glioblastoma: post-hoc analysis of the EORTC-26101 trial.,"BACKGROUND


This study validated a previously described diffusion-MRI phenotype as a potential predictive imaging biomarker in patients with recurrent glioblastoma receiving bevacizumab (BEV).
METHODS


A total of 396/596 patients (66%) from the prospective randomized phase II/III EORTC-26101 trial (with n=242 in the BEV and n=154 in the non-BEV arm) met the inclusion criteria with availability of anatomical and diffusion MRI-sequences at baseline prior treatment. Apparent diffusion coefficient (ADC) histograms from the contrast-enhancing tumor volume were fitted to a double Gaussian distribution and the mean of the lower curve (ADClow) was used for further analysis. The predictive ability of ADClow was assessed with biomarker threshold models and multivariable Cox-regression for overall and progression-free survival (OS, PFS).
RESULTS


ADClow was associated with PFS (HR=0.625,p=0.007) and OS (HR=0.656,p=0.031). However, no (predictive) interaction between ADClow and the treatment arm was present (p=0.865 for PFS, p=0.722 for OS). Independent (prognostic) significance of ADClow was retained after adjusting for epidemiological, clinical and molecular characteristics (p≤0.02 for OS, p≤0.01 PFS). The biomarker threshold model revealed an optimal ADClow cutoff of 1241*10-6mm²/s for OS. Thereby, median OS for BEV-patients with ADClow≥1241 was 10.39 months vs. 8.09 months for those with ADClow<1241 (p=0.004). Similarly, median OS for non-BEV patients with ADClow≥1241 was 9.80 months vs. 7.79 months for those with ADClow<1241 (p=0.054).
CONCLUSIONS


ADClow is an independent prognostic parameter for stratifying OS and PFS in patients with recurrent glioblastoma. Consequently, the previously suggested role of ADClow as predictive imaging biomarker could not be confirmed within this phase II/III trial.",2020,"However, no (predictive) interaction between ADClow and the treatment arm was present (p=0.865 for PFS, p=0.722 for OS).","['patients with recurrent glioblastoma', 'patients with recurrent glioblastoma receiving bevacizumab (BEV', 'recurrent glioblastoma', '396/596 patients (66%) from the prospective randomized phase II/III EORTC-26101 trial (with n=242 in the BEV and n=154 in the non-BEV arm) met the inclusion criteria with availability of anatomical and diffusion MRI-sequences at baseline prior treatment']",['bevacizumab'],"['median OS', 'Apparent diffusion coefficient (ADC) histograms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1136216', 'cui_str': 'Magnetic Resonance Imaging, Diffusion'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",,0.0516596,"However, no (predictive) interaction between ADClow and the treatment arm was present (p=0.865 for PFS, p=0.722 for OS).","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schell', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Irada', 'Initials': 'I', 'LastName': 'Pflüger', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Brugnara', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Isensee', 'Affiliation': 'Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Neuberger', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Foltyn', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sahm', 'Affiliation': 'Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nowosielski', 'Affiliation': 'Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Heiland', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Platten', 'Affiliation': 'Department of Neurology, Mannheim Medical Center, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Klaus H', 'Initials': 'KH', 'LastName': 'Maier-Hein', 'Affiliation': 'Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'von Deimling', 'Affiliation': 'Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kickingereder', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}]",Neuro-oncology,['10.1093/neuonc/noaa120']
285,32393980,Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial.,"BACKGROUND


Saturated-fat intake and endotoxemia can impair cognition. However, their acute impact on cognitive performance is unknown.
OBJECTIVE


This study assessed the impact of 2 high-fat meals and endotoxemia on attention.
METHODS


In this double-blind, randomized crossover trial, 51 women (n = 32 breast cancer survivors, n = 19 noncancer controls; mean ± SD age: 53 ± 8 y) completed the Continuous Performance Test (CPT) and had their blood drawn to assess endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14), and the LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal. Women again completed the CPT 5 h postmeal. At 1 to 4 wk later, women completed the same protocol but consumed the other meal.
RESULTS


In adjusted models, women had more difficulty distinguishing target stimuli from distractors after consuming the high-saturated-fat meal than they did after the oleic-sunflower-oil meal (B = 4.44, SE = 1.88, P = 0.02). Women with higher baseline LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04). Those with higher LBP and LBP:sCD14 were less able to sustain their attention throughout the entire CPT, as reflected by their progressively slower (B = 0.002, SE = 0.0006, P = 0.003; and B = 2.43, SE = 0.090, P = 0.008, respectively) and more erratic (B = 0.003, SE = 0.0008, P < 0.0001; and B = 3.29, SE = 1.17, P = 0.006, respectively) response times. Additionally, women with higher baseline LBP or sCD14 were less able to maintain or increase response speeds at higher interstimulus intervals (B = 0.002, SE = 0.0006, P = 0.02; and B = 0.006, SE = 0.003, P = 0.03, respectively), indicating greater difficulty adapting to changing task demands. Significant meal type by LBP and LBP:sCD14 interactions emerged (P < 0.05), such that high LBP and LBP:sCD14 erased between-meal cognitive differences, uniformly impairing performance.
CONCLUSIONS


These results suggest that higher LBP, sCD14, and LBP:sCD14 and saturated-fat intake individually and jointly influence attention. Endotoxemia may override the relative cognitive benefit of healthier oil choices.This trial is registered at clinicaltrials.gov as NCT04247763.",2020,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","['Women with higher baseline', '51 women (n\xa0=\xa032 breast cancer survivors, n\xa0=\xa019 noncancer controls; mean ± SD age: 53 ± 8 y']","['Afternoon distraction', 'LBP', 'Continuous Performance Test (CPT', 'LBP to sCD14 ratio 1 h prior to eating either a high-saturated-fat meal or a high-oleic-sunflower-oil meal']","['endotoxemia markers LPS binding protein (LBP), soluble CD14 (sCD14', 'cognitive performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}]",51.0,0.151899,"LBP had less consistent response times (B = 0.002, SE = 0.0008, P = 0.04).","[{'ForeName': 'Annelise A', 'Initials': 'AA', 'LastName': 'Madison', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Belury', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andridge', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'M Rosie', 'Initials': 'MR', 'LastName': 'Shrout', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Renna', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Malarkey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Bailey', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Janice K', 'Initials': 'JK', 'LastName': 'Kiecolt-Glaser', 'Affiliation': 'Institute for Behavioral Medicine Research, The Ohio State University College of Medicine, Columbus, OH, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa085']
286,32393991,"Letter to the editor regarding ""Intramedullary fixation versus anatomically contoured plating of unstable fractures: a randomized control trial"" by Badenhorst et al.",,2020,,[],"['Letter to the editor regarding ""Intramedullary fixation versus anatomically contoured plating of unstable fractures']",[],[],"[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0559876', 'cui_str': 'Unstable fracture'}]",[],,0.0157977,,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India. dr.aditya.agg@gmail.com.'}, {'ForeName': 'Rajesh Kumar', 'Initials': 'RK', 'LastName': 'Rajnish', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Bachhal', 'Affiliation': 'Department of Orthopaedics, PGIMER, Sector 12, Chandigarh, India.'}]",International orthopaedics,['10.1007/s00264-020-04602-0']
287,32394103,"Rationale and study design for ablation of paroxysmal atrial fibrillation guided by ablation index: a multi-center, prospective randomized trial (PAF-AI trial).","BACKGROUND


Pulmonary vein isolation (PVI) has become the cornerstone of atrial fibrillation (AF) ablation, but long-term success rates remains suboptimal, due in large part to late PV reconnection and insufficient ostial substrate modification.
OBJECTIVE


To evaluate whether ablation index (AI)-guided PVI with electrical isolation and quantified ostial substrate modification improves clinical outcomes when compared with contact force (CF)-guided ablation in patients with paroxysmal atrial fibrillation (PAF).
METHODS


The PAF-AI trial (ChiCTR1900022041) is a prospective, multi-center, randomized controlled clinical trial enrolling patients with PAF with an indication for catheter ablation. Patients are randomized into a 2:1 fashion to two treatment arms: AI-guided PVI (n = 151) and CF-guided PVI (n = 75). In the AI-guided PVI group, real-time automated display of radiofrequency applications (Visitag™) is used with AI ≥ 500 recommended at the anterior/superior/inferior walls and 350-400 at the posterior wall. In CF-guided PVI group, the value and direction of CF are displayed, with the lesion dots manually annotated. The primary endpoint is the freedom from AF recurrence at 12 months following ablation, without antiarrhythmic drug. The primary pre-specified secondary endpoints include intraprocedural efficiency and peri-procedural complications.
CONCLUSIONS


PAF-AI trial compares the effectiveness and safety of two different strategies of PVI in patients with PAF, AI-guided PVI versus more established CF-guided PVI. This prospective, multi-center, randomized controlled trial, with comparative data evaluating procedural and long-term follow-up results, aims to evaluate the impact of AI-guided strategy on AF ablation compared with the current standard of care RF ablation approach.",2020,"In the AI-guided PVI group, real-time automated display of radiofrequency applications (Visitag™) is used with AI ≥ 500 recommended at the anterior/superior/inferior walls and 350-400 at the posterior wall.","['patients with paroxysmal atrial fibrillation (PAF', 'patients with PAF with an indication for catheter ablation']","['Pulmonary vein isolation (PVI', 'contact force (CF)-guided ablation', 'ablation index (AI)-guided PVI with electrical isolation and quantified ostial substrate modification', 'AI-guided PVI (n\u2009=\u2009151) and CF-guided PVI', 'paroxysmal atrial fibrillation guided by ablation index', 'care RF ablation approach']","['freedom from AF recurrence', 'intraprocedural efficiency and peri-procedural complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.0791964,"In the AI-guided PVI group, real-time automated display of radiofrequency applications (Visitag™) is used with AI ≥ 500 recommended at the anterior/superior/inferior walls and 350-400 at the posterior wall.","[{'ForeName': 'Ruhong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': ""Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Zhejiang, 310016, Hangzhou, People's Republic of China.""}, {'ForeName': 'Minglong', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""The First Peoples' Hospital of Yunnan Province, Yunnan, China.""}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': ""Xijing Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Anli', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xingpeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Beijing Chaoyang Hospital affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weizhu', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""The First Peoples' Hospital of Yunnan Province, Yunnan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Xijing Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Beijing Chaoyang Hospital affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Genqing', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Shanghai General Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yuegang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""Department of Cardiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Zhejiang, 310016, Hangzhou, People's Republic of China. cyjiang@zju.edu.cn.""}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00763-5']
288,32394139,Using Video Modules and Simulation Learning to Improve IUD Counseling Among Internal Medicine Residents-a Randomized Controlled Educational Trial.,,2020,,['Internal Medicine Residents'],['Video Modules and Simulation Learning to Improve IUD Counseling'],[],"[{'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],,0.0786634,,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hirsch', 'Affiliation': ""Divison of Women's Health, Depart of General Internal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. hhirsch@bwh.harvard.edu.""}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Batur', 'Affiliation': ""Ob/Gyn & Women's Health Institute, Cleveland, OH, USA.""}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Spencer', 'Affiliation': 'Cleveland Clinic, Internal Medicine Residency Program, Cleveland, OH, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McNamara', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-05832-z']
289,32394218,Landiolol hydrochloride for prevention of atrial fibrillation during esophagectomy: a randomized controlled trial.,"INTRODUCTION


Landiolol hydrochloride reduces the incidence of perioperative atrial fibrillation (AF) in cardiac surgery; however, little evidence is available regarding its effects in other types of surgery, including esophagectomy. We assessed the hypothesis that landiolol reduces perioperative AF and other complications associated with esophagectomy.
METHODS


This single-center, randomized, double-blind, parallel-group study enrolled patients scheduled for esophagectomy. Patients were divided into those given landiolol at 3 μg/kg/min or placebo for 24 h. The primary outcome was the proportion of patients who developed AF within 96 h starting at 9:00 AM on the day of surgery. The secondary outcomes were the proportion of patients whose AF appeared within 24 h, other complications based on the Clavien-Dindo classification, and the intensive care unit and hospital stays.
RESULTS


Despite early study termination, 80 patients were screened, and 56 were enrolled (28/group) from September 2016 to June 2018. AF occurred within 96 h of surgery in six (21.4%) patients in the landiolol group and five (17.9%) patients in the placebo group (odds ratio, 1.26; 95% confidence interval, 0.33-4.7) and within 24 h of surgery in three (10.7%) patients in the landiolol group and two (7.1%) patients in the placebo group. There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups.
CONCLUSION


Although our small sample size prevents definitive conclusions, landiolol might not reduce the occurrence of AF or other complications.
TRIAL REGISTRATION


UMIN, UMIN000024040. Registered 13 September 2016, http://www.umin.ac.jp/ctr/index/htm.",2020,"There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups.
","['cardiac surgery', '80 patients were screened, and 56 were enrolled (28/group) from September 2016 to June 2018', 'atrial fibrillation during esophagectomy']","['esophagectomy', 'Landiolol hydrochloride', 'landiolol at 3\u2009μg/kg/min or placebo', 'placebo']","['AF', 'number of intensive care unit or hospital stays', 'proportion of patients whose AF appeared within 24\u2009h, other complications based on the Clavien-Dindo classification, and the intensive care unit and hospital stays', 'incidence of complications', 'proportion of patients who developed AF']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",80.0,0.551778,"There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups.
","[{'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Aoki', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-Ku, Hamamatsu-shi, Shizuoka, 431-3192, Japan. ysyaoki27@gmail.com.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Centre, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Anesthesiology, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Anesthesiology, Shizuoka General Hospital, Shizuoka, Japan.'}]",JA clinical reports,['10.1186/s40981-020-00338-3']
290,32394219,The Effects of Acceptance and Commitment Therapy (ACT) Intervention on Inflammation and Stress Biomarkers: a Randomized Controlled Trial.,"BACKGROUND


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


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


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


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


ClinicalTrials.gov Identifier: NCT01738256, Registered 17 August, 2012.",2020,A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers.,"['Participants', 'working-age adults with psychological distress and overweight/obesity', 'people with overweight/obesity and psychological distress']","['acceptance and commitment therapy (ACT', 'ACT-based face-to-face (n\u2009=\u200965; six group sessions led by a psychologist), (2) ACT-based mobile (n\u2009=\u200973; one group session and mobile app', 'Acceptance and Commitment Therapy (ACT) Intervention', 'ACT']","['hsCRP', 'Inflammation and Stress Biomarkers', 'high-sensitivity C-reactive protein (hsCRP) level', 'General PF and weight-related PF', 'low-grade systemic inflammation', 'questionnaires (Acceptance and Action Questionnaire, Acceptance and Action Questionnaire for Weight-Related Difficulties', 'Systemic inflammation and stress markers']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.112618,A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers.,"[{'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Järvelä-Reijonen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland. elina.jarvela-reijonen@uef.fi.'}, {'ForeName': 'Sampsa', 'Initials': 'S', 'LastName': 'Puttonen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O. Box 40, FI-00251, Helsinki, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karhunen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Sairanen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Laitinen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O. Box 40, FI-00251, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Department of Environmental and Biological Sciences, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Pihlajamäki', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Korpela', 'Affiliation': 'Medical Faculty, Pharmacology, Medical Nutrition Physiology and Human Microbe Research Program, University of Helsinki, P.O. Box 63, FI-00014, Helsinki, Finland.'}, {'ForeName': 'Miikka', 'Initials': 'M', 'LastName': 'Ermes', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09891-8']
291,32394228,"The GLP-1 receptor agonist lixisenatide reduces postprandial glucose in patients with diabetes secondary to total pancreatectomy: a randomised, placebo-controlled, double-blinded crossover trial.","AIMS/HYPOTHESIS


Treatment of diabetes secondary to total pancreatectomy remains a challenge and insulin constitutes the only glucose-lowering treatment for these patients. We hypothesised that the glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide would improve postprandial glucose tolerance in totally pancreatectomised patients.
METHODS


In a double-blinded, randomised, crossover study, 12 totally pancreatectomised individuals (age: 65.0 ± 9.5 mean±SD years; BMI: 22.9 ± 3.9 kg/m 2 ) and 12 healthy control individuals (age 66.1 ± 7.6 years; BMI: 24.0 ± 2.9 kg/m 2 ) underwent two 3 h liquid mixed-meal tests (with paracetamol for assessment of gastric emptying) after single-dose injection of 20 μg of lixisenatide or placebo. Basal insulin was given the night before each experimental day; no insulin was given during study days.
RESULTS


Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001). In the pancreatectomy group a mean peak glucose concentration of 23.3 ± 1.0 mmol/l was reached at time point 134 ± 11 min with placebo, compared with a mean peak glucose concentration of 18 ± 1.4 mmol/l (p = 0.008) at time point 148 ± 13 min (p = 0.375) with lixisenatide. In the control group a mean peak concentration of 8.2 ± 0.4 mmol/l was reached at time point 70 ± 13 min with placebo, compared with a mean peak concentration of 5.5 ± 0.1 mmol/l (p < 0.001) at time point 8 ± 25 min (p = 0.054) with lixisenatide. Lixisenatide also reduced gastric emptying and postprandial glucagon responses in the pancreatectomy group (66 ± 84 vs 1190 ± 311 pmol/l × min, p = 0.008) and in the control group (141 ± 100 vs 190 ± 100 pmol/l × min, p = 0.034). In the pancreatectomy group, C-peptide was undetectable in plasma. In the control group, postprandial plasma C-peptide responses were reduced with lixisenatide (18 ± 17 vs 189 ± 31 nmol/l × min, p < 0.001).
CONCLUSIONS/INTERPRETATION


The GLP-1 receptor agonist lixisenatide reduces postprandial plasma glucose excursions in totally pancreatectomised patients. The mode of action seems to involve deceleration of gastric emptying and reduced postprandial responses of gut-derived glucagon.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02640118.
FUNDING


This study was funded by an unrestricted investigator-initiated study grant from Sanofi. Support was also received from from the Novo Nordisk Foundation Center for Basic Metabolic Research, the A.P. Møller Foundation for the Advancement of Medical Science and the Faculty of Health and Medical Sciences, University of Copenhagen.",2020,"Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001).","['patients with diabetes secondary to total pancreatectomy', 'totally pancreatectomised patients', '12 totally pancreatectomised individuals (age: 65.0\u2009±\u20099.5 mean±SD years; BMI: 22.9\u2009±\u20093.9\xa0kg/m 2 ) and 12 healthy control individuals (age 66.1\u2009±\u20097.6\xa0years; BMI: 24.0\u2009±\u20092.9\xa0kg/m 2 ) underwent']","['placebo, lixisenatide', 'glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide', 'lixisenatide or placebo', 'GLP-1 receptor agonist lixisenatide', 'two 3\xa0h liquid mixed-meal tests (with paracetamol', 'placebo']","['mean peak glucose concentration', 'postprandial plasma C-peptide responses', 'postprandial glucose tolerance', 'mean peak concentration', 'gastric emptying and postprandial glucagon responses', 'postprandial plasma glucose excursions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",12.0,0.174112,"Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001).","[{'ForeName': 'Caroline T B', 'Initials': 'CTB', 'LastName': 'Juel', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Andersen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Carsten P', 'Initials': 'CP', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Storkholm', 'Affiliation': 'Department of Surgery and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark. filip.krag.knop.01@regionh.dk.'}]",Diabetologia,['10.1007/s00125-020-05158-9']
292,32394643,Accuracy and Safety of Robot-Assisted Drilling Decompression for Osteonecrosis of the Femoral Head.,"OBJECTIVE


To investigate the safety and superiority of robot-assisted femoral head drilling decompression in the treatment of femoral head necrosis.
METHODS


A total of 63 patients who underwent borehole decompression of the femoral head in our hospital from January 2016 to March 2019 were recruited. Patients were divided into two groups for comparison according to surgical methods. In the robot-assisted surgery group, there were 30 cases with 41 femoral heads. The conventional group had 33 cases and 46 femoral heads. All patients signed the consent form before the operation. The follow-up time was 6 months. The incision lengths, operation times, intraoperative blood loss, intraoperative fluoroscopies, guide needle punctures, postoperative Harris scores, and postoperative complications of the two groups were compared.
RESULTS


The incision length of the robot surgery group was 5.16 ± 0.41 cm, while that of the traditional surgery group was 7.42 ± 0.50 cm. The operation time of the robot surgery group was 46.99 ± 4.94 min, while that of the traditional surgery group was 55.01 ± 6.19 min. The fluoroscopy frequency of the robot surgery group was 10.50 ± 1.78 times, while that of the traditional surgery group was 17.91 ± 2.20 times. The intraoperative blood loss in the robotic surgery group was 20.62 ± 2.52 mL, while that in the conventional surgery group was 52.72 ± 3.39 mL. In the robot operation group, each femoral head guide needle was punctured three times, and the puncture was successful one time. The number of guided needle punctures in the traditional group was 8.02 ± 1.73. The difference between the two groups was statistically significant (P < 0.05). The Harris score was 69.53 ± 7.51 in the robot surgery group and 68.38 ± 7.26 in the traditional surgery group one month after surgery, 78.52 ± 6.49 in the robot surgery group and 76.41 ± 7.95 in the traditional surgery group three months after surgery, and 83.32 ± 8.62 in the robot surgery group and 81.74 ± 6.20 in the traditional surgery group six months after surgery. There was no significant difference between the two groups (P > 0.05). In the traditional group, there was one case of incision infection and one case of femoral head collapse during follow-up. In the robot group, there were no complications, such as incision infection and deep vein thrombosis. No collapse of the femoral head was found in the robot group during follow-up.
CONCLUSION


The positioning system of the orthopaedic robot is an ideal method for the treatment of femoral head necrosis. This method has the advantages of simple operation, accurate drilling, a short operation time, less surgical trauma, less radioactivity, and good recovery of hip joint function.",2020,"In the traditional group, there was one case of incision infection and one case of femoral head collapse during follow-up.","['Osteonecrosis of the Femoral Head', '30 cases with 41 femoral heads', '63 patients who underwent borehole decompression of the femoral head in our hospital from January 2016 to March 2019 were recruited']","['robot-assisted femoral head drilling decompression', 'Robot-Assisted Drilling Decompression']","['number of guided needle punctures', 'incision infection and deep vein thrombosis', 'incision lengths, operation times, intraoperative blood loss, intraoperative fluoroscopies, guide needle punctures, postoperative Harris scores, and postoperative complications', 'incision infection', 'collapse of the femoral head', 'incision length', 'fluoroscopy frequency', 'intraoperative blood loss', 'femoral head collapse', 'operation time']","[{'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",63.0,0.0163949,"In the traditional group, there was one case of incision infection and one case of femoral head collapse during follow-up.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Ya-Jing', 'Initials': 'YJ', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Long', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Lan', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Kai-Nan', 'Initials': 'KN', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}]",Orthopaedic surgery,['10.1111/os.12678']
293,32394650,[Significance and operation mode of moxibustion intervention for the group under quarantine after close contact with COVID-19].,"On the base of the idea of traditional Chinese medicine as ""disease prevention"", the mode and the protocol of the moxibustion intervention for the group under quarantine after close contact with coronavirus disease 2019 (COVID-19) were explored. The group under quarantine after close contact with COVID-19 was taken as the subjects. By the non-contact physician-patient communication network platform co-developed by China Association of Acupuncture-Moxibustion, Hunan Provincial Association of Acupuncture-Moxibustion, Data Center of China Academy of Chinese Medical Sciences and Yuge Medicine Company, an exploratory randomized controlled trial was designed. A total of 100 cases were included and randomized into a moxibustion group and a conventional intervention group, 50 cases in each one. In the moxibustion group, moxibustion intervention was used. In the conventional intervention group, the conventional observation was adopted without moxibusiton intervention applied. The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc. The results were evaluated before intervention, in 14 days of intervention and 2 weeks after intervention separately. In this research, on the base of internet plus technology and with the internet communication platform adopted, through mobile phone WeChat App, it was to implement the subject screen, the random allocation and the instruction of moxibustion intervention as well as the quality control of patient's diary and data collection. It is anticipated that the significance and the implementation mode of moxibustion intervention can be assessed preliminarily for the group under quarantine after close contact with COVID-19.",2020,"The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc.",['A total of 100 cases'],"['moxibustion intervention', 'moxibustion', 'conventional intervention']","['symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013985', 'cui_str': 'Emotional Disturbances'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",100.0,0.0282429,"The outcomes included the symptoms changes, e.g. anxiety, emotional disturbance, fatigue, headache and diarrhea, as well as whether quarantine release and the case confirmed or not, etc.","[{'ForeName': 'Mai-Lan', 'Initials': 'ML', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Ai', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Dai', 'Affiliation': 'Business School of Central South University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'First Affiliated Hospital of Hunan University of CM.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Chang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina of Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Bao-Yan', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing 100700.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200224-k0004']
294,32394651,[Acupuncture at acupoints along the meridians for primary insomnia: a multi-center randomized controlled trial].,"OBJECTIVE


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


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


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


The acupuncture at acupoints along the meridians could improve the sleep quality in patients with primary insomnia, and the therapeutic effect of acupoint along the meridians is better than that of non-acupoint.",2020,"The interclass and between-groups ET before and after treatment had no significant difference ( P >0.05).
","['patients with primary insomnia', '333 patients with primary insomnia', 'primary insomnia']","['acupuncture at Sanyinjiao (SP 6) and Baihui (GV 20', 'acupuncture', 'Acupuncture', 'acupuncture at non-acupoint and Baihui (GV 20']","['AIS scores', 'Pittsburgh sleep quality index (PSQI) and Athens insomnia scale (AIS) scores', 'PSQI scores', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",333.0,0.0267501,"The interclass and between-groups ET before and after treatment had no significant difference ( P >0.05).
","[{'ForeName': 'Xue-Fen', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xue-Na', 'Initials': 'XN', 'LastName': 'Zheng', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xin-Ran', 'Initials': 'XR', 'LastName': 'Wei', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Zeng-Hui', 'Initials': 'ZH', 'LastName': 'Yue', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190430-k0001']
295,32394652,[Therapeutic effect on post-stroke spastic paralysis of upper extremity treated with combination of kinematic-acupuncture therapy and rehabilitation training].,"OBJECTIVE


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


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


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


For the patients with post-stroke spastic paralysis of the upper extremity at the non-acute stage, the combined treatment with kinematic-acupuncture therapy and rehabilitation training obviously improves the motor function of the upper extremity and the muscle tone of elbow joint and metacarpophalangeal joint. The therapeutic effect of this combination is better than that of the combined treatment of the conventional acupuncture with rehabilitation training. Additionally, this combined therapy improves the ability of daily life activity.",2020,"Compared with the control group, MAS grades of elbow joint and metacarpophalangeal joint were improved more markedly in the observation group in 14 days of treatment ( P <0.05).",['60 patients of post-stroke spastic paralysis of the upper extremity at the non-acute stage'],"['conventional acupuncture with rehabilitation training', 'kinematic-acupuncture therapy and rehabilitation training']","['MAS grades of elbow joint and metacarpophalangeal joint', 'MBI score', 'score of simplified Fugl-Meyer scale of the upper extremity (FMA-UE), the grade of the modified Ashworth scale (MAS) and the score of the modified Barthel index scale (MBI', 'motor function of the upper extremity and the muscle tone of elbow joint and metacarpophalangeal joint', 'MAS grades of shoulder joint, elbow joint, wrist joint and metacarpophalangeal joint', 'FMA-UE score', 'ability of daily life activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085621', 'cui_str': 'Spastic paralysis'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal joint structure'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",60.0,0.0281837,"Compared with the control group, MAS grades of elbow joint and metacarpophalangeal joint were improved more markedly in the observation group in 14 days of treatment ( P <0.05).","[{'ForeName': 'Xin-Yun', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}, {'ForeName': 'Qiu-Fang', 'Initials': 'QF', 'LastName': 'Xia', 'Affiliation': 'Department of Chinese Medicine Rehabilitation, Shanghai First Rehabilitation Hospital.'}, {'ForeName': 'Hui-Wen', 'Initials': 'HW', 'LastName': 'Zhu', 'Affiliation': 'Department of Chinese Medicine Rehabilitation, Shanghai First Rehabilitation Hospital.'}, {'ForeName': 'Shu-Yun', 'Initials': 'SY', 'LastName': 'Jiang', 'Affiliation': 'Institute of Tuina, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Institute of Tuina, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM.'}, {'ForeName': 'Run-Jia', 'Initials': 'RJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190505-0006']
296,32394653,[Effect of early electroacupuncture intervention on conscious state of patients after traumatic brain injury surgery].,"OBJECTIVE


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


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


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


Early electroacupuncture intervention can effectively promote the recovery of consciousness after traumatic brain injury surgery, and has a curative long-term effect.",2020,"At 3 months of follow-up, the GOS and BI scores of the observation group were better than those of the control group ( P <0.05).
","['100 patients with traumatic coma', 'patients after traumatic brain injury surgery', 'patients after traumatic brain injury (TBI) surgery']","['electroacupuncture intervention', 'EA at Neiguan (PC 6) and Shuigou (GV 26) with disperse-dense wave, 2 Hz/100', 'electroacupuncture (EA', 'awakening drugs and neurotrophic drugs']","['GOS and BI scores', 'conscious state', 'Glasgow coma score (GCS', 'GCS scores', 'Glasgow outcome scale (GOS) and Barthel index (BI) scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394016', 'cui_str': 'Post-traumatic coma'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}]",100.0,0.0202375,"At 3 months of follow-up, the GOS and BI scores of the observation group were better than those of the control group ( P <0.05).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Xue-Ling', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Zi', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Chao-Hua', 'Initials': 'CH', 'LastName': 'Yang', 'Affiliation': 'Neurosurgery, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, First Affiliated Hospital of Southern University of Science and Technology.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190506-0005']
297,32386891,A Nitrate-Rich Vegetable Intervention Elevates Plasma Nitrate and Nitrite Concentrations and Reduces Blood Pressure in Healthy Young Adults.,"BACKGROUND


Emerging evidence suggests that increasing dietary nitrate intake may be an effective approach to reduce blood pressure. Beetroot juice is often used to supplement dietary nitrate, whereas nitrate intake levels from habitual diet are low. An increase in the habitual intake of nitrate-rich vegetables may represent an alternative to nitrate supplementation. However, the effectiveness and acceptability of a nitrate-rich-vegetables diet remain to be established.
OBJECTIVE


The aim was to investigate the effect and feasibility of two different intervention strategies to increase dietary nitrate intake, on plasma nitrate/nitrite concentrations and blood pressure.
DESIGN


A randomized, crossover trial was used.
PARTICIPANTS


Participants were healthy men and women (both n=15; age: 24±6 years) from the Netherlands.
INTERVENTION


Participants were instructed to consume ∼400 mg nitrate at lunch, provided through nitrate-rich vegetables and dietary counseling, or beetroot juice supplementation. Both interventions lasted 1 week, with 1-week washout (January to April 2017).
MAIN OUTCOME


Plasma nitrate and nitrite concentrations and resting systolic and diastolic blood pressure were measured in an overnight fasted state (before and after intervention) and ∼2.5 hours after lunch (before and throughout intervention on day 1, 4, and 7).
STATISTICAL ANALYSIS


Two-factor (time × treatment) repeated-measures analyses of variance were performed.
RESULTS


Mean plasma nitrate concentrations increased with both interventions, with a larger increase in beetroot juice vs nitrate-rich vegetables, both in a fasted state and ∼2.5 hours after lunch (day 1, beetroot juice: 2.31±0.56 mg/dL [373±90 μmol/L] vs nitrate-rich vegetables: 1.71±0.83 mg/dL [277±134 μmol/L]; P<0.001). Likewise, mean plasma nitrite concentrations increased with both interventions, but were higher after lunch in beetroot juice than in nitrate-rich vegetables (day 1: 2.58±1.52 μg/dL [560±331 nmol/L] vs 2.15±1.21 μg/dL [468±263 nmol/L]; P=0.020). Fasting mean systolic and diastolic blood pressure did not change, but mean systolic and diastolic blood pressure assessed ∼2.5 hours after lunch were significantly reduced throughout both intervention periods (P<0.05), with no differences between beetroot juice and nitrate-rich vegetables (day 1, systolic blood pressure: -5.1±9.5 mm Hg and diastolic blood pressure: -5.3±8.9 mm Hg).
CONCLUSION


Short-term consumption of dietary nitrate in the form of nitrate-rich vegetables represents an effective means to increase plasma nitrate and nitrite concentrations, and reduces blood pressure to the same extent as beetroot juice supplementation.",2020,"Fasting mean systolic and diastolic blood pressure did not change, but mean systolic and diastolic blood pressure assessed ∼2.5 hours after lunch were significantly reduced throughout both intervention periods (P<0.05), with no differences between beetroot juice and nitrate-rich vegetables (day 1, systolic blood pressure:","['Two-factor (time\xa0× treatment', 'Healthy Young Adults', 'Participants were healthy men and women (both n=15; age: 24±6 years) from the Netherlands']","['consume ∼400 mg nitrate at lunch, provided through nitrate-rich vegetables and dietary counseling, or beetroot juice supplementation', 'Nitrate-Rich Vegetable Intervention', 'dL']","['mean plasma nitrite concentrations', 'blood pressure', 'Mean plasma nitrate concentrations', 'beetroot juice vs nitrate-rich vegetables', 'plasma nitrate/nitrite concentrations and blood pressure', 'plasma nitrate and nitrite concentrations', 'mean systolic and diastolic blood pressure assessed ∼2.5 hours after lunch', 'beetroot juice and nitrate-rich vegetables (day 1, systolic blood pressure', 'Fasting mean systolic and diastolic blood pressure', 'Plasma nitrate and nitrite concentrations and resting systolic and diastolic blood pressure']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1879668', 'cui_str': 'After lunch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",,0.0144949,"Fasting mean systolic and diastolic blood pressure did not change, but mean systolic and diastolic blood pressure assessed ∼2.5 hours after lunch were significantly reduced throughout both intervention periods (P<0.05), with no differences between beetroot juice and nitrate-rich vegetables (day 1, systolic blood pressure:","[{'ForeName': 'Cindy M T', 'Initials': 'CMT', 'LastName': 'van der Avoort', 'Affiliation': ''}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Jonvik', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nyakayiru', 'Affiliation': ''}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': ''}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': ''}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2020.02.014']
298,32386922,Stability of acute responses to drugs in humans across repeated testing: Findings with alcohol and amphetamine.,"BACKGROUND


Controlled drug challenge studies provide valuable information about the acute behavioral effects of drugs, including individual differences that may affect risk for abuse. One question that arises in such studies is whether a single administration of a drug (and placebo) provides an accurate measure of response to the drug.
METHODS


Here, we examined data from two studies, one with alcohol and one with amphetamine, in which participants received two administrations of the drug and placebo. In this analysis we assess the stability of acute subjective and cardiovascular responses to the drugs across the two administrations. We examine i) systematic increases or decreases to the drugs from the first to the second administration, ii) test-retest reliability within individuals and iii) the accuracy of the acute drug responses to predict drug choice in a later session.
RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies. Test-retest reliability within individuals was high. Responses during the first drug administration were as accurate in predicting drug choice as responses during both administrations combined.
CONCLUSIONS


Our findings indicate that a single administration of drug (and placebo) provides a good index of an individual's responses to alcohol or amphetamine, when participants are tested under controlled experimental conditions.",2020,"RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.",[],"['drug (and placebo', 'amphetamine', 'placebo']",['stability of acute subjective and cardiovascular responses'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0465427,"RESULTS


Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA. Electronic address: hdew@uchicago.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107989']
299,32386939,Effect of Protective Cover on the Quality of Life of Patients With Tracheostomy-A Quasi-Experimental Study.,"PURPOSE


Patients with tracheostomy experience problems such as the inability to speak, swallowing disorders, and impairment of body image. These problems adversely affect patients' quality of life (QoL). This study aimed to investigate the effect of discharge training and the use of a protective cover on the QoL of patients with tracheostomy and the problems experienced after discharge.
DESIGN


A quasi-experimental study.
METHODS


All patients (n = 24) were followed for 3 months after the preoperative period. Patients in the control group (CG) received routine care after surgery, whereas patients in the intervention group (IG) received routine care, discharge training, and a protective stoma cover.
FINDINGS


The 90th postdischarge day QoL scores between the CG and IG were statistically significant. Respiratory problems were the most common postdischarge problems in both groups. Patients in the CG significantly experienced more problems than those in the IG during the postdischarge period.
CONCLUSIONS


This study provides that patients can benefit from discharge training and protective cover and that health care professionals become aware of the cover for future use.",2020,"Patients in the CG significantly experienced more problems than those in the IG during the postdischarge period.
","['patients with tracheostomy and the problems experienced after discharge', 'Patients With Tracheostomy-A Quasi-Experimental Study', 'Patients with tracheostomy experience problems']","['discharge training', 'routine care, discharge training, and a protective stoma cover', 'Protective Cover']","['90th postdischarge day QoL scores', ""patients' quality of life (QoL"", 'Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",24.0,0.0315949,"Patients in the CG significantly experienced more problems than those in the IG during the postdischarge period.
","[{'ForeName': 'Çiğdem Canbolat', 'Initials': 'ÇC', 'LastName': 'Seyman', 'Affiliation': 'Faculty of Nursing, Department of Surgical Nursing, Hacettepe University, Ankara, Turkey. Electronic address: cigdem_canbolat@hotmail.com.'}, {'ForeName': 'Sevilay Şenol', 'Initials': 'SŞ', 'LastName': 'Çelik', 'Affiliation': 'Faculty of Nursing, Koç University, İstanbul, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.01.013']
300,32386940,Effects of Relaxation Techniques on Acute Postlaminectomy Pain: A Three-Arm Randomized Controlled Clinical Trial.,"PURPOSE


This study compared the effects of Benson relaxation with progressive muscle relaxation on pain severity after laminectomy.
DESIGN


Three-arm randomized, nonblinded, and parallel group trial.
METHODS


The study was conducted with 93 patients who underwent lumbar laminectomy. Patients were randomly assigned to three groups of Benson relaxation + routine care (n = 31), progressive muscle relaxation + routine care (n = 31), and routine care (n = 31). The two relaxation methods were performed at 2 (time 1), 12 (time 2), and 24 (time 3) hours after patients' regaining full consciousness in postoperative wards. Pain severity was assessed using the visual analog scale once before laminectomy, before and also 20 minutes after each relaxation session. In the control group, pain severity was measured at the same times as in the two relaxation groups.
FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group). However, no significant differences were found between Benson relaxation and progressive muscle relaxation in any of the three times.
CONCLUSIONS


The results suggest that both Benson and progressive muscle relaxation techniques can decrease acute postlaminectomy pain in the immediate postoperative period in adult patients.",2020,"FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group).","['adult patients', '93 patients who underwent lumbar laminectomy', 'Acute Postlaminectomy Pain']","['Relaxation Techniques', 'Benson relaxation with progressive muscle relaxation', 'Benson relaxation\xa0+\xa0routine care (n\xa0= 31), progressive muscle relaxation\xa0+\xa0routine care (n\xa0= 31), and routine care']","['acute postlaminectomy pain', 'Benson relaxation and progressive muscle relaxation', 'Pain severity', 'pain severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",93.0,0.0186028,"FINDINGS


Both Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group).","[{'ForeName': 'Seyed Amir Hosein', 'Initials': 'SAH', 'LastName': 'Pishgooie', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fakhridokht', 'Initials': 'F', 'LastName': 'Akbari', 'Affiliation': 'Department of Nursing, Behbahan Faculty of Medical Sciences, Behbahan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Keyvanloo Shahrestanaki', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Operating Room Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Momen', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing, AJA University of Medical Sciences, Tehran, Iran. Electronic address: Rezamomen88@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.02.004']
301,32387007,Intramuscular Versus Buccal Midazolam for Pediatric Seizures: A Randomized Double-Blinded Trial.,"BACKGROUND


We compared the efficacy and safety of intramuscular with buccal midazolam as first-line treatment for active seizures in children brought to the emergency department.
METHODS


In a double-blind, double-dummy randomized trial, patients with an active seizure lasting more than five minutes received blinded treatments on arrival. We employed deferred consent. The proportion of patients with cessation of seizure within five minutes of drug administration was the primary efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects were secondary outcomes.
RESULTS


We enrolled 150 children presenting with active seizure, age range 4.5 to 167.5 months. Cessation of seizure occurred in 61% of the intramuscular and 46% of the buccal treatment groups, (P = 0.07, difference 15.5%, 95% confidence interval for the difference -1.0 to 32.0%). Proportions requiring additional anti-seizure treatment were 39% in the intramuscular and 51% in the buccal groups. Mean duration of seizure activity after administration of study medication was 15.9 minutes (S.D. 28.7) in the intramuscular and 17.8 minutes (S.D. 27.5) in the buccal group. One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
CONCLUSIONS


Efficacy and safety of intramuscular midazolam as first-line treatment for pediatric seizures compare favorably to that of buccal midazolam.",2020,"One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
","['150 children presenting with active seizure, age range 4.5 to 167.5\xa0months', 'active seizures in children brought to the emergency department', 'Pediatric Seizures', 'patients with an active seizure lasting more than five\xa0minutes received blinded treatments on arrival']","['buccal midazolam', 'Intramuscular Versus Buccal Midazolam', 'midazolam']","['efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects', 'Proportions requiring additional anti-seizure treatment', 'efficacy and safety', 'respiratory depression and hypotension', 'Mean duration of seizure activity', 'Cessation of seizure']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0730597', 'cui_str': 'Duration of seizure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",150.0,0.442737,"One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.
","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Alansari', 'Affiliation': 'Department of Emergency Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine - Qatar, Doha, Qatar. Electronic address: dkmaa@hotmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Barkat', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'AbdelNasir H', 'Initials': 'AH', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Shahaza Alali', 'Initials': 'SA', 'LastName': 'Al Jawala', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Shadi Ahmad', 'Initials': 'SA', 'LastName': 'Othman', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Emergency Medicine, Hamad Medical Corporation, Doha, Qatar.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.03.011']
302,32387012,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in ≥56-year-olds: A Phase III randomized study.,"BACKGROUND


Invasive meningococcal disease has a high mortality rate in individuals aged ≥56 years, but no vaccine is currently licensed in the USA for this age group. This study assessed the safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) compared with a meningococcal quadrivalent polysaccharide vaccine (MPSV4) in this age group.
METHODS


This was a Phase III, modified double-blind, randomized, non-inferiority study (NCT02842866) across 35 clinical sites in the USA and Puerto Rico in individuals aged ≥56 years. A single dose of the MenACYW-TT (n = 451) or MPSV4 vaccine (n = 455) was administered on Day 0. A serum bactericidal assay with human (hSBA) and baby rabbit (rSBA) complement was used to measure antibodies against serogroups A, C, W, and Y test strains at baseline and Day 30. Safety data were collected up to six months post-vaccination.
RESULTS


The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively). At Day 30, participants achieving hSBA titers ≥1:8 were higher for all serogroups after MenACYW-TT vs. MPSV4 (77.4-91.7 vs. 63.1-84.2%, respectively). No safety concerns were identified for either vaccine.
CONCLUSION


MenACYW-TT was well-tolerated and immunogenic in ≥56-year-olds, offering the potential to replace MPSV4 in this age group.",2020,"The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively).","['≥56-year-olds', 'individuals aged ≥56\xa0years', '35 clinical sites in the USA and Puerto Rico in individuals aged ≥56\xa0years']","['quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'meningococcal quadrivalent polysaccharide vaccine (MPSV4', 'investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT', 'MPSV4 vaccine', 'human (hSBA) and baby rabbit (rSBA']","['Immunogenicity and safety', 'hSBA titers ≥1:8', 'safety and immunogenicity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.257761,"The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively).","[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Esteves-Jaramillo', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: Alex.Esteves@sanofi.com.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Koehler', 'Affiliation': 'Heartland Research Associates, LLC, Wichita, KS, USA. Electronic address: tmk@heartlandresearch.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeanfreau', 'Affiliation': 'MedPharmics LLC, Metairie, LA, USA. Electronic address: robertjeanfreau@medpharmics.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neveu', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: david.neveu@sanofi.com.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: emilia.jordanov@sanofi.com.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Singh Dhingra', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: mandeepsingh.dhingra@sanofi.com.'}]",Vaccine,['10.1016/j.vaccine.2020.04.067']
303,32387214,"Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis- an open Labeled, randomized controlled trial.","AIMS & OBJECTIVES


The hand-sewn method of bowel anastomosis is the most common because of its affordability, familiarity and easy availability of materials. It can be done in single or double layers, with different surgeons preferring one technique over the other. Double layer intestinal anastomosis (DLIA) is time-consuming, challenging to perform, and carries possibly a higher risk of devascularisation, infection, and necrosis. Studies conducted so far do not show a significant difference between the two, but have concluded that more studies are required to determine this definitively. This study attempted to see whether the single layer intestinal anastomosis (SLIA) is non-inferior to DLIA in terms of incidence of anastomotic leak. It also compared mortality, morbidity, and length of hospitalisation (LOH) between the two groups.
MATERIALS AND METHODS


This was a parallel arm, open labelled, non-inferiority randomized controlled trial conducted in the department of surgery in a tertiary care centre between October 2016 and March 2018. Patients who fulfilled the inclusion criteria were randomly allotted to two groups: Patients undergoing SLIA and patients undergoing DLIA. After the procedure, all patients were assessed for anastomotic leak, morbidity, mortality and LOH in the postoperative period. A 3-month follow-up period was observed for complications.
RESULTS


A total of 106 patients were randomised, 52 in SLIA and 54 in DLIA. Baseline demographic and clinicopathological characteristics between the two groups were comparable. The most common indication for intestinal anastomosis was ostomy closure in both groups. There was no significant difference between the two groups in terms of anastomotic leak, other complications, mortality and LOH.
CONCLUSION


SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.",2020,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","['Patients who fulfilled the inclusion criteria', 'department of surgery in a tertiary care centre between October 2016 and March 2018', '106 patients were randomised, 52 in SLIA and 54 in DLIA']","['single layered intestinal anastomosis', 'single layer intestinal anastomosis (SLIA', 'Double layer intestinal anastomosis (DLIA', 'SLIA and patients undergoing DLIA']","['anastomotic leak, other complications, mortality and LOH.\nCONCLUSION', 'mortality, morbidity, and length of hospitalisation (LOH', 'Baseline demographic and clinicopathological characteristics', 'anastomotic leak, morbidity, mortality, and the length of hospitalisation', 'anastomotic leak, morbidity, mortality and LOH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",106.0,0.173847,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aniruthan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Amuda Ravichandar', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Gubbi Shamanna', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: dr.sreenathgs@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.066']
304,32387326,The Influence of Postoperative Environment on Patient Pain and Satisfaction: A Randomized Trial.,"BACKGROUND


Improving the patient experience, controlling pain with non-opiate therapies, and preparing for value based reimbursement are increasingly important foci for both physicians and hospitals.
OBJECTIVES


We sought to determine if the addition of music and a natural landscape image to postoperative hospital rooms would result in improved pain and satisfaction scores among inpatients undergoing pelvic reconstructive surgery.
STUDY DESIGN


This was an Institutional Review Board approved, randomized controlled trial. Eligible candidates were 18-85 years old, English speaking, and scheduled to undergo native tissue vaginal vault suspension for symptomatic pelvic organ prolapse. Exclusions included history of a chronic pain or substance abuse. Subjects were advised the purpose of the study was to assess the impact of changes to the hospital environment on patient experience, but were blinded to their group and intervention details. Changes included a landscape image mounted to the wall, as well as access to a speaker with preprogrammed music selections. The intervention group was instructed to listen to their preferred music for a minimum of two 30-minute sessions postoperatively. The control group had a standard hospital room, without music or landscape. All patient rooms were private. The primary outcome was the Visual Analogue Scale (VAS) for pain on the morning of post-operative day one. Secondary outcomes included narcotic use, likelihood to refer family to the same hospital facility, satisfaction with care and the hospital, and perception of a healing environment. A sample size of 43 subjects per arm was calculated in order to detect a difference of 10mm in VAS pain score.
RESULTS


One hundred thirty-three subjects were enrolled; primary outcome data was available for 92 (46 per arm). The mean age was 63.8 (SD 9.5) years, median Charlson Comorbidity score was 2 (min=0,max=7), and 94.6% were Caucasian. On postoperative day one, median VAS scores for pain were low (28.8mm (0,86), 24.5mm (0,81)), and did not differ between intervention and control, respectively (p=0.57). Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar. However, the intervention group displayed a higher likelihood to refer family members to the hospital (98mm(47, 100), 96mm(65, 100), p=0.037). At 2 weeks postoperative, the intervention group demonstrated higher satisfaction with their care (98mm (34, 100), 95mm (42, 100), p=0.032), the hospital (98mm (71, 100), 94mm (6, 100), p=0.004), and the healing environment provided during their stay (98mm (52, 100), 92mm (19, 100), p=0.020), than those in standard hospital rooms.
CONCLUSION


In this randomized trial, we demonstrated music and landscape imagery did not significantly impact post-operative pain scores, however they had a positive impact on the postoperative experience. Further, this impact appeared to broaden two weeks following surgery. Given the importance of value-based care, interventions such as these should be emphasized in an effort to enhance patient satisfaction, quality scores and overall well-being.",2020,Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar.,"['One hundred thirty-three subjects were enrolled; primary outcome data was available for 92 (46 per arm', 'The mean age was 63.8 (SD 9.5) years, median Charlson Comorbidity score was 2 (min=0,max=7), and 94.6% were Caucasian', 'inpatients undergoing pelvic reconstructive surgery', 'Exclusions included history of a chronic pain or substance abuse', 'Eligible candidates were 18-85 years old, English speaking, and scheduled to undergo native tissue vaginal vault suspension for symptomatic pelvic organ prolapse']","['standard hospital room, without music or landscape', 'Postoperative Environment']","['VAS pain score', 'Total morphine equivalents', 'healing environment', 'nursing pain scores', 'narcotic use, likelihood to refer family to the same hospital facility, satisfaction with care and the hospital, and perception of a healing environment', 'Patient Pain and Satisfaction', 'higher satisfaction with their care', 'Visual Analogue Scale (VAS) for pain on the morning of post-operative day one', 'pain and satisfaction scores', 'median VAS scores for pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0227794', 'cui_str': 'Structure of fornix of vagina'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",133.0,0.174362,Total morphine equivalents (p=0.817) and nursing pain scores (p=0.774) were also similar.,"[{'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Division FPMRS.'}, {'ForeName': 'Catrina C', 'Initials': 'CC', 'LastName': 'Crisp', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Division FPMRS.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Shatkin-Margolis', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Division FPMRS.'}, {'ForeName': 'Tiffanie', 'Initials': 'T', 'LastName': 'Tam', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Division FPMRS.'}, {'ForeName': 'Eunsun', 'Initials': 'E', 'LastName': 'Yook', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Hatton Research Institute.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kleeman', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Division FPMRS.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Pauls', 'Affiliation': 'Cincinnati, Ohio, TriHealth Good Samaritan Hospital, Division FPMRS.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.006']
305,32387408,"A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma.","INTRODUCTION


Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β 2 -agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®.
METHODS


This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. The study population was enriched for patients who were responsive to ICS therapy. The primary objective of the present study was to show non-inferiority of these doses, i.e. the low (80 μg) and high (320 μg) doses of MF delivered via Breezhaler® once daily, compared with the corresponding low (200 μg) and high (800 μg) doses of MF delivered via Twisthaler® once daily. The primary endpoint was 24h post-dose trough forced expiratory volume in one second (FEV 1 ), after four weeks of treatment in patients with asthma. A secondary objective was to evaluate the efficacy of MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler® in terms of Asthma Control Questionnaire-5 (ACQ-5) after one, two, three and four weeks of treatment.
RESULTS


The LS mean difference in trough FEV 1  after four weeks of treatment between MF low dose 80 μg (Breezhaler®) and MF low dose 200 μg (Twisthaler®) was 27 mL (95% CI -34, 89); for MF high dose 320 μg (Breezhaler®) and MF high dose 800 μg (Twisthaler®) the difference was 0 mL (95% CI -60, 61). These differences were neither clinically nor statistically significant. All treatment arms provided similar clinically relevant improvements in ACQ-5 after four weeks of treatment compared with baseline. Both treatments showed a similar safety profile with a low incidence of adverse events.
CONCLUSION


The similarities in effects on lung function and ACQ after four weeks of treatment demonstrate the comparability of MF at low (80 μg) and high (320 μg) doses delivered with Breezhaler® with MF at low (200 μg) and high (800 μg) doses delivered with Twisthaler®, respectively. The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.",2020,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","['739 adolescents and adults with persistent asthma', 'patients with asthma', 'patients who were responsive to ICS therapy']","['ICS', 'MF 80 μg and 320 μg delivered via Breezhaler®, and MF 200 μg and 800 μg delivered via Twisthaler®', 'Mometasone furoate (MF', 'MF high dose 800 μg (Twisthaler®', 'mometasone furoate delivered via Breezhaler® or Twisthaler®']","['ACQ-5', 'efficacy and safety', '24h post-dose trough forced expiratory volume in one second (FEV 1 ', 'lung function and ACQ']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",739.0,0.543909,"The study formally demonstrated that MF, delivered via Breezhaler®, is non-inferior to MF, delivered via Twisthaler® at corresponding ICS doses.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Tanase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Motoi', 'Initials': 'M', 'LastName': 'Hosoe', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Demin', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patalano', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hederer', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kanniess', 'Affiliation': 'Gemeinschaftspraxis Reinfeld, Reinfeld, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland. Electronic address: hanns-christian.tillmann@novartis.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101919']
306,32289353,Risk of contamination when planning psychological therapy trials can be assessed using a simple framework.,"OBJECTIVES


The objective of this study was to develop and pilot a standard framework that could be used to assess risk of contamination in psychological therapy trials, at the protocol development stage.
STUDY DESIGN AND SETTING


We developed and piloted a risk of contamination framework on a sample of 100 psychological therapy trial protocols registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry (www.isrctn.com). We assessed all protocols as being low or high risk via three possible sources of contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm.
RESULTS


Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%). We identified 14 studies that had a potentially high risk for contamination. Most of these (N = 10) were identified as risk of contamination arising from a therapist in the intervention arm.
CONCLUSION


The risk of contamination framework we piloted in this study could be a helpful tool for researchers aiming to identify and manage risk of contamination in their trial protocol development. We found that the risk of contamination was relatively low in the psychological therapy trials we sampled for this study, as measured by our framework, and could usually be mitigated through reasonable adjustments to the study design.",2020,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","['contamination: 1) participants in the control arm, 2) participants in the intervention arm, 3) therapists in the intervention arm']",[],['risk of contamination'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",10.0,0.109149,"Overall, we found that the risk of contamination across all three sources was low for most studies (86 of 100 trial protocols; 86%).","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': ""Department of Psychology, University of Bath, Bath BA2 7AY; King's College London, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), De Crespigny Park, London SE5 8AF. Electronic address: p.c.jacobsen@bath.ac.uk.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Acute and Rehabilitation Directorate Psychology Team, North East London NHS Foundation Trust, Goodmayes Hospital, Barley Lane, Ilford IG3 8XJ; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road W1T 7DN.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.04.005']
307,32388179,Do menopausal status and APOE4 genotype alter the long-term effects of intensive lifestyle intervention on cognitive function in women with type 2 diabetes mellitus?,"In the Look AHEAD trial, randomization to Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE) did not result in differences in cognitive outcomes. However, menopause and APOE genotype are factors that affect the response to this intervention. The effect of this intervention on a single cognitive assessment was examined in 3 groups of women: premenopausal or <5 years postmenopausal (N = 594), within 5-10 years (n = 388), and ≥10 years postmenopausal (n = 963), and as a function of continuous years since menopause. The late postmenopausal group in the ILI had worse composite z-scores compared to those in the DSE, whereas the younger premenopausal or early postmenopausal women in the ILI had better composite z-scores than the DSE. A significant interaction between years since menopause and intervention arm, but not baseline age, was observed on executive function domains. ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause. These findings emphasize the importance of assessing menopause and APOE status to understand how weight loss impacts cognition.",2020,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"['women with type 2 diabetes mellitus', '3 groups of women: premenopausal or <5\xa0years postmenopausal (N\xa0= 594), within 5-10\xa0years (n\xa0= 388), and ≥10\xa0years postmenopausal (n\xa0= 963), and as a function of continuous years since menopause']","['Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE', 'intensive lifestyle intervention']","['cognitive function', 'composite z-scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.020602,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"[{'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: hyassine@usc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Brinton', 'Affiliation': 'Departments of Pharmacology and Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Hugenschmidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2020.03.020']
308,32388198,Cost-Effectiveness Analysis of Xpert MTB/RIF for Multi-Outcomes of Presumptive Pulmonary Tuberculosis Patients in Thailand.,"OBJECTIVES


The cost-effectiveness of screening adult patients for pulmonary tuberculosis is not clear. As such, this study aims to identify the cost-effectiveness between the Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear. Multi-outcomes were correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs).
METHODS


A decision tree model was constructed to reveal a possible clinical pathway of tuberculosis diagnosis. The researchers used a clinical study to establish the probability of all clinical pathways for input into this model. The sample size was calculated following the correct diagnosis. Participants were randomly divided into 2 groups. A structural questionnaire and the Thai version of quality of life (EQ-5D-5L) were used for interviewing.
RESULTS


The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear. Both the correct diagnosis and QALYs of the base case analysis presented the Xpert MTB/RIF method as dominant. A Monte Carlo model, which analyzed the Xpert MTB/RIF method, revealed that the average number of patients who were correctly diagnosed was 673, the QALYs were 945.85 years, and the total cost was $143 110.64. For the sputum AFB smear method, the average number who received a correct diagnosis was 592, the QALYs were 940.40 years, and the total cost was $196 666.84. Probabilistic and one-way sensitivity analysis confirmed that the Xpert MTB/RIF remained dominant.
CONCLUSIONS


These results provide useful information for the National Strategic Plan to screen all adult patients for pulmonary tuberculosis.",2020,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"['Presumptive Pulmonary Tuberculosis Patients in Thailand', 'adult patients for pulmonary tuberculosis']","['Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear', 'Xpert MTB/RIF']","['total cost', 'correct diagnosis', 'quality of life (EQ-5D-5L', 'cost-effectiveness', 'correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1318720', 'cui_str': 'Acid fast stain'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0222549,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"[{'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Khumsri', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Department of Preventive and Social Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Hanvoravongchai', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Thailand Research Center for Health Services System, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Hiransuthikul', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand. Electronic address: nhiransu@yahoo.com.'}, {'ForeName': 'Charoen', 'Initials': 'C', 'LastName': 'Chuchottaworn', 'Affiliation': 'Department of Medical Services, Central Chest Institute of Thailand, Ministry of Public Health, Nonthaburi, Thailand.'}]",Value in health regional issues,['10.1016/j.vhri.2019.09.010']
309,32388274,Effects of seafood consumption on mercury exposure in Norwegian pregnant women: A randomized controlled trial.,"BACKGROUND


Seafood provides nutrients that are important for optimal development of the unborn child. However, seafood is also a source of contaminants including mercury (Hg) and methylmercury (MeHg) that may have adverse effects on neurodevelopment of the fetus. Humans are predominantly exposed to MeHg through seafood consumption, however, levels of MeHg vary considerably between species.
OBJECTIVES


Investigate, in a randomized controlled trial (RCT) during pregnancy, if an increased intake of Atlantic cod (Gadus morhua), a fish species with relatively low levels of MeHg contamination, influences total hair Hg (THHg) concentrations in humans.
METHODS


Pregnant women (n = 137) were enrolled in the RCT ""Mommy's Food"" (2016-2017), which was designed to increase iodine status. Participants were randomly assigned to intervention (400 g of cod fillets per week) or control (continued habitual diet) groups for 16 weeks (gestational week 20-36). THHg concentrations were measured at baseline and post-intervention using thermal decomposition, amalgamation, and atomic absorption spectrophotometry (US EPA method 7473). The trial is registered in ClinicalTrials.gov, NCT02610959.
RESULTS


Post-intervention, the intervention group had median (inter-quartile range) THHg concentrations of 554 (392-805) µg/kg, and the control group 485 (341-740) µg/kg (p = 0.186). When adjusting for baseline THHg concentrations, there was a significant difference between the groups in those participants with baseline THHg concentrations below 534 µg/kg. Post-intervention, 8% of the study population exceeded the US EPA reference dose in hair (1,000 µg/kg) (intervention group: n = 6, control group: n = 4).
CONCLUSION


THHg concentrations were generally low in both study groups of pregnant women, despite the relatively high seafood intake. While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.",2020,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","['Pregnant women (n\u202f=\u202f137', 'Norwegian pregnant women', 'humans']","['RCT', 'seafood consumption', 'intervention (400\xa0g of cod fillets per week) or control (continued habitual diet']","['total hair Hg (THHg) concentrations', 'iodine status', 'THHg concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0184934', 'cui_str': 'Filleting'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",7473.0,0.204374,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","[{'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway. Electronic address: synnoeve.naess@hi.no.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Nerhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisa Kolden', 'Initials': 'LK', 'LastName': 'Midtbø', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Bank', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway; University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Josef D', 'Initials': 'JD', 'LastName': 'Rasinger', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Maria Wik', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}]",Environment international,['10.1016/j.envint.2020.105759']
310,32388690,Challenging the Stigma of Mental Illness Through Creative Storytelling: A Randomized Controlled Trial of This Is My Brave.,"This Is My Brave (TIMB) is a contact-based mental illness stigma reduction program set in theaters. A randomized controlled trial of TIMB, compared the effect of TIMB videos to a comparison and control condition video. Pre- and post-surveys (153 adults) assessed mental illness stigma, beliefs about recovery and empowerment, and willingness to seek treatment. Univariate ANCOVAs revealed participants in the TIMB video condition experienced a greater reduction in perceived difference from people with mental illnesses than the comparison and control groups. Participants in the comparison and TIMB video conditions experienced greater reductions in social distance than the control group. Contrary to our hypothesis, participants in the TIMB video condition did not endorse improved beliefs about recovery and empowerment as compared to the comparison and control groups. These findings provide evidence for TIMB as an effective program for stigma reduction, particularly reducing perceived difference from people with mental illnesses and decreasing desired social distance.",2020,Univariate ANCOVAs revealed participants in the TIMB video condition experienced a greater reduction in perceived difference from people with mental illnesses than the comparison and control groups.,[],"['TIMB videos', 'Creative Storytelling', 'TIMB']","['social distance', 'mental illness stigma, beliefs about recovery and empowerment, and willingness to seek treatment']",[],"[{'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",153.0,0.108947,Univariate ANCOVAs revealed participants in the TIMB video condition experienced a greater reduction in perceived difference from people with mental illnesses than the comparison and control groups.,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kosyluk', 'Affiliation': 'Department of Mental Health Law & Policy, College of Behavioral and Community Sciences, The University of South Florida, 13301 Bruce B Downs Blvd, MHC 2735, Tampa, FL, 33612, USA. kkosyluk@usf.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'This Is My Brave, Leesburg, USA.'}, {'ForeName': 'Kyaien', 'Initials': 'K', 'LastName': 'Conner', 'Affiliation': 'University of South Florida, Tampa, USA.'}, {'ForeName': 'Diana Rivera', 'Initials': 'DR', 'LastName': 'Macias', 'Affiliation': 'University of Texas at El Paso, El Paso, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Macias', 'Affiliation': 'University of Texas at El Paso, El Paso, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Michelle Beekman', 'Affiliation': 'University of South Florida, Tampa, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Her', 'Affiliation': 'University of South Florida, Tampa, USA.'}]",Community mental health journal,['10.1007/s10597-020-00625-4']
311,32388694,Supporting Infant Emotion Regulation Through Attachment-Based Intervention: a Randomized Controlled Trial.,"Infant emotion regulation has long-term implications for human development, highlighting the need for preventive interventions that support emotion regulation early in life. Such interventions may be especially important for infants higher in emotional reactivity who need to regulate their emotions more frequently and intensely than infants lower in emotional reactivity. The current randomized trial examined main and moderated effects of an attachment-based intervention on (a) infants' use of mother-oriented and self-soothing emotion regulation strategies and (b) infant emotion dysregulation in 186 low-income, predominantly Latino infants. We tested the brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention in the context of home-based federal Early Head Start (EHS) services. Control participants received home-based EHS plus 10 weekly books. Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31). Infant emotional reactivity moderated intervention impacts on mother-oriented emotion regulation strategies and on infant emotion dysregulation: We found stronger effects of the intervention for infants relatively higher in emotional reactivity. Findings are discussed in terms of the preventive value of attachment-based interventions for supporting early emotion regulation.",2020,Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31).,"['186 low-income, predominantly Latino infants', 'infants relatively higher in emotional reactivity']","['home-based EHS plus 10 weekly books', 'attachment-based intervention', 'brief (10-session) Attachment and Biobehavioral Catch-up (ABC) intervention', 'mother-oriented and self-soothing emotion regulation strategies and (b) infant emotion dysregulation']",['infant emotion dysregulation'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",186.0,0.0256925,Intent-to-treat analyses with covariates revealed main effects of the intervention on infants' use of mother-oriented emotion regulation strategies during a brief (40-s) novel and potentially fear-inducing procedure (d = 0.31).,"[{'ForeName': 'Allison D', 'Initials': 'AD', 'LastName': 'Hepworth', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood St., Baltimore, MD, 21201, USA. allison.hepworth@ssw.umaryland.edu.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Berlin', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood St., Baltimore, MD, 21201, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Martoccio', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Cannon', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Berger', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Brenda Jones', 'Initials': 'BJ', 'LastName': 'Harden', 'Affiliation': 'University of Maryland, College Park, MD, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01127-1']
312,32388774,Greek Traditional Dance as a Practice for Managing Stress and Anxiety in Cancer Patients.,"Stress and anxiety levels in cancer patients tend to decrease by performing bodily-kinesthetic and musical activities. The hypothesis of the present study is that attending lessons in Greek traditional dance is an effective method for managing anxiety and stress in patients diagnosed with cancer of any type both during and after treatment. The study was conducted on 300 cancer patients (150 experimental subjects, 150 controls) selected by Attica hospitals and nonprofit cancer patients' organizations. Each patient in the experimental group attended an 8-week Greek traditional dance lesson program. Lessons were held twice per week, lasting 60 min each. A similar group of cancer patients not participating in any organized physical activity during the same time period served as a control group. Data were collected using the Depression Anxiety Stress Scale 21 (Dass-21) questionnaire and subjected to reliability analysis (Cronbach's alpha) and deviation-dependent analysis (one-way repeated). Both stress and anxiety values decreased significantly in the experimental group (stress value: initial mean = 16.27, second mean = 2.58, final mean = 6.77, p < 0.001; anxiety value: initial mean = 15.59, second mean = 2.81, final mean = 5.35, p < 0.001). In contrast, no significant fluctuation was observed in the control group. Thus, there was a significant decrease in stress and anxiety values in cancer patients who attended Greek traditional dances lessons with important psychotherapeutic significance.",2020,"Both stress and anxiety values decreased significantly in the experimental group (stress value: initial mean = 16.27, second mean = 2.58, final mean = 6.77, p < 0.001; anxiety value: initial mean = 15.59, second mean = 2.81, final mean = 5.35, p < 0.001).","['patients diagnosed with cancer of any type both during and after treatment', 'Cancer Patients', 'cancer patients', ""300 cancer patients (150 experimental subjects, 150 controls) selected by Attica hospitals and nonprofit cancer patients' organizations""]",['8-week Greek traditional dance lesson program'],"['organized physical activity', 'stress and anxiety values', ""Depression Anxiety Stress Scale 21 (Dass-21) questionnaire and subjected to reliability analysis (Cronbach's alpha) and deviation-dependent analysis"", 'Stress and anxiety levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029247', 'cui_str': 'Non-profit organization'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",300.0,0.0138193,"Both stress and anxiety values decreased significantly in the experimental group (stress value: initial mean = 16.27, second mean = 2.58, final mean = 6.77, p < 0.001; anxiety value: initial mean = 15.59, second mean = 2.81, final mean = 5.35, p < 0.001).","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Karathanou', 'Affiliation': 'School of Physical Education & Sport Sciences, Democritus University of Thrace, Komotini, Greece. ikarathan@yahoo.gr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bebetsos', 'Affiliation': 'School of Physical Education & Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Filippou', 'Affiliation': 'School of Physical Education & Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Psirri', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Attica, Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Konas', 'Affiliation': 'National School of Public Health, University of Western Attica, Athens, Greece.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01761-x']
313,32388857,"Assisted breastfeeding technique to improve knowledge, attitude, and practices of mothers with cleft lip- and palate-affected infants: A randomized trial.","BACKGROUND


Cleft lip and palate is one of the most common developmental anomalies affecting the craniofacial region leading to an array of problems including the inability to feed properly.
OBJECTIVES


This study aimed to compare the effectiveness of specially designed audio-visual module over traditional instructional module in improving the assisted breastfeeding habits.
METHODOLOGY


Sixteen patients received training regarding the feeding practices through the traditional instructional method, and 16 subjects received training through audio-visual module. Infants in both the groups received the standard care. These infants were followed up longitudinally for 6 months. During the follow up period, the growth parameters were recorded monthly. The knowledge, attitude, and practices of the mothers regarding feeding practices were assessed using KAP questionnaire.
RESULTS


There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices. Correspondingly, the growth parameters also showed significant difference.
CONCLUSION


The custom-made audio-visual module would help the mothers adapt better to the stressful situation following the birth of the infant affected with cleft lip and palate.",2020,"There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices.","['Sixteen patients received', 'mothers with cleft lip- and palate-affected infants']","['training regarding the feeding practices through the traditional instructional method, and 16 subjects received training through audio-visual module', 'specially designed audio-visual module over traditional instructional module', 'Assisted breastfeeding technique']",[],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],16.0,0.0277095,"There was significant improvement in the knowledge of the mothers from baseline to 6 months, however, the practices indicated that the mothers belonging to the audio-visual module group showed better understating of the condition and earlier adaptation of the breastfeeding practices.","[{'ForeName': 'Prashanth Sadashiva', 'Initials': 'PS', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, JSS Dental College & Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Pediatrics, JSS Hospital, JSS Academy of Higher Education & Research, Mysuru, India.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12464']
314,32394780,Evaluating the Effectiveness of I-NEED Program: Improving Nurses' Detection and Management of Elder Abuse and Neglect-A 6-Month Prospective Study.,"Elder abuse and neglect (EAN) goes largely unrecognized and underreported globally by health care professionals. Despite acknowledging their role to intervene elder abuse, health care professionals lacked knowledge and skills in this issue. This is a single-blinded, three-armed, cluster randomized controlled trials aimed to evaluate the effectiveness of the face-to-face  I mproving  N urses' d E tection and manag E ment of el D er abuse and neglect (I-NEED) intensive training program and I-NEED educational video in improving primary care nurses' knowledge, attitude, and confidence to intervene EAN; 390 primary care nurses were randomized equally into two intervention groups-ITP group (intensive training program) and ITP+ group (intensive training program and educational video)-and a control group. The knowledge, attitudes, and confidence to intervene EAN were measured using questionnaires at four intervals during 6-month follow-up. A total of 269 primary care nurses participated in this study. There was a significant increase in knowledge, attitude, and confidence to intervene EAN immediately post intervention observed in both intervention groups compared to the control group ( p  < .001). At the end of sixth month, there was an increase of knowledge favoring ITP group than the ITP+ group ( p  < .001). There is, however, no significant difference in attitude score between ITP and ITP+ group. There is a significant difference of confidence to intervene among the participants between both intervention groups with ITP+ participants reporting higher scores post intervention ( p  < .05). An intensive training module improved the knowledge, attitude, and confidence to intervene EAN. Other co-existing barriers for abuse victims getting help, resources, policy, and law of EAN need further highlights.",2020,"At the end of sixth month, there was an increase of knowledge favoring ITP group than the ITP+ group ( p  < .001).","['390 primary care nurses', '269 primary care nurses participated in this study']","['el D er abuse and neglect (I-NEED) intensive training program', 'ITP', 'face-to-face  I mproving', 'ITP group (intensive training program) and ITP+ group (intensive training program and educational video)-and a control group']","['attitude score', 'knowledge, attitude, and confidence to intervene EAN', 'knowledge, attitudes, and confidence to intervene EAN']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021540', 'cui_str': 'Inosine triphosphate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]",269.0,0.0162201,"At the end of sixth month, there was an increase of knowledge favoring ITP group than the ITP+ group ( p  < .001).","[{'ForeName': 'Fadzilah Hanum', 'Initials': 'FH', 'LastName': 'Mohd Mydin', 'Affiliation': 'University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Choo', 'Initials': 'C', 'LastName': 'Wan Yuen', 'Affiliation': 'University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sajaratulnisah', 'Initials': 'S', 'LastName': 'Othman', 'Affiliation': 'University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Noran Naqiah', 'Initials': 'NN', 'LastName': 'Mohd Hairi', 'Affiliation': 'University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Farizah', 'Initials': 'F', 'LastName': 'Mohd Hairi', 'Affiliation': 'University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Zainudin', 'Initials': 'Z', 'LastName': 'Ali', 'Affiliation': 'Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Suriyati', 'Initials': 'S', 'LastName': 'Abdul Aziz', 'Affiliation': 'Ministry of Health Malaysia, Putrajaya, Malaysia.'}]",Journal of interpersonal violence,['10.1177/0886260520918580']
315,32394821,[Evaluation of a Manualized Group Program for Siblings of Children with Diseases or Disabilities].,"Evaluation of a Manualized Group Program for Siblings of Children with Diseases or Disabilities  This study evaluates a manualized group program for siblings of children with life-threatening/life-limiting diseases or disabilities. The program aims to activate resources and to reduce emotional and behavioral problems, using cognitive-behavioral methods and experience-based interventions. In this multi-center study, 13 GeschwisterTREFFs were conducted by 11 study sites in Germany. Prior to and after the intervention 97 siblings aged 7 to 14 years and their parents were examined with standardized questionnaires. At baseline, the siblings of children with diseases or disabilities showed significant more emotional and behavioral problems compared to the respective norm samples. After the intervention, the siblings reported declined problem behavior scores that were mostly in the range of the particular norm values. Furthermore, the children indicated a significant improvement of self-esteem, self-efficacy, school competences and relations to their siblings. However, parents reported more problem behavior and less health-related quality of life of their children at both assessments. The present multi-center study showed the interventions' feasibility in different settings and confirmed expected improvements of target variables during the intervention period. Randomized-controlled trails are warranted to verify our results.",2020,"Furthermore, the children indicated a significant improvement of self-esteem, self-efficacy, school competences and relations to their siblings.","['siblings of children with life-threatening/life-limiting diseases or disabilities', '97 siblings aged 7 to 14 years and their parents', 'Siblings of Children with Diseases or Disabilities', '13 GeschwisterTREFFs were conducted by 11 study sites in Germany']","['manualized group program', 'Manualized Group Program']","['problem behavior and less health-related quality of life', 'problem behavior scores', 'self-esteem, self-efficacy, school competences and relations to their siblings', 'emotional and behavioral problems']","[{'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",13.0,0.0188384,"Furthermore, the children indicated a significant improvement of self-esteem, self-efficacy, school competences and relations to their siblings.","[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Engelhardt-Lohrke', 'Affiliation': 'Elternhilfe für krebskranke Kinder Leipzig e.V Philipp-Rosenthal-Str. 21 04103 Leipzig Deutschland Elternhilfe für krebskranke Kinder Leipzig e.V.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schepper', 'Affiliation': 'Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Universitätsklinikum Leipzig Deutschland Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie.'}, {'ForeName': 'Jessy', 'Initials': 'J', 'LastName': 'Herrmann', 'Affiliation': 'Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Universitätsklinikum Leipzig Deutschland Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Kowalewski', 'Affiliation': 'Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.) Deutschland Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.).'}, {'ForeName': 'Thore', 'Initials': 'T', 'LastName': 'Spilger', 'Affiliation': 'Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.) Deutschland Institut für Sozialmedizin in der Pädiatrie Augsburg (ISPA e.V.).'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Weiß', 'Affiliation': 'Selbstständige Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie Universitätsklinikum Leipzig Deutschland Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Martini', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie Medizinische Fakultät am Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Deutschland Klinik und Poliklinik für Psychiatrie und Psychotherapie.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.3.203']
316,32394851,[Antihypertensive and Vasoprotective Effects of Combined Pharmacotherapy in Patients with Arterial Hypertension and Prediabetes].,"Aim To evaluate effects of different types of combination drug therapy on indexes of 24-h blood pressure monitoring (24-h BPM), arterial stiffness, and central aortic pressure (CAP) in patients with arterial hypertension (AH) and prediabetes.Materials and methods The study included 120 patients with AH and prediabetes. After randomization using envelopes, three treatment groups were formed: group 1, patients receiving perindopril, indapamide SR, and metformin (n=40); group 2, patients receiving perindopril, moxonidin, and metformin (n=40); and group 3, patients receiving perindopril, indapamide SR, and amlodipine (n=40). 24-h BPM, determination of arterial stiffness, and measurement of CAP were performed for all patients.Results After 24 weeks of treatment, patients of all groups showed statistically significant improvements of most indexes of 24-h BPM, arterial stiffness, and CAP. In groups 2 and 3, the treatment was associated with significantly more pronounced beneficial changes in 24-BPM, arterial stiffness, and CAP compared to group 1. Antihypertensive and vasoprotective effects of the perindopril+moxonidin+metformin and perindopril+indopamide SR+amlodipine combinations were comparable.Conclusion The observed statistically significant antihypertensive and vasoprotective effects of the perindopril+moxonidin+metformin combination along with its known positive metabolic effect allow recommendation of this combination therapy to patients with AH and prediabetes as an effective strategy for BP control.",2020,"In groups 2 and 3, the treatment was associated with significantly more pronounced beneficial changes in 24-BPM, arterial stiffness, and CAP compared to group 1.","['Patients with Arterial Hypertension and Prediabetes', 'patients with arterial hypertension (AH) and prediabetes', '120 patients with AH and prediabetes']","['perindopril, indapamide SR, and metformin', 'Combined Pharmacotherapy', 'perindopril+moxonidin+metformin', 'perindopril, indapamide SR, and amlodipine', 'combination drug therapy', 'perindopril, moxonidin, and metformin', 'perindopril+moxonidin+metformin and perindopril+indopamide SR+amlodipine combinations']","['24-BPM, arterial stiffness, and CAP', '24-h blood pressure monitoring (24-h BPM), arterial stiffness, and central aortic pressure (CAP', '24-h BPM, arterial stiffness, and CAP', '24-h BPM, determination of arterial stiffness, and measurement of CAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0066837', 'cui_str': 'moxonidine'}]","[{'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",120.0,0.0285572,"In groups 2 and 3, the treatment was associated with significantly more pronounced beneficial changes in 24-BPM, arterial stiffness, and CAP compared to group 1.","[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Skibitskiy', 'Affiliation': 'State Budget Educational Institution of Higher Professional Education ""Kuban State Medical University"" of the Ministry of Health of the Russian Federation.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Gutova', 'Affiliation': 'State budgetary health institution of the Republic of Adygea ""Maykop City Clinical Hospital"".'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Fendrikova', 'Affiliation': 'State Budget Educational Institution of Higher Professional Education ""Kuban State Medical University"" of the Ministry of Health of the Russian Federation.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Skibitskiy', 'Affiliation': 'State Budget Educational Institution of Higher Professional Education ""Kuban State Medical University"" of the Ministry of Health of the Russian Federation.'}]",Kardiologiia,['10.18087/cardio.2020.4.n1112']
317,32394874,Combination Therapy against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (Fungisome TM ) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy.,"Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe, and is a major public health problem in the Indian subcontinent. Miltefosine received approval in 2002 to treat VL in India, and the Indian National Vector Borne Disease Control Programme later adopted a single dose (10 mg/kg) of liposomal amphotericin B. We report results of a randomized trial comparing the efficacy of combination therapy with an Indian preparation of liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine (2.5 mg/kg/day for 14 days;  n  = 66) in comparison to miltefosine monotherapy (2.5 mg/kg/day for 28 days;  n  = 78). Nine patients in the miltefosine group and three in the combination therapy group had to discontinue therapy because of serious adverse events. At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups. By per-protocol analysis, by 6 months after completion of treatment, 12 of 69 patients in the miltefosine monotherapy arm (17.4%, 95% CI: 10.24-28%) and none in the combination therapy arm had relapse. Over 5 years of follow-up, 10 patients in the miltefosine monotherapy arm (all within 0.5-2 years after completing therapy) and none in the combination therapy arm experienced post-kala-azar dermal leishmaniasis. Combination therapy offered benefits over miltefosine monotherapy for VL in India.",2020,"At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups.","['Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe']","['Miltefosine', 'miltefosine', 'liposomal amphotericin', 'miltefosine monotherapy', 'liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine', 'Liposomal Amphotericin B (Fungisome TM ) and Short-Course Miltefosine']","['relapse', 'discontinue therapy because of serious adverse events', 'clinical and parasitological cure rate']","[{'cui': 'C0023290', 'cui_str': 'Visceral leishmaniasis'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0037724', 'cui_str': 'Southern Europe'}]","[{'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}]",,0.0417871,"At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups.","[{'ForeName': 'Rama Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Mehebubar', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Sukhen', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.'}, {'ForeName': 'Santanu Kumar', 'Initials': 'SK', 'LastName': 'Tripathi', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rudra Prosad', 'Initials': 'RP', 'LastName': 'Goswami', 'Affiliation': 'Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, India.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0931']
318,32395278,Development and validation of nomograms for predicting overall and cancer-specific survival in young patients with non-small cell lung cancer.,"Background


Young patients with non-small cell lung cancer (NSCLC) represent a distinct subgroup of patients with this disease. This study aimed to construct nomograms to predict the overall survival (OS) and cancer-specific survival (CSS) of young patients with NSCLC.
Methods


NSCLC patients under 50 years old diagnosed between 2010 and 2016 were selected from the Surveillance, Epidemiology, and End Results (SEER) database and randomly divided into training (n=1,357) and validation (n=678) cohorts at a ratio of 2:1. Independent prognostic factors for OS or CSS were identified through the log-rank test, Cox proportional hazards models or competing risk model and further integrated to construct nomograms. The predictive capability of the nomogram was assessed by Harrell's concordance index (C-index), the calibration curve and risk group stratification.
Results


A total of 2,035 patients were enrolled. In the training cohort, insurance, marital status, histological type, grade, T stage, N stage and surgery were identified as independent prognostic for OS and CSS. The C-index value were 0.759 [95% confidence interval (CI): 0.731-0.787] for OS and 0.810 (95% CI: 0.803-0.818) for BCSS in the training cohort and 0.751 (95% CI: 0.711-0.790) for OS and 0.807 (95% CI: 0.795-0.819) for CSS in the validation cohort. The calibration curves showed optimal agreement between the predicted and actual survival both in internal and external validation. In addition, patients in the validation cohort within different risk groups exhibited significantly different survival even in each TNM stage.
Conclusions


Nomograms were developed and validated to predict OS and CSS of young patients with NSCLC in our study. A prospective study with more potential prognostic factors and the latest TNM classification is required to ameliorate this model.",2020,The C-index value were 0.759 [95% confidence interval (CI): 0.731-0.787] for OS and 0.810,"['young patients with NSCLC.\nMethods\n\n\nNSCLC patients under 50 years old diagnosed between 2010 and 2016 were selected from the Surveillance, Epidemiology, and End Results (SEER) database and randomly divided into training (n=1,357) and validation (n=678) cohorts at a ratio of 2:1', '2,035 patients were enrolled', 'young patients with non-small cell lung cancer', '\n\n\nYoung patients with non-small cell lung cancer (NSCLC']",[],"['survival', 'overall survival (OS) and cancer-specific survival (CSS', 'C-index value']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",2035.0,0.0726775,The C-index value were 0.759 [95% confidence interval (CI): 0.731-0.787] for OS and 0.810,"[{'ForeName': 'Yizhou', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}]",Journal of thoracic disease,['10.21037/jtd.2020.03.03']
319,32388511,Randomized Controlled Trial of Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP after Extubation of VLBW Infants.,"BACKGROUND AND OBJECTIVES


Nasal continuous positive airway pressure (NCPAP) is a useful method of respiratory support after extubation. However, some infants fail despite CPAP use and require reintubation. Some evidence suggests that synchronized nasal intermittent positive pressure ventilation (NIPPV) may decrease extubation failure in preterm infants. Nonsynchronized NIPPV (NS-NIPPV) is being widely used in preterm infants without conclusive evidence of its benefits and side effects. Our aim was to evaluate whether NS-NIPPV decreases extubation failure compared with NCPAP in ventilated very low birth weight infants (VLBWI) with respiratory distress syndrome (RDS).
METHODS


Randomized controlled trial of ventilated VLBWI being extubated for the first time. Before extubation, infants were randomized to receive NCPAP or NS-NIPPV. Primary outcome was the need for reintubation within 72 h.
RESULTS


220 infants were included. The mean ± SD birth weight was 1,027 ± 256 g and gestational age 27.8 ± 1.9 weeks. Demographic and clinical characteristics were similar in both groups. Extubation failure was 32.4% for NCPAP versus 32.1% for NS-NIPPV, p = 0.98. The frequency of deaths, bronchopulmonary dysplasia, intraventricular hemorrhage, air leaks, necrotizing enterocolitis and duration of respiratory support did not differ between groups.
CONCLUSIONS


In this population of VLBWI, NS-NIPPV did not decrease extubation failure after RDS compared with NCPAP.",2020,"Extubation failure was 32.4% for NCPAP versus 32.1% for NS-NIPPV, p = 0.98.","['after Extubation of VLBW Infants', 'ventilated very low birth weight infants (VLBWI) with respiratory distress syndrome (RDS', 'preterm infants']","['Nonsynchronized NIPPV (NS-NIPPV', 'Nasal continuous positive airway pressure (NCPAP', 'NCPAP or NS-NIPPV', 'NS-NIPPV', 'Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP', 'ventilated VLBWI', 'NCPAP', 'synchronized nasal intermittent positive pressure ventilation (NIPPV']","['extubation failure', 'frequency of deaths, bronchopulmonary dysplasia, intraventricular hemorrhage, air leaks, necrotizing enterocolitis and duration of respiratory support', 'need for reintubation', 'mean ± SD birth weight', 'Extubation failure']","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C3665969', 'cui_str': 'Nasal CPAP'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",220.0,0.490166,"Extubation failure was 32.4% for NCPAP versus 32.1% for NS-NIPPV, p = 0.98.","[{'ForeName': 'Alberto S', 'Initials': 'AS', 'LastName': 'Estay', 'Affiliation': 'Departamento de Neonatología, Pontificia Universidad Católica de Chile, Santiago, Chile, albertoestay@gmail.com.'}, {'ForeName': 'Gonzalo L', 'Initials': 'GL', 'LastName': 'Mariani', 'Affiliation': 'Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Claudio A', 'Initials': 'CA', 'LastName': 'Alvarez', 'Affiliation': 'Hospital Dr. Gustavo Fricke, Viña del Mar, Chile.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Milet', 'Affiliation': 'Hospital Dr. Sotero del Río, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Agost', 'Affiliation': 'Hospital Luis Carlos Lagomaggiore, Mendoza, Argentina.'}, {'ForeName': 'Claudia P', 'Initials': 'CP', 'LastName': 'Avila', 'Affiliation': 'Hospital San José, Santiago, Chile.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Roldan', 'Affiliation': 'Hospital Fernández, Buenos Aires, Argentina.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Abdala', 'Affiliation': 'Hospital Español, Mendoza, Argentina.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Keller', 'Affiliation': 'Hospital Universitario Austral, Buenos Aires, Argentina.'}, {'ForeName': 'María F', 'Initials': 'MF', 'LastName': 'Galletti', 'Affiliation': 'Instituto Universitario del Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Departamento de Neonatología, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neonatology,['10.1159/000506164']
320,32388512,"A new two-step anesthesia for 23- or 25-gauge vitrectomy surgery: A prospective, randomized clinical trial.","Objective：To investigate the safety and efficacy of topical anesthesia combined with sub-conjunctival anesthesia (termed two-step anesthesia) for 23- or 25-gauge pars plana vitrectomy or other posterior segment surgery. Methods：Patients (n = 90) requiring 23-/25- vitrectomy or other posterior segment surgery were randomized into three groups. Group 1 received peribulbar anesthesia, Group 2 received retrobulbar anesthesia and Group 3 received two-step anesthesia. A 5-point visual analog pain scale (VAPS) was used to measure self-report of patient pain. Complications were recorded for subsequent analysis. Results: VAPS for overall intraoperative pain ranged from 0 - 3 (1.07±1.07) in Group 1, from 0 - 2 (0.69±0.93) in Group 2 and from 0 - 3 (1.06±0.98,) in Group 3Assessment of surgeon discomfort score ranged from 0 - 2 (0.31±0.66) in Group 1, from 0 - 3 (0.38±0.82) in Group 2 and from 0 - 2 (0.47±0.62) in Group 3. Both scores reveal no significant difference among the three groups. While there were no complications noted in Group 1, there was an ocular perforation in Group 2. Additionally, there were no complications in Group 3 related to the anesthetic technique. Conclusions: Results suggest that two-step anesthesia is a safe and effective anesthetic approach for select patients with undergoing 23- or 25-gauge pars plana vitrectomy or other posterior segment surgeries. It may offer a viable alternative to peribulbar anesthesia and retrobulbar anesthesia for carefully selected 23- or 25-gauge cannular-access ocular surgeries.",2020,"VAPS for overall intraoperative pain ranged from 0 - 3 (1.07±1.07) in Group 1, from 0 - 2 (0.69±0.93) in Group 2 and from 0 - 3 (1.06±0.98,) in Group 3Assessment of surgeon discomfort score ranged from 0 - 2 (0.31±0.66) in Group 1, from 0 - 3 (0.38±0.82) in Group 2 and from 0 - 2 (0.47±0.62) in Group 3.",['Methods：Patients (n = 90) requiring 23-/25- vitrectomy or other posterior segment surgery'],"['peribulbar anesthesia', 'peribulbar anesthesia and retrobulbar anesthesia', '25-gauge vitrectomy surgery', '25-gauge pars plana vitrectomy', 'VAPS', '25-gauge pars plana vitrectomy or other posterior segment surgery', 'topical anesthesia combined with sub-conjunctival anesthesia (termed two-step anesthesia', 'retrobulbar anesthesia and Group 3 received two-step anesthesia']","['ocular perforation', 'surgeon discomfort score', 'overall intraoperative pain', 'safety and efficacy', 'Complications', '5-point visual analog pain scale (VAPS']","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0459804', 'cui_str': 'Retrobulbar space'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0860533', 'cui_str': 'Ocular perforation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}]",90.0,0.035818,"VAPS for overall intraoperative pain ranged from 0 - 3 (1.07±1.07) in Group 1, from 0 - 2 (0.69±0.93) in Group 2 and from 0 - 3 (1.06±0.98,) in Group 3Assessment of surgeon discomfort score ranged from 0 - 2 (0.31±0.66) in Group 1, from 0 - 3 (0.38±0.82) in Group 2 and from 0 - 2 (0.47±0.62) in Group 3.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Zhuyun', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': ''}, {'ForeName': 'Radouil', 'Initials': 'R', 'LastName': 'Tzekov', 'Affiliation': ''}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}]",Ophthalmic research,['10.1159/000508510']
321,32388522,Photobiomodulation therapy for the management of recurrent aphthous stomatitis in children: clinical effectiveness and parental satisfaction.,"BACKGROUND


This study aims to evaluate the effectiveness of the photobiomodulation therapy (PBMT) in the treatment of minor recurrent aphthous stomatitis (MiRAS) in children, in terms of pain relief, lesion size reduction and the parental satisfaction of the therapy.
MATERIAL AND METHODS


This randomized controlled study was carried out on 60 children with clinical diagnosis of MiRAS. Patients were randomized into two groups: group A receiving laser therapy and group B receiving sham therapy (placebo). Laser therapy (diode laser, λ: 645 nm) was administered on day 1 (T0) for three consecutive days. Patients were evaluated also on day 4 (T1), on day 7 (T2) and on day 10 (T3). Oral aphthous lesions size was assessed through a periodontal probe to measure the diameter length (mm); pain was evaluated through the Visual Analogue Scale (VAS); parental satisfaction was assessed through a questionnaire.
RESULTS


The difference in the reduction of ulcers diameters between the two groups resulted statistically significant at T1 and at T2 (p<0.05). A statistically significant difference in pain reduction between two groups was found at T1 (p<0.05). No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
CONCLUSIONS


PBMT is to be considered effective in the treatment of MiRAS in children and well- accepted by the parents of the children themselves.",2020,"No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
","['60 children with clinical diagnosis of MiRAS', 'minor recurrent aphthous stomatitis (MiRAS) in children', 'children']","['laser therapy and group B receiving sham therapy (placebo', 'Photobiomodulation therapy', 'Laser therapy (diode laser, λ: 645 nm', 'photobiomodulation therapy (PBMT']","['diameter length (mm); pain', 'pain reduction', 'reduction of ulcers diameters', 'Visual Analogue Scale (VAS); parental satisfaction', 'Oral aphthous lesions size']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}]",60.0,0.0304179,"No statistically significant difference between the two groups of parents was found as concerns the parental acceptance of the procedure and the discomfort for the need of multiple appointments.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bardellini', 'Affiliation': 'Dental Clinic, p.le Spedali Civili n.1 25133 Brescia elena.bardellini@unibs.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Veneri', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majorana', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23573']
322,32388527,"Influence of surgical ultrasound used in the detachment of flaps, osteotomy and odontosection in lower third molar surgeries. A prospective, randomized, and ""split-mouth"" clinical study.","BACKGROUND


As third molar surgery is the most commonly procedure performed in Dentistry and has been accompanied by serious postoperative disorders such as pain, edema and trismus, the study aimed to evaluate if ultrasound device would be able to reduce such postoperative features. The aim of this study was to assess the effects of soft tissue flap elevation, osteotomy and odontosection using piezosurgery versus conventional technique in mandibular third molar extractions.
MATERIAL AND METHODS


Twenty patients with impacted mandibular third molars underwent tooth extractions using two different methods. Ten patients were included in the Piezo Flap Group (PFG - the flap was elevated using piezosurgery) and ten patients were part of the Piezo Ostectomy Group (POG - osteotomy and odontosection were carried out with ultrasound tips). The contralateral tooth was included in the Control Group (CG - conventional technique). The patients were evaluated at postoperative periods of 1, 3, 7 and 14-days. The measured parameters were duration of surgery, pain, trismus and swelling.
RESULTS


The mean duration of surgery for the PFG was 17.21 minutes (CG 10.07 minutes) and POG was 40.09 minutes (CG 15.97 minutes). There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05). There was a statistically significant difference in swelling between the PFG and POG, presenting less swelling at the 3-day postoperative period (p=0.038; p<0,05). However, for the remaining analyzed periods there was no difference (p>0.05).
CONCLUSIONS


Piezosurgery for tissue elevation of the surgical flap, osteotomy and dental sectioning in mandibular third molar extraction surgery promoted less edema in the early postoperative stages in mandibular third molar extractions despite the longer surgical duration.",2020,There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05).,"['Ten patients were included in the', 'Twenty patients with impacted mandibular third molars underwent tooth extractions using two different methods', 'mandibular third molar extractions']","['Piezo Flap Group (PFG - the flap was elevated using piezosurgery', 'surgical ultrasound', 'soft tissue flap elevation, osteotomy and odontosection using piezosurgery versus conventional technique', 'Piezo Ostectomy Group (POG - osteotomy and odontosection were carried out with ultrasound tips']","['pain and trismus', 'duration of surgery, pain, trismus and swelling', 'mean duration of surgery for the PFG', 'swelling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0302269', 'cui_str': 'Excision of bone'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",20.0,0.0692077,There was no statistically significant difference in pain and trismus for any of the postoperative periods evaluated in PFG and POG (p>0.05).,"[{'ForeName': 'L-D', 'Initials': 'LD', 'LastName': 'Silva', 'Affiliation': 'Department of Surgery and Integrated Clinics Araçatuba School of Dentistry - UNESP Rua José Bonifácio, 1193 CEP 16015-050 São Paulo, Brazil daniela.ponzoni@unesp.br.'}, {'ForeName': 'E-N', 'Initials': 'EN', 'LastName': 'Reis', 'Affiliation': ''}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Bonardi', 'Affiliation': ''}, {'ForeName': 'V-N', 'Initials': 'VN', 'LastName': 'Lima', 'Affiliation': ''}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Aranega', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ponzoni', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23447']
323,32388627,Mentalization-based treatment in groups for adolescents with Borderline Personality Disorder: 3- and 12-month follow-up of a randomized controlled trial.,"Mentalization-based treatment in groups (MBT-G) has never been tested in adolescents with Borderline Personality Disorder (BPD) in a randomized controlled trial. The current study aimed to test the long-term effectiveness of MBT-G in an adolescent sample with BPD or BPD features (≥ 4 DSM-5 BPD criteria). Hundred and eleven patients with BPD (n = 106) or BPD features (n = 5) were randomized to either (1) a 1-year modified MBT-G program comprising three MBT introductory sessions, five individual case formulation sessions, 37 weekly MBT group sessions, and six MBT-Parent sessions, or (2) treatment as usual (TAU), defined as at least 12 individual monthly treatment sessions with follow-up assessments at 3 and 12 months post treatment. The primary outcome was the score on the Borderline Personality Features Scale for Children (BPFS-C), and secondary outcomes included clinician-rated BPD symptoms and global level of functioning as well as self-reported self-harm, depression, externalizing and internalizing symptoms, and caregiver reports. There were no statistically significant differences between MBT-G and TAU on the primary outcome measure or any of the secondary outcomes. Both groups showed improvement on the majority of clinical and social outcomes at both follow-up points, although remission rates were modest with just 35% in MBT-G and 39% in TAU 2 years after inclusion into the study. MBT-G was not superior to TAU in improving borderline features in adolescents. Although improvement was observed equally in both interventions over time, the patients continued to exhibit prominent BPD features, general psychopathology and decreased functioning in the follow-up period, which points to a need for more research and better understanding of effective components in early intervention programs. The ClinicalTrials.gov identifier is NCT02068326.",2020,There were no statistically significant differences between MBT-G and TAU on the primary outcome measure or any of the secondary outcomes.,"['adolescents with Borderline Personality Disorder', 'adolescent sample with BPD or BPD features (≥\u20094 DSM-5 BPD criteria', 'adolescents with Borderline Personality Disorder (BPD', 'Hundred and eleven patients with BPD (n\u2009=\u2009106) or BPD features (n\u2009=\u20095', 'adolescents']","['TAU', 'MBT group sessions, and six MBT-Parent sessions, or (2) treatment as usual (TAU', 'MBT-G']","['remission rates', 'score on the Borderline Personality Features Scale for Children (BPFS-C), and secondary outcomes included clinician-rated BPD symptoms and global level of functioning as well as self-reported self-harm, depression, externalizing and internalizing symptoms, and caregiver reports', 'majority of clinical and social outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",11.0,0.0574788,There were no statistically significant differences between MBT-G and TAU on the primary outcome measure or any of the secondary outcomes.,"[{'ForeName': 'Mie Sedoc', 'Initials': 'MS', 'LastName': 'Jørgensen', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Fælledvej 6, 4200, Slagelse, Denmark. mipjo@regionsjaelland.dk.'}, {'ForeName': 'Ole Jakob', 'Initials': 'OJ', 'LastName': 'Storebø', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Fælledvej 6, 4200, Slagelse, Denmark.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Bo', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Fælledvej 6, 4200, Slagelse, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Poulsen', 'Affiliation': 'Department of Psychology, University of Copenhagen, 2A Øster Farimagsgade, 1353, Copenhagen, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gondan', 'Affiliation': 'Department of Psychology, University of Copenhagen, 2A Øster Farimagsgade, 1353, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Beck', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Fælledvej 6, 4200, Slagelse, Denmark.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, Melbourne, Australia, and Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'Research Department of Clinical, Education and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Pedersen', 'Affiliation': 'Child and Adolescent Psychiatric Department, Region Zealand, Smedegade 16, 4000, Roskilde, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Simonsen', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Fælledvej 6, 4200, Slagelse, Denmark.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01551-2']
324,32388632,Benefit of a nurse-led telephone-based intervention prior to the first urogynecology outpatient visit: a randomized-controlled trial.,"INTRODUCTION AND HYPOTHESIS


Triage has become a valid tool to reduce workload during the first consultation in a specialized clinic. A nurse-led telephone intervention prior to the first urogynecologic visit reduces visit duration and increases patients' and physicians' satisfaction.
METHODS


All patients scheduled for their very first visit were recruited. They were randomized into an intervention group (prior contact by a specialized urogynecology nurse) and a control group (no contact). The intervention included a questionnaire about history and symptoms. Patients were prompted to complete a bladder diary. Primary outcome was duration of the consultation; secondary outcomes were patients' and physicians' satisfaction with the intervention.
RESULTS


Fifty-five patients were allocated to the intervention group and 53 to the control group with no difference regarding age, BMI, parity, menopausal status and primary diagnosis. Mean duration of the telephone call was 10.8 min (SD 4.4). The consultation was significantly shorter in the intervention group than in the control group (mean difference: 4 min and 8 s, p = 0.017). In the intervention group, 79% of the patients found the consultation quality ""excellent,"" 86% would return, and 77% would recommend our clinic to a relative or friend compared with 68%, 67% and 66%, respectively, in the control group. Physicians were ""very satisfied"" or ""satisfied"" with the patient preparation.
CONCLUSIONS


A nurse-led intervention reduces the duration of the first uroynecologic consultation and is associated with high patient and physician satisfaction. Further research should evaluate whether it also decreases the number of follow-up visits and further referrals.",2020,"The consultation was significantly shorter in the intervention group than in the control group (mean difference: 4 min and 8 s, p = 0.017).","['Fifty-five patients', 'All patients scheduled for their very first visit were recruited']","['intervention group (prior contact by a specialized urogynecology nurse) and a control group (no contact', 'nurse-led telephone-based intervention']","['consultation quality ""excellent', ""duration of the consultation; secondary outcomes were patients' and physicians' satisfaction with the intervention"", 'Mean duration of the telephone call']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",55.0,0.0525178,"The consultation was significantly shorter in the intervention group than in the control group (mean difference: 4 min and 8 s, p = 0.017).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jimènez Torres', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Beitl', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hummel Jimènez', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mayer', 'Affiliation': 'Department of Nursing Sciences, University of Vienna, Alser Straße 23, 1080, Wien, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zehetmayer', 'Affiliation': 'Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Umek', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria. wolfgang.umek@meduniwien.ac.at.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Veit-Rubin', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18, 1090, Wien, Austria.'}]",International urogynecology journal,['10.1007/s00192-020-04318-0']
325,32388647,"Suprascapular nerve block in hemiplegic shoulder pain: comparison of the effectiveness of placebo, local anesthetic, and corticosteroid injections-a randomized controlled study.","BACKGROUND


Shoulder pain is a common complication of hemiplegic patients that can interrupt their rehabilitation program and is associated with poorer outcomes. The usefulness of the suprascapular nerve block. (SSNB) in the stroke population has been suggested, but some concerns still remain.
OBJECTIVES


To investigate the effect of SSNB on pain intensity and passive range ofmotion (PROM) in patients with hemiplegic shoulder pain (HSP).
STUDY DESIGN


A prospective, double blind, randomized controlled trial was conductedin 34 stroke patients with HSP. They were randomly divided into three groups: Localanesthetic (LA) injection into the trapezius muscle (placebo group), LA injection into thesuprascapular notch, and LA and corticosteroid (CS) injections into the suprascapularnotch.The main outcome was visual analog scale (VAS) scores evaluated before andafter administration of the injection at 1 hour, 1 week, and 1 month.
RESULTS


There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group). When changes in VAS scores were compared between the groups, the LA+CS group demonstrated a higher decrease in VAS than the placebo group. Improvement in the PROM was seen only in the LA and LA+CS groups.
CONCLUSIONS


The findings of this study support the use of an SSNB with or without CS, to increase the range of motion in the affected shoulder, especially during the rehabilitation period.",2020,"There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group).","['patients with hemiplegic shoulder pain (HSP', 'hemiplegic patients', 'hemiplegic shoulder pain', '34 stroke patients with HSP']","['Suprascapular nerve block', 'SSNB', 'LA+CS', 'Localanesthetic (LA) injection into the trapezius muscle (placebo group), LA injection into thesuprascapular notch, and LA and corticosteroid (CS) injections into the suprascapularnotch', 'placebo, local anesthetic, and corticosteroid injections', 'placebo']","['visual analog scale (VAS) scores', 'PROM', 'pain intensity and passive range ofmotion (PROM', 'VAS', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.235594,"There were significant decreases in the VAS scores with all three injections at all follow-up time points (p: 0.001 for the placebo group, p <0.001 for the LA group, and p <0.001 for the LA+CS group).","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Terlemez', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey. ranakaynar@hotmail.com.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Çiftçi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mahir', 'Initials': 'M', 'LastName': 'Topaloglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mahir Topaloglu; MD. Koc University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Beril', 'Initials': 'B', 'LastName': 'Dogu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kuran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Saglik Bilimleri University, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-020-04362-0']
326,32388650,Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial.,"Applying lung protective mechanical ventilation (LPV) during general anaesthesia even in patients with non-injured lungs is recommended. However, the effects of an individual PEEP-optimisation on respiratory mechanics, oxygenation and their potential correlation with the inflammatory response and postoperative complications have not been evaluated have not been compared to standard LPV in patients undergoing major abdominal surgery. Thirty-nine patients undergoing open radical cystectomy were enrolled in this study. In the study group (SG) optimal PEEP was determined by a decremental titration procedure and defined as the PEEP value resulting the highest static pulmonary compliance. In the control group (CG) PEEP was set to 6 cmH2O. Primary endpoints were intraoperative respiratory mechanics and gas exchange parameters. Secondary outcomes were perioperative procalcitonin kinetics and postoperative pulmonary complications. Optimal PEEP levels (median = 10, range: 8-14 cmH2O), PaO2/FiO2 (451.24 ± 121.78 mmHg vs. 404.15 ± 115.87 mmHg, P = 0.005) and static pulmonary compliance (52.54 ± 13.59 ml cmH2O-1 vs. 45.22 ± 9.13 ml cmH2O-1, P < 0.0001) were significantly higher, while driving pressure (8.26 ± 1.74 cmH2O vs. 9.73 ± 4.02 cmH2O, P < 0.0001) was significantly lower in the SG as compared to the CG. No significant intergroup differences were found in procalcitonin kinetics (P = 0.076). Composite outcome results indicated a non-significant reduction of postoperative complications in the SG. Intraoperative PEEP-optimization resulted in significant improvement in gas exchange and pulmonary mechanics as compared to standard LPV. Whether these have any effect on short and long term outcomes require further investigations. Trial registration: Clinicaltrials.gov, identifier: NCT02931409.",2020,No significant intergroup differences were found in procalcitonin kinetics (P = 0.076).,"['patients undergoing major abdominal surgery', 'Thirty-nine patients undergoing', 'patients with non-injured lungs']","['open radical cystectomy', 'intraoperative positive end-expiratory pressure optimization', 'lung protective mechanical ventilation (LPV', 'Intraoperative PEEP-optimization', 'individual PEEP-optimisation']","['intraoperative respiratory mechanics and gas exchange parameters', 'procalcitonin kinetics', 'driving pressure', 'postoperative complications', 'static pulmonary compliance', 'gas exchange and pulmonary mechanics', 'Optimal PEEP levels', 'perioperative procalcitonin kinetics and postoperative pulmonary complications', 'respiratory mechanics and the inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0974141,No significant intergroup differences were found in procalcitonin kinetics (P = 0.076).,"[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruszkai', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Pest Megyei Flór Ferenc Hospital, Semmelweis Square 1, Kistarcsa, 2143, Hungary. z.ruszkai.md@gmail.com.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Kiss', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University of Szeged, Semmelweis Street 6, Szeged, 6725, Hungary.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'László', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University of Szeged, Semmelweis Street 6, Szeged, 6725, Hungary.'}, {'ForeName': 'Gergely Péter', 'Initials': 'GP', 'LastName': 'Bokrétás', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Vizserálek', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'Vámossy', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Surány', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Buzogány', 'Affiliation': 'Department of Urology, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Bajory', 'Affiliation': 'Department of Urology, University of Szeged, Kálvária Avenue 57, Szeged, 6725, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': 'Centre for Translational Medicine, University of Pécs, Szigeti Street 12, Pécs, 7624, Hungary.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00519-6']
327,32388895,Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC): Updated analysis of 93 randomised patients - control survival is much better than previously assumed.,"AIMS


Lung metastases from colorectal cancer are resected in selected patients in the belief that this confers a significant survival advantage. It is generally assumed that the five-year survival of these patients would be near zero without metastasectomy. We have tested the clinical effectiveness of this practice in PulMiCC, a randomised controlled non-inferiority trial.
METHODS


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


From 2010 to 2016, 93 participants were randomised, aged 35 to 86 years, with 1-6 lung metastases at a median of 2.7 years after colorectal cancer resection. 29% had prior liver metastasectomy. Characteristics were well-matched and similar to observational studies. The median survival after metastasectomy was 3.5 years (95%CI:3.1,6.6) compared with 3.8 years (95%CI:3.1,4.6) for controls. The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56). Use of chemotherapy or local ablation was infrequent and similar in each group.
CONCLUSIONS


The control group patients who do not have lung metastasectomy have better survival than is assumed. Survival in the metastasectomy group are comparable with the many single arm follow-up studies. The groups were well matched with features similar to reported case series.",2020,"The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56).","['From 2010 to 2016, 93 participants were randomised, aged 35 to 86 years, with 1-6 lung metastases at a median of 2.7 years after colorectal cancer resection', '14 hospitals recruited patients with resectable lung metastases into a two-arm trial', 'Colorectal Cancer (PulMiCC']",['chemotherapy or local ablation'],"['Survival', 'median survival']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.290895,"The estimated unadjusted hazard ratio for death within five years, comparing metastasectomy to control, was 0.93 (95%CI:0.56,1.56).","[{'ForeName': 'Misel', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Thoracic Surgery Clinic, Institute for Lung Diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tsang', 'Affiliation': 'Basildon and Thurrock University Hospitals NHS Foundation Trust, Basildon, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shackcloth', 'Affiliation': 'Liverpool Heart And Chest Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Batchelor', 'Affiliation': 'Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Coonar', 'Affiliation': 'Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Jurjees', 'Initials': 'J', 'LastName': 'Hasan', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'Royal Free London NHS Foundation Trust and Division of Surgery, UCL, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Marchbank', 'Affiliation': 'Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grumett', 'Affiliation': 'New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical & Interventional Trials Unit (SITU), University College London, London, UK, W1W 7JN.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK, CF14 4Y.'}, {'ForeName': 'Vern', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, UK, CB2 0SR.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, UK, WC1H 0BT.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15113']
328,32388918,"Safety of Candesartan, Amlodipine, and Atorvastatin in Combination: Interaction Study in Healthy Subjects.","For efficient cardiovascular risk protection antihypertensive treatment is often combined with cholesterol-lowering treatment, although solid data of interaction and side effects are missing. This is a prospective, single-center interaction study conducted in a fixed sequence design at steady state of candesartan, amlodipine, and atorvastatin. Five-day monotherapy of candesartan 8 mg was followed by 5-day atorvastatin 40 mg monotherapy and subsequently 9-day amlodipine 5 mg monotherapy; each treatment separated by washout phases. Immediately after amlodipine monotherapy, all 3 drugs were administered concomitantly for 5 days. Pharmacokinetic parameters as well as safety were assessed. Eighteen healthy subjects enrolled and completed the study. No significant difference in the maximum concentration (C max  ) and the area the under plasma concentration-time curve (AUC) for amlodipine and AUC of atorvastatin was detected following combination versus monotherapy. C max  of atorvastatin decreased slightly but clinically not relevantly when given in combination. A statistically significant but not below 0.80-fold decrease between candesartan following combination vs monotherapy was detected for C max  and AUC. In general, all treatments were well tolerated. Concluding, systemic exposure of candesartan, amlodipine, and atorvastatin is not clinically significantly changed upon coadministration. These data support a fixed-dose combination of the 3 components for dual cardiovascular risk prevention.",2020,No significant difference in the maximum concentration (C max  ) and the area the under plasma concentration-time curve (AUC) for amlodipine and AUC of atorvastatin was detected following combination versus monotherapy.,"['Healthy Subjects', 'Eighteen healthy subjects enrolled and completed the study']","['atorvastatin', 'Candesartan, Amlodipine, and Atorvastatin', 'candesartan, amlodipine, and atorvastatin', 'atorvastatin 40 mg monotherapy', 'candesartan', 'amlodipine 5 mg monotherapy', 'amlodipine monotherapy']","['maximum concentration (C max  ) and the area the under plasma concentration-time curve (AUC) for amlodipine and AUC of atorvastatin', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C1124796', 'cui_str': 'Amlodipine 5 MG'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]",18.0,0.0377875,No significant difference in the maximum concentration (C max  ) and the area the under plasma concentration-time curve (AUC) for amlodipine and AUC of atorvastatin was detected following combination versus monotherapy.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gundlach', 'Affiliation': 'Midas Pharma GmbH, Ingelheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wolf', 'Affiliation': 'Midas Pharma GmbH, Ingelheim, Germany.'}, {'ForeName': 'Isam', 'Initials': 'I', 'LastName': 'Salem', 'Affiliation': 'International Pharmaceutical Research Center, Amman, Jordan.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Randerath', 'Affiliation': 'Apontis Pharma GmbH & Co. KG, Monheim, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Seiler', 'Affiliation': 'Midas Pharma GmbH, Ingelheim, Germany.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.787']
329,32389006,Effectiveness of a comprehensive post-operative health education program in improving quality of life after gastric cancer surgery.,"BACKGROUND


Patients with gastric cancer often experience postoperative problems such as dumping syndrome, abdominal cramps, and nausea, which have profound effects on their mental health and quality of life. Earlier studies have shown that comprehensive health education can dramatically improve the quality of life of cancer patients after surgery. Thus, in this study, we conducted a health education intervention program in patients who had undergone surgical treatment for gastric cancer and evaluated the effectiveness of this program in improving the postoperative quality of life, with an attempt to offer evidence for better postoperative management of gastric cancer patients.
METHODS


Totally, 80 patients with gastric cancer who underwent surgery at our center from February 2018 to February 2019 were equally divided into an observation group and control group according to the random number table method. The observation group was offered with interventions regarding health education, including disease awareness-raising, instructions on behavior and lifestyle, rehabilitation management, and mental health counseling, and the control group received the routine nursing intervention. The quality of life one month before and after surgery was assessed by using the Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-STO22.
RESULTS


The baseline data and quality of life showed no significant differences between the observation group and the control group one month before surgery (both P>0.05). One month after the surgery, the scores of dysphagia, pain/discomfort, reflux symptoms, and emotional issues and overall score in the observation group decreased significantly (34.86±2.170, 38.66±3.08, 32.26±2.76, 49.55±4.20, and 54.26±7.03, respectively), which were also significantly lower than those in the control group (36.33±3.10, 44.29±3.72, 33.64±3.10, 53.56±3.25, and 60.17±7.28, respectively; all P<0.05).
CONCLUSIONS


The comprehensive health education intervention program can effectively improve the quality of life in patients after gastric cancer surgery and deserves further application in clinical settings.",2020,The baseline data and quality of life showed no significant differences between the observation group and the control group one month before surgery (both P>0.05).,"['patients who had undergone surgical treatment for gastric cancer', '80 patients with gastric cancer who underwent surgery at our center from February 2018 to February 2019', 'gastric cancer patients', 'Patients with gastric cancer', 'after gastric cancer surgery', 'patients after gastric cancer surgery', 'cancer patients after surgery']","['health education intervention program', 'interventions regarding health education, including disease awareness-raising, instructions on behavior and lifestyle, rehabilitation management, and mental health counseling, and the control group received the routine nursing intervention', 'comprehensive post-operative health education program']","['quality of life', 'scores of dysphagia, pain/discomfort, reflux symptoms, and emotional issues and overall score', 'baseline data and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",80.0,0.0296071,The baseline data and quality of life showed no significant differences between the observation group and the control group one month before surgery (both P>0.05).,"[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Second Ward, Department of Gastrointestinal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Second Ward, Department of Gastrointestinal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hou', 'Affiliation': 'Second Ward, Department of Gastrointestinal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Lixiu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Second Ward, Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China. lihuiyanlhyy@sina.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.14']
330,32389012,Efficacy and safety of Qinzhuliangxue decoction for treating atopic eczema: a randomized controlled trial.,"BACKGROUND


Atopic eczema is the most common type of skin disorder in both children and adults. It is characterized by erythema, pruritus, papules, xeransis, and lichenification. Qinzhuliangxue decoction (QZLXD), a Chinese herbal medicine (CHM) prepared with several ingredients that are used to treat eczema, was formulated according to the traditional Chinese medicine (TCM) theory. This study aimed to investigate the efficacy and safety of QZLXD administration for treating atopic eczema compared to those of Runzaozhiyang capsules (RZZYC).
METHODS


A total of 176 patients were enrolled at the Shanghai Yueyang Hospital and were randomly assigned to the QZLXD treatment group (n=82) or the RZZYC control group (n=86). The differences in Eczema Area and Severity Index (EASI), Dermatology Life Quality Index, itching score, recurrence rate, and adverse events (AEs) were compared between the groups.
RESULTS


The EASI score (x2=14.181, P=0.003), recurrence rate (x2=7.398, P=0.007), and itching score (F=-3.427, P=0.001) were lower in the QZLXD group than in the RZZYC group. Incidence of AEs was similar between the RZZYC and QZLXD groups (P=0.434).
CONCLUSIONS


QZLXD is recommended for the treatment of subacute atopic eczema because QZLXD showed good efficiency with low recurrence rate and tolerable AEs.",2020,"Incidence of AEs was similar between the RZZYC and QZLXD groups (P=0.434).
","['176 patients were enrolled at the Shanghai Yueyang Hospital', 'atopic eczema']","['Qinzhuliangxue decoction (QZLXD', 'Runzaozhiyang capsules (RZZYC', 'Qinzhuliangxue decoction', 'RZZYC control', 'QZLXD', 'Chinese herbal medicine (CHM']","['Efficacy and safety', 'efficacy and safety', 'Eczema Area and Severity Index (EASI), Dermatology Life Quality Index, itching score, recurrence rate, and adverse events (AEs', 'Incidence of AEs', 'itching score', 'recurrence rate', 'EASI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",176.0,0.111501,"Incidence of AEs was similar between the RZZYC and QZLXD groups (P=0.434).
","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Department of Surgery of Traditional Chinese Medicine, Xiangshan Traditional Chinese Medicine Hospital, Shanghai 200020, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China. xuwenbin@shyueyanghospital.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China; Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China. 13661956326@163.com.'}]",Annals of palliative medicine,['10.21037/apm.2020.04.17']
331,32389105,Study protocol and statistical analysis plan for the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial.,"BACKGROUND


Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes.
OBJECTIVE


To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION


A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L).
MAIN OUTCOME MEASURES


The primary endpoint is incident hypoglycaemia (< 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes.
RESULTS AND CONCLUSION


The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised.
TRIAL REGISTRATION


This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.",2020,"To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes.
","['450 critically ill patients with type 2 diabetes', 'intensive care unit (ICU) patients with type 2 diabetes', 'patients without type 2 diabetes', 'patients with type 2 diabetes', 'Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial', 'Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID']",['liberal blood glucose (target 10.0-14.0 mmol/L) or usual care (target 6.0-10.0 mmol/L'],"['biochemical and feasibility outcomes', 'incident hypoglycaemia']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0556994', 'cui_str': 'Lucid'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",450.0,0.153555,"To detail the protocol, analysis and reporting plans for a randomised clinical trial - the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial - which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes.
","[{'ForeName': 'Alexis P', 'Initials': 'AP', 'LastName': 'Poole', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia. Alexis.Poole@adelaide.edu.au.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Finnis', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Anstey', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Department of Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Biradar', 'Affiliation': 'Department of Intensive Care, Lyell McEwin Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Doherty', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Department of Intensive Care, Western Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Angaj', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Intensive Care Unit, Northern Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Clinical Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Palash', 'Initials': 'P', 'LastName': 'Kar', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Kruger', 'Affiliation': 'Department of Intensive Care, Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maiden', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mårtensson', 'Affiliation': 'Section of Anaesthesia and Intensive Care Medicine, Department of Physiology and Pharmacology, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care and High Dependency Unit, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Secombe', 'Affiliation': 'Department of Intensive Care, Alice Springs Hospital, Alice Springs, NT, Australia.'}, {'ForeName': 'Antony E', 'Initials': 'AE', 'LastName': 'Tobin', 'Affiliation': ""Department of Intensive Care, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia. Adam.Deane@mh.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
332,32389147,Psychological and demographic characteristics of 368 patients with dissociative seizures: data from the CODES cohort.,"BACKGROUND


We examined demographic, clinical, and psychological characteristics of a large cohort (n = 368) of adults with dissociative seizures (DS) recruited to the CODES randomised controlled trial (RCT) and explored differences associated with age at onset of DS, gender, and DS semiology.
METHODS


Prior to randomisation within the CODES RCT, we collected demographic and clinical data on 368 participants. We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life. We undertook comparisons based on reported age at DS onset (<40 v. ⩾40), gender (male v. female), and DS semiology (predominantly hyperkinetic v. hypokinetic).
RESULTS


Our cohort was predominantly female (72%) and characterised by high levels of socio-economic deprivation. Two-thirds had predominantly hyperkinetic DS. Of the total, 69% had ⩾1 comorbid M.I.N.I. diagnosis (median number = 2), with agoraphobia being the most common concurrent diagnosis. Clinical levels of distress were reported by 86% and characteristics associated with maladaptive personality traits by 60%. Moderate-to-severe functional impairment, high levels of somatic symptoms, and impaired quality of life were also reported. Women had a younger age at DS onset than men.
CONCLUSIONS


Our study highlights the burden of psychopathology and socio-economic deprivation in a large, heterogeneous cohort of patients with DS. The lack of clear differences based on gender, DS semiology and age at onset suggests these factors do not add substantially to the heterogeneity of the cohort.",2020,"We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life.","['age at DS onset (<40 v. ⩾40), gender (male v. female), and DS semiology (predominantly hyperkinetic v. hypokinetic', 'patients with DS', '368 patients with dissociative seizures', 'large cohort (n = 368) of adults with dissociative seizures (DS', 'Women had a younger age at DS onset than men', 'Our cohort was predominantly female (72%) and characterised by high levels of socio-economic deprivation', '368 participants']",[],"['quality of life', 'maladaptive personality traits', 'personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life', 'Clinical levels of distress', 'psychiatric comorbidity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233574', 'cui_str': 'Hyperkinetic'}, {'cui': 'C0086439', 'cui_str': 'Hypokinetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233851', 'cui_str': 'Maladaptive personality trait'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0349245', 'cui_str': 'Dissociative convulsions'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",368.0,0.231839,"We assessed psychiatric comorbidity using the Mini-International Neuropsychiatric Interview (M.I.N.I.) and a screening measure of personality disorder and measured anxiety, depression, psychological distress, somatic symptom burden, emotional expression, functional impact of DS, avoidance behaviour, and quality of life.","[{'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'John D C', 'Initials': 'JDC', 'LastName': 'Mellers', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK.'}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Eastwood', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Centre for Social Justice and Global Responsibility, School of Law and Social Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Mosweu', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Pilecka', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Richardson', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Medford', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychological medicine,['10.1017/S0033291720001051']
333,32389236,Voice Quality in Laryngeal Cancer Patients: A Randomized Controlled Study of the Effect of Voice Rehabilitation.,"OBJECTIVES


The study aimed to investigate the short-term and long-term effects of voice rehabilitation in patients treated with radiotherapy for laryngeal cancer as measured by both the acoustic measure smoothed cepstral peak prominence (CPPS) and perceptual measures. A secondary aim was to investigate the relationship between acoustic and perceptual measures.
METHODS


In total, 37 patients received voice rehabilitation post-radiotherapy and 37 patients constituted the irradiated control group. Outcome measures were mean CPPS for connected speech and ratings with the auditory-perceptual Grade, Roughness, Breathiness, Asthenia and Strain (GRBAS) scale. Outcome measures were analyzed 1 (baseline), 6, 12, and 24 months post-radiotherapy, where voice rehabilitation was conducted between the first two time-points. Additional recordings were acquired from vocally healthy participants for comparison.
RESULTS


CPPS values of the voice rehabilitation group and vocally healthy group were not significantly different at 24 months post-radiotherapy. Ten out of 19 patients who received voice rehabilitation yielded a CPPS value above the threshold for normal voice 24 months post-radiotherapy, compared to 11 out of 26 in the irradiated control group. No statistically significant correlations were found between CPPS and perceptual parameters of GRBAS.
CONCLUSION


Voice rehabilitation for irradiated laryngeal cancer patients may have positive effects on voice quality up to 24 months post-radiotherapy. The relationship between CPPS and GRBAS as well as the applicability of CPPS for evaluation over several points of measurement needs to be studied further.",2020,"RESULTS


CPPS values of the voice rehabilitation group and vocally healthy group were not significantly different at 24 months post-radiotherapy.","['vocally healthy participants for comparison', 'Laryngeal Cancer Patients', 'patients treated with radiotherapy for laryngeal cancer', '19 patients who received', 'irradiated laryngeal cancer patients']","['voice rehabilitation', 'Voice rehabilitation', 'Voice Rehabilitation', 'voice rehabilitation post-radiotherapy']","['Voice Quality', 'CPPS value', 'voice quality', 'voice rehabilitation', 'CPPS and perceptual parameters of GRBAS', 'mean CPPS for connected speech and ratings with the auditory-perceptual Grade, Roughness, Breathiness, Asthenia and Strain (GRBAS) scale']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0007107', 'cui_str': 'Malignant tumor of larynx'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0559307', 'cui_str': 'Breathy voice quality'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",37.0,0.0270345,"RESULTS


CPPS values of the voice rehabilitation group and vocally healthy group were not significantly different at 24 months post-radiotherapy.","[{'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Millgård', 'Affiliation': 'Sahlgrenska University Hospital, Department of Otorhinolaryngology, Gothenburg, Sweden. Electronic address: m.millgard@gmail.com.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuomi', 'Affiliation': 'Sahlgrenska University Hospital, Department of Otorhinolaryngology, Gothenburg, Sweden; Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.09.011']
334,32389349,Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial.,"AIM


The aim of this study was to examine the effect of a water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment on pain in young children undergoing burn wound care in hydrotherapy.
METHODS


This study was a prospective, within-subject crossover trial of 38 children aged 6 months to 7 years old (mean age=1.8 years old). Each hydrotherapy procedure was divided into two equivalent wound care segments (No hybrid VR during one segment vs. Hybrid VR during the other segment, treatment order was randomized). Pain was measured using the 0-10 FLACC (Face, Legs, Activity, Cry Consolability scale) and the 0-10 NRS-obs (Numerical Rating Scale-obs).
RESULTS


Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002). Patients' pain levels rated by the nurses using the NRS-obs were non-significant between both groups (p=0.135). No side effects were reported.
CONCLUSION


Projector-Based Hybrid VR helped in reducing the pain related to hydrotherapy procedures in young children with burn wound injuries. This is the first study using virtual reality distraction with young children, and our findings are especially important because a large percentage of pediatric burn patients are very young. Additional research and development are recommended.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02986464, registered on June 12, 2016.",2020,"RESULTS


Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002).","['young children', 'young children undergoing burn wound care in hydrotherapy', 'young children with burn injuries during hydrotherapy sessions', 'young children with burn wound injuries', '38 children aged 6 months to 7 years old (mean age=1.8 years old']","['virtual reality distraction', 'projector-based hybrid virtual reality', 'water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment', 'Projector-Based Hybrid VR']","[""patients' comfort levels"", 'Pain', 'procedural pain levels', 'pain']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C3856907', 'cui_str': 'Projector'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0444914', 'cui_str': 'Domed'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",38.0,0.0313682,"RESULTS


Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002).","[{'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Khadra', 'Affiliation': 'Faculty of Nursing, University of Montreal: 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: christelle.khadra@umontreal.ca.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Nursing, University of Montreal: 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: ariane.ballard@umontreal.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paquin', 'Affiliation': ""Department in Creation and New Media, Université du Québec en Abitibi-Témiscamingue, Campus Rouyn-Noranda: 445, boul. de l'Université, Rouyn-Noranda (Quebec) J9X 5E4, Canada. Electronic address: david.Paquin@uqat.ca.""}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Cotes-Turpin', 'Affiliation': ""Department in Creation and New Media, Université du Québec en Abitibi-Témiscamingue, Campus Rouyn-Noranda: 445, boul. de l'Université, Rouyn-Noranda (Quebec) J9X 5E4, Canada. Electronic address: casey.cotes-turpin@uqat.ca.""}, {'ForeName': 'Hunter G', 'Initials': 'HG', 'LastName': 'Hoffman', 'Affiliation': 'Department of Mechanical Engineering, University of Washington: 3900 E Stevens Way NE, Seattle WA 98195, USA. Electronic address: hunthoff9@gmail.com.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Perreault', 'Affiliation': 'Department of Surgery, CHU Sainte-Justine: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: isabelperreault2@gmail.com.'}, {'ForeName': 'Jean-Simon', 'Initials': 'JS', 'LastName': 'Fortin', 'Affiliation': 'Emergency Department, Hôpital de Granby: 205 Boulevard Leclerc O, Granby (Quebec) J2G 1T7, Canada. Electronic address: js.fo@icloud.com.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Department of Psychoeducation and Psychology, Université du Québec en Outaouais, 283, boulevard Alexandre-Taché, Gatineau (Quebec) J9A 1L8, Canada. Electronic address: stephane.bouchard@uqo.ca.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Théroux', 'Affiliation': 'School of Health Professions, Murdoch University: 90 South Street, Murdoch Western Australia 6150, Australia. Electronic address: jean.Theroux@murdoch.edu.au.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Le May', 'Affiliation': 'Faculty of Nursing, University of Montreal: 2375, Chemin de la Côte-Ste-Catherine, Montreal (Quebec) H3T 1A8, Canada; CHU Sainte-Justine Research Center: 3175 Chemin de la Côte-Sainte-Catherine, Montreal (Quebec) H3T 1C5, Canada. Electronic address: sylvie.lemay@umontreal.ca.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.04.006']
335,32395501,Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study.,"Background


The ATTEMPT study is a multicenter, randomized controlled trial which is investigator-based and open label in nature. For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group). To improve the quality of the study's analysis and to minimize analysis bias based on the study's findings.
Methods


The design of the statistical analysis plan (SAP) was created by chief investigators and statisticians and received permission from the aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) management committee. Treatment allocation and research data were reviewed by the Data Safety and Monitoring Committee and researchers were kept blind. We produced data shells based on a pre-existing published protocol and produced detailed descriptions of statistical analyses. This study includes primary, secondary and safety endpoints. Relevant statistical comparisons were planned and discussed in a transparent manner. They are publicly available, verifiable and were determined prior to the data collection process being completed.
Results


We developed a SAP for the ATTEMPT study and an outline and list of mock tables were also created. We produced descriptions of analyses of baseline characteristics, patient care approaches, efficacy measures, and outcomes. This study defined five previously specified subgroups and compared the statistics of groups within these subgroups.
Conclusions


This SAP has been developed for the ATTEMPT study and has high-quality standards of internal validity to minimize analysis bias.
Trial registration


ClinicalTrials.gov number, NCT02067195.",2020,"For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group).","['patients with ST-Elevation Myocardial infarction undergoing Primary', '560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary', 'patients with ST-elevation myocardial infarction undergoing primary']","['periprocedural aggressive hydration (treatment group) or general hydration (control group', 'percutaneous coronary intervention to prevenT contrast-induced nephropathy', 'percutaneous coronary intervention', 'percutaneous coronary intervention (pPCI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",[],560.0,0.0803154,"For the study, 560 patients with ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (pPCI) have been randomized (1:1) for treatment with periprocedural aggressive hydration (treatment group) or general hydration (control group).","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Zhaodong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou 510515, China.'}, {'ForeName': 'Guoli', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Feier', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': ""Department of Emergency and Critical Care Medicine, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Shiqun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Provincial Key Laboratory of Coronary Heart Disease, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China.""}]",Annals of translational medicine,['10.21037/atm.2020.03.192']
336,32395686,Gastroscopy Should Come Before Colonoscopy Using CO 2  Insufflation in Same Day Bidirectional Endoscopies: A Randomized Controlled Trial.,"Background and Aims


Same day bidirectional endoscopies (esophagogastroduodenoscopies [EGD]s and colonoscopies) are routinely performed. However, the best sequence of procedures is unknown, as is whether the use of carbon dioxide (CO 2 ) affects the preferred sequence of procedures. This study aims to determine the preferred sequence of procedures and choice of insufflation gas (air or CO 2 ) in patients undergoing same day bidirectional endoscopies.
Methods


Two hundred adults with a clinical indication for same day bidirectional endoscopies were randomized equally into four groups: A1 (EGD first, CO 2  as insufflator); A2 (EGD first, air as insufflator); B1 (colonoscopy first, CO 2  as insufflator); and B2 (colonoscopy first, air as insufflator). All procedures were performed with conscious sedation (Midazolam/Fentanyl). The primary outcome was patients' overall comfort/satisfaction with the procedures and sedation received, as assessed by questionnaires and validated scoring scales (Nurse-Assessed Patient Comfort Score [NAPCOMS], La Crosse [WI]) collected during the procedures, before discharge, and on day 7 postprocedure.
Results


Two hundred patients were randomized, with data available for 186. Mean Midazolam dose between groups was significantly less in the EGD first groups ( P =0.01). During the procedures, no differences were found in patients' comfort as per the nurse reported NAPCOMS scores ( P =0.19) or the Lacrosse (WI) endoscopy scores ( P =0.05). On postprocedure days 0 and 7, no differences were found in the patients' reported Lacrosse (WI) scores, nausea, sore throat, dizziness, satisfaction with sedation or overall level of procedural satisfaction ( P >0.05 for each). However, bloating and discomfort were significantly lower in the CO 2  arms ( P <0.001).
Conclusions


This randomized controlled trial using validated patient comfort scoring assessments for same day bidirectional endoscopies demonstrated that the sequence of procedures affects the sedation used but does not affect overall patient comfort or satisfaction. Lesser sedation is needed in the EGD first group, and less postprocedural abdominal pain/discomfort and bloating is seen with CO 2  insufflation.",2020,Mean Midazolam dose between groups was significantly less in the EGD first groups ( P =0.01).,"['patients undergoing same day bidirectional endoscopies', 'Two hundred adults with a clinical indication for same day bidirectional endoscopies', 'Two hundred patients were randomized, with data available for 186']","['conscious sedation (Midazolam/Fentanyl', 'insufflation gas (air or CO 2 ', 'A1 (EGD first, CO 2  as insufflator); A2 (EGD first, air as insufflator); B1 (colonoscopy first, CO 2  as insufflator); and B2 (colonoscopy first, air as insufflator']","['postprocedural abdominal pain/discomfort and bloating', 'Lacrosse (WI) scores, nausea, sore throat, dizziness, satisfaction with sedation or overall level of procedural satisfaction', 'overall comfort/satisfaction with the procedures and sedation received, as assessed by questionnaires and validated scoring scales (Nurse-Assessed Patient Comfort Score [NAPCOMS], La Crosse [WI', 'Lacrosse (WI) endoscopy scores', 'overall patient comfort or satisfaction', 'bloating and discomfort', 'NAPCOMS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0021639', 'cui_str': 'Insufflator'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0022909', 'cui_str': 'Lacrosse'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",200.0,0.0535872,Mean Midazolam dose between groups was significantly less in the EGD first groups ( P =0.01).,"[{'ForeName': 'Fahd', 'Initials': 'F', 'LastName': 'Jowhari', 'Affiliation': ""Gastrointestinal Diseases Research Unit, Department of Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hookey', 'Affiliation': ""Gastrointestinal Diseases Research Unit, Department of Medicine, Queen's University, Kingston, Ontario, Canada.""}]",Journal of the Canadian Association of Gastroenterology,['10.1093/jcag/gwy074']
337,32389738,Topical tacalcitol as neoadjuvant for photodynamic therapy of acral actinic keratoses: an intra-patient randomized study.,"BACKGROUND


photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) is a well described and widely practiced treatment for actinic keratoses (AKs) on the head and face. Less is known about its use for AKs on upper extremities, that can be challenging for the dermatologist. The aim of our study was to compare the combination of topical tacalcitol before 5-ALA-PDT vs conventional 5-ALA-PDT for acral AKs in a prospective, randomized, intra-individual clinical study.
METHODS


patients with AKs of both upper extremities underwent keratolytic pretreatment with topical tacalcitol on the back of one hand and/or forearm (right vs left), randomly selected, for fifteen consecutive days before PDT. All patients underwent one session of 5-ALA-PDT. Visual analog scale for pain was assessed immediately after PDT session and any side effects were recorded after 3 days. Efficacy was evaluated with lesion count (LC) prior to treatment (V0) and 90 days (V1) after PDT.
RESULTS


twenty-one patients with multiple acral AKs were enrolled and completed the study. At V1, neoadjuvant combination of topical tacalcitol plus PDT was significantly more effective than PDT alone (percentage reduction in total lesion count were 44.4% vs 31.5%, respectively). There was no significant difference in VAS pain score between the two treatment modalities. Mild erythema was the only local side effect reported for both treatment regimens (52.4%, tacalcitol plus PDT vs 42.9%, PDT alone).
CONCLUSIONS


neoadjuvant use of topical tacalcitol might be useful to improve PDT efficacy, especially in hard-to-treat AKs on extremities.",2020,"At V1, neoadjuvant combination of topical tacalcitol plus PDT was significantly more effective than PDT alone (percentage reduction in total lesion count were 44.4% vs 31.5%, respectively).","['acral actinic keratoses', 'twenty-one patients with multiple acral AKs were enrolled and completed the study', 'patients with AKs of both upper extremities underwent keratolytic pretreatment with topical tacalcitol on the back of one hand and/or forearm (right vs left']","['topical tacalcitol before 5-ALA-PDT vs conventional 5-ALA-PDT', 'topical tacalcitol plus PDT', '5-ALA-PDT', 'photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA', 'Topical tacalcitol']","['VAS pain score', 'total lesion count', 'Efficacy', 'Mild erythema', 'Visual analog scale for pain', 'PDT efficacy']","[{'cui': 'C0439746', 'cui_str': 'Acral'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0230332', 'cui_str': 'Both upper extremities'}, {'cui': 'C0022585', 'cui_str': 'Keratolytic agent'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0953467', 'cui_str': 'Tacalcitol'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0953467', 'cui_str': 'Tacalcitol'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",21.0,0.0428265,"At V1, neoadjuvant combination of topical tacalcitol plus PDT was significantly more effective than PDT alone (percentage reduction in total lesion count were 44.4% vs 31.5%, respectively).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Borgia', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Riso', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Catalano', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Marialorena', 'Initials': 'M', 'LastName': 'Coppola', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Giuffrida', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy. Electronic address: roberta_giuffrida@hotmail.it.'}, {'ForeName': 'Serafinella Patrizia', 'Initials': 'SP', 'LastName': 'Cannavò', 'Affiliation': 'Department of Clinical and Experimental Medicine, Dermatology, University of Messina, Messina, 98125, Italy.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101803']
338,32389740,Administration of commensal Shewanella sp. MR-7 ameliorates lipopolysaccharide-induced intestine dysfunction in turbot (Scophthalmus maximus L.).,"This study was designed to evaluate whether the administration of commensal Shewanella sp. MR-7 (MR-7) could ameliorate lipopolysaccharide (LPS)-induced intestine dysfunction in turbot. Fish (body weight: 70.00 ± 2.00 g) were randomly divided into three groups including the control group treated with dough, the LPS group treated with dough plus LPS, and the LPS+MR-7 (LMR) group treated with dough plus LPS and MR-7. These three groups with 24 fish each were force-fed with 1g dough daily for 7 continuous days. The results revealed that MR-7 administration ameliorated LPS-induced intestinal injury, showing higher intestinal villus and microvillus height. Further results showed that MR-7 could inhibit LPS-induced activation of TLR-NF-κB signaling thus maintaining the normal expression levels of cytokines and finally ameliorate the intestinal inflammatory response in turbot. Compared with the LPS group, LMR group had less goblet cells and lower mucin-2 expression level. Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3). Further investigations indicated that MR-7 partially counteracted LPS-induced changes in gut microbiota composition, enhanced the beneficial bacteria Lactobacillus and reduced the Pseudomonas, thus maintaining the overall microbiota balance. Taken together, the administration of MR-7 could effectively restore LPS-induced intestine function disorder in turbot by ameliorating inflammatory response, mucosal barrier dysfunction and microbiota dysbiosis.",2020,"Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3).",[],"['control group treated with dough, the LPS group treated with dough plus LPS, and the LPS+MR-7 (LMR) group treated with dough plus LPS and MR-7', 'commensal Shewanella sp. MR-7', 'LPS', 'LMR', 'MR-7']","['gut microbiota composition', 'overall microbiota balance', 'intestinal villus and microvillus height', 'goblet cells and lower mucin-2 expression level']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C0579220', 'cui_str': 'Shewanella'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0227266', 'cui_str': 'Intestinal villus'}, {'cui': 'C0026049', 'cui_str': 'Microvillus'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0506994', 'cui_str': 'Goblet Cells'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1528289', 'cui_str': 'MUC2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.019845,"Moreover, MR-7 restored LPS-induced down-regulation of tight junction protein-related gene expression (zonula occluden-1, occludin, tricellulin and claudin-3).","[{'ForeName': 'Beili', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Chaoqun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Chengdong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Kangsen', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Mariculture (Ministry of Education), Ocean University of China, Qingdao, 266003, China; Laboratory for Marine Fisheries Science and Food Production Processes, Qingdao National Laboratory for Marine Science and Technology, Qingdao, 266237, China. Electronic address: hegen@ouc.edu.cn.'}]",Fish & shellfish immunology,['10.1016/j.fsi.2020.04.068']
339,32389808,Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.,"INTRODUCTION


Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice.
MATERIAL AND METHODS


Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet.
PRIMARY OUTCOMES


Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism.
SECONDARY OUTCOMES


Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation.
DISCUSSION


This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
CLINICAL TRIAL REGISTRATION


NCT03146156.",2020,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","['pregnancy (LIPP', 'Overweight/class 1 obese women after a previous pregnancy, ~12', 'women planning for pregnancy']","['LIPP', 'lifestyle intervention']","['umbilical cord blood insulin resistance, lipid profile and inflammation', 'maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life', 'utero metabolic milieu', 'neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",1.0,0.119724,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy.
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gordesky', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Tierney-Ginn"", 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America. Electronic address: John.Kirwan@pbrc.edu.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Catalano', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106024']
340,32390133,Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis.,"BACKGROUND


Malnutrition is common in patients with chronic kidney disease (CKD) on dialysis. Oral protein-based nutritional supplements are often provided to patients whose oral intake is otherwise insufficient to meet their energy and protein needs. Evidence for the effectiveness of oral protein-based nutritional supplements in this population is limited.
OBJECTIVES


The aims of this review were to determine the benefits and harms of using oral protein-based nutritional supplements to improve the nutritional state of patients with CKD requiring dialysis.
SEARCH METHODS


We searched the Cochrane Kidney and Transplant Register of Studies up to 12 December 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA


Randomised controlled trials (RCTs) of patients with CKD requiring dialysis that compared oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo.
DATA COLLECTION AND ANALYSIS


Two authors independently assessed studies for eligibility, risk of bias, and extracted data from individual studies. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference and 95% CI for continuous outcomes.
MAIN RESULTS


Twenty-two studies (1278 participants) were included in this review. All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis. The follow-up period ranged from one to 12 months. The majority of studies were at unclear risk of selection, performance, and reporting bias. The detection bias was high for self-reported outcomes. Oral protein-based nutritional supplements probably lead to a higher mean change in serum albumin compared to the control group (16 studies, 790 participants: MD 0.19 g/dL, 95% CI 0.05 to 0.33; moderate certainty evidence), although there was considerable heterogeneity in the combined analysis (I 2  = 84%). The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect). Oral protein-based nutritional supplements also probably leads to a higher mean serum albumin at the end of the intervention (14 studies, 715 participants: MD 0.14 g/dL, 95% CI 0 to 0.27; moderate certainty evidence), however heterogeneity was again high (I 2  = 80%). Again the increase was more evident in HD participants (9 studies, 498 participants: MD 0.21 g/dL, 95% CI 0.03 to 0.38; P = 0.02 for overall effect) and malnourished participants (7 studies, 377 participants: MD 0.25 g/dL, 95% CI 0.02 to 0.47; P = 0.03 for overall effect). Compared to placebo or no supplement, low certainty evidence showed oral protein-based nutritional supplements may result in a higher serum prealbumin (4 studies, 225 participants: MD 2.81 mg/dL, 95% CI 2.19 to 3.43), and mid-arm muscle circumference (4 studies, 216 participants: MD 1.33 cm, 95% CI 0.24 to 2.43) at the end of the intervention. Compared to placebo or no supplement, oral protein-based nutritional supplements may make little or no difference to weight (8 studies, 365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants: MD -0.04 kg/m 2 , 95% CI -0.74 to 0.66; moderate certainty evidence) and lean mass (5 studies, 189 participants: MD 1.27 kg, 95% CI -1.61 to 4.51; low certainty evidence). Due to very low quality of evidence, it is uncertain whether oral protein-based nutritional supplements affect triceps skinfold thickness, mid-arm circumference, C-reactive protein, Interleukin 6, serum potassium, or serum phosphate. There may be little or no difference in the risk of developing gastrointestinal intolerance between participants who received oral protein-based nutritional supplements compared with placebo or no supplement (6 studies, 426 participants: RR 2.81, 95% CI 0.58 to 13.65, low certainty evidence). It was not possible to draw conclusions about cost or quality of life, and deaths were not reported as a study outcome in any of the included studies.
AUTHORS' CONCLUSIONS


Overall, it is likely that oral protein-based nutritional supplements increase both mean change in serum albumin and serum albumin at end of intervention and may improve serum prealbumin and mid-arm muscle circumference. The improvement in serum albumin was more evident in haemodialysis and malnourished participants. However, it remains uncertain whether these results translate to improvement in nutritional status and clinically relevant outcomes such as death. Large well-designed RCTs in this population are required.",2020,"The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect).","['patients with CKD requiring dialysis', 'Twenty-two studies (1278 participants', 'patients with CKD requiring dialysis that compared', '365 participants: MD 2.83 kg, 95% CI -0.43 to 6.09; low certainty evidence), body mass index (9 studies, 368 participants', 'people with chronic kidney disease requiring dialysis', 'All participants were adults on maintenance dialysis of whom 79% were on haemodialysis (HD) and 21% peritoneal dialysis', 'patients with chronic kidney disease (CKD) on dialysis']","['Oral protein-based nutritional supplements', 'placebo or no supplement, oral protein-based nutritional supplements', 'Oral protein-based supplements versus placebo', 'oral protein-based nutritional supplements', 'oral protein-based nutritional supplements to no oral protein-based nutritional supplements or placebo', 'placebo']","['serum albumin', 'moderate certainty evidence) and lean mass', 'serum prealbumin and mid-arm muscle circumference', 'cost or quality of life, and deaths', 'mean serum albumin', 'serum albumin and serum albumin', 'risk of developing gastrointestinal intolerance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0562347', 'cui_str': 'Mid arm muscle circumference'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]",,0.257445,"The increase was more evident in HD participants (10 studies, 526 participants: MD 0.28 g/dL, 95% CI 0.11 to 0.46; P = 0.001 for overall effect) and malnourished participants (8 studies, 405 participants: MD 0.31 g/dL, 95% CI 0.10 to 0.52, P = 0.003 for overall effect).","[{'ForeName': 'Jia Yee', 'Initials': 'JY', 'LastName': 'Mah', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Suet Wan', 'Initials': 'SW', 'LastName': 'Choy', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Roberts', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Desai', 'Affiliation': 'Department of Dietetics/Renal, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Corken', 'Affiliation': 'Department of Dietetics/Renal, Eastern Health, Box Hill, Australia.'}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Gwini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Clayton, Australia.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'McMahon', 'Affiliation': 'Integrated Renal Service, Eastern Health, Box Hill, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012616.pub2']
341,32390143,CORRIGENDUM: Is Placebo Response Responsible for Many Phase III Failures?,,2020,,[],[],[],[],[],[],,0.0327224,,[],Clinical pharmacology and therapeutics,['10.1002/cpt.1730']
342,31631761,Implementing a peer-support programme by group videoconferencing for isolated carers of people with dementia.,"INTRODUCTION


Carers support programmes are commonly delivered in person, limiting attendance opportunities for rural carers and others who have access barriers. Studies using technology typically use text-based forums rather than real-time technology such as videoconferencing (VC). Delivering home-based carers support programmes by VC may mitigate barriers for accessing support. We report implementation findings for delivering a telehealth peer-support programme for isolated carers of people with dementia.
METHODS


Participants were recruited through aged care providers, peak bodies and media activities. Inclusion criteria were primary dementia caregiver with Internet access and being socially or geographically isolated. The study design was a staggered randomised waitlist design. Measures included the UCLA Loneliness Scale (ULS-6) and selected scales from the e-Health Literacy Questionnaire. Recruitment activities utilised digital processes. Participants completed a six-week programme delivered by VC. Qualitative data comprised logs detailing administration and IT procedures and difficulties. Post programme, 28 participants undertook semi-structured interviews. Data were analysed using descriptive statistics and thematic analysis.
RESULTS


There were 16 groups comprising 69 participants located throughout Australia, with 87% using their own devices. Technical issues were few but included connection problems, which were compounded by low digital literacy skills. Qualitative data themes included changing perceptions in using technology, differences in communicating by VC and technical support required. Recruitment activities were time-consuming and would benefit from IT tailored for group-based work. Eight groups continued to meet on a self-organised basis.
DISCUSSION


Providing peer-support groups using telehealth may have the potential to develop self-sustaining peer networks for isolated caregivers of people with dementia.",2019,Providing peer-support groups using telehealth may have the potential to develop self-sustaining peer networks for isolated caregivers of people with dementia.,"['isolated carers of people with dementia', '28 participants undertook semi-structured interviews', 'There were 16 groups comprising 69 participants located throughout Australia, with 87% using their own devices', 'Participants were recruited through aged care providers, peak bodies and media activities', 'Inclusion criteria were primary dementia caregiver with Internet access and being socially or geographically isolated']",['telehealth peer-support programme'],['UCLA Loneliness Scale (ULS-6) and selected scales from the e-Health Literacy Questionnaire'],"[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",69.0,0.0677973,Providing peer-support groups using telehealth may have the potential to develop self-sustaining peer networks for isolated caregivers of people with dementia.,"[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Banbury', 'Affiliation': 'CQUniversity, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Parkinson', 'Affiliation': 'CQUniversity, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gordon', 'Affiliation': 'CQUniversity, Australia.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': 'CQUniversity, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19873793']
343,32392833,"Effects of Augmented-Reality-Based Exercise on Muscle Parameters, Physical Performance, and Exercise Self-Efficacy for Older Adults.","This study was intended to determine the applicability of an augmented-reality-based muscle reduction prevention exercise program for elderly Korean women by observing changes in exercise self-efficacy and verifying the effectiveness of the program in the elderly after the application of the program. A total of 27 participants, who were elderly women aged 65+ and had not participated in any exercise programs until this study, were recruited for this study. They were divided into an experimental group (13 people) and a control group (14 people), and then the augmented-reality-based muscle reduction prevention exercise program was applied. This was a 30-min program, which included regular, aerobic, and flexibility exercises, and it was applied 5 times a week for 12 weeks. As a result of observing changes, it was found that the appendicular skeletal muscle mass (ASM) (F = 11.222,  p  < 0.002) and the skeletal muscle index (SMI) (kg/m 2 ) (F = 10.874,  p  < 0.003) muscle parameters increased more in the experimental group compared to the control group, and there was a significant increase in gait speed (m/s) (F = 7.221,  p  < 0.005). For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110,  p  < 0.033), 2-min step test (2MST) (F = 6.621,  p  < 0.020), and the timed up-and-go test (TUG) (F = 5.110,  p  < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464,  p  < 0.001). Finally, the augmented-reality-based exercise program in this study was found to be effective in inducing physical activity in the elderly. Therefore, the augmented-reality-based muscle reduction prevention exercise program is considered to be effective in increasing the sustainability of exercise, thus preventing muscle reduction in the elderly.",2020,"For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110,  p  < 0.033), 2-min step test (2MST) (F = 6.621,  p  < 0.020), and the timed up-and-go test (TUG) (F = 5.110,  p  < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464,  p  < 0.001).","['elderly Korean women', '27 participants, who were elderly women aged 65+ and had not participated in any exercise programs until this study, were recruited for this study', 'Older Adults']","['Augmented-Reality-Based Exercise', 'augmented-reality-based muscle reduction prevention exercise program', 'control group (14 people), and then the augmented-reality-based muscle reduction prevention exercise program']","['exercise self-efficacy', 'appendicular skeletal muscle mass (ASM', 'physical activity', 'gait speed (m/s', 'skeletal muscle index (SMI', 'Muscle Parameters, Physical Performance, and Exercise Self-Efficacy', 'chair stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",27.0,0.0120384,"For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110,  p  < 0.033), 2-min step test (2MST) (F = 6.621,  p  < 0.020), and the timed up-and-go test (TUG) (F = 5.110,  p  < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464,  p  < 0.001).","[{'ForeName': 'Sangwan', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Exercise Rehabilitation Convergence Institute, Gachon University191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'Jiyoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation & Welfare, Gachon University 191 Hombakmoero, Yeonsu-gu, Incheon 406799, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093260']
344,32392835,Myofunctional Trainer versus Twin Block in Developing Class II Division I Malocclusion: A Randomized Comparative Clinical Trial.,"This study aimed to evaluate and compare the dentoalveolar effects of the myofunctional trainer T4K TM  versus twin block in children with class II division I malocclusion. Two parallel arm randomized comparative clinical trial was conducted, including twenty healthy children, 9-12 years old, showing Angle's class II division I malocclusion due to mandibular retrusion. Children were randomly assigned into two groups according to the appliance used; Group 1: T4k, and Group II: twin block. Follow-up was done every 4 weeks for 9 months. Postoperative cephalometric X ray, study casts and photographs were taken for measurements and comparison. T4K showed a statistically significant reduction in the overjet (-2.50 ± 1.00 mm) ( p  < 0.0001), and a significant increase in the lower arch perimeter (LAP) (1.19 ± 0.96 mm) ( p  = 0.01). The twin block showed a statistically significant reduction in the overjet (-3.75 ± 1.10 mm) ( p  < 0.0001), a significant reduction in the overbite (-16.22 ± 17.02 %) ( p  = 0.03), and a significant increase in the LAP (1.69 ± 0.70 mm) ( p  < 0.0001). The overjet showed a higher significant decrease in the twin block group than in T4K ( p  = 0.03). The mean values of the overbite were significantly decreased in twin block than in T4k ( p  < 0.0001). Both groups showed significant dentoalveolar improvements toward class I occlusion; however, the twin block showed significantly better results than T4K appliance.",2020,"T4K showed a statistically significant reduction in the overjet (-2.50 ± 1.00 mm) ( p  < 0.0001), and a significant increase in the lower arch perimeter (LAP) (1.19 ± 0.96 mm) ( p  = 0.01).","['children with class II division I malocclusion', ""twenty healthy children, 9-12 years old, showing Angle's class II division I malocclusion due to mandibular retrusion"", 'I Malocclusion']","['myofunctional trainer T4K TM  versus twin block', 'Myofunctional Trainer versus Twin Block in Developing Class II Division']","['lower arch perimeter (LAP', 'mean values of the overbite']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714535', 'cui_str': 'Malocclusion, Angle class II'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3494426', 'cui_str': 'Mandibular Retrusion'}]","[{'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C1293097', 'cui_str': 'Division'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}]",20.0,0.0771243,"T4K showed a statistically significant reduction in the overjet (-2.50 ± 1.00 mm) ( p  < 0.0001), and a significant increase in the lower arch perimeter (LAP) (1.19 ± 0.96 mm) ( p  = 0.01).","[{'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Elhamouly', 'Affiliation': 'Pediatric Dentistry and Oral Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}, {'ForeName': 'Azza A', 'Initials': 'AA', 'LastName': 'El-Housseiny', 'Affiliation': 'Pediatric Dentistry and Oral Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}, {'ForeName': 'Hanan A', 'Initials': 'HA', 'LastName': 'Ismail', 'Affiliation': 'Orthodontic Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}, {'ForeName': 'Laila M El', 'Initials': 'LME', 'LastName': 'Habashy', 'Affiliation': 'Pediatric Dentistry and Oral Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria 21526, Egypt.'}]",Dentistry journal,['10.3390/dj8020044']
345,32392863,The Effect of Mind Subtraction Meditation Intervention on Smartphone Addiction and the Psychological Wellbeing among Adolescents.,"As the smartphone has become an indispensable device in modern lives, consequential psychosocial problems such as smartphone addiction have been getting attention worldwide, especially regarding adolescents. Based on its positive effect on young individuals' mental health, mind subtraction meditation has been widely applied to many school-based programs in South Korea. This study aims to identify the effects of a school program based on mind subtraction on the smartphone addiction of adolescents. A total of 49 high school sophomores, 24 from the experimental group (mean age = 16), and 25 from the control group (mean age = 16) are included in this case-control study. The experimental group is given the meditation program sessions in the morning, two times a week for 20 min per session, for a total of 12 weeks. The experimental group shows improvements regarding the 'smartphone addiction' section ( p  < 0.001), for instant satisfaction ( p  < 0.001) and long-term satisfaction ( p  < 0.001). Concerning the 'self-control' section and decreasing stress ( p  < 0.001), problem focusing ( p  < 0.001), and social support navigation ( p  = 0.018), there are improvements in these 'stress coping strategies' sections. This study directly shows the positive effect of mind subtraction meditation on smartphone addiction in adolescents and, thus, provides guidance to the future development of smartphone addiction prevention programs for young individuals.",2020,"The experimental group shows improvements regarding the 'smartphone addiction' section ( p  < 0.001), for instant satisfaction (","['Adolescents', ""young individuals' mental health"", 'young individuals', 'A total of 49 high school sophomores, 24 from the experimental group (mean age = 16), and 25 from the control group (mean age = 16) are included in this case-control study', 'adolescents']","['meditation program sessions', 'Mind Subtraction Meditation Intervention', 'mind subtraction meditation', 'school program based on mind subtraction']","['Smartphone Addiction and the Psychological Wellbeing', ""smartphone addiction' section"", 'long-term satisfaction', 'instant satisfaction ', 'social support navigation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",49.0,0.016192,"The experimental group shows improvements regarding the 'smartphone addiction' section ( p  < 0.001), for instant satisfaction (","[{'ForeName': 'Eun-Hi', 'Initials': 'EH', 'LastName': 'Choi', 'Affiliation': 'Department of Nursing, Eulji University, Daejeon 34824, Korea.'}, {'ForeName': 'Min Young', 'Initials': 'MY', 'LastName': 'Chun', 'Affiliation': ""Department of Global Medical Science, Sungshin Women's University, Seoul 02844, Korea.""}, {'ForeName': 'Insoo', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'Department of Paramedic Science, Korea National University of Transportation, Chungcheongbuk-do 27909, Korea.'}, {'ForeName': 'Yang-Gyeong', 'Initials': 'YG', 'LastName': 'Yoo', 'Affiliation': 'Department of Nursing, Kunsan National University, Jeollabuk-do 54150, Korea.'}, {'ForeName': 'Min-Jae', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': ""Research Institute of Basic Science, Sungshin Women's University, Seoul 02844, Korea.""}]",International journal of environmental research and public health,['10.3390/ijerph17093263']
346,32392882,"The Preventive role of Regular Physical Training in Ventricular Remodeling, Serum Cardiac Markers, and Exercise Performance Changes in Breast Cancer in Women Undergoing Trastuzumab Therapy-An REH-HER Study.","Cardiotoxicity is known as a severe clinical problem in oncological practice that reduces the options for cancer therapy. Physical exercise is recognized as a well-established protective measure for many heart and cancer diseases. In our study, we hypothesized that supervised and moderate-intensity exercise training would prevent heart failure and its consequences induced by trastuzumab therapy. The aim of this study was to examine the effect of physical training on ventricular remodeling, serum cardiac markers, and exercise performance in women with human epidermal growth receptor 2 (HER2+) breast cancer (BC) undergoing trastuzumab therapy. This was a prospective, randomized, clinical controlled trial. Forty-six BC women were randomized into either an intervention group (IG) or a control group (CG). An exercise program (IG) was performed after 3-6 months of trastuzumab therapy at 5 d/week (to 80% maximum heart rate (HRmax)) for 9 weeks. We then evaluated their cardiac function using echocardiography, a 6-Minute Walk Test (6MWT), and plasma parameters (C-reactive protein (CRP), myoglobin (MYO), interleukin-6 (IL-6), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK)). After the physical training program, we did not observe any significant changes in the left ventricular (LV) ejection fraction (LVEF) and 6MWT ( p  > 0.05) in the IG compared to the CG (decrease  p  < 0.05). The differences in the blood parameters were not significant ( p  < 0.05). To conclude, moderate-intensity exercise training prevented a decrease in the LVEF and physical capacity during trastuzumab therapy in HER2+ BC. Further research is needed to validate our results.",2020,The differences in the blood parameters were not significant ( p  < 0.05).,"['Forty-six BC women', 'Breast Cancer in Women', 'women with human epidermal growth receptor 2 (HER2+) breast cancer (BC) undergoing trastuzumab therapy']","['trastuzumab therapy', 'supervised and moderate-intensity exercise training', 'Regular Physical Training', 'physical training', 'Physical exercise', 'intervention group (IG) or a control group (CG', 'moderate-intensity exercise training']","['blood parameters', '6-Minute Walk Test (6MWT), and plasma parameters (C-reactive protein (CRP), myoglobin (MYO), interleukin-6 (IL-6), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK', 'heart failure', 'ventricular remodeling, serum cardiac markers, and exercise performance', 'Cardiotoxicity', 'LVEF and physical capacity', 'left ventricular (LV) ejection fraction (LVEF) and 6MWT']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",46.0,0.0258682,The differences in the blood parameters were not significant ( p  < 0.05).,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Hojan', 'Affiliation': 'Department of Rehabilitation, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Procyk', 'Affiliation': 'Central Labolatory, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Horyńska-Kęstowicz', 'Affiliation': 'Department of Rehabilitation, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Leporowska', 'Affiliation': 'Central Labolatory, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Litwiniuk', 'Affiliation': 'Department of Chemotherapy, Greater Poland Cancer Centre, 61-866 Poznan, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9051379']
347,32393129,Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial.,"BACKGROUND


Cost is frequently cited as a barrier to optimal medication use, but the extent to which copayment assistance interventions are used when available, and their impact on evidence-based medication persistence and major adverse cardiovascular events is unknown.
METHODS AND RESULTS


The ARTEMIS trial (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) randomized 301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12  inhibitors in the 1 year post-myocardial infarction. In the intervention group, we used multivariable logistic regression to identify patient and medication cost characteristics associated with voucher use. We then used this model to stratify both intervention and usual care patients by likelihood of voucher use, and examined the impact of the voucher intervention on 1-year P2Y 12  inhibitor persistence (no gap in pharmacy supply >30 days) and major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke). Among 10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention. Of these, 1742 (28.4%) never used the voucher, although 1729 (99.2%) voucher never-users filled at least one P2Y 12  inhibitor prescription in the 1 year post-myocardial infarction. Characteristics most associated with voucher use included: discharge on ticagrelor, planned 1-year course of P2Y 12  inhibitor treatment, white race, commercial insurance, and higher out-of-pocket medication costs (c-statistic 0.74). Applying this propensity model to stratify all enrolled patients by likelihood of voucher use, the intervention improved medication persistence the most in patients with high likelihood of voucher use (adjusted interaction  P =0.03, odds ratio, 1.86 [95% CI, 1.48-2.33]). The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction  P =0.04).
CONCLUSIONS


Among patients discharged after myocardial infarction, those with higher copayments and greater out-of-pocket medication costs were more likely to use a copayment assistance voucher, but some classes of patients were less likely to use a copayment assistance voucher. Patients at low likelihood of voucher use benefitted least from copayment assistance, and other interventions may be needed to improve medication-taking behaviors and clinical outcomes in these patients.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02406677.",2020,"The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction  P =0.04).
","['301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12  inhibitors in the 1 year post-myocardial infarction', '10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention']",[],"['major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke', 'major adverse cardiovascular events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",10102.0,0.0693459,"The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction  P =0.04).
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Fanaroff', 'Affiliation': 'Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Leonard Davis Institute of Health Economics, Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia (A.C.F.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Division of Cardiology, Duke University, Durham, NC. (E.D.P., T.Y.W.).'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'the Duke Clinical Research Institute, Duke University, Durham, NC. (E.D.P., L.A.K., K.J.A., T.Y.W.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'the Duke Clinical Research Institute, Duke University, Durham, NC. (E.D.P., L.A.K., K.J.A., T.Y.W.).'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA (G.C.F.).'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH (T.D.H.).'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Division of Cardiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. (C.P.P.).""}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. (N.K.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, MO (D.J.C.).'}, {'ForeName': 'Nipun', 'Initials': 'N', 'LastName': 'Atreja', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Bhalla', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca, Wilmington, DE (N.A., N.B., J.M.E.).'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiology, Duke University, Durham, NC. (E.D.P., T.Y.W.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006182']
348,32393152,"The ties that bind: Cancer history, communication, and screening intention associations among diverse families.","OBJECTIVE


Breast and cervical cancers are screen-detectable; yet, challenges exist with ensuring uptake of mammography and Pap smear. Family, a central factor in developing knowledge to carry out health promotion behaviors, may be an asset to improving intention to screen among non-adherent women from underrepresented minority groups. We explored familial cancer; communication; and breast and cervical screening intention among non-adherent Black, Latina, and Arab women in the United States who participated in a randomized controlled trial of the Kin Keeper SM  Cancer Prevention Intervention study. The intervention was a culturally-targeted breast and cervical cancer literacy tool for Black, Latina, and Arab women, consisting of two family-focused education sessions on the cancers, their screening guidelines, and risk-reducing health-related behaviors.
METHODS


For this secondary analysis, we assessed family cancer history, family communication, and screening intention for breast and cervical cancer in age-eligible, non-adherent participants. Descriptive statistics examined sample characteristics of the intervention and control groups. Odds ratios were estimated from logistic regression modeling to assess the intervention and sample characteristic effects on screening intention.
RESULTS


Of the 516 participants, 123 and 98 were non-adherent to breast and cervical cancer screening, respectively. The intervention (OR = 1.95 for mammography; OR = 1.62 for Pap smear) and highly communicative (OR = 2.57 for mammography; OR = 3.68 for Pap smear) families reported greater screening intention. Family history of cancer only increased screening intention for mammography (OR = 2.25).
CONCLUSION


Family-focused approaches supporting communication may increase breast and cervical cancer screening intention among non-adherent, underrepresented minority groups.",2020,The intervention (OR = 1.95 for mammography; OR = 1.62 for Pap smear) and highly communicative (OR = 2.57 for mammography; OR = 3.68 for Pap smear) families reported greater screening intention.,"['in age-eligible, non-adherent participants', 'non-adherent Black, Latina, and Arab women in the United States who participated in a randomized controlled trial of the Kin Keeper SM  Cancer Prevention Intervention study', '516 participants, 123 and 98 were non-adherent to breast and cervical cancer screening, respectively']","['culturally-targeted breast and cervical cancer literacy tool for Black, Latina, and Arab women, consisting of two family-focused education sessions']","['Odds ratios', 'family cancer history, family communication, and screening intention for breast and cervical cancer']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0682416', 'cui_str': 'Ruanda language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0260515', 'cui_str': 'Family history of cancer'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",516.0,0.02534,The intervention (OR = 1.95 for mammography; OR = 1.62 for Pap smear) and highly communicative (OR = 2.57 for mammography; OR = 3.68 for Pap smear) families reported greater screening intention.,"[{'ForeName': 'Timiya S', 'Initials': 'TS', 'LastName': 'Nolan', 'Affiliation': 'Martha S. Pitzer Center for Women, Children & Youth, College of Nursing, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Martha S. Pitzer Center for Women, Children & Youth, College of Nursing, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Karen Patricia', 'Initials': 'KP', 'LastName': 'Williams', 'Affiliation': 'Martha S. Pitzer Center for Women, Children & Youth, College of Nursing, The Ohio State University, Columbus, OH, USA.'}]",Journal of medical screening,['10.1177/0969141320920900']
349,32393158,Blending Traditional Vocational Services and Individualized Placement and Support for Formerly Incarcerated Veterans.,"OBJECTIVE


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


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


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


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


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


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study.","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'LePage', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Crawford', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Daisha J', 'Initials': 'DJ', 'LastName': 'Cipher', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Kemol', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Rock', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Julie A Parish', 'Initials': 'JAP', 'LastName': 'Johnson', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Washington', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ottomanelli', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900421']
350,32393169,Does the revised intubating laryngeal tube (ILTS-D2) perform better than the intubating laryngeal mask (Fastrach)? - a randomised simulation research study.,"BACKGROUND


The intubating laryngeal tube (ILTS-D™) and the intubating laryngeal mask (Fastrach™) are devices that facilitate both extraglottic application and blind tracheal intubation. A revised model of the iLTS-D (for scientific reasons called ILTS-D2) has been designed but not yet evaluated. Therefore, we compared the ILTS-D2 with the established Fastrach under controlled conditions in a prospective randomised controlled simulation research study.
METHODS


After ethical approval, we randomised 126 medical students into two groups. Each participant received either Fastrach or ILTS-D2 to perform five consecutive ventilation attempts in a manikin. The primary endpoint was the time to ventilation in the last attempt of using the devices as extraglottic devices. Secondary endpoints were the time to tracheal intubation and the success rates.
RESULTS


There was no relevant difference between the two devices in the time to ventilation in the last of five attempts (Fastrach: median 14 s [IQR: 12-15]; ILTS-D2: median 13 s [IQR: 12-15], p = 0.592). Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001). For both devices, the success rates were 100% in the last attempt.
CONCLUSIONS


Concerning extraglottic airway management, we could not detect a relevant difference between the revised ILTS-D2 and the Fastrach under laboratory conditions. We advocate for an evaluation of the ILTS-D2 in randomised controlled clinical trials.
TRIAL REGISTRATION


Identifier at clinicaltrials.gov: NCT03542747. May 31, 2018.",2020,Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001).,['126 medical students into two groups'],"['intubating laryngeal tube (ILTS-D™) and the intubating laryngeal mask (Fastrach™', 'Fastrach or ILTS-D2']","['2\u2009s faster blind tracheal intubation using the Fastrach', 'time to tracheal intubation and the success rates', 'time to ventilation', 'time to ventilation in the last attempt of using the devices as extraglottic devices', 'success rates']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}]","[{'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.115281,Secondary endpoints showed a 2 s faster blind tracheal intubation using the Fastrach than using the ILTS-D2 (Fastrach: median 14 s [IQR: 13-17]; ILTS-D2: median 16 s [IQR: 15-20] p < 0.001).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ott', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany. ottth@uni-mainz.de.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Tschöpe', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Toenges', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Buggenhagen', 'Affiliation': 'Rudolf-Frey Lernklinik Central Education Platform, Medical Centre of the Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Engelhard', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kriege', 'Affiliation': 'Department of Anaesthesiology, Medical Centre of the Johannes Gutenberg University, Langenbeckstr. 1, 55131, Mainz, Germany.'}]",BMC anesthesiology,['10.1186/s12871-020-01029-3']
351,32393216,"The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.","BACKGROUND


Low back pain is a prevalent condition that causes a substantial health burden. Despite intensive and expensive clinical efforts, its prevalence is growing. Nonpharmacologic treatments are effective at improving pain-related outcomes; however, treatment effect sizes are often modest. Physical therapy (PT) and cognitive behavioral therapy (CBT) have the most consistent evidence of effectiveness. Growing evidence also supports mindfulness-based approaches. Discussions with providers and patients highlight the importance of discussing and trying options to find the treatment that works for them and determining what to do when initial treatment is not successful. Herein, we present the protocol for a study that will evaluate evidence-based, protocol-driven treatments using PT, CBT, or mindfulness to examine comparative effectiveness and optimal sequencing for patients with chronic low back pain.
METHODS


The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE) Study will be a multisite, comparative effectiveness trial using a sequential multiple assessment randomized trial design enrolling 945 individuals with chronic low back pain. The co-primary outcomes will be disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale). After baseline assessment, participants will be randomly assigned to PT or CBT. At week 10, participants who have not experienced at least 50% improvement in disability will be randomized to cross-over phase-1 treatments (e.g., PT to CBT) or to Mindfulness-Oriented Recovery Enhancement (MORE). Treatment will consist of 8 weekly sessions. Long-term outcome assessments will be performed at weeks 26 and 52.
DISCUSSION


Results of this study may inform referring providers and patients about the most effective nonoperative treatment and/or sequence of nonoperative treatments to treat chronic low back pain.
TRIAL REGISTRATION


This study was prospectively registered on March 1, 2019, with Clinicaltrials.gov under the registration number NCT03859713 (https://clinicaltrials.gov/ct2/show/NCT03859713).",2020,The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE),"['945 individuals with chronic low back pain', 'chronic, nonspecific low back pain', 'patients with chronic low back pain']","['Physical therapy (PT) and cognitive behavioral therapy (CBT', 'nonpharmacologic treatment']","['disability', 'disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",945.0,0.158168,The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE),"[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Skolasky', 'Affiliation': 'Department of Orthopaedic Surgery, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA. rskolas1@jhmi.edu.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Rachel V', 'Initials': 'RV', 'LastName': 'Aaron', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Patti', 'Initials': 'P', 'LastName': 'Ephraim', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Brennan', 'Affiliation': 'Intermountain Healthcare, 36\u2009S State St, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': ""Department of Population Health Sciences, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lane', 'Affiliation': ""Department of Physical Therapy and Athletic Training, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Minick', 'Affiliation': 'Intermountain Healthcare, 36\u2009S State St, Salt Lake City, UT, 84111, USA.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': ""College of Social Work, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': ""College of Social Work, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': ""Department of Physical Therapy and Athletic Training, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.""}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03324-z']
352,32393220,Digital versus analogue chest drainage system in patients with primary spontaneous pneumothorax: a randomized controlled trial.,"BACKGROUND


Patients with a primary spontaneous pneumothorax (PSP) who are treated with chest tube drainage are traditionally connected to an analogue chest drainage system, containing a water seal and using a visual method of monitoring air leakage. Electronic systems with continuous digital monitoring of air leakage provide better insight into actual air leakage and changes in leakage over time, which may lead to a shorter length of hospital stay.
METHODS


We performed a randomized controlled trial comparing the digital with analogue system, with the aim of demonstrating that use of a digital drainage system in PSP leads to a shorter hospital stay.
RESULTS


In 102 patients enrolled with PSP we found no differences in total duration of chest tube drainage and hospital stay between the groups. However, in a post-hoc analysis, excluding 19 patients needing surgery due to prolonged air leakage, hospital stay was significantly shorter in the digital group (median 1 days, IQR 1-5 days) compared to the analogue group (median 3 days, IQR 2-5 days) (p 0.014). Treatment failure occurred in 3 patients in both groups; the rate of recurrence within 12 weeks was not significantly different between groups (16% in the digital group versus 8% in the analogue group, p 0.339).
CONCLUSION


Length of hospital stay was not shorter in patients with PSP when applying a digital drainage system compared to an analogue drainage system. However, in the large subgroup of uncomplicated PSP, a significant reduction in duration of drainage and hospital stay was demonstrated with digital drainage. These findings suggest that digital drainage may be a practical alternative to manual aspiration in the management of PSP.
TRIAL REGISTRATION


Registered 22 September 2013 - Retrospectively registered, Trial NL4022 (NTR4195).",2020,Length of hospital stay was not shorter in patients with PSP when applying a digital drainage system compared to an analogue drainage system.,"['102 patients enrolled with', 'Patients with a primary spontaneous pneumothorax (PSP) who are treated with', 'patients with primary spontaneous pneumothorax']","['chest tube drainage', 'PSP', 'Digital versus analogue chest drainage system']","['Treatment failure', 'Length of hospital stay', 'total duration of chest tube drainage and hospital stay', 'rate of recurrence', 'prolonged air leakage, hospital stay', 'duration of drainage and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1868193', 'cui_str': 'Primary spontaneous pneumothorax'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}]",102.0,0.12327,Length of hospital stay was not shorter in patients with PSP when applying a digital drainage system compared to an analogue drainage system.,"[{'ForeName': 'Dieuwertje', 'Initials': 'D', 'LastName': 'Ruigrok', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Peter W A', 'Initials': 'PWA', 'LastName': 'Kunst', 'Affiliation': 'Department of Pulmonary Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Marielle M J', 'Initials': 'MMJ', 'LastName': 'Blacha', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Tomlow', 'Affiliation': 'Department of Pulmonary Medicine, NWZG, Alkmaar, The Netherlands.'}, {'ForeName': 'Jacobine W', 'Initials': 'JW', 'LastName': 'Herbrink', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Eva J', 'Initials': 'EJ', 'LastName': 'Japenga', 'Affiliation': 'Department of Pulmonary Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Boersma', 'Affiliation': 'Department of Pulmonary Medicine, NWZG, Alkmaar, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'van der Lee', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Mooren', 'Affiliation': 'Department of Pulmonary Medicine, Spaarne Gasthuis, PO Box 417 2000, AK, Haarlem, the Netherlands. k.mooren@spaarnegasthuis.nl.'}]",BMC pulmonary medicine,['10.1186/s12890-020-1173-3']
353,32393245,Using alcohol consumption diary data from an internet intervention for outcome and predictive modeling: a validation and machine learning study.,"BACKGROUND


Alcohol use disorder (AUD) is highly prevalent and presents a large treatment gap. Self-help internet interventions are an attractive approach to lowering thresholds for seeking help and disseminating evidence-based programs at scale. Internet interventions for AUD however suffer from high attrition and since continuous outcome measurements are uncommon, little is known about trajectories and processes. The current study investigates whether data from a non-mandatory alcohol consumption diary, common in internet interventions for AUD, approximates drinks reported at follow-up, and whether data from the first half of the intervention predict treatment success.
METHODS


N = 607 participants enrolled in a trial of online self-help for AUD, made an entry in the non-mandatory consumption diary (total of 9117 entries), and completed the follow-up assessment. Using multiple regression and a subset of calendar data overlapping with the follow-up, scaling factors were derived to account for missing entries per participant and week. Generalized estimating equations with an inverse time predictor were then used to calculate point-estimates of drinks per week at follow-up, the confidence intervals of which were compared to that from the measurement at follow-up. Next, calendar data form the first half of the intervention were retained and summary functions used to create 18 predictors for random forest machine learning models, the classification accuracies of which were ultimately estimated using nested cross-validation.
RESULTS


While the raw calendar data substantially underestimated drinks reported at follow-up, the confidence interval of the trajectory-derived point-estimate from the adjusted data overlapped with the confidence interval of drinks reported at follow-up. Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
CONCLUSIONS


Data from a non-mandatory alcohol consumption diary, adjusted for missing entries, approximates follow-up data at a group level, suggesting that such data can be used to reveal trajectories and processes during treatment and possibly be used to impute missing follow-up data. At an individual level, however, calendar data from the first half of the intervention did not have high predictive accuracy, presumable due to a high rate of missing data and unclear missing mechanisms.",2020,"Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
","['N\xa0', '607 participants enrolled in a trial of online self-help for AUD, made an entry in the non-mandatory consumption diary (total of 9117 entries), and completed the follow-up assessment']",['Self-help internet interventions'],['prediction accuracies'],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",607.0,0.047745,"Machine learning models achieved prediction accuracies of 64% (predicting non-hazardous drinking) and 48% (predicting AUD severity decrease), in both cases with higher sensitivity than specificity.
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden. philip.lindner@ki.se.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Center for Dependency Disorders, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}]",BMC medical research methodology,['10.1186/s12874-020-00995-z']
354,32393252,Metabolic effects of PCSK9 inhibition with Evolocumab in subjects with elevated Lp(a).,"BACKGROUND


Epidemiological studies substantiated that subjects with elevated lipoprotein(a) [Lp(a)] have a markedly increased cardiovascular risk. Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) lowers both LDL cholesterol (LDL-C) as well as Lp(a), albeit modestly. Effects of PCSK9 inhibition on circulating metabolites such as lipoprotein subclasses, amino acids and fatty acids remain to be characterized.
METHODS


We performed nuclear magnetic resonance (NMR) metabolomics on plasma samples derived from 30 individuals with elevated Lp(a) (> 150 mg/dL). The 30 participants were randomly assigned into two groups, placebo (N = 14) and evolocumab (N = 16). We assessed the effect of 16 weeks of evolocumab 420 mg Q4W treatment on circulating metabolites by running lognormal regression analyses, and compared this to placebo. Subsequently, we assessed the interrelationship between Lp(a) and 14 lipoprotein subclasses in response to treatment with evolocumab, by running multilevel multivariate regression analyses.
RESULTS


On average, evolocumab treatment for 16 weeks resulted in a 17% (95% credible interval: 8 to 26%, P < 0.001) reduction of circulating Lp(a), coupled with substantial reduction of VLDL, IDL and LDL particles as well as their lipid contents. Interestingly, increasing concentrations of baseline Lp(a) were associated with larger reduction in triglyceride-rich VLDL particles after evolocumab treatment.
CONCLUSIONS


Inhibition of PCSK9 with evolocumab markedly reduced VLDL particle concentrations in addition to lowering LDL-C. The extent of reduction in VLDL particles depended on the baseline level of Lp(a). Our findings suggest a marked effect of evolocumab on VLDL metabolism in subjects with elevated Lp(a).
TRIAL REGISTRATION


Clinical trial registration information is registered at ClinicalTrials.gov on April 14, 2016 with the registration number NCT02729025.",2020,"Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) lowers both LDL cholesterol (LDL-C) as well as Lp(a), albeit modestly.","['subjects with elevated Lp(a', 'subjects with elevated lipoprotein(a) [Lp(a', '30 individuals with elevated Lp(a) (>\u2009150\u2009mg/dL', '30 participants']","['proprotein convertase subtilisin/kexin type 9 (PCSK9', 'PCSK9 inhibition', 'evolocumab 420\u2009mg Q4W treatment', 'PCSK9 inhibition with Evolocumab', 'evolocumab', 'nuclear magnetic resonance (NMR) metabolomics', 'placebo']","['cardiovascular risk', 'LDL cholesterol (LDL-C', 'triglyceride-rich VLDL particles', 'concentrations of baseline Lp(a', 'VLDL particle concentrations', 'VLDL metabolism', 'VLDL, IDL and LDL particles', 'circulating Lp(a']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0523559', 'cui_str': 'IDL cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",30.0,0.409188,"Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) lowers both LDL cholesterol (LDL-C) as well as Lp(a), albeit modestly.","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Experimental Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. xiang.zhang@wur.nl.'}, {'ForeName': 'Lotte C A', 'Initials': 'LCA', 'LastName': 'Stiekema', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Albert K', 'Initials': 'AK', 'LastName': 'Groen', 'Affiliation': 'Department of Experimental Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}]",Lipids in health and disease,['10.1186/s12944-020-01280-0']
355,32393274,"Secondary surgical cytoreduction needs to be assessed taking into account surgical technique, completeness of cytoreduction, and extent of disease.","Recent evidence suggested that secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival in patients with platinum-sensitive recurrent ovarian cancer.This statement is based on a phase III multicenter, randomized clinical trial that lacks a description of the surgical protocol, the surgical technique, and the surgical variables. In a study that evaluates surgical cytoreduction, it is mandatory to assess the grade of cytoreductive surgery achieved (Sugarbaker PH, Langenbeck's Arch Surg 384:576-87, 1999), the extent of disease using PCI (Peritoneal Cancer Index), the technique itself, and the existence of a multidisciplinary approach with extensive upper abdominal procedures in experienced centers (Ren et al, BMC Cancer 15:1-12, 2015). There is evidence proving that the quality of cytoreduction (Al Rawahi et al, Cochrane Database Syst Rev 2013, 2013), the measurement of the amount of disease by PCI (Elzarkaa et al, J Gynecol Oncol 29, 2018), and a multidisciplinary approach with supramesocolic procedures (Ren et al, BMC Cancer 15:1-12, 2015) impact overall survival.This study fails to compare chemotherapy with secondary cytoreductive surgery since, due to the lack of variables, we can assess neither the performed surgery nor its criteria. This study should not be taken into account to recommend chemotherapy alone over a surgical approach in this group of patients.",2020,Recent evidence suggested that secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival in patients with platinum-sensitive recurrent ovarian cancer.,['patients with platinum-sensitive recurrent ovarian cancer'],[],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0724334,Recent evidence suggested that secondary surgical cytoreduction followed by chemotherapy does not result in longer overall survival in patients with platinum-sensitive recurrent ovarian cancer.,"[{'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Segura-Sampedro', 'Affiliation': 'Department of General and Digestive Surgery, Son Espases University Hospital, Spain, 07010 Palma de Mallorca, Spain. Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain. School of Medicine, University of the Balearic Islands (UIB), Palma de Mallorca, Spain. segusamjj@gmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Morales-Soriano', 'Affiliation': 'Department of General and Digestive Surgery, Son Espases University Hospital, Spain, 07010 Palma de Mallorca, Spain. Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Arjona-Sánchez', 'Affiliation': 'General & Digestive Surgery Department, University Hospital Reina Sofía, School of Medicine, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cascales-Campos', 'Affiliation': 'General & Digestive Surgery Department, University Hospital Virgen de la Arrixaca, School of Medicine, University of Murcia, Murcia, Spain.'}]",World journal of surgical oncology,['10.1186/s12957-020-01853-4']
356,32396257,"Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet in Advanced Parkinson's Disease.","BACKGROUND


A dopamine agonist patch is an important treatment option for PD.
OBJECTIVES


A randomized, double-blind, parallel-group, placebo-controlled trial was conducted to evaluate superiority of ropinirole hydrochloride patch over placebo and noninferiority to ropinirole hydrochloride extended-release tablet.
METHODS


PD patients using levodopa received ropinirole patch (up to 64 mg/d), ropinirole tablets (up to 16 mg/d), or placebo once-daily (double-dummy technique). The primary endpoint was the change from baseline in the total score for the UPDRS Part III (on state) at week 16.
RESULTS


The change of the least squares mean (95% confidence interval) in the UPDRS Part III total score was -9.8 (-10.8 to -8.7) with ropinirole patch, -4.3 (-5.8 to -2.8) with placebo, and -10.1 (-11.2 to -9.1) with ropinirole tablet. The difference between the ropinirole patch and placebo groups was -5.4 (-7.3 to -3.6), demonstrating superiority of the patch over placebo. The difference between the ropinirole patch and tablet groups was 0.3 (-1.2 to 1.8). The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet. In all three groups, most adverse events were mild or moderate and there were no serious safety concerns.
CONCLUSIONS


Once-daily ropinirole patch was effective in advanced PD patients, having demonstrated superiority over placebo and noninferiority to ropinirole tablet, without causing serious safety problems. Ropinirole patch can be an alternative option for PD patients. © 2020 International Parkinson and Movement Disorder Society.",2020,"The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet.","['advanced PD patients', 'PD patients', ""Advanced Parkinson's Disease"", 'PD patients using']","['dopamine agonist patch', 'Ropinirole patch', 'ropinirole tablet', 'ropinirole tablets', 'ropinirole patch', 'levodopa received ropinirole patch', 'ropinirole hydrochloride', 'ropinirole hydrochloride patch over placebo', 'Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet', 'ropinirole patch and placebo', 'placebo']","['UPDRS Part III total score', 'total score for the UPDRS Part III (on state']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C1247870', 'cui_str': 'ropinirole Oral Tablet'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0771840', 'cui_str': 'Ropinirole hydrochloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2344623', 'cui_str': 'ropinirole Extended Release Oral Tablet'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.637977,"The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet.","[{'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Neurology, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Neurology, Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Hospital, Ehime, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Uchida', 'Affiliation': 'Office for Promoting Medical Research, Showa University, Tokyo, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Terahara', 'Affiliation': 'Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Okawa', 'Affiliation': 'Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fukuta', 'Affiliation': 'Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28071']
357,32396285,Strategies to change body composition in older adults: do type of exercise and dose distribution matter?,"BACKGROUND


This study aims to analyze changes in sedentary elderlies' body composition, comparing the impact of two dose distributions: continuous (60 min/session) vs. accumulated (30 min/session in the morning and 30 min/session in the afternoon), on two types of physical exercise programs (multicomponent-training [MCT] vs. walking interval-training [WIT]).
METHODS


Forty-six sedentary overweight elderly (71.3±4.3 years) were evaluated by bioimpedance with a pre-post 2x2 factorial design. Participants were distributed in four homogeneous groups, considering gait and health parameters.
RESULTS


The overall sample showed significant improvements in fat mass (% and kg) and fat-free mass (kg) following 15 weeks of training. There was a main effect of ""type of exercise"" and a moderating effect of ""dose distribution"" reflected in the interaction of both factors. Bonferroni analyses of the type*dose interaction revealed significant improvements in all groups, except for MCT-accumulated, on both body composition compartments.
CONCLUSIONS


Starting exercise training, properly periodized and supervised by physical-education trainers, improves body composition of sedentary elderlies regardless of the type of exercise. Accumulated strategies were beneficial only when applied to WIT. Although MCT training improves body composition with only 2 days/week, WIT-accumulated could be a key element in the design of weight control policies looking for breaking sedentary behaviors.",2020,The overall sample showed significant improvements in fat mass (% and kg) and fat-free mass (kg) following 15 weeks of training.,"['Forty-six sedentary overweight elderly (71.3±4.3 years', 'older adults']","['Starting exercise training, properly periodized and supervised by physical-education trainers', 'MCT training', 'physical exercise programs (multicomponent-training [MCT] vs. walking interval-training [WIT']","['body composition', 'fat mass']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0043197', 'cui_str': 'Wit as Topic'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",46.0,0.0639447,The overall sample showed significant improvements in fat mass (% and kg) and fat-free mass (kg) following 15 weeks of training.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain - pablo.monteagudo@uv.es.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pesce', 'Affiliation': 'Department of Movement, Human and Health Sciences, Foro Italico University, Rome, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10321-9']
358,32396287,Bioelectrical impedance vector analysis (BIVA) in renal transplant recipients during an unsupervised physical exercise program.,"BACKGROUND


Muscle weakness, incorrect body water distribution and reduced exercise tolerance are the main characteristics found in renal transplant recipients after surgical treatment. Regular physical supervised exercise programs, at moderate intensity, have been promoted to contrast these aspects, while few data are available for long-term unsupervised mixed exercise plans. Bioelectrical impedance vector analysis (BIVA) provides a semi-quantitative evaluation of body cell mass and body water. This study aims to approach the role of the BIVA analysis in the follow-up of Renal Transplant Group (RTG) and analyze the impact of unsupervised exercise program.
METHODS


Thirteen male RTG and ten healthy subjects, adherent to a tailored exercise program, at moderate intensity and prescribed in an unsupervised way, have been followed up for one year. Every six months all the subjects have been submitted to the ergometric test, echocardiographic exam and an analysis of body composition by bioimpedance. They were compared to a healthy control group (HG).
RESULTS


A significant reduction of the BMI was observed at the end of the study in the RTG group (T0 24.8±3.2, T12 24.2±3.2 kg/m2; P<0.05). BIVA has shown a lower right quadrant for RTG. All echocardiographic parameters were in a normal range, and no differences were found over time.
CONCLUSIONS


Unsupervised tailored and mixed exercise intervention reduces some cardiovascular risks factors. However, it does not modify the frailty of RTG. BIVA analysis seems to have appropriate sensitivity to highlight this aspect.",2020,"A significant reduction of the BMI was observed at the end of the study in the RTG group (T0 24.8±3.2, T12 24.2±3.2 kg/m2; P<0.05).","['renal transplant recipients after surgical treatment', 'Thirteen male RTG and ten healthy subjects', 'renal transplant recipients during an']","['Regular physical supervised exercise programs', 'unsupervised physical exercise program', 'Unsupervised tailored and mixed exercise intervention', 'unsupervised exercise program']","['cardiovascular risks factors', 'BMI', 'Bioelectrical impedance vector analysis (BIVA']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",13.0,0.0194693,"A significant reduction of the BMI was observed at the end of the study in the RTG group (T0 24.8±3.2, T12 24.2±3.2 kg/m2; P<0.05).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Mascherini', 'Affiliation': 'Sport and Exercise Medicine Unit, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zappelli', 'Affiliation': 'Sport and Exercise Medicine Unit, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Castizo Olier', 'Affiliation': 'TecnoCampus Mataró-Maresme, Higher Institute of Health Sciences, Mataró, Barcelona, Spain.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Leone', 'Affiliation': 'Sport and Exercise Medicine Unit, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Musumeci', 'Affiliation': 'Research Center on Motor Activities (CRAM), Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Totti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Irurtia', 'Affiliation': 'National Institute of Physical Education of Catalunya (INEFC), Barcelona, Spain.'}, {'ForeName': 'Giulio S', 'Initials': 'GS', 'LastName': 'Roi', 'Affiliation': 'Department of Education and Research, Isokinetic Medical Group, Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Mosconi', 'Affiliation': 'Department of Nephrology and Dialysis, Morgagni-Pierantoni Hospital, Forlì, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Sella', 'Affiliation': 'Sports Medicine Unit, Regional Hospital of Ravenna, Ravenna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nanni Costa', 'Affiliation': 'Italian National Transplant Center, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': 'Sport and Exercise Medicine Unit, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy - laura.stefani@unifi.it.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10181-8']
359,32203229,Short-term effects of carbohydrates differing in glycemic index (GI) consumed at lunch on children's cognitive function in a randomized crossover study.,"BACKGROUND


Intervention studies suggest an influence of breakfast dietary glycemic index (GI) on children's cognition. The Cognition Intervention Study Dortmund-GI-I study examined whether lunch dietary GI might have short-term effects on selected cognitive parameters.
METHODS


A randomized crossover study was performed at a comprehensive school on 2 test days. One hundred and eighty-nine participants (5th and 6th grade) were randomly assigned to one of the two sequences, medium-high GI (m-hGI) or high-medium GI (h-mGI), following block randomization. In the first period, one group received a dish containing hGI rice (GI: 86) ad libitum, the other mGI rice (GI: 62)-1 week later, in the second period, vice versa. Tonic alertness, task switching, and working memory updating were tested with a computerized test battery 45 min after beginning of lunch break. Treatment effects were estimated using the t test for normally distributed data or the Wilcoxon rank-sum test for non-normally distributed data.
RESULTS


The crossover approach revealed no effects of lunch dietary GI on the tested cognitive parameters in the early afternoon. However, we determined carryover effects for two parameters, and therefore analyzed only data of the first period. The reaction time of the two-back task (working memory updating) was faster (p = 0.001) and the count of commission errors in the alertness task was lower (p = 0.04) in the hGI group.
CONCLUSION


No evidence of short-term effects of lunch dietary GI on cognition of schoolchildren was found. Potential positive effects on single parameters of working memory updating and tonic alertness favoring hGI rice need to be verified.",2020,"The reaction time of the two-back task (working memory updating) was faster (p = 0.001) and the count of commission errors in the alertness task was lower (p = 0.04) in the hGI group.
","[""children's cognition"", 'One hundred and eighty-nine participants (5th and 6th grade', ""children's cognitive function""]","['GI', 'dish containing hGI rice (GI: 86) ad libitum, the other mGI rice', 'medium-high GI (m-hGI) or high-medium GI (h-mGI', 'carbohydrates differing in glycemic index (GI) consumed at lunch', 'breakfast dietary glycemic index (GI', 'lunch dietary GI']","['count of commission errors', 'Tonic alertness, task switching, and working memory updating', 'reaction time of the two-back task (working memory updating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]","[{'cui': 'C0020498', 'cui_str': 'Vertebral Ankylosing Hyperostosis'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",189.0,0.0254779,"The reaction time of the two-back task (working memory updating) was faster (p = 0.001) and the count of commission errors in the alertness task was lower (p = 0.04) in the hGI group.
","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University, Bochum, Germany. kathrin.jansen@ruhr-uni-bochum.de.""}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Tempes', 'Affiliation': 'University of Education, Freiburg, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Drozdowska', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University, Bochum, Germany.""}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Gutmann', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University, Bochum, Germany.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Falkenstein', 'Affiliation': 'Institute for Work, Learning and Ageing (ALA), Bochum, Germany.'}, {'ForeName': 'Anette E', 'Initials': 'AE', 'LastName': 'Buyken', 'Affiliation': 'Public Health Nutrition, Institute of Nutrition, Consumption and Health, Paderborn University, Paderborn, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Libuda', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Rudolf', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lücke', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University, Bochum, Germany.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Kersting', 'Affiliation': ""Research Department of Child Nutrition, University Children's Hospital, Ruhr University, Bochum, Germany.""}]",European journal of clinical nutrition,['10.1038/s41430-020-0600-0']
360,32392455,Lurasidone in Children and Adolescents with Bipolar Depression Presenting with Mixed (Subsyndromal Hypomanic) Features:  Post Hoc  Analysis of a Randomized Placebo-Controlled Trial.,"Objectives:  To evaluate the efficacy and safety of lurasidone in the treatment of children and adolescents with bipolar depression presenting with mixed (subsyndromal hypomanic) features.  Methods:  Patients, 10-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5), diagnosis of bipolar I depression were randomized to 6 weeks of double-blind treatment with once-daily flexible doses of lurasidone 20-80 mg or placebo. The presence of mixed (subsyndromal hypomanic) features in this pediatric bipolar depression trial was defined as a Young Mania Rating Scale score of 5 or greater at study baseline. Key efficacy measures included change from baseline to week 6 in the Children's Depression Rating Scale-Revised (CDRS-R) score (primary endpoint) and Clinical Global Impressions-Bipolar Severity (CGI-BP-S) score, using a mixed model for repeated measures analysis.  Results:  At baseline, subsyndromal hypomanic features were present in 54.2% of patients. Treatment with lurasidone (vs. placebo) was associated with significantly greater reductions in CDRS-R scores at week 6, independent of the presence (-21.5 vs. -15.9,  p  < 0.01; effect size  d  = 0.43) or absence (-20.5 vs. -14.9,  p  < 0.01;  d  = 0.44) of subsyndromal hypomanic features. Likewise, lurasidone (vs. placebo) was associated with significantly greater reductions in CGI-BP-S scores at week 6, independent of the presence (-1.6 vs. -1.1,  p  < 0.001,  d  = 0.51) or absence (-1.3 vs. -1.0,  p  = 0.05;  d  = 0.31) of these subsyndromal hypomanic features. Rates of protocol-defined treatment-emergent hypomania or mania were similar for lurasidone and placebo in patients with (lurasidone 8.2% vs. placebo 9.0%) or without subsyndromal hypomanic features (lurasidone 1.3% vs. placebo 3.7%).  Conclusions:  In this  post hoc  analysis of a randomized placebo-controlled trial, lurasidone was found to be efficacious in the treatment of child and adolescent patients with bipolar depression who presented with mixed (subsyndromal hypomanic) features. No differences in safety profile, including the risk of treatment-emergent mania, were observed in patients with or without subsyndromal hypomanic features in this study.",2020,Rates of protocol-defined treatment-emergent hypomania or mania were similar for lurasidone and placebo in patients with (lurasidone 8.2% vs. placebo 9.0%) or without subsyndromal hypomanic features (lurasidone 1.3% vs. placebo 3.7%).  ,"['Children and Adolescents with Bipolar Depression Presenting with Mixed (Subsyndromal Hypomanic) Features:  Post', 'children and adolescents with bipolar depression presenting with mixed (subsyndromal hypomanic) features', 'Methods:  Patients, 10-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 5th ed', 'child and adolescent patients with bipolar depression who presented with mixed (subsyndromal hypomanic) features']","['lurasidone (vs. placebo', 'lurasidone', 'Placebo', 'lurasidone 20-80\u2009mg or placebo', 'Lurasidone', 'lurasidone and placebo', 'placebo']","[""Children's Depression Rating Scale-Revised (CDRS-R) score (primary endpoint) and Clinical Global Impressions-Bipolar Severity (CGI-BP-S) score"", 'subsyndromal hypomanic features', 'CDRS-R scores', 'CGI-BP-S scores', 'Young Mania Rating Scale score', 'Rates of protocol-defined treatment-emergent hypomania or mania', 'efficacy and safety', 'risk of treatment-emergent mania']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.344768,Rates of protocol-defined treatment-emergent hypomania or mania were similar for lurasidone and placebo in patients with (lurasidone 8.2% vs. placebo 9.0%) or without subsyndromal hypomanic features (lurasidone 1.3% vs. placebo 3.7%).  ,"[{'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, and Fort Lee, New Jersey, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Siu', 'Affiliation': ""COS and Associates Ltd., Central, Hong Kong, People's Republic of China.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, and Fort Lee, New Jersey, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, and Fort Lee, New Jersey, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0018']
361,32392560,"The Results Given in the Paper by Bruyère et al. ""Multicenter, Randomized, Placebo-Controlled Study [of] the Efficacy of a Combination of Propolis and Cranberry… (DUAB®) in Preventing Low Urinary Tract Infection Recurrence in Women… [with] Recurrent Cystitis"" Should Be Used with Great Caution.",,2020,,['Women'],"['Placebo', 'Combination of Propolis and Cranberry… (DUAB®']",['… [with] Recurrent Cystitis'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}]","[{'cui': 'C0581366', 'cui_str': 'Recurrent cystitis'}]",,0.0523368,,"[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Botto', 'Affiliation': 'Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Dreyfus', 'Affiliation': 'DReyfusConsultancyInternational, Methodology & Statistics, Bouère, France, jf@jfdreyfus.org.'}]",Urologia internationalis,['10.1159/000506020']
362,31525069,Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials.,"BACKGROUND


Impaired left ventricular function is associated with worse prognosis among patients with aortic stenosis treated medically or with surgical aortic valve replacement. It is unclear whether reduced left ventricular ejection fraction (LVEF) is an independent predictor of adverse outcomes after transcatheter aortic valve replacement.
METHODS AND RESULTS


Patients who underwent transcatheter aortic valve replacement in the PARTNER 2 trials (Placement of Aortic Transcatheter Valves) and registries were stratified according to presence of reduced LVEF (<50%) at baseline, and 2-year risk of cardiovascular mortality was compared using Kaplan-Meier methods and multivariable Cox proportional hazards regression. Of 2991 patients, 839 (28%) had reduced LVEF. These patients were younger, more often males, and were more likely to have comorbidities, such as coronary disease, diabetes mellitus, and renal insufficiency. Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%,  P <0.0001) and all-cause mortality (27.4% versus 19.2%,  P <0.0001). Mean aortic valve gradient was not associated with clinical outcomes other than heart failure hospitalizations (hazard ratio [HR], 0.99; CI, 0.99-1.00;  P =0.03). After multivariable adjustment, patients with reduced versus normal LVEF had significantly higher adjusted risk of cardiovascular death (adjusted HR, 1.42, 95% CI, 1.11-1.81;  P =0.005), but not all-cause death (adjusted HR, 1.20; 95% CI, 0.99-1.47;  P =0.07). When LVEF was treated as continuous variable, it was associated with increased 2-year risk of both cardiovascular mortality (adjusted HR per 10% decrease in LVEF, 1.16; 95% CI, 1.07-1.27;  P =0.0006) and all-cause mortality (adjusted HR, 1.09; 95% CI, 1.01-1.16;  P =0.02).
CONCLUSIONS


In this patient-level pooled analysis of PARTNER 2 patients who underwent transcatheter aortic valve replacement, baseline LVEF was an independent predictor of 2-year cardiovascular mortality.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01314313, NCT02184442, NCT03222128, and NCT02184441.",2019,"Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%,  P <0.0001) and all-cause mortality (27.4% versus 19.2%,  P <0.0001).","['Patients who underwent', 'Of 2991 patients, 839 (28%) had reduced LVEF', 'patients with aortic stenosis treated medically or with surgical aortic valve replacement']","['LVEF', 'Aortic Transcatheter Valves', 'transcatheter aortic valve replacement', 'transcatheter aortic valve replacement, baseline LVEF', 'Baseline Left Ventricular Ejection Fraction', 'Transcatheter Aortic Valve Replacement']","['adjusted risk of cardiovascular death', '2-year risk of cardiovascular mortality', '2-year cardiovascular mortality', '2-year risk of both cardiovascular mortality', 'Mean aortic valve gradient', 'cause mortality', 'crude rates of 2-year cardiovascular mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428905', 'cui_str': 'Aortic valve ventriculoarterial gradient'}]",2991.0,0.285593,"Compared with patients with normal LVEF, patients with low LVEF had higher crude rates of 2-year cardiovascular mortality (19.8% versus 12.0%,  P <0.0001) and all-cause mortality (27.4% versus 19.2%,  P <0.0001).","[{'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Furer', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Elmariah', 'Affiliation': 'Department of Cardiology, Massachusetts General Hospital, Boston (S.E., J.P.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Department of Medicine, Quebec Heart & Lung Institute Laval University, Canada (P.P.).'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Herrmann', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia (H.C.H.).'}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY (R.T.H., S.K., M.C.A., M.B.L., D.B.).'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY (R.T.H., S.K., M.C.A., M.B.L., D.B.).'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'MedStar Heart & Vascular Institute, Georgetown University School of Medicine, Washington, DC (V.H.T.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (P.S.D.).'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Department of Medicine (Cardiovascular Medicine), Stanford University, CA (W.F.F.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Passeri', 'Affiliation': 'Department of Cardiology, Massachusetts General Hospital, Boston (S.E., J.P.).'}, {'ForeName': 'S Chris', 'Initials': 'SC', 'LastName': 'Malaisrie', 'Affiliation': 'Division of Cardiac Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL (S.C.M.).'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Genereux', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (P.G.).'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.F., S.C., B.R., M.C.A., A.C., T.M., O.B.-Y., M.B.L., D.B.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.118.005809']
363,32397219,Changes in Gait Performance in Stroke Patients after Taping with Scapular Setting Exercise.,"The purpose of this study was to investigate the effects of combined taping with scapular setting exercise on the gait performance of stroke patients. Twenty stroke patients were randomly allocated to two groups: the taping with scapular setting exercise (TSSE) group ( n  = 10) and scapular setting exercise (SSE) group ( n  = 10). Intervention was performed for one week, and pre- and postintervention results for TSSE and SSE were compared. Outcomes were determined using the inertia measurement unit, which can measure spatiotemporal gait parameters, and using the timed up-and-go test. Two-way repeated analysis was used to compare pre- and postintervention results. In the TSSE group, intervention significantly improved cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results more than in the SSE group. TSSE was found to improve all spatiotemporal gait parameters examined; thus, we recommend TSSE be considered as an intervention to improve gait parameters in stroke patients.",2020,"In the TSSE group, intervention significantly improved cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results more than in the SSE group.","['stroke patients', 'Stroke Patients after Taping with Scapular Setting Exercise', 'Twenty stroke patients']","['taping with scapular setting exercise (TSSE) group ( n  = 10) and scapular setting exercise (SSE', 'TSSE', 'combined taping with scapular setting exercise']","['gait performance', 'Gait Performance', 'gait parameters', 'cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}]",20.0,0.0156449,"In the TSSE group, intervention significantly improved cadence, gait speed, stride length, step length, gait cycle, swing phase duration, double support duration, and timed up-and-go test results more than in the SSE group.","[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do, 27600, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 330-714, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020128']
364,32397235,Effects of a Motion Seat System on Driver's Passive Task-Related Fatigue: An On-Road Driving Study.,"Passive task-related (TR) fatigue caused by monotonous driving can negatively affect driving safety by impairing driver alertness and performance. This study aims to evaluate the effectiveness of a motion seat system on the driver's passive TR fatigue in terms of driving performance, physiological response, and subjective fatigue by using automotive and physiological sensors those applicable to on-road driving environment. Twenty drivers (5 females and 15 males; age = 38.5 ± 12.2) with more than two years of driving experience participated in an on-road experiment with two driving conditions: driving in the static seat condition during the first half of the driving session and then in the static (static-static, SS) or motion seat (static-motion, SM) condition during the second half. The SM condition showed significantly lower passive TR fatigue by 4.4~56.5% compared to the SS condition in terms of the standard deviation of velocity, percentage of eyelid closure rate (PERCLOS), and the ratio of low- to high-frequency power (LF/HF) of electrocardiography signals. The drivers rated significantly lower subjective state changes of overall fatigue, mental fatigue, passive TR fatigue, drowsiness, and decreased concentration in the SM condition than those in the SS condition. The findings of the study support the use of a motion seat system can be an effective countermeasure to reduce passive TR fatigue.",2020,"The SM condition showed significantly lower passive TR fatigue by 4.4~56.5% compared to the SS condition in terms of the standard deviation of velocity, percentage of eyelid closure rate (PERCLOS), and the ratio of low- to high-frequency power (LF/HF) of electrocardiography signals.","['Twenty drivers (5 females and 15 males; age = 38.5 ± 12.2) with more than two years of driving experience participated in an on-road experiment with two driving conditions: driving in the static seat condition during the first half of the driving session and then in the static (static-static, SS) or motion seat (static-motion, SM) condition during the second half', ""Driver's Passive Task-Related Fatigue""]","['motion seat system', 'Motion Seat System']","['Passive task-related (TR) fatigue', 'subjective state changes of overall fatigue, mental fatigue, passive TR fatigue, drowsiness, and decreased concentration in the SM condition', 'passive TR fatigue']","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C1444752', 'cui_str': 'Status during'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0443172', 'cui_str': 'Changed status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0139913,"The SM condition showed significantly lower passive TR fatigue by 4.4~56.5% compared to the SS condition in terms of the standard deviation of velocity, percentage of eyelid closure rate (PERCLOS), and the ratio of low- to high-frequency power (LF/HF) of electrocardiography signals.","[{'ForeName': 'Seunghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Minjae', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Hayoung', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Sunwoo', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Body Test Team 3, Hyundai Motor Company, Hwaseong 18280, Korea.'}, {'ForeName': 'Heecheon', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}]","Sensors (Basel, Switzerland)",['10.3390/s20092688']
365,32397344,A Randomized Comparison of Plasma Levobupivacaine Concentrations Following Thoracic Epidural Analgesia and Subpleural Paravertebral Analgesia in Open Thoracic Surgery.,"BACKGROUND


The aim of this study was to compare plasma levobupivacaine concentrations in thoracic epidural and subpleural paravertebral analgesia.
METHODS


Forty-four patients indicated for open lung resection had an epidural catheter inserted preoperatively or a subpleural catheter surgically. A bolus of 0.25% levobupivacaine at a dosage of 0.5 mg × kg -1  was given after the thoracotomy closure. Plasma levobupivacaine level at 30 min was the primary outcome. Pharmacokinetic modeling was performed subsequently. Secondary outcomes included the quality of analgesia, complications, and patients'mobility.
RESULTS


Plasma concentrations were similar 30 min after application-0.389 mg × L -1  in the epidural and 0.318 mg × L -1  in the subpleural group ( p  = 0.33) and lower in the subpleural group at 120 min ( p  = 0.03). The areas under the curve but not maximum concentrations were lower in the subpleural group. The time to reach maximum plasma level was similar in both groups-27.6 vs. 24.2 min. No clinical symptoms of local anesthetic toxicity were recorded.
CONCLUSIONS


Levobupivacaine systemic concentrations were low in both groups without the symptoms of toxicity. This dosage should be safe for postoperative analgesia after thoracotomy.",2020,The time to reach maximum plasma level was similar in both groups-27.6 vs. 24.2 min.,"['Forty-four patients indicated for', 'Open Thoracic Surgery']","['open lung resection', 'Plasma Levobupivacaine Concentrations', 'Thoracic Epidural Analgesia and Subpleural Paravertebral Analgesia', 'epidural catheter inserted preoperatively or a subpleural catheter surgically', 'levobupivacaine']","['local anesthetic toxicity', 'Plasma concentrations', 'time to reach maximum plasma level', 'plasma levobupivacaine concentrations', 'Plasma levobupivacaine level', ""quality of analgesia, complications, and patients'mobility""]","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0473977', 'cui_str': 'Local anesthetic toxicity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0783513,The time to reach maximum plasma level was similar in both groups-27.6 vs. 24.2 min.,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Matek', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Cernohorsky', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Trca', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Zdenek', 'Initials': 'Z', 'LastName': 'Krska', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hoskovec', 'Affiliation': '1st Department of Surgery-Department of Abdominal, Thoracic Surgery and Traumatology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bruthans', 'Affiliation': 'Department of Anaesthesia and Intensive Care, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sima', 'Affiliation': 'Institute of Pharmacology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Michalek', 'Affiliation': 'Department of Anaesthesia and Intensive Care, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, 128 00 Prague, Czech Republic.'}]",Journal of clinical medicine,['10.3390/jcm9051395']
366,32397586,Basic Laparoscopic Skills Training Is Equally Effective Using 2D Compared to 3D Visualization: A Randomized Controlled Trial.,"Reduced depth perception due to two-dimensional (2D) visualization of a three-dimensional (3D) space represents a main challenge in acquiring basic laparoscopic skills (BLS); 3D visualization might increase training efficiency. This study aimed to assess whether BLS training on a standard box trainer using 2D is at least equally effective compared to 3D. Medical students were randomized to training of Fundamentals of Laparoscopic Surgery (FLS) tasks using either 2D or 3D for four weeks. Baseline and post-training tests were performed using the assigned visualization modality. Data of 31 participants were analyzed ( n  = 16 2D,  n  = 15 3D). Baseline test scores did not differ significantly between groups; only at the peg transfer task and total scores, the 3D group performed better than the 2D group. All scores improved significantly in both groups, with post training scores not differing significantly between groups. Non-inferiority of 2D compared to 3D was demonstrated for total score improvement and improvement in all individual FLS tasks except for suturing with extracorporeal knot tying. Post training test performance did not change significantly when changing to the unfamiliar modality. In conclusion, BLS training using standard 2D is at least equally effective as with 3D, without significant disadvantages when changing to the other modality.",2020,Non-inferiority of 2D compared to 3D was demonstrated for total score improvement and improvement in all individual FLS tasks except for suturing with extracorporeal knot tying.,"['31 participants were analyzed ( n  = 16 2D,  n  = 15 3D']","['Basic Laparoscopic Skills Training', 'BLS training', 'Laparoscopic Surgery (FLS) tasks']",['Reduced depth perception'],[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}]",31.0,0.035656,Non-inferiority of 2D compared to 3D was demonstrated for total score improvement and improvement in all individual FLS tasks except for suturing with extracorporeal knot tying.,"[{'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Montanari', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwameis', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Veit-Rubin', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Kuessel', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Husslein', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9051408']
367,32397596,Acute Effects of a Single Football Training or Match on Passive Hip Rotation Range of Motion in Semi-Professional Football Players: A Pilot Study.,"BACKGROUND AND OBJECTIVES


The repetitive loading forces generated during football activities may induce alterations in the hip rotation range of motion (ROM) in players. The objective of this study was to evaluate the acute effects of a training and a match on bilateral passive hip rotation ROM in both lower limbs in soccer.
MATERIAL AND METHODS


Twenty-eight male players were divided into two groups: 14 players (28 limbs) with normal bilateral hip rotation ROM (NH group) and 14 players (28 limbs) with restricted bilateral hip ROM (RH group). Passive bilateral hip rotation ROM was measured, by goniometer, before and after training or a match. Internal-rotation ROM (ROM IR ), external-rotation ROM (ROM ER ), total ROM (ROM TOT ) and relative internal rotation (ROM REL ) were calculated.
RESULTS


The NH group did not show substantial changes in hip ROM after a training nor a match. After a training session, only the RH group exhibited a substantial increase in ROM IR , ROM ER  and ROM TOT . After a match, only the RH group exhibited a substantial increase in ROM ER  and ROM TOT  and exhibited a substantial decrease in ROM REL . Comparing both groups, there were significant differences within ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL  after a match.
CONCLUSIONS


Despite the small sample size of the present study, the findings indicate that a single football activity leads to significant changes in hip rotation ROM in players with restricted bilateral hip external-rotation ROM. However, these changes did not reach reference cut-off scores.",2020,"Comparing both groups, there were significant differences within ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL  after a match.
","['Semi-Professional Football Players', 'players with restricted bilateral hip external-rotation ROM', 'soccer', 'Twenty-eight male players were divided into two groups: 14 players (28 limbs) with']","['Single Football Training or Match', 'normal bilateral hip rotation ROM (NH group) and 14 players (28 limbs) with restricted bilateral hip ROM (RH group', 'training and a match on bilateral passive hip rotation ROM']","['ROM IR , ROM ER  and ROM TOT ', 'Internal-rotation ROM (ROM IR ), external-rotation ROM (ROM ER ), total ROM (ROM TOT ) and relative internal rotation (ROM REL ', 'hip ROM', 'Passive Hip Rotation Range of Motion', 'ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL', 'ROM ER  and ROM TOT', 'ROM REL ', 'Passive bilateral hip rotation ROM', 'hip rotation ROM']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0035018', 'cui_str': 'rel Oncogene'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",28.0,0.0259294,"Comparing both groups, there were significant differences within ROM changes for ROM ER  and ROM TOT  after training and for ROM ER  and ROM REL  after a match.
","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street, 41009 Seville, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Abuín-Porras', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blanco-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'de-la-Cueva-Reguera', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Faculty of Nursing and Podiatry, Universidade da Coruña, 15403 Ferrol, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea, Villaviciosa de Odón, 28670 Madrid, Spain.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56050228']
368,32397597,"A 4 Year Human, Randomized, Radiographic Study of Scalloped versus Non-Scalloped Cemented Implants.","Marginal bone loss (MBL) is a key factor in long-term implant success rate. Among the different factors that influence MBL, it is the different implant shoulder designs, such as scalloped or non-scalloped, which have been widely studied on screw retained but not on cemented retained implants. Thus, the aim of the present study was to evaluate the MBL around scalloped and non-scalloped cemented retained dental implants after 4 years of loading, in humans. A total of 15 patients were enrolled in the present study. A radiographic and clinical examination was performed after implant placement (T0) and after 4 years from it (T1). The results demonstrated a differential MBL (T1-T0) of 2.436 ± 1.103 mm and 1.923 ± 1.021 mm, respectively for test (scalloped) and control (non-scalloped) groups with a statistically significant difference between them. On the other hand, no statistically significant differences were found between the groups in terms of prosthetic complication and abutment decementation, whilst ceramic crowns chipping was shown in both groups. In conclusion, the use of a scalloped platform did not provide better results on the maintenance of MBL after 4 years follow-up. In this study, this probably was determined by multiple factors, among which was the subcrestal insertion of scalloped implants.",2020,"On the other hand, no statistically significant differences were found between the groups in terms of prosthetic complication and abutment decementation, whilst ceramic crowns chipping was shown in both groups.","['after 4 years of loading, in humans', 'A total of 15 patients were enrolled in the present study']","['MBL around scalloped and non-scalloped cemented retained dental implants', 'Scalloped versus Non-Scalloped Cemented Implants']","['Marginal bone loss (MBL', 'prosthetic complication and abutment decementation']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0324026', 'cui_str': 'Scallop'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",15.0,0.0479813,"On the other hand, no statistically significant differences were found between the groups in terms of prosthetic complication and abutment decementation, whilst ceramic crowns chipping was shown in both groups.","[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Sinjari', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': ""D'Addazio"", 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Santilli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': ""D'Avanzo"", 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Imena', 'Initials': 'I', 'LastName': 'Rexhepi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Tonino', 'Initials': 'T', 'LastName': 'Traini', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Piattelli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Caputi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}]","Materials (Basel, Switzerland)",['10.3390/ma13092190']
369,32397609,Hydrolyzed Chicken Extract (ProBeptigen ® ) on Cognitive Function in Healthy Middle-Aged People: A Randomized Double-Blind Trial.,"Cognitive decline is an important issue of global public health. Cognitive aging might begin at middle adulthood, the period particularly vulnerable to stress in lifespan. Essence of chicken (EOC) has consistently demonstrated its beneficial effects on various cognitive domains as nutritional supplementation. This study primarily aimed to examine the cognitive enhancement effects of ProBeptigen® (previously named CMI-168), hydrolyzed peptides extracted from EOC, in healthy middle-aged people under mild stress. Ninety healthy subjects were randomly assigned into the ProBeptigen® or placebo group for eight weeks. Neurocognitive assessment, event-related potentials (ERPs), and blood tests were conducted before, during, and after the treatment. The ProBeptigen® group outperformed placebo group on Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task in the Cambridge Neuropsychological Test Automated Battery (CANTAB). The anti-inflammatory effects of ProBeptigen® in humans were also confirmed, with progressively declining high-sensitivity C-reactive protein (hs-CRP) levels. Regular dietary supplementation of ProBeptigen® is suggested to improve verbal short- and long-term memory as well as spatial working memory, and reduce inflammation in middle-aged healthy individuals with stress. The effects of ProBeptigen® on cognition warrant further investigation. (NCT03612752).",2020,The ProBeptigen® group outperformed placebo group on Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task in the Cambridge Neuropsychological Test Automated Battery (CANTAB).,"['Ninety healthy subjects', 'middle-aged healthy individuals with stress', 'Healthy Middle-Aged People', 'healthy middle-aged people under mild stress']","['chicken (EOC', 'ProBeptigen® or placebo', 'ProBeptigen®', 'Hydrolyzed Chicken Extract (ProBeptigen ® ', 'ProBeptigen® (previously named CMI-168), hydrolyzed peptides extracted from EOC', 'placebo']","['Cognitive Function', 'Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task', 'Neurocognitive assessment, event-related potentials (ERPs), and blood tests']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}]",90.0,0.166073,The ProBeptigen® group outperformed placebo group on Logical Memory subtests of Wechsler Memory Scale-third edition (WMS-III) and Spatial Working Memory task in the Cambridge Neuropsychological Test Automated Battery (CANTAB).,"[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Cheng-Chang', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Kuan-Yu', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Ying-Chin', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan.'}, {'ForeName': 'Pei-Jung', 'Initials': 'PJ', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Pei-Hsiu', 'Initials': 'PH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nakao', 'Affiliation': ""Research and Development, BRAND'S Suntory Asia, Singapore 138623, Singapore.""}, {'ForeName': 'Mandy Y L', 'Initials': 'MYL', 'LastName': 'Ow', 'Affiliation': ""Research and Development, BRAND'S Suntory Asia, Singapore 138623, Singapore.""}, {'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Hsieh', 'Affiliation': 'PhD Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University, Taipei 110, Taiwan.'}, {'ForeName': 'Chaur-Jong', 'Initials': 'CJ', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, Shuang-Ho Hospital, Taipei Medical University, New Taipei 235, Taiwan.'}]",Nutrients,['10.3390/nu12051362']
370,32393498,Plasmodium faciparum  carrying  pf k13 polymorphisms harbour the SVMNT allele of  pfcrt  in north-western Indonesia.,"Artemisinin-based combination therapy is the first-line antimalarial regimen in Indonesia. Susceptibility of  Plasmodium falciparum  to artemisinin is falling in the Greater Mekong sub-Region, but it is not known whether the efficacy of current combinations is also threatened in nearby Sumatera. We evaluated the genetic loci  pfcrt, pfmdr1  and  pfk13 , considered to be under selection by artemisinin combination therapy, among 404  P. falciparum  infections identified by PCR detection in a cross-sectional survey of 3,731 residents of three Regencies. The  pfcrt  haplotype SVMNT (codons 72-76) was the most prevalent and displayed significant linkage disequilibrium with the  pfmdr1  haplotype YY (codons 86, 184) (OR 26.7, 95% CI 5.96 - 239.4;  P <0.001). This contrasts with Mekong countries, where the CVIET haplotype of  pfcrt  predominates. Among 231 evaluable isolates, only nine (3.9%) showed any evidence of non-synonymous gene variants in the propeller domain of  pfk13  The Thr474Ala variant was seen in six individuals, and Cys580Tyr identified with low confidence in only a single isolate from an asymptomatic individual. Among a subset of 117 symptomatic  P. falciparum- infected individuals randomized to receive either dihydroartemisinin-piperaquine or artemether-lumefantrine, treatment outcome was not associated with pre-treatment genotype. However, sub-microscopic persistent parasites at day 28 or day 42 of follow-up were significantly more likely to harbor the  pfmdr1  haplotype NF (codons 86, 184) than were pre-treatment isolates (P<0.001 for both treatment groups). Current ACT regimens appear to be effective in Sumatera, but evidence of persistent sub-microscopic infection in some patients suggests further detailed studies of drug susceptibility should be undertaken.",2020,"Among 231 evaluable isolates, only nine (3.9%) showed any evidence of non-synonymous gene variants in the propeller domain of  pfk13  ","['Plasmodium faciparum  carrying  pf k13 polymorphisms harbour the SVMNT allele of  pfcrt  in north-western Indonesia', '3,731 residents of three Regencies']","['dihydroartemisinin-piperaquine or artemether-lumefantrine', 'Artemisinin-based combination therapy']",[],"[{'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1673263', 'cui_str': 'KRT13 protein, human'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],,0.0499095,"Among 231 evaluable isolates, only nine (3.9%) showed any evidence of non-synonymous gene variants in the propeller domain of  pfk13  ","[{'ForeName': 'Inke N D', 'Initials': 'IND', 'LastName': 'Lubis', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Hendri', 'Initials': 'H', 'LastName': 'Wijaya', 'Affiliation': 'Department of Paediatrics, University of Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Munar', 'Initials': 'M', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, University of Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Chairuddin P', 'Initials': 'CP', 'LastName': 'Lubis', 'Affiliation': 'Department of Paediatrics, University of Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Khalid B', 'Initials': 'KB', 'LastName': 'Beshir', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Sutherland', 'Affiliation': 'Department of Infection Biology, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom colin.sutherland@lshtm.ac.uk.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02539-19']
371,32393551,Alterations in plasma triglycerides and ceramides: links with cardiac function in humans with type 2 diabetes.,"Cardiac dysfunction in type 2 diabetes (T2D) is associated with excessive fatty acid uptake, oxidation, and generation of toxic lipid species by the heart. It is not known whether decreasing lipid delivery to the heart can effect improvement in cardiac function in humans with T2D.  Thus, our objective was to test the hypothesis that lowering lipid delivery to the heart would result in evidence of decreased 'lipotoxicity' - improved cardiac function, and salutary effects on plasma biomarkers of cardiovascular risk. Thus, we performed a double-blind, randomized, placebo-controlled, parallel design study of the effects of 12 weeks of fenofibrate-induced lipid-lowering on cardiac function, inflammation and oxidation biomarkers, and on the ratio of two plasma ceramides - Cer d18:1 (4E) (1OH, 3OH)/24:0  and Cer d18:1 (4E) (1OH, 3OH)/16:0 - (i.e., 'C24:0/C16:0'), which is associated with decreased risk of cardiac dysfunction and heart failure. Fenofibrate lowered plasma TG and cholesterol but did not improve heart systolic or diastolic function. Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation. Overall, plasma TG lowering correlated with improvement of cardiac relaxation (diastolic function) as measured by tissue Doppler-derived parameter é. Moreover, lowering the plasma C24:0/C16:0 ceramide ratio was correlated with worse diastolic function. These findings indicate that fenofibrate treatment per se is not sufficient to effect changes in cardiac function; however, decreases in plasma TG may be linked to improved diastolic function. In contrast, decreases in plasma C24:0/C16:0 are linked with worsening cardiac function.",2020,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"['humans with type 2 diabetes', 'humans with T2D', 'type 2 diabetes (T2D']","['Fenofibrate', 'fenofibrate', 'fenofibrate-induced lipid-lowering', 'placebo']","['plasma C24:0/C16:0', 'risk of cardiac dysfunction and heart failure', 'cardiac function, inflammation and oxidation biomarkers, and on the ratio of two plasma ceramides - Cer d18:1 (4E) (1OH, 3OH)/24:0 \xa0and Cer d18:1 (4E) ', 'cardiac relaxation (diastolic function', 'plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers', 'plasma TG and cholesterol', 'Cardiac dysfunction', 'heart systolic or diastolic function', 'plasma C24:0/C16:0 ceramide ratio', 'diastolic function']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0237504', 'cui_str': 'CER'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.0435397,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Division of Cardiology, United States lpeterso@wustl.edu.'}, {'ForeName': 'Xuntian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Medicine, Washington University, United States.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Washington University School of Medicine, United States.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Washington Univeristy School of Medicine, United States.'}, {'ForeName': 'Marsha S', 'Initials': 'MS', 'LastName': 'Farmer', 'Affiliation': 'Washington University School of Medicine, United States.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ory', 'Affiliation': 'Department of Medicine, Washington University, United States.'}, {'ForeName': 'Jean E', 'Initials': 'JE', 'LastName': 'Schaffer', 'Affiliation': 'Washington University School of Medicine, United States.'}]",Journal of lipid research,['10.1194/jlr.RA120000669']
372,32393559,Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.,"PURPOSE


To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).
METHODS


A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model.
RESULTS


Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49,  P  = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39,  P  = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53,  P  = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61,  P  = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92,  P  = 0.020). No adverse events were reported.
CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.",2020,"CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections.","['Patients with KOA (n = 76', 'Knee Osteoarthritis', 'university primary care clinic in Hong Kong', 'patients with KOA', 'knee osteoarthritis (KOA']","['DPT or NS', 'Intra-Articular Hypertonic Dextrose (Prolotherapy', 'intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection']","['EuroQol-5D VAS score', 'WOMAC composite score', 'WOMAC function score', 'pain, improved function and quality of life', 'Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score', 'WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score', 'adverse events', 'WOMAC pain score', 'VAS pain intensity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",76.0,0.385251,"CONCLUSION


Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections.","[{'ForeName': 'Regina Wing', 'Initials': 'RW', 'LastName': 'Shan Sit', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong reginasit@cuhk.edu.hk.'}, {'ForeName': 'Ricky Wing', 'Initials': 'RW', 'LastName': 'Keung Wu', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rabago', 'Affiliation': 'Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Kenneth Dean', 'Initials': 'KD', 'LastName': 'Reeves', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, The University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Dicken Cheong', 'Initials': 'DC', 'LastName': 'Chun Chan', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Benjamin Hon', 'Initials': 'BH', 'LastName': 'Kei Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Vincent Chi', 'Initials': 'VC', 'LastName': 'Ho Chung', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Samuel Yeung', 'Initials': 'SY', 'LastName': 'Shan Wong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.'}]",Annals of family medicine,['10.1370/afm.2520']
373,31823292,Free-Spins Spur Gamblers to Quit EGMs Early: An Online EGM Study.,"Free-spins on slot machines introduce a salient moment of potentially large wins that might influence people to either quit or continue a gambling session. Two theoretical models make different predictions about why people quit a gambling session. From a behaviourist perspective, people quit a session when they are either satiated or the lack of rewards lead to the extinction of behaviour. Alternatively, from a behavioural-finance perspective, people quit due to the disposition effect: a general finding whereby investors tend to sell shares or other assets when the price has increased, but keep assets that have dropped in value. From the behaviourist perspective, we predict that people experience free spins as a moment of intermittent reinforcement, which should encourage them to continue gambling longer. According to the disposition effect, however, the large win would trigger risk-aversion, signalling an opportunity to ""cash out"" and lock-in the gain. In the present study, 188 gamblers (72 female) were randomly allocated to one of three conditions: control, early free-spins and late free-spins, in an online EGM simulation (points only). Consistent with the disposition effect, participants who received early free-spins quit earlier, placing significantly fewer bets, than those in control condition. The study suggests that free-spins, rather than being reinforcing within session, may signal an opportunity to quit early. In the discussion, however, we speculate on whether future research could demonstrate that a perceived lack of free spins in a session may keep players engaged longer.",2020,"Consistent with the disposition effect, participants who received early free-spins quit earlier, placing significantly fewer bets, than those in control condition.",['188 gamblers (72 female'],"['control, early free-spins and late free-spins, in an online EGM simulation', 'Quit EGMs']",[],"[{'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",[],188.0,0.0343463,"Consistent with the disposition effect, participants who received early free-spins quit earlier, placing significantly fewer bets, than those in control condition.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rockloff', 'Affiliation': 'Central Queensland University, Bundaberg, Australia. m.rockloff@cqu.edu.au.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stuart', 'Affiliation': 'Central Queensland University, Bundaberg, Australia.'}, {'ForeName': 'Hyoun S', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'University of Calgary, Calgary, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'University of Calgary, Calgary, Canada.'}]",Journal of gambling studies,['10.1007/s10899-019-09925-1']
374,31830776,Effects of probiotics or broccoli supplementation on Helicobacter pylori eradication with standard clarithromycin-based triple therapy.,"BACKGROUND/AIMS


The eradication failure rate of standard triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin) for Helicobacter pylori infection has increased owing to antibiotic resistance in Korea. We assessed whether Saccharomyces boulardii probiotic or broccoli sprout extract sulforaphane supplementation could increase the H. pylori eradication rate and/or reduce antibiotic-associated adverse events.
METHODS


A total of 217 patients with H. pylori-positive chronic gastritis or peptic ulcer disease were recruited. Clarithromycin resistance was assessed in all patients by testing for A2142G and A2143G point mutations in H. pylori 23S rRNA using a dual-priming polymerase chain reaction (PCR) oligonucleotide. Thirty-four patients (17.3%) were clarithromycin-resistant and were excluded from the study. Finally, 183 patients with infections not resistant to clarithromycin were randomly assigned to triple therapy only (group A, n = 61), triple therapy plus probiotics (group B, n = 61), or triple therapy plus sulforaphane (group C, n = 61) groups. CYP2C19 polymorphisms were examined at position G681A of exon 5 and G636A of exon 4 by PCR with restriction fragment length polymorphism (PCR-RFLP) analysis. H. pylori eradication was assessed by 13C-urea breath test 4 weeks after treatment completion.
RESULTS


The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses. The frequencies of overall adverse events in the groups also did not differ (A vs. B: p = 0.574; A vs. C: p = 1.000).
CONCLUSION


Probiotic or sulforaphane with triple therapy for H. pylori infection neither increased the eradication rate nor reduced the occurrence of adverse events.",2020,"The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses.","['217 patients with H. pylori-positive chronic gastritis or peptic ulcer disease were recruited', 'Thirty-four patients (17.3%) were clarithromycin-resistant and were excluded from the study', '183 patients with infections not resistant to']","['triple therapy plus probiotics', 'dual-priming polymerase chain reaction (PCR) oligonucleotide', 'Saccharomyces boulardii probiotic or broccoli sprout extract sulforaphane supplementation', 'triple therapy plus sulforaphane', 'Probiotic or sulforaphane', 'standard clarithromycin-based triple therapy', 'probiotics or broccoli supplementation', 'standard triple therapy (proton pump inhibitor, clarithromycin, and amoxicillin', 'clarithromycin']","['frequencies of overall adverse events', 'H. pylori infection', 'eradication failure rate', 'Clarithromycin resistance', 'occurrence of adverse events', 'eradication rate', 'Helicobacter pylori eradication', 'H. pylori eradication rate and/or reduce antibiotic-associated adverse events', 'eradication rates', 'H. pylori eradication']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085695', 'cui_str': 'Chronic gastritis'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0028953', 'cui_str': 'Oligonucleotide'}, {'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C1707048', 'cui_str': 'broccoli sprout extract'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0330498', 'cui_str': 'Brassica oleracea'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",217.0,0.107694,"The eradication rates were similar among the groups both in the intention- to-treat (A = 85.2%, B = 89.6%, and C = 81.6%) and per-protocol (A = 89.2%, B = 86.8%, and C = 96.3%) analyses.","[{'ForeName': 'Young Woon', 'Initials': 'YW', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoo Min', 'Initials': 'YM', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chi Hyuk', 'Initials': 'CH', 'LastName': 'Oh', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Shin Ju', 'Initials': 'SJ', 'LastName': 'Oh', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun-Hyung', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Wook', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2019.139']
375,31831847,Gait ability required to achieve therapeutic effect in gait and balance function with the voluntary driven exoskeleton in patients with chronic spinal cord injury: a clinical study.,"STUDY DESIGN


A non-randomized open-label single-arm clinical trial.
OBJECTIVES


To analyze the effect of body weight supported treadmill training (BWSTT) with the voluntary driven exoskeleton (VDE) in persons with differing levels and completeness of spinal cord injury (SCI) and differing walking abilities.
SETTING


Keio University Hospital, Tokyo, Japan.
METHODS


Twenty individuals with chronic SCI (age, 43 ± 17 years) classified as American Spinal Injury Association Impairment Scale grade A (n = 2), B (n = 4), C (n = 8), or D (n = 6) who had reached a plateau in recovery. Participants underwent twenty 60 min sessions of BWSTT with the hybrid assisted limb. The speed, distance, and duration walked in every 60 min training session were recorded. The Walking Index for SCI Scale II (WISCI-II), 10 meters walk test (10MWT), 2 min walk test, timed up and go (TUG) test, Berg Balance Scale (BBS), lower extremity motor score (LEMS), Barthel Index, and Functional Independence Measure were evaluated at pre and post intervention.
RESULTS


There was a significant improvement in 10MWT, TUG, and BBS after the intervention. Walking ability significantly improved in participants with high walking ability at baseline (WISCI-II score 6-20; n = 12) but not in participants with low walking ability (WISCI-II score 0-3; n = 8). Significant improvement of BBS was also shown in participants with high walking ability at baseline.
CONCLUSIONS


Patients with high walking ability at baseline responded better to the training than those with low walking ability.",2020,Walking ability significantly improved in participants with high walking ability at baseline (WISCI-II score 6-20; n = 12) but not in participants with low walking ability (WISCI-II score 0-3; n = 8).,"['persons with differing levels and completeness of spinal cord injury (SCI) and differing walking abilities', 'patients with chronic spinal cord injury', 'Twenty individuals with chronic SCI (age, 43\u2009±\u200917 years) classified as American Spinal Injury Association Impairment Scale grade A (n\u2009=\u20092), B (n\u2009=\u20094), C (n\u2009=\u20098), or D (n\u2009=\u20096) who had reached a plateau in recovery', 'Keio University Hospital, Tokyo, Japan']","['voluntary driven exoskeleton', 'body weight supported treadmill training (BWSTT) with the voluntary driven exoskeleton (VDE']","['10MWT, TUG, and BBS', 'BBS', 'speed, distance, and duration walked', 'Walking ability', 'Walking Index for SCI Scale II (WISCI-II), 10 meters walk test (10MWT), 2\u2009min walk test, timed up and go (TUG) test, Berg Balance Scale (BBS), lower extremity motor score (LEMS), Barthel Index, and Functional Independence Measure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4720884', 'cui_str': 'American Spinal Injury Association impairment scale'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}]",20.0,0.0297895,Walking ability significantly improved in participants with high walking ability at baseline (WISCI-II score 6-20; n = 12) but not in participants with low walking ability (WISCI-II score 0-3; n = 8).,"[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Okawara', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Orthopaedic Surgery, National Hospital Organization, Murayama Medical Center, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Sugai', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osahiko', 'Initials': 'O', 'LastName': 'Tsuji', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Narihito', 'Initials': 'N', 'LastName': 'Nagoshi', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan. masa@a8.keio.jp.'}]",Spinal cord,['10.1038/s41393-019-0403-0']
376,30017177,High-density lipoprotein function is associated with atherosclerotic burden and cardiovascular outcomes in type 2 diabetes.,"BACKGROUND AND AIMS


Measures of HDL function are emerging tools for assessing cardiovascular disease (CVD) event risk. HDL-apoA-I exchange (HAE) reflects HDL capacity for reverse cholesterol transport.
METHODS


HAE was measured in 93 participants with type 2 diabetes (T2D) and at least one additional CVD risk factor in the Asker and Bærum Cardiovascular Diabetes study. At baseline and after seven years, the atherosclerotic burden was assessed by invasive coronary angiography. Major CVD events were registered throughout the study.
RESULTS


Linear regression analysis demonstrated a significant inverse association between HAE and atherosclerotic burden. Cox proportional hazard regression analysis showed a significant association between HAE and a composite of major CVD events when controlling for waist-hip ratio, HR = 0.89, 95% CI = 0.80-1.00 and p=0.040.
CONCLUSIONS


Despite the relatively small size of the study population and the limited number of CVD events, these findings suggest that HAE provides valuable information in determining CVD risk.",2019,"Cox proportional hazard regression analysis showed a significant association between HAE and a composite of major CVD events when controlling for waist-hip ratio, HR ","['type 2 diabetes', '93 participants with type 2 diabetes (T2D) and at least one additional CVD risk factor in the Asker and Bærum Cardiovascular Diabetes study']","['HAE', 'HDL-apoA-I exchange (HAE']","['atherosclerotic burden', 'Major CVD events']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",93.0,0.0943292,"Cox proportional hazard regression analysis showed a significant association between HAE and a composite of major CVD events when controlling for waist-hip ratio, HR ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heier', 'Affiliation': ""Children's Hospital Oakland Research Institute, 5700 Martin Luther King Jr Way, Oakland, CA, 94609, USA; Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: martin.heier@medisin.uio.no.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Vestre Viken HF, Bærum Hospital, Department of Medical Research, Gjettum, Norway.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Borja', 'Affiliation': ""Children's Hospital Oakland Research Institute, 5700 Martin Luther King Jr Way, Oakland, CA, 94609, USA.""}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Brunborg', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Endresen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Department of Transplantation Medicine, University of Oslo and Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Vestre Viken HF, Bærum Hospital, Department of Medical Research, Gjettum, Norway.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Oda', 'Affiliation': ""Children's Hospital Oakland Research Institute, 5700 Martin Luther King Jr Way, Oakland, CA, 94609, USA.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2018.07.005']
377,30239259,The predictive capacity of self-reported motivation vs. early observed motivational language in cognitive behavioural therapy for generalized anxiety disorder.,"Client motivation to change is often considered a key factor in psychotherapy. To date, research on this client construct has largely relied on self-report, which is prone to response bias and ceiling effects. Moreover, self-reported motivation has been inconsistently related to treatment outcome. Early observed client in-session language may be a more valid measure of initial motivation and thus a promising predictor of outcome. The predictive ability of motivational factors has been examined in addiction treatment but has been limited in other populations. Addressing this lack, the present study investigated 85 clients undergoing cognitive behavioural therapy (CBT) alone and CBT infused with motivational interviewing (MI-CBT) for severe generalized anxiety disorder. There were two aims: (1) to compare the predictive capacity of motivational language vs. two self-report measures of motivation on worry reduction and (2) to examine the influence of treatment condition on motivational language. Findings indicated that motivational language explained up to 35% of outcome variance, event 1-year post-treatment. Self-reported motivation did not predict treatment outcome. Moreover, MI-CBT was associated with a significant decrease in the most detrimental type of motivational language compared to CBT alone. These findings support the importance of attending to in-session motivational language in CBT and learning to respond to these markers using motivational interviewing.",2019,"Moreover, MI-CBT was associated with a significant decrease in the most detrimental type of motivational language compared to CBT alone.","['severe generalized anxiety disorder', '85 clients undergoing', 'generalized anxiety disorder']","['cognitive behavioural therapy (CBT) alone and CBT infused with motivational interviewing (MI-CBT', 'cognitive behavioural therapy']",['motivational language'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}]",85.0,0.0163961,"Moreover, MI-CBT was associated with a significant decrease in the most detrimental type of motivational language compared to CBT alone.","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Poulin', 'Affiliation': 'a Department of Psychology, York University , Toronto , ON , Canada.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Button', 'Affiliation': 'a Department of Psychology, York University , Toronto , ON , Canada.'}, {'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'a Department of Psychology, York University , Toronto , ON , Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'b Department of Psychological and Brain Sciences, University of Massachusetts , Amherst , MA , USA.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'c Department of Psychology, Ryerson University , Toronto , ON , Canada.'}]",Cognitive behaviour therapy,['10.1080/16506073.2018.1517390']
378,30359681,Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.,"BACKGROUND


Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials of 12 months' duration or less; however, long-term data are lacking.
OBJECTIVE


We sought to evaluate the long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma (SEA).
METHODS


COLUMBA (Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects, NCT01691859) was an open-label extension study in patients with SEA previously enrolled in DREAM (Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma, NCT01000506). Patients received 100 mg of subcutaneous mepolizumab every 4 weeks plus standard of care until a protocol-defined stopping criterion was met. Safety end points included frequency of adverse events (AEs), serious AEs, and AEs of special interest. Efficacy end points included annualized exacerbation rates, changes from baseline in Asthma Control Questionnaire 5 scores, and blood eosinophil counts. Immunogenicity was also assessed.
RESULTS


Overall, 347 patients were enrolled for an average of 3.5 years (maximum, 4.5 years; total exposure, 1201 patient-years). On-treatment AEs were reported in 94% of patients (exposure-adjusted rate, 3688 events/1000 patient-years). The most frequently reported on-treatment AEs were respiratory tract infection, headache, bronchitis, and asthma worsening. Seventy-nine (23%) patients experienced 1 or more on-treatment serious AEs; there were 6 deaths, none of which were assessed as related to mepolizumab. For patients with 156 weeks or greater enrollment, the exacerbation rate was 0.74 events/y (weeks 0-156), a 56% reduction from the off-treatment period between DREAM and COLUMBA. For all patients, at the first postbaseline assessment, the mean Asthma Control Questionnaire 5 score was reduced by 0.47 points, and blood eosinophil counts were reduced by 78%, with similar improvements maintained throughout the study. The immunogenicity profile (8% anti-drug antibodies) was consistent with previous studies.
CONCLUSION


These data support the long-term safety and efficacy of mepolizumab in patients with SEA.",2019,"On-treatment AEs were reported in 94% of patients (exposure-adjusted rate, 3688 events/1000 patient-years).","['patients with SEA previously enrolled in', 'patients with severe eosinophilic asthma (SEA', 'patients with SEA', '347 patients were enrolled for an average of 3.5\xa0years (maximum, 4.5\xa0years; total exposure, 1201 patient-years', 'patients with severe eosinophilic asthma']","['Mepolizumab', '100\xa0mg of subcutaneous mepolizumab', 'mepolizumab', 'DREAM', 'placebo']","['annualized exacerbation rates, changes from baseline in Asthma Control Questionnaire 5 scores, and blood eosinophil counts', 'Immunogenicity', 'mean Asthma Control Questionnaire 5 score', 'immunogenicity profile', 'blood eosinophil counts', 'exacerbation rate', 'frequency of adverse events (AEs), serious AEs, and AEs of special interest', 'respiratory tract infection, headache, bronchitis, and asthma worsening']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",347.0,0.0970959,"On-treatment AEs were reported in 94% of patients (exposure-adjusted rate, 3688 events/1000 patient-years).","[{'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Khatri', 'Affiliation': 'Respiratory Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moore', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Priority Research Center for Healthy Lungs and Center of Excellence in Severe Asthma, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Leigh', 'Affiliation': 'Department of Medicine and Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'Department of Respiratory Diseases PhyMedExp, University of Montpellier, Montpellier, France; Hôpital Arnaud de Villeneuve, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Fundación Cidea Allergy and Respiratory Research Unit, Buenos Aires, Argentina.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Barros', 'Affiliation': 'School of Medicine, Universidad de Valparaiso, Valparaiso, Chile; Hospital Carlos van Buren, Valparaiso, Chile.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Mainz University Hospital, Mainz, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Howarth', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton and NIHR Respiratory Biomedical Research Unit, Southampton General Hospital, Southampton, United Kingdom; Global Respiratory Franchise, GSK House, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Respiratory Medical Franchise, GSK, Research Triangle Park, NC.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Gilson', 'Affiliation': 'Respiratory Research and Development, GSK, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Price', 'Affiliation': 'Clinical Statistics, GSK, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Ortega', 'Affiliation': 'Respiratory, Medical Affairs, GSK, La Jolla, Calif. Electronic address: hortega@gossamerbio.com.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.09.033']
379,30452533,Systolic Blood Pressure Trajectories in the Acute Phase and Clinical Outcomes in 2-Year Follow-up Among Patients With Ischemic Stroke.,"BACKGROUND


Optimal blood pressure (BP) levels during acute ischemic stroke have not been established. We studied associations between systolic BP trajectories during acute phase and subsequent clinical outcomes among patients with ischemic stroke.
METHODS


A total of 4,036 patients with acute ischemic stroke and elevated BP from the China Antihypertensive Trial in Acute Ischemic Stroke trial were included in this analysis. Three BPs were measured every 2 hours in day 1, every 4 hours during days 2 and 3, and every 8 hours thereafter until hospital discharge or death. Clinical outcomes were assessed at 3, 12, and 24 months. Latent variable mixture modeling was used to identify subgroups that share a similar underlying trajectory of systolic BP during the first 7 days after stroke onset. Logistic regression and Cox proportional hazards models were used to examine the associations between systolic BP trajectories and clinical outcomes during follow-up.
RESULTS


We identified 5 systolic BP trajectories of high, high-to-moderate-low, moderate-high, moderate-low, and low. Compared to participants in high trajectory, multiple-adjusted odds ratios (95% confidence interval) of all-cause mortality at 3 months for individuals in high-to-moderate-low, moderate-high, moderate-low, and low were 0.34 (0.15-0.77), 0.58 (0.32-1.04), 0.29 (0.15-0.56), and 0.56 (0.26-1.19), respectively. Likewise, the corresponding hazard ratios for all-cause mortality in 24 months were 0.66 (0.44-1.00), 0.74 (0.53-1.05), 0.45 (0.32-0.66), and 0.61 (0.40-0.93), respectively. Similar associations were observed for recurrent stroke and cardiovascular disease, and in both the intervention and control groups.
CONCLUSIONS


Patients with moderate-low systolic BP during acute ischemic stroke had a lower risk of adverse clinical outcomes.",2019,"Compared to participants in high trajectory, multiple-adjusted odds ratios (95% confidence interval) of all-cause mortality at 3 months for individuals in high-to-moderate-low, moderate-high, moderate-low, and low were 0.34 (0.15-0.77), 0.58 (0.32-1.04), 0.29 (0.15-0.56), and 0.56 (0.26-1.19), respectively.","['acute ischemic stroke', 'Patients With Ischemic Stroke', '4,036 patients with acute ischemic stroke and elevated BP from the China Antihypertensive Trial in Acute Ischemic Stroke trial', 'patients with ischemic stroke']",[],"['recurrent stroke and cardiovascular disease', 'Systolic Blood Pressure Trajectories', 'systolic BP trajectories', 'systolic BP trajectories and clinical outcomes', 'blood pressure (BP) levels']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",4036.0,0.096783,"Compared to participants in high trajectory, multiple-adjusted odds ratios (95% confidence interval) of all-cause mortality at 3 months for individuals in high-to-moderate-low, moderate-high, moderate-low, and low were 0.34 (0.15-0.77), 0.58 (0.32-1.04), 0.29 (0.15-0.56), and 0.56 (0.26-1.19), respectively.","[{'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Dali', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Hebei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Yingxian', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Bu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Jinchao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Yutian County Hospital, Hebei, China.'}, {'ForeName': 'Qunwei', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Taishan Medical College, Shandong, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': ""Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner Mongolia, China.""}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Xuzhou Medical College, Jiangsu, China.'}, {'ForeName': 'Jintao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The 88th Hospital of PLA, Shandong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of hypertension,['10.1093/ajh/hpy174']
380,30601374,Optimal Timing for Trichomonas vaginalis Test of Cure Using Nucleic Acid Amplification Testing.,"BACKGROUND


The optimal timing for nucleic acid amplification testing (NAAT) posttreatment for Trichomonas vaginalis has not been fully established. Testing too soon posttreatment may detect remnant nucleic acid that is not from viable organisms, falsely misclassifying person as infected. The purpose of this study was to examine how long T. vaginalis nucleic acid is detectable postmetronidazole (MTZ) treatment.
METHODS


Women diagnosed with T. vaginalis treated with MTZ (2 g single-dose or 500 mg twice daily for 7 days multidose) self-collected a vaginal swab for NAAT at baseline and each week postcompletion of treatment through test of cure (TOC) at week 4, when a culture was also performed. Women who reported interim sexual exposure or who were culture positive at 4 weeks were excluded. Time to first negative NAAT was examined using Kaplan Meier analysis.
RESULTS


All women receiving multidose metronidazole were NAAT-negative by 21 days and those receiving single dose by 28 days postcompletion of treatment. Though over half (60.7%) of the cohort reinitiated sex during follow-up¸ all reported using condoms during sex or that they and their partner were treated before sex. Six (6.7%) of 89 had a positive NAAT following their first negative NAAT.
CONCLUSIONS


The optimal timing for T. vaginalis retesting after completion of treatment is 3 weeks for those receiving multidose MTZ and 4 weeks for those receiving single-dose, though sexual reexposure and false negatives should be considered.",2019,Though over half (60.7%) of the cohort reinitiated sex during follow-up¸ all reported using condoms during sex or that they and their partner were treated before sex.,"['Women who reported interim sexual exposure or who were culture positive at 4 weeks were excluded', 'Women diagnosed with T. vaginalis treated with']","['multidose metronidazole', 'MTZ (2 g single-dose or 500 mg twice daily for 7 days multidose) self-collected a vaginal swab for NAAT']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0233921', 'cui_str': 'Sexual exposure'}, {'cui': 'C0159125', 'cui_str': 'Culture positive'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",[],,0.101153,Though over half (60.7%) of the cohort reinitiated sex during follow-up¸ all reported using condoms during sex or that they and their partner were treated before sex.,"[{'ForeName': 'Megan Clare', 'Initials': 'MC', 'LastName': 'Craig-Kuhn', 'Affiliation': ''}, {'ForeName': 'Charleigh', 'Initials': 'C', 'LastName': 'Granade', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Muzny', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Van Der Pol', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lillis', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Norine', 'Initials': 'N', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kissinger', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000968']
381,30642911,"Induction of Peripheral Effector CD8 T-cell Proliferation by Combination of Paclitaxel, Carboplatin, and Bevacizumab in Non-small Cell Lung Cancer Patients.","PURPOSE


Chemotherapy has long been the standard treatment for advanced stage non-small cell lung cancer (NSCLC), but checkpoint inhibitors are now approved for use in several patient groups and combinations. To design optimal combination strategies, a better understanding of the immune-modulatory capacities of conventional treatments is needed. Therefore, we investigated the immune-modulatory effects of paclitaxel/carboplatin/bevacizumab (PCB), focusing on the immune populations associated with the response to checkpoint inhibitors in peripheral blood.
EXPERIMENTAL DESIGN


A total of 223 patients with stage IV NSCLC, enrolled in the NVALT12 study, received PCB, with or without nitroglycerin patch. Peripheral blood was collected at baseline and after the first and second treatment cycle, proportions of T cells, B cells, and monocytes were determined by flow cytometry. Furthermore, several subsets of T cells and the expression of Ki67 and coinhibitory receptors on these subsets were determined.
RESULTS


Although proliferation of CD4 T cells remained stable following treatment, proliferation of peripheral blood CD8 T cells was significantly increased, particularly in the effector memory and CD45RA +  effector subsets. The proliferating CD8 T cells more highly expressed programmed death receptor (PD)-1 and cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) compared with nonproliferating CD8 T cells. Immunologic responders (iR; >2 fold increased proliferation after treatment) did not show an improved progression-free (PFS) or overall survival (OS).
CONCLUSIONS


Paclitaxel/carboplatin/bevacizumab induces proliferation of CD8 T cells, consisting of effector cells expressing coinhibitory checkpoint molecules. Induction of proliferation was not correlated to clinical outcome in the current clinical setting. Our findings provide a rationale for combining PCB with checkpoint inhibition in lung cancer.",2019,"Immunologic responders (iR; >2 fold increased proliferation after treatment) did not show an improved progression-free (PFS) or overall survival (OS).
","['223 patients with stage IV NSCLC, enrolled in the NVALT12 study, received', 'advanced stage non-small cell lung cancer (NSCLC', 'Non-small Cell Lung Cancer Patients']","['PCB, with or without nitroglycerin patch', 'paclitaxel/carboplatin/bevacizumab (PCB', 'Paclitaxel/carboplatin/bevacizumab', 'Paclitaxel, Carboplatin, and Bevacizumab']","['proliferation of CD4 T cells', 'Immunologic responders', 'Peripheral blood', 'proliferating CD8 T cells more highly expressed programmed death receptor (PD)-1 and cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4', 'proliferation of peripheral blood CD8 T cells', 'progression-free (PFS) or overall survival (OS', 'proportions of T cells, B cells, and monocytes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0699222', 'cui_str': 'Nitroglycerin Transdermal System'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720947', 'cui_str': 'Death Domain Receptors'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}]",223.0,0.0620304,"Immunologic responders (iR; >2 fold increased proliferation after treatment) did not show an improved progression-free (PFS) or overall survival (OS).
","[{'ForeName': 'Pauline L', 'Initials': 'PL', 'LastName': 'de Goeje', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Myrthe', 'Initials': 'M', 'LastName': 'Poncin', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Bezemer', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Margaretha E H', 'Initials': 'MEH', 'LastName': 'Kaijen-Lambers', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'Groningen University Medical Center, Department of Respiratory Disease, Groningen, the Netherlands.'}, {'ForeName': 'Egbert F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Anne-Marie C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Respiratory Disease, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kunert', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Rudi W', 'Initials': 'RW', 'LastName': 'Hendriks', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonary Medicine, Erasmus MC, Rotterdam, the Netherlands. j.aerts@erasmusmc.nl.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2243']
382,32394019,Surgical vs. drug therapy in patients with patent foramen ovale and cryptogenic stroke.,"OBJECTIVE


This study aimed to investigate the effectiveness of risk scoring for predicting stroke recurrence after percutaneous patent foramen ovale (PFO) closure or medication therapy in patients with PFO and a history of cryptogenic stroke.
METHODS


This study included 559 patients with PFO and cryptogenic stroke who were treated in our hospital from January 2013 to January 2018 and were followed up for 15-72 months. After calculating the risk scores for stroke recurrence, we randomly divided the patients into two groups (ratio, 1:1): Patients in one group underwent PFO closure and those in the other received drug therapy.
RESULTS


Patients in the PFO closure group had a lower risk of recurrent stroke than those in the drug therapy group (1.1% vs. 4.2%). Moreover, serious bleeding was less frequent in the PFO closure group than in the drug therapy group (0% vs. 3.2%), although the incidence of atrial fibrillation or flutter did not significantly differ between the groups (p = 0.67). Interestingly, a subgroup analysis revealed no inter-treatment group difference in the rate of cryptogenic stroke recurrence among patients with risk scores of 0-1. By contrast, PFO closure yielded superior outcomes among patients with risk scores of ≥2.
CONCLUSION


Compared with drug therapy, PFO closure reduced the risk of recurrent stroke among patients with a risk score of ≥2 and reduced the incidence of serious bleeding without increasing the risk of new-onset atrial fibrillation or atrial flutter.",2020,"Compared with drug therapy, PFO closure reduced the risk of recurrent stroke among patients with a risk score of ≥2 and reduced the incidence of serious bleeding without increasing the risk of new-onset atrial fibrillation or atrial flutter.","['patients with risk scores of ≥2', '559 patients with PFO and cryptogenic stroke who were treated in our hospital from January 2013 to January 2018 and were followed up for 15-72\xa0months', 'patients with patent foramen ovale and cryptogenic stroke', 'patients with PFO and a\xa0history of cryptogenic stroke']","['PFO closure', 'percutaneous patent foramen ovale (PFO) closure or medication therapy']","['serious bleeding', 'rate of cryptogenic stroke recurrence', 'stroke recurrence', 'risk of recurrent stroke', 'incidence of atrial fibrillation or flutter', 'recurrent stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0189967', 'cui_str': 'Closure of patent foramen ovale'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",559.0,0.022675,"Compared with drug therapy, PFO closure reduced the risk of recurrent stroke among patients with a risk score of ≥2 and reduced the incidence of serious bleeding without increasing the risk of new-onset atrial fibrillation or atrial flutter.","[{'ForeName': 'Yunbing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Cardiac Electrophysiological Center, Mianyang Central Hospital, 621000, Mianyang, Sichuan, China. liuyunbing999@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Cardiac Electrophysiological Center, Mianyang Central Hospital, 621000, Mianyang, Sichuan, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Cardiac Electrophysiological Center, Mianyang Central Hospital, 621000, Mianyang, Sichuan, China.'}]",Herz,['10.1007/s00059-020-04921-3']
383,32394024,"Detection of Aspiration, Penetration, and Pharyngeal Residue During Flexible Endoscopic Evaluation of Swallowing (FEES): Comparing the Effects of Color, Coating, and Opacity.","The aim of this study was to assess the effects of color, coating, and opacity on the detection of aspiration, penetration, and residue during flexible endoscopic evaluations of swallowing (FEES). Thirty dysphagic adults underwent FEES while swallowing five 5 mL thin liquid boluses (1 × each, randomized): white water, blue water, white milk, blue milk, and barium water. To assess the effects of color, blue milk was compared to white milk. To assess the effects of coating, barium, white water, and white milk were compared to each other. To assess the effects of opacity, blue milk was compared to blue water. Videos were blindly analyzed and judged for the presence of pharyngeal residue, penetration, and aspiration. Repeated measures analyses were used to assess differences in the frequency of detection across bolus types. Pharyngeal residue was detected more frequently for liquids that were blue, had a coating effect, or were opaque (p < 0.05) when compared to liquids that were white, did not have a coating effect, or were translucent, respectively. Penetration and aspiration were detected more frequently for liquids that had a coating effect (p < 0.05), but not for liquids that were colored blue or opaque (p > 0.05). Coating appears to be the most important factor detecting thin liquid residue, penetration, and aspiration during FEES. Given these findings, standardized use of boluses that possess a coating effect (e.g., white-dyed water or barium) is highly recommended to enhance the sensitivity of identifying impairments in swallowing safety and efficiency during FEES.",2020,"Penetration and aspiration were detected more frequently for liquids that had a coating effect (p < 0.05), but not for liquids that were colored blue or opaque (p > 0.05).",['Thirty dysphagic adults underwent'],"['Flexible Endoscopic Evaluation of Swallowing (FEES', 'FEES while swallowing five 5\xa0mL thin liquid boluses', 'Color, Coating, and Opacity']","['Pharyngeal residue', 'Detection of Aspiration, Penetration, and Pharyngeal Residue', 'Penetration and aspiration']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",30.0,0.019729,"Penetration and aspiration were detected more frequently for liquids that had a coating effect (p < 0.05), but not for liquids that were colored blue or opaque (p > 0.05).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Curtis', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA. jac2406@tc.columbia.edu.'}, {'ForeName': 'Zeina N', 'Initials': 'ZN', 'LastName': 'Seikaly', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA.'}, {'ForeName': 'Avery E', 'Initials': 'AE', 'LastName': 'Dakin', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Troche', 'Affiliation': 'Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Thorndike Building, Room 955, New York, NY, 10027, USA.'}]",Dysphagia,['10.1007/s00455-020-10131-0']
384,32394049,A Large-Scale Replication of the Effectiveness of the KiVa Antibullying Program: a Randomized Controlled Trial in the Netherlands.,"This study evaluates the effectiveness of the KiVa antibullying program in the Netherlands through a randomized controlled trial of students in grades 3-4 (Dutch grades 5-6). The sample involved 98 schools who volunteered to participate in the research, with 245 classes and 4383 students at the baseline (49% girls; M age = 8.7 years), who participated in five measurement waves, collected in three consecutive school years. After the baseline, two-thirds of the schools were assigned to the intervention condition (KiVa or KiVa+, the latter included an additional intervention component of network feedback to teachers) and one-third to the control condition (waiting list, care as usual) with a stratified randomization procedure. The effects of the intervention on self-reported victimization and bullying were tested using cross-classified ordered multinomial models and binomial logistic regression models. These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation. The results showed that for students in control schools, the odds of being a victim were 1.29-1.63 higher, and the odds of being a bully were 1.19-1.66 higher than for KiVa students. No significant differences between KiVa and KiVa+ emerged. Overall, the findings provide evidence of the effectiveness of the KiVa program in the Netherlands.",2020,"These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation.","['students in grades 3-4 (Dutch grades 5-6', '98 schools who volunteered to participate in the research, with 245 classes and 4383 students at the baseline (49% girls; M age\u2009=\u20098.7\xa0years), who participated in five measurement waves, collected in three consecutive school years']","['KiVa Antibullying Program', 'intervention condition (KiVa or KiVa+, the latter included an additional intervention component of network feedback to teachers) and one-third to the control condition (waiting list, care as usual) with a stratified randomization procedure', 'KiVa antibullying program']",['odds of being a victim'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1278569', 'cui_str': 'WAS A'}]",98.0,0.0250472,"These longitudinal models showed that self-reported victimization and bullying reduced more strongly in KiVa-schools compared with control schools, with stronger effects after two school years than after one school year of implementation.","[{'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Huitsing', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands. g.e.huitsing@rug.nl.'}, {'ForeName': 'Gerine M A', 'Initials': 'GMA', 'LastName': 'Lodder', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}, {'ForeName': 'Wiliam J', 'Initials': 'WJ', 'LastName': 'Browne', 'Affiliation': 'School of Education, University of Bristol, Bristol, UK.'}, {'ForeName': 'Beau', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}, {'ForeName': 'Rozemarijn', 'Initials': 'R', 'LastName': 'Van der Ploeg', 'Affiliation': 'Department of Pedagogy and Educational Science, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Veenstra', 'Affiliation': 'Department of Sociology, University of Groningen, and Interuniversity Center for Social Science Theory and Methodology (ICS), Groningen, The Netherlands.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01116-4']
385,32394089,Simulation Training in Neuroangiography: Transfer to Reality.,"PURPOSE


Endovascular simulation is an established and validated training method, but there is still no proof of direct patient's benefit, defined as lower complication rate. In this study, the impact of such a training was investigated for rehearsal of patient-specific cases as well as for a structured simulation curriculum to teach angiographer novices.
MATERIALS AND METHODS


A total of 40 patients undergoing a diagnostic neuroangiography were randomized in a training and control group. In all training group patients, the angiographer received a patient-anatomy-specific rehearsal on a high-fidelity simulator prior to the real angiography. Radiation exposure, total duration, fluoroscopy time and amount of contrast agent of the real angiography were recorded. Silent cerebral ischemia was counted by magnetic resonance diffusion-weighted imaging (DWI). Additionally, the first 30 diagnostic neuroangiographies of six novices were compared (n total  = 180). Three novices had undergone a structured simulation curriculum; three had acquired angiographic skills without simulation.
RESULTS


No differences were found in the number of DWI lesions or in other quality measures of the angiographies performed with and without patient-specific rehearsal. A structured simulation curriculum for angiographer novices reduced fluoroscopy time significantly and radiation exposure. The curriculum had no influence on the total duration of the examination, the amount of contrast medium or the number of catheters used.
CONCLUSION


There was no measurable benefit of patient-anatomy-specific rehearsal for an unselected patient cohort. A structured simulation-based curriculum to teach angiographic skills resulted in a reduction of fluoroscopy time and radiation dose in the first real angiographies of novice angiographers.
LEVEL OF EVIDENCE


Level 4, part 1: randomized trial, part 2: historically controlled study.",2020,"A structured simulation-based curriculum to teach angiographic skills resulted in a reduction of fluoroscopy time and radiation dose in the first real angiographies of novice angiographers.
",['40 patients undergoing a diagnostic neuroangiography'],['patient-anatomy-specific rehearsal on a high-fidelity simulator prior to the real angiography'],"['number of DWI lesions', 'total duration of the examination, the amount of contrast medium or the number of catheters used', 'Radiation exposure, total duration, fluoroscopy time and amount of contrast agent of the real angiography', 'fluoroscopy time', 'patient-anatomy-specific rehearsal', 'Silent cerebral ischemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0449806', 'cui_str': 'Number of catheters'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}]",40.0,0.0386447,"A structured simulation-based curriculum to teach angiographic skills resulted in a reduction of fluoroscopy time and radiation dose in the first real angiographies of novice angiographers.
","[{'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Kreiser', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. kornelia.kreiser@tum.de.'}, {'ForeName': 'Kim G', 'Initials': 'KG', 'LastName': 'Gehling', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Ströber', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Zimmer', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Jan S', 'Initials': 'JS', 'LastName': 'Kirschke', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02479-5']
386,32397821,Feasibility and Acceptability of Implementing a Culturally Adapted Cooking Curriculum for Burundian and Congolese Refugee Families.,"Pika Pamoja (Cook Together) is an eight-session cooking curriculum for Burundian and Congolese refugee families, culturally adapted from the evidence-based iCook 4-H curriculum to address dietary acculturation barriers to and facilitators of food security. The goal of this study was to determine the feasibility and acceptability of implementing Pika Pamoja.Researchers and a multilingual community aid implemented Pika Pamoja in a pre-post pilot intervention with randomized control (n = 5)/treatment (n = 5) dyads (youth/mother). Feasibility (recruitment/retention, implementation, fidelity testing, and assessment procedures) and acceptability (process and program evaluations) measures were collected.All 10 dyads (control and treatment) were retained throughout the study. All fidelity measures were 91% or above. The final youth assessment instrument included scales for cooking skills (α = 0.93), cooking self-efficacy (α = 0.90), openness to new foods (α = 0.81), and eating (α = 0.68), playing (α = 0.90), and setting healthful goals (α = 0.88) together as a family. The final adult instrument included scales for cooking, eating, and playing together (α = 0.68), kitchen proficiency (α = 0.89), and food security (α = 0.79). Participant feedback was uniformly positive.Based on these results, Pika Pamoja was feasible to implement and was accepted by the priority population. Larger scale studies to measure the effectiveness of Pika Pamoja to increase food security among refugee families are needed.",2020,Larger scale studies to measure the effectiveness of Pika Pamoja to increase food security among refugee families are needed.,['Burundian and Congolese Refugee Families'],['Implementing a Culturally Adapted Cooking Curriculum'],"['cooking self-efficacy (α\xa0=\xa00.90), openness to new foods', 'food security', 'setting healthful goals', 'Feasibility (recruitment/retention, implementation, fidelity testing, and assessment procedures) and acceptability (process and program evaluations) measures']","[{'cui': 'C0337830', 'cui_str': 'Congolese'}, {'cui': 'C1446393', 'cui_str': 'Refugee family'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0547049', 'cui_str': 'Openness'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0033336', 'cui_str': 'Evaluation, Program'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0139176,Larger scale studies to measure the effectiveness of Pika Pamoja to increase food security among refugee families are needed.,"[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'McElrone', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, Tennessee, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Colby', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, Tennessee, USA.'}, {'ForeName': 'Hillary N', 'Initials': 'HN', 'LastName': 'Fouts', 'Affiliation': 'Department of Child & Family Studies, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Spence', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, Tennessee, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, Tennessee, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzen-Castle', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NB, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Olfert', 'Affiliation': 'Department of Human Nutrition and Foods, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Kendra K', 'Initials': 'KK', 'LastName': 'Kattelmann', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD, USA.'}, {'ForeName': 'Adrienne A', 'Initials': 'AA', 'LastName': 'White', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME, USA.'}]",Ecology of food and nutrition,['10.1080/03670244.2020.1759575']
387,32397850,Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients with Mixed Dyslipidemia: A Pilot Clinical Trial.,"To evaluate the effect of berberine (BBR) plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia. A double-blind randomized pilot clinical trial with parallel groups was carried out in 36 patients, aged 30-60 years with mixed dyslipidemia [triglycerides (TG) ≥1.7 mM and total cholesterol (TC) ≥5.2 mM]. Patients were assigned to 3 groups of 12 patients each, receiving oral administration during 90 days of BBR 500 mg t.i.d., bezafibrate 400 mg b.i.d., or BBR 500 mg t.i.d. plus bezafibrate 400 mg b.i.d, respectively. Clinical evaluation, lipid profile, glucose, creatinine, and uric acid levels were measured before and after the pharmacological intervention. Kruskal-Wallis, Wilcoxon, Mann-Whitney U, and  χ 2  tests were used for statistical analyses; a  P  ≤ .05 was considered statistically significant. BBR reduced TC levels. Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations. BBR plus bezafibrate decreased TG (2.6 ± 0.8 vs. 1.3 ± 0.7 mM,  P  = .007), TC (6.3 ± 0.7 vs. 4.6 ± 1.2 mM,  P  = .005), LDL-C (3.4 ± 0.6 vs. 2.2 ± 1.3 mM,  P  = .037), and VLDL (0.5 ± 0.2 vs. 0.2 ± 0.1 mM,  P  = .007) levels. Bezafibrate and BBR plus bezafibrate significantly decreased TG, TC, LDL-C, and VLDL concentrations, and thus, remitting the diagnosis of mixed dyslipidemia in 90% of the patients.",2020,"Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations.","['patients with mixed dyslipidemia', '36 patients, aged 30-60 years with mixed dyslipidemia [triglycerides (TG) ≥1.7\u2009mM and total cholesterol (TC', 'Patients with Mixed Dyslipidemia']","['berberine (BBR) plus bezafibrate', 'Bezafibrate', 'BBR plus bezafibrate', 'Bezafibrate and BBR plus bezafibrate', 'Berberine Plus Bezafibrate', 'BBR 500\u2009mg t.i.d., bezafibrate 400\u2009mg b.i.d., or BBR 500\u2009mg t.i.d. plus bezafibrate']","['Kruskal-Wallis, Wilcoxon, Mann-Whitney U, and  χ', 'TG, TC, LDL-C, and VLDL concentrations, and thus, remitting the diagnosis of mixed dyslipidemia', 'BBR reduced TC levels', 'VLDL', 'Clinical evaluation, lipid profile, glucose, creatinine, and uric acid levels', 'TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]","[{'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1128912', 'cui_str': 'Bezafibrate 400 MG'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",36.0,0.042287,"Bezafibrate decreased TG, TC, low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein (VLDL) concentrations.","[{'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'León-Martínez', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martínez-Abundis', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González-Ortiz', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Karina G', 'Initials': 'KG', 'LastName': 'Pérez-Rubio', 'Affiliation': 'Health Science University Center, Department of Physiology, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2020.0029']
388,32397852,Topical Alpha-1 Adrenergic Receptor Agonist Applied to the Nipple/Areola Complex Improves Female Orgasmic Function.,"Background:  The impact of nipple sensation and its relationship to sexual function have often been neglected in medical literature. However, several recent studies report the importance of the nipple/areola complex (NAC) in sexual arousal and overall function. The nipple is composed of smooth muscle that can be erected  via  adrenergic nerves. In two complementary studies, we demonstrate that stimulation of the alpha-1 adrenergic receptor in the NAC with topical adrenergic agents can initiate erection of the nipple, increase NAC sensitivity, and improve sexual function.  Materials and Methods:  Thirteen breast surgery patients with nipple sensitivity loss were recruited to an unblinded study of topical phenylephrine hydrochloride. Sensitivity to pressure was measured before and after the application of the intervention to the NAC. In a second pilot study, 35 women completed a double-blinded placebo-controlled trial of a novel formulation, RJ101, containing a norepinephrine releasing agent. The intervention or placebo was applied to the NAC 30 minutes before sexual activity over the 4-week trial period. The arousal, lubrication, and orgasm domains of the female sexual function index (FSFI) were used to measure sexual function.  Results:  The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients. In addition, it was shown that intermittent application of the alpha-1 agonist for 8 weeks increased basal NAC sensitivity. In the follow-up pilot study, we demonstrate that stimulation of the NAC with RJ101 produced statistically significant increases versus placebo in the lubrication and orgasm domains of the FSFI,  p  = 0.0226 and  p  = 0.0269, respectively.  Conclusion:  For the first time, we demonstrate that the application of a topical alpha-1 adrenergic receptor agonist or a norepinephrine-releasing agent increases the sensitivity of the NAC and subsequently significantly improves sexual function.",2020,The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients.,"['13 breast augmentation patients', 'Thirteen breast surgery patients with nipple sensitivity loss', '35 women completed a double-blinded']","['phenylephrine hydrochloride', 'topical phenylephrine hydrochloride', 'norepinephrine releasing agent', 'placebo']","['basal NAC sensitivity', 'sexual function', 'nipple sensitivity to pressure', 'Sensitivity to pressure', 'arousal, lubrication, and orgasm domains of the female sexual function index (FSFI']","[{'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0031470', 'cui_str': 'Phenylephrine hydrochloride'}, {'cui': 'C3212565', 'cui_str': 'Phenylephrine-containing product in cutaneous dose form'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",35.0,0.0262157,The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients.,"[{'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goren', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCoy', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krychman', 'Affiliation': 'Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, California, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Applied Biology, Inc., Irvine, California, USA.'}, {'ForeName': 'Amadej', 'Initials': 'A', 'LastName': 'Lah', 'Affiliation': 'Estetika Fabjan D.O.O., Kranj, Slovenia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Lonky', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Irvine, California, USA.'}]",Journal of women's health (2002),['10.1089/jwh.2019.8188']
389,32397926,"2B, 2C, or 3: What Should Be the Angiographic Target for Endovascular Treatment in Ischemic Stroke?","Background and Purpose- A score of ≥2B on the modified Thrombolysis in Cerebral Infarction scale is generally regarded as successful reperfusion after endovascular treatment for ischemic stroke. The extended Thrombolysis in Cerebral Infarction (eTICI) includes a 2C grade, which indicates near-perfect reperfusion. We investigated how well the respective eTICI scores of 2B, 2C, and 3 correlate with clinical outcome after endovascular treatment. Methods- We used data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands. We included patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available. Our primary outcome was the distribution on the modified Rankin Scale at 90 days per eTICI grade. We performed (ordinal) logistic regression analyses, using eTICI 2B as reference group, and adjusted for potential confounders. Results- In total, 2807/3637 (77%) patients met the inclusion criteria. Of these, 17% achieved reperfusion grade eTICI 0 to 1, 14% eTICI 2A, 25% eTICI 2B, 12% eTICI 2C, and 32% eTICI 3. Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01). Procedure times decreased with increasing reperfusion grades. We found a positive association between reperfusion grade and functional outcome, which continued to increase after eTICI 2B (adjusted common odds ratio, 1.22 [95% CI, 0.96-1.57] for eTICI 2C versus 2B; adjusted common odds ratio, 1.33 [95% CI, 1.09-1.62] for eTICI 3 versus 2B). Conclusions- Our results indicate a continuous relationship between reperfusion grade and functional outcome, with eTICI 3 leading to the best outcomes. Although this implies that interventionists should aim for the highest possible reperfusion grade, further research on the optimal strategy is necessary.",2020,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"['patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available', 'Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands']","['Methods', 'Endovascular Treatment', ' and Purpose', 'Conclusions']","['reperfusion grade eTICI', 'Cerebral Infarction scale', 'occlusion location', 'distribution on the modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.078079,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'From the Department of Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands (N.E.L., Y.B.W.E.M.R., J.M.C.).'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands (M.K., K.M.T., B.J.E., C.B.L.M.M.).'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands (M.K., K.M.T., B.J.E., C.B.L.M.M.).'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Center for Medical Decision Making, Erasmus MC University Medical Center Rotterdam, the Netherlands (H.F.L.).'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, China (G.Z.).'}, {'ForeName': 'Ido R', 'Initials': 'IR', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, the Hague, the Netherlands (I.R.v.d.W.).'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center Rotterdam, the Netherlands (A.C.G.M.v.E.).'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands (M.K., K.M.T., B.J.E., C.B.L.M.M.).'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, the Netherlands (M.K., K.M.T., B.J.E., C.B.L.M.M.).'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands (N.E.L., Y.B.W.E.M.R., J.M.C.).'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology, Amsterdam UMC, University of Amsterdam, the Netherlands (N.E.L., Y.B.W.E.M.R., J.M.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028891']
390,32398047,"Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial).","BACKGROUND


Atrial fibrillation (AF) is the most frequent cardiac arrhythmia which increases the risk of thromboembolic complications and impairs quality of life. An important part of a therapeutic approach for AF is sinus rhythm restoration. Antiarrhythmic agents used in pharmacological cardioversion have limited efficacy and potential risk of proarrhythmia. Simultaneously, underlying conditions of AF should be treated (e.g. electrolyte imbalance, increased blood pressure, neurohormonal disturbances, atrial volume overload). There is still the need for an effective and safe approach to increase AF cardioversion efficacy. This randomized, double-blind, placebo-controlled, superiority clinical study is performed in patients with AF in order to evaluate the clinical efficacy of intravenous canrenone in sinus rhythm restoration.
METHODS


Eighty eligible patients with an episode of AF lasting less than 48 h are randomized in a 1:1 ratio to receive canrenone or placebo. Patients randomized to a treatment intervention are receiving canrenone intravenously at a dose of 200 mg within 2-3 min. Subjects assigned to a control group obtain the same volume of 0.9% saline within the same time. The primary endpoint includes return of sinus rhythm documented in the electrocardiogram within 2 h after drug or placebo administration. Other endpoints and safety outcomes analyses, due to expected lack of statistical power, are exploratory.
DISCUSSION


Current evidence supports renin-angiotensin-aldosterone system (RAAS) inhibition as an upstream therapy in AF management. Excess aldosterone secretion results in proarrhythmic effects. Among the RAAS inhibitors, only canrenone is administered intravenously. Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload. It has been already used in primary and secondary hyperaldosteronism in the course of chronic liver dysfunction and in heart failure.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03536806. Registered on 25 May 2018.",2020,"Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload.","['patients with atrial fibrillation - a protocol', 'Eighty eligible patients with an episode of AF lasting less than 48\u2009h are randomized in a 1:1 ratio to receive', 'patients with AF']","['intravenous canrenone', 'canrenone or placebo', 'canrenone', 'potassium canreonate-canrenone', 'placebo']","['blood pressure, neurohormonal disturbances, atrial volume overload', 'plasma level of potassium, lowers blood pressure and reduces preload', 'AF cardioversion efficacy', 'return of sinus rhythm documented in the electrocardiogram within 2\u2009h after drug or placebo administration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0006882', 'cui_str': 'Canrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",80.0,0.350949,"Canrenone additionally increases the plasma level of potassium, lowers blood pressure and reduces preload.","[{'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Dąbrowski', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland. rdabrowski@ikard.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Syska', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Mączyńska', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Farkowski', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sawicki', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Kubaszek-Kornatowska', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Michałek', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Kowalik', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Hryniewiecki', 'Affiliation': 'National Institute of Cardiology, ul. Alpejska 42, Warsaw, 04-628, Poland.'}]",Trials,['10.1186/s13063-020-04277-3']
391,32398065,An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial.,"BACKGROUND


Inappropriate prescribing of antibiotics for acute respiratory infections at the primary care level represents the major source of antibiotic misuse in healthcare, and is a major driver for antimicrobial resistance worldwide. In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.
METHODS


We will use a parallel-group, cluster-randomised, controlled, superiority trial with blinded outcome evaluation but unblinded treatment (providers and patients). We will randomise 34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio). In the control arm, antibiotic prescribing and management will continue through usual care. In the intervention arm, we will implement an antibiotic stewardship programme targeting family physicians and patients/caregivers. The family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation. The patient/caregiver component involves patient education via family physicians, leaflets and videos. The primary outcome is the proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s). Secondary outcomes will address how frequently specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and a long-term benefit evaluation. The duration of the intervention will be 12 months, with another 24 months' post-trial long-term follow-up.
DISCUSSION


Our study is one of the first trials to evaluate the effect of an antibiotic stewardship programme in primary care settings in a low- or middle-income country (LMIC). All interventional activities will be designed to be embedded into routine primary care with strong local ownership. Through the trial we intend to impact on clinical practice and national policy in antibiotic prescription for primary care facilities in rural China and other LMICs.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN96892547. Registered on 18 August 2019.",2020,"In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.
","['primary care facilities in rural China and other LMICs', 'primary care settings in a low- or middle-income country (LMIC', 'rural Chinese primary care facilities', ""China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages"", '34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio']","['family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation', 'comprehensive antibiotic stewardship programme', 'antibiotic stewardship programme']","['proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s', 'specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0337952', 'cui_str': 'Primary care hospital'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",,0.170445,"In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages.
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhuo', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zhitong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joseph Paul', 'Initials': 'JP', 'LastName': 'Hicks', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jinkun', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Haldane', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walley', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds, UK.'}, {'ForeName': 'Yubao', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'National Center for Respiratory Diseases, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, Laboratory of Guangdong-Hong Kong -Macao Great Bay, Guangzhou Medical University, 151 Yanjiang Xi Rd, Guangzhou City, 510120, Guangdong, China. nanshan@vip.163.com.'}]",Trials,['10.1186/s13063-020-04303-4']
392,32398077,Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania.,"BACKGROUND


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


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


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


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


Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.",2020,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"['15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016', 'healthy birth spacing', ""women's access to PPFP in Tanzania""]","['intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services', 'postpartum family planning intervention']","['rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling', 'PPIUD counseling']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",15264.0,0.213227,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Pearson', 'Affiliation': 'Ipas, Chapel Hill, NC, USA. pearsone@ipas.org.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Senderowicz', 'Affiliation': 'University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pradhan', 'Affiliation': 'World Bank, Washington, DC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Family Medicine and Primary Care, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Projestine', 'Initials': 'P', 'LastName': 'Muganyizi', 'Affiliation': 'Association of Gynaecologists and Obstetricians of Tanzania (AGOTA), Dar es Salaam, Tanzania.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",BMC women's health,['10.1186/s12905-020-00956-0']
393,32398091,A randomised controlled crossover trial investigating the short-term effects of different types of vegetables on vascular and metabolic function in middle-aged and older adults with mildly elevated blood pressure: the VEgetableS for vaScular hEaLth (VESSEL) study protocol.,"BACKGROUND


A diet rich in fruits and vegetables is recommended for cardiovascular health. However, the majority of Australians do not consume the recommended number of vegetable servings each day. Furthermore, intakes of vegetables considered to have the greatest cardiovascular benefit are often very low. Results from prospective observational studies indicate that a higher consumption of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower) is associated with lower cardiovascular disease risk. This may be due to the presence of specific nutrients and bioactive compounds found almost exclusively, or at relatively high levels, in cruciferous vegetables. Therefore, the aim of this randomised controlled crossover trial is to determine whether regular consumption of cruciferous vegetables results in short-term improvement in measures related to cardiovascular disease risk, including ambulatory blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation.
METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period. During the intervention period, participants will consume 4 servings (~ 300 g) of cruciferous vegetables per day as a soup (~ 500-600 mL/day). The 'control' soup will consist of other commonly consumed vegetables (potato, sweet potato, carrot, pumpkin). Both soups will be approximately matched for energy, protein, fat, and carbohydrate content. All measurements will be performed at the beginning and end of each intervention period.
DISCUSSION


The findings of this study will provide evidence regarding the potential cardiometabolic health benefits of cruciferous vegetables, which may contribute to the revision of dietary and clinical guidelines.
TRIAL REGISTRATION


The trial was registered with the Australian New Zealand Clinical Trial Registry on 19th September 2019 (ACTRN12619001294145).",2020,"METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period.","['Twenty-five participants (50-75\u2009years) with mildly elevated blood pressure (systolic blood pressure 120-160\u2009mmHg', 'middle-aged and older adults with mildly elevated blood pressure']","['cruciferous vegetables', 'regular consumption of cruciferous vegetables']","['vascular and metabolic function', 'ambulatory blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0453113', 'cui_str': 'Brassica vegetable'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",25.0,0.0701994,"METHODS


Twenty-five participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week intervention periods in random order, separated by a 2-week washout period.","[{'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Connolly', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Radavelli-Bagatini', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Croft', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Boyce', 'Affiliation': 'Centre for Integrative Metabolomics and Computational Biology, School of Science, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'James', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Reindolf', 'Initials': 'R', 'LastName': 'Anokye', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Seng Khee', 'Initials': 'SK', 'LastName': 'Gan', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Schultz', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Mithen', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Blekkenhorst', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Royal Perth Hospital Research Foundation, Rear 50, Murray Street, Joondalup, Perth, WA, 6000, Australia. l.blekkenhorst@ecu.edu.au.'}]",Nutrition journal,['10.1186/s12937-020-00559-3']
394,32398130,Evaluation of a communication skills training to facilitate addressing palliative care related topics in advanced cancer patients: study protocol of a multicenter randomized controlled trial (PALLI-KOM).,"BACKGROUND


Early integration of palliative care concurrently to standard cancer care is associated with several benefits for patients and their caregivers. However, communication barriers on part of the caring physicians often impede a timely referral to palliative care. This study describes the protocol of the evaluation of a communication skills training aiming to strengthen the ability of physicians to address palliative care related topics adequately and early during disease trajectory.
METHODS


We will implement a communication skills training and evaluate it within a prospective, multi-centered, two-armed randomized controlled trial (RCT), which will be conducted at four sites in Germany. Eligible subjects are all physicians treating patients with advanced cancer in their daily routine. An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection. At pre- and post-measurement points, participants will conduct videotaped conversations with standardized simulated patients (SP). Primary outcome will be the external rating of communication skills and consulting competencies addressing palliative care related topics. Secondary outcomes on core concepts of palliative care, basic knowledge, attitudes, confidence and self-efficacy will be assessed by standardized questionnaires and self-developed items. A further external assessment of the quality of physician-patient-interaction will be conducted by the SP. Longitudinal quantitative data will be analyzed using covariate-adjusted linear mixed-models.
DISCUSSION


If the communication skills training proves to be effective, it will provide a feasible intervention to promote an earlier communication of palliative care related topics in the care of advanced cancer patients. This would help to further establish early integration of palliative care as it is recommended by national and international guidelines.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00017025 (date of registration: 4 June 2019).",2020,An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection.,"['advanced cancer patients', 'patients and their caregivers', 'Eligible subjects are all physicians treating patients with advanced cancer in their daily routine']",['communication skills training'],"['core concepts of palliative care, basic knowledge, attitudes, confidence and self-efficacy will be assessed by standardized questionnaires and self-developed items', 'external rating of communication skills and consulting competencies addressing palliative care related topics']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]",,0.0914104,An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection.,"[{'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Harnischfeger', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. n.harnischfeger@uke.de.'}, {'ForeName': 'Hilke M', 'Initials': 'HM', 'LastName': 'Rath', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Ullrich', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Alt-Epping', 'Affiliation': 'Department of Palliative Medicine, University Medical Center Goettingen, Goettingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Letsch', 'Affiliation': 'Department of Hematology, Oncology and Tumor Immunology, Campus Kiel, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Medical Department, Division of Hematology, Oncology and Tumor Immunology, Campus Virchow Clinic, Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Oechsle', 'Affiliation': 'Department of Oncology, Hematology and BMT, Palliative Care Unit, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bergelt', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMC palliative care,['10.1186/s12904-020-00568-3']
395,32398149,Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study.,"BACKGROUND


Shared decision making (SDM) implementation remains challenging. The factors that promote or hinder implementation of SDM tools for use during the consultation, including contextual factors such as clinician burnout and organizational support, remain unclear. We explored these factors in the context of a practical multicenter randomized trial evaluating the effectiveness of an SDM conversation tool for patients with atrial fibrillation considering anticoagulation therapy.
METHODS


In this cross-sectional study, we recruited clinicians who were regularly involved in conversations with patients regarding anticoagulation for atrial fibrillation. Clinicians reported their characteristics and burnout symptoms using the two-item Maslach Burnout Inventory. Clinicians were trained in using the SDM tool, and they recorded their perceptions of the tool's normalization potential using the Normalization MeAsure Development (NoMAD) survey instrument and verbally reflected on their answers to these survey questions. When possible, the training sessions and clinicians' verbal responses to the conversation tool were recorded.
RESULTS


Our study comprised 183 clinicians recruited into the trial (168 with survey responses and 112 with recordings). Overall, clinicians gave high scores to the normalization potential of the intervention; they endorsed all domains of normalization to the same extent, regardless of site, clinician characteristics, or burnout ratings. In interviews, clinicians paid significant attention to making sense of the tool. Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and ""evidence-based"" and their perceptions of having time in the consultation to use it.
CONCLUSIONS


While time in the consultation remains a barrier, we did not find a significant association between burnout symptoms and normalization of an SDM conversation tool. Possible areas for improving the normalization of SDM conversation tools in clinical practice include enabling collaboration among clinicians to implement the tool and reporting how clinicians elsewhere use the tool. Direct measures of normalization (i.e., observing how often clinicians access the tool in practice outside of the clinical trial) may further elucidate the role that contextual factors, such as clinician burnout, play in the implementation of SDM.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02905032. Registered on 9 September 2016.",2020,"Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and ""evidence-based"" and their perceptions of having time in the consultation to use it.
","['183 clinicians recruited into the trial (168 with survey responses and 112 with recordings', 'patients with atrial fibrillation considering anticoagulation therapy', 'patients with atrial fibrillation', 'recruited clinicians who were regularly involved in conversations with patients regarding anticoagulation for atrial fibrillation']",['SDM conversation tool'],[],"[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0566061', 'cui_str': 'Does make conversation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",[],183.0,0.0285299,"Tool buy-in seemed to depend heavily on their ability to see the tool as accurate and ""evidence-based"" and their perceptions of having time in the consultation to use it.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Spencer-Bonilla', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Thota', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Organick', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Ponce', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kunneman', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Giblon', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Branda', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Sivly', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Behnken', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'May', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA. montori.victor@mayo.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04305-2']
396,32398160,"Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study.","BACKGROUND


Studies have shown disparate results on the consequences of morphine use in ST-segment elevation myocardial infarction (STEMI). No study has evaluated alternative treatments that could be at least non-inferior to morphine without its potentially damaging consequences for myocardial function and platelet reactivity. The aim of this study was to evaluate whether nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A) is non-inferior to morphine to control chest pain in STEMI patients.
METHODS


This multicenter, open-label, cluster-randomized, controlled, non-inferiority study compared NOO-A with morphine in 684 prehospital patients with ongoing suspected STEMI of < 12 h duration and a pain rating score ≥ 4. The primary endpoint was the proportion of patients achieving pain relief (numeric rating score ≤ 3) after 30 min. Secondary safety endpoints included serious adverse events and death at 30 days.
RESULTS


The median baseline pain score was 7.0 in both groups. The primary endpoint occurred in 51.7% of the NOO-A group and 73.6% of the morphine group (absolute risk difference - 21.7%; 95% confidence interval - 29.6 to - 13.8). At 30 days, the rate of serious adverse events was 16.0 and 18.8% in the NOO-A and morphine groups respectively (p = NS). The rate of death was 1.8% (NOO-A group) and 3.8% (morphine group) (p = NS).
CONCLUSION


Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting. Rates of serious adverse events did not differ between groups.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02198378.",2020,Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting.,"['684 prehospital patients with ongoing suspected STEMI of <\u200912\u2009h duration and a pain rating score\u2009≥\u20094', 'STEMI patients', 'ST elevation myocardial infarction']","['nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A', 'NOO-A with morphine', 'Nitrous oxide/oxygen plus acetaminophen', 'morphine']","['rate of death', 'proportion of patients achieving pain relief (numeric rating score', 'median baseline pain score', 'serious adverse events and death at 30\u2009days', 'rate of serious adverse events', 'Rates of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",684.0,0.243387,Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting.,"[{'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Charpentier', 'Affiliation': 'Emergency Department, Toulouse University Hospital, INSERM UMR 1027, University Toulouse III Paul Sabatier, Toulouse, France. charpentier.s@chu-toulouse.fr.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinski', 'Affiliation': 'Emergency Department - SAMU 33, CHU de Bordeaux; INSERM U1219 - Injury Epidemiology Transport Occupation"" team, University Bordeaux II, 33000, Bordeaux, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bounes', 'Affiliation': 'SAMU31, Toulouse University Hospital; University Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Ricard-Hibon', 'Affiliation': 'Pôle Emergency Department, SAMU - Centre Hospitalier René Dubos Pontoise, 95300, Pontoise, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'El-Khoury', 'Affiliation': 'Emergency Department and RESCUe Network, Lucien Hussel Hospital, Vienne, France.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Department of Cardiology, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Ageron', 'Affiliation': 'Emergency Department, Centre Hospitalier Annecy Genevois, Annecy, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Manzo-Silberman', 'Affiliation': 'Cardiology department, Lariboisire Hospital, APHP, Paris, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Soulat', 'Affiliation': 'SAMU 35 SMUR Urgences adultes, Centre Hospitalier Universitaire Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'SAMU 93 - UF Recherche-Enseignement-Qualité Université Paris 13, Sorbonne Paris Cité, Inserm U942 Hôpital Avicenne, AP-HP, 125, rue de Stalingrad, 93009, Bobigny, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gérard', 'Affiliation': ""Hospices Civils de Lyon SAMU 69 - Hôpital Édouard HERRIOT 5, place d'Arsonval, 69437, LYON Cedex 03, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Bregeaud', 'Affiliation': 'Hospital Centre of Chateauroux, Chateauroux, France.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Bongard', 'Affiliation': 'Department of Epidemiology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bonnefoy-Cudraz', 'Affiliation': 'Hôpital cardiologique Louis-Pradel, 69500, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Scandinavian journal of trauma, resuscitation and emergency medicine",['10.1186/s13049-020-00731-y']
397,32398199,First-line tuberculosis treatment with double-dose rifampicin is well tolerated.,"OBJECTIVE:  To compare the occurrence of unfavourable treatment and safety outcomes of double-dose rifampicin (RMP; 20 mg/kg/d, intervention) with standard dose (10 mg/kg/d, control) in a first-line tuberculosis (TB) treatment regimen for smear-positive TB patients in Bangladesh. DESIGN:  This was a randomised clinical trial. The primary efficacy and safety endpoints were the occurrence of an unfavourable treatment outcome (death, failure, relapse or loss to follow-up) and the occurrence of any serious drug-related adverse event (SAE). RESULTS:  In primary efficacy analysis, among 343 control and 347 intervention patients, respectively 15.5% and 11.8% had an unfavourable outcome. In safety analysis, among 349 intervention and 352 control patients, respectively 4.3% and 2.6% experienced an SAE. These differences were not significant. There was a significantly lower occurrence of SAEs, explained by a lower occurrence of hepatic toxicity, in a RMP double-dosed but erroneously HZE (isoniazid+pyrazinamide+ethambutol) under-dosed subgroup. CONCLUSIONS:  Our findings show that there is no statistically significant difference in terms of efficacy and safety between standard and double-dose RMP. An accidental finding (related to dosage levels of the standard regimen) suggests that high-dose RMP is potentially a lesser cause of hepatotoxicity. Larger trials with more power, or trials with at least a triple-dose might be needed to clearly see the effect of high-dose RMP on unfavourable outcomes.",2020,"There was a significantly lower occurrence of SAEs, explained by a lower occurrence of hepatic toxicity, in a RMP double-dosed but erroneously HZE (isoniazid+pyrazinamide+ethambutol) under-dosed subgroup.",['smear-positive TB patients in Bangladesh'],"['double-dose rifampicin (RMP', 'rifampicin']","['occurrence of an unfavourable treatment outcome (death, failure, relapse or loss to follow-up) and the occurrence of any serious drug-related adverse event (SAE', 'hepatic toxicity', 'tolerated', 'efficacy and safety']","[{'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0348754', 'cui_str': 'Toxic liver disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.278209,"There was a significantly lower occurrence of SAEs, explained by a lower occurrence of hepatic toxicity, in a RMP double-dosed but erroneously HZE (isoniazid+pyrazinamide+ethambutol) under-dosed subgroup.","[{'ForeName': 'A K J', 'Initials': 'AKJ', 'LastName': 'Maug', 'Affiliation': 'Damien Foundation Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Hossain', 'Affiliation': 'Damien Foundation Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gumusboga', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Decroo', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Research Foundation Flanders, Brussels.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Mulders', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Braet', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buyze', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arango', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schurmans', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Herssens', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Demeulenaere', 'Affiliation': 'Damien Foundation Bangladesh, Brussels, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lynen', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'de Jong', 'Affiliation': 'Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Van Deun', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, The Union, Paris, France.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0063']
398,32398341,Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol.,"INTRODUCTION


Bloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.
METHODS AND ANALYSIS


We will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors ( Staphylococcus aureus ,  Staphylococcus lugdunensis ,  Candida  and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.
ETHICS AND DISSEMINATION


The study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.
TRIAL REGISTRATION NUMBER


The BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).",2020,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","['patients with blood cultures confirming a pathogenic bacterium after hospital admission', 'hospitalised patients with bloodstream infections', '3626 patients across 60 hospitals and 6 countries', 'patients admitted to hospital']","['antibiotic treatment', 'placebo']","['Antibiotic Length', 'hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms', '90-day survival', 'non-inferiority margin of 4% absolute mortality', 'Bacteremia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0741103', 'cui_str': 'Allergy to antibiotic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",3626.0,0.403099,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases & Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada Nick.Daneman@sunnybrook.ca.'}, {'ForeName': 'Asgar H', 'Initials': 'AH', 'LastName': 'Rishu', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra L', 'Initials': 'RL', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Departments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': 'Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Royal Columbian Hospital, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Melborne, Victoria, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038300']
399,32398420,Omalizumab and other biologics in drug desensitization.,"PURPOSE OF REVIEW


Omalizumab has been proposed for controlling adverse reactions during drug desensitization. Our aim is to know the current evidence involving the use of omalizumab in drug-allergy desensitization.
RECENT FINDINGS


Drug-allergy desensitization is not risk free, but it is a useful procedure and has been applied for drug hypersensitivity reactions with mast cells degranulation through IgE and non-IgE mechanisms. Since 2007, omalizumab has been considered as a potential strategy to prevent adverse reactions.Our review found few case reports and only one randomized double-blind, placebo-controlled study, using different omalizumab regimens prior to drug desensitization. This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies.
SUMMARY


Omalizumab or other IgE-targeting biologics, either a fixed dose of 300 mg omalizumab or a dose-related total IgE level and body mass weight may be an option for patients with IgE-mediated or mast cell drug reactions in troublesome desensitization.",2020,"This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies.
",[],"['omalizumab', 'Omalizumab', 'placebo']",[],[],"[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.217773,"This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernandez', 'Affiliation': 'Allergy Section, Alicante General University Hospital, ISABIAL-UMH.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ruano-Zaragoza', 'Affiliation': 'Allergy Section, Alicante General University Hospital, Alicante.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Blanca-Lopez', 'Affiliation': 'Allergy Service, Infanta Leonor University Hospital.'}]",Current opinion in allergy and clinical immunology,['10.1097/ACI.0000000000000648']
400,32398433,"High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial.","BACKGROUND


Over 6 million esophagogastroduodenoscopy (EGD) procedures are performed in the United States each year. Patients having anesthesia for advanced EGD procedures, such as interventional procedures, are at high risk for hypoxemia.
METHODS


Our primary study aim was to evaluate whether high-flow nasal cannula (HFNC) oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD. Secondarily, we studied whether HFNC oxygen reduces hypercarbia or hypotension. After obtaining written informed consent, adults having anesthesia for advanced EGD, expected to last longer than 15 minutes, were randomly assigned to receive HFNC oxygen or standard nasal cannula (SNC) oxygen. The primary outcome was occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation <92% for at least 15 consecutive seconds. Secondary outcomes were occurrence of one or more hypercarbia or hypotension events. A hypercarbia event was defined by a transcutaneous CO2 measurement 20 mm Hg or more above baseline, and a hypotension event was defined by a mean arterial blood pressure measurement 25% or more below baseline.
RESULTS


Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures. Eight randomized patients did not complete study procedures due to changes in their anesthesia or endoscopy plan. One patient was excluded from analysis because their procedure was aborted after 1 minute. Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03). There was no difference in the incidence of hypercarbia or hypotension between the groups. The HR for hypercarbia with HFNC oxygen was 1.29 (95% CI, 0.89-1.88; P = .17), and the HR for hypotension was 1.25 (95% CI, 0.86-1.82; P = .25).
CONCLUSIONS


HFNC oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD and may offer an opportunity to enhance patient safety during these procedures.",2020,"Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03).","['adults having anesthesia for advanced EGD, expected to last longer than 15 minutes', 'Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures', 'Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy']","['HFNC oxygen or standard nasal cannula (SNC) oxygen', 'High-Flow Nasal Cannula Oxygen', 'high-flow nasal cannula (HFNC) oxygen', 'HFNC oxygen']","['hypotension event', 'occurrence of one or more hypercarbia or hypotension events', 'occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation', 'incidence of hypoxemia', 'incidence of hypercarbia or hypotension', 'hypercarbia or hypotension', 'HR for hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",271.0,0.426427,"Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Mazzeffi', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Petrick', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Greenwald', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Darwin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Goldberg', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bigeleisen', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Chow', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Kaplowitz', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rock', 'Affiliation': 'From the Department of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004837']
401,31818057,Effects of cardioselective beta-blockade on plasma catecholamines and performance during different forms of exercise.,"BACKGROUND


Beta-blockers are still frequently used in cardiovascular diseases but may negatively influence the exercise capacity. The aim of the study was to analyze the effect of beta-blockade on physical performance and plasma level of catecholamine during different forms of exercise.
METHODS


Ten prehypertensive athletes (age: 25.1±2.5 years, BMI: 24.4±2.4 kg/m2) performed repeated incremental exercise and steady-state-tests without and with the cardioselective beta-blocker bisoprolol (5mg/day). The cardiopulmonary, metabolic and the catecholamine responses were monitored.
RESULTS


Beta-blocker treatment had no effect on maximum power output (Pmax), lactate and the maximal oxygen uptake (VO2max) (Pmax: 269.0±41.5 vs. 269.0±41.5 W; lactate: 8.7±2.6 vs. 8.6±3.2 mmol/L and VO2max: 3110±482 vs. 3077±425 mL/min, respectively; P not significant). Epinephrine and norepinephrine showed a similar exponential increase to maximum load with and without beta-blockade (epinephrinemax 1.92±1.8 vs. 1.93±1.3 nmol/L; P not significant; norepinephrinemax 12.78±7.9 vs. 16.89±12.2 nmol/L; P not significant). Beta-blockade lowered heart rate (HR) and systolic blood pressure (SBP) at rest and under maximum load (ΔHRrest: 10.6±11.1 bpm, P<0.05, ΔHR-Max: 27.8±6.6 bpm, P<0.01; ΔSBPrest: 19.4±9.3 mmHg, P<0.05, ΔSBPmax: 17.7±15.3 mmHg, P<0.01). The maximum oxygen pulse was higher in the tests performed under beta-blockade (IET: ΔVO2/HR: 3.1±2.2 mL/beat, P<0.01; SST: ΔVO2/HR: 3.4±1.4 mL/beat, P<0.001).
CONCLUSIONS


Despite beta blockade and resulting differences in cardiopulmonary regulation during the exercise tests, the maximal oxygen capacity and the catecholamine concentration was similar. Higher exercise intensities (>50% Pmax) are associated with a marked increase in plasma catecholamines, which are not influenced by treatment with bisoprolol 5 mg/day.",2020,Beta-blockade lowered heart rate (HR) and systolic blood pressure (SBP) at rest and under maximum load,['Ten prehypertensive athletes (age: 25.1±2.5 years'],"['cardioselective beta-blockade', 'incremental exercise and steady-state-tests without and with the cardioselective beta-blocker bisoprolol', 'Epinephrine and norepinephrine', 'VO2max', 'beta-blockade']","['physical performance and plasma level of catecholamine', 'Higher exercise intensities', 'maximal oxygen capacity and the catecholamine concentration', 'maximum oxygen pulse', 'plasma catecholamines and performance', 'maximum power output (Pmax), lactate and the maximal oxygen uptake (VO2max', 'plasma catecholamines', 'Beta-blockade lowered heart rate (HR) and systolic blood pressure (SBP) at rest and under maximum load']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0304516', 'cui_str': 'Beta-1 adrenergic receptor antagonist'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0857652', 'cui_str': 'Plasma catecholamines'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0443144', 'cui_str': 'At rest'}]",10.0,0.0615573,Beta-blockade lowered heart rate (HR) and systolic blood pressure (SBP) at rest and under maximum load,"[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Fikenzer', 'Affiliation': 'Cardiology Clinic and Polyclinic Hospital, Leipzig University Hospital, Leipzig, Germany - fikenzer@rz.uni-leipzig.de.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Fikenzer', 'Affiliation': 'Cardiology Clinic and Polyclinic Hospital, Leipzig University Hospital, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Cardiology Clinic and Polyclinic Hospital, Leipzig University Hospital, Leipzig, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institute of Sport Medicine and Prevention, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Antina', 'Initials': 'A', 'LastName': 'Schulze', 'Affiliation': 'Institute of Sport Medicine and Prevention, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institute of Sport Medicine and Prevention, University of Leipzig, Leipzig, Germany.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10225-3']
402,30652973,Targeting protein disulfide isomerase with the flavonoid isoquercetin to improve hypercoagulability in advanced cancer.,"BACKGROUND


Protein disulfide isomerase (PDI) is a thiol isomerase secreted by vascular cells that is required for thrombus formation. Quercetin flavonoids inhibit PDI activity and block platelet accumulation and fibrin generation at the site of a vascular injury in mouse models, but the clinical effect of targeting extracellular PDI in humans has not been studied.
METHODS


We conducted a multicenter phase II trial of sequential dosing cohorts to evaluate the efficacy of targeting PDI with isoquercetin to reduce hypercoagulability in cancer patients at high risk for thrombosis. Patients received isoquercetin at 500 mg (cohort A, n = 28) or 1000 mg (cohort B, n = 29) daily for 56 days, with laboratory assays performed at baseline and the end of the study, along with bilateral lower extremity compression ultrasound. The primary efficacy endpoint was a reduction in D-dimer, and the primary clinical endpoint included pulmonary embolism or proximal deep vein thrombosis.
RESULTS


The administration of 1000 mg isoquercetin decreased D-dimer plasma concentrations by a median of -21.9% (P = 0.0002). There were no primary VTE events or major hemorrhages observed in either cohort. Isoquercetin increased PDI inhibitory activity in plasma (37.0% in cohort A, n = 25, P < 0.001; 73.3% in cohort B, n = 22, P < 0.001, respectively). Corroborating the antithrombotic efficacy, we also observed a significant decrease in platelet-dependent thrombin generation (cohort A median decrease -31.1%, P = 0.007; cohort B median decrease -57.2%, P = 0.004) and circulating soluble P selectin at the 1000 mg isoquercetin dose (median decrease -57.9%, P < 0.0001).
CONCLUSIONS


Isoquercetin targets extracellular PDI and improves markers of coagulation in advanced cancer patients.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02195232.
FUNDING


Quercegen Pharmaceuticals; National Heart, Lung, and Blood Institute (NHLBI; U54HL112302, R35HL135775, and T32HL007917); and NHLBI Consortium Linking Oncology and Thrombosis (U01HL143365).",2019,The administration of 1000 mg isoquercetin decreased D-dimer plasma concentrations by a median of -21.9% (P = 0.0002).,"['advanced cancer patients', 'advanced cancer', 'cancer patients at high risk for thrombosis']","['flavonoid isoquercetin', 'PDI with isoquercetin', 'isoquercetin']","['PDI inhibitory activity in plasma', 'platelet-dependent thrombin generation', 'major hemorrhages', 'antithrombotic efficacy', 'circulating soluble P selectin', 'D-dimer plasma concentrations', 'reduction in D-dimer, and the primary clinical endpoint included pulmonary embolism or proximal deep vein thrombosis']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C3891959', 'cui_str': 'isoquercetin'}, {'cui': 'C0072354', 'cui_str': 'Protein disulfide-isomerase'}]","[{'cui': 'C0072354', 'cui_str': 'Protein disulfide-isomerase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",,0.426744,The administration of 1000 mg isoquercetin decreased D-dimer plasma concentrations by a median of -21.9% (P = 0.0002).,"[{'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Zwicker', 'Affiliation': 'Division of Hemostasis and Thrombosis and.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Schlechter', 'Affiliation': 'Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Stopa', 'Affiliation': 'Division of Hemostasis and Thrombosis and.'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Liebman', 'Affiliation': 'Jane Anne Nohl Division of Hematology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Caughey', 'Affiliation': 'Mount Auburn Hospital, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': 'Division of Hemostasis and Thrombosis and.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Kuemmerle', 'Affiliation': 'White River Junction Veterans Affairs Medical Center, White River Junction, Vermont, USA.'}, {'ForeName': 'Ellice', 'Initials': 'E', 'LastName': 'Wong', 'Affiliation': 'Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Wun', 'Affiliation': 'Division of Hematology Oncology, University of California Davis School of Medicine, VA Northern California Health Care System, Sacramento, California, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'McLaughlin', 'Affiliation': 'York Hospital, York, Maine, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hidalgo', 'Affiliation': 'Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Neuberg', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Furie', 'Affiliation': 'Division of Hemostasis and Thrombosis and.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flaumenhaft', 'Affiliation': 'Division of Hemostasis and Thrombosis and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.125851']
403,31020351,Application of time-dependent modeling for the exposure-efficacy analysis of ceritinib in untreated ALK-rearranged advanced NSCLC patients.,"PURPOSE


Ceritinib 750 mg/day was approved for the treatment of patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) based on ASCEND-4 study. The objective of this article is to introduce the use of time-dependent modeling approach in the updated exposure-efficacy analysis of ceritinib for the first-line indication.
METHODS


Exposure-efficacy analyses, including data from 156 patients, were first conducted using time-independent logistic regression model for response of complete or partial response and Cox regression model for progression-free survival (PFS). The exposure measure used was average C trough , which is defined as the geometric mean of all evaluable C trough  for each patient. To further investigate the impact of exposure measure on exposure-efficacy analyses, a time-dependent modeling approach was used, where exposure at different time intervals was associated with the corresponding response endpoints in a longitudinal manner.
RESULTS


With exposure measure being average C trough , it was observed that higher exposure was associated with reduced efficacy in terms of response (odds ratio = 0.77) and PFS [hazard ratio (HR) = 1.12]. These time-independent models do not account for the impact of time-varying concentration due to dose modifications. Subsequently, a new time-dependent modeling approach was used, where exposure and efficacy were associated longitudinally in the analyses. The results showed that the odds ratio of response became 1.07, and the HR of PFS became 1.04, indicating no apparent reverse relationship between exposure and efficacy across the exposure range studied.
CONCLUSION


The drug effect on efficacy in clinical trials could be better characterized using time-dependent exposure-response models.",2019,"The results showed that the odds ratio of response became 1.07, and the HR of PFS became 1.04, indicating no apparent reverse relationship between exposure and efficacy across the exposure range studied.
","['156 patients', 'patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) based on ASCEND-4 study', 'untreated ALK-rearranged advanced NSCLC patients']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",[],[],,0.0316417,"The results showed that the odds ratio of response became 1.07, and the HR of PFS became 1.04, indicating no apparent reverse relationship between exposure and efficacy across the exposure range studied.
","[{'ForeName': 'Yvonne Y', 'Initials': 'YY', 'LastName': 'Lau', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. yvonne.lau@novartis.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Yu-Yun', 'Initials': 'YY', 'LastName': 'Ho', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03830-5']
404,32393654,Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction.,"OBJECTIVE


To test whether intensive atorvastatin (ATV) increases the efficacy of transplantation with autologous bone marrow mononuclear cells (MNCs) in patients suffering from anterior ST-elevated myocardial infarction (STEMI).
METHODS


This clinical trial was under a 2×2 factorial design, enrolling 100 STEMI patients, randomly into four groups of regular (RA) or intensive ATV (IA) with MNCs or placebo. The primary endpoint was the change of left ventricular ejection fraction (LVEF) at 1-year follow-up from baseline, primarily assessed by MRI. The secondary endpoints included other parameters of cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers.
RESULTS


All the STEMI patients with transplantation of MNCs showed significantly increased LVEF change values than those with placebo (p=0.01) with only in the IA+MNCs patients group demonstrating significantly elevation of LVEF than in the IA+placebo group (+12.6% (95%CI 10.4 to 19.3) vs +5.0% (95%CI 4.0 to 10.0), p=0.001), pointing to a better synergy between ATV and MNCs (p=0.019). PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced. All these above benefits of MNCs were also attributed to IA+MNCs instead of RA+MNCs group of patients with STEMI.
CONCLUSIONS


Intensive ATV treatment augments the therapeutic efficacy of MNCs in patients with anterior STEMI at the convalescent stage. The treatment with the protocol of intensive ATV and MNC combination offers a clinically essential approach for myocardial infarction.
TRIAL REGISTRATION NUMBER


NCT00979758.",2020,"PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced.","['acute myocardial infarction', 'enrolling 100 STEMI patients', 'patients with anterior STEMI at the convalescent stage', 'patients suffering from anterior ST-elevated myocardial infarction (STEMI']","['IA+placebo', 'autologous bone marrow mononuclear cells (MNCs', 'intensive atorvastatin (ATV', 'regular (RA) or intensive ATV (IA) with MNCs or placebo', 'bone marrow mononuclear cells with intensive atorvastatin', 'intensive ATV and MNC combination', 'placebo']","['viable areas of myocardium', 'LVEF change values', 'cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers', 'blood aminoterminal pro-B-type natriuretic peptide', 'elevation of LVEF', 'scar sizes', 'change of left ventricular ejection fraction (LVEF', 'therapeutic efficacy of MNCs']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0210243', 'cui_str': 'atevirdine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}]","[{'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0565965', 'cui_str': 'Change values'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}]",100.0,0.276779,"PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced.","[{'ForeName': 'Yue-Jin', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yangyjfw@126.com.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Geng', 'Affiliation': 'The Center for Cardiovascular Biology and Atherosclerosis, Department of Internal Medicine, University of Texas McGovern School of Medicine at Houston, Houston, Texas, USA.'}, {'ForeName': 'Run-Lin', 'Initials': 'RL', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Center for Cardiac Critical Care, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Xia-Qiu', 'Initials': 'XQ', 'LastName': 'Tian', 'Affiliation': 'Center for Cardiac Critical Care, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Pei-Sen', 'Initials': 'PS', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Nuclear Medicine, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Lu', 'Affiliation': 'Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shi-Hua', 'Initials': 'SH', 'LastName': 'Zhao', 'Affiliation': 'Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Echocardiography, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, Center for Coronary Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Open heart,['10.1136/openhrt-2019-001139']
405,32393728,Comparison of Cardioprotective Effects of Propofol versus Sevoflurane in Pediatric Living Donor Liver Transplantation.,"BACKGROUND Our study compared the myocardiac protective effect of propofol vs. sevoflurane in pediatric patients receiving living donor liver transplantation (LDLT) surgery. MATERIAL AND METHODS We randomly and equally divided 120 children who underwent LDLT into a sevoflurane group and a propofol group. Preoperative, intraoperative, and postoperative data were collected and compared between the 2 groups. The concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1 at 5 min after induction (T0), 30 min in the anhepatic period (T1), and 3 h after reperfusion (T2), and at the end of surgery (T3) were measured. RESULTS There was no statistically significant difference in the characteristics of children in the 2 groups. Compared with T0, the levels of IL-6 and TNF-alpha at T1, T2, and T3 were higher, while the HMGB1 at T2 and T3 were higher (P<0.05). A similar trend for IL-6, TNF-alpha, and HMGB1 at different time points in the 2 groups was observed. Compared with T0, the cTnI and CK-MB at T2 and T3 were significantly higher (P<0.05), but there was no significant difference at different time points in the 2 groups. For the adverse events, there was no significant difference between the 2 groups. CONCLUSIONS Our study shows that the cardioprotective effect in pediatric patients undergoing living donor liver transplantation is similar with propofol and sevoflurane anesthesia.",2020,"The concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1 at 5 min after induction (T0), 30 min in the anhepatic period (T1), and 3 h after reperfusion (T2), and at the end of surgery (T3) were measured.","['pediatric patients undergoing living donor liver transplantation', 'Pediatric Living Donor Liver Transplantation', '120 children who underwent', 'pediatric patients receiving living donor liver transplantation (LDLT) surgery']","['propofol', 'sevoflurane anesthesia', 'LDLT', 'Propofol', 'sevoflurane', 'propofol vs. sevoflurane', 'Sevoflurane']","['Preoperative, intraoperative, and postoperative data', 'levels of IL-6 and TNF-alpha', 'IL-6, TNF-alpha, and HMGB1', 'concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}]",120.0,0.0693214,"The concentrations of cTnI, CK-MB, IL-6, TNF-alpha, and HMGB1 at 5 min after induction (T0), 30 min in the anhepatic period (T1), and 3 h after reperfusion (T2), and at the end of surgery (T3) were measured.","[{'ForeName': 'Yiqi', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Shaoting', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Tianjin First Center Hospital, Tianjin, China (mainland).'}]",Annals of transplantation,['10.12659/AOT.923398']
406,32394350,Carboplatin plus taxanes are non-inferior to epirubicin plus cyclophosphamide followed by taxanes as adjuvant chemotherapy for early triple-negative breast cancer.,"PURPOSE


Platinum plays an important role in the treatment of triple-negative breast cancer (TNBC) in neoadjuvant and metastatic settings. However, its role in an adjuvant setting remains unclear.
METHODS


In this non-inferior randomized phase 2 trial, we randomly assigned 308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery to receive either six cycles of TP (docetaxel: 75 mg/m 2  or paclitaxel 175 mg/m 2  d1; carboplatin AUC = 5, day 1), or four cycles of EC (epirubicin: 90 mg/m 2 ; cyclophosphamide: 600 mg/m 2 , day 1) followed by four cycles of T (docetaxel: 75 mg/m 2  or paclitaxel 175 mg/m 2 , day 1). The primary end point was the disease-free survival (DFS) rate at 5 years. Both regimens were repeated every 3 weeks. The prognostic and predictive value of germline breast cancer gene mutations and programmed death ligand-1 (PD-L1) expression was evaluated.
RESULTS


At a median follow-up of 66.9 months, the 5-year DFS rate was 85.8% in the EC-T arm, and 84.4% in the TP arm (p non-inferiority = 0.034, p log-rank = 0.712). The 5-year overall survival (OS) rate was 94.4% in the EC-T arm and 93.5% in the TP arm (p = 0.770). Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm. Patients with PD-L1 expressing tumors showed significantly improved DFS and OS.
CONCLUSIONS


This study indicates that carboplatin plus taxanes could be a feasible adjuvant chemotherapy for patients with early TNBC who are cannot tolerate intensive chemotherapy with anthracycline.",2020,"Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm.","['patients with early TNBC who are cannot tolerate intensive chemotherapy with', 'early triple-negative breast cancer', '308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery']","['carboplatin plus taxanes', 'cyclophosphamide', 'TP (docetaxel: 75\xa0mg/m 2  or paclitaxel 175\xa0mg/m 2  d1; carboplatin AUC', 'T (docetaxel: 75\xa0mg/m 2  or paclitaxel', 'epirubicin plus cyclophosphamide', 'Carboplatin plus taxanes', 'EC (epirubicin', 'anthracycline']","['5-year DFS rate', '5-year overall survival (OS) rate', 'frequencies of G3/4 neutrocytopenia and G3/4 alopecia', 'rates of G1-4 thrombocytopenia', 'DFS and OS', 'disease-free survival (DFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",308.0,0.0638024,"Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Du', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wenmiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shandong Cancer Hospital/Institute, Jinan, 250117, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, 101100, China.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Zhu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Todorovic', 'Affiliation': 'Clinical Centre of MontenegroClinic for Oncology and Radiotherapy, Podgorica, Montenegro.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. yuanpeng01@hotmail.com.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xubingheBM@163.com.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05648-9']
407,32394438,Efficacy of a fasting-mimicking diet in functional therapy for depression: A randomised controlled pilot trial.,"OBJECTIVE


This randomized controlled trial examined the efficacy of adding a fasting-mimicking diet to a structured psychotherapy protocol for treating depression.
DESIGN


Of 20 patients with depression, 10 were randomly assigned to psychotherapy and dieting (i.e., experimental group) and the other 10 to psychotherapy only (i.e., control group). Patients in both groups received 20 individual sessions of functional therapy along with nutrition consultation. Patients in the control group were instructed to maintain their usual daily diets.
RESULTS


Both treatments were effective in reducing depression as well as increasing self-esteem and quality of life. The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group.
CONCLUSIONS


The study revealed initial evidence of the efficacy of combining psychotherapy with a fasting-mimicking diet to treat depression and its correlates.",2020,"The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group.
","['depression', '20 patients with depression']","['fasting-mimicking diet', '20 individual sessions of functional therapy along with nutrition consultation', 'fasting-mimicking diet to a structured psychotherapy protocol']","['self-esteem and psychological quality of life', 'self-esteem and quality of life']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",20.0,0.0355997,"The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Maniaci', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'La Cascia', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Giammanco', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ferraro', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Chianetta', 'Affiliation': 'Department of Health Promotion, Mother, and Child Care, Internal Medicine and Medical Specialties, (PROMISE), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Di Peri', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Zaira', 'Initials': 'Z', 'LastName': 'Sardella', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Citarrella', 'Affiliation': 'Department of Health Promotion, Mother, and Child Care, Internal Medicine and Medical Specialties, (PROMISE), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Mannella', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Larcan', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Montana', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Mario G', 'Initials': 'MG', 'LastName': 'Mirisola', 'Affiliation': 'Department of Surgical, Oncological, and Oral Sciences, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Longo', 'Affiliation': 'Department of Biological Sciences, Longevity Institute, Davis School of Gerontology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Rizzo', 'Affiliation': 'Department of Health Promotion, Mother, and Child Care, Internal Medicine and Medical Specialties, (PROMISE), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'La Barbera', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}]",Journal of clinical psychology,['10.1002/jclp.22971']
408,32394478,"Pain reduction realized with extracorporeal shock wave therapy for the treatment of symptoms associated with interstitial cystitis/bladder pain syndrome-A prospective, multicenter, randomized, double-blind, placebo-controlled study.","AIMS


Extracorporeal shock wave therapy (ESWT) inhibited bladder inflammation and pain in preclinical studies. We assessed ESWT for the treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS).
METHODS


This double-blind, randomized, placebo-controlled physician-initiated study enrolled 54 patients with IC/BPS. The patients were assigned to ESWT (N = 24; 2000 shocks, frequency of 3 Hz, and maximum total energy flow density 0.25 mJ/mm 2  ) once a week for 4 weeks at suprapubic bladder area or placebo (N = 25; shock wave setting without energy transmission). The primary endpoint was the average changes in O'Leary-Sant symptom scores (OSS) between baseline and 4 weeks after treatment. Secondary endpoints included visual analog scale (VAS, 0-10) for pain, the average changes of variables in a 3-day voiding diary, and global response assessment of patient satisfaction.
RESULTS


At 4 weeks posttreatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. However, there were no difference in mean change between ESWT vs placebo groups. A significantly higher proportion of patients on ESWT responded as improved in the VAS ≥ 3 vs placebo (P = .035). At 12 weeks posttreatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (ESWT vs placebo; P = .011). The finding was associated with an improvement in frequency - 1.0 ± 2.3 vs 0.7 ± 3.2 (ESWT vs placebo; P = .065). No significant adverse events were found in either group.
CONCLUSIONS


A reduction in pain was discovered in this trial assessing ESWT in patients with IC/BPS but OSS, which was the primary outcome parameter, was not improved.",2020,"No significant adverse events were found in either group.
","['54 patients with IC/BPS', 'symptoms associated with interstitial cystitis/bladder pain syndrome', 'refractory interstitial cystitis/bladder pain syndrome (IC/BPS']","['extracorporeal shock wave therapy', 'Extracorporeal shock wave therapy (ESWT', 'ESWT', 'ESWT vs placebo', 'placebo']","[""average changes in O'Leary-Sant symptom scores (OSS"", 'VAS\u2009≥', 'adverse events', 'pain', 'visual analog scale (VAS, 0-10) for pain, the average changes of variables in a 3-day voiding diary, and global response assessment of patient satisfaction', 'OSS and VAS pain scale', 'Pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449206', 'cui_str': 'OSS'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",54.0,0.673396,"No significant adverse events were found in either group.
","[{'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Chuang', 'Affiliation': 'Department of Urology, Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan City, Taiwan.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Meng', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chancellor', 'Affiliation': 'Department of urology, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.'}, {'ForeName': 'Hann-Chorng', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Urology, Hualien Tzu Chi General Hospital, Tzu Chi Medical Foundation, Buddhist Tzu Chi University, Hualien, Taiwan.'}]",Neurourology and urodynamics,['10.1002/nau.24382']
409,32394496,A preliminary study on the effectiveness of a stress management program for healthcare-related undergraduates with at-risk mental state.,"PURPOSE


This study aimed to examine the effects of a stress management program on stress perception and coping strategies for healthcare-related undergraduates with at-risk mental state (ARMS).
DESIGN AND METHODS


A randomized experimental design with pretest and posttest was used. Of the 2812 students screened, 65 were identified as having ARMS, 52 enrolled in the study, and 49 (75%) completed the study.
FINDINGS


Significance was found for subjects with schizotypal traits in emotion expression and problem-avoidance coping strategies. Subjects with trait anxiety improved significantly in interpersonal deficits after the program.
PRACTICE IMPLICATIONS


Students with different trait risks reported benefits in different stress-coping strategies from the program.",2020,"FINDINGS


Significance was found for subjects with schizotypal traits in emotion expression and problem-avoidance coping strategies.","['2812 students screened, 65 were identified as having ARMS, 52 enrolled in the study, and 49 (75%) completed the study', 'healthcare-related undergraduates with at-risk mental state (ARMS', 'healthcare-related undergraduates with at-risk mental state', 'subjects with schizotypal traits in emotion expression and problem-avoidance coping strategies']",['stress management program'],"['interpersonal deficits', 'stress perception and coping strategies']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",,0.0160177,"FINDINGS


Significance was found for subjects with schizotypal traits in emotion expression and problem-avoidance coping strategies.","[{'ForeName': 'Fong-Gang', 'Initials': 'FG', 'LastName': 'Wang', 'Affiliation': 'Department of Forensic Psychiatry, Changhua Christian Hospital, Changhua City, Taiwan.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Lou', 'Affiliation': 'Department of Public Health (in Nursing), China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Siang-Han', 'Initials': 'SH', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Wen-Jiuan', 'Initials': 'WJ', 'LastName': 'Yen', 'Affiliation': 'School of Nursing, Chung-Shan Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Ching-Lun', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Department of Public Health (in Epidemiology and Preventive Medicine), China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Wei-Fen', 'Initials': 'WF', 'LastName': 'Ma', 'Affiliation': 'School of Nursing, China Medical University, Taichung City, Taiwan.'}]",Perspectives in psychiatric care,['10.1111/ppc.12528']
410,32394601,"Re: Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial: At which gestational ages should magnesium sulphate be given to women at risk of preterm birth?",,2020,,['infants born preterm'],"['magnesium sulphate', 'placebo']",['cerebral palsy'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]",,0.793615,,"[{'ForeName': 'Mads Langager', 'Initials': 'ML', 'LastName': 'Larsen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Krebs', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital Amager Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Gija', 'Initials': 'G', 'LastName': 'Rackauskaite', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Christina Engel', 'Initials': 'CE', 'LastName': 'Hoei-Hansen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16268']
411,32394625,"Corrigendum to ""Models of Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval for Healthy Subjects Who Received Placebo in Phase I Trials"".",,2020,,['Healthy Subjects'],['Placebo'],"['Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.0401805,,[],Clinical and translational science,['10.1111/cts.12773']
412,32394657,[Effect of warming acupuncture on uterine blood perfusion in patients with failed high-quality freeze-thawed embryo transfer].,"OBJECTIVE


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


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


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


Warming acupuncture enhances uterine blood perfusion and improves uterine endometrial receptivity so that the clinical pregnancy rate is increased after re-transfer in the patients with failed high-quality freeze-thawed embryo transfer.",2020,"After treatment, the endometrial thickness was increased and PI decreased obviously in the two groups ( P <0.05) and PI in the observation group was lower than that in the control group ( P <0.05).","['A total of 72 patients of failed high-quality FET', 'patients with failed high-quality freeze-thawed embryo transfer', 'patients with failed high-quality freeze-thawed embryo transfer (FET']","['Warming acupuncture', 'warming acupuncture']","['uterine endometrial receptivity', 'clinical pregnancy rate', 'uterine blood flow', 'proportion of ER during the implantation window period', 'proportion of type a and type A of endometrium', 'endometrial thickness', 'recovery time of sufficient uterine blood flow', 'uterine artery pulsation index (PI), endometrial thickness, endometrial type, uterine blood perfusion, the recovery time of sufficient uterine blood flow, the endomentrial receptivity (ER) during the implantation window period and the clinical pregnancy rate', 'uterine blood perfusion']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",72.0,0.0210532,"After treatment, the endometrial thickness was increased and PI decreased obviously in the two groups ( P <0.05) and PI in the observation group was lower than that in the control group ( P <0.05).","[{'ForeName': 'Wen-Wu', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Department of TCM, Foshan Women and Children Health Care Center, Foshan 528000, Guangdong Province, China.'}, {'ForeName': 'Ju-Sheng', 'Initials': 'JS', 'LastName': 'Tian', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Third Affiliated Hospital of Guangzhou University of CM.'}, {'ForeName': 'Xiu-An', 'Initials': 'XA', 'LastName': 'Gao', 'Affiliation': 'Department of TCM, Foshan Women and Children Health Care Center, Foshan 528000, Guangdong Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190504-k0002']
413,32394658,"[Effect of acupuncture on patients with cancer-related fatigue and serum levels of CRP, IL-6, TNF-α and sTNF-R1].","OBJECTIVE


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


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


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


①Acupuncture can improve the related symptoms of depression, weakness and headache in patients with CRF, strengthen their cognition of the support from society and family, and boost the confidence in curing the disease. ②Acupuncture can effectively down-regulate serum levels of the relative inflammatory factors, which may be its possible mechanism on treating CRF.",2020,"The serum levels of CPR, IL-6 and TNF-α in the observation were lower than those in the control group ( P <0.05).
","['patients with CRF', 'patients with cancer-related fatigue and serum levels of CRP, IL-6, TNF-α and sTNF-R1', '80 patients with CRF']","['acupuncture', '①Acupuncture', '②Acupuncture', 'conventional chemoradiotherapy and symptomatic treatment, while no particular anti-fatigue intervention']","['serum levels of CPR and IL-6', 'cancer-related fatigue (CRF', 'related symptoms of depression, weakness and headache', 'scores of functional assessment of cancer therapy-fatigue (FACT-F) in Chinese and McGill quality of life questionnaire (MQOL), serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α) and soluble TNF receptor-1 (sTNF-R1', 'score changes of physiological, psychological and social support dimension', 'score of social support dimension', 'scores of physiological and psychological dimension', 'serum levels of CPR, IL-6 and TNF-α in the observation', 'FACT-F score', 'serum levels of IL-6, TNF-α and sTNF-R1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",80.0,0.0266516,"The serum levels of CPR, IL-6 and TNF-α in the observation were lower than those in the control group ( P <0.05).
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qing', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Jian-Fu', 'Initials': 'JF', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Cang-Huan', 'Initials': 'CH', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Yan-Long', 'Initials': 'YL', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Ke-Jie', 'Initials': 'KJ', 'LastName': 'He', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190423-k0002']
414,32394663,[Application of expertise-based pragmatic randomized controlled trial in acupuncture-moxibustion clinical research].,"According to clinical practice, the characteristics and issues of pragmatic randomized controlled trial(PRCT) and expertise-based randomized controlled trial (EBRCT) in acupuncture-moxibustion clinical research were summarized. The characteristics of expertise-based pragmatic randomized controlled trial (EB-PRCT), which is the combination of above two, and its application in acupuncture-moxibustion clinical trial were explored. PRCT emphasizes the clinical practice, the positive control of standard therapy and the the blind performance on data collection and statistics. PRCT has the advantage of flexible grouping, nevertheless, it also has shortcomings such as higher cost and lack of typical subjects. EBRCT emphasizes the participation of professional acupuncturists, so that the therapeutic effect is ensured, the compliance of subjects and the bias of manipulation are improved. Thus, the replacement scheme of acupuncturists is essential in EBRCT. Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.",2020,"Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.",[],"['acupuncture-moxibustion', 'PRCT']",[],[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],2.0,0.132677,"Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.","[{'ForeName': 'Ze-Gong', 'Initials': 'ZG', 'LastName': 'Xu', 'Affiliation': 'College of Chinese Medicine, Guangzhou University of CM, Guangzhou 510006, Guangdong Province, China.'}, {'ForeName': 'Shu-Qi', 'Initials': 'SQ', 'LastName': 'Ge', 'Affiliation': 'Clinical Medical College of Acupuncture- Moxibustion and Rehabilitation, Guangzhou University of CM, Guangzhou 510006, Guangdong Province, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Lu', 'Affiliation': 'Clinical Medical College of Acupuncture- Moxibustion and Rehabilitation, Guangzhou University of CM, Guangzhou 510006, Guangdong Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190514-0001']
415,32394686,Evaluation of the cardioprotective effects of crystalloid del Nido cardioplegia solution via a rapid and accurate cardiac marker: Heart-type fatty acid-binding protein.,"BACKGROUND/AIM


Our aim in this study was to compare the efficacy and safety of crystalloid del Nido solution and cold blood cardioplegia solution on clinical and laboratory parameters.
MATERIALS AND METHODS


Sixty patients who underwent elective coronary bypass operation between July 2019 and January 2020 were included in our study. Patients were divided into two groups of 30 patients using del Nido solution (DNS) and cold blood cardioplegia solution (CBCS), which were given for cardiac arrest. Demographic data, preoperative, postoperative 0. hour, 6. hour and 4. day Creatine Kinase Myocardial Band (CK-MB) and troponin I values were compared with a specific cardiac enzyme Heart-type fatty acid-binding protein (H-FABP).
RESULTS


We found that aortic cross clamp duration and cardiopulmonary bypass (CPB) time were shorter in patients using del Nido solution than cold blood cardioplegia solution (57.30±23.57 minutes, 76.07±27.18 minutes, p=0.006) (95.07±23.06 minutes, 114.13±33.93, p=0.014). Total cardioplegia solution volume was higher in the cold blood cardioplegia solution group (1426.67±416.00 vs 1200±310.73 p=0.02). Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP were comparable in del Nido solution and cold blood cardioplegia solution groups.
CONCLUSION


According to these results, when we compare both demographic data and CK-MB, Troponin-I and H-FABP levels, both cardioplegia solutions were comparable regarding safety and efficacy in terms of myocardial protection.",2020,"Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP were comparable in del Nido solution and cold blood cardioplegia solution groups.
",['Sixty patients who underwent elective coronary bypass operation between July 2019 and January 2020 were included in our study'],"['del Nido solution (DNS) and cold blood cardioplegia solution (CBCS', 'crystalloid del Nido cardioplegia solution', 'crystalloid del Nido solution and cold blood cardioplegia solution']","['aortic cross clamp duration and cardiopulmonary bypass (CPB) time', 'demographic data and CK-MB, Troponin-I and H-FABP levels', 'efficacy and safety', 'day Creatine Kinase Myocardial Band (CK-MB) and troponin', 'Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP', 'Total cardioplegia solution volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C1312696', 'cui_str': 'FABP3 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0201934', 'cui_str': 'Cardiac enzymes/isoenzymes measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",60.0,0.0963738,"Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP were comparable in del Nido solution and cold blood cardioplegia solution groups.
","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kirişci', 'Affiliation': ''}, {'ForeName': 'Aydemir', 'Initials': 'A', 'LastName': 'Koçarslan', 'Affiliation': ''}, {'ForeName': 'Duygun', 'Initials': 'D', 'LastName': 'Altintaş Aykan', 'Affiliation': ''}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Alkan Baylan', 'Affiliation': ''}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Doğaner', 'Affiliation': ''}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Orak', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-2002-53']
416,32394723,"Effects of depot medroxyprogesterone acetate, copper intrauterine devices, and levonorgestrel implants on early HIV disease progression.","BACKGROUND


Limited data exist on the effects of contraceptives on HIV disease progression. We studied the impact of DMPA-IM, the copper IUD and levonorgestrel (LNG) implant on HIV disease progression.
METHODS


We included women 16-35 years randomized to DMPA-IM, copper IUD, or levonorgestrel implant with incident HIV infection during the ECHO trial (n=382). We analyzed HIV viral load and CD4 cell count according to participants' randomized method and also conducted a 'continuous use' analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean viral load and CD4 cell levels by contraceptive group censoring at ART initiation. We compared time to CD4 count <350 cells/mm3 and viral suppression (VL < 40 copies/ml) following ART initiation using Cox proportional hazards models.
RESULTS


At HIV detection, DMPA-IM users had lower VL relative to copper IUD (-0.28 log10 copies/ml; 95% CI: -0.55, -0.01) and LNG implant (-0.27, CI: -0.55, 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm3 (CI: 11, 121). Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
CONCLUSIONS


We found no evidence of more rapid early HIV disease progression among women using DMPA-IM. Our finding of more rapid progression among copper IUD users should be interpreted cautiously.",2020,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","['women using DMPA-IM', 'women 16-35 years randomized to']","['DMPA-IM, copper IUD, or levonorgestrel implant', 'DMPA-IM, the copper IUD and levonorgestrel (LNG) implant', 'depot medroxyprogesterone acetate, copper intrauterine devices, and levonorgestrel implants']","['mean viral load and CD4 cell levels', 'time to viral suppression', 'VL relative to copper IUD', 'HIV viral load and CD4 cell count', 'early HIV disease progression', 'time to CD4 count <350 cells/mm3 and viral suppression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0039215', 'cui_str': 'T lymphocyte positive for CD4 antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}]",382.0,0.424447,"Women using DMPA-IM (HR= 0.6, CI: 0.3, 1.1) and LNG implant (HR = 0.6, CI: 0.3, 1.0) progressed to CD4 <350 slower than copper IUD users and time to viral suppression was faster for DMPA-IM than copper IUD (HR=1.5 (CI: 1.0, 2.3) and LNG implant 1.4 (CI: 0.9-2.2) users in continuous use analysis.
","[{'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Morrison', 'Affiliation': 'FHI 360, Clinical Sciences, 359 Blackwell Street, Durham, North Carolina, United States, 27701; cmorrison@fhi360.org.'}, {'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'University of Witwatersrand/Fort Hare/Walter Sisulu, East London, South Africa; justhof@gmail.com.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'University of Washington, Medicine, Seattle, Washington, United States; kkthomas@uw.edu.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health and HIV Institute, 162357, Hillbrow, South Africa; hrees@wrhi.ac.za.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Philip', 'Affiliation': 'ICAP, Coumbia University, New York, New York, United States; nmp6@cumc.columbia.edu.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, 162357, Hillbrow, South Africa; tpalanee@wrhi.ac.za.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'FHI 360, Contraceptive Technology Innovation, Durham, North Carolina, United States; knanda@fhi360.org.'}, {'ForeName': 'Gonasagrie', 'Initials': 'G', 'LastName': 'Nair', 'Affiliation': 'Emavundleni Research Centre, , Capetown, South Africa; lulu.nair@hiv-research.org.za.'}, {'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': '7KEMRI-RCTP Study Centre, Kisumu, Kenya; maricianah@gmail.com.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, North Carolina, United States; tmastro@fhi360.org.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'University of Washington, Medicine, Seattle, Washington, United States; mllind89@uw.edu.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Department of Epidemiology, Seattle, United States; rheffron@uw.edu.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Edward', 'Affiliation': 'Aurum Institute for Health Research, 72030, Johannesburg, South Africa; vedward@auruminstitute.org.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Deese', 'Affiliation': 'FHI 360, Contraceptive Technology Innovation, Durham, North Carolina, United States; jdeese@fhi360.org.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynaecology, University of the Witwatersrand, Durban, South Africa; mbeksinska@mru.ac.za.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, Department of Obstetrics and Gynaecology, University of the Witwatersrand, Durban, South Africa; ibeesham@mru.ac.za.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Stringer', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Medicine, Seattle, Washington, United States; jbaeten@uw.edu.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, Soshanguve, South Africa; kahmed@setshaba.org.za.'}]",AIDS research and human retroviruses,['10.1089/AID.2020.0015']
417,32398580,Transverse vs. parasagittal in-plane approaches in ultrasound-guided paravertebral block using a microconvex probe: A randomised controlled trial.,"BACKGROUND


Several approaches have been proposed for ultrasound-guided thoracic paravertebral block, but the best approach remains unclear.
OBJECTIVE


We compared two ultrasound-guided in-plane approaches using a microconvex probe, transverse and parasagittal. We assessed whether either approach would facilitate successful catheter placement in the paravertebral space.
DESIGN


Randomised controlled trial.
SETTING


University hospital, July 2015 to March 2016.
PATIENTS


Sixty patients scheduled to undergo thoracotomy were randomly allocated into two groups.
INTERVENTIONS


A microconvex probe was placed transversely between adjacent ribs (transverse) or sagittally between adjacent transverse processes (parasagittal). When the Tuohy needle reached the paravertebral space, a catheter was inserted to a depth of 4 cm. Then, 0.5-ml radiocontrast was injected through the catheter under fluoroscopy.
MAIN OUTCOME MEASURES


The primary outcome was successful catheter placement in the paravertebral space; secondary outcomes were 0 to 100 mm visual analogue scale pain score and morphine consumption in the first 24 h.
RESULTS


All patients received the allocated paravertebral block. Correct catheter placement occurred in 23 (77%) and 24 patients (80%) using the transverse (n=30) and parasagittal approaches (n=30), respectively (P = 1.00). Five patients were excluded due to changes in surgical procedure. Postoperative pain, represented by median [IQR] visual analogue scale score, was 19.5 [12 to 25] at rest and 55 [44 to 77] on movement with the transverse approach (n=28) vs. 22 [12 to 33.5] at rest and 59 [41.5 to 75] on movement with the parasagittal approach (n=27) (P = 0.57 at rest, P = 0.76 on movement). Median morphine consumption was 11.5 [5 to 21] and 11 [5 to 18] mg in the transverse and parasagittal approaches, respectively (P = 0.99).
CONCLUSION


There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
TRIAL REGISTRATION


UMIN Clinical Trials Registry identifier: UMIN000015988.",2020,"There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
","['University hospital, July 2015 to March 2016', 'Sixty patients scheduled to undergo thoracotomy']",[],"['Median morphine consumption', 'successful catheter placement in the paravertebral space; secondary outcomes were 0 to 100\u200amm visual analogue scale pain score and morphine consumption', 'Correct catheter placement', 'Postoperative pain', 'median [IQR] visual analogue scale score']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0883301', 'cui_str': 'Catheter placement'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",5.0,0.212423,"There were no clinically significant differences between approaches for continuous ultrasound-guided thoracic paravertebral block using a microconvex probe, and both approaches achieved a high rate of correct catheter placement.
","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Anaesthesiology, Nagoya University Graduate School of Medicine (TF, KN), Department of Surgical Center (YS) and Department of Anaesthesiology, Nagoya University Hospital, Nagoya, Japan (SS).'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': ''}, {'ForeName': 'Sonoe', 'Initials': 'S', 'LastName': 'Shinya', 'Affiliation': ''}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001223']
418,32398581,"Prophylactic Norepinephrine infusion and Leg Wrapping for postspinal hypotension in elective caesarean delivery: A randomised, double-blind, placebo-controlled trial.","BACKGROUND


Because of its alpha and beta agonist properties, norepinephrine infusion is currently being studied for the prevention of spinal hypotension during caesarean delivery. Vasopressor infusions are not always possible if there is an unavailability of infusion pumps. Leg wrapping with crepe bandage is an effective technique for prevention of postspinal hypotension and could be useful in resource-poor settings.
OBJECTIVE


The aim of this study was to compare the incidence of hypotension with norepinephrine infusion or leg wrapping with a control group in women undergoing caesarean delivery with spinal anaesthesia.
DESIGN


A randomised, placebo-controlled, double-blinded trial.
SETTING


Single centre, tertiary level institute, India.Study period 3 April 2018 to 31 March 2019.
PATIENTS


One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy.
INTERVENTION


In group Leg Wrapping, crepe bandage was applied tightly from metatarsus to groin. Group Norepinephrine and the control group received sham leg wrapping. In group Norepinephrine, the women received a norepinephrine infusion according to their body weight, while group Leg Wrapping and the control group received a 0.9% normal saline infusion at a similar rate. All three groups received a 500 ml co-load of Ringer's solution over 15 min. Noninvasive SBP was monitored every 2 min until delivery, and every 5 min thereafter. Any hypotensive event (SBP < 20% of baseline) was treated with an intravenous bolus of norepinephrine (7.5 μg).
MAIN OUTCOME MEASURES


The primary outcome was the incidence of hypotension. The secondary outcomes were performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes.
RESULTS


The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both). Performance error calculations showed that SBP was maintained closer to baseline with the norepinephrine infusion.
CONCLUSION


Norepinephrine infusion and leg wrapping can both reduce the incidence of postspinal hypotension during elective caesarean delivery compared with saline infusion alone.
TRIAL REGISTRATION


Clinical trial number and registry URL: CTRI/2018/04/012917 registered at Clinical Trial Registry of India http://www.ctri.nic.in/Clinicaltrials/login.php.",2020,The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both).,"['Study period 3 April 2018 to 31 March 2019', 'postspinal hypotension in elective caesarean delivery', 'Single centre, tertiary level institute, India', 'One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy', 'women undergoing caesarean delivery with spinal anaesthesia']","['saline infusion alone', 'norepinephrine infusion', 'Prophylactic Norepinephrine infusion and Leg Wrapping', 'Norepinephrine', ""500\u200aml co-load of Ringer's solution"", 'Vasopressor infusions', 'Leg wrapping with crepe bandage', 'norepinephrine', 'sham leg wrapping', 'normal saline infusion', 'norepinephrine infusion or leg wrapping with a control group', 'placebo']","['postspinal hypotension', 'Noninvasive SBP', 'incidence of hypotension', 'performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes', 'incidences of hypotension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0445414', 'cui_str': 'Wrapping'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0460462', 'cui_str': 'Cotton crepe bandage'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",144.0,0.410984,The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both).,"[{'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sundararajan', 'Affiliation': 'From the Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth (Deemed University), Puducherry, India (MS, CR, RP, RM).'}, {'ForeName': 'Charulatha', 'Initials': 'C', 'LastName': 'Ravindran', 'Affiliation': ''}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Ponnusamy', 'Affiliation': ''}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Murugesan', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001231']
419,32398633,Potentiation of Bench Press Throw Performance Using a Heavy Load and Velocity-Based Repetition Control.,"Tsoukos, A, Brown, LE, Terzis, G, Veligekas, P, and Bogdanis, GC. Potentiation of bench press throw performance using a heavy load and velocity-based repetition control. J Strength Cond Res XX(X): 000-000, 2020-The acute effects of heavy load bench press exercise on subsequent bench press throw (BPT) performance and surface electromyographic (sEMG) activity were examined using movement velocity control. Eleven resistance-trained men completed 3 conditions in randomized and counterbalanced order. In 2 conditions, bench press was performed as fast as possible against a load of 80% of 1 repetition maximum, until mean velocity dropped to 90% (C90) or 70% (C70) of the fastest repetition. In the control condition, no bench press was performed. Single maximal BPT efforts were performed in all conditions after warm-up and throughout the 12 minutes of subsequent recovery. Mean propulsive velocity (MPV), peak velocity (PV), and sEMG activity of the prime mover muscles were measured during the BPT efforts. The total number of repetitions and volume load during bench press were significantly greater in C70 compared with C90 (6.5 ± 1.9 vs. 3.4 ± 0.9 repetitions and 557.8 ± 177.8 vs. 293.8 ± 95.7 kg, p < 0.01). In C90, MPV was increased 5.3-7.4% (p < 0.01) for a prolonged period (4-12 minutes), while in C70, MPV increased only at 10 minutes (+5.9%, p < 0.01) and 12 minutes (+4.3%, p < 0.01). Peak velocity was improved only in the C90 at 8-12th min by 3.6-4.7% (p ≤ 0.05). Surface electromyographic activity of the pectoralis major muscle was significantly greater than baseline at 10 minutes of recovery only in the C90 (p < 0.01). Performance gains may be optimized by taking into account the individual fatigue profiles, allowing a percentage drop of only 10% in movement velocity during the conditioning bench press exercise.",2020,"In C90, MPV was increased 5.3-7.4% (p < 0.01) for a prolonged period (4-12 minutes), while in C70, MPV increased only at 10 minutes (+5.9%, p < 0.01) and 12 minutes (+4.3%, p < 0.01).",['Eleven resistance-trained men'],"['J Strength Cond Res XX(X', 'heavy load bench press exercise']","['Mean propulsive velocity (MPV), peak velocity (PV), and sEMG activity of the prime mover muscles', 'total number of repetitions and volume load during bench press', 'Peak velocity', 'Surface electromyographic activity of the pectoralis major muscle', 'subsequent bench press throw (BPT) performance and surface electromyographic (sEMG) activity', 'C70, MPV']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",,0.0320619,"In C90, MPV was increased 5.3-7.4% (p < 0.01) for a prolonged period (4-12 minutes), while in C70, MPV increased only at 10 minutes (+5.9%, p < 0.01) and 12 minutes (+4.3%, p < 0.01).","[{'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsoukos', 'Affiliation': 'School of Physical Education and Sports Science, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Lee E', 'Initials': 'LE', 'LastName': 'Brown', 'Affiliation': 'Human Performance Laboratory, California State University, Fullerton, Fullerton, California.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Terzis', 'Affiliation': 'School of Physical Education and Sports Science, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Veligekas', 'Affiliation': 'School of Physical Education and Sports Science, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Bogdanis', 'Affiliation': 'School of Physical Education and Sports Science, National & Kapodistrian University of Athens, Athens, Greece.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003633']
420,32398642,Oxytocin biases eye-gaze to dynamic and static social images and the eyes of fearful faces: associations with trait autism.,"A key functional effect of intranasal oxytocin with potential therapeutic relevance for autism-spectrum disorder is its reported facilitation of attention towards social stimuli, notably the eye region of faces. In the current randomized placebo-controlled within-subject experiment on 40 healthy males, we investigated the robustness of this facilitation of attention by intranasal oxytocin (24IU) towards social cues. Eye-tracking measures of preference for dynamic and static social vs. non-social stimuli were taken in four different paradigms where autistic individuals tend to exhibit reduced interest in social stimuli. Additionally, we investigated whether oxytocin increases attention towards the eyes relative to other salient face regions in an emotional face paradigm. Results showed that the time spent viewing both dynamic and static social vs. non-social stimuli was negatively associated with trait autism and significantly increased following intranasal oxytocin. For face stimuli, oxytocin primarily increased gaze towards the eyes of fearful expression faces but not for other face emotions. Overall, our findings demonstrate that oxytocin significantly shifts gaze preference towards social vs. non-social stimuli and to the eyes of fearful faces. Importantly, oxytocin appears generally to shift attention more towards salient social stimuli of particular relevance in the context of autism providing further support for its potential therapeutic use in autism-spectrum disorder.",2020,"A key functional effect of intranasal oxytocin with potential therapeutic relevance for autism-spectrum disorder is its reported facilitation of attention towards social stimuli, notably the eye region of faces.","['40 healthy males', 'autism-spectrum disorder']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'intranasal oxytocin (24IU) towards social cues', 'placebo']","['time spent viewing both dynamic and static social vs. non-social stimuli', 'shifts gaze preference towards social vs. non-social stimuli', 'trait autism']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]",40.0,0.0281423,"A key functional effect of intranasal oxytocin with potential therapeutic relevance for autism-spectrum disorder is its reported facilitation of attention towards social stimuli, notably the eye region of faces.","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Le', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Kou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Meina', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, 611731, Chengdu, China. kkendrick@uestc.edu.cn.'}]",Translational psychiatry,['10.1038/s41398-020-0830-x']
421,32398907,Effect of  Agnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting) in the management of  Kati Sandhigata Vata  (lumbar spondylosis).,"Background


Agnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting) are the treatment modalities mentioned in Ayurveda texts to combat the clinical condition of  Sandhigata Vata  (osteoarthritis) which occurs due to provoked  Vata Dosha  and/or  Vyana Vayu  overlapped with  Kapha . Lumbar spondylosis is a degenerative disorder presenting with lower back pain, stiffness, numbness, difficulty in movement etc., with evidence of osteophytes and reduced disc height in plain film radiograph.
Aims and Objectives


The aim of the study was to evaluate the role of  Agnikarma  and  Raktamokshana  in the management of  Kati Sandhigata Vata  (lumbar spondylosis).
Materials and Methods


After obtaining CTRI registration, total 32 cases of lumbar spondylosis were registered and allocated into two groups by simple random sampling method. 16 patients were treated with  Agnikarma  with  Panchadhatu   Shalaka  (group A) and 16 patients were treated with  Raktamokshana  by modified  Shringa   Yantra  (group B).
Results


The result was assessed using the Wilcoxon signed-rank test and paired  t -test. Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.
Conclusion


Agnikarma  was found more effective in relieving pain and numbness in lower back and  Raktamokshana  was found better in relieving pain and stiffness of lower back.",2019,"Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.
","['Kati Sandhigata Vata  (lumbar spondylosis', '16 patients were treated with  Agnikarma  with  Panchadhatu   Shalaka  (group A) and 16 patients were treated with', 'total 32 cases of lumbar spondylosis']","['Agnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting', 'Raktamokshana  by modified  Shringa   Yantra  (group B', '\n\n\nAgnikarma  (therapeutic heat burns) and  Raktamokshana  (therapeutic bloodletting']","['relieving pain and stiffness of lower back', 'relieving lower back pain, stiffness, numbness and painful movements', 'relieving pain and numbness']","[{'cui': 'C0149983', 'cui_str': 'Lumbar spondylosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0150611', 'cui_str': 'Heat therapy'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",16.0,0.0144258,"Significant results were observed in relieving lower back pain, stiffness, numbness and painful movements in both the groups.
","[{'ForeName': 'Foram', 'Initials': 'F', 'LastName': 'Joshi', 'Affiliation': 'Department of Shalyatantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.'}, {'ForeName': 'Vyasadeva', 'Initials': 'V', 'LastName': 'Mahanta', 'Affiliation': 'Department of Shalyatantra, AIIA, New Delhi, India.'}, {'ForeName': 'Tukaram S', 'Initials': 'TS', 'LastName': 'Dudhamal', 'Affiliation': 'Department of Shalyatantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.'}, {'ForeName': 'Sanjay Kumar', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Shalyatantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India.'}]",Ayu,['10.4103/ayu.AYU_142_16']
422,32398908,"Efficacy of  Sattvavajaya Chikitsa  in the form of relaxation techniques and  Guda Pippalimula Churna  in the management of  Anidra  (insomnia) - An open labelled, randomized comparative clinical trial.","Background


Condition of insomnia may not be a life-threatening illness, but it has tendency to damage the person's daily life. In the current era of modernization, most of the person are is suffering from stress either it is personal or professional. Stress may cause sleeping problems or make existing problems worse.  Sattvavajaya   Chikitsa  is a specialized type of treatment influencing the psychological aspect of body. It can be applied in the form of  Yogic  practices and other mind control techniques. With this research interest, the present study has been undertaken to assess the efficacy of the  Sattvavajaya   Chikitsa  in the form of relaxation techniques (RT) and  Guda   Pippalimula   Churna  in  Anidra  (insomnia).
Objectives


The objective of the study was to evaluate the efficacy of  Sattvavajaya   Chikitsa  in the form of RT and  Guda   Pippalimula   Churna  in  Anidra .
Materials and Methods


The study was an open-labeled randomized clinical trial in which sixty patients having symptoms of  Anidra  belonging to the age group of 20-60 years were enrolled and received  Sattvavajaya   Chikitsa  (RT) and  Guda   Pippalimula   Churna  orally in 2gm dosage with jaggery for 28 days. The assessment of symptoms was done on the basis of relief in the scores given to signs and symptoms according to their severity.
Results


Both the groups showed significant results in chief as well as associated symptoms of disease. Regarding overall effect of therapy in both the groups, marked improvement is high followed by moderate improvement. No adverse reactions were documented.
Conclusion


Sattvavajaya   Chikitsa  and  Guda   Pippalimula   Churna  are effective on  Anidra , but  Sattvavajaya   Chikitsa  was found more effective in reducing  Manasa  symptoms such as  Chinta  (tension),  Bhaya  (fear) and  Krodha  (anger).",2019,"No adverse reactions were documented.
","['Anidra  (insomnia) ', 'sixty patients having symptoms of  Anidra  belonging to the age group of 20-60 years were enrolled and received']",['Sattvavajaya   Chikitsa  (RT) and  Guda'],"['symptoms of disease', 'Chinta  (tension),  Bhaya  (fear) and  Krodha  (anger', 'adverse reactions', 'Sattvavajaya', 'Conclusion\n\n\nSattvavajaya   Chikitsa  and  Guda']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.0343107,"No adverse reactions were documented.
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Rawal', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Vyas', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Baghel', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}, {'ForeName': 'Shubhangi', 'Initials': 'S', 'LastName': 'Kamble', 'Affiliation': 'Department of Basic Principles, IPGT and RA, GAU, Jamnagar, Gujarat, India.'}]",Ayu,['10.4103/ayu.AYU_91_17']
423,32394654,"["" SHAO 's five-needle method"" as the main treatment for allergic rhinitis and asthma syndrome: a multi-center randomized controlled trial].","OBJECTIVE


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


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


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


"" SHAO 's five-needle method"" can improve the clinical symptoms and pulmonary function, reduce the count of eosinophils in peripheral blood in patients with allergic rhinitis and asthma syndrome, and the curative effect is better than routine acupuncture.",2020,"After treatment, FEV1 and PEF in the two groups were increased ( P <0.01), eosinophil count in peripheral blood was decreased ( P <0.01), and the improvement in the observation group was greater than that in the control group ( P <0.01,  P <0.05).
","['patients with allergic rhinitis and asthma syndrome', '210 patients with allergic rhinitis and asthma syndrome', 'allergic rhinitis and asthma syndrome']","['routine acupuncture, and the acupoints of Feishu (BL 13), Zhongfu (LU 1), Taiyuan (LU 9), Dingchuan (EX-B 1), Danzhong (CV 17), Yintang (GV 29), Fengmen (BL 12) and Zusanli', ' SHAO \'s five-needling method"", and the acupoints of Feishu (BL 13), Dazhui (GV 14), Fengmen (BL 12), Yintang (GV 29), Shangyingxiang (EX-HN 8) and Hegu', ' SHAO \'s five-needle method"" and routine acupoint selection']","['total effective rate', 'eosinophil count in peripheral blood', 'clinical therapeutic effect', 'total score of symptoms and signs', 'forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and eosinophils in peripheral blood', 'score of symptoms and signs', 'FEV1 and PEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C2606491', 'cui_str': 'zhongfu'}, {'cui': 'C0450836', 'cui_str': 'Dingchuan'}, {'cui': 'C0450834', 'cui_str': 'Yintang'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}]",210.0,0.0211125,"After treatment, FEV1 and PEF in the two groups were increased ( P <0.01), eosinophil count in peripheral blood was decreased ( P <0.01), and the improvement in the observation group was greater than that in the control group ( P <0.01,  P <0.05).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Su-Ju', 'Initials': 'SJ', 'LastName': 'Shao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Xiao-Yong', 'Initials': 'XY', 'LastName': 'Qin', 'Affiliation': 'Department of Acupuncture and Moxibustion, Kaifeng Hospital of TCM.'}, {'ForeName': 'Qing-Bo', 'Initials': 'QB', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Henan University of CM.'}, {'ForeName': 'Xiao-Gang', 'Initials': 'XG', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Jin-Shuang', 'Initials': 'JS', 'LastName': 'Hua', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Bo-Yong', 'Initials': 'BY', 'LastName': 'Shao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Cong-Cong', 'Initials': 'CC', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190412-0007']
424,32394655,[Clinical observation on gastroesophageal reflux asthma treated with  tongdu jiangni  needling technique].,"OBJECTIVE


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


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


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


The  tongdu jiangni  needling technique of acupuncture effectively relieves the symptoms of gastroesophageal reflux asthma and improves the quality of life in the patients and its effect is better than omeprazole enteric capsules.",2020,"After treatment, ACT score was increased as compared with that before treatment in either group ( P <0.05) and the increase range of ACT score in the acupuncture group was larger than that of the western medication group ( P <0.05).",['60 patients with gastroesophageal reflux asthma'],"['acupuncture', 'tongdu jiangni  needling technique', 'OME', 'acupuncture (acupuncture', 'omeprazole enteric capsules (OME', 'Acupuncture']","['quality of life', 'range of RDQ score', 'gastroesophageal reflux asthma', 'symptoms of gastroesophageal reflux asthma', 'score of reflux disease diagnostic questionnaire (RDQ), the score of asthma control test (ACT) and the tenderness threshold', 'increase range of ACT score', 'effective and curative rate', 'tenderness thresholds', '②RDQ score', 'asthma control rate', 'ACT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0029883', 'cui_str': 'Middle ear effusion'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.0259268,"After treatment, ACT score was increased as compared with that before treatment in either group ( P <0.05) and the increase range of ACT score in the acupuncture group was larger than that of the western medication group ( P <0.05).","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Bai', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Forth Medicine Center of the General Military Hospital.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Wei-Bing', 'Initials': 'WB', 'LastName': 'Pan', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191112-k0001']
425,32394656,[Post-stroke constipation treated with acupoint embedding therapy: a multi-center randomized controlled trial].,"OBJECTIVE


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


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


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


The acupoint embedding therapy remarkably increases the spontaneous bowel movements, improves in feces form and defecation difficulty and strengthens the quality of life in the patients of post-stroke constipation.",2020,"Compared with the values before treatment, the weekly average SBMs and BSFS scores after treatment were all increased obviously in the two groups ( P <0.01), and PAC-QOL score and the score of defecation difficulty were reduced remarkably ( P <0.01).",['210 patients of post-stroke constipation'],"['acupoint embedding', 'absorbable surgical suture', 'acupoint embedding therapy']","['average SBMs and BSFS scores', 'spontaneous bowel movements, improves in feces form and defecation difficulty and strengthens the quality of life', 'average spontaneous bowel movements (SBMs), Bristol stool form score (BSFS), the score of the patient assessment of constipation quality of life questionnaire (PAC-QOL) and the score of defecation difficulty', 'range of PAC-QOL score and the defecation difficulty score', 'PAC-QOL score and the score of defecation difficulty', 'increase range of SBMs and BSFS scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0038969', 'cui_str': 'Surgical suture'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C2732393', 'cui_str': 'Bristol stool form score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",210.0,0.0336442,"Compared with the values before treatment, the weekly average SBMs and BSFS scores after treatment were all increased obviously in the two groups ( P <0.01), and PAC-QOL score and the score of defecation difficulty were reduced remarkably ( P <0.01).","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Zhejiang Provincial Tongde Hospital, Hangzhou 310012, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Zhejiang Provincial Tongde Hospital, Hangzhou 310012, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Zhejiang Provincial Tiantai County Hospital of TCM.'}, {'ForeName': 'Chun-Mei', 'Initials': 'CM', 'LastName': 'Lu', 'Affiliation': 'Qinshan Street Community Health Service Center of Haiyan County, Zhejiang province.'}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Zhou', 'Affiliation': 'Zhejiang Provincial Haiyan County Hospital of TCM.'}, {'ForeName': 'Ping-Hua', 'Initials': 'PH', 'LastName': 'Wu', 'Affiliation': 'Gongshu District Mishixiang Street Community Health Service Center of Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Zheng', 'Affiliation': 'Yuhang District Wuchang Street Community Health Service Center of Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Xin-Wei', 'Initials': 'XW', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Zhejiang Provincial Tongde Hospital, Hangzhou 310012, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190507-k0004']
426,32394733,"Perceived Stress, Subjective, and Objective Symptoms of Disturbed Sleep in Men and Women with Stable Heart Failure.","Objective/Background : Sleep disturbance is prevalent among patients with heart failure (HF) and is associated with increased morbidity and mortality. Stress also affects health and quality of life among patients with cardiovascular disease and likely plays a prominent role in HF. However, little is known about the associations between stress and sleep among HF patients. Participants : One hundred fifty-three stable New York Heart Association (NYHA) Classification I-IV HF patients with at least low symptoms of insomnia (M age :63.0 ± 12.8, 42% Women). Methods:  We examined baseline stress, sleep disturbance, and sleep-related characteristics from a randomized controlled trial of cognitive behavioral therapy for insomnia, including the Perceived Stress Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Sleep Disturbance Questionnaire, Dysfunctional Beliefs about Sleep Scale, PROMIS Cognitive Ability, SF-36 Mental Health, and wrist actigraphy. We used Pearson correlations and general linear models to assess stress-sleep associations, including the potential moderating effects of sex and symptom severity (NYHA). Results : There were moderate-to-large correlations between stress and self-reported sleep disturbance, dysfunctional beliefs about sleep, cognitive ability, and mental health ( p 's < 0.01). High stress was associated with more objectively-measured (i.e., actigraph-assessed) awakenings and sleep fragmentation among women than men ( β  = - 0.04,  p  < 0.01;  β  = - 0.71,  p  = 0.04). Relationships between stress and objectively-measured sleep did not vary by symptom severity. Conclusions : Perceived stress is related to sleep disturbance among HF patients, and effects may be sex-dependent. Subsequent research should determine the temporal links between sleep and stress, and optimal opportunities for intervention among HF patients.",2020,Relationships between stress and objectively-measured sleep did not vary by symptom severity.,"['Participants ', 'patients with cardiovascular disease', 'One hundred fifty-three stable New York Heart Association (NYHA) Classification I-IV HF patients with at least low symptoms of insomnia (M age :63.0\xa0±\xa012.8, 42% Women', 'HF patients', 'patients with heart failure (HF', 'Men and Women with Stable Heart Failure']","[' ', 'cognitive behavioral therapy']","['objectively-measured (i.e., actigraph-assessed) awakenings and sleep fragmentation', 'health and quality of life', 'Perceived Stress Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Sleep Disturbance Questionnaire, Dysfunctional Beliefs about Sleep Scale, PROMIS Cognitive Ability, SF-36 Mental Health, and wrist actigraphy', 'Perceived Stress, Subjective, and Objective Symptoms of Disturbed Sleep', 'Sleep disturbance', 'sleep disturbance, dysfunctional beliefs about sleep, cognitive ability, and mental health', 'morbidity and mortality', 'baseline stress, sleep disturbance, and sleep-related characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0347296,Relationships between stress and objectively-measured sleep did not vary by symptom severity.,"[{'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Gaffey', 'Affiliation': 'Department of Internal Medicine (Cardiovascular Medicine), Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Conley', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine (Cardiovascular Medicine), Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Garrett I', 'Initials': 'GI', 'LastName': 'Ash', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': ""O'Connell"", 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Linsky', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': 'Yale School of Nursing, Orange, Connecticut.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1762601']
427,32394757,Economic evaluation of a multimodal intervention in pre-frail and frail older people with diabetes mellitus: the MID-FRAIL Project.,"Background : The aim of this study was to estimate the incremental cost-utility ratio (ICUR) of a multi-modal intervention in frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality-adjusted life years (QALYs) in different European countries. Methods : The MID-FRAIL study was a cluster randomized multicentre trial conducted in seven European countries. A cost-utility analysis was carried out based on this study, conducted from the perspective of the health care system with a time horizon of one year. Univariate and probabilistic analysis were carried out to test the robustness of the results. Results : The cost estimation showed the offsetting health effect of the intervention programme on total health care costs. The mean annual health care costs were 25% higher among patients in usual care. The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice. Conclusions : The MID-FRAIL intervention programme showed to be the dominant option in comparison with usual care practice. It saved costs to the health care system and achieved worthwhile health gains. This finding should encourage its implementation, at least, in the trial participant countries. Key words : diabetes; T2DM; frailty; older people, health care costs; cost-utility; economic evaluation; multimodal intervention.",2020,The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.,"['frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality-adjusted life years (QALYs) in different European countries', 'pre-frail and frail older people with diabetes mellitus', 'seven European countries']","['multi-modal intervention', 'multimodal intervention']","['incremental cost-utility ratio (ICUR', 'total health care costs', 'mean annual health care costs']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",25.0,0.0428674,The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice.,"[{'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Peña Longobardo', 'Affiliation': 'Department of Economic Analysis and Finance. University of Castilla-La Mancha. Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Oliva-Moreno', 'Affiliation': 'Department of Economic Analysis and Finance. University of Castilla-La Mancha. Toledo, Spain.'}, {'ForeName': 'Neboa', 'Initials': 'N', 'LastName': 'Zozaya', 'Affiliation': 'Department of Health Economics. Weber. MadridR Spain. University of Las Palmas de Gran Canaria. Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Aranda-Reneo', 'Affiliation': 'Department of Economic Analysis and Finance. University of Castilla-La Mancha. Toledo, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP). Universitat Internacional de Catalunya (UIC). Barcelona; Spain.'}, {'ForeName': 'Laosa', 'Initials': 'L', 'LastName': 'Olga', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe, Madrid, Spain.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sinclair', 'Affiliation': 'Foundation for Diabetes Research in Older People, Diabetes Frail Ltd, Luton, UK.'}, {'ForeName': 'Leocadio', 'Initials': 'L', 'LastName': 'Rodriguez Manas', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe, Madrid, Spain.'}]",Expert review of pharmacoeconomics & outcomes research,['10.1080/14737167.2020.1766970']
428,32394772,Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students.,"Background:  College students are among the most vulnerable groups to problems associated with high-risk drinking consequences such as illness, injury, sexual abuse, and death. Promising mobile health (mHealth) approaches, such as smartphone (SP) apps, can be used in interventions to address or prevent excessive drinking.  Method : The aim of the investigation was to examine the efficacy of a theoretically based mHealth SP app for alcohol intervention in two independent samples ( N   =   379): Mandated participants (Study 1) and voluntary participants (Study 2). Study 1 included a controlled trial with Mandated participants randomized into either an in-person Brief Motivational Interviewing BMI ( n   =   70) or BMI + SP app intervention ( n   =   71). Study 2 included Voluntary participants who participated in either a Control group ( n   =   157) or the BMI + SP app intervention ( n   =   81). Participants in both studies completed baseline and 6-week assessments.  Results : In Study 1, peak Blood Alcohol Concentration (BAC) of participants in the in-person BMI group had increased slightly at six weeks, while it had decreased for the app-based BMI + SP group. Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group.  Conclusions:  The BMI + SP app was effective with both Mandated and Voluntary participants. Future testing with the BMI + SP app is needed to assess whether reach, adoptability, portability, and sustainability are greater with the mHealth smartphone app for alcohol intervention than in-person approaches.",2020,Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group.  ,"['High-Risk Drinking in College Students', 'two independent samples ( N \u2009 = \u2009 379): Mandated participants (Study 1) and voluntary participants (Study 2', 'Study 2 included Voluntary participants who participated in either a Control group ( n \u2009 = \u2009 157) or the BMI\u2009+\u2009SP app intervention ( n \u2009 = \u2009 81', 'College students']","['Theory-Based mHealth Intervention', 'person Brief Motivational Interviewing BMI ( n \u2009 = \u2009 70) or BMI\u2009+\u2009SP app intervention']","['peak Blood Alcohol Concentration (BAC', 'drinking and consequences']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",379.0,0.024291,Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group.  ,"[{'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Kazemi', 'Affiliation': 'College of Health and Human Services, School of Nursing, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Maureen J', 'Initials': 'MJ', 'LastName': 'Levine', 'Affiliation': 'Psychology Department, Central Michigan University, Mount Pleasant, Michigan, USA.'}, {'ForeName': 'Shaoyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shehab', 'Affiliation': 'Department of Software and Information Systems, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Jerika C', 'Initials': 'JC', 'LastName': 'Norona', 'Affiliation': 'Addictions Research Program, Mental Illness Research, Education, and Clinical Center (MIRECC), San Francisco VA Health Care System & University of California, San Francisco, California, USA.'}]",Substance use & misuse,['10.1080/10826084.2020.1756851']
429,32394777,"Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety.","Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI. Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre- and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET+CTI and 20 (44%) in the control group. The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38;  P =0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET+CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET+CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02272426.",2020,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"['Stroke', 'We enrolled 131 participants, of whom 37 withdrew from the study', 'patients presenting with recent stroke to a comparison of a']","['Combined Aerobic, Resistance, and Cognitive Training', 'combined aerobic, resistance, and cognitive training intervention (CARET+CTI', 'supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI', ' Physical exercise and cognitive training']","['Greater gains in physical, cognitive, and mood outcomes', 'feasibility, adherence, and safety', 'feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety', 'strength, endurance, and cognition', 'Feasibility and Safety', 'observed-over-expected visit ratio']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",131.0,0.0361699,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marialaura', 'Initials': 'M', 'LastName': 'Simonetto', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bustillo', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Perez-Pinzon', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Kunjan R', 'Initials': 'KR', 'LastName': 'Dave', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Carolina M', 'Initials': 'CM', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marti', 'Initials': 'M', 'LastName': 'Flothmann', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Mendoza-Puccini', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Junco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Zuzel', 'Initials': 'Z', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Gomes-Osman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Rundek', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015377']
430,32394880,Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial.,"New dengue vaccines are needed to prevent this globally expanding vector-borne disease. The V180 vaccine candidate consists of four recombinant, soluble, dengue virus envelope glycoproteins and has been previously evaluated in two clinical trials for safety and immunogenicity in  Flavivirus -naive participants (NCT01477580 and NCT01477580). Here, we report on a randomized, placebo-controlled, double-blind study of the safety and immunogenicity of the V180 vaccine in subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301]). The study was designed to evaluate whether this recombinant subunit vaccine could boost the neutralizing antibody responses induced by dengue LATV. Twenty participants who had previously received one or two doses of dengue LATV were randomized and received a single dose of V180 nonadjuvanted ( N  = 8), V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) ( N  = 8), or placebo ( N  = 4). Immunogenicity was measured using a plaque reduction neutralization test at days 1, 15, 28, and 180 after vaccination. In addition, vaccine safety (solicited and unsolicited adverse events) was assessed using a vaccination report card for 28 days following vaccination, and serious adverse events were captured from the time of informed consent through the final study visit at 6 months after vaccination. The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.",2020,The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.,"['Adults', 'Twenty participants who had previously received one or two doses of dengue LATV', 'subjects who have previously received the live attenuated tetravalent vaccine (LATV) developed by the National Institute of Allergy and Infectious Diseases (protocol #V180-002 [CIR-301']","['V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) ', 'placebo', 'Tetravalent Recombinant Subunit Dengue Vaccine', 'recombinant subunit vaccine', 'Live Attenuated Tetravalent Dengue Vaccine', 'V180 vaccine']","['vaccine safety (solicited and unsolicited adverse events', 'tolerated and immunogenic', 'neutralizing antibody responses', 'Immunogenicity and Safety', 'Immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1513895', 'cui_str': 'National Institute of Allergy and Infectious Diseases'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0002372', 'cui_str': 'algeldrate'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]",20.0,0.508172,The results of the study demonstrate that the V180 vaccine is generally well tolerated and immunogenic in these dengue-seropositive volunteers.,"[{'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Pierce', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Microbiology and Molecular Genetics, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Palmtama', 'Initials': 'P', 'LastName': 'Grier', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Beulah P', 'Initials': 'BP', 'LastName': 'Sabundayo', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of International Health, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Sausser', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Amy Falk', 'Initials': 'AF', 'LastName': 'Russell', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hyatt', 'Affiliation': 'Department of Medicine, Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Cook', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Sachs', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wen-Tseng Lee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Liman', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Beth-Ann', 'Initials': 'BA', 'LastName': 'Coller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0042']
431,32394890,Effects of exercise training on sleep quality and heart rate variability in middle-aged and older adults with poor sleep quality: a randomized controlled trial.,"STUDY OBJECTIVES


We aimed (1) to investigate the effect of a 12-week exercise training on sleep quality and heart rate variability (HRV) in middle-aged and older adults with poor sleep quality and (2) to examine the factors associated with the improvements in sleep quality and HRV parameters.
METHODS


Forty adults aged ≥ 40 years with poor sleep quality (mean age = 62 years; 82.5% female) participated in this study. They were randomized into the exercise group or control group. Each exercise training program consisted of 40 min of supervised aerobic exercise training and 10 min of stretching class, three times a week for 12 weeks. Outcome measures included both subjective (Pittsburgh sleep quality index, PSQI) and objective (actigraphy recordings) sleep quality assessments, cardiopulmonary exercise test, and HRV assessment.
RESULTS


The exercise group showed significant improvements in the global score (p = 0.003), all subscales of PSQI (p < 0.05), and some HRV parameters compared to the control group. Multiple regression analysis indicated that exercise participation was associated with either the sleep quality (β = -0.617, R² = 0.407; F = 6.226, p < 0.001) or HFnu (β = 0.503, R² = 0.225; F = 3.200, p = 0.003) after adjustment for basic characteristics. However, the statistical significance between exercise participation and HFnu diminished after controlling for PSQI.
CONCLUSIONS


Our results indicated that moderate-intensity exercise training had a beneficial effect on sleep quality and cardiac autonomic function. Middle-aged and older adults with poor sleep quality were encouraged engaged in a moderate intensity aerobic exercise training to improve their sleep quality and cardiac autonomic function.",2020,"The exercise group showed significant improvements in the global score (p = 0.003), all subscales of PSQI (p < 0.05), and some HRV parameters compared to the control group.","['Forty adults aged ≥ 40 years with poor sleep quality (mean age = 62 years; 82.5% female', 'middle-aged and older adults with poor sleep quality', 'middle-aged and older adults with poor sleep quality and (2', 'Middle-aged and older adults with poor sleep quality']","['exercise training', 'exercise group or control group', 'exercise training program consisted of 40 min of supervised aerobic exercise training', 'moderate intensity aerobic exercise training', 'moderate-intensity exercise training']","['sleep quality and HRV parameters', 'sleep quality and cardiac autonomic function', 'sleep quality and heart rate variability (HRV', 'HRV parameters', 'subjective (Pittsburgh sleep quality index, PSQI) and objective (actigraphy recordings) sleep quality assessments, cardiopulmonary exercise test, and HRV assessment', 'global score', 'sleep quality', 'subscales of PSQI', 'sleep quality and heart rate variability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0236019,"The exercise group showed significant improvements in the global score (p = 0.003), all subscales of PSQI (p < 0.05), and some HRV parameters compared to the control group.","[{'ForeName': 'Tseng-Hau', 'Initials': 'TH', 'LastName': 'Tseng', 'Affiliation': 'Department of Rehabilitation, China Medical University Hospital, Taiwan.'}, {'ForeName': 'Hsi-Chung', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry and Center of Sleep Disorders, National Taiwan University and Hospital, Taiwan.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'School and Graduate Institute of Physical Therapy and Physical Therapy Center, National Taiwan University and Hospital, Taiwan.'}, {'ForeName': 'Meng-Yueh', 'Initials': 'MY', 'LastName': 'Chien', 'Affiliation': 'School and Graduate Institute of Physical Therapy and Center for Obesity, Lifestyle and Metabolic Surgery, National Taiwan University and Hospital, Taipei, Taiwan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8560']
432,32395099,Enhancing nicotine replacement therapy usage and adherence through a mobile intervention: Secondary data analysis of a single-arm feasibility study in Mexico.,"INsTRODUCTION


Nicotine Replacement Therapy (NRT) is an effective treatment for smoking cessation. However, medication usage and adherence remain a challenge that contributes to low smoking cessation rates. In Mexico, 8 in 10 smokers are interested in quitting. However, only 6% of Mexican smokers use medication for smoking cessation. The objective of this study is to assess the feasibility and acceptability of a mobile health (mHealth) intervention to increase usage and adherence of NRT in Mexico.
METHODS


The study involves a secondary data analysis. Forty smokers were recruited to participate in a single-arm pilot study. Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support. The intervention allows two-way interactivity text messaging between participants and a tobacco treatment specialist. NRT was offered to participants in accordance with practice guidelines in Mexico. Outcome measures included utilization of NRT, text messaging interactivity with the program, and biochemically verified abstinence at 12 weeks.
RESULTS


Thirty smokers met the criteria for use of NRT. Average age of participants was 38.1 years (SD=10.7), and they were primarily male (56.7%) with at least an undergraduate degree (60%). All participants requested NRT at baseline, and 60% requested a refill at week 4. During the 12-week intervention period, participants sent 620 messages to the program (mean=20.6, SD=18.34) of which 79 messages (12.7%) were related to NRT. Three themes were identified in the messages related to NRT: enthusiasm, instructions, and side effects. At 12 weeks, 40% of participants reported using NRT <75% of the days. Finally, 30% of participants (9/30) were biochemically verified abstinent using intention-to-treat analysis at 12 weeks.
CONCLUSIONS


An mHealth intervention appears to offer a promising strategy to increase usage and adherence of NRT in Mexico. Additional testing as a formal randomized clinical trial appears warranted.",2020,Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support.,"['Average age of participants was 38.1 years (SD=10.7), and they were primarily male (56.7%) with at least an undergraduate degree (60', 'Mexico', 'Thirty smokers met the criteria for use of NRT', 'Forty smokers']","['Nicotine Replacement Therapy (NRT', 'mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support', 'NRT', 'mobile health (mHealth) intervention']","['utilization of NRT, text messaging interactivity with the program, and biochemically verified abstinence at 12 weeks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}]",40.0,0.0560818,Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support.,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cartujano-Barrera', 'Affiliation': 'Department of Cancer Prevention and Control, Hackensack University Medical Center, Hackensack, United States.'}, {'ForeName': 'Rosibel', 'Initials': 'R', 'LastName': 'Rodríguez-Bolaños', 'Affiliation': 'Departamento de Investigación sobre Tabaco, Instituto Nacional de Salud Pública, Cuernavaca, Mexico.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Arana-Chicas', 'Affiliation': 'Department of Cancer Prevention and Control, Hackensack University Medical Center, Hackensack, United States.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gallegos-Carrillo', 'Affiliation': 'Unidad de Investigación Epidemiológica y en Servicios de Salud, Delegación Morelos, Instituto Mexicano del Seguro Social, Cuernavaca, Mexico.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'N Flores', 'Affiliation': 'Unidad de Investigación Epidemiológica y en Servicios de Salud, Delegación Morelos, Instituto Mexicano del Seguro Social, Cuernavaca, Mexico.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Pérez-Rubio', 'Affiliation': 'Laboratorio HLA, Instituto Nacional de Enfermedades Respiratorias, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Ramcés', 'Initials': 'R', 'LastName': 'Falfán-Valencia', 'Affiliation': 'Laboratorio HLA, Instituto Nacional de Enfermedades Respiratorias, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'F Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, United States.'}, {'ForeName': 'Luz Myriam', 'Initials': 'LM', 'LastName': 'Reynales-Shigematsu', 'Affiliation': 'Departamento de Investigación sobre Tabaco, Instituto Nacional de Salud Pública, Cuernavaca, Mexico.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, United States.'}]",Tobacco induced diseases,['10.18332/tid/120076']
433,32395379,Pro-inflammatory Cytokine Levels and Cancer-related Fatigue in Breast Cancer Survivors: Effects of an Exercise Adherence Program.,"Purpose


This study aimed to determine the effect of an exercise intervention on subjective cancer-related fatigue (CRF) and pro-inflammatory cytokine levels in breast cancer survivors (BCS).
Methods


BCS with greater than moderate CRF (≥ 4) were recruited and randomly assigned to experimental or control groups. The experimental group participated in a 12-week exercise adherence program (Better Life after Cancer - Energy, Strength, and Support; BLESS). Interleukin (IL)-6 and tumor necrosis factor-α (TNF-α) levels were determined at 3 time points (M1: baseline, M2: post-intervention, and M4: 6 months after intervention). Subjective fatigue was measured using the Korean version of the revised Piper Fatigue Scale.
Results


In this analysis of participants with physiological fatigue measures available (19 experimental, 21 control), there were no statistically significant differences in IL-6 (F = 1.157,  p  = 0.341), TNF-α levels (F = 0.878,  p  = 0.436), and level of fatigue (F = 2.067,  p  = 0.118) between the 2 groups at baseline. Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p  = 0.022). There was no significant relationship between subjective and physiological fatigue at the 3 measurement points.
Conclusion


The BLESS intervention improved CRF in BCS immediately at post-intervention, and this study presents clinical feasibility for the management of CRF in BCS in the early survivorship phase who are already experiencing fatigue.",2020,Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p  = 0.022).,"['Breast Cancer Survivors', 'breast cancer survivors (BCS']","['exercise intervention', 'Interleukin ', 'Exercise Adherence Program', 'exercise adherence program (Better Life after Cancer - Energy, Strength, and Support; BLESS']","['subjective cancer-related fatigue (CRF) and pro-inflammatory cytokine levels', 'TNF-α levels', 'IL)-6 and tumor necrosis factor-α (TNF-α) levels', 'Fatigue', 'IL-6', 'Subjective fatigue', 'level of fatigue', 'subjective and physiological fatigue']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0334036,Fatigue in the experimental group showed statistically significant improvement compared to the control only at M2 ( p  = 0.022).,"[{'ForeName': 'Sung Hae', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Health. Welfare and Education, Tongmyong University, Busan, Korea.'}, {'ForeName': 'Yoon Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jeehee', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Yun Hee', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Kang', 'Affiliation': 'Department of Sports Industry Studies, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyunki', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Biobehavioral Center, Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Hyangkyu', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Mo-Im Kim Nursing Research Institute, College of Nursing, Yonsei University, Seoul, Korea.'}]",Journal of breast cancer,['10.4048/jbc.2020.23.e22']
434,32395387,Efficacy of non-surgical treatment accompanied by professional toothbrushing in the treatment of chronic periodontitis in patients with type 2 diabetes mellitus: a randomized controlled clinical trial.,"Purpose


The present study aimed to evaluate the clinical benefit of additional toothbrushing accompanying non-surgical periodontal treatment on oral and general health in patients with type 2 diabetes mellitus (T2DM).
Methods


We conducted a doubled-blind randomized controlled trial in 60 T2DM patients between June 2013 and June 2014. The patients were randomly assigned to the scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT) group, in which additional toothbrushing was performed by toothpick methods; or the control group. Microbiological and oral examinations were performed for up to 12 weeks following treatment. Non-surgical treatment was conducted in the experimental groups. The SRP group received scaling and root planing and the SRPAT group received additional toothbrushing with the Watanabe method once a week from the first visit through the fifth visit. The primary outcomes were changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels. Periodontal health status was measured by periodontal pocket depth, the calculus index, and bleeding on probing (BOP).
Results


Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group. Furthermore, only the SRPAT group showed a statistically significant decrease in serum endotoxin levels.
Conclusions


Non-surgical periodontal treatment was effective in improving HbA1c and serum endotoxin levels in T2DM patients. Furthermore, non-surgical treatment with additional tooth brushing had a more favourable effect on gingival bleeding management.Trial RegistrationClinical Research Information Service Identifier: KCT000416.",2020,"Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group.","['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM', '60 T2DM patients between June 2013 and June 2014', 'T2DM patients']","['scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT', 'additional toothbrushing accompanying non-surgical periodontal treatment', 'non-surgical treatment accompanied by professional toothbrushing']","['changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels', 'periodontal pocket depth, the calculus index, and bleeding on probing (BOP', 'Periodontal health status', 'BOP', 'periodontal health and HbA1c', 'HbA1c and serum endotoxin levels', 'serum endotoxin levels', 'chronic periodontitis', 'gingival bleeding management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",60.0,0.0362263,"Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group.","[{'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive and Public Health Dentistry, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Yoon Young', 'Initials': 'YY', 'LastName': 'Choi', 'Affiliation': 'Department of Preventive and Public Health Dentistry, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Youngnim', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Immunology and Molecular Microbiology, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Bo Hyoung', 'Initials': 'BH', 'LastName': 'Jin', 'Affiliation': 'Department of Preventive and Public Health Dentistry, Seoul National University School of Dentistry, Seoul, Korea.'}]",Journal of periodontal & implant science,['10.5051/jpis.2020.50.2.83']
435,32395434,"Comparison of patient-reported outcomes of treatment with low- and intermediate molecular weight hyaluronic acid in Japanese patients with symptomatic knee osteoarthritis: A prospective, randomized, single-blind trial.","Objectives


The objective of this study was to compare the clinical outcomes of treatment with low- or intermediate-molecular-weight hyaluronic acid (HA) in patients with knee osteoarthritis (OA).
Methods


In total, 59 patients with OA who fulfilled the criteria of the American College of Rheumatology for OA were enrolled. Patients were randomly assigned in a 1:1 ratio to the low- or intermediate-molecular-weight HA group. An intraarticular injection of HA into the knee joint was performed five times per week. The visual analog scale for pain (pain VAS) and Japanese Knee Osteoarthritis Measure (JKOM) score were analyzed at baseline and week 6 to assess the outcomes.
Results


Pain VAS and JKOM score were significantly improved in both groups. At follow-up, there were no significant between-group differences in pain VAS or total JKOM score. Moreover, reduction in pain VAS and JKOM score was not significantly different between the two groups.
Conclusions


Both low- and intermediate-molecular-weight HA have significant efficacy in the first-line treatment of patients with knee OA as indicated by patient-reported outcomes. However, there does not appear to be any difference between the efficacy of low- and intermediate-molecular-weight HA as indicated by the JKOM score. We believe that the results of this study provide important insights into the clinical management of Japanese patients with knee OA.",2020,"At follow-up, there were no significant between-group differences in pain VAS or total JKOM score.","['patients with knee osteoarthritis (OA', 'Japanese patients with knee OA', '59 patients with OA who fulfilled the criteria of the American College of Rheumatology for OA were enrolled', 'Japanese patients with symptomatic knee osteoarthritis']","['low- or intermediate-molecular-weight hyaluronic acid (HA', 'low- and intermediate molecular weight hyaluronic acid', 'low- or intermediate-molecular-weight HA group']","['visual analog scale for pain (pain VAS) and Japanese Knee Osteoarthritis Measure (JKOM) score', 'pain VAS and JKOM score', 'pain VAS or total JKOM score', 'Pain VAS and JKOM score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",59.0,0.0328174,"At follow-up, there were no significant between-group differences in pain VAS or total JKOM score.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Orthopedic Surgery, Kamagaya General Hospital, Chiba, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Ikari', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Yano', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}]","Asia-Pacific journal of sports medicine, arthroscopy, rehabilitation and technology",['10.1016/j.asmart.2020.04.001']
436,32395439,Short Term Intake of  Undaria pinnatifida  Does Not Affect Bone Biomarkers in Young Korean Women with Low Calcium Intake.,"Calcium intake is essential for bone health, but young Korean women have low calcium intakes. Seaweeds have high calcium content, which may affect calcium metabolism. Twenty nine females aged 18-39 years with low calcium intake (< 400 mg/day) participated in a 19-day open-label randomized controlled trial. During the first five days, participants adhered to a controlled-feeding protocol followed by a two-week supplementation period in free-living conditions. The treatment group (n = 14) received an additional 200 mg Ca/day through  Undaria pinnatifida  and  Porphyra  in meals during the controlled-feeding period, and as  U. pinnatifida  noodles during days 6-19. Mineral intake (Ca, P, Mg, Na, and K) was assessed from diet composites and three 24-hour recalls during the controlled-feeding and free-living periods, respectively. Fasting serum levels of calcium, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D (1,25[OH]D), phosphorus, parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assessed at baseline, day 6, and day 19. Statistical analyses were performed by Student's  t -test and mixed ANOVA. Mean intakes of all minerals during days 1-5 and mean Ca and Mg intakes during days 6-19 were greater in the treatment group compared to the control group. No group effect or group and time interaction was observed in serum biomarkers. Serum 1,25(OH)D increased while PTH and ALP tended to decrease on day 6 but returned to baseline values on day 20. Short-term intake of  U. pinnatifida  and  Porphyra  does not affect calcium metabolism in young Korean women with low calcium intakes.
Trial Registration


Clinical Research Information Service Identifier: KCT0003307.",2020,"Serum 1,25(OH)D increased while PTH and ALP tended to decrease on day 6 but returned to baseline values on day 20.","['Twenty nine females aged 18-39 years with low calcium intake (< 400 mg/day) participated in a 19-day open-label randomized controlled trial', 'young Korean women with low calcium intakes', 'Young Korean Women with Low Calcium Intake', 'young Korean women']","['Calcium intake', 'additional 200 mg Ca/day through  Undaria pinnatifida  and  Porphyra  in meals']","['Serum 1,25(OH)D increased while PTH and ALP', 'Mineral intake (Ca, P, Mg, Na, and K', 'Ca and Mg intakes', 'serum biomarkers', 'calcium metabolism', 'Fasting serum levels of calcium, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D (1,25[OH]D), phosphorus, parathyroid hormone (PTH), and alkaline phosphatase (ALP', 'Mean intakes', 'Undaria pinnatifida']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0619485', 'cui_str': 'A 19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}, {'cui': 'C0996258', 'cui_str': 'Porphyra'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0518042', 'cui_str': 'Mineral intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}]",29.0,0.110886,"Serum 1,25(OH)D increased while PTH and ALP tended to decrease on day 6 but returned to baseline values on day 20.","[{'ForeName': 'Clara Yongjoo', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, Chonnam National University, Gwangju 61186, Korea.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, Chonnam National University, Gwangju 61186, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Integrative Medicine, Korea University College of Medicine, Seoul 02841, Korea.'}]",Clinical nutrition research,['10.7762/cnr.2020.9.2.90']
437,32399109,Effect of tranexamic acid on symptomatic venous thromboembolism in patients undergoing primary total knee arthroplasty.,"Introduction


This study aimed to investigate the effect of tranexamic acid (TXA) with sequential routine anticoagulation on postoperative symptomatic venous thromboembolism (VTE) in patients undergoing primary total knee arthroplasty (TKA).
Material and methods


This was a prospective study with randomized trials. From January 2013 to May 2015, 1880 patients undergoing primary TKA were enrolled in this study. Seven hundred and twenty patients who received TXA injection were included in the TXA group while 1160 patients who received placebo injection were included in the control group. Patients in the TXA group were treated with intravenous TXA or topical intravenous TXA, and all received sequential routine anticoagulation 12 h after the operation. We extracted data of patients' sex, age, primary diagnoses, and comorbidities that could potentially affect the prevalence rate of VTE. To discuss the risk factors of symbolic VTE, comparisons were made within the TXA group between patients with symbolic VTE and non-symbolic VTE. Logistic regression analysis was performed to analyze the concurrent effects of various factors on the prevalence rate of postoperative VTE.
Results


Thigh perimeter was not closely associated with TXA injection. Within the TXA group, 24 (3.3%) patients had perioperative symptomatic VTE, 16 (2.2%) deep vein thrombosis (DVT) and 8 (1.1%) pulmonary embolism. High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis.
Conclusions


Increased BMI, low Fbg, and simultaneous bilateral TKA could act as risk factors for postoperative symptomatic VTE treated with TXA.",2020,"High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis.
","['patients undergoing primary total knee arthroplasty', 'Seven hundred and twenty patients who received TXA injection were included in the TXA group while 1160 patients who received', 'From January 2013 to May 2015, 1880 patients undergoing primary TKA', 'patients undergoing primary total knee arthroplasty (TKA']","['tranexamic acid (TXA', 'TXA', 'intravenous TXA or topical intravenous TXA', 'placebo injection', 'sequential routine anticoagulation', 'tranexamic acid']","['High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA', 'prevalence rate of VTE', 'pulmonary embolism', 'deep vein thrombosis (DVT', 'postoperative symptomatic venous thromboembolism (VTE', 'symptomatic venous thromboembolism', 'perioperative symptomatic VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C4237836', 'cui_str': 'Tranexamic Acid Injection'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0553681', 'cui_str': 'Hypofibrinogenemia'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1880.0,0.0766469,"High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis.
","[{'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Longchao', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xisheng', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiliang', 'Initials': 'J', 'LastName': 'Zhai', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Gao', 'Affiliation': 'Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Archives of medical science : AMS,['10.5114/aoms.2020.92444']
438,32399130,A Clinical Randomized Controlled Trial of Acupuncture Treatment of Gastroparesis Using Different Acupoints.,"Objective


To explore the effect of ""selecting acupoints by site"" on the synergy effect of ""acupoint compatibility"" according to the clinical efficacy of acupuncture treatment of patients with gastroparesis.
Methods


A total of 99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers and randomly divided into group A (33 cases), group B (33 cases, 1 case of shedding), and group C (33 cases, 1 case of shedding). In group A, acupuncture was performed at Zhongwan (CV 12) and Zusanli (ST 36); in group B, acupuncture was performed at Neiguan (PC 6) and Zusanli (ST 36); in group C, acupuncture was performed at nonacupoint and Zusanli (ST 36). Treatment was performed for 30 minutes every day, 5 days as a course of treatment. There were 2 days off between courses and three courses in total. Differences in a main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36) were compared between each group before and after treatment and 4 weeks after the end of treatment. The difference of gastric emptying rate was compared before and after treatment.
Results


The GCSI scores of each group after treatment and at follow-up were significantly lower than those before treatment ( P  < 0.01), and the reduction in group A was greater than that of groups B and C ( P  < 0.01). The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05). The effect was best in group A, followed by group B. After treatment, the barium meal in the stomach of the three groups was significantly reduced compared with before treatment ( P  < 0.01). There was no statistical difference between the groups. The results of SF-36 showed that acupuncture treatment can improve health status, to a certain extent, and there was no significant difference in the three groups.
Conclusion


(1) Acupuncture is an effective method for the treatment of gastroparesis. (2) The combination of Zhongwan (CV 12) with Zusanli (ST 36) showed the most promising effect on relief of the symptoms in patients with gastroparesis. (3) ""Selecting acupoints by site"" is the key factor affecting the synergy effect of ""acupoint compatibility."" This trial was registered with the International Center for Clinical Trials (registration no. NCT02594397).",2020,The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05).,"['99 patients who met the diagnostic criteria for gastroparesis were enrolled in 3 clinical centers', 'patients with gastroparesis']","['acupuncture', 'Acupuncture']","['gastric emptying rate', 'GCSI scores', 'score of each symptom', 'health status', 'main symptom index of gastroparesis (GCSI) scores, 9 symptom scores, and a health questionnaire (SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0967114', 'cui_str': 'goblet cell silencer inhibitor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",99.0,0.0357108,The score of each symptom was meaningfully lower than that before treatment ( P  < 0.01 or  P  < 0.05).,"[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Xuefen', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ping', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xiaoli', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'College of Acu-Moxibustion and Tuina, Hunan University of Traditional Chinese Medicine, Changsha, Hunan 410208, China.'}]",Pain research & management,['10.1155/2020/8751958']
439,32399201,An evaluation of a personalised text message reminder compared to a standard text message on postal questionnaire response rates: an embedded randomised controlled trial.,"Background : Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates.  Methods : A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression.  Results : A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained.  Conclusions : Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence.  Registration : ISRCTN22202133; SWAT 35.",2020,"A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  ","['older people', '403 participants were randomised: 201 to the personalised text and 202 to the standard text', 'OTIS participants who provided a mobile phone number', 'Registration ']","['personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire', 'personalised text message reminder']","['proportion of participants who returned the questionnaire', 'postal questionnaire response rates', 'response rates', 'time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness', 'median time to response']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1301584', 'cui_str': 'Surname'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",403.0,0.200782,"A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  ","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Welch', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.22361.1']
440,32399253,"Acthar Gel (repository corticotropin injection) for persistently active SLE: study design and baseline characteristics from a multicentre, randomised, double-blind, placebo-controlled trial.","Objective


SLE is a chronic inflammatory autoimmune disease characterised by the excessive production of autoantibodies, immune complexes and proinflammatory cytokines. Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides. RCI is approved by the US Food and Drug Administration for use during an exacerbation or as maintenance therapy in select cases of SLE. This paper discusses the design and baseline characteristics of a multicentre, double-blind, randomised, placebo-controlled, 24-week clinical trial evaluating the effect of RCI in reducing disease activity for patients with persistently active SLE despite moderate-dose corticosteroid use.
Methods


Efficacy will be evaluated using the SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA). The primary efficacy endpoint will be the proportion of SRI-4 responders at week 16. Secondary and exploratory endpoints will include changes in disease activity scores over time, prednisone dose and biomarkers of inflammation and bone turnover. The safety and tolerability profile of RCI will also be evaluated through adverse event profiles, physical examination, clinical laboratory tests and serum cortisol levels.
Results


Target enrolment for this global study is 270 patients, and as of 15 November 2019, the modified intent-to-treat population included 169 patients. The study cohort had 91.7% women, had a mean age of 39.7 years, mean SLEDAI-2K total score of 9.9, mean BILAG-2004 total score of 18.1, mean PGA of 59.7 and mean prednisone or equivalent daily dose of 11.1 mg. A total of 79.3% and 64.5% of patients were receiving concomitant antimalarial or immunosuppressive therapy, respectively.
Conclusions


Data from this study will provide valuable insights into the therapeutic role of RCI in refractory SLE, as well as important information regarding its safety profile.",2020,"Methods


Efficacy will be evaluated using the SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA).","['patients with persistently active SLE despite moderate-dose corticosteroid use', '270 patients, and as of 15 November 2019, the modified intent-to-treat population included 169 patients', 'The study cohort had 91.7% women, had a mean age of 39.7 years, mean SLEDAI-2K total score of 9.9, mean BILAG-2004 total score of 18.1, mean PGA of 59.7 and mean prednisone or equivalent daily dose of 11.1\u2009mg']","['Repository corticotropin injection (RCI', 'RCI', 'Acthar Gel (repository corticotropin injection', 'placebo']","['proportion of SRI-4 responders', 'disease activity', 'safety and tolerability profile of RCI', ""SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA"", 'disease activity scores over time, prednisone dose and biomarkers of inflammation and bone turnover']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",,0.466664,"Methods


Efficacy will be evaluated using the SLE Responder Index-4 (SRI-4), SLE Disease Activity Index-2000 (SLEDAI-2K), British Isles Lupus Assessment Group-2004 (BILAG-2004) and Physician's Global Assessment (PGA).","[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Connolly-Strong', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, New Jersey, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.'}]",Lupus science & medicine,['10.1136/lupus-2020-000383']
441,32399413,Anatomic and functional results of idiopathic macular epiretinal membrane surgery.,"AIM


To assess the impact of macular surgery on the functional and anatomic outcomes in patients with grade 2 epiretinal membrane (ERM), and the effect of internal limiting membrane (ILM) peeling on visual acuity and to analyze the long-term effect of pars plana vitrectomy (PPV) on intraocular pressure (IOP).
METHODS


Pseudophakic eyes (62 eyes) diagnosed as idiopathic grade 2 ERM with at least 6mo postoperative follow-up were included in this retrospective study. The fellow eye was nonvitrectomized. Patients were divided into two groups: group 1 (29 eyes) treated with ERM and ILM peeling and group 2 (33 eyes) with only ERM peeling. Preoperative and postoperative best corrected visual acuity (BCVA), slit-lamp, and a dilated fundus examination was performed. IOP was measured with Goldman applanation tonometer before, day 1 and first week and each visit after surgery. The incidence of significant IOP elevation was compared between vitrectomized eyes and nonvitrectomized fellow eyes.
RESULTS


Visual improvement was statistically significant and similar in both groups ( P =0.008 in group 1,  P =0.002 in group 2,  P =0.09 inter-group). The amount of decrease in central macular thickness was statistically significant and similar in both groups ( P =0.005 group 1,  P =0.008 group 2,  P =0.37 intergroup). At the final follow-up (14.1±9.6mo) the incidence of significant IOP elevation was 4% in vitrectomized eyes (three eyes) and 3% (two eyes) in the nonvitrectomized fellow eyes ( P =0.12). Four eyes (12.1%) had recurrent ERM after a mean follow-up of 8.6±1.1mo in group 2, there was no recurrence in group 1 ( P =0.01).
CONCLUSION


Recurrence of ERM may be decreased by ILM peeling during ERM surgery. However, it seems that ILM peeling do not affect the functional outcome and 23-gauge PPV alone do not have a significant effect on IOP.",2020,"The amount of decrease in central macular thickness was statistically significant and similar in both groups ( P =0.005 group 1,  P =0.008 group 2,  P =0.37 intergroup).","['patients with grade 2 epiretinal membrane (ERM', 'Pseudophakic eyes (62 eyes) diagnosed as idiopathic grade 2 ERM with at least 6mo postoperative follow-up', 'idiopathic macular epiretinal membrane surgery']","['pars plana vitrectomy (PPV', 'ERM and ILM peeling and group 2 (33 eyes) with only ERM peeling', 'internal limiting membrane (ILM) peeling', 'macular surgery']","['recurrent ERM', 'incidence of significant IOP elevation', 'central macular thickness', 'Recurrence of ERM', 'IOP', 'intraocular pressure (IOP', 'Preoperative and postoperative best corrected visual acuity (BCVA), slit-lamp, and a dilated fundus examination', 'Visual improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",,0.0762792,"The amount of decrease in central macular thickness was statistically significant and similar in both groups ( P =0.005 group 1,  P =0.008 group 2,  P =0.37 intergroup).","[{'ForeName': 'Mehmet Ozgur', 'Initials': 'MO', 'LastName': 'Cubuk', 'Affiliation': 'Department of Ophthalmology, Istanbul Research and Education Hospital, Istanbul 34025, Turkey.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Ophthalmology, Istanbul Research and Education Hospital, Istanbul 34025, Turkey.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.13']
442,32399460,Cost Analysis of Biliary Drainage Using Metal versus Plastic Stents in Hepatocellular Carcinoma Patients with Obstructive Jaundice.,"Background


The optimal method of biliary drainage for biliary obstruction caused by hepatocellular carcinoma (HCC) is controversial, and the possible endoscopic application of plastic and metal stents is the least invasive procedure to improve patients' quality of life.
Aim


Our objective was to study cost evaluation based on a clinical efficacy of both procedures in a randomized trial comparing both approaches in patients with biliary obstruction caused by HCC.
Methods


The strategy of management was based on clinical effectiveness of biliary drainage with either metal or plastic stents in 90 patients over a 1-year follow-up period. Total (direct and indirect) costs were evaluated.
Results


The direct costs were EGP 40,857.84 and 21,802.62 per patient with plastic and metal stents, respectively. Concerning the indirect costs, EGP 888 and 454 were spent for each patient with plastic and metal stents, respectively. The differences in the costs resulted from patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up.
Conclusions


Based on this analysis, the use of metal stents rather than plastic stents in biliary drainage is more cost effective for this group of patients.",2020,"The differences in the costs resulted from patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up.
","['Hepatocellular Carcinoma Patients with Obstructive Jaundice', 'patients with biliary obstruction caused by HCC', 'biliary obstruction caused by hepatocellular carcinoma (HCC', 'patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up', '90 patients over a 1-year follow-up period']","['Biliary Drainage Using Metal versus Plastic Stents', 'biliary drainage', 'biliary drainage with either metal or plastic stents']","['direct costs', 'Total (direct and indirect) costs']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}, {'cui': 'C0400979', 'cui_str': 'Obstruction of biliary tree'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",,0.072641,"The differences in the costs resulted from patients with plastic stent insertion requiring more second endoscopic retrograde cholangiopancreatography procedures and more medication, medical consultation, and hospitalization during the year of follow-up.
","[{'ForeName': 'Esam', 'Initials': 'E', 'LastName': 'Elshimi', 'Affiliation': 'Hepatology Department, National Liver Institute, Menoufia University, Shebin Al-Kom, Egypt.'}, {'ForeName': 'Wesam', 'Initials': 'W', 'LastName': 'Morad', 'Affiliation': 'Epidemiology and Preventive Medicine Department, National Liver Institute, Menoufia University, Shebin Al-Kom, Egypt.'}]",Gastrointestinal tumors,['10.1159/000503862']
443,32399492,Comparison of surgical cricothyroidotomy training: a randomized controlled trial of a swine model versus an animated robotic manikin model.,"Background


Airway obstruction remains a preventable cause of death on the battlefield. Surgical cricothyroidotomy is an essential skill for immediate airway management in trauma. Training for surgical cricothyroidotomy has been undertaken using simulators, cadavers or animal models. The ideal approach to training for this low volume and high-risk procedure is unknown. We hypothesized that current simulation technology provides an equal or better education for surgical cricothyroidotomy when compared with animal tissue training.
Methods


We performed a prospective randomized controlled study comparing training for surgical cricothyroidotomy using hands-on training on swine versus inanimate manikin. We enrolled medical students who had never performed or had formal instruction on surgical cricothyroidotomy. We randomized their instruction to use either a swine model or the inanimate version of the Operative Experience Inc. advanced surgical manikin. Participants' skills were then evaluated on human cadavers and on an advanced robotic manikin. Tests were scored using checklists modified from Objective Structured Assessment of Technical Skills and Tactical Combat Casualty Care. We compared scores between the groups using Wilcoxon rank sum tests and generalized linear models.
Results


Forty-eight participants were enrolled and trained; 30 participants completed the first testing session; 25 completed the second testing session. The mean time to establish an airway from the incision until the cuff was blown up was 95±52 s. There were no significant differences in any of the outcome measures between the two training groups.
Discussion


Measured performance was not different between subjects trained to perform surgical cricothyroidotomy on an animal model or a high fidelity manikin. The use of an advanced simulator has the potential to replace live tissue for this procedure mitigating concerns over animal rights.
Levels of evidence


I.",2020,"There were no significant differences in any of the outcome measures between the two training groups.
","['Forty-eight participants were enrolled and trained; 30 participants completed the first testing session; 25 completed the second testing session', 'enrolled medical students who had never performed or had formal instruction on surgical cricothyroidotomy']","['surgical cricothyroidotomy training', 'surgical cricothyroidotomy using hands-on training on swine versus inanimate manikin', 'swine model or the inanimate version of the Operative Experience Inc. advanced surgical manikin', 'Surgical cricothyroidotomy', 'animated robotic manikin model']",['mean time to establish an airway'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0396636', 'cui_str': 'Open cricothyroidotomy'}]","[{'cui': 'C0396636', 'cui_str': 'Open cricothyroidotomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",48.0,0.027439,"There were no significant differences in any of the outcome measures between the two training groups.
","[{'ForeName': 'Vinciya', 'Initials': 'V', 'LastName': 'Pandian', 'Affiliation': 'Department of Nursing Faculty, Johns Hopkins School of Nursing, Baltimore, Maryland, United States.'}, {'ForeName': 'William Robert', 'Initials': 'WR', 'LastName': 'Leeper', 'Affiliation': 'Department of Surgery, London Health Sciences Centre, Victorial Hospital, London, Ontario, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Pugh', 'Affiliation': 'Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, Maryland, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bowyer', 'Affiliation': 'Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States.'}, {'ForeName': 'Elliott R', 'Initials': 'ER', 'LastName': 'Haut', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}]",Trauma surgery & acute care open,['10.1136/tsaco-2019-000431']
444,32399500,"Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD): a phase 2, multicentre, double-blind, randomized, placebo-controlled trial.","Type 1 diabetes is a common autoimmune disease due to destruction of pancreatic β cells, resulting in lifelong need for insulin. Evidence suggest that maintaining residual β-cell function can improve glucose control and reduce risk of hypoglycaemia and vascular complications. Non-clinical, preclinical and some preliminary clinical data suggest that low-dose interleukin-2 (IL-2) therapy could block pancreatic β cells destruction by increasing the number of functional regulatory T cells (Tregs) that inhibit islet-specific autoreactive effector T cells (Teffs). However, there is lack of data on the effect of low-dose IL-2 in newly diagnosed children and adolescents with T1D as well as lack of specific data on its potential effect on β-cell function. The '  I nterleukin-2  T herapy of  A utoimmunity in  D iabetes (ITAD)' is a phase 2, multicentre, double-blind, randomised, placebo-controlled trial in children and adolescents (6-18 years; having detectable C-peptide) initiated within 6 weeks of T1D diagnosis. A total of 45 participants will be randomised in a 2:1 ratio to receive either ultra-low dose IL-2 (aldesleukin), at a dose of 0.2 x 10  6  IU/m  2  twice-weekly, given subcutaneously, or placebo, for 6 months. The primary objective is to assess the effects of ultra-low dose aldesleukin administration on endogenous β-cell function as measured by frequent home dried blood spot (DBS) fasting and post-prandial C-peptide in children and adolescents with newly diagnosed T1D. The secondary objectives are: 1) to assess the efficacy of regular dosing of aldesleukin in increasing Treg levels; 2) to confirm the clinical safety and tolerability of ultra-low dose aldesleukin; 3) to assess changes in the immune system indicating benefit or potential risk for future gains/loss in β-cell function and immune function; 4) to assess treatment effect on glycaemic control. Trial registration: EudraCT 2017-002126-20 (06/02/2019).",2020,The '  I nterleukin-2  T herapy of  ,"['Autoimmunity in Diabetes (ITAD', 'children and adolescents (6-18 years; having detectable C-peptide) initiated within 6 weeks of T1D diagnosis', 'newly diagnosed children and adolescents with T1D', 'children and adolescents with newly diagnosed T1D', '45 participants']","['Interleukin-2 Therapy', 'ultra-low dose IL-2 (aldesleukin', 'aldesleukin', 'ultra-low dose aldesleukin', 'placebo']","['endogenous β-cell function', 'risk of hypoglycaemia and vascular complications']","[{'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0199975', 'cui_str': 'Interleukin-2 therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0218986', 'cui_str': 'Aldesleukin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",45.0,0.644247,The '  I nterleukin-2  T herapy of  ,"[{'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Wicker', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Sylwia', 'Initials': 'S', 'LastName': 'Kopijasz', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scudder', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Todd', 'Affiliation': 'JDRF/Wellcome Diabetes and Inflammation Laboratory, Nuffield Department of Medicine, Wellcome Centre for Human Genetics, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, OX3 7BN, UK.'}, {'ForeName': 'Paul R V', 'Initials': 'PRV', 'LastName': 'Johnson', 'Affiliation': 'Islet Transplant Research Group, Nuffield Department of Surgical Sciences, Centre for Diabetes, Endocrinology and Metabolism (OCDEM), University of Oxford, Oxford, OX3 9DU, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.15697.1']
445,32395294,Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: a study protocol for multicenter randomized controlled trial.,"Background


With the evolution and adoption of video-assisted thoracoscopic surgery (VATS), options for anesthesia control have also seen major developments. Intubated anesthesia with single lung mechanical ventilation VATS (MV-VATS) is considered the standard of care in VATS. However, this type of ventilation strategy has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated anesthesia related adverse effects, non-intubated spontaneous ventilation VATS (SV-VATS) strategies have been proposed in recent years and widely applied.
Methods


We established a two-arm parallel multicenter randomized controlled trial for comparative analysis of the outcomes of patients undergoing either SV-VATS or MV-VATS for spontaneous pneumothorax. Outcomes of interest include safety during operation, total analgesic dose, recovery time, postoperative complication rates, postoperative pain score, length of hospitalization, inflammation index, medical cost, etc. The recruitment target is 316 patients. Patients will be eligible if their chest CT is diagnosed with ""localized lung bullae"" and need VATS resection. Patients will be randomized into the SV-VATS (test group) or MV-VATS (control group) after signing informed consent and surgical anesthesia evaluation.
Discussion


This protocol has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou Medical university. Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter. Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
Trial registration


NCT03016858; pre-results.",2020,"Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
","['316 patients', 'spontaneous pneumothorax', 'patients undergoing either SV-VATS or MV-VATS for spontaneous pneumothorax', 'spontaneous pneumothorax patients']","['video-assisted thoracoscopic surgery (VATS', 'SV-VATS', 'Intubated anesthesia with single lung mechanical ventilation VATS (MV-VATS', 'Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery', 'MV-VATS (control group) after signing informed consent and surgical anesthesia evaluation']","['overall surgical risk', 'safety during operation, total analgesic dose, recovery time, postoperative complication rates, postoperative pain score, length of hospitalization, inflammation index, medical cost, etc']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149781', 'cui_str': 'Spontaneous pneumothorax'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.175773,"Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Cui', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Jingpei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia, First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.'}]",Journal of thoracic disease,['10.21037/jtd.2020.02.13']
446,32395319,Long-term results of a single-center prospective randomized trial assessing efficacy of a shortened course of adjuvant chemotherapy after radical cystectomy in patients with locally advanced bladder cancer.,"Introduction


This study assesses the efficacy and tolerability of two cycles of adjuvant chemotherapy (AC) with gemcitabine and cisplatin after radical cystectomy in patients with a high risk of progression of muscle-invasive urothelial bladder cancer as compared to chemotherapy at relapse, in a prospective randomized study.
Material and methods


From 2008 to 2013, all patients after radical cystectomy at our institution for primary or recurrent urothelial bladder cancer with stage pT3-4 and/or pN+ on histopathology and without contraindications to combination cisplatin-based chemotherapy, were randomized either to two cycles of gemcitabine and cisplatin chemotherapy or to follow-up and chemotherapy at the time of relapse. The study endpoints were overall, cancer-specific, and disease-free survival.
Results


The study included 100 patients, of whom 53 received AC and the other 47 were assigned to the control arm. Out of 53 allocated to AC arm, 16 patients did not start chemotherapy or received only one cycle of AC. The median follow-up for patients in the AC and control arms was 88 and 86 months, respectively. In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively.
Conclusions


Two cycles of AC with gemcitabine and cisplatin in patients with high-risk urothelial bladder cancer after radical cystectomy does not improve overall, cancer-specific, and disease-free survival. Only 53% of patients randomized to AC received the entire planned treatment.",2020,"In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively.
","['patients with a high risk of progression of muscle-invasive urothelial bladder cancer', 'patients with locally advanced bladder cancer', 'at our institution for primary or recurrent urothelial bladder cancer with stage pT3-4 and/or pN+ on histopathology and without contraindications to combination cisplatin-based chemotherapy', 'patients with high-risk urothelial bladder cancer after', '100 patients, of whom 53 received AC and the other 47 were assigned to the control arm']","['adjuvant chemotherapy (AC) with gemcitabine and cisplatin after radical cystectomy', 'radical cystectomy', 'adjuvant chemotherapy', 'gemcitabine and cisplatin chemotherapy or to follow-up and chemotherapy', 'gemcitabine and cisplatin']","['hazard ratio for death from any cause, death from bladder cancer, and disease relapse', 'overall, cancer-specific, and disease-free survival', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332393', 'cui_str': 'pT3 category'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",100.0,0.107976,"In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45-1.11; p = 0.13), 0.84 (95% CI 0.50-1.41; p = 0.51), and 0.77 (95% CI 0.46-1.28; p = 0.31), respectively.
","[{'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Zhegalik', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Sergey L', 'Initials': 'SL', 'LastName': 'Polyakov', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Rolevich', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Volkov', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Minich', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Vladimir Ju', 'Initials': 'VJ', 'LastName': 'Vasilevich', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Andrey A', 'Initials': 'AA', 'LastName': 'Mokhort', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Sergey A', 'Initials': 'SA', 'LastName': 'Krasny', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}, {'ForeName': 'Oleg G', 'Initials': 'OG', 'LastName': 'Sukonko', 'Affiliation': 'Department of Urology, N.N. Alexandrov National Research Cancer Center, Minsk, Belarus.'}]",Central European journal of urology,['10.5173/ceju.2020.0032']
447,32395324,Efficacy and safety of fURS in stones larger than 20 mm: is it still the threshold?,"Introduction


The aim of this article was to evaluate the safety and efficiency of flexible ureteroscopy (fURS) in the management of renal calculi larger than 20 mm.
Material and methods


A total of 92 cases with renal calculi were managed with fURS and divided into two groups depending on the size of the stones; <20 mm and >20 mm (Group 1 and Group 2, respectively). The groups were compared with respect to treatment-related parameters including success, complication rates, hospitalization period and need for auxiliary procedures with an emphasis on the rate of infections. Success rates were also compared in each group according to stone location.
Results


Overall success rates after 3 months showed that stone-free rates in both groups were 84.1% (< 20 mm) and 58.33% (>20 mm) respectively (p = 0.008). The success rates of upper/mid pole (100% vs. 80%) and pelvis stones (83.3% vs. 75%) showed no statistically significant difference (p = 0.5, p = 0.51 respectively). Success rates for stones located in the lower pole were 75% vs. 14.28% respectively (p = 0.008). The rate of infectious complications was significantly higher in cases undergoing fURS for relatively larger stones (22.9%) as compared to smaller calculi (6.8%) (p = 0.032). No complications were recorded in Group 1, while 2 cases in Group 2 (4.1%) developed ureteral stricture.
Conclusions


Despite the relatively low stone-free rates in lower pole stones, our current results indicate that fURS can be an effective and safe treatment alternative to PNL in larger renal stones (>20 mm) located in the pelvis and in the upper part of the calyceal system of the involved kidney.",2020,Success rates for stones located in the lower pole were 75% vs. 14.28% respectively (p = 0.008).,"['92 cases with renal calculi were managed with', 'stones larger than 20 mm', 'renal calculi larger than 20 mm']","['fURS', 'flexible ureteroscopy (fURS']","['safety and efficiency', 'Overall success rates', 'stone-free rates', 'success rates of upper/mid pole', 'Efficacy and safety', 'No complications', 'rate of infectious complications', 'ureteral stricture', 'success, complication rates, hospitalization period and need for auxiliary procedures with an emphasis on the rate of infections', 'pelvis stones', 'Success rates']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3887590', 'cui_str': 'Stricture of ureter'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]",92.0,0.0299937,Success rates for stones located in the lower pole were 75% vs. 14.28% respectively (p = 0.008).,"[{'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Karagöz', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Ismet Bilger', 'Initials': 'IB', 'LastName': 'Erihan', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Ömer Gökhan', 'Initials': 'ÖG', 'LastName': 'Doluoğlu', 'Affiliation': 'Department of Urology, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Çağlar', 'Initials': 'Ç', 'LastName': 'Uğurlu', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bağcıoğlu', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Uslu', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Sarıca', 'Affiliation': 'Department of Urology, Kafkas University Faculty of Medicine, Kars, Turkey.'}]",Central European journal of urology,['10.5173/ceju.2020.0056']
448,32395440,Effects of Chromium Picolinate Supplementation on Cardiometabolic Biomarkers in Patients with Type 2 Diabetes Mellitus: a Randomized Clinical Trial.,"Type 2 diabetes mellitus (T2DM) is a serious public health problem accompanies with several complications. This study was conducted to evaluate the effects of chromium picolinate (CrPic) supplementation on the glycemic status and lipid profile in patients with T2DM. The patients with T2DM (n = 52) were randomly allocated into 2 groups. One group received 400 µg CrPic per day and the other group took placebo; the intervention duration was 8 weeks. Anthropometric indices and metabolic factors were measured at the beginning, and at end of the study. The patients were recommended not to change their normal diet, life style and medication. No significant changes were observed for weight, body mass index, and fasting blood glucose (FBG) in both groups; while intra-groups changes in homeostatic model assessment for insulin resistance (HOMA-IR) value was significant (p < 0.05). Results of analysis of covariance showed that there were significance differences between groups in total cholesterol, low density lipoprotein cholesterol and HOMA-IR at the end of the intervention adjusting for baseline levels (p = 0.035, 0.030 and < 0.001, respectively). In this study, oral supplementation with 400 µg CrPic for eight weeks did not alter FBG concentration as well as anthropometric parameters in individuals with T2DM. However, the modest beneficial effects of chromium supplementation on insulin resistance as indicated by HOMA-IR and lipid profile were found.",2020,"No significant changes were observed for weight, body mass index, and fasting blood glucose (FBG) in both groups; while intra-groups changes in homeostatic model assessment for insulin resistance (HOMA-IR) value was significant (p < 0.05).","['patients with T2DM (n = 52', 'Type 2 diabetes mellitus (T2DM', 'individuals with T2DM', 'Patients with Type 2 Diabetes Mellitus', 'patients with T2DM']","['chromium supplementation', '400 µg CrPic per day and the other group took placebo', 'chromium picolinate (CrPic) supplementation', 'Chromium Picolinate Supplementation']","['total cholesterol, low density lipoprotein cholesterol and HOMA-IR', 'insulin resistance', 'Anthropometric indices and metabolic factors', 'HOMA-IR and lipid profile', 'FBG concentration', 'glycemic status and lipid profile', 'Cardiometabolic Biomarkers', 'homeostatic model assessment for insulin resistance (HOMA-IR) value', 'weight, body mass index, and fasting blood glucose (FBG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",52.0,0.0250518,"No significant changes were observed for weight, body mass index, and fasting blood glucose (FBG) in both groups; while intra-groups changes in homeostatic model assessment for insulin resistance (HOMA-IR) value was significant (p < 0.05).","[{'ForeName': 'Aria Tavakoli', 'Initials': 'AT', 'LastName': 'Talab', 'Affiliation': ""Be'sat Hospital, Hamadan University of Medical Sciences, Hamadan 6517838678, Iran.""}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}, {'ForeName': 'Seyyed Mustafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Pasdar', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}, {'ForeName': 'Shahryar', 'Initials': 'S', 'LastName': 'Eghtesadi', 'Affiliation': 'Islamic Azad University; Tehran Medical Branch and Science & Research Branch, Tehran 1477983855, Iran.'}, {'ForeName': 'Azimeh', 'Initials': 'A', 'LastName': 'Izadi', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz 5166614711, Iran.""}, {'ForeName': 'Mir Amir', 'Initials': 'MA', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Urmia University of Medical Sciences, Urmia 5714783734, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hossseini Azar', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Urmia University of Medical Sciences, Urmia 5714783734, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran 1593716615, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mehaki', 'Affiliation': 'Department of Biostatistics, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6715847141, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Department of Nutrition, Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6719851351, Iran.'}]",Clinical nutrition research,['10.7762/cnr.2020.9.2.97']
449,32395474,The effect of RAS blockers on the clinical characteristics of COVID-19 patients with hypertension.,"Background


Coronavirus disease 2019 (COVID-19), caused by a novel coronavirus (designated as SARS-CoV-2) has become a pandemic worldwide. Based on the current reports, hypertension may be associated with increased risk of sever condition in hospitalized COVID-19 patients. Angiotensin-converting enzyme 2 (ACE2) was recently identified to functional receptor of SARS-CoV-2. Previous experimental data revealed ACE2 level was increased following treatment with ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). Currently doctors concern whether these commonly used renin-angiotensin system (RAS) blockers-ACEIs/ARBs may increase the severity of COVID-19.
Methods


We extracted data regarding 50 hospitalized hypertension patients with laboratory confirmed COVID-19 in the Renmin Hospital of Wuhan University from Feb 7 to Mar 03, 2020. These patients were grouped into RAS blockers group (Group A, n=20) and non-RAS blockers group (Group B, n=30) according to the basic blood pressure medications. All patients continued to use pre-admission antihypertensive drugs. Clinical severity (symptoms, laboratory and chest CT findings, etc.), clinical course, and short time outcome were analyzed after hospital admission.
Results


Ten (50%) and seventeen (56.7%) of the Group A and Group B participants were males (P=0.643), and the average age was 52.65±13.12 and 67.77±12.84 years (P=0.000), respectively. The blood pressure of both groups was under effective control. There was no significant difference in clinical severity, clinical course and in-hospital mortality between Group A and Group B. Serum cardiac troponin I (cTnI) (P=0.03), and N-terminal (NT)-pro hormone BNP (NT-proBNP) (P=0.04) showed significant lower level in Group A than in Group B. But the patients with more than 0.04ng/mL or elevated NT-proBNP level had no statistical significance between the two groups. In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
Conclusions


We observed there was no obvious difference in clinical characteristics between RAS blockers and non-RAS blockers groups. These data suggest ACEIs/ARBs may have few effects on increasing the clinical severe conditions of COVID-19.",2020,"In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
","['COVID-19 patients with hypertension', '50 hospitalized hypertension patients with laboratory confirmed COVID-19 in the Renmin Hospital of Wuhan University from Feb 7 to Mar 03, 2020', 'hospitalized COVID-19 patients']","['non-RAS blockers', 'RAS blockers', 'Angiotensin-converting enzyme 2 (ACE2']","['Clinical severity (symptoms, laboratory and chest CT findings, etc.), clinical course, and short time outcome', 'blood pressure', 'elevated NT-proBNP level', 'cTnI or NT-proBNP level', 'clinical severity, clinical course and in-hospital mortality', 'ACE2 level', 'Serum cardiac troponin I (cTnI) (P=0.03), and N-terminal (NT)-pro hormone BNP (NT-proBNP']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449259', 'cui_str': 'Clinical course'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.0317682,"In patients over 65 years or under 65 years, cTnI or NT-proBNP level showed no difference between the two groups.
","[{'ForeName': 'Zheyong', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jiatian', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yumeng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Infection Disease, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xuejuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Critical Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Critical Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Chouwen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yunzeng', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Kaihuan', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Hepatobiliary Surgery, Renmin Hospital of Wuhan University, Wuhan 430200, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}]",Annals of translational medicine,['10.21037/atm.2020.03.229']
450,32395481,TRIB3  rs6037475 is a potential biomarker for predicting felodipine drug response in Chinese patients with hypertension.,"Background


Our previous studies have found that single nucleotide polymorphisms (SNPs) of  tribbles homolog 3  ( TRIB3 ) are related to the hypotensive effects of calcium-channel blockers (CCBs) and angiotensin-converting enzyme (ACE) inhibitors. In this study, we aimed at exploring and validating the effect of  TRIB3  polymorphism on antihypertensive drugs responses.
Methods


A total of 830 hypertensive patients, who were administered with open-labeled hydrochlorothiazide (12.5 mg once daily) and randomly assigned to off-labeled felodipine (5 mg) or a matched placebo combination treatment (1:1), were selected from the Felodipine Event Reduction (FEVER) study. A strategy of screening 259 samples and validating the remaining 531 samples was implemented. Four functional SNPs were selected (rs2295490, rs11470129, rs4815567 and rs6037475 in  TRIB3 ). A mixed linear model was performed to analyze the effects of  TRIB3  SNPs on antihypertensive drugs responses.
Results


We found that  TRIB3  rs6037475 CC genotype was associated with a reduction of diastolic blood pressure (DBP) (P=6.3×10 -3 ) in the felodipine treatment group of screening set, and was also associated with a reduction of systolic blood pressure (SBP) (P=0.021), DBP (P=6.0×10 -3 ) and mean arterial pressure (MAP) (P=0.021) in the felodipine treatment group of the validation set. As for the reductions influenced by the rs2295490, rs11470129 and rs4815567 genetic variations, however, the adjusted P-value did not reach statistical significance. Combined screening and validation set analysis found that patients with  TRIB3  rs6037475 CC genotype had a significant higher mean SBP, DBP and MAP than those with TT genotype in the felodipine treatment group (CC  vs . TT -10.2±0.74  vs . -17.8±0.21, P=7.8×10 -3 ; -4.6±0.50  vs . -10.2±0.23, P=3.0×10 -4 ; -6.5±0.54  vs.  -12.7±0.14, P=3.0×10 -4 , respectively).
Conclusions


These results suggest that  TRIB3  rs6037475 genetic variation can be useful as a bio-marker for predicting felodipine drug response in Chinese patients with hypertension.",2020,"Combined screening and validation set analysis found that patients with  TRIB3  rs6037475 CC genotype had a significant higher mean SBP, DBP and MAP than those with TT genotype in the felodipine treatment group (CC  vs .","['Chinese patients with hypertension', '830 hypertensive patients']","['Felodipine', 'labeled felodipine', 'open-labeled hydrochlorothiazide', 'placebo combination treatment', 'felodipine']","['mean arterial pressure (MAP', 'mean SBP, DBP and MAP', 'DBP', 'systolic blood pressure (SBP', 'diastolic blood pressure (DBP']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517889', 'cui_str': '830'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0015772', 'cui_str': 'Felodipine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",830.0,0.0196581,"Combined screening and validation set analysis found that patients with  TRIB3  rs6037475 CC genotype had a significant higher mean SBP, DBP and MAP than those with TT genotype in the felodipine treatment group (CC  vs .","[{'ForeName': 'Fazhong', 'Initials': 'F', 'LastName': 'He', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, China.'}, {'ForeName': 'Mouze', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Yinxiang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department II of Thoracic Medicine, Hunan Cancer Hospital, Changsha 519000, China.'}, {'ForeName': 'Ligong', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410078, China.'}, {'ForeName': 'Zhiling', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Zhuhai People's Hospital (Zhuhai hospital affiliated with Jinan University), Zhuhai 519000, China.""}]",Annals of translational medicine,['10.21037/atm.2020.03.176']
451,32395806,Preoperative hypnosis for pain management after arthroscopic repair of anterior cruciate ligament.,"BACKGROUND


The practice of hypnoanalgesia in orthopedics is rare and the literature is poor.
AIM


The purpose of this pilot study was to verify the efficacy of hypnosis for the management of postoperative analgesia after arthroscopic repair of anterior cruciate ligament.
METHODS


This was a prospective clinical trial over a period of 6 months (March - August 2015) including 25 patients scheduled for arthroscopic repair of anterior cruciate ligament under spinal anesthesia. All these patients had preoperative hypnosis in addition to the standard multimodal analgesia protocol (group H) and were compared to historical group (group S) who received only a standard multimodal analgesia protocol.
RESULTS


Pain scores were significantly lower for the hypnosis group during the first 48 hours postoperatively (p = 0,006). The total dose of morphine at 48 hours was: 13,6 mg (95% CI [4,58; 22,62]) in the group H and 10,2 mg (95% CI [1,64 ; 18,76]) in group S with no statistically significant difference (p = 0,178) Conclusion: Results of this pilot study in orthopedic surgery suggested that hypnosis reduced postoperative pain scores as demonstrated in other surgeries.",2020,"RESULTS


Pain scores were significantly lower for the hypnosis group during the first 48 hours postoperatively (p = 0,006).","['pain management after arthroscopic repair of anterior cruciate ligament', '25 patients scheduled for arthroscopic repair of anterior cruciate ligament under spinal anesthesia']","['hypnosis', 'Preoperative hypnosis', 'morphine']","['postoperative pain scores', 'Pain scores']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",25.0,0.0582498,"RESULTS


Pain scores were significantly lower for the hypnosis group during the first 48 hours postoperatively (p = 0,006).","[{'ForeName': 'Khaireddine', 'Initials': 'K', 'LastName': 'Raddaoui', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Radhouani', 'Affiliation': ''}, {'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Zoghlami', 'Affiliation': ''}, {'ForeName': 'Emna', 'Initials': 'E', 'LastName': 'Trigui', 'Affiliation': ''}, {'ForeName': 'Hayet', 'Initials': 'H', 'LastName': 'Maghraoui', 'Affiliation': ''}, {'ForeName': 'Olfa', 'Initials': 'O', 'LastName': 'Kaabachi', 'Affiliation': ''}]",La Tunisie medicale,[]
452,32395828,Retention of basic suturing skills with brief or extended practice in veterinary students.,"OBJECTIVE


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


Prospective study.
SAMPLE POPULATION


Fifteen first-year veterinary students.
METHODS


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


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


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


Prolonged distributed practice is recommended to train students for more complex tasks such as placement of a strangle knot.",2020,These students lost some confidence (P = .03) and repositioned suture more frequently (P = .03) while constructing the strangle knot at the final time point compared with students trained for 8 weeks.,"['Students', 'veterinary students', 'Fifteen first-year veterinary students']","[""2-week practice (TWP) or an 8-week practice (EWP) to learn how to tie surgeon's, strangle, and miller's knots""]",['superior knot tying skills'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0560032', 'cui_str': 'knot'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0560032', 'cui_str': 'knot'}]",,0.0300033,These students lost some confidence (P = .03) and repositioned suture more frequently (P = .03) while constructing the strangle knot at the final time point compared with students trained for 8 weeks.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shaver', 'Affiliation': 'Department of Specialty Medicine, College of Veterinary Medicine, Midwestern University, Glendale, Arizona.'}, {'ForeName': 'Nalani', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'College of Veterinary Medicine, Midwestern University, Glendale, Arizona.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Clinical Sciences, College of Veterinary Medicine, Auburn University, Auburn, Alabama.'}]",Veterinary surgery : VS,['10.1111/vsu.13439']
453,32395836,Effectiveness of an avatar educational application for improving heart failure patients' knowledge and self-care behaviors: A pragmatic randomized controlled trial.,"AIM


To evaluate the effectiveness of education using avatars for improving patients' heart failure knowledge and self-care.
BACKGROUND


A lack of knowledge and self-care contributes to poor outcomes and rehospitalization for people with heart failure.
DESIGN


A multi-centered, non-blinded pragmatic randomized controlled trial.
METHODS


Heart failure patients were randomly assigned to intervention (avatar education application) or usual care groups. Participants were followed up at baseline, 30 days and 90 days. ANCOVA was used to compare the scores of heart failure knowledge and self-care, between the two groups. Fisher's Exact test was used to compare the two groups' HF-cause readmission. Bivariate exact binary logistic regression was used to identity the predictors associated with baseline levels of knowledge.
RESULTS


A total of 36 participants were recruited (between October 2018 and March 2019). The mean age of participants was 67.5 (SD 11.3) years; At enrollment, approximately half (47.2%) have been living with Heart Failure for over five years. Two groups were comparable at baseline in their demographic and clinical characteristics. At 90 days, the intervention group participants had a higher increase in knowledge score on the Dutch Heart Failure Knowledge Scales compared with the control group (22.2% vs. 3.7% p = 0.002, partial η 2  =0.262, 95% CI -2.755, -0.686). There was no between-group difference observed at 30-day or 90-day follow-up, on self-care behaviour (Self-care of heart failure index) or healthcare use. Overall satisfaction with the avatar app was 91.3%.
CONCLUSION


The addition of a co-designed avatar app to usual care improved knowledge in our group of Heart Failure participants at 30 days and continued to increase up to 90 days. The results suggest that our avatar app was perceived as an enjoyable and engaging means of delivering critical knowledge and self-care information.
IMPACT


Heart failure is associated with poor clinical outcomes (i.e. readmission rates and mortality rate) and substantial economic burden. The effectiveness of Heart Failure patient education using avatar have not been investigated previously. In this study, the avatar app improved knowledge and self-care behaviors. This innovation could be used at the bedside, at home by nurses, patients and families.",2020,"At 90 days, the intervention group participants had a higher increase in knowledge score on the Dutch Heart Failure Knowledge Scales compared with the control group (22.2% vs. 3.7% p = 0.002, partial η 2  =0.262, 95% CI -2.755, -0.686).","['Heart failure patients', 'The\u202fmean\xa0age\u202fof participants was\u202f67.5 (SD 11.3) years', 'A total of 36 participants were recruited (between October 2018 and March 2019', 'people with heart failure']","['avatar educational application', 'intervention (avatar education application) or usual care groups']","['knowledge score on the Dutch Heart Failure Knowledge Scales', '30-day or 90-day follow-up, on self-care behaviour (Self-care of heart failure index) or healthcare use', 'scores of heart failure knowledge and self-care', ""heart failure patients' knowledge and self-care behaviors"", 'Overall\u202fsatisfaction', 'knowledge and self-care behaviors']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",36.0,0.0906889,"At 90 days, the intervention group participants had a higher increase in knowledge score on the Dutch Heart Failure Knowledge Scales compared with the control group (22.2% vs. 3.7% p = 0.002, partial η 2  =0.262, 95% CI -2.755, -0.686).","[{'ForeName': 'Parichat', 'Initials': 'P', 'LastName': 'Wonggom', 'Affiliation': 'Department of Adult Nursing, Faculty of Nursing, Khon Kaen University, Khon kaen, Thailand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nolan', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Adelaide, South Australia, Adelaide, Australia.'}, {'ForeName': 'Robyn A', 'Initials': 'RA', 'LastName': 'Clark', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Adelaide, South Australia, Adelaide, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Barry', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Adelaide, South Australia, Adelaide, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Burdeniuk', 'Affiliation': 'Cardiac Services, Flinders Medical Centre, Southern Adelaide Local Health Network Adelaide, South Australia, Adelaide, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nesbitt', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Adelaide, South Australia, Adelaide, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': ""O'toole"", 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Adelaide, South Australia, Adelaide, Australia.'}, {'ForeName': 'Huiyun', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University Adelaide, South Australia, Adelaide, Australia.'}]",Journal of advanced nursing,['10.1111/jan.14414']
454,32395842,Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).,"AIM


To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact ®  ) against a silver dressing (Aquacel ®  Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain and time to complete healing.
DESIGN


Open randomized controlled trial, with blinded endpoint.
METHODS


Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 subjects recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, time to healing), level of pain, adverse effects and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA typing technique through polymerase chain reaction to obtain the level of colony forming units. Measures will be collected at baseline, 4, 8 and 12 weeks.
DISCUSSION


Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced.
IMPACT


Current evidence regarding the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design, based on conditions of routine clinical practice in Primary Health Care and nursing homes.",2020,"Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced.
","['Primary Health Care and nursing homes', 'chronic venous leg ulcers', 'Patients with chronic venous leg ulcers with signs of critical colonization', '204 subjects recruited in Primary Health Care and nursing homes', ""microorganisms' colonization of vascular ulcers""]","['hydrophobic dressing', 'hydrophobic dressing (Cutimed Sorbact ®  ) against a silver dressing (Aquacel ®  Ag Extra', 'Hydrophobic dressings']","['sociodemographic variables, wound-related variables (area, exudate, time to healing), level of pain, adverse effects and health-related quality of life', 'health-related quality of life, level of pain and time to complete healing']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1319597', 'cui_str': 'Silver dressing'}, {'cui': 'C0967370', 'cui_str': 'Aquacel'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",204.0,0.0905079,"Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced.
","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Morilla-Herrera', 'Affiliation': 'University of Málaga, Faculty of Health Sciences. Department of Nursing, Málaga, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Morales-Asencio', 'Affiliation': 'University of Málaga, Faculty of Health Sciences. Department of Nursing, Málaga, Spain.'}, {'ForeName': 'Alberto José', 'Initials': 'AJ', 'LastName': 'Gómez-González', 'Affiliation': 'University of Málaga, Faculty of Health Sciences. Department of Nursing, Málaga, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Díez-de Los Ríos', 'Affiliation': 'Distrito Sanitario Málaga - Valle del Guadalhorce, Málaga, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Lupiáñez-Pérez', 'Affiliation': 'University of Málaga, Faculty of Health Sciences. Department of Nursing, Málaga, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'García-Mayor', 'Affiliation': 'University of Málaga, Faculty of Health Sciences. Department of Nursing, Málaga, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aranda-Gallardo', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Moya-Suárez', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Shakira', 'Initials': 'S', 'LastName': 'Kaknani-Uttumchandani', 'Affiliation': 'University of Málaga, Faculty of Health Sciences. Department of Nursing, Málaga, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Acosta-Andrade', 'Affiliation': ''}]",Journal of advanced nursing,['10.1111/jan.14412']
455,32395892,Resting-state and task-based centrality of dorsolateral prefrontal cortex predict resilience to 1 Hz repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is used to investigate normal brain function in healthy participants and as a treatment for brain disorders. Various subject factors can influence individual response to rTMS, including brain network properties. A previous study by our group showed that ""virtually lesioning"" the left dorsolateral prefrontal cortex (dlPFC; important for cognitive flexibility) using 1 Hz rTMS reduced performance on a set-shifting task. We aimed to determine whether this behavioural response was related to topological features of pre-TMS resting-state and task-based functional networks. 1 Hz (inhibitory) rTMS was applied to the left dlPFC in 16 healthy participants, and to the vertex in 17 participants as a control condition. Participants performed a set-shifting task during fMRI at baseline and directly after a single rTMS session 1-2 weeks later. Functional network topology measures were calculated from resting-state and task-based fMRI scans using graph theoretical analysis. The dlPFC-stimulated group, but not the vertex group, showed reduced setshifting performance after rTMS, associated with lower task-based betweenness centrality (BC) of the dlPFC at baseline (p = .030) and a smaller reduction in task-based BC after rTMS (p = .024). Reduced repeat trial accuracy after rTMS was associated with higher baseline resting state node strength of the dlPFC (p = .017). Our results suggest that behavioural response to 1 Hz rTMS to the dlPFC is dependent on baseline functional network features. Individuals with more globally integrated stimulated regions show greater resilience to rTMS effects, while individuals with more locally well-connected regions show greater vulnerability.",2020,"The dlPFC-stimulated group, but not the vertex group, showed reduced setshifting performance after rTMS, associated with lower task-based betweenness centrality (BC) of the dlPFC at baseline (p = .030) and a smaller reduction in task-based BC after rTMS (p = .024).","['healthy participants', '16 healthy participants, and to the vertex in 17 participants as a control condition']","['Hz (inhibitory) rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['setshifting performance', 'lower task-based betweenness centrality (BC) of the dlPFC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",16.0,0.018738,"The dlPFC-stimulated group, but not the vertex group, showed reduced setshifting performance after rTMS, associated with lower task-based betweenness centrality (BC) of the dlPFC at baseline (p = .030) and a smaller reduction in task-based BC after rTMS (p = .024).","[{'ForeName': 'Sophie M D D', 'Initials': 'SMDD', 'LastName': 'Fitzsimmons', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Douw', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Ysbrand D', 'Initials': 'YD', 'LastName': 'van der Werf', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Anatomy and Neurosciences, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vriend', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, De Boelelaan 1117, Amsterdam, Netherlands.'}]",Human brain mapping,['10.1002/hbm.25005']
456,32396095,Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games for Children with Hemiplegia: Development and Proof-of-Concept.,"We describe the development and three case reports of a home-based intervention for children with hand hemiplegia that integrates custom video games with contralaterally controlled functional electrical stimulation (CCFES). With CCFES, stimulated opening of the more-affected hand is modulated by volitional opening of the less-affected hand. Video games that solicit goal-oriented, skill-requiring movement have shown promise for treating hemiplegia, but they have not previously been combined with electrical stimulation in children. Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia were assigned six weeks of therapy in lab and at home. The goal was to determine if children could tolerate 9 lab treatment sessions and administer up to 7.5 hrs/wk of CCFES video game therapy at home. The feasibility of this intervention for home use was assessed by device logs, end-of-treatment interviews, and motor function/impairment assessments. With caregiver help, the children were all able to attend 9 lab sessions and built up to 7.5 hrs/wk of therapy by week 3. They averaged 5-7 hrs/wk of home intervention overall. Motor outcomes improved for all three participants at treatment end, but mostly regressed at 4-weeks follow-up. Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2. We found preliminary indications that CCFES-integrated video game therapy can provide a high dose of hand motor control therapy at home and in the lab. Improvements in motor outcomes were also observed, but more development and study is needed.",2020,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","['Children with Hemiplegia', 'Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia', 'children with hand hemiplegia that integrates']","['custom video games with contralaterally controlled functional electrical stimulation (CCFES', 'CCFES-integrated video game therapy', 'home-based intervention', 'CCFES video game therapy', 'Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games']",['Motor outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.063265,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Curby', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Suder', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katholi', 'Affiliation': ''}, {'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2992036']
457,32396131,A Sexual Health Promotion App for Transgender Women (Trans Women Connected): Development and Usability Study.,"BACKGROUND


HIV severely impacts the transgender communities in the United States, and transgender women have the highest HIV incidence rates among any identified risk group. Guided by formative research with transgender women and by an expert advisory panel of transgender women, we designed a prototype mobile app to promote HIV prevention among transgender women.
OBJECTIVE


This study aimed to develop and test the usability and acceptability of the prototype Trans Women Connected mobile app.
METHODS


We engaged in a 3-phase prototype development process. After conducting formative research about the health needs of this population, we outlined a theory-based app framework and developed three prototype activities (ie, a vision board, a pre-exposure prophylaxis [PrEP] education activity, and an interactive map). We then tested the usability and acceptability of the mobile app and activities with 16 transgender women using pre- and posttests, think-aloud protocols, and open-ended questions.
RESULTS


Participants reported high acceptability for the mobile app; the mean rating across all usability and likability questions was 5.9 out of 7. Service utilization intention, goal setting, and social support increased at posttest compared with pretest. Increases in self-efficacy in finding lesbian, gay, bisexual, transgender, and queer-friendly services; intention to seek online social support; and PrEP knowledge were statistically significant. Participants described the app as attractive and useful and perceived all three activities positively.
CONCLUSIONS


This study describes the development and usability and acceptability evaluation of a prototype mobile app designed for and with transgender women for HIV prevention. The usability testing findings provided important insights toward refining and the further development of the Trans Women Connected mobile app. The results suggest that a mobile health intervention can support positive changes. The remaining development and efficacy randomized trial of the Trans Women Connected mobile app is currently underway.",2020,"Service utilization intention, goal setting, and social support increased at posttest compared with pretest.","['transgender women for HIV prevention', 'Transgender Women (Trans Women Connected']","['prototype Trans Women Connected mobile app', 'mobile health intervention']","['mean rating across all usability and likability questions', 'Service utilization intention, goal setting, and social support', 'usability and acceptability', 'self-efficacy']","[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",16.0,0.0849745,"Service utilization intention, goal setting, and social support increased at posttest compared with pretest.","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Sun', 'Affiliation': 'School of Public Health, Oregon Health & Science University-Portland State University, Portland, OR, United States.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Anderson', 'Affiliation': 'School of Public Health, Oregon Health & Science University-Portland State University, Portland, OR, United States.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Kuhn', 'Affiliation': 'dfusion, Scotts Valley, CA, United States.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Mayer', 'Affiliation': 'Department of Anthropology, Portland State University, Portland, OR, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Klein', 'Affiliation': 'Department of Anthropology, Portland State University, Portland, OR, United States.'}]",JMIR mHealth and uHealth,['10.2196/15888']
458,32396179,Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.,"Importance


Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.
Objective


To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.
Design, Setting, and Participants


Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.
Interventions


Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).
Main Outcome and Measure


The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).
Results


Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.
Conclusions and Relevance


Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.
Trial Registration


ClinicalTrials.gov Identifier: NCT01719887.",2020,"The primary outcome was Disabilities of Arm, Shoulder and Hand","['closed humeral shaft fractures', 'patients with closed humeral shaft fracture, internal fixation surgery', ' 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial', 'Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma', 'Patients', '2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019', '82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion', 'With Closed Displaced Humeral Shaft Fractures', '82 patients who were randomized (mean age, 48.9 years']","['surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing', 'Surgery vs Functional Bracing', 'surgical treatment with open reduction and internal plate fixation (n\u2009=\u200938) or to nonsurgical treatment with functional bracing (n\u2009=\u200944']","['mean DASH score', 'Disabilities of Arm, Shoulder and Hand', 'DASH) score', 'functional outcomes', 'fracture nonunion']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588210', 'cui_str': 'Bone structure of shaft of humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}]",82.0,0.141729,"The primary outcome was Disabilities of Arm, Shoulder and Hand","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Rämö', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Bakir O', 'Initials': 'BO', 'LastName': 'Sumrein', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Lepola', 'Affiliation': 'Orthopedics and Traumatology, Tampere University Hospital, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lähdeoja', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Mdas AB, Ystad, Sweden.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Orthopedics and Traumatology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3182']
459,32396180,Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.,"Importance


Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.
Objective


To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.
Design, Setting, and Participants


Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017.
Interventions


Participants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface.
Main Outcomes and Measures


The primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events.
Results


Among the 220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 [95% CI, -1.8 to -0.9]; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 [95% CI, -1.5 to -0.7]), WOMAC stiffness subscore (between-group difference, -1.4 [95% CI, -1.9 to -0.9]), and WOMAC global score (between-group difference, -1.2 [95% CI, -1.6 to -0.8]) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment.
Conclusions and Relevance


Among participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device.
Trial Registration


ClinicalTrials.gov Identifier: NCT02363712.",2020,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","['Swiss university hospital', 'Participants (N\u2009=\u2009220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017', '220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up', 'People With Knee Osteoarthritis', 'people with symptomatic knee osteoarthritis', 'participants with knee pain from osteoarthritis']","['Biomechanical Footwear', 'biomechanical footwear therapy', 'calibrated biomechanical footwear therapy', 'biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n\u2009=\u2009111) or to control footwear (n\u2009=\u2009109) that had visible outsole pods that were not adjustable and did not create a convex walking surface']","['pain and physical function', 'WOMAC physical function subscore', 'WOMAC stiffness subscore', 'Knee Pain', 'serious adverse events', 'pain', 'knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms', 'mean standardized WOMAC pain subscore', 'WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms', 'WOMAC global score']","[{'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",220.0,0.172357,"The results were consistent for WOMAC physical function subscore (between-group difference, -1.1","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Reichenbach', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England.'}, {'ForeName': 'Cesar A', 'Initials': 'CA', 'LastName': 'Hincapié', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heldner', 'Affiliation': 'Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lenz', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Harald M', 'Initials': 'HM', 'LastName': 'Bonel', 'Affiliation': 'Department for Diagnostic, Interventional, and Pediatric Radiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Jones', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford Manchester, Manchester, England.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Hawker', 'Affiliation': 'Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}]",JAMA,['10.1001/jama.2020.3565']
460,32396519,"Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.","OBJECTIVE


To describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials.
METHODS


Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 (tofacitinib and placebo) in the AS population.
RESULTS


Overall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12.
CONCLUSION


Tofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.",2020,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","['patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis', 'patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS', 'patients with inflammatory rheumatic musculoskeletal diseases', 'Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment', '3330 patients were included in this analysis']","['tofacitinib 5 or 10 mg twice daily or placebo', 'conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS', 'tofacitinib', 'placebo']","['multiple pain measures', 'pain improvements', ""Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3"", 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}]",3330.0,0.247993,"In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6).","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Glasgow Biomedical Research Centre, Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Rheumatology Research Group, Swedish Medical Center and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Baer', 'Affiliation': 'Baer Weinberg MPC, Scarborough, Ontario, Canada.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Lukic', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gruben', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA David.Gruben@pfizer.com.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Ming-Ann', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Maniccia', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}]",RMD open,['10.1136/rmdopen-2019-001042']
461,32396535,"Proficiency based progression simulation training significantly reduces utility strikes; A prospective, randomized and blinded study.","OBJECTIVES


We evaluated a simulation-based training curriculum with quantitatively defined performance benchmarks for utility workers location and excavation of utility services.
BACKGROUND


Damaging buried utilities is associated with considerable safety risks to workers and substantial cost to employers.
METHODS


In a prospective, randomized and blinded study we assessed the impact of Proficiency Based Progression (PBP) simulation training on the location and excavation of utility services work.
RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group. When implemented across all workers in the same division there was a 35-61% reduction in utility strikes (p = 0.028) and an estimated cost saving of £116,000 -£2,175,000 in the 12 months (47,000 work hours) studied.
CONCLUSIONS


The magnitude of the training benefit of PBP simulation training in the utilities sector appears to be the same as it is in surgery, cardiology and procedure-based medicine.
APPLICATION


Quality-assured utility worker simulation training significantly reduces utility damage and associated costs.",2020,"RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group.",[],"['Proficiency based progression simulation training', 'PBP simulation training', 'Proficiency Based Progression (PBP) simulation training']","['performance errors', 'utility strikes']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]",,0.038472,"RESULTS


PBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group.","[{'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Faculty of Life and Health Sciences, Ulster University, Magee Campus, Londonderry, Northern Ireland, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': 'Group Training and Development Manager, ReachActive Unit 4B Lough Sheever Corporate Park, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cleary', 'Affiliation': 'ReachActive, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hamilton', 'Affiliation': 'ReachActive, Hertford, England, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGlinchey', 'Affiliation': 'ReachActive, Mullingar, Co. Westmeath, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kiely', 'Affiliation': 'Flux Learning Ltd., Clonakilty, Co Cork, Ireland.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Bunting', 'Affiliation': 'School of Psychology, Coleraine, Co. Londonderry, Northern Ireland, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0231979']
462,32396564,The effect of monetary incentive on survey response for vulnerable children and youths: A randomized controlled trial.,"AIM


In surveys non-responders may introduce bias and lower the validity of the studies. Ways to increase response rates are therefore important. The purpose of the study was to investigate if an unconditional monetary incentive can increase the response rate for vulnerable children and youths in a postal questionnaire survey.
METHODS


The study was designed as a randomized controlled trial. The study population consisted of 262 children and youth who participated in an established intervention study aimed at creating networks for different groups of vulnerable children and youths. The mean age of the participants was 16.7 years (range 11-28) and 67.9% were female. The questionnaire was adapted to three different age groups and covered different aspects of the participants' life situation, including the dimensions from the Strengths and Difficulties Questionnaire (SDQ). In the follow-up survey, participants were randomly allocated to two groups that either received a €15 voucher for a supermarket together with the questionnaire or only received the questionnaire. We used Poisson regression to estimate the differences in response rate (Rate Ratio RR) between the intervention group and the control group.
RESULTS


The response rate was 75.5% in the intervention group and 42.9% in the control group. The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38-2.17). We did not find any significant differences in scales scores between the two groups for the five scales of the SDQ. In stratified analyses, we found the effect of the incentive to be higher for males (RR 2.81; 95% CI 1.61-4.91) than for females (1.43; 95% CI 1.12-1.84).
CONCLUSIONS


Monetary incentives can increase the response rate for vulnerable children and youths in surveys.
TRIAL REGISTRATION


The trial was retrospectively registered at ClinicalTrials.gov Identifier: NCT01741675.",2020,"The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38-2.17).","['The mean age of the participants was 16.7 years (range 11-28) and 67.9% were female', 'vulnerable children and youths', '262 children and youth who participated in an established intervention study aimed at creating networks for different groups of vulnerable children and youths', 'vulnerable children and youths in a postal questionnaire survey', 'vulnerable children and youths in surveys']","['monetary incentive', '€15 voucher for a supermarket together with the questionnaire or only received the questionnaire']","['survey response', 'response rate', 'response rate (Rate Ratio RR', 'scales scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",262.0,0.0763144,"The response rate in the intervention group was significantly higher than in the control group when adjusting for age and gender (Rate Ratio, RR 1.73; 95% CI 1.38-2.17).","[{'ForeName': 'Jan Hyld', 'Initials': 'JH', 'LastName': 'Pejtersen', 'Affiliation': 'VIVE-The Danish Center for Social Science Research, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0233025']
463,32396578,Special footwear designed for pregnant women and its effect on kinematic gait parameters during pregnancy and postpartum period.,"During pregnancy, an array of changes occurs in women body to enable the growth and development of the future baby and the consequent delivery. These changes are reflected in the range of motion of trunk, pelvis, lower limbs and other body segments, affect the locomotion and some of these changes may persist to the postpartum period. The aim of this study was to describe the changes affecting the gait during pregnancy and to determine the effect of tested footwear on kinematic gait characteristics during pregnancy as previous studies indicate that special orthopaedic insoles and footwear might be useful in prevention of the common musculoskeletal pain and discomfort related to pregnancy. Participants from the control group (n = 18), without any intervention, and the experimental group (n = 23), which was wearing the tested shoes, were measured at their 14, 28 and 37 gestational weeks and 28 weeks postpartum to capture the complete pregnancy-related changes in gait. The gait 3D kinematic data were obtained using Simi Motion System. The differences between the control and experimental group at the first data collection session in most of the analysed variables, as well as relatively high standard deviations of analysed variables indicate large individual differences in the gait pattern. The effect of tested footwear on kinematic gait pattern changes may be explained by its preventive effect against the foot arches falling. In the control group, changes associated previously with the foot arches falling and hindfoot hyperpronation were observed during advanced phases of pregnancy and postpartum, e.g. increase in knee flexion or increase in spinal curvature. For the comprehensive evaluation of the tested footwear on pregnancy gait pattern, future studies combining the kinematic and dynamic plantographic methods are needed.",2020,"The differences between the control and experimental group at the first data collection session in most of the analysed variables, as well as relatively high standard deviations of analysed variables indicate large individual differences in the gait pattern.",['pregnant women'],[],"['knee flexion or increase in spinal curvature', 'kinematic gait parameters', 'foot arches falling and hindfoot hyperpronation']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}]",,0.0341883,"The differences between the control and experimental group at the first data collection session in most of the analysed variables, as well as relatively high standard deviations of analysed variables indicate large individual differences in the gait pattern.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Gimunová', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zvonař', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sebera', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Turčínek', 'Affiliation': 'Department of Informatics, Faculty of Business and Economics, Mendel University, Brno, Czech Republic.'}, {'ForeName': 'Kateřina', 'Initials': 'K', 'LastName': 'Kolářová', 'Affiliation': 'Department of Kinesiology, Faculty of Sports Studies, Masaryk University, Brno, Czech Republic.'}]",PloS one,['10.1371/journal.pone.0232901']
464,32396592,Kinetic profile and urinary excretion of phenyl-γ-valerolactones upon consumption of cranberry: a dose-response relationship.,"Cranberries are a rich source of poly(phenols), mainly monomeric and oligomeric flavan-3-ols. However, information on the appearance of their main circulating microbial metabolites, namely phenyl-γ-valerolactones and phenylvaleric acid, is lacking despite its relevance to understanding the health effects attributed to cranberries. The aim of this study was to evaluate the absorption, metabolism and urinary excretion of cranberry flavan-3-ols through the targeted analysis of phenyl-γ-valerolactones and their related phenylvaleric acids, considering also their potential as biomarkers of flavan-3-ol intake and inter-individual variability in their appearance in plasma and urine. A six-arm acute crossover, randomized, double-blinded, controlled intervention trial was performed in ten healthy males who consumed a cranberry juice drink (375, 716, 1131, 1396, 1741 mg of total flavan-3-ols) or an isocaloric control drink with one-week washout. Plasma and urine were analyzed by UHPLC-ESI-QqQ-MS/MS and 22 compounds were identified. Glucuronide and sulfate conjugates of 5-(3',4'-dihydroxyphenyl)-γ-valerolactone were the main circulating and excreted metabolites after cranberry juice intake, with glucuronidation appearing to be the most favorable conjugation route. These compounds reached maximum plasma concentration at about 4-6 h. Plasma and urinary concentrations of the sum of the metabolites increased in relation to the amounts of cranberry flavan-3-ols provided by the drink, showing a clear and linear dose-dependent relationship and underscoring their potential as biomarkers of flavan-3-ol intake. A high inter-individual variability in circulating and urinary metabolite levels was observed and, interestingly, some subjects seemed to display a greater efficiency in metabolizing flavan-3-ols and producing phenyl-γ-valerolactones.",2020,"These compounds reached maximum plasma concentration at about 4-6 h. Plasma and urinary concentrations of the sum of the metabolites increased in relation to the amounts of cranberry flavan-3-ols provided by the drink, showing a clear and linear dose-dependent relationship and underscoring their potential as biomarkers of flavan-3-ol intake.","['ten healthy males who consumed a cranberry juice drink (375, 716, 1131, 1396, 1741 mg of total flavan-3-ols) or an']","['isocaloric control drink with one-week washout', ""5-(3',4'-dihydroxyphenyl)-γ-valerolactone"", 'Glucuronide']","['circulating and urinary metabolite levels', 'absorption, metabolism and urinary excretion of cranberry flavan-3-ols', 'Plasma and urine', 'maximum plasma concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1572601', 'cui_str': 'CRANBERRY JUICE'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0443441', 'cui_str': 'Valerolactone'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.0386886,"These compounds reached maximum plasma concentration at about 4-6 h. Plasma and urinary concentrations of the sum of the metabolites increased in relation to the amounts of cranberry flavan-3-ols provided by the drink, showing a clear and linear dose-dependent relationship and underscoring their potential as biomarkers of flavan-3-ol intake.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Favari', 'Affiliation': 'Human Nutrition Unit, Department of Food & Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Human Nutrition Unit, Department of Food & Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Curti', 'Affiliation': 'Department of Food & Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Istas', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. ana.rodriguez-mateos@kcl.ac.uk.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heiss', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Parma, Italy. daniele.delrio@unipr.it and School of Advanced Studies on Food and Nutrition, University of Parma, Parma, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Mateos', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. ana.rodriguez-mateos@kcl.ac.uk.""}]",Food & function,['10.1039/d0fo00806k']
465,32395750,To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial.,"STUDY QUESTION


Is the clinical pregnancy rate (CPR) following a frozen embryo transfer (FET) in a natural cycle (NC) higher after spontaneous ovulation than after triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET]?
SUMMARY ANSWER


The CPR did not vary significantly between the two FET preparation protocols.
WHAT IS KNOWN ALREADY


Although the use of FET is continuously increasing, the most optimal endometrial preparation protocol is still under debate. For transfer in the NC specifically, conflicting results have been reported in terms of the outcome following spontaneous or triggered ovulation.
STUDY DESIGN, SIZE, DURATION


In a tertiary hospital setting, subjects were randomized with a 1:1 allocation into two groups between January 2014 and January 2019. Patients in group A underwent an NC-FET, while in group B, a modified NC-FET was performed with a subcutaneous hCG injection to trigger ovulation. In neither group was additional luteal phase support administered. All embryos were vitrified-warmed on Day 3 and transferred on Day 4 of embryonic development. The primary outcome was CPR at 7 weeks. All patients were followed further until 10 weeks of gestation when the ongoing pregnancy rate (OPR) was defined by the observation of foetal cardiac activity on ultrasound scan. Other secondary outcomes included biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET.
PARTICIPANTS/MATERIALS, SETTING, METHODS


A total of 260 patients (130 per study arm) were randomized, of whom 12 withdrew consent after study arm allocation. A total of 3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons. Of the 229 actually commencing monitoring for the study FET cycle, 7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a spontaneous LH surge before the ovulation trigger could be administered, although they were allocated to group B. Given the above, an intention-to-treat (ITT) analysis was performed taking into account 248 patients (125 in group A and 123 in group B), as well as a per protocol (PP) analysis on a subset of 173 patients (110 in group A and 63 in group B).
MAIN RESULTS AND THE ROLE OF CHANCE


Demographic features were evenly distributed between the study groups, as were the relevant fresh and frozen ET cycle characteristics. According to the ITT analysis, the CPR and OPR in group A (33.6% and 27.2%, respectively) and group B (29.3% and 24.4%, respectively) did not vary significantly [relative risk (RR) 0.87, 95% CI (0.60;1.26), P = 0.46 and RR 0.90, 95% CI (0.59;1.37), P = 0.61, respectively]. Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups. In contrast, more clinic visits and blood samplings for cycle monitoring were required in the NC-FET group (4.05 ± 1.39) compared with the modified NC-FET group (3.03 ± 1.16, P = <0.001), while the number of ultrasound scans performed were comparable (1.70 ± 0.88 in group A versus 1.62 ± 1.04 in group B). The additional PP analysis was in line with the ITT results: CPR in group A was 36.4% versus 38.1% in group B [RR 1.05, 95% CI (0.70;1.56), P = 0.82].
LIMITATIONS, REASONS FOR CAUTION


The results are limited by the high drop-out rate for the PP analysis in the modified NC-FET group as more than one-third of the subjects allocated to this group ovulated spontaneously before ovulation triggering. Nonetheless, this issue is inherent to routine clinical practice and is an important observation of an event that can only be avoided by performing a very extensive monitoring that limits the practical advantages associated with modified NC-FET. Furthermore, although this is the largest randomized controlled trial (RCT) investigating this specific research question so far, a higher sample size would allow smaller differences in clinical outcome to be detected, since currently they may be left undetected.
WIDER IMPLICATIONS OF THE FINDINGS


This RCT adds new high-quality evidence to the existing controversial literature concerning the performance of NC-FET versus modified NC-FET. Based on our results showing no statistically significant differences in clinical outcomes between the protocols, the treatment choice may be made according to the patient's and treating physician's preferences. However, the modified NC-FET strategy reduces the need for hormonal monitoring and may therefore be considered a more patient-friendly and potentially cost-effective approach.
STUDY FUNDING/COMPETING INTEREST(S)


No specific funding was available for this study. None of the authors have a conflict of interest to declare with regard to this study.
TRIAL REGISTRATION NUMBER


NCT02145819.
TRIAL REGISTRATION DATE


8 January 2014.
DATE OF FIRST PATIENT’S ENROLMENT


21 January 2014.",2020,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"['’S ENROLMENT\n\n\n21 January 2014', '3 women conceived spontaneously before initiating the study cycle and 16 did not start for personal or medical reasons', '7 patients needed to be switched to a hormonal replacement treatment protocol due to the absence of follicular development, 12 had no embryo available for transfer after warming and 37 had a', '260 patients (130 per study arm']","['FET', 'triggered ovulation [natural cycle frozen embryo transfer (NC-FET) versus modified NC-FET', 'NC-FET', 'frozen embryo transfer (FET']","['clinical pregnancy rate (CPR', 'biochemical pregnancy rate, early pregnancy loss and the number of visits, blood samples and ultrasonographic examinations prior to FET', 'CPR', 'pregnancy rate (OPR', 'spontaneous LH surge', 'Biochemical pregnancy rate and early pregnancy loss', 'clinic visits and blood samplings for cycle monitoring', 'number of ultrasound scans']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",3.0,0.159805,Biochemical pregnancy rate and early pregnancy loss were also found to be not statistically significantly different between the groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stubbe', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'Valencian Institute of Infertility Reproductive Medicine Associates (IVI-RMA) Lisboa, Avenida Infante Dom Henrique 333 H 1-9, 1800-282 Lisbon, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Van Landuyt', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roelens', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Camus', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Vos', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van de Vijver', 'Affiliation': 'Fertiliteit, AZ Sint-Jan, Ruddershove 10, 8000 Brugge, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa026']
466,32395800,Simulation training for continuing professional development of nurses in cardiology and cardiovascular surgery.,"BACKGROUND


Nurses play a key role in cardiac arrest management, especially those assigned to cardiac intensive care units, where they are often actively involved in cardiopulmonary resuscitation.
AIM


To evaluate the effect of simulation training in in continuing professional development of nurses in this setting.
METHODS


A comparative study using paired samples (where the candidate was his own control with repeated measures before and after intervention), was conducted among nurses working in the cardiology and cardiovascular surgery division of our institution. The primary endpoint was the change in skills judged on the basis of competency score of 20 assessed before and after simulation training.
RESULTS


32 nurses participated in the training session. Despite a median job seniority of 8.5 years [4.0 - 12.5], only 44% of nurses had already participated in a simulation session. Although most of the candidates (84%) had previously performed chest compressions, only 34% had delivered an electrical defibrillation during their exercise. We showed a significant increase in overall scores from 8.0 [5.0 - 9.8] to 17.5 [17.0 - 19.0] after the simulation training session (p<0.0001). All the criteria judged in the evaluation grid (basic life support, manual electrical defibrillation) were significantly improved and the most positive effect was observed in the manual defibrillation where the prior experience of the participants was limited.
CONCLUSIONS


Simulation learning had a major positive impact on the development of nurses' skills in terms of cardiopulmonary resuscitation.",2020,"All the criteria judged in the evaluation grid (basic life support, manual electrical defibrillation) were significantly improved and the most positive effect was observed in the manual defibrillation where the prior experience of the participants was limited.
","['32 nurses participated in the training session', 'nurses in cardiology and cardiovascular surgery']","['Simulation training', 'simulation training']","['change in skills judged on the basis of competency score', 'overall scores']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",32.0,0.0462256,"All the criteria judged in the evaluation grid (basic life support, manual electrical defibrillation) were significantly improved and the most positive effect was observed in the manual defibrillation where the prior experience of the participants was limited.
","[{'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Boudiche', 'Affiliation': ''}, {'ForeName': 'Saida', 'Initials': 'S', 'LastName': 'Zelfani', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ben Hammamia', 'Affiliation': ''}, {'ForeName': 'Fathia', 'Initials': 'F', 'LastName': 'Mghaieth Zghal', 'Affiliation': ''}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Ouaghlani', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Ben Halima', 'Affiliation': ''}, {'ForeName': 'Hela', 'Initials': 'H', 'LastName': 'Manai', 'Affiliation': ''}, {'ForeName': 'Jalel', 'Initials': 'J', 'LastName': 'Ziadi', 'Affiliation': ''}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Rekik', 'Affiliation': ''}, {'ForeName': 'Monoom', 'Initials': 'M', 'LastName': 'Rajhi', 'Affiliation': ''}, {'ForeName': 'Oussema', 'Initials': 'O', 'LastName': 'Gharsallaoui', 'Affiliation': ''}, {'ForeName': 'Abdeljelil', 'Initials': 'A', 'LastName': 'Farhati', 'Affiliation': ''}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Ouali', 'Affiliation': ''}, {'ForeName': 'Noureddine', 'Initials': 'N', 'LastName': 'Larbi', 'Affiliation': ''}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Denguir', 'Affiliation': ''}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Daghfous', 'Affiliation': ''}, {'ForeName': 'Mohamed Sami', 'Initials': 'MS', 'LastName': 'Mourali', 'Affiliation': ''}]",La Tunisie medicale,[]
467,32395901,A randomised controlled trial comparing deep neuromuscular blockade reversed with sugammadex with moderate neuromuscular block reversed with neostigmine.,"Deep neuromuscular block aims to improve operative conditions during laparoscopic surgery with a lower intra-abdominal pressure. Studies are conflicting on whether meaningful improvements in quality of recovery occur beyond emergence, and whether lower intra-abdominal pressure is achieved. In this pragmatic randomised trial with 1:1 allocation, adults undergoing elective laparoscopic surgery were allocated to moderate neuromuscular block reversed with neostigmine, or deep neuromuscular block reversed with sugammadex. Allocation was revealed to the anaesthetist only. Primary outcome was cognitive recovery of the Postoperative Quality of Recovery Scale, 7 days after surgery. Secondary outcomes included recovery in other domains of the Postoperative Quality of Recovery Scale at 15 min and 40 min; days 1, 3, 7, 14; and 1 and 3 months after surgery. Chi-square test was used for the primary outcome, and generalised linear mixed model for recovery over time between groups. Of 350 participants randomised, 140 (deep) and 144 (moderate) were analysed for the primary outcome. There was no difference in the Postoperative Quality of Recovery Scale cognitive domain at day 7 (deep 92.9% vs. moderate 91.8%, OR 1.164; 95%CI 0.486-2.788, p = 0.826), or at any other time-point. No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery. Length of stay in the recovery area (mean (SD) deep 108 (58) vs. moderate 109 (57) min, p = 0.78) and hospital (1.8 (1.9) vs. 2.6 (3.5) days, p = 0.019) was not different. Intra-abdominal pressure and surgical operating conditions were not different between groups. Deep neuromuscular block did not improve quality of recovery compared with moderate neuromuscular block in operative laparoscopic surgery over a 1-h duration.",2020,"No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery.","['adults undergoing elective laparoscopic surgery', '350 participants randomised, 140 (deep) and 144 (moderate']","['neostigmine, or deep neuromuscular block reversed with sugammadex', 'neostigmine', 'laparoscopic surgery']","['Length of stay', 'Postoperative Quality of Recovery Scale cognitive domain', 'physiological, emotive, activities of daily living, nociception, or overall recovery', 'recovery in other domains of the Postoperative Quality of Recovery Scale', 'Intra-abdominal pressure and surgical operating conditions', 'cognitive recovery of the Postoperative Quality of Recovery Scale', 'quality of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",350.0,0.636283,"No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boggett', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chahal', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Griffiths', 'Affiliation': ""Department of Anaesthesia, Royal Women's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Riedel', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bowyer', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}]",Anaesthesia,['10.1111/anae.15094']
468,32395926,Blood glucose level after infusing an activated charcoal suspension for acute drug poisoning.,"OBJECTIVES


Activated charcoal in suspension contains 600 mg/mL of sucrose. We aimed to assess the impact of an activated charcoal suspension on blood glucose levels in patients with acute medication poisoning.
MATERIAL AND METHODS


We identified drug patients whose blood glucose levels were measured before and after administration of activated charcoal to treat poisoning. The impact on blood glucose level was compared to changes after breakfast in a control group not receiving treatment for poisoning.
RESULTS


Fifty-five poisoned patients were included. Eighty-two percent had higher blood glucose levels after activated charcoal administration. The mean glucose levels before and 1 hour after treatment were 98.2 mg/dL and 124.2 mg/dL, respectively (P<.001). The increase did not translate to adverse clinical events. Glucose levels increased in 82.6% of the 23 patients in the control group. Mean glucose levels before breakfast and 1 hour later were 117.1 mg/dL and 152.0 mg/dL (P<.001).
CONCLUSION


Activated charcoal induces an increase in blood glucose level that is statistically but not clinically significant. The increase is comparable to the increase after breakfast.",2020,Glucose levels increased in 82.6% of the 23 patients in the control group.,"['patients with acute medication poisoning', 'Fifty-five poisoned patients were included', 'acute drug poisoning']","['charcoal in suspension contains 600 mg/mL of sucrose', 'activated charcoal suspension', 'activated charcoal to treat poisoning']","['Blood glucose level', 'Mean glucose levels', 'blood glucose level', 'blood glucose levels', 'Glucose levels', 'mean glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}]","[{'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0001275', 'cui_str': 'Activated Charcoal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",55.0,0.0168581,Glucose levels increased in 82.6% of the 23 patients in the control group.,"[{'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Amigó-Tadín', 'Affiliation': 'Área de Urgencias, Hospital Clínic, Barcelona, España. Grupo de Investigación ""Urgencias: Procesos y patologías"", IDIBAPS, Barcelona, España.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pané-Vila', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital Clínic, Barcelona, España.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Nogué-Xarau', 'Affiliation': 'Área de Urgencias, Hospital Clínic, Barcelona, España. Grupo de Investigación ""Urgencias: Procesos y patologías"", IDIBAPS, Barcelona, España.'}]",Emergencias : revista de la Sociedad Espanola de Medicina de Emergencias,[]
469,32396017,"Effects of blackcurrant extract on arterial functions in older adults: A randomized, double-blind, placebo-controlled, crossover trial.","Purpose : Blackcurrant extract mainly contains anthocyanins. Several reports suggest that anthocyanins have beneficial effect for cardiovascular functions. The aim of this study was to examine the effect of 7-day intake of New Zealand blackcurrant (NZBC) extract on arterial functions, e.g. arterial stiffness, and serum lipids. Methods : A randomized, double-blind, placebo-controlled, crossover design study with a washout period of 28 days was conducted. Fourteen older adults participated in this study (age 73.3 ± 1.7 years). Participants took either a 7-day course of placebo or two capsules of NZBC extract (each 300 mg capsule contains 35% blackcurrant extract). Participants took one of the two trials first and then took the other after a washout period. Carotid-femoral pulse-wave velocity, an index of central arterial stiffness, and central blood pressure were measured at baseline and again at the end of the 7-day study period. Results : Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake. In addition, carotid-femoral pulse-wave velocity ( P  = .04) and central blood pressure ( P  = .001) in the NZBC intake trial decreased significantly more than in the placebo intake trial. No effects were observed on serum lipids. Conclusion : These results suggest that short-term NZBC intake reduces central arterial stiffness and central blood pressure in older adults. Therefore, anthocyanin-rich blackcurrants might be beneficial for maintaining or improving cardiovascular health as an alternative to pharmaceutical medications. Abbreviations : Aix: augmentation index; BP: blood pressure; cfPWV: carotid-femoral pulse-wave velocity;  CVD: cardiovascular diseases; DBP: diastolic blood pressure;  faPWV: femoral-ankle pulse-wave velocity; FG: fasting glucose; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol; MBP: mean blood pressure; NZBC: New Zealand blackcurrant; PP: pulse pressure; SBP: systolic blood pressure; TG: triglycerides.",2020,"Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake.","['older adults', 'Fourteen older adults participated in this study (age 73.3\xa0±\xa01.7\xa0years', 'Abbreviations ']","['anthocyanins', 'Blackcurrant extract mainly contains anthocyanins', 'blackcurrant extract', 'New Zealand blackcurrant (NZBC) extract', 'placebo or two capsules of NZBC extract', 'NZBC intake', 'placebo']","['carotid-femoral pulse-wave velocity', 'Carotid-femoral pulse-wave velocity, an index of central arterial stiffness, and central blood pressure', 'central arterial stiffness and central blood pressure', 'arterial functions', 'serum lipids', 'arterial functions, e.g. arterial stiffness, and serum lipids', 'central blood pressure']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",14.0,0.385975,"Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake.","[{'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, Tokyo, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakazato', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University, Tokyo, Japan.'}, {'ForeName': 'Mark Elisabeth Theodorus', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, Chichester, UK.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1764015']
470,32396038,Hypertrophy of Lumbopelvic Muscles in Inactive Women: A 36-Week Pilates Study.,"BACKGROUND


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


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


Controlled laboratory study.
LEVEL OF EVIDENCE


Level 3.
METHOD


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


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


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


The benefits of Pilates in rehabilitation or training are likely elicited by neuromuscular rather than morphological adaptations. Pilates has no significant impact on muscle volume and does not alter side-to-side ratios in muscle volume (degree of asymmetry) of the lumbopelvic muscles.",2020,"Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints.","['Inactive Women', 'A total of 12 inactive, healthy women (35.7 ± 5.4 years) without previous experience in Pilates']",['supervised Pilates program'],"['volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles', 'muscle volume and reduce potential side-to-side asymmetries of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles (gluteus maximus, medius, and minimus']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0224417', 'cui_str': 'Structure of iliopsoas muscle'}, {'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}]",,0.0151886,"Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints.","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dorado', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'López-Gordillo', 'Affiliation': 'Department of Physical Education Department, University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Serrano-Sánchez', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'José A L', 'Initials': 'JAL', 'LastName': 'Calbet', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Sanchis-Moysi', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}]",Sports health,['10.1177/1941738120918381']
471,32396205,Effect of Psychoeducation on Stress in Parents of Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Study.,"The current experimental pre-/posttest study sought to determine the effect of psychoeducation on the stress levels of parents of children with attention-deficit/hyperactivity disorder (ADHD). A total of 172 parents participated and were randomly assigned to experimental (n = 86) and control (n = 86) groups. There was no significant difference between mean pretest scores of parents in the experimental and control groups on the Caregiver Stress Scale (p > 0.005); however, significant differences were found between pre- and post-test scores in the experimental group after psychoeducation and at 6-month follow up (p < 0.001). There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05). In the light of the findings, psychiatric nurses can use psychoeducation programs to support families of children with ADHD to reduce their stress levels. [Journal of Psychosocial Nursing and Mental Health Services, xx(x), xx-xx.].",2020,There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05).,"['parents of children with attention-deficit/hyperactivity disorder (ADHD', '172 parents participated and were randomly assigned to experimental (n = 86) and control (n = 86) groups', 'With Attention-Deficit/Hyperactivity Disorder', 'Parents of Children']","['Psychoeducation', 'psychoeducation']","['Caregiver Stress Scale', 'pre- and posttest scores and pretest scores and 6-month follow-up scores']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",172.0,0.0289188,There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05).,"[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Gümüs', 'Affiliation': ''}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Ergün', 'Affiliation': ''}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Dikeç', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200506-01']
472,32396206,Effectiveness of a Nurse-Led Intervention for Adolescents With Problematic Internet Use.,"The current study assessed the effect of an intervention on problematic internet use (PIU), biopsychosocial functioning, and academic performance in 100 adolescents with PIU in grades 9 and 11 in Ernakulam District, Kerala, India. Students from four comparable schools were randomly assigned to experimental and wait-list control groups after being screened for PIU. The experimental group participated in a 10-week intervention and parents of these adolescents were provided with two sessions. The wait-list control group received the intervention after the posttest. A PIU questionnaire, sociodemographic data, internet usage pattern, a biopsychosocial functioning tool, and academic performance were used to assess participants at baseline and immediately after and 3 months postintervention. Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05). Thus, the intervention was effective in reducing PIU among adolescents and improved their physical, psychological, and social functioning and academic performance. [Journal of Psychosocial Nursing and Mental Health Services, xx(x), xx-xx.].",2020,"Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05).","['Students from four comparable schools', '100 adolescents with PIU in grades 9 and 11 in Ernakulam District, Kerala, India', 'Adolescents With Problematic Internet Use']",['Nurse-Led Intervention'],"['PIU; physical, psychological, and social functioning; and academic performance', 'physical, psychological, and social functioning and academic performance', 'problematic internet use (PIU), biopsychosocial functioning, and academic performance']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",100.0,0.0373189,"Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05).","[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Krishnan', 'Affiliation': ''}, {'ForeName': 'Adhin', 'Initials': 'A', 'LastName': 'Bhaskar', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200506-03']
473,32396250,"Comparison of 40% trichloroacetic acid and cryotherapy for the treatment of plantar warts; a single-blind, randomized clinical trial.","BACKGROUND


Plantar warts can cause pain near the toes and the sole of the foot and may result in referral for treatment. This study was aimed at comparing 40% trichloroacetic acid (TCA) and cryotherapy (Cryo) for the treatment of plantar warts.
METHODS


This single-blind, randomized clinical trial was performed on 60 subjects presenting with plantar wart in Sabzevar, Iran in 2018. The first intervention group was treated with 40% TCA in four sessions within four weeks. The second intervention group was treated with Cryo using liquid nitrogen in four sessions within eight weeks.
RESULTS


The mean (SD) age of subjects was 20.16 ± 5.96 years and 68.33% (n=41) were male. Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
CONCLUSION


Findings suggest that although 40% TCA was almost as effective as Cryo in the treatment of plantar warts, considering the lower adverse effects of TCA 40% group as compared to the Cryo group, it could be a proper alternative. This article is protected by copyright. All rights reserved.",2020,"Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
","['60 subjects presenting with plantar wart in Sabzevar, Iran in 2018', 'The mean (SD) age of subjects was 20.16 ±\u20095.96\u2009years and 68.33% (n=41) were male', 'plantar warts']","['Cryo using liquid nitrogen', 'TCA', 'trichloroacetic acid (TCA) and cryotherapy (Cryo', 'trichloroacetic acid and cryotherapy', '40% TCA']",['resolution rate of warts'],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}]","[{'cui': 'C0043037', 'cui_str': 'Verruca'}]",60.0,0.041248,"Although the resolution rate of warts in the TCA 40% group was greater than the Cryo group, there was no statistical association found between the two groups by adjusting age, sex, and basal time (P = 0.648).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': 'Dermatologist, Department of Dermatology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kheirkhah', 'Affiliation': 'General practitioner, Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': 'MSc in Epidemiology, Department of Biostatistics and Epidemiology, School of Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Smitha', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'MSc in Biotechnology, Clinical Research Pvt Ltd, Bangalore University, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'MSc in Epidemiology, Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Dermatologic therapy,['10.1111/dth.13559']
474,32396288,Comparison of the effects of different weekly frequencies of resistance training on metabolic health markers and body fat in older women.,"BACKGROUND


The purpose of this study was to compare the effects of a 24-week resistance-training (RT) program performed 2 vs. 3 times per week on body fat and metabolic health markers in older women.
METHODS


Thirty-nine women (≥60 years old) were randomly assigned to two groups according to RT frequency (G2x=two sessions per week, N.=19; and G3x=three sessions per week, N.=20) and were submitted to two 12-week stages of whole-body RT. In the first stage, participants performed 1 set of 10 to 15 repetitions in each of eight exercises, whereas in the second stage, they performed 2 sets of 10 to 15 repetitions. Body fat was estimated by DXA, while biochemical analyses were performed on venous blood samples collected in the morning hours after a 12 hours' fasting and after a minimum of 48 hours since the last physical exercise session.
RESULTS


After the 24 weeks of RT, only G3x significantly reduced body fat mass (G2x=0.0%; G3x=-5.1%), whereas both G2x and G3x reduced blood glucose and C-reactive protein levels. Both groups improved HDL-C after the first 12-week stage compared to baseline, although the changes from pre- to post-training were not significantly different between groups. No significant difference was observed compared to baseline for total cholesterol, VLDL-C, LDL-C, and triglycerides for either group.
CONCLUSIONS


These results suggest that RT-induced changes in health markers may occur regardless of RT frequency, whereas performing RT three times per week may be needed for reducing total body fat mass in older women.",2020,"No significant difference was observed compared to baseline for total cholesterol, VLDL-C, LDL-C, and triglycerides for either group.
","['older women', 'Thirty-nine women (≥60 years old']","['24-week resistance-training (RT) program', 'resistance training']","['blood glucose and C-reactive protein levels', 'Body fat', 'body fat and metabolic health markers', 'total cholesterol, VLDL-C, LDL-C, and triglycerides', 'total body fat mass', 'metabolic health markers and body fat', 'HDL-C', 'body fat mass']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",39.0,0.0118361,"No significant difference was observed compared to baseline for total cholesterol, VLDL-C, LDL-C, and triglycerides for either group.
","[{'ForeName': 'Fábio L', 'Initials': 'FL', 'LastName': 'Pina', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Paraná, Londrina, Brazil.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Laboratory of Metabolism, Nutrition, and Exercise, Physical Education and Sport Center, Londrina State University, Londrina, Brazil - joaonunes.jpn@hotmail.com.'}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Paraná, Londrina, Brazil.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Laboratory of Metabolism, Nutrition, and Exercise, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Letícia T', 'Initials': 'LT', 'LastName': 'Cyrino', 'Affiliation': 'Laboratory of Metabolism, Nutrition, and Exercise, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Nelson H', 'Initials': 'NH', 'LastName': 'Carneiro', 'Affiliation': 'Laboratory of Metabolism, Nutrition, and Exercise, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': 'Clinical Analyses Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Jerry L', 'Initials': 'JL', 'LastName': 'Mayhew', 'Affiliation': 'Truman State University, Kirksville, MO, USA.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Laboratory of Metabolism, Nutrition, and Exercise, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10315-3']
475,32392169,RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions: The RAMBO Trial.,"AIMS


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


RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary angiography and interventions) was a prospective, randomized, two-arm, single-centre, open-labelled trial, enrolling a total of 430 patients undergoing coronary angiography. Patients were randomly assigned to biplane or monoplane imaging. The primary efficacy measure, the operator radiation dose at the level of the left arm as measured by a wearable electronic dosimeter, was significantly higher in the biplane as compared with the monoplane group (4 [1-13] µSv versus 2 [0-6.8] µSv, p&lt;0.001). The dose area product was 11955 [7095-18246] mGy*cm2 and 8349 [5851-14159] mGy*cm2 in the biplane and the monoplane groups (p&lt;0.001). While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
CONCLUSIONS


Biplane imaging for coronary angiography and PCI is related with an increased radiation exposure to the interventional cardiologist as compared with monoplane imaging. Monoplane imaging should be considered for advanced radioprotection in cardiac catheterization, with biplane imaging used for selected cases.",2020,"While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
",['430 patients undergoing coronary angiography'],"['biplane or monoplane imaging', 'RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary angiography and interventions', 'biplane versus monoplane coronary angiography and percutaneous coronary interventions (PCI', 'RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions']","['amount of contrast medium', 'fluoroscopy time', 'operator radiation dose at the level of the left arm as measured by a wearable electronic dosimeter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0230347', 'cui_str': 'Left upper arm structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0180488', 'cui_str': 'Dosimeter'}]",430.0,0.0355147,"While fluoroscopy time did not differ among groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p&lt;0.001).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Leistner', 'Affiliation': 'Department of Cardiology, Charité Berlin - University Medicine, Campus Benjamin Franklin, Berlin; and DZHK (German Centre for Cardiovascular Research), partner site Berlin, Berlin, Germany.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Schlender', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steiner', 'Affiliation': ''}, {'ForeName': 'Aslihan', 'Initials': 'A', 'LastName': 'Erbay', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Klotsche', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schauerte', 'Affiliation': ''}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Haghikia', 'Affiliation': ''}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Rauch-Kröhnert', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sinning', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': ''}, {'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Mochmann', 'Affiliation': ''}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Skurk', 'Affiliation': ''}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': ''}, {'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Stähli', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00217']
476,32392381,Early parenting intervention promotes 24-month psychomotor development in preterm children.,"AIM


Although parenting is key to promoting healthy development of at-risk preterm infants, parents have often restricted access to neonatal intensive care units (NICUs). This study aimed to assess the effect of an early parenting intervention on the psychomotor outcome in preterm children at 24 months corrected age.
METHODS


Forty-two preterm children and their parents were consecutively recruited at a level III NICU in Northern Italy and randomly allocated to early intervention (two educational peer-group sessions and four individual infant observation sessions) or care as usual (no educational or infant observation sessions). During NICU stay parents provided information on daily holding and skin-to-skin. Psychomotor development was measured at 24 months of corrected age using the Griffith Mental Development Scales.
RESULTS


There were no significant differences in socio-demographic and clinical variables between early intervention (n = 21; 13 females) and care as usual (n = 21; 12 females) groups. At 24 months corrected age, children in the early intervention arm had greater scores for global psychomotor development as well as for Hearing-Speech and Personal-Social sub-scales, compared to those in the care as usual group.
CONCLUSION


The present NICU parenting intervention was found to be associated with better psychomotor outcomes in preterm children at 24-month-age. The effects were especially evident for domains related to language and socio-emotional functioning. Results are promising and should be retested with more heterogenous and representative preterm sample.",2020,There were no significant differences in socio-demographic and clinical variables between early intervention (n = 21; 13 females) and care as usual (n = 21; 12 females) groups.,"['preterm children at 24 months corrected age', 'preterm children at 24-month-age', 'Forty-two preterm children and their parents were consecutively recruited at a level III NICU in Northern Italy and randomly allocated to', 'preterm children']","['NICU parenting intervention', 'early parenting intervention', 'Early parenting intervention', 'early intervention (two educational peer-group sessions and four individual infant observation sessions) or care as usual (no educational or infant observation sessions']","['socio-demographic and clinical variables', 'global psychomotor development as well as for Hearing-Speech and Personal-Social sub-scales', 'language and socio-emotional functioning', 'Psychomotor development']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0423539', 'cui_str': 'Finding of ability to hear voice'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",42.0,0.0345804,There were no significant differences in socio-demographic and clinical variables between early intervention (n = 21; 13 females) and care as usual (n = 21; 12 females) groups.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Pisoni', 'Affiliation': 'NICU, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Provenzi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Moncecchi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Caporali', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Naboni', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Stronati', 'Affiliation': 'NICU, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Montirosso', 'Affiliation': '0-3 Center, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Borgatti', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Orcesi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15345']
477,32392422,Mild dehydration impaired intermittent sprint performance and thermoregulation in females.,"The effects of mild dehydration during ice hockey are well-studied in males, but not females. In a randomized, crossover design 11 female varsity hockey players drank no fluid (1.7±0.3% body mass loss) or water to maintain hydration during simulated-hockey exercise. Core temperature (P<0.01) and perceived fatigue (P=0.02) were higher and sprint power lower (P<0.01) when mildly dehydrated. Thus, mild dehydration may impair hockey performance and thermoregulation while increasing perceived fatigue in females. • Female stop-and-go sport athletes may benefit their in-game sprint performance and thermoregulation by following personalized in-game hydration to prevent becoming mildly dehydrated.",2020,Core temperature (P<0.01) and perceived fatigue (P=0.02) were higher and sprint power lower (P<0.01) when mildly dehydrated.,"['females', '11 female varsity hockey players drank no fluid (1.7±0.3% body mass loss) or water to maintain hydration during simulated-hockey exercise']",[],['Core temperature (P<0.01) and perceived fatigue'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016074', 'cui_str': 'Field hockey'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],"[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",11.0,0.11411,Core temperature (P<0.01) and perceived fatigue (P=0.02) were higher and sprint power lower (P<0.01) when mildly dehydrated.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Driscoll', 'Affiliation': 'University of Guelph, 3653, Psychology, Guelph, Ontario, Canada ; driscoll.rl@gmail.com.'}, {'ForeName': 'Devin Goddard', 'Initials': 'DG', 'LastName': 'McCarthy', 'Affiliation': 'McMaster University, 3710, Kinesiology , Rm AB123, Ivor Wynne Centre, McMaster University , 1280 Main St West, Hamilton, ON, Canada, L8S 4L8 , Hamilton, Ontario, Canada , L8S 4L8.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Palmer', 'Affiliation': 'St. Francis Xavier University, Antigonish, Nova Scotia, Canada ; matt.s.palmer@gmail.com.'}, {'ForeName': 'Lawrence L', 'Initials': 'LL', 'LastName': 'Spriet', 'Affiliation': 'University of Guelph , Dept. of Human Health and Nutritional Sciences , Guelph, Ontario, Canada , N1G 2W1 ; lspriet@uoguelph.ca.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0040']
478,32392574,Autosomal-dominant polycystic kidney disease: tolvaptan use in adolescents and young adults with rapid progression.,"BACKGROUND


The phase 3 Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO 3:4) clinical trial demonstrated the beneficial effect of tolvaptan on kidney growth and function in subjects aged 18-50 years over a 3-year period. However, it did not specifically assess the use of tolvaptan in adolescents and young adults (AYAs) with ADPKD.
METHODS


A post hoc analysis of the TEMPO 3:4 trials was performed for patients aged 18-24 years. The primary outcome was the annual rate of change in total kidney volume (TKV). The secondary outcome was to evaluate long-term safety of tolvaptan using Hy's law of hepatotoxicity.
RESULTS


A total of 51 patients in the 18-24 age group were analyzed (tolvaptan: 29, placebo: 22). The tolvaptan group had a lower mean percentage of TKV growth per year compared to the placebo group (3.9% vs. 6.5%, P = 0.0491). For secondary outcomes, 63 patients in the AYA subgroup were evaluated. In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity.
CONCLUSIONS


This post hoc analysis suggests that tolvaptan, with appropriate patient selection and management, can provide effective and acceptably safe treatment in AYAs with ADPKD.
IMPACT


Tolvaptan slows the increase in total kidney volume in patients aged 18-24 years with ADPKD.Tolvaptan posed no risk of potential liver injury measured via Hy's law of hepatotoxicity in the AYA stratum.This study suggests that tolvaptan has beneficial outcomes in AYAs.This post hoc analysis suggests the need for additional studies with a larger pediatric patient population.The impact is significant as tolvaptan had not been specifically examined in the AYA patient population previously.",2020,"In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity.
","['A total of 51 patients in the 18-24 age group were analyzed (tolvaptan: 29', 'patients aged 18-24 years', 'patients aged 18-24 years with', 'adolescents and young adults (AYAs) with ADPKD', '63 patients in the AYA subgroup were evaluated', 'adolescents and young adults with rapid progression', 'subjects aged 18-50 years over a 3-year period']","['tolvaptan', 'ADPKD.Tolvaptan', 'placebo']","['total kidney volume', 'kidney growth and function', 'annual rate of change in total kidney volume (TKV', ""evaluate long-term safety of tolvaptan using Hy's law of hepatotoxicity"", 'TKV growth per year']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0023150', 'cui_str': 'Law'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0439508', 'cui_str': '/year'}]",,0.140569,"In both the AYA and adult groups, none of the patients met the criteria for Hy's law of hepatotoxicity.
","[{'ForeName': 'Rupesh', 'Initials': 'R', 'LastName': 'Raina', 'Affiliation': 'Department of Nephrology, Akron Nephrology Associates/Cleveland Clinic Akron General Medical Center, Akron, OH, USA. rraina@akronchildrens.org.'}, {'ForeName': 'Ronith', 'Initials': 'R', 'LastName': 'Chakraborty', 'Affiliation': ""Department of Nephrology, Akron Children's Hospital, Akron, OH, USA.""}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'DeCoy', 'Affiliation': 'Ohio University Heritage College of Osteopathic Medicine, Athens, OH, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kline', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN, USA.'}]",Pediatric research,['10.1038/s41390-020-0942-2']
479,32392699,Comparison of the Hemodynamic Performance of Two Neuromuscular Electrical Stimulation Devices Applied to the Lower Limb.,"Currently, 1% of the population of the Western world suffers from venous leg ulcers as a result of chronic venous insufficiency. Current treatment involves the use of moist wound healing, compression bandages, and intermittent pneumatic compression. Neuromuscular electrical stimulation is a novel potential new therapeutic method for the promotion of increased lower limb hemodynamics. The aim of this study was to measure the hemodynamic changes in the lower limb with the use of two neuromuscular electrical stimulation devices. Twelve healthy volunteers received two neuromuscular stimulation device interventions. The Geko TM  and National University of Ireland (NUI) Galway neuromuscular electrical stimulation devices were randomized between dominant and non-dominant legs. Hemodynamic measurements of peak venous velocity (cm/s), the time average mean velocity (TAMEAN) (cm/s), and ejected volume (mL) of blood were recorded. Peak venous velocity was significantly increased by the Geko TM  and the NUI Galway device compared to baseline blood flow ( p  < 0.0001), while only the voluntary contraction produced significant increases in TAMEAN and ejected volume (both  p  < 0.05). Neuromuscular muscular electrical stimulation can produce adequate increases in lower limb hemodynamics sufficient to prevent venous stasis. Greater use of neuromuscular stimulation devices could be considered in the treatment of conditions related to chronic venous insufficiency but requires further research.",2020,"Peak venous velocity was significantly increased by the Geko TM  and the NUI Galway device compared to baseline blood flow ( p  < 0.0001), while only the voluntary contraction produced significant increases in TAMEAN and ejected volume (both  p  < 0.05).",['Twelve healthy volunteers'],"['neuromuscular electrical stimulation devices', 'neuromuscular stimulation device interventions', 'Neuromuscular electrical stimulation', 'Neuromuscular muscular electrical stimulation', 'Two Neuromuscular Electrical Stimulation Devices', 'neuromuscular stimulation devices']","['hemodynamic changes', 'Peak venous velocity', 'Hemodynamic measurements of peak venous velocity (cm/s), the time average mean velocity (TAMEAN']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0454448', 'cui_str': 'Neuromuscular stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429871', 'cui_str': 'Venous velocity'}, {'cui': 'C0204901', 'cui_str': 'Hemodynamic measurements'}, {'cui': 'C0439392', 'cui_str': 'cm/s'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",12.0,0.0233083,"Peak venous velocity was significantly increased by the Geko TM  and the NUI Galway device compared to baseline blood flow ( p  < 0.0001), while only the voluntary contraction produced significant increases in TAMEAN and ejected volume (both  p  < 0.05).","[{'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Avazzadeh', 'Affiliation': 'Physiology, School of Medicine, NUI Galway, University Road, Galway H91 TK33, Ireland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': ""O'Farrell"", 'Affiliation': 'Physiology, School of Medicine, NUI Galway, University Road, Galway H91 TK33, Ireland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Physiology, School of Medicine, NUI Galway, University Road, Galway H91 TK33, Ireland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': 'Physiology, School of Medicine, NUI Galway, University Road, Galway H91 TK33, Ireland.'}, {'ForeName': 'Gearóid', 'Initials': 'G', 'LastName': 'ÓLaighin', 'Affiliation': 'Electrical & Electronic Engineering, School of Engineering, NUI Galway, University Road, Galway H91 TK33, Ireland.'}, {'ForeName': 'Leo R', 'Initials': 'LR', 'LastName': 'Quinlan', 'Affiliation': 'Physiology, School of Medicine, NUI Galway, University Road, Galway H91 TK33, Ireland.'}]",Journal of personalized medicine,['10.3390/jpm10020036']
480,31072272,Single joint exercises do not provide benefits in performance and anthropometric changes in recreational bodybuilders.,"The purpose of the present study was to compare the changes in anthropometric measures and muscle performance in users and non-users of androgenic anabolic steroids (AAS) performing resistance training (RT) programmes involving only multiple joint (MJ) exercises or a combination of MJ and single joint (SJ) exercises. Thirty recreational bodybuilders were divided into 4 groups: non-AAS users performing only MJ exercises (MJ), non-AAS users performing MJ + SJ (MJ + SJ), AAS users performing only MJ exercises (AAS - MJ) and AAS users performing MJ + SJ exercises (AAS - MJ + SJ). Before and after 8 weeks of training, the participants were tested for 10 repetition maximum (10RM) in different RT exercises. Flexed arm circumference (FAC), biceps and triceps skinfolds were measured. No interactions were found between time and the performance of SJ exercise in any variable ( p  > .05). However, there was a significant interaction between AAS use and time ( p  < .001), such that AAS users showed greater 10RM gains in all exercises, skinfold decreases and increases in FAC than non-users. In conclusion, our study shows that the addition of SJ exercises to MJ exercises brings no additional benefit in terms of muscle performance and anthropometric changes in trained men, either if they were using AAS or not. These results suggest that trained men can save time not including SJ in their routines and still achieve optimal results. Moreover, our results show that AAS use is associated with greater increases in muscle strength and FAC and greater reductions in biceps and triceps skinfold thickness.",2020,"Thirty recreational bodybuilders were divided into 4 groups: non-AAS users performing only MJ exercises (MJ), non-AAS users performing MJ + SJ (MJ + SJ), AAS users performing only MJ exercises (AAS - MJ) and AAS users performing MJ + SJ exercises (AAS - MJ + SJ).","['Thirty recreational bodybuilders', 'users and non-users of']","['MJ and single joint (SJ) exercises', 'Single joint exercises', 'non-AAS users performing only MJ exercises (MJ), non-AAS users performing MJ\u2009+\u2009SJ (MJ\u2009+\u2009SJ), AAS users performing only MJ exercises (AAS\u2009-\u2009MJ) and AAS users performing MJ\u2009+\u2009SJ exercises (AAS\u2009-\u2009MJ\u2009+\u2009SJ', 'SJ exercises to MJ exercises', 'AAS', 'androgenic anabolic steroids (AAS) performing resistance training (RT) programmes']","['10RM gains', 'performance of SJ exercise', 'Flexed arm circumference (FAC), biceps and triceps skinfolds', 'muscle strength and FAC', 'anthropometric measures and muscle performance', 'FAC', 'biceps and triceps skinfold thickness']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0054427', 'cui_str': 'CAF protocol'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518022', 'cui_str': 'Triceps skin fold thickness'}]",30.0,0.0213579,"Thirty recreational bodybuilders were divided into 4 groups: non-AAS users performing only MJ exercises (MJ), non-AAS users performing MJ + SJ (MJ + SJ), AAS users performing only MJ exercises (AAS - MJ) and AAS users performing MJ + SJ exercises (AAS - MJ + SJ).","[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiania, Brasil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Coswig', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, Pará, Brasil.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Raiol', 'Affiliation': 'Centro de Ciências Biológicas e da Saúde, Centro Universitário do Estado do Pará, Belém, Pará, Brasil.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Centre for Health, Exercise and Sport Science, Southampton Solent University, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'Centre for Health, Exercise and Sport Science, Southampton Solent University, Southampton, UK.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Sport and Exercise Sciences Research Unit, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiania, Brasil.'}]",European journal of sport science,['10.1080/17461391.2019.1611932']
481,31107728,The Association Between Acculturation and Parental Feeding Practices in Families With Overweight and Obese Hispanic/Latino Children.,"This study examines the association between acculturation and parental feeding practices in low-income Latinos. Overweight/obese children (N = 117), aged 5 to 14 years, and their parents were recruited from a rural health clinic. Findings show that more acculturated parents have greater control over their child's eating behavior (P = .04). Parents who perceive their child as having a weight problem also have more control over their child's eating behavior (P = .02). Control measured from regulation of how much and when the child should eat to offering sweets and screen time for good behavior. Results underscore the need for interventions to consider parental acculturation and perceptions of child weight.",2019,Findings show that more acculturated parents have greater control over their child's eating behavior (P = .04).,"['Overweight/obese children (N = 117), aged 5 to 14 years, and their parents were recruited from a rural health clinic', 'Families With Overweight and Obese Hispanic/Latino Children', 'low-income Latinos']",[],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035960', 'cui_str': 'Rural health center'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],[],117.0,0.0129166,Findings show that more acculturated parents have greater control over their child's eating behavior (P = .04).,"[{'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Mojica', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis (Dr Mojica); Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore (Dr Liang); Division of Hospital Medicine, School of Medicine, Oregon Health & Science University, Portland (Dr Foster); and Director, Latino Research Institute, Mexican American and Latina/o Studies, University of Texas at Austin (Dr Parra-Medina).'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Byron A', 'Initials': 'BA', 'LastName': 'Foster', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Parra-Medina', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000226']
482,32400089,Effect of preoperative in-bed exercises and mobilization training on postoperative anxiety and mobilization level.,"AIM


This study examines the effect of preoperative training on postoperative mobility and anxiety levels in patients undergoing total knee arthroplasty.
METHODS


This was a randomized controlled study. The sample of this study consisted of 60 (30 experimental group, 30 control group) total knee arthroplasty patients who were admitted to a public hospital's orthopedic department between January 2019 and May 2019. To collect data, a demographic information form, patient mobility scale, observer mobility scale, and state-trait anxiety inventory were used. The patients in the intervention group practiced bed exercise and mobilization training before total knee arthroplasty surgery. The control group had no intervention.
RESULTS


It was determined that the patient mobility scale (2.0 ± 0.83) and observer mobility scale scores (6.93 ± 1.61) of the patients in the experimental group were significantly lower than the patients in the control group (respectively: 4.16 ± 1.31, 11.0 ± 1.74; p < .05). In the postoperative period, the mean scores of the state (38.86 ± 6.11) and trait anxiety scores (38.26 ± 3.85) of the patients in the experimental group were found to be significantly lower than the patients in the control group (respectively: 59.03 ± 9.10, 43.80 ± 4.38; p < .05).
CONCLUSION


Preoperative training reduced the postoperative anxiety and increased the level of patient mobility after total knee arthroplasty in this study.",2020,"In the postoperative period, the mean scores of the state (38.86 ± 6.11) and trait anxiety scores (38.26 ± 3.85) of the patients in the experimental group were found to be significantly lower than the patients in the control group (respectively: 59.03 ± 9.10, 43.80 ± 4.38; p < .05).
","[""60 (30 experimental group, 30 control group) total knee arthroplasty patients who were admitted to a public hospital's orthopedic department between January 2019 and May 2019"", 'patients undergoing total knee arthroplasty']","['bed exercise and mobilization training before total knee arthroplasty surgery', 'preoperative training', 'Preoperative training', 'preoperative in-bed exercises and mobilization training']","['observer mobility scale scores', 'patient mobility scale', 'level of patient mobility', 'postoperative anxiety and mobilization level', 'postoperative mobility and anxiety levels', 'postoperative anxiety', 'patient mobility scale, observer mobility scale, and state-trait anxiety inventory', 'trait anxiety scores']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}]","[{'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0263229,"In the postoperative period, the mean scores of the state (38.86 ± 6.11) and trait anxiety scores (38.26 ± 3.85) of the patients in the experimental group were found to be significantly lower than the patients in the control group (respectively: 59.03 ± 9.10, 43.80 ± 4.38; p < .05).
","[{'ForeName': 'Mahinur Durmus', 'Initials': 'MD', 'LastName': 'Iskender', 'Affiliation': 'Department of Medical Services and Technique, Tasköprü Vocational School of Higher Education, Kastamonu University, Kastamonu, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Bektas', 'Affiliation': 'Kastamonu Public Hospital, Kastamonu, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Eren', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Yalova University, Yalova, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12339']
483,32400190,Physical activity promotion: precise matching of message frames and affect types.,"Objective:  Matching between affect orientations and message frames have been shown to enhance the persuasiveness of health messages. Based on a two-dimensional regulatory model (direction: approach/avoidance, valence: appetitive/aversive), this study examined whether a precise matching between affect and message frame would enhance physical activity (PA) attitudes, intentions, and behaviours. Design:  Using a 2 (gain/loss frames) x 2 (positive/negative end-states) design, 147 college students were randomly assigned to one message-frame condition (gain-positive, gain-negative, loss-positive, or loss-negative). Four identified affect types (approach-positive, approach-negative, avoidance-positive, and avoidance-negative) were considered as matched, respectively, with the four message-frame conditions. The participants were subsequently grouped into fully-matched, direction-matched only, valence-matched only, or unmatched. Main Outcome Measures:  The immediate PA attitude and intention after the experiment and the PA attitudes, intentions, and behaviours at a two-week follow-up were reported. Results:  Post-manipulation and follow-up intentions were greater in the fully-matched as compared with the unmatched group. Follow-up physical activity was more in the valence-matched than the unmatched group. No other differences were found across the matching types. Conclusion:  Findings partially supported the importance of a precise matching between affect orientations and message frames. The affect types may characterize an individual's sensitivity towards the corresponding regulatory information.",2020,Results:  Post-manipulation and follow-up intentions were greater in the fully-matched as compared with the unmatched group.,['147 college students'],"['dimensional regulatory model (direction: approach/avoidance, valence: appetitive/aversive']","['PA attitudes, intentions, and behaviours', 'physical activity (PA) attitudes, intentions, and behaviours']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",147.0,0.0268415,Results:  Post-manipulation and follow-up intentions were greater in the fully-matched as compared with the unmatched group.,"[{'ForeName': 'Kin-Kit', 'Initials': 'KK', 'LastName': 'Li', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Candy H-Y', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon Tong, Hong Kong.'}]",Psychology & health,['10.1080/08870446.2020.1761973']
484,32400227,"Correlates of Posttraumatic Stress Symptoms among Formerly Incarcerated, Homeless Women.","Posttraumatic stress symptoms are a pressing issue among women experiencing incarceration and homelessness. Baseline data were collected among formerly incarcerated homeless women (N = 130) who were on average 38.9 (SD = 11.36, range 19-64) years of age and recruited into a pilot randomized control trial (RCT) intervention program. A logistic regression was used to assess correlates of PTSD symptoms. The majority of the sample self-reported witnessing violence (85%) and had moderate PTSD symptoms (M = 1.61, SD = 1.62, range: 0-4). No past month drug use ( p  = 0.006), higher anger scores ( p  = 0.002), greater emotional support ( p  = 0.009), and psychological frailty ( p  = 0.02) were significantly associated with higher odds of PTSD symptoms. Moreover, women who experienced minor family conflicts had lower odds of PTSD symptoms relative to those that had family conflicts most of the time ( p  = 0.02). Similarly, controlling for all other variables, women who had a higher positive social interaction score also had lower odds of PTSD symptoms ( p  = 0.006). These findings are a call to action for academicians, service providers, and health practitioners to develop an intervention which integrates comprehensive PTSD screening, and discussion of ways to build coping skills, relationships with family and social networks, and utilizes a trauma-informed approach during reentry.",2020,"No past month drug use ( p  = 0.006), higher anger scores ( p  = 0.002), greater emotional support ( p  = 0.009), and psychological frailty ( p  = 0.02) were significantly associated with higher odds of PTSD symptoms.","['women experiencing incarceration and homelessness', 'formerly incarcerated homeless women (N\u2009=\u2009130) who were on average 38.9 (SD = 11.36, range 19-64) years of age', 'Homeless Women']",[],"['psychological frailty', 'higher anger scores', 'witnessing violence', 'PTSD symptoms', 'greater emotional support', 'positive social interaction score', 'moderate PTSD symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.015236,"No past month drug use ( p  = 0.006), higher anger scores ( p  = 0.002), greater emotional support ( p  = 0.009), and psychological frailty ( p  = 0.02) were significantly associated with higher odds of PTSD symptoms.","[{'ForeName': 'Benissa E', 'Initials': 'BE', 'LastName': 'Salem', 'Affiliation': 'School of Nursing, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Hudson', 'Affiliation': 'School of Nursing, Azusa Pacific University, Azusa, California, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'School of Nursing, University of California, Irvine, California, USA.'}, {'ForeName': 'Jaemilyn', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'School of Nursing, San Bernardino and College of the Desert, California State University, San Bernardino, California, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Toyama', 'Affiliation': 'School of Nursing, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Los Angeles County Department of Health Services, Los Angeles, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Faucette', 'Affiliation': 'Housing for Health/Office of Diversion and Reentry, Los Angeles County Department of Health Services, Los Angeles, California, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Adeline M', 'Initials': 'AM', 'LastName': 'Nyamathi', 'Affiliation': 'School of Nursing, University of California, Irvine, California, USA.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1720050']
485,32397695,Pilot study on non-celiac gluten sensitivity: effects of Bifidobacterium longum ES1 co-administered with a gluten-free diet.,"BACKGROUND


Bifidobacterium longum ES1 is a strain probiotic, colonizing the human gut and capable of a degradative action on gliadin. In an attempt to find new nutritional solutions aimed at improving the quality of life of patients with non-celiac gluten sensitivity (NCGS) we evaluated the effectiveness of the this strain, in association with a gluten-free diet, comparing its efficacy versus diet therapy alone.
METHODS


The experimental design included a non-randomized, open-label, 1:1 intervention study in parallel groups. Enrolled patients with symptoms attributable to NCGS, and with negative diagnoses of both wheat allergy and celiac disease, were included in this three-month trial divided into four outpatient visits (baseline, T1, T2 and T3). Fifteen patients for each group completed the experimental protocol.
RESULTS


Our results showed that a combination of diet and probiotic determined a more significant reduction in the frequency and intensity of intestinal and extra-intestinal symptoms, and a clear improvement in stool consistency.
CONCLUSIONS


Although carried out on a small number of patients, our pilot trial leads us to conclude that a combined strategy of naturally gluten-free diet therapy with administration of the probiotic strain ES1 appears to offer a greater advantage than the dietary regime alone in improving the clinical symptomatic picture and in stabilizing the intestinal microbiota.",2020,"Our results showed that a combination of diet and probiotic determined a more significant reduction in the frequency and intensity of intestinal and extra-intestinal symptoms, and a clear improvement in stool consistency.
","['Enrolled patients with symptoms attributable to NCGS, and with negative diagnoses of both wheat allergy and celiac disease', 'patients with non-celiac gluten sensitivity (NCGS', 'non-celiac gluten sensitivity']","['probiotic strain ES1', 'Bifidobacterium longum ES1 co-administered with a gluten-free diet']","['quality of life', 'stool consistency', 'frequency and intensity of intestinal and extra-intestinal symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0949570', 'cui_str': 'Allergy to wheat'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0631734', 'cui_str': 'Es1'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",15.0,0.0147521,"Our results showed that a combination of diet and probiotic determined a more significant reduction in the frequency and intensity of intestinal and extra-intestinal symptoms, and a clear improvement in stool consistency.
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Pierro', 'Affiliation': 'Scientific Department, Velleja Research, Milan, Italy - f.dipierro@vellejaresearch.com.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergomas', 'Affiliation': 'Occupational Medicine Unit, Clinica del Lavoro Luigi Devoto, Obesity and Work Center at IRCCS Foundation Policlinico Hospital of Milan, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marraccini', 'Affiliation': 'Occupational Medicine Unit, Clinica del Lavoro Luigi Devoto, Obesity and Work Center at IRCCS Foundation Policlinico Hospital of Milan, Milan, Italy.'}, {'ForeName': 'Mariarosaria', 'Initials': 'M', 'LastName': 'Ingenito', 'Affiliation': 'Occupational Medicine Unit, Clinica del Lavoro Luigi Devoto, Obesity and Work Center at IRCCS Foundation Policlinico Hospital of Milan, Milan, Italy.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Occupational Medicine Unit, Clinica del Lavoro Luigi Devoto, Obesity and Work Center at IRCCS Foundation Policlinico Hospital of Milan, Milan, Italy.'}, {'ForeName': 'Luisella', 'Initials': 'L', 'LastName': 'Vigna', 'Affiliation': 'Occupational Medicine Unit, Clinica del Lavoro Luigi Devoto, Obesity and Work Center at IRCCS Foundation Policlinico Hospital of Milan, Milan, Italy.'}]",Minerva gastroenterologica e dietologica,['10.23736/S1121-421X.20.02673-2']
486,32397728,Nanolaser in cataract surgery and its impact on corneal endotelium.,"PURPOSE


To compare safety and efficacy of new nanolaser photofragmentation technique with standard ultrasound phacoemulsification cataract surgery technique. Metods: A group of 20 patients - 40 eyes who underwent bilateral cataract surgery, one eye with ultrasound phacoemulsification (group I), n = 20 fellow eye with nanosecond laser framentation (group II ). Lens Opacities Classification System III was used to classify cataract stage. All 40 eyes had stage III cataract, Nucleus Opalescence was NO2 - NO3. Uncorrected visual acuity (UCVA), endothelial cells density (DEC), hexagonal cells rate, index of endothelial cells pleomorfism, and corneal thickness were evaluated prior to surgery and at day 7 follow up.
RESULTS


All 40 eyes had uneventful surgery,without complications. Preoperative UCVA in group I was 0,70±0,07 and 0,68 ± 0,10 in group II. At follow up check 7 days after surgery UCVA was 0,98 ± 0,05 in group 1 and 0,98 ± 0,04 in group II (p-NS). The mean DEC (cells/mm2) before surgery was 2508 ± 205,54 in group 1 and 2472 ± 287,85 in group II. After surgery density decreased to 2024,92±271,50 in group 1 and 2138,5 ± 390,85 in group II. Difference in endothelial cells decrease between groups showed no statistical significance. There was no statistical significance in differences of hexagonal cells rate and corneal thickness between both groups pre and postoperatively.
CONCLUSION


Nanolaser lens photofragmentation and ultrasound phacoemulsification can be considered equal regarding impact on endothelial cells.",2019,"At follow up check 7 days after surgery UCVA was 0,98 ± 0,05 in group 1 and 0,98 ± 0,04 in group II (p-NS).","['Metods', 'All 40 eyes had stage III cataract, Nucleus Opalescence was NO2 - NO3', '20 patients - 40 eyes who underwent']","['new nanolaser photofragmentation technique with standard ultrasound phacoemulsification cataract surgery technique', '20 fellow eye with nanosecond laser framentation', 'Nanolaser lens photofragmentation and ultrasound phacoemulsification', 'Preoperative UCVA', 'bilateral cataract surgery, one eye with ultrasound phacoemulsification']","['uneventful surgery,without complications', 'hexagonal cells rate and corneal thickness', 'safety and efficacy', 'endothelial cells decrease', 'corneal endotelium', 'Uncorrected visual acuity (UCVA), endothelial cells density (DEC), hexagonal cells rate, index of endothelial cells pleomorfism, and corneal thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0281268,"At follow up check 7 days after surgery UCVA was 0,98 ± 0,05 in group 1 and 0,98 ± 0,04 in group II (p-NS).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Juhás', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Juhás Ml', 'Affiliation': ''}]",Ceska a slovenska oftalmologie : casopis Ceske oftalmologicke spolecnosti a Slovenske oftalmologicke spolecnosti,['10.31348/2019/4/4']
487,32397748,"Comparing the effects of multi-session anodal trans-cranial direct current stimulation of primary motor and dorsolateral prefrontal cortices on fatigue and quality of life in patients with multiple sclerosis: a double-blind, randomized, sham-controlled trial.","OBJECTIVE


To compare the effects of anodal trans-cranial direct current stimulation (a-tDCS) over primary motor and dorsolateral prefrontal cortices on Fatigue Severity Scale and its lasting effect on fatigue reduction and improvement in quality of life in patients with multiple sclerosis.
DESIGN


A randomized, double-blinded, sham-controlled parallel clinical trial study.
SETTING


Neurological physiotherapy clinics.
SUBJECTS


Thirty-nine participants were randomly assigned to three groups: dorsolateral prefrontal cortex a-tDCS, primary motor a-tDCS (experimental groups) and sham a-tDCS. Finally, 36 participants completed the whole study ( n  = 12 in each group).
INTERVENTIONS


Participants in the experimental groups received six-session a-tDCS (1.5 mA, 20 minutes) during two weeks (three sessions per week). The sham group received six sessions of 20-minute sham stimulation.
MAIN MEASURES


The Fatigue Severity Scale and quality of life were assessed before, immediately and four weeks after the intervention.
RESULTS


Findings indicated a significant reduction in the Fatigue Severity Scale and a significant increase in the quality of life in both experimental groups, immediately after the intervention ( P  < 0.001), while Fatigue Severity Scale and quality of life changes were not significant in the sham a-tDCS group ( P  > 0.05). In addition, improvement of the variables remained four weeks after the intervention in dorsolateral prefrontal cortex a-tDCS (mean differences (95% confidence interval): 0.03 (-0.63 to 0.68) as compared to primary motor (-0.62 (-0.11 to -1.14) and sham a-tDCS groups (-0.47 (-1.37 to 0.43)).
CONCLUSION


Both primary motor and dorsolateral prefrontal cortex a-tDCS as compared to sham intervention can immediately improve fatigue and quality of life. However, the effects last up to four weeks only by the dorsolateral prefrontal cortex a-tDCS.",2020,Both primary motor and dorsolateral prefrontal cortex a-tDCS as compared to sham intervention can immediately improve fatigue and quality of life.,"['patients with multiple sclerosis', 'Neurological physiotherapy clinics', 'Thirty-nine participants', '36 participants completed the whole study ( n \u2009=\u200912 in each group']","['multi-session anodal trans-cranial direct current stimulation', 'dorsolateral prefrontal cortex a-tDCS, primary motor a-tDCS (experimental groups) and sham a-tDCS', 'anodal trans-cranial direct current stimulation (a-tDCS', 'six-session a-tDCS']","['quality of life', 'fatigue and quality of life', 'Fatigue Severity Scale', 'Fatigue Severity Scale and quality of life changes', 'dorsolateral prefrontal cortex a-tDCS', 'Fatigue Severity Scale and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4042764', 'cui_str': 'Neurophysiotherapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",39.0,0.0917939,Both primary motor and dorsolateral prefrontal cortex a-tDCS as compared to sham intervention can immediately improve fatigue and quality of life.,"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mortezanejad', 'Affiliation': 'Neuromuscular Rehabilitation Research Centre, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Centre, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Masoudian', 'Affiliation': 'Neurology Ward, Department of Internal Medicine, Kosar Hospital, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Discipline of Physiotherapy, Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.'}]",Clinical rehabilitation,['10.1177/0269215520921506']
488,32397802,Comparison of Retrograde Intrarenal Surgery and Percutaneous Nephrolithotomy Used in the Treatment of 2-4 cm Kidney Stones in Terms of Pain and Need for Additional Analgesics: A Prospective Randomized Study.,"Purpose:  To compare the effects of retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) on postoperative pain and their differences in terms of the postoperative need for analgesics in the treatment of 2-4 cm kidney stones.  Methods:  A total of 132 patients who suffered from renal stones 2-4 cm in size and had surgery at our urology clinic between April 2015 and April 2017 were enrolled in this prospective study (NCT02430168). Patients were randomized into either the RIRS group (Group 1) or PNL group (Group 2) in a ratio of 1:1. Postoperative visual analog scale (VAS) values at 8 and 24 hours postoperatively and analgesic treatments of patients were recorded.  Results:  Patients from both groups had similar demographic characteristics. Stone-free states were achieved in 37 (74%) patients in the RIRS group and 45 (90%) patients in the PNL group. Postoperative complication rates were similar in two groups. Moreover, there was no statistically significant difference between the groups in terms of the postoperative need for analgesics ( P  = .309). However, the PNL group had higher VAS values ( P  < .001).  Conclusion:  Although the early postoperative pain scales were high in the PNL group, there was no significant difference between the groups in terms of the standard analgesic treatments for achieving patient's comfort. PNL, which has similar complications, but with higher success rates, compared with RIRS, did not require additional analgesic treatment during postoperative pain management. Thus, in our opinion, PNL should still remain as a first choice in treatment of 2-4 cm renal stones.",2020,"Although the early postoperative pain scales were high in the PNL group, there was no significant difference between the groups in terms of the standard analgesic treatments for achieving patient's comfort.","['2-4\u2009cm kidney stones', '132 patients who suffered from renal stones 2-4\u2009cm in size and had surgery at our urology clinic between April 2015 and April 2017', '2-4\u2009cm Kidney Stones in Terms of Pain and Need for Additional Analgesics']","['Retrograde Intrarenal Surgery and Percutaneous Nephrolithotomy', 'RIRS', 'PNL', 'retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL']","['VAS values', 'postoperative pain', 'postoperative need for analgesics', 'early postoperative pain scales', 'Postoperative visual analog scale (VAS) values', 'Stone-free states', 'Postoperative complication rates']","[{'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",132.0,0.0268037,"Although the early postoperative pain scales were high in the PNL group, there was no significant difference between the groups in terms of the standard analgesic treatments for achieving patient's comfort.","[{'ForeName': 'Mehmet Çağlar', 'Initials': 'MÇ', 'LastName': 'Çakıcı', 'Affiliation': 'Department of Urology, Istanbul Medeniyet University Goztepe Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nihat', 'Initials': 'N', 'LastName': 'Karakoyunlu', 'Affiliation': 'Department of Urology, Diskapi Yildirim Beyazit Education and Research Hospital, Health Sciences University, Ankara, Turkey.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Sari', 'Affiliation': 'Department of Urology, Bozok University School of Medicine, Yozgat, Turkey.'}, {'ForeName': 'Hakki Ugur', 'Initials': 'HU', 'LastName': 'Ozok', 'Affiliation': 'Department of Urology, Karabük University School of Medicine, Karabük, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Selmi', 'Affiliation': 'Department of Urology, Bozok University School of Medicine, Yozgat, Turkey.'}, {'ForeName': 'Ibrahim Guven', 'Initials': 'IG', 'LastName': 'Kartal', 'Affiliation': 'Department of Urology, Diskapi Yildirim Beyazit Education and Research Hospital, Health Sciences University, Ankara, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Nalbant', 'Affiliation': 'Department of Urology, Lokman Hekim Etlik Hospital, Ankara, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Sagnak', 'Affiliation': 'Department of Urology, Diskapi Yildirim Beyazit Education and Research Hospital, Health Sciences University, Ankara, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Ersoy', 'Affiliation': 'Department of Urology, Diskapi Yildirim Beyazit Education and Research Hospital, Health Sciences University, Ankara, Turkey.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0179']
489,32397978,Reduced frequency of Intravitreal methotrexate injection lowers the risk of Keratopathy in Vitreoretinal lymphoma patients.,"BACKGROUND


Intravitreal methotrexate has been proven to be an effective treatment method for vitreoretinal lymphoma. However, keratopathy occurs as the major side effect during treatment in most cases. The purpose of this study is to describe the characteristics of primary central nervous system lymphoma (PCNSL) with intraocular involvement and to attempt to reduce the incidence of keratopathy caused by intravitreal methotrexate.
METHODS


The medical records of 22 PCNSL patients with intraocular involvement (33 eyes) were reviewed. Patients were divided into two groups. Group A (22 eyes) received the induction-consolidation-maintenance regimen, which consisted of intravitreal methotrexate injection at a dosage of 400 μg/0.1 ml twice a week for the first four weeks, weekly for the following eight weeks, and then monthly for the last nine months. Patients with a poor systemic condition were assigned to Group B (8 eyes), who were started on the treatment protocol described above and switched directly to monthly injection (9 months) when ocular remission was achieved.
RESULTS


Blurred vision (31%) and floaters (25%) were common presenting symptoms. Vitritis was the most common clinical sign and was present in 29 eyes (90%) on B-ultrasound examination. Diagnosis was made by 25G-pars plana vitrectomy, and most diagnoses were diffuse large B-cell lymphoma. Ocular remission was achieved after 8.2 (SD = 4.6) injections of methotrexate. The mean VA (visual acuity) was improved from LogMAR 0.65 to 0.3 (P = 0.002). Keratopathy was observed in 21 eyes (66%) after an average of 8.2 (SD = 2.3) injections. With a reduced injection frequency, the incidence of keratopathy was lowered from 86.4% (Group A) to 25.0% (Group B) without ocular recurrence during follow-up.
CONCLUSIONS


Intravitreal methotrexate is a safe, effective and flexible treatment for PCNSL patients with intraocular involvement. Keratopathy is the most common adverse effect and can be controlled by reducing the injection frequency.",2020,Vitritis was the most common clinical sign and was present in 29 eyes (90%) on B-ultrasound examination.,"['Patients with a poor systemic condition', 'Vitreoretinal lymphoma patients', 'PCNSL patients with intraocular involvement', '22 PCNSL patients with intraocular involvement (33 eyes']","['25G-pars plana vitrectomy', 'Intravitreal methotrexate injection', 'methotrexate', 'induction-consolidation-maintenance regimen, which consisted of intravitreal methotrexate injection']","['Blurred vision', 'ocular recurrence', 'Ocular remission', 'Keratopathy', 'incidence of keratopathy', 'mean VA (visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4034144', 'cui_str': 'Methotrexate Injection'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0235270', 'cui_str': 'Keratopathy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.014977,Vitritis was the most common clinical sign and was present in 29 eyes (90%) on B-ultrasound examination.,"[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Xianjin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Qingping', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Qingjian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China.'}, {'ForeName': 'Bobin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Huashan Hospital, Fudan University, No.12 Wulumuqi Road, Shanghai, 200040, China.'}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Ophthalmology, Huashan Hospital North, Fudan University, Shanghai, China. jianjiangxiao@163.com.'}]",BMC ophthalmology,['10.1186/s12886-020-01464-3']
490,32397980,"Efficacy and safety of myrrh in patients with incomplete abortion: a randomized, double-blind, placebo-controlled clinical study.","BACKGROUND


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


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


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


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


This study was retrospectively registered at Iranian Registry of Clinical Trials (www.irct.ir) IRCT code: IRCT20140317017034N7.",2020,"After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001).","['patients with incomplete abortion', '80 patients with ultrasound-documented retained products of conception (RPOC']","['capsules containing 500\u2009mg of Myrrh oleo-gum-resin or a placebo', 'placebo']","['efficacy and safety of Myrrh', 'Efficacy and safety', 'rate of successful complete abortion', 'no serious drug-related adverse effects', 'mean diameter of the RPOC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000810', 'cui_str': 'Incomplete miscarriage'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0033270', 'cui_str': 'Retained products of conception'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0230953', 'cui_str': 'Structure of product of conception'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0233105', 'cui_str': 'Abortion complete'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033270', 'cui_str': 'Retained products of conception'}]",80.0,0.464431,"After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001).","[{'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ajdari', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. nasadi2012@yahoo.ca.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Abolhasanzadeh', 'Affiliation': 'Department of Radiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02946-z']
491,32398024,Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial.,"BACKGROUND


Visceral adipose tissue (VAT) is a strong risk factor for cardiovascular disease and increases with age. While supervised exercise (SE) may be an effective approach, web-based exercise (WE) have other advantages such as being more readily accessible. Therefore, we evaluated the effects of WE on VAT, body composition and cardiometabolic risk markers in centrally obese older adults and compared the effects of WE to SE. We also explored the feasibility of WE.
METHODS


In a randomized controlled trial conducted in Umeå, Sweden during January 2018 - November 2018, N = 77, 70-year-old men and women with central obesity (> 1 kg VAT for women, > 2 kg for men) were randomized to an intervention group (n = 38) and a wait-list control group (n = 39). The intervention group received 10 weeks of SE while the wait-list control group lived as usual. Following a 10-week wash-out-period, the wait-list control group received 10 weeks of WE. The primary outcome was changes in VAT. Secondary outcomes included changes in fat mass (FM), lean body mass (LBM), blood lipids, fasting blood glucose. Additionally, we explored the feasibility of WE defined as adherence and participant experiences.
RESULTS


WE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05). The adherence to WE was 85% and 87-97% of the participants rated aspects of the WE intervention > 4 on a scale of 1-5. Comparing SE to WE, there was no significant difference in decrease of VAT (Cohen's δ effect size [ES], 0.5, 95% CI, - 24 to 223, P = 0.11), although SE decreased FM by 619 g (ES, 0.5, 95% CI, 22 to 1215, P < 0.05) compared to WE.
CONCLUSIONS


Ten weeks of vigorous WE is insufficient to decrease VAT in centrally obese older adults, but sufficient to decrease FM while preserving LBM. The high adherence and positive experiences of the WE intervention implies that it could serve as an alternative exercise strategy for older adults with central obesity, with increased availability for a larger population.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03450655), retrospectively registered February 28, 2018.",2020,"WE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05).","['older adults with central obesity', 'Umeå, Sweden during January 2018 - November 2018, N\u2009=\u200977, 70-year-old men and women with central obesity (>\u20091\u2009kg VAT for women, >\u20092\u2009kg for men', 'centrally obese older adults']","['Web-based exercise versus supervised exercise', 'wait-list control group', 'supervised exercise (SE', '10\u2009weeks of SE while the wait-list control group lived as usual']","['VAT', 'changes in fat mass (FM), lean body mass (LBM), blood lipids, fasting blood glucose', 'changes in VAT', 'VAT, body composition and cardiometabolic risk markers', 'SE decreased FM']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.245774,"WE had no significant effect on VAT (P = 0.5), although it decreased FM by 450 g (95% confidence interval [CI], 37 to 836, P < 0.05).","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Ballin', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Unit of Geriatric Medicine, Umeå University, 901 87, Umeå, Sweden. marcel.ballin@umu.se.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hult', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Björk', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Lundberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Unit of Geriatric Medicine, Umeå University, 901 87, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nordström', 'Affiliation': 'Department of Public Health and Clinical Medicine, Section of Sustainable Health, Umeå University, Umeå, Sweden.'}]",BMC geriatrics,['10.1186/s12877-020-01577-w']
492,32398040,PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial.,"BACKGROUND


Pelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT, in the restaging of recurrent prostate cancer (PCa). At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT). Since the majority of patients treated with MDT relapse within 2 years in adjacent lymph node regions, with an estimated median time to progression of 12-18 months, combining MDT with whole pelvic radiotherapy (WPRT) may improve oncological outcomes in these patients. The aim of this prospective multicentre randomized controlled phase II trial is to assess the impact of the addition of WPRT to MDT and short-term androgen deprivation therapy (ADT) on metastasis-free survival (MFS) in the setting of oligorecurrent pelvic nodal recurrence.
METHODS & DESIGN


Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following radical local treatment for PCa, will be randomized in a 1:1 ratio between arm A: MDT and 6 months of ADT, or arm B: WPRT added to MDT and 6 months of ADT. Patients will be stratified by type of PET-tracer (choline, FACBC or PSMA) and by type of MDT (sLND or SBRT). The primary endpoint is MFS and the secondary endpoints include clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT. Estimated study completion: December 31, 2023.
DISCUSSION


This is the first prospective multicentre randomized phase II trial assessing the potential of combined WPRT and MDT as compared to MDT alone on MFS for patients with nodal oligorecurrent PCa.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03569241, registered June 14, 2018, ; Identifier on Swiss National Clinical Trials Portal (SNCTP): SNCTP000002947, registered June 14, 2018.",2020,"At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT).","['patients with nodal oligorecurrent PCa', 'OligoRecurrent nodal prostate cancer Metastases (STORM', 'Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following', 'registered June 14, 2018, ; Identifier on Swiss National Clinical Trials Portal (SNCTP']","['radical local treatment for PCa', 'WPRT', 'combined WPRT and MDT', 'stereotactic body radiotherapy (SBRT', 'MDT alone on MFS', 'MDT (sLND or SBRT', 'MDT with whole pelvic radiotherapy (WPRT', 'WPRT to MDT and short-term androgen deprivation therapy (ADT', 'PEACE V - Salvage Treatment']","['clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT', 'metastasis-free survival (MFS', 'oncological outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.149516,"At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Bruycker', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Spiessens', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dirix', 'Affiliation': 'Department of Radiation oncology, Iridium Cancer Network, GZ Antwerp, Antwerp, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Koutsouvelis', 'Affiliation': 'Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Semac', 'Affiliation': 'Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Liefhooghe', 'Affiliation': 'Department of Radiation oncology, AZ Groeninge, Kortrijk, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gomez-Iturriaga', 'Affiliation': 'Cruces University Hospital (Biocruces Health Research Institute), Barakaldo, Spain.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Everaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Otte', 'Affiliation': 'Department of Radiation oncology, Jules Bordet Institute and Hôpital Erasme, University Clinics of Brussels, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papachristofilou', 'Affiliation': 'Clinic of Radiotherapy & Radiation Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scorsetti', 'Affiliation': 'Humanitas Clinical and Research Hospital, IRCSS, Radiotherapy and Radiosurgery Department, Rozzano, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shelan', 'Affiliation': 'Department of Radiation oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'Epworth Healthcare, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ameye', 'Affiliation': 'Department of Urology, AZ Maria-Middelares Ghent, Ghent, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guckenberger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zürich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Heikkilä', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Putora', 'Affiliation': 'Department of Radiation oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zapatero', 'Affiliation': 'University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Conde-Moreno', 'Affiliation': 'Department of Radiation oncology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Couñago', 'Affiliation': 'Department of Radiation oncology, University Hospital of Quirón, Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Goetghebeur', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reynders', 'Affiliation': 'Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zilli', 'Affiliation': 'Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland. Thomas.Zilli@hcuge.ch.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium. piet.ost@ugent.be.'}]",BMC cancer,['10.1186/s12885-020-06911-4']
493,32398112,"Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials.","BACKGROUND


Modified Sijunzi decoction (SJZD) has been used to treat ulcerative colitis (UC) in remission. However, more rigorous clinical trials are necessary to evaluate its effectiveness. Therefore, a series of single-case randomised controlled trials (N-of-1 trials) is proposed to compare the efficacy of modified SJZD with mesalazine for treating UC in remission.
METHODS


This is a single-site, hospital-based, double-blind N-of-1 trial for 10 single subjects. Three cycles of N-of-1 trials are planned. There are two treatment periods in each cycle. Modified SJZD combined with mesalazine placebo or mesalazine combined with modified SJZD placebo will be randomised during each 8-week treatment period. There is no washout period in the study. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria.
DISCUSSION


Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses. The findings will be interpreted with caution. We anticipate that the results will show that modified SJZD is effective for patients with UC in remission.
TRIAL REGISTRATION


Chinese Clinical Trial Register, ID: ChiCTR1900024086. Registered on 24 June 2019.",2020,Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses.,"['10 single subjects', 'patients with UC in remission']","['modified SJZD', 'Modified Sijunzi decoction', 'mesalazine placebo or mesalazine combined with modified SJZD placebo', 'modified SJZD with mesalazine', 'Modified Sijunzi decoction (SJZD']","['visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses', 'ulcerative colitis']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4743423', 'cui_str': 'Sijunzi decoction'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]",10.0,0.586393,Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses.,"[{'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jie-Min', 'Initials': 'JM', 'LastName': 'Deng', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Hou', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Peng', 'Affiliation': 'The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shi-Jing', 'Initials': 'SJ', 'LastName': 'Zhang', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Mi', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qi-Long', 'Initials': 'QL', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xia-Lin', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Feng-Bin', 'Initials': 'FB', 'LastName': 'Liu', 'Affiliation': 'The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. liufb163@163.com.'}, {'ForeName': 'Xin-Lin', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China. chenxlsums@126.com.'}]",Trials,['10.1186/s13063-020-04315-0']
494,32398113,Propranolol for familial cerebral cavernous malformation (Treat_CCM): study protocol for a randomized controlled pilot trial.,"BACKGROUND


Cerebral cavernous malformations (CCMs) are vascular malformations characterized by clusters of enlarged leaky capillaries in the central nervous system. They may result in intracranial haemorrhage, epileptic seizure(s), or focal neurological deficits, and potentially lead to severe disability. Globally, CCMs represent the second most common intracranial vascular malformation in humans, and their familial form (FCCMs) accounts for one-fifth of cases. Neurosurgical excision, and perhaps stereotactic radiosurgery, is the only available therapeutic option. Case reports suggest that propranolol might modify disease progression.
METHODS


Treat_CCM is a prospective, randomized, open-label, blinded endpoint (PROBE), parallel-group trial involving six Italian clinical centres with central reading of brain magnetic resonance imaging (MRI) and adverse events. Patients with symptomatic FCCMs are randomized (2:1 ratio) either to propranolol (40-80 mg twice daily) in addition to standard care or to standard care alone (i.e. anti-epileptic drugs or headache treatments). The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs. The secondary outcomes are MRI changes over time (i.e. de novo CCM lesions, CCM size and signal characteristics, iron deposition, and vascular leakage as assessed by quantitative susceptibility mapping and dynamic contrast enhanced permeability), disability, health-related quality of life, depression severity, and anxiety (SF-36, BDI-II, State-Trait Anxiety Inventory).
DISCUSSION


Treat_CCM will evaluate the safety and efficacy of propranolol for CCMs following promising case reports in a randomized controlled trial. The direction of effect on the primary outcome and the consistency of effects on the secondary outcomes (even if none of them yield statistically significant differences) of this external pilot study may lead to a larger sample size in a definitive phase 2 trial.
TRIAL REGISTRATION


ClinicalTrails.gov, NCT03589014. Retrospectively registered on 17 July 2018.",2020,The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs.,"['six Italian clinical centres with central reading of brain magnetic resonance imaging (MRI) and adverse events', 'familial cerebral cavernous malformation (Treat_CCM', 'Retrospectively registered on 17 July 2018', 'Patients with symptomatic FCCMs']","['Propranolol', 'propranolol (40-80\u2009mg twice daily) in addition to standard care or to standard care alone (i.e. anti-epileptic drugs or headache treatments', 'propranolol', 'Neurosurgical excision, and perhaps stereotactic radiosurgery']","['MRI changes over time (i.e. de novo CCM lesions, CCM size and signal characteristics, iron deposition, and vascular leakage as assessed by quantitative susceptibility mapping and dynamic contrast enhanced permeability), disability, health-related quality of life, depression severity, and anxiety (SF-36, BDI-II, State-Trait Anxiety Inventory', 'safety and efficacy', 'intracranial haemorrhage or focal neurological deficit attributable to CCMs']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2931263', 'cui_str': 'Hereditary cavernous hemangioma of brain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0085203', 'cui_str': 'Radiosurgery'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0333596', 'cui_str': 'Deposition of iron'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C2919945', 'cui_str': 'Cavernous hemangioma of brain'}]",,0.228911,The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs.,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lanfranconi', 'Affiliation': 'Department of Neurology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Padiglione Monteggia-piano 3, Via Francesco Sforza 35, 20122, Milan, Italy. silvia.lanfranconi@policlinico.mi.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Scola', 'Affiliation': 'Department of Neuroradiology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Giulio Andrea', 'Initials': 'GA', 'LastName': 'Bertani', 'Affiliation': 'Department of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zarino', 'Affiliation': 'Department of Neurosurgery, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pallini', 'Affiliation': 'Department of Neurosurgery, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': ""d'Alessandris"", 'Affiliation': 'Department of Neurosurgery, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Mazzon', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Contrada Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marino', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Contrada Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Carriero', 'Affiliation': 'Cerebrovascular Disease Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Scelzo', 'Affiliation': 'Cerebrovascular Disease Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faragò', 'Affiliation': 'Department of Neuroradiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Giovanni Celoria 11, 20133, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Castori', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Fusco', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Petracca', 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': ""d'Agruma"", 'Affiliation': 'Division of Medical Genetics, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 2, 71013, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tassi', 'Affiliation': '""Claudio Munari"" Epilepsy Surgery Centre, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell\'Ospedale Maggiore 3, 20162, Milan, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': ""d'Orio"", 'Affiliation': '""Claudio Munari"" Epilepsy Surgery Centre, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell\'Ospedale Maggiore 3, 20162, Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Lampugnani', 'Affiliation': 'Laboratory of Vascular Biology, IFOM, Firc Institute for Molecular Oncology, Via Adamello 16, 20139, Milan, Italy.'}, {'ForeName': 'Enrico Bjorn', 'Initials': 'EB', 'LastName': 'Nicolis', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Vasamì', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Novelli', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Research Methodology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Jennifer Marie Theresia Anna', 'Initials': 'JMTA', 'LastName': 'Meessen', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': 'Rustam Al-Shahi', 'Initials': 'RA', 'LastName': 'Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Little France Crescent 49, Edinburgh, EH16 4SB, UK.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Dejana', 'Affiliation': 'Laboratory of Vascular Biology, IFOM, Firc Institute for Molecular Oncology, Via Adamello 16, 20139, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Laboratory of Cardiovascular Clinical Pharmacology, Mario Negri Institute for Pharmacological Research-IRCCS, Via Mario Negri, 2, 20156, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4202-x']
495,32398119,The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients - a protocol for a prosprective randomized clinical trial.,"BACKGROUND


Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery. Studies indicate that supplemental oxygen decreases sympathetic nerve activity and might, therefore, improve cardiovascular function. Thus, we will test the effect of perioperative supplemental oxygen administration on NT-proBNP release after surgery.
METHODS/DESIGN


We will conduct a single-center, double-blinded, randomized trial at the Medical University of Vienna, including 260 patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery. Patients will be randomly assigned to receive 80% versus 30% oxygen during surgery and for 2 h postoperatively. The primary outcome will be the difference in maximum NT-proBNP release after surgery. As secondary outcomes we will assess the effect of supplemental oxygen on postoperative maximum troponin T concentration, oxidation-reduction potential, von Willebrand factor concentration and perioperative fluid requirements. We will perform outcome measurements 2 h after surgery, on postoperative day 1 and on postoperative day 3. The NT-proBNP concentration and the oxidation-reduction potential will also be measured within 72 h before discharge.
DISCUSSION


Our trial should determine whether perioperative supplemental oxygen administration will reduce the postoperative release of NT-proBNP in patients with preoperative increased cardiovascular risk factors undergoing noncardiac surgery.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03366857. Registered on 8th December 2017.",2020,"BACKGROUND


Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery.","['patients with preoperative increased cardiovascular risk factors undergoing noncardiac surgery', 'noncardiac surgery', '260 patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery', 'cardiac risk patients']",['supplemental oxygen'],"['NT-proBNP release', 'cardiovascular function', 'maximum NT-proBNP release', 'postoperative maximum troponin T concentration, oxidation-reduction potential, von Willebrand factor concentration and perioperative fluid requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",260.0,0.663905,"BACKGROUND


Elevated postoperative N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations are predictive for cardiac adverse events in noncardiac surgery.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. barbara.kabon@meduniwien.ac.at.'}, {'ForeName': 'Markus Falkner', 'Initials': 'MF', 'LastName': 'von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Starlinger', 'Affiliation': 'Department of Surgery, Medical University of Vienna, 1090, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Taschner', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zotti', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Goshin', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Drlicek', 'Affiliation': 'Franziskus Spital, Anaesthesia and Intensive Care, 1050, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]",Trials,['10.1186/s13063-020-04336-9']
496,32398120,Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial.,"BACKGROUND


An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to investigate if this individualized treatment algorithm gives a better functional outcome than treating all patients either operatively or non-operatively per default.
METHODS/DESIGN


This study is conducted as a multicenter, three-armed randomized controlled trial. Participants are included from four hospitals in Denmark and randomized 1:1:1 to one of three parallel groups: 1) Intervention group-participants are treated according to an individualized treatment algorithm; 2) Control group A-participants are treated non-operatively; 3) Control group B-participants are treated operatively. The individualized treatment algorithm for the intervention group is based on an ultrasonographic examination; tendon overlap and elongation below 7% is to be treated non-operatively, while no tendon overlap and/or elongation above 7% will be treated operatively. Over a period of 3 years, 300 participants will be included. The primary outcome is the heel-rise work test at 12 months post-injury. Secondary outcomes are tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures, and other complications. The primary analysis will be conducted as an intention-to-treat analysis.
DISCUSSION


This trial will indicate if treatment of acute Achilles tendon rupture can be individualized based on elongation and tendon overlap. It is hypothesized that different patients will benefit from different treatments instead of offering all the same treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03525964. Registered 16 May 2018.",2020,"BACKGROUND


An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment.","['patients either operatively or non-operatively per default', '300 participants will be included', 'Participants are included from four hospitals in Denmark']","['Copenhagen Achilles Rupture Treatment Algorithm (CARTA', 'Individualized treatment', 'Intervention group-participants are treated according to an individualized treatment algorithm; 2) Control group A-participants are treated non-operatively; 3) Control group B-participants are treated operatively', 'individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA']","['heel-rise work test at 12\u2009months post-injury', 'tendon elongation, the Achilles tendon Total Rupture Score (ATRS), the rate of re-ruptures, and other complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",300.0,0.144609,"BACKGROUND


An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment.","[{'ForeName': 'Maria Swennergren', 'Initials': 'MS', 'LastName': 'Hansen', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark. maria_swennergren@hotmail.com.'}, {'ForeName': 'Marianne Toft', 'Initials': 'MT', 'LastName': 'Vestermark', 'Affiliation': 'Department of Orthopedic Surgery, Viborg Regional Hospital, Heiberbs Allé 4, 8800, Viborg, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hölmich', 'Affiliation': 'Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital, Kettegård Alle 30, 2650, Amager-Hvidovre, Denmark.'}]",Trials,['10.1186/s13063-020-04332-z']
497,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND


With advancing age, changes in the central nervous system may lead to motor functional deficits. Non-invasive brain stimulation techniques are suggested to help modifying brain function.
OBJECTIVES


The aim of the current study was to investigate the effect of using multi session anodal transcranial Direct Current Stimulation (a-tDCS) over the primary motor cortex (M1) on the hand function in healthy older adults.
METHOD


In this randomized, double-blinded, sham-controlled study 32 participants received active or sham a-tDCS (1 mA, 20 min, for five consecutive days) and performed the Purdue Pegboard Test (PPT) on the first day before tDCS application, immediately (T1), 30 min (T2), and one week after the last session (5th day) (T3) of the stimulation.
RESULTS


There was a significant improvement for PPT (p < 0.05) in a-tDCS group at all post-test values except for PPT for left hand (PPTL) at T1. Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
CONCLUSION


The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group.
","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063']
498,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND


Fatigue is one of the most common symptoms in patients with multiple sclerosis (MS). Currently, there is no approved medication for MS-related fatigue.
OBJECTIVE


In this study, we aim to evaluate the safety and efficacy of memantine for improving fatigue in patients with MS.
METHODS


This was a pilot randomized, double-blind, placebo-controlled clinical trial. Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria were randomized to receive either memantine (20 mg/day) or placebo and were assessed at baseline and three months after treatment. The change in the severity of fatigue was determined by the Modified Fatigue Impact Scale (MFIS).
RESULTS


Sixty-four patients were randomly allocated to the memantine (n = 32) and placebo (n = 32) groups. Sixteen patients in the memantine group and 24 patients in the placebo group completed the study. The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702). No serious adverse events were reported, except for dizziness and sedation in four patients in the experimental arm, which resulted in discontinuation.
CONCLUSION


This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844']
499,32335356,"Efficacy and safety of curcumin in combination with paclitaxel in patients with advanced, metastatic breast cancer: A comparative, randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


The clinical efficacy of curcumin has not yet been established for the treatment of cancer, despite a large body of evidence from numerous preclinical studies suggesting the therapeutic potential of curcumin, particularly in a synergistic combination with paclitaxel. The main obstacle in using curcumin for adjunctive cancer therapy is its low bioavailability via oral administration.
PURPOSE


We assessed the efficacy and safety of intravenous curcumin infusion in combination with paclitaxel in patients with metastatic and advanced breast cancer.
STUDY DESIGN


A randomized, double-blind, placebo-controlled, parallel-group comparative clinical study was conducted.
METHODS


A total of 150 women with advanced and metastatic breast cancer were randomly assigned to receive either paclitaxel (80 mg/m 2 ) plus placebo or paclitaxel plus curcumin (CUC-1®, 300 mg solution, once per week) intravenously for 12 weeks with 3 months of follow-up. The primary outcome was determined based on the objective response rate (ORR), as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). The secondary outcomes were progression-free survival (PFS), time to tumor progression (TTP), time to tumor treatment failure (TTTF), safety, and quality of life.
RESULTS


The intention-to-treat (ITT) analysis revealed that the ORR of curcumin was significantly higher than that of the placebo (51% vs. 33%, p < 0.01) at 4 weeks of follow-up. The difference between the groups was even greater when only patients who had completed the treatment (61% vs. 38%, odds ratio ==2.64, p < 0.01) were included. A superior effect of curcumin vs placebo was observed in both patients who had completed the treatment and all patients included in the ITT analysis, 3 months after termination of the treatment. No other significant differences were observed between the curcumin and the placebo groups, except for fatigue (3 vs. 10 patients, respectively; odds ratio ==3.7, p = 0.05). However, the patients' self-assessed overall physical performance was significantly higher with curcumin than the placebo during the treatment and at the end of the follow-up, suggesting better tolerance in the curcumin group.
CONCLUSIONS


Overall, treatment with curcumin in combination with paclitaxel was superior to the paclitaxel-placebo combination with respect to ORR and physical performance after 12 weeks of treatment. Intravenously administered curcumin caused no major safety issues and no reduction in quality of life, and it may be beneficial in reducing fatigue.
ADVANCES IN KNOWLEDGE


This is the first clinical study to explore the efficacy and safety of administering curcumin intravenously in combination with chemotherapy in the treatment of cancer patients.",2020,"No other significant differences were observed between the curcumin and the placebo groups, except for fatigue (3 vs. 10 patients, respectively; odds ratio ==3.7, p = 0.05).","['patients with advanced, metastatic breast cancer', '150 women with advanced and metastatic breast cancer', 'cancer patients', 'patients with metastatic and advanced breast cancer']","['paclitaxel-placebo', 'placebo', 'intravenous curcumin infusion in combination with paclitaxel', 'paclitaxel', 'curcumin intravenously in combination with chemotherapy', 'placebo or paclitaxel plus curcumin (CUC-1®', 'curcumin', 'curcumin vs placebo']","['ORR of curcumin', 'fatigue', 'overall physical performance', 'efficacy and safety', 'objective response rate (ORR), as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST', 'progression-free survival (PFS), time to tumor progression (TTP), time to tumor treatment failure (TTTF), safety, and quality of life', 'quality of life', 'ORR and physical performance', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",150.0,0.24233,"No other significant differences were observed between the curcumin and the placebo groups, except for fatigue (3 vs. 10 patients, respectively; odds ratio ==3.7, p = 0.05).","[{'ForeName': 'Tatul', 'Initials': 'T', 'LastName': 'Saghatelyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia. Electronic address: saghatelyan@armtelemed.org.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Tananyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Janoyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tadevosyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Hasmik', 'Initials': 'H', 'LastName': 'Petrosyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Araxia', 'Initials': 'A', 'LastName': 'Hovhannisyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Hayrapetyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Arustamyan', 'Affiliation': 'National Center of Oncology, 76 Fanarjyan str, 0052 Yerevan, Armenia.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Arnhold', 'Affiliation': 'BRIU GmbH, Germany, Altkönigstrasse10, 65462 Königstein, Germany.'}, {'ForeName': 'Andre-Robert', 'Initials': 'AR', 'LastName': 'Rotmann', 'Affiliation': 'Center of Complementary Oncology, Obere Martkstrasse 7, 63110 Rodgau Nieder-Roden, Germany.'}, {'ForeName': 'Areg', 'Initials': 'A', 'LastName': 'Hovhannisyan', 'Affiliation': 'Sport Medicine & Anti-Doping Service Republican Centre, Yerevan, Acharyan Str., 2/6, Yerevan, Armenia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Panossian', 'Affiliation': 'Phytomed AB, Bofinkvagen 1, Vaxtorp 31275, Sweden. Electronic address: ap@phytomed.se.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153218']
500,32338063,"Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial.","Objective:  DBPR108, a novel dipeptidyl-peptidase-4 inhibitor, has shown great antihyperglycemic effect in animal models. This study was to evaluate the efficacy and safety of DBPR108 monotherapy in type 2 diabetes mellitus (T2DM). Methods:  This was a 12-week, double-blind, placebo-controlled phase II clinical trial. The newly diagnosed or inadequately controlled untreated T2DM patients were randomized to receive 50, 100, 200 mg DBPR108 or placebo in a ratio of 1:1:1:1. The primary efficacy outcome was HbA1c change from baseline to week 12. Relevant secondary efficacy parameters and safety were assessed. The clinical trial registration is NCT04124484. Results:  Overall, 271 of the 276 randomized patients, who received 50 mg ( n  = 68), 100 mg ( n  = 67), 200 mg ( n  = 69) DBPR108 or placebo ( n  = 67), were included in full analysis set. At week 12, HbA1c change from baseline was -0.04 ± 0.77 in placebo group, -0.51 ± 0.71, -0.75 ± 0.73, and -0.57 ± 0.78 (%,  p  < .001 vs. placebo) in 50, 100, and 200 mg DBPR108 groups, respectively. Since week 4, DBPR108 monotherapy resulted in significant improvements in secondary efficacy parameters. At end of 12-week treatment, the goal of HbA1c ≤7% was achieved in 29.85, 58.82, 55.22, and 47.83% of the patients in placebo, 50, 100, and 200 mg DBPR108 groups, respectively. The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group. Conclusions:  The study results support DBPR108 100 mg once daily as the primary dosing regimen for T2DM patients in phase III development program.",2020,The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group.,"['type 2 diabetes mellitus (T2DM', 'newly diagnosed or inadequately controlled untreated T2DM patients', 'patients with type 2 diabetes', 'T2DM patients in phase III development program']","['DBPR108 or placebo', 'placebo', 'DBPR108 monotherapy']","['secondary efficacy parameters', 'efficacy and safety', 'mild hypoglycemia', 'incidence of adverse events', 'Efficacy and safety']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0033333', 'cui_str': 'Program development'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",276.0,0.553928,The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yushan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Affiliated Hospital of Beihua University, Jilin, China.'}, {'ForeName': 'Chaoli', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia, China.'}, {'ForeName': 'Kuanzhi', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'The Third Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Third Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Yueyang, Hunan, China.""}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Emergency General Hospital, Beijing, China.'}, {'ForeName': 'Zhongyuan', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Renmin Hospital of Wuhan University, Hubei, China.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Xinjiang Uiger Municipal People's Hospital, Xinjiang, China.""}, {'ForeName': 'Shuangqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Inner Mongolia Baogang Hospital, Inner Mongolia, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The second Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Anhui Provincial Hospital, Anhui, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Huashan Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Jining First People's Hospital, Shandong, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shiyan Taihe Hospital, Hubei, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Wuhan Puai Hospital, Hubei, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Support Force of Chinese PLA, Fujian, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Mingbiao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}]",Current medical research and opinion,['10.1080/03007995.2020.1761311']
501,32283187,Mediators of intervention effects on dietary fat intake in low-income overweight or obese women with young children.,"PURPOSE


We investigated whether autonomous motivation and self-efficacy might mediate the association between a lifestyle behavior intervention and dietary fat intake in low-income overweight or obese women with young children.
METHODS


Participants were randomized to an intervention or comparison group. Intervention participants received a 16-week intervention aimed to prevent weight gain through promotion of stress management, healthy eating and physical activity. During the intervention phase, participants viewed a designated video lesson at home and dialed in a peer support group teleconference every week (weeks 1-4) then every other week (weeks 5-16). Potential mediation effects were analyzed using sequential mixed-effects linear models and path analysis.
RESULTS


The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001). In other words, autonomous motivation and self-efficacy mediated the association between the lifestyle behavior intervention and dietary fat intake.
CONCLUSION


To decrease dietary fat intake for low-income overweight or obese women with young children, strategies, such as those promoting peer encouragement, may be warranted in interventions to enhance autonomous motivation and/or practical skills for increasing self-efficacy.",2020,"The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001).","['Participants', 'low-income overweight or obese women with young children']","['16-week intervention aimed to prevent weight gain through promotion of stress management, healthy eating and physical activity', 'lifestyle behavior intervention and dietary fat intake']","['dietary fat intake', 'autonomous motivation', 'self-efficacy', 'higher levels of self-efficacy']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0425440', 'cui_str': 'Dietary fat intake'}]","[{'cui': 'C0425440', 'cui_str': 'Dietary fat intake'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0336699,"The intervention led to increased autonomous motivation (β = 0.34, standard error [SE] = 0.15, P = 0.005), which subsequently increased self-efficacy (β = 0.18, SE = 0.35, P < 0.001), and higher levels of self-efficacy were associated with decreased dietary fat intake (β = -0.22, SE = 0.28, P < 0.001).","[{'ForeName': 'Mei-Wei', 'Initials': 'MW', 'LastName': 'Chang', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Avenue, Columbus, OH, 43210, USA. Electronic address: chang.1572@osu.edu.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'The Ohio State University College of Nursing, 1585 Neil Avenue, Columbus, OH, 43210, USA.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Michigan State University College of Nursing, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: lingjiyi@msu.edu.'}, {'ForeName': 'Duane T', 'Initials': 'DT', 'LastName': 'Wegener', 'Affiliation': 'The Ohio State University Department of Psychology, 1835 Neil Avenue, Columbus, OH, 43210, USA. Electronic address: wegener.1@osu.edu.'}, {'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'Michigan State University College of Nursing, 1355 Bogue St, East Lansing, MI, 48824, USA. Electronic address: robbin76@msu.edu.'}]",Appetite,['10.1016/j.appet.2020.104700']
502,32398441,Dexmedetomidine 2▒ppm is Appropriate for the Enhancement Effect of Local Anesthetic Action of Lidocaine in Inferior Alveolar Nerve Block: A Randomized Crossover Study; A Study that Awaits Confirmation in a Larger Trial.,"OBJECTIVE


Local anesthesia is essential for pain management in dentistry. The duration of anesthetic action of addition of 5.0 and 7.5 of DEX was significantly longer than addition of adrenaline, and the mean duration of anesthetic action of addition of 2.5▒ppm DEX was also longer than addition of adrenaline. We hypothesized that it is possible to safely achieve equal local anesthesia effect as with 1:80,000 adrenaline without using adrenaline or felypressin, by addition of less than 2.5▒ppm DEX to the local anesthetic solution.
METHODS


Nineteen healthy volunteers were randomly assigned by a computer to receive 1.8▒mL of one of three drug combinations (1.8% lidocaine with 1.0▒ppm (1.8▒μg) DEX, lidocaine with 2.0▒ppm (3.6▒μg) DEX or lidocaine with 1:80000 (22.5▒μg) adrenaline), to produce inferior alveolar nerve block. Pulp latency and lower lip numbness (for assessing onset and duration of anesthesia) were tested, and sedation level, blood pressure and heart rate were recorded every 2▒min for 10▒min, every 5▒min from 10-20▒min, and every 10▒min from 20-60▒min.
RESULTS


Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point. Anesthesia onset was not different between groups. Anesthesia duration was not different between groups.Blood pressure and heart rate did not change in any group. Sedation score did not indicate deep sedation in any of the groups.
DISCUCCION


DEX at a concentration of 1.0-2.0▒ppm enhances the local anesthetic action of lidocaine. DEX at 2.0▒ppm produces similar enhancement of local anesthesia effect as addition of 1:80,000 adrenaline.",2020,"RESULTS


Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point.","['Nineteen healthy volunteers', 'Inferior Alveolar Nerve Block', 'pain management in dentistry']","['DEX', 'Lidocaine', 'adrenaline or felypressin', 'Dexmedetomidine', 'lidocaine', 'DEX or lidocaine', 'DEX, lidocaine', 'adrenaline', 'lidocaine with 1.0▒ppm (1.8▒μg']","['Pulp latency', 'Anesthesia duration', 'local anesthesia effect', 'duration of anesthetic action', 'Blood pressure and heart rate', 'Sedation score', 'local anesthetic action', 'mean duration of anesthetic action', 'sedation level, blood pressure and heart rate', 'Pulp latency and lower lip numbness']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226942', 'cui_str': 'External lower lip'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}]",19.0,0.121872,"RESULTS


Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ouchi', 'Affiliation': 'Department of Dental Anesthesiology, Field of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000839']
503,32398443,"Evaluation of the Efficacy of Prolonged Pregabalin Administration before and after Surgery in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Randomized, Double-Blind Study.","CONTEXT AND OBJECTIVES


Reconstruction of the knee ligament causes postoperative pain, and delayed rehabilitation.
OBJECTIVES


The primary objective of this study was to evaluate the effect of a prolonged pre and postoperative pregabalin use for arthroscopic anterior cruciate ligament repair.
METHODS


Group 1 (N: 25) patients received pregabalin 75▒mg/day, and group 2 (N: 25) received placebo, 7 days before and 7 days after surgery. Spinal anesthesia was performed using 0.5% hyperbaric bupivacaine (15▒mg). The following were evaluated: pain intensity immediately after the surgery, 12 h, 24 h, 1 week, 2 weeks, 1 month and 2 months after surgery using a numerical scale; dose of postoperative supplementary analgesic for 2 months; time to first analgesic requirement, and side effects during 2 months. For supplementation, the participants received 1▒g dipyrone; if no pain control, 100▒mg ketoprofen was administered; if there was no effect, 100▒mg tramadol was administered; and if no pain control, 5▒mg intravenous morphine was administered until pain control.
RESULTS


There was no difference between the groups regarding pain intensity (P: 0.077). In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery. There was no significant difference in the incidence of nausea and vomiting, and dizziness was higher in the pregabalin group (G1: 12 patients; G2: 3 patients; P: 0.005).
DISCUSSION


A prolonged pre and postoperative pregabalin prescription for anterior cruciate ligament repair decreased the need for supplementary analgesics during the first 24 postoperative hours but increased dizziness.",2020,"In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery.","['arthroscopic anterior cruciate ligament repair', 'Patients', 'Group 1', 'Undergoing Arthroscopic Anterior Cruciate Ligament Repair']","['morphine', 'tramadol', 'hyperbaric bupivacaine', 'pregabalin', 'Prolonged Pregabalin', 'ketoprofen', 'prolonged pre and postoperative pregabalin', 'dipyrone', 'placebo']","['dizziness', 'pain intensity', 'morphine consumption', 'nausea and vomiting, and dizziness', 'time to first analgesic requirement, and side effects']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",25.0,0.135105,"In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery.","[{'ForeName': 'Alexandro Ferraz', 'Initials': 'AF', 'LastName': 'Tobias', 'Affiliation': 'Universidade Federal de São Paulo.'}, {'ForeName': 'Ed Carlos Rey', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Universidade Federal do Maranhão.'}, {'ForeName': 'Claudio Alex de Oliveira', 'Initials': 'CAO', 'LastName': 'Honda', 'Affiliation': 'Universidade Federal do Maranhão.'}, {'ForeName': 'Emanuel Cabral', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Universidade Federal do Maranhão.'}, {'ForeName': 'Caio Marcio Barros', 'Initials': 'CMB', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal do Maranhão.'}, {'ForeName': 'Plinio da Cunha', 'Initials': 'PDC', 'LastName': 'Leal', 'Affiliation': 'Universidade Federal do Maranhão.'}, {'ForeName': 'Rioko Kimiko', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'Universidade Federal de São Paulo.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000841']
504,32398466,Treatment of neurogenic lower urinary tract symptoms: main contributions from 2018 and 2019.,"PURPOSE OF REVIEW


This review aims to update the studies involving the treatment of lower urinary tract symptoms (LUTS) in neurogenic patients, published in the last two years.
RECENT FINDINGS


Treatment of neurogenic LUTS (NLUTS) patients with β3 adrenoreceptor agonists was investigated in real-life conditions. A randomized controlled trial compared the efficacy of antimuscarinics versus onabotulinum toxin A in neurogenic patients. The use of desmopressin to treat nocturia in multiple sclerosis patients is also reported. The long-term treatment with BontA efficacy, its discontinuation, and possible strategies to maintain patients on treatment were also evaluated. Sacral neuromodulation and tibial nerve stimulation are continuously being evaluated in neurogenic patients, especially in the last years.
SUMMARY


The management of urinary tract infections and vesical lithiasis, two common complications in NLUTS patients, and the management of both these patients was assessed in clinical trials.A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.",2020,A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.,"['neurogenic patients', 'multiple sclerosis patients']","['antimuscarinics versus onabotulinum toxin A', 'desmopressin']",['urinary tract infections and vesical lithiasis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0023869', 'cui_str': 'Lithiasis'}]",,0.0265182,A trial evaluating the use of the anti-Nogo-A antibody after a spinal cord injury to facilitate neuronal rewiring and prevent or improve NLUTS was reported for the first time.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Abreu-Mendes', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário de São João.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário de São João.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martins-Silva', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário de São João.'}]",Current opinion in urology,['10.1097/MOU.0000000000000774']
505,32398500,The Effect of Rehospitalization and Emergency Department Visits on Subsequent Adherence to Weight Telemonitoring.,"BACKGROUND


Weight telemonitoring may be an effective way to improve patients' ability to manage heart failure and prevent unnecessary utilization of health services. However, the effectiveness of such interventions is dependent upon patient adherence.
OBJECTIVE


The purpose of this study was to determine how adherence to weight telemonitoring changes in response to 2 types of events: hospital readmissions and emergency department visits.
METHODS


The Better Effectiveness After Transition-Heart Failure trial examined the effectiveness of a remote telemonitoring intervention compared with usual care for patients discharged to home after hospitalization for decompensated heart failure. Participants were followed for 180 days and were instructed to transmit weight readings daily. We used Poisson regression to determine the within-person effects of events on subsequent adherence.
RESULTS


A total of 625 events took place during the study period. Most of these events were rehospitalizations (78.7%). After controlling for the number of previous events and discharge to a skilled nursing facility, the rate for adherence decreased by nearly 20% in the 2 weeks after a hospitalization compared with the 2 weeks before (adjusted rate ratio, 0.81; 95% confidence interval: 0.77-0.86; P < .001).
CONCLUSIONS


Experiencing a rehospitalization had the effect of diminishing adherence to daily weighing. Providers using telemonitoring to monitor decompensation and manage medications should take advantage of the potential ""teachable moment"" during hospitalization to reinforce the importance of adherence.",2020,The Better Effectiveness,['patients discharged to home after hospitalization for decompensated heart failure'],['remote telemonitoring intervention'],"['Better Effectiveness', 'rate for adherence']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0488464,The Better Effectiveness,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Haynes', 'Affiliation': 'Sarah C. Haynes, PhD, MPH Department of Pediatrics, University of California Davis, Sacramento, California. Daniel J. Tancredi, PhD Department of Pediatrics and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Kathleen Tong, MD Adventist Heart and Vascular Institute, St. Helena, California. Jeffrey S. Hoch, PhD Department of Public Health Sciences and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California. Michael K. Ong, MD, PhD Division of General Internal Medicine and Health Services Research, University of California Los Angeles and VA Greater Los Angeles Healthcare System, California. Theodore G. Ganiats, MD Department of Family Medicine and Public Health, University of California San Diego School of Medicine, La Jolla, California. Lorraine S. Evangelista, PhD, RN Sue and Bill Gross School of Nursing, University of California Irvine, California. Jeanne T. Black, PhD, MBA Department of Orthopaedics, Cedars-Sinai Medical Center, Los Angeles, California. Andrew Auerbach, MD, MPH Department of Medicine, University of California San Francisco School of Medicine. Patrick S. Romano, MD, MPH Division of General Medicine and Center for Healthcare Policy and Research, University of California Davis, Sacramento, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': ''}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': ''}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Ganiats', 'Affiliation': ''}, {'ForeName': 'Lorraine S', 'Initials': 'LS', 'LastName': 'Evangelista', 'Affiliation': ''}, {'ForeName': 'Jeanne T', 'Initials': 'JT', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': ''}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000689']
506,32398578,"The Effect of Semirecumbent and Right Lateral Positions on the Gastric Residual Volume of Mechanically Ventilated, Critically Ill Patients.","BACKGROUND


Delay in stomach discharge is a challenge for patients who are tube fed and may result in serious side effects such as pneumonia and malnutrition.
PURPOSE


This study was designed to determine the respective effects of the semirecumbent (SR) supine and right lateral (RL) with a flatbed positions on the gastric residual volume (GRV) of mechanically ventilated, critically ill adult patients.
METHODS


A randomized, crossover clinical trial design was used to investigate GRV in 36 critically ill, ventilated adult patients who were hospitalized in the intensive care unit. GRV was measured at 3 hours after three consecutive feedings. GRV was first measured in all of the participants in the supine position; after which, participants were randomly assigned into one of two therapeutic positioning groups (Group A: assessment in the SR position and then the RL position; Group B: assessment in the RL position and then the SR position).
RESULTS


GRV was significantly lower in both the SR and RL positions than in the supine position. GRV in the SR and RL positions did not vary significantly. The in-group measurements for GRV did not significantly differ for any of the three positions. In Group A, GRV was significantly lower at each subsequent measurement point.
CONCLUSION/IMPLICATIONS FOR PRACTICE


Positioning patients in the RL and SR positions rather than in the supine position is an effective strategy to reduce GRV. Furthermore, placing patients in either the RL or SR position is an effective intervention to promote faster digestion and feedings.",2020,The in-group measurements for GRV did not significantly differ for any of the three positions.,"['mechanically ventilated, critically ill adult patients', 'Mechanically Ventilated, Critically Ill Patients', '36 critically ill, ventilated adult patients who were hospitalized in the intensive care unit']","['semirecumbent (SR) supine and right lateral (RL) with a flatbed positions', 'Semirecumbent and Right Lateral Positions']","['GRV', 'gastric residual volume (GRV']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}]","[{'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",36.0,0.0318326,The in-group measurements for GRV did not significantly differ for any of the three positions.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Farsi', 'Affiliation': ''}, {'ForeName': 'Maaʼsoumeh', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'MSc, Researcher, Student Research Committee, Faculty of Nursing, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': ""PhD, Assistant Professor, Harvard Medical School and Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Zareiyan', 'Affiliation': 'PhD, Associate Professor, Faculty of Nursing, Community Health Department, Aja University of Medical Sciences, Tehran, Iran.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000377']
507,32398710,Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial.,"In the last forty years therapy outcomes for depression have remained the same with approximately 50% of patients responding to treatments. Advances are urgently required. We hypothesised that a recent treatment, metacognitive therapy (MCT), might be more effective, by targeting mental control processes that directly contribute to depression. We assessed the clinical efficacy of MCT compared to current best psychotherapy practice, CBT, in adults with major depressive disorder. A parallel randomized single-blind trial was conducted in a primary care outpatient setting. This trial is registered with the ISCRTN registry, number ISRCTN82799488. In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part. 85 were randomly allocated to MCT and 89 to CBT. Randomisation was performed independently following pre-treatment assessment and was stratified for severity of depression (low < 20 vs high > =20) on the Hamilton Depression Rating Scale (HDRS) and on sex (male/female). Assessors and trial statisticians were blind to treatment allocation. Each treatment arm consisted of up to 24 sessions of up to 60 minutes each, delivered by trained clinical psychologists. The co-primary outcome measures were assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II) at post treatment. Secondary outcomes were scores six months post treatment on these measures and a range of symptom and mechanism variables. A key trial design feature was that each treatment was implemented to maximize individual patient benefit; hence time under therapy and number of sessions delivered could vary. Treated groups in the trial were very similar on most baseline characteristics. Data were analyzed on the basis of intention to treat (ITT). No differences were found on the HDRS at post treatment or follow-up (-0.95 [-2.88 to 0.98], p = 0.336; and -1.61 [-3.65 to 0.43], p = 0.122), but floor effects on this outcome were high. However, a significant difference favouring MCT was found on the BDI-II at post treatment (-5.49 [95% CI -8.90 to -2.08], p = 0.002), which was maintained at six-month follow-up (-4.64 [-8.21 to -1.06], p = 0.011). Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-ratio=2.42 [1.20 to 4.92], p = 0.014). At follow-up the proportions were 74% compared to 56% recovery (odds-ratio=2.19 [1.05 to 4.54], p = 0.036). Significant differences favouring MCT, also maintained over time, were observed for most secondary outcomes. The results were robust against controlling for time under therapy and when outcomes were assessed at a common 90 day mid-term time-point. Limitations of the study include the use of only two therapists where one treated 69% of patients, possible allegiance effects as the study was conducted in an established CBT clinic and the chief investigator is the originator of MCT and group differences in time under therapy. Never the less evidence from this study suggests that MCT had considerable beneficial effects in treating depression that may exceed CBT.",2020,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"['In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part', 'primary care outpatient setting', 'Adults with Major Depression', 'adults with major depressive disorder']","['metacognitive therapy (MCT', 'Metacognitive Therapy versus Cognitive Behaviour Therapy', 'MCT']","['range of symptom and mechanism variables', 'MCT', 'Hamilton Depression Rating Scale (HDRS', 'assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II', 'HDRS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",174.0,0.0879843,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Callesen', 'Affiliation': 'Cektos - Center for Kognitiv - og Metakognitiv Terapi, Riddergade 7, 1 sal, 4700, Næstved, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'University of Manchester, NIHR School for Primary Care Research, Manchester Academic Health Sciences Centre, Williamson Building, Manchester, M13 9PL, UK.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'University of Manchester, Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, Manchester, M13 9PL, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'University of Manchester, School of Psychological Sciences, Faculty of Biology, Medicine and Health, Rawnsley Building, MRI, Manchester, M13 9WL, UK. adrian.wells@manchester.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-64577-1']
508,32398738,"Impact of different cord clamping strategies on short term neuromonitoring among preterm infants: a randomized, controlled trial.",,2020,,['preterm infants'],['cord clamping strategies'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]",[],,0.201929,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA. pagarwal@dmc.org.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': ""Children's Research Center of Michigan, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0684-3']
509,32398754,Variance in respiratory quotient among daily activities and its association with obesity status.,"BACKGROUND/OBJECTIVES


The ability to adapt the level of daily fuel utilization to substrate availability is given by the respiratory quotient (RQ), which its variance is an indicator of metabolic flexibility. Metabolic inflexibility is associated with many pathologies including obesity, but evidence relies on bed-rest studies and exercise-based interventions. Our goal was to examine the associations for RQ variance in response to daily living activities with obesity, in healthy adults.
SUBJECTS/METHODS


Participants (N = 50; 25 women), 20-64 years were lying for 60 min and randomly performed three conditions for 10 min each (sitting, standing, 1 sit/stand/sit transition min -1 ). RQ was measured by indirect calorimetry and fat mass (FM), trunk FM (TFM), and fat-free mass (FFM) by DXA.
RESULTS


RQ variance among the three conditions was inversely associated with BMI (ß = 0.005; p < 0.001), FM (ß = 0.007; p = 0.024), and TFM (ß = 0.008; p = 0.026). A positive association was found between RQ variance and FFM (ß = -0.007; p = 0.024). No interactions for sex were found (p ≥ 0.05).
CONCLUSIONS


These findings suggest that a higher RQ variance in response to daily living metabolic challenges such as transitioning between sitting and standing is associated with lower overall and central obesity, as well as with a higher FFM, in healthy adults. Thus, RQ variance may work as an indication of metabolic flexibility, but these findings were obtained in a young and non-obese adult population without considering their fitness levels. Thus, further research in this field is warranted.",2020,A positive association was found between RQ variance and FFM (ß ,"['healthy adults', 'Participants (N\u2009=\u200950; 25 women), 20-64 years']",[],"['RQ variance and FFM (ß', 'TFM', 'indirect calorimetry and fat mass (FM), trunk FM (TFM), and fat-free mass (FFM', 'BMI', 'FM', 'RQ']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.034016,A positive association was found between RQ variance and FFM (ß ,"[{'ForeName': 'Pedro B', 'Initials': 'PB', 'LastName': 'Júdice', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz-Quebrada, Portugal. pedrojudice@fmh.ulisboa.pt.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Analiza M', 'Initials': 'AM', 'LastName': 'Silva', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz-Quebrada, Portugal.'}]",International journal of obesity (2005),['10.1038/s41366-020-0591-x']
510,32398848,Localized versus 360° intraoperative laser retinopexy in cases of rhegmatogenous retinal detachment with mild-to-moderate grade proliferative vitreoretinopathy.,"BACKGROUND/OBJECTIVES


To compare the efficacy of intraoperative localized and 360° laser retinopexy in cases of rhegmatogenous retinal detachment (RRD) treated with pars plana vitrectomy and air tamponade.
SUBJECTS/METHODS


In this interventional, prospective, randomized, comparative study, 93 consecutive cases of RRD were enroled. After randomization 48 eyes received circumferential, while 45 underwent localized intraoperative laser retinopexy. Number and position of the retinal breaks, presence of proliferative vitreoretinopathy and/or lattice degeneration were recorded. Anatomical and visual outcome of the two groups were compared at 6 months postoperatively.
RESULTS


Baseline characteristics did not significantly differ between groups. The single-operation reattachment rate was 86.66% in localized group and 89.58% in 360° group. The difference was not significant. (P = 0.46, χ 2  test). At 6 months postoperatively, visual acuity (logMAR) was 0.06 ± 0.05 in localized group and 0.05 ± 0.03 in 360° group. The difference was not statistically significant (P = 0.673, t-test).
CONCLUSIONS


Localized laser resulted to be as effective as 360° laser application; this may lead some advantages in term of lower invasiveness, reduction risk of complications and time saving.",2020,The single-operation reattachment rate was 86.66% in localized group and 89.58% in 360° group.,"['cases of rhegmatogenous retinal detachment with mild-to-moderate grade proliferative vitreoretinopathy', 'cases of rhegmatogenous retinal detachment (RRD) treated with pars plana vitrectomy and air tamponade', '93 consecutive cases of RRD were enroled']","['intraoperative localized and 360° laser retinopexy', 'Localized versus 360° intraoperative laser retinopexy', 'localized intraoperative laser retinopexy']","['single-operation reattachment rate', 'visual acuity (logMAR', 'and/or lattice degeneration', 'Anatomical and visual outcome', 'Number and position of the retinal breaks, presence of proliferative vitreoretinopathy']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1868761', 'cui_str': 'Retinopexy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0154856', 'cui_str': 'Retinal lattice degeneration'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0035321', 'cui_str': 'Retinal tear'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",93.0,0.0776211,The single-operation reattachment rate was 86.66% in localized group and 89.58% in 360° group.,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Loiudice', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. ldcpasquale@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Montesel', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sartini', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Morganti', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Statistics, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Posarelli', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Nardi', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Figus', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Giamberto', 'Initials': 'G', 'LastName': 'Casini', 'Affiliation': 'Ophthalmology Unit, Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}]","Eye (London, England)",['10.1038/s41433-020-0950-9']
511,32398852,Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol.,"PURPOSE


To assess the 12-month efficacy and safety of simultaneously administered intravitreal dexamethasone implant (DEX implant) and ranibizumab (simultaneous double protocol) injections in comparison with ranibizumab monotherapy as the first-line treatment of diabetic macular oedema (DMO).
METHODS


Prospective, consecutive, clinical interventional study. Patients were randomized into two groups: 24 naive DMO patients (34 eyes) who received simultaneous double-protocol therapy and 22 DMO patients (34 eyes) who received ranibizumab monotherapy were included. Monthly ranibizumab (0.5 mg) was administered for the first 6 months and later on, an as-needed treatment basis. DEX implant injection was performed at any time during the loading dose of the three consecutive monthly injections of ranibizumab, and with as-needed reinjections of ranibizumab from 6th month onwards. Change in visual acuity was the primary efficacy endpoint. Secondary efficacy endpoints were a gain of ≥15 letters and a change in the central foveal thickness.
RESULTS


Mean BCVA increased from baseline to month 12 in the simultaneously double-protocol therapy group compared with the ranibizumab monotherapy group (21.6 versus 9.6 letters [P < 0.001]). The corresponding proportions of eyes gaining ≥15 letters were 60% versus 29.4% (P < 0.0001). Moreover, the mean reductions in the central foveal thickness were 413 versus 282 µm (P = 0.001). At 12 month, the simultaneous double-protocol therapy decreased a significant number of foveal cysts and subfoveal neuroretinal detachment compared with those by ranibizumab monotherapy.
CONCLUSIONS


The simultaneous addition of DEX implant at any time during the three monthly loading doses of ranibizumab in patients with DMO significantly improved the visual outcomes and revealed superior anatomic outcomes than those with the ranibizumab monotherapy.",2020,The corresponding proportions of eyes gaining ≥15 letters were 60% versus 29.4% (P < 0.0001).,"['and 22 DMO patients (34 eyes) who received', '24 naive DMO patients (34 eyes) who received', 'diabetic macular oedema (DMO', 'diabetic macular edema']","['ranibizumab', 'dexamethasone implant injections', 'intravitreal dexamethasone implant (DEX implant) and ranibizumab (simultaneous double protocol) injections', 'Intravitreal ranibizumab', 'DEX implant injection', 'simultaneous double-protocol therapy', 'Monthly ranibizumab', 'ranibizumab monotherapy']","['visual acuity', 'visual outcomes and revealed superior anatomic outcomes', 'foveal cysts and subfoveal neuroretinal detachment', 'gain of ≥15 letters and a change in the central foveal thickness', 'central foveal thickness', 'corresponding proportions of eyes gaining ≥15 letters', 'Mean BCVA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1142543', 'cui_str': 'Foveal cyst'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.180795,The corresponding proportions of eyes gaining ≥15 letters were 60% versus 29.4% (P < 0.0001).,"[{'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Kaya', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University School of Medicine, Izmir, Turkey. mahmutkaya78@yahoo.com.'}, {'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Kocak', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Taylan', 'Initials': 'T', 'LastName': 'Ozturk', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Bolluk', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Ayhan', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Suleyman', 'Initials': 'S', 'LastName': 'Kaynak', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}]","Eye (London, England)",['10.1038/s41433-020-0949-2']
512,32398945,"Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.","Purpose


Osteosarcoma is a rare cancer and a third of patients who have completed primary treatment will develop osteosarcoma recurrence. The Src pathway has been implicated in the metastatic behavior of osteosarcoma; about 95% of samples examined express Src or have evidence of downstream activation of this pathway. Saracatinib (AZD0530) is a potent and selective Src kinase inhibitor that was evaluated in adults in Phase 1 studies. The primary goal of this study was to determine if treatment with saracatinib could increase progression-free survival (PFS) for patients who have undergone complete resection of osteosarcoma lung metastases in a double-blinded, placebo-controlled trial.  Patients and Methods . Subjects with recurrent osteosarcoma localized to lung and who had complete surgical removal of all lung nodules were randomized within six weeks after complete surgical resection. Saracatinib, or placebo, was administered at a dose of 175 mg orally, once daily, for up to thirteen 28-day cycles.
Results


Thirty-seven subjects were included in the analyses; 18 subjects were randomized to receive saracatinib and 19 to receive placebo. Intent-to-treat analysis demonstrated a median PFS of 19.4 months in the saracatinib treatment group and 8.6 months in the placebo treatment group ( p =0.47). Median OS was not reached in either arm.
Conclusions


Although saracatinib was well tolerated in this patient population, there was no apparent impact of the drug in this double-blinded, placebo-controlled trial on OS, and Src inhibition alone may not be sufficient to suppress metastatic progression in osteosarcoma. There is a suggestion of potential clinical benefit as evidenced by longer PFS in patients randomized to saracatinib based on limited numbers of patients treated.",2020,"Median OS was not reached in either arm.
","['Thirty-seven subjects were included in the analyses; 18 subjects', 'Subjects with recurrent osteosarcoma localized to lung and who had complete surgical removal of all lung nodules', 'patients who have undergone complete resection of osteosarcoma lung metastases', 'Patients with Recurrent Osteosarcoma Localized to the Lung']","['Saracatinib (AZD0530', 'Placebo', 'Saracatinib, or placebo', 'placebo']","['progression-free survival (PFS', 'Median OS', 'median PFS']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0278779', 'cui_str': 'Osteosarcoma recurrent'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}]","[{'cui': 'C2828242', 'cui_str': 'saracatinib'}, {'cui': 'C1706679', 'cui_str': 'AZD 0530'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",37.0,0.645536,"Median OS was not reached in either arm.
","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Baird', 'Affiliation': 'Center for Cancer Research, NCI, NIH, Building 10 CRC, Room 1W-3750, MSC 110410 Center Drive, Bethesda, MD 20892-1104, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glod', 'Affiliation': 'Center for Cancer Research, NCI, NIH, Building 10-CRC, Room 1-5750, Bethesda, MD 20892-1100, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Center for Cancer Research, NCI, NIH, 9609 Medical Center Drive, Room 2W334, MSC 9716, Bethesda, MD 20892, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Reinke', 'Affiliation': 'SARC, 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Pressey', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave., MLC 7015, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, 4650 Sunset Boulevard Mail Stop # 54, Los Angeles, CA 90027, USA.""}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Federman', 'Affiliation': ""Mattel Children's Hospital, David Geffen School of Medicine, University of California, 10833 Le Conte Avenue, Los Angeles, CA 90095-6901, USA.""}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA 94305, USA.'}, {'ForeName': 'Sant', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Research Center, 2811 Wilshire Boulevard, Suite 411, Santa Monica, CA 90403, USA.'}, {'ForeName': 'Joanne P', 'Initials': 'JP', 'LastName': 'Lagmay', 'Affiliation': ""University of Florida Health Shands Children's Hospital, 1600 SW Archer HD 204, Gainesville, FL 32610, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goldberg', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Milhem', 'Affiliation': 'University of Iowa Hospitals and Clinics, 200 Hawkins Drive C32 GH, Iowa City, IA 52242, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Loeb', 'Affiliation': ""Children's Hospital at Montefiore, Albert Einstein College of Medicine, 3411 Wayne Ave., Room 910, Bronx, New York, NY 10467, USA.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Butrynski', 'Affiliation': 'Willamette Valley Cancer Institute and Research Center, 520 Country Club Road, Eugene, OR 97401, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Turpin', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 3333 Burnett Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Staddon', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania Health System, 230 W. Washington Square, Philadelphia, PA 19106, USA.'}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Stanford University School of Medicine, 1000 Welch Road Suite 300, MC 5798, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'The Royal Marsden Hospital and Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK.'}, {'ForeName': 'Eve T', 'Initials': 'ET', 'LastName': 'Rodler', 'Affiliation': 'Comprehensive Cancer Center University of California, Davis, 2279 45th Street, Sacramento, CA 95717, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Schuetze', 'Affiliation': 'University of Michigan, 1500 East Medical Center Dr. Ann Arbor, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Okuno', 'Affiliation': 'Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Helman', 'Affiliation': ""Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California Children's Hospital Los Angeles, 4650 Sunset Blvd Mail Stop 57, Los Angeles, CA 90027, USA.""}]",Sarcoma,['10.1155/2020/7935475']
513,32398946,Long-Term Follow-up of a Randomized Study of Oral Etoposide versus  Viscum album  Fermentatum Pini as Maintenance Therapy in Osteosarcoma Patients in Complete Surgical Remission after Second Relapse.,"Background


In relapsed osteosarcoma, the 5-yr postrelapse disease-free survival (PRDFS) rate after the second relapse is <20%. In June 2007, a randomized study was started comparing oral etoposide vs  Viscum album  fermentatum Pini (an extract derived from the parasitic plant  Viscum album  L., European mistletoe) as maintenance therapy in patients with metastatic osteosarcoma in complete surgical remission after the second relapse. The primary endpoint was the PRDFS rate at 12 months (compared to the historical control rate). This is a long-term updated result.  Patients and Methods . 10 patients received oral etoposide 50 mg/m 2  daily for 21 days every 28 days for 6 months, and 9 patients received  Viscum album  fermentatum Pini 3 times/wk subcutaneously for 1 year. The study closed early in July 2011 due to insufficient recruitment. Lymphocyte subpopulations were analyzed at T0, T3, T6, T9, and T12 months.
Results


On 30 June 2019, at a median follow-up ITT of 83 months (range 3-144 ms), a median PRDFS of 106 ms (2-144) was observed in the  Viscum  arm with 5/9 patients who never relapse vs a PRDFS of 7 months (3-134) in the etoposide arm (all patients in the Etoposide arm relapsed) (hazard ratio HR = 0.287, 95% CI: 0.076-0.884,  p =0.03). Model forecast 10-yr overall survival rates as 64% in the  Viscum  arm and 33% in the etoposide arm. Lymphocyte subpopulation counts (CD3, CD4, and CD56) showed an increase in the Viscum arm while a decrease was observed in the etoposide arm during treatment.
Conclusions


After 12 years from the start of the trial, the patients in the  Viscum  arm continue to show a considerably longer PRDFS compared to oral etoposide, and a trend for an advantage in OS is evident even if the number of treated patients is too small to draw conclusions.  Viscum  as maintenance treatment after complete surgical remission in relapsed osteosarcoma should be further investigated and compared with other drugs.",2020,"Lymphocyte subpopulation counts (CD3, CD4, and CD56) showed an increase in the Viscum arm while a decrease was observed in the etoposide arm during treatment.
","['patients with metastatic osteosarcoma in complete surgical remission after the second relapse', 'Osteosarcoma Patients in Complete Surgical Remission after Second Relapse']","['oral etoposide', 'Oral Etoposide', 'Viscum album', 'etoposide']","['median PRDFS', 'overall survival rates', 'PRDFS rate', 'Lymphocyte subpopulation counts (CD3, CD4, and CD56', 'Lymphocyte subpopulations', '5-yr postrelapse disease-free survival (PRDFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278512', 'cui_str': 'Metastatic osteosarcoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0331018', 'cui_str': 'Viscum album'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}]",,0.0672894,"Lymphocyte subpopulation counts (CD3, CD4, and CD56) showed an increase in the Viscum arm while a decrease was observed in the etoposide arm during treatment.
","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Longhi', 'Affiliation': 'Chemotherapy Division, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Cesari', 'Affiliation': 'Chemotherapy Division, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Serra', 'Affiliation': 'Laboratory of Experimental Oncology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Erminia', 'Initials': 'E', 'LastName': 'Mariani', 'Affiliation': 'Immunoreumathology and Tissue Regeneration Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}]",Sarcoma,['10.1155/2020/8260730']
514,32399045,A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.,"Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections versus exercise therapy in the treatment of partial and full-thickness supraspinatus tears. Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears. Enrolled patients were randomized to either ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy. Patients could cross over to BMC treatment after at least 3 months of exercise therapy. Patients completed the Disability of the Arm, Shoulder and Hand (DASH) scores as the primary outcome measure. Secondary outcomes included the numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review. At this midterm review, results from 25 enrolled patients who have reached at least 12-month follow-up are presented. No serious adverse events were reported. Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months ( p  < .05). Patients reported a mean 89% improvement at 24 months, with sustained functional gains and pain reduction. MRI review showed a size decrease of most tears post-BMC treatment. These findings suggest that ultrasound-guided BMC and platelet product injections are a safe and useful alternative to conservative exercise therapy of torn, nonretracted supraspinatus tendons. This trial is registered with NCT01788683.",2020,"Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months ( p  < .05).","['rotator cuff tears', 'partial and full-thickness supraspinatus tears', 'Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears', '25 enrolled patients who have reached at least 12-month follow-up are presented']","['ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy', 'autologous BMC and platelet product injections versus exercise therapy', 'Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products']","['sustained functional gains and pain reduction', 'serious adverse events', 'Disability of the Arm, Shoulder and Hand (DASH) scores', 'numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review']","[{'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0443116', 'cui_str': 'Platelet product'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",25.0,0.0836088,"Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months ( p  < .05).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Centeno', 'Affiliation': 'Centeno-Schultz Clinic, 403 Summit Blvd 201, Broomfield, Colorado 80021, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Fausel', 'Affiliation': 'Centeno-Schultz Clinic, 403 Summit Blvd 201, Broomfield, Colorado 80021, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Stemper', 'Affiliation': 'Regenexx, LLC, 6151 Thornton Ave #200, Des Moines, Iowa 50321, USA.'}, {'ForeName': 'Ugochi', 'Initials': 'U', 'LastName': 'Azuike', 'Affiliation': 'Centeno-Schultz Clinic, 403 Summit Blvd 201, Broomfield, Colorado 80021, USA.'}, {'ForeName': 'Ehren', 'Initials': 'E', 'LastName': 'Dodson', 'Affiliation': 'Regenexx, LLC, 6151 Thornton Ave #200, Des Moines, Iowa 50321, USA.'}]",Stem cells international,['10.1155/2020/5962354']
515,32399072,Design exploration predicts designer creativity: a deep learning approach.,"This study examined brain activation in graphic designers responding to pictorial stimulation during exploration tasks and determined the predictive effects of design exploration on designer creativity through a deep learning approach. The top and bottom 25% (10 each participants) were assigned high-creativity and low-creativity groups, respectively. The results provided the following indications. (i) Shallow architectures had higher prediction accuracy than deeper architectures. (ii) The prediction accuracy of shallow long short-term memory networks was higher than that of convolution neural networks. (iii) Bandpower exhibited increased prediction accuracy, and shallow LSTM networks with differing power spectra among independent components outperformed other deep learning methods. (iv) Direct acyclic graph networks did not improve prediction accuracy. (v) Design exploration could effectively predict designer creativity.",2020,"Bandpower exhibited increased prediction accuracy, and shallow LSTM networks with differing power spectra among independent components outperformed other deep learning methods.",[],[],"['prediction accuracy', 'prediction accuracy, and shallow LSTM networks', 'designer creativity']",[],[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",,0.0316321,"Bandpower exhibited increased prediction accuracy, and shallow LSTM networks with differing power spectra among independent components outperformed other deep learning methods.","[{'ForeName': 'Yu-Cheng', 'Initials': 'YC', 'LastName': 'Liu', 'Affiliation': 'Department of Bio-Industry Communication and Development, National Taiwan University, No. 1, Sec. 4, Roosevelt Road, Taipei, 10617 Taiwan.'}, {'ForeName': 'Chaoyun', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Bio-Industry Communication and Development, National Taiwan University, No. 1, Sec. 4, Roosevelt Road, Taipei, 10617 Taiwan.'}]",Cognitive neurodynamics,['10.1007/s11571-020-09569-7']
516,32399107,Peptide-based formula versus standard-based polymeric formula for critically ill children: is it superior for patients' tolerance?,"Introduction


Malnutrition affects 50% of hospitalized children and 25-70% of critically ill children. Enteral tube feeding is generally considered the preferred modality for critically ill pediatric patients. Clinical advantages of using peptide-based formulas are still controversial in critically ill children. The aim of this study was to compare the effect of a peptide-based formula versus a standard polymeric formula on feeding tolerance and whether this will affect the outcome among critically ill children.
Material and methods


This single blind case control study was conducted on 180 randomly selected critically ill children in the pediatric critical care unit (PICU) of Ain Shams University. Patients were divided into 2 groups: a group receiving a standard polymeric formula (group 1; 90 patients) and a group receiving a peptide-based formula (group II; 90 patients). Nutritional requirements, days to reach full enteral feeding, feeding intolerance symptoms and anthropometric measurements were recorded for all patients at admission together with their pediatric risk of mortality score (PRISM). Length of PICU stay, occurrence of sepsis together with survival were analyzed at discharge as outcome measures.
Results


Patients receiving a peptide-based formula showed a significant decrease in feeding interruptions and abdominal distention ( p  < 0.000), reached full enteral feeding faster (2.60 ±0.74 days versus 5.36 ±1.00 days in patients received polymeric standard formula;  p  < 0.001) and improved weight gain ( p  < 0.028). Moreover, duration of sepsis was significantly shorter ( p  < 0.045), but no difference in mortality was recorded between patient groups.
Conclusions


Peptide-based formula feeding was better tolerated than standard polymeric formula feeding in critically ill pediatric patients. However, the choice of patients receiving the peptide-based formula needs to be further evaluated.",2020,"Results


Patients receiving a peptide-based formula showed a significant decrease in feeding interruptions and abdominal distention ( p  < 0.000), reached full enteral feeding faster (2.60 ±0.74 days versus 5.36 ±1.00 days in patients received polymeric standard formula;  p  < 0.001) and improved weight gain ( p  < 0.028).","['critically ill pediatric patients', '180 randomly selected critically ill children in the pediatric critical care unit (PICU) of Ain Shams University', 'critically ill children']","['peptide-based formula versus a standard polymeric formula', 'peptide-based formulas', 'peptide-based formula', 'standard polymeric formula', 'Enteral tube feeding', 'Peptide-based formula versus standard-based polymeric formula']","['full enteral feeding faster', 'feeding interruptions and abdominal distention', 'weight gain', 'mortality score (PRISM', 'mortality', 'Length of PICU stay, occurrence of sepsis together with survival', 'duration of sepsis']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0475502', 'cui_str': 'Pediatric risk of mortality'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",180.0,0.0463907,"Results


Patients receiving a peptide-based formula showed a significant decrease in feeding interruptions and abdominal distention ( p  < 0.000), reached full enteral feeding faster (2.60 ±0.74 days versus 5.36 ±1.00 days in patients received polymeric standard formula;  p  < 0.001) and improved weight gain ( p  < 0.028).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mervat', 'Initials': 'M', 'LastName': 'Mansour', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yasmin Gamal', 'Initials': 'YG', 'LastName': 'El Gendy', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}]",Archives of medical science : AMS,['10.5114/aoms.2020.94157']
517,32399254,A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer.,"Background


Fear of cancer recurrence (FCR) is common in people affected by breast cancer. FCR is associated with increased health service and medication use, anxiety, depression and reduced quality of life. Existing interventions for FCR are time and resource intensive, making implementation in a National Health Service (NHS) setting challenging. To effectively manage FCR in current clinical practice, less intensive FCR interventions are required. Mini-AFTERc is a structured 30-min counselling intervention delivered over the telephone and is designed to normalise moderate FCR levels by targeting unhelpful behaviours and misconceptions about cancer recurrence.This multi-centre non-randomised controlled pilot trial will investigate the feasibility of delivering the Mini-AFTERc intervention, its acceptability and usefulness, in relation to specialist breast cancer nurses (SBCNs) and patients. This protocol describes the rationale, methods and analysis plan for this pilot trial of the Mini-AFTERc intervention in everyday practice.
Methods


This study will run in four breast cancer centres in NHS Scotland, two intervention and two control centres. SBCNs at intervention centres will be trained to deliver the Mini-AFTERc intervention. Female patients who have completed primary breast cancer treatment in the previous 6 months will be screened for moderate FCR (FCR4 score: 10‑14). Participants at intervention centres will receive the Mini-AFTERc intervention within 2 weeks of recruitment. SBCNs will audio record the intervention telephone discussions with participants. Fidelity of intervention implementation will be assessed from audio recordings. All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months. Normalisation process theory (NPT) will form the framework for semi-structured interviews with 20% of patients and all SBCNs. Interviews will explore participants' experience of the study, acceptability and usefulness of the intervention and factors influencing implementation within clinical practice. The ADePT process will be adopted to systematically problem solve and refine the trial design.
Discussion


Findings will provide evidence for the potential effectiveness, fidelity, acceptability and practicality of the Mini-AFTERc intervention, and will inform the design and development of a large randomised controlled trial (RCT).
Trial registration


ClinicalTrials.gov: NCT0376382. Registered 4th December 2018, https://clinicaltrials.gov/ct2/show/NCT03763825.",2020,"All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months.","['specialist breast cancer nurses (SBCNs) and patients', 'patients affected by breast cancer', 'Female patients who have completed primary breast cancer treatment in the previous 6\u2009months will be screened for moderate FCR (FCR4 score: 10‑14', 'four breast cancer centres in NHS Scotland, two intervention and two control centres', 'people affected by breast cancer']","['nurse-led intervention (Mini-AFTERc', 'Mini-AFTERc intervention']","['FCR, anxiety, depression and quality of life', 'health service and medication use, anxiety, depression and reduced quality of life']","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]","[{'cui': 'C0233705', 'cui_str': 'Fear of getting cancer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.13518,"All participants will complete three separate follow-up questionnaires assessing changes in FCR, anxiety, depression and quality of life over 3 months.","[{'ForeName': 'Calum T', 'Initials': 'CT', 'LastName': 'McHale', 'Affiliation': '1Division of Population and Behavioural Sciences, School of Medicine, University of St Andrews, St Andrews, KY16 9TF UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Cruickshank', 'Affiliation': '2Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Torrens', 'Affiliation': '2Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Armes', 'Affiliation': '3School of Health Sciences, University of Surrey, Guildford, Surrey UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fenlon', 'Affiliation': '4College of Human and Health Sciences, Swansea University, Swansea, UK.'}, {'ForeName': 'Elspeth', 'Initials': 'E', 'LastName': 'Banks', 'Affiliation': '5National Cancer Research Institute, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Kelsey', 'Affiliation': '6School of Computer Science, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Gerald M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': '1Division of Population and Behavioural Sciences, School of Medicine, University of St Andrews, St Andrews, KY16 9TF UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00610-4']
518,32399267,Clinical efficacy and quality of life after transrectal natural orifice specimen extraction for the treatment of middle and upper rectal cancer.,"Background


Laparoscopic anterior resection with natural orifice specimen extraction (NOSE) avoids extra abdominal extraction incision during colorectal surgery. Some surgeons realized the benefits of NOSE on clinical efficacy. We compared the clinical efficacy of laparoscopic NOSE, laparoscopic non-NOSE and open surgery (OS) for short-term recovery and quality of life (QoL).
Methods


A single randomized controlled trial of NOSE for middle and upper rectal cancer between April 2014 and February 2018. Preoperative and postoperative clinical variables were analyzed and compared between the groups. Preoperative and 6 months postoperative QoL was assessed with the SF-36 QoL questionnaire.
Results


A total of 378 patients were enrolled, 334 patients randomly divided into NOSE group (n=104), non-NOSE group (n=119), OS group (n=111). The NOSE group was superior to the other two groups on the QoL after surgery. The NOSE group had the lowest postoperative VAS score between three groups. The postoperative time for bowel function recovery and the length of hospital stay was statistically significantly different among the three groups, with the NOSE group having the shortest time. The incidence of postoperative complications was lower in the NOSE group (12/104, 11.5%) than in the non-NOSE group (20/119, 16.8%), the difference was statistically significant. The Kaplan-Meier (K-M) survival curve showed no statistically significant difference in the disease-free survival (DFS) rate between the three groups.
Conclusions


Comparing NOSE to non-NOSE and OS, the NOSE had significantly better functional recovery and better QoL. The NOSE group had a significant lower surgical complication rate than the non-NOSE group.",2020,"The Kaplan-Meier (K-M) survival curve showed no statistically significant difference in the disease-free survival (DFS) rate between the three groups.
","['middle and upper rectal cancer', '378 patients were enrolled, 334 patients randomly divided into NOSE group (n=104), non-NOSE group (n=119), OS group (n=111', 'for middle and upper rectal cancer between April 2014 and February 2018']","['laparoscopic NOSE, laparoscopic non-NOSE and open surgery (OS', 'NOSE', 'transrectal natural orifice specimen extraction', '\n\n\nLaparoscopic anterior resection with natural orifice specimen extraction (NOSE']","['Clinical efficacy and quality of life', 'Kaplan-Meier (K-M) survival', 'functional recovery and better QoL', 'quality of life (QoL', 'incidence of postoperative complications', 'postoperative time for bowel function recovery and the length of hospital stay', 'lowest postoperative VAS score', 'SF-36 QoL questionnaire', 'surgical complication rate', 'disease-free survival (DFS) rate']","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",378.0,0.0345761,"The Kaplan-Meier (K-M) survival curve showed no statistically significant difference in the disease-free survival (DFS) rate between the three groups.
","[{'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Kai-Jing', 'Initials': 'KJ', 'LastName': 'Wang', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Guy R', 'Initials': 'GR', 'LastName': 'Orangio', 'Affiliation': 'Department of Surgery, Louisiana State University, New Orleans, LA, USA.'}, {'ForeName': 'Jun-Yi', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.'}]",Journal of gastrointestinal oncology,['10.21037/jgo.2020.03.05']
519,32399286,Weight Change and Its Association with Cardiometabolic Risk Markers in Overweight and Obese Women.,"Objectives


To examine the association of weight loss magnitude with changes in cardiometabolic risk markers in overweight and obese women from low socioeconomic areas engaged in a lifestyle intervention.
Methods


Analyses were performed on 243 women (mean body mass index 31.27 ± 4.14 kg/m 2 ) who completed a 12-month lifestyle intervention in low socioeconomic communities in Klang Valley, Malaysia. Analysis of covariance (ANCOVA) was used to compare changes of cardiometabolic risk factors across weight change categories (2% gain, ±2% maintain, >2 to <5% loss, and 5 to 20% loss) within intervention and control group.
Results


A graded association for changes in waist circumference, fasting insulin, and total cholesterol ( p =0.002, for all variables) across the weight change categories were observed within the intervention group at six months postintervention. Participants who lost 5 to 20% of weight had the greatest improvements in those risk markers (-5.67 cm CI: -7.98 to -3.36, -4.27  μ U/mL CI: -7.35, -1.19, and -0.59 mmol/L CI: -.99, -0.19, respectively) compared to those who did not. Those who lost >2% to <5% weight reduced more waist circumference (-4.24 cm CI: -5.44 to -3.04) and fasting insulin (-0.36  μ U/mL CI: -1.95 to 1.24) than those who maintained or gained weight. No significant association was detected in changes of risk markers across the weight change categories within the control group except for waist circumference and adiponectin.
Conclusion


Weight loss of >2 to <5% obtained through lifestyle intervention may represent a reasonable initial weight loss target for women in the low socioeconomic community as it led to improvements in selected risk markers, particularly of diabetes risk.",2020,"No significant association was detected in changes of risk markers across the weight change categories within the control group except for waist circumference and adiponectin.
","['Overweight and Obese Women', 'overweight and obese women from low socioeconomic areas engaged in a lifestyle intervention', '243 women (mean body mass index 31.27\u2009±\u20094.14\u2009kg/m 2 ) who completed a 12-month lifestyle intervention in low socioeconomic communities in Klang Valley, Malaysia']",['μ U/mL CI'],"['fasting insulin', 'waist circumference, fasting insulin, and total cholesterol', 'waist circumference', 'cardiometabolic risk markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}]","[{'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",243.0,0.0307575,"No significant association was detected in changes of risk markers across the weight change categories within the control group except for waist circumference and adiponectin.
","[{'ForeName': 'Liyana', 'Initials': 'L', 'LastName': 'Ahmad Zamri', 'Affiliation': 'Endocrine and Metabolic Unit, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Appannah', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'Siti Yazmin', 'Initials': 'SY', 'LastName': 'Zahari Sham', 'Affiliation': 'Department of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'Fazliana', 'Initials': 'F', 'LastName': 'Mansor', 'Affiliation': 'Endocrine and Metabolic Unit, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Rashidah', 'Initials': 'R', 'LastName': 'Ambak', 'Affiliation': 'Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Noor Safiza', 'Initials': 'NS', 'LastName': 'Mohd Nor', 'Affiliation': 'Allied Health Sciences Division, Ministry of Health Malaysia, 62050 Putrajaya, Malaysia.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Aris', 'Affiliation': 'Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170 Shah Alam, Selangor, Malaysia.'}]",Journal of obesity,['10.1155/2020/3198326']
520,32399295,Influence of 8-Week Aerobic Training on the Skin Microcirculation in Patients with Ischaemic Heart Disease.,"Materials and Methods


In the study, 48 men took part with a stabilized and pharmacologically controlled ischaemic disease. The participants were randomly divided into two groups with 24 people in each of them. The research group participated in an aerobic march training. The march was taking place 3 times a week for 30-40 minutes over a period of 8 weeks. In the time of training, the subjects did not practise any other physical activity for 8 weeks. The measurement of skin microcirculation was done by using the laser Doppler flowmeter estimating the values of regular flow and the reactions provoked in response to occlusion and temperature. Signal frequency was also analysed which was received by means of laser Doppler flowmetry in the range from 0.01 to 2 Hz during the regular flow.
Results


During the first measurement in relation to the initial values, a decrease in body mass was noted by 2.21 kg on average as well as reduction of systolic and diastolic pressure by 10.4 mmHg and 3.68 mmHg, respectively. The regular flow (RF) increased after the training by 2.21%. The provoked reactions were as follows: hyperemic (PRHmax): an increase occurred by 8.76% and hyperthermic (THmax): an increase occurred by 5.38%. The time needed to achieve PRHmax was reduced by 42% and to achieve THmax, by 22%. The heart rhythm and the signal strength of neurogenic rhythm decreased by approximately 8% and 24%, respectively. The signal strength of endothelial rhythm increased by 19%. In the second measurement, a recourse was noted in the values of indicators under investigation, which were assuming values close to the initial ones. In the control group, the measurement values did not change significantly.
Conclusions


8 weeks of systematic aerobic training provides a significant improvement of endothelium functioning, expressed by reactivity improvement in skin microcirculation in patients suffering from ischaemic heart disease. It points to aerobic training as a nonpharmacological effective cardioprotective factor. The improvement effects of skin vascular bed functioning in the group of patients with IHD are impermanent, and they disappear after the period in which patients did not exercise physical activity.",2020,"In the control group, the measurement values did not change significantly.
","['Patients with Ischaemic Heart Disease', 'patients suffering from ischaemic heart disease', '48 men took part with a stabilized and pharmacologically controlled ischaemic disease']","['aerobic training', 'systematic aerobic training', '8-Week Aerobic Training', 'aerobic march training']","['body mass', 'time needed to achieve PRHmax', 'systolic and diastolic pressure', 'regular flow (RF', 'signal strength of endothelial rhythm', 'Signal frequency', 'Skin Microcirculation', 'endothelium functioning', 'heart rhythm and the signal strength of neurogenic rhythm', 'skin microcirculation', 'skin vascular bed functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",48.0,0.0151882,"In the control group, the measurement values did not change significantly.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Szyguła', 'Affiliation': 'The Witelon State University of Applied Sciences in Legnica, Faculty of Health Science and Physical Education, Legnica, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wierzbicka', 'Affiliation': 'The Witelon State University of Applied Sciences in Legnica, Faculty of Health Science and Physical Education, Legnica, Poland.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Sondel', 'Affiliation': 'The Witelon State University of Applied Sciences in Legnica, Faculty of Health Science and Physical Education, Legnica, Poland.'}]",Journal of aging research,['10.1155/2020/4602067']
521,32315769,"Commentary on ""Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study"".",,2020,,[],['Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery'],[],[],"[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.158978,,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Bechtolsheim', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany. Electronic address: felix.bechtolsheim@uniklinikum-dresden.de.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.086']
522,32315823,Coping with social wounds: How social pain and social anxiety influence access to social rewards.,"BACKGROUND AND OBJECTIVES


Prior studies have shown that people display signs of increased social approach motivation and affiliative behaviour in response to social exclusion. This response is considered an adaptive strategy that serves to repair damage to social networks and increase access to mood-enhancing social rewards. However, heightened trait social anxiety (SA) has been linked to decreased approach motivation and responsiveness to social rewards. In the current preliminary experimental study, we tested whether trait SA inhibits the expected increase in social approach following the pain of exclusion. We then tested whether diminished social approach is associated with reduced positive affect.
METHODS


Participants played a game of Cyberball and were randomly assigned to receive significantly fewer passes (exclusion condition) or an equal number of passes (control condition) as other players. Subsequently, participants were given the opportunity to engage in an online social interaction activity with avatars they believed were other participants.
RESULTS


Analyses revealed that the exclusion condition led to greater social pain than the control condition. Across conditions, greater social pain was associated with higher levels of approach motivation in anticipation of the social interaction activity, but only for individuals with lower levels of trait SA. Finally, when controlling for levels of trait SA, social pain was associated with positive affect following the social interaction activity, but only for individuals with higher levels of approach motivation.
LIMITATIONS


Participants consisted predominantly of female undergraduates, limiting generalizability of these data. As well, hypotheses were supported for the measure of approach motivation but not the measure of approach behaviour. Finally, this study was not powered to enable moderated mediation analyses, which would have provided the most direct test of the hypothesized model.
CONCLUSIONS


Heightened approach motivation in the face of social pain may facilitate increased positive affect. However, higher levels of trait SA dampen approach motivation. Future well-powered studies should use moderated mediation analyses to test the hypothesized model more parsimoniously.",2020,"RESULTS


Analyses revealed that the exclusion condition led to greater social pain than the control condition.","['Participants played a game of Cyberball and were randomly assigned to', 'Participants consisted predominantly of female undergraduates']",['receive significantly fewer passes (exclusion condition) or an equal number of passes (control condition'],"['higher levels of trait SA dampen approach motivation', 'levels of trait SA, social pain', 'social pain']","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0296943,"RESULTS


Analyses revealed that the exclusion condition led to greater social pain than the control condition.","[{'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hudd', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada. Electronic address: thudd@uwaterloo.ca.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101572']
523,32315954,"Screening for oral cancer: Future prospects, research and policy development for Asia.","Although the incidence of oral cavity cancer is high among low and middle income countries in Asia where the risk habits (tobacco smoking, tobacco chewing and betel quid use) are common, the benefits for introducing oral cancer screening for the whole population in these countries still remains controversial. It is disappointing, but not surprising that many of studies, without control arms, could not provide a clear answer as to whether screening is effective in reducing mortality or combating rising incidence trends. Only one Indian study that reported a randomized controlled trial (RCT) elucidated that mass screening for high risk groups could significantly reduce the cancer mortality or down-stage cancers detected by screening. Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer. In this review we discuss advantages and disadvantages for oral cancer screening particularly with reference to high incidence countries in Asia. If screening is undertaken, we propose that it is targeted to high risk groups and to combine screening with education on risky life-styles so that overall incidence can be reduced in the future. Further research on increasing public awarenes and impact of professional education such as e-learning to reduce diagnostic delays, studies on the natural history of oral potentially malignant disorders and cancer, comprehensive tobacco and areca nut cessation programs, developing tools to identify high-risk individuals and high-risk lesions are proposed.",2020,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.",['oral cancer'],[],['cancer mortality'],"[{'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}]",[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0484795,"Several professional organizations that considered any potential benefits of oral cancer screening remain unconvinced that the current knowledge on its natural history, available tests and interventions to treat potentially malignant disorders satisfy the desirable criteria to recommend organized screening for oral cancer.","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Maxillofacial Surgery School of Dentistry, Aichi Gakuin University, Nagoya, Japan. Electronic address: tnagao@dpc.agu.ac.jp.'}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Warnakulasuriya', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, WHO Collaborating Centre for Oral Cancer, UK.""}]",Oral oncology,['10.1016/j.oraloncology.2020.104632']
524,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE


The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI).
DESIGN


Controlled laboratory study.
PARTICIPANTS


Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm.
MAIN OUTCOME MEASURES


DFROM was assessed in a straight and bent-leg position.
RESULTS


No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
CONCLUSIONS


Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001']
525,32325419,"Efficacy and safety of the therapeutic cancer vaccine tecemotide (L-BLP25) in early breast cancer: Results from a prospective, randomised, neoadjuvant phase II study (ABCSG 34).","BACKGROUND


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


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


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


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


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


Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.","[{'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria. Electronic address: christian.singer@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Pfeiler', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hubalek', 'Affiliation': 'Breast Center Schwaz, BKH Schwaz, Schwaz, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bartsch', 'Affiliation': 'Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Stöger', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Breast Unit, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal Germany, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Department of Pathology, Medical University of Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Muy-Kheng', 'Initials': 'MK', 'LastName': 'Maria Tea', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breastcenter Carinthia, St. Veit, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sevelda', 'Affiliation': 'Karl Landsteiner Institute for Gynecologic Oncology and Senology, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breastcenter St. Anna, Lucerne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Exner', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Jakesz', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Division of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tinchon', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Medical University of Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Frantal', 'Affiliation': 'Department of Statistics, Austrian Breast & Colorectal Cancer Study Group (ABCSG), Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.03.018']
526,32330764,Preventing college student nonmedical prescription stimulant use: Development of vested interest theory-based persuasive messages.,"Vested interest theory (VIT) predicts that perceived importance and hedonic relevance of an expected behavioral outcome affects attitude-behavior consistency. Applied to college students' nonmedical use of prescription stimulants (NUPS), the theory posits that persuasive information that weakens vested perceptions regarding assumed advantages of stimulant misuse will reduce usage intentions. The current study developed and experimentally assessed persuasive messages that targeted perceptions of vested interest (VI), and examined if message effectiveness varied as a function of users' risk status. Appeals that focused on the physical harms of misuse served as the comparison condition. College student participants (N = 282) were randomly assigned to one of four message conditions. To examine group differences, data were analyzed in a 2 (VIT-based message: yes, no) × 2 (Physical harms emphasized: yes, no) × 3 (User status: resolute, vulnerable, user) between-subjects factorial design. Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005. In vulnerable nonusers, these messages also decreased NUPS intentions p = .006. The effect of exposure to the physical harm communication was not significant. Findings support the potential of VIT-guided messages in NUPS prevention, and the lack of effect of messages focused on physical consequences of misuse.",2020,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"['College student participants (N\xa0=\xa0282', 'college students']","['Vested interest theory (VIT', 'NUPS', 'nonmedical use of prescription stimulants (NUPS']",['cognitive functioning'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",282.0,0.0167375,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Candice.Donaldson@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Jason.Siegel@cgu.edu.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: William.Crano@cgu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106440']
527,32179237,Side effects of induced lateral eye movements during aversive ideation.,"BACKGROUND AND OBJECTIVES


Eye Movement Desensitization and Reprocessing (EMDR) is a treatment for posttraumatic stress disorder. It uses a dual-task approach, in which patients recall an aversive memory while making lateral eye movements. Research has shown that this 'eye movements' intervention reduces subjective memory vividness and emotionality. This study examined whether it also reduces memory accuracy on a visual discrimination task.
METHODS


Participants (68 undergraduates) underwent an aversive conditioning phase, in which two pictures of male faces were followed by shock. Then they recalled one face with (experimental condition) and one without (control condition) making lateral eye movements. Finally, they completed a stimulus discrimination test with slightly different faces shortly after the intervention and one day later.
RESULTS


Results showed that the eye movements intervention led to increased false-positive rates one day later.
LIMITATIONS


Our intervention targeted newly formed memory rather than consolidated memory.
CONCLUSIONS


The results inform theory about EMDR's mechanisms of change and suggest that the treatment may have side effects regarding memory accuracy.",2020,"BACKGROUND AND OBJECTIVES


Eye Movement Desensitization and Reprocessing (EMDR) is a treatment for posttraumatic stress disorder.","['Participants (68 undergraduates) underwent an', 'posttraumatic stress disorder']","['Reprocessing (EMDR', 'aversive conditioning phase']","['false-positive rates', 'memory accuracy']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0419655,"BACKGROUND AND OBJECTIVES


Eye Movement Desensitization and Reprocessing (EMDR) is a treatment for posttraumatic stress disorder.","[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Leer', 'Affiliation': 'Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Utrecht University, Utrecht, the Netherlands. Electronic address: I.M.Engelhard@uu.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101566']
528,32398909,Efficacy of  Seetarama Vati  (A Sri Lankan traditional drug) and  Vatari Guggulu  in the management of  Amavata  (rheumatoid arthritis)-an open labeled randomized comparative clinical trial.,"Introduction


Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease caused by type III hypersensitivity reaction due to antigen antibody complexes which deposit at the joints resulting in arthritis. As per the concept of Ayurveda, it can be co-related with  Amavata , the disease arising from deranged metabolism and  Vata  vitiation. Despite of advancement in diagnostic approach of RA, management of it remains challenge.  Vatari Guggulu  and  Seetarama Vati  are the formulations having analgesics properties due to their  Ushna  (metabolism enhancing) and  Tikshna Guna  (micro channel cleaning) and simultaneously possess anti-inflammatory properties.
Aims and Objectives


To evaluate and compare the efficacy of  Vatari Guggulu  and  Seetarama Vati  in the management of  Amavata  w.s.r. to rheumatoid arthritis.
Material and Methods


For the present study, 58 patients were selected and divided into two groups. Patients of group A and group B were given  Vatari Guggulu  and  Seetarama Vati  respectively with warm water after meal for one month. Before administration of trial drugs in both of groups' patients were given 4-6 grams of  Triphala  powder depending upon the  Koshtha  of the patient, on empty stomach early morning for the purpose of  Koshtha Shuddhi  (purgation) for 3 days. In addition to assess effect on signs and symptoms of  Amavata , haematological investigation, biochemical investigation including quantitative C-reactive protein (CRP) and rheumatoid factor (RA factor) and routine urinary examination were carried out before and after treatment in all the registered patients. The effect of therapy was assessed on the basis of changes in score in comparison to end point score.
Discussion


All the cardinal and associate complaints were statistically significant improved after the course of the trial drug. Most of the functional parameters had statistically significant improvement after treatment except left side foot pressure and DAS 28 scale in B group. Biochemical and hematological parameters were within normal limit before and after treatment. The difference of effect of trial drug on chief complaints was statistically insignificant. The difference of effect of trial drug on associate complaints was statistically insignificant. Difference of effect of trial drugs on ESR of both the groups was statistically insignificant. The difference of effect of trial drug on RA factor and CRP between groups was statistically significant. The difference of effect of trial drug on functional parameters between groups were statistically significant.
Conclusion


The study revealed that, though both the trial drugs;  Vatari Guggulu  and  Seetarama Vati  are effective in the management of  Amavata , but clinically  Seetarama Vati  is comparatively more effective than  Vatari Guggulu  in the management of  Amavata .",2019,Most of the functional parameters had statistically significant improvement after treatment except left side foot pressure and DAS 28 scale in B group.,"['Amavata  (rheumatoid', '58 patients were selected and divided into two groups']","['Seetarama Vati  (A Sri Lankan traditional drug) and  Vatari Guggulu', 'Tikshna Guna  (micro channel cleaning', 'Vatari Guggulu  and  Seetarama Vati  respectively with warm water after meal for one month', 'Vatari Guggulu  and  Seetarama Vati']","['quantitative C-reactive protein (CRP) and rheumatoid factor (RA factor) and routine urinary examination', 'functional parameters', 'left side foot pressure and DAS 28 scale', 'ESR', 'chief complaints', 'Biochemical and hematological parameters', 'RA factor and CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0061999', 'cui_str': 'gugulu extract'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C4082115', 'cui_str': 'One month'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",58.0,0.0396733,Most of the functional parameters had statistically significant improvement after treatment except left side foot pressure and DAS 28 scale in B group.,"[{'ForeName': 'M G Sandeepanie K', 'Initials': 'MGSK', 'LastName': 'Maragalawaththa', 'Affiliation': 'Medical Officer, Chamal Rajpraksha Ayurved Research Hospital, Hambantola, Srilanka.'}, {'ForeName': 'Mandip', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Kayachikitsa, IPGT & RA, Jamnagar, Gujarat, India.'}]",Ayu,['10.4103/ayu.AYU_65_18']
529,32398910,Role of  Terminalia arjuna  Wight and Arn. in the treatment of chronic coronary artery disease from pharmacovigilance point of view.,"Background and Objectives


Terminalia   arjuna  Wight and Arn. ( Arjuna ) has been used in indigenous system for the treatment of cardiac ailments since 500 BC. However, there is a lack of vigilance studies during long-term therapy. The present clinical study was planned to examine the long-term safety of  Arjuna  as an adjunct drug in chronic coronary artery disease (CAD) patients.
Materials and Methods


During the study period, a total of 35 patients of chronic CAD were enrolled to receive  Arjuna  bark extract powder (500 mg three times daily) along with conventional drugs. The control group (35 patients) received conventional drugs alone. Hemogram, liver function tests and kidney function tests were done at baseline and then every 6 months until the end of the study. Electrocardiography was done every 6 months and echocardiography was done yearly for left ventricular ejection fraction and regional wall motion abnormalities. Any adverse drug reactions reported by the patients were also recorded.
Results


The mean age of patients in test and control groups was 60.88 ± 9.02 and 58.51 ± 12.64 years, respectively. There was a predominance of male patients in both the groups. The patients were observed for duration ranging from 9 months to 4 years and 9 months. Other than baring gastritis and constipation, no other noteworthy adverse effects were reported. No significant difference was found in laboratory value on baseline and end of therapy in both the groups.
Conclusion


The results of the present study concluded that  Arjuna  is safe and effective in patients with chronic coronary artery disease.",2019,"No significant difference was found in laboratory value on baseline and end of therapy in both the groups.
","['chronic coronary artery disease (CAD) patients', 'patients with chronic coronary artery disease', '35 patients of chronic CAD']","['conventional drugs alone', 'Arjuna  bark extract powder', 'Electrocardiography']","['adverse drug reactions', 'laboratory value', 'Hemogram, liver function tests and kidney function tests']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0200631', 'cui_str': 'Complete blood count without differential'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0218981,"No significant difference was found in laboratory value on baseline and end of therapy in both the groups.
","[{'ForeName': 'Shridhar', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Cardiology, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Chopra', 'Affiliation': 'Department of Pharmacology, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Bhandari', 'Affiliation': 'Physiology, Government Institute of Medical Sciences, Greater Noida, Uttar Pradesh, India.'}]",Ayu,['10.4103/ayu.AYU_114_18']
530,32398911,Comparison of antiplaque effectiveness of herbal toothpaste: A randomized triple-blinded cross-over clinical trial.,"Background


Cleansing the teeth with a toothbrush and paste is an indubitable mechanical plaque control method practiced by almost everyone. Eliminating dental plaque is an essential, fundamental and mandatory step to prevent the occurrence of periodontal diseases that are rife globally. The aim of the present study is to compare the antiplaque effectiveness of a prepared herbal and commercially available dentifrice.
Materials and Methods


Thirty healthy individuals within the age group of 18-25 years were recruited to participate in the study. After achieving induced gingivitis and measuring plaque levels using Turesky modification of the Quigley Hein Plaque index in all the subjects, they were randomly divided into test arms A and B. Commercial dentifrice was distributed to one group, whereas the other group received prepared herbal dentifrice. Supervised brushing was carried out for 5 min, and plaque amounts after brushing were noted. After a washout period of 1 week, the same steps were repeated as per the cross-over study protocol. Unpaired  t -test and paired  t -tests were employed with  P  < 0.05.
Results


Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant ( P  = 0.001). The mean plaque scores of commercial dentifrice (1.93 ± 1.52) were less than that of the prepared herbal dentifrice (2.35 ± 1.39) after brushing.
Conclusion


The prepared herbal dentifrice had good antiplaque action. However, the plaque inhibitory action of self-prepared herbal toothpaste was marginally less when compared to commercial dentifrice.",2019,Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant ( P  = 0.001).,['Thirty healthy individuals within the age group of 18-25 years were recruited to participate in the study'],"['herbal toothpaste', 'herbal dentifrice', 'prepared herbal and commercially available dentifrice']","['mean plaque scores', 'plaque scores']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0184761,Both the toothpastes show the difference in plaque scores immediately after brushing when compared to baseline and was statistically significant ( P  = 0.001).,"[{'ForeName': 'Ramamurthy', 'Initials': 'R', 'LastName': 'Shanmugapriya', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ulaganathan', 'Initials': 'U', 'LastName': 'Arunmozhi', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Rathinasamy', 'Initials': 'R', 'LastName': 'Kadhiresan', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sudarsan', 'Initials': 'S', 'LastName': 'Sabitha', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Ravikumar', 'Initials': 'R', 'LastName': 'Anirudhya', 'Affiliation': 'Department of Periodontics, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Govindarajan', 'Initials': 'G', 'LastName': 'Sujatha', 'Affiliation': 'Department of Oral Pathology, Sri Venkateswara Dental College and Hospital, Chennai, Tamil Nadu, India.'}]",Ayu,['10.4103/ayu.AYU_185_19']
531,32336678,Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic.,,2020,,[],[],[],[],[],[],,0.190025,,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC srinivas.murthy@cw.bc.ca.""}]",CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne,['10.1503/cmaj.200438']
532,32399326,Intracameral Triamcinolone Acetonide Versus Topical Dexamethasone: A Comparison of Anti-inflammatory Effects After Phacoemulsification.,"Study objective and design The objective of this study was to determine the effectiveness of triamcinolone acetonide when used as a single dose as compared to the topical use of dexamethasone to control the inflammation after phacoemulsification. The study was a randomized controlled trial conducted in the Department of Ophthalmology at the District Headquarter (DHQ) Teaching Hospital, Dera Ghazi Khan, from March 1, 2018, to August 31, 2019. Materials and methods Eighty patients were included in the study. All patients were assigned to two groups of 40 patients each using the lottery method. Group A patients were treated with a 1-mg intracameral injection of triamcinolone acetonide postoperatively after phacoemulsification. Group B patients were administered 0.1% dexamethasone eye drops with a dosage of one drop every four hours for four weeks. Postoperative follow-up was planned for day one, day seven, and day 28. Results The postoperative inflammation cell values of Group A on day one, day seven, and day 28 were 1.68 ±0.84, 0.22 ±0.15, and 0.12 ±0.23, respectively, while the postoperative inflammation cell values of Group B on day one, day seven, and day 28 were 1.91 ±0.75, 0.28 ±0.15, and 0.09 ±0.20, respectively. The postoperative inflammation flare values of Group A on day one, day seven, and day 28 were 0.31 ±0.37, 0.03 ±0.44, and 0.00 ±0.22, respectively, while the postoperative inflammation flare values of Group B on day one, day seven, and day 28 were 0.25 ±0.26, 0.22 ±0.46, and 0.02 ±0.18, respectively. Conclusion The efficacy of both modes of treatments is comparable; however, triamcinolone acetonide is preferable to dexamethasone, as its intracameral injection generally results in better compliance than multiple dosages of topical eye drops of dexamethasone.",2020,"The postoperative inflammation flare values of Group A on day one, day seven, and day 28 were 0.31 ±0.37, 0.03 ±0.44, and 0.00 ±0.22, respectively, while the postoperative inflammation flare values of Group B on day one, day seven, and day 28 were 0.25 ±0.26, 0.22 ±0.46, and 0.02 ±0.18, respectively.","['Materials and methods Eighty patients were included in the study', 'Department of Ophthalmology at the District Headquarter (DHQ) Teaching Hospital, Dera Ghazi Khan, from March 1, 2018, to August 31, 2019']","['dexamethasone', 'triamcinolone acetonide', 'Intracameral Triamcinolone Acetonide Versus Topical Dexamethasone']","['postoperative inflammation flare values', 'postoperative inflammation cell values']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",80.0,0.0446916,"The postoperative inflammation flare values of Group A on day one, day seven, and day 28 were 0.31 ±0.37, 0.03 ±0.44, and 0.00 ±0.22, respectively, while the postoperative inflammation flare values of Group B on day one, day seven, and day 28 were 0.25 ±0.26, 0.22 ±0.46, and 0.02 ±0.18, respectively.","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Haider Shaheen', 'Affiliation': 'Ophthalmology, District Headquarter Teaching Hospital, Dera Ghazi Khan, PAK.'}, {'ForeName': 'Muhammad Saad', 'Initials': 'MS', 'LastName': 'Ullah', 'Affiliation': 'Ophthalmology, District Headquarter Teaching Hospital, Dera Ghazi Khan, PAK.'}, {'ForeName': 'Syed Ahmer', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Ophthalmology, District Headquarter Teaching Hospital, Dera Ghazi Khan, PAK.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Furqan', 'Affiliation': 'Anesthesia and Critical Care, Chaudhry Pervaiz Elahi Institute of Cardiology, Multan, PAK.'}]",Cureus,['10.7759/cureus.7592']
533,32399396,Evidence for using dextromethorphan-quinidine for the treatment of agitation in dementia.,"Behavioral and psychological symptoms including agitation are common in dementia, and are associated with decreased quality of life, increased risk of institutionalization, and greater patient and caregiver distress. Pharmacological agents used for management of behavioral and psychological symptoms of dementia are limited by their tolerability, prompting a need for identifying efficacious and safe pharmacological treatments for managing agitation in dementia. The combination of dextromethorphan and quinidine sulfate is approved for pseudobulbar affect, and may be effective in managing agitation in dementia. A review of literature found only one randomized controlled trial that evaluated the use of dextromethorphan-quinidine for the management of agitation in dementia when compared to placebo. Data from this trial demonstrated that dextromethorphan-quinidine decreased agitation in dementia, and was well tolerated. Although promising, further research is needed before dextromethorphan-quinidine combination can be accepted as a standard treatment for agitation in dementia.",2020,"Behavioral and psychological symptoms including agitation are common in dementia, and are associated with decreased quality of life, increased risk of institutionalization, and greater patient and caregiver distress.",['agitation in dementia'],"['dextromethorphan-quinidine', 'dextromethorphan and quinidine sulfate', 'placebo']",['tolerated'],"[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C2946981', 'cui_str': 'Dextromethorphan / Quinidine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0034415', 'cui_str': 'Quinidine sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0561217,"Behavioral and psychological symptoms including agitation are common in dementia, and are associated with decreased quality of life, increased risk of institutionalization, and greater patient and caregiver distress.","[{'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Tampi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Cleveland Clinic Akron General, Akron, OH 44106, United States.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwell Health-Staten Island University Hospital, Staten Island, NY 10306, United States.'}, {'ForeName': 'Padmapriya', 'Initials': 'P', 'LastName': 'Marpuri', 'Affiliation': 'Department of Psychiatry, Einstein Medical Center, Philadelphia, PA 19141, United States.'}, {'ForeName': 'Deena J', 'Initials': 'DJ', 'LastName': 'Tampi', 'Affiliation': 'Diamond Healthcare, Richmond, VA 23219, United States.'}]",World journal of psychiatry,['10.5498/wjp.v10.i4.29']
534,32399407,Collagen crosslinking with photoactivated riboflavin in advanced infectious keratitis with corneal melting: Electrophysiological Study.,"AIM


To assess the effect of photoactivated chromophore for keratitis crosslinking (PACK-CXL) in case of severe keratitis with melting on the electrophysiological function of the retina and the optic nerve.
METHODS


The study included 32 eyes of 32 patients with smear positive severe infectious keratitis with corneal melting. The patients were randomly divided into two groups. Group I (control group) included 16 eyes received systemic and topical antimicrobial drugs guarded by culture and sensitivity test. Group II underwent CXL and then continued their antimicrobial treatment. Full field electroretinogram (ERG) and flash visual evoked potential (VEP) were done for each patient in both groups basically and then 1wk, 1 and 3mo post-treatment to assess the changes in the electrophysiological function of the retina and optic nerve.
RESULTS


Healing of 10 eyes in group I in comparison to 14 eyes in group II was recorded. The mean duration of healing was 36.56±5.21d in group I  vs  20.2±4.4d in group II ( P <0.005). In group II, ERG showed an insignificant reduction of all parameters of ERG and VEP after CXL. The amplitude of scotopic rod response, oscillatory potential amplitude, flicker amplitude and photopic cone response were insignificantly decreased ( P =0.4, 0.8, 0.1, and 0.3 respectively). There were insignificant prolongation of latencies of scotopic rod, oscillatory potential, flicker and photopic cone response ( P =0.2, 0.7, 0.5 and 0.1). There was slight delay in latency of VEP without a significant reduction in amplitude.
CONCLUSION


CXL is an effective technique in treatment of severe infectious keratitis with melting as it halts the melting process with acceptable safety on the retinal and optic nerve function.",2020,"There were insignificant prolongation of latencies of scotopic rod, oscillatory potential, flicker and photopic cone response ( P =0.2, 0.7, 0.5 and 0.1).","['32 eyes of 32 patients with smear positive severe infectious keratitis with corneal melting', 'advanced infectious keratitis with corneal melting']","['CXL', 'photoactivated chromophore for keratitis crosslinking (PACK-CXL', 'Collagen crosslinking with photoactivated riboflavin', 'systemic and topical antimicrobial drugs guarded by culture and sensitivity test']","['mean duration of healing', 'ERG and VEP', 'slight delay in latency of VEP', 'amplitude of scotopic rod response, oscillatory potential amplitude, flicker amplitude and photopic cone response', 'latencies of scotopic rod, oscillatory potential, flicker and photopic cone response', 'Full field electroretinogram (ERG) and flash visual evoked potential (VEP']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3898765', 'cui_str': 'Keratitis caused by infection'}, {'cui': 'C1168305', 'cui_str': 'Corneal melt'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0022568', 'cui_str': 'Keratitis'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1136254', 'cui_str': 'Antimicrobial-containing product'}, {'cui': 'C0278253', 'cui_str': 'Guarded prognosis'}, {'cui': 'C0430388', 'cui_str': 'Culture and susceptibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0015217', 'cui_str': 'Visual evoked potential'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0439724', 'cui_str': 'Full field'}, {'cui': 'C0429415', 'cui_str': 'Flash visual evoked potentials'}]",32.0,0.0240024,"There were insignificant prolongation of latencies of scotopic rod, oscillatory potential, flicker and photopic cone response ( P =0.2, 0.7, 0.5 and 0.1).","[{'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Awad', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Abdelkader', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Ameera G', 'Initials': 'AG', 'LastName': 'Abdelhameed', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Walid M', 'Initials': 'WM', 'LastName': 'Gaafar', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}, {'ForeName': 'Tharwat H', 'Initials': 'TH', 'LastName': 'Mokbel', 'Affiliation': 'Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura PO.35516, Egypt.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.07']
535,32399409,Effect of capsular tension ring implantation on predicted refractive error after cataract surgery in patients with pseudoexfoliation syndrome.,"AIM


To investigate the effect of capsular tension ring (CTR) implantation on predicted refractive error after cataract surgery in patients with pseudoexfoliation (PEX) syndrome.
METHODS


This double-blind randomized clinical trial was conducted on 60 patients with PEX syndrome referring to Imam Khomeini Hospital affiliated to Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, for undergoing cataract surgery. The study population was divided into two groups, namely CTR group ( n =30) and non-CTR group (control group;  n =30). The refractive error and anterior chamber depth (ACD) were measured 1wk, 1mo, and 3mo after phacoemulsification (PE) surgery.
RESULTS


The results indicated no statistically significant difference between the two groups in terms of predicted refractive error (obtained by subtracting preoperative predicted refractive error from actual postoperative refractive error) 1wk ( P =0.47), 1mo ( P= 0.30), and 3mo ( P =0.06) after the PE surgery. Regarding the CTR group, the changes of ACD was statistically significant 1 and 3mo after the PE surgery, compared to those obtained 1wk post-surgery ( P =0.005).
CONCLUSION


The CTR implantation in PEX cataractous patients without zonulysis has no statistically significant effect on the predicted refraction and ACD changes after PE. The predicted refraction error has a hyperopic shift in both groups. The results reveal the unnecessary of calculating modified IOL in CTR implantation.",2020,The CTR implantation in PEX cataractous patients without zonulysis has no statistically significant effect on the predicted refraction and ACD changes after PE.,"['patients with pseudoexfoliation syndrome', '60 patients with PEX syndrome referring to Imam Khomeini Hospital affiliated to Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran, for undergoing cataract surgery', 'patients with pseudoexfoliation (PEX) syndrome']","['capsular tension ring implantation', 'capsular tension ring (CTR) implantation']","['refractive error and anterior chamber depth (ACD', 'predicted refractive error', 'changes of ACD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206368', 'cui_str': 'Pseudoexfoliation glaucoma'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1444765', 'cui_str': 'Capsular tension ring'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.130662,The CTR implantation in PEX cataractous patients without zonulysis has no statistically significant effect on the predicted refraction and ACD changes after PE.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Malekahmadi', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Kazemi', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Sharifipour', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Ostadian', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Mahdian Rad', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Mirdehghan', 'Affiliation': 'Department of Ophthalmology, Infectious Ophthalmologic Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 6193673111, Iran.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.09']
536,32399410,Pentacam changes in primary angle-closure glaucoma after different lines of treatment.,"AIM


To assess the changes in the anterior chamber parameters using Pentacam following four different lines of treatment of primary angle-closure glaucoma (PACG).
METHODS


A retrospective comparative study included 126 patients (126 eye) presented within 24-48h after acute angle-closure glaucoma (AACG). Patients were divided into 2 groups: group A (68 eyes) with controlled intraocular pressure (IOP) ≤21 mm Hg, which included subgroup A1 (34 eyes) with clear lens underwent Nd:YAG laser peripheral iridotomy (LPI) and subgroup A2 (34 eyes) with cataract underwent standard phacoemulsification; and group B (58 eyes) with uncontrolled IOP, which included subgroup B1 (30 eyes) with clear lens underwent trabeculectomy and subgroup B2 (28 eyes) with cataract underwent combined phacoemulsification and trabeculectomy. Patients were followed up for at least 3mo. Primary outcomes were Pentacam anterior segment measurements [anterior chamber angle (ACA) and depth (ACD)]. Secondary outcomes were changes in IOP, visual acuity (VA) and recorded complications.
RESULTS


At the 3 rd  month, there was significant increase in the ACA values in all studied groups compared to preoperative values ( P <0.001). The highest percent of increase in ACA was recorded in phacotrabeculectomy group B2 (128.40%). There was significant increase in ACD values at 3 rd  month compared with baseline values ( P <0.001) for groups A1, A2, and B2; without change in B1 trabeculectomy group. The maximum deepening of ACD was noticed in group B2 with 94.27% increase. Significant decrease in postoperative IOP in groups A2, B1 and B2 ( P <0.001,  P =0.014, and  P <0.001 respectively). In group A1 there was significant increase in 3 rd  month postoperative IOP from baseline values ( P <0.001). The maximum decrease in IOP was noticed in group B2 with 59.54% decrease. VA improvement in 3 rd  month postoperative was recorded in all studied groups, maximum VA improvement was observed in group B2 up to 0.2 logMAR.
CONCLUSION


Pentacam can be a helpful tool in studying and comparing the effect of the different lines of management of PACG on the anterior chamber measures. Phacotrabeculectomy was proved to be an effective line for managing PACG with resultant significant increase in the anterior chamber parameters, IOP reduction as well as maximum VA improvement. LPI has only temporary effect on IOP with significant changes in ACA and ACD. Phacoemuslification alone can be an option in treating PACG. Trabeculectomy resulted in temporary increase in the anterior chamber parameter which subsequently returned to baseline values.",2020,"Significant decrease in postoperative IOP in groups A2, B1 and B2 ( P <0.001,  P =0.014, and  P <0.001 respectively).","['primary angle-closure glaucoma (PACG', '126 patients (126 eye) presented within 24-48h after acute angle-closure glaucoma (AACG']","['LPI', 'Trabeculectomy', 'YAG laser peripheral iridotomy (LPI) and subgroup A2 (34 eyes) with cataract underwent standard phacoemulsification', 'uncontrolled IOP, which included subgroup B1 (30 eyes) with clear lens underwent trabeculectomy and subgroup B2 (28 eyes) with cataract underwent combined phacoemulsification and trabeculectomy', 'controlled intraocular pressure (IOP) ≤21 mm Hg, which included subgroup A1 (34 eyes) with clear lens underwent Nd']","['anterior chamber parameters, IOP reduction', 'changes in IOP, visual acuity (VA) and recorded complications', 'ACA values', 'ACD values', 'postoperative IOP', 'Pentacam anterior segment measurements [anterior chamber angle (ACA) and depth (ACD', 'anterior chamber parameter', 'maximum deepening of ACD', '3 rd  month postoperative IOP', 'ACA', 'IOP', 'maximum VA improvement']","[{'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0154946', 'cui_str': 'Acute angle-closure glaucoma'}]","[{'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0197497', 'cui_str': 'Anterior segment of eye incision'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0458088', 'cui_str': 'O/E - lens normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",126.0,0.0617764,"Significant decrease in postoperative IOP in groups A2, B1 and B2 ( P <0.001,  P =0.014, and  P <0.001 respectively).","[{'ForeName': 'Tharwat H', 'Initials': 'TH', 'LastName': 'Mokbel', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Abd-Elmonem', 'Initials': 'AE', 'LastName': 'Elhesy', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Alnagdy', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Mohammed F', 'Initials': 'MF', 'LastName': 'Elashri', 'Affiliation': 'Department of Ophthalmology, Kafrelshiekh University, Kafr el-Shiekh 33516, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Eissa', 'Affiliation': 'Department of Ophthalmology, General Organization for Teaching Hospitals and Institutes, Cairo 11562, Egypt.'}, {'ForeName': 'Walid M', 'Initials': 'WM', 'LastName': 'Gaafar', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}, {'ForeName': 'Sherein M', 'Initials': 'SM', 'LastName': 'Hagras', 'Affiliation': 'Mansoura Ophthalmic Center, Faculty of Medicine, Mansoura University, Mansoura 35516, Egypt.'}]",International journal of ophthalmology,['10.18240/ijo.2020.04.10']
537,32399799,Effect of FAmily CEntered (FACE®) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial.,"Trial tested effect of advance care planning on family/surrogates' understanding of patients' end-of-life treatment preferences longitudinally. A multisite, assessor-blinded, intent-to-treat, parallel-group, randomized controlled clinical trial in five hospital-based HIV clinics enrolled 449 participants aged 22 to 77 years during October 2013-March 2017. Patients living with HIV/family dyads were randomized at 2:1 ratio to 2 weekly ~ 60-min sessions either ACP (n = 155 dyads)-(1) ACP facilitated conversation, (2) Advance directive completion; or Control (n = 68 dyads)-(1) Developmental/relationship history, (2) Nutrition/exercise tips. ACP families/surrogates were more likely to accurately report patients' treatment preferences at Time 1 (T 1 ) and 12 months post-intervention (T 2 ) compared to controls, experiencing high congruence longitudinally (high→high transition), [63·6% vs 37·7% (difference = 25·9%, 95% CI: 11·3%, 40·4%, χ 2  = 11·52, p = 0·01)], even as patients' preferences changed over time. ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3). Conversations matter.",2020,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","['five hospital-based HIV clinics enrolled 449 participants aged 22 to 77\xa0years during October 2013-March 2017', 'Patients living with HIV/family dyads', 'Longitudinal Congruence in End-of-Life Treatment Preferences']","['Control (n\u2009=\u200968 dyads)-(1', 'FAmily CEntered (FACE®', 'ACP (n\u2009=\u2009155 dyads)-(1', 'advance care planning', 'Advance Care Planning']",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001369', 'cui_str': 'Acyl Carrier Protein'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",[],449.0,0.0733186,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA. mlyon@childrensnational.org.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Squires', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Scott', 'Affiliation': 'MedStar: Health Research Institute and Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Benator', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Briggs', 'Affiliation': 'Respecting Choices, Coalition to Transform Advance Care Innovations, Washington, DC, USA.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Greenberg', 'Affiliation': ""Medical Education, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Yao Iris', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics & Study Methodology, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02909-y']
538,32399853,"Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses.","BACKGROUND AND OBJECTIVE


SUVN-G3031 is a novel, potent, and selective histamine-3 receptor (H 3 R) inverse agonist in development for the treatment of narcolepsy. Our objective was to characterize the safety, tolerability, and pharmacokinetics of SUVN-G3031 in healthy young adults after single and multiple doses, and to evaluate the effect of food, gender, and age on the pharmacokinetics.
METHODS


A single ascending dose (SAD) and a multiple ascending dose (MAD) study for 14 days was conducted in healthy young adults using a randomized, double-blind study design. The effect of food, gender, and age on SUVN-G3031 pharmacokinetics (6 mg as a single dose) was evaluated using an open-label, two-period, randomized, crossover design in fed and fasted states. Pharmacokinetics and safety assessments were conducted throughout the study.
RESULTS


Single doses of SUVN-G3031 up to 20 mg and multiple doses up to 6 mg once daily were found to be safe and well tolerated in healthy young adults. The most frequently reported adverse events were abnormal dreams, dyssomnia, and hot flushes. SUVN-G3031 exposure was dose proportional across the tested doses. Steady state was achieved on day 6 after once-daily dosing. Renal excretion (~ 60%) of unchanged SUVN-G3031 was the major route of elimination. Food, gender, and age did not have any clinically meaningful effect on SUVN-G3031 exposure.
CONCLUSION


SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile. Clinical Trials Registration (https://clinicaltrials.gov): NCT04072380 and NCT02342041.",2020,"SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.","['Healthy Human Subjects Following Single and Multiple Oral Doses', 'healthy human subjects', 'healthy young adults']",[],"['Renal excretion', 'safety, tolerability, and pharmacokinetics', 'Safety, Tolerability, and Pharmacokinetics', 'safe and well tolerated']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0520693,"SUVN-G3031 was found to be safe and well tolerated in healthy human subjects without any effect of age, gender, and food on the pharmacokinetics and safety profile.","[{'ForeName': 'Ramakrishna', 'Initials': 'R', 'LastName': 'Nirogi', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India. nvsrk@suven.com.'}, {'ForeName': 'Koteshwara', 'Initials': 'K', 'LastName': 'Mudigonda', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Gopinadh', 'Initials': 'G', 'LastName': 'Bhyrapuneni', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Nageswara Rao', 'Initials': 'NR', 'LastName': 'Muddana', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shinde', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Goyal', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Santosh Kumar', 'Initials': 'SK', 'LastName': 'Pandey', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Abdul Rasheed', 'Initials': 'AR', 'LastName': 'Mohammed', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Jyothsna', 'Initials': 'J', 'LastName': 'Ravula', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Jetta', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}, {'ForeName': 'Veera Raghava Chowdary', 'Initials': 'VRC', 'LastName': 'Palacharla', 'Affiliation': 'Discovery Research, Suven Life Sciences Ltd., Serene Chambers, Road # 7, Banjara Hills, Hyderabad, 500 034, India.'}]",Clinical drug investigation,['10.1007/s40261-020-00920-8']
539,32399866,Defibrillation threshold testing during implantable cardioverter defibrillator implantation: 5-year follow-up.,"PURPOSE


Defibrillation threshold (DFT) testing is a routine practice in some Asian countries for patients receiving an implantable cardioverter defibrillator (ICD). However, there are few long-term data about the necessity of intraoperative DFT testing in an Asian population. We investigated the safety of DFT testing and the long-term clinical outcomes in Asian patients undergoing ICD implantation.
METHODS


All patients undergoing de novo transvenous ICD implantation were randomized to undergo periprocedural DFT testing. The study included 67 patients (50 males; 51.5 ± 16.9 years) who underwent ICD implantation with (n = 33) or without (n = 34) intraoperative DFT testing between March 2012 and February 2014. We compared first-shock success, composite safety end points (the sum of complications recorded at 30 days), arrhythmic death, and all-cause mortality.
RESULTS


The baseline clinical characteristics and the procedural-related adverse event rate (3.0% with DFT vs. 0% with non-DFT, p = 0.214) did not differ between groups. The programmed output of the first shock was lower in the DFT testing group (22.9 ± 4.4 J vs. 25.3 ± 5.4 J, p = 0.007). However, there were no significant differences between groups for all-cause mortality (12.1% vs. 17.6%, p = 0.526) or first-shock success rate for ventricular arrhythmia (100% vs. 88.2%, p = 0.471).
CONCLUSIONS


There were no between-group differences in periprocedural safety, complications, and long-term clinical outcomes. Our results suggest that DFT testing in Asian patients allows reduction of the programmed output of the first shock, but does not affect long-term clinical outcomes.",2020,"However, there were no significant differences between groups for all-cause mortality (12.1% vs. 17.6%, p = 0.526) or first-shock success rate for ventricular arrhythmia (100% vs. 88.2%, p = 0.471).
","['patients receiving an implantable cardioverter defibrillator (ICD', 'Asian patients', 'Asian patients undergoing ICD implantation', 'All patients undergoing de novo transvenous ICD implantation', '67 patients (50 males; 51.5\u2009±\u200916.9\xa0years) who underwent ICD implantation with (n\u2009=\u200933) or without (n\u2009=\u200934) intraoperative DFT testing between March 2012 and February 2014']","['Defibrillation threshold (DFT) testing', 'implantable cardioverter defibrillator implantation', 'periprocedural DFT testing']","['procedural-related adverse event rate', 'periprocedural safety, complications, and long-term clinical outcomes', 'programmed output of the first shock', 'first-shock success rate for ventricular arrhythmia', 'cause mortality', 'arrhythmic death, and all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",67.0,0.122104,"However, there were no significant differences between groups for all-cause mortality (12.1% vs. 17.6%, p = 0.526) or first-shock success rate for ventricular arrhythmia (100% vs. 88.2%, p = 0.471).
","[{'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Division, Chosun University Hospital, 365, Pilmun daero, Dong-gu, Gwangju, South Korea.'}, {'ForeName': 'Hyung Wook', 'Initials': 'HW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Medical School, 42, Jebong-ro, Dong-gu, Gwangju, 61469, South Korea. mdhwp@naver.com.'}, {'ForeName': 'Hyung Ki', 'Initials': 'HK', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Medical School, 42, Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Ki Hong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Medical School, 42, Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Nam Sik', 'Initials': 'NS', 'LastName': 'Yoon', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Medical School, 42, Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}, {'ForeName': 'Jeong Gwan', 'Initials': 'JG', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Medical School, 42, Jebong-ro, Dong-gu, Gwangju, 61469, South Korea.'}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-020-00733-x']
540,32216456,"Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study.","BACKGROUND


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


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


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


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


This study is registered at ClinicalTrials.gov (NCT02174861).",2020,"Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.","['chronic migraine patients', 'patients with chronic migraine']","['placebo or once-monthly erenumab 70\u2009mg or 140\u2009mg', 'erenumab']","['adverse event profile', 'Adverse event incidence rates', 'Efficacy']","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.411908,"Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.","[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jan Lewis', 'Initials': 'JL', 'LastName': 'Brandes', 'Affiliation': 'Nashville Neuroscience Group and Vanderbilt University Department of Neurology, Nashville, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Doležil', 'Affiliation': 'Prague Headache Center DADO MEDICAL sro, Prague, Czech Republic.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Winner', 'Affiliation': 'Premiere Research Institute, Nova Southeastern University, West Palm Beach, FL, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Global Biostatistical Science, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Global Development, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Global Development, Amgen Inc, Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420912726']
541,32396668,Effectiveness of a short web-based film targeting parental oral health knowledge in a well-child care setting.,"Young children rely on their parents with respect to oral health routines. However, parental knowledge on this topic is often insufficient. Well-child care may be an excellent route to reach parents because almost all of them attend. To evaluate the effectiveness of an 8.5 min web-based film about oral health, provided by well-child care, a non-blinded quasi-experimental study was performed. Parents attending well-child care clinics in the Netherlands were assigned to an intervention (n = 88) or control group (n = 41). The control group received care as usual. We measured parental knowledge of oral health with a questionnaire (range of scores 1-12) before and directly after the intervention, and 6 months later, and assessed differences between the intervention and the control group. Parental oral health knowledge improved after watching the film: the intervention group's mean score of 11.1 (SD 1.3) was greater than the mean score of 7.1 (SD 2.0) of the control group (Cohen's d = 2.64). Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25). A web-based educational film delivered in a well-child care setting can be an effective way to address oral health and to improve parental knowledge.",2020,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).",['Parents attending well-child care clinics in the Netherlands'],['short web-based film targeting parental oral health knowledge'],"['parental knowledge of oral health', 'Parental oral health knowledge']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0312641,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).","[{'ForeName': 'Deborah Ashley', 'Initials': 'DA', 'LastName': 'Verlinden', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'Schuller', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sijmen A', 'Initials': 'SA', 'LastName': 'Reijneveld', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research TNO, Leiden, the Netherlands.'}]",European journal of oral sciences,['10.1111/eos.12700']
542,32396700,Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial.,"INTRODUCTION


Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.
METHODS


ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression.
RESULTS


PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit.
CONCLUSIONS


There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.",2020,PrEP initiation did not differ across study randomized groups (p = 0.7).,"['participants either off-site via referral or on site via trained trial staff', 'African women', '7830 women aged 16 to 35\xa0years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18\xa0months, from 2015 to 2018', 'African women in a large HIV endpoint-driven clinical trial']",['Oral pre-exposure prophylaxis (PrEP'],"['PrEP uptake', 'HIV seroincidence rates']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454695', 'cui_str': 'African country'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",7830.0,0.194832,PrEP initiation did not differ across study randomized groups (p = 0.7).,"[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Beesham', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Welch', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Heffron', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pleaner', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kidoguchi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Baron', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Louw', 'Affiliation': 'Madibeng Centre for Research, Brits, South Africa.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Joanne R', 'Initials': 'JR', 'LastName': 'Batting', 'Affiliation': 'Effective Care Research Unit (ECRU), Fort Hare and Eastern Cape Department of Health, Universities of the Witwatersrand, East London, South Africa.'}, {'ForeName': 'Mookho', 'Initials': 'M', 'LastName': 'Malahleha', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Veronique C', 'Initials': 'VC', 'LastName': 'Bailey', 'Affiliation': 'Setshaba Research Centre, Tshwane, South Africa.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25491']
543,32396866,Framing Social Comparison Feedback With Financial Incentives for Physical Activity Promotion: A Randomized Trial.,"BACKGROUND


Social comparison feedback is often used in physical activity interventions but the optimal design of feedback is unknown.
METHODS


This 4-arm, randomized trial consisted of a 13-week intervention period and 13-week follow-up period. During the intervention, 4-person teams were entered into a weekly lottery valued at about $1.40/day and contingent on the team averaging ≥7000 steps per day. Social comparison feedback on performance was delivered weekly for 26 weeks, and varied by reference point (50th vs 75th percentile) and forgiveness in use of activity data (all 7 d or best 5 of 7 d). The primary outcome was the mean proportion of participant-days achieving the 7000-step goal.
RESULTS


During the intervention period, the unadjusted mean proportion of participant-days that the goal was achieved was 0.47 (95% confidence interval [CI]: 0.38 to 0.56) in the 50th percentile arm, 0.38 (95% CI: 0.30 to 0.37) in the 75th percentile arm, 0.40 (95% CI: 0.31 to 0.49) in the 50th percentile with forgiveness arm, and 0.47 (95% CI: 0.38 to 0.55) in the 75th percentile with forgiveness arm. In adjusted models during the intervention and follow-up periods, there were no significant differences between arms.
CONCLUSIONS


Changing social comparison feedback did not impact physical activity.",2020,"In adjusted models during the intervention and follow-up periods, there were no significant differences between arms.
",['Physical Activity Promotion'],[],['mean proportion of participant-days achieving the 7000-step goal'],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0701457,"In adjusted models during the intervention and follow-up periods, there were no significant differences between arms.
","[{'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': ''}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Rosin', 'Affiliation': ''}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': ''}, {'ForeName': 'Scarlett L', 'Initials': 'SL', 'LastName': 'Bellamy', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hoffer', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shuttleworth', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hilbert', 'Affiliation': ''}, {'ForeName': 'Jingsan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xingmei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0313']
544,32396914,The Effect of Lavender Oil on Sleep Quality and Vital Signs in Palliative Care: A Randomized Clinical Trial.,"BACKGROUND


This study was conducted to determine the effect of lavender oil on sleep quality and vital signs in palliative care patients.
METHODS


We examined 68 patients in a palliative care unit. Vital signs of all the patients were assessed, and also their sleep quality was evaluated using the Richards-Campbell Sleep Questionnaire. Lavender was applied to patients in the experimental group. During the intervention, vital signs of the patients were monitored at 4-h intervals throughout the night, and sleep quality was evaluated during the morning. The same evaluation processes were performed for the control group.
RESULTS


It was observed in the evaluation that lavender application did not affect the vital signs of the patients but it ensured a deeper sleep on the 2nd day after the intervention, facilitated their falling asleep and sleeping again when they were awakened and enhanced sleep quality (p < 0.05). Also, this application decreased the awakening frequency on the 1st and 2nd days and enhanced overall sleep quality (p < 0.05) after the intervention.
CONCLUSIONS


Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.",2020,"CONCLUSIONS


Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.","['Palliative Care', '68 patients in a palliative care unit', 'palliative care patients']","['Lavender Oil', 'lavender oil', 'Lavender']","['awakening frequency', 'overall sleep quality', 'sleep quality and vital signs', 'Sleep Quality and Vital Signs', 'sleep quality']","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",68.0,0.0296234,"CONCLUSIONS


Lavender has no effect on the vital signs of palliative care patients but is an effective and reliable approach to enhance their sleep quality.","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Nursing, University Faculty of Health Sciences, İstanbul Sabahattin Zaim University, Istanbul, Turkey, d.atici1987@hotmail.com.'}, {'ForeName': 'Vildan', 'Initials': 'V', 'LastName': 'Kocatepe', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Acıbadem Mehmet Ali Aydınlar University, Istanbul, Turkey.'}, {'ForeName': 'Gülbeyaz', 'Initials': 'G', 'LastName': 'Can', 'Affiliation': 'Department of Internal Medicine Nursing, Faculty of Florence Nightingale Nursing, Istanbul University - Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Sulu', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Akış', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Güleser', 'Initials': 'G', 'LastName': 'Şahin', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Eylem', 'Initials': 'E', 'LastName': 'Aktay', 'Affiliation': 'Palliative Care Unit, Süreyyapaşa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Complementary medicine research,['10.1159/000507319']
545,32396917,"Improving Cost-effectiveness and Access to Cognitive Behavior Therapy for Depression: Providing Remote-Ready, Computer-Assisted Psychotherapy in Times of Crisis and Beyond.","INTRODUCTION


There is growing evidence that computer-delivered or computer-assisted forms of cognitive behavior therapy (CCBT) are helpful, but cost-effectiveness versus standard therapies is not well established.
OBJECTIVE


To evaluate the cost-effectiveness of a therapist-supported method for CCBT in comparison to standard cognitive behavior therapy (CBT).
METHODS


A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact). Outcomes were assessed at baseline, weeks 8 and 16, and at 3 and 6 months post-treatment. Economic analyses took into account the costs of services received and work/social role impairment.
RESULTS


In the context of almost identical efficacy, a form of CCBT that used only about one third the amount of therapist contact as conventional CBT was highly cost-effective compared to conventional therapy and reduced the adjusted cost of treatment by USD 945 per patient.
CONCLUSIONS


A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery.",2020,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"['154 drug-free major depressive disorder outpatients', 'Depression']","['cognitive behavior therapy (CCBT', 'Cognitive Behavior Therapy', 'therapist-supported method for CCBT', 'CCBT', 'standard cognitive behavior therapy (CBT', 'standard CBT']",['cost-effectiveness'],"[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0290312,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's College, London, United Kingdom.""}, {'ForeName': 'Marna S', 'Initials': 'MS', 'LastName': 'Barrett', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tracy D', 'Initials': 'TD', 'LastName': 'Eells', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jesse H', 'Initials': 'JH', 'LastName': 'Wright', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000508143']
546,32222613,Remembering happy times instead of sticking to negative memories after social exclusion.,"BACKGROUND & OBJECTIVES


Previous research shows that difficulty disengaging from negative (self-related) stimuli (i.e. negative self-referential processing; NSP) is a vulnerability factor for depression (Gotlib & Joormann, 2010) and contributes to its recurrence (LeMoult, Kircanski, Prasad, & Gotlib, 2017). The Emotional Reversal Learning Task (ERLT) was designed to investigate this, and we examined its construct validity by inducing social rejection, an etiological process of depression, within the ERLT model. We expected excluded participants to have difficulty disengaging from NSP.
METHODS


We administered Cyberball to 130 participants randomly assigned to the excluded or included condition. Participants then completed the ERLT: They chose a valence option (positive or negative), retrieved a memory of the same valence, and then were rewarded or punished for their valence choice. For the first phase, retrieving a negative memory was probabilistically rewarded, and this action-outcome contingency was twice reversed during the task. We used Q-learning models to analyze learning rates.
RESULTS


Excluded participants had no more difficulty disengaging from NSP than included participants: Bayesian computational modeling identified no difference between conditions regarding learning that retrieving negative memories was punished. Exploratory analyses found that excluded participants learned the association between retrieving positive memories and reward quicker than included participants, however.
LIMITATIONS


Doubts remain regarding whether participants fully understood action-outcome contingencies, and we did not explicitly check whether participants truly retrieved memories, which could have affected results.
CONCLUSIONS


We did not find support for the construct validity of the ERLT when using social exclusion to model depressogenic development within the ERLT.",2020,We did not find support for the construct validity of the ERLT when using social exclusion to model depressogenic development within the ERLT.,['130 participants randomly assigned to the excluded or included condition'],['Emotional Reversal Learning Task (ERLT'],[],"[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],130.0,0.0369476,We did not find support for the construct validity of the ERLT when using social exclusion to model depressogenic development within the ERLT.,"[{'ForeName': 'M Annelise', 'Initials': 'MA', 'LastName': 'Blanchard', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, University of Leuven, Belgium. Electronic address: marie.blanchard@uclouvain.be.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Belmans', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, University of Leuven, Belgium.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Ludwig-Maximilians-University Munich, Germany.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Center for the Psychology of Learning and Experimental Psychopathology, University of Leuven, Belgium.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101570']
547,32224333,A pilot study augmenting cognitive behavioral therapy for panic disorder with attention bias modification: Clinical and psychophysiological outcomes.,"BACKGROUND AND OBJECTIVES


Studies show that attentional bias towards threat is a key maintenance factor for panic disorder (PD). Attentional bias may be an important mechanism of symptom reduction, and thus, a useful target for optimizing outcomes. The current study examined whether an attention bias modification (ABM) task enhanced CBT outcomes. Multiple methods for assessing PD were used, including physiological measurement and clinician-rated assessment.
METHODS


Adults with panic disorder (N = 24) received seven sessions of CBT with either ABM or sham attention tasks. Psychophysiological reaction to a loud tones startle paradigm was assessed before and after treatment.
RESULTS


Across both groups, panic symptom severity decreased with CBT. The ABM group showed greater reductions in PD symptoms compared to the placebo group. Notably, however, changes in attentional bias were not associated with symptom reductions across groups. No significant group differences on psychophysiological assessment were observed.
LIMITATIONS


This study is limited by the small sample size, which rendered our power to investigate mediators and moderators insufficient. More research is needed to validate the effect of attention bias modification on attentional bias to threat.
CONCLUSIONS


This pilot study suggests that future research should investigate attentional bias in conjunction with CBT. A larger sample would provide opportunity to further investigate the mechanisms through which ABM works, along with potential moderating factors and the use of psychophysiological measurements in panic disorder.",2020,"No significant group differences on psychophysiological assessment were observed.
","['panic disorder with attention bias modification', 'Adults with panic disorder (N\xa0=\xa024']","['CBT with either ABM or sham attention tasks', 'placebo', 'cognitive behavioral therapy']","['Psychophysiological reaction to a loud tones startle paradigm', 'panic symptom severity', 'PD symptoms', 'attentional bias', 'psychophysiological assessment']","[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0401351,"No significant group differences on psychophysiological assessment were observed.
","[{'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Baker', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: awbaker@mgh.harvard.edu.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Hellberg', 'Affiliation': 'University of North Carolina Chapel Hill Department of Psychology and Neuroscience, 235 E. Cameron Avenue, Chapel Hill, NC, 27599-3270, USA. Electronic address: shellberg@unc.edu.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Jacoby', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: rjjacoby@mgh.harvard.edu.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Losiewicz', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA. Electronic address: Naomi.Simon@numc.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Orr', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: scott_orr@hms.harvard.edu.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Marques', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: lmarques@mgh.harvard.edu.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Massachusetts General Hospital, One Bowdoin Square, Boston, MA, 02114, USA; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA; New York University Langone Health Department of Psychiatry, One Park Avenue, 8th floor, New York, NY, 10016, USA. Electronic address: Naomi.Simon@numc.org.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101568']
548,32244028,Network topology and machine learning analyses reveal microstructural white matter changes underlying Chinese medicine Dengzhan Shengmai treatment on patients with vascular cognitive impairment.,"With the increasing incidence of cerebrovascular diseases and dementia, considerable efforts have been made to develop effective treatments on vascular cognitive impairment (VCI), among which accumulating practice-based evidence has shown great potential of the traditional Chinese medicine (TCM). Current randomized double-blind controlled trial has been designed to evaluate the 6-month treatment effects of Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations on VCI, and to explore the underlying neural mechanisms with graph theory-based analysis and machine learning method based on diffusion tensor imaging (DTI) data. A total of 82 VCI patients were recruited and randomly assigned to drug (45 with DZSM) and placebo (37 with placebo) groups, and neuropsychological and neuroimaging data were acquired at baseline and after 6-month treatment. After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains. And with the reconstruction of white matter structural network, there were more streamlines connecting the left thalamus and right hippocampus in the drug groups (p < 0.001 uncorrected), with decreasing nodal efficiency of the right olfactory associated with slower decline in the general cognition (r = -0.364, p = 0.048). Moreover, support vector machine classification analyses revealed significant white matter network alterations after treatment in the drug groups (accuracy of baseline vs. 6-month later, 68.18 %). Taking together, the present study showed significant efficacy of DZSM treatment on VCI, which might result from white matter microstructure alterations and the topological changes in brain structural network.",2020,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","['82 VCI patients', 'patients with vascular cognitive impairment']","['Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations', 'placebo', 'Network topology and machine learning', 'placebo (37 with placebo', 'DZSM']","['general cognition', 'white matter network alterations', 'nodal efficiency', ""performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}]","[{'cui': 'C3885966', 'cui_str': 'shengmai'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002812', 'cui_str': 'Regional Anatomy'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.257526,"After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, Beijing, 100069, PR China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'China-Japan Friendship Hospital 100029, PR China.'}, {'ForeName': 'Caishui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Xuwen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Wenxiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Shaokun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China. Electronic address: chengweidong888@sina.com.'}, {'ForeName': 'Zhanjun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China. Electronic address: zhang_rzs@bnu.edu.cn.'}]",Pharmacological research,['10.1016/j.phrs.2020.104773']
549,32399578,"Zinc Oxide Inhibits Axillary Colonization by Members of the Genus Corynebacterium and Attenuates Self-perceived Malodour: A Randomized, Double-blind, Placebo-controlled Trial.","Malodour from the axilla is commonly caused by specific microbes, and may be inhibited by zinc oxide. The aim of this study was to determine the effects of zinc oxide on the axillary microbiota, odour and pH in a randomized, double-blind, placebo-controlled trial in 30 healthy volunteers. In each participant one axilla was treated with zinc oxide and the other with a placebo for 13 days. The microbiota and pH were analysed before and during treatment. At the final visit, the participants judged their own axillary odour for comparison. With zinc oxide treatment total bacterial growth and, specifically, that of odour-producing Corynebacterium spp. and Staphylococcus hominis, decreased (p < 0.05), despite an increase (p < 0.0005) in skin-surface pH. Compared with the placebo, zinc oxide treatment reduced (p = 0.005) self-perceived malodour. In vitro, Corynebacterium spp. (19 isolated strains) survival was reduced (p < 0.0005) at pH 5.0 compared with pH 6.0; growth inhibition by zinc oxide occurred at ≤ 400 mg/l, and cell death occurred at ≤ 10,000 mg/l for 12 (63%) of the strains. In conclusion, application of zinc oxide reduced malodour and the counts of causative bacteria, but increased the pH of the axilla.",2020,"and Staphylococcus hominis, decreased (p < 0.05), despite an increase (p < 0.0005) in skin-surface pH. Compared with the placebo, zinc oxide treatment reduced (p = 0.005) self-perceived malodour.","['Members of the Genus Corynebacterium and Attenuates Self-perceived Malodour', '30 healthy volunteers']","['Placebo', 'placebo, zinc oxide', 'zinc oxide', 'Zinc Oxide', 'placebo']","['cell death', 'growth inhibition by zinc oxide', 'microbiota and pH', 'counts of causative bacteria']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0010148', 'cui_str': 'Corynebacterium'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}]","[{'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",30.0,0.376573,"and Staphylococcus hominis, decreased (p < 0.05), despite an increase (p < 0.0005) in skin-surface pH. Compared with the placebo, zinc oxide treatment reduced (p = 0.005) self-perceived malodour.","[{'ForeName': 'Magnus S', 'Initials': 'MS', 'LastName': 'Ågren', 'Affiliation': 'Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital, University of Copenhagen, DK-2400 Copenhagen NV, Denmark. E-mail: magnusspagren@gmail.com.'}, {'ForeName': 'Khaled S A', 'Initials': 'KSA', 'LastName': 'Ghathian', 'Affiliation': ''}, {'ForeName': 'Amalie K S', 'Initials': 'AKS', 'LastName': 'Frederiksen', 'Affiliation': ''}, {'ForeName': 'Morten J', 'Initials': 'MJ', 'LastName': 'Bjerrum', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Calum', 'Affiliation': ''}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Danielsen', 'Affiliation': ''}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Menon', 'Affiliation': ''}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Hædersdal', 'Affiliation': ''}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jorgensen', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3499']
550,32399632,Ecological momentary assessment of temptations and lapses in non-daily smokers.,"RATIONALE


Little is known about relapse among non-daily, intermittent smokers (ITS), who have difficulty quitting, despite a lack of dependence.
OBJECTIVES


To analyze situations associated with temptations to smoke and smoking lapses among ITS trying to maintain abstinence.
METHODS


Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study. EMA data captured participants' situations and states in temptations (n = 976), including those that eventuated in lapses (n = 147), for up to 6 weeks. Randomly timed assessments assessed background states (n = 11,446). Participants also reported coping performed to prevent lapses. Multilevel analyses compared temptations to background situations, and lapse episodes to resolved temptations.
RESULTS


Temptations were marked by exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption, as well as more negative affect. Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods. Both behavioral and cognitive coping responses were associated with avoiding lapsing, but behavioral coping had much larger effects. The effects of affective distress on lapse risk were mediated by its effects on coping.
CONCLUSIONS


Smoking cues play a major role in ITS' temptations and lapses, perhaps indicating a degree of behavioral dependence. Affective distress also played a role in ITS lapses, undermining the idea that the affective distress seen in daily smokers' lapses is due to nicotine withdrawal. The data reinforce the important role of coping in preventing lapses.",2020,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","['non-daily smokers', 'Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study']",[],"['Affective distress', 'exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption', 'smoking cues and availability of cigarettes, alcohol consumption']","[{'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",130.0,0.0228674,"Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods.","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA. shiffman@pitt.edu.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, 130 N. Bellefield Ave, Suite 510, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health & Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05539-3']
551,32399662,Empagliflozin attenuates neointimal hyperplasia after drug-eluting-stent implantation in patients with type 2 diabetes.,"The effects of empagliflozin, a sodium-glucose co-transporter 2 inhibitor, on neointimal response after drug-eluting-stent (DES) implantation remains unknown. Insufficiently controlled diabetes patients with coronary artery disease planned for DES stenting were consecutively enrolled. The patients were assigned to receive empagliflozin in addition to standard therapy or intensive therapy using other glucose-lowering drugs (oGLD). The primary endpoint was thickness of neointimal hyperplasia (NIH) 12 months after stenting assessed by optical coherence tomography (OCT). A total of 28 patients were analyzed (n = 15 in the empagliflozin group, n = 13 in the oGLD group). The levels of glucose profile were not significantly different between both groups at follow-up [HbA1c; 7.2 ± 0.8 vs 7.3 ± 0.9%, p = 0.46]. In OCT analysis, neointima was significantly less in the empagliflozin group than the oGLD group [mean NIH thickness: 137 ± 32 vs 168 ± 39 μm, p = 0.02]. Changes of systolic and diastolic blood pressure (BP), changes of body mass index, and changes of hematocrit after additional treatment were significantly associated with NIH attenuation, whereas no correlation was observed in changes in blood glucose parameters. Multivariate logistic regression analysis revealed that changes in systolic BP was the strongest predictor for NIH attenuation, followed by changes in diastolic BP. In patients with type 2 diabetes, standard plus empagliflozin attenuated neointimal progression as compared with intensive standard therapy after DES implantation. Our data possibly support a beneficial effect of empagliflozin in type 2 diabetes required for coronary revascularization therapy.",2020,"In OCT analysis, neointima was significantly less in the empagliflozin group than the oGLD group","['Insufficiently controlled diabetes patients with coronary artery disease planned for DES stenting were consecutively enrolled', '28 patients were analyzed (n\u2009=\u200915 in the empagliflozin group, n\u2009=\u200913 in the oGLD group', 'patients with type 2 diabetes']","['Empagliflozin', 'empagliflozin in addition to standard therapy or intensive therapy using other glucose-lowering drugs (oGLD', 'oGLD', 'empagliflozin']","['neointimal progression', 'diastolic BP', 'neointimal hyperplasia', 'Changes of systolic and diastolic blood pressure (BP), changes of body mass index, and changes of hematocrit', 'systolic BP', 'neointimal response', 'levels of glucose profile', 'blood glucose parameters', 'thickness of neointimal hyperplasia (NIH) 12\xa0months after stenting assessed by optical coherence tomography (OCT']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4049446', 'cui_str': 'Neointimal hyperplasia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",28.0,0.0256448,"In OCT analysis, neointima was significantly less in the empagliflozin group than the oGLD group","[{'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Hashikata', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan. t_hashikata@med.kitasato-u.ac.jp.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Ikutomi', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Jimba', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Shindo', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Kakuda', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Katsushika', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Kishi', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Masashiro', 'Initials': 'M', 'LastName': 'Matsushita', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa, Tokyo, 141-0022, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01621-0']
552,32399752,Impact of the Bayesian penalized likelihood algorithm (Q.Clear®) in comparison with the OSEM reconstruction on low contrast PET hypoxic images.,"PURPOSE


To determine the impact of the Bayesian penalized likelihood (BPL) reconstruction algorithm in comparison to OSEM on hypoxia PET/CT images of NSCLC using  18 F-MIZO and  18 F-FAZA.
MATERIALS AND METHODS


Images of low-contrasted (SBR = 3) micro-spheres of Jaszczak phantom were acquired. Twenty patients with lung neoplasia were included. Each patient benefitted from  18 F-MISO and/or  18 F-FAZA PET/CT exams, reconstructed with OSEM and BPL. Lesion was considered as hypoxic if the lesion SUV max  > 1.4. A blind evaluation of lesion detectability and image quality was performed on a set of 78 randomized BPL and OSEM images by 10 nuclear physicians. SUV max , SUV mean,  and hypoxic volumes using 3 thresholding approaches were measured and compared for each reconstruction.
RESULTS


The phantom and patient datasets showed a significant increase of quantitative parameters using BPL compared to OSEM but had no impact on detectability. The optimal beta parameter determined by the phantom analysis was β350. Regarding patient data, there was no clear trend of image quality improvement using BPL. There was no correlation between SUV max  increase with BPL and either SUV or hypoxic volume from the initial OSEM reconstruction. Hypoxic volume obtained by a SUV > 1.4 thresholding was not impacted by the BPL reconstruction parameter.
CONCLUSION


BPL allows a significant increase in quantitative parameters and contrast without significantly improving the lesion detectability or image quality. The variation in hypoxic volume by BPL depends on the method used but SUV > 1.4 thresholding seems to be the more robust method, not impacted by the reconstruction method (BPL or OSEM).
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02490696. Registered 1 June 2015.",2020,The phantom and patient datasets showed a significant increase of quantitative parameters using BPL compared to OSEM but had no impact on detectability.,"['Twenty patients with lung neoplasia were included', 'Images of low-contrasted (SBR = 3) micro-spheres of Jaszczak phantom were acquired']","['Bayesian penalized likelihood algorithm (Q.Clear®', 'Bayesian penalized likelihood (BPL) reconstruction algorithm', 'OSEM']","['detectability', 'lesion detectability or image quality', 'Hypoxic volume', 'quantitative parameters', 'SUV max , SUV mean,  and hypoxic volumes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",20.0,0.0261638,The phantom and patient datasets showed a significant increase of quantitative parameters using BPL compared to OSEM but had no impact on detectability.,"[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Texte', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Gouel', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Thureau', 'Affiliation': 'QuantIF-LITIS EA4108, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Lequesne', 'Affiliation': 'Clinical Research Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Barres', 'Affiliation': 'Nuclear Medicine Department, Jean Perrin Cancer Center, Clermont-Ferrand, France.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Edet-Sanson', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Decazes', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vera', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Hapdey', 'Affiliation': 'Nuclear Medicine Department, Henri Becquerel Cancer Center, Rouen, France. sebastien.hapdey@chb.unicancer.fr.'}]",EJNMMI physics,['10.1186/s40658-020-00300-3']
553,32396409,"A Prospective Randomized Controlled Trial of Irrigation ""Bag Squeeze"" to Manage Pain for Patients Undergoing Flexible Cystoscopy.","PURPOSE


Determine if ""bag-squeeze"" technique decreases pain during flexible cystoscopy in men.
METHODS AND MATERIALS


A single center, prospective, double-blinded randomized controlled trial recruiting 200 consenting participants who were ambulatory, outpatient males who had undergone a prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the ""bag-squeeze"" (group A) or the sham bag-squeeze procedure (group B). Following the cystoscopy, participants completed a pain questionnaire: visual analogue scale. Differences in mean pain score between groups were evaluated using a Students T test with two-sided alpha of 0.05.
RESULTS


Two hundred patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients, 97 were randomized to bag-squeeze (group A) and 93 to sham bag-squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively. (p<0.005).
CONCLUSION


This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.Patient Summary:Squeezing the irrigation bag during a flexible cystoscopy improves pain perception by males and we recommend this to be the standard of care.",2020,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","['Ten participants were ineligible because they required secondary procedures', 'Two hundred patients', 'Patients Undergoing Flexible Cystoscopy', '200 consenting participants who were ambulatory, outpatient males who had undergone a prior cystoscopy and were not expected to require any secondary procedures', '190 eligible patients, 97 were randomized to', 'men', 'Men with prior urethral stricture or bladder neck contracture']","['bag-squeeze', 'flexible cystoscopy', 'Irrigation ""Bag Squeeze', 'bag-squeeze"" technique', 'cystoscopy with the ""bag-squeeze"" (group A) or the sham bag-squeeze procedure', 'irrigation bag during a flexible cystoscopy']","['mean pain score', 'pain questionnaire: visual analogue scale', 'pain perception', 'pain']","[{'cui': 'C0445275', 'cui_str': 'Secondary procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",200.0,0.261447,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","[{'ForeName': 'Mohamad Baker', 'Initials': 'MB', 'LastName': 'Berajoui', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ishan', 'Initials': 'I', 'LastName': 'Aditya', 'Affiliation': 'University of Toronto, School of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'JaimeOmar', 'Initials': 'J', 'LastName': 'Herrera-Caceres', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Qaoud', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lajkosz', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ajib', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Glase', 'Affiliation': 'Department of Neurosciences, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hersey', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Miran', 'Initials': 'M', 'LastName': 'Kenk', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hamilton', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Zlotta', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Perlis', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001139']
554,32396412,A novel CpG-methylation-based nomogram predicts survival in colorectal cancer.,"Aberrant DNA methylation is significantly associated with the prognosis of patients with colorectal cancer (CRC). Therefore, the aim of this study was to develop a CpG-methylation-based nomogram for prognostic prediction in CRC. First, 378 CRC patients with methylation data from The Cancer Genome Atlas were randomly divided into training cohort (n = 249) and test cohort (n = 129). A multistep screening strategy was performed to identify six CpG sites that were significantly associated with overall survival in the training cohort. Then, Cox regression modelling was performed to construct a prognostic signature based on the candidate CpG sites. The six-CpG signature successfully separated patients into high-risk and low-risk groups in both training and test cohorts, and its performance was superior to that of previously published methylation markers ( P  < 0.05). Furthermore, we established a prognostic nomogram incorporating this signature, TNM stage, and age. The nomogram exhibited better prediction for overall survival in comparison with the three independent prognostic factors in the training cohort (C-index: 0.798 vs 0.620 to 0.737;  P  < 0.001). In the test cohort, the performance of nomogram was also superior to that of the three independent prognostic factors (C-index: 0.715 vs 0.590 to 0.665;  P  < 0.05). Meanwhile, the calibration curves for survival probability showed good agreement between prediction by nomogram and actual observation in both training and test cohorts. Together, the present study provides a novel CpG-methylation-based nomogram as a promising predictor for overall survival of CRC patients, which may help improve decision-making regarding the personalized treatments of patients with CRC.",2020,"The six-CpG signature successfully separated patients into high-risk and low-risk groups in both training and test cohorts, and its performance was superior to that of previously published methylation markers ( P  < 0.05).","['patients with CRC', '378 CRC patients with methylation data from The Cancer Genome Atlas', 'colorectal cancer', 'patients with colorectal cancer (CRC']",[],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",378.0,0.037205,"The six-CpG signature successfully separated patients into high-risk and low-risk groups in both training and test cohorts, and its performance was superior to that of previously published methylation markers ( P  < 0.05).","[{'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Danwen', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, Zhongnan Hospital of Wuhan University, Clinical Medical Research Center of Peritoneal Cancer of Wuhan, Key Laboratory of Tumor Biological Behavior of Hubei Province, Clinical Cancer Study Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Maohui', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Department of Gastrointestinal Surgery, Zhongnan Hospital of Wuhan University, Clinical Medical Research Center of Peritoneal Cancer of Wuhan, Key Laboratory of Tumor Biological Behavior of Hubei Province, Clinical Cancer Study Center of Hubei Province, Wuhan, China.'}, {'ForeName': 'Xiongzhi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}]",Epigenetics,['10.1080/15592294.2020.1762368']
555,32396474,Factors Associated with HIV Disclosure Status Among iENGAGE Cohort of New to HIV Care Patients.,"HIV disclosure is an important behavior with implications for HIV treatment and prevention but understudied among new to HIV care patients who face unique challenges adjusting to a new diagnosis. This study evaluated the factors associated with HIV disclosure status and patterns of HIV disclosure among new to HIV care patients. A cross-sectional study was conducted evaluating the iENGAGE (integrating ENGagement and Adherence Goals upon Entry) cohort. Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016. The primary and secondary outcomes included HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure), respectively. Logistic and Multinomial Logistic Regression were used to evaluate the association of participant factors with HIV disclosure and patterns of HIV disclosure, respectively. Of 371 participants, the average age was 37 ± 12 years, 79.3% were males, and 62.3% were African Americans. A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers. In multivariable regression, black race, emotional support, and unmet needs predicted any HIV and broad disclosure, whereas males, emotional support, active coping, and acceptance were associated with selective disclosure. Interventions to promote early disclosure should focus on coping strategies and unmet needs, particularly among black and male people living with HIV initiating care.",2020,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","['Of 371 participants, the average age was 37\u2009±\u200912 years, 79.3% were males, and 62.3% were African Americans', 'Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016', 'black and male people living with HIV initiating care', 'HIV care patients']",[],"['HIV status', 'males, emotional support, active coping, and acceptance', 'HIV disclosure status and patterns of HIV disclosure', 'HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure', 'HIV Disclosure Status']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]",,0.0384234,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","[{'ForeName': 'Riddhi A', 'Initials': 'RA', 'LastName': 'Modi', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Willig', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Andrew O', 'Initials': 'AO', 'LastName': 'Westfall', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rivet', 'Initials': 'R', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Education, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Martin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Raper', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeanne C', 'Initials': 'JC', 'LastName': 'Keruly', 'Affiliation': 'Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zinski', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Crane', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}]",AIDS patient care and STDs,['10.1089/apc.2019.0271']
556,32396510,[Surgical Treatment of Clavicle Midshaft Fractures - Prospective Randomized Trial].,"PURPOSE OF THE STUDY Comparison of the outcomes of clavicle midshaft fractures using two different surgical techniques, namely intramedullar osteosynthesis using elastic stable intramedullary nailing (ESIN) with medial cap and extramedullar plate osteosynthesis. MATERIAL AND METHODS The prospective randomized trial was conducted at the Department of Trauma Surgery of the Department of Surgery of the University Hospital Hradec Králové in the Czech Republic at the Level I Trauma Center between 2014 and 2018 and compared two types of osteosynthesis of clavicle midshaft fractures. 60 patients were enrolled in the study and were randomly assigned to one of the two groups. In Group 1, the participants were treated by ESIN and in Group 2 by plate osteosynthesis. The operative technique was chosen by the sealed envelope method. According to the randomization list created by a specialised statistical company, every envelope was marked with a unique number and contained the intramedullar ""IM"", or the extramedullar ""EM"" sign. RESULTS The observation of statistical parameters by unpaired t test detected significantly different results: a shorter incision using ESIN osteosynthesis (median = 2.9 cm) compared with plate osteosynthesis (median 14 cm, p < 0.001), longer X-ray exposure using ESIN (median = 325 s) compared with plate osteosynthesis (median = 16.5 s, p < 0.001) and radiation dose using ESIN (median = 996 cGy/cm2) compared with plate osteosynthesis (median = 4 cGy/cm2, p < 0.001). The difference in other parameters such as operative time, in-patient length of stay and duration of rehabilitation was not statistically significant. The time to clavicle fracture repair was comparable in both the surgical arms, i.e. approximately 3 months. Also, the duration of incapacity for work was not statistically different. Functional Constant Shoulder Score at a one-year followup is comparable in both the two arms (p = 0.268). The Dunn s method necessitated a longer operative time when treating multifragmental midshaft clavicle fracture by the ESIN compared to simple fractures. No statistically significant difference was detected in the operative time of different procedures and in the number of bone fragments. The functional outcome was excellent in 25 patients (83%) in each method. DISCUSSION Most midshaft clavicle fractures are still treated non-operatively with good outcomes. The indication for surgical treatment is the dislocation of fragments greater than the width of the clavicle bone, the shortening of fragments greater than 2 cm and the angulation of more than 30°. Patient after operative treatment profits from bone healing by absolute or relative stability. In recent years, new intramedullar techniques other than open plate reduction and fixation have emerged. For example, elastic stable intramedullary titan nailing. Both the methods are full-fledged without functional differences in longterm follow-up. CONCLUSIONS We consider the intramedullar osteosynthesis to be the most appropriate surgical approach for simple midshaft spiral, oblique and transverse clavicle fractures and also wedge oblique fractures. Plate osteosynthesis is useful for all types of fractures. No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used. The determining factor for the received radiation dose is solely the surgical method, not the type of fracture. There is a statistically significant difference in shorter X-ray exposure and lower received radiation dose in plate fixation and reduction. The complication rate is comparable in both the methods. Key words: elastic stable intramedullary nailing, midshaft clavicle fracture, ESIN, TEN, titan elastic nail, clavicle plate osteosynthesis, 3.5 LCP clavicular plate, indication for midshaft fracture treatment.",2020,"No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used.","['Department of Trauma Surgery of the Department of Surgery of the University Hospital Hradec Králové in the Czech Republic at the Level', '60 patients were enrolled in the study']","['surgical techniques, namely intramedullar osteosynthesis using elastic stable intramedullary nailing (ESIN) with medial cap and extramedullar plate osteosynthesis', 'ESIN', 'elastic stable intramedullary titan nailing', 'Plate osteosynthesis']","['operative time, in-patient length of stay and duration of rehabilitation', 'bone healing by absolute or relative stability', 'rate of bone healing', 'Functional Constant Shoulder Score', 'duration of incapacity for work', 'time to clavicle fracture repair', 'operative time', 'complication rate', 'number of bone fragments', 'shorter X-ray exposure']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0242756', 'cui_str': 'Titan'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3698366', 'cui_str': 'Bone fragment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",60.0,0.0237448,"No statistically significant difference in the rate of bone healing was observed after intramedullar or extramedullar ostesynthesis, but multifragmentary fractures healed faster when plate osteosynthesis was used.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Šimek', 'Affiliation': 'Katedra vojenské chirurgie, Fakulta vojenského zdravotnictví, Univerzita obrany v Brně, Hradec Králové.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Šmejkal', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frank', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hyšpler', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dědek', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Páral', 'Affiliation': ''}]",Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca,[]
557,32396966,Kinesiotaping Diminishes Delayed Muscle Soreness but does not Improve Muscular Performance.,"This study aimed at determining the effect of kinesio-taping (KT) on muscle performance and delayed onset muscle soreness (DOMS) after exercise induced muscle damaged. Sixty-six healthy men volunteered to participate (age:18-25 y/o), who performed 200 isokinetic lengthening contractions of the dominant quadriceps. Then subjects were randomized to either control (no treatment), sham (no tape tension), or KT (10% tape tension) groups. Muscle performance was assessed by peak torque and muscular work during maximal isometric and concentric isokinetic contractions. DOMS intensity was assessed using a visual analog scale. Measurements were taken pre-exercise (Pre), 48 h and 96 h post-exercise. Repeated measures ANOVA was used for comparisons within group, and ANCOVA for comparisons among groups. Muscle damage was confirmed in all participants by an increase in CK activity level (p<0.01). Decrease in isometric and isokinetic peak torque was detected at 48 h in the control and sham groups (p<0.01). Muscular work decreased in all groups at 48 h (p<0.01). No differences between groups were detected in muscular performance variables. Increase in DOMS intensity was determined in all groups at 48 h. Comparisons between groups showed lower DOMS intensity in the KT group at 48 h. KT decreased DOMS intensity perception after exercise-induced muscle damage; however, it did not impact muscular performance.",2020,Decrease in isometric and isokinetic peak torque was detected at 48 h in the control and sham groups (p<0.01).,"['Sixty-six healthy men volunteered to participate (age:18-25\u2009y/o), who performed 200 isokinetic lengthening contractions of the dominant quadriceps']","['control (no treatment), sham (no tape tension), or KT', 'kinesio-taping (KT']","['CK activity level', 'muscle performance and delayed onset muscle soreness (DOMS', 'isometric and isokinetic peak torque', 'Muscle performance', 'Muscle damage', 'peak torque and muscular work during maximal isometric and concentric isokinetic contractions', 'DOMS intensity', 'muscular performance variables', 'Muscular work', 'Delayed Muscle Soreness', 'DOMS intensity perception', 'Muscular Performance']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",66.0,0.0608429,Decrease in isometric and isokinetic peak torque was detected at 48 h in the control and sham groups (p<0.01).,"[{'ForeName': 'Maria Alejandra', 'Initials': 'MA', 'LastName': 'Camacho', 'Affiliation': 'Physical Therapy School, Universidad Industrial de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Herrera', 'Affiliation': 'Physical Therapy School, Universidad Industrial de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Jose Angelo', 'Initials': 'JA', 'LastName': 'Barela', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista Julio de Mesquita Filho, Instituto de Biociência Campus de Rio Claro, Rio Claro, Brazil.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Carolina Delgado-Diaz', 'Affiliation': 'Physical Therapy School, Universidad Industrial de Santander, Bucaramanga, Colombia.'}]",International journal of sports medicine,['10.1055/a-1088-5223']
558,32396972,Effect of Sodium Bicarbonate Mouth Wash on Salivary pH and Interleukin-1β Levels among Smokers.,"OBJECTIVE


Smoking induces changes in salivary pH and inflammatory biomarker levels associated with oral diseases. This study examined the effect of alkaline oral rinse to modify this effect of smoking on salivary study parameters.
MATERIALS AND METHODS


A double-blind randomized controlled trial (RCT) on systemically healthy smokers was conducted. A total of 78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria. An alkaline mouthwash was provided to the intervention group and a placebo to control group. Salivary pH and inflammatory biomarker interleukin (IL)-1β levels were evaluated at baseline and at follow-up (14 ± 2 days).
STATISTICAL ANALYSIS


Chi-squared test, independaent  t -test, and paired  t -test were used to observe the changes in parameters among and between groups before and after intervention using SPSS v16 with a significance level of  p ≤0.050.
RESULTS


Sixty eight salivary samples were analyzed. All study parameters of the study sample were statistically insignificant between both intervention and control groups at baseline. pH level was 6.56 ± 0.53 at baseline and 6.62 ± 0.45 at follow-up in the intervention group; respective values for control group were 6.70 ± 0.36 and 6.83 ± 0.44 and the changes were not significant ( p ≥0.071). IL-1β level was 9.39 ± 10.23 pg/µL at baseline and 5.40 ± 6.62 pg/µL at a follow-up in the intervention group and the change was significant ( p  = 0.001); respective values for the control group were 10.63 ± 11.50, and 9.33 ± 11.73 and the difference was nonsignificant ( p  = 0.076).
CONCLUSION


This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.",2020,This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.,"['78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria', 'systemically healthy smokers', 'Smokers']","['alkaline oral rinse', 'Sodium Bicarbonate Mouth Wash', 'sodium bicarbonate mouth rinse', 'placebo']","['IL)-1β levels', 'Salivary pH and inflammatory biomarker interleukin', 'IL-1β levels', 'IL-1β level', 'Salivary pH and Interleukin-1β Levels', 'pH level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1304686', 'cui_str': 'pH - finding'}]",78.0,0.107795,This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.,"[{'ForeName': 'Syed Ameer', 'Initials': 'SA', 'LastName': 'Hamza', 'Affiliation': 'Department of Oral Medicine, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Wahid', 'Affiliation': 'Department of Pathology, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Afzal', 'Affiliation': 'Department of Immunology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Asif', 'Affiliation': 'Department of Periodontology, University Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Mian Farrukh', 'Initials': 'MF', 'LastName': 'Imran', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Zohaib', 'Initials': 'Z', 'LastName': 'Khurshid', 'Affiliation': 'Department of Prosthodontics and Dental Implantology, College of Dentistry, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia.'}, {'ForeName': 'Syed Akhtar Hussain', 'Initials': 'SAH', 'LastName': 'Bokhari', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia.'}]",European journal of dentistry,['10.1055/s-0040-1709896']
559,32397013,Comparison of Steroid Treatment with and without Hyperbaric Oxygen Therapy for Idiopathic Sudden Sensorineural Hearing Loss.,"Background and Objectives


In this study, we compared the outcomes of patients with idiopathic sudden sensorineural hearing loss who underwent steroid treatment with or without hyperbaric oxygen (HBO) therapy and were followed-up in our clinic.
Subjects and Methods


Patients were divided into two groups according to their treatment regimen. Steroid group received intravenous 1 mg/kg methylprednisolone which was due to be completed in 2-3 weeks with decreasing doses, and five doses of 0.5 mL intratympanic dexamethasone. Steroid+HBO group received the same steroid treatment with the addition of HBO therapy. The audiologic results of both treatment groups were compared after considering the patients' risk factors.
Results


There was no significant difference between the steroid and Steroid+HBO groups in terms of hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss. Hearing gain was similar when evaluated by audiogram type and admission time in both treatment groups.
Conclusions


We found that the addition of HBO therapy to systemic plus intratympanic steroid treatment did not affect hearing gain at all degrees of hearing loss in this study. Furthermore, audiogram type and admission time did not affect hearing gain between the two groups.",2020,"There was no significant difference between the steroid and Steroid+HBO groups in terms of hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss.","['Idiopathic Sudden Sensorineural Hearing Loss', 'Subjects and Methods\n\n\nPatients', 'patients with idiopathic sudden sensorineural hearing loss who underwent']","['steroid treatment with or without hyperbaric oxygen (HBO) therapy', 'dexamethasone', 'Steroid+HBO', 'Steroid Treatment with and without Hyperbaric Oxygen Therapy', 'intravenous 1 mg/kg methylprednisolone']","['audiogram type and admission time', 'Furthermore, audiogram type and admission time', 'hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss', 'Hearing gain', 'hearing gain', 'hearing loss']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0018786', 'cui_str': 'Hearing examination'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}]",,0.0292978,"There was no significant difference between the steroid and Steroid+HBO groups in terms of hearing gain and degree of recovery, both at all degrees of hearing loss, and in severe and profound hearing loss.","[{'ForeName': 'Abitter', 'Initials': 'A', 'LastName': 'Yücel', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Konya Health Application and Research Center, University of Health Sciences Turkey, Konya, Turkey.'}, {'ForeName': 'Yaşar', 'Initials': 'Y', 'LastName': 'Özbuğday', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Konya Training and Research Hospital, University of Health Sciences Turkey, Konya, Turkey.'}]",Journal of audiology & otology,['10.7874/jao.2019.00486']
560,32397081,Acute Effects of Aerobic Exercise on Cognitive Attention and Memory Performance: An Investigation on Duration-Based Dose-Response Relations and the Impact of Increased Arousal Levels.,"Current evidence indicates that acute aerobic exercise might increase domain-specific cognitive performance. However, only a small number of studies deduced the impact on lower and higher cognitive functions systematically or analyzed dose-response relationships and the underlying mechanisms. This study aimed to expose the dose-response relationships by investigating the influence of exercise duration on subjective and objective arousal, cognitive attention and visual recognition memory tasks. Nineteen participants (eight female; 25.69 ± 3.11 years) were included in a randomized, three-armed intervention study in a cross-over design. The participants completed three different interventions consisting of either 15, 30 or 45 min of cycling at 60-70% VO 2 max. Arousal and cognitive measurements were taken before and immediately after (<2 min) exercise. All three interventions led to significant but comparable effects on self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE) ( p  < 0.05). Analysis of variance (ANOVA) indicated significant effects of exercise duration on visual recognition memory accuracy. Reaction times for higher and lower cognitive tasks did not change after exercise. Fifteen minutes of aerobic exercise was feasible to induce beneficial changes in self-perceived arousal. Processing speed of visual recognition memory and attention remained unaltered. Exercise exceeding fifteen minutes seemed to negatively impact visual recognition memory accuracy.",2020,"All three interventions led to significant but comparable effects on self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE) ( p  < 0.05).",['Nineteen participants (eight female; 25.69 ± 3.11 years'],"['Aerobic Exercise', 'aerobic exercise']","['Cognitive Attention and Memory Performance', 'self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE', 'Arousal and cognitive measurements', 'subjective and objective arousal, cognitive attention and visual recognition memory tasks', 'visual recognition memory accuracy', 'domain-specific cognitive performance', 'Reaction times for higher and lower cognitive tasks']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",19.0,0.17255,"All three interventions led to significant but comparable effects on self-perceived arousal, heart rate (HR) and rating of perceived exertion (RPE) ( p  < 0.05).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hacker', 'Affiliation': 'Department of Sports Medicine, Institute of Psychology and Sports Sciences, Goethe University, 60487 Frankfurt, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, 60590 Frankfurt, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Institute of Psychology and Sports Sciences, Goethe University, 60487 Frankfurt, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Engeroff', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University, 60590 Frankfurt, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9051380']
561,31110098,Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials.,"OBJECTIVES


(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.
DESIGN


Risk-interval design SETTING: Three randomised controlled trials conducted in Europe.
PARTICIPANTS


A total of 5026 healthy 2-month-old to 15-month-old infants.
INTERVENTIONS


4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.
OUTCOME MEASURES


Primary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.
RESULTS


Compared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%-49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.
CONCLUSIONS


The cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.
TRIALS REGISTRATION NUMBER


NCT00657709, NCT00847145, NCT00721396 and NCT02712177; Pre-results.",2019,Co-administration reduced AEFI risk by 4%-49% with the greatest impact among infants with prior AEFI(s).,['A total of 5026 healthy 2-month-old to 15-month-old infants'],"['co-administration of four-component meningococcal serogroup B vaccine (4CMenB', 'immunisation with four-component meningococcal serogroup B vaccine (4CMenB', '4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine']","['Adverse events', 'overall incidence of fever', 'Fever recurrence risk', 'Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site', 'moderate/severe fevers', 'AEFI risk', 'cumulative risk of AEFI', 'incidence of 4CMenB injection site tenderness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2721654', 'cui_str': 'Adverse event following immunisation'}, {'cui': 'C0863083', 'cui_str': 'Injection site tenderness'}]",5026.0,0.134229,Co-administration reduced AEFI risk by 4%-49% with the greatest impact among infants with prior AEFI(s).,"[{'ForeName': 'Joseline Guetsop', 'Initials': 'JG', 'LastName': 'Zafack', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bureau', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Danuta M', 'Initials': 'DM', 'LastName': 'Skowronski', 'Affiliation': 'Communicable Diseases and Immunization Service, British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'De Serres', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec City, Quebec, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-026953']
562,32399899,Forced Expiratory Flow (FEF 25-75% ) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis.,"INTRODUCTION


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


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


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


In pediatric patients, FEF 25-75%  may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV 1  and should be evaluated as an additional lung function measurement.",2020,"Tiotropium Respimat ®  consistently improved FEF 25-75%  and FEV 1  versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant.","['Change from baseline in trough FEF 25-75%  and trough', 'pediatric patients with asthma', 'children (aged 6-11\xa0years) and adolescents (aged 12-17\xa0years) with symptomatic moderate (VivaTinA-asthma ®  and PensieTinA-asthma ® ) and mild (CanoTinA-asthma ®  and RubaTinA-asthma ® ) asthma', 'children with asthma', 'A total of 1590 patients were included in the analysis', 'Children and Adolescents with Symptomatic Asthma Receiving']","['placebo', 'placebo Respimat ®', 'Tiotropium', 'tiotropium']","['bronchodilator responsiveness', 'forced expiratory volume', 'Forced Expiratory Flow', 'FEF', 'Forced expiratory flow']","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}]",1590.0,0.229548,"Tiotropium Respimat ®  consistently improved FEF 25-75%  and FEV 1  versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant.","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, The Breathing Institute, Children's Hospital of Colorado, University of Colorado School of Medicine, Aurora, CO, USA. stanley.szefler@childrenscolorado.org.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Goldstein', 'Affiliation': 'Allergy and Asthma Care of Long Island, Rockville Centre, NY, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vogelberg', 'Affiliation': 'University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Bensch', 'Affiliation': 'Allergy, Immunology and Asthma Medical Group, Inc., Stockton, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Given', 'Affiliation': 'Allergy and Respiratory Center, Canton, OH, USA.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Jugovic', 'Affiliation': 'TA Respiratory Diseases/Biosimilars Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'TA Respiratory Diseases/Biosimilars Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty Ltd, Sydney, NSW, Australia.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sigmund', 'Affiliation': 'Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG., Biberach an der Riss, Germany.'}, {'ForeName': 'Eckard H', 'Initials': 'EH', 'LastName': 'Hamelmann', 'Affiliation': 'Klinik für Kinder- Und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Klinikum Bethel EvKB, Bielefeld, Germany.'}]",Pulmonary therapy,['10.1007/s41030-020-00117-6']
563,32400000,"A Multicenter Randomized Three-Arm Phase II Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) with Leuprolide + Letrozole, and (3) Everolimus + EDT in Patients with Unresectable Fibrolamellar Carcinoma.","LESSONS LEARNED


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


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


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


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


Neither EDT nor mTOR inhibition improved outcomes in FLC. Other treatment strategies are needed.",2020,"Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort.","['Patients with Unresectable Fibrolamellar Carcinoma', 'advanced fibrolamellar carcinoma', 'Twenty-eight patients were enrolled', 'Patients']","['Everolimus, (2) Estrogen Deprivation Therapy (EDT) with Leuprolide + Letrozole, and (3) Everolimus + EDT', 'everolimus/letrozole/leuprolide', 'Estrogen deprivation therapy with letrozole and leuprolide, alone or in combination with the mTOR inhibitor, everolimus', 'everolimus), arm B (letrozole/leuprolide; estrogen deprivation therapy [EDT]), or arm C (everolimus/letrozole/leuprolide', 'FLC']","['Stable disease', 'overexpression of mTOR and S6 kinase', 'elevated aspartate transaminase', 'vomiting', 'anemia', 'nausea', 'Median overall survival (OS', 'Grade 3 adverse events', ""progression-free survival (PFS) at 6 months (PFS6) assessed using a Simon's minimax two-stage design, hypothesizing an improvement in PFS6"", 'alanine transaminase (ALT; 36%), and alkaline phosphatase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334287', 'cui_str': 'Hepatocellular carcinoma, fibrolamellar'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0334287', 'cui_str': 'Hepatocellular carcinoma, fibrolamellar'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0073337', 'cui_str': 'Ribosomal Protein S6 Kinase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0220989', 'cui_str': 'Acquired partial lipodystrophy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}]",28.0,0.0597627,"Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort.","[{'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'El Dika', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaQuaglia', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Allison F', 'Initials': 'AF', 'LastName': ""O'Neill"", 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ly', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Ang', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gordan', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0367']
564,32400032,Six-month breastfeeding maintenance after a self-efficacy promoting programme: an exploratory trial.,"BACKGROUND


Breastfeeding care plays a fundamental role in establishing breastfeeding and longer duration after discharge. Practices though vary among professionals involved and are often inconsistent with good practices recommended, being a threat to women's breastfeeding self-efficacy. Breastfeeding self-efficacy is considered a predictor for successful breastfeeding and a significant variable amenable to intervention for promoting lactation AIM: To evaluate the efficacy, feasibility and acceptability of a new breastfeeding self-efficacy promoting programme (SIALAC) on 6-month breastfeeding maintenance.
METHODS


In this exploratory multi-centre controlled trial, participants were allocated into control and intervention groups sequentially. Professionals in charge of the treatment groups were trained in between, with an especial focus on reducing practice variability. Control and intervention group women received usual care, and the intervention group received in addition SIALAC, a three-stage breastfeeding self-efficacy promoting programme. Primary outcome was breastfeeding maintenance up to 6 months analysed by Kaplan-Meier and Cox proportional hazard regression analysis. Student's t-test or chi-square tests were also used for continuous and categorical variables. Data on breastfeeding status and breastfeeding self-efficacy were collected at baseline, and 4, 8 and 24 weeks after birth.
RESULTS


From May 2014 through November 2015, participants were enrolled. The sample consisted of 112 women. No relevant socio-demographic or obstetric difference was found between groups. The intervention achieved a significant difference between groups in breastfeeding survival (X 2   = 4.94, p = 0.026). Six-month breastfeeding maintenance was significantly higher in the intervention group (67% vs. 55%; X 2   = 5.384, p = 0.020). Breastfeeding dropout in the control group was 3.3 (CI 1.1, 10.1) times higher than that of the intervention group at 6 months. Breastfeeding self-efficacy scores were higher in the intervention group although without significant statistical difference. The programme showed good acceptability.
CONCLUSION


Breastfeeding self-efficacy promoting programme SIALAC was beneficial in fostering 6-month breastfeeding survival. Full-scale trial should consider feasibility-related issues identified.",2020,"The intervention achieved a significant difference between groups in breastfeeding survival (X 2   = 4.94, p = 0.026).","['112 women', 'From May 2014 through November 2015, participants were enrolled']","['usual care, and the intervention group received in addition SIALAC']","['good acceptability', 'breastfeeding survival', 'breastfeeding status and breastfeeding self-efficacy', 'relevant socio-demographic or obstetric difference', 'Breastfeeding dropout', 'breastfeeding maintenance up to 6 months analysed by Kaplan-Meier and Cox proportional hazard regression analysis', 'Breastfeeding self-efficacy scores']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0516831', 'cui_str': 'Breastfeeding maintenance'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0034980', 'cui_str': 'Analysis, Regression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",112.0,0.0569016,"The intervention achieved a significant difference between groups in breastfeeding survival (X 2   = 4.94, p = 0.026).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Antoñanzas-Baztán', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Belintxon', 'Affiliation': 'ImPuLS Research Group, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Marín-Fernández', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Redín-Areta', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Agurtzane', 'Initials': 'A', 'LastName': 'Mujika', 'Affiliation': 'ImPuLS Research Group, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pumar-Méndez', 'Affiliation': 'ImPuLS Research Group, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lopez-Dicastillo', 'Affiliation': 'ImPuLS Research Group, University of Navarra, Pamplona, Spain.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12870']
565,32397192,Effects of a Multicomponent Exercise Program in Physical Function and Muscle Mass in Sarcopenic/Pre-Sarcopenic Adults.,"This study aimed to assess the effects of a multicomponent exercise program on physical function and muscle mass in older adults with sarcopenia or pre-sarcopenia. Moreover, we aim to standardize the exercise program for easy incorporation in the daily life of community-dwelling older adults as a secondary outcome. A single-blind randomized controlled trial was conducted with individuals (≥60 years) who had sarcopenia or pre-sarcopenia ( n  = 72). Participants were randomly assigned to the exercise and control groups. The exercise program consisted of 12 weekly 60-minute sessions that included resistance, balance, flexibility, and aerobic training. Outcome measures were physical function and muscle mass. Assessments were conducted before and immediately after the intervention. Among the 72 participants (mean age: 75.0 ± 6.9 years; 70.8% women), 67 (93.1%) completed the trial. Group-by-time interactions on the chair stand ( p  = 0.02) and timed ""up and go"" ( p  = 0.01) tests increased significantly in the exercise group. Although the exercise group showed a tendency to prevent loss of muscle mass, no significant interaction effects were observed for cross-sectional muscle area and muscle volume. The 12-week exercise program improved physical function in the intervention group. Although it is unclear whether the program is effective in increasing muscle mass, a multicomponent exercise program would be an effective treatment for physical function among older adults with sarcopenia.",2020,"Group-by-time interactions on the chair stand ( p  = 0.02) and timed ""up and go"" ( p  = 0.01) tests increased significantly in the exercise group.","['72 participants (mean age: 75.0 ± 6.9 years; 70.8% women), 67 (93.1%) completed the trial', 'community-dwelling older adults', 'older adults with sarcopenia', 'Sarcopenic/Pre-Sarcopenic Adults', 'individuals (≥60 years) who had sarcopenia or pre-sarcopenia ( n  = 72', 'older adults with sarcopenia or pre-sarcopenia']","['Multicomponent Exercise Program', 'multicomponent exercise program', 'exercise program']","['physical function', 'physical function and muscle mass', 'Physical Function and Muscle Mass', 'loss of muscle mass']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",72.0,0.0366604,"Group-by-time interactions on the chair stand ( p  = 0.02) and timed ""up and go"" ( p  = 0.01) tests increased significantly in the exercise group.","[{'ForeName': 'Hyuma', 'Initials': 'H', 'LastName': 'Makizako', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Tomioka', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Wada', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Kiyama', 'Affiliation': 'Department of Physical Therapy, School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Tsutsumimoto', 'Affiliation': 'Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu 474-5811, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Ohishi', 'Affiliation': 'Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima 890-8520, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Kiuchi', 'Affiliation': 'Graduate School of Health Sciences, Kagoshima University, Kagoshima 890-8544, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Kubozono', 'Affiliation': 'Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima 890-8520, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Takenaka', 'Affiliation': 'Tarumizu Municipal Medical Center Tarumizu Chuo Hospital, Kagoshima 891-2124, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9051386']
566,30467342,Genetic variation in CRHR1 is associated with short-term respiratory response to corticosteroids in preterm infants at risk for bronchopulmonary dysplasia.,"BACKGROUND


Bronchopulmonary dysplasia (BPD) is an orphan disease and advances in prevention and treatment are lacking. The clinical efficacy of systemic corticosteroid therapy to reduce the severity of lung disease and BPD is highly variable. Our objective was to assess whether candidate SNPs in corticosteroid metabolism and response genes are associated with short-term phenotypic response to systemic corticosteroids in infants at high risk for BPD.
METHODS


Pharmacogenetic analysis of data from a large randomized controlled trial (TOLSURF) in infants treated with dexamethasone or hydrocortisone using multivariate linear regression. The primary outcome was a change in respiratory severity score (RSS, mean airway pressure x FiO2) at day 7 of corticosteroid treatment.
RESULTS


rs7225082 in the intron of CRHR1 is significantly associated with the magnitude of decrease in RSS 7 days after starting treatment with systemic corticosteroid (meta-analysis P = 2.8 × 10 -4 ). Each T allele at rs7225082 is associated with a smaller absolute change in RSS at day 7, i.e., less response to systemic corticosteroids.
CONCLUSIONS


Genetic variability is associated with corticosteroid responsiveness with regard to respiratory status in preterm infants. Identification of genetic markers of corticosteroid responsiveness may allow for therapeutic individualization, with the goal of optimizing the risk-to-benefit ratio for an individual child.",2019,"Each T allele at rs7225082 is associated with a smaller absolute change in RSS at day 7, i.e., less response to systemic corticosteroids.
","['preterm infants at risk for bronchopulmonary dysplasia', 'infants at high risk for BPD', 'preterm infants', 'Bronchopulmonary dysplasia (BPD']","['dexamethasone or hydrocortisone', 'systemic corticosteroid therapy']","['severity of lung disease and BPD', 'RSS, mean airway pressure x FiO2', 'change in respiratory severity score']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",,0.463213,"Each T allele at rs7225082 is associated with a smaller absolute change in RSS at day 7, i.e., less response to systemic corticosteroids.
","[{'ForeName': 'Tamorah', 'Initials': 'T', 'LastName': 'Lewis', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, MO, USA. trlewis@cmh.edu.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Truog', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Norberg', 'Affiliation': ""Children's Mercy Hospital, Department of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Ballard', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric research,['10.1038/s41390-018-0235-1']
567,30661082,Dried blood spot compared to plasma measurements of blood-based biomarkers of brain injury in neonatal encephalopathy.,"BACKGROUND


Data correlating dried blood spots (DBS) and plasma concentrations for neonatal biomarkers of brain injury are lacking. We hypothesized that candidate biomarker levels determined from DBS can serve as a reliable surrogate for plasma levels.
METHODS


In the context of a phase II multi-center trial evaluating erythropoietin for neuroprotection in neonatal encephalopathy (NE), DBS were collected at enrollment ( < 24 h), day 2, 4, and 5. Plasma was collected with the first and last DBS. The relationship between paired DBS-plasma determinations of brain-specific proteins and cytokines was assessed by correlation and Bland-Altman analyses. For analytes with consistent DBS-plasma associations, DBS-derived biomarker levels were related to brain injury by MRI and 1-year outcomes.
RESULTS


We enrolled 50 newborns with NE. While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations, Bland-Altman plots demonstrated that the methods are not interchangeable, with a 2 to 4-fold error between measurements. No significant relationships were found between DBS levels of TNFα, IL-6, and IL-8 and outcomes.
CONCLUSION


Further work is needed to optimize elution and assay methods before using DBS specimens as a reliable surrogate for plasma levels of candidate brain injury biomarkers in NE.",2019,"While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations,",['50 newborns with NE'],['Dried blood spot'],"['Plasma', 'DBS levels of TNFα, IL-6, and IL-8 and outcomes', 'While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",50.0,0.106799,"While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations,","[{'ForeName': 'An N', 'Initials': 'AN', 'LastName': 'Massaro', 'Affiliation': ""Pediatrics - Division of Neonatology, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA. anguyenm@cnmc.org.""}, {'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'Neurology and Pediatrics, UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Theo K', 'Initials': 'TK', 'LastName': 'Bammler', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'MacDonald', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Pediatrics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Neurology and Pediatrics, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Mayock', 'Affiliation': 'Pediatrics-Division of Neonatology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Neurology and Pediatrics, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA.""}, {'ForeName': 'Krisa', 'Initials': 'K', 'LastName': 'van Meurs', 'Affiliation': 'Pediatrics, Stanford, Palo Alto, CA, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Afsharinejad', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Pediatrics-Division of Neonatology, University of Washington, Seattle, WA, USA.'}]",Pediatric research,['10.1038/s41390-019-0298-7']
568,30769272,Decrease in oxidized high-density lipoprotein is associated with slowed progression of coronary artery calcification: Subanalysis of a prospective multicenter study.,"BACKGROUND AND AIMS


Oxidized high-density lipoprotein (oxHDL) is characterized by reduced anti-inflammatory properties compared with HDL. However, the role of oxHDL in the pathogenesis of coronary artery calcification (CAC), a marker of subclinical atherosclerosis, remains unclear. We prospectively investigated the association between the change in oxHDL and progression of CAC in a substudy of a multicenter study.
METHODS


In the principal study, patients with a CAC score of 1-999 were treated with pitavastatin with/without eicosapentaenoic acid. Measurement of CAC with multidetector-row computed tomography and a blood test were performed at baseline and at the 1-year follow-up. In the principal study, the increase in CAC did not differ among treatment groups. In this substudy, patients were divided into two groups: CAC progression (change in Agatston score of >0) and no CAC progression.
RESULTS


In total, 140 patients were analyzed. The oxHDL level significantly decreased from 167 (132-246) at baseline to 122 (103-149) after treatment (median [25 th -75th percentile], U/ml) (p < 0.001). The annual change in CAC was significantly positively associated with changes in oxHDL (r = 0.17, p = 0.04), triglycerides (r = 0.17, p = 0.04), and high-sensitivity C-reactive protein (r = 0.22, p = 0.01) but was not associated with changes in low-density lipoprotein cholesterol or HDL-cholesterol. Multiple logistic analysis demonstrated that the decrease in oxHDL per 10 U/ml was independently associated with CAC progression (odds ratio, 0.95; 95% confidence interval, 0.90-0.99; p = 0.04).
CONCLUSIONS


The decrease in oxHDL is associated with the attenuation of CAC progression, suggesting that oxHDL is a potential target for atherosclerosis prevention.",2019,"ml was independently associated with CAC progression (odds ratio, 0.95; 95% confidence interval, 0.90-0.99; p = 0.04).
","['patients with a CAC score of 1-999 were treated with', '140 patients were analyzed']","['pitavastatin with/without eicosapentaenoic acid', 'Oxidized high-density lipoprotein (oxHDL']","['triglycerides', 'CAC progression', 'oxHDL level', 'CAC', 'high-sensitivity C-reactive protein', 'low-density lipoprotein cholesterol or HDL-cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",140.0,0.0397192,"ml was independently associated with CAC progression (odds ratio, 0.95; 95% confidence interval, 0.90-0.99; p = 0.04).
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miki', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan. Electronic address: miyoshit@cc.okayama-u.ac.jp.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kotani', 'Affiliation': 'Division of Community and Family Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Kunihisa', 'Initials': 'K', 'LastName': 'Kohno', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Asonuma', 'Affiliation': 'Department of Cardiology, Kasaoka Daichi Hospital, Kasaoka, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sakuragi', 'Affiliation': 'Department of Cardiovascular Medicine, Iwakuni Medical Center, Iwakuni, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Koyama', 'Affiliation': 'Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama, Japan.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2019.01.032']
569,32400245,Analysis on the correlation between Eustachian tube function and outcomes of type I tympanoplasty for chronic suppurative otitis media.,"Background:  The potential influence of Eustachian tube dysfunction (ETD) on the efficacy of tympanoplasty is controversial. Objective:  This study aims to investigate the correlation between Eustachian tube function (ETF) and outcomes of type I tympanoplasty for chronic suppurative otitis media (CSOM). Materials and Methods:  53 patients with CSOM and receiving type I tympanoplasty were divided into a dysfunction group (Eustachian tube score; ETS ≤ 5points) and a normal group (ETS > 5 points) according to their preoperative ETS. During the one-year follow-up, the ETS, hearing results, and eardrum condition of the patients were recorded and analyzed. Results:  The ETS improved significantly from 2.57 (±1.73SD) to 4.68 (±2.00SD), while the mean air-bone gap (ABG) decreased significantly from 20.94 (±9.04SD) dB to 16.43 (±9.06SD) dB in the dysfunction group ( p  < .05). The postoperative ABG showed no significant difference in the two groups. The healing rate of the tympanic membrane was 96.43% in the dysfunction group, and 100% in the normal group. Conclusions and significance:  The ETF was significantly improved after type I tympanoplasty for CSOM combined with ETD, and the postoperative efficacy was not adversely affected. The ETD may not influence the outcomes of type I tympanoplasty for CSOM.",2020,"The healing rate of the tympanic membrane was 96.43% in the dysfunction group, and 100% in the normal group.","['chronic suppurative otitis media', 'chronic suppurative otitis media (CSOM', '53 patients with CSOM and receiving type I tympanoplasty']","['dysfunction group (Eustachian tube score; ETS ≤ 5points) and a normal group (ETS > 5 points) according to their preoperative ETS', 'Eustachian tube dysfunction (ETD', 'Eustachian tube function (ETF']","['mean air-bone gap (ABG', 'healing rate of the tympanic membrane', 'postoperative ABG', 'postoperative efficacy', 'ETF']","[{'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015183', 'cui_str': 'Structure of pharyngotympanic tube'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0271468', 'cui_str': 'Eustachian tube disorder'}, {'cui': 'C0457584', 'cui_str': 'Eustachian tube function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",53.0,0.0205689,"The healing rate of the tympanic membrane was 96.43% in the dysfunction group, and 100% in the normal group.","[{'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}, {'ForeName': 'Jiabing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Graduate School, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1754462']
570,32400274,Blood flow restriction resistance training in a recreationally active person with Parkinson's disease.,"Background : Blood flow restriction (BFR) applied during low intensity resistance training (LIRT) exercise produces hypertrophy and strength gains equivalent to traditional training. The effectiveness of BFR-LIRT on persons with Parkinson Disease (PD) has not been investigated. Objective : To determine the effects of BFR-LIRT on a recreationally active person with PD in regards to function, strength, Restless Leg Syndrome (RLS) and safety. Methods: A single subject, A-B-A design was utilized. Each phase lasted 6 weeks. Outcome measures included: 30-second sit-to-stand; Timed Up and Go (TUG); RLS Questionnaire; 3-RM of Cybex Leg Press (LP); Leg Curl (LC); and Leg Extension (LE) measured every 3 weeks for 18 weeks. The intervention phase (B, weeks 6-12) included four lower extremity resistance exercises (LP, LC, LE, calf presses on the LP) with the addition of BFR. The two standard deviation band method was used to determine significance. Results : All outcome measures except the TUG improved significantly by the end of intervention phase. Conclusion : The combination of BFR with LIRT safely lead to an increase in lower extremity strength and function in a person with PD, while decreasing their RLS (improvement from moderate to mild symptoms) resulting in a better quality of life for the participant.",2020,All outcome measures except the TUG improved significantly by the end of intervention phase.,"[""recreationally active person with Parkinson's disease"", 'persons with Parkinson Disease (PD']","[' : Blood flow restriction (BFR) applied during low intensity resistance training', 'BFR-LIRT', 'LIRT) exercise', 'Blood flow restriction resistance training']","['TUG', 'extremity resistance exercises (LP, LC, LE, calf presses on the LP', 'lower extremity strength and function', '30-second sit-to-stand; Timed Up and Go (TUG); RLS Questionnaire; 3-RM of Cybex Leg Press (LP); Leg Curl (LC); and Leg Extension (LE']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0345574,All outcome measures except the TUG improved significantly by the end of intervention phase.,"[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Douris', 'Affiliation': 'Department of Physical Therapy, New York Institute of Technology (NYIT), Old Westbury, NY, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Physical Therapy, New York Institute of Technology (NYIT), Old Westbury, NY, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Werner', 'Affiliation': 'Department of Physical Therapy, New York Institute of Technology (NYIT), Old Westbury, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Petrizzo', 'Affiliation': 'Department of Exercise Science, Health Studies, Physical Education and Sport Management, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'DiFrancisco-Donoghue', 'Affiliation': 'NYIT College of Osteopathic Medicine, Department of Osteopathic Medicine, NYIT Center for Sports Medicine, Old Westbury, NY, USA.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1762812']
571,32400321,Effectiveness trial of an online self-help intervention for sexual problems after cancer.,"Sexual dysfunction affects over 60% of cancer survivors. Internet interventions have improved sexual function, but with considerable clinician guidance, restricting scalability. This pragmatic trial evaluated an online, self-help intervention. As with many unguided digital interventions, attrition was high. Given low numbers in other groups, this paper focuses on 30% of female patient participants who completed 3-month questionnaires and visited the intervention site (N = 60). Benefits included increased sexually active individuals at follow-up (p < 0.001, Effect size = 0.54), improved sexual function (p < 0.001, Effect size = -0.76, N = 41), and increased use of sexual aids (p = 0.01, Effect size=-0.14, N = 58). The intervention has been revised to improve patient engagement.",2020,"Benefits included increased sexually active individuals at follow-up (p < 0.001, Effect size = 0.54), improved sexual function (p < 0.001, Effect size = -0.76, N = 41), and increased use of sexual aids (p = 0.01, Effect size=-0.14, N = 58).","['female patient participants who completed 3-month questionnaires and visited the intervention site (N\u2009=\u200960', 'sexual problems after cancer']",['online self-help intervention'],"['use of sexual aids', 'sexual function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0856619', 'cui_str': 'Sexual problem'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",,0.0573806,"Benefits included increased sexually active individuals at follow-up (p < 0.001, Effect size = 0.54), improved sexual function (p < 0.001, Effect size = -0.76, N = 41), and increased use of sexual aids (p = 0.01, Effect size=-0.14, N = 58).","[{'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Schover', 'Affiliation': 'Will2Love, Houston, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Strollo', 'Affiliation': 'Behavioral and Epidemiology Research Group, American Cancer Society, Inc., Atlanta, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Stein', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fallon', 'Affiliation': 'Behavioral and Epidemiology Research Group, American Cancer Society, Inc., Atlanta, USA.'}, {'ForeName': 'Tenbroeck', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Behavioral and Epidemiology Research Group, American Cancer Society, Inc., Atlanta, USA.'}]",Journal of sex & marital therapy,['10.1080/0092623X.2020.1762813']
572,32335159,Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women.,"BACKGROUND


Caloric restriction (CR) without micronutrient deficiency has been shown to increase both lifespan and healthspan. In animals, CR has been demonstrated to increase glutathione (GSH), a neuroprotective antioxidant, in the brain and preserve brain mitochondrial function by altering neuroenergetics. In humans it has been associated with improvements in mood states and cognitive function. However, most CR studies have employed a 30-60% reduction in calories which is likely too stringent for most people to adhere to long-term. Thus, there is an unmet need for nutritional supplements which can mimic the biological effects of CR, without the need for calorie limitations.
AIM


The purpose of the present randomized, placebo-controlled clinical trial was to use Proton ( 1 H) Magnetic Resonance Spectroscopic (MRS) measurements to determine non-invasively whether a blend of micronutrients, a putative CR mimetic, positively modulates metabolites related to neuroprotection and neuroenergetics in the brain.
METHODS


Healthy middle-aged men and women (N = 63 [33 women]; age: 40-60 years) were randomized in a double-blind manner to 6 weeks supplementation with either the putative CR mimetic or placebo. At baseline and 6 weeks, subjects underwent MRS at 3 T to investigate changes in brain chemistry, including the neurometabolites: GSH, Glutamate (Glu), Glutamine (Gln) and N-Acetylaspartate (NAA).
RESULTS


GSH, a marker of antioxidant and cellular redox status, increased in the brain of participants in the supplement group. The supplement group also showed an increase in the Glu/Gln ratio, a marker of excitatory neurotransmission and bioenergetics. A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
CONCLUSIONS


The present study reveals that 6-weeks daily supplementation with a micronutrient blend elicits positive changes in brain neurochemistry. This is the first study to demonstrate that a putative CR mimetic increases brain GSH concentrations and improves neuroprotection and neuroenergetics in the brain of healthy humans. This study was registered at www.clinicaltrials.gov as NCT02439983.",2020,"A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
","['Healthy middle-aged men and women (N\u202f=\u202f63 [33 women]; age: 40-60 years', 'healthy middle-aged men and women', 'healthy humans']","['putative CR mimetic', 'putative CR mimetic or placebo', 'neurometabolites: GSH, Glutamate (Glu), Glutamine (Gln) and N-Acetylaspartate (NAA', 'Proton ( 1 H) Magnetic Resonance Spectroscopic (MRS', 'placebo']","['marker of antioxidant and cellular redox status', 'NAA/H 2 O, a marker of neuronal integrity', 'brain GSH concentrations', 'glutathione concentrations', 'glutathione (GSH', 'Glu/Gln ratio, a marker of excitatory neurotransmission and bioenergetics']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}]",,0.190371,"A trend for an increase in NAA/H 2 O, a marker of neuronal integrity, was observed in females in the supplement group.
","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mastaloudis', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Sheth', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA. Electronic address: chandni.sheth@utah.edu.'}, {'ForeName': 'Shelly N', 'Initials': 'SN', 'LastName': 'Hester', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Wood', 'Affiliation': 'Pharmanex Research, NSE Products, Inc., Provo, UT, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prescot', 'Affiliation': 'Department of Radiology, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McGlade', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}, {'ForeName': 'Perry F', 'Initials': 'PF', 'LastName': 'Renshaw', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Yurgelun-Todd', 'Affiliation': 'Department of Psychiatry, University of Utah School of Medicine, Salt Lake City, UT, USA; Diagnostic Neuroimaging, University of Utah, Salt Lake City, UT, USA; George E. Wahlen Department of Veterans Affairs Medical Center, VA VISN 19 Mental Illness Research, Education and Clinical Center (MIRREC), Salt Lake City, UT, USA.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.04.017']
573,32335288,The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers.,"BACKGROUND


While smoking continues to be the most preventable cause of mortality in the United States, most current smokers remain not ready to quit at any given time. Engaging these 'motivation phase' smokers with brief experiences to build confidence and practice skills related to cessation could lead to sooner and more successful quit attempts. Increasingly available mobile technology and gamification can be used to provide smokers with accessible and engaging support.
METHODS


We describe our protocol for conducting a randomized controlled trial evaluating Take a Break, an mHealth-based smoking pre-cessation challenge designed for smokers not ready to quit. Participants in the intervention receive 1) Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge. Access to coping mini-games and motivational messaging continues for 6-months. Both intervention and comparison group participants receive brief Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages for three weeks. Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
CONCLUSION


Take a Break is an innovative approach to engage those not prepared for a quit attempt. Take a Break provides motivation phase smokers with tools and a brief experience to prepare them for a quit attempt, filling a gap in tobacco cessation support and current research.",2020,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","['engage lower-motivated smokers', 'smokers not ready to quit']","['Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge', 'Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages']","['number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3853073', 'cui_str': 'Smoking assessment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0313065,"Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months.
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Amante', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America. Electronic address: daniel.amante@umassmed.edu.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, United States Department of Veterans Affairs, Ann Arbor, MI, United States of America; Systems, Populations and Leadership Department, School of Nursing, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Morley', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Conigliaro', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America; Feinstein Institute for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Mattocks', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; VA Central Western Massachusetts Healthcare System, Leeds, MA, United States of America.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States of America.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America; Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Department of Population and Quantitative Health Science, University of Massachusetts Medical School, Worcester, MA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106002']
574,32272255,COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.,"BACKGROUND


Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown.
HYPOTHESIS


The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose.
STUDY DESIGN


COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours.
CONCLUSIONS


The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.",2020,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"['patients with ST elevation myocardial infarction (STEMI', 'patients with STEMI undergoing primary percutaneous coronary interventions', 'approximately 674 patients presenting with STEMI planned for primary PCI', 'patients presenting with STEMI planned for primary PCI', 'STEMI patients undergoing primary percutaneous coronary intervention (PCI']","['Prasugrel tablets', 'prasugrel crushed tablets']","['death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year', 'bleeding events', 'percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C2710119', 'cui_str': 'prasugrel Oral Tablet'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]",674.0,0.146697,Evidence suggests that administration of crushed tablets of the P2Y 12  inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"[{'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Maasstad Hospital, Rotterdam; University Medical Center Utrecht, Netherlands. Electronic address: g.vlachojannis@umcutrecht.nl.'}, {'ForeName': 'Rosanne F', 'Initials': 'RF', 'LastName': 'Vogel', 'Affiliation': 'University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Wilschut', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Miguel E', 'Initials': 'ME', 'LastName': 'Lemmert', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Academic Medical Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'van Vliet', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'van der Waarden', 'Affiliation': 'Ambulance Zorg Rotterdam-Rijnmond, Rotterdam, Netherlands.'}, {'ForeName': 'Rutger-Jan', 'Initials': 'RJ', 'LastName': 'Nuis', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Paradies', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Group, Groupe Hospitalier Pitie-Salpetriere Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}]",American heart journal,['10.1016/j.ahj.2020.03.005']
575,32289325,Caloric compensation and appetite control in children of different weight status and predisposition to obesity.,"To prevent childhood obesity it is critical to identify behavioral phenotypes for overeating, especially among children who are predisposed to obesity. We examined caloric compensation and appetite control in 212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk (LR) for obesity based on maternal obesity. In a within-subjects crossover design, children ate breakfast, lunch, dinner, and snacks in the laboratory once a week for two weeks. Children's percentage compensation index (%COMPX) was computed at breakfast. Twenty-five minutes before breakfast, children received one of two compulsory preloads, which varied in energy density (ED) and caloric content [Low ED (LED): 1.00 kcal/g; 100 kcal; High ED (HED): 1.60 kcal/g; 160 kcal]. Children's appetite was measured hourly using Visual Analog Scales, which were used to compute 3-h post-prandial area under the curve (AUCs) after breakfast and the satiety quotient (SQ), which allows between-group comparisons of a fixed amount of a food's potency to reduce appetite sensations per unit of intake. There were no significant differences in %COMPX, SQ, or AUC among LR-NW, HR-NW, and HR-OB children (P > 0.10). SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009). Further, the SQ and AUC for Desire to Eat and AUC for Prospective Consumption significantly predicted energy intake during the remainder of the day (P < 0.03). In this study, HR-NW children did not differ from LR-NW or HR-OB children in their caloric compensation or appetite control. Foods with a high satiating effect may facilitate appetite control and help to moderate daily energy intake in all children, including at-risk children.",2020,SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009).,"['212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk (LR) for obesity based on maternal obesity', 'children who are predisposed to obesity', 'children of different weight status and predisposition to obesity']","['caloric content [Low ED (LED): 1.00\u202fkcal/g; 100\u202fkcal; High ED (HED', 'Caloric compensation and appetite control']","[""Children's percentage compensation index"", 'COMPX, SQ, or AUC among LR-NW, HR-NW, and HR-OB children', ""Children's appetite"", 'SQs for Hunger and Prospective Consumption', 'energy intake']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0746977', 'cui_str': 'Maternal Obesity'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",212.0,0.0314051,SQs for Hunger and Prospective Consumption were higher and SQ for Fullness lower after consuming the LED compared to the HED preload (P < 0.009).,"[{'ForeName': 'Tanja V E', 'Initials': 'TVE', 'LastName': 'Kral', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: tkral@nursing.upenn.edu.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Quinn', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, Philadelphia, PA, USA.'}]",Appetite,['10.1016/j.appet.2020.104701']
576,32289518,Effects of supervised high-intensity resistance and impact training or machine-based isometric training on regional bone geometry and strength in middle-aged and older men with low bone mass: The LIFTMOR-M semi-randomised controlled trial.,"INTRODUCTION


Few data exist on the effects of bone-targeted exercise on geometric and biomechanical indices of bone strength in men. The Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men (LIFTMOR-M) trial was designed to compare the efficacy and safety of two novel, supervised, twice-weekly, high-intensity exercise programs in middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures. The current report includes secondary outcomes of the LIFTMOR-M exercise intervention trial.
PURPOSE


Our goal was to determine the effects of two supervised, twice-weekly, high-intensity exercise programs on bone geometry and strength of the proximal femur, and distal and proximal sites of the tibia and radius in middle-aged and older men with osteopenia and osteoporosis.
METHODS


Generally-healthy men (≥45 years), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community. Eligible participants were randomised to either eight months of twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training. Intervention group outcomes were compared at baseline and eight months with a matched but non-randomised control group (CON) who self-selected to usual activities. DXA scans (Medix DR, Medilink, France) of the skeletally non-dominant proximal femur were analysed using 3D hip software (DMS Group, France) to derive femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments. Total FN cortical thickness was determined as well as anterior, posterior, lateral and medial subregions. pQCT scans (XCT-3000, Stratec, Germany) of the 4 and 38% sites of the tibia, and 4 and 66% sites of the radius were conducted to determine a range of geometric and bone structural strength indices. Intervention effects were examined using univariate ANCOVA of percent change, and repeated measures ANCOVA of raw baseline and follow-up data, controlling for initial values, using intention-to-treat and per-protocol approaches.
RESULTS


Ninety-three men (67.1 ± 7.5 yrs, 175.2 ± 6.7 cm, 82.1 ± 11.6 kg, 26.7 ± 3.5 kg/m 2 ) with lower than average aBMD (LS T-score -0.06 ± 1.04, FN T-score -1.58 ± 0.58, TH T-score -1.00 ± 0.58) were recruited, and designated CON (n = 26) or randomised to HiRIT (n = 34) or IAC (n = 33). Compliance to the supervised exercise programs did not differ (HiRIT 77.8 ± 16.6% versus IAC 78.5 ± 14.8%, p = 0.872). HiRIT improved medial FN cortical thickness compared with CON (5.6 ± 1.7% versus -0.1 ± 1.9%, p = 0.028) and IAC (5.6 ± 1.7% versus 0.7 ± 1.7%, p = 0.044). Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index all declined for CON compared with maintenance for both HiRIT and IAC (all p < 0.05). HiRIT maintained distal tibia trabecular area compared with a loss in CON (0.2 ± 0.5% versus -1.6 ± 0.5%, p = 0.013). HiRIT and IAC maintained distal radius total BMC compared with loss in CON (-0.1 ± 0.7% versus -3.7 ± 0.8%, p = 0.001; 1.3 ± 0.7% versus -3.7 ± 0.8%, p < 0.001, respectively). HiRIT and IAC maintained distal radius total bone strength index compared with loss in CON (1.4 ± 1.4% versus -6.0 ± 1.6%, p = 0.001; 0.2 ± 1.3% versus -6.0 ± 1.6%, p = 0.004, respectively). HiRIT reduced proximal radius cortical area compared with CON (-3.1 ± 1.0% versus 1.1 ± 1.2%, p = 0.011) and IAC (-3.1 ± 1.0% versus -0.2 ± 1.0%, p = 0.042). No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
CONCLUSION


Findings indicate that supervised HiRIT provides a positive stimulus to cortical bone at the medial FN compared with supervised IAC exercise, and both HiRIT and IAC preserve bone strength at the distal tibia and distal radius. These effects may translate into a reduced risk of lower and upper extremity fracture in middle-aged and older men with low bone mass.",2020,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","['middle-aged and older men with osteopenia and osteoporosis', 'Eligible participants', 'middle-aged and older men with low bone mass', 'Ninety-three men (67.1\u202f±\u202f7.5\u202fyrs, 175.2\u202f±\u202f6.7\u202fcm, 82.1\u202f±\u202f11.6\u202fkg, 26.7\u202f±\u202f3.5\u202fkg/m 2 ) with lower than average aBMD (LS T-score -0.06\u202f±\u202f1.04, FN T-score -1.58\u202f±\u202f0.58, TH T-score -1.00\u202f±\u202f0.58) were recruited, and designated CON (n\u202f=\u202f26) or randomised to', 'men', 'Generally-healthy men (≥45\u202fyears), with low lumbar spine (LS) and/or proximal femur areal bone mineral density (aBMD), were recruited from the community', 'middle-aged and older men with osteopenia and osteoporosis on musculoskeletal health and risk factors related to falls and fractures']","['IAC', 'high-intensity exercise programs', 'Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation', 'supervised high-intensity resistance and impact training or machine-based isometric training', 'HiRIT', 'twice-weekly supervised high-intensity progressive resistance and impact training (HiRIT) or supervised machine-based isometric axial compression (IAC) exercise training']","['HiRIT maintained distal tibia trabecular area', 'pQCT-derived bone outcome', 'femoral neck (FN) and total hip (TH) bone mineral content (BMC), volume, and volumetric bone mineral density (vBMD) for total, trabecular and cortical bone compartments', 'Total FN cortical thickness', 'Distal tibia total BMC, vBMD, area and bone strength index, and trabecular BMC and bone strength index', 'DXA scans (Medix DR, Medilink, France', 'HiRIT and IAC maintained distal radius total BMC', 'HiRIT and IAC maintained distal radius total bone strength index', 'efficacy and safety', 'regional bone geometry and strength', 'medial FN cortical thickness', 'HiRIT reduced proximal radius cortical area']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C5191362', 'cui_str': '1.04'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0588205', 'cui_str': 'Bone structure of proximal radius'}]",93.0,0.0493938,"No between-group differences were detected in any pQCT-derived bone outcome at the diaphyseal tibia 38% site.
","[{'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Weis', 'Affiliation': 'The Bone Clinic, Brisbane, Queensland, Australia.'}, {'ForeName': 'Belinda R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia; The Bone Clinic, Brisbane, Queensland, Australia. Electronic address: b.beck@griffith.edu.au.'}]",Bone,['10.1016/j.bone.2020.115362']
577,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND


The impact of high distraction, real-world environments on dual-task interference and flexibility of attentional prioritization during dual-task walking in people with stroke is unknown.
RESEARCH QUESTION


How does a real-world environment affect dual-task performance and flexible task prioritization during dual-task walking in adults with and without stroke?
METHODS


Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated. Single and dual-task walking were examined in two different environments (lab hallway, hospital lobby). Two different dual-task combinations were assessed (Stroop-gait, speech-gait). Each dual-task was performed first without explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction in randomized order.
RESULTS


People with stroke had significantly slower dual-task gait speed (Stroop only) in the lobby than the lab, but the effect was not clinically meaningful. Stroop reaction time for all participants was also slower in the lobby than the lab. All participants slowed their walking speed while generating spontaneous speech, but this effect was not influenced by environment. The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
SIGNIFICANCE


Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
578,32304828,"IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods.","BACKGROUND


African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS.
METHODS


This is a mixed-methods study that includes a randomized-controlled trial, ""IMPROVE"", to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
DISCUSSION


Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.",2020,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
","['older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds', '220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged', 'African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS', 'Participants are ≥65\u202fyears old and within five years of treatment completion for stage I-III breast cancer']","['moderate intensity aerobic and resistance group exercise intervention', 'exercise intervention', 'community-based exercise intervention']","['functional and health outcomes', 'change in Short Physical Performance Battery (SPPB) Scores', 'change in SPPB scores at 52\u202fweeks, change in body composition and biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",220.0,0.0741916,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms.
","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Owusu', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America. Electronic address: Cynthia.owusu@case.edu.'}, {'ForeName': 'Nora L', 'Initials': 'NL', 'LastName': 'Nock', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hergenroeder', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, MetroHealth Medical Center, Cleveland, OH, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Austin', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bennet', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cerne', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic, Department of Hematology/Oncology, Cleveland, OH, United States of America.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Petkac', 'Affiliation': 'University Hospitals of Cleveland, Cleveland, OH, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schluchter', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Penn State University College of Medicine, Hershey, PA, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Webb-Hooper', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'California Baptist University, Riverside, CA, United States of America.'}, {'ForeName': 'Oghenerukeme', 'Initials': 'O', 'LastName': 'Asagba', 'Affiliation': 'West Virginia University School of Medicine, Morgantown, WV, United States of America.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Wimbley', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Berger', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106001']
579,32400704,Comparison of four techniques for turbulent phase screens simulation.,"In the study, we introduce a new technique, sparse spectrum with uniform wave vectors (SU), for generation of phase screen samples. In a manner similar to the known sparse spectrum (SS) technique, it uses a trigonometric series with random discrete spectral support. However, in contrast to the SS technique, random wave vectors are uniformly distributed on individual segments of the wave vector plane partition in the SU technique. We compare the accuracy and computational effectiveness of the SU technique with the subharmonics complemented discrete Fourier transform (DFT) technique, SS technique, and randomized DFT technique [ J. Opt. Soc. Am. B36, 3249 (2019)JOBPDE0740-322410.1364/JOSAB.36.003249]. The SU and SS techniques generate unbiased samples and indicate superior computational effectiveness for 1 MP and larger screens.",2020,The SU and SS techniques generate unbiased samples and indicate superior computational effectiveness for 1 MP and larger screens.,[],"['SU technique with the subharmonics complemented discrete Fourier transform (DFT) technique, SS technique, and randomized DFT technique [ J. Opt']",[],[],"[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0282183', 'cui_str': 'Fourier Transform'}]",[],,0.012396,The SU and SS techniques generate unbiased samples and indicate superior computational effectiveness for 1 MP and larger screens.,"[{'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Charnotskii', 'Affiliation': ''}]","Journal of the Optical Society of America. A, Optics, image science, and vision",['10.1364/JOSAA.385754']
580,32334702,"Effectiveness of reactive focal mass drug administration and reactive focal vector control to reduce malaria transmission in the low malaria-endemic setting of Namibia: a cluster-randomised controlled, open-label, two-by-two factorial design trial.","BACKGROUND


In low malaria-endemic settings, screening and treatment of individuals in close proximity to index cases, also known as reactive case detection (RACD), is practised for surveillance and response. However, other approaches could be more effective for reducing transmission. We aimed to evaluate the effectiveness of reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) in the low malaria-endemic setting of Zambezi (Namibia).
METHODS


We did a cluster-randomised controlled, open-label trial using a two-by-two factorial design of 56 enumeration area clusters in the low malaria-endemic setting of Zambezi (Namibia). We randomly assigned these clusters using restricted randomisation to four groups: RACD only, rfMDA only, RAVC plus RACD, or rfMDA plus RAVC. RACD involved rapid diagnostic testing and treatment with artemether-lumefantrine and single-dose primaquine, rfMDA involved presumptive treatment with artemether-lumefantrine, and RAVC involved indoor residual spraying with pirimiphos-methyl. Interventions were administered within 500 m of index cases. To evaluate the effectiveness of interventions targeting the parasite reservoir in humans (rfMDA vs RACD), in mosquitoes (RAVC vs no RAVC), and in both humans and mosquitoes (rfMDA plus RAVC vs RACD only), an intention-to-treat analysis was done. For each of the three comparisons, the primary outcome was the cumulative incidence of locally acquired malaria cases. This trial is registered with ClinicalTrials.gov, number NCT02610400.
FINDINGS


Between Jan 1, 2017, and Dec 31, 2017, 55 enumeration area clusters had 1118 eligible index cases that led to 342 interventions covering 8948 individuals. The cumulative incidence of locally acquired malaria was 30·8 per 1000 person-years (95% CI 12·8-48·7) in the clusters that received rfMDA versus 38·3 per 1000 person-years (23·0-53·6) in the clusters that received RACD; 30·2 per 1000 person-years (15·0-45·5) in the clusters that received RAVC versus 38·9 per 1000 person-years (20·7-57·1) in the clusters that did not receive RAVC; and 25·0 per 1000 person-years (5·2-44·7) in the clusters that received rfMDA plus RAVC versus 41·4 per 1000 person-years (21·5-61·2) in the clusters that received RACD only. After adjusting for imbalances in baseline and implementation factors, the incidence of malaria was lower in clusters receiving rfMDA than in those receiving RACD (adjusted incidence rate ratio 0·52 [95% CI 0·16-0·88], p=0·009), lower in clusters receiving RAVC than in those that did not (0·48 [0·16-0·80], p=0·002), and lower in clusters that received rfMDA plus RAVC than in those receiving RACD only (0·26 [0·10-0·68], p=0·006). No serious adverse events were reported.
INTERPRETATION


In a low malaria-endemic setting, rfMDA and RAVC, implemented alone and in combination, reduced malaria transmission and should be considered as alternatives to RACD for elimination of malaria.
FUNDING


Novartis Foundation, Bill & Melinda Gates Foundation, and Horchow Family Fund.",2020,"After adjusting for imbalances in baseline and implementation factors, the incidence of malaria was lower in clusters receiving rfMDA than in those receiving RACD (adjusted incidence rate ratio 0·52","['low malaria-endemic setting of Zambezi (Namibia', 'low malaria-endemic setting of Namibia', 'Between Jan 1, 2017, and Dec 31, 2017', '56 enumeration area clusters in the low malaria-endemic setting of Zambezi (Namibia', '55 enumeration area clusters had 1118 eligible index cases that led to 342 interventions covering 8948 individuals']","['rfMDA plus RAVC', 'RACD only, rfMDA only, RAVC plus RACD, or rfMDA plus RAVC', 'RAVC', 'primaquine, rfMDA', 'RACD', 'reactive focal mass drug administration and reactive focal vector control', 'rfMDA', 'reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC']","['incidence of malaria', 'cumulative incidence of locally acquired malaria cases', 'serious adverse events', 'cumulative incidence of locally acquired malaria']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0027366', 'cui_str': 'Namibia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031249', 'cui_str': 'Pest control'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",8948.0,0.313784,"After adjusting for imbalances in baseline and implementation factors, the incidence of malaria was lower in clusters receiving rfMDA than in those receiving RACD (adjusted incidence rate ratio 0·52","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hsiang', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA; Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA. Electronic address: michelle.hsiang@utsouthwestern.edu.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ntuku', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kathryn W', 'Initials': 'KW', 'LastName': 'Roberts', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Mi-Suk Kang', 'Initials': 'MK', 'LastName': 'Dufour', 'Affiliation': 'Division of Prevention Science, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Whittemore', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Tambo', 'Affiliation': 'Multidisciplinary Research Centre, University of Namibia, Windhoek, Namibia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McCreesh', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Oliver F', 'Initials': 'OF', 'LastName': 'Medzihradsky', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA; Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Prach', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Griffith', 'Initials': 'G', 'LastName': 'Siloka', 'Affiliation': 'Zambezi Ministry of Health and Social Services, Katima, Namibia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Siame', 'Affiliation': 'Zambezi Ministry of Health and Social Services, Katima, Namibia.'}, {'ForeName': 'Cara Smith', 'Initials': 'CS', 'LastName': 'Gueye', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Schrubbe', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Immunology and Infection, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Scott', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sofonias', 'Initials': 'S', 'LastName': 'Tessema', 'Affiliation': 'Division of Experimental Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Greenhouse', 'Affiliation': 'Division of Experimental Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Erlank', 'Affiliation': 'Wits Research Institute for Malaria, South African Medical Research Council Collaborating Centre for Multi-Disciplinary Research on Malaria, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lizette L', 'Initials': 'LL', 'LastName': 'Koekemoer', 'Affiliation': 'Wits Research Institute for Malaria, South African Medical Research Council Collaborating Centre for Multi-Disciplinary Research on Malaria, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Hugh J W', 'Initials': 'HJW', 'LastName': 'Sturrock', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mwilima', 'Affiliation': 'Zambezi Ministry of Health and Social Services, Katima, Namibia.'}, {'ForeName': 'Stark', 'Initials': 'S', 'LastName': 'Katokele', 'Affiliation': 'National Vector-Borne Diseases Control Programme, Namibia Ministry of Health and Social Services, Windhoek, Namibia.'}, {'ForeName': 'Petrina', 'Initials': 'P', 'LastName': 'Uusiku', 'Affiliation': 'National Vector-Borne Diseases Control Programme, Namibia Ministry of Health and Social Services, Windhoek, Namibia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Immo', 'Initials': 'I', 'LastName': 'Kleinschmidt', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Wits Research Institute for Malaria, South African Medical Research Council Collaborating Centre for Multi-Disciplinary Research on Malaria, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Southern African Development Community, Malaria Elimination Eight Secretariat, Windhoek, Namibia.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Mumbengegwi', 'Affiliation': 'Multidisciplinary Research Centre, University of Namibia, Windhoek, Namibia.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, CA, USA; Multidisciplinary Research Centre, University of Namibia, Windhoek, Namibia.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30470-0']
581,32335402,Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.,"BACKGROUND


Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest.
OBJECTIVES


Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up.
METHODS


In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL [""low T""] vs. ≥300 ng/dL [""normal T""]) on rates of pre-specified CV outcomes, using Cox proportional hazards models.
RESULTS


Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
CONCLUSIONS


In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke.
CONDENSED ABSTRACT


In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The ""low T"" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.",2020,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","['2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline', '2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean', 'androgen-deficient men with atherosclerotic cardiovascular disease', 'male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to']",['niacin or placebo plus simvastatin'],"['low baseline testosterone concentrations and increased risk of subsequent CV events', 'CHD death, MI, and stroke composite endpoint', 'Testosterone concentrations and risk of cardiovascular events', 'coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization', 'secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke', 'low baseline testosterone (T) concentrations and subsequent CV outcomes', 'rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007794', 'cui_str': 'Cerebral revascularisation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",2118.0,0.309705,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively.
","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA. Electronic address: william.boden@va.gov.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Miller', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'McGovern', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Kashyap', 'Affiliation': 'Long Beach VA Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle, WA.'}]",American heart journal,['10.1016/j.ahj.2020.03.016']
582,32272256,"No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.","The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.",2020,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","['200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration', 'patients undergoing first isolated']","['saphenous vein grafts', 'coronary computed tomography angiography', 'nonemergent coronary artery bypass grafting (CABG', 'saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique', 'no-touch or conventional open skeletonized vein harvesting technique', 'coronary artery surgery (SWEDEGRAFT']","['patency of coronary artery bypass grafts', 'wound healing in the vein graft sites and the composite outcome of major adverse cardiac events', 'proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0398206', 'cui_str': 'Harvesting of vein'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",200.0,0.0320323,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","[{'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Ragnarsson', 'Affiliation': 'Skane University Hospital and Lund University, Lund, Sweden. Electronic address: sigurdur.ragnarsson@med.lu.se.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Janiec', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Dreifaldt', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ericsson', 'Affiliation': 'Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holmgren', 'Affiliation': 'University Hospital of Umea, Umea, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hultkvist', 'Affiliation': 'Linkoping University Hospital, Linkoping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Sartipy', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ternström', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Per Vikholm', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Domingos', 'Initials': 'D', 'LastName': 'de Souza', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thelin', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}]",American heart journal,['10.1016/j.ahj.2020.03.009']
583,32280035,Adolescent cognitive control and mediofrontal theta oscillations are disrupted by neglect: Associations with transdiagnostic risk for psychopathology in a randomized controlled trial.,"Children that have experienced psychosocial neglect display impairments in self-monitoring and controlling their behavior (cognitive control) and are at broad, transdiagnostic risk for psychopathology. However, the neural underpinnings of such effects remain unclear. Event-related mediofrontal theta oscillations reflect a neural process supporting cognitive control that may relate to transdiagnostic psychopathology risk. Recent work demonstrates reduced mediofrontal theta in rodent models of neglect; however, similar findings have not been reported in humans. Here, 136 children reared in Romanian institutions were randomly assigned to either a high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group. The intervention ended at 54 months; event-related mediofrontal theta and psychopathology were assessed at 12- and 16-year follow-up assessments. Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for. Earlier placement into foster care yielded greater mediofrontal activity by age 16. Moreover, foster care placement was associated with the developmental trajectory of mediofrontal theta across the adolescent period (ages 12-16), which was, in turn, associated with greater reductions in transdiagnostic risk across this same period. These data reflect the first experimental evidence that the development of mediofrontal theta is impacted by removal from situations of neglect in humans, and further characterizes the importance of studying developmental change in mediofrontal theta during the adolescent period.",2020,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.",['136 children reared in Romanian institutions'],['high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group'],"['Adolescent cognitive control and mediofrontal theta oscillations', 'transdiagnostic risk', 'mediofrontal activity']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",136.0,0.0417503,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Buzzell', 'Affiliation': 'University of Maryland, College Park, MD, United States. Electronic address: gbuzzell@umd.edu.'}, {'ForeName': 'Sonya V', 'Initials': 'SV', 'LastName': 'Troller-Renfree', 'Affiliation': 'Teachers College, Columbia University, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Debnath', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Bowers', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Harvard Medical School, Boston, MA, United States; Boston Children's Hospital, Boston, MA, United States; Harvard Graduate School of Education, Boston, MA, United States.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2020.100777']
584,32289619,Serum osteoprotegerin as a long-term predictor for patients with stable coronary artery disease and its association with diabetes and statin treatment: A CLARICOR trial 10-year follow-up substudy.,"BACKGROUND AND AIMS


Elevated circulating levels of osteoprotegerin (OPG) are known to add to the prediction of cardiovascular mortality. Our objective was to clarify the long-term risk associated with serum OPG and the possible influence of diabetes and statins on OPG levels in patients with stable coronary artery disease (CAD).
METHODS


We assessed the placebo-treated group (n = 1998) from the CLARICOR trial (NCT00121550), a cohort with stable CAD. At entry, 15% of the participants had diabetes and 41% received statins. Serum OPG levels were measured in blood drawn at randomization. Participants were followed through public registers for 10 years.
RESULTS


OPG levels correlated positively with diabetes status, age, CRP and female sex, but negatively with the use of statins. CAD participants with diabetes had significantly elevated serum OPG levels compared to participants without diabetes, p < 0.0001. The participants without diabetes treated with statins presented with significantly lower serum OPG levels than the corresponding non-statin-users (p < 0.0001). However, statin use showed no association with OPG levels in the participants with diabetes. High OPG levels at entry showed long-term associations with all-cause mortality and cardiovascular events (hazard ratio associated with factor 10 OPG increase 15.9 (95% CI 11.0-22.9) and 6.38 (4.60-8.90), p = 0.0001, even after adjustment for standard predictors (3.16 (1.90-5.25) and 2.29 (1.53-3.44), p < 0.0001).
CONCLUSIONS


Circulating OPG holds long-term independent predictive ability for all-cause mortality and cardiovascular events in CAD participants. OPG levels were associated with diabetes, age, and female sex and statin treatment was associated with lower OPG levels in the absence of diabetes.",2020,"CAD participants with diabetes had significantly elevated serum OPG levels compared to participants without diabetes, p < 0.0001.","['Participants were followed through public registers for 10 years', 'participants with diabetes', 'patients with stable coronary artery disease and its association with diabetes and statin treatment', 'CAD participants', 'CAD participants with diabetes', 'patients with stable coronary artery disease (CAD']","['statins', 'placebo']","['High OPG levels', 'Serum OPG levels', 'OPG levels', 'mortality and cardiovascular events', 'serum OPG levels', 'Serum osteoprotegerin']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0879435,"CAD participants with diabetes had significantly elevated serum OPG levels compared to participants without diabetes, p < 0.0001.","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bjerre', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: mette.bjerre@clin.au.dk.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Department of Biostatistics, Institute of Public Health Research, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, S, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology, Rigshospitalet University of Copenhagen, Denmark.'}, {'ForeName': 'Hans Jørn', 'Initials': 'HJ', 'LastName': 'Kolmos', 'Affiliation': 'Department of Clinical Microbiology, Odense University Hospital, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society/Division of Family Medicine, Karolinska Institute, Stockholm, Sweden; Department of Health and Social Sciences, Dalarna University, Falun, Sweden.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Holbæk Hospital, Holbæk, Denmark; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.03.030']
585,32289741,Dulaglutide reduces binge episodes in type 2 diabetic patients with binge eating disorder: A pilot study.,"AIMS


Binge eating disorder (BED) is the most common eating disorder in the United States and Europe and is associated with obesity and type 2 diabetes (T2D). Presence and severity of BED have been associated with worse metabolic control and greater BMI in T2D patients. Glucagon Like Peptide-1 (GLP1) receptors are present in central nervous system areas involved in appetite regulation and treatment with GLP-1 receptor agonists modulates appetite and reward-related brain areas in humans. We evaluated the effects of treatment with dulaglutide on eating behavior in T2D outpatients with BED.
METHODS


This was a pilot open label, prospective controlled study. Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED. Patients were randomly assigned to receive either Dulaglutide 1,5 mg/sett or Gliclazide 60 mg for 12 weeks. We evaluated baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes after treatment. A multivariate linear regression model was used to verify the association between Δ BES from baseline with Δ Hba1c and variation of anthropometric parameters after treatment.
RESULTS


After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide. Reduction in BES was associated with reduction in body weight (p < 0.0001) and HbA1c (p = 0.033).
CONCLUSION


Dulaglutide treatment reduces binge eating behaviour in T2D patients with BED.",2020,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","['T2D patients', 'type 2 diabetic patients with binge eating disorder', 'T2D outpatients with BED', 'Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED', 'T2D patients with BED']","['Dulaglutide 1,5 mg/sett or Gliclazide', 'Dulaglutide treatment', 'dulaglutide', 'Dulaglutide', 'gliclazide']","['BMI', 'percentage fat mass', 'binge eating behaviour', 'binge episodes', 'baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes', 'Reduction in BES', 'eating behavior', 'body weight']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0375975,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Da Porto', 'Affiliation': 'Internal Medicine, University of Udine, Italy. Electronic address: daporto.andrea@gmail.com.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Casarsa', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Catena', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavarape', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Sechi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.03.009']
586,32305456,Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol.,"Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings are more effective sites for focused case finding and intervention. Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment (SURE). SURE is a brief, interactive program consistent with motivational interviewing and incorporates empowerment strategies. The proposed multisite randomized clinical trial (N = 186) will test whether SURE relative to control is associated with reduced IPV, greater positive affect and well-being, and greater perceived emotional support. We will also evaluate the role of theoretical mediators of empowerment and self-efficacy. Finally, we will estimate the resources needed and costs to deliver SURE, as well as the incremental cost effectiveness of SURE compared with treatment as usual. If SURE is found to be efficacious and cost effective, it can be easily integrated into clinical care and will fill a critical gap for a vulnerable, high-risk population.",2020,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","['perinatal women seeking mental health treatment', 'women who seek mental health treatment, mental health clinics', 'perinatal women', 'women and their developing fetus/infant']","['Intimate partner victimization (IPV', 'Computerized intervention']",['adverse physical and emotional outcomes'],"[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",186.0,0.0511695,"Our team has successfully tested an innovative, computerized intervention, Strength for U in Relationship Empowerment","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Akron, Akron, OH 44325-4301, USA. Electronic address: johnsod@uakron.edu.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ted R', 'Initials': 'TR', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, Calverton, MD, USA; School of Public Health, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Muzik', 'Affiliation': 'Department of Psychiatry, Obstetrics & Gynecology, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ""Division of Research, Women and Infant's Hospital, Providence, RI, USA.""}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ""Department of Medicine, Women and Infant's Hospital, Providence, RI, USA; Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106011']
587,32305457,"Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.","BACKGROUND


Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings.
METHODS


Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost.
CONCLUSION


TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.",2020,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.",[],['stepped-wedge hybrid type'],"['time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction', 'acceptability, adoption/penetration, fidelity, sustainability and cost']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.050151,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: Tracy.Battaglia@bmc.org.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States of America; Division of Internal Medicine and Primary Care, Department of Medicine, Tufts Medical Center, Boston, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America; Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Karen Burns', 'Initials': 'KB', 'LastName': 'White', 'Affiliation': 'Initiative to Eliminate Cancer Disparities, Dana Farber/Harvard Cancer Center, Boston, MA, United States of America.'}, {'ForeName': 'Stephenie C', 'Initials': 'SC', 'LastName': 'Lemon', 'Affiliation': 'Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106007']
588,32305825,Effect of pregnancy and exclusive breastfeeding on multiple sclerosis relapse rate and degree of disability within two years after delivery.,"OBJECTIVES


Pregnancy and lactation are important issues for women with multiple sclerosis (MS). The purpose of this study was to investigate the effect of pregnancy and exclusive breastfeeding on the rate of relapse and degree of disability within two years after delivery among patients with relapsing remitting multiple sclerosis (RRMS).
PATIENTS AND METHODS


30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017. Each patient was examined every three months for 33 months. In the study group, patients were examined at the beginning of pregnancy, and then every three months till 24th months after delivery.
RESULTS


In the study group, Expanded Disability Status Scale (EDSS) during the third trimester of pregnancy, between four to nine month after delivery, and the last 6 months of the study were significantly lower than the control group (p < 0.05). At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05). Also, EDSS during the second and third trimesters of pregnancy were significantly lower than the EDSS before pregnancy (p < 0.05). The mean number of relapses in the second and third trimesters of pregnancy, between four to six months after delivery, and the total number of relapses were significantly lower than the control group.
CONCLUSION


Pregnancy and exclusive breastfeeding can have a positive effect in reducing relapse rate and disability. This effect will continue until the 24th month after childbirth.",2020,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","['patients with relapsing remitting multiple sclerosis (RRMS', '30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017', 'women with multiple sclerosis (MS']",['pregnancy and exclusive breastfeeding'],"['total number of relapses', 'Expanded Disability Status Scale (EDSS', 'relapse rate and disability', 'mean EDSS', 'multiple sclerosis relapse rate and degree of disability', 'rate of relapse and degree of disability', 'mean number of relapses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0139494,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Nouri', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Abdorreza Naser', 'Initials': 'AN', 'LastName': 'Moghadasi', 'Affiliation': 'Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.ghaffari@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105829']
589,32311521,"A Commentary on the article: Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study, Int J Surg. 2020 Mar 17. pii: S1743-9191(20)30231-4. doi: 10.1016/j.ijsu.2020.03.019.",,2020,,['pii'],['fluorescent imaging during laparoscopic surgery'],['peritoneal perfusion'],"[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0758544,,"[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Karimian', 'Affiliation': 'Tehran University of Medical Sciences-TUMS, Iran. Electronic address: faramarz.karimian@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.074']
590,32315958,"Effects of oral butyrate and inulin supplementation on inflammation-induced pyroptosis pathway in type 2 diabetes: A randomized, double-blind, placebo-controlled trial.","PURPOSE


Pyroptosis, a form of inflammatory programmed cell death, is activated in diabetic patients. This study was conducted to investigate the effects of daily consumption of sodium butyrate (NaBut) and high-performance (HP) inulin supplementation, individually or in combination, on the expression of pyroptosis-related genes, microRNA (miR) 146a-5p, miR-9-5p and biomarkers of oxidative stress in patients with type 2 diabetes (T2DM).
METHODS


In this study, we conducted a randomized, double-blinded, placebo-controlled clinical involving sixty patients with type 2 diabetes. Participants received 600 mg/d of NaBut (group A), 10 g/d of HP inulin (group B), 600 mg/d of NaBut + 10 g/d of HP inulin (group C) or placebo (group D) for 45 consecutive days. We assessed the pyroptosis-related genes mRNA expression in peripheral blood mononuclear cells (PBMCs), as well as the plasmatic levels of miR-146a and miR-9 before and after the intervention. Moreover, blood samples of the patients at baseline and following the intervention were tested for total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase levels using enzyme-linked immunosorbent assay (ELISA). This study was registered on the Iranian Registry of Clinical Trials website (identifier: IRCT201605262017N29; https://www.irct.ir/).
RESULTS


Following butyrate supplementation, the relative expression levels of TLR2/4, NF-κB1, Caspase-1, NLRP3, IL-1β & IL-18 were significantly downregulated (p < 0.05). Furthermore, butyrate and concomitant use of butyrate and inulin caused a significant increase in the fold change of miR-146a and miR-9 compared with the placebo group (p < 0.05). Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
CONCLUSION


In summary, the change in expression level of miR-146a-5p and miR-9-5p due to butyrate supplementation may have a pivotal role in alleviating of diabetes via inhibiting pyroptosis by targeting TLR2 and NF-κB1. These microRNAs might be considered as potential therapeutic targets in the treatment of type 2 diabetes but further researches is required to prove the link.",2020,"Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
","['type 2 diabetes', 'sixty patients with type 2 diabetes', 'patients with type 2 diabetes (T2DM', 'diabetic patients']","['oral butyrate and inulin supplementation', 'placebo', '600\xa0mg/d of NaBut', 'NaBut\xa0+\xa010\xa0g/d of HP inulin', 'sodium butyrate (NaBut) and high-performance (HP) inulin supplementation', 'HP inulin']","['total antioxidant capacity', 'relative expression levels of TLR2/4, NF-κB1, Caspase-1, NLRP3, IL-1β & IL-18', 'expression of pyroptosis-related genes, microRNA (miR) 146a-5p, miR-9-5p and biomarkers of oxidative stress', 'fold change of miR-146a and miR-9', 'blood samples', 'superoxide dismutase', 'total antioxidant capacity (TAC), superoxide dismutase (SOD) and catalase levels using enzyme-linked immunosorbent assay (ELISA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0142812', 'cui_str': 'Butyric Acid, Sodium Salt'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C2610960', 'cui_str': 'Caspase-1 Dependent Cell Death'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C3884166', 'cui_str': 'MIRN9 microRNA, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]",60.0,0.227835,"Interestingly, the changes in total antioxidant capacity (p = 0.047) and superoxide dismutase (p = 0.006) were significantly increased after butyrate and concomitant use of butyrate and inulin supplement, respectively.
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Students Research Committee, School of Health, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mohammad Asghari', 'Initials': 'MA', 'LastName': 'Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Cancer and Inflammation Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bahadir Rostamzadeh', 'Initials': 'BR', 'LastName': 'Shabestari', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Nasirzadeh', 'Affiliation': 'School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell And Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Mansoori', 'Affiliation': 'Department of Cancer and Inflammation Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell And Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'Ghavami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ghafaris@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}]",Cytokine,['10.1016/j.cyto.2020.155101']
591,32315965,Baduanjin mind-body exercise improves logical memory in long-term hospitalized patients with schizophrenia: A randomized controlled trial.,"Neurocognitive impairment is one of the core symptoms in schizophrenia and poses a great challenge to effective treatment. Sixty-one long-term hospitalized patients with schizophrenia were recruited and randomly assigned to two groups: Baduanjin exercise and brisk walking. Patients in the Baduanjin group received 24 weeks of Baduanjin training (5 days/week, 40 min/day), while patients in the brisk walking group received 24 weeks of brisk walking (5 days/week, 40 min/day). Scores on the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale were used to evaluate the logical memory (LM), processing speed, and clinical symptoms of all participants, while the score of Trail Making Test-A (TMT-A) was applied to assess the visual attention and graphomotor speed, at baseline and the 16th week and 24th week of intervention. The one-way repeated measures analysis of variance (ANOVA) was used to test the differences in neurocognitive changes between the two groups. Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328). A significant effect of time was also detected in the LM immediate (F=10.24, p = 0.000) and LM delayed (F=4.93, p = 0.009) scores and in the completion time of the TMT-A (F=33.10, p = 0.000), but not in the DSST scores (F=2.12, p = 0.122). Baduanjin exercise could improve logical memory in the long-term hospitalized patients with schizophrenia.",2020,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","['long-term hospitalized patients with schizophrenia', 'hospitalized patients with schizophrenia', 'Sixty-one long-term hospitalized patients with schizophrenia']","['Baduanjin exercise', 'Baduanjin training', 'brisk walking group received 24 weeks of brisk walking', 'Baduanjin exercise and brisk walking', 'Baduanjin mind-body exercise']","['LM immediate', 'logical memory (LM), processing speed, and clinical symptoms', 'neurocognitive changes', 'LM delayed', 'logical memory', 'visual attention and graphomotor speed', 'completion time of the TMT-A', 'Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale', 'DSST scores']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0321369,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","[{'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Mental Health Center and Psychiatric Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: limingli0517@qq.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Yusubujiang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: 577827619@qq.com.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102046']
592,32320843,"Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial.","BACKGROUND


Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers.
METHODS


BANSAR is a pragmatic randomised controlled trial conducted in antenatal clinic in seven public hospitals in Hong Kong, China. An estimated 1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking will be randomised (1:1) to receive brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care). Outcome will be assessed at 3 and 6 months after treatment initiation. The primary outcome is carbon monoxide-verified (<4 part per million) abstinence at 6 months post-treatment initiation. Secondary outcomes include self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers.
COMMENT


This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population. The findings may be particularly relevant to low and middle-income countries, where male-to-female smoking ratios and birth rates tend to be higher than higher-income countries.
TRIAL REGISTRATION


ClinicalTrials.gov, number NCT03671707.",2020,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","['1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking', 'smoking expectant fathers', 'antenatal clinic in seven public hospitals in Hong Kong, China', 'expectant fathers']","['nicotine replacement therapy sampling and active referral (BANSAR', 'brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care']","['carbon monoxide-verified (<4 part per million) abstinence', 'self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers']","[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",,0.144204,"This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population.","[{'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Ju', 'Initials': 'CJ', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wing-Cheong', 'Initials': 'WC', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Kwong Wah Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Yin', 'Initials': 'KY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Elizabeth Hospital, Hong Kong.'}, {'ForeName': 'Ka Wang', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics & Gynecology, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Kwa', 'Affiliation': 'Department of Obstetrics & Gynecology, United Christian Hospital, Hong Kong.'}, {'ForeName': 'Kar-Hung', 'Initials': 'KH', 'LastName': 'Siong', 'Affiliation': 'Department of Obstetrics & Gynecology, Tuen Mun Hospital, Hong Kong.'}, {'ForeName': 'Kwok-Keung', 'Initials': 'KK', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics & Gynecology, Pamela Youde Nethersole Eastern Hospital, Hong Kong.'}, {'ForeName': 'Kai-Wan', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Princess Margaret Hospital, Hong Kong.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong. Electronic address: mpwang@hku.hk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106006']
593,32320894,Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy.,"BACKGROUND


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


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


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


The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.",2020,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"['98 subjects participated in the SOC group and 103 in the PVS group', 'non-small cell lung cancer']","['Powered Vascular Stapler in Video-Assisted Thoracic Surgery Lobectomy', 'standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy', 'SOC staplers', 'vascular stapler (PVS', 'PVS with SOC staplers']","['frequency of postoperative bleeding-related interventions', 'Procedure-related adverse events', 'incidence of intraoperative hemostatic interventions', 'Rates of intraoperative hemostatic interventions']","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}]",98.0,0.124483,The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.,"[{'ForeName': 'Laureano', 'Initials': 'L', 'LastName': 'Molins', 'Affiliation': 'Department of Thoracic Surgery, Barcelona University, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanuti', 'Affiliation': 'Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Force', 'Affiliation': 'Department of Surgery, The Emory Clinic, Atlanta, Georgia, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Woolley', 'Affiliation': 'Consultant Thoracic Surgeon, Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Krantz', 'Affiliation': 'Division of Thoracic Surgery, Northshore University Health System, Evanston, Illinois, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Creedon', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Schwiers', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Singleton', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA. Electronic address: dsingl12@its.jnj.com.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Waggoner', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fryrear', 'Affiliation': 'Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.023']
594,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND


Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study.
OBJECTIVE


To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial.
METHODS


We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale.
RESULTS


We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
CONCLUSIONS


The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833']
595,32302788,Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): A cluster randomized trial of a computerized clinical decision support tool.,"BACKGROUND


Clinical decision support (CDS) tools designed to digest, filter, organize, and present health data are becoming essential in providing clinical and cost-effective care. Many are not rigorously evaluated for benefit before implementation. We assessed whether computerized CDS for primary care providers would improve atrial fibrillation (AF) management and outcomes as compared to usual care.
METHODS


Overall, 203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n = 99) or CDS (n = 104). Providers recruited 1,145 adult patients with AF to participate. The intervention was access to an evidenced-based, point-of-care computerized CDS designed to support guideline-based AF management. The primary efficacy outcome was a composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year. Patients were the units of intention-to-treat analysis.
RESULTS


No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
CONCLUSIONS


IMPACT-AF rigorously assessed a CDS tool in a highly representative sample of primary care providers and their patients; however, no impact on outcomes was observed. Considering the proliferating use of CDS applications, this study highlights the need for efficacy assessments prior to adoption and clinical implementation.",2020,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","['1,145 adult patients with AF to participate', 'Atrial Fibrillation (IMPACT-AF', '203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n\u202f=\u202f99) or CDS (n\u202f=\u202f104']",['computerized CDS'],"['atrial fibrillation (AF) management and outcomes', 'composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year', 'primary efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1145.0,0.0610574,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months.
","[{'ForeName': 'Jafna L', 'Initials': 'JL', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada; Heart and Stroke Foundation of Nova Scotia Endowed Chair in Cardiovascular Outcomes Research, Halifax, Nova Scotia, Canada. Electronic address: jafna.cox@dal.ca.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Foster', 'Affiliation': ""Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'MacKillop', 'Affiliation': 'Sydney Primary Care Medical Clinic, Sydney, Nova Scotia, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciaccia', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Shurjeel H', 'Initials': 'SH', 'LastName': 'Choudhri', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hamilton', 'Affiliation': 'QEII Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Nemis-White', 'Affiliation': 'Strive Health Management Consulting Ltd, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Departments of Anesthesia/Pediatrics, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, Centre for Evaluation of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute (PHRI), Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.019']
596,32305787,A prospective randomized controlled study of combined spinal-general anesthesia vs. general anesthesia for laparoscopic gynecological surgery: Opioid sparing properties.,"STUDY OBJECTIVE


We aimed to determine the magnitude of peri-operative opioid sparing effect when general anesthesia is combined with spinal analgesia for laparoscopic gynecological surgery.
DESIGN


A prospective randomized controlled study; a three-group trial with two comparisons (each intervention group to control).
SETTING


Operating room and postoperative recovery area.
PATIENTS


Patients aged between 18 and 65 years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20 min. Of 102 randomized patients, 99 completed the study.
INTERVENTIONS


Patients were randomized to general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75 mg; sufentanil 2.5 μg) or low-dose (levobupivacaine 7.5 mg; sufentanil 2.5 μg) spinal analgesia.
MEASUREMENTS


Primary endpoints were perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30 min, 1 h, 2 h, 4 h and 24 h post-surgery. Secondary endpoints were patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects.
MAIN RESULTS


Intra-operative sufentanil (median [95% CI]) consumption was 16.1 (10.5-22.6) μg/h in the control group versus 4.7 (3.2-9.2) μg/h in the very-low-dose and versus 2.9 (0.0-4.0) μg/h in the low-dose spinal analgesia groups (p < 0.001, for both comparisons). Median (95% CI) piritramide consumption at 24 h post-surgery was 7.5 (3-8) mg in the control group versus 5 (0-7.5) mg in the very-low dose spinal analgesia group (p = 0.182) and versus 2 (0-2.5) mg in the low-dose spinal analgesia group (p = 0.001). Postoperative pain scores were consistently <3 only in the low dose spinal analgesia group. Patient satisfaction with anesthetic care and participation in research was very high in all groups.
CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.",2020,"CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.","['102 randomized patients, 99 completed the study', 'laparoscopic gynecological surgery', 'Patients aged between 18 and 65\xa0years with American Society of Anesthesiologists physical status 1 or 2 who were scheduled for inpatient elective laparoscopic gynecological surgery with expected pneumoperitoneum duration of at least 20\xa0min']","['combined spinal-general anesthesia vs. general anesthesia', 'spinal analgesia', 'general anesthesia alone (control group) or combined with very-low-dose (levobupivacaine 3.75\xa0mg; sufentanil 2.5\xa0μg) or low-dose (levobupivacaine 7.5\xa0mg; sufentanil 2.5\xa0μg) spinal analgesia']","['Postoperative pain scores', 'perioperative opioid consumption and pain scores (11-point numeric rating scale) at 30\xa0min, 1\xa0h, 2\xa0h, 4\xa0h and 24\xa0h post-surgery', 'peri-operative opioid consumption', 'patient satisfaction with anesthetic care and participation in research, sevoflurane consumption and adverse effects', 'piritramide consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0031982', 'cui_str': 'Pirinitramide'}]",102.0,0.196443,"CONCLUSIONS


Low-dose spinal analgesia in combination with general anesthesia reduces peri-operative opioid consumption in laparoscopic gynecological surgery in immediate postoperative period.","[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia. Electronic address: markozdravkovic@gmail.com.'}, {'ForeName': 'Mirt', 'Initials': 'M', 'LastName': 'Kamenik', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Management, University Medical Centre Maribor, Ljubljanska ulica 5, 2000 Maribor, Slovenia; Faculty of Medicine, University of Maribor, Taborska ulica 8, 2000 Maribor, Slovenia.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109808']
597,32305794,Hemodynamic profiles with and without left uterine displacement: A randomized study in term pregnancies receiving subarachnoid blockade for cesarean delivery.,"STUDY OBJECTIVE


The aim of this study was to evaluate the effect of left uterine displacement (LUD) on maternal hemodynamic measures following subarachnoid blockade (SAB) for cesarean delivery (CD). The primary outcome was cardiac output (CO) differences between the LUD and non-LUD groups pre-delivery.
DESIGN


Prospective, randomized, controlled study.
SETTING


Obstetric operating room.
MATERIALS AND METHODS


We studied hemodynamic profiles in sixty healthy women with term pregnancies who underwent elective CD with SAB. Hemodynamics were measured using a non-invasive CO monitor, the Nexfin™. All women received a crystalloid 10 mL/kg preload, and hypotension was treated with ephedrine boluses.
INTERVENTIONS


Sixty women with term pregnancies were randomized into two groups: LUD group (received 15-30° LUD after SAB, n = 30) and non-LUD group (no LUD after SAB, n = 30).
MEASUREMENTS


Patient's hemodynamic variables including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), CO, systemic vascular resistance (SVR), and left ventricular contractility index (dP/dT) were measured continuously from pre-SAB until end of surgery.
MAIN RESULTS


In pre-delivery phase at 5 min after spinal anesthesia, the LUD group had significantly higher CO (7.20 ± 1.78 [95%CI 6.53-7.87] vs. 6.23 ± 1.44 L/min [95% CI 5.69-6.77]; p = 0.016) and higher dP/dT (784 ± 313 vs. 604 ± 241 mmHg/s; p = 0.020) than the non-LUD group. The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
CONCLUSIONS


The study demonstrates modest hemodynamic advantages (higher CO, less hypotension, higher dP/dT) with pre-delivery LUD. The results support maternal hemodynamic benefits of LUD until delivery in women with term pregnancies undergoing CD with SAB.",2020,"The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
","['sixty healthy women with term pregnancies who underwent elective CD with SAB', 'Sixty women with term pregnancies', 'Obstetric operating room', 'term pregnancies receiving subarachnoid blockade for cesarean delivery', 'women with term pregnancies undergoing CD with SAB', 'cesarean delivery (CD', '313 vs. 604\xa0±', '241', 'Hemodynamic profiles with and without left uterine displacement']","['ephedrine boluses', 'left uterine displacement (LUD', 'crystalloid 10\xa0mL/kg preload, and hypotension', 'subarachnoid blockade (SAB', 'LUD group (received 15-30° LUD after SAB, n\xa0=\xa030) and non-LUD']","['cardiac output (CO) differences', 'maternal hemodynamic measures', 'CO', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), CO, systemic vascular resistance (SVR), and left ventricular contractility index (dP/dT', 'maternal systolic hypotension']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",60.0,0.185135,"The LUD group had a lower incidence of maternal systolic hypotension at 5-min post-SAB (16.7% vs. 53.3% in non-LUD group, p = 0.003).
","[{'ForeName': 'Yanipan', 'Initials': 'Y', 'LastName': 'Chungsamarnyart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Petch', 'Initials': 'P', 'LastName': 'Wacharasint', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, USA. Electronic address: bcarvalho@stanford.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109796']
598,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128']
599,32199197,Evolving role of regorafenib for the treatment of advanced cancers.,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib. Regorafenib was initially approved for mCRC based on improved overall survival (OS) in the randomized, placebo-controlled, phase 3 CORRECT trial, which was confirmed in an expanded population of Asian patients in the randomized, placebo-controlled phase 3 CONCUR trial. Approvals in GIST, and more recently in HCC, were based on the results from the randomized, placebo-controlled, phase 3 GRID and RESORCE trials, respectively. In this review, we provide a comprehensive summary of the clinical evidence for approval of regorafenib in mCRC, GIST, and HCC, present emerging evidence of regorafenib activity in other tumor types (namely, gastroesophageal cancer, sarcomas, biliary tract cancer, and glioblastoma), and discuss trials in progress within the context of regorafenib's mechanism of action. We describe recent advances and key lessons learned with regorafenib, including the importance of managing common drug-related toxicities using dose-optimization strategies, the search for biomarkers to predict response to treatment, and highlight some of the unaddressed questions and future directions for regorafenib across tumors.",2020,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib.","['advanced cancers', 'refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on']","['regorafenib', 'placebo', 'sorafenib', 'Regorafenib', 'oral tyrosine kinase inhibitor (TKI']",['overall survival (OS'],"[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.175471,"Regorafenib is an oral tyrosine kinase inhibitor (TKI) approved for the treatment of refractory metastatic colorectal cancer (mCRC), advanced gastrointestinal stromal tumors (GIST) previously treated with imatinib and sunitinib, and unresectable hepatocellular carcinoma (HCC) following progression on sorafenib.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center, Germantown, TN, USA. Electronic address: agrothey@westclinic.com.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Léon Bérard Centre and Claude Bernard University, Lyon, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bruix', 'Affiliation': 'BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Barcelona, Spain.'}]",Cancer treatment reviews,['10.1016/j.ctrv.2020.101993']
600,32208176,The effects of short-term moderate intensity aerobic exercise and long-term detraining on electrocardiogram indices and cardiac biomarkers in postmenopausal women.,"OBJECTIVE


The purpose of this study was to investigate the effects of 12-week of moderate-intensity aerobic exercise and 5-month detraining on electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P) in postmenopausal women (PMWs).
MATERIALS AND METHODS


Thirty-one PMWs (aged 50-70 yrs) were randomized to exercise (EX, n = 16) and control (C, n = 15) groups. EX group performed of 12-week of warm up- walking/jogging moderate intensity aerobic exercise training program- recovery (60 min/day, 3 days/week at 70% of maximal heart rate reserve), and then 5-month detraining remained. C group maintain their normal lifestyle during 8 months. The ECG indices and cardiac serum levels were measured at baseline, after 12-week exercise, and after 5-month detraining.
RESULTS


After 12-week exercise intervention, P-R interval, serum PTH and serum Vit D were significantly increased in the EX group compared to the C group (P = 0.020, P = 0.001 and P = 0.001, respectively). After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
CONCLUSIONS


The results suggested that 12-week of moderate intensity aerobic exercise increased the P-R interval, PTH and Vit D, as severe Vit D deficiency status (below 10 ng/ml) improved to Vit D deficiency status (between 10 and 20 ng/ml) in PMWs. Also, long-term positive adaptations to aerobic exercise such as increased Vit D were observed even after 5-month detraining. In addition, P-R segment and S-T interval decreased after 5-month detraining in sedentary PMWs, which may be a sign of atrial positive adaptations to aerobic exercise.",2020,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","['postmenopausal women (PMWs', 'postmenopausal women', 'Thirty-one PMWs (aged 50-70\xa0yrs']","['warm up- walking/jogging moderate intensity aerobic exercise training program- recovery', 'exercise (EX', 'short-term moderate intensity aerobic exercise and long-term detraining', 'moderate-intensity aerobic exercise and 5-month detraining', 'moderate intensity aerobic exercise']","['Vit D', 'electrocardiogram (ECG) indices and serum levels of 25-hydroxivitamin D (Vit D), parathyroid hormone (PTH), calcium (Ca 2+ ), and phosphorus (P', 'ECG indices and cardiac serum levels', 'electrocardiogram indices and cardiac biomarkers', 'P-R interval, serum PTH and serum Vit D', 'serum Vit D', 'Vit D deficiency status', 'P-R segment and S-T interval', 'P-R interval, PTH and Vit D, as severe Vit D deficiency status']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0520879', 'cui_str': 'P-R segment, function (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0251744,"After 5-month detraining, P-R segment and S-T interval were significantly decreased (P = 0.042 and P = 0.001, respectively) while serum Vit D was significantly increased (P = 0.014) in the EX group compared to the C group.
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Exercise Physiology, Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Exercise Physiology, Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Fellowship of Balloon Angioplasty, Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Clinical Biochemistry, Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2020.03.004']
601,32217148,"Oleoylethanolamide supplementation in obese patients newly diagnosed with non-alcoholic fatty liver disease: Effects on metabolic parameters, anthropometric indices, and expression of PPAR-α, UCP1, and UCP2 genes.","The effects of oleoylethanolamide (OEA) on NAFLD are yet to be examined in human. The objective of the present study was to examine the effects of OEA supplementation along with weight loss intervention on the expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices among obese patients with NAFLD. In this triple-blind placebo-controlled randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group along with calorie-restricted diets for 12 weeks. At pre-and post-intervention phase, mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations were assessed. There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint. A significant decrease in the anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration was also observed in the OEA group, compared to the placebo group. OEA treatment significantly resulted in decreased serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations. Importantly, a significant improvement in TG, ALT, AST, ALT/AST, HDL-C levels as well as appetite sensations by OEA were under the influence of body mass index (BMI). Although liver steatosis severity was significantly reduced in both groups, the between-group differences did not reach statistical significance (P = 0.061). In conclusion, the present study, for the first time, revealed that OEA supplementation significantly improved anthropometric and metabolic risk factors related to NAFLD.",2020,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","['76 obese patients newly diagnosed with NAFLD', 'obese patients newly diagnosed with non-alcoholic fatty liver disease', 'obese patients with NAFLD']","['OEA', 'oleoylethanolamide (OEA', 'Oleoylethanolamide supplementation', 'placebo', 'OEA supplementation', 'OEA or placebo']","['liver steatosis severity', 'mRNA expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, serum levels of metabolic parameters as well as diet and appetite sensations', 'serum levels of triglyceride (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), ALT/AST, increased serum levels of high-density lipoprotein cholesterol (HDL-C), and improved appetite sensations', 'expression levels of PPAR-α, UCP1, and UCP2 genes', 'TG, ALT, AST, ALT/AST, HDL-C levels', 'anthropometric indices, energy and carbohydrate intakes, glycemic parameters, except for hemoglobin A1c concentration', 'expression of PPAR-α, uncoupling proteins 1and 2 (UCP1 and UCP2) genes in the peripheral blood mononuclear cells (PBMCs), metabolic parameters, and anthropometric indices', 'anthropometric and metabolic risk factors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",76.0,0.0855709,"There was a significant increase in the expression levels of PPAR-α, UCP1, and UCP2 genes in the PBMCs, compared to the placebo at the endpoint.","[{'ForeName': 'Helda', 'Initials': 'H', 'LastName': 'Tutunchi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: helda.nutrition@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ostadrahimi@tbzmed.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saghafi-Asl', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Saghafiaslm@gmail.com.'}, {'ForeName': 'Mohammad-Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mhosseinzadeh@tums.ac.ir.'}, {'ForeName': 'Abolhasan', 'Initials': 'A', 'LastName': 'Shakeri', 'Affiliation': 'Department of Radiology, Imam Reza Teaching Hospital, Clinical Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: shakeria@tbzmed.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: m.asghari862@gmail.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Neda.roshanravan10@gmail.com.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Farrin', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: nazilafarrin@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naemi', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Hasankhani', 'Affiliation': 'Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Pharmacological research,['10.1016/j.phrs.2020.104770']
602,32220760,Performance of PI-RADS v2 assessment categories assigned prior to MR-US fusion biopsy in a new fusion biopsy program.,"OBJECTIVE


To validate the performance of PI-RADS v2 for detection of clinically significant prostate cancer (csPca, Gleason ≥7) within the context of a new fusion biopsy program.
MATERIAL AND METHODS


Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified. Diagnostic performance of PI-RADS v2 was calculated using fusion biopsy results as reference standard using receiver operating characteristic curve analysis. Patient and lesion characteristics were analyzed with one-way ANOVA and Wilcoxon rank sum test.
RESULTS


Of 83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7. csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001). For prediction of csPCa, patient-level AUC was 0.68 and lesion-level AUC was 0.77. Biopsy threshold of PI-RADS ≥3 was 92.6% sensitive and 22.1% specific. A threshold of PI-RADS ≥4 was 87.2% sensitive and 58.1% specific. Rate of csPca detection on concurrent standard 12 core biopsy only was 6.7%.
CONCLUSION


PI-RADS v2 assessment categories assigned prior to biopsy predict pathologic outcome reasonably well in a new prostate fusion biopsy program. Biopsy threshold of PI-RADS ≥3 is highly sensitive. A threshold of ≥4 increases specificity but misses some csPCa.",2020,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","['Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified', '83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7']",['MR-US fusion biopsy'],"['csPCa rates', 'Diagnostic performance of PI-RADS', 'Rate of csPca detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]",83.0,0.0252138,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","[{'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Trent', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Graham.Trent@somalumni.umaryland.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ye', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Nancy.y.ye@kp.org.'}, {'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Chopra', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 100 North Greene Street, Suite 411, Baltimore, MD 21201, United States of America. Electronic address: rchen@umm.edu.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Wong-You-Cheong', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: jwong@umm.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naslund', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: mnaslund@som.umaryland.edu.'}, {'ForeName': 'Mohummad M', 'Initials': 'MM', 'LastName': 'Siddiqui', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: msiddiqui@som.umaryland.edu.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Wnorowski', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: AmeliaWnorowski@umm.edu.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.004']
603,32234313,Does misperception of fruit and vegetable intake adequacy affect progression through the stages of behavior change after nutritional intervention?,"Pseudomaintenance (PM) is a Transtheoretical Model (TTM) stage of change that refers to individuals who believe they eat enough fruit and vegetables (FV) despite their low FV intake. It is not known how they change behavior after usual TTM-based interventions. Thus, this randomized controlled community trial describes the effect of PM on progression through the stages of change for FV intake among adult and elderly health promotion service users after TTM-based intervention. The stage of change for FV intake was assessed; FV intake was estimated from brief validated questions at baseline (n = 3414) and follow-up (n = 1782). Individuals whose perception of adequacy matched the estimated intake were labeled as ""concordant perception,"" while those with low intake who believed that their intake was adequate were classified as being in PM. The intervention group received the intervention while the control group received usual care. The prevalence of ""no stage progression"" at follow-up was close to 50% for those in PM at baseline. After adjustment for demographics, randomization, self-efficacy, decisional balance, and baseline intake, users in PM at baseline had higher odds [OR = 1.53 (1.21-1.94)] of progressing to higher stages for fruit and no difference in progression for vegetables. We propose strategies to approach FV intake in future studies and reinforce the need for additional trials aimed at describing changes in FV intake among individuals in PM, in order to continue answering the scientific questions that we began to investigate.",2020,"The prevalence of ""no stage progression"" at follow-up was close to 50% for those in PM at baseline.",['adult and elderly health promotion service users after TTM-based intervention'],"['Pseudomaintenance (PM', 'intervention while the control group received usual care', 'PM']","['self-efficacy, decisional balance, and baseline intake, users in PM', 'prevalence of ""no stage progression', 'FV intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0477207,"The prevalence of ""no stage progression"" at follow-up was close to 50% for those in PM at baseline.","[{'ForeName': 'Maria Cecília Ramos de', 'Initials': 'MCR', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Federal de Minas Gerais, Grupo de Pesquisa de Intervenções em Nutrição, 190 Alfredo Balena Avenue, Nursing School, Room 316, Santa Efigênia, 30130-100, Belo Horizonte, MG, Brazil. Electronic address: ceciliaramosnutri@gmail.com.'}, {'ForeName': 'Mariana Carvalho de', 'Initials': 'MC', 'LastName': 'Menezes', 'Affiliation': 'Universidade Federal de Ouro Preto, Escola de Nutrição, Departamento de Nutrição Clínica e Social, Programa de Pós-Graduação em Saúde e Nutrição, Grupo de Pesquisa de Intervenções em Nutrição, Dois Street, Morro do Cruzeiro Campus, Nutrition School, Room 65, 35400-000, Ouro Preto, MG, Brazil. Electronic address: marysnut@gmail.com.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'Universidade de Brasilia, Faculdade de Ciências da Saúde, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição Humana, Darcy Ribeiro Campus, Health Sciences School, 70910-900, Brasília (North Wing), DF, Brazil. Electronic address: natachatoral@hotmail.com.'}, {'ForeName': 'Aline Cristine Souza', 'Initials': 'ACS', 'LastName': 'Lopes', 'Affiliation': 'Universidade Federal de Minas Gerais, Escola de Enfermagem, Departamento de Nutrição, Programa de Pós-Graduação em Nutrição e Saúde, Grupo de Pesquisa de Intervenções em Nutrição, 190 Alfredo Balena Avenue, Nursing School, Room 316, Santa Efigênia, 30130-100, Belo Horizonte, MG, Brazil. Electronic address: alinelopesenf@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104682']
604,32234531,Which strategies to manage problem foods were related to weight loss in a randomized clinical trial?,"Individuals managing their weight are often faced with problem foods that are difficult to resist eating. In the context of a weight-loss intervention, we characterized the most commonly reported problem foods and the behavioral strategies used to manage them, and examined which strategies were related to weight loss. Women with overweight and obesity (N = 186) participated in a one-year randomized trial of three interventions (NCT01474759): standard advice to eat less food, choosing portions based on energy density, and using pre-portioned foods. At Months 0, 6, and 12 of the trial, participants listed the foods they found most problematic and reported the frequency of using eight behavioral strategies to control intake of these foods, including three practices for avoiding exposure to problem foods and three for consuming them but limiting intake. The responses showed that 82% of the top three problem foods were in the categories of sweet baked items, salty snacks, starchy side dishes, chocolate and candy, and ice cream. After one year, women who reported more frequently using the strategy of limiting portions of problem foods had a greater rate of weight loss (kg/week), regardless of their intervention group (p < 0.0001). Among women who limited portions of problem foods less frequently, those using pre-portioned foods had greater initial weight loss compared to the other two groups, but then regained weight at a greater rate (p < 0.0001). The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss. These results suggest that adopting and maintaining strategies to manage portions of problem foods, rather than avoiding exposure to them, can be a more useful approach for weight loss.",2020,The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss.,['Women with overweight and obesity'],"['standard advice to eat less food, choosing portions based on energy density, and using pre-portioned foods']","['rate of weight loss', 'categories of sweet baked items, salty snacks, starchy side dishes, chocolate and candy, and ice cream', 'initial weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0020747', 'cui_str': 'Ice cream'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",186.0,0.0213008,The three avoidance strategies for problem foods were reported to be frequently used but were not found to be related to weight loss.,"[{'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Roe', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA. Electronic address: LSR7@psu.edu.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",Appetite,['10.1016/j.appet.2020.104687']
605,32246953,Teaching people to eat according to appetite - Does the method of glucose measurement matter?,"BACKGROUND


Hunger training teaches people to eat according to their appetite using pre-prandial glucose measurement. Previous hunger training interventions used fingerprick blood glucose, however continuous glucose monitoring (CGM) offers a painless and convenient form of glucose monitoring. The aim of this randomised feasibility trial was to compare hunger training using CGM with fingerprick glucose monitoring in terms of adherence to the protocol, acceptability, weight, body composition, HbA1c, psychosocial variables, and the relationship between adherence measures and weight loss.
METHODS


40 adults with obesity were randomised to either fingerpricking or scanning with a CGM and followed identical interventions for 6 months, which included 1 month of only eating when glucose was under their individualised glucose cut-off. For months 2-6 participants relied on their sensations of hunger to guide their eating and filled in a booklet.
RESULTS


90% of the fingerpricking group and 85% of the scanning group completed the study. Those using the scanner measured their glucose an extra 1.9 times per day (95% CI 0.9, 2.8, p < 0.001) compared with those testing by fingerprick. Both groups lost similar amounts of weight over 6 months (on average 4 kg), were satisfied with the hunger training program and wanted to measure their glucose again within the next year. There were no differences between groups in terms of intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health. Frequency of glucose testing and booklet entry both predicted a clinically meaningful amount of weight loss.
CONCLUSIONS


Either method of measuring glucose is effective for learning to eat according to hunger using the hunger training program. As scanning with a CGM encouraged better adherence to the protocol without sacrificing outcome results, future interventions should consider using this new technology in hunger training programs.",2020,"There were no differences between groups in terms of intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health.",['40 adults with obesity'],"['continuous glucose monitoring (CGM', 'hunger training using CGM with fingerprick glucose monitoring', 'fingerpricking or scanning with a CGM and followed identical interventions for 6 months, which included 1 month of only eating when glucose was under their individualised glucose cut-off']","['intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health', 'adherence to the protocol, acceptability, weight, body composition, HbA1c, psychosocial variables']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C1518543', 'cui_str': 'Off'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",40.0,0.0289517,"There were no differences between groups in terms of intervention acceptability, weight, body composition, HbA1c, eating behaviours, or psychological health.","[{'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Jospe', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: michelle.jospe@otago.ac.nz.'}, {'ForeName': 'Willemijn E', 'Initials': 'WE', 'LastName': 'de Bruin', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: w.debruin@otago.ac.nz.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Centre for Biostatistics, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: jill.haszard@otago.ac.nz.'}, {'ForeName': 'Jim I', 'Initials': 'JI', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: jim.mann@otago.ac.nz.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brunton', 'Affiliation': 'Information Technology Services, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: mark.brunton@otago.ac.nz.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, PO Box 56, Dunedin, 9054, New Zealand. Electronic address: rachael.taylor@otago.ac.nz.'}]",Appetite,['10.1016/j.appet.2020.104691']
606,32247156,Association between delirium prediction scores and days spent with delirium.,"PURPOSE


To determine the correlation and discriminative value of the E-PRE-DELIRIC and PRE-DELIRIC scores with delirium exposure to evaluate the prognostic value of both models.
METHODS


A secondary analysis of a randomized clinical trial enrolling 1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2 days. Days spent with delirium (≥1 positive CAM-ICU) or coma (≥1 RASS ≤-4) in the 28-days after ICU admission were calculated. Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium.
RESULTS


The correlation between the overall E-PRE-DELIRIC and PRE-DELIRIC scores and days spent with delirium were: R = 0.08 (P = .005) and R = 0.26 (P < .001), respectively. The correlation between both prediction scores and days spent with coma or delirium were R = 0.21 (P < .0001) and R = 0.46 (P < .0001), respectively. The highest Area Under the Receiver Operating Characteristic for both E-PRE-DELIRIC [0.57 (95% CI:0.51-0.62)] and PRE-DELIRIC [0.58 (95% CI:0.53-0.62)] was found in the long delirium exposure group.
CONCLUSION


The E-PRE-DELIRIC and PRE-DELIRIC model each poorly correlate and discriminate with days spent with delirium in the 28 days after ICU admission.",2020,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"['1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2\xa0days', 'Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium']",[],"['overall E-PRE-DELIRIC and PRE-DELIRIC scores', 'prediction scores and days spent with coma or delirium']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",1506.0,0.138306,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"[{'ForeName': 'Hidde', 'Initials': 'H', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'School of Pharmacy, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. Electronic address: Mark.vandenBoogaard@radboudumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.008']
607,32247219,Choosing endotracheal tube size in children: Which formula is best?,"OBJECTIVES


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


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


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


When using an endotracheal tube with a polyurethane cuff, the Duracher formula provided the best estimate for choosing the correct size.",2020,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
","['Patients', 'children', '135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender']","['cuffed endotracheal tubes', 'cuffed endotracheal tube for endotracheal intubation', 'three formulae (Duracher, Cole, or Khine']","['postoperative incidence of stridor, throat pain/soreness, and hoarseness', 'intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure', 'intracuff pressure', 'postoperative incidence of adverse events (throat pain, hoarseness, and stridor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C3809781', 'cui_str': 'Cole disease'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",135.0,0.0226457,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
","[{'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Manimalethu', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Krishna', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Shabana Z', 'Initials': 'SZ', 'LastName': 'Shafy', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: shabana.shafy@nationwidechildrens.org.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hakim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA; Department of Anesthesiology & Pain Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110016']
608,31951819,"D-cycloserine as adjunct to brief computerised CBT for spider fear: Effects on fear, behaviour, and cognitive biases.","BACKGROUND AND OBJECTIVES


In anxiety disorders, cognitive behavioural therapy (CBT) improves information-processing biases such as implicit fear evaluations and avoidance tendencies, which predicts treatment response. Thus, these cognitive biases might constitute important treatment targets. This study investigated (i) whether information-processing biases could be changed following single-session computerised CBT for spider fear, and (ii) whether this effect could be augmented by administration of D-cycloserine (DCS).
METHODS


Spider-fearful individuals were randomized to receiving either 250 mg of DCS (n = 21) or placebo (n = 17). Three hours after drug administration, they received single-session computerized CBT, characterized by psychoeducation and exposure elements. Spider fear was assessed using self-report, behavioural, and information processing (Extrinsic Affective Simon Task & Approach Avoidance Task) measures at baseline (before drug administration), post-treatment, 1-day, and 1-month follow-up.
RESULTS


Linear mixed-effects analyses indicated significant improvements on self-report and behavioural spider fear indices following CBT, but not on cognitive bias measures. There was no evidence of an augmentation effect of DCS on any outcome. Cognitive bias measures at 1-day were not predictive of 1-month follow-up spider fear in adjusted linear regression analyses.
LIMITATIONS


Results might be biased by limited representativeness of the sample (high education and intelligence, largely Caucasian ethnicity, young age). The study was also only powered for detection of medium-sized DCS effects.
CONCLUSIONS


These findings do not provide evidence for information-processing biases relating to treatment outcome following computerised CBT for spider fear or augmentation with DCS.",2020,These findings do not provide evidence for information-processing biases relating to treatment outcome following computerised CBT for spider fear or augmentation with DCS.,['Spider-fearful individuals'],"['cognitive behavioural therapy (CBT', 'DCS', 'placebo', '250\xa0mg of DCS']","['fear, behaviour, and cognitive biases', 'self-report and behavioural spider fear indices', 'self-report, behavioural, and information processing (Extrinsic Affective Simon Task & Approach Avoidance Task) measures', 'Cognitive bias measures']","[{'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C0443058', 'cui_str': 'Simon (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0560813,These findings do not provide evidence for information-processing biases relating to treatment outcome following computerised CBT for spider fear or augmentation with DCS.,"[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kappelmann', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Max Planck Institute of Psychiatry, Munich, Germany; International Max Planck Research School for Translational Psychiatry (IMPRS-TP), Munich, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Suesse', 'Affiliation': 'Oxford Institute of Clinical Psychology Doctorate Training, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Steudte-Schmiedgen', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Reinoud', 'Initials': 'R', 'LastName': 'Kaldewaij', 'Affiliation': 'Donders Institute for Brain, Cognition, and Behaviour, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Trust, Oxford, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Rinck', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. Electronic address: andrea.reinecke@psych.ox.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101546']
609,31638498,Mental performance in 8-year-old children fed reduced protein content formula during the 1st year of life: safety analysis of a randomised clinical trial.,"In humans, maximum brain development occurs between the third trimester of gestation and 2 years of life. Nutrition during these critical windows of rapid brain development might be essential for later cognitive functioning and behaviour. In the last few years, trends on protein recommendations during infancy and childhood have tended to be lower than that in the past. It remains to be demonstrated that lower protein intakes among healthy infants, a part of being able to reduce obesity risk, is safe in terms of mental performance achievement. Secondary analyses of the EU CHOP, a clinical trial in which infants from five European countries were randomised to be fed a higher or a lower protein content formula during the 1st year of life. Children were assessed at the age of 8 years with a neuropsychological battery of tests that included assessments of memory (visual and verbal), attention (visual, selective, focused and sustained), visual-perceptual integration, processing speed, visual-motor coordination, verbal fluency and comprehension, impulsivity/inhibition, flexibility/shifting, working memory, reasoning, visual-spatial skills and decision making. Internalising, externalising and total behaviour problems were assessed using the Child Behaviour Checklist 4-18. Adjusted analyses considering factors that could influence neurodevelopment, such as parental education level, maternal smoking, child's gestational age at birth and head circumference, showed no differences between feeding groups in any of the assessed neuropsychological domains and behaviour. In summary, herewith we report on the safety of lower protein content in infant formulae (closer to the content of human milk) according to long-term mental performance.",2019,"In the last few years, trends on protein recommendations during infancy and childhood have tended to be lower than that in the past.","['8-year-old children fed', 'healthy infants']","['EU CHOP', 'reduced protein content formula']","['Mental performance', 'Internalising, externalising and total behaviour problems', 'memory (visual and verbal), attention (visual, selective, focused and sustained), visual-perceptual integration, processing speed, visual-motor coordination, verbal fluency and comprehension, impulsivity/inhibition, flexibility/shifting, working memory, reasoning, visual-spatial skills and decision making', ""parental education level, maternal smoking, child's gestational age at birth and head circumference""]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0042828', 'cui_str': 'Visual Motor Coordination'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}]",,0.0777526,"In the last few years, trends on protein recommendations during infancy and childhood have tended to be lower than that in the past.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Escribano', 'Affiliation': 'Pediatrics Research Unit, Faculty of Medicine, Universitat Rovira i Virgili, IISPV, Reus, 43201, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Luque', 'Affiliation': 'Pediatrics Research Unit, Faculty of Medicine, Universitat Rovira i Virgili, IISPV, Reus, 43201, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Canals-Sans', 'Affiliation': 'Research Centre for Behavioural Assessment (CRAMC), Universitat Rovira i Virgili, IISPV, Tarragona, 43007, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ferré', 'Affiliation': 'Pediatrics Research Unit, Faculty of Medicine, Universitat Rovira i Virgili, IISPV, Reus, 43201, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Division of Nutritional Medicine and Metabolism, Hauner Children's Hospital, University of Munich Medical Centre, Munich, 80337, Germany.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Grote', 'Affiliation': ""Division of Nutritional Medicine and Metabolism, Hauner Children's Hospital, University of Munich Medical Centre, Munich, 80337, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': ""Division of Nutritional Medicine and Metabolism, Hauner Children's Hospital, University of Munich Medical Centre, Munich, 80337, Germany.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gruszfeld', 'Affiliation': ""Neonatal Intensive Care Unit and Department of Gastroenterology, Hepatology and Eating Disorders, Children's Memorial Health Institute, Warsaw, 04730, Poland.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Szott', 'Affiliation': ""Neonatal Intensive Care Unit and Department of Gastroenterology, Hepatology and Eating Disorders, Children's Memorial Health Institute, Warsaw, 04730, Poland.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Verduci', 'Affiliation': 'Department of Paediatrics, San Paolo Hospital, University of Milan, Milan, 20142, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Riva', 'Affiliation': 'Department of Paediatrics, San Paolo Hospital, University of Milan, Milan, 20142, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Brasselle', 'Affiliation': 'Department of Paediatrics, CHC St Vincent, Liège-Rocourt, 4000, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Poncelet', 'Affiliation': ""Department of Paediatrics, University Children's Hospital Queen Fabiola, Université Libre de Bruxelles, Brussels, Belgium.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Closa-Monasterolo', 'Affiliation': 'Pediatrics Research Unit, Faculty of Medicine, Universitat Rovira i Virgili, IISPV, Reus, 43201, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114515000768']
610,31675390,Bypassing the blues: Insomnia in the depressed post-CABG population.,"BACKGROUND


BACKGROUND: Recovery from coronary artery bypass graft (CABG) surgery often is complicated by depression and insomnia, resulting in poorer health-related quality of life and clinical outcomes. We explored the relationships among depression, insomnia, quality of life, and the impact of a collaborative care strategy on reducing insomnia in patients after CABG surgery.
METHODS


METHODS: Patients with a Patient Health Questionnaire score ≥10 were randomized to nurse-delivered collaborative care for depression (n = 150) or their physician’s usual care (n = 152). A convenience sample of patients without depression (n = 151) served as the control group. Using the Hamilton Depression Rating Scale sleep questions, we created an “insomnia index.”
RESULTS


RESULTS: At baseline, 63% of participants who were depressed vs 12% of those who were not depressed reported insomnia. Compared with usual care, fewer collaborative care participants reported insomnia at 8 months, and they tended to have a lower insomnia score (insomnia index change score −0.95 and −1.47, respectively; P = .05) with no time-by- randomization interaction, Cohen’s d = 0.22 (95% confidence interval, −0.001 to 0.43). Participants with baseline insomnia reported greater improvements in mental health–related quality of life (Medical Outcomes Survey 36-item Short Form Mental Component Summary score; −3.32, P = .02), but insomnia was not a significant moderator of the effect of collaborative care.
CONCLUSIONS


CONCLUSIONS: This is the first study to examine the long-term impact on insomnia among post-CABG patients treated for depression. Future collaborative care studies could consider including a therapeutic focus for insomnia.",2020,"Short Form Mental Component Summary score; -3.32, P = .02), but insomnia was not a significant moderator of the effect of collaborative care.
","['patients without depression (n = 151) served as the control group', 'Patients with a Patient Health Questionnaire score ≥10', 'patients after CABG surgery', 'insomnia among post-CABG patients treated for depression', 'Participants with baseline insomnia']","[""nurse-delivered collaborative care for depression (n = 150) or their physician's usual care"", 'coronary artery bypass graft (CABG) surgery']","['insomnia', 'Hamilton Depression Rating Scale sleep questions', 'mental health-related quality of life ', 'insomnia score (insomnia index change score', 'insomnia index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.126656,"Short Form Mental Component Summary score; -3.32, P = .02), but insomnia was not a significant moderator of the effect of collaborative care.
","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Waterman', 'Affiliation': ''}, {'ForeName': 'Bea Herbeck', 'Initials': 'BH', 'LastName': 'Belnap', 'Affiliation': ''}, {'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Gebara', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': ''}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Western Psychiatric Institute and Clinic, Pittsburgh, PA, 15213 USA. E-MAIL: karpjf@upmc.edu'}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
611,32247220,Surgical resection of macrocystic lymphatic malformations of the head and neck: Short and long-term outcomes.,"BACKGROUND


Controversy exists on management of lymphatic malformations, with schools of thought advocating for observation, surgery or sclerotherapy. This study sought to examine outcomes after surgical resection of pediatric cervicofacial macrocystic lymphatic malformations (MLM).
METHODS


Case series with planned data collection on pediatric patients with cervicofacial MLM who underwent surgical resection at a tertiary referral center for vascular anomalies from January 1995 to June 2016. For consistency in patient population analysis, patients who had pre-surgical sclerotherapy or had mixed or microcystic disease were excluded. The main outcome was complete response rate (CR) and long-term recurrence-free survival (RFS).
RESULTS


Sixty-three patients who underwent excision of MLM were included, 52.4% were female, 77.8% Caucasian. The majority had de Serres stage I-III (96.8%) affecting the neck (71.4%). Patients were discharged the same day (28.6%), or had a 1 day median length-of-stay (interquartile range (IQR) = 2). Surgical complications included seroma/hematoma (9.5%), transient nerve weakness (facial nerve, sympathetic chain, or phrenic nerve, 6.3%), and infection (1.6%). On long-term follow-up (median: 12 months, IQR 1-43 months), a single surgery achieved CR in 90.5% of patients. RFS was achieved in 86% of patients in our observation period of up to 15 years. Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively).
CONCLUSIONS


Surgery is safe and effective as first line treatment for selected MLM. For stage I-III MLM CR and long-term RFS can be achieved with a single surgery. A direct and randomized comparison of treatment modalities is needed.",2020,"Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively).
","['pediatric patients with cervicofacial MLM who underwent surgical resection at a tertiary referral center for vascular anomalies from January 1995 to June 2016', 'Surgical resection of macrocystic lymphatic malformations of the head and neck', 'patient population analysis, patients who had pre-surgical sclerotherapy or had mixed or microcystic disease were excluded', 'Sixty-three patients who underwent excision of MLM were included, 52.4% were female, 77.8% Caucasian']",[],"['transient nerve weakness (facial nerve, sympathetic chain, or phrenic nerve, 6.3%), and infection', 'seroma/hematoma', 'bilaterality, advanced staging, and partial response', 'complete response rate (CR) and long-term recurrence-free survival (RFS', 'RFS']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2314896', 'cui_str': 'FAMMM'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0158570', 'cui_str': 'Vascular malformation'}, {'cui': 'C0398368', 'cui_str': 'Lymphatic malformation'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C0228972', 'cui_str': 'Sympathetic trunk structure'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",63.0,0.129015,"Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively).
","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bonilla-Velez', 'Affiliation': ""Division of Pediatric Otolaryngology and Center for the Investigation of Congenital Aberrancies of Vascular Development, Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, USA; Department of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W Markham St #543, Little Rock, AR, USA. Electronic address: juliana.bonilla-velez@seattlechildrens.org.""}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Moore', 'Affiliation': 'College of Medicine, University of Arkansas for Medical Sciences, 4301 W Markham St #550, Little Rock, AR, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': 'Department of Pediatrics and Biostatistics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckmiller', 'Affiliation': ""Baylor College of Medicine. 1 Baylor Plaza, Houston, TX, USA; Children's Hospital of San Antonio, 333 N Santa Rosa St, San Antonio, TX, USA.""}, {'ForeName': 'Gresham T', 'Initials': 'GT', 'LastName': 'Richter', 'Affiliation': ""Division of Pediatric Otolaryngology and Center for the Investigation of Congenital Aberrancies of Vascular Development, Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, USA; Department of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W Markham St #543, Little Rock, AR, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110013']
612,32251766,Temperament profiles are associated with dietary behavior from childhood to adulthood.,"BACKGROUND AND OBJECTIVES


Temperament may be associated with eating behaviors over the lifespan. This study examined the association of toddlerhood temperament with dietary behavior and dietary intervention outcomes across 18 years.
METHODS


The study comprised 660 children (52% boys) from The Special Turku Intervention Project (STRIP), which is a longitudinal randomized controlled trial from the age of 7 months until the age of 20 years (1990-2010). Temperament was assessed using Carey temperament scales when the participants were 2 years of age. Latent profile analysis yielded three temperament groups, which were called negative/low regulation (19% of the children), neutral/average regulation (52%) and positive/high regulation (28%). Dietary behavior was examined from 2 to 20 years of age using food records, which were converted into a diet score (mean = 15.7, SD 4.6). Mixed random-intercept growth curve analysis was the main analytic method.
RESULTS


Dietary behavior showed a significant quadratic U-shaped curve over time (B for quadratic association = 0.39, P<.001; B for linear association = 0.09, P = 0.58). Children in the negative/low regulation temperament group had a lower diet score (less healthy diet) across the 18 years compared to children in the neutral/average or in the positive/high regulation group. Temperament was not associated with the rate of change in diet over time. Temperament did not have any interactive effects with the intervention (F [2, 627], P = 0.72).
CONCLUSION


Children with a temperament profile characterized by high negative mood, high irregularity and high intensity in emotion expression constitute a risk group for less healthy eating over the lifespan.",2020,"Temperament did not have any interactive effects with the intervention (F [2, 627], P = 0.72).
","['18 years', '660 children (52% boys) from The Special Turku Intervention Project (STRIP), which is a longitudinal randomized controlled trial from the age of 7 months until the age of 20 years (1990-2010']",[],"['lower diet score', 'Carey temperament scales', 'Dietary behavior']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",660.0,0.0437514,"Temperament did not have any interactive effects with the intervention (F [2, 627], P = 0.72).
","[{'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Lipsanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Elovainio', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland; National Institute for Health and Welfare, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hakulinen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Tremblay', 'Affiliation': 'Healthy Active Living and Obesity Research Group, CHEO Research Institute, Ottawa, Canada.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Rovio', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Department of Public Health, University of Turku, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Jaakkola', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'National Institute for Health and Welfare, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Institute of Biomedicine, University of Turku, Department of Pediatrics and AdolescentMedicine, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Department of Medicine, University of Turku and Division of Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland; Centre for Population Health Research, University of Turku and Turku University Hospital, Finland; Department of Clinical Physiology and Nuclear Medicine, Turku University Hospital, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland; Paavo Nurmi Centre, Sports & Exercise Medicine Unit, Department of Health and Physical Activity, University of Turku, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pulkki-Råback', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Finland; Research Centre for Child Psychiatry, Faculty of Medicine, University of Turku, Finland. Electronic address: laura.pulkki-raback@helsinki.fi.'}]",Appetite,['10.1016/j.appet.2020.104681']
613,32251871,"Public opinion and legislations related to brain death, circulatory death and organ donation.","BACKGROUND


It is poorly understood how public perception of the difference between brain death and circulatory death may influence attitudes towards organ donation. We investigated the public opinion on brain death versus circulatory death and documented inconsistencies in the legislations of countries with different cultural and socioeconomic backgrounds.
METHODS


Using a crowdsourcing approach, we randomized 1072 participants from 30 countries to a case report of organ donation after brain death or to one following circulatory death. Further, we sampled guidelines from 24 countries and 5 continents.
RESULTS


Of all participants, 73% stated they would be willing to donate all organs, while 16% would want to donate some of their organs. To increase the rate of donations, 47% would agree with organ donation without family consent as the default. Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11). However, participants exposed to ""circulatory death"" were more certain that the patient was truly dead (87.9% ± 19.7%) than participants exposed to ""brain death"" (84.1% ± 22.7%; Cohen's d 0.18; p = 0:004). Sampling of guidelines revealed large differences between countries regarding procedures required to confirm brain death and circulatory death, respectively.
CONCLUSIONS


Implementation of organ donation after circulatory death is unlikely to negatively influence the willingness to donate organs, but legislation is still brain death-based in most countries. The time seems ripe to increase the rate of circulatory death-based organ donation.",2020,"Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11).","['24 countries and 5 continents', '1072 participants from 30 countries to a case report of organ donation after brain death or to one following circulatory death']",[],"['rate of circulatory death-based organ donation', 'rate of donations', 'brain death and circulatory death', 'circulatory death']","[{'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",[],"[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}]",1072.0,0.124868,"Exposure to ""brain death"" was not associated with a lesser likelihood of participants agreeing with organ donation (82.1%) compared to ""circulatory death"" (81.9%; relative risk 1.02, 95% CI 0.99 to 1.03; p = .11).","[{'ForeName': 'Marwan H', 'Initials': 'MH', 'LastName': 'Othman', 'Affiliation': 'Departments of Neurology, Rigshospitalet, Copenhagen University Hospital, Denmark.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Department of Biomedical Engineering, University at Buffalo, State University of New York, NY, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kondziella', 'Affiliation': 'Departments of Neurology, Rigshospitalet, Copenhagen University Hospital, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: daniel.kondziella@regionh.dk.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116800']
614,32332669,Adductor canal block versus periarticular infiltration for pain control following total knee arthroplasty: Study protocol for a randomized controlled trial.,"BACKGROUND


Periarticular infiltration (PAI) and adductor canal block (ACB) have become popular modes of pain management after total knee arthroplasty. The purpose of our study is to evaluate the efficacy of ACB in comparison with PAI for pain control in patients undergoing primary total knee arthroplasty.
METHODS


This study is a prospective, 2-arm, parallel-group, open-label randomized controlled trial that is conducted at a single university hospital in China. A total of 120 patients who meet inclusion criteria are randomized in a ratio of 1:1 to either ACB or PAI group. The primary outcome is visual analog scale score at rest 24 hours after surgery, whereas the secondary outcomes include visual analog scale score at 48 hours after surgery, satisfaction, opioid consumption, and complications. All pain scores are assessed by an independent observer who is blinded to the allocation of groups.
RESULTS


This study has limited inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is expected to provide evidence of better therapy for the pain management after total knee arthroplasty.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5410).",2020,"The primary outcome is visual analog scale score at rest 24 hours after surgery, whereas the secondary outcomes include visual analog scale score at 48 hours after surgery, satisfaction, opioid consumption, and complications.","['total knee arthroplasty', 'patients undergoing primary total knee arthroplasty', 'single university hospital in China', '120 patients who meet inclusion criteria']","['Adductor canal block versus periarticular infiltration', 'adductor canal block (ACB', 'ACB or PAI', 'ACB']","['visual analog scale score at 48\u200ahours after surgery, satisfaction, opioid consumption, and complications', 'All pain scores', 'visual analog scale score at rest 24\u200ahours after surgery']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",120.0,0.330022,"The primary outcome is visual analog scale score at rest 24 hours after surgery, whereas the secondary outcomes include visual analog scale score at 48 hours after surgery, satisfaction, opioid consumption, and complications.","[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Ningbo No.6 Hospital, Zhejiang Province, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019903']
615,32332670,"Effects of Photobiomodulation in Children with Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial: Study protocol clinical trial (SPIRIT compliant).","Hypotonia, particularly of the masticatory and oropharyngeal muscles, is 1 of the main characteristics of Down Syndrome (DS), resulting in impaired speech, chewing and swallowing. Moreover, the complete or partial obstruction of the airways during sleep may occur due to hypotonia of the tongue, leading to snoring and sleep disorders, such as obstructive apnea and sleep bruxism. OBJECTIVE:: Analyze salivary levels of dopamine and cortisol and muscle activity before and after treatment with low-level laser therapy administered to acupoints in children with DS. METHODS:: A randomized, controlled, clinical trial will be conducted. Individuals 4 to 17 years of age with a diagnosis of DS and possible sleep bruxism will be screened at the Integrated Health Clinic of Nove de Julho University. We will evaluate orofacial dysfunction (Nordic Orofacial Test - Screening questionnaire), Masseter muscle activity during sleep will be assessed by BiteStrip and the masticatory muscles will be evaluated by electromyography (BTS TMJOINT) head posture as well as salivary cortisol and dopamine. After the evaluations, the participants will be randomized into 2 groups: Grupo 1 - treatment with low-level laser therapy at a wavelength of 808 nm; Group 2 - sham treatment (simulated laser therapy). Treatment will be conducted twice per week for a total of 12 sessions. The data will be tabulated and treated using GraphPad Prism version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation. The ANOVA 2-way will be used for comparisons between the groups, with the significance level set to 5% (P < .05).ClinicalTrials registration number: NCT04211870.",2020,"Hypotonia, particularly of the masticatory and oropharyngeal muscles, is 1 of the main characteristics of Down Syndrome (DS), resulting in impaired speech, chewing and swallowing.","['Individuals 4 to 17 years of age with a diagnosis of DS and possible sleep bruxism will be screened at the Integrated Health Clinic of Nove de Julho University', 'Children with Down Syndrome and Possible Sleep Bruxism', 'children with DS']","['low-level laser therapy', 'Photobiomodulation', 'Grupo 1 - treatment with low-level laser therapy at a wavelength of 808\u200anm; Group 2 - sham treatment (simulated laser therapy']",['salivary levels of dopamine and cortisol and muscle activity'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.110042,"Hypotonia, particularly of the masticatory and oropharyngeal muscles, is 1 of the main characteristics of Down Syndrome (DS), resulting in impaired speech, chewing and swallowing.","[{'ForeName': 'Mônica da Consolação Canuto', 'Initials': 'MDCC', 'LastName': 'Salgueiro', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Marcela Letícia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Andréa Oliver', 'Initials': 'AO', 'LastName': 'Gomes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Marcelo Mendes', 'Initials': 'MM', 'LastName': 'Pinto', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Carolina Carvalho', 'Initials': 'CC', 'LastName': 'Bortoletto', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Olga Maria', 'Initials': 'OM', 'LastName': 'Altavista', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Alessandro Melo', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Daniela de Fátima Teixeira da', 'Initials': 'DFTD', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Elaine Marcilio', 'Initials': 'EM', 'LastName': 'Santos', 'Affiliation': 'Universidade Metropolitana de Santos, UNIMES, Santos.'}, {'ForeName': 'Paula Midori', 'Initials': 'PM', 'LastName': 'Castelo', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Diadema, SP, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo.'}]",Medicine,['10.1097/MD.0000000000019904']
616,32332672,Continuous versus single shot adductor canal block for postoperative pain relief after total knee arthroplasty: A protocol for randomized controlled trial.,"BACKGROUND


Adductor canal block has become a popular mode of pain management after total knee arthroplasty. This study compared a single-injection adductor canal block (SACB) with continuous adductor canal block (CACB). The hypothesis was that the 2 groups would have equivalent analgesia at 48 hours post-neural blockade.
METHODS


This is a double-blinded, randomized, controlled, equivalency trial that is conducted at a single university hospital in China. A total of 60 patients who meet inclusion criteria are randomized in a ratio of 1:1 to either CACB (0.5% ropivacaine 20 mL followed by continuous infusion of 0.2% ropivacaine at 5 mL/h for 48 hours) or SACB (0.5% ropivacaine 20 mL) group. The primary outcome is pain scores at 48 hours utilizing the visual analog scale, whereas the secondary outcomes include opioid consumption, Timed Up & Go test, ambulation distances at discharge, length of stay, and maximal flexion at discharge. All pain scores are assessed by an independent observer who is blinded to the allocation of groups.
RESULTS


This study has limited inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is expected to provide evidence of better therapy for the pain management after total knee arthroplasty.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5431).",2020,This study compared a single-injection adductor canal block (SACB) with continuous adductor canal block (CACB).,"['60 patients who meet inclusion criteria', 'after total knee arthroplasty', 'single university hospital in China', 'total knee arthroplasty']","['SACB (0.5% ropivacaine', 'CACB', 'ropivacaine 20\u200amL followed by continuous infusion of 0.2% ropivacaine', 'single-injection adductor canal block (SACB) with continuous adductor canal block (CACB', 'Continuous versus single shot adductor canal block']","['postoperative pain relief', 'opioid consumption, Timed Up & Go test, ambulation distances at discharge, length of stay, and maximal flexion at discharge', 'All pain scores', 'pain scores at 48\u200ahours utilizing the visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.630888,This study compared a single-injection adductor canal block (SACB) with continuous adductor canal block (CACB).,"[{'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Qingjun', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Department of Orthopedics Centre.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Medicine, Sunshine Union Hospital, Shandong, China.'}]",Medicine,['10.1097/MD.0000000000019918']
617,31739249,Attentional bias modification with a new paradigm: The effect of the Detection Engagement and Savoring Positivity (DESP) task on eye-tracking of attention.,"BACKGROUND AND OBJECTIVES


We tested the effect of a new Attentional Bias Modification (ABM) task - the Detection Engagement and Savoring Positivity (DESP) task - on attentional biases. The DESP is innovative in that it involves a procedure of savoring the positivity of various pictures.
METHODS


Participants were randomly assigned to the DESP or to a placebo control condition (experiment 1; n = 38) or a condition controlling for savoring (experiment 2; n = 54) in a pre-post/training experimental design. During one week, the participants completed the DESP or the control task once a day between three and six times. We assessed the effects of the DESP task on various attentional biases (i.e. positive, negative and threat) by computing dwell time from an eye-tracking technology before and after the training, and also one week after the post-training session in experiment 2.
RESULTS


In both experiments, the attentional bias toward positive stimuli between the pre- and the post-training increased significantly more in the DESP task condition than in the control conditions. Negative and threat attentional biases were not significantly affected by the experimental manipulations. Experiment 2 revealed that the DESP task - including the savoring instruction - increased significantly more the positive attentional bias than a task excluding this step and that this effect remained significant one week after the post-training session.
LIMITATIONS


Our samples were mainly composed of women participants. This prevents generalization of the findings.
CONCLUSIONS


The DESP task offers promising perspectives for sustainably improving attention to positive information.",2020,Negative and threat attentional biases were not significantly affected by the experimental manipulations.,['Participants'],"['Detection Engagement and Savoring Positivity (DESP) task', 'DESP task', 'new Attentional Bias Modification (ABM) task - the Detection Engagement and Savoring Positivity (DESP) task ', 'DESP', 'placebo control condition (experiment 1; n\u202f=\u202f38) or a condition controlling for savoring (experiment 2; n\u202f=\u202f54) in a pre-post/training experimental design']","['attentional bias toward positive stimuli', 'DESP task condition', 'Negative and threat attentional biases', 'DESP task - including the savoring instruction ', 'various attentional biases', 'positive attentional bias']",[],"[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]",,0.030815,Negative and threat attentional biases were not significantly affected by the experimental manipulations.,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Corman', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Aubret', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ghazal', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Berthon', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chausse', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lohou', 'Affiliation': 'Université Clermont Auvergne (UCA), CNRS, SIGMA Clermont, Institut Pascal, Clermont-Ferrand, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Dambrun', 'Affiliation': 'Université Clermont-Auvergne (UCA), UMR CNRS 6024, LAPSCO, Clermont-Ferrand, France. Electronic address: michael.dambrun@uca.fr.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101525']
618,31305282,A Randomized Controlled Trial Evaluating the BREASTChoice Tool for Personalized Decision Support About Breast Reconstruction After Mastectomy.,"OBJECTIVE


To evaluate a web-based breast reconstruction decision aid, BREASTChoice.
SUMMARY AND BACKGROUND DATA


Although postmastectomy breast reconstruction can restore quality of life and body image, its morbidity remains substantial. Many patients lack adequate knowledge to make informed choices. Decisions are often discordant with patients' preferences.
METHODS


Adult women with stages 0-III breast cancer considering postmastectomy breast reconstruction with no previous reconstruction were randomized to BREASTChoice or enhanced usual care (EUC).
RESULTS


Three hundred seventy-six patients were screened; 120 of 172 (69.8%) eligible patients enrolled. Mean age = 50.7 years (range 25-77). Most were Non-Hispanic White (86.3%) and had a college degree (64.3%). Controlling for health literacy and provider seen, BREASTChoice users had higher knowledge than those in EUC (84.6% vs. 58.2% questions correct; P < 0.001). Those using BREASTChoice were more likely to know that reconstruction typically requires more than 1 surgery, delayed reconstruction lowers one's risk, and implants may need replacement over time (all ps < 0.002). BREASTChoice compared to EUC participants also felt more confident understanding reconstruction information (P = 0.009). There were no differences between groups in decisional conflict, decision process quality, shared decision-making, quality of life, or preferences (all ps > 0.05). There were no differences in consultation length between BREASTChoice and EUC groups (mean = 29.7 vs. 30.0 minutes; P > 0.05). BREASTChoice had high usability (mean score = 6.3/7). Participants completed BREASTChoice in about 27 minutes.
CONCLUSIONS


BREASTChoice can improve breast reconstruction decision quality by improving patients' knowledge and providing them with personalized risk estimates. More research is needed to facilitate point-of-care decision support and examine BREASTChoice's impact on patients' decisions over time.",2020,"There were no differences between groups in decisional conflict, decision process quality, shared decision-making, quality of life, or preferences (all ps > 0.05).","['Adult women with stages 0-III breast cancer considering postmastectomy breast reconstruction with no previous reconstruction', 'Three hundred seventy-six patients were screened; 120 of 172 (69.8%) eligible patients enrolled', 'Mean age = 50.7 years (range 25-77']","['BREASTChoice or enhanced usual care (EUC', 'BREASTChoice']","['decisional conflict, decision process quality, shared decision-making, quality of life, or preferences', 'breast reconstruction decision quality', 'consultation length']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",[],"[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0034380'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",376.0,0.0456635,"There were no differences between groups in decisional conflict, decision process quality, shared decision-making, quality of life, or preferences (all ps > 0.05).","[{'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Clara N', 'Initials': 'CN', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sydney E', 'Initials': 'SE', 'LastName': 'Philpott-Streiff', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Randi E', 'Initials': 'RE', 'LastName': 'Foraker', 'Affiliation': 'Division of General Medical Sciences, Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Olsen', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Merrill', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}]",Annals of surgery,['10.1097/SLA.0000000000003444']
619,31982416,Computer-assisted motivational interviewing for contraceptive use in women leaving prison: A randomized controlled trial.,"OBJECTIVES


Rates of unintended pregnancies in women with a history of incarceration are high and access to contraception before and after arrest can be limited. Individualized counseling can better prepare women for healthy pregnancy or provide an opportunity for contraceptive education and access within correctional facilities. In this study, we assessed the efficacy of motivational interviewing as an individualized intervention to increase the initiation of contraceptive methods while incarcerated and continuation after release in female inmates who wanted to avoid pregnancy for at least one year after release.
STUDY DESIGN


We performed an RCT in a population of incarcerated women who wanted to avoid pregnancy. Women were randomized to either a computer-assisted motivational interviewing intervention group (n = 119) or an educational video with counseling control group. (n = 113). The primary outcome was initiation of a method of birth control prior to release from the correctional facility.
RESULTS


Initiation of contraception was higher in the intervention group (56% vs. 42%, p = 0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration. There was no difference between the groups in the rates of pregnancies or STIs or continuation of contraception after release, which was generally low (21%).
CONCLUSION


Computer-assisted motivational interviewing did not improve uptake or continuation of contraception in this study.
IMPLICATIONS


Periods of incarceration provide an opportunity to offer contraceptive services to women who want to avoid a pregnancy. Motivational interviewing may not be an effective method to affect contraceptive behaviors in this population. Future research should explore the family planning values and preferences of women who become involved with the correctional system.",2020,"RESULTS


Initiation of contraception was higher in the intervention group (56% vs. 42%, p=0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration.","['women with a history of incarceration', 'Women', 'Leaving Prison', 'female inmates who wanted to avoid pregnancy for at least one year after release', 'population of incarcerated women who wanted to avoid pregnancy']","['Computer-assisted motivational interviewing', 'computer-assisted motivational interviewing intervention group (n=119) or an educational video with counseling control group', 'motivational interviewing', 'Individualized counseling', 'Computer-Assisted Motivational Interviewing']","['uptake or continuation of contraception', 'rates of pregnancies or STIs or continuation of contraception', 'Initiation of contraception', 'initiation of a method of birth control prior to release from the correctional facility']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392751', 'cui_str': 'Incarcerated (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C3838863', 'cui_str': 'Initiation of contraception (regime/therapy)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0442681', 'cui_str': 'Penal institution (environment)'}]",,0.137903,"RESULTS


Initiation of contraception was higher in the intervention group (56% vs. 42%, p=0.03), but this difference was not significant after controlling for number of male partners within the year prior to incarceration.","[{'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Brousseau', 'Affiliation': 'Warren Alpert Medical School of Brown University, Women & Infants Hospital, 101 Dudley Street, Providence, RI 02905, USA. Electronic address: ebrousseau@wihri.org.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Clarke', 'Affiliation': 'Warren Alpert Medical School of Brown University, Women & Infants Hospital, 101 Dudley Street, Providence, RI 02905, USA; Rhode Island Department of Corrections, Medical Program Director, 39 Howard Avenue, Cranston, RI 02920, USA. Electronic address: Jennifer_clarke@doc.ri.gov.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dumont', 'Affiliation': 'Rhode Island Department of Health, Division of Community Health & Equity, 3 Capitol Hill, Providence, RI, 02908, USA. Electronic address: dora.dumont@health.ri.gov.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'University of Rhode Island, Department of Psychology, 306 Chafee Hall, 142 Flagg Road, Kingston, RI 02881, USA. Electronic address: LARStein@uri.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roberts', 'Affiliation': 'Brown University Center for Primary Care & Prevention, Memorial Hospital of Rhode Island, USA. Electronic address: MRoberts@carene.org.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van den Berg', 'Affiliation': 'School of Public Health, Brown University, Center for Alcohol & Addiction Studies, Department of Behavioral & Social Sciences, 121 South Main Street, Providence, RI 02912, USA. Electronic address: Jacob_vandenberg@brown.edu.'}]",Contraception,['10.1016/j.contraception.2020.01.004']
620,32155470,Effects of the video game 'Mindlight' on anxiety of children with an autism spectrum disorder: A randomized controlled trial.,"BACKGROUND AND OBJECTIVES


In the clinical setting, a large proportion of children with an autism spectrum disorder (ASD) experience impairing anxiety symptoms. Recently, an applied videogame called Mindlight has been developed that focuses on decreasing anxiety in children. The present study involved a randomized controlled trial (RCT) investigating the effect of Mindlight on (sub)clinical anxiety symptoms in children with an ASD.
METHODS


In total, 109 children of 8-16 years old with an ASD and (sub)clinical anxiety symptoms were randomly assigned to the experimental (N = 53) or the control (N = 56) condition. Children in the experimental condition played Mindlight, children in the control condition played a commercial game (Triple Town) for 1 h per week, for six consecutive weeks. All children and parents completed assessments at baseline, post-intervention and 3-months follow-up.
RESULTS


Results showed no differences in decrease of child-rated anxiety symptoms between both conditions. However, the decrease of parent-rated anxiety symptoms was significantly larger in the experimental condition.
LIMITATIONS


Mechanisms of change associated with treatment outcomes were not investigated in the present study. Therefore, it remains unclear which specific or non-specific factors contributed to the decrease in anxiety symptoms in both conditions.
CONCLUSIONS


The present study provided some preliminary evidence that video games are a promising new intervention vehicle for children with an ASD and anxiety, at least according to parents. However, further research on working mechanisms is needed, in order to specify to what extent and for which children with ASD Mindlight could be an effective anxiety treatment.",2020,"RESULTS


Results showed no differences in decrease of child-rated anxiety symptoms between both conditions.","['children with an autism spectrum disorder', 'children with an ASD and anxiety, at least according to parents', 'children', 'children with an ASD', 'children with an autism spectrum disorder (ASD) experience impairing anxiety symptoms', '109 children of 8-16 years old with an ASD and (sub)clinical anxiety symptoms']","[""video game 'Mindlight"", 'Mindlight']","['parent-rated anxiety symptoms', 'anxiety symptoms', 'child-rated anxiety symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",109.0,0.105935,"RESULTS


Results showed no differences in decrease of child-rated anxiety symptoms between both conditions.","[{'ForeName': 'Lieke A M W', 'Initials': 'LAMW', 'LastName': 'Wijnhoven', 'Affiliation': 'Mental Health Care Institute GGZ Oost-Brabant, P.O. Box 3, 5427, ZG, Boekel, the Netherlands; Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands. Electronic address: l.wijnhoven@pwo.ru.nl.'}, {'ForeName': 'Daan H M', 'Initials': 'DHM', 'LastName': 'Creemers', 'Affiliation': 'Mental Health Care Institute GGZ Oost-Brabant, P.O. Box 3, 5427, ZG, Boekel, the Netherlands; Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands. Electronic address: d.creemers@ggzoostbrabant.nl.'}, {'ForeName': 'Ad A', 'Initials': 'AA', 'LastName': 'Vermulst', 'Affiliation': 'Mental Health Care Institute GGZ Oost-Brabant, P.O. Box 3, 5427, ZG, Boekel, the Netherlands. Electronic address: a.vermulst@home.nl.'}, {'ForeName': 'Ramón J L', 'Initials': 'RJL', 'LastName': 'Lindauer', 'Affiliation': 'Mental Health Care Institute De Bascule, P.O. Box 303, 1115, ZG, Duivendrecht, the Netherlands; Faculty of Medicine, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, the Netherlands. Electronic address: r.lindauer@debascule.com.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands; Mental Health Care Institute Pluryn, P.O. Box 53, 6500, AB, Nijmegen, the Netherlands; Arizona State University, REACH Institute, P.O. Box 876005, Tempe, AZ, USA. Electronic address: royotten@pluryn.nl.'}, {'ForeName': 'Rutger C M E', 'Initials': 'RCME', 'LastName': 'Engels', 'Affiliation': 'Erasmus University, Erasmus School of Social and Behavioral Sciences, P.O. Box 1738, 3000, DR, Rotterdam, the Netherlands. Electronic address: rutger.engels@eur.nl.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Granic', 'Affiliation': 'Behavioural Science Institute, Radboud University, P.O. Box 9104, 6500, HE, Nijmegen, the Netherlands. Electronic address: i.granic@pwo.ru.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101548']
621,32171997,Context matters: The role of subjective arousal during Attentional Bias Modification targeting socially anxious students.,"BACKGROUND AND OBJECTIVES


Attentional Bias Modification (ABM) paradigms targeting anxiety aim to reduce attentional biases for threatening stimuli and thereby reduce anxiety. Based on cognitive theories of performance and learning, elevated levels of arousal during ABM might enhance its effectiveness by making training more engaging and activating fear schemas. This study investigated whether elevated levels of arousal during ABM would increase its effectiveness in reducing attentional bias, stress reactivity, and post-event processing.
METHOD


We randomly assigned 79 high socially anxious students to a session of ABM or control training preceded by either a social stress or control induction to manipulate arousal. Training outcomes were attentional bias, stress reactivity, and post-event processing. Subjective arousal was assessed before, during, and after training.
RESULTS


Results indicated that ABM was not successful in reducing attentional bias, stress reactivity or post-event processing, and that the effects of ABM were not moderated by subjective arousal. There was a trend towards ABM being more effective than control training in reducing attentional bias directly after training when participants were more aroused. However, this effect was not maintained one day after the training.
LIMITATIONS


The arousal manipulation did not result in significant between-group differences in subjective arousal.
CONCLUSIONS


This study did not provide support for the moderating role of arousal in ABM training effects. Replications with more effective mood induction procedures and more power are needed as a trend finding was observed suggesting that higher levels of arousal improved the direct ABM effects on attentional bias.",2020,There was a trend towards ABM being more effective than control training in reducing attentional bias directly after training when participants were more aroused.,"['79 high socially anxious students', 'socially anxious students']","['ABM', 'ABM or control training preceded by either a social stress or control induction to manipulate arousal', 'control training']","['attentional bias, stress reactivity or post-event processing', 'Subjective arousal', 'attentional bias, stress reactivity, and post-event processing', 'arousal manipulation', 'subjective arousal', 'attentional bias']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]",79.0,0.0681693,There was a trend towards ABM being more effective than control training in reducing attentional bias directly after training when participants were more aroused.,"[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Nuijs', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: M.D.Nuijs@uva.nl.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Larsen', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: H.Larsen@uva.nl.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Bögels', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: S.M.Bogels@uva.nl.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Wiers', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. Electronic address: r.w.wiers@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salemink', 'Affiliation': 'Department of Developmental Psychology, Adapt Lab, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands; Clinical Psychology, Utrecht University, Heidelberglaan 1, 3584 CS, Utrecht, the Netherlands. Electronic address: E.Salemink@uu.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101545']
622,32172171,PSA and VIM DBS efficiency in essential tremor depends on distance to the dentatorubrothalamic tract.,"OBJECTIVE


To investigate the relation between deep brain stimulation (DBS) of the posterior-subthalamic-area (PSA) and the ventral-intermediate-nucleus (VIM) and the distance to the dentatorubrothalamic tract (DRTT) in essential tremor (ET).
METHODS


Tremor rating scale (TRS) hemi-scores were analyzed in 13 ET patients, stimulated in both the VIM and the PSA in a randomized, crossover trial. Distances of PSA and VIM contacts to population-based DRTTs were calculated. The relationships between distance to DRTT and stimulation amplitude, as well as DBS efficiency (TRS improvement per amplitude) were investigated.
RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts. Proximity to the DRTT was related to lower amplitudes (p < 0.001) and higher DBS efficiency (p = 0.017).
CONCLUSIONS


Differences in tremor outcome and stimulation parameters between contacts in the PSA and the VIM can be explained by their different distance to the DRTT.",2020,"RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.",[],"['deep brain stimulation (DBS) of the posterior-subthalamic-area (PSA) and the ventral-intermediate-nucleus (VIM', 'VIM']","['PSA and VIM DBS efficiency', 'DBS efficiency', 'TRS hemi-scores', 'DBS efficiency (TRS improvement per amplitude', 'Tremor rating scale (TRS) hemi-scores']",[],"[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0222045'}]",13.0,0.0220309,"RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.","[{'ForeName': 'Till A', 'Initials': 'TA', 'LastName': 'Dembek', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany. Electronic address: till.dembek@uk-koeln.de.'}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wirths', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'University of Cologne, Institute of Medical Statistics and Computational Biology, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steffen', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Mauritius', 'Initials': 'M', 'LastName': 'Hövels', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany; Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Research Center Jülich, Jülich, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102235']
623,32332617,"Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study.","INTRODUCTION


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


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


This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).",2020,"Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
","['patients with uncontrolled hypertension taking 2 or more antihypertensive drugs', 'General practitioners and nurses', 'hypertensive patients who are receiving treatment but have suboptimal control of blood pressure', '424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited']","['multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise', 'blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise', 'intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice']","['systolic blood pressure', 'Cardiovascular risk and mortality', 'adequate blood pressure control', 'blood pressure control (<140/90\u200amm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",424.0,0.0453177,"Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
","[{'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'Unda Villafuerte', 'Affiliation': ""Coll D'en Rabassa Healthcare Centre.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera Cànaves', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lorente Montalvo', 'Affiliation': 'Santa Ponça Health Care Centre.'}, {'ForeName': 'María Lucía', 'Initials': 'ML', 'LastName': 'Moreno Sancho', 'Affiliation': 'Son Cladera Healthcare Centre, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Bartolomé', 'Initials': 'B', 'LastName': 'Oliver Oliver', 'Affiliation': 'Spanish Society of Family and Community Pharmacy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bassante Flores', 'Affiliation': 'Palliative Care Health Centre.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Estela Mantolan', 'Affiliation': 'Dalt San Joan Healthcare Centre, Mahó, Menorca.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Pou Bordoy', 'Affiliation': 'Camp Redó Healthcare Centre.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Rodríguez Ruiz', 'Affiliation': 'Primary Care Research Unit of Menorca, Balearic Health Services (IB-Salut), Menorca, Balearic Islands, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Requena Hernández', 'Affiliation': ""Coll D'en Rabassa Healthcare Centre.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Leiva', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Matíes', 'Initials': 'M', 'LastName': 'Torrent Quetglas', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Coll Benejam', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': ""D'Agosto Forteza"", 'Affiliation': 'Son Serra La Vileta Healthcare Centre.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rigo Carratalà', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019769']
624,31733608,Establishing the dose of memory support to improve patient memory for treatment and treatment outcome.,"BACKGROUND AND OBJECTIVES


Patient memory for the contents of treatment sessions is poor and this is associated with worse treatment outcome. Preliminary findings indicate that treatment provider use of memory support can be helpful in enhancing patient memory for treatment and improving outcome. The development of a novel Memory Support Intervention is currently underway. A key step in this process is to establish the dose of memory support that treatment providers deliver in treatment-as-usual, as well as the optimal dose of memory support needed to maximize patient memory for treatment points and outcomes.
METHODS


Forty-two adults with major depressive disorder (MDD) were randomized to receive either cognitive therapy plus memory support (CS + Memory Support; n = 22) or cognitive therapy as-usual (CT-as-usual; n = 20). Patients completed a free recall of treatment points task at post-treatment. Outcome measures were administered at baseline and post-treatment.
RESULTS


Treatment providers delivering CT-as-usual used, on average, 8.39 instances of memory support and 3.40 different types of memory support per session. Receiver Operating Characteristics (ROC) analyses using the combined sample indicate that 12.45 instances of memory support and 3.88 to 4.13 different types of memory support are needed to maximize patient recall and functional outcome.
LIMITATIONS


Dosing recommendations were established using a limited sample of participants receiving cognitive therapy for MDD.
CONCLUSIONS


Treatment providers appear to deliver a suboptimal amount of memory support. Delivering the optimal dose of memory support could improve treatment outcome.",2020,"RESULTS


Treatment providers delivering CT-as-usual used, on average, 8.39 instances of memory support and 3.40 different types of memory support per session.","['participants receiving cognitive therapy for MDD', 'Forty-two adults with major depressive disorder (MDD']",['cognitive therapy plus memory support (CS\xa0+\xa0Memory Support; n\u202f=\u202f22) or cognitive therapy as-usual (CT-as-usual; n\u202f=\u202f20'],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],42.0,0.0491982,"RESULTS


Treatment providers delivering CT-as-usual used, on average, 8.39 instances of memory support and 3.40 different types of memory support per session.","[{'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: jaylee24@gmail.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: donglu0305@gmail.com.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: ngumport@berkeley.edu.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, Department of Psychology, 2121 Berkeley Way #1650, Berkeley, CA, 94720-1650, USA. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101526']
625,31734573,Investigating the therapeutic potential of cognitive bias modification for high anxiety sensitivity.,"BACKGROUND AND OBJECTIVES


Individuals with high anxiety sensitivity (AS) display negative interpretive biases in response to uncomfortable but nondangerous physical sensations. Research suggests that modifying interpretation biases associated with AS leads to changes in AS. The present study sought to replicate and extend this research by addressing limitations of previous studies, increasing the amount of training and adding a follow-up period.
METHOD


Participants high in AS were randomly assigned to four sessions of computerized interpretation bias modification (CBM-I) training or four sessions of computerized ""sham"" training (control condition) over a 2-week period. The outcomes were AS, interpretive biases, and reactions to induced physical sensations. Assessments occurred at baseline, during training, immediately after the final training session, and 2 weeks after the final training; number of re-assessments varied by outcome.
RESULTS


The CBM-I condition did not outperform the control condition. At the end of the training period, the CBM-I condition displayed limited reductions in AS and interpretation biases. There were no changes in reactions to induced physical sensations. Similar results were found in the control condition for all outcomes.
LIMITATIONS


The control task and the dose of training may have obscured potential effects of CBM-I.
CONCLUSIONS


When considered within the context of previous research, the experimental effects and therapeutic potential of CBM-I for high AS appear to be minimal. However, methodological questions need to be resolved before such a conclusion can be considered definitive.",2020,The CBM-I condition did not outperform the control condition.,"['Individuals with high anxiety sensitivity (AS', 'Participants high in AS']","['computerized interpretation bias modification (CBM-I) training or four sessions of computerized ""sham"" training (control condition']","['AS, interpretive biases, and reactions to induced physical sensations', 'reactions to induced physical sensations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0146785,The CBM-I condition did not outperform the control condition.,"[{'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'MacDonald', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Koerner', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada. Electronic address: naomi.koerner@psych.ryerson.ca.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Vickers', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Tessie', 'Initials': 'T', 'LastName': 'Mastorakos', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101521']
626,30048324,The Accuracy of Low-dose Computed Tomography Protocol in Patients With Suspected Acute Appendicitis: The OPTICAP Study.,"OBJECTIVE


To compare diagnostic accuracy of contrast enhanced low-dose computed tomography (CT) accomplished in the OPTICAP trial phantom phase to standard CT in patients with suspected acute appendicitis.
BACKGROUND


Increasing use of CT as the gold standard in diagnosing acute appendicitis has raised concerns regarding radiation exposure. Unenhanced low-dose CT protocols have shown similar diagnostic accuracy with standard CT for diagnosing appendicitis. To our knowledge, there are no other trials in which the same patient with suspected acute appendicitis underwent both standard and low-dose CT allowing interpatient comparison.
METHODS


OPTICAP is an interpatient protocol sequence randomized noninferiority single-center trial performed at Turku University Hospital between November, 2015 and August, 2016. Sixty patients with suspected acute appendicitis and body mass index <30 kg/m were enrolled to undergo both standard and low-dose contrast enhanced CT scans, which were categorized as normal, uncomplicated or complicated appendicitis by 2 radiologists in blinded manner. All patients with CT confirmed appendicitis underwent appendectomy to obtain histopathology.
RESULTS


The low-dose protocol was not inferior to standard protocol in terms of diagnostic accuracy; 79% [95% confidence interval (CI) 66%-89%) accurate diagnosis in low-dose and 80% (95% CI 67%-90%) in standard CT by primary radiologist. Accuracy to categorize appendicitis severity was 79% for both protocols. The mean radiation dose of low-dose CT was significantly lower compared with standard CT (3.33 and 4.44 mSv, respectively).
CONCLUSION


Diagnostic accuracy of contrast enhanced low-dose CT was not inferior to standard CT in diagnosing acute appendicitis or distinguishing between uncomplicated and complicated acute appendicitis in patients with a high likelihood of acute appendicitis. Low-dose CT enabled significant radiation dose reduction.",2020,Diagnostic accuracy of contrast enhanced low-dose CT was not inferior to standard CT in diagnosing acute appendicitis or distinguishing between uncomplicated and complicated acute appendicitis in patients with a high likelihood of acute appendicitis.,"['patients with a high likelihood of acute appendicitis', 'patients with suspected acute appendicitis', 'All patients with CT confirmed appendicitis underwent appendectomy to obtain histopathology', 'Sixty patients with suspected acute appendicitis and body mass index <30\u200akg/m were enrolled to undergo both', 'Turku University Hospital between November, 2015 and August, 2016', 'Patients With Suspected Acute Appendicitis']","['Unenhanced low-dose CT protocols', 'standard and low-dose contrast enhanced CT scans', 'contrast enhanced low-dose CT', 'Low-dose Computed Tomography Protocol', 'standard CT', 'contrast enhanced low-dose computed tomography (CT']","['categorize appendicitis severity', 'Diagnostic accuracy', 'mean radiation dose of low-dose CT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0056574', 'cui_str': 'CT protocol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]",60.0,0.0473139,Diagnostic accuracy of contrast enhanced low-dose CT was not inferior to standard CT in diagnosing acute appendicitis or distinguishing between uncomplicated and complicated acute appendicitis in patients with a high likelihood of acute appendicitis.,"[{'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Sippola', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Virtanen', 'Affiliation': 'Department of Radiology, Medical Imaging Center of Southwest Finland, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Tammilehto', 'Affiliation': 'Department of Radiology, Medical Imaging Center of Southwest Finland, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Grönroos', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Hurme', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Niiniviita', 'Affiliation': 'Department of Radiology, Medical Imaging Center of Southwest Finland, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Lietzen', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Salminen', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}]",Annals of surgery,['10.1097/SLA.0000000000002976']
627,30946077,Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial.,"OBJECTIVE


This study aimed to evaluate the effect of inferior mesenteric artery (IMA) embolization during endovascular aneurysm repair (EVAR) in patients at high risk of type II endoleak (T2EL) in randomized controlled trial (RCT).
SUMMARY BACKGROUND DATA


Several studies have demonstrated a reduction of T2EL by IMA embolization before EVAR. However, there have been no RCT confirming the efficacy of IMA embolization.
METHODS


Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible. Patients at high risk of T2EL (IMA patency with IMA ≥3 mm, LAs ≥2 mm, or an aortoiliac-type aneurysm) were prospectively randomized to receive EVAR with or without IMA embolization. The primary endpoint was occurrence of T2EL during follow-up. Secondary endpoints included aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL. This trial is registered with the University Hospital Medical Information Network, number UMIN000022147.
RESULTS


One hundred thirteen patients had high risk and 106 were randomized. In the intention-to-treat analysis, the incidence of T2EL was significantly lower in the embolization group [24.5% vs 49.1%; P = 0.009, absolute risk reduction = 24.5%; 95% confidence interval (CI), 6.2-40.5, number needed to treat = 4.1; 95% CI, 2.5-16.1]. The aneurysmal sac shrunk significantly more in the embolization group (-5.7 ± 7.3 mm vs -2.8 ± 6.6 mm; P = 0.037), and the incidence of aneurysmal sac growth related to T2EL was significantly lower in the embolization group (3.8% vs 17.0%; P = 0.030). There were no complications related to IMA embolization or reinterventions associated with T2EL.
CONCLUSIONS


Our results demonstrated the effectiveness of IMA embolization during EVAR in high-risk patients for the prevention of T2EL, which is suggested for avoiding aneurysmal sac enlargement related to T2EL.",2020,"There were no complications related to IMA embolization or reinterventions associated with T2EL.
","['One hundred thirteen patients had high risk and 106 were randomized', 'Patients scheduled for elective EVAR between April 2014 and March 2018 were eligible', 'Type II Endoleak', 'patients at high risk of type II endoleak (T2EL', 'Patients at high risk of T2EL (IMA patency with IMA ≥3\u200amm, LAs ≥2\u200amm, or an aortoiliac-type aneurysm']","['Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization', 'inferior mesenteric artery (IMA) embolization during endovascular aneurysm repair (EVAR', 'IMA embolization', 'EVAR with or without IMA embolization']","['aneurysmal sac changes, adverse events from IMA embolization, and reintervention rate due to T2EL', 'aneurysmal sac shrunk', 'occurrence of T2EL', 'incidence of T2EL', 'incidence of aneurysmal sac growth related to T2EL']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1504464', 'cui_str': 'Perigraft Leak'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]","[{'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0162860', 'cui_str': 'Mesenteric Artery, Inferior'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.246153,"There were no complications related to IMA embolization or reinterventions associated with T2EL.
","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Samura', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine, Minami-kogushi, Ube, Japan.'}, {'ForeName': 'Noriyasu', 'Initials': 'N', 'LastName': 'Morikage', 'Affiliation': ''}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Otsuka', 'Affiliation': ''}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Mizoguchi', 'Affiliation': ''}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': ''}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nagase', 'Affiliation': ''}, {'ForeName': 'Takasuke', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': ''}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamashita', 'Affiliation': ''}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Suehiro', 'Affiliation': ''}, {'ForeName': 'Kimikazu', 'Initials': 'K', 'LastName': 'Hamano', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003299']
628,31714640,Therapeutic Drug Monitoring of Newer Antiepileptic Drugs: A Randomized Trial for Dosage Adjustment.,"OBJECTIVE


Therapeutic drug monitoring (TDM) of antiepileptic drugs (AEDs) is widely established for older generation AEDs, whereas there is limited evidence about newer AEDs. Our aim is to assess the benefit of TDM of newer generation AEDs in epilepsy.
METHODS


We performed a randomized, controlled trial comparing systematic with rescue TDM of lamotrigine, levetiracetam, oxcarbazepine, topiramate, brivaracetam, zonisamide, or pregabalin. Participants were adults with epilepsy, in whom treatment with newer generation AEDs was initiated or needed adjustment. In the systematic TDM arm, AED plasma levels were available at each appointment, whereas in the rescue TDM arm, levels were known only if a study endpoint was reached (inefficacy or adverse events). The primary outcome was the proportion of participants followed 1 year without reaching one of the predefined endpoints.
RESULTS


A total of 151 participants were enrolled; global retention in the study was similar in both arms (56% overall, 58% in the systematic, and 53% in the rescue TDM arm, p = 0.6, Cox regression). There was no difference in terms of outcome regarding treatment efficacy or tolerability. Partial adherence of clinicians to TDM (adjusting or not AED dosage based on blood levels) did not explain this lack of benefit.
INTERPRETATION


This study provides class A evidence that systematic drug level monitoring of newer generation AEDs does not bring tangible benefits in the management of patients with epilepsy. Poor correlation between clinical effects and drug levels likely accounts for this finding. However, TDM is useful in several situations, such as pregnancy, as well as when there are compliance issues. ANN NEUROL 2020;87:22-29.",2020,There was no difference in term of outcome regarding treatment efficacy or tolerability.,"['Participants were adults with epilepsy, in whom treatment with newer generation AEDs was initiated or needed adjustment', 'patients with epilepsy', '151 participants were enrolled']","['lamotrigine, levetiracetam, oxcarbazepine, topiramate, brivaracetam, zonisamide, or pregabalin', 'TDM']","['efficacy or tolerability', 'proportion of participants followed over one year without reaching one of the predefined endpoint', 'global retention', 'AED plasma levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",151.0,0.217395,There was no difference in term of outcome regarding treatment efficacy or tolerability.,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aícua-Rapún', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'André', 'Affiliation': 'Service of Clinical Pharmacology, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ryvlin', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andreas F', 'Initials': 'AF', 'LastName': 'Hottinger', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Laurent A', 'Initials': 'LA', 'LastName': 'Decosterd', 'Affiliation': 'Laboratory of Clinical Pharmacology Laboratory, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Buclin', 'Affiliation': 'Service of Clinical Pharmacology, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Clinical Neurosciences, Neurology Service, Lausanne University Hospital (Vaud University Hospital Center) and University of Lausanne, Lausanne, Switzerland.'}]",Annals of neurology,['10.1002/ana.25641']
629,32088652,Comparison of MS inflammatory activity in women using continuous versus cyclic combined oral contraceptives.,"BACKGROUND


Many women with multiple sclerosis (MS) report fluctuating symptoms across their menstrual cycle. Oral contraceptives (OCs) alter hormonal levels across the menstrual cycle. While cyclic OCs administer hormones for 21 days, followed by a week of placebo, continuous OCs can administer continuous doses of hormones for up to 3 months. Previous studies have suggested that OC use is associated with lower MS-related inflammation. We hypothesized that due to reduced hormonal fluctuations, women with MS might experience less inflammatory activity (clinical relapses+MRI) on continuous OCs than on cyclic OCs.
METHODS


We performed a retrospective analysis of prospectively collected data. For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation, we extracted data on OC use from the Electronic Medical Records (EMR). All variables were confirmed using manual clinical chart review. We identified 19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type. Inflammatory activity in the two groups was then compared using log-rank tests (time to new relapse, new T2-weighted lesion formation, and gadolinium-enhancing lesion formation) and t-tests (annualized relapse rate). We also performed subgroup analyses in women with at least 1 year (N = 28) and 2 years (N = 21) of clinical observation. A power calculation was performed.
RESULTS


There was no difference in time to relapse (p = 0.50) between continuous and cycling OC users. However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05). In patients with at least 1 year of observation, there was a significant difference in time to T2 lesion formation (p = 0.03) and time to contrast-enhancing lesion formation (p = 0.02).
CONCLUSION


In this exploratory study, women on continuous OCs showed a trend towards less inflammatory activity on MRI relative to women on cyclic OCs. This difference was not reflected in relapse rates. We estimate that 342 patients would be required for an adequately powered cohort study to evaluate such an effect. Our findings provide reassurance that for women using continuous OCs to alleviate menstrual fluctuations in symptoms, there is not an increase in MS-related inflammatory activity.",2020,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","['19 women with relapsing forms of MS on continuous OCs and matched them (2:1 when possible) to women on cyclic OCs for OC formulation, age, MS duration and DMT type', 'women with at least 1 year (N\u202f=\u202f28) and 2 years (N\u202f=\u202f21) of clinical observation', '342 patients', 'For women with MS aged 18-50 seen at the UCSF Center for MS and Neuroinflammation', 'women using continuous versus cyclic combined oral contraceptives']","['Oral contraceptives (OCs', 'placebo, continuous OCs']","['MS inflammatory activity', 'time to relapse', 'time to contrast-enhancing lesion formation', 'Inflammatory activity', 'relapse rates', 'longer time to contrast-enhancing lesion formation', 'longer time to T2 lesion formation', 'time to T2 lesion formation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",342.0,0.070475,"However, continuous OC users showed a statistical trend to longer time to T2 lesion formation (p = 0.09) and longer time to contrast-enhancing lesion formation (p = 0.05).","[{'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chelsea.chen@ucsf.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Krishnakumar', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: tanya.krishnakumar@ucsf.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rowles', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: william.rowles@ucsf.edu.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: annika.anderson@ucsf.edu.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: chao.zhao@ucsf.edu.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Do', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: lvtieu@gmail.com.'}, {'ForeName': 'Riley', 'Initials': 'R', 'LastName': 'Bove', 'Affiliation': 'Weill Institute for the Neurosciences, Department of Neurology, University of California, San Francisco, CA, United States. Electronic address: riley.bove@ucsf.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.101970']
630,32146231,The efficacy and safety of multiple-dose intravenous tranexamic acid in reducing perioperative blood loss in patients with thoracolumbar burst fracture.,"OBJECTIVE


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


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


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


Intravenous TXA used in the treatment of thoracolumbar burst fracture underwent pedicle screw fixation via Wiltse approach is effective and safe in decreasing perioperative blood loss. The two-dose TXA regimen can further reduce blood loss and alleviate post-operative inflammation response, without affecting prethrombotic state molecular marks and without increasing the risk of complications.",2020,"There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
","['patients with thoracolumbar burst fracture', '264 patients with single-segment thoracolumbar burst fracture without neurologic injury underwent']","['tranexamic acid', 'pedicle screw fixation', 'pedicle screw fixation via Wiltse approach', '20 mg/kg TXA', 'TXA', 'tranexamic acid (TXA']","['hidden blood loss (HBL), total blood loss (TBL), intraoperative blood loss (IBL), transfusion rate, maximum hemoglobin (Hb) drop, prethrombotic state molecular markers, liver and renal function, coagulation function, inflammatory factor and adverse events', 'level of interleukin-6 (IL-6', 'blood loss and alleviate post-operative inflammation response', 'HBL, TBL and maximum Hb drop', 'live and renal function, coagulation function, prethrombotic state molecular markers, transfusion rate and complications', 'perioperative blood loss', 'level of C-reactive protein (CRP', 'IBL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0345035,"There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Dalian Medical University, Dalian, 116000, China; Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Nan', 'Affiliation': ""Department of Orthopedics, Dalian Medical University, Dalian, 116000, China; Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Orthopaedic Implants, Shanghai, 200011, China.""}, {'ForeName': 'Shengfei', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China. Electronic address: zhangliang6320@sina.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105766']
631,32151851,A calcium channel or angiotensin converting enzyme inhibitor/angiotensin receptor blocker regime to reduced blood pressure variability in acute ischaemic stroke (CAARBS): A feasibility trial.,"BACKGROUND


Trials of lowering blood pressure in patients with acute ischaemic stroke not undergoing thrombolysis have not demonstrated improved outcomes with intervention. Rather than absolute levels, it may be that blood pressure variability is important. However, there are no prospective randomised trials investigating the benefit of reducing blood pressure variability in this patient group.
AIMS


The primary aim of this trial was to determine the feasibility of recruitment to a randomised trial investigating the effect of different antihypertensive medications on blood pressure variability.
METHODS


CAARBS was a multi-centre, open-label, randomised parallel group controlled feasibility trial. Adults with a first mild-moderate ischaemic stroke or transient ischaemic attack, requiring antihypertensive therapy for secondary prevention, were randomised to a calcium channel blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Blood pressure and variability were measured at baseline, three weeks, and three months. Compliance with measurements and treatment was monitored.
RESULTS


Fourteen patients were recruited to the trial (0.6% of those screened), nine of whom completed follow-up. The majority of patients screened (98.1%) were ineligible. Compliance with the intervention was good, as were measurement completion rates (88.9% or higher in all cases except ambulatory measurements). No major adverse events were recorded.
CONCLUSIONS


Recruitment to the trial was difficult due to patient ineligibility, suggesting that the current protocol is unlikely to be successful if scaled for a definitive trial. However, the intervention was safe, and compliance was good, suggesting a future trial with modified eligibility criteria could be successful.
TRIAL REGISTRATION


ISRCTN10853487.",2020,"No major adverse events were recorded.
","['patients with acute ischaemic stroke not undergoing thrombolysis', 'Adults with a first mild-moderate ischaemic stroke or transient ischaemic attack, requiring antihypertensive therapy for secondary prevention', 'acute ischaemic stroke (CAARBS', 'Fourteen patients were recruited to the trial (0.6% of those screened), nine of whom completed follow-up']","['calcium channel blocker or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker', 'calcium channel or angiotensin converting enzyme inhibitor/angiotensin receptor blocker regime', 'antihypertensive medications']","['Blood pressure and variability', 'blood pressure variability', 'major adverse events', 'measurement completion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",14.0,0.278614,"No major adverse events were recorded.
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK. Electronic address: willdavison@doctors.org.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Appiah', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; NIHR Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Iain J', 'Initials': 'IJ', 'LastName': 'McGurgan', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rothwell', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116753']
632,32171078,"Triple artemisinin-based combination therapies versus artemisinin-based combination therapies for uncomplicated Plasmodium falciparum malaria: a multicentre, open-label, randomised clinical trial.","BACKGROUND


Artemisinin and partner-drug resistance in Plasmodium falciparum are major threats to malaria control and elimination. Triple artemisinin-based combination therapies (TACTs), which combine existing co-formulated ACTs with a second partner drug that is slowly eliminated, might provide effective treatment and delay emergence of antimalarial drug resistance.
METHODS


In this multicentre, open-label, randomised trial, we recruited patients with uncomplicated P falciparum malaria at 18 hospitals and health clinics in eight countries. Eligible patients were aged 2-65 years, with acute, uncomplicated P falciparum malaria alone or mixed with non-falciparum species, and a temperature of 37·5°C or higher, or a history of fever in the past 24 h. Patients were randomly assigned (1:1) to one of two treatments using block randomisation, depending on their location: in Thailand, Cambodia, Vietnam, and Myanmar patients were assigned to either dihydroartemisinin-piperaquine or dihydroartemisinin-piperaquine plus mefloquine; at three sites in Cambodia they were assigned to either artesunate-mefloquine or dihydroartemisinin-piperaquine plus mefloquine; and in Laos, Myanmar, Bangladesh, India, and the Democratic Republic of the Congo they were assigned to either artemether-lumefantrine or artemether-lumefantrine plus amodiaquine. All drugs were administered orally and doses varied by drug combination and site. Patients were followed-up weekly for 42 days. The primary endpoint was efficacy, defined by 42-day PCR-corrected adequate clinical and parasitological response. Primary analysis was by intention to treat. A detailed assessment of safety and tolerability of the study drugs was done in all patients randomly assigned to treatment. This study is registered at ClinicalTrials.gov, NCT02453308, and is complete.
FINDINGS


Between Aug 7, 2015, and Feb 8, 2018, 1100 patients were given either dihydroartemisinin-piperaquine (183 [17%]), dihydroartemisinin-piperaquine plus mefloquine (269 [24%]), artesunate-mefloquine (73 [7%]), artemether-lumefantrine (289 [26%]), or artemether-lumefantrine plus amodiaquine (286 [26%]). The median age was 23 years (IQR 13 to 34) and 854 (78%) of 1100 patients were male. In Cambodia, Thailand, and Vietnam the 42-day PCR-corrected efficacy after dihydroartemisinin-piperaquine plus mefloquine was 98% (149 of 152; 95% CI 94 to 100) and after dihydroartemisinin-piperaquine was 48% (67 of 141; 95% CI 39 to 56; risk difference 51%, 95% CI 42 to 59; p<0·0001). Efficacy of dihydroartemisinin-piperaquine plus mefloquine in the three sites in Myanmar was 91% (42 of 46; 95% CI 79 to 98) versus 100% (42 of 42; 95% CI 92 to 100) after dihydroartemisinin-piperaquine (risk difference 9%, 95% CI 1 to 17; p=0·12). The 42-day PCR corrected efficacy of dihydroartemisinin-piperaquine plus mefloquine (96% [68 of 71; 95% CI 88 to 99]) was non-inferior to that of artesunate-mefloquine (95% [69 of 73; 95% CI 87 to 99]) in three sites in Cambodia (risk difference 1%; 95% CI -6 to 8; p=1·00). The overall 42-day PCR-corrected efficacy of artemether-lumefantrine plus amodiaquine (98% [281 of 286; 95% CI 97 to 99]) was similar to that of artemether-lumefantrine (97% [279 of 289; 95% CI 94 to 98]; risk difference 2%, 95% CI -1 to 4; p=0·30). Both TACTs were well tolerated, although early vomiting (within 1 h) was more frequent after dihydroartemisinin-piperaquine plus mefloquine (30 [3·8%] of 794) than after dihydroartemisinin-piperaquine (eight [1·5%] of 543; p=0·012). Vomiting after artemether-lumefantrine plus amodiaquine (22 [1·3%] of 1703) and artemether-lumefantrine (11 [0·6%] of 1721) was infrequent. Adding amodiaquine to artemether-lumefantrine extended the electrocardiogram corrected QT interval (mean increase at 52 h compared with baseline of 8·8 ms [SD 18·6] vs 0·9 ms [16·1]; p<0·01) but adding mefloquine to dihydroartemisinin-piperaquine did not (mean increase of 22·1 ms [SD 19·2] for dihydroartemisinin-piperaquine vs 20·8 ms [SD 17·8] for dihydroartemisinin-piperaquine plus mefloquine; p=0·50).
INTERPRETATION


Dihydroartemisinin-piperaquine plus mefloquine and artemether-lumefantrine plus amodiaquine TACTs are efficacious, well tolerated, and safe treatments of uncomplicated P falciparum malaria, including in areas with artemisinin and ACT partner-drug resistance.
FUNDING


UK Department for International Development, Wellcome Trust, Bill & Melinda Gates Foundation, UK Medical Research Council, and US National Institutes of Health.",2020,"Both TACTs were well tolerated, although early vomiting (within 1 h) was more frequent after dihydroartemisinin-piperaquine plus mefloquine (30 [3·8%] of 794) than after dihydroartemisinin-piperaquine (eight [1·5%] of 543; p=0·012).","['patients with uncomplicated P falciparum malaria at 18 hospitals and health clinics in eight countries', 'The median age was 23 years (IQR 13 to 34) and 854 (78%) of 1100 patients were male', 'Eligible patients were aged 2-65 years, with acute, uncomplicated P falciparum malaria alone or mixed with non-falciparum species, and a temperature of 37·5°C or higher, or a history of fever in the past 24 h. Patients', 'uncomplicated Plasmodium falciparum malaria', '1100 patients were given either']","['lumefantrine plus amodiaquine', 'artesunate-mefloquine', 'artemether-lumefantrine plus amodiaquine', 'mefloquine', 'dihydroartemisinin-piperaquine plus mefloquine', 'artesunate-mefloquine or dihydroartemisinin-piperaquine plus mefloquine; and in Laos, Myanmar, Bangladesh, India, and the Democratic Republic of the Congo they were assigned to either artemether-lumefantrine or artemether-lumefantrine plus amodiaquine', 'Triple artemisinin-based combination therapies (TACTs', 'amodiaquine', 'Triple artemisinin-based combination therapies versus artemisinin-based combination therapies', 'dihydroartemisinin-piperaquine or dihydroartemisinin-piperaquine plus mefloquine', 'dihydroartemisinin-piperaquine', 'artemether-lumefantrine', 'mefloquine and artemether-lumefantrine plus amodiaquine TACTs']","['42-day PCR corrected efficacy', 'overall 42-day PCR-corrected efficacy', 'tolerated', 'safety and tolerability', 'Vomiting', 'early vomiting', 'electrocardiogram corrected QT interval', 'efficacy, defined by 42-day PCR-corrected adequate clinical and parasitological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0023034', 'cui_str': 'Laos'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0618927', 'cui_str': 'TACT'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic (qualifier value)'}]",1100.0,0.288372,"Both TACTs were well tolerated, although early vomiting (within 1 h) was more frequent after dihydroartemisinin-piperaquine plus mefloquine (30 [3·8%] of 794) than after dihydroartemisinin-piperaquine (eight [1·5%] of 543; p=0·012).","[{'ForeName': 'Rob W', 'Initials': 'RW', 'LastName': 'van der Pluijm', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rupam', 'Initials': 'R', 'LastName': 'Tripura', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Hoglund', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Pyae Phyo', 'Affiliation': 'Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia; School of Public Health, National Institute of Public Health, Phnom Penh, Cambodia.'}, {'ForeName': 'Akhter', 'Initials': 'A', 'LastName': 'Ul Islam', 'Affiliation': ""Ramu Upazila Health Complex, Cox's Bazar, Bangladesh.""}, {'ForeName': 'Anupkumar R', 'Initials': 'AR', 'LastName': 'Anvikar', 'Affiliation': 'National Institute of Malaria Research, Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Parthasarathi', 'Initials': 'P', 'LastName': 'Satpathi', 'Affiliation': 'Midnapore Medical College, Midnapur, India.'}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Satpathi', 'Affiliation': 'Ispat General Hospital, Rourkela, India.'}, {'ForeName': 'Prativa Kumari', 'Initials': 'PK', 'LastName': 'Behera', 'Affiliation': 'Ispat General Hospital, Rourkela, India.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Tripura', 'Affiliation': 'Agartala Medical College, Tripura, India.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Baidya', 'Affiliation': 'Agartala Medical College, Tripura, India.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Onyamboko', 'Affiliation': 'Kinshasa Mahidol Oxford Research Unit (KIMORU), Kinshasa, Democratic Republic of the Congo; Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Yok', 'Initials': 'Y', 'LastName': 'Sovann', 'Affiliation': 'Pailin Provincial Health Department, Pailin, Cambodia.'}, {'ForeName': 'Seila', 'Initials': 'S', 'LastName': 'Suon', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sokunthea', 'Initials': 'S', 'LastName': 'Sreng', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sivanna', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Sampov Meas Referral Hospital, Pursat, Cambodia.'}, {'ForeName': 'Savuth', 'Initials': 'S', 'LastName': 'Oun', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Chanaki', 'Initials': 'C', 'LastName': 'Amaratunga', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Kitipumi', 'Initials': 'K', 'LastName': 'Chutasmit', 'Affiliation': 'Phu Sing hospital, Phu Sing, Sisaket, Thailand.'}, {'ForeName': 'Chalermpon', 'Initials': 'C', 'LastName': 'Saelow', 'Affiliation': 'Phu Sing hospital, Phu Sing, Sisaket, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Runcharern', 'Affiliation': 'Khun Han Hospital, Khun Han, Sisaket, Thailand.'}, {'ForeName': 'Weerayuth', 'Initials': 'W', 'LastName': 'Kaewmok', 'Affiliation': 'Khun Han Hospital, Khun Han, Sisaket, Thailand.'}, {'ForeName': 'Nhu Thi', 'Initials': 'NT', 'LastName': 'Hoa', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngo Viet', 'Initials': 'NV', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Borimas', 'Initials': 'B', 'LastName': 'Hanboonkunupakarn', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Callery', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Akshaya Kumar', 'Initials': 'AK', 'LastName': 'Mohanty', 'Affiliation': 'Infectious Disease Biology Unit, IGH, Rourkela Research Unit of ILS, Bhubeneswar, DBT, Rourkela, India.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heaton', 'Affiliation': 'Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar.'}, {'ForeName': 'Myo', 'Initials': 'M', 'LastName': 'Thant', 'Affiliation': 'Defence Services Medical Research Centre, Yangon, Myanmar.'}, {'ForeName': 'Kripasindhu', 'Initials': 'K', 'LastName': 'Gantait', 'Affiliation': 'Midnapore Medical College, Midnapur, India.'}, {'ForeName': 'Tarapada', 'Initials': 'T', 'LastName': 'Ghosh', 'Affiliation': 'Midnapore Medical College, Midnapur, India.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Amato', 'Affiliation': 'Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Pearson', 'Affiliation': 'Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Jacob', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Gonçalves', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Waithira', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Woodrow', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Grobusch', 'Affiliation': 'Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'van Vugt', 'Affiliation': 'Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Fairhurst', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA; AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Phaik Yeong', 'Initials': 'PY', 'LastName': 'Cheah', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Peto', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'von Seidlein', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; WorldWide Antimalarial Resistance Network - Asia Regional Centre, Bangkok, Thailand.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Maude', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; The Open University, Milton Keynes, UK; Harvard T H Chan School of Public Health, Harvard University, Boston, MA USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winterberg', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Thuy-Nhien', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dominic P', 'Initials': 'DP', 'LastName': 'Kwiatkowski', 'Affiliation': 'Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Podjanee', 'Initials': 'P', 'LastName': 'Jittamala', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Pyin Oo Lwin, Myanmar.'}, {'ForeName': 'Tin Maung', 'Initials': 'TM', 'LastName': 'Hlaing', 'Affiliation': 'Defence Services Medical Research Centre, Yangon, Myanmar.'}, {'ForeName': 'Kesinee', 'Initials': 'K', 'LastName': 'Chotivanich', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rekol', 'Initials': 'R', 'LastName': 'Huy', 'Affiliation': 'National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Fanello', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Kinshasa Mahidol Oxford Research Unit (KIMORU), Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ashley', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos.'}, {'ForeName': 'Mayfong', 'Initials': 'M', 'LastName': 'Mayxay', 'Affiliation': 'Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos; Institute of Research and Education Development (IRED), University of Health Sciences, Ministry of Health, Vientiane, Laos.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Newton', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos.'}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Valecha', 'Affiliation': 'National Institute of Malaria Research, Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar.'}, {'ForeName': 'Sasithon', 'Initials': 'S', 'LastName': 'Pukrittayakamee', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; The Royal Society of Thailand, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Faiz', 'Affiliation': 'Malaria Research Group and Dev Care Foundation, Dhaka, Bangladesh.'}, {'ForeName': 'Olivo', 'Initials': 'O', 'LastName': 'Miotto', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK; Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK; Wellcome Sanger Institute, Hinxton, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK. Electronic address: arjen@tropmedres.ac.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30552-3']
633,31880632,Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy: A Randomized Controlled Trial.,"BACKGROUND


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


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


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


For anesthesiologists with experience in neuraxial ultrasonography, the use of ultrasound significantly reduces the technical difficulties of spinal anesthesia in patients with abnormal spinal anatomy compared with the landmark-guided technique. Our results can lead to practical suggestions that encourage the use of neuraxial ultrasonography for spinal anesthesia in such patients.",2020,The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012).,"['patients with anatomical alterations of the lumbar spine', 'Patients With Abnormal Spinal Anatomy', 'Forty-four patients with abnormal spinal anatomy including documented lumbar scoliosis and previous spinal surgery', 'patients with abnormal spinal anatomy']","['ultrasound-assisted technique', 'Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia', 'surface landmark-guided or preprocedural ultrasound-assisted spinal anesthesia', 'neuraxial ultrasonography']","['median (interquartile range [IQR; range]) number of needle passes', 'periprocedural pain scores', 'incidences of complications', 'success rate on the first pass, total procedure time, periprocedural pain scores, and the incidences of radicular pain, paresthesia, and bloody tap during the neuraxial procedure', 'total procedure time, defined as the sum of the time for identifying landmarks and performing spinal anesthesia', 'number of needle passes required for successful dural puncture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",44.0,0.0703103,The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012).,"[{'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004600']
634,30286004,"Predicting the Size of a Left Double-Lumen Tube for Asian Women Based on the Combination of the Diameters of the Cricoid Ring and Left Main Bronchus: A Randomized, Prospective, Controlled Trial.","BACKGROUND


There are limited data about how to choose the correct size of a double-lumen tube (DLT). It is especially difficult to select an appropriate DLT for Asian women because of their small stature. The primary aim of this study was to compare the overall accuracy of the DLT selected based on the combination of transverse diameter of cricoid ring and the equivalent diameter of the left main bronchus (ED-LMB) with that based on the ED-LMB alone for Asian women.
METHODS


In this study, 80 consecutive and blinded female patients were assigned randomly to 2 groups. The overall accuracy of the selection of DLT was compared between the Combined group and LMB group. The accuracy of the selection of tracheal segment and bronchial segment was also compared between the 2 groups. The postoperative hoarseness and sore throat were investigated by blinded assessors.
RESULTS


The overall accuracy of selection of the DLTs was higher in the Combined group than that in the LMB group (87.5% vs 60.0%; P = .010). The accuracy of selection of tracheal segment was also higher in the Combined group (92.5% vs 67.5%; P = .010). The accuracy of selection of bronchial segment was similar between the groups (95.0 % vs 86.1%; P = .246). The severity of sore throat was higher in the LMB group at 24 hours after the operation (P = .001).
CONCLUSIONS


The correct size of DLT for Asian women should be selected based on the combination of transverse diameter of cricoid ring and the ED-LMB.",2020,"The severity of sore throat was higher in the LMB group at 24 hours after the operation (P = .001).
","['Asian women', '80 consecutive and blinded female patients']",['LMB'],"['postoperative hoarseness and sore throat', 'accuracy of selection of bronchial segment', 'accuracy of selection of tracheal segment', 'overall accuracy of selection of the DLTs', 'severity of sore throat']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",80.0,0.0766817,"The severity of sore throat was higher in the LMB group at 24 hours after the operation (P = .001).
","[{'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Shiqing', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wenxu', 'Affiliation': 'Radiology.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Yuqiang', 'Affiliation': 'Thoracic Surgery, Shengjing Hospital, China Medical University, Shenyang, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Youjing', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000003839']
635,32278103,The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial.,"BACKGROUND


The shape and cross-sectional area (CSA) of internal jugular vein (IJV) are easily affected by external factors. That causes venous collapsibility. We tried to distend IJV by increasing the pressure on patients' abdomen in order to improve the success rate of internal jugular vein catheterization (IJVC).
MATERIALS AND METHODS


Patients undergoing IJVC were randomly allocated to two groups: Group 1 and Group 2. For patients in Group 1, the pressure on abdomen was increased by placing a 3000 ml bag of normal saline (NS). No special treatment was arranged for patients in Group 2. Transverse images of right IJV were captured at the outer edge which was parallel to the cricoid by ultrasonography. CSA, circumference (CF), transverse diameter (TD) and anteroposterior diameter (APD) of right IJV were measured and compared. All patients underwent ultrasound-guided short-axis puncturing. The success rates of one-off puncturing in two groups were recorded and compared.
RESULTS


The results under ultrasonography assessments show that CF, CSA, APD and success rate of puncturing in Group 1 were significantly higher than that of Group 2 (P < 0.05), while TD was not significantly increased (P > 0.05). There was no significant difference in complications between two groups (P > 0.05).
CONCLUSION


Pressure on the abdomen could significantly increase CSA of IJV. That helps improving the success rate of one-off puncturing.",2020,"There was no significant difference in complications between two groups (P>0.05).
","['Patients undergoing IJVC', 'conscious patients']","['ultrasound-guided short-axis puncturing', 'internal jugular vein catheterization under ultrasound-guidance']","['CSA of IJV', 'Transverse images of right IJV', 'success rates of one-off puncturing', 'success rate', 'success rate of internal jugular vein catheterization (IJVC', 'CSA, circumference (CF), transverse diameter (TD) and anteroposterior diameter (APD) of right IJV', 'CF, CSA, APD and success rate of puncturing', 'pressure on abdomen', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0313309,"There was no significant difference in complications between two groups (P>0.05).
","[{'ForeName': 'Jing-Li', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: xpch-xz@163.com.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Shanghai University of Medicine & Health Sciences Affiliated Zhoupu Hospital, No.1500 Zhouyuan Road, Pudong, Shanghai, 201318, China. Electronic address: gpmshiyan@126.com.'}, {'ForeName': 'Zhan-Fang', 'Initials': 'ZF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.069']
636,32332664,Ultrasound-guided continuous thoracic paravertebral block alleviates postoperative delirium in elderly patients undergoing esophagectomy: A randomized controlled trial.,"BACKGROUND


Delirium is a common postoperative complication in older patients undergoing thoracic surgery and presages poor outcomes. Postoperative pain is an important factor in the progression of delirium. The purpose of this study was to test whether continuous thoracic paravertebral block (PVB), a more effective approach for analgesia, could decrease the incidence of delirium in elderly patients undergoing esophagectomy.
METHODS


A total of 180 geriatric patients undergoing esophagectomy were randomly divided into 2 groups and treated with PVB or patient-controlled analgesia (PCA). Perioperative plasma CRP, IL-1β, IL-6, and TNF-α levels were detected in all patients. Pain intensity was measured by a numerical rating scale. Delirium was assessed using the confusion assessment method.
RESULTS


The incidence of postoperative delirium was significantly lower in the PVB group than in the PCA group. Patients in the PVB group had lower plasma CRP, IL-1β, IL-6, and TNF-α levels and less pain when coughing after surgery.
CONCLUSIONS


Ultrasound-guided continuous thoracic paravertebral block improved analgesia, reduced the inflammatory reaction and decreased the occurrence of delirium after surgery.",2020,"Perioperative plasma CRP, IL-1β, IL-6, and TNF-α levels were detected in all patients.","['older patients undergoing thoracic surgery', '180 geriatric patients undergoing esophagectomy', 'elderly patients undergoing esophagectomy']","['PVB', 'Ultrasound-guided continuous thoracic paravertebral block', 'continuous thoracic paravertebral block (PVB', 'PVB or patient-controlled analgesia (PCA']","['Pain intensity', 'incidence of postoperative delirium', 'Delirium', 'Postoperative pain', 'inflammatory reaction', 'lower plasma CRP, IL-1β, IL-6, and TNF-α levels and less pain', 'Perioperative plasma CRP, IL-1β, IL-6, and TNF-α levels']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",180.0,0.0765672,"Perioperative plasma CRP, IL-1β, IL-6, and TNF-α levels were detected in all patients.","[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': ""Department of Anesthesiology, The People's Hospital of Leshan, Leshan.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, The Affiliated Xuzhou City Hospital of Xuzhou Medical University.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Heng', 'Affiliation': 'Department of Anesthesiology, Xuzhou Tumor Hospital, Xuzhou.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Pang', 'Affiliation': ""Department of Anesthesiology, The People's Hospital of Leshan, Leshan.""}, {'ForeName': 'Fu-Guo', 'Initials': 'FG', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, The People's Hospital of Leshan, Leshan.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou.'}, {'ForeName': 'Jun-Feng', 'Initials': 'JF', 'LastName': 'Zhong', 'Affiliation': ""Department of Anesthesiology, The People's Hospital of Shaoxing, Shaoxing.""}, {'ForeName': 'Pan-Pan', 'Initials': 'PP', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, The Affiliated Xuzhou City Hospital of Xuzhou Medical University.'}, {'ForeName': 'Cong-You', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Bei-Ping', 'Initials': 'BP', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Affiliated Xuzhou City Hospital of Xuzhou Medical University.'}]",Medicine,['10.1097/MD.0000000000019896']
637,31790884,The influence of ruminative processing mode on the trajectory of intrusive memories following a negative mood induction.,"BACKGROUND AND OBJECTIVES


Rumination following an event, particularly in an abstract as opposed to concrete processing mode, is associated with increased intrusive memory frequency. However, the temporal trajectory of intrusive memories following abstract and concrete rumination remains unclear. We examined the association between processing mode and the frequency of intrusive memories over a 6-h time period following a negative mood induction.
METHODS


One hundred and sixteen community participants watched a video sequence designed to induce negative mood. Participants were then randomised into condition (abstract, concrete or distraction) and completed a verbally mediated task designed to induce the respective processing mode. Participants then completed hourly ratings of rumination and intrusive memories about the video after leaving the laboratory.
RESULTS


Negative mood and intrusive memories were reliably induced. There were no differences in the frequency of intrusive memories between the abstract and concrete conditions. In contrast, participants in the distraction condition reported significantly more sensory intrusive memories than either ruminative condition. Three classes were found among participants following the video (intrusion free, rapid remitters, slow remitters). Condition was not predictive of class membership.
LIMITATIONS


It cannot be ruled out that the differences between rumination and distraction conditions were due to task differences.
CONCLUSIONS


In contrast to previous findings, our results suggest that any form of rumination about an event (whether in an abstract or concrete mode) may temporarily result in fewer intrusive memories in comparison to distraction. Processing mode does not appear to predict particular trajectories of intrusions following a mood induction.",2020,"Three classes were found among participants following the video (intrusion free, rapid remitters, slow remitters).",['One hundred and sixteen community participants watched a video sequence designed to induce negative mood'],"['condition (abstract, concrete or distraction) and completed a verbally mediated task designed to induce the respective processing mode']","['frequency of intrusive memories', 'Negative mood and intrusive memories', 'sensory intrusive memories']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0557857', 'cui_str': 'Concrete (substance)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",116.0,0.0343643,"Three classes were found among participants following the video (intrusion free, rapid remitters, slow remitters).","[{'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Stavropoulos', 'Affiliation': 'Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney, NSW, Australia. Electronic address: adele.y.stavropoulos@student.uts.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Berle', 'Affiliation': 'Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney, NSW, Australia; School of Psychiatry, University of New South Wales, Sydney, NSW, Australia. Electronic address: david.berle@uts.edu.au.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101528']
638,32334074,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,"BACKGROUND


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


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


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


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


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


NCT02263937.",2020,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","['Dementia with Lewy bodies (DLB', 'Patients were aged between 50-80 years, had mild-moderate dementia symptoms and were living with a carer-informant', 'six DLB patients recruited from two UK neuroscience centres', 'DLB patients', 'six patients (five male, mean age 71.33 years']","['NBM DBS', 'Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation', 'image guided stereotactic implantation of bilateral DBS electrodes', 'active or sham stimulation', 'Meynert (NBM DBS']","['severity of neuropsychiatric symptoms', 'tolerated', 'safety and tolerability', 'functional connectivity in discrete cognitive networks on resting state fMRI', 'functional connectivity changes', 'Safety and tolerability', 'standardised measurements of cognitive, psychiatric and motor symptoms', 'antibiotic-associated colitis, prolonging his hospital stay']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",6.0,0.353614,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gratwicke', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: j.gratwicke@ucl.ac.uk.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kahan', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Brechany', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNichol', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Beigi', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Akram', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Oswal', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Day', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mancini', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Yousry', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McKeith', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Schott', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: t.foltynie@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.04.010']
639,32143065,Remembering the past to live better in the future: A feasibility randomised controlled trial of memory specificity training for motivation in psychosis.,"BACKGROUND AND OBJECTIVES


People with a diagnosis of psychosis often experience low motivation and reduced activity levels. Autobiographical memory deficits have been identified in people with psychosis and this may limit the role of memory retrieval in supporting motivation. This pilot study adapted a recently developed protocol, Memflex, which aims to enhance autobiographical memory and has shown promise in depression. Our brief intervention targets experiential negative symptoms of psychosis using supported autobiographical memory retrieval.
METHOD


A sample of 31 participants with psychosis were recruited from inpatient and community settings and randomised in a 2:1 ratio to either a basic recall control or an enhanced recall intervention group. Participants were asked to generate positive autobiographical memories linked to activities they wish to repeat in the future. The enhanced recall condition received additional prompts from the Memflex protocol, and the basic recall condition received no additional support.
RESULTS


The intervention delivered was acceptable (rated >80%) and feasible (94% adherence) to those who took part. Participants were able to generate positive autobiographical memories linked to their goals and experienced appropriate emotions linked to these. The controlled preliminary effect sizes (0.2-0.34) showed encouraging signals for self-efficacy, motivation and a reduction in negative mood.
LIMITATIONS


As this was a pilot study with a small sample size between-group tests of statistical significance were not conducted, and therefore findings should be interpreted with caution.
CONCLUSIONS


These findings suggest that guided autobiographical memory retrieval may be an effective way tool for targeting motivation in people with psychosis.",2020,The intervention delivered was acceptable (rated >80%) and feasible (94% adherence) to those who took part.,"['31 participants with psychosis', 'people with psychosis', 'psychosis']","['basic recall control or an enhanced recall intervention group', 'memory specificity training']",['positive autobiographical memories'],"[{'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}]",31.0,0.117268,The intervention delivered was acceptable (rated >80%) and feasible (94% adherence) to those who took part.,"[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. Electronic address: clementine.edwards@kcl.ac.uk.""}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Garety', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hardy', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101564']
640,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM


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


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


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


Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
641,32145678,"Randomized control trial of evaluation of Clemastine effects on visual evoked potential, nerve fiber layer and ganglion cell layer complex in patients with optic neuritis.","OBJECTIVES


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


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


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


In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group. In contrast to control group, p100 wave's amplitude recovered in a significant manner in treatment group.",2020,"In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group.","['patients with optic neuritis', '25 patients with acute optic neuritis']","['Clemastine', 'Clemastine, a first-generation and CNS (central nervous system)-penetrant H1 receptor antagonist', 'placebo']","['GCL thickness', 'RNFL thickness loss', 'VEP and peripapillary OCT (optical coherence tomography', 'RNFL and GCL thickness', 'visual evoked potential, nerve fiber layer and ganglion cell layer complex', 'visual evoked potential (VEP), retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) complex']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}]","[{'cui': 'C0008929', 'cui_str': 'Clemastine'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0034814', 'cui_str': 'Receptors, H1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0442163', 'cui_str': 'Peripapillary (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0228071', 'cui_str': 'Ganglion cell (cell)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",25.0,0.0182228,"In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Moghaddasi', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nabovvati', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran. Electronic address: m.nabovvati@gmail.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Koushki', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Soltansanjari', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Sardarinia', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nafise', 'Initials': 'N', 'LastName': 'Mohebi', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedhossein', 'Initials': 'S', 'LastName': 'Rabani', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105741']
642,32189042,Varied movement errors drive learning of dynamic balance control during walking in people with incomplete spinal cord injury: a pilot study.,"The purpose of this study was to determine whether the application of a varied pelvis perturbation force would improve dynamic balance control and gait stability of people with incomplete spinal cord injury (iSCI). Fourteen participants with iSCI completed the test in two conditions, i.e., walking paired with pelvis perturbation force and treadmill walking only, with 1-week interval in between. The order of the testing condition was randomized across participants. For the pelvis pertubation condition, subjects walked on a treadmill with no force for 1 min, with a varied pelvis perturbation force that was bilaterally applied in the medial-lateral direction for 10 min, without force for 1 min, and then with the perturbation for another 10 min after a sitting break. For the treadmill only condition, a protocol that was similar to the perturbation condition was used but no force was applied. Margin of stability (MoS), weight shifting, and other spatiotemporal gait parameters were calculated. Compared to treadmill training only, participants showed significant smaller MoS and double-leg support time after treadmill walking with pelvis perturbation. In addition, participants showed significantly greater improvements in overground walking speed after treadmill walking with pelvis perturbation than treadmill only (p = 0.021). Results from this study suggest that applying a varied pelvis perturbation force during treadmill walking could improve dynamic balance control in people with iSCI, which could be transferred to overground walking. These findings may be used to develop a new intervention to improve balance and walking function in people with iSCI.",2020,"Compared to treadmill training only, participants showed significant smaller MoS and double-leg support time after treadmill walking with pelvis perturbation.","['people with incomplete spinal cord injury (iSCI', 'people with iSCI', 'people with incomplete spinal cord injury', 'Fourteen participants with iSCI']","['treadmill training', 'Varied movement errors drive learning of dynamic balance control during walking']","['overground walking speed', 'dynamic balance control', 'dynamic balance control and gait stability', 'smaller MoS and double-leg support time', 'Margin of stability (MoS), weight shifting, and other spatiotemporal gait parameters']","[{'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.0682445,"Compared to treadmill training only, participants showed significant smaller MoS and double-leg support time after treadmill walking with pelvis perturbation.","[{'ForeName': 'Jui-Te', 'Initials': 'JT', 'LastName': 'Lin', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Chao-Jung', 'Initials': 'CJ', 'LastName': 'Hsu', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Weena', 'Initials': 'W', 'LastName': 'Dee', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'W Zev', 'Initials': 'WZ', 'LastName': 'Rymer', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Legs and Walking Lab, Shirley Ryan AbilityLab, 355 East Erie Street, 23rd Floor, Chicago, IL, 60611, USA. w-ming@northwestern.edu.'}]",Experimental brain research,['10.1007/s00221-020-05776-0']
643,32194255,Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study.,"BACKGROUND


Laparoscopy is the gold standard for many surgical procedures and is embraced as minimally invasive surgery in the enhanced recovery after surgery programme. Lowering intra-abdominal pressure during laparoscopy may decrease the degree of surgical injury and further enhance patient outcomes. This study aims to assess the effect of low pressure pneumoperitoneum on peritoneal perfusion during laparoscopic surgery.
MATERIALS AND METHODS


We performed a prospective randomized intervention study in 30 adults undergoing colorectal robot assisted laparoscopic surgery at a secondary care medical center in the Netherlands between June and December 2018. A 3 min video recording of the parietal peritoneum was made with the Da Vinci® Firefly mode following intravenous injection of 0.2 mg/kg indocyanine green at a pneumoperitoneum pressure of 8, 12 or 16 mmHg. Observers were blinded for the level of intra-abdominal pressure that was used. Fluorescent intensity in [-] over time was extracted from each video in MATLAB. Time to reach maximal fluorescent intensity (TMFI) and maximum fluorescent intensity (MFI) were compared among groups. The study was registered at clinicaltrials.gov (NCT03928171).
RESULTS


Mean TMFI was shorter at low pressure (8 mmHg) than standard pressure (12 and 16 mmHg): 44 ± 12 versus 58 ± 18 s (p = 0.032), respectively. Mean MFI was higher at 8 mmHg than 12 and 16 mmHg (222 ± 25 versus 188 ± 54, p = 0.033). Regression analysis identified intra-abdominal pressure, mean arterial pressure and female gender as significant predictors of peritoneal perfusion.
CONCLUSION


Low pressure pneumoperitoneum was associated with improved perfusion of the parietal peritoneum. Current available evidence supported feasibility and enhanced postoperative recovery. Future investigations should focus on optimizing factors that facilitate lower intra-abdominal pressure and explore effects on other clinically relevant patient outcomes such as anastomotic leakage and immune homeostasis.",2020,Mean TMFI was shorter at low pressure (8 mmHg) than standard pressure (12 and 16 mmHg): 44 ± 12 versus 58 ± ,['30 adults undergoing colorectal robot assisted laparoscopic surgery at a secondary care medical center in the Netherlands between June and December 2018'],"['fluorescent imaging during laparoscopic surgery', 'indocyanine green', 'low pressure pneumoperitoneum']","['peritoneal perfusion', 'Lowering intra-abdominal pressure', 'Mean MFI', 'Time to reach maximal fluorescent intensity (TMFI) and maximum fluorescent intensity (MFI', 'Fluorescent intensity', 'Mean TMFI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",30.0,0.229307,Mean TMFI was shorter at low pressure (8 mmHg) than standard pressure (12 and 16 mmHg): 44 ± 12 versus 58 ± ,"[{'ForeName': 'Kim I', 'Initials': 'KI', 'LastName': 'Albers', 'Affiliation': 'Radboudumc Department of Surgery, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands; Radboudumc Department of Anaesthesiology, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands. Electronic address: kim.albers@radboudumc.nl.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Polat', 'Affiliation': 'Canisius Wilhelmina Hospital Department of Surgery, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Loonen', 'Affiliation': 'Radboudumc Technology Centre 3D Lab, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Leon J', 'Initials': 'LJ', 'LastName': 'Graat', 'Affiliation': 'St Antonius Hospital Department of Surgery, Koekoekslaan 1, 3435 CM, Nieuwegein, the Netherlands.'}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Mulier', 'Affiliation': 'AZ Sint-Jan Brugge-Oostende Department of Anaesthesiology, Kaïrostraat 84, 8400, Oostende, Belgium.'}, {'ForeName': 'Marc Mj', 'Initials': 'MM', 'LastName': 'Snoeck', 'Affiliation': 'Canisius Wilhelmina Hospital Department of Anaesthesiology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands.'}, {'ForeName': 'Ivo F', 'Initials': 'IF', 'LastName': 'Panhuizen', 'Affiliation': 'Canisius Wilhelmina Hospital Department of Anaesthesiology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, the Netherlands.'}, {'ForeName': 'Ad A', 'Initials': 'AA', 'LastName': 'Vermulst', 'Affiliation': 'Statistician at GGZ (Mental Health Care) Oost Brabant, Kluisstraat, 2 5427 EM, Boekel, the Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Scheffer', 'Affiliation': 'Radboudumc Department of Anaesthesiology, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': 'Radboudumc Department of Surgery, Geert Grooteplein Zuid 10, 6525GA, Nijmegen, the Netherlands.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.019']
644,32330093,Increasing standing tolerance in office workers with standing-induced back pain.,"Sit-stand desks are popular however many people have standing-induced low back pain (LBP). People with LBP have fewer standing weight shifts compared with back-healthy people. Participants were classified as standing-tolerant or intolerant. Participants were provided sit-stand desks for 12 weeks. Participants were assigned to intervention (graded standing exposure and exercise) or control (no instruction) conditions. Participants reported weekly sitting time and average/worst LBP. Standing weight shifts and LBP were re-assessed post-intervention. All groups decreased sitting time (range: 30-50%) over 12 weeks. Sitting time and average LBP were correlated in all standing-intolerant individuals, worst LBP and sitting time were correlated for intervention group only. All standing-intolerant individuals increased standing weight shifts and decreased LBP after 12-weeks. Standing-intolerant individuals benefitted from 12-weeks of sit-stand desk use regardless of intervention. Motivated individuals with standing-induced LBP may increase standing tolerance with sit-stand desk use. Additional benefits may exist when structured guidance is provided.  Practitioner summary:  Many people are standing-intolerant due to low back pain (LBP). This lab and field-based study showed some benefits from structured approaches to gradually progress standing time when transitioning to standing work. Using a sit-stand desk for 12 weeks resulted in decreased LBP and sitting time in standing-intolerant people.  Abbreviations:  LBP: low back pain; OSPAQ: Occupational Sitting and Physical Activity Questionnaire; VAS: visual analog scale; GRF: ground reaction force; WeekVASMAX: worst low back pain reported on visual analog scale for prior week; WeekVASAVE: average low back pain reported on visual analog scale for prior week; ICC: intraclass correlation coefficient; LabVASMAX: worst low back pain reported on visual analog scale during lab-based standing; LabVASAVE: average low back pain reported on visual analog scale during lab-based standing; FvR,L: vertical ground reaction force for right and left force plate; BWSSMALL: small (10-29% body weight) body weight shift; BWSLARGE: large (> 30% body weight) body weight shift; ActivPALSED: ActivePAL data for sedentary time; ActivPALSTND: ActivePAL data for standing time; ANOVA: analysis of variance; Standing Intolerant-INT: standing intolerant participants assigned to intervention condition; Standing Intolerant-CON: standing intolerant participants assigned to control condition; Standing Tolerant-INT: standing tolerant participants assigned to intervention condition; Standing Tolerant-CON: standing tolerant participants assigned to control condition; SI: standing intolerant; ST: standing tolerant; INT: intervention; CON: control.",2020,Using a sit-stand desk for 12 weeks resulted in decreased LBP and sitting time in standing-intolerant people.,['office workers with standing-induced back pain'],"['LBP', 'intervention (graded standing exposure and exercise) or control (no instruction) conditions']","['Sitting time and average LBP', 'Standing weight shifts and LBP', 'sitting time', 'weekly sitting time and average/worst LBP', 'standing tolerance', 'LBP and sitting time', 'standing weight shifts and decreased LBP', 'standing weight shifts']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0589035', 'cui_str': 'Standing tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0292197,Using a sit-stand desk for 12 weeks resulted in decreased LBP and sitting time in standing-intolerant people.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nelson-Wong', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Gallagher', 'Affiliation': 'College of Education and Health Professions, University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Antonioli', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ferguson', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}, {'ForeName': 'James Blake', 'Initials': 'JB', 'LastName': 'Miller', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, CO, USA.'}]",Ergonomics,['10.1080/00140139.2020.1761034']
645,24956457,Ultrasound and shockwave therapy for acute fractures in adults.,"BACKGROUND


The morbidity and socioeconomic costs of fractures are considerable. The length of time to healing is an important factor in determining a person's recovery after a fracture. Ultrasound may have a therapeutic role in reducing the time to union after fracture. This is an update of a review previously published in February 2012.
OBJECTIVES


To assess the effects of low-intensity ultrasound (LIPUS), high-intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW) as part of the treatment of acute fractures in adults.
SEARCH METHODS


We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (2 June 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 5), MEDLINE (1946 to May Week 3 2014), EMBASE (1980 to 2014 Week 22), trial registers and reference lists of articles.
SELECTION CRITERIA


Randomised and quasi-randomised controlled trials evaluating ultrasound treatment in the management of acute fractures in adults. Studies had to include participants over 18 years of age with acute fractures, reporting outcomes such as function; time to union; non-union; secondary procedures such as for fixation or delayed union or non-union; adverse effects; pain; costs; and patient adherence.
DATA COLLECTION AND ANALYSIS


Two authors independently extracted data from the included studies. Treatment effects were assessed using mean differences, standardised mean differences or risk ratios using a fixed-effect model, except where there was substantial heterogeneity, when data were pooled using a random-effects model. Results from 'worst case' analyses, which gave more conservative estimates of treatment effects for time to fracture union, are reported in preference to those from 'as reported' analyses.
MAIN RESULTS


We included 12 studies, involving 622 participants with 648 fractures. Eight studies were randomised placebo-controlled trials, two were randomised controlled trials without placebo controls, one was a quasi-randomised placebo-controlled trial and one was a quasi-randomised controlled trial without placebo control. Eleven trials tested LIPUS and one trial tested ECSW. Four trials included participants with conservatively treated upper limb complete fractures and six trials included participants with lower limb complete fractures; these were surgically fixed in four trials. The remaining two trials reported results for conservatively treated tibial stress fractures.'Risk of bias' assessment of the included studies was hampered by the poor reporting of methods, frequently resulting in the risk of bias of individual domains being judged as 'unclear'. Both quasi-randomised studies were at high risk of bias, including selection and attrition bias. Three studies were at low risk of selection bias relating to allocation concealment the majority of studies were at low risk of performance bias as they employed a form of intervention blinding.Only limited data were available from three of only four studies reporting on functional outcome. One study of complete fractures found little evidence of a difference between the two groups in the time to return to work (mean difference (MD) 1.95 days favouring control, 95% confidence interval (CI) -2.18 to 6.08; 101 participants). Pooled data from two studies found LIPUS did not significantly affect the time to return to training or duty in soldiers or midshipmen with stress fractures (MD -8.55 days, 95% CI -22.71 to 5.61; 93 participants).We adopted a conservative strategy for data analysis that was more likely to underestimate than to overestimate a benefit of the intervention. After pooling results from eight studies (446 fractures), the data showed no statistically significant reduction in time to union of complete fractures treated with LIPUS (standardised mean difference (SMD) -0.47, 95% CI -1.14 to 0.20). This result could include a clinically important benefit or harm, and should be seen in the context of the highly significant statistical heterogeneity (I² = 90%). This heterogeneity was not explained by the a priori subgroup analyses (upper limb versus lower limb fracture, smoking status). An additional subgroup analysis comparing conservatively and operatively treated fractures raised the possibility that LIPUS may be effective in reducing healing time in conservatively managed fractures, but the test for subgroup differences did not confirm a significant difference between the subgroups.Pooled results from five of the eight trials (333 fractures) reporting proportion of delayed union or non-union showed no significant difference between LIPUS and control (10/168 versus 13/165; RR 0.75; 95% CI 0.24 to 2.28). Adverse effects directly associated with LIPUS and associated devices were found to be few and minor, and compliance with treatment was generally good. One study reporting on pain scores found no difference between groups at eight weeks (101 participants).One quasi-randomised study found no significant difference in non-union at 12 months between internal fixation supplemented with ECSW and internal fixation alone (3/27 versus 6/30; RR 0.56, 95% CI 0.15 to 2.01). There was a clinically small but statistically significant difference in the visual analogue scores for pain in favour of ECSW at three month follow-up (MD -0.80, 95% CI -1.23 to -0.37). The only reported complication was infection, with no significant difference between the two groups.
AUTHORS' CONCLUSIONS


While a potential benefit of ultrasound for the treatment of acute fractures in adults cannot be ruled out, the currently available evidence from a set of clinically heterogeneous trials is insufficient to support the routine use of this intervention in clinical practice. Future trials should record functional outcomes and follow-up all trial participants.",2014,Pooled data from two studies found LIPUS did not significantly affect the time to return to training or duty in soldiers or midshipmen with stress fractures (,"['acute fractures in adults', '622 participants with 648 fractures', 'participants with conservatively treated upper limb complete fractures and six trials included participants with lower limb complete fractures']","['placebo', 'ECSW and internal fixation alone', 'ECSW', 'Ultrasound and shockwave therapy', 'placebo control', 'ultrasound treatment', 'low-intensity ultrasound (LIPUS), high-intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW']","['non-union', 'length of time to healing', 'pain scores', 'visual analogue scores for pain', 'function; time to union; non-union; secondary procedures such as for fixation or delayed union or non-union; adverse effects; pain; costs; and patient adherence', 'healing time', 'delayed union or non-union', 'time to union of complete fractures']","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445275', 'cui_str': 'Secondary procedure (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",622.0,0.159969,Pooled data from two studies found LIPUS did not significantly affect the time to return to training or duty in soldiers or midshipmen with stress fractures (,"[{'ForeName': 'Xavier L', 'Initials': 'XL', 'LastName': 'Griffin', 'Affiliation': 'Warwick Orthopaedics, Warwick Medical School, University of Warwick, Clinical Sciences Building, Clifford Bridge Road, Coventry, UK, CV2 2DX.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': ''}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Metcalfe', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008579.pub3']
646,32298704,Pain-modulating effects of oxytocin in patients with chronic low back pain.,"The neuropeptide oxytocin (OT) has been shown to play a modulatory role in nociception. However, analgesic effects of OT in chronic pain conditions remain elusive and the neural underpinnings have not yet been investigated in humans. Here, we conducted an exploratory, randomized, placebo-controlled, cross-over study to examine effects of intranasal OT in male patients suffering from chronic low back pain (CBP) versus healthy controls (HC). N = 22 participants with CBP and 22 HCs were scanned using functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back. During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs. Spontaneously experienced pain in contrast to heat pain was associated with activation changes in the medial frontal cortex (MFC) and the anterior cingulate cortex (ACC) as reported in previous studies. However, we did not observe OT effects on spontaneously experienced pain in CBP patients. Overall, our preliminary data may suggest that the striatum is a key structure underlying the pain-modulating effects of OT in patients with chronic pain and adds to the growing evidence linking the neuropeptide to pain modulation in humans. Further studies on neuronal OT effects in larger samples of chronic back pain patients are needed to understand probable mechanisms of OT effects in chronic pain.",2020,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"['N\u202f=\u202f22 participants with CBP and 22\u202fHCs', 'male patients suffering from chronic low back pain (CBP) versus healthy controls (HC', 'patients with chronic low back pain', 'chronic back pain patients', 'patients with chronic pain']","['neuropeptide oxytocin (OT', 'OT', 'OT versus PL', 'intranasal OT', 'placebo', 'functional magnetic resonance imaging (fMRI) while they continuously rated either spontaneously occurring back pain or acute thermal pain stimuli applied to the lower back', 'oxytocin']","['BOLD responses', 'pain intensity ratings', 'medial frontal cortex (MFC) and the anterior cingulate cortex (ACC', 'OT effects']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004600', 'cui_str': 'Back'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",22.0,0.105867,During heat pain processing we found that OT versus PL attenuated pain intensity ratings and increased BOLD responses in the caudate nucleus of the striatum in CBP versus HCs.,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boll', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ueltzhoeffer', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany; Department of Psychology and Psychotherapy, Ludwigs-Maximilian-University München, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Nees', 'Affiliation': 'Department of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Grinevich', 'Affiliation': 'Department of Neuropeptide Research in Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Germany. Electronic address: Sabine.Herpertz@med.uni-heidelberg.de.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108105']
647,32302646,Acute stress affects implicit but not explicit motor imagery: A pilot study.,"Motor imagery (MI) is the capacity to mentally perform one or a set of movements without concomitant overt action. MI training has been show to enhance the subsequent motor performance. While the benefits of MI to manage stress have been extensively documented, the reverse impact of stress on MI received far less attention. The present study thus aimed to evaluate whether acute stress might influence MI abilities. Thirty participants were assigned either to a stress or a control group. The Socially Evaluated Cold Pressor Test (SECPT) was used to induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress being monitored during the experiment. Stress induction was followed by both implicit (laterality judgment) and explicit (sequential pointing) MI tasks. Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered. These exploratory findings provide a deeper understanding of stress effects on cognition, and practically support that under stressful conditions, as during a sport competition or rehabilitation contexts, explicit MI should be prioritized.",2020,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.",['Thirty participants'],"['explicit motor imagery', 'Motor imagery (MI', 'MI training']","['induce stress, with heart rate, electrodermal activity, salivary cortisol, and self-report perceived levels of stress', 'deleterious impact of stress on implicit MI, while explicit MI']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]",30.0,0.0137573,"Main results showed a deleterious impact of stress on implicit MI, while explicit MI was not altered.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schlatter', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: sophie.schlatter@univ-lyon1.fr.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Guillot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: aymeric.guillot@univ-lyon1.fr.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faes', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: camille.faes@univ-lyon1.fr.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Saruco', 'Affiliation': 'Neurologische Universitätsklinik, Bergmannsheil gGmbH, Forschungsgruppe Plastizität, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany. Electronic address: elodie.saruco@ruhr-uni-bochum.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Collet', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: christian.collet@univ-lyon1.fr.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Di Rienzo', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: franck.di-rienzo@univ-lyon1.fr.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Debarnot', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology-EA 7424, University of Lyon, University Claude Bernard Lyon 1, 69 622 Villeurbanne, France. Electronic address: ursula.debarnot@univ-lyon1.fr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.04.011']
648,32304734,Cetirizine inhibits gender-specific blood cell dynamics upon allergen contact in allergic rhinitis.,"IgE-mediated inflammatory responses upon allergen contact in allergic rhinitis (AR) are associated with rapid alterations of circulating blood cell numbers detectable in a complete blood count (CBC). Aim of this study was to evaluate whether intake of antihistamines may modulate allergen-induced CBC dynamics in male and female patients. A total of N = 112 specific allergen challenges were performed in otherwise healthy AR subjects. Seventy-two (n = 72) subjects received placebo and forty (n = 40) received cetirizine (H1-receptor antagonist) per os prior to allergen exposure in a randomized, double-blind trial at the Vienna Challenge Chamber (VCC); a subgroup of twenty-five (n = 25) subjects received cetirizine and placebo on different study days (parallel group). Blood samples and symptom scores were taken at baseline and immediately after 6 h of airway challenge simulating ambient allergen contact. Female sex was associated with a pronounced circulating monocyte increase (p < .01) and male sex with an eosinophil decrease (p < .05) in the placebo group, but not in cetirizine treated subjects. The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes. A more prominent thrombocyte increase in female subjects (p < .05) was noted upon allergen exposure, regardless of prior cetirizine intake. Cetirizine inhibited the mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers, but did not affect thrombocyte increase upon allergen challenge. It further diminished gender-specific blood cell dynamics. Overall, as reflected in a simple CBC, cetirizine critically diminished immediate and late innate immune responses subsequent to allergen exposure.",2020,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"['allergic rhinitis', 'Seventy-two (n\u202f=\u202f72) subjects received', 'allergic rhinitis (AR', 'male and female patients', 'otherwise healthy AR subjects']","['cetirizine (H1-receptor antagonist) per os prior to allergen exposure', 'cetirizine and placebo', 'Cetirizine', 'antihistamines', 'placebo', 'cetirizine']","['circulating erythrocytes', 'segmented neutrophils', 'Blood samples and symptom scores', 'mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers', 'circulating monocyte increase']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0034814', 'cui_str': 'Histamine H1 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0229640', 'cui_str': 'Segmented neutrophil'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0553698', 'cui_str': 'Monocyte count increased'}]",72.0,0.125116,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria. Electronic address: galateja.jordakieva@meduniwien.ac.at.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Department of Environmental Health, Medical University of Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen-Jarolim', 'Affiliation': 'Institute of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria; The Interuniversity Messerli Research Institute, Medical University Vienna, University of Veterinary Medicine Vienna, University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2020.108422']
649,31569161,"Prevention of Early Postoperative Decline: A Randomized, Controlled Feasibility Trial of Perioperative Cognitive Training.","BACKGROUND


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


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


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


A CT program designed for use in the preoperative period is an attractive target for future investigations of cognitive prehabilitation in older cardiac surgery patients. Changes in the functionality of the program and enrichment techniques may improve adherence in future trials. Further investigation is necessary to determine the potential efficacy of cognitive prehabilitation to reduce the risk of postoperative delirium and POCD.",2020,"CT participants agreed significantly more than controls that their memory (median [IQR], 75 [54-82] vs 51 [49-54]; P = .01) and thinking ability (median [IQR], 78 [64-83] vs 50 [41-68]; P = .01) improved as a result of their participation in the study.
","['Sixty-five percent of eligible patients were enrolled', 'Early Postoperative Decline', 'older cardiac surgery patients', 'Participants included 45 older adults age 60-90 undergoing cardiac surgery at least 10 days from enrollment']","['perioperative CT via a mobile device or a usual care control', 'CT', 'perioperative CT program', 'Perioperative Cognitive Training', 'Cognitive training (CT']","['Median (interquartile range [IQR]) adherence', 'hospital mortality', 'Patient satisfaction', 'postoperative delirium and POCD', 'Confusion Assessment Method and the Montreal Cognitive Assessment', 'Median (IQR) training times', 'incidence of postoperative delirium', 'POCD', 'thinking ability']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3496286'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",45.0,0.2064,"CT participants agreed significantly more than controls that their memory (median [IQR], 75 [54-82] vs 51 [49-54]; P = .01) and thinking ability (median [IQR], 78 [64-83] vs 50 [41-68]; P = .01) improved as a result of their participation in the study.
","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': ""O'Gara"", 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Mueller', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Doris Vanessa I', 'Initials': 'DVI', 'LastName': 'Gasangwa', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Patxot', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Shaefi', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Khabbaz', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascal-Leone', 'Affiliation': 'Department of Neurology, Division of Cognitive Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': 'Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'From the Department of Anesthesia, Critical Care and Pain Medicine.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004469']
650,32334176,"The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 h: A randomized, controlled, non-inferiority trial.","BACKGROUND


Peripheral intravenous catheters are widely used for infusion therapy. To prevent phlebitis, routine catheter replacement at 72 or 96 h remains widely practiced.
OBJECTIVE


To investigate the non-inferiority of clinically indicated peripheral intravenous catheter replacement compared with routine replacement every 96 h to prevent phlebitis. Phlebitis severity, catheter indwelling time, and other catheter failure types were also compared.
SETTING


Multi-center trial in wards at two hospitals in Sao Paulo, Brazil.
DESIGN


The REplacement of PEripheral intravenous CaTheters according to clinical signs or every 96 h (RESPECT) trial was a Randomized, non-blinded, controlled, non-inferiority trial.
PARTICIPANTS


1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96 h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided. Exclusion criteria were: bloodstream infection and/or sepsis, neutrophil count of ≤1000/mm 3 , and simultaneous use of more than one peripheral intravenous catheter. Recruitment occurred within 96 h of peripheral intravenous catheter insertion. Randomization was performed using a computer-generated, concealed list.
METHODS


As intervention, clinically indicated replacement group patients underwent peripheral intravenous catheter removal only at the end of therapy or in the presence of phlebitis, infiltration, occlusion, displacement, accidental removal, or bloodstream infection. Routine 96-h replacement group patients (control) had their catheters replaced every 96-h, unless clinical reasons required earlier replacement. The primary outcome was Phlebitis and the analyses were carried out on intention-to-treat and per-protocol bases.
RESULTS


Demographic and clinical variables were similar between groups, with the exception to type of admission (p = 0.025) more frequent in clinically indicated patients and surgical on routine replacement group. Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis. Phlebitis/1000 catheter-days, was 14.9 in the clinically indicated group and 23.8 in the routine replacement group (p = 0.006). The survival analysis showed no significant between-group difference in the occurrence of the first phlebitis episode.
CONCLUSIONS


Clinically indicated peripheral intravenous catheter replacement was not inferior to routine (96 h) replacement regarding phlebitis occurrence, and was associated with significantly less phlebitis per 1000 days.
TRIAL REGISTRATION


Registered with www.clinicaltrials.gov (NCT02568670).",2020,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","['Multi-center trial in wards at two hospitals in Sao Paulo, Brazil', '1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96\xa0h; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided']","['peripheral intravenous catheters', 'peripheral intravenous catheter replacement', 'peripheral intravenous catheter removal']","['Phlebitis', 'phlebitis', 'intention-to-treat and per-protocol bases', 'Phlebitis severity, catheter indwelling time, and other catheter failure types']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",1319.0,0.175394,"Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Vendramim', 'Affiliation': 'Specialist in pediatric intensive care, M.Sc., Ph.D. in Health Science of Federal University of Sao Paulo, 258 Aimberê, St. Sao Paulo, Brazil. Electronic address: patvendramim@gmail.com.'}, {'ForeName': 'Ariane Ferreira Machado', 'Initials': 'AFM', 'LastName': 'Avelar', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: ariane.machado@unifesp.br.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Griffith University - Australia, Australia. Electronic address: c.rickard@griffith.edu.au.'}, {'ForeName': 'Mavilde da Luz Gonçalves', 'Initials': 'MDLG', 'LastName': 'Pedreira', 'Affiliation': 'Federal University of Sao Paulo, Brazil. Electronic address: mpedreira@unifesp.br.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103504']
651,32334292,The impact of fascia iliaca compartment block on chronic postsurgical pain in patients undergoing hip fracture repair.,"STUDY OBJECTIVE


Chronic postsurgical pain (CPSP), i.e. pain persisting >3 months, may appear after any type of surgery. There is a paucity of literature addressing CPSP development after hip fracture repair and the impact of any analgesic intervention on the development of CPSP in patients after hip fracture surgery. This study is the first aiming to examine the impact of ultrasound-guided fascia iliaca compartment block (USG FICB) on the development of CPSP after hip fracture repair.
DESIGN


Prospective randomized study.
SETTING


Operating room.
PATIENTS


182 patients scheduled for hip fracture surgery.
INTERVENTIONS


Patients were randomized to receive a USG FICB (FICB group) or a sham saline injection (sham FICB group), twenty minutes before positioning for spinal anesthesia.
MEASUREMENTS


The hip - related characteristic pain intensity (CPI) at 3- months post-surgery was the primary outcome measure. Presence and severity of hip-related pain at 3- and 6-months post-surgery, numeric rating pain scale (NRS) scores at 6, 24, 36, 48 postoperative hours, total 24-hour tramadol PCA administration and timing of the first tramadol dose, were documented as well.
MAIN RESULTS


FICB group presented with lower CPI scores 3- months postoperatively (p < 0.01), as well as lower percentage of patients with high-grade CPSP, 3 and 6 months postoperatively (p < 0.001). FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05). The overall sample of 182 patients reported a considerably high incidence of hip -related CPSP (60% at 3 months, 45% at 6 months).
CONCLUSIONS


USG FICB in the perioperative setting may reduce the incidence, intensity and severity of CPSP at 3 and 6 months after hip fracture surgery, providing safe and effective postoperative analgesia.",2020,"FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05).","['patients undergoing hip fracture repair', 'patients after hip fracture surgery', '182 patients reported a considerably high incidence of hip -related', '182 patients scheduled for hip fracture surgery']","['fascia iliaca compartment block', 'ultrasound-guided fascia iliaca compartment block (USG FICB', 'USG FICB (FICB group) or a sham saline injection', 'FICB']","['CPI scores', 'NRS scores', 'CPSP', 'hip - related characteristic pain intensity (CPI', 'numeric rating pain scale (NRS) scores', 'incidence, intensity and severity of CPSP', 'chronic postsurgical pain', 'Presence and severity of hip-related pain', 'total 24-hour tramadol PCA administration and timing of the first tramadol dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0246008', 'cui_str': 'CPI(1)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",182.0,0.129944,"FICB group also showed significantly lower NRS scores in all instances, lower total 24 - hour tramadol consumption and higher mean time to first tramadol dose (p < 0.05).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Diakomi', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georgoudis', 'Affiliation': 'Physiotherapy Department, University of West Attica, Athens, Greece.'}, {'ForeName': 'Erifili', 'Initials': 'E', 'LastName': 'Argyra', 'Affiliation': 'Department of Anesthesiology, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Argyro', 'Initials': 'A', 'LastName': 'Mela', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Siafaka', 'Affiliation': 'Department of Anesthesiology, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Department of Anesthesiology, Asklepieion Hospital of Voula, Athens, Greece. Electronic address: makrisalexandros@hotmail.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109801']
652,28351446,"On the relationship between head circumference, brain size, prenatal long-chain PUFA/5-methyltetrahydrofolate supplementation and cognitive abilities during childhood.","Head circumference in infants has been reported to predict brain size, total grey matter volume (GMV) and neurocognitive development. However, it is unknown whether it has predictive value on regional and subcortical brain volumes. We aimed to explore the relationship between several head circumference measurements since birth and distributions of GMV and subcortical volumes at later childhood. We examined seventy-four, Caucasian, singleton, term-born infants born to mothers randomised to receive fish oil and/or 5-methyltetrahydrofolate or placebo prenatal supplementation. We assessed head circumference at birth and at 4 and 10 years of age and cognitive abilities at 7 years of age. We obtained brain MRI at 10 years of age, on which we performed voxel-based morphometry, cortical surface extraction and subcortical segmentation. Analyses were controlled for sex, age, height, weight, family status, laterality and total intracranial volume. Prenatal supplementation did not affect head circumference at any age, cognitive abilities or total brain volumes. Head circumference at 4 years presented the highest correlation with total GMV, white matter volume and brain surface area, and was also strongly associated with GMV of frontal, temporal and occipital areas, as well as with caudate nucleus, globus pallidus, putamen and thalamus volumes. As relationships between brain volumes in childhood and several outcomes extend into adulthood, we have found that ages between 0 and 4 years as the optimal time for brain growth; postnatal factors might have the most relevant impact on structural maturation of certain cortical areas and subcortical nuclei, independent of prenatal supplementation.",2019,"Head circumference at 4 years presented the highest correlation with total GMV, white matter volume and brain surface area, and was also strongly associated with GMV of frontal, temporal and occipital areas, as well as with caudate nucleus, globus pallidus, putamen and thalamus volumes.","['head circumference at birth and at 4 and 10 years of age and cognitive abilities at 7 years of age', 'seventy-four, Caucasian, singleton, term-born infants born to mothers randomised to']",['receive fish oil and/or 5-methyltetrahydrofolate or placebo prenatal supplementation'],"['head circumference at any age, cognitive abilities or total brain volumes', 'Head circumference']","[{'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0049315', 'cui_str': 'mefolinate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.0287462,"Head circumference at 4 years presented the highest correlation with total GMV, white matter volume and brain surface area, and was also strongly associated with GMV of frontal, temporal and occipital areas, as well as with caudate nucleus, globus pallidus, putamen and thalamus volumes.","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Catena', 'Affiliation': 'Mind, Brain, and Behavior Research Center, University of Granada. 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez-Zaldívar', 'Affiliation': 'EURISTIKOS Excellence Centre for Paediatric Research, University of Granada. 18016 Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Diaz-Piedra', 'Affiliation': 'Mind, Brain, and Behavior Research Center, University of Granada. 18011 Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Torres-Espínola', 'Affiliation': 'EURISTIKOS Excellence Centre for Paediatric Research, University of Granada. 18016 Granada, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Brandi', 'Affiliation': 'EURISTIKOS Excellence Centre for Paediatric Research, University of Granada. 18016 Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pérez-García', 'Affiliation': 'Mind, Brain, and Behavior Research Center, University of Granada. 18011 Granada, Spain.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Decsi', 'Affiliation': 'Department of Paediatrics, University of Pécs, H-7624 Pécs, Hungary.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Dr. von Hauner Children's Hospital, Ludwig-Maximilians University of Munich Medical Centre, D-80337 München, Germany.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campoy', 'Affiliation': 'EURISTIKOS Excellence Centre for Paediatric Research, University of Granada. 18016 Granada, Spain.'}]",The British journal of nutrition,['10.1017/S0007114516004281']
653,31453973,The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?,"OBJECTIVE


The Kronos Early Estrogen Prevention Study (KEEPS) was designed to address gaps in understanding the effects of timely menopausal hormone treatments (HT) on cardiovascular health and other effects of menopause after the premature termination of the Women's Health Initiative.
METHOD


The KEEPS was a randomized, double-blinded, placebo-controlled trial to test the hypothesis that initiation of HT (oral conjugated equine estrogens [o-CEE] or transdermal 17β-estradiol [t-E2]) in healthy, recently postmenopausal women (n = 727) would slow the progression of atherosclerosis as measured by changes in carotid artery intima-media thickness (CIMT).
RESULTS


After 4 years, neither HT affected the rate of increase in CIMT. There was a trend for reduced accumulation of coronary artery calcium with o-CEE. There were no severe adverse effects, including venous thrombosis. Several ancillary studies demonstrated a positive effect on mood with o-CEE, and reduced hot flashes, improved sleep, and maintenance of bone mineral density with both treatments. Sexual function improved with t-E2. There were no significant effects of either treatment on cognition, breast pain, or skin wrinkling. Variants of genes associated with estrogen metabolism influenced the age of menopause and variability in effects of the HT on CIMT. Platelet activation associated with the development of white matter hyperintensities in the brain.
CONCLUSIONS


KEEPS and its ancillary studies have supported the value and safety of the use of HT in recently postmenopausal women and provide a perspective for future research to optimize HT and health of postmenopausal women. The KEEPS continuation study continues to pursue these issues.",2019,"There were no severe adverse effects, including venous thrombosis.","['postmenopausal women', 'healthy, recently postmenopausal women (n\u200a=\u200a727']","['HT (oral conjugated equine estrogens [o-CEE] or transdermal 17β-estradiol [t-E2', 'Estrogen Prevention Study (KEEPS', 'placebo', 'KEEPS']","['carotid artery intima-media thickness (CIMT', 'severe adverse effects, including venous thrombosis', 'reduced accumulation of coronary artery calcium', 'rate of increase in CIMT', 'cognition, breast pain, or skin wrinkling', 'Platelet activation', 'hot flashes, improved sleep, and maintenance of bone mineral density', 'Sexual function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",,0.167681,"There were no severe adverse effects, including venous thrombosis.","[{'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Departments of Surgery and Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Naftolin', 'Affiliation': 'Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Asthana', 'Affiliation': 'Education and Clinical Center, William S. Middleton Memorial Veterans Hospital, University of Wisconsin School of Medicine and Public Health and the Geriatric Research, Madison, WI.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Black', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City, UT.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Department of Medicine, Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles, Torrance, CA.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'N Maritza', 'Initials': 'NM', 'LastName': 'Dowling', 'Affiliation': 'Departments of Acute and Chronic Care, Epidemiology and Biostatistics, George Washington University School of Nursing and Milken Institute School of Public Health, Washington, DC.'}, {'ForeName': 'Carey E', 'Initials': 'CE', 'LastName': 'Gleason', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Wisconsin School of Medicine and Public Health and the William S. Middleton Memorial VA, Geriatric Research, Education and Clinical Center, Madison, WI.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Atherosclerosis Research Unit, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Muthuvel', 'Initials': 'M', 'LastName': 'Jayachandran', 'Affiliation': 'Department of Physiology and Biomedical Engineering, Division of Nephrology and Hypertension, Division of Hematology Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rogerio A', 'Initials': 'RA', 'LastName': 'Lobo', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, NY.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Pal', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Nanette F', 'Initials': 'NF', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': 'Phoenix Veterans Administration Health Care System, Phoenix, AZ.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001326']
654,32062566,Alleviation of ADHD symptoms by non-invasive right prefrontal stimulation is correlated with EEG activity.,"Attention deficit hyperactivity disorder (ADHD) is a prevalent disorder with effective pharmacological treatment that benefits most patients. However, about one-third fail to benefit while others search non-pharmacological alternatives, and for those options are scarce. One alternative treatment option is to alter abnormal right prefrontal cortex (rPFC) activity, given that rPFC abnormality has been repeatedly implicated in ADHD neurophathology. Here, we evaluated whether targeting the rPFC with multiple sessions of repetitive transcranial magnetic stimulation (rTMS), which can modulate neuronal excitability, activity, and plasticity in a non-invasive manner, will affect clinical symptoms in adults suffering from ADHD. Concomitantly, we used EEG to characterize electrophysiological alterations induced by treatment and to search for correlation between baseline neuronal activity and clinical response. Forty-three drug free adults with ADHD were randomized to receive either Real, Active Control, or Sham treatment (13 females, age ranging 21-46; n = 15, 14, 14, respectively), and underwent three weeks of daily high-frequency (18 Hz) stimulation sessions. We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085). Furthermore, based on EEG recorded within the first treatment session we established a novel biomarker, composed of the Alpha and Low-gamma power, which highly correlated the magnitude of the clinical outcome (r = 0.92, p = 0.0001). Taken together, the results of this pilot study indicate safety and effectiveness of rTMS directed to the rPFC for treatment of adult ADHD patients. The biomarker is suggested to reflect the responsiveness of the cortex to this rTMS intervention. Following validation of the results in larger samples, this study may represent a step towards a non-pharmacological treatment for adults with ADHD using EEG-based selection of optimal candidates for treatment.",2020,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"['Forty-three drug free adults with ADHD', 'adults suffering from ADHD', 'adult ADHD patients']","['Real, Active Control, or Sham treatment', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS']",['symptoms'],"[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0294365,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Alyagon', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hamutal', 'Initials': 'H', 'LastName': 'Shahar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Aviad', 'Initials': 'A', 'LastName': 'Hadar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Lazarovits', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Shalev', 'Affiliation': 'Psychiatry Department, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102206']
655,32078947,"Effect of an upright (vs. stooped) posture on interpretation bias, imagery, and emotions.","BACKGROUND AND OBJECTIVES


Adopting an upright (vs. stooped) posture has been related to positive effects on emotional and cognitive processes. However, there is no evidence concerning the effect of posture on two key processes associated with the maintenance of depression: interpretation bias and vividness of mental imagery. The objectives were to investigate the effect of adopting an upright (vs. stooped) posture on interpretation bias and vividness of positive and negative mental imagery, and to explore the interplay between these processes and depression-related emotions.
METHODS


The sample consisted of 54 participants (M age  = 22.00, 64.8% women), who were randomly assigned to the upright or stooped condition. Participants answered self-report measures while they were adopting a specific posture. Posture was monitored through inertial technology.
RESULTS


Main results were that: upright (vs. stooped) posture led to more positive interpretations of ambiguous information and increased positive emotions related to depression (happiness, optimism and vigor); time in an upright position was associated with change in interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology moderated the effect of posture on the change in interpretation bias.
LIMITATIONS


Limitations are related to the use of non-clinical sample, the use of short-term measurements, and the lack of an experimental condition adopting the usual posture.
CONCLUSIONS


Posture interacts with mechanisms involved in the maintenance of depression, as well as with depression-related emotions. This study has clinical implications that should be continued explored in order to clarify the role of manipulating the posture in individuals with depressive symptomatology.",2020,"RESULTS


Main results were that: upright (vs. stooped) posture led to more positive interpretations of ambiguous information and increased positive emotions related to depression (happiness, optimism and vigor); time in an upright position was associated with change in interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology moderated the effect of posture on the change in interpretation bias.
","['individuals with depressive symptomatology', '54 participants (M age \xa0=\xa022.00, 64.8% women']",['upright (vs. stooped) posture'],"['interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology', 'interpretation bias, imagery, and emotions', 'positive emotions related to depression (happiness, optimism and vigor); time']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1262869', 'cui_str': 'Posture'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",54.0,0.0751306,"RESULTS


Main results were that: upright (vs. stooped) posture led to more positive interpretations of ambiguous information and increased positive emotions related to depression (happiness, optimism and vigor); time in an upright position was associated with change in interpretation bias and vividness of positive mental imagery; and level of depressive symptomatology moderated the effect of posture on the change in interpretation bias.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Miragall', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN). Instituto Carlos III, Spain. Electronic address: marta.miragall@uv.es.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Borrego', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de Investigación e Innovación en Bioingeniería. Universitat Politècnica de València, Valencia, Spain. Electronic address: adborgon@i3b.upv.es.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN). Instituto Carlos III, Spain. Electronic address: ausias.cebolla@uv.es.'}, {'ForeName': 'Ernestina', 'Initials': 'E', 'LastName': 'Etchemendy', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain. Electronic address: ernestina.etchemendy@uv.es.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Navarro-Siurana', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain. Electronic address: jesnasiu@alumni.uv.es.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de Investigación e Innovación en Bioingeniería. Universitat Politècnica de València, Valencia, Spain; Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales Vithas-NISA. Fundación Hospitales NISA, Valencia, Spain. Electronic address: rllorens@i3b.upv.es.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Blackwell', 'Affiliation': 'Department of Psychology, Ruhr-Universität Bochum, Germany; Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-Universität Bochum, Germany. Electronic address: Simon.Blackwell@ruhr-uni-bochum.de.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Valencia, Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN). Instituto Carlos III, Spain. Electronic address: Rosa.Banos@uv.es.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101560']
656,32086006,A personalized approach-avoidance modification intervention to reduce negative body image. A placebo-controlled pilot study.,"BACKGROUND AND OBJECTIVES


Drive for thinness is considered an important factor in the onset and maintenance of negative body image and can be conceptualized as a motivational approach tendency towards thin bodies. The goal of this study was to test whether training thinness-related approach-avoidance tendencies is effective in improving body satisfaction using a personalized training with individuals' own body pictures.
METHODS


Undergraduate women scoring high on drive for thinness (N = 104) were randomly assigned to an experimental, placebo or no training control condition. The experimental training consisted of four training sessions in which participants pushed away thin versions of their own body pictures and pulled closer realistic pictures of themselves. The same stimuli were shown with 50/50 contingency in the placebo training.
RESULTS


The experimental training procedure did not show an effect on self-reported body satisfaction or drive for thinness after one session, four sessions, or one week later. While reaction time indices suggested a marginally significant change in approach-avoidance tendencies in the expected direction, this effect may have been driven by relatively strong thin-approach tendencies in the experimental condition before the start of the training.
LIMITATIONS


High error rates limit the interpretability of the effects on approach-avoidance tendencies. Selection was based on a single item assessing drive for thinness.
CONCLUSIONS


Taken together, our study did not provide evidence that training approach-avoidance tendencies is effective in improving negative body image.",2020,"The experimental training procedure did not show an effect on self-reported body satisfaction or drive for thinness after one session, four sessions, or one week later.",['Undergraduate women scoring high on drive for thinness (N\xa0=\xa0104'],"['placebo', 'training thinness-related approach-avoidance tendencies', 'placebo or no training control condition']",['approach-avoidance tendencies'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0039870', 'cui_str': 'Leanness'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0039870', 'cui_str': 'Leanness'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",104.0,0.0910549,"The experimental training procedure did not show an effect on self-reported body satisfaction or drive for thinness after one session, four sessions, or one week later.","[{'ForeName': 'Klaske A', 'Initials': 'KA', 'LastName': 'Glashouwer', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, the Netherlands; Department of Eating Disorders, Accare Child and Adolescent Psychiatry, Groningen, the Netherlands. Electronic address: k.a.glashouwer@rug.nl.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Timmerman', 'Affiliation': 'Faculty of Behavioural and Social Sciences, DataLab - Research Support, University of Groningen, the Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101544']
657,31877361,A behavioral intervention can decrease asthma exacerbations in older adults.,"BACKGROUND


Older adults have higher rates of asthma morbidity and mortality compared with younger age groups. Few interventions are tailored to this population.
OBJECTIVE


To evaluate a self-management asthma intervention in older adults.
METHODS


Adults age 55 and older with persistent asthma were enrolled into blinded, randomized controlled trial of a 6-session asthma self-management intervention. This educational intervention was conducted in group sessions and through individual telephone calls. Outcomes including asthma exacerbations (defined as unscheduled office visits, emergency department visits, or hospitalizations for asthma), spirometric values, FeNO, asthma control, asthma quality of life, and asthma self-management were assessed at 3, 6, and 12 months.
RESULTS


One hundred eighty-nine subjects were enrolled, 172 were randomized and received at least 1 treatment dose, and 145 (84%) were analyzed at 12 months. On a modified intent-to-treat analysis, those in the intervention group were less likely to have an asthma exacerbation (26.9% vs 47.1%, P = .01), had a lower asthma exacerbation rate (0.8 vs 1.9, P = .02), had better asthma control (19.9 vs 18.6, P = .08), and had a higher asthma self-management score (8.9 vs 8.4, P = .03). After a mixed-model analysis to control for confounding factors, a decrease in asthma exacerbations (P = .02), as well as a decreased asthma exacerbation rate (P = .04), remained statistically significant, whereas asthma control and self-management did not. No other significant outcome differences were found.
CONCLUSION


A 6-session asthma self-management intervention can successfully decrease asthma exacerbations among older adults.",2020,"After a mixed model analysis to control for confounding factors, a decrease in asthma exacerbations (p = 0.02), as well as a decreased asthma exacerbation rate (p = 0.04), remained statistically significant while asthma control and self-management did not.","['Adults age 55 and above with persistent asthma', 'Older adults', 'older adults', '189 subjects']","['behavioral intervention', '6-session asthma self-management intervention', 'self-management asthma intervention']","['higher asthma self-management score', 'asthma morbidity and mortality', 'asthma exacerbations', 'asthma exacerbation rate', 'asthma exacerbations (defined as unscheduled office visits, emergency department visits, or hospitalizations for asthma), spirometric values, FeNO, asthma control, asthma quality of life, and asthma self-management', 'asthma exacerbation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1319219', 'cui_str': 'Asthma self-management'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319219', 'cui_str': 'Asthma self-management'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}]",189.0,0.072295,"After a mixed model analysis to control for confounding factors, a decrease in asthma exacerbations (p = 0.02), as well as a decreased asthma exacerbation rate (p = 0.04), remained statistically significant while asthma control and self-management did not.","[{'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Baptist', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; University of Michigan School of Public Health, Ann Arbor, Michigan. Electronic address: abaptist@med.umich.edu.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Peter X', 'Initials': 'PX', 'LastName': 'Song', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Carpenter', 'Affiliation': 'Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Lavoisier J', 'Initials': 'LJ', 'LastName': 'Cardozo', 'Affiliation': 'Division of Geriatric Medicine, Department of Internal Medicine, Wayne State University, Detroit, Michigan.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2019.12.015']
658,32173607,Nasal high flow improves ventilation during propofol sedation: A randomized cross-over study in healthy volunteers.,"OBJECTIVE


Hypoventilation and carbon dioxide (CO 2 ) retention are common during sedation. The current study investigated the ventilation responses to nasal high flow (NHF) during sedation with propofol.
METHODS


NHF of 30 L/min and 60 L/min with room air was applied during wakefulness and sedation in 10 male volunteers. Ventilation was monitored by respiratory inductance plethysmography, transcutaneous partial pressure of CO 2  (TcCO 2 ), and SpO 2 .
RESULTS


During sedation, NHF of 30 L/min and 60 L/min reduced the TcCO 2  by 2.9 ± 2.7 mmHg (p = 0.025) and by 3.6 ± 3.4 mmHg (p = 0.024) without affecting SpO 2  and reduced the mean respiratory rate by 3 ± 3 breaths/min (p = 0.011) and by 4 ± 3 breaths/min (p = 0.003), respectively.
CONCLUSION


During sedation with propofol, NHF without supplemental oxygen attenuated CO 2  retention and reduced the respiratory rate. The findings show that NHF can improve ventilation during sedation, which may reduce the risk of complications related to hypoventilation.",2020,"The findings show that NHF can improve ventilation during sedation, which may reduce the risk of complications related to hypoventilation.","['NHF of 30\u2009L/min and 60\u2009L/min with room air was applied during wakefulness and sedation in 10 male volunteers', 'healthy volunteers']","['propofol sedation', 'propofol, NHF without supplemental oxygen attenuated CO', 'propofol', 'NHF']","['Nasal high flow improves ventilation', 'respiratory rate', 'mean respiratory rate', 'respiratory inductance plethysmography, transcutaneous partial pressure of CO 2  (TcCO 2 ), and SpO 2 ']","[{'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}]",10.0,0.0290219,"The findings show that NHF can improve ventilation during sedation, which may reduce the risk of complications related to hypoventilation.","[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Revie', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan. Electronic address: ayuse@nagasaki-u.ac.jp.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103429']
659,31124836,Pharmacokinetic and Pharmacodynamic Analysis of Alfaxalone Administered as a Bolus Intravenous Injection of Phaxan in a Phase 1 Randomized Trial.,"BACKGROUND


Previous formulations of alfaxalone have shown it to be a fast-acting intravenous anesthetic with high therapeutic index. Alfaxalone has been reformulated for human use as Phaxan, an aqueous solution of 10 mg/mL of alfaxalone and 13% betadex. This study assessed the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of alfaxalone given as a bolus intravenous injection of this formulation to human male volunteers.
METHODS


A dose of 0.5 mg/kg (0.42-0.55 mg/kg) of alfaxalone [mean (range)] was given by single intravenous bolus injection to 12 healthy subjects. Plasma alfaxalone concentrations and bispectral index (BIS) values were analyzed using an integrated pharmacokinetic-pharmacodynamic (PKPD) model using nonlinear mixed-effects models. Effect (BIS) was described using a sigmoidal fractional maximum effect (EMAX) model. All parameters were scaled using allometry and standardized to a 70-kg person using exponents of 0.75 for clearance parameters (CL, Q2, and Q3), 1.0 for volumes (V1, V2, and V3), and 0.25 for time-related parameters half-time keo (t1/2keo).
RESULTS


A 3-compartment model used to fit PK data with an additional compartment, linked by t1/2keo to describe the effect compartment, yielded alfaxalone PK parameter estimates: CL: 1.08 L/min; 0.87-1.34 L/min (median; 95% confidence interval [CI]); central volume of distribution (V1): 0.99 L; 0.53-2.05 L (median; 95% CI); intercompartment CLs (Q2): 0.87 L/min; 0.32-1.71 L/min (median; 95% CI) and Q3: 0.46 L/min; 0.19-1.03 L/min (median; 95% CI); and peripheral volumes of distribution (V2): 6.36 L; 2.79-10.7 L (median; 95% CI) and V3: 19.1 L; 8.61-37.4 L (median; 95% CI). PD interrogation assumed a baseline BIS of 96, with an estimated EMAX: 0.94; 0.71-0.99 (median; 95% CI), a plasma concentration (Cp) for 50% effect (C50): 0.98 mg/L; 0.83-1.09 mg/L (median; 95% CI), and a Hill coefficient (γ): 12.1; 6.7-15 (median; 95% CI). The t1/2keo was 8 minutes; 4.70-12.8 minutes (median; 95% CI). The mean time to a BIS 50 was 0.94 minutes (standard deviation [SD] = 0.2 minutes).
CONCLUSIONS


After a single bolus intravenous injection, alfaxalone has a high plasma CL equal to hepatic blood flow as reported for earlier studies of bolus injections of a previous formulation of alfaxalone. The plasma levels associated with BIS values of <60 are comparable to those previously reported in patients anesthetized with alfaxalone. The t1/2keo is relatively high, but the large Hill coefficient contributes to rapid onset and offset of action. This information can inform future studies of this formulation.",2020,"The mean time to a BIS 50 was 0.94 minutes (standard deviation [SD] = 0.2 minutes).
","['human male volunteers', '12 healthy subjects']","['alfaxalone', 'Alfaxalone']","['Plasma alfaxalone concentrations and bispectral index (BIS) values', 'pharmacokinetic (PK) and pharmacodynamic (PD) characteristics', 'plasma concentration (Cp', 'Effect (BIS', 'mean time to a BIS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0051482', 'cui_str': 'alfaxalone'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0051482', 'cui_str': 'alfaxalone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",12.0,0.198523,"The mean time to a BIS 50 was 0.94 minutes (standard deviation [SD] = 0.2 minutes).
","[{'ForeName': 'Colin S', 'Initials': 'CS', 'LastName': 'Goodchild', 'Affiliation': 'From Drawbridge Pharmaceuticals Pty Ltd, Malvern, Victoria, Australia.'}, {'ForeName': 'Juliet M', 'Initials': 'JM', 'LastName': 'Serrao', 'Affiliation': 'From Drawbridge Pharmaceuticals Pty Ltd, Malvern, Victoria, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Sear', 'Affiliation': 'Nuffield Department of Anaesthetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Anaesthesiology, University of Auckland, Auckland, New Zealand.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004204']
660,30898331,Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial.,"OBJECTIVES


To assess the effects of mindfulness-based relapse prevention for alcohol dependence (MBRP-A) intervention on drinking and related consequences.
METHODS


123 alcohol-dependent adults in early recovery, recruited from outpatient treatment programs, were randomly assigned to MBRP-A (intervention plus usual-care; N = 64) or Control (usual-care-alone; N = 59) group. MBRP-A consisted of eight-weekly sessions and home practice. Outcomes were assessed at baseline, 8 weeks and 26 weeks (18 weeks post-intervention), and compared between groups using repeated measures analysis.
RESULTS


Outcome analysis included 112 participants (57 MBRP-A; 55 Control) who provided follow-up data. Participants were 41.0 ± 12.2 years old, 56.2% male, and 91% white. Prior to ""quit date,"" they reported drinking on 59.4 ± 34.8% (averaging 6.1 ± 5.0 drinks/day) and heavy drinking (HD) on 50.4 ± 35.5% of days. Their drinking reduced after the ""quit date"" (before enrollment) to 0.4 ± 1.7% (HD: 0.1 ± 0.7%) of days. At 26 weeks, the MBRP-A and control groups reported any drinking on 11.5 ± 22.5% and 5.9 ± 11.6% of days and HD on 4.5 ± 9.3% and 3.2 ± 8.7% of days, respectively, without between-group differences (ps ≥ 0.05) in drinking or related consequences during the follow-up period. Three MBRP-A participants reported ""relapse,"" defined as three-consecutive HD days, during the study. Subgroup analysis indicated that greater adherence to session attendance and weekly home practice minutes were associated with improved outcomes.
CONCLUSIONS


MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone; a return to drinking and relapse to HD were rare in both groups. However, greater adherence to MBRP-A intervention may improve long-term drinking-related outcomes.",2019,"CONCLUSIONS


MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone; a return to drinking and relapse to HD were rare in both groups.","['112 participants (57 MBRP-A; 55 Control) who provided follow-up data', 'alcohol dependence', 'Participants were 41.0\u202f±\u202f12.2\u202fyears old, 56.2% male, and 91% white', '123 alcohol-dependent adults in early recovery, recruited from outpatient treatment programs']","['MBRP-A (intervention plus usual-care; N\u202f=\u202f64) or Control (usual-care-alone; N\u202f=\u202f59) group', 'Mindfulness-based relapse prevention', 'mindfulness-based relapse prevention for alcohol dependence (MBRP-A) intervention']","['relapse', 'adherence to session attendance and weekly home practice minutes']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",123.0,0.0485957,"CONCLUSIONS


MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone; a return to drinking and relapse to HD were rare in both groups.","[{'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Zgierska', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: Aleksandra.Zgierska@fammed.wisc.edu.'}, {'ForeName': 'Cindy A', 'Initials': 'CA', 'LastName': 'Burzinski', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: Cindy.Burzinski@fammed.wisc.edu.'}, {'ForeName': 'Marlon P', 'Initials': 'MP', 'LastName': 'Mundt', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: Marlon.Mundt@fammed.wisc.edu.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'McClintock', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: asmcclintock@wisc.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America. Electronic address: jcox@uwhealth.org.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Coe', 'Affiliation': 'University of Wisconsin-Madison, Harlow Center for Biological Psychology, 22 N Charter St, Madison, WI 53715, United States of America. Electronic address: ccoe@wisc.edu.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Miller', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Psychiatry, 6001 Research Park Boulevard, Madison, WI 53719, United States of America. Electronic address: michael.miller@uwmf.wisc.edu.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Fleming', 'Affiliation': 'University of Wisconsin-Madison, School of Medicine and Public Health, Department of Family Medicine and Community Health, 1100 Delaplaine Court, Madison, WI 53715, United States of America; Northwestern University, Feinberg School of Medicine, Department of Psychiatry and Behavioral Sciences, Abbott Hall Suite 1320, 710 N Lake Shore Drive, Chicago, IL 60611, United States of America. Electronic address: m-fleming@northwestern.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.013']
661,32120028,Phase I randomized trial of liothyronine for remyelination in multiple sclerosis: A dose-ranging study with assessment of reliability of visual outcomes.,"BACKGROUND


Thyroid hormone promotes remyelination in multiple sclerosis (MS) animal models through a variety of mechanisms. Liothyronine (L-T3) is a short-acting thyroid hormone with demonstrated safety and tolerability for short-term and chronic use in euthyroid adults with other health conditions, but has not been studied in people with MS. The objectives of this single-center, phase I, placebo-controlled, clinical trial were to determine the safety, tolerability, and optimal dosing of L-T3 in people with MS in preparation for a phase 2 remyelination clinical trial. Secondary goals included exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week.
METHODS


Groups of six clinically stable people with MS were randomized in a 4:2 ratio to receive L-T3 or placebo. The first group received 50 mcg total daily dose (TDD) of L-T3, with escalating doses of L-T3 in subsequent groups, up to potentially 150 mcg TDD in the final group. Prior to enrollment for the next dose-escalated group, all safety measures for the prior dose were reviewed. The maximum tolerated dose (MTD) was considered to be the dose below which two or more participants experienced dose limiting symptoms or one participant experienced a serious adverse event. After the MTD was reached, no further patients were enrolled. Visual evoked potentials (VEP) P100 latency with two different check sizes (17' and 34') and Sloan low contrast letter acuity (LCLA) were measured pre- and post-treatment. To determine whether there was a treatment effect, the placebo and L-T3 groups were compared using a clustered bootstrap regression estimation. A linear mixed effects model was used to determine test-retest reliability of VEP and LCLA in all eyes.
RESULTS


Between May 2016 and November 2016, 15 people with MS were randomized to L-T3 (n = 10) or placebo (n = 5). Subjects were adherent to the study drug and the MTD was 75 mcg TDD. No serious adverse events were observed and the most common adverse events were poor sleep and loose stools. No treatment effect of L-T3 was observed over one week. Therefore, data from patients on L-T3 and placebo were pooled to explore VEP and LCLA reliability. The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively. The mean differences in values between visits 1 and 2 for VEP 17' and 34' and LCLA were 1.9 ms/eye (SD 6.5), 0.4 ms/eye (6.3), and 0.8/eye (3.6), respectively.
CONCLUSIONS


This study confirms the short-term safety and tolerability of L-T3 in people with MS, with 75 mcg TDD as the MTD. Our results also support that, despite small variations over one week, VEP with various check sizes and Sloan LCLA are reliable functional and clinical outcome measures that could be used in remyelination clinical trials in MS. A future phase 2 clinical trial to investigate the efficacy of L-T3 as a remyelination therapy may be warranted. This trial was registered on clinicaltrials.gov (NCT02760056).",2020,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","['euthyroid adults with other health conditions', 'Groups of six clinically stable people with MS', 'people with MS in preparation for a phase 2 remyelination clinical trial', 'Between May 2016 and November 2016, 15 people with MS', 'people with MS, with 75 mcg TDD as the MTD', 'multiple sclerosis']","['Liothyronine (L-T3', '50 mcg total daily dose (TDD) of L-T3', 'L-T3', 'placebo', 'liothyronine', 'L-T3 or placebo']","['serious adverse events', 'Sloan low contrast letter acuity (LCLA', 'exploration of the reliability of functional and clinical measurements of myelination in the anterior visual pathway over one week', 'serious adverse event', 'Visual evoked potentials (VEP) P100 latency', 'VEP and LCLA reliability', 'safety and tolerability', 'maximum tolerated dose (MTD', 'safety, tolerability']","[{'cui': 'C0117002', 'cui_str': 'Euthyroid (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0334220', 'cui_str': 'Remyelination'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0042829', 'cui_str': 'Visual Pathways'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}]",15.0,0.117628,"The intraclass correlations of VEP 17', VEP 34' and LCLA were 0.836, 0.860, and 0.932, respectively.","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Wooliscroft', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: wooliscr@ohsu.edu.'}, {'ForeName': 'Ghadah', 'Initials': 'G', 'LastName': 'Altowaijri', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hildebrand', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: hildeand@ohsu.edu.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Samuels', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, CR107, Portland, OR 97239, United States. Electronic address: samuelsm@ohsu.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: oken@ohsu.edu.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Bourdette', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States. Electronic address: bourdett@ohsu.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR L226 97239, United States; Department of Neurology, Department of Veterans Affairs Portland Health Care System, 3710 S.W. U.S. Veterans Hospital Rd., Portland, OR 97239, United States. Electronic address: cameromi@ohsu.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102015']
662,32174482,Transfer and retention effects of gait training with anterior-posterior perturbations to postural responses after medio-lateral gait perturbations in older adults.,"BACKGROUND


Gait perturbations, occurring in any direction in daily life, may result in a fall. In fall prevention, gait perturbation training is a promising approach. Treadmill perturbations in anterior-posterior direction can easily be applied by accelerations or decelerations of the belt, but it is unknown whether training effects transfer to reactive recovery in medio-lateral direction. We aimed to evaluate the transfer and retention effects of gait training with treadmill perturbations in anterior-posterior direction to medio-lateral reactive recovery.
METHODS


30 community dwelling older adults (>65 years) participated in this study. They were randomly assigned to a treadmill training session either with 16 anterior-posterior perturbations or with treadmill walking. The assessments contained a walking trial with 4 anterior-posterior and 4 medio-lateral perturbations. Deviations in trunk velocity from unperturbed walking were summed over the first three strides after perturbation as a measure of recovery.
FINDINGS


An exposure to gait perturbations during the baseline assessment led to significant improvement of recovery responses. For anterior-posterior perturbations, both groups showed better recovery immediately and 1-week post-intervention, and no group x time interaction was found.. For medio-lateral perturbations, both groups showed better recovery immediately and 1-week post-intervention, and again no group × time interaction.
INTERPRETATION


Baseline assessment with perturbations in anterior-posterior and medio-lateral directions caused significant improvements that were retained. Short-term training can be effective in dynamic stabilization of one's trunk, but our findings do not exclude that multi-directional perturbations may be needed.",2020,"For medio-lateral perturbations, both groups showed better recovery immediately and 1-week post-intervention, and again no group × time interaction.
","['30 community dwelling older adults (>65\xa0years', 'older adults']","['treadmill training session either with 16 anterior-posterior perturbations or with treadmill walking', 'gait training', 'gait training with anterior-posterior perturbations', 'gait perturbation training']",['recovery responses'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],30.0,0.0321226,"For medio-lateral perturbations, both groups showed better recovery immediately and 1-week post-intervention, and again no group × time interaction.
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Rieger', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT Amsterdam, Amsterdam, the Netherlands; Motek Medical BV, Hogehilweg 18C, 1101 CD Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Papegaaij', 'Affiliation': 'Motek Medical BV, Hogehilweg 18C, 1101 CD Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pijnappels', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Steenbrink', 'Affiliation': 'Motek Medical BV, Hogehilweg 18C, 1101 CD Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'van Dieën', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Van der Boechorststraat 7, 1081 BT Amsterdam, Amsterdam, the Netherlands. Electronic address: j.van.dieen@vu.nl.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.104988']
663,32330694,Loading modality and age influence teriparatide-induced bone formation in the human femoral neck.,"Teriparatide (TPTD) reduces risk of both vertebral and nonvertebral fracture, but increases bone mineral density (BMD) much more at the spine than the hip. TPTD and mechanical loading may have a synergistic anabolic effect on BMD, which may help explain these site-specific differences. Under normal daily activity, the femoral neck (FN) is under bending, placing one side under tension and the other under compression. We sought to further understand the relationship between mechanical loading and TPTD at the hip by investigating the effect of tensile versus compressive loading on TPTD stimulated bone formation indices in the human FN. Thirty-eight patients receiving total hip replacements for osteoarthritis were randomized to receive placebo (PBO) or TPTD for a mean treatment duration of 6 weeks prior to surgery, and double tetracycline labeling was administered to allow assessment of bone formation. The FN was harvested during surgery and analyzed for dynamic bone formation indices in the compressive and tensile regions of the endocortical and periosteal envelopes. Regression models relating outcome measures to patient characteristics including sex, age, body weight, and FN geometry were also analyzed. Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface. The level of bone formation in both TPTD and placebo groups was greater on the tensile endocortical surface and the compressive periosteal surface. There was a trend toward decreased endocortical eroded surface with TPTD in the compressive but not the tensile region. Patient age and sex explained the greatest variability in endocortical bone formation, and patient body mass and sex explained the greatest variability in periosteal bone formation. Our data represent the first dynamic comparison of teriparatide treatment under two loading modalities in human FN samples. Future work could determine whether specific hip loading intervention could amplify the benefits of teriparatide on the hip in clinical settings.",2020,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","['Thirty-eight patients receiving total hip replacements for osteoarthritis', 'human femoral neck', 'human FN']","['teriparatide', 'TPTD versus placebo', 'placebo', 'tetracycline labeling', 'teriparatide-induced bone formation', 'Teriparatide (TPTD', 'placebo (PBO) or TPTD']","['level of bone formation', 'bone mineral density (BMD', 'tensile endocortical surface', 'bone formation', 'patient characteristics including sex, age, body weight, and FN geometry']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}]",38.0,0.027878,"Overall, bone formation was higher with TPTD versus placebo on the endocortical surface, but not the periosteal surface.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Rooney', 'Affiliation': 'Nancy E. and Peter C. Meinig School of Biomedical Engineering, Cornell University, 101 Weill Hall, Ithaca, NY 14853, USA. Electronic address: amr427@cornell.edu.'}, {'ForeName': 'Mathias P G', 'Initials': 'MPG', 'LastName': 'Bostrom', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA. Electronic address: BostromM@hss.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dempster', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Pathology, Columbia University, 630 West 168th St., New York, NY 10025, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Research Division, Hospital for Special Surgery, 515 East 71st St., New York, NY 10021, USA; Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA; Department of Epidemiology, Columbia University, 722 West 168th St., New York, NY 10032, USA. Electronic address: jwn5@cumc.columbia.edu.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Regional Bone Center, Helen Hayes Hospital, 55 N Route 9W, West Haverstraw, NY 10993, USA. Electronic address: zhouh@helenhayeshosp.org.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, 622 West 168th St., New York, NY 10032, USA. Electronic address: fc14@cumc.columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115373']
664,32330749,Human gut microbiome composition and tryptophan metabolites were changed differently by fast food and Mediterranean diet in 4 days: a pilot study.,"Diets rich in animal source foods vs plant-based diets have different macronutrient composition, and they have been shown to have differential effects on the gut microbiome. In this study, we hypothesized that diets with very different nutrient composition are able to change gut microbiome composition and metabolites in a very short period. We compared a fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish. Ten healthy subjects participated in a controlled crossover study in which they consumed a Med diet and FF diet in randomized order for 4 days each, with a 4-day washout between treatments. Fecal DNA was extracted and the 16S V4 region amplified using polymerase chain reaction followed by sequencing on an Illumina MiSeq. Plasma metabolites and bile acids were analyzed using liquid chromatography-mass spectrometry. Certain bile-tolerant microbial genera and species including Collinsella, Parabacteroides, and Bilophila wadsworthia significantly increased after the FF diet. Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet. Bacterially produced metabolites indole-3-lactic acid and indole-3-propionic acid, which have been shown to confer beneficial effects on neuronal cells, increased after the Med diet and decreased after the FF diet. Interindividual variability in response to the treatments may be related to differences in background diet, for example as shown by differences in Bilophila response in relationship to the saturated fat content of the baseline diet. In conclusion, an animal fat-rich, low-fiber FF diet v. a high-fiber Med diet altered human gut microbiome composition and its metabolites after just 4 days.",2020,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.",['Ten healthy subjects'],"['fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish', 'Med diet and FF diet']","['Collinsella, Parabacteroides, and Bilophila wadsworthia', 'Plasma metabolites and bile acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452929', 'cui_str': 'Burger'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C1047126', 'cui_str': 'Collinsella'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C1005848', 'cui_str': 'Bilophila wadsworthia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]",10.0,0.0227447,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: egbeals@ucdavis.edu.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chrhodes@ucdavis.edu.'}, {'ForeName': 'Hannah Eve', 'Initials': 'HE', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: rsacchi@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.03.005']
665,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


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


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


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
666,31484659,"A Randomized, Placebo-Controlled, Double-Blind, Dose Escalation, Single Dose, and Steady-State Pharmacokinetic Study of 9cUAB30 in Healthy Volunteers.","9cUAB30 is a synthetic analogue of 9-cis retinoic acid with chemoprevention activity in cell lines and animal models. The purpose of this phase I placebo-controlled, double-blinded, dose escalation study of 9cUAB30 was to evaluate its safety, pharmacokinetics, and determine a dose for future phase II studies. Participants received a single dose of study drug (placebo or 9cUAB30) on day 1 followed by a 6-day drug-free period and then 28 days of continuous daily dosing starting on day 8. Fifty-three healthy volunteers were enrolled into five dose cohorts (20, 40, 80, 160, and 240 mg). Participants were randomized within each dose level to receive either 9cUAB30 ( n  = 8) or placebo ( n  = 2). 9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol. Treatment-emergent grade 3 hypertension occurred in 1 of 8 participants at the 20 mg dose level and in 2 of 8 at the 240 mg dose level, all considered unlikely related to study agent; no other grade 3 adverse events were observed. The AUC increased, as expected, between day 1 (single dose) and day 36 (steady state). Pharmacokinetics were linear in dose escalation through 160 mg. 9cUAB30 administered by daily oral dosing has a favorable safety and pharmacokinetic profile. On the basis of the observed safety profile and lack of linearity in pharmacokinetics at doses greater than 160 mg, the recommended phase II dose with the current formulation is 160 mg once daily.",2019,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","['Healthy Volunteers', 'Fifty-three healthy volunteers']","['placebo', 'Placebo', '9cUAB30', 'drug (placebo or 9cUAB30']","['grade 3 adverse events', 'serum triglycerides or cholesterol', 'grade 3 hypertension']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1311390', 'cui_str': '(9Z)-UAB30'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",53.0,0.180973,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Kolesar', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington, Kentucky. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Andrews', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Green', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Tom C', 'Initials': 'TC', 'LastName': 'Havighurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'Wollmer', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'DeShong', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Laux', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'Muccio', 'Affiliation': 'Biochemistry and Molecular Genetics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Grubbs', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'House', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Bailey', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0310']
667,31490252,Fibrinogen Concentrate as an Alternative to Cryoprecipitate in a Postcardiopulmonary Transfusion Algorithm in Infants Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial.,"BACKGROUND


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


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


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


Our findings suggest that FC may be considered as an alternative to cryoprecipitate for the treatment of hypofibrinogenemia in infants with bleeding after CPB. Although we found no significant differences between secondary outcomes or AEs, further studies are needed to assess safety.",2020,"There were no significant differences in secondary outcomes or AEs.
","['infants undergoing open-heart surgery', 'Between June 2016 and January 2018, we enrolled 60 patients with complete data available for 25 patients who received cryoprecipitate and 29 patients who received', 'Infants undergoing cardiac surgery', 'infants with bleeding after CPB', 'Infants', 'Undergoing Cardiac Surgery', ""60 infants (<12 months) undergoing nonemergent cardiac surgery with CPB at 2 tertiary care children's hospitals to receive either""]","['cryoprecipitate or FC in a post-CPB transfusion algorithm', 'FC', 'Fibrinogen Concentrate']","['number of intraoperative allogenic blood product transfusions', 'secondary outcomes or AEs', '24-hour chest tube output (CTO), mechanical ventilation time, adverse events (AEs), intensive care unit (ICU) length of stay (LOS), hospital LOS, postoperative thrombosis, and death within 30 days of surgery', 'impaired fibrin formation, inadequate clot formation, and increased bleeding']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0919822', 'cui_str': 'Postoperative thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery (qualifier value)'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",60.0,0.356393,"There were no significant differences in secondary outcomes or AEs.
","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Emory University, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Departments of Pathology, Microbiology, and Immunology.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Hedlin', 'Affiliation': 'Department of Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kamra', 'Affiliation': ""Department of Anesthesiology, Stanford University School of Medicine, Lucile Packard Children's Hospital, Palo Alto, California.""}, {'ForeName': 'E Dean', 'Initials': 'ED', 'LastName': 'McKenzie', 'Affiliation': ""Division of Congenital Heart Surgery, Department of Surgery, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas.""}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Hanley', 'Affiliation': 'Departments of Cardiovascular Surgery.'}, {'ForeName': 'Glyn D', 'Initials': 'GD', 'LastName': 'Williams', 'Affiliation': ""Department of Anesthesiology, Stanford University School of Medicine, Lucile Packard Children's Hospital, Palo Alto, California.""}, {'ForeName': 'Nina A', 'Initials': 'NA', 'LastName': 'Guzzetta', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Emory University, Children's Healthcare of Atlanta, Atlanta, Georgia.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004384']
668,31461053,The Impact of Upper Face Botulinum Toxin Injections on Eyebrow Height and Forehead Lines: A Randomized Controlled Trial and an Algorithmic Approach to Forehead Injection.,,2019,,[],"['Upper Face Botulinum Toxin Injections', 'Algorithmic Approach to Forehead Injection']",['Eyebrow Height and Forehead Lines'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0015420', 'cui_str': 'Eyebrows'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",,0.0681484,,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhai', 'Affiliation': ""Department No. 16, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China, public_qi@163.com.""}, {'ForeName': 'Zuoliang', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000005963']
669,31461054,Reply: The Impact of Upper Face Botulinum Toxin Injections on Eyebrow Height and Forehead Lines: A Randomized Controlled Trial and an Algorithmic Approach to Forehead Injection.,,2019,,[],['Upper Face Botulinum Toxin Injections'],['Eyebrow Height and Forehead Lines'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0015420', 'cui_str': 'Eyebrows'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",,0.0647933,,"[{'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Jabbour', 'Affiliation': 'Department of Plastic and Reconstructive Surgery Department of Dermatology Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Kechichian', 'Affiliation': ''}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Nasr', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000005964']
670,31971158,Does a Free-Trial Approach Increase Purchase and Use of a Household Water Treatment and Safe Storage Product in Rural Haiti?,"A cluster, randomized control trial was conducted to assess the effects of social marketing approach on purchase rates and water treatment behavior of Klorfasil, a chlorine-based household water treatment product among seven villages in Thomassique, Haiti, from May to December 2016. Villages were randomized to the free-trial (257 households) or cost-sharing (240 households) group. Households in the free-trial group were allowed 30 days of free Klorfasil use before purchase decision. Households who purchased Klorfasil were then followed up for 30, 60, and 180 days. At the last follow-up, respondents were asked if they would like to repurchase Klorfasil. Questionnaire survey and water quality assessment by residual-free chlorine were conducted in each survey. Chi-square test,  t -test, and logistic regression were applied. The first purchase rate of the cost-sharing group was significantly higher than that of the free-trial group (79.2% versus 67.3%). By contrast, the repurchase rate of the free-trial group was higher (82.9% versus 66.3%). However, the overall repurchase rate was 71.6% and the proportion of long-term users was significantly higher in the cost-sharing group (56% versus 47%). Water treatment rates in the cost-sharing group were significantly higher than those in the free-trial group in the first and final surveys (odds ratio [OR] = 0.15, OR = 0.32). Households with high and medium economic status both had significantly higher purchase rates than low economic status households (OR = 4.40, OR = 1.94). Households with higher educated respondents had significantly better water treatment practices (OR = 2.15). The free-trial approach did not increase the first purchase rate but increased the repurchase rate later. The cost-sharing approach significantly encouraged long-term usage.",2020,"Water treatment rates in the cost-sharing group were significantly higher than those in the free-trial group in the first and final surveys (odds ratio [OR] = 0.15, OR = 0.32).","['seven villages in Thomassique, Haiti, from May to December 2016']",['social marketing approach'],"['overall repurchase rate', 'repurchase rate', 'Questionnaire survey and water quality assessment', 'purchase rates']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",257.0,0.0300443,"Water treatment rates in the cost-sharing group were significantly higher than those in the free-trial group in the first and final surveys (odds ratio [OR] = 0.15, OR = 0.32).","[{'ForeName': 'Feng-Jen', 'Initials': 'FJ', 'LastName': 'Tsai', 'Affiliation': 'Master Program in Global Health and Development, College of Public Health, Taipei Medical University, Taipei City, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Chia-Ping', 'Initials': 'CP', 'LastName': 'Lin', 'Affiliation': 'Master Program in Global Health and Development, College of Public Health, Taipei Medical University, Taipei City, Taiwan.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0606']
671,30395745,Infographics or video; which one is more effective in asthmatic patients' health? a randomized clinical trial.,"Objective:  Asthma disease is a complex  medical condition for which the control of symptoms depends on sufficient patient knowledge, self-care, and adherence to medication protocols. Researchers conducted this study to  evaluate the impact of infographics and video on asthma  patients'  adherence to medication.  Methods:  A randomized clinical trial in which 80 asthmatics were enrolled and allocated to two  study groups  (infographic and video groups).  Researchers used questionnaires  to gather demographic data.  A nurse assessed Morisky adherence to medication. Researchers performed data analysis using  repeated measurements and Least Significant Difference (LSD) in SPSS software version 23.  Results:  There was no significant difference between the two study tracks ( P  > 0.05) in the demographic data and adherence to medication in the pretest. The differences between the two intervention groups throughout the one-month follow-up were statistically significant ( P  < 0.05). There were significant differences between the two intervention groups in pretest and post-test, and pretest and follow-up ( P  < 0.05). However, there were no significant differences between the two intervention groups in post-test and follow-up ( P  > 0.05).  Conclusions:  According to the study findings, both the infographic and video formats may have led to an increase in adherence to medication protocols among asthma patients; but it seems that the infographic format is preferred for long- term use because it does not require usage of a facility. However, education format of asthmatic people is dependent on conditions and patient preferences.",2019,There was no significant difference between the two study tracks (P > 0.05) in the demographic data and adherence to medication in the pretest.,"[""asthmatic patients' health"", 'asthma patients', '80 asthmatics']",['Infographics or video'],['demographic data and adherence to medication'],"[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}]",80.0,0.0406324,There was no significant difference between the two study tracks (P > 0.05) in the demographic data and adherence to medication in the pretest.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ebrahimabadi', 'Affiliation': 'Member of Student Research Committee, Nursing and Midwifery School, Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Korosh', 'Initials': 'K', 'LastName': 'Rezaei', 'Affiliation': 'Academic Member of Department of Medical-Surgical, Nursing and Midwifery School, Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Abdollatif', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': 'Department of Internal Medicine Amir Al momenin Hospital, Arak University of Medical Sciences , Arak , Iran.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'Academic Member of College of Doctoral Studies, Grand Canyon University , Phoenix , Arizona , USA.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Abedi', 'Affiliation': 'Academic Member of Traditional and Complementary Medicine Research Center (TCMRC), Department of Medical-Surgical, Nursing and Midwifery School, Arak University of Medical Sciences , Arak , Iran.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1536143']
672,32322880,Neural correlates of cognitive bias modification for interpretation.,"The effectiveness of cognitive bias modification for interpretation (CBM-I), a treatment method employed to reduce social anxiety (SA), has been examined. However, the neural correlates of CBM-I remain unclear, and we aimed to elucidate brain activities during intervention and activity changes associated with CBM-I effectiveness in a pre-post intervention comparison. Healthy participants divided into two groups (CBM, control) were scanned before, during and after intervention using functional magnetic resonance imaging. Ambiguous social situations followed by positive outcomes were repeatedly imagined by the CBM group during intervention, while half of the outcomes in the control group were negative. Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group. Furthermore, altered activities in the somatomotor and somatosensory areas, occipital lobe and posterior cingulate gyrus during interpreting ambiguous social situations showed a significant group × change in SA interaction. Our result suggests that when facing ambiguous social situations, positive imagery instilled by CBM-I is recalled, and interpretations are modified to contain social reward. These findings may help to suggest an alternative manner of enhancing CBM-I effectiveness from a cognitive-neuroscience perspective.",2020,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.",['Healthy participants'],[],"['social anxiety (SA', 'activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0458361', 'cui_str': 'Somesthetic area'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0220369,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sakaki', 'Affiliation': 'Department of Functional Brain Imaging, Graduate School of Medicine, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nozawa', 'Affiliation': 'Research Institute for the Earth Inclusive Sensing Empathizing with Silent Voices, Tokyo Institute of Technology, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa026']
673,31499528,Menopausal Estrogen-Alone Therapy and Health Outcomes in Women With and Without Bilateral Oophorectomy: A Randomized Trial.,"Background


Whether health outcomes of menopausal estrogen therapy differ between women with and without bilateral salpingo-oophorectomy (BSO) is unknown.
Objective


To examine estrogen therapy outcomes by BSO status, with additional stratification by 10-year age groups.
Design


Subgroup analyses of the randomized Women's Health Initiative Estrogen-Alone Trial. (ClinicalTrials.gov: NCT00000611).
Setting


40 U.S. clinical centers.
Participants


9939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status.
Intervention


Conjugated equine estrogens (CEE) (0.625 mg/d) or placebo for a median of 7.2 years.
Measurements


Incidence of coronary heart disease and invasive breast cancer (the trial's 2 primary end points), all-cause mortality, and a ""global index"" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture) during the intervention phase and 18-year cumulative follow-up.
Results


The effects of CEE alone did not differ significantly according to BSO status. However, age modified the effect of CEE in women with prior BSO. During the intervention phase, CEE was significantly associated with a net adverse effect (hazard ratio for global index, 1.42 [95% CI, 1.09 to 1.86]) in older women (aged ≥70 years), but the global index was not elevated in younger women (P trend by age = 0.016). During cumulative follow-up, women aged 50 to 59 years with BSO had a treatment-associated reduction in all-cause mortality (hazard ratio, 0.68 [CI, 0.48 to 0.96]), whereas older women with BSO had no reduction (P trend by age = 0.034). There was no significant association between CEE and outcomes among women with conserved ovaries, regardless of age.
Limitations


The timing of CEE in relation to BSO varied; several comparisons were made without adjustment for multiple testing.
Conclusion


The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age. Among women with prior BSO, in those aged 70 years or older, CEE led to adverse effects during the treatment period, whereas women randomly assigned to CEE before age 60 seemed to derive mortality benefit over the long term.
Primary Funding Source


The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and U.S. Department of Health and Human Services. Wyeth Ayerst donated the study drugs.",2019,"The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age.","['women with prior BSO', 'women aged 50 to 79 years with prior hysterectomy and known oophorectomy status', 'Participants\n\n\n9939', 'women with and without bilateral salpingo-oophorectomy (BSO', 'women with prior BSO, in those aged 70 years or older, CEE', 'Women']","['Intervention\n\n\nConjugated equine estrogens (CEE', 'Bilateral Oophorectomy', 'Menopausal Estrogen-Alone Therapy', 'CEE', 'placebo', 'menopausal estrogen therapy']","['global index', 'cause mortality', 'BSO status', 'coronary heart disease and invasive breast cancer', 'mortality benefit', 'cause mortality, and a ""global index"" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0029936', 'cui_str': 'Oophorectomy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0046018', 'cui_str': 'CEES'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0278321', 'cui_str': 'Castration, Female'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0279494'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]",,0.296687,"The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age.","[{'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.E.M., S.S.B.).""}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': 'Shari S', 'Initials': 'SS', 'LastName': 'Bassuk', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.E.M., S.S.B.).""}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'City of Hope National Medical Center, Duarte, and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California (R.T.C.).'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland (J.E.R.).'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'MedStar Health Research Institute, Bonita Springs, Florida, and Georgetown-Howard Universities, Washington, DC (B.V.H.).'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona (C.A.T.).'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Stanford Prevention Research Center, Stanford, California (M.L.S.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, Florida (A.M.K.).'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Crandall', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (C.J.C.).'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island (C.B.E., S.L.).'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Henderson', 'Affiliation': 'Stanford University, Stanford, California (V.W.H.).'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island (C.B.E., S.L.).'}, {'ForeName': 'Juhua', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Brown University, Providence, Rhode Island; Indiana University, Bloomington, Indiana (J.L.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rohan', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York (T.R.).'}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California (A.H.S.).'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'University of Kentucky, Lexington, Kentucky (G.W.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'University at Buffalo, the State University of New York, Buffalo, New York (J.W.).'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington (A.K.A., G.L.A., R.L.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0274']
674,31663962,"A Randomized Controlled Trial of Enhanced Recovery After Surgery Versus Standard of Care Recovery for Emergency Cesarean Deliveries at Mbarara Hospital, Uganda.","BACKGROUND


Enhanced recovery after surgery (ERAS) expedites return to patient baseline and functional status by reducing surgical trauma, stress, and organ dysfunction. Despite the potential benefits of enhanced recovery protocols, limited research has been done in low-resource settings, where 95% of cesarean deliveries are emergent and could possibly benefit from the application of ERAS protocols.
METHODS


In a prospective, randomized, single-blind, controlled trial, mothers delivering by emergency cesarean delivery were randomly assigned to either an ERAS or a standard of care (SOC) recovery arm. Patients in the ERAS arm were treated with a modified ERAS protocol that included modified counseling and education, prophylactic antibiotics, antiemetics, normothermia, restrictive fluid administration, and multimodal analgesia. They also received early initiation of mobilization, feeding, and urethral catheter removal. The primary end point was length of hospital stay. The secondary end points were complications and readmission rates. Mean length of stay in the intervention and control arms were compared using t tests. Statistical analyses were performed using STATA version 13 (College Station, TX).
RESULTS


A total of 160 patients were enrolled in the study, with 80 randomized to each arm. There was a statistically significant shorter length of stay for the ERAS arm compared to SOC, with a difference of -18.5 hours (P < .001, 95% confidence interval [CI], -23.67, -13.34). The incidence of complications of severe pain and headache was lower in the ERAS arm compared to SOC (P = .001 for both complications). However, pruritus was more common in the ERAS arm compared to SOC (P = .023).
CONCLUSIONS


Use of an ERAS protocol for women undergoing emergency cesarean delivery in a low-income setting is feasible and reduces length of hospital stay without generally increasing the complication rate.",2020,"However, pruritus was more common in the ERAS arm compared to SOC (P = .023).
","['A total of 160 patients were enrolled in the study, with 80 randomized to each arm', 'women undergoing emergency cesarean', 'mothers delivering by emergency cesarean delivery']","['ERAS', 'Enhanced Recovery', 'ERAS or a standard of care (SOC) recovery arm', 'modified ERAS protocol that included modified counseling and education, prophylactic antibiotics, antiemetics, normothermia, restrictive fluid administration, and multimodal analgesia', 'ERAS protocol']","['Mean length of stay', 'shorter length of stay', 'length of hospital stay', 'incidence of complications of severe pain and headache', 'complications and readmission rates']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered (finding)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",160.0,0.131825,"However, pruritus was more common in the ERAS arm compared to SOC (P = .023).
","[{'ForeName': 'Moris', 'Initials': 'M', 'LastName': 'Baluku', 'Affiliation': 'From the Departments of Anaesthesia and Critical Care.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Bajunirwe', 'Affiliation': 'Community Health.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ngonzi', 'Affiliation': 'Obstetrics and Gynaecology, Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kiwanuka', 'Affiliation': 'From the Departments of Anaesthesia and Critical Care.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Ttendo', 'Affiliation': 'From the Departments of Anaesthesia and Critical Care.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004495']
675,31774306,Intragastric administration of the bitter tastant quinine lowers the glycemic response to a nutrient drink without slowing gastric emptying in healthy men.,"The rate of gastric emptying and the release of gastrointestinal (GI) hormones are major determinants of postprandial blood-glucose concentrations and energy intake. Preclinical studies suggest that activation of GI bitter-taste receptors potently stimulates GI hormones, including glucagon-like peptide-1 (GLP-1), and thus may reduce postprandial glucose and energy intake. We evaluated the effects of intragastric quinine on the glycemic response to, and the gastric emptying of, a mixed-nutrient drink and the effects on subsequent energy intake in healthy men. The study consisted of 2 parts:  part A  included 15 lean men, and  part B  included 12 lean men (aged 26 ± 2 yr). In each part, participants received, on 3 separate occasions, in double-blind, randomized fashion, intragastric quinine (275 or 600 mg) or control, 30 min before a mixed-nutrient drink ( part A ) or before a buffet meal ( part B ). In  part A , plasma glucose, insulin, glucagon, and GLP-1 concentrations were measured at baseline, after quinine alone, and for 2 h following the drink. Gastric emptying of the drink was also measured. In  part B , energy intake at the buffet meal was quantified. Quinine in 600 mg (Q600) and 275 mg (Q275) doses alone stimulated insulin modestly ( P  < 0.05). After the drink, Q600 and Q275 reduced plasma glucose and stimulated insulin ( P  < 0.05), Q275 stimulated GLP-1 ( P  < 0.05), and Q600 tended to stimulate GLP-1 ( P  = 0.066) and glucagon ( P  = 0.073) compared with control. Quinine did not affect gastric emptying of the drink or energy intake. In conclusion, in healthy men, intragastric quinine reduces postprandial blood glucose and stimulates insulin and GLP-1 but does not slow gastric emptying or reduce energy intake under our experimental conditions.",2020,"After the drink, Q600 and Q275 reduced plasma glucose and stimulated insulin (P<0.05), Q275 stimulated GLP-1 (P<0.05), and Q600 tended to stimulate GLP-1 (P=0.066) and glucagon (P=0.073), compared with control.","['two parts; part A included 15, and part B 12, lean men (aged 26±2 years', 'healthy men']",['intragastric quinine'],"['glycemic response', 'postprandial glucose and energy intake', 'Gastric emptying and the release of gastrointestinal (GI) hormones', 'Gastric emptying', 'Q600 and Q275 reduced plasma glucose and stimulated insulin (P<0.05), Q275 stimulated GLP-1 (P<0.05), and Q600 tended to stimulate GLP-1', 'gastric emptying', 'plasma glucose, insulin, glucagon and GLP-1 concentrations']","[{'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric (qualifier value)'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal Hormones'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.078914,"After the drink, Q600 and Q275 reduced plasma glucose and stimulated insulin (P<0.05), Q275 stimulated GLP-1 (P<0.05), and Q600 tended to stimulate GLP-1 (P=0.066) and glucagon (P=0.073), compared with control.","[{'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Bitarafan', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}, {'ForeName': 'Penelope C E', 'Initials': 'PCE', 'LastName': 'Fitzgerald', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}, {'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Little', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Meyerhof', 'Affiliation': 'Center for Integrative Physiology and Molecular Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, SA, Australia.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00294.2019']
676,30996338,"Visual Function Questionnaire as an outcome measure for homonymous hemianopia: subscales and supplementary questions, analysis from the VISION trial.","BACKGROUND


We conduct supplementary analyses of the NEI VFQ-25 data to evaluate where changes occurred within subscales of the NEI VFQ-25 leading to change in the composite scores between the three treatment arms, and evaluate the NEI VFQ-25 with and without the Neuro 10 supplement.
METHODS


A prospective, multicentre, parallel, single-blind, three-arm RCT of fourteen UK acute stroke units was conducted. Stroke survivors with homonymous hemianopia were recruited. Interventions included: Fresnel prisms for minimum 2 h, 5 days/week over 6-weeks (Arm a), Visual search training for minimum 30 min, 5 days/week over 6-weeks (Arm b) and standard care-information only (Arm c). Primary and secondary outcomes (including NEI VFQ-25 data) were measured at baseline, 6, 12 and 26 weeks after randomisation.
RESULTS


Eighty seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years). At 26 weeks, outcomes for 24, 24 and 22 patients, respectively, were compared to baseline. NEI VFQ-25 (with and without Neuro 10) responses improved from baseline to 26 weeks with visual search training compared to Fresnel prisms and standard care. In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'.
CONCLUSIONS


Composite scores differed systematically for the NEI VFQ-25 (Neuro 10) versus NEI VFQ-25 at all time points. For subscale scores, descriptive statistics suggest clinically relevant improvement in distance activities and vision-specific dependency subscales for NEI VFQ-25 scores in the visual search treatment arm.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN05956042.",2019,"In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'.
","['Stroke survivors with homonymous hemianopia', 'fourteen UK acute stroke units', 'seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years', 'Eighty']","['visual search training', 'Visual search training', 'NEI VFQ-25']","[""colour vision' and 'ocular pain"", 'Visual Function Questionnaire', 'distance activities and vision-specific dependency subscales for NEI VFQ-25 scores', 'NEI VFQ-25 data']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0271202', 'cui_str': 'Hemianopsia, Homonymous'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}]","[{'cui': 'C0086032', 'cui_str': 'Daylight Vision'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",87.0,0.249442,"In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'.
","[{'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Rowe', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Liverpool, L69 3GB, UK. rowef@liverpool.ac.uk.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Hepworth', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Conroy', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Naomi E A', 'Initials': 'NEA', 'LastName': 'Rainford', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bedson', 'Affiliation': 'Clinical Trials Research Unit, University of Liverpool, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Howard', 'Affiliation': 'Department of Orthoptics, Salford Royal NHS Foundation Trust, Manchester, M6 8HD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollock', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Shipman', 'Affiliation': 'Department of Orthoptics, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dodridge', 'Affiliation': 'Department of Orthoptics, Oxford University Hospitals NHS Trust, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Stevie', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Eye Clinic Support Service, Royal National Institute of Blind People, Birmingham, B29 6NA, UK.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Noonan', 'Affiliation': 'Department of Ophthalmology, Aintree University Hospital NHS Foundation Trust, Liverpool, L9 7AL, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': ""Division of Health and Social Care, King's College, London, WC2B 5RL, UK.""}]","Eye (London, England)",['10.1038/s41433-019-0441-z']
677,30629458,Omega-3 fatty acid supplementation attenuates skeletal muscle disuse atrophy during two weeks of unilateral leg immobilization in healthy young women.,"Omega-3 (n-3) fatty acid supplementation enhances muscle protein synthesis and muscle size. Whether n-3 fatty acid supplementation attenuates human muscle disuse atrophy is unknown. We determined the influence of n-3 fatty acid supplementation on muscle size, mass, and integrated rates of myofibrillar protein synthesis (MyoPS) following 2 wk of muscle disuse and recovery in women. Twenty women (BMI = 23.0 ± 2.3 kg/m 2 , age = 22 ± 3 yr) underwent 2 wk of unilateral limb immobilization followed by 2 wk of return to normal activity. Starting 4 wk prior to immobilization, participants consumed either 5 g/d of n-3 fatty acid or an isoenergetic quantity of sunflower oil (control). Muscle size and mass were measured pre- and postimmobilization, and after recovery. Serial muscle biopsies were obtained to measure integrated (daily) MyoPS. Following immobilization, the decline in muscle volume was greater in the control group compared to the n-3 fatty acid group (14 vs. 8%, P < 0.05) and was not different from preimmobilization at recovery in the n-3 fatty acid group; however, it was still lower in the control group ( P < 0.05). Muscle mass was reduced in the control group only ( P < 0.05). MyoPS was higher in the n-3 group compared with the control group at all times ( P < 0.05). We conclude that n-3 fatty acid supplementation attenuates skeletal muscle disuse atrophy in young women, which may be mediated by higher rates of MyoPS.-McGlory, C., Gorissen, S. H. M., Kamal, M., Bahniwal, R., Hector, A. J., Baker, S. K., Chabowski, A., Phillips, S. M. Omega-3 fatty acid supplementation attenuates skeletal muscle disuse atrophy during two weeks of unilateral leg immobilization in healthy young women.",2019,"Following immobilization, the decline in muscle volume was greater in the control group compared to the n-3 fatty acid group (14 vs. 8%, P < 0.05) and was not different from preimmobilization at recovery in the n-3 fatty acid group; however, it was still lower in the control group ( P < 0.05).","['healthy young women', 'women', 'Twenty women (BMI = 23.0 ± 2.3 kg/m 2 , age = 22 ± 3 yr', 'young women']","['Omega-3 (n-3) fatty acid supplementation', 'n-3 fatty acid supplementation', 'Omega-3 fatty acid supplementation', 'n-3 fatty acid or an isoenergetic quantity of sunflower oil (control', 'unilateral limb immobilization', 'n-3 fatty acid']","['MyoPS', 'Muscle mass', 'muscle size, mass, and integrated rates of myofibrillar protein synthesis (MyoPS', 'decline in muscle volume']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1262163', 'cui_str': 'Limb immobilisation'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.0298407,"Following immobilization, the decline in muscle volume was greater in the control group compared to the n-3 fatty acid group (14 vs. 8%, P < 0.05) and was not different from preimmobilization at recovery in the n-3 fatty acid group; however, it was still lower in the control group ( P < 0.05).","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stefan H M', 'Initials': 'SHM', 'LastName': 'Gorissen', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ravninder', 'Initials': 'R', 'LastName': 'Bahniwal', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Hector', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Medicine, McMaster University, Hamilton, Ontario, Canada; and.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chabowski', 'Affiliation': 'Department of Physiology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201801857RRR']
678,32323904,Fractional microneedling radiofrequency in striae alba: Do growth factors add value?,"BACKGROUND


Various treatment modalities have been applied to treat striae alba (SA) with low satisfaction rate. Fractional microneedling radiofrequency (FMR) provides deep dermal coagulation, thereby inducing collagen synthesis and tissue tightening. The addition of platelet-derived lyophilized growth factors may add to the effect of FMR.
OBJECTIVES


To evaluate and compare the efficacy and safety of FMR alone or combined with lyophilized growth factors in the treatment of SA.
METHODS


In this left-right comparative study, 25 patients suffering from SA on the abdomen received four sessions of FMR with lyophilized growth factors on one side and with saline (as placebo) on the other side at 4 weeks interval. Photographic and biopsy documentation of the progress of the SA was carried out before the start of the treatment and 4 weeks after the last session. Calculation of the width of SA before treatment and after 4 sessions was done by Adobe Photoshop CS6.
RESULTS


There was a significant improvement in SA width after treatment in both the lyophilized growth factors (P = <.0001) and placebo sides (P = <.0001), the lyophilized growth factors being superior (P = .002). Patient satisfaction was more on the lyophilized growth factors (LGF) side (P = .034). Erythema and hyperpigmentation were less on the lyophilized growth factors side. Histopathologically, both showed improvement with no difference between LGF and placebo (epidermal thickness (P = .456), collagen content (P = .297), elastin content (P = .239)).
CONCLUSION


The combination of FMR and lyophilized growth factors improves SA outcome.",2020,"Histopathologically, both showed improvement with no difference between LGF and placebo (epidermal thickness (p= 0.456), collagen content (p= 0.297), elastin content (p= 0.239)).
","['striae alba', '25 patients suffering from striae alba on the abdomen received 4 sessions of']","['fractional microneedling radiofrequency alone or combined with lyophilized growth factors', 'fractional microneedling radiofrequency with lyophilized growth factors on one side and with saline (as placebo']","['Erythema and hyperpigmentation', 'efficacy and safety', 'Patient satisfaction', 'elastin content', 'striae alba width', 'collagen content']","[{'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0013765', 'cui_str': 'Elastin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0152459', 'cui_str': 'Linear atrophy'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]",25.0,0.0647965,"Histopathologically, both showed improvement with no difference between LGF and placebo (epidermal thickness (p= 0.456), collagen content (p= 0.297), elastin content (p= 0.239)).
","[{'ForeName': 'Ahmed Abdelfattah', 'Initials': 'AA', 'LastName': 'Afify', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Heba M', 'Initials': 'HM', 'LastName': 'Fawzy', 'Affiliation': 'Histology and Cell Biology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Nuha Hussain', 'Initials': 'NH', 'LastName': 'Ali Al-Rubaiay', 'Affiliation': 'MIU University, Cairo, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdallah', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13447']
679,30940887,The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.,"PURPOSE


In this study we compared the anatomic and functional outcomes of two steroid treatments on rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD), namely treatment with oral prednisolone (1 mg/kg daily) for 3-7 days before vitrectomy or a single periocular injection of methylprednisolone (40 mg) 1-3 days before vitrectomy. We also analyzed the outcomes of the eyes with subsided CD and the eyes with persistent CD that underwent drainage of suprachoroidal fluids during the vitrectomy.
METHODS


This was a prospective randomized study. Seventy five eyes with RRD combined with CD were divided into 2 groups based on the two different treatment regimens as above. The eyes in each group were further divided into 2 subgroups (A: CD subsided eyes; B: CD persistent eyes) according to the response of CD to the treatment of steroids. Retinal reattachment rates were measured at 6 months after the removal of silicone oil.
RESULTS


At 6 months after silicone oil removal, the retinal reattachment rate was similar (p = 0.666) in the oral prednisolone group (91.7%, 33/36) and the periocular injection group (94.9%, 37/39). Similar retinal reattachment rates (p = 0.364) were also found in the CD subsided eyes (97.1%, 34/35) and the CD persistent eyes (90.0%, 36/40). The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25).
CONCLUSIONS


For RRD combined with CD, eyes treated with a single periocular injection of methylprednisolone (40 mg, 1-3 days before pars plana vitrectomy) combined with the drainage of suprachoroidal fluids during the surgery had similar anatomic and functional outcomes compared to the eyes treated with oral prednisolone for 3-7 days before vitrectomy.",2019,"The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25).
","['rhegmatogenous retinal detachment combined with choroidal detachment', 'Seventy five eyes with RRD combined with CD']","['methylprednisolone and drainage of suprachoroidal fluid', 'oral prednisolone', 'methylprednisolone', 'rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD', 'steroid treatments', 'silicone oil', 'prednisolone']","['retinal reattachment rate', 'Retinal reattachment rates', 'Similar retinal reattachment rates']","[{'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0395611', 'cui_str': 'Drainage of suprachoroidal fluid (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0185042', 'cui_str': 'Refixation (procedure)'}]",75.0,0.0482548,"The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25).
","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325027, China. weiyongdoctor@163.com.'}, {'ForeName': 'RongLe', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Shaanxi Ophthalmic Medical Center, Xi'an No.4 Hospital, Affiliated Guangren Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an, 710004, China.""}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Xiamen Eye Center Affiliated to Xiamen University, Xiamen, 361000, China.'}, {'ForeName': 'Xiuju', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Xiamen Eye Center Affiliated to Xiamen University, Xiamen, 361000, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325027, China.'}]","Eye (London, England)",['10.1038/s41433-019-0420-4']
680,32323144,Cost-utility analysis of factor VIII diet therapies prepared using blood plasma vs. recombinant technique for patients with hemophilia A.,"BACKGROUND


Hemophilia is known as one of the most common coagulation disorders whose treatment costs are particularly high in developing countries, and about 90% of them are related to factor VIII (FVIII) and direct medical costs (DMCs). Thus, the present study aimed to analyze cost-utility of two FVIII diet therapies prepared using blood plasma and recombinant technique.
METHODS


This study was an economic evaluation fulfilled through a cost-utility approach. To this end, a total number of 120 patients were randomly selected using Krejcie & Morgan's Table and then received blood plasma and recombinant FVIII. The decision tree structure was also utilized to estimate economic and clinical outcomes. Moreover, costs were reviewed from societal perspective. Quality-adjusted life year (QALY) was subsequently determined as the measure of effectiveness (MOE). Besides, one-way (univariate) sensitivity analysis was performed to quantify uncertainty effects of the study parameters. The information was ultimately analyzed using the TreeAge Pro 2011 and the Microsoft Office Excel 2010 software.
RESULTS


The results revealed that the recombinant diet therapy had higher costs and effectiveness compared with blood-plasma-derived FVIII, so that the mean costs of these two diet therapies were equal to 37,624 and 20,349 purchasing power parity (PPP) $ with utility scores of 0.78 and 0.62; respectively. Since the incremental cost-effectiveness ratio (ICER) for the recombinant medications was over three times of the threshold level, it was considered as overwhelming because of its high cost in spite of its better effectiveness. Moreover, the results of one-way (univariate) sensitivity analysis demonstrated the highest sensitivity to the utility in patients who had been injected with blood-plasma-derived FVIII and had been successfully treated.
CONCLUSION


The study results revealed that FVIII prepared using blood plasma for hemophilia A patients had higher cost-effectiveness compared with that made using recombinant technique. Graphical abstract.",2020,"The results revealed that the recombinant diet therapy had higher costs and effectiveness compared with blood-plasma-derived FVIII, so that the mean costs of these two diet therapies were equal to 37,624 and 20,349 purchasing power parity (PPP) $ with utility scores of 0.78 and 0.62; respectively.","['120 patients', 'patients with hemophilia A']",['recombinant diet therapy'],"['cost-effectiveness', 'incremental cost-effectiveness ratio (ICER', 'Quality-adjusted life year (QALY', 'effectiveness (MOE', 'costs and effectiveness']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0176148,"The results revealed that the recombinant diet therapy had higher costs and effectiveness compared with blood-plasma-derived FVIII, so that the mean costs of these two diet therapies were equal to 37,624 and 20,349 purchasing power parity (PPP) $ with utility scores of 0.78 and 0.62; respectively.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Lotfi', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Talebianpour', 'Affiliation': 'Department of health management and health economics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khosro', 'Initials': 'K', 'LastName': 'Keshavarz', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Emadi', 'Affiliation': 'School of pharmacy and Medical Sciences, University of South Australia , Adelaide, SA, Australia.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Bordbar', 'Affiliation': 'Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Peivand', 'Initials': 'P', 'LastName': 'Bastani', 'Affiliation': 'Health Human Resources Research Center, School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran. bastanip@sums.ac.ir.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00347-8']
681,30444150,"Safety profile of the SQ house dust mite sublingual immunotherapy-tablet in Japanese adult patients with house dust mite-induced allergic asthma: a randomized, double-blind, placebo-controlled phase I study.","Objective:  The SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet has demonstrated effective treatment of HDM-induced allergic asthma in patients 18 years or older in European trials. This study investigated its safety and immunology profile in Japanese adult patients with mild-to-moderate HDM-induced allergic asthma.  Methods:  In this randomized, double-blind, placebo-controlled study, 48 Japanese patients were randomly assigned to a daily treatment of SQ HDM SLIT-tablet or placebo (3:1) for 14 d with or without an up-dosing regimen. Active groups comprised 5000, 10,000 or 20,000 Japanese Allergy Unit (JAU) for 14 d, and the up-dosing group comprised 5,000 JAU in day 1-3, 10,000 JAU in day 4-7 and 20,000 JAU in day 8-14.  Results:  No marked differences were observed in the incidence rate of adverse events (AEs) and their severity among active groups. The five most common investigational medicinal product (IMP)-related AEs were local events at the application site observed within 30 min after the intake of the SQ HDM SLIT-tablet. Although most events recovered within 1 h, mouth edema indicated a different profile of duration with more than 25% of the events lasting for more than 1 h.  Conclusions:  The SQ HDM SLIT-tablet of up to 20,000 JAU was well tolerated, and safety profile was acceptable for Japanese subjects with HDM-induced allergic asthma.",2019,No marked differences were observed in the incidence rate of adverse events (AEs) and their severity among active groups.,"['patients 18\xa0years or older in European trials', 'Japanese subjects with HDM-induced allergic asthma', 'Japanese adult patients with mild-to-moderate HDM-induced allergic asthma', 'Japanese adult patients with house dust mite-induced allergic asthma', '48 Japanese patients']","['SQ house dust mite sublingual immunotherapy-tablet', 'SQ house dust mite (HDM) sublingual immunotherapy', 'placebo', 'SQ HDM SLIT-tablet or placebo']","['incidence rate of adverse events (AEs', 'tolerated, and safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3539110', 'cui_str': 'house dust mites'}]","[{'cui': 'C3539110', 'cui_str': 'house dust mites'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",48.0,0.196027,No marked differences were observed in the incidence rate of adverse events (AEs) and their severity among active groups.,"[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Okamiya', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Hisakuni', 'Initials': 'H', 'LastName': 'Sekino', 'Affiliation': 'Department of Internal Medicine, Sekino Hospital , Tokyo , Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Azuma', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sakaguchi', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Nemoto', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Muramatsu', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Maekawa', 'Affiliation': 'Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Medicine, Division of Respiratory Medicine and Allergology, School of Medicine, Showa University , Tokyo , Japan.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1541353']
682,32324065,Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.,"Objective:  To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Methods:  Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. Least-squares mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). Results:  Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three placebo-controlled studies where ertugliflozin was initiated as a single agent, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 and 15 mg was -0.8 and -1.0%, respectively. In an active-comparator study, when initiated as a single agent, the change from baseline in HbA1c at week 52 was -0.5, -0.7, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and glimepiride, respectively. In a placebo-controlled study, when initiated in combination with sitagliptin, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin was -1.3 and -1.6%, respectively. In an active-comparator study, when initiated in combination with sitagliptin, the change from baseline in HbA1c at week 26 was -1.4, -1.6, and -0.9 for ertugliflozin 5 mg/sitagliptin, ertugliflozin 15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin. The incidences of overall and prespecified AEs in Hispanic/Latino patients were generally consistent with the known safety profile of ertugliflozin. Conclusion:  Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM.  Clinicaltrials.gov identifiers:  NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.",2020,Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin.,"['1178 Hispanic/Latino patients', 'Hispanic/Latino patients with type 2 diabetes (T2DM', 'Hispanic/Latino patients with type 2 diabetes mellitus', 'Hispanic/Latino patients', 'Hispanic/Latino patients with T2DM', 'data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies']","['placebo', 'Ertugliflozin', 'glimepiride', 'ertugliflozin']","['Ertugliflozin efficacy', 'efficacy and safety', 'HbA1c, BW, and SBP', 'glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP', 'Reductions in BW and SBP', 'Efficacy and safety']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.084421,Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tarasenko', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Misoo C', 'Initials': 'MC', 'LastName': 'Ellison', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1760227']
683,32324082,Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus.,"Objective:  To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor ertugliflozin across racial groups in patients with type 2 diabetes mellitus (T2DM). Methods:  Pooled analysis of data from randomized, double-blind studies in the ertugliflozin phase III development program. Seven placebo- and comparator-controlled studies were used to assess safety ( N  = 4859) and three placebo-controlled studies were used to assess efficacy ( N  = 1544). Least-squares (LS) mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). Results:  At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups. The placebo-adjusted LS mean change (95% confidence interval) from baseline in HbA1c was -0.8% (-1.0, -0.7) and -1.0% (-1.1, -0.8) with ertugliflozin 5 mg and 15 mg, respectively, in the White subgroup, -0.7% (-1.2, -0.2) and -0.8% (-1.3, -0.3) in the Black subgroup, and -0.8% (-1.1, -0.5) and -1.0% (-1.3, -0.8) in the Asian subgroup. The incidences of overall AEs, serious AEs and AEs leading to discontinuation from study medication were similar between the ertugliflozin 5 mg, 15 mg and non-ertugliflozin groups within each racial subgroup. The incidence of female genital mycotic infection (GMI) was higher with ertugliflozin than non-ertugliflozin across all racial subgroups. The incidence of male GMI was higher with ertugliflozin than non-ertugliflozin in the White sub-group; however, there were few male GMI events in the non-White subgroups. Conclusions:  In patients with T2DM, treatment with ertugliflozin improved HbA1c, body weight and SBP across all racial subgroups. Ertugliflozin had a generally similar safety profile across racial subgroups and was generally well tolerated.  Clinicaltrials.gov identifiers:  NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.",2020,"At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups.","['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Ertugliflozin', 'sodium-glucose cotransporter 2 inhibitor ertugliflozin', 'placebo', 'ertugliflozin']","['incidence of female genital mycotic infection (GMI', 'efficacy and safety', 'tolerated', 'glycated hemoglobin (HbA1c), body weight, and systolic blood pressure (SBP', 'HbA1c, body weight, and SBP', 'HbA1c, body weight and SBP', 'incidence of male GMI', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",,0.166963,"At Week 26, ertugliflozin provided a greater reduction in HbA1c, body weight and SBP versus placebo in all racial subgroups.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tarasenko', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co. Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1760228']
684,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND


No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2.
METHODS


We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.
RESULTS


A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events.
CONCLUSIONS


In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282']
685,31365365,"Primary Fascial Closure During Laparoscopic Ventral Hernia Repair Improves Patient Quality of Life: A Multicenter, Blinded Randomized Controlled Trial.","BACKGROUND


Observational studies have reported conflicting results with primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR).
OBJECTIVE


The aim of the study was to determine whether when evaluated in a randomized controlled trial (RCT), PFC compared to bridged repair would improve patient quality of life (QoL).
METHODS


In this blinded, multicenter RCT, patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan) were randomized to PFC versus bridged repair. Primary outcome was change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction. Secondary outcomes were postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence. The trial was powered to detect a difference in change in QoL of 7 points between the study groups. Outcomes were compared with Mann-Whitney U test or chi-square.
RESULTS


A total of 129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years. Patients from both groups were similar at baseline. On median follow-up of 24 months (range: 9-42), patients treated with LVHR-PFC had on average a 12-point higher improvement in QoL compared to bridged repair (improvement in QoL, 41.3 ± 31.5 vs 29.7 ± 28.7, P value = 0.047). There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups.
CONCLUSIONS


Among patients undergoing elective LVHR, the fascial defect should be closed. This is the first RCT demonstrating that PFC with LVHR significantly improves patient QoL.
TRIAL REGISTRATION


This trial was registered with clinicaltrials.gov (NCT02363790).",2020,"There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups.
","['129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years', 'patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan', 'patients undergoing elective LVHR']","['PFC', 'primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR', 'Primary Fascial Closure', 'Laparoscopic Ventral Hernia Repair', 'PFC versus bridged repair']","['QoL', 'postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence', 'Patient Quality of Life', 'patient quality of life (QoL', 'change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction', 'surgical site occurrence, eventration, or hernia recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0015207', 'cui_str': 'Eventration (morphologic abnormality)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",129.0,0.440522,"There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups.
","[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX.'}, {'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Holihan', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Roth', 'Affiliation': 'Department of Surgery, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Tsuda', 'Affiliation': 'Department of Surgery, University of Nevada Las Vegas Medicine, Las Vegas, NV.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Vaziri', 'Affiliation': 'Department of Surgery, George Washington University, Washington, DC.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX.'}]",Annals of surgery,['10.1097/SLA.0000000000003505']
686,32320490,Effects of single green tea ingestion on pharmacokinetics of nadolol in healthy volunteers.,"AIMS


The aim of this study was to investigate the effects of a single green tea (GT), administered concomitantly or 1 hour before nadolol intake on nadolol pharmacokinetics.
METHODS


In a randomized 3-phase crossover study, 11 healthy volunteers received an oral administration of nadolol with, or 1 hour after preingestion of brewed GT, or with water in a volume of 150 mL.
RESULTS


Geometric mean ratio with 90% confidence interval for nadolol AUC 0-48  was 0.371 (0.303-0.439) with concomitant GT. In addition, ingestion of GT 1 hour before nadolol administration resulted in a significant reduction of nadolol AUC 0-48  with geometric mean ratio of 0.536 (0.406-0.665). There were no differences in time to maximal plasma concentration and renal clearance of nadolol among groups.
CONCLUSION


These results suggest that single concomitant ingestion of GT substantially decreases plasma concentrations of nadolol. Moreover, the reduction in nadolol bioavailability could persist for at least 1 hour after drinking a cup of GT.",2020,"There were no differences in t max  and renal clearance of nadolol among groups.
","['healthy volunteers', '11 healthy volunteers']","['single green tea (GT', 'single green tea ingestion', 'nadolol', 'oral administration of nadolol with, or 1 hour after pre-ingestion of brewed GT, or with water in a volume of 150 ml']","['plasma concentrations of nadolol', 'nadolol AUC', 'nadolol bioavailability', 'Geometric mean ratio (GMR', 't max  and renal clearance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027302', 'cui_str': 'Nadolol'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}]",11.0,0.0518496,"There were no differences in t max  and renal clearance of nadolol among groups.
","[{'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Misaka', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Abe', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Miura', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Shikama', 'Affiliation': 'Centre for Medical Education and Career Development, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Fromm', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Hirooki', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}, {'ForeName': 'Kenju', 'Initials': 'K', 'LastName': 'Shimomura', 'Affiliation': 'Department of Bioregulation and Pharmacological Medicine, School of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.14315']
687,32135451,Effect of neuromuscular training augmented with knee valgus control instructions on lower limb biomechanics of male runners.,"OBJECTIVE


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


Controlled laboratory Study.
SETTING


University research laboratory.
PARTICIPANTS


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


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


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


NMT plus VCIs was effective to reduce kinetics and improve kinematics in novice runners. Also, it could reduce injury incidence. This protocol may be an option for both athletic trainers and coaches for preventing of lower limbs' injury in male runners.",2020,This protocol may be an option for both athletic trainers and coaches for preventing of lower limbs' injury in male runners.,"['novice runners', 'male runners', 'male novice runners', 'University research laboratory', '60 male novice runners randomly assigned into']","['neuromuscular training augmented with knee valgus control instructions', 'neuromuscular training (NMT) with knee valgus control instructions (VCIs', 'NMT', 'NMT plus VCIs']",['Kinematic and kinetic'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",60.0,0.112322,This protocol may be an option for both athletic trainers and coaches for preventing of lower limbs' injury in male runners.,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran. Electronic address: letafatkaramir@yahoo.com.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Rabiei', 'Affiliation': 'Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address: Pouya.Rabiei@vub.be.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Afshari', 'Affiliation': 'Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran. Electronic address: minaafshar.ma8@gmail.com.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.02.009']
688,32143084,The effect of body weight reduction using a lower body positive pressure treadmill on plantar pressure measures while running.,"OBJECTIVE


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


Crossover Study Design.
SETTING


Laboratory.
PARTICIPANTS


12 recreational runners.
MAIN OUTCOME MEASURES


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


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


LBPPT is useful for reducing the pressure across the entire foot. Additionally, the anterior translation of the COP location at initial contact with reduced %BW may provide an additional gait retraining tool for prevention and treatment of running injuries as reducing %BW moves the runner away from a rearfoot strike pattern.",2020,"As the %BW decreased, there were corresponding significant decreases in the pressure-time integral and peak pressures in all four regions of the foot.",['12 recreational runners'],"['body weight reduction using a lower body positive pressure treadmill', 'LBPPT']","['Lower Body Positive Pressure Treadmill (LBPPT', 'body weight reduction', 'pressure-time integral and peak pressures', 'COP location', 'Pressure-time integral, peak pressure, instance of peak pressure, contact area, contact time and center of pressure (COP) location at initial contact across four foot regions']",[],"[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.0303033,"As the %BW decreased, there were corresponding significant decreases in the pressure-time integral and peak pressures in all four regions of the foot.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hodges-Long', 'Affiliation': 'UVA Outpatient Therapy at Fontaine, 545 Ray C. Hunt Drive, Suite 2100, PO Box 801055, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cross', 'Affiliation': 'UVA Outpatient Therapy at Fontaine, 545 Ray C. Hunt Drive, Suite 2100, PO Box 801055, Charlottesville, VA, 22903, USA. Electronic address: kevin.cross@virginia.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Magrum', 'Affiliation': 'UVA Outpatient Therapy at Fontaine, 545 Ray C. Hunt Drive, Suite 2100, PO Box 801055, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Feger', 'Affiliation': 'Curry School of Education, Department of Kinesiology, University of Virginia, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'Curry School of Education, Department of Kinesiology, University of Virginia, Charlottesville, VA, 22903, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.02.011']
689,31841026,Dobutamine reverses the cardio-suppressive effects of terlipressin without improving renal function in cirrhosis and ascites: a randomized controlled trial.,"Acute kidney injury and hepatorenal syndrome (HRS) are frequent complications in patients with cirrhosis and ascites. First-line treatment is terlipressin, which reverses HRS in ~40% of patients but also lowers cardiac output (CO). We aimed to investigate whether reversing the cardio-suppressive effect of terlipressin with the β-adrenoceptor agonist dobutamine would increase CO and thereby increase the glomerular filtration rate (GFR). We randomized 25 patients with cirrhosis, ascites, and impaired renal function (2:2:1):  group A  received terlipressin followed by the addition of dobutamine;  group B  received dobutamine and terlipressin as monotherapies; and  group C  received placebo. Renal and cardiac functions were assessed during 8 clearance periods of 30 min, and concentrations of vasoactive hormones were measured. Dobutamine as a monotherapy increased CO (1.03 L/min,  P  < 0.01) but had no significant effects on GFR. Renin ( P  < 0.05), angiotensin II ( P  < 0.005), and aldosterone ( P  < 0.05) increased after dobutamine infusion. Terlipressin as a monotherapy improved GFR (18.9 mL·min -1 ·m -2 ,  P  = 0.005) and mean arterial pressure (MAP) (14 mmHg,  P  = 0.001) but reduced CO (-0.92 L/min,  P  < 0.005) and renin ( P  < .005). A combined treatment of dobutamine and terlipressin had a positive effect on CO (1.19 L/min,  P  < 0.05) and increased renin ( P  < 0.005), angiotensin II ( P  < 0.005), and aldosterone ( P  < 0.05), but it had no significant effects on MAP or GFR. Dobutamine reversed the cardio-suppressive effect of terlipressin in cirrhosis, ascites, and impaired renal function. However, dobutamine reduced peripheral vascular resistance, activated renin-angiotensin-aldosterone system, and did not improve GFR compared with terlipressin as a monotherapy. Therefore, dobutamine cannot be recommended in cirrhosis and ascites. NEW & NOTEWORTHY  This study shows that the cardio-suppressive effects of the vasopressin receptor agonist terlipressin can be reversed by dobutamine. This is a novel observation in patients with decompensated cirrhosis. Furthermore, we show that dobutamine reduced the peripheral vascular resistance and activated the renin-angiotensin system, whereas renal function was not further improved by terlipressin alone.",2020,"Terlipressin as a monotherapy improved GFR (18.9 ml/min/m2, p=.005) and mean arterial pressure (MAP) (14 mmHg, P=.001) but reduced CO (-0.92 L/min, P<.005) and renin (P<.005).","['patients with cirrhosis and ascites', 'cirrhosis and ascites', 'patients with cirrhosis, ascites and impaired renal function (2:2:1']","['dobutamine', 'dobutamine and terlipressin as monotherapies and Group C received placebo', 'β-adrenoceptor agonist dobutamine', 'dobutamine and terlipressin', 'Dobutamine', 'terlipressin followed by add-on of dobutamine', 'terlipressin']","['Renal and cardiac functions', 'mean arterial pressure (MAP', 'cirrhosis, ascites and impaired renal function', 'increased renin (P<.005), angiotensin II (P<.005) and aldosterone', 'GFR', 'cardiac output (CO', 'glomerular filtration rate (GFR', 'concentrations of vasoactive hormones', 'CO', 'renal function', 'peripheral vascular resistance, activated RAAS', 'Renin (P<.05), angiotensin II (P<.005) and aldosterone (P<.05']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]","[{'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",,0.087151,"Terlipressin as a monotherapy improved GFR (18.9 ml/min/m2, p=.005) and mean arterial pressure (MAP) (14 mmHg, P=.001) but reduced CO (-0.92 L/min, P<.005) and renin (P<.005).","[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Israelsen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Emilie Kristine', 'Initials': 'EK', 'LastName': 'Dahl', 'Affiliation': 'Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Bjørn Stæhr', 'Initials': 'BS', 'LastName': 'Madsen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Wiese', 'Affiliation': 'Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Bendtsen', 'Affiliation': 'Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Møller', 'Affiliation': 'Center for Functional and Diagnostic Imaging and Research, Department of Clinical Physiology and Nuclear Medicine 260, Faculty of Health Sciences Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Annette Dam', 'Initials': 'AD', 'LastName': 'Fialla', 'Affiliation': 'Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Boye L', 'Initials': 'BL', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiovascular and Renal Research, Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Krag', 'Affiliation': 'Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark.'}]",American journal of physiology. Gastrointestinal and liver physiology,['10.1152/ajpgi.00328.2019']
690,30501974,"Recurrence after low-dose radioiodine ablation and recombinant human thyroid-stimulating hormone for differentiated thyroid cancer (HiLo): long-term results of an open-label, non-inferiority randomised controlled trial.","BACKGROUND


Two large randomised trials of patients with well-differentiated thyroid cancer reported in 2012 (HiLo and ESTIMABL1) found similar post-ablation success rates at 6-9 months between a low administered radioactive iodine ( 131 I) dose (1·1 GBq) and the standard high dose (3·7 GBq). However, recurrence rates following radioactive iodine ablation have previously only been reported in observational studies, and recently in ESTIMABL1. We aimed to compare recurrence rates between radioactive iodine doses in HiLo.
METHODS


HiLo was a non-inferiority, parallel, open-label, randomised controlled factorial trial done at 29 centres in the UK. Eligible patients were aged 16-80 years with histological confirmation of differentiated thyroid cancer requiring radioactive iodine ablation (performance status 0-2, tumour stage T1-T3 with the possibility of lymph-node involvement but no distant metastasis and no microscopic residual disease, and one-stage or two-stage total thyroidectomy). Patients were randomly assigned (1:1:1:1) to 1·1 GBq or 3·7 GBq ablation, each prepared with either recombinant human thyroid-stimulating hormone (rhTSH) or thyroid hormone withdrawal. Patients were followed up at annual clinic visits. Recurrences were diagnosed at each hospital with a combination of established methods according to national standards. We used Kaplan-Meier curves and hazard ratios (HRs) for time to first recurrence, which was a pre-planned secondary outcome. This trial is registered with ClinicalTrials.gov, number NCT00415233.
RESULTS


Between Jan 16, 2007, and July 1, 2010, 438 patients were randomly assigned. At the end of the follow-up period in Dec 31, 2017, median follow-up was 6·5 years (IQR 4·5-7·6) in 434 patients (217 in the low-dose group and 217 in the high-dose group). Confirmed recurrences were seen in 21 patients: 11 who had 1·1 GBq ablation and ten who had 3·7 GBq ablation. Four of these (two in each group) were considered to be persistent disease. Cumulative recurrence rates were similar between low-dose and high-dose radioactive iodine groups (3 years, 1·5% vs 2·1%; 5 years, 2·1% vs 2·7%; and 7 years, 5·9% vs 7·3%; HR 1·10 [95% CI 0·47-2·59]; p=0·83). No material difference in risk was seen for T3 or N1 disease. Recurrence rates were also similar among patients who were prepared for ablation with rhTSH and those prepared with thyroid hormone withdrawal (3 years, 1·5% vs 2·1%; 5 years, 2·1% vs 2·7%; and 7 years, 8·3% vs 5·0%; HR 1·62 [95% CI 0·67-3·91]; p=0·28). Data on adverse events were not collected during follow-up.
INTERPRETATION


The recurrence rate among patients who had 1·1 GBq radioactive iodine ablation was not higher than that for 3·7 GBq, consistent with data from large, recent observational studies. These findings provide further evidence in favour of using low-dose radioactive iodine for treatment of patients with low-risk differentiated thyroid cancer. Our data also indicate that recurrence risk was not affected by use of rhTSH.
FUNDING


Cancer Research UK.",2019,"Recurrence rates were also similar among patients who were prepared for ablation with rhTSH and those prepared with thyroid hormone withdrawal (3 years, 1·5% vs 2·1%; 5 years, 2·1% vs 2·7%; and 7 years, 8·3% vs 5·0%; HR 1·62 [95% CI 0·67-3·91]; p=0·28).","['HiLo was a non-inferiority, parallel, open-label, randomised controlled factorial trial done at 29 centres in the UK', 'patients who had 1·1', 'differentiated thyroid cancer (HiLo', 'Between Jan 16, 2007, and July 1, 2010', '21 patients: 11 who had 1·1 GBq ablation and ten who had 3·7 GBq ablation', '438 patients were randomly assigned', 'Eligible patients were aged 16-80 years with histological confirmation of differentiated thyroid cancer requiring radioactive iodine ablation (performance status 0-2, tumour stage T1-T3 with the possibility of lymph-node involvement but no distant metastasis and no microscopic residual disease, and one-stage or two-stage total thyroidectomy', 'patients with low-risk differentiated thyroid cancer', 'patients with well-differentiated thyroid cancer']","['1·1 GBq or 3·7 GBq ablation, each prepared with either recombinant human thyroid-stimulating hormone (rhTSH) or thyroid hormone withdrawal', 'radioactive iodine ablation', 'radioiodine ablation and recombinant human thyroid-stimulating hormone', 'GBq radioactive iodine ablation', 'radioactive iodine']","['Recurrence rates', 'recurrence risk', 'adverse events', 'Recurrence', 'recurrence rates', 'Cumulative recurrence rates', 'recurrence rate']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C1688582', 'cui_str': 'Gigabecquerel'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0475372', 'cui_str': 'Tumor stage T1'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}]","[{'cui': 'C1688582', 'cui_str': 'Gigabecquerel'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C4522017', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",438.0,0.216196,"Recurrence rates were also similar among patients who were prepared for ablation with rhTSH and those prepared with thyroid hormone withdrawal (3 years, 1·5% vs 2·1%; 5 years, 2·1% vs 2·7%; and 7 years, 8·3% vs 5·0%; HR 1·62 [95% CI 0·67-3·91]; p=0·28).","[{'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UCL Cancer Institute, University College London, London, UK.'}, {'ForeName': 'Ujjal', 'Initials': 'U', 'LastName': 'Mallick', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Newbold', 'Affiliation': 'Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Harmer', 'Affiliation': 'Independent Doctors Federation, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UCL Cancer Institute, University College London, London, UK. Electronic address: a.hackshaw@ucl.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(18)30306-1']
691,32320797,Tiotropium Respimat Efficacy and Safety in Asthma: Relationship to Age.,"BACKGROUND


Data are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma.
OBJECTIVE


To determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma.
METHODS


Post hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 μg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β 2 -agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 μg once daily, salmeterol 50 μg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV 1 ; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories.
RESULTS


Across the age categories, treatment-by-age subgroup interaction P values for trough FEV 1  were .13 and .77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age.
CONCLUSIONS


Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting β 2 -agonist therapy was effective and well tolerated in patients with asthma independent of age.",2020,"Across the age categories, treatment-by-age subgroup interaction p-values for trough FEV 1  were 0.13 and 0.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the two continuum analyses.","['patients with asthma independent of age', 'older versus younger patients with asthma', 'asthma', 'older versus younger adults with asthma', 'adults with asthma']","['tiotropium Respimat 5μg once-daily (QD) with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β 2 -agonist (LABA', 'placebo', 'Tiotropium', 'tiotropium 2.5 or 5μg QD, salmeterol 50μg twice-daily, or placebo', 'tiotropium Respimat', 'LABA therapy']","['Efficacy endpoints: trough and peak forced expiratory volume in 1 second (FEV 1 ); trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage', 'effective and well tolerated', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.455248,"Across the age categories, treatment-by-age subgroup interaction p-values for trough FEV 1  were 0.13 and 0.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the two continuum analyses.","[{'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Doherty', 'Affiliation': 'University of Kentucky, Lexington, Ky. Electronic address: dedohe0@email.uky.edu.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty. Ltd., Sydney, NSW, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Zaremba-Pechmann', 'Affiliation': 'Boehringer Ingelheim, Biberach an der Riss, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, The Netherlands.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.04.013']
692,32320844,Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.,"INTRODUCTION


Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.
INTERVENTION


This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.
METHODS


This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.
CONCLUSION


This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
TRIAL REGISTRATION


Clinical Trials.gov: NCT03255967.",2020,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[""Persons living with Alzheimer's disease and related dementias (ADRD"", '345 persons living with ADRD and their informal caregiver dyads', 'persons living with dementia and their informal caregivers']","['Aliviado Dementia Care', 'Aliviado Dementia Care program or usual care']","['caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization', 'person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use', 'quality of life (QOL', 'quality of life', 'QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.117164,"If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.
","[{'ForeName': 'Alycia A', 'Initials': 'AA', 'LastName': 'Bristol', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Convery', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sotelo', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Schneider', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Shih-Yin', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'NYU Rory Meyers College of Nursing, United States.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Rupper', 'Affiliation': 'University of Utah School of Medicine, United States; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Galvin', 'Affiliation': 'Comprehensive Center for Brain Health, University of Miami Miller School of Medicine, United States.'}, {'ForeName': 'Abraham A', 'Initials': 'AA', 'LastName': 'Brody', 'Affiliation': 'The Hartford Institute for Geriatric Nursing, NYU Rory Meyers College of Nursing, United States. Electronic address: Ab.Brody@nyu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106005']
693,32320846,Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial.,"BACKGROUND


A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months.
METHODS


A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle.
DISCUSSION


The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020.",2020,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","['persons at risk of hospital admission', ""Participants' experiences""]","[""intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare"", 'Proactive health support (PaHS) - telephone-based self-management support']","['Cost-effectiveness', 'mental health composite score of the SF-36v2 questionnaire', 'Quality of life', 'hospital admissions and improve quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.110494,"This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469).","[{'ForeName': 'Kirstine Skov', 'Initials': 'KS', 'LastName': 'Benthien', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: kirstine.skov.benthien@regionh.dk.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Rasmussen', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark. Electronic address: kra@regionsjaelland.dk.'}, {'ForeName': 'Camilla Palmhøj', 'Initials': 'CP', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: camilla.palmhoj@rm.dk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hjarnaa', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: louise.hjarnaa@regionh.dk.'}, {'ForeName': 'Maja Kjær', 'Initials': 'MK', 'LastName': 'Rasmussen', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: maja.kjaer.rasmussen@rsyd.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kidholm', 'Affiliation': 'Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark. Electronic address: kristian.kidholm@rsyd.dk.'}, {'ForeName': 'Berit Kjærside', 'Initials': 'BK', 'LastName': 'Nielsen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: beritnie@rm.dk.'}, {'ForeName': 'Nina Konstantin', 'Initials': 'NK', 'LastName': 'Nissen', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: niniss@rm.dk.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Fredens', 'Affiliation': 'DEFACTUM - Social & Health Services and Labour Market, Aarhus, Denmark. Electronic address: mia.fredens@rm.dk.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Winther', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark. Electronic address: susanne.winther@rn.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Grønkjær', 'Affiliation': 'Clinical Nursing Research Unit, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: mette.groenkjaer@rn.dk.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Toft', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. Electronic address: ulla.toft@regionh.dk.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106004']
694,31183514,Pharmacokinetic and exposure-response analysis of pertuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer.,"PURPOSE


To characterize the pharmacokinetics (PK) of pertuzumab and trastuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer in the randomized, double-blind, phase III JACOB study (NCT01774786), and to evaluate the appropriateness of the pertuzumab regimen in these patients.
METHODS


Patients received 840 mg intravenous pertuzumab or placebo plus trastuzumab q3w and chemotherapy. Pertuzumab and trastuzumab were administered until disease progression or unacceptable toxicity. Chemotherapy was administered for up to six cycles or disease progression or unacceptable toxicity. Serum concentrations of pertuzumab and trastuzumab were measured. Pertuzumab PK was characterized across treatment cycles. The impact of anti-drug antibodies (ADAs) on pertuzumab PK and the impact of pertuzumab on trastuzumab PK were assessed. An exploratory exposure-efficacy analysis was also conducted.
RESULTS


In total, 374 patients in the pertuzumab arm had evaluable PK data. The mean observed pertuzumab steady-state serum trough (minimum) concentration (C min,ss ) ± standard deviation was 114 ± 51.8 μg/mL. The target pertuzumab C min,ss  of ≥ 20 μg/mL was reached in 99.3% of patients at Cycle 5 (steady state) and beyond. Greater than 90% of patients were above the PK target right after the first pertuzumab dose. There was no apparent impact of ADAs on pertuzumab PK nor of pertuzumab on trastuzumab PK. There were no differences in overall survival across Cycle 1 pertuzumab (C min ) or Cycle 5 pertuzumab (C min,ss ) exposure quartiles.
CONCLUSIONS


Pertuzumab exposure in JACOB was consistent with prior studies in advanced gastric cancer and breast cancer. The 840 mg q3w dose allowed the majority of patients in JACOB to achieve target pertuzumab concentrations and appears to be an appropriate dose selection.",2019,"There were no differences in overall survival across Cycle 1 pertuzumab (C min ) or Cycle 5 pertuzumab (C min,ss ) exposure quartiles.
","['patients with HER2-positive metastatic gastric or gastroesophageal junction cancer', 'advanced gastric cancer and breast cancer', '374 patients in the pertuzumab arm had evaluable PK data']","['anti-drug antibodies (ADAs', 'pertuzumab and trastuzumab', 'Chemotherapy', 'pertuzumab', '840\xa0mg intravenous pertuzumab or placebo plus trastuzumab q3w and chemotherapy', 'Pertuzumab and trastuzumab']","['mean observed pertuzumab steady-state serum trough (minimum) concentration (C min,ss )\u2009±\u2009standard deviation', 'overall survival across Cycle 1 pertuzumab (C min ) or Cycle 5 pertuzumab (C min,ss ) exposure quartiles', 'Serum concentrations of pertuzumab and trastuzumab']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]",,0.101176,"There were no differences in overall survival across Cycle 1 pertuzumab (C min ) or Cycle 5 pertuzumab (C min,ss ) exposure quartiles.
","[{'ForeName': 'Whitney P', 'Initials': 'WP', 'LastName': 'Kirschbrown', 'Affiliation': 'Clinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Nijem', 'Affiliation': 'Clinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Paulo M', 'Initials': 'PM', 'LastName': 'Hoff', 'Affiliation': 'Instituto do Câncer de São Paulo, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manish A', 'Initials': 'MA', 'LastName': 'Shah', 'Affiliation': 'Medical Oncology/Solid Tumor Program, Sandra and Edward Meyer Cancer Center, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Girish', 'Affiliation': 'Clinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Clinical Pharmacology, Genentech Research and Early Development, DNA Way, MS463a, South San Francisco, CA, 94080, USA. gargamit1@gmail.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03871-w']
695,32319963,Use of a Smartphone-Based Mobile App for Weight Management in Obese Minority Stroke Survivors: Pilot Randomized Controlled Trial With Open Blinded End Point.,"BACKGROUND


Minorities have an increased incidence of early-onset, obesity-related cerebrovascular disease. Unfortunately, effective weight management in this vulnerable population has significant barriers.
OBJECTIVE


Our objective was to determine the feasibility and preliminary treatment effects of a smartphone-based weight loss intervention versus food journals to monitor dietary patterns in minority stroke patients.
METHODS


Swipe out Stroke was a pilot prospective randomized controlled trial with open blinded end point. Minority stroke patients and their caregivers were screened for participation using cluster enrollment. We used adaptive randomization for assignment to a behavior intervention with (1) smartphone-based self-monitoring or (2) food journal self-monitoring. The smartphone group used Lose it! to record meals and communicate with us. Reminder messages (first 30 days), weekly summaries plus reminder messages on missed days (days 31-90), and weekly summaries only (days 91-180) were sent via push notifications. The food journal group used paper diaries. Both groups received 4 in-person visits (baseline and 30, 90, and 180 days), culturally competent counseling, and educational materials. The primary outcome was reduced total body weight.
RESULTS


We enrolled 36 stroke patients (n=23, 64% African American; n=13, 36% Hispanic), 17 in the smartphone group, and 19 in the food journal group. Mean age was 54 (SD 9) years; mean body mass index was 35.7 (SD 5.7) kg/m2; education, employment status, and family history of stroke or obesity did not differ between the groups. Baseline rates of depression (Patient Health Questionnaire-9 [PHQ-9] score median 5.5, IQR 3.0-9.5), cognitive impairment (Montreal Cognitive Assessment score median 23.5, IQR 21-26), and inability to ambulate (5/36, 14% with modified Rankin Scale score 3) were similar. In total, 25 (69%) stroke survivors completed Swipe out Stroke (13/17 in the smartphone group, 12/19 in the food journal group); 1 participant in the smartphone group died. Median weight change at 180 days was 5.7 lb (IQR -2.4 to 8.0) in the smartphone group versus 6.4 lb (IQR -2.2 to 12.5; P=.77) in the food journal group. Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03). Clinically relevant depression rates remained in the zero to minimal range for the smartphone group compared with mild to moderate range in the food journal group at day 90 (PHQ-9 score 3.5 vs 4.5; P=.39) and day 180 (PHQ-9 score 3 vs 6; P=.12).
CONCLUSIONS


In a population of obese minority stroke survivors, the use of a smartphone did not lead to a significant difference in weight change compared with keeping a food journal. The presence of baseline depression (19/36, 53%) was a confounding variable, which improved with app engagement. Future studies that include treatment of poststroke depression may positively influence intervention efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02531074; https://www.clinicaltrials.gov/ct2/show/NCT02531074.",2020,Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03).,"['Swipe out Stroke', 'Mean age was 54 (SD 9) years; mean body mass index was 35.7 (SD 5.7) kg/m2; education, employment status, and family history of stroke or obesity did not differ between the groups', 'Minority stroke patients and their caregivers', 'obese minority stroke survivors', '36 stroke patients (n=23, 64% African American; n=13, 36% Hispanic), 17 in the smartphone group, and 19 in the food journal group', 'minority stroke patients', 'Obese Minority Stroke Survivors']","['culturally competent counseling, and educational materials', 'Smartphone-Based Mobile App', 'behavior intervention with (1) smartphone-based self-monitoring or (2) food journal self-monitoring', 'smartphone-based weight loss intervention']","['Baseline rates of depression (Patient Health Questionnaire-9', 'reduced total body weight', 'weight change', 'stroke survivors completed Swipe out Stroke', 'inability to ambulate', 'Median weight change', 'depression rates', 'cognitive impairment (Montreal Cognitive Assessment score', 'Depression']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0260518', 'cui_str': 'Family history of stroke'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}]",36.0,0.176623,Depression was significantly lower at 30 days in the smartphone group than in the food journal group (PHQ-9 score 2 vs 8; P=.03).,"[{'ForeName': 'Nneka L', 'Initials': 'NL', 'LastName': 'Ifejika', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Minal', 'Initials': 'M', 'LastName': 'Bhadane', 'Affiliation': 'College of Optometry, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Chunyan C', 'Initials': 'CC', 'LastName': 'Cai', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Noser', 'Affiliation': 'Institute for Stroke and Cerebrovascular Disease, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Grotta', 'Affiliation': 'Clinical Innovation and Research Institute, Memorial Hermann Hospital - Texas Medical Center, Houston, TX, United States.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Savitz', 'Affiliation': 'Institute for Stroke and Cerebrovascular Disease, University of Texas Health Science Center at Houston, Houston, TX, United States.'}]",JMIR mHealth and uHealth,['10.2196/17816']
696,31721596,Short halt in vaping modifies cardiorespiratory parameters and urine metabolome: a randomized trial.,"Propylene glycol and glycerol are e-cigarette constituents that facilitate liquid vaporization and nicotine transport. As these small hydrophilic molecules quickly cross the lung epithelium, we hypothesized that short-term cessation of vaping in regular users would completely clear aerosol deposit from the lungs and reverse vaping-induced cardiorespiratory toxicity. We aimed to assess the acute effects of vaping and their reversibility on biological/clinical cardiorespiratory parameters [serum/urine pneumoproteins, hemodynamic parameters, lung-function test and diffusing capacities, transcutaneous gas tensions (primary outcome), and skin microcirculatory blood flow]. Regular e-cigarette users were enrolled in this randomized, investigator-blinded, three-period crossover study. The periods consisted of nicotine-vaping (nicotine-session), nicotine-free vaping (nicotine-free-session), and complete cessation of vaping (stop-session), all maintained for 5 days before the session began. Multiparametric metabolomic analyses were used to verify subjects' protocol compliance. Biological/clinical cardiorespiratory parameters were assessed at the beginning of each session (baseline) and after acute vaping exposure. Compared with the nicotine- and nicotine-free-sessions, a specific metabolomic signature characterized the stop-session. Baseline serum club cell protein-16 was higher during the stop-session than the other sessions ( P  < 0.01), and heart rate was higher in the nicotine-session ( P  < 0.001). Compared with acute sham-vaping in the stop-session, acute nicotine-vaping (nicotine-session) and acute nicotine-free vaping (nicotine-free-session) slightly decreased skin oxygen tension ( P  < 0.05). In regular e-cigarette-users, short-term vaping cessation seemed to shift baseline urine metabolome and increased serum club cell protein-16 concentration, suggesting a decrease in lung inflammation. Additionally, acute vaping with and without nicotine decreased slightly transcutaneous oxygen tension, likely as a result of lung gas exchanges disturbances.",2020,Baseline serum club-cell protein-16 was higher during the stop-session than the other sessions ( p<0.01 ) and heart rate was higher in the nicotine-session ( p<0.001 ).,['Regular e-cigarette users'],"['acute nicotine-vaping (nicotine-session) and acute nicotine-free vaping (nicotine-free-session', 'nicotine-vaping (nicotine-session), nicotine-free vaping (nicotine-free-session), and complete cessation of vaping (stop-session', 'nicotine']","['slightly transcutaneous oxygen tension', 'biological/clinical cardio-respiratory parameters (serum/urine pneumoproteins, hemodynamic parameters, lung-function test and diffusing capacities, transcutaneous gas tensions (primary outcome) and skin microcirculatory blood flow', 'Baseline serum club-cell protein-16', 'skin oxygen tension ( p<0.05 ', 'heart rate', 'lung inflammation']","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.0184367,Baseline serum club-cell protein-16 was higher during the stop-session than the other sessions ( p<0.01 ) and heart rate was higher in the nicotine-session ( p<0.001 ).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chaumont', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Tagliatti', 'Affiliation': 'Department of Human Biology and Toxicology, University of Mons, Mons, Belgium.'}, {'ForeName': 'El Mehdi', 'Initials': 'EM', 'LastName': 'Channan', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Colet', 'Affiliation': 'Department of Human Biology and Toxicology, University of Mons, Mons, Belgium.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'Laboratory of Toxicology and Applied Pharmacology, Institute of Experimental and Clinical Research, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Morra', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Deprez', 'Affiliation': 'Department of Clinical Chemistry, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Van Muylem', 'Affiliation': 'Chest Department, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Debbas', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schaefer', 'Affiliation': 'Cardio-Pulmonary Exercise Laboratory, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Vitalie', 'Initials': 'V', 'LastName': 'Faoro', 'Affiliation': 'Cardio-Pulmonary Exercise Laboratory, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'van de Borne', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}]",American journal of physiology. Lung cellular and molecular physiology,['10.1152/ajplung.00268.2019']
697,30414855,Efficacy and safety of the histamine H 4  receptor antagonist ZPL-3893787 in patients with atopic dermatitis.,"BACKGROUND


H 4  receptor antagonists are potential novel treatments for inflammatory skin diseases, including atopic dermatitis (AD).
OBJECTIVE


We sought to study the efficacy and safety of ZPL-3893787 (a selective H 4  receptor antagonist) in patients with moderate-to-severe AD.
METHODS


A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate ZPL-3893787 (30 mg) once-daily oral therapy in adults with moderate-to-severe AD. Patients were randomized (2:1) to ZPL-3893787 (n = 65) or placebo (n = 33) for 8 weeks. Patients had a history of AD for more than 12 months, Eczema Area and Severity Index (EASI) scores of 12 or greater and 48 or less, Investigator's Global Assessment (IGA) scores of 3 or greater, pruritus scores of 5 or greater (0- to 10-point scale), and AD on 10% or greater of body surface area. Efficacy parameters included EASI, IGA, SCORAD, and pruritus assessment.
RESULTS


Treatment with oral ZPL-3893787 showed a 50% reduction in EASI score compared with 27% for placebo. The placebo-adjusted reduction in EASI score at week 8 was 5.1 (1-sided P = .01). Clear or almost-clear IGA scores were 18.5% with ZPL-3893787 versus 9.1% with placebo. SCORAD scores exhibited 41% reduction with ZPL-3893787 versus 26% with placebo (placebo-adjusted reduction of 10.0, P = .004). There was a 3-point reduction (scale, 1-10) in pruritus with ZPL-3893787, but there was a similar reduction with placebo, resulting in a nonsignificant difference (P = .249). Patient-reported pruritus subscores obtained from SCORAD were reduced with ZPL-3893787 compared with placebo at week 8 (nonsignificant). ZPL-3893787 was well tolerated.
CONCLUSION


For the first time, these results showed that ZPL-3893787 improved inflammatory skin lesions in patients with AD, confirming H 4  receptor antagonism as a novel therapeutic option.",2019,"RESULTS


Treatment with oral ZPL-3893787 showed a 50% reduction in EASI score compared with 27% for placebo.","['patients with moderate-to-severe AD', 'Patients had a history of AD for more than 12\xa0months', 'patients with atopic dermatitis', 'adults with moderate-to-severe AD']","['placebo', 'ZPL-3893787 (30\xa0mg) once-daily oral therapy', 'ZPL-3893787', 'histamine H 4  receptor antagonist ZPL-3893787', 'placebo (placebo']","['EASI, IGA, SCORAD, and pruritus assessment', 'inflammatory skin lesions', ""Investigator's Global Assessment (IGA) scores of 3 or greater, pruritus scores"", 'EASI score', 'Clear or almost-clear IGA scores', 'tolerated', 'Efficacy and safety', 'pruritus subscores', 'Eczema Area and Severity Index (EASI) scores', 'SCORAD scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.315791,"RESULTS


Treatment with oral ZPL-3893787 showed a 50% reduction in EASI score compared with 27% for placebo.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Werfel', 'Affiliation': 'Klinik für Dermatologie, Allergologie und Venerologie, Medizinische Hochschule Hannover, Hannover, Germany. Electronic address: Werfel.Thomas@mh-hannover.de.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Layton', 'Affiliation': 'ParamStat, Ash, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yeadon', 'Affiliation': 'Ziarco Pharma, Discovery Park, Sandwich, United Kingdom.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Whitlock', 'Affiliation': 'Ziarco Pharma, Discovery Park, Sandwich, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Osterloh', 'Affiliation': 'Ostermed, Birmingham Business Park, Birmingham, United Kingdom.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Jimenez', 'Affiliation': 'Ziarco Pharma, Discovery Park, Sandwich, United Kingdom.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Ziarco Pharma, Discovery Park, Sandwich, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lynch', 'Affiliation': 'MAC Clinical Research, Leeds, United Kingdom.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Asher', 'Affiliation': 'MAC Clinical Research, Manchester, United Kingdom.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsianakas', 'Affiliation': 'Department of Dermatology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Purkins', 'Affiliation': 'Ziarco Pharma, Discovery Park, Sandwich, United Kingdom.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.07.047']
698,30529451,A computerized decision support tool to implement asthma guidelines for children and adolescents.,"BACKGROUND


Multicenter randomized controlled trials (RCTs) for asthma management that incorporate usual-care regimens could benefit from standardized application of evidence-based guidelines.
OBJECTIVE


We sought to evaluate performance of a computerized decision support tool, the Asthma Control Evaluation and Treatment (ACET) Program, to standardize usual-care regimens for asthma management in RCTs.
METHODS


Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014. A computerized decision support tool scored asthma control and assigned an appropriate treatment step based on published guidelines. Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates) were collected at visits and entered into the ACET Program. Changes in control levels and treatment steps were examined during the trials.
RESULTS


At screening, more than half of the participants were rated as having symptoms that were not controlled or poorly controlled. The proportion of participants who gained good control between screening and randomization increased significantly in all 3 trials. Between 51% and 70% had symptoms that were well controlled by randomization. The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit. Nighttime symptoms were the most common control-level determinant; there were few (<1%) instances of complete overlap of factors. FEV 1  was the driver of control-level assignment in 30% of determinations.
CONCLUSION


The ACET Program decision support tool facilitated standardized asthma assessment and treatment in multicenter RCTs and was associated with attaining and maintaining good asthma control in most participants.",2019,The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit.,"['Children and adolescents with persistent uncontrolled asthma living in urban census tracts were recruited into 3 multicenter RCTs (each with a usual-care arm) between 2004 and 2014', 'children and adolescents', 'asthma management in RCTs']",['Asthma Control Evaluation and Treatment (ACET) Program'],"['Nighttime symptoms', 'Control-level determinants (symptoms, rescue medication use, pulmonary function measure, and adherence estimates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0007663', 'cui_str': 'Censuses'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0948677,The proportion of well-controlled participants remained constant or improved slightly from randomization until the last posttreatment visit.,"[{'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Kercsmar', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: carolyn.kercsmar@cchmc.org.""}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Department of Medicine, Division of Allergy and Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Calatroni', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gergen', 'Affiliation': 'Division of Allergy, Immunology, and Transplantation, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bloomberg', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Gruchalla', 'Affiliation': 'Department of Internal Medicine/Pediatrics, Division of Allergy and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Pulmonology, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatrics, Division of Pulmonary Medicine, Children's Hospital Colorado, Aurora, Colo.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Department of Pediatrics, Division of Allergy and Immunology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.""}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': 'Department of Pediatrics, Division of Pulmonary Medicine, National Jewish Health and University of Colorado, Denver School of Medicine, Denver, Colo.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine and Trauma Services, Children's National Medical Center, Washington, DC.""}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Wildfire', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, NC.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Zoratti', 'Affiliation': 'Department of Pediatrics, Division of Allergy and Immunology, Henry Ford Health System and Wayne State University School of Medicine, Detroit, Mich.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'Department of Medicine, Division of Allergy and Immunology, University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2018.10.060']
699,32250836,"Effect of a brief progressive resistance training program in hospital porters on pain, work ability, and physical function.","BACKGROUND


Hospital porters are possibly exposed to the greatest mechanical loads within the hospital environment. However, the evidence about preventive strategies in this population is scarce.
OBJECTIVE


To investigate the effect of a workplace-based progressive resistance-training program on musculoskeletal pain among hospital porters.
METHOD


A total of 37 hospital porters (27 women, 10 men) participated. Participants allocated to the intervention group performed five brief resistance training sessions/week, for 9 weeks during working hours at the hospital. Intensity was progressively increased. Participants allocated to the control group maintained their usual physical activity. The primary outcome was pain assessed with the patient global impression of pain change scale. Secondary outcome measures were average pain intensity, work ability, use of analgesics, and physical function. Additionally, perceived general changes were evaluated at follow-up: wellness, satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues.
RESULTS


For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group. Significant between-group interactions were found for work impairment due to diseases (d = -1.2), hips/thighs pain (d = 0.7), ankles/feet pain (d = 0.4), the Biering-Sorensen test (d = -0.6) and the push-ups test (d = -2.3) favoring the intervention group. All between-group differences were clinically important.
CONCLUSION


A progressive resistance training program performed at the workplace is feasible and effective in reducing musculoskeletal pain and improving work ability and physical function among hospital porters.",2020,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","['musculoskeletal pain among hospital porters', 'A total of 37 hospital porters (27 women, 10 men) participated']","['workplace-based progressive resistance-training program', 'progressive resistance training program', 'brief resistance training sessions', 'control group maintained their usual physical activity']","['work satisfaction', 'pain assessed with the patient global impression of pain change scale', 'musculoskeletal pain and improving work ability and physical function', 'satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues', 'desire for practicing exercise', 'greater wellbeing', 'average pain intensity, work ability, use of analgesics, and physical function', 'ankles/feet pain', 'hips/thighs pain', 'Intensity', 'pain, work ability, and physical function', 'lower general pain']","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0402674', 'cui_str': 'Hospital porter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",37.0,0.0521316,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Escriche-Escuder', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; National Research Centre for the Working Environment, Copenhagen, Denmark. Electronic address: joaquin.calatayud@uv.es.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Sport Sciences, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Aiguadé', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Lleida, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102162']
700,32321052,Plasma rich in growth factors (PRGF) in non-surgical periodontal therapy: a randomized clinical trial.,"The aim of this split mouth, double blinded, randomized clinical trial was to evaluate the clinical efficacy of use of Plasma rich in growth factors (PRGF) as an adjunct to scaling and root planing (SRP) in the treatment of periodontal pockets. Twenty six patients (15 males, 11 females) diagnosed with generalized periodontitis with Pocket Depth > 5mm and plaque index score < 1.5, were randomly allocated by using computer generated random sequence, into two groups, one treated with intra-pocket application of PRGF adjunct to SRP and other with SRP alone. The clinical outcomes like pocket depth (PD), relative attachment level (RAL) and sulcus bleeding index (SBI) were assessed at baseline, 3 months and 6 months. Twenty two patients (44 sites) were analyzed at the end of 6 month follow-up, using SPSS 20.0v software. There was a significant statistical difference observed between both the groups favouring SRP +PRGF group in terms of PD (p = 0.007) and RAL (p = 0.021) at the end of 6 month follow-up. Also there was a statistical significant difference (< 0.001) at all time points compared to baseline, for all parameters in intra-group comparison. Moreover, the sites with PD>4mm necessitating further treatment after 6-month follow-up were significantly lesser for SRP+PRGF group. The use of PRGF technology in non-surgical periodontal therapy, by single intra-pocket application in to periodontal pockets as an adjunct to SRP, in chronic periodontitis patients, was found to be effective in reduction of pocket depth and gain in clinical attachment level.",2020,There was a significant statistical difference observed between both the groups favouring SRP +PRGF group in terms of PD (p = 0.007) and RAL (p = 0.021) at the end of 6 month follow-up.,"['Twenty six patients (15 males, 11 females) diagnosed with generalized periodontitis with Pocket Depth > 5mm and plaque index score < 1.5', 'periodontal pockets', 'chronic periodontitis patients']","['SRP +PRGF', 'SRP+PRGF', 'PRGF technology', 'PRGF adjunct to SRP and other with SRP alone', 'scaling and root planing (SRP']","['clinical outcomes like pocket depth (PD), relative attachment level (RAL) and sulcus bleeding index (SBI']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0521738,There was a significant statistical difference observed between both the groups favouring SRP +PRGF group in terms of PD (p = 0.007) and RAL (p = 0.021) at the end of 6 month follow-up.,"[{'ForeName': 'Saurav', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Adrita', 'Initials': 'A', 'LastName': 'Purkayastha', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Rinkee', 'Initials': 'R', 'LastName': 'Mohanty', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Rashmita', 'Initials': 'R', 'LastName': 'Nayak', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Satpathy', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Abhaya Chandra', 'Initials': 'AC', 'LastName': 'DAS', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Gatha', 'Initials': 'G', 'LastName': 'Mohanty', 'Affiliation': 'Siksha O Anusandhan University, Institute of Dental Sciences, Department of Periodontics & Oral implantology, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Sital', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Private Practice, Bhubaneswar, India.'}, {'ForeName': 'Massimo Del', 'Initials': 'MD', 'LastName': 'Fabbro', 'Affiliation': 'University of Milan, Department of Biomedical, Surgical & Dental Sciences, Milano, Italy.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0034']
701,32035361,"Eccentric, but not concentric blood flow restriction resistance training increases muscle strength in the untrained limb.","OBJECTIVES


Little is known regarding the variables or mechanisms mediating cross-education as a result of resistance training. Therefore, the purpose of the present study was to examine the effects of low-load eccentric-only blood flow restriction (Ecc-BFR) and low-load concentric-only BFR (Con-BFR) on indices of cross-education.
DESIGN


Thirty-six women were randomly assigned to 4-wks of unilateral resistance training with Ecc-BFR (n = 12), Con-BFR (n = 12) or control (no intervention, n = 12) group. Eccentric peak torque, concentric peak torque, maximal voluntary isometric contraction torque, muscle thickness, and muscle activation were assessed from the contralateral, untrained arm.
RESULTS


Muscle strength (collapsed across mode) increased from 0-wk to 2-wks (4.9%) and 4-wks (13.0%) for Ecc-BFR only. There were increases in muscle activation (collapsed across mode and group) regardless of training modality, but there were no changes in muscle size for any of the conditions.
CONCLUSIONS


The findings of the present study indicated that low-load Ecc-BFR increased muscle strength. The increases in muscle strength as a result of Ecc-BFR were not mode-specific. Thus, low-load Ecc-BFR provides a unique alternative to maintain muscle function in an untrained limb that may have application during limb immobilization and rehabilitation practices.",2020,"There were increases in muscle activation (collapsed across mode and group) regardless of training modality, but there were no changes in muscle size for any of the conditions.
",['Thirty-six women'],"['low-load eccentric-only blood flow restriction (Ecc-BFR) and low-load concentric-only BFR (Con-BFR', 'concentric blood flow restriction resistance training', 'unilateral resistance training with Ecc-BFR (n\xa0=\xa012), Con-BFR (n\xa0=\xa012) or control (no intervention, n\xa0=\xa012) group']","['Muscle strength', 'low-load Ecc-BFR increased muscle strength', 'muscle size', 'muscle strength', 'Eccentric peak torque, concentric peak torque, maximal voluntary isometric contraction torque, muscle thickness, and muscle activation', 'muscle activation']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}]",36.0,0.0116183,"There were increases in muscle activation (collapsed across mode and group) regardless of training modality, but there were no changes in muscle size for any of the conditions.
","[{'ForeName': 'Ethan C', 'Initials': 'EC', 'LastName': 'Hill', 'Affiliation': 'School of Kinesiology & Physical Therapy, Division of Kinesiology, University of Central Florida, Orlando, FL, 32816, USA. Electronic address: https://ethan.hill@ucf.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.01.013']
702,31086274,The effect of paired corticospinal-motoneuronal stimulation on maximal voluntary elbow flexion in cervical spinal cord injury: an experimental study.,"STUDY DESIGN


Randomised, controlled, crossover study.
OBJECTIVES


Paired corticospinal-motoneuronal stimulation (PCMS) involves repeatedly pairing stimuli to corticospinal neurones and motoneurones to induce changes in corticospinal transmission. Here, we examined whether PCMS could enhance maximal voluntary elbow flexion in people with cervical spinal cord injury.
SETTING


Neuroscience Research Australia, Sydney, Australia.
METHODS


PCMS comprised 100 pairs of transcranial magnetic and electrical peripheral nerve stimulation (0.1 Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5 ms before antidromic motoneuronal potentials. On two separate days, sets of five maximal elbow flexions were performed by 11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after PCMS or control (100 peripheral nerve stimuli) conditioning. During contractions, supramaximal biceps brachii stimulation elicited superimposed twitches, which were expressed as a proportion of resting twitches to give maximal voluntary activation. Maximal torque and electromyographic activity were also assessed.
RESULTS


Baseline median (range) maximal torque was 11 Nm (6-41 Nm) and voluntary activation was 92% (62-99%). Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67).
CONCLUSIONS


Possible explanations for the lack of effect include a potential ceiling effect for voluntary activation, or that PCMS may be less effective for elbow flexors than distal muscles. Despite results, previous studies suggest that PCMS is worthy of further investigation.",2019,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67).
","['cervical spinal cord injury', 'Neuroscience Research Australia, Sydney, Australia', '11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after', 'people with cervical spinal cord injury', 'PCMS comprised 100 pairs of']","['PCMS or control (100 peripheral nerve stimuli) conditioning', 'Paired corticospinal-motoneuronal stimulation (PCMS', 'PCMS', 'transcranial magnetic and electrical peripheral nerve stimulation (0.1\u2009Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5\u2009ms before antidromic motoneuronal potentials', 'paired corticospinal-motoneuronal stimulation']","['maximal voluntary elbow flexion', 'voluntary activation', 'Maximal torque and electromyographic activity', 'Baseline median (range) maximal torque']","[{'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0035168'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0436544', 'cui_str': 'Electrical peripheral nerve stimulation (procedure)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039062', 'cui_str': 'Synapses'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0859074,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67).
","[{'ForeName': 'Siobhan C', 'Initials': 'SC', 'LastName': 'Dongés', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia. janet.taylor@ecu.edu.au.'}]",Spinal cord,['10.1038/s41393-019-0291-3']
703,31502253,Drug-Placebo Additivity in Randomized Clinical Trials.,"In randomized clinical trials (RCTs), it is assumed that nonspecific effects beyond action of pharmacological agents are roughly equivalent in drug and placebo treatment groups. Hence, since the inception of RCTs, drug efficacy is determined by comparing outcomes in active to those in placebo control arms. However, quantitation of efficacy is based on an unproven assumption, that drug and placebo responses are always additive. Response to treatment in RCTs can be differentially influenced by the perturbing effects of patient expectations, side effects, and pharmacogenomic interactions in both drug and placebo arms. Ability to control for these effects requires understanding of when and where they arise, how to mitigate, analyze, and even leverage their impact. Here, we examine three factors that influence additivity: expectation, side effects, and pharmacogenomics. Furthermore, to provide novel insights into nonadditivity and solutions for managing it, we introduce systems pharmacogenomics, a network approach to integrating and analyzing the effects of the numerous interacting perturbations to which a patient is exposed in RCTs.",2019,"Furthermore, to provide novel insights into non-additivity and solutions for managing it, we introduce systems pharmacogenomics, a network approach to integrating and analyzing the effects of the numerous interacting perturbations to which a patient is exposed in RCTs.",[],[],[],[],[],[],,0.124466,"Furthermore, to provide novel insights into non-additivity and solutions for managing it, we introduce systems pharmacogenomics, a network approach to integrating and analyzing the effects of the numerous interacting perturbations to which a patient is exposed in RCTs.","[{'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Loscalzo', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1626']
704,31242752,Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia.,"BACKGROUND


Hypertriglyceridemia is associated with increased cardiovascular risk and may be caused by impaired lipoprotein clearance. Angiopoietin-like protein 3 (ANGPTL3) inhibits lipoprotein lipase activity, increasing triglycerides and other lipids. Evinacumab, an ANGPTL3 inhibitor, reduced triglycerides in healthy human volunteers and in homozygous familial hypercholesterolemic individuals. Results from 2 Phase 1 studies in hypertriglyceridemic subjects are reported here.
METHODS


Subjects with triglycerides >150 but ≤450 mg/dL and low-density lipoprotein cholesterol ≥100 mg/dL (n=83 for single ascending dose study [SAD]; n=56 for multiple ascending dose study [MAD]) were randomized 3:1 to evinacumab:placebo. SAD subjects received evinacumab subcutaneously at 75/150/250 mg, or intravenously at 5/10/20 mg/kg, monitored up to day 126. MAD subjects received evinacumab subcutaneously at 150/300/450 mg once weekly, 300/450 mg every 2 weeks, or intravenously at 20 mg/kg once every 4 weeks up to day 56 with 6 months of follow-up. The primary outcomes were incidence and severity of treatment-emergent adverse events. Efficacy analyses included changes in triglycerides and other lipids over time.
RESULTS


In the SAD, 32 (51.6%) versus 9 (42.9%) subjects on evinacumab versus placebo reported treatment-emergent adverse events. In the MAD, 21 (67.7%) versus 9 (75.0%) subjects on subcutaneously evinacumab versus placebo and 6 (85.7%) versus 1 (50.0%) on intravenously evinacumab versus placebo reported treatment-emergent adverse events. No serious treatment-emergent adverse events or events leading to death or treatment discontinuation were reported. Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%) SAD, 1 [14.3%] MAD) were observed with evinacumab (none in the placebo groups), which were single elevations and were not dose-related. Dose-dependent reductions in triglycerides were observed in both studies, with maximum reduction of 76.9% at day 3 with 10 mg/kg intravenously (P<0.0001) in the SAD and of 83.1% at day 2 with 20 mg/kg intravenously once every 4 weeks (P=0.0003) in the MAD. Significant reductions in other lipids were observed with most evinacumab doses versus placebo.
CONCLUSION


Evinacumab was well-tolerated in 2 Phase 1 studies. Lipid changes in hypertriglyceridemic subjects were similar to those observed with ANGPTL3 loss-of-function mutations. Because the latter is associated with reduced cardiovascular risk, ANGPTL3 inhibition may improve clinical outcomes.
CLINICAL TRIAL REGISTRATION


https://www.clinicaltrials.gov. Unique identifiers: NCT01749878 and NCT02107872.",2019,"Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%)","['healthy human volunteers and in homozygous familial hypercholesterolemic individuals', 'n=83 for single ascending dose study [SAD]; n=56 for multiple ascending dose study [MAD', 'hypertriglyceridemic subjects', 'Subjects with triglycerides >150 but ≤450 mg/dL and LDL-C ≥100 mg/dL']","['evinacumab SC', 'evinacumab subcutaneously (SC', 'Evinacumab', 'placebo', 'Angiopoietin-like protein 3', 'evinacumab:placebo']","['triglycerides', 'changes in triglycerides and other lipids over time', 'aspartate aminotransferase', 'Elevations in alanine aminotransferase', 'Lipid changes', 'No serious TEAEs or events leading to death or treatment discontinuation', 'incidence and severity of treatment-emergent adverse events (TEAEs', 'creatinine phosphokinase']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505321', 'cui_str': 'Angiopoietin-related Protein'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",,0.249051,"Elevations in alanine aminotransferase (7 [11.3%] SAD), aspartate aminotransferase (4 [6.5%] SAD), and creatinine phosphokinase (2 [3.2%)","[{'ForeName': 'Zahid', 'Initials': 'Z', 'LastName': 'Ahmad', 'Affiliation': 'Division of Nutrition and Metabolic Diseases, Department of Internal Medicine, Center for Human Nutrition, University of Texas Southwestern Medical Center, Dallas (Z.A.).'}, {'ForeName': 'Poulabi', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hamon', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Bouzelmat', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sasiela', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mellis', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Hayes', 'Initials': 'H', 'LastName': 'Dansky', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gipe', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY (P.B., S.H., K.-C.C., A.B., W.JS., R.P., S.M., H.D., D.A.G.).'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Division of Translational Medicine and Human Genetics, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia (R.L.D.).'}]",Circulation,['10.1161/CIRCULATIONAHA.118.039107']
705,32314970,Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.,"BACKGROUND


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


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


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


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


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


Clinicaltrials.gov NCT01295216; https://clinicaltrials.gov/ct2/show/NCT01295216.",2020,An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion.,"['212 individuals originally enrolled in the study in Peru', 'Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group', 'low-resource urban settings in Peru, 4 years after the completion of the original study']","['mobile health (mHealth) interventions', 'motivational interview calls and SMS text messaging', 'mHealth intervention']","['body weight', 'blood pressure', 'body weight, BMI, and self-reported target behaviors', 'changes in systolic', 'Cardiometabolic Risk Factors', 'BMI', 'risk of developing hypertension', 'body weight and BMI', 'diastolic', 'systolic and diastolic blood pressure levels and hypertension incidence', 'blood pressure levels and body weight', 'blood pressure levels', 'lower body weight']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205313', 'cui_str': 'Original'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]",212.0,0.145874,An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pauschardt', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Journal of medical Internet research,['10.2196/14595']
706,32315696,Testing the effects of transcranial direct current stimulation (tDCS) on the face inversion effect and the N170 event-related potentials (ERPs) component.,"The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces). We combined tDCS and EEG simultaneously to examine the effects of tDCS on the face inversion effect behaviourally and on the N170 ERPs component. The results from two experiments (overall N = 112) show that anodal tDCS delivered at Fp3 site for 10 min at 1.5 mA (double-blind and between-subjects) can reduce behaviourally the face inversion effect compared to sham (control) stimulation. The ERP results provide some evidence for tDCS being able to influence the face inversion effect on the N170. Specifically, we find a dissociation of the tDCS-induced effects where for the N170 latencies the tDCS reduces the usual face inversion effect (delayed N170 in response to inverted vs. upright faces) compared to sham. Contrarily, the same tDCS procedure on the same participants increased the inversion effect seen in the N170 amplitudes by making the negative deflection for the inverted faces that much greater than that for upright faces. We interpret our results in the context of the literature on the face inversion effect and the N170 peak component. In doing so, we extend our results to previous studies investigating the effects of tDCS on perceptual learning and face recognition.",2020,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,[],"['tDCS', 'transcranial direct current stimulation (tDCS', 'anodal tDCS']",['perceptual learning and face recognition'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0243991,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Civile', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: c.civile@exeter.ac.uk.'}, {'ForeName': 'Emika', 'Initials': 'E', 'LastName': 'Waguri', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Quaglia', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wooster', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Rossy', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: i.p.l.mclaren@exeter.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107470']
707,31674058,"Oral ferroportin inhibitor VIT-2763: First-in-human, phase 1 study in healthy volunteers.","Restriction of iron availability by ferroportin inhibition is a novel approach to treating non-transfusion-dependent thalassemia (β-thalassemia intermedia). This first-in-human, Phase I study (https://www.clinicaltrialsregister.eu; EudraCT no. 2017-003395-31) assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses (SAD and MAD) of the oral ferroportin inhibitor, VIT-2763, in healthy volunteers. Participants received VIT-2763 5/15/60/120/240 mg or placebo in the SAD phase and VIT-2763 60/120 mg once daily, VIT-2763 60/120 mg twice daily, or placebo for 7 days in the MAD phase. Seventy-two participants completed treatment. VIT-2763 was well tolerated and demonstrated a similar safety profile to the placebo. There were no serious or severe adverse events, or discontinuations due to adverse events. VIT-2763 absorption was relatively fast, with detectable levels 15 to 30 minutes post-dose. Following multiple dosing there was no apparent change in absorption and accumulation was minimal. Mean elimination half-life was 1.9 to 5.3 hours following single dosing, and 2.1 to 3.8 hours on Day 1 and 2.6 to 5.3 hours on Day 7, following repeated dosing. There was a temporary decrease in mean serum iron levels with VIT-2763 single doses ≥60 mg and all multiple doses; mean calculated transferrin saturation (only assessed following multiple dosing) also temporarily decreased. A shift in mean serum hepcidin peaks followed administration of all iron-lowering doses of VIT-2763. This effect was less pronounced after 7 days of multiple dosing (aside from with 120 mg once daily). These results support the initiation of clinical studies in patients with non-transfusion-dependent thalassemia and documented iron overload due to ineffective erythropoiesis.",2020,There was a temporary decrease in mean serum iron levels with VIT-2763 single doses ≥ ,"['patients with non-transfusion-dependent thalassemia and documented iron overload due to ineffective erythropoiesis', 'healthy volunteers']","['placebo', 'SAD phase and VIT-2763 60/120 mg once daily, VIT-2763 60/120 mg twice daily, or placebo', 'VIT-2763 5/15/60/120/240 mg or placebo', 'Oral ferroportin inhibitor VIT-2763']","['safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses (SAD and MAD', 'Mean elimination half-life', 'serious or severe adverse events', 'transferrin saturation', 'VIT-2763 absorption', 'mean serum iron levels', 'absorption and accumulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3805143', 'cui_str': 'Non-transfusion dependent thalassaemia'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0282193', 'cui_str': 'Iron Overload'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0392708', 'cui_str': 'Ineffective erythropoiesis (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0915115', 'cui_str': 'solute carrier family 40 (iron-regulated transporter), member 1'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}]",72.0,0.0548298,There was a temporary decrease in mean serum iron levels with VIT-2763 single doses ≥ ,"[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Richard', 'Affiliation': 'Research and Development, Vifor Pharma Group, Glattbrugg, Switzerland.'}, {'ForeName': 'Jan Jaap', 'Initials': 'JJ', 'LastName': 'van Lier', 'Affiliation': 'Early Development Services, PRA Health Sciences, Groningen, Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Roubert', 'Affiliation': 'Research and Development, Vifor Pharma Group, Glattbrugg, Switzerland.'}, {'ForeName': 'Teba', 'Initials': 'T', 'LastName': 'Haboubi', 'Affiliation': 'Research and Development, Vifor Pharma Group, Glattbrugg, Switzerland.'}, {'ForeName': 'Udo-Michael', 'Initials': 'UM', 'LastName': 'Göhring', 'Affiliation': 'Research and Development, Vifor Pharma Group, Glattbrugg, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Dürrenberger', 'Affiliation': 'Chemical and Preclinical Research and Development, Vifor (International) AG, St. Gallen, Switzerland.'}]",American journal of hematology,['10.1002/ajh.25670']
708,32077550,The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303).,"BACKGROUND


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


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


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


Anlotinib can benefit patients with advanced NSCLC with BM and is highly potent in the management of intracranial lesions. Its special effect on BM and cerebral tissue merits further investigation. (ClinicalTrials.gov ID: NCT02388919).",2020,"Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders.",['A total of 437 patients were included; 97 cases were recorded with BM at baseline'],['placebo'],"['neural toxicities', 'progression-free survival (PFS) and overall survival (OS', 'intracranial objective response rate', 'psychological symptoms', 'disease control rate', 'Time to brain progression (TTBP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",437.0,0.467281,"Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders.","[{'ForeName': 'Shunjun', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of General Internal Medicine, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhanhong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yalei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': ""Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2019-0838']
709,32311110,Exposure-response relationships of dapagliflozin on cardiorenal risk markers and adverse events: A pooled analysis of 13 phase II/III trials.,"AIMS


Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been developed as oral glucose lowering drug. The original dosefinding studies focused on optimal glycaemic effects. However, dapagliflozin also affects various cardiorenal risk markers and provides cardiorenal protection. To evaluate whether the currently registered doses of 5 and 10 mg are optimal for cardiorenal efficacy and safety, we characterized the relationship between dapagliflozin exposure and nonglycaemic cardiorenal risk markers as well as adverse events.
METHODS


Data were obtained from a pooled database of 13 24-week randomized controlled clinical trials of the clinical development programme of dapagliflozin. The exposure-response relationship was quantified using population pharmacodynamic and repeated time-to-event models.
RESULTS


A dose of 10 mg dapagliflozin resulted in an average individual exposure of 638 ng h/mL (95% prediction interval [PI]: 354-1061 ng h/mL), which translated to 71.2% (95% PI: 57.9-80.5%), 61.1% (95% PI: 58.0-64.8%), 91.3% (95% PI: 85.4-94.6%) and 25.7% (95% PI: 23.5-28.3%) of its estimated maximum effect for fasting plasma glucose, haematocrit, serum creatinine and urinary albumin-creatinine ratio, respectively.
CONCLUSION


We demonstrate that doses higher than 10 mg could provide additional beneficial effects in haematocrit, systolic blood pressure, urinary albumin-creatinine ratio and uric acid, without obvious increases in the rate of adverse events. These results raise the question whether future outcome studies assessing the benefits of higher than currently registered dapagliflozin doses are merited.",2020,"We demonstrate that doses higher than 10 mg could provide additional beneficial effects in hematocrit, systolic blood pressure, urinary albumin creatinine ratio and uric acid, without obvious increases in the rate of adverse events.",[],"['dapagliflozin', 'Dapagliflozin']","['hematocrit, systolic blood pressure, urinary albumin creatinine ratio and uric acid', 'fasting plasma glucose, haematocrit, serum creatinine and urinary albumin-creatinine ratio', 'cardio-renal risk markers and adverse events', 'rate of adverse events']",[],"[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0796205,"We demonstrate that doses higher than 10 mg could provide additional beneficial effects in hematocrit, systolic blood pressure, urinary albumin creatinine ratio and uric acid, without obvious increases in the rate of adverse events.","[{'ForeName': 'Jeroen V', 'Initials': 'JV', 'LastName': 'Koomen', 'Affiliation': 'Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14318']
710,32311162,Aggressive lymphoma subtype is a risk factor for venous thrombosis. Development of lymphoma - specific venous thrombosis prediction models.,"Venous thromboembolic events (VTE) are a frequent complication of lymphoma. We conducted a retrospective analysis to compare VTE risk in diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Subjects were randomly assigned to training and validation sets to identify risk factors of VTE and evaluate risk model performance, including the Khorana score. A group of 790 patients were diagnosed from 2002 to 2014 (DLBCL = 542, FL = 248). Median follow- up was 49 months. We observed 106 VTE, with higher incidence in DLBCL (5-year cumulative incidence = 16.3% vs 3.8% in FL patients). Five-year OS for patients with VTE was 51.4% vs 73.1% in patients without VTE (P < .001). Baseline VTE risk factors identified in the training cohort included lymphoma subtype, previous VTE, ECOG performance status ≥2, decreased albumin, increased calcium, elevated WBC, absolute lymphocyte count or monocyte count, and presence of bulky disease. Addition of new variables to the Khorana score improved its performance measured by Akaike information criterion and Concordance index. A new risk model including lymphoma subtype, albumin, WBC count, and bulky disease was validated in time-based ROC analyses. These findings were confirmed in the validation cohort. Lymphoma subtypes have different VTE risk. The effect of lymphoma subtype was independent from disease burden and the use of systemic therapy. The Khorana risk-score was validated in time to event analyses, and a more robust lymphoma-specific VTE risk score is proposed. These findings suggest lymphoma patients with highest VTE risk can be identified with baseline parameters.",2020,Addition of new variables to the Khorana score improved its performance measured by Akaike information criterion and Concordance index.,['diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL'],[],"['Khorana risk-score', 'calcium, elevated WBC, absolute lymphocyte count or monocyte count, and presence of bulky disease', 'lymphoma subtype, albumin, WBC count, and bulky disease', 'Venous thromboembolic events (VTE']","[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.0310593,Addition of new variables to the Khorana score improved its performance measured by Akaike information criterion and Concordance index.,"[{'ForeName': 'Gouri', 'Initials': 'G', 'LastName': 'Dharmavaram', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Shufen', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Sundaram', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA.'}, {'ForeName': 'Sabarish', 'Initials': 'S', 'LastName': 'Ayyappan', 'Affiliation': 'Division of Hematology, Oncology and Bone & Marrow Transplantation, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Boughan', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gallogly', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Malek', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Leland', 'Initials': 'L', 'LastName': 'Metheny', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Tomlinson', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Folashade', 'Initials': 'F', 'LastName': 'Otegbeye', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Hillard M', 'Initials': 'HM', 'LastName': 'Lazarus', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Pingfu', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'de Lima', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Paolo F', 'Initials': 'PF', 'LastName': 'Caimi', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplant Program, Division of Hematology and Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.'}]",American journal of hematology,['10.1002/ajh.25837']
711,32035624,Reducing the incidence of venous air embolism in contrast-enhanced CT angiography using preflushing of the power injector.,"AIM


To evaluate whether preflushing before connecting a power injector to a patient's catheter reduces the incidence of venous air embolism (VAE) in contrast-enhanced computed tomography (CT) angiography (CTA).
MATERIALS AND METHODS


With the approval from the local ethics committee, consecutive patients were divided randomly into a control group and a preflushing group and underwent CTA from June to November 2017. The control group underwent the conventional injection procedure. In the preflushing group, the injector tubes were flushed at high speed (10 ml/s) with saline before being connected to the patients' indwelling catheters. The locations, number, and sizes of VAE were analysed. The difference in the incidence of VAE between the two groups was compared.
RESULTS


A total of 4,900 adults (control/preflushing, 2,190/2,710) were included and 228 (4.65%) patients were found to have 318 VAEs (285 bubbles and 33 gas-liquid plane VAEs). The incidence of VAE in the preflushing group (3.21%) was lower than that in the control group (6.44%); a similar trend was observed for multiple VAEs (p<0.05). VAEs occurred in the following locations from high to low frequency: right atrium>pulmonary artery trunk>superior vena cava>right ventricle>left brachial vein>right brachial vein. There was no significant difference in the location, shape, or diameters (p=0.19) of VAEs between the two groups.
CONCLUSIONS


The proposed preflushing procedure is simple yet effective in reducing the incidence of VAE by 50.16% in patients with CTA, thus improving safety during power injection.",2020,"There was no significant difference in the location, shape, or diameters (p=0.19) of VAEs between the two groups.
","['4,900 adults (control/preflushing, 2,190/2,710) were included and 228 (4.65%) patients were found to have 318 VAEs (285 bubbles and 33 gas-liquid plane VAEs']","['contrast-enhanced computed tomography (CT) angiography (CTA', 'superior vena cava>right ventricle', 'conventional injection procedure']","['incidence of venous air embolism', 'low frequency: right atrium>pulmonary artery trunk', 'incidence of venous air embolism (VAE', 'VAEs', 'location, shape, or diameters (p=0.19) of VAEs', 'incidence of VAE']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0042459', 'cui_str': 'Vena Cava, Superior'}, {'cui': 'C0225883', 'cui_str': 'Right Ventricle'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0595954', 'cui_str': 'Venous air embolism (disorder)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0225844', 'cui_str': 'Right Atrium'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]",4900.0,0.0213758,"There was no significant difference in the location, shape, or diameters (p=0.19) of VAEs between the two groups.
","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'GE Healthcare, Computed Tomography Research Center, Beijing, 100176, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China. Electronic address: yj1118@mail.xjtu.edu.cn.""}]",Clinical radiology,['10.1016/j.crad.2019.12.025']
712,32311455,"Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal.","OBJECTIVES


To quantify the presence of two model highly permeable drugs, paracetamol and danazol, in the upper gastrointestinal lumen under conditions simulating the situation after disintegration of immediate release dosage forms administered in bioavailability/bioequivalence studies in the fed state. To understand the drug transfer process from the antral contents through the upper small intestine based on luminal drug data.
METHODS


8 healthy male adult volunteers participated in a randomized, single dose, two-phase, crossover study. After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube. The drugs were administered in solution form (Phase I) and in suspension form (Phase II) with a glass of tap water to the antrum of the stomach, 30 min after the initiation of meal administration. Samples were aspirated from the antrum and the upper small intestine up to 4 hours post drug administration.
RESULTS


Apparent concentrations in the aqueous contents of the antrum were higher than apparent concentrations in the micellar contents of the upper small intestine for paracetamol; the opposite was observed for danazol. Based on total drug amount per volume data in contents of the upper gastrointestinal lumen, the transfer of paracetamol (aqueous solution or suspension) and danazol (aqueous suspension) through the upper small intestine could be described as an apparent first-order process. Transfer of a long-chain triglyceride solution of danazol was highly variable.
CONCLUSIONS


Concentrations in the aqueous/micellar phase of luminal contents and values of parameters controlling the transfer from bulk gastric contents through the upper small intestine after a high-calorie, high-fat meal, were reported for the first time for highly permeable drugs. Data are expected to enhance the development of biorelevant in vitro and physiologically based biopharmaceutics modelling methodologies.",2020,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.",['8 healthy male adult volunteers'],"['paracetamol and danazol', 'danazol', 'paracetamol (aqueous solution or suspension) and danazol (aqueous suspension']",[],"[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],8.0,0.0387024,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105351']
713,30257794,The effect of surgeon versus technologist control of fluoroscopy on radiation exposure during pediatric ureteroscopy: A randomized trial.,"BACKGROUND


Fluoroscopy is commonly used during pediatric ureteroscopy (PURS) for urolithiasis, and the most important contributor to overall radiation exposure is fluoroscopy time (FT). One factor that may impact FT is who controls activation of the fluoroscope: the urologist (with a foot pedal) or the radiation technologist (as directed by the urologist). While there are plausible reasons to believe that either approach may lead to reduced FT, there are no systematic investigations of this question. We sought to compare FT with surgeon-control versus technologist control during PURS for urolithiasis.
METHODS


We conducted a randomized controlled trial (Clinicaltrials.gov ID number: NCT02224287). Institutional Review Board approval was sought and obtained for this study. All subjects (or their legal guardians) provided informed consent. Each patient (age 5-26 years) was randomized to surgeon- or technologist-controlled fluoroscope activation. Block randomization was stratified by the surgeon. For technologist control, the surgeon verbally directed the technologist to activate the fluoroscope. For surgeon control, a foot pedal was used by the surgeon. The technologist controlled c-arm positioning, settings, and movement. The primary outcome was total FT for the procedure. Secondary outcomes included radiation exposure (entrance surface air kerma [ESAK] mGy). We also analyzed clinical and procedural predictors of FT and exposure. Mixed linear models accounting for clustering by surgeon were developed.
RESULTS


Seventy-three procedures (5 surgeons) were included. The number of procedures per surgeon ranged from seven to 36. Forty-three percent were pre-stented. Thirty-one procedures were left side, 35 were right side, and seven were bilateral. Stones were treated in 71% of procedures (21% laser, 14% basket, and 65% laser/basket). Stone locations were distal ureter (11.5%), proximal/mid-ureter (8%), renal (69%), and ureteral/renal (11.5%). An access sheath was used in 77%. Median stone size was 8.0 mm (range 2.0-20.0). Median FT in the surgeon control group was 0.5 min (range 0.01-6.10) versus 0.55 min (range 0.10-5.50) in the technologist-control group (p = 0.284). Median ESAK in the surgeon control group was 46.02 mGy (range 5.44-3236.80) versus 46.99 mGy (range: 0.17-1039.31) in the technologist-control group (p = 0.362). Other factors associated with lower FT on univariate analysis included female sex (p = 0.015), no prior urologic surgeries (p = 0.041), shorter surgery (p = 0.011), and no access sheath (p = 0.006). On multivariable analysis only female sex (p = 0.017) and no access sheath (p = 0.049) remained significant. There was significant variation among surgeons (p < 0.0001); individual surgeon median FT ranged from 0.40 to 2.95 min.
CONCLUSIONS


Fluoroscopy time and radiation exposure are similar whether the surgeon or technologist controls fluoroscope activation. Other strategies to reduce exposure might focus on surgeon-specific factors, given the significant variation between surgeons.",2018,"Stones were treated in 71% of procedures (21% laser, 14% basket, and 65% laser/basket).","['Each patient (age 5-26 years', 'Seventy-three procedures (5 surgeons) were included', 'pediatric ureteroscopy']","['FT with surgeon-control versus technologist control', 'surgeon versus technologist control of fluoroscopy', 'surgeon- or technologist-controlled fluoroscope activation']","['Median FT', 'Fluoroscopy time and radiation exposure', 'shorter surgery', 'radiation exposure (entrance surface air kerma [ESAK] mGy', 'total FT for the procedure', 'no prior urologic surgeries', 'Median stone size', 'Median ESAK']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0260280', 'cui_str': 'Technologist (occupation)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0337095', 'cui_str': 'Entrance (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C3873195', 'cui_str': 'Milligray (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",,0.0955527,"Stones were treated in 71% of procedures (21% laser, 14% basket, and 65% laser/basket).","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Kokorowski', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Jeanne S', 'Initials': 'JS', 'LastName': 'Chow', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Bartley G', 'Initials': 'BG', 'LastName': 'Cilento', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Don-Soo', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kurtz', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Logvinenko', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'MacDougall', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA. Electronic address: caleb.nelson@childrens.harvard.edu.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2018.04.035']
714,30773796,Comparison of myocardial microcirculatory perfusion after catheter-administered intracoronary thrombolysis with anisodamine versus standard thrombus aspiration in patients with ST-elevation myocardial infarction.,"OBJECTIVE


To evaluate efficacy, safety and feasibility of targeted intracoronary injection using pro-urokinase combined with anisodamine (TCA) versus thrombus aspiration (TA) in ST-elevation myocardial infarction (STEMI) patients with high thrombus loads.
BACKGROUND


The best method of avoiding thrombus detachment and stroke in PCI patients with high thrombus loads has not yet been established.
METHODS


STEMI patients receiving coronary artery angiography or percutaneous coronary intervention (CAG/PCI) with thrombus grade ≥ 3 from January 1, 2017 to June 30, 2018 were randomly assigned to targeted intracoronary thrombolysis (pro-urokinase and anisodamine via catheter (TCA) group), or the TA group which followed the standard thrombus aspiration procedure. Parameters compared included thrombus grade, index of microcirculatory resistance (IMR), postoperative myocardial SPECT, thrombosis in myocardial infarction (TIMI) scores including flow grade, corrected TIMI frame counts (CTFCs), and TIMI myocardial perfusion grade (TMPG). Adverse events were followed up within 3 months.
RESULTS


Thirty-nine patients were finally enrolled. In primary CAG/PCI, the TCA group had higher percentages of TIMI 3 flow and lower IMR values compared with the TA group. The ratio of TMPG 3 grade in the TCA group was higher in repeat CAG, and the perfusion descending area (PDA) presented by SPECT was lower than in the TA group. No significant difference was seen in major adverse coronary events (MACEs) or bleeding events at follow-up.
CONCLUSIONS


TCA appears to be effective, safe, and feasible for repatency and reduction of high thrombus burden in primary PCI and may protect myocardial microcirculation with improved outcomes.",2019,"In primary CAG/PCI, the TCA group had higher percentages of TIMI 3 flow and lower IMR values compared with the TA group.","['Thirty-nine patients were finally enrolled', 'PCI patients with high thrombus loads', 'STEMI patients receiving coronary artery angiography or percutaneous coronary intervention (CAG/PCI) with thrombus grade\u2009≥\u20093 from January 1, 2017 to June 30, 2018', 'patients with ST-elevation myocardial infarction']","['intracoronary injection using pro-urokinase combined with anisodamine (TCA) versus thrombus aspiration (TA', 'anisodamine versus standard thrombus aspiration', 'TCA', 'TA group which followed the standard thrombus aspiration procedure', 'intracoronary thrombolysis (pro-urokinase and anisodamine via catheter (TCA']","['Adverse events', 'thrombus grade, index of microcirculatory resistance (IMR), postoperative myocardial SPECT, thrombosis in myocardial infarction (TIMI) scores including flow grade, corrected TIMI frame counts (CTFCs), and TIMI myocardial perfusion grade (TMPG', 'TIMI 3 flow and lower IMR values', 'major adverse coronary events (MACEs) or bleeding events', 'efficacy, safety and feasibility']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0141582', 'cui_str': 'saruplase'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0051920', 'cui_str': 'anisodamine'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0642334', 'cui_str': 'TMPG'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",39.0,0.0307132,"In primary CAG/PCI, the TCA group had higher percentages of TIMI 3 flow and lower IMR values compared with the TA group.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xin-Shun', 'Initials': 'XS', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Guo-Zhen', 'Initials': 'GZ', 'LastName': 'Hao', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yun-Fa', 'Initials': 'YF', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Wei-Ze', 'Initials': 'WZ', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': ""Department of Cardiology, Xingtai People's Hospital, Xingtai, Hebei, China.""}, {'ForeName': 'Qing-Min', 'Initials': 'QM', 'LastName': 'Wei', 'Affiliation': ""Department of Cardiology, Xingtai People's Hospital, Xingtai, Hebei, China.""}, {'ForeName': 'Xiang-Hua', 'Initials': 'XH', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28112']
715,30815856,"Dose-Response Pharmacological Study of Mephedrone and Its Metabolites: Pharmacokinetics, Serotoninergic Effects, and Impact of CYP2D6 Genetic Variation.","Mephedrone (MEPH), the most widely consumed synthetic cathinone, has been associated with acute toxicity episodes. The aim of this report was to study its metabolic disposition and the impact of genetic variation of CYP2D6 on MEPH metabolism, in a dose range compatible with its recreational use. A randomized, crossover, phase I clinical trial was performed. Subjects received 50 and 100 mg (n = 3) and 150 and 200 mg (n = 6) of mephedrone and were genetically and phenotypically characterized for the CYP2D6 allelic variation. Our results showed a linear kinetics of mephedrone at the dose range assayed: plasma concentrations, cardiovascular and subjective effects, and blood serotonin concentrations all correlated in a dose-dependent manner. Mephedrone metabolic disposition is mediated by CYP2D6. Mephedrone pharmacology presented a linear dose-dependence within the range of doses tested. The metabolism of mephedrone by CYP2D6 implies that recreational users with no or low CYP2D6 functionality are exposed to unwanted acute toxicity episodes.",2019,"Our results showed a linear kinetics of mephedrone at the dose range assayed: plasma concentrations, cardiovascular and subjective effects, and blood serotonin concentrations all correlated in a dose-dependent manner.",[],['Mephedrone (MEPH'],"['plasma concentrations, cardiovascular and subjective effects, and blood serotonin concentrations']",[],"[{'cui': 'C2932852', 'cui_str': 'MMCAT compound'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}]",,0.0592638,"Our results showed a linear kinetics of mephedrone at the dose range assayed: plasma concentrations, cardiovascular and subjective effects, and blood serotonin concentrations all correlated in a dose-dependent manner.","[{'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Olesti', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Magí', 'Initials': 'M', 'LastName': 'Farré', 'Affiliation': 'School of Medicine, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Marcel Lí', 'Initials': 'ML', 'LastName': 'Carbó', 'Affiliation': 'Pompeu Fabra University (CEXS-UPF), Barcelona, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Papaseit', 'Affiliation': 'School of Medicine, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Perez-Mañá', 'Affiliation': 'School of Medicine, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Torrens', 'Affiliation': 'School of Medicine, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Yubero-Lahoz', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Mitona', 'Initials': 'M', 'LastName': 'Pujadas', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Óscar J', 'Initials': 'ÓJ', 'LastName': 'Pozo', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre', 'Affiliation': 'Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1417']
716,32244111,Glucocorticoids and cortical decoding in the phobic brain.,"Glucocorticoids reduce phobic fear in anxiety disorders and enhance psychotherapy, possibly by reducing the retrieval of fear memories and enhancing the consolidation of new corrective memories. Glucocorticoid signaling in the basolateral amygdala can influence connected fear and memory-related cortical regions, but this is not fully understood. Previous studies investigated specific pathways moderated by glucocorticoids, for example, visual-temporal pathways; however, these analyses were limited to a-priori selected regions. Here, we performed whole-brain pattern analysis to localize phobic stimulus decoding related to the fear-reducing effect of glucocorticoids. We reanalyzed functional magnetic resonance imaging (fMRI) data from a previously published study with spider-phobic patients and healthy controls. The patients received glucocorticoids or a placebo before the exposure to spider images. There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls. Decoding in the ACC and the right insula showed strong evidence for correlation with experienced fear. Patients with cortisol reported a reduction of fear by 10-13%; however, there was only weak evidence for changes in neural decoding compared to placebo which was found in the precuneus, the opercular cortex, and the left cerebellum.",2020,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,['spider-phobic patients and healthy controls'],"['placebo', 'glucocorticoids', 'Glucocorticoids', 'glucocorticoids or a placebo', 'functional magnetic resonance imaging (fMRI']","['neural decoding', 'reduction of fear']","[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0236284,There was moderate evidence that patients with phobia had higher decoding of phobic content in the anterior cingulate cortex (ACC) and the left and right anterior insula compared to controls.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schwab', 'Affiliation': 'Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Population Health, University of Oxford, United Kingdom; Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland. Electronic address: simon.schwab@uzh.ch.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Federspiel', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland; Japan Science and Technology Agency, PRESTO, Saitama, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Nakataki', 'Affiliation': 'Department of Psychiatry, University of Tokushima, Tokushima, Japan.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Strik', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wiest', 'Affiliation': 'Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Dept. of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany; Freiburg Brain Imaging Center, University Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Quervain', 'Affiliation': 'Division of Cognitive Neuroscience, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Leila M', 'Initials': 'LM', 'LastName': 'Soravia', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111066']
717,32220635,"An Invited Commentary on ""Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial"" (Int J Surg. 2020;76:37-44).",,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.137814,,"[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Caputo', 'Affiliation': 'Department of Surgery, University Campus Bio-Medico of Rome, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Coppola', 'Affiliation': 'Department of Surgery, University Campus Bio-Medico of Rome, Rome, Italy. Electronic address: a.coppola@unicampus.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.040']
718,30426653,"Use of monitoring data to improve implementation of a home fortification program in Bihar, India.","This paper describes the use of program-monitoring data to track program performance and inform activities. Monitoring data were collected as part of an effectiveness trial of multiple micronutrient powders (MNPs) for children 6-18 months in Bihar, India. Communities (n = 70; reaching over 10,000 children) were randomized to receive either counselling on infant and young child feeding or both counselling and MNPs. Government frontline health workers (FLWs) implemented and monitored program activities with support from CARE India and university partners. Monitoring data were collected over the duration of the entire program to assess program impact pathways using various checklists, which captured information about (a) attendance and training of FLWs at health subcentre meetings, (b) distribution of MNPs, (c) receipt and use of MNPs at the household level, and (d) midline mixed methods survey. At the beginning of the program, 72% of households reported receiving and 53% reported currently consuming MNPs. These numbers fell to 40% and 43% at midline, respectively. The main barrier to use by household was a lack of MNPs, due in part to infrequent FLW distribution. However, FLWs rarely reported MNP shortages at Anganwadi centres. Side effects also emerged as a barrier and were addressed through revised recommendations for MNP use. Qualitative data indicated high community acceptance of MNPs and a good understanding of the program by FLWs. The use of real-time program data allowed for recognition of key program issues and decision-making to enhance program implementation.",2019,The use of real-time program data allowed for recognition of key program issues and decision-making to enhance program implementation.,"['children 6-18\xa0months in Bihar, India', 'Communities (n\xa0=\xa070; reaching over 10,000 children', 'Government frontline health workers (FLWs']",['counselling on infant and young child feeding or both counselling and MNPs'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],10000.0,0.018386,The use of real-time program data allowed for recognition of key program issues and decision-making to enhance program implementation.,"[{'ForeName': 'Rukshan', 'Initials': 'R', 'LastName': 'Mehta', 'Affiliation': 'Doctoral Program in Nutrition and Health Sciences, Laney Graduate School, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Doctoral Program in Nutrition and Health Sciences, Laney Graduate School, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Indrajit', 'Initials': 'I', 'LastName': 'Chaudhuri', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Amy Webb', 'Initials': 'AW', 'LastName': 'Girard', 'Affiliation': 'Doctoral Program in Nutrition and Health Sciences, Laney Graduate School, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Doctoral Program in Nutrition and Health Sciences, Laney Graduate School, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Verma', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kekre', 'Affiliation': 'The Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Srikantiah', 'Affiliation': 'CARE India, Patna, India.'}, {'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Young', 'Affiliation': 'Doctoral Program in Nutrition and Health Sciences, Laney Graduate School, Emory University, Atlanta, Georgia.'}]",Maternal & child nutrition,['10.1111/mcn.12753']
719,31441816,Second Uterine Curettage and the Number of Chemotherapy Courses in Postmolar Gestational Trophoblastic Neoplasia: A Randomized Controlled Trial.,,2019,,['Postmolar Gestational Trophoblastic Neoplasia'],[],[],"[{'cui': 'C1135868', 'cui_str': 'Gestational Trophoblastic Neoplasms'}]",[],[],,0.148793,,[],Obstetrics and gynecology,['10.1097/AOG.0000000000003424']
720,31162191,XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial.,"OBJECTIVES


To investigate whether XueBiJing injection improves clinical outcomes in critically ill patients with severe community-acquired pneumonia.
DESIGN


Prospective, randomized, controlled study.
SETTING


Thirty-three hospitals in China.
PATIENTS


A total of 710 adults 18-75 years old with severe community-acquired pneumonia.
INTERVENTIONS


Participants in the XueBiJing group received XueBiJing, 100 mL, q12 hours, and the control group received a visually indistinguishable placebo.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was 8-day improvement in the pneumonia severity index risk rating. Secondary outcomes were 28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay. Improvement in the pneumonia severity index risk rating, from a previously defined endpoint, occurred in 203 (60.78%) participants receiving XueBiJing and in 158 (46.33%) participants receiving placebo (between-group difference [95% CI], 14.4% [6.9-21.8%]; p < 0.001). Fifty-three (15.87%) XueBiJing recipients and 84 (24.63%) placebo recipients (8.8% [2.4-15.2%]; p = 0.006) died within 28 days. XueBiJing administration also decreased the mechanical ventilation time and the total ICU stay duration. The median mechanical ventilation time was 11.0 versus 16.5 days for the XueBiJing and placebo groups, respectively (p = 0.012). The total duration of ICU stay was 12 days for XueBiJing recipients versus 16 days for placebo recipients (p = 0.004). A total of 256 patients experienced adverse events (119 [35.63%] vs 137 [40.18%] in the XueBiJing and placebo groups, respectively [p = 0.235]).
CONCLUSIONS


In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay.",2019,"In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay.","['Thirty-three hospitals in China', '710 adults 18-75 years old with severe community-acquired pneumonia', 'With Severe Community-Acquired Pneumonia', 'Critically Ill Patients', 'critically ill patients with severe community-acquired pneumonia']","['control group received a visually indistinguishable placebo', 'XueBiJing injection', 'placebo', 'XueBiJing Injection Versus Placebo']","['pneumonia severity index risk rating', 'pneumonia severity index', 'median mechanical ventilation time', 'adverse events', 'mortality, duration of mechanical ventilation and duration of ICU stay', '28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay', 'mechanical ventilation time and the total ICU stay duration', 'total duration of ICU stay']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C1321595', 'cui_str': 'Pneumonia severity of illness index'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",710.0,0.531953,"In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay.","[{'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Department of Medical Statistics, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yongming', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Institute of Field Surgery, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Emergency Medicine, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Emergency Medicine, First Affiliated Hospital of Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Luyi', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Intensive Care Unit, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency Medicine, First People's Hospital of Yunnan Province, Kunming, China.""}, {'ForeName': 'Zhongmin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Intensive Care Unit, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory Medicine, People's Liberation Army General Hospital of Rocket Forces, Beijing, China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': ""Department of Respiratory Medicine, People's Liberation Army General Hospital of Shenyang Military Command, Shenyang, China.""}, {'ForeName': 'Youguang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Respiratory Medicine, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Intensive Care Unit, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Zhongzhi', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Emergency Medicine, Wuhan General Hospital of Guangzhou Military Command, Wuhan, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Shuming', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Emergency Medicine, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yanfen', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Emergency Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Intensive Care Unit, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory Medicine, The First Affiliated Hospital of The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'Department of Respiratory Medicine, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Respiratory Medicine, People's Liberation Army Air Force General Hospital, Beijing, China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Medicine, West China Hospital of Sichuan University, Sichuan, China.'}, {'ForeName': 'Xuezhong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Emergency Medicine, Beijing Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiaoge', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, The Fourth Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Xianyao', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Intensive Care Unit, First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Respiratory Medicine, Taihe Hospital, Hubei University of Medicine, Shiyan, China.'}, {'ForeName': 'Yingping', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Emergency Medicine, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Emergency, Hunan Provincial People's Hospital, Hunan, China.""}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Biostatistics, Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'General Office, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, first Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hongcai', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chunxue', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Critical care medicine,['10.1097/CCM.0000000000003842']
721,31640455,Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial.,"Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long-term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre-specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.",2019,Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time.,['912 patients with high/extreme surgical risk and symptomatic aortic stenosis'],"['transcatheter aortic valve replacement with the Lotus valve', 'transcatheter aortic valve replacement', 'Stenotic Aortic Valve through Implantation of Lotus', 'Pacemaker Implantation and Dependency', 'Transcatheter Aortic Valve Replacement']","['baseline right bundle branch block and depth of implantation; diabetes mellitus', 'mortality or stroke', 'Mortality and stroke', 'baseline right bundle branch block, female sex, and depth of implantation', 'Rehospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0330839', 'cui_str': 'Loteae'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]","[{'cui': 'C0085615', 'cui_str': 'Right bundle branch block (disorder)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",912.0,0.317885,Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time.,"[{'ForeName': 'Christopher U', 'Initials': 'CU', 'LastName': 'Meduri', 'Affiliation': 'Piedmont Heart Institute Atlanta GA.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center The Lindner Research Center Cincinnati OH.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rajagopal', 'Affiliation': 'Piedmont Heart Institute Atlanta GA.'}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Cedars-Sinai Heart Institute Los Angeles CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': ""O'Hair"", 'Affiliation': ""Aurora St. Luke's Medical Center Milwaukee WI.""}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Dresden University Hospital, Heart Center Dresden Germany.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Washington Hospital Center Washington DC.'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Babliaros', 'Affiliation': 'Emory University Hospital Emory University Atlanta GA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stoler', 'Affiliation': 'Baylor Heart & Vascular Hospital Dallas TX.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Mishkel', 'Affiliation': ""St. John's Hospital Springfield IL.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Rizik', 'Affiliation': 'HonorHealth and the Scottsdale-Lincoln Health Network Scottsdale AZ.'}, {'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Iyer', 'Affiliation': 'University at Buffalo/Gates Vascular Institute Buffalo NY.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schindler', 'Affiliation': 'University of Pittsburgh Medical Center Pittsburgh PA.'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Allocco', 'Affiliation': 'Boston Scientific Corp Marlborough MA.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Meredith', 'Affiliation': 'Boston Scientific Corp Marlborough MA.'}, {'ForeName': 'Ted E', 'Initials': 'TE', 'LastName': 'Feldman', 'Affiliation': 'Edwards Lifesciences Irvine California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center Houston TX.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012594']
722,32301122,Rosuvastatin use increases plasma fibrinolytic potential: a randomised clinical trial.,"We conducted a study to assess the effect of rosuvastatin use on fibrinolysis in patients with previous venous thromboembolism (VTE). This was a post hoc analysis within the STAtins Reduce Thrombophilia (START) study (NCT01613794). Plasma fibrinolytic potential, fibrinogen, plasmin inhibitor, plasminogen activator inhibitor-1 (PAI-1) and thrombin-activatable fibrinolysis inhibitor (TAFI) were measured before and after four weeks of rosuvastatin or no treatment in participants with prior confirmed VTE, after ending anticoagulant therapy. In the non-rosuvastatin group (n = 121), plasma fibrinolytic potential and individual fibrinolysis parameters did not change at the end of the study versus the baseline, whereas in the rosuvastatin group (n = 126), plasma fibrinolytic potential increased: the mean clot lysis time decreased by 8·75 min (95% CI -13·8 to -3·72), and plasmin inhibitor levels and TAFI activity were lower at the end of the study (-0·05 U/ml; 95% CI -0·07 to -0·02 and -4·77%; 95% CI -6·81 to -2·73, respectively). PAI-1 levels did not change and fibrinogen levels were 0·17 g/l (95% CI 0·04-0·29) higher. In participants with prior VTE, rosuvastatin use led to an increased fibrinolytic potential compared with non-statin use. Our findings support the need for further studies on the possible role for statins in the secondary prevention of VTE.",2020,"In participants with prior VTE, rosuvastatin use led to an increased fibrinolytic potential compared with non-statin use.","['patients with previous venous thromboembolism (VTE', 'participants with prior confirmed VTE, after ending anticoagulant therapy']","['rosuvastatin', 'Rosuvastatin']","['Plasma fibrinolytic potential, fibrinogen, plasmin inhibitor, plasminogen activator inhibitor-1 (PAI-1) and thrombin-activatable fibrinolysis inhibitor (TAFI', 'plasmin inhibitor levels and TAFI activity', 'plasma fibrinolytic potential increased: the mean clot lysis time', 'plasma fibrinolytic potential', 'PAI-1 levels', 'fibrinogen levels', 'plasma fibrinolytic potential and individual fibrinolysis parameters', 'fibrinolytic potential']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0032139', 'cui_str': 'Plasmin inhibitor'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0255161', 'cui_str': 'Carboxypeptidase U'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0200464', 'cui_str': 'Fibrinolysin assay, screening'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0523053,"In participants with prior VTE, rosuvastatin use led to an increased fibrinolytic potential compared with non-statin use.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schol-Gelok', 'Affiliation': 'Departments of Hospital Pharmacy and Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Moniek P M', 'Initials': 'MPM', 'LastName': 'de Maat', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Biedermann', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Departments of Hospital Pharmacy and Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank W G', 'Initials': 'FWG', 'LastName': 'Leebeek', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'Lijfering', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Felix J M', 'Initials': 'FJM', 'LastName': 'van der Meer', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Dingeman C', 'Initials': 'DC', 'LastName': 'Rijken', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jorie', 'Initials': 'J', 'LastName': 'Versmissen', 'Affiliation': 'Departments of Hospital Pharmacy and Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marieke J H A', 'Initials': 'MJHA', 'LastName': 'Kruip', 'Affiliation': 'Department of Haematology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}]",British journal of haematology,['10.1111/bjh.16648']
723,31392826,Comprehensive analysis of five long noncoding RNAs expression as competing endogenous RNAs in regulating hepatoma carcinoma.,"Liver cancer is the most common cancer and is the epitome of a recalcitrant cancer. Increasing evidence shown that long noncoding RNAs (lncRNA) were associated with cancer-related death and could function as a competing endogenous RNA (ceRNA). To explore regulatory roles and potential prognostic biomarkers of lncRNA for liver cancer, RNA-sequencing expression data were downloaded from the TCGA database and GEO database. A total of 357 patients were randomly divided into a discovery group and a validation group, of which 313 patients can obtain clinical data. In discovery phrase, 58 lncRNAs, 16 miRNAs, and 34 mRNAs were screened to construct the ceRNA network based on 252 patients employed from discovery group. Univariate and multivariate Cox hazard regression analysis model revealed that five lncRNAs (AATK-AS1, C10orf91, LINC00162, LINC00200, and LINC00501) from 58 lncRNAs were formulated to predict the overall survival (OS). We used the value of gene expression and regression coefficients to construct a risk score based on the five lncRNAs. Next, we validated our model in the GSE116174 dataset (n = 64) and the validation group (n = 94) from TCGA database. Subgroup analysis suggest that the five lncRNAs played critical parts in early stage in cancer from both discovery and validation groups. The five lncRNAs were also found to be associated with immune cells infiltration including CD4 +  memory activated, NK cells activated and mast cells activated, then the results were also validated according to the validation group. Furthermore, KEGG pathway enrichment analysis showed that these nine coexpressed modules using the method of WGCNA, and many of these pathways are associated with the development and progression of disease. At last, the transcription factor binding sites (TFBS) of the five lncRNAs were predicted, which help us to understand the potential mechanism that the TFBS adjusted the ceRNA network. In summary, the ceRNA regulatory network may contribute to a better understanding of liver cancer mechanism and provide potential prognostic biomarkers and therapeutic targets.",2019,"The five lncRNAs were also found to be associated with immune cells infiltration including CD4 +  memory activated, NK cells activated and mast cells activated, then the results were also validated according to the validation group.",['357 patients'],[],"['overall survival (OS', 'immune cells infiltration including CD4 +  memory activated, NK cells activated and mast cells activated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0024880', 'cui_str': 'Basophils, Tissue'}]",313.0,0.0154378,"The five lncRNAs were also found to be associated with immune cells infiltration including CD4 +  memory activated, NK cells activated and mast cells activated, then the results were also validated according to the validation group.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lou', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Tianjin Medical University Second Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Tianjin Medical University Second Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Tianjin Medical University Second Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ya-Qing', 'Initials': 'YQ', 'LastName': 'Wei', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Tianjin Medical University Second Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Tianjin Medical University Second Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jin-Jin', 'Initials': 'JJ', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatopancreatobiliary Surgery, Tianjin Medical University Second Hospital, Tianjin Medical University, Tianjin, China.'}]",Cancer medicine,['10.1002/cam4.2468']
724,31347292,A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer.,"PURPOSE


Notch signaling dysregulation is implicated in the development of pancreatic adenocarcinoma (PDAC). Tarextumab is a fully human IgG2 antibody that inhibits Notch2/3 receptors.
PATIENTS AND METHODS


Aphase 2, randomized, placebo-controlled, multicenter trial evaluated the activity of tarextumab in combination with nab-paclitaxel and gemcitabine in patients with metastatic PDAC. Patients were stratified based on ECOG performance score and Ca 19-9 level and randomized 1:1 to nab-paclitaxel, gemcitabine with either tarextumab or placebo. Based on preclinical and phase Ib results suggesting a positive correlation between Notch3 gene expression and tarextumab anti-tumor activity, patients were also divided into subgroups of low, intermediate, and high Notch3 gene expression. Primary endpoint was overall survival (OS) in all and in patients with the three Notch3 gene expression subgroups (≥25th, ≥50% and ≥75% percentiles); secondary end points included progression-free survival (PFS), 12-month OS, overall response rate (ORR), and safety and biomarker investigation.
RESULTS


Median OS was 6.4 months in the tarextumab group vs 7.9 months in the placebo group (HR = 1.34 [95% CI = 0.95, 1.89], P = .0985). No difference observed in OS in the Notch3 gene expression subgroups. PFS in the tarextumab-treated group (3.7 months) was significantly shorter compared with the placebo group (5.5 months) (hazard ratio was 1.43 [95% CI = 1.01, 2.01]; P = .04). Grade 3 diarrhea and thrombocytopenia were more common in the tarextumab group.
CONCLUSIONS


The addition of tarextumab to nab-paclitaxel and gemcitabine did not improve OS, PFS, or ORR in first-line metastatic PDAC, and PFS was specifically statistically worse in the tarextumab-treated patients.
CLINICAL TRIAL REGISTRY NO


NCT01647828.",2019,"PFS in the tarextumab-treated group (3.7 months) was significantly shorter compared with the placebo group (5.5 months) (hazard ratio was 1.43 [95% CI = 1.01, 2.01];","['patients with untreated metastatic pancreatic cancer', 'patients with metastatic PDAC', 'Patients were stratified based on ECOG performance score and Ca 19-9 level and randomized 1:1 to', 'pancreatic adenocarcinoma (PDAC']","['nab-paclitaxel and gemcitabine with tarextumab or placebo', 'placebo', 'nab-paclitaxel, gemcitabine with either tarextumab or placebo', 'tarextumab in combination with nab-paclitaxel and gemcitabine', 'tarextumab to nab-paclitaxel and gemcitabine']","['OS, PFS, or ORR in first-line metastatic PDAC, and PFS', 'PFS', 'overall survival (OS', 'Median OS', 'Grade 3 diarrhea and thrombocytopenia', 'OS', 'progression-free survival (PFS), 12-month OS, overall response rate (ORR), and safety and biomarker investigation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4053948', 'cui_str': 'tarextumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.10106,"PFS in the tarextumab-treated group (3.7 months) was significantly shorter compared with the placebo group (5.5 months) (hazard ratio was 1.43 [95% CI = 1.01, 2.01];","[{'ForeName': 'Zishuo Ian', 'Initials': 'ZI', 'LastName': 'Hu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Noelle K', 'Initials': 'NK', 'LastName': 'LoConte', 'Affiliation': 'University of Wisconsin, Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hatoum', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritch', 'Affiliation': 'Froedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hool', 'Affiliation': 'Torrance Memorial Physician Network, Redondo Beach, California.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leach', 'Affiliation': 'Virginia Piper Cancer Institute, Minneapolis, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Henderson, Nevada.'}, {'ForeName': 'Davendra P S', 'Initials': 'DPS', 'LastName': 'Sohal', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strickler', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Ravindranath', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Comprehensive Blood and Cancer Center, Bakersfield, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Washington University School of Medicine, Saint Louis, Missouri.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Firdaus', 'Affiliation': 'Oncology Hematology Cancer, Inc., Cincinnati, Ohio.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Kapoun', 'Affiliation': 'Oncomed Pharmaceuticals Inc, Redwood City, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Holmgren', 'Affiliation': 'Oncomed Pharmaceuticals Inc, Redwood City, California.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Oncomed Pharmaceuticals Inc, Redwood City, California.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Dupont', 'Affiliation': 'Oncomed Pharmaceuticals Inc, Redwood City, California.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer medicine,['10.1002/cam4.2425']
725,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


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


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


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


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
726,31314957,Impact on health-related quality of life deterioration-free survival of a first-line therapy combining nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial.,"BACKGROUND


The phase II AFUGEM GERCOR trial aimed to assess the efficacy of a first-line therapy combining nab-paclitaxel plus either gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group) in patients with previously untreated metastatic pancreatic cancer. Results of progression-free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group. This paper presents health-related quality of life (HRQoL) data as a secondary endpoint.
METHODS


HRQoL was assessed using the EORTC QLQ-C30 questionnaire at baseline and at each chemotherapy cycle until the end of treatment. The HRQoL deterioration-free survival (QFS) was used as a modality of longitudinal analysis. QFS was defined as the time between randomization and the first definitive HRQoL score deterioration as compared to the baseline score, or death. Sensitivity analysis was performed excluding death as an event. Univariate Cox models were used to estimate hazard ratios (HRs) and 90% confidence intervals (CIs) of the treatment effect.
RESULTS


Between 2013 and 2014, 114 patients were randomized in a 1:2 ratio (39 in the gemcitabine group and 75 in the sLV5FU2 group). Patients in the sLV5FU2 group seemed to present longer QFS than those of the gemcitabine group for 14 out of 15 dimensions, with HRs < 1. Results of the sensitivity analysis excluding death as an event were significantly in favor of the sLV5FU2 group for physical functioning (HR = 0.51 [90% CI 0.27-0.97]) and pain (HR = 0.26 [90% CI 0.09-0.74]).
CONCLUSION


The nab-paclitaxel plus simplified leucovorin and fluorouracil combination had no negative impact in exploratory HRQoL analyses.",2019,Results of progression-free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group.,"['114 patients were randomized in a 1:2 ratio (39 in the', 'Between 2013 and 2014', 'patients with previously untreated metastatic pancreatic cancer', 'patients with metastatic pancreatic cancer']","['gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group', 'paclitaxel plus simplified leucovorin and fluorouracil combination', 'gemcitabine', 'gemcitabine or simplified leucovorin and fluorouracil', 'sLV5FU2']","['pain', 'QFS', 'progression-free survival', 'EORTC QLQ-C30 questionnaire', 'HRQoL deterioration-free survival (QFS']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",114.0,0.0451296,Results of progression-free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group.,"[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Charton', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepato-Gastroenterology, Groupe hospitalier Pitié Salpêtrière, Sorbonne University, UPMC University, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Department of Digestive Oncology, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Desramé', 'Affiliation': 'Department of Hepato-Gastroenterology, Hôpital Privé Jean Mermoz, Lyon, France.'}, {'ForeName': 'Benoist', 'Initials': 'B', 'LastName': 'Chibaudel', 'Affiliation': 'Department of Oncology, Institut Franco-Britannique, Levallois-Perret, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Department of Oncology, AP-HP, Hôpital Saint-Antoine, Sorbonne University, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Debourdeau', 'Affiliation': 'Department of Oncology, Institut Saint Catherine, Avignon, France.'}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Oncology, Hôpital Layne Mont de Marsan, Mont de Marsan, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepato-Gastroenterology, Hôpital Trousseau, Tours, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': 'CHU La Timone, Marseille, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': 'Department of Oncology, CHU Henri Mondor, Créteil, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': 'Department of Hepato-Gastroenterology, CHU Saint Louis, Paris, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Guerin-Meyer', 'Affiliation': ""Department of Oncology, Institut de cancérologie de L'Ouest Paul Papin, Angers, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Volet', 'Affiliation': 'Department of Hepato-Gastroenterology, CHU Robert Debré, Reims, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Oncology, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.'}]",Cancer medicine,['10.1002/cam4.2311']
727,30828771,Microdosed Cocktail of Three Oral Factor Xa Inhibitors to Evaluate Drug-Drug Interactions with Potential Perpetrator Drugs.,"OBJECTIVES


The aim of this study was to prove the suitability of simultaneously administered microdoses of the factor Xa inhibitors (FXaIs) rivaroxaban, apixaban and edoxaban (100 µg in total). To evaluate drug-drug interactions, the impact of ketoconazole, a known strong inhibitor of cytochrome P450 3A4 and P-glycoprotein, was studied.
METHODS


In a crossover clinical trial, 18 healthy volunteers were randomized to the two treatments using microdoses of rivaroxaban, apixaban and edoxaban alone and when coadministered with ketoconazole. Plasma and urine concentrations of microdosed apixaban, edoxaban and rivaroxaban were quantified using a validated ultra-performance liquid chromatography-tandem mass spectrometry assay with a lower limit of quantification of 2.5 pg/ml.
RESULTS


The microdosed FXaI cocktail showed similar pharmacokinetic parameters compared with published data, using normal therapeutic doses of each FXaI. Ketoconazole significantly increased exposure, with geometric mean AUC ratios of 1.90 (apixaban), 2.35 (edoxaban) and 2.27 (rivaroxaban).
CONCLUSION


The microdosed FXaI cocktail approach was able to precisely predict the drug interaction with ketoconazole. This is the first study that has been conducted to evaluate drug-drug interactions with a drug class, and the low administered doses also allow evaluation in vulnerable target populations.
STUDY PROTOCOL


EudraCT 2016-003024-23.",2019,"Ketoconazole significantly increased exposure, with geometric mean AUC ratios of 1.90 (apixaban), 2.35 (edoxaban) and 2.27 (rivaroxaban).
","['EudraCT 2016-003024-23', '18 healthy volunteers']","['factor Xa inhibitors (FXaIs) rivaroxaban, apixaban and edoxaban', 'Ketoconazole', 'ketoconazole', 'rivaroxaban, apixaban and edoxaban alone and when coadministered with ketoconazole', 'edoxaban and rivaroxaban', 'FXaI']","['Plasma and urine concentrations', 'geometric mean AUC ratios']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4553708', 'cui_str': 'Factor Xa inhibitor'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",18.0,0.084234,"Ketoconazole significantly increased exposure, with geometric mean AUC ratios of 1.90 (apixaban), 2.35 (edoxaban) and 2.27 (rivaroxaban).
","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany. gerd.mikus@med.uni-heidelberg.de.'}, {'ForeName': 'Kathrin I', 'Initials': 'KI', 'LastName': 'Foerster', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Schaumaeker', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Lehmann', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Burhenne', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00749-1']
728,32307124,"Changes in Firearm and Medication Storage Practices in Homes of Youths at Risk for Suicide: Results of the SAFETY Study, a Clustered, Emergency Department-Based, Multisite, Stepped-Wedge Trial.","STUDY OBJECTIVE


We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
METHODS


We used a stepped-wedge clustered design rolled out at 4 hospital sites to assess primary preregistered outcomes (self-reported storage changes caregivers made to household firearms and medications), assessed by survey 2 weeks after the ED visit. Three logistic models provided estimates of the intervention effect: an unadjusted model, a model with hospital-level fixed effects, and a model that further adjusts for time.
RESULTS


Of the 575 caregiver participants, 208 were firearm owners (123 in usual care, 85 in the intervention). Baseline (pre-ED visit) characteristics did not differ between usual care and intervention phases. During the 2-year study period, twice as many caregivers whose child visited the ED after (compared with before) a hospital adopted the intervention improved firearm storage and 3 times as many improved medication storage (odds ratio [OR]=2.1 [95% confidence interval {CI} 1.0 to ∞] and OR=3.0 [95% CI 2.2 to ∞], respectively). After adjusting for time, the intervention effect for medications persisted (OR=2.0 [95% CI 1.0 to ∞]); the effect on firearms did not (OR=0.7 [95% CI 0.1 to ∞]).
CONCLUSION


To our knowledge, this study is the first controlled trial to estimate the effectiveness of an intervention on firearm and medication storage in homes of youths at elevated risk of suicide. We found evidence that caregivers' medication storage improved after their child's ED visit, with evidence suggestive of improvement for firearm storage.",2020,"We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
","[""caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern"", 'Homes of Youths at Risk for Suicide', 'homes of youths at elevated risk of suicide', 'Of the 575 caregiver participants, 208 were firearm owners (123 in usual care, 85 in the intervention']",['counseling intervention'],['firearm storage and 3 times as many improved medication storage'],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",575.0,0.122917,"We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Northeastern University, Boston, MA; Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA. Electronic address: ma.miller@northeastern.edu.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Salhi', 'Affiliation': 'Northeastern University, Boston, MA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barber', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Azrael', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beatriz', 'Affiliation': 'Northeastern University, Boston, MA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Berrigan', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Brandspigel', 'Affiliation': 'Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Betz', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Runyan', 'Affiliation': 'Colorado School of Public Health, Aurora, CO.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.02.007']
729,31165663,Effect of Ticagrelor Versus Clopidogrel on Aortic Stiffness in Patients With Coronary Artery Disease.,"Background We compared the acute and midterm effect of ticagrelor versus clopidogrel on aortic stiffness. Methods and Results We studied 117 patients in a randomized, assessor-blinded, parallel-group trial. The acute effect of ticagrelor was studied in 58 patients randomized (1:1) to receive a loading dose of clopidogrel (600 mg) or ticagrelor (180 mg). Carotid-femoral pulse wave velocity (cf PWV ) was measured before, 3, and 24 hours after the loading dose. The midterm effect (30-day treatment period) was studied in 59 subjects who underwent percutaneous coronary intervention and were randomized to either clopidogrel (75 mg, OD) or ticagrelor (90 mg BID). cf PWV was measured before and at 30 days of treatment. Circulating markers of inflammation and endothelial function were measured at all study points. Repeated-measures analysis showed a significant main effect for treatment ( P=0.03), with the ticagrelor showing a reduction in cf PWV after treatment. cf PWV at 24 hours was significantly lower in the ticagrelor group compared with the clopidogrel group ( P=0.017) (maximal response reduction by 0.42±0.26 m/s). At 30 days, cf PWV decreased in the ticagrelor group, whereas there was no change with clopidogrel (-0.43±0.57 versus 0.12±0.14 m/s, P=0.004). There were no significant changes in both the acute and midterm study period in the pro-inflammatory and endothelial function parameters. Conclusions URL : https://www.clinicaltrials.gov . Unique identifier: NCT02071212. Ticagrelor decreases cf PWV for 24 hours after the loading dose and at 1 month post-percutaneous coronary intervention compared with clopidogrel. Considering that aortic stiffness is an independent predictor of cardiovascular events, this finding may have clinical implications regarding the beneficial effect of ticagrelor. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT02071212.",2019,There were no significant changes in both the acute and midterm study period in the pro-inflammatory and endothelial function parameters.,"['58 patients randomized (1:1', 'Patients With Coronary Artery Disease', '117 patients', '59 subjects who underwent percutaneous coronary intervention']","['Ticagrelor Versus Clopidogrel', 'ticagrelor', 'clopidogrel', 'Ticagrelor']","['Circulating markers of inflammation and endothelial function', 'Carotid-femoral pulse wave velocity (cf PWV ', 'cf PWV', 'pro-inflammatory and endothelial function parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",58.0,0.157143,There were no significant changes in both the acute and midterm study period in the pro-inflammatory and endothelial function parameters.,"[{'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Vlachopoulos', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Georgakopoulos', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Pietri', 'Affiliation': '2 Hypertension Unit Athens Heart Center Athens Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Ioakeimidis', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koutouzis', 'Affiliation': '3 Second Department of Cardiology Red Cross General Hospital Athens Greece.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vaina', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Aznaouridis', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Toutouzas', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Latsios', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Terentes-Printzios', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}, {'ForeName': 'Aggeliki', 'Initials': 'A', 'LastName': 'Rigatou', 'Affiliation': '3 Second Department of Cardiology Red Cross General Hospital Athens Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': '1 First Department of Cardiology Hippokration Hospital Athens Medical School Athens Greece.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012521']
730,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND


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


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


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


Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5']
731,32304590,Response to letter to the editor regarding article 'Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation'.,,2020,Thank you for giving us the opportunity to reply to Dr. Oh's letter about our recently published manuscript 'Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation'.,[],[],[],[],[],[],,0.0149721,Thank you for giving us the opportunity to reply to Dr. Oh's letter about our recently published manuscript 'Randomised simulation trial found an association between rescuers' height and weight and chest compression quality during paediatric resuscitation'.,"[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bibl', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gröpel', 'Affiliation': 'Department of Applied Psychology: Work, Education and Economy, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Centre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Olischar', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15313']
732,32304676,"Impact of sugar taxes and front-of-package nutrition labels on purchases of protein, calcium and fibre.","Taxes and front-of-package (FOP) labels can be effective interventions for reducing consumption of sugar, saturated fat, and sodium; however, few studies have examined their impact on intake of 'positive' nutrients. The current study explored the impact of sugar taxes and FOP labels on the protein, calcium and fibre density of snack food purchases. A total of 3584 Canadians aged 13 years and older participated in an experimental marketplace using a 3 × 8 between-within group experiment. Participants received $5 and viewed images of 20 snack food products available for purchase. Participants were randomized to one of five FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered). Upon conclusion, participants received the product and any change from one of the purchasing tasks. The results indicate that participants purchased snack foods with higher fibre density when either sugar tax was applied (+0.1 g/100 kcal) compared to no tax, and when they were assigned to see the multiple traffic light (+0.4 g/100 kcal) or health star rating (+0.3 g/100 kcal) FOP labels, compared to no FOP label. There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions. Overall, the findings suggest that as consumers respond to tax or labelling policies by moving away from sugars, sodium, and saturated fat, there may be no downside-or even an increase-in 'positive' nutrient density.",2020,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,['3584 Canadians aged 13\u202fyears and older participated in an experimental marketplace using a 3\u202f×\u202f8 between-within group experiment'],"['sugar taxes and front-of-package nutrition labels', 'multiple traffic light (+0.4\u202fg/100\u202fkcal) or health star rating (+0.3\u202fg/100\u202fkcal) FOP labels', 'sugar taxes and FOP labels', 'Taxes and front-of-package (FOP) labels', 'FOP label conditions (no label, high in, multiple traffic light, health star rating, or nutrition grade) and completed three within-subject purchasing tasks with different sugar tax conditions (no tax, 20%, tiered']","['purchases of protein, calcium and fibre']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0039371', 'cui_str': 'Tax'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",3584.0,0.0287178,There were no significant differences in the protein or calcium density of snack foods purchased across the tax or FOP labelling conditions.,"[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Acton', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: rbacton@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada. Electronic address: david.hammond@uwaterloo.ca.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106091']
733,24214176,Combined corticosteroid and long-acting beta₂-agonist in one inhaler versus placebo for chronic obstructive pulmonary disease.,"BACKGROUND


Both long-acting beta2-agonists (LABA) and inhaled corticosteroids (ICS) have been recommended in guidelines for the treatment of chronic obstructive pulmonary disease (COPD). Their coadministration in a combination inhaler may facilitate adherence to medication regimens and improve efficacy.
OBJECTIVES


To determine the efficacy and safety of combined ICS and LABA for stable COPD in comparison with placebo.
SEARCH METHODS


We searched the Cochrane Airways Group Specialised Register of trials, reference lists of included studies and manufacturers' trial registries. The date of the most recent search was June 2013.
SELECTION CRITERIA


We included randomised and double-blind studies of at least four weeks' duration. Eligible studies compared combined ICS and LABA preparations with placebo.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed study risk of bias and extracted data. Dichotomous data were analysed as fixed-effect odds ratios (OR) or rate ratios (RR) with 95% confidence intervals (95% CI), and continuous data as mean differences with 95% confidence intervals.
MAIN RESULTS


Nineteen studies met the inclusion criteria (with 10,400 participants randomly assigned, lasting between 4 and 156 weeks, mean 42 weeks). Studies used three different combined preparations (fluticasone/salmeterol, budesonide/formoterol or mometasone/formoterol). The studies were generally at low risk of bias for blinding but at unclear or high risk for attrition bias because of participant dropouts. Compared with placebo, both fluticasone/salmeterol and budesonide/formoterol reduced the rate of exacerbations. Mometasone/formoterol reduced the number of participants experiencing one or more exacerbation. Pooled analysis of the combined therapies indicated that exacerbations were less frequent when compared with placebo (Rate Ratio 0.73; 95% CI 0.69 to 0.78, 7 studies, 7495 participants); the quality of this evidence when GRADE criteria were applied was rated as moderate. Participants included in these trials had on average one or two exacerbations per year, which means that treatment with combined therapy would lead to a reduction of one exacerbation every two to four years in these individuals. An overall reduction in mortality was seen, but this outcome was dominated by the results of one study (TORCH) of fluticasone/salmeterol. Generally, deaths in the smaller, shorter studies were too few to contribute to the overall estimate. Further longer studies on budesonide/formoterol and mometasone/formoterol are required to clarify whether this is seen more widely. When a baseline risk of death of 15.2% from the placebo arm of TORCH was used, the three-year number needed to treat for an additional beneficial outcome (NNTB) with fluticasone/salmeterol to prevent one extra death was 42 (95% CI 24 to 775). All three combined treatments led to statistically significant improvement in health status measurements, although the mean differences observed are relatively small in relation to the minimum clinically important difference. Furthermore, symptoms and lung function assessments favoured combined treatments. An increase in the risk of pneumonia was noted with combined inhalers compared with placebo treatment (OR 1.62, 95% CI 1.36 to 1.94), and the quality of this evidence was rated as moderate, but no dose effect was seen. The three-year NNTH for one extra case of pneumonia was 17, based on a 12.3% risk of pneumonia in the placebo arm of TORCH. Fewer participants withdrew from the combined treatment arms for adverse events or lack of efficacy.
AUTHORS' CONCLUSIONS


Combined inhaler therapy led to around a quarter fewer COPD exacerbations than were seen with placebo. A significant reduction in all-cause mortality was noted, but this outcome was dominated by one trial (TORCH), emphasising the need for further trials of longer duration. Increased risk of pneumonia is a concern; however, this did not translate into increased exacerbations, hospitalisations or deaths. Current evidence does not suggest any major differences between inhalers in terms of effects, but nor is the evidence strong enough to demonstrate that all are equivalent. To permit firmer conclusions about the effects of combined therapy, more data are needed, particularly in relation to the profile of adverse events and benefits in relation to different formulations and doses of inhaled ICS. Head-to-head comparisons are necessary to determine whether one combined inhaler is better than the others.",2013,"An increase in the risk of pneumonia was noted with combined inhalers compared with placebo treatment (OR 1.62, 95% CI 1.36 to 1.94), and the quality of this evidence was rated as moderate, but no dose effect was seen.","['chronic obstructive pulmonary disease', 'Participants included in these trials had on average one or two exacerbations per year, which means that treatment with combined therapy would lead to a reduction of one exacerbation every two to four years in these individuals', 'Nineteen studies met the inclusion criteria (with 10,400 participants randomly assigned, lasting between 4 and 156 weeks, mean 42 weeks', 'chronic obstructive pulmonary disease (COPD']","['budesonide/formoterol and mometasone/formoterol', 'TORCH', 'fluticasone/salmeterol and budesonide/formoterol', 'placebo', 'acting beta2-agonists (LABA) and inhaled corticosteroids (ICS', 'Combined corticosteroid and long-acting beta₂-agonist', 'combined ICS and LABA', 'fluticasone/salmeterol', 'combined preparations (fluticasone/salmeterol, budesonide/formoterol or mometasone/formoterol', 'Mometasone/formoterol']","['Furthermore, symptoms and lung function assessments', 'extra death', 'health status measurements', 'efficacy and safety', 'rate of exacerbations', 'mortality', 'exacerbations, hospitalisations or deaths', 'COPD exacerbations', 'number of participants experiencing one or more exacerbation', 'risk of pneumonia', 'fixed-effect odds ratios (OR) or rate ratios (RR', 'adverse events or lack of efficacy']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1276807', 'cui_str': 'Budesonide / formoterol'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0939232', 'cui_str': 'fluticasone / salmeterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]",10400.0,0.740361,"An increase in the risk of pneumonia was noted with combined inhalers compared with placebo treatment (OR 1.62, 95% CI 1.36 to 1.94), and the quality of this evidence was rated as moderate, but no dose effect was seen.","[{'ForeName': 'Luis Javier', 'Initials': 'LJ', 'LastName': 'Nannini', 'Affiliation': 'Pulmonary Section, Hospital E Peron, Ruta 11 Y Jm Estrada, G. Baigorria, Santa Fe - Rosario, Argentina, 2152.'}, {'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Poole', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Milan', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Holmes', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Normansell', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003794.pub4']
734,32302791,"A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.","This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.",2020,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","['chronic pain', '300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study']","['Structural equation modeling (SEM', 'telehealth group sessions of CT, MM, or AS', 'chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS', 'cognitive, behavioral and mindfulness-based psychosocial treatments']","['Pain Interference scale', 'cognitive content, cognitive process, and/or activity level', 'PROMIS 5-item']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",300.0,0.103487,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Battalio', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borckardt', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106000']
735,32301258,Intravenous immunoglobulin significantly reduces exposure of concomitantly administered anti-C5 monoclonal antibody tesidolumab.,"Awareness of drug-drug interactions is critical in organ transplant recipient management. However, biologic agents interfering with monoclonal antibodies is not widely considered. We report the effect of high-dose intravenous immunoglobulin (IVIg) on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the human anti-C5 monoclonal antibody tesidolumab (LFG316) in end-stage renal disease patients awaiting kidney transplant. In this single-center, phase 1, open-label, parallel-group study, 8 patients were assigned to receive either single-dose tesidolumab + IVIg or tesidolumab alone, with 56-day follow-up. Within-group PK parameters were consistent. Mean tesidolumab exposure decreased 34%, clearance increased 63%, and half-life decreased 41% comparing tesidolumab + IVIg to tesidolumab alone. IVIg influence on tesidolumab elimination was most evident in the first 3 weeks. Complete suppression of both total and alternative complement activities was maintained for 4 weeks in the tesidolumab alone group and for 2 weeks in the tesidolumab + IVIg group. Tesidolumab was well tolerated. IVIg infused before tesidolumab affected tesidolumab PK and PD, resulting in a shortened period of full complement activity inhibition. These findings suggest a clinically relevant impact of IVIg on monoclonal antibody clearance and indirectly hint at an IVIg mechanism of action in treating autoimmune diseases and allosensitization by accelerating pathogenic IgG antibody degradation. Trial registration number: NCT02878616.",2020,Complete suppression of both total and alternative complement activities was maintained for 4 weeks in the tesidolumab alone group and for 2 weeks in the tesidolumab+IVIg group.,['end-stage renal disease patients awaiting kidney transplant'],"['Intravenous Immunoglobulin', 'tesidolumab+IVIg', 'high-dose intravenous immunoglobulin (IVIg', 'tesidolumab+IVIg or tesidolumab alone, with 56-day follow-up', 'Tesidolumab', 'human anti-C5 monoclonal antibody tesidolumab (LFG316']","['Complete suppression of both total and alternative complement activities', 'tolerated', 'safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD', 'Mean tesidolumab exposure', 'tesidolumab elimination']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",8.0,0.0177664,Complete suppression of both total and alternative complement activities was maintained for 4 weeks in the tesidolumab alone group and for 2 weeks in the tesidolumab+IVIg group.,"[{'ForeName': 'Stanley C', 'Initials': 'SC', 'LastName': 'Jordan', 'Affiliation': 'Comprehensive Transplant Center, Transplant Immunotherapy Program Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kucher', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bagger', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Hockey', 'Affiliation': 'Biometrics Matters Ltd., Hamilton, New Zealand.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Ammerman', 'Affiliation': 'Comprehensive Transplant Center, Transplant Immunotherapy Program Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vo', 'Affiliation': 'Comprehensive Transplant Center, Transplant Immunotherapy Program Cedars-Sinai Medical Center, Los Angeles, California, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15922']
736,31190609,Statins Reduce Epicardial Adipose Tissue Attenuation Independent of Lipid Lowering: A Potential Pleiotropic Effect.,"Background High epicardial adipose tissue (EAT) attenuation (Hounsfield units [ HUs] ) on computed tomography is considered a marker of inflammation and is associated with an increased risk of cardiovascular events. Statins reduce the volume of EAT , but it is unknown whether they affect EAT HUs . Methods and Results We reviewed the chest computed tomographic scans of 420 postmenopausal women randomized to either 80 mg of atorvastatin or 40 mg of pravastatin daily and rescanned after 1 year to measure change in coronary artery calcium score. EAT HUs were measured near the proximal right coronary artery and remote from any area of coronary artery calcium. Computed tomographic images were also queried for subcutaneous adipose tissue (SubQ) attenuation ( HUs ) change over time. The mean patients' age was 65±6 years. The baseline EAT HU value was higher than the SubQ HU value (-89.4±24.0 HU versus -123.3±30.4 HU ; P<0.001). The EAT HU value decreased significantly in the entire cohort (-5.4±29.7 HU [-6% change]; P<0.001), but equally in the patients given atorvastatin and pravastatin (-6.35+31 HU and -4.55+28 HU ; P=0.55). EAT HU change was not associated with change in total cholesterol, low-density lipoprotein cholesterol, coronary artery calcium, and EAT volume (all P=not significant). Change in high-density lipoprotein cholesterol was marginally associated with EAT HU change ( P=0.07). Statin treatment did not induce a change in SubQ HUs . Conclusions Statins induced a decrease in EAT HUs over time, independent of intensity of low-density lipoprotein cholesterol lowering. The positive effect on EAT and the neutral effect on SubQ suggest that statins induced a decrease in metabolic activity in EAT by reduction in cellularity, vascularity, or inflammation. The clinical significance of the observed change in EAT HUs remains to be demonstrated.",2019,"The EAT HU value decreased significantly in the entire cohort (-5.4±29.7 HU [-6% change]; P<0.001), but equally in the patients given atorvastatin and pravastatin (-6.35+31 HU and -4.55+28 HU ; P=0.55).","[""mean patients' age was 65±6\xa0years"", '420 postmenopausal women']","['atorvastatin and pravastatin', 'EAT', ' High epicardial adipose tissue (EAT) attenuation (Hounsfield units [ HUs] ', '80\xa0mg of atorvastatin or 40\xa0mg of pravastatin']","['cellularity, vascularity, or inflammation', 'EAT HUs over time, independent of intensity of low-density lipoprotein cholesterol lowering', 'total cholesterol, low-density lipoprotein cholesterol, coronary artery calcium, and EAT volume', 'high-density lipoprotein cholesterol', 'SubQ HUs ', 'volume of EAT', 'subcutaneous adipose tissue (SubQ) attenuation ( HUs ) change over time', 'baseline EAT HU value', 'metabolic activity in EAT', 'coronary artery calcium score', 'EAT HU value']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}]",420.0,0.0884402,"The EAT HU value decreased significantly in the entire cohort (-5.4±29.7 HU [-6% change]; P<0.001), but equally in the patients given atorvastatin and pravastatin (-6.35+31 HU and -4.55+28 HU ; P=0.55).","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Raggi', 'Affiliation': '1 Mazankowski Alberta Heart Institute and Department of Medicine University of Alberta Edmonton Alberta Canada.'}, {'ForeName': 'Varuna', 'Initials': 'V', 'LastName': 'Gadiyaram', 'Affiliation': '2 Division of Cardiology Emory University Atlanta GA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': '3 Department of Biostatistics and Bioinformatics Emory University Atlanta GA.'}, {'ForeName': 'Zhengjia', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': '3 Department of Biostatistics and Bioinformatics Emory University Atlanta GA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Lopaschuk', 'Affiliation': '4 Department of Pediatrics University of Alberta Edmonton Alberta Canada.'}, {'ForeName': 'Arthur E', 'Initials': 'AE', 'LastName': 'Stillman', 'Affiliation': '1 Mazankowski Alberta Heart Institute and Department of Medicine University of Alberta Edmonton Alberta Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013104']
737,30945118,"Effect of Oral Semaglutide on the Pharmacokinetics of Lisinopril, Warfarin, Digoxin, and Metformin in Healthy Subjects.","BACKGROUND


Oral semaglutide is a tablet co-formulation of the human glucagon-like peptide-1 (GLP-1) analog semaglutide with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). The absorption of coadministered oral drugs may be altered due to enhancement by SNAC, potential gastric emptying delay by semaglutide, or other mechanisms. Two one-sequence crossover trials investigated the effect of oral semaglutide on the pharmacokinetics of lisinopril, warfarin, digoxin, and metformin.
METHODS


In trial 1, 52 healthy subjects received lisinopril (20 mg single dose) or warfarin (25 mg single dose) with subsequent coadministration with SNAC alone (300 mg single dose), followed by oral semaglutide 20 mg once daily (steady state). In trial 2, 32 healthy subjects received digoxin (500 μg single dose) or metformin (850 mg twice daily for 4 days), with subsequent coadministration with SNAC alone followed by oral semaglutide, as in trial 1.
RESULTS


There were no apparent effects of oral semaglutide on area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C max ) for lisinopril, warfarin, and digoxin. The AUC of metformin was increased by 32% (90% confidence interval 1.23-1.43) by oral semaglutide coadministration versus metformin alone, whereas the C max  was unaffected. SNAC alone did not affect exposure of lisinopril, warfarin, digoxin, or metformin. Adverse events were in line with those previously observed for GLP-1 receptor agonists.
CONCLUSIONS


Oral semaglutide or SNAC alone did not appear to affect the exposure of lisinopril, warfarin, or digoxin, and, based on its wide therapeutic index, the higher metformin exposure with oral semaglutide was not considered clinically relevant.",2019,"The AUC of metformin was increased by 32% (90% confidence interval 1.23-1.43) by oral semaglutide coadministration versus metformin alone, whereas the C max  was unaffected.","['Healthy Subjects', '32 healthy subjects received', '52 healthy subjects received']","['SNAC', 'lisinopril', 'lisinopril, warfarin, digoxin, and metformin', 'metformin', 'GLP-1) analog semaglutide with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl', 'lisinopril, warfarin, digoxin, or metformin', 'SNAC alone', 'SNAC alone followed by oral semaglutide', 'digoxin', 'lisinopril, warfarin, or digoxin', 'warfarin', 'Lisinopril, Warfarin, Digoxin, and Metformin', 'Oral Semaglutide']","['Adverse events', 'AUC of metformin', 'oral semaglutide on area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C max ) for lisinopril, warfarin, and digoxin']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}]",52.0,0.0270316,"The AUC of metformin was increased by 32% (90% confidence interval 1.23-1.43) by oral semaglutide coadministration versus metformin alone, whereas the C max  was unaffected.","[{'ForeName': 'Tine A', 'Initials': 'TA', 'LastName': 'Bækdal', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark. tabq@novonordisk.com.'}, {'ForeName': 'Jeanett', 'Initials': 'J', 'LastName': 'Borregaard', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.'}, {'ForeName': 'Cilie W', 'Initials': 'CW', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Anderson', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 108-110, 2860, Søborg, Denmark.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00756-2']
738,31161947,"Efficacy of Platelet-Rich Plasma for the Treatment of Interstitial Supraspinatus Tears: A Double-Blinded, Randomized Controlled Trial.","BACKGROUND


The benefits of platelet-rich plasma (PRP) for the treatment of rotator cuff tears remain inconclusive, as it is administered either as an adjuvant to surgical repair or as a primary infiltration without targeting the index lesion, which could dilute its effect.
PURPOSE


To determine whether PRP infiltrations are superior to saline solution infiltrations (placebo) at improving healing, pain, and function when injected under ultrasound guidance within isolated interstitial supraspinatus tears.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


In this single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic isolated interstitial tears of the supraspinatus, confirmed by magnetic resonance arthrography, were randomized to PRP or saline injections. Each patient received 2 injections with a 1-month interval. The primary outcome was the change in lesion volume, calculated on magnetic resonance arthrography, at 7 months. The secondary outcomes were improvements in shoulder pain and the Single Assessment Numerical Evaluation (SANE) score at >12 months.
RESULTS


Preoperative patient characteristics did not differ between the 2 groups. At 7 months, there were no significant differences between the PRP and control groups in terms of a decrease in lesion size (-0.3 ± 23.6 mm 3  vs -8.1 ± 84.7 mm 3 , respectively;  P  = .175); reduction of pain on a visual analog scale (VAS) (-2.3 ± 3.0 vs -2.0 ± 3.0, respectively;  P  = .586); and improvement in SANE (16.7 ± 20.0 vs 14.9 ± 29.0, respectively;  P  = .650), Constant (8.6 ± 13.0 vs 10.7 ± 19.0, respectively;  P  = .596), and American Shoulder and Elbow Surgeons (19.5 ± 20.0 vs 21.9 ± 28.0, respectively;  P  = .665) scores. At >12 months, there were no significant differences between the PRP and control groups in terms of a reduction of pain on a VAS (-3.3 ± 2.6 vs -2.3 ± 3.2, respectively;  P  = .087) or improvement in the SANE score (24.4 ± 27.5 vs 23.4 ± 24.9, respectively;  P  = .846). At 19.5 ± 5.3 months, the incidence of adverse effects (pain >48 hours, frozen shoulder, extension of lesion) was significantly higher in the PRP group than the control group (54% vs 26%, respectively;  P  = .020).
CONCLUSION


PRP injections within interstitial supraspinatus tears did not improve tendon healing or clinical scores compared with saline injections and were associated with more adverse events.
REGISTRATION


NCT02672085 (ClinicalTrials.gov identifier).",2019,"At 7 months, there were no significant differences between the PRP and control groups in terms of a decrease in lesion size (-0.3 ± 23.6 mm 3  vs -8.1 ± 84.7 mm 3 , respectively;  P  = .175); reduction of pain on a visual analog scale (VAS) (-2.3 ± 3.0 vs -2.0 ± 3.0, respectively;  P  = .586); and improvement in SANE (16.7 ± 20.0 vs 14.9 ± 29.0, respectively;  P  = .650), Constant (8.6 ± 13.0 vs 10.7 ± 19.0, respectively;  P  = .596), and American Shoulder and Elbow Surgeons (19.5 ± 20.0 vs 21.9 ± 28.0, respectively;  P  = .665) scores.","['Interstitial Supraspinatus Tears', '80 adults with symptomatic isolated interstitial tears of the supraspinatus, confirmed by magnetic resonance arthrography']","['PRP injections', 'saline solution infiltrations (placebo', 'Platelet-Rich Plasma', 'PRP', 'platelet-rich plasma (PRP', 'PRP or saline injections']","['change in lesion volume, calculated on magnetic resonance arthrography', 'SANE score', 'tendon healing or clinical scores', 'lesion size', 'shoulder pain and the Single Assessment Numerical Evaluation (SANE) score', 'reduction of pain on a visual analog scale (VAS', 'reduction of pain on a VAS', 'healing, pain, and function', 'incidence of adverse effects (pain >48 hours, frozen shoulder, extension of lesion']","[{'cui': 'C0439059', 'cui_str': 'Supraspinatus rupture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}]",80.0,0.673041,"At 7 months, there were no significant differences between the PRP and control groups in terms of a decrease in lesion size (-0.3 ± 23.6 mm 3  vs -8.1 ± 84.7 mm 3 , respectively;  P  = .175); reduction of pain on a visual analog scale (VAS) (-2.3 ± 3.0 vs -2.0 ± 3.0, respectively;  P  = .586); and improvement in SANE (16.7 ± 20.0 vs 14.9 ± 29.0, respectively;  P  = .650), Constant (8.6 ± 13.0 vs 10.7 ± 19.0, respectively;  P  = .596), and American Shoulder and Elbow Surgeons (19.5 ± 20.0 vs 21.9 ± 28.0, respectively;  P  = .665) scores.","[{'ForeName': 'Adrien J', 'Initials': 'AJ', 'LastName': 'Schwitzguebel', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Kolo', 'Affiliation': 'Rive Droite, Geneva, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Tirefort', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'Kourhani', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gremeaux', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Saffarini', 'Affiliation': 'Medical Department, ReSurg, Nyon, Switzerland.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lädermann', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland.'}]",The American journal of sports medicine,['10.1177/0363546519851097']
739,31166116,Adaptation of Running Biomechanics to Repeated Barefoot Running: A Randomized Controlled Study.,"BACKGROUND


Previous studies have shown that changing acutely from shod to barefoot running induces several changes to running biomechanics, such as altered ankle kinematics, reduced ground-reaction forces, and reduced loading rates. However, uncertainty exists whether these effects still exist after a short period of barefoot running habituation.
PURPOSE/HYPOTHESIS


The purpose was to investigate the effects of a habituation to barefoot versus shod running on running biomechanics. It was hypothesized that a habituation to barefoot running would induce different adaptations of running kinetics and kinematics as compared with a habituation to cushioned footwear running or no habituation.
STUDY DESIGN


Controlled laboratory study.
METHODS


Young, physically active adults without experience in barefoot running were randomly allocated to a barefoot habituation group, a cushioned footwear group, or a passive control group. The 8-week intervention in the barefoot and footwear groups consisted of 15 minutes of treadmill running at 70% of VO 2  max (maximal oxygen consumption) velocity per weekly session in the allocated footwear. Before and after the intervention period, a 3-dimensional biomechanical analysis for barefoot and shod running was conducted on an instrumented treadmill. The passive control group did not receive any intervention but was also tested prior to and after 8 weeks. Pre- to posttest changes in kinematics, kinetics, and spatiotemporal parameters were then analyzed with a mixed effects model.
RESULTS


Of the 60 included participants (51.7% female; mean ± SD age, 25.4 ± 3.3 years; body mass index, 22.6 ± 2.1 kg·m -2 ), 53 completed the study (19 in the barefoot habituation group, 18 in the shod habituation group, and 16 in the passive control group). Acutely, running barefoot versus shod influenced foot strike index and ankle, foot, and knee angles at ground contact ( P  < .001), as well as vertical average loading rate ( P  = .003), peak force ( P  < .001), contact time ( P  < .001), flight time ( P  < .001), step length ( P  < .001), and cadence ( P  < .001). No differences were found for average force ( P  = .391). After the barefoot habituation period, participants exhibited more anterior foot placement ( P  = .006) when running barefoot, while no changes were observed in the footwear condition. Furthermore, barefoot habituation increased the vertical average loading rates in both conditions (barefoot,  P  = .01; shod,  P  = .003) and average vertical ground-reaction forces for shod running ( P  = .039). All other outcomes (ankle, foot, and knee angles at ground contact and flight time, contact time, cadence, and peak forces) did not change significantly after the 8-week habituation.
CONCLUSION


Changing acutely from shod to barefoot running in a habitually shod population increased the foot strike index and reduced ground-reaction force and loading rates. After the habituation to barefoot running, the foot strike index was further increased, while the force and average loading rates also  increased  as compared with the acute barefoot running situation. The increased average loading rate is contradictory to other studies on acute adaptations of barefoot running.
CLINICAL RELEVANCE


A habituation to barefoot running led to increased vertical average loading rates. This finding was unexpected and questions the generalizability of acute adaptations to long-term barefoot running. Sports medicine professionals should consider these adaptations in their recommendations regarding barefoot running as a possible measure for running injury prevention.
REGISTRATION


DRKS00011073 (German Clinical Trial Register).",2019,"Furthermore, barefoot habituation increased the vertical average loading rates in both conditions (barefoot,  P  = .01; shod,  P  = .003) and average vertical ground-reaction forces for shod running ( P  = .039).","['Young, physically active adults without experience in barefoot running', 'Of the 60 included participants (51.7% female; mean ± SD age, 25.4 ± 3.3 years; body mass index, 22.6 ± 2.1 kg·m -2 ), 53 completed the study (19 in the barefoot habituation group, 18 in the shod habituation group, and 16 in the passive control group']","['Running Biomechanics to Repeated Barefoot Running', 'Pre', '3-dimensional biomechanical analysis for barefoot and shod running was conducted on an instrumented treadmill', 'barefoot and footwear groups consisted of 15 minutes of treadmill running at 70% of VO 2  max (maximal oxygen consumption) velocity per weekly session', 'barefoot habituation group, a cushioned footwear group, or a passive control group', 'habituation to barefoot versus shod running']","['vertical average loading rates', 'average vertical ground-reaction forces', 'outcomes (ankle, foot, and knee angles at ground contact and flight time, contact time, cadence, and peak forces', 'foot strike index and ankle, foot, and knee angles at ground contact', 'contact time', 'step length', 'kinematics, kinetics, and spatiotemporal parameters', 'peak force', 'vertical average loading rate', 'flight time', 'average loading rate', 'foot strike index and reduced ground-reaction force and loading rates', 'anterior foot placement', 'foot strike index']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336894', 'cui_str': 'Footwear (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0038452', 'cui_str': 'Strikes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.0648057,"Furthermore, barefoot habituation increased the vertical average loading rates in both conditions (barefoot,  P  = .01; shod,  P  = .003) and average vertical ground-reaction forces for shod running ( P  = .039).","[{'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Hollander', 'Affiliation': 'Department of Sports and Exercise Medicine, Institute of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Liebl', 'Affiliation': 'Department of Financial Economics and Statistics, Bonn University, Bonn, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Meining', 'Affiliation': 'Department of Human Movement and Exercise Science, Institute of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement and Exercise Science, Institute of Human Movement Science, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Willwacher', 'Affiliation': 'Institute of Biomechanics and Orthopaedics, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Department of Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University Jena, Jena, Germany.'}]",The American journal of sports medicine,['10.1177/0363546519849920']
740,32304731,Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity.,"Food insecurity, the inability to acquire adequate food due to insufficient resources for food, is associated with an increased risk for obesity and associated health problems. This study assessed the feasibility and initial efficacy of a prefilled online grocery shopping cart (i.e., default option) in promoting healthier grocery purchases in individuals with food insecurity. Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits. Compared to nutrition education, the default shopping cart resulted in the purchase of significantly more ounces of whole grains (Mean Difference [M diff ] = -4.05; 95% Confidence Interval [CI] = -6.14, -1.96; p < .001), cups of fruits (M diff  = -1.51; 95% CI = -2.51, -0.59; p = .002) and vegetables (M diff  = -2.21; 95% CI = -4.01, -0.41; p = .02), foods higher in fiber (mg; M diff  = -15.65; 95% CI = -27.43, -3.87; p = .01), and lower in sodium (mg; M diff  = 1642.66; 95% CI = 660.85, 2624.48; p = .002), cholesterol (mg; M diff  = 463.86; 95% CI = 198.76, 728.96; p = .001), and grams of fat (M diff  = 75.42; 95% CI = 42.81, 108.03; p < .001) and saturated fat (M diff  = 26.20; 95% CI = 14.07, 38.34; p < .001). The use of a default online shopping cart appears to improve nutritional quality of food purchases in individuals facing financial constraints.",2020,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","['individuals with food insecurity', 'Fifty participants recruited from food pantries in New York in 2018 were randomized to', 'individuals facing financial constraints']","['review nutrition information before purchasing groceries online (n\u202f=\u202f23) or modify a prefilled, nutritionally balanced online shopping cart (n\u202f=\u202f27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits', 'prefilled online grocery shopping cart (i.e., default option']","['grams of fat (M diff', 'nutritional quality of food purchases', 'saturated fat', 'feasibility and initial efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441061', 'cui_str': 'Shopping cart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.161297,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","[{'ForeName': 'Jaime A', 'Initials': 'JA', 'LastName': 'Coffino', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA. Electronic address: jcoffino@albany.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Udo', 'Affiliation': 'Department of Health Policy, Management, and Behavior, University at Albany, State University of New York, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA.'}]",Appetite,['10.1016/j.appet.2020.104714']
741,32302665,Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial.,"AIMS


Hypoglycemia is one of the most important complications associated with Ramadan fasting in people with type 2 diabetes. LixiRam (NCT02941367) was the first randomized trial comparing safety and efficacy of lixisenatide + basal insulin (BI) vs. sulphonylurea + BI in people with type 2 diabetes who fast during Ramadan. This post hoc analysis focuses on the LixiRam study population from India.
METHODS


Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug were randomized 1:1 to receive lixisenatide + BI or to continue sulphonylurea + BI treatment.
RESULTS


In total, 150 participants were randomized in India. One participant (1.3%) with lixisenatide + BI vs. 5 participants (6.8%) with sulphonylurea + BI experienced ≥1 documented symptomatic hypoglycemic event during the Ramadan fast (odds ratio [OR]: 0.22; 95% confidence interval [CI]: 0.02-1.93). Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75] vs. 14.7% [11/75], respectively; OR: 0.09; 95% CI: 0.01-0.69). No new safety signals were identified.
CONCLUSIONS


A combination of lixisenatide prandial GLP1-RA + BI may be a suitable treatment option for people with type 2 diabetes who elect to fast during Ramadan. Clinical Trial Registry: clinicaltrials.gov (NCT02941367).",2020,Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75],"['people with type 2 diabetes who fast during Ramadan', 'Indian people with type 2 diabetes mellitus during Ramadan fast', 'Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug', 'people with type 2 diabetes', '150 participants were randomized in India', 'people with type 2 diabetes who elect to fast during Ramadan']","['lixisenatide + basal insulin (BI) vs. sulphonylurea + BI', 'lixisenatide prandial GLP1-RA + BI', 'lixisenatide + BI vs. sulphonylurea + BI', 'lixisenatide plus basal insulin treatment regimen', 'lixisenatide + BI or to continue sulphonylurea + BI treatment']","['symptomatic hypoglycemic event', 'Incidence of any hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C2350813', 'cui_str': 'EHMT1 protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",150.0,0.0907296,Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75],"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Sahay', 'Affiliation': 'Department of Endocrinology, Osmania Medical College, Hyderabad, India. Electronic address: sahayrk@gmail.com.'}, {'ForeName': 'Khadijah', 'Initials': 'K', 'LastName': 'Hafidh', 'Affiliation': 'Rashid Hospital, Dubai, United Arab Emirates.'}, {'ForeName': 'Khier', 'Initials': 'K', 'LastName': 'Djaballah', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Coudert', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Azar', 'Affiliation': 'American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Shehadeh', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Hanif', 'Affiliation': 'University Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hassanein', 'Affiliation': 'Dubai Hospital, Dubai, United Arab Emirates.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108148']
742,32302702,Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial.,"INTRODUCTION


Cytotoxic agents have immunomodulatory effects, providing a rationale for combining atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1]) with chemotherapy. The randomized phase III IMpower131 study (NCT02367794) evaluated atezolizumab with platinum-based chemotherapy in stage IV squamous NSCLC.
METHODS


A total of 1021 patients were randomized 1:1:1 to receive atezolizumab+carboplatin+paclitaxel (A+CP) (n = 338), atezolizumab+carboplatin+nab-paclitaxel (A+CnP) (n = 343), or carboplatin+nab-paclitaxel (CnP) (n = 340) for four or six 21-day cycles; patients randomized to the A+CP or A+CnP arms received atezolizumab maintenance therapy until progressive disease or loss of clinical benefit. The coprimary end points were investigator-assessed progression-free survival (PFS) and overall survival (OS) in the intention-to-treat (ITT) population. The secondary end points included PFS and OS in PD-L1 subgroups and safety. The primary PFS (January 22, 2018) and final OS (October 3, 2018) for A+CnP versus CnP are reported.
RESULTS


PFS improvement with A+CnP versus CnP was seen in the ITT population (median, 6.3 versus 5.6 mo; hazard ratio [HR] = 0.71, 95% confidence interval [CI]: 0.60-0.85; p = 0.0001). Median OS in the ITT population was 14.2 and 13.5 months in the A+CnP and CnP arms (HR = 0.88, 95% CI: 0.73-1.05; p = 0.16), not reaching statistical significance. OS improvement with A+CnP versus CnP was observed in the PD-L1-high subgroup (HR = 0.48, 95% CI: 0.29-0.81), despite not being formally tested. Treatment-related grade 3 and 4 adverse events and serious adverse events occurred in 68.0% and 47.9% (A+CnP) and 57.5% and 28.7% (CnP) of patients, respectively.
CONCLUSIONS


Adding atezolizumab to platinum-based chemotherapy significantly improved PFS in patients with first-line squamous NSCLC; OS was similar between the arms.",2020,"Treatment-related grade 3-4 adverse events (AEs) and serious AEs occurred in 68.0% and 47.9% (A+CnP) and 57.5% and 28.7% (CnP) of patients.
","['patients with first-line squamous NSCLC', 'Advanced Squamous Non-Small-Cell Lung Cancer (IMpower131', 'stage IV squamous non-small cell lung cancer (NSCLC', '1021 patients']","['atezolizumab with platinum-based chemotherapy', 'atezolizumab+carboplatin+paclitaxel (A+CP', 'A+CP or A+CnP', 'atezolizumab+carboplatin+nab-paclitaxel (A+CnP) (n=343), or carboplatin+nab-paclitaxel (CnP', 'Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel', 'atezolizumab to platinum-based chemotherapy', 'atezolizumab maintenance therapy']","['PFS and OS in PD-L1 subgroups and safety', 'Treatment-related grade 3-4 adverse events (AEs) and serious AEs', 'investigator-assessed progression-free survival (PFS) and overall survival (OS) in the intention-to-treat (ITT) population', 'OS improvement with A+CnP vs CnP', 'Median OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1021.0,0.214137,"Treatment-related grade 3-4 adverse events (AEs) and serious AEs occurred in 68.0% and 47.9% (A+CnP) and 57.5% and 28.7% (CnP) of patients.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jotte', 'Affiliation': 'Department of Medical Oncology, Rocky Mountain Cancer Centers, Denver, Colorado; US Oncology, Houston, Texas. Electronic address: robert.jotte@usoncology.com.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Cappuzzo', 'Affiliation': 'Department of Oncology and Hematology, Azienda Unità Sanitaria Locale della Romagna, Ravenna, Italy.'}, {'ForeName': 'Ihor', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Department of Oncology and Radiology, Sumy State University, Sumy, Ukraine.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Chemotherapeutic Department, Moscow City Oncology Hospital, Moscow Healthcare Department, Moscow, Russia.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Department of Medical Oncology, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Department of Cancer Research, Florida Cancer Specialists, Lady Lake, Florida; Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Soo', 'Affiliation': 'Department of Hematology-Oncology, National University Hospital, Singapore.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Conter', 'Affiliation': 'Department of Medicine, William Osler Health System, Brampton, Ontario, Canada.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kozuki', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Kuan-Chieh', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Product Development, Oncology Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Graupner', 'Affiliation': 'Product Development, Oncology F. Hoffmann-La Roche, Ltd., Basel, Switzerland.'}, {'ForeName': 'Shawn W', 'Initials': 'SW', 'LastName': 'Sun', 'Affiliation': 'Product Development, Oncology Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Hoang', 'Affiliation': 'Product Development, Oncology Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jessop', 'Affiliation': 'Department of Clinical Safety, Roche Products Ltd., Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McCleland', 'Affiliation': 'Product Development, Oncology Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ballinger', 'Affiliation': 'Product Development, Oncology Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': 'Product Development, Oncology Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'Department of Thoracic Oncology, AdventHealth Cancer Institute, Orlando, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.03.028']
743,30793411,Reproducibility of a battery of human evoked pain models to detect pharmacological effects of analgesic drugs.,"BACKGROUND


Although reproducibility is considered essential for any method used in scientific research, it is investigated only rarely; thus, strikingly little has been published regarding the reproducibility of evoked pain models involving human subjects. Here, we studied the reproducibility of a battery of evoked pain models for demonstrating the analgesic effects of two analgesic compounds.
METHODS


A total of 81 healthy subjects participated in four studies involving a battery of evoked pain tests in which mechanical, thermal and electrical stimuli were used to measure pain detection and tolerance thresholds. Pharmacodynamic outcome variables were analysed using a mixed model analysis of variance, and a coefficient of variation was calculated by dividing the standard deviation by the least squares means.
RESULTS


A total of 76 subjects completed the studies. After being administered pregabalin, the subjects' pain tolerance thresholds in the cold pressor and pressure stimulation tests were significantly increased compared to the placebo group. Moreover, the heat pain detection threshold in UVB-irradiated skin was significantly increased in subjects who were administered ibuprofen compared to the placebo group. Variation among all evoked pain tests ranged from 2.2% to 30.6%.
CONCLUSIONS


Four studies using a similar design showed reproducibility with respect to the included evoked pain models. The relatively high consistency and reproducibility of two analgesics at doses known to be effective in treating clinically relevant pain supports the validity of using this pain test battery to investigate the analgesic activity and determine the active dosage of putative analgesic compounds in early clinical development.
SIGNIFICANCE


The consistency and reproducibility of measuring the profile of an analgesic at clinically relevant doses illustrates that this pain test battery is a valid tool for demonstrating the analgesic activity of a test compound and for determining the optimal active dose in early clinical drug development.",2019,"After being administered pregabalin, the subjects' pain tolerance thresholds in the cold pressor and pressure stimulation tests were significantly increased compared to the placebo group.","['81 healthy subjects', 'human subjects', '76 subjects completed the studies']","['ibuprofen', 'pregabalin', 'placebo']","['pressure stimulation tests', 'heat pain detection threshold in UVB-irradiated skin', 'pain detection and tolerance thresholds', 'evoked pain tests']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0201780', 'cui_str': 'Stimulation test (procedure)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",81.0,0.0812758,"After being administered pregabalin, the subjects' pain tolerance thresholds in the cold pressor and pressure stimulation tests were significantly increased compared to the placebo group.","[{'ForeName': 'Pieter S', 'Initials': 'PS', 'LastName': 'Siebenga', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'van Amerongen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Okkerse', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Denney', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Pinky', 'Initials': 'P', 'LastName': 'Dua', 'Affiliation': 'Pfizer Ltd., Cambridge, UK.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Butt', 'Affiliation': 'Pfizer Ltd., Cambridge, UK.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Hay', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Geert J', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]","European journal of pain (London, England)",['10.1002/ejp.1379']
744,31087060,Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model.,"CONTEXT


We previously developed and validated an inexpensive and parsimonious prediction model of 2-year all-cause mortality in real-life patients with type 2 diabetes.
OBJECTIVE


This model, now named ENFORCE (EstimatioN oF mORtality risk in type 2 diabetiC patiEnts), was investigated in terms of (i) prediction performance at 6 years, a more clinically useful time-horizon; (ii) further validation in an independent sample; and (iii) performance comparison in a real-life vs a clinical trial setting.
DESIGN


Observational prospective randomized clinical trial.
SETTING


White patients with type 2 diabetes.
PATIENTS


Gargano Mortality Study (GMS; n = 1019), Foggia Mortality Study (FMS; n = 1045), and Pisa Mortality Study (PMS; n = 972) as real-life samples and the standard glycemic arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) clinical trial (n = 3150).
MAIN OUTCOME MEASURE


The endpoint was all-cause mortality. Prediction accuracy and calibration were estimated to assess the model's performances.
RESULTS


ENFORCE yielded 6-year mortality C-statistics of 0.79, 0.78, and 0.75 in GMS, FMS, and PMS, respectively (P heterogeneity = 0.71). Pooling the three cohorts showed a 6-year mortality C-statistic of 0.80. In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value significantly lower than that obtained in the pooled real-life samples (P < 0.0001). This difference resembles that observed with other models comparing real-life vs clinical trial settings, thus suggesting it is a true, replicable phenomenon.
CONCLUSIONS


The time horizon of ENFORCE has been extended to 6 years and validated in three independent samples. ENFORCE is a free and user-friendly risk calculator of all-cause mortality in white patients with type 2 diabetes from a real-life setting.",2019,"In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value which is significantly lower than that obtained in the pooled real-life samples (P<0.0001).","['White patients with type 2 diabetes', 'real-life type 2 diabetic patients', 'type2 diabetiC patiEnts (ENFORCE']",[],"['cause mortality', 'Foggia Mortality Study (FMS', '6-year mortality C-statistics', 'Pisa Mortality Study (PMS; n=972) as real-life samples and the standard glycemic arm of the ACCORD clinical trial (n=3150']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]",[],"[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",3150.0,0.0556168,"In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value which is significantly lower than that obtained in the pooled real-life samples (P<0.0001).","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Copetti', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Shah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontana', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Scarale', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Menzaghi', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'De Cosmo', 'Affiliation': 'Department of Clinical Sciences, Fondazione IRCCS ""Casa Sollievo Della Sofferenza"", San Giovanni Rotondo, Italy.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Garofolo', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Sorrentino', 'Affiliation': 'Unit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lamacchia', 'Affiliation': 'Unit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Penno', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, Massachusetts.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Trischitta', 'Affiliation': 'Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00215']
745,31771991,Initial Results from Mobile Low-Dose Computerized Tomographic Lung Cancer Screening Unit: Improved Outcomes for Underserved Populations.,"INTRODUCTION


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


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


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


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


This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease. If confirmed in a planned randomized trial, this will be policy changing, as these groups usually present with advanced disease; this approach will produce better survival data at lower cost per case.",2020,"This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease.","['550 patients (20% black, 3% Hispanic, 70% rural) with a male-to-female ratio of 1.1:1, median age 61\u2009years (range, 55-64), and found 12 lung cancers at initial screen (2.2%), including 6 at stage I-II (58% of total lung cancers early stage) and 38 Lung-RADS 4 (highly suspicious) lesions that are being followed closely', 'screen uninsured and underinsured patients, otherwise with eligibility criteria identical to that of the National Lung Screening Trial, with the only difference being exclusion of patients eligible for Medicare (which provides financial coverage for CT-based lung cancer screening']","['Mobile Low-Dose Computerized Tomographic Lung Cancer Screening Unit', 'CT scanning unit']",['lung cancer mortality'],"[{'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087132', 'cui_str': 'Underinsured'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",550.0,0.0516046,"This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Raghavan', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Mellisa', 'Initials': 'M', 'LastName': 'Wheeler', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Doege', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Doty', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Levy', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Kia A', 'Initials': 'KA', 'LastName': 'Dungan', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Davis', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Mileham', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carrizosa', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0802']
746,31696762,Five-Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents.,"Background The choice of optimal drug-eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long-term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus-eluting stents (BP-SES) versus durable polymer everolimus-eluting stents (DP-EES) in patients with DM. Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin-strut BP-SES or thin-strut DP-EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (risk ratio, 1.23; 95% CI, 0.87-1.73 [ P =0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (risk ratio, 0.98; 95% CI, 0.77-1.26 [ P =0.90;  P  for interaction=0.31]). Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP-SES or DP-EES. There was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin-strut BP-SES or thin-strut DP-EES. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104.",2019,"Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP-SES or DP-EES.","['2119 patients, 486 (22.9%) presented with DM', 'patients with DM', 'patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain']","['percutaneous coronary intervention with biodegradable polymer sirolimus-eluting stents (BP-SES) versus durable polymer everolimus-eluting stents (DP-EES', 'ultrathin-strut BP-SES or thin-strut DP-EES', 'Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents', 'Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent', 'optimal drug-eluting stent therapy']","['Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis', 'target lesion failure', 'target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",2119.0,0.148871,"Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP-SES or DP-EES.","[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Iglesias', 'Affiliation': 'Division of Cardiology Geneva University Hospitals Geneva Switzerland.'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Institute of Social and Preventive Medicine and Clinical Trials Unit Bern University Hospital Bern Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': 'Division of Cardiology Geneva University Hospitals Geneva Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tüller', 'Affiliation': 'Department of Cardiology Triemlispital Zurich Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Lanz', 'Affiliation': 'Department of Cardiology Bern University Hospital Bern Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rigamonti', 'Affiliation': 'Division of Cardiology Geneva University Hospitals Geneva Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Muller', 'Affiliation': 'Department of Cardiology Lausanne University Hospital Lausanne Switzerland.'}, {'ForeName': 'Igal', 'Initials': 'I', 'LastName': 'Moarof', 'Affiliation': 'Department of Cardiology Kantonsspital Aarau Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology University and Hospital Fribourg Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': 'Department of Cardiology Kantonsspital St Gallen Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology Basel University Hospital Basel Switzerland.'}, {'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': 'Department of Cardiology Kantonsspital Luzern Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology Bern University Hospital Bern Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research Centre Li Ka Shing Knowledge Institute of St Michael's Hospital University of Toronto Canada.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology Bern University Hospital Bern Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Department of Cardiology Bern University Hospital Bern Switzerland.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013607']
747,31707940,Does Race Influence Decision Making for Advanced Heart Failure Therapies?,"Background Race influences medical decision making, but its impact on advanced heart failure therapy allocation is unknown. We sought to determine whether patient race influences allocation of advanced heart failure therapies. Methods and Results Members of a national heart failure organization were randomized to clinical vignettes that varied by patient race (black or white man) and were blinded to study objectives. Participants (N=422) completed Likert scale surveys rating factors for advanced therapy allocation and think-aloud interviews (n=44). Survey results were analyzed by least absolute shrinkage and selection operator and multivariable regression to identify factors influencing advanced therapy allocation, including interactions with vignette race and participant demographics. Interviews were analyzed using grounded theory. Surveys revealed no differences in overall racial ratings for advanced therapies. Least absolute shrinkage and selection operator regression selected no interactions between vignette race and clinical factors as important in allocation. However, interactions between participants aged ≥40 years and black vignette negatively influenced heart transplant allocation modestly (-0.58; 95% CI, -1.15 to -0.0002), with adherence and social history the most influential factors. Interviews revealed sequential decision making: forming overall impression, identifying urgency, evaluating prior care appropriateness, anticipating challenges, and evaluating trust while making recommendations. Race influenced each step: avoiding discussing race, believing photographs may contribute to racial bias, believing the black man was sicker compared with the white man, developing greater concern for trust and adherence with the black man, and ultimately offering the white man transplantation and the black man ventricular assist device implantation. Conclusions Black race modestly influenced decision making for heart transplant, particularly during conversations. Because advanced therapy selection meetings are conversations rather than surveys, allocation may be vulnerable to racial bias.",2019,Participants (N=422) completed Likert scale surveys rating factors for advanced therapy allocation and think-aloud interviews (n=44).,"['Participants (N=422) completed Likert scale surveys rating factors for advanced therapy allocation and think-aloud interviews (n=44', 'Members of a national heart failure organization were randomized to clinical vignettes that varied by patient race (black or white man']",[],"['overall racial ratings', 'heart transplant allocation']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}]",,0.0853556,Participants (N=422) completed Likert scale surveys rating factors for advanced therapy allocation and think-aloud interviews (n=44).,"[{'ForeName': 'Khadijah', 'Initials': 'K', 'LastName': 'Breathett', 'Affiliation': 'Division of Cardiovascular Medicine Department of Medicine Sarver Heart Center University of Arizona Tucson AZ.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Yee', 'Affiliation': 'Sarver Heart Center, Clinical Research Office University of Arizona Tucson AZ.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pool', 'Affiliation': 'College of Nursing University of Arizona Tucson AZ.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hebdon', 'Affiliation': 'College of Nursing University of Arizona Tucson AZ.'}, {'ForeName': 'Janice D', 'Initials': 'JD', 'LastName': 'Crist', 'Affiliation': 'College of Nursing University of Arizona Tucson AZ.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Knapp', 'Affiliation': 'Statistics Consulting Lab Bio5 Institute University of Arizona Tucson AZ.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Larsen', 'Affiliation': 'Sarver Heart Center, Clinical Research Office University of Arizona Tucson AZ.'}, {'ForeName': 'Sade', 'Initials': 'S', 'LastName': 'Solola', 'Affiliation': 'Department of Medicine University of Arizona Tucson AZ.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Luy', 'Affiliation': 'University of Rochester Rochester New York U.S.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Herrera-Theut', 'Affiliation': 'University of Arizona Medical School Tucson AZ.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Zabala', 'Affiliation': 'University of Arizona Medical School Tucson AZ.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Psychology University of Arizona Tucson AZ.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'McEwen', 'Affiliation': 'College of Nursing University of Arizona Tucson AZ.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Calhoun', 'Affiliation': 'Center for Population Health Sciences University of Arizona Tucson AZ.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Sweitzer', 'Affiliation': 'Division of Cardiovascular Medicine Department of Medicine Sarver Heart Center University of Arizona Tucson AZ.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013592']
748,31256356,Changes in Gut Microbiome after Bariatric Surgery Versus Medical Weight Loss in a Pilot Randomized Trial.,"BACKGROUND


Gut microbiota likely impact obesity and metabolic diseases. We evaluated the changes in gut microbiota after surgical versus medical weight loss in adults with diabetes and obesity.
METHODS


We performed 16S rRNA amplicon sequencing to identify the gut microbial composition at baseline and at 10% weight loss in adults with diabetes who were randomized to medical weight loss (MWL, n = 4), adjustable gastric banding (AGB, n = 4), or Roux-en-Y gastric bypass (RYGB, n = 4).
RESULTS


All participants were female, 75% reported black race with mean age of 51 years. At similar weight loss amount and glycemic improvement, the RYGB group had the most number of bacterial species (10 increased, 1 decreased) that significantly changed (p < 0.05) in relative abundance. Alpha-diversity at follow-up was significantly lower in AGB group compared to MWL and RYGB (observed species for AGB vs. MWL, p = 0.0093; AGB vs. RYGB, p = 0.0093). The relative abundance of Faecalibacterium prausnitzii increased in 3 participants after RYGB, 1 after AGB, and 1 after MWL.
CONCLUSIONS


At similar weight loss and glycemic improvement, the greatest alteration in gut microbiota occurred after RYGB with an increase in the potentially beneficial bacterium, F. prausnitzii. Gut microbial diversity tended to decrease after AGB and increase after RYGB and MWL. Future studies are needed to determine the impact and durability of gut microbial changes over time and their role in long-term metabolic improvement after bariatric surgery in adults with type 2 diabetes.
CLINICAL TRIAL REGISTRATION


NCTDK089557- ClinicalTrials.gov.",2019,"Alpha-diversity at follow-up was significantly lower in AGB group compared to MWL and RYGB (observed species for AGB vs. MWL, p = 0.0093; AGB vs. RYGB, p = 0.0093).","['adults with diabetes and obesity', 'adults with diabetes', 'adults with type 2 diabetes', 'All participants were female, 75% reported black race with mean age of 51\xa0years']","['adjustable gastric banding (AGB, n\u2009=\u20094), or Roux-en-Y gastric bypass (RYGB, n\u2009=\u20094']","['Alpha-diversity', 'weight loss and glycemic improvement', 'gut microbiota', 'relative abundance of Faecalibacterium prausnitzii', 'number of bacterial species']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3854330', 'cui_str': 'Gastric band (physical object)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0317558', 'cui_str': 'Fusobacterium prausnitzii'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0255897,"Alpha-diversity at follow-up was significantly lower in AGB group compared to MWL and RYGB (observed species for AGB vs. MWL, p = 0.0093; AGB vs. RYGB, p = 0.0093).","[{'ForeName': 'Clare J', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Divisions of Endocrinology, Diabetes & Metabolism, The Johns Hopkins University, 1830 E. Monument St, Baltimore, MD, 21287, USA. clee158@jhmi.edu.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Florea', 'Affiliation': 'Division of General Internal Medicine, The Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Sears', 'Affiliation': 'Bloomberg-Kimmel Institute for Cancer Immunotherapy, The Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Maruthur', 'Affiliation': 'Division of General Internal Medicine, The Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Potter', 'Affiliation': 'Division of Gastroenterology and Hepatology, The Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schweitzer', 'Affiliation': 'Department of Surgery, The Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Magnuson', 'Affiliation': 'Department of Surgery, The Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, The Johns Hopkins University, Baltimore, MD, USA.'}]",Obesity surgery,['10.1007/s11695-019-03976-4']
749,30075059,Corticosteroids for preventing neonatal respiratory morbidity after elective caesarean section at term.,"BACKGROUND


Infants born at term by elective caesarean section are more likely to develop respiratory morbidity than infants born vaginally. Prophylactic corticosteroids in singleton preterm pregnancies accelerate lung maturation and reduce the incidence of respiratory complications.
OBJECTIVES


The objective of this review was to assess the effect of prophylactic corticosteroid administration before elective caesarean section at term, as compared to usual management without corticosteroids, in reducing neonatal respiratory morbidity and admission to special care with respiratory complications.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register (14 June 2017), and reference lists of retrieved studies.
SELECTION CRITERIA


Randomised controlled trials comparing prophylactic antenatal corticosteroid administration (betamethasone or dexamethasone) with placebo or with no treatment, given before elective caesarean section at term (at or after 37 weeks of gestation).
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS


We included four trials (3956 women and 3893 neonates) at a moderate risk of bias, comparing prophylactic administration of betamethasone or dexamethasone versus placebo or usual treatment without steroids in term elective caesarean section. Women randomised to treatment group received either two intramuscular doses of betamethasone in the 48 hours before delivery, or intramuscular dexamethasone (two or four doses) prior to delivery (at 37 weeks' gestation or 48 hours before delivery), and were compared to the control group who received a saline placebo or treatment as usual.Prophylactic antenatal corticosteroid administration appeared to decrease the risk of respiratory distress syndrome (RDS) (risk ratio (RR) 0.48; 95% confidence interval (CI) 0.27 to 0.87; 4 studies; 3817 participants; low-quality evidence), transient tachypnoea of the neonate (TTN) (RR 0.43; 95% CI 0.29 to 0.65; 4 studies; 3821 participants; low-quality evidence), admission to the neonatal intensive care unit (NICU) for respiratory morbidity (RR 0.42; 95% CI 0.22 to 0.79; 3 studies; 3441 participants), and admission to neonatal special care (all levels) for respiratory complications (RR 0.45; 95% CI 0.22 to 0.90; 1 study; 942 participants; low-quality evidence). Administration of antenatal corticosteroids also appeared to reduce admission to neonatal special care (RR 0.62; 95% CI 0.43 to 0.89; 2 studies; 2169 participants) and neonatal intensive care (RR 0.14; 95% CI 0.03 to 0.61; 1 study; 452 participants) for any indication, compared to placebo or usual care. Finally, prophylactic antenatal corticosteroids also appeared to reduce the length of stay in NICU by 2.70 days (mean difference (MD) -2.70; 95% CI -2.76 to -2.64; 2 studies; 32 participants).No reduction was found in the need for mechanical ventilation (RR 0.67; 95% CI 0.27 to 1.68; 3 studies; 3441 participants; very-low quality), perinatal death (RR 0.67; 95% CI 0.11 to 4.10; 4 studies; 3893 participants) or neonatal sepsis (RR 1.00; 95% CI 0.06 to 15.95; 2 studies; 2214 participants) .There were no reported events of neonatal respiratory complications (other than RDS and tachypnoea of the newborn (TTN)), chronic lung disease, duration of mechanical ventilation or maternal postpartum infection, therefore results on these outcomes are non-estimable. The studies did not provide data on other pre-defined outcomes.The quality of evidence, as assessed using GRADE was low for the outcomes of RDS, TTN and admission to NICU for respiratory morbidity, indicating that the true effect could potentially be substantially different from our estimate of effect.
AUTHORS' CONCLUSIONS


The results from the four trials are promising, but more high-quality studies with larger sample sizes that are adequately powered to detect the effect of prophylactic antenatal corticosteroids on outcomes of respiratory morbidity are needed, given the potential of the current studies for bias. Consideration should be given to the balance between statistical significance and clinical significance, particularly in view of the low event rates of significant respiratory morbidity (RDS or admission to NICU for respiratory complications) in this population. In addition, further trials on the long-term outcomes of these infants are needed to identify any potential harms and complications of antenatal corticosteroid administration at term.",2018,"Administration of antenatal corticosteroids also appeared to reduce admission to neonatal special care (RR 0.62; 95% CI 0.43 to 0.89; 2 studies; 2169 participants) and neonatal intensive care (RR 0.14; 95% CI 0.03 to 0.61; 1 study; 452 participants) for any indication, compared to placebo or usual care.","['Infants born at term by elective caesarean section', 'singleton preterm pregnancies', '3956 women and 3893 neonates) at a moderate risk of bias, comparing prophylactic administration of', 'in term elective caesarean section']","['betamethasone', 'Prophylactic corticosteroids', 'placebo', 'prophylactic antenatal corticosteroid administration (betamethasone or dexamethasone', 'betamethasone or dexamethasone versus placebo or usual treatment without steroids', 'intramuscular dexamethasone', 'saline placebo', 'prophylactic corticosteroid', 'antenatal corticosteroids', 'Corticosteroids']","['neonatal intensive care', 'need for mechanical ventilation', 'chronic lung disease, duration of mechanical ventilation or maternal postpartum infection', 'neonatal respiratory morbidity', 'neonatal respiratory complications', 'low-quality evidence), admission to the neonatal intensive care unit (NICU) for respiratory morbidity', 'perinatal death', 'transient tachypnoea of the neonate (TTN', 'risk of respiratory distress syndrome (RDS', 'neonatal sepsis', 'reduce admission to neonatal special care', 'respiratory complications', 'respiratory morbidity', 'length of stay in NICU']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0021711', 'cui_str': 'Infant, Newborn, Intensive Care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C3665339', 'cui_str': 'Bacterial sepsis of newborn (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",3956.0,0.344199,"Administration of antenatal corticosteroids also appeared to reduce admission to neonatal special care (RR 0.62; 95% CI 0.43 to 0.89; 2 studies; 2169 participants) and neonatal intensive care (RR 0.14; 95% CI 0.03 to 0.61; 1 study; 452 participants) for any indication, compared to placebo or usual care.","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Sotiriadis', 'Affiliation': 'Second Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki, 92 Tsimiski Street, Thessaloniki, Greece, 546 22.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Makrydimas', 'Affiliation': ''}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Papatheodorou', 'Affiliation': ''}, {'ForeName': 'John Pa', 'Initials': 'JP', 'LastName': 'Ioannidis', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McGoldrick', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006614.pub3']
750,31718441,Metabolic Dysfunction in Continuous-Flow Left Ventricular Assist Devices Patients and Outcomes.,"Background Metabolic impairment is common in heart failure patients. Continuous-flow left ventricular assist devices (CF-LVADs) improve hemodynamics and outcomes in patients with advanced heart failure; however, the effect of CF-LVADs on metabolic status is unknown. This study aims to evaluate the changes in metabolic status following CF-LVAD implantation and measure the correlation of metabolic status with outcomes. Methods and Results Prospective data on CF-LVAD patients were obtained. Metabolic evaluation, including hemoglobin A1C, free and total testosterone, thyroid-stimulating hormone (TSH), and free T4, was obtained before and at multiple time points following implantation. Patients with nonelevated thyroid-stimulating hormone and normal hemoglobin A1C and testosterone levels were defined as having normal metabolic status. Baseline characteristics, hemodynamics, and outcomes were collected. One hundred six patients were studied, of which 56 had paired data at baseline and 1- to 3-month follow-up. Before implantation, 75% of patients had insulin resistance, 86% of men and 39% of women had low free testosterone, and 44% of patients had abnormal thyroid function. There was a significant improvement in hemoglobin A1C, free testosterone, and thyroid-stimulating hormone following implantation ( P <0.001 for all). Patients with normal hemoglobin A1C (<5.7%) following implantation had higher 1-year survival free of heart failure readmissions (78% versus 23%;  P <0.001). Patients with normal metabolic status following implantation also had higher 1-year survival free of heart failure readmissions (92% versus 54%;  P =0.04). Conclusions Metabolic dysfunction is highly prevalent in advanced heart failure patients and improves after CF-LVAD implantation. Normal metabolic status is associated with a significantly higher rate of 1-year survival free of heart failure readmissions.",2019,"There was a significant improvement in hemoglobin A1C, free testosterone, and thyroid-stimulating hormone following implantation ( P <0.001 for all).","['patients with advanced heart failure', 'heart failure patients', 'Patients with nonelevated thyroid-stimulating hormone and normal hemoglobin A1C and testosterone levels were defined as having normal metabolic status', 'advanced heart failure patients', 'One hundred six patients were studied, of which 56 had paired data at baseline and 1- to 3-month follow-up']","['CF-LVAD implantation', 'Continuous-flow left ventricular assist devices (CF-LVADs', 'CF-LVADs']","['abnormal thyroid function', 'Metabolic Dysfunction', 'hemoglobin A1C, free testosterone, and thyroid-stimulating hormone following implantation', '1-year survival free of heart failure readmissions', 'Metabolic evaluation, including hemoglobin A1C, free and total testosterone, thyroid-stimulating hormone (TSH), and free T4', 'insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",106.0,0.164913,"There was a significant improvement in hemoglobin A1C, free testosterone, and thyroid-stimulating hormone following implantation ( P <0.001 for all).","[{'ForeName': 'Ann B', 'Initials': 'AB', 'LastName': 'Nguyen', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Imamura', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Besser', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodgers', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Raikhelkar', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalantari', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Nitasha', 'Initials': 'N', 'LastName': 'Sarswat', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'LaBuhn', 'Affiliation': 'Section of Cardiac Surgery Department of Surgery University of Chicago IL.'}, {'ForeName': 'Valluvan', 'Initials': 'V', 'LastName': 'Jeevanandam', 'Affiliation': 'Section of Cardiac Surgery Department of Surgery University of Chicago IL.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sayer', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Section of Cardiology Department of Medicine University of Chicago IL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013278']
751,31228880,The time course of ineffective sham-blinding during low-intensity (1 mA) transcranial direct current stimulation.,"Studies using transcranial direct current stimulation (tDCS) typically compare an active protocol relative to a shorter sham (placebo) protocol. Both protocols are presumed to be perceptually identical on the scalp, and thus represent an effective method of delivering double-blinded experimental designs. However, participants often show above-chance accuracy when asked which condition involved active/sham retrospectively. We assessed the time course of sham-blinding during active and sham tDCS. We predicted that participants would be aware that the current is switched on for longer in the active versus sham protocol. Thirty-two adults were tested in a preregistered, double-blinded, within-subjects design. A forced-choice reaction time task was undertaken before, during and after active (10 min 1 mA) and sham (20 s 1 mA) tDCS. The anode was placed over the left primary motor cortex (C3) to target the right hand, and the cathode on the right forehead. Two probe questions were asked every 30 s: ""Is the stimulation on?"" and ""How sure are you?"". Distinct periods of non-overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time). These began immediately after sham ramp-down and lasted until the active protocol had ended. We therefore show a failure of placebo control during 1 mA tDCS. These results highlight the need to develop more effective methods of sham-blinding during transcranial electrical stimulation protocols, even when delivered at low-intensity current strengths.",2019,"Distinct periods of non-overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time).",['Thirty-two adults'],"['sham-blinding during active and sham tDCS', 'shorter sham (placebo', 'transcranial direct current stimulation (tDCS']",[],"[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],32.0,0.411108,"Distinct periods of non-overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greinacher', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Buhôt', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Möller', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Learmonth', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}]",The European journal of neuroscience,['10.1111/ejn.14497']
752,30458263,Randomized trial seeking to induce the Hawthorne effect found no evidence for any effect on self-reported alcohol consumption online.,"OBJECTIVE


We tested the hypothesis that participants who know the behavioral focus of a study and are thus aware that a particular behavior is being studied will modify that behavior, independently of any possible effect of assessment, thereby dismantling a Hawthorne effect into two putative components.
STUDY DESIGN AND SETTING


We undertook a three-arm individually randomized trial online among students: group A (control) were told they were completing a lifestyle survey; group B were told the focus of the survey was alcohol consumption; and group C additionally answered 20 questions on their alcohol use and its consequences before answering the same lifestyle questions as Groups A and B. Nondrinkers were excluded, and all groups were aware they would be followed up after 1 month.
RESULTS


Outcome data were obtained for 4,583 of 5,478 trial participants (84% follow-up rate). There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks.
CONCLUSIONS


There is no evidence that any form of Hawthorne effect exists in relation to self-reported alcohol consumption online among university students in usual research practice. Attention to study contexts is warranted for investigating research participation effects.",2019,"There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks.
",['university students'],['alcohol consumption; and group C additionally answered 20 questions on their alcohol use and its consequences before answering the same lifestyle questions'],['primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445247', 'cui_str': 'Same (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0341787,"There were no differences between the three groups on primary (overall volume consumed) or secondary outcome measures (drinking frequency and amount per typical occasion) in the intervening 4 weeks.
","[{'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia; Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Attia', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Weaver', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Kypros', 'Initials': 'K', 'LastName': 'Kypri', 'Affiliation': 'Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia. Electronic address: kypros.kypri@newcastle.edu.au.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2018.11.016']
753,32203984,Uses and Limitations of the Restricted Mean Survival Time: Illustrative Examples From Cardiovascular Outcomes and Mortality Trials in Type 2 Diabetes.,"The restricted mean survival time (RMST) has been advocated as an alternative or a supplement to the hazard ratio for reporting the effect of an intervention in a randomized clinical trial. The RMST difference allows quantification of the postponement of an outcome during a specified (restricted) interval and corresponds to the difference between the areas under the 2 survival curves for the intervention and control groups. This article presents examples of the use of the RMST in a research and a clinical context. First, the authors demonstrate how the RMST difference can answer research questions about the efficacy of different treatments. Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality. The authors show how these measures may be used to mitigate uncertainty about the efficacy of intensive glucose control. Second, the authors demonstrate how the RMST difference may be used in the setting of a clinical consultation to guide the decision to start or discontinue a treatment. They then discuss the advantages of the RMST over the absolute risk difference, the number needed to treat, and the median survival time difference. They argue that the RMST difference is both easy to interpret and flexible in its application to different settings. Finally, they highlight the major limitations of the RMST, including difficulties in comparing studies of heterogeneous designs and in inferring the long-term effects of treatments using trials of short duration, and summarize the available statistical software for calculating the RMST.",2020,Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality.,"['Type 2 Diabetes', 'adults with type 2 diabetes']",['pharmacologic or strategy-driven glucose-lowering interventions'],"['survival curves', 'mean survival time (RMST', 'median survival time difference']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",,0.0528335,Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality.,"[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kloecker', 'Affiliation': 'Leicester Real World Evidence Unit and Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (D.E.K., K.K., F.Z.).'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (M.J.D.).'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Leicester Real World Evidence Unit and Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (D.E.K., K.K., F.Z.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaccardi', 'Affiliation': 'Leicester Real World Evidence Unit and Diabetes Reasearch Centre, Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom (D.E.K., K.K., F.Z.).'}]",Annals of internal medicine,['10.7326/M19-3286']
754,31425620,Advanced sperm selection techniques for assisted reproduction.,"BACKGROUND


Assisted reproductive technologies (ART) including in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), combine gametes to enhance the probability of fertilisation and pregnancy. Advanced sperm selection techniques are increasingly employed in ART, most commonly in cycles utilising ICSI. Advanced sperm selection techniques are proposed to improve the chance that structurally intact and mature sperm with high DNA integrity are selected for fertilisation. Strategies include selection according to surface charge; sperm apoptosis; sperm birefringence; ability to bind to hyaluronic acid; and sperm morphology under ultra-high magnification. These techniques are intended to improve ART outcomes.
OBJECTIVES


To evaluate the effectiveness and safety of advanced sperm selection techniques on ART outcomes.
SEARCH METHODS


We conducted a systematic search of electronic databases (Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL via the Cochrane Register of Studies Online, MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL); trials registers (ClinicalTrials.gov, Current Controlled Trials, and the World Health Organization International Clinical Trials Registry Platform); conference abstracts (Web of Knowledge); and grey literature (OpenGrey) for relevant randomised controlled trials (RCTs). We handsearched the reference lists of included studies and similar reviews. The search was conducted in June 2018.
SELECTION CRITERIA


We included RCTs comparing advanced sperm selection techniques versus standard IVF, ICSI, or another technique. We excluded studies of intracytoplasmic morphologically selected sperm injection (IMSI), as they are subject to a separate Cochrane Review. Primary outcomes measured were live birth and miscarriage per woman randomly assigned. Secondary outcome measures included clinical pregnancy per woman randomly assigned. Secondary adverse events measured included miscarriage per clinical pregnancy and foetal abnormality.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed study eligibility and risk of bias and extracted data. Any disagreements were resolved by consultation with a third review author. We consulted study investigators to resolve queries. Risk ratios (RRs) were calculated with 95% confidence intervals (CIs). We combined studies using a fixed-effect model. We evaluated the quality of the evidence using GRADE methods.
MAIN RESULTS


We included eight RCTs (4147 women). The quality of evidence ranged from very low to low. The main limitations were imprecision, performance bias, and attrition bias.Hyaluronic acid selected sperm-intracytoplasmic sperm injection (HA-ICSI) compared to ICSITwo RCTs compared the effects of HA-ICSI versus ICSI on live birth. The quality of the evidence was low. There may be little or no difference between groups: 25% chance of live birth with ICSI versus 24.5% to 31% with HA-ICSI (RR 1.09, 95% CI 0.97 to 1.23, 2903 women, I 2  = 0%, low-quality evidence). Three RCTs reported on miscarriage. HA-ICSI may decrease miscarriage per woman randomly assigned: 7% chance of miscarriage with ICSI versus 3% to 6% chance with HA-ICSI (RR 0.61, 95% CI 0.45 to 0.83, 3005 women, I 2  = 0%, low-quality evidence) and per clinical pregnancy: 20% chance of miscarriage with ICSI compared to 9% to 16% chance with HA-ICSI (RR 0.62, 95% CI 0.46 to 0.82, 1065 women, I 2  = 0%, low-quality evidence). Four RCTs reported on clinical pregnancy. There may be little or no difference between groups: 37% chance of pregnancy with ICSI versus 34% to 40% chance with HA-ICSI (RR 1.00, 95% CI 0.92 to 1.09, 3492 women, I 2  = 0%, low-quality evidence).HA-ICSI compared to SpermSlowOne RCT compared HA-ICSI to SpermSlow. The quality of the evidence was very low. We are uncertain whether HA-ICSI improves live birth compared to SpermSlow (RR 1.13, 95% CI 0.64 to 2.01, 100 women) or clinical pregnancy (RR 1.05, 95% CI 0.66 to 1.68, 100 women). We are uncertain whether HA-ICSI reduces miscarriage per woman (RR 0.80, 95% CI 0.23 to 2.81, 100 women) or per clinical pregnancy (RR 0.76, 95% CI 0.24 to 2.44, 41 women).Magnetic-activated cell sorting (MACS) compared to ICSIOne RCT compared MACS to ICSI for live birth; three reported clinical pregnancy; and two reported miscarriage. The quality of the evidence was very low. We are uncertain whether MACS improves live birth (RR 1.95, 95% CI 0.89 to 4.29, 62 women) or clinical pregnancy (RR 1.05, 95% CI 0.84 to 1.31, 413 women, I 2  = 81%). We are also uncertain if MACS reduces miscarriage per woman (RR 0.95, 95% CI 0.16 to 5.63, 150 women, I 2  = 0%) or per clinical pregnancy (RR 0.51, 95%CI 0.09 to 2.82, 53 women, I 2 =0)Zeta sperm selection compared to ICSIOne RCT evaluated Zeta sperm selection. The quality of the evidence was very low. We are uncertain of the effect of Zeta sperm selection on live birth (RR 2.48, 95% CI 1.34 to 4.56, 203 women) or clinical pregnancy (RR 1.82, 95% CI 1.20 to 2.75, 203 women). We are also uncertain if Zeta sperm selection reduces miscarriage per woman (RR 0.73, 95% CI 0.16 to 3.37, 203 women) or per clinical pregnancy (RR 0.41, 95% CI 0.10 to 1.68, 1 RCT, 62 women).MACS compared to HA-ICSIOne RCT compared MACS to HA-ICSI. This study did not report on live birth. The quality of the evidence was very low. We are uncertain of the effect on miscarriage per woman (RR 1.52, 95% CI 0.10 to 23.35, 78 women) or per clinical pregnancy (RR 1.06, 95% CI 0.07 to 15.64, 37 women). We are also uncertain of the effect on clinical pregnancy (RR 1.44, 95% CI 0.91 to 2.27, 78 women).
AUTHORS' CONCLUSIONS


The evidence suggests that sperm selected by hyaluronic acid binding may have little or no effect on live birth or clinical pregnancy but may reduce miscarriage. We are uncertain of the effect of Zeta sperm selection on live birth, clinical pregnancy, and miscarriage due principally to the very low quality of the evidence for this intervention. We are uncertain of the effect of the other selection techniques on live birth, miscarriage, or pregnancy.Further high-quality studies, including the awaited data from the identified ongoing studies, are required to evaluate whether any of these advanced sperm selection techniques can be recommended for use in routine practice.",2019,"We are uncertain whether MACS improves live birth (RR 1.95, 95% CI 0.89 to 4.29, 62 women) or clinical pregnancy (RR 1.05, 95% CI 0.84 to 1.31, 413 women,",['eight RCTs (4147 women'],"['ICSITwo RCTs', 'advanced sperm selection techniques', 'Hyaluronic acid selected sperm-intracytoplasmic sperm injection (HA-ICSI', 'intracytoplasmic morphologically selected sperm injection (IMSI', 'HA-ICSI', 'SpermSlowOne RCT', 'ICSIOne RCT', 'Zeta sperm selection', 'MACS']","['clinical pregnancy', 'live birth and miscarriage', 'live birth, miscarriage, or pregnancy', 'live birth or clinical pregnancy', 'clinical pregnancy per woman randomly assigned', 'imprecision, performance bias, and attrition bias', 'miscarriage per clinical pregnancy and foetal abnormality', 'live birth', 'Risk ratios (RRs']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1719914', 'cui_str': 'Zeta'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",1065.0,0.623261,"We are uncertain whether MACS improves live birth (RR 1.95, 95% CI 0.89 to 4.29, 62 women) or clinical pregnancy (RR 1.05, 95% CI 0.84 to 1.31, 413 women,","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Lepine', 'Affiliation': 'Department of Obstetrics and Gynaecology, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'McDowell', 'Affiliation': ''}, {'ForeName': 'Leigh M', 'Initials': 'LM', 'LastName': 'Searle', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Kroon', 'Affiliation': ''}, {'ForeName': 'Demián', 'Initials': 'D', 'LastName': 'Glujovsky', 'Affiliation': ''}, {'ForeName': 'Anusch', 'Initials': 'A', 'LastName': 'Yazdani', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010461.pub3']
755,31034102,Expectations influence treatment outcomes in patients with low back pain. A secondary analysis of data from a randomized clinical trial.,"BACKGROUND


Low back pain (LBP) is a global public health challenge, which causes high healthcare costs and the highest burden on society in terms of years lived with disability. While patients' expectations for improvement may have effects on LBP treatment outcomes, it remains unclear if psychological profiles modify this relationship. Therefore, the objectives of this study were to investigate if (a) patients' expectations predicted short-term outcome, and (b) psychological profile, pain intensity and self-rated health modified the relationship between expectations and outcome.
METHODS


Data were collected between April 2012 and January 2016 during the inclusion into a randomized controlled trial. Potentially eligible participants were identified through 40 chiropractic clinics located across Sweden. Patients' expectations, psychological profile, pain intensity, activity limitation and self-rated health were collected from patients with recurrent persistent LBP during their first chiropractic visit (n = 593). Subjective improvement was measured at the fourth visit.
RESULTS


Patients with a high expectation of improvement had 58% higher risk to report an improvement at the fourth visit (RR = 1.58, 95% CI: 1.28, 1.95). Controlling for potential confounders only slightly decreased the strength of this association (RR = 1.49, 95% CI: 1.20, 1.86). Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.
CONCLUSIONS


Baseline patients' expectations play an important role when predicting LBP treatment outcomes. Clinicians should consider and address patients' expectations at the first visit to best inform prognosis.
SIGNIFICANCE


This study confirms the importance of patients' expectations in a clinical setting. Patients' expectations predict the short-term outcome of chiropractic care for LBP. Pain intensity, psychological profile and self-rated health did not modify this relationship.",2019,"Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.
","['Data were collected between April 2012 and January 2016 during the inclusion into a randomized controlled trial', 'patients with low back pain', 'Potentially eligible participants were identified through 40 chiropractic clinics located across Sweden']",[],"['Subjective improvement', 'Pain intensity, psychological profile and self-rated health', ""Patients' expectations, psychological profile, pain intensity, activity limitation and self-rated health"", 'Baseline pain intensity, psychological profile and self-rated health']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]",,0.130218,"Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eklund', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, The Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'De Carvalho', 'Affiliation': ""Discipline of Medicine, Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pagé', 'Affiliation': 'Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Melker S', 'Initials': 'MS', 'LastName': 'Johansson', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Pohlman', 'Affiliation': 'Research Institute, Parker University, Dallas, Texas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Swain', 'Affiliation': 'Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, Australia.'}]","European journal of pain (London, England)",['10.1002/ejp.1407']
756,32295716,"Twelve-month mortality from the ""How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention (HEAT-PPCI) Trial"".","BACKGROUND


There is ongoing uncertainty regarding the safety and efficacy of unfractionated heparin and bivalirudin when used for systemic anticoagulation in patients undergoing primary percutaneous coronary intervention (PPCI). This paper reports 12-month mortality from the HEAT-PPCI randomised trial.
METHODS


In this open-label, randomised controlled trial (RCT) we enrolled consecutive adults with suspected ST-elevation myocardial infarction (STEMI). Patients were randomised to heparin (bolus 70 U/kg) or bivalirudin (bolus 0.75 mg/kg followed by an infusion 1.75 mg/kg/h for the duration of the procedure). We report the pre-specified secondary outcome of all-cause mortality at 12 months. Mortality was classified as cardiovascular or not, blinded to treatment allocation. Deaths in the first 28 days were classified by formal event adjudication and later events classified from death certificates.
RESULTS


Mortality status at 12 months was obtained for 1805/1812 = 99.6% of participants. Overall mortality was 160/1812 = 8.9%. There were more deaths in those randomised to bivalirudin (95/902 = 10.5% vs 65/903 = 7.2%; HR 1.48; 95% CI 1.08 to 2.03; p = 0.015). Most deaths were classified as cardiovascular (71/902 = 7.9% in the bivalirudin group and 53/904 = 5.9% in the heparin group). The difference between the rates of cardiovascular deaths in each treatment group did not reach statistical significance: HR 1.35; 95% CI 0.95 to 1.93; p = 0.095.
CONCLUSIONS


At 12 months, treatment with bivalirudin, rather than heparin, was associated with a higher rate of all-cause mortality. Cardiovascular mortality was higher with bivalirudin although this difference was not statistically significant.",2020,Most deaths were classified as cardiovascular (71/902 = 7.9% in the bivalirudin group and 53/904 = 5.9% in the heparin group).,"['patients undergoing primary percutaneous coronary intervention (PPCI', 'enrolled consecutive adults with suspected ST-elevation myocardial infarction (STEMI']","['heparin', 'bivalirudin', 'unfractionated heparin and bivalirudin']","['Cardiovascular mortality', 'higher rate of all-cause mortality', 'Deaths', 'Mortality status', 'Mortality', 'Overall mortality', 'rates of cardiovascular deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.344544,Most deaths were classified as cardiovascular (71/902 = 7.9% in the bivalirudin group and 53/904 = 5.9% in the heparin group).,"[{'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Blake', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, United Kingdom of Great Britain and Northern Ireland. Electronic address: s.blake4@nhs.net.'}, {'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Shahzad', 'Affiliation': 'Manchester University NHS Foundation Trust, Southmoor Rd, Wythenshawe, Manchester M23 9LT, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kemp', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mars', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Rod H', 'Initials': 'RH', 'LastName': 'Stables', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, United Kingdom of Great Britain and Northern Ireland.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.03.065']
757,31997084,Effects of Green Tea Extract on Atorvastatin Pharmacokinetics in Healthy Volunteers.,"BACKGROUND AND OBJECTIVES


Green tea catechins were recently reported to inhibit drug transporters such as organic anion-transporting polypeptides (OATPs) and metabolic enzymes, affecting the bioavailability of many drugs. This study aimed to evaluate the clinical significance of the effects of different doses of green tea extract on the pharmacokinetic parameters of atorvastatin and to rationalize the associated interaction mechanism.
METHODS


A randomized, double-blind, three-phase crossover study involving 12 healthy volunteers was performed. Participants received a single dose of atorvastatin 40 mg alone (control group), atorvastatin 40 mg plus a capsule containing 300 mg of dry green tea extract, or atorvastatin 40 mg plus a capsule containing 600 mg of dry green tea extract. Plasma samples taken from the volunteers were analyzed for atorvastatin using liquid chromatography-tandom mass spectrometry (LC/MS/MS).
RESULTS


Compared to atorvastatin alone, the administration of 300 mg or 600 mg of the green tea extract along with atorvastatin decreased the peak plasma concentration (C max ) of atorvastatin by 25% and 24%, respectively (P < 0.05), and the area under the plasma concentration-time curve (AUC 0-∞ ) of atorvastatin by 24% and 22%, respectively (P < 0.05). Additionally, administration of 300 mg or 600 mg of the green tea extract increased the apparent oral clearance (CL/F) of atorvastatin by 31% and 29%, respectively. The time to C max  (T max ) and the elimination half-life (t 1/2 ) of atorvastatin did not differ among the three phases. The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract.
CONCLUSION


Green tea extract decreases the absorption but not the elimination of atorvastatin, possibly by inhibiting OATP, albeit not in a dose-dependent manner. Coadministration of green tea extract with atorvastatin may necessitate the monitoring of the plasma concentration of atorvastatin in clinical practice.",2020,"The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract.
","['12 healthy volunteers', 'Healthy Volunteers']","['Green Tea Extract', 'green tea extract with atorvastatin', 'atorvastatin', 'green tea extract', 'atorvastatin 40\xa0mg alone (control group), atorvastatin 40\xa0mg plus a capsule containing 300\xa0mg of dry green tea extract, or atorvastatin 40\xa0mg plus a capsule containing 600\xa0mg of dry green tea extract', 'Green tea extract']","['Atorvastatin Pharmacokinetics', 'peak plasma concentration (C max ) of atorvastatin', 'time to C max  (T max ) and the elimination half-life', 'area under the plasma concentration-time curve (AUC 0-∞ ) of atorvastatin', 'apparent oral clearance (CL/F) of atorvastatin', 'pharmacokinetic parameters of atorvastatin']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",12.0,0.0478265,"The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract.
","[{'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Abdelkawy', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Abdelaziz', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelmageed', 'Affiliation': 'Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Donia', 'Affiliation': 'Pharmaceutical Technology Department, Faculty of Pharmacy, Menofia University, Menofia City, Egypt.'}, {'ForeName': 'Noha M', 'Initials': 'NM', 'LastName': 'El-Khodary', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt. nohamahmoud_55@hotmail.com.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00608-6']
758,32142869,Impact of Early Prophylactic Cranial Irradiation With Hippocampal Avoidance on Neurocognitive Function in Patients With Limited Disease Small Cell Lung Cancer. A Multicenter Phase 2 Trial (SAKK 15/12).,"PURPOSE


Our purpose was to evaluate neurocognitive function (NCF) and clinical outcomes after early hippocampal avoidance (HA) prophylactic cranial irradiation (PCI) in limited disease (LD) small cell lung cancer (SCLC).
METHODS AND MATERIALS


In a phase 2 trial, patients with LD SCLC received HA-PCI concomitant with the second cycle of chemotherapy and thoracic radiation therapy. All patients underwent objective NCF testing at baseline, 6 weeks, and 6 and 12 months after HA-PCI. NCF tests included Hopkins Verbal Learning Test Revised, Controlled Oral Word Association, and Trail Making Tests A and B. The primary endpoint was NCF decline at 6 months after HA-PCI. We assumed ≤30% of patients with no NCF decline to be unpromising. Secondary endpoints included brain metastases-free survival (BMFS), overall survival (OS), and safety of the concomitant treatment.
RESULTS


Among the 44 patients enrolled in the trial, 38 had evaluable NCF assessment at 6 months after HA-PCI. The proportion of evaluable patients showing no NCF decline at 6 and 12 months was 34.2% (90% confidence interval [CI], 21.6-48.8) and 48.5% (95% CI, 30.8-66.5), respectively. Median follow-up was 13.2 months (95% CI, 12.6-14.1). At 12 months, BMFS was 84.2% and OS was 87.7% (95% CI, 73.0-94.7). Four patients died of SCLC, 1 of respiratory failure, 1 of hemorrhage, and 1 for unknown reason. The most frequently reported grade ≥3 acute adverse events were anemia (21.4%), febrile neutropenia (19.1%), and fatigue (14.3%).
CONCLUSIONS


The proportion of patients showing no NCF decline 6 and 12 months after early HA-PCI does not appear to be better than, but rather similar to, that observed in patients receiving sequential PCI without HA. Early HA-PCI in LD SCLC is feasible, with observation of promising BMFS and OS in this selected population.",2020,"At 12 months, BMFS was 84.2%, and OS was 87.7% (95% CI: 73.0 - 94.7).","['44 patients enrolled in the trial, 38 had evaluable NCF assessment at 6 months after HA-PCI']","['early hippocampal avoidance (HA) prophylactic cranial irradiation (PCI', 'chemotherapy and thoracic radiotherapy']","['Hopkins Verbal Learning Test Revised, Controlled Oral Word Association, and Trail Making Tests (TMT', 'NCF decline', 'BMFS', 'febrile neutropenia', 'fatigue', 'brain metastases free survival (BMFS), overall survival (OS), and safety of the concomitant treatment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",44.0,0.245472,"At 12 months, BMFS was 84.2%, and OS was 87.7% (95% CI: 73.0 - 94.7).","[{'ForeName': 'Hansjörg', 'Initials': 'H', 'LastName': 'Vees', 'Affiliation': 'Radiotherapy Institute, Hirslanden Klinik, Zurich, Switzerland. Electronic address: hansjoerg.vees@hirslanden.ch.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Caparrotti', 'Affiliation': 'Radiation Oncology, University Hospital of Geneva - HUG, Geneva, Switzerland.'}, {'ForeName': 'Eric Innocents', 'Initials': 'EI', 'LastName': 'Eboulet', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Xyrafas', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fuhrer', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Meier', 'Affiliation': 'Radiation Oncology, Cantonal Hospital of Winterthur, Winterthur, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mark', 'Affiliation': 'Medical Oncology, Cantonal Hospital of Graubünden, Chur, Switzerland.'}, {'ForeName': 'Olgun', 'Initials': 'O', 'LastName': 'Elicin', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Aebersold', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Zwahlen', 'Affiliation': 'Medical Oncology, Cantonal Hospital of Graubünden, Chur, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Finazzi', 'Affiliation': 'Clinic of Radiotherapy and Radiation Oncology, University Hospital of Basel, Basel, Switzerland.'}, {'ForeName': 'Abdelkarim Said', 'Initials': 'AS', 'LastName': 'Allal', 'Affiliation': 'Radiation Oncology, Cantonal Hospital of Fribourg - HFR, Fribourg, Switzerland.'}, {'ForeName': 'Paul Martin', 'Initials': 'PM', 'LastName': 'Putora', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, Bern, Switzerland; Radiation Oncology, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Martucci', 'Affiliation': 'Radiation Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Christine Biaggi', 'Initials': 'CB', 'LastName': 'Rudolf', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': 'Quality of Life Office SAKK Coordinating Center and International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.02.029']
759,32203978,Effects of Interleukin-1β Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial.,"Background


Inflammatory cytokines, such as interleukin (IL)-1β, alter iron homeostasis and erythropoiesis, resulting in anemia, but whether inhibition of IL-1β can reverse these effects is unclear.
Objective


To determine whether IL-1β inhibition with canakinumab reduces incident anemia and improves hemoglobin levels among those with prevalent anemia.
Design


Exploratory analysis of a randomized controlled trial. (ClinicalTrials.gov: NCT01327846).
Setting


Many clinical sites in 39 countries.
Participants


8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry.
Intervention


Random assignment to receive placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months.
Measurements


Primary outcome was incident anemia (hemoglobin level <130 g/L in men or <120 g/L in women).
Results


Anemia incidence increased with rising baseline levels of high-sensitivity C-reactive protein (hsCRP), and both hsCRP and IL-6 decreased among participants receiving canakinumab compared with the placebo group. During a median follow-up of 3.7 years, participants without baseline anemia who received canakinumab at any dosage had significantly less incident anemia than those who received placebo (hazard ratio, 0.84 [95% CI, 0.77 to 0.93]; P < 0.001). Compared with placebo, the greatest benefits of IL-1β inhibition on incident anemia were observed among participants with the most robust anti-inflammatory response, an effect corroborated in formal mediation analyses. Among those with baseline anemia, canakinumab increased mean hemoglobin levels by 11.3 g/L (P < 0.001) compared with placebo after 2 years of treatment. Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
Limitation


CANTOS was not designed to assess the cause of anemia in individual trial participants.
Conclusion


These exploratory analyses of randomized trial data provide proof of principle that inflammation inhibition, at least through the IL-1β/IL-6 signaling pathway, reduces the incidence of anemia and improves hemoglobin levels in patients with anemia.
Primary Funding Source


Novartis Pharmaceuticals.",2020,"Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
","['Participants\n\n\n8683 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants without anemia at trial entry and 1303 with prevalent anemia at trial entry', 'those with prevalent anemia', '39 countries', 'Incident Anemia', 'patients with anemia']","['Interleukin-1β Inhibition', 'placebo', 'placebo or canakinumab']","['mean hemoglobin levels', 'hsCRP and IL-6', 'hemoglobin levels', 'incident anemia', 'risk for infection', 'incident anemia (hemoglobin level', 'thrombocytopenia and neutropenia']","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C1265848', 'cui_str': 'Inflammatory thrombosis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",,0.720694,"Canakinumab increased the risk for infection and was associated with mild cases of thrombocytopenia and neutropenia, none of which was grade 3 or higher.
","[{'ForeName': 'Mounica', 'Initials': 'M', 'LastName': 'Vallurupalli', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey (T.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (M.V., J.G.M., R.J.G., P.L., N.B., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-2945']
760,32017777,Effects of remote limb ischemic conditioning on muscle strength in healthy young adults: A randomized controlled trial.,"Remote limb ischemic conditioning (RLIC) is a clinically feasible method in which brief, sub-lethal bouts of ischemia protects remote organs or tissues from subsequent ischemic injury. A single session of RLIC can improve exercise performance and increase muscle activation. The purpose of this study, therefore, was to assess the effects of a brief, two-week protocol of repeated RLIC combined with strength training on strength gain and neural adaptation in healthy young adults. Participants age 18-40 years were randomized to receive either RLIC plus strength training (n = 15) or sham conditioning plus strength training (n = 15). Participants received RLIC or sham conditioning over 8 visits using a blood pressure cuff on the dominant arm with 5 cycles of 5 minutes each alternating inflation and deflation. Visits 3-8 paired conditioning with wrist extensors strength training on the non-dominant (non-conditioned) arm using standard guidelines. Changes in one repetition maximum (1 RM) and electromyography (EMG) amplitude were compared between groups. Both groups were trained at a similar workload. While both groups gained strength over time (P = 0.001), the RLIC group had greater strength gains (9.38 ± 1.01 lbs) than the sham group (6.3 ± 1.08 lbs, P = 0.035). There was not a significant group x time interaction in EMG amplitude (P = 0.231). The RLIC group had larger percent changes in 1 RM (43.8% vs. 26.1%, P = 0.003) and EMG amplitudes (31.0% vs. 8.6%, P = 0.023) compared to sham conditioning. RLIC holds promise for enhancing muscle strength in healthy young and older adults, as well as clinical populations that could benefit from strength training.",2020,"While both groups gained strength over time (P = 0.001), the RLIC group had greater strength gains (9.38 ± 1.01 lbs) than the sham group (6.3 ± 1.08 lbs, P = 0.035).","['Participants age 18-40 years', 'healthy young and older adults', 'healthy young adults']","['RLIC', 'sham conditioning plus strength training', 'Remote limb ischemic conditioning (RLIC', 'RLIC or sham conditioning over 8 visits using a blood pressure cuff on the dominant arm with 5 cycles of 5 minutes each alternating inflation and deflation', 'RLIC plus strength training', 'remote limb ischemic conditioning', 'RLIC combined with strength training', 'wrist extensors strength training']","['time interaction in EMG amplitude', 'RM', 'repetition maximum (1 RM) and electromyography (EMG) amplitude', 'exercise performance and increase muscle activation', 'EMG amplitudes', 'strength gains', 'muscle strength', 'strength gain and neural adaptation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff, device (physical object)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]",,0.0365265,"While both groups gained strength over time (P = 0.001), the RLIC group had greater strength gains (9.38 ± 1.01 lbs) than the sham group (6.3 ± 1.08 lbs, P = 0.035).","[{'ForeName': 'Swati M', 'Initials': 'SM', 'LastName': 'Surkar', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Marghuretta D', 'Initials': 'MD', 'LastName': 'Bland', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Mattlage', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Gidday', 'Affiliation': 'Departments of Ophthalmology, Physiology, and Neuroscience, Louisiana State University Health Sciences Center, New Orleans, LA, United States of America.'}, {'ForeName': 'Jin-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hershey', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine, St. Louis, MO, United States of America.'}]",PloS one,['10.1371/journal.pone.0227263']
761,32203980,Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes: A Randomized Trial.,"Background


Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies.
Objective


To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1-risk MDS.
Design


Multicenter, randomized, double-blind, placebo-controlled trial (TELESTO). (ClinicalTrials.gov: NCT00940602).
Setting


60 centers in 16 countries.
Participants


225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities.
Intervention


Deferasirox dispersible tablets (10 to 40 mg/kg per day) (n = 149) or matching placebo (n = 76).
Measurements


The primary end point was EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first.
Results


Median time on treatment was 1.6 years (interquartile range [IQR], 0.5 to 3.1 years) in the deferasirox group and 1.0 year (IQR, 0.6 to 2.0 years) in the placebo group. Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]). Adverse events occurred in 97.3% of deferasirox recipients and 90.8% of placebo recipients. Exposure-adjusted incidence rates of adverse events (≥15 events per 100 patient treatment-years) in deferasirox versus placebo recipients, respectively, were 24.7 versus 23.9 for diarrhea, 21.8 versus 18.7 for pyrexia, 16.7 versus 22.7 for upper respiratory tract infection, and 15.9 versus 0.9 for increased serum creatinine concentration.
Limitations


The protocol was amended from a phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants. There was differential follow-up between treatment groups.
Conclusion


The findings support ICT in iron-overloaded patients with low- to intermediate-1-risk MDS, with longer EFS compared with placebo and a clinically manageable safety profile. Therefore, ICT may be considered in these patients.
Primary Funding Source


Novartis Pharma AG.",2020,"Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]).","['Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes', 'Participants\n\n\n225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities', 'Setting\n\n\n60 centers in 16 countries', 'patients with lower-risk myelodysplastic syndromes (MDS', 'iron-overloaded patients with low- or intermediate-1-risk MDS', 'phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants']","['matching placebo', 'placebo', '\n\n\nIron chelation therapy (ICT', 'ICT', 'Iron Chelation']","['adverse events', 'EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first', 'Adverse events', 'serum creatinine concentration', 'Median EFS']","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0282193', 'cui_str': 'Iron Overload'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C4324477', 'cui_str': 'Transformation to acute myeloid leukaemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",225.0,0.554516,"Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]).","[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Angelucci', 'Affiliation': 'Hematology and Transplant Center, IRCCS Ospedale Policlinico San Martino, Genova, Italy (E.A.).'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (J.L.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Greenberg', 'Affiliation': 'Stanford University Medical Center, Stanford, California (P.G.).'}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Institute of Hematology, First Affiliated Hospital of Soochow University, Suzhou, China (D.W.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Shandong University, Jinan, China (M.H.).'}, {'ForeName': 'Efreen Horacio', 'Initials': 'EH', 'LastName': 'Montano Figueroa', 'Affiliation': 'Department of Hematology, Hospital General de México, Mexico City, Mexico (E.H.M.).'}, {'ForeName': 'Maria Guadalupe', 'Initials': 'MG', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology, Hospital de Especialidades, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico (M.G.R.).'}, {'ForeName': 'Xunwei', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (X.D., J.G.).'}, {'ForeName': 'Jagannath', 'Initials': 'J', 'LastName': 'Ghosh', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (X.D., J.G.).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland (M.I.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas (G.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0916']
762,32291620,Efficacy of furosemide-albumin compared with furosemide in critically ill hypoalbuminemia patients admitted to intensive care unit: a prospective randomized clinical trial.,"BACKGROUND


Some physicians co-administer albumin with loop diuretics to overcome diuretic resistance in critically ill hypoalbuminemia patients, though previous studies have reported conflicting results on this matter.
OBJECTIVE


The effects of adding albumin to furosemide to enhance its efficacy in critically ill hypoalbuminemia patients are evaluated.
METHODS


This was a non-blinded randomized trial. 49 adult critically ill patients with hypoalbuminemia and generalized edema who received randomly furosemide and furosemide/albumin complex were enrolled. The patients' urine was collected at intervals of 2, 4, 6 and 8 h after initiation of the furosemide treatment, and the urine output and urinary excretion of furosemide and sodium were measured. The urinary excretion of furosemide was considered an indicator of drug efficacy.
RESULTS


The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group. No significant correlation between APACHE II scores and serum albumin levels and the urinary excretion of furosemide was seen.
CONCLUSION


The results indicated that there is not statistically significant differences between groups with furosemide alone and combined with albumin in urinary furosemide excretion. It seems that adding albumin for furosemide pharmacotherapy regime is not recommended as an intervention to increase furosemide efficacy in critically ill hypoalbuminemia patients.
TRIAL REGISTRATION


IRCT with the registration number IRCT201412132582N12 in 23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract.",2020,"The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group.","['49 adult critically ill patients with hypoalbuminemia and generalized edema who received', 'critically ill hypoalbuminemia patients', 'critically ill hypoalbuminemia patients admitted to intensive care unit', '23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract']","['furosemide-albumin', 'albumin to furosemide', 'furosemide', 'randomly furosemide and furosemide/albumin complex']","['APACHE II scores and serum albumin levels', 'urinary excretion of furosemide', 'furosemide efficacy', 'urine output and urinary excretion of furosemide and sodium', 'urinary furosemide excretion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239981', 'cui_str': 'Hypoalbuminemia'}, {'cui': 'C0151603', 'cui_str': 'Anasarca'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]",49.0,0.10447,"The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group.","[{'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sahra', 'Initials': 'S', 'LastName': 'Zahedi', 'Affiliation': 'Iranian Evidence Based Medicine Center of Excellence, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Pourakbar', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parina', 'Initials': 'P', 'LastName': 'Asgharian', 'Affiliation': 'Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Shahabi', 'Affiliation': 'Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishehkar', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. hamishehkar@gmail.com.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00339-8']
763,32271146,Combined aerobic resistance exercise improves dialysis adequacy and quality of life in patients on maintenance hemodialysis
.,"OBJECTIVE


This study aims to compare the effect of pure aerobic exercise and combined aerobic resistance exercise on dialysis adequacy and quality of life in patients on maintenance hemodialysis.
MATERIALS AND METHODS


A total of 45 patients on maintenance hemodialysis were divided into three groups: pure aerobic exercise group, combined aerobic resistance exercise group, and control group. Patients in the control group were only given the usual treatment, which included dietary guidance, drug therapy, and hemodialysis. The other training groups underwent 12-week exercise intervention therapy on the basis of the usual treatment. Blood samples were collected before and after the hemodialysis, at the beginning and end of the intervention for these three groups. Then, the blood urea nitrogen (BUN) concentration was determined, the urea clearance index (Kt/v) and urea degradation rate (URR) were calculated, the dialysis adequacy was evaluated, and the short form-36 (SF-36) scale was used to evaluate the life quality.
RESULTS


Before intervention, there was no significant difference in general health condition (GH), Kt/v, URR, SF-36 total score, and the score of each dimension in the three groups. After the intervention therapy, the Kt/v, URR, GH, vitality (VT), and SF-36 total score markedly improved in the pure aerobic exercise group, while the Kt/v, URR, GH, VT, physical functioning (PF), and SF-36 total score significantly increased in the combined aerobic resistance exercise group. Furthermore, compared with the pure aerobic exercise group, the improvement effect of body function (PF score) was better in the combined aerobic resistance exercise group.
CONCLUSION


Both pure aerobic exercise and combined aerobic resistance exercise can significantly improve the dialysis adequacy and quality of life of maintenance hemodialysis patients. Compared with the pure aerobic exercise group, the effect of combined aerobic resistance exercise on PF was better.
.",2020,Both pure aerobic exercise and combined aerobic resistance exercise can significantly improve the dialysis adequacy and quality of life of maintenance hemodialysis patients.,"['patients on maintenance hemodialysis', '45 patients on maintenance hemodialysis', 'maintenance hemodialysis patients', 'patients on maintenance hemodialysis\u2029']","['combined aerobic resistance exercise', 'pure aerobic exercise and combined aerobic resistance exercise', 'pure aerobic exercise group, combined aerobic resistance exercise group, and control group', 'Combined aerobic resistance exercise', 'pure aerobic exercise', 'exercise intervention therapy']","['urea clearance index (Kt/v) and urea degradation rate (URR', 'short form-36 (SF-36) scale', 'body function (PF score', 'Blood samples', 'dialysis adequacy and quality of life', 'general health condition (GH), Kt/v, URR, SF-36 total score, and the score of each dimension', 'Kt/v, URR, GH, vitality (VT), and SF-36 total score', 'URR, GH, VT, physical functioning (PF), and SF-36 total score', 'blood urea nitrogen (BUN) concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",45.0,0.022542,Both pure aerobic exercise and combined aerobic resistance exercise can significantly improve the dialysis adequacy and quality of life of maintenance hemodialysis patients.,"[{'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Qige', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN110033']
764,30677126,The effect of strengthening health literacy in nursing homes on employee pain and consequences of pain ‒ a stepped-wedge intervention trial.,"Objective This study examined the effectiveness of a workplace health literacy intervention on pain intensity, bothersomeness of pain, and sickness absence. Methods The quasi-experimental stepped-wedge cluster trial evaluated an intervention with two elements: (i) courses for employees and management to organize a joint foundation of knowledge about pain prevention and management with communication tools, and (ii) structured dialogs between employee and supervisor, to develop action plans to prevent and reduce pain. Monthly measurements were taken of pain intensity (0-10 scale), bothersomeness (days/month), and pain-related absence (days/month). Results Six workplaces were recruited, and 88% of employees (509) participated in evaluations. At baseline, mean pain level was 4.0, mean bothersomeness was 3.8 days/month, and mean pain-related absence was 0.6 days/month. From linear mixed models, pain intensity was reduced by -0.28 [95% confidence interval (CI) -0.52- -0.04] corresponding to a 7% reduction. For employees with pain >3 at baseline, the reduction was -0.74 (95% CI -1.11- -0.38) or 12%. There was no significant mean change in bothersomeness or sickness absence among all employees. Conclusion This intervention was both feasible and effective in shifting the overall mean pain level downwards for the entire population by 7%, with an accentuated effect among employees with pain levels >3. Organizing health literacy in nursing homes might be a feasible and effective way to build work environment efforts targeting the needs of employees. Future studies should investigate whether organizing health literacy is effective in other workplace settings and for employees with other health challenges.",2019,"This intervention was both feasible and effective in shifting the overall mean pain level downwards for the entire population by 7%, with an accentuated effect among employees with pain levels >3.","['Results Six workplaces were recruited, and 88% of employees (509) participated in evaluations']","['intervention with two elements: (i) courses for employees and management to organize a joint foundation of knowledge about pain prevention and management with communication tools, and (ii) structured dialogs between employee and supervisor', 'workplace health literacy intervention', 'strengthening health literacy']","['pain intensity (0-10 scale), bothersomeness (days/month), and pain-related absence', 'employee pain and consequences of pain', 'pain intensity, bothersomeness of pain, and sickness absence', 'bothersomeness or sickness absence', 'mean pain level', 'pain intensity']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0556971', 'cui_str': 'days/month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",6.0,0.0809642,"This intervention was both feasible and effective in shifting the overall mean pain level downwards for the entire population by 7%, with an accentuated effect among employees with pain levels >3.","[{'ForeName': 'Anne Konring', 'Initials': 'AK', 'LastName': 'Larsen', 'Affiliation': 'National Research Centre for the Working Environment, Lersø Parkallé 105, Copenhagen, Denmark. akl@nrcwe.dk.'}, {'ForeName': 'Lau Caspar', 'Initials': 'LC', 'LastName': 'Thygesen', 'Affiliation': ''}, {'ForeName': 'Ole Steen', 'Initials': 'OS', 'LastName': 'Mortensen', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Punnett', 'Affiliation': ''}, {'ForeName': 'Marie Birk', 'Initials': 'MB', 'LastName': 'Jørgensen', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3801']
765,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS


Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS


At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
766,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES


Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS


In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS


Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS


Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
767,31229663,"A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.","BACKGROUND CONTEXT


Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN).
PURPOSE


The purpose of this RCT was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology.
STUDY DESIGN/SETTING


A prospective, parallel, open label RCT was conducted at 20 U.S. sites.
PATIENT SAMPLE


A total of 140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care.
OUTCOME MEASURES


Oswestry Disability Index (ODI) was collected at baseline, 3, 6, 9, and 12-months postprocedure. Secondary outcome measures included a 10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment.
METHODS


Patients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their 3-month primary endpoint visit.
RESULTS


The interim analysis showed clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm. This resulted in a data management committee recommendation to halt enrollment in the study and offer early cross-over to the control arm. These results are comprised of the outcomes of the 104 patients included in the intent-to-treat analysis of the 3-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm. Baseline ODI was 46.1, VAS was 6.67, and mean age was 50 years. The percentage of patients with LBP symptoms ≥5 years was 67.3%. Comparing the RF ablation arm to the standard care arm, the mean changes in ODI at 3 months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<.001). Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 cm (p<.001). In the RF ablation arm, 74.5% of patients achieved a ≥10-point improvement in ODI, compared with 32.7% in the standard care arm (p<0.001).
CONCLUSIONS


Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.",2019,The interim analysis showed clear statistical superiority (p < 0.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared to the standard care arm.,"['140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 to S1', 'chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology', 'patients with chronic vertebrogenic related LBP', 'Patients', '104 patients included in the intent-to-treat (ITT) analysis of the 3-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm', 'Chronic Low Back Pain']","['RF ablation or to continue standard care', 'Intraosseous Basivertebral Nerve Ablation', 'radiofrequency (RF) ablation of the basivertebral nerve (BVN', 'RF ablation of the BVN or continue standard care', 'RF ablation']","['Mean changes in VAS', 'Oswestry Disability Index (ODI', '10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI', 'pain and function', 'ODI']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}]",140.0,0.110935,The interim analysis showed clear statistical superiority (p < 0.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared to the standard care arm.,"[{'ForeName': 'Jad G', 'Initials': 'JG', 'LastName': 'Khalil', 'Affiliation': 'William Beaumont Hospital, Department of Orthopaedic Surgery, 3811 West 13 Mile Rd, Royal Oak, MI 48073, USA. Electronic address: jadkhalil@gmail.com.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Smuck', 'Affiliation': 'Stanford Orthopedic Surgery, 450 Broadway St, Pavillion C, Redwood City, CA 94063, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Koreckij', 'Affiliation': ""Saint Luke's Hospital, Medical Plaza Bldg 1, Ste. 610, 4320 Wornall Rd, Kansas City, MO 64111, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keel', 'Affiliation': 'Emory Orthopedics/Spine Center, 59 Executive Park South NE, Atlanta, GA 30329, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Beall', 'Affiliation': 'Clinical Investigations, LLC, 1800 S. Renaissance Blvd, Ste 110, Edmond, OK 73013, USA.'}, {'ForeName': 'Bradly', 'Initials': 'B', 'LastName': 'Goodman', 'Affiliation': 'Alabama Clinical Therapeutics, LLC, 52 Medical Park East Drive, Suite 203, Birmingham, Alabama 35235, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kalapos', 'Affiliation': 'Penn State Hershey Medical Center, 500 University Drive, H066, Hershey, PA 17033, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'Oklahoma Spine Hospital, 14100 Parkway Commons Drive, Ste 103, Oklahoma City, OK 73134, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Garfin', 'Affiliation': 'University of California San Diego, 9500 Gilman Drive, #0602, La Jolla, CA 92093-0602, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2019.05.598']
768,31039579,Neural predictors of treatment response to brain stimulation and psychological therapy in depression: a double-blind randomized controlled trial.,"Standard depression treatments, including antidepressant medication and cognitive behavioural therapy (CBT), are ineffective for many patients. Prefrontal transcranial direct current stimulation (tDCS) has been proposed as an alternative treatment, but has shown inconsistent efficacy for depression, and its mechanisms are poorly understood. We recruited unmedicated patients with major depressive disorder (N = 71 approached; N = 39 randomised) for a mechanistic, double-blind, randomized controlled trial consisting of eight weekly sessions of prefrontal tDCS administered to the left prefrontal cortex prior to CBT. We probed (1) whether tDCS improved the efficacy of CBT relative to sham stimulation; and (2) whether neural measures predicted clinical response. We found a modest and non-significant effect of tDCS on clinical outcome over and above CBT (active: 50%; sham: 31.6%; odds ratio: 2.16, 95% CI = 0.59-7.99), but a strong relationship, predicted a priori, between baseline activation during a working memory task in the stimulated prefrontal region and symptom improvement. Repeating our analyses of symptom outcome splitting the sample according to this biomarker revealed that tDCS was significantly superior to sham in individuals with high left prefrontal cortex activation at baseline; we also show 86% accuracy in predicting clinical response using this measure. Exploratory analyses revealed several other regions where activation at baseline was associated with subsequent response to CBT, irrespective of tDCS. This mechanistic trial revealed variable, but predictable, clinical effects of prefrontal tDCS combined with CBT for depression. We have discovered a potential explanation for this variability: individual differences in baseline activation of the region stimulated. Such a biomarker could potentially be used to pre-select patients for trials and, eventually, in the clinic.",2019,"We found a modest and non-significant effect of tDCS on clinical outcome over and above CBT (active: 50%; sham: 31.6%; odds ratio: 2.16, 95% CI = 0.59-7.99), but a strong relationship, predicted a priori, between baseline activation during a working memory task in the stimulated prefrontal region and symptom improvement.","['unmedicated patients with major depressive disorder (N\u2009=\u200971 approached; N\u2009=\u200939 randomised', 'depression']","['antidepressant medication and cognitive behavioural therapy (CBT', 'Prefrontal transcranial direct current stimulation (tDCS', 'prefrontal tDCS', 'brain stimulation and psychological therapy', 'tDCS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}]",[],,0.175638,"We found a modest and non-significant effect of tDCS on clinical outcome over and above CBT (active: 50%; sham: 31.6%; odds ratio: 2.16, 95% CI = 0.59-7.99), but a strong relationship, predicted a priori, between baseline activation during a working memory task in the stimulated prefrontal region and symptom improvement.","[{'ForeName': 'Camilla L', 'Initials': 'CL', 'LastName': 'Nord', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK. Camilla.Nord@mrc-cbu.cam.ac.uk.'}, {'ForeName': 'D Chamith', 'Initials': 'DC', 'LastName': 'Halahakoon', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Limbachya', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Charpentier', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Níall', 'Initials': 'N', 'LastName': 'Lally', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Walsh', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Leibowitz', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0401-0']
769,31122678,Development of a structured virtual reality curriculum for laparoscopic appendicectomy.,"BACKGROUND


Laparoscopic appendicectomy (LA) is a common surgical emergency procedure mainly performed by trainees. The aim was to develop a step-wise structured virtual reality (VR) curriculum for LA to allow junior surgeons to hone their skills in a safe and controlled environment.
METHODS


A prospective randomized study was designed using a high-fidelity VR simulator. Thirty-five novices and 25 experts participated in the assessment and their performances were compared to assess construct validity. Learning curve analysis was performed.
RESULTS


Five of the psychomotor tasks and all appendicectomy tasks showed construct validity. Learning was demonstrated in the majority of construct-valid tasks. A novel goal-directed VR curriculum for LA was constructed.
CONCLUSIONS


A step-wise structured VR curriculum for LA is proposed with a framework which includes computer generated metrics and supports deliberate practice, spacing intervals, human instruction/feedback and assessment. Future study should test the feasibility of its implementation and transferability of acquired skill.",2020,Five of the psychomotor tasks and all appendicectomy tasks showed construct validity.,[],"['step-wise structured virtual reality (VR) curriculum for LA', 'Laparoscopic appendicectomy (LA']",[],[],"[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]",[],35.0,0.0316028,Five of the psychomotor tasks and all appendicectomy tasks showed construct validity.,"[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Sinitsky', 'Affiliation': 'Division of Surgery & Interventional Science, Royal Free Campus, UCL, London, UK.'}, {'ForeName': 'Bimbi', 'Initials': 'B', 'LastName': 'Fernando', 'Affiliation': 'Division of Surgery & Interventional Science, Royal Free Campus, UCL, London, UK.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Potts', 'Affiliation': 'Institute of Health Informatics, UCL, London, UK.'}, {'ForeName': 'Panagis', 'Initials': 'P', 'LastName': 'Lykoudis', 'Affiliation': 'Division of Surgery & Interventional Science, Royal Free Campus, UCL, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hamilton', 'Affiliation': 'Division of Surgery & Interventional Science, Royal Free Campus, UCL, London, UK.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Berlingieri', 'Affiliation': 'Division of Surgery & Interventional Science, Royal Free Campus, UCL, London, UK; Centre for Screen-Based Medical Simulation, Royal Free Hospital, London, UK. Electronic address: p.berlingieri@ucl.ac.uk.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.04.020']
770,31376878,Endogenous cortisol and conditioned placebo effects on pain - A randomized trial.,"Placebo effects can be induced by learning and conditioning processes, which in turn are influenced and modulated by glucocorticoids. Accordingly, previous research has shown that intervention-related associative learning can be modulated through exogenous as well as endogenous glucocorticoids. Thus, the aim of this study was to elucidate whether placebo effects induced by conditioning is modulated by daily fluctuations of endogenous cortisol levels in healthy male and female subjects. Overall 77 participants underwent a two-phased placebo conditioning paradigm for pain analgesia. Subjects were randomized in two groups, which underwent placebo preconditioning either in the morning (08:00-10:00, i.e. with high endogenous cortisol levels) or in the afternoon (16:00-18:00, i.e. with low endogenous cortisol levels). Placebo effects were assessed two days later at noontime (12:00-13:00), with possible differences between groups as an indicator of glucocorticoid modulation on the placebo learning. Results indicated a significant conditioned placebo-induced analgesia, resulting in a placebo effect of small to medium size. Cortisol levels on conditioning day significantly differed between groups and cortisol levels were similar during assessment of placebo effects. Groups did not differ in their mean reduction in pain sensation, thus the placebo effect was not affected by differences in cortisol levels during the conditioning of placebo effects. The present study does not indicate a moderation of placebo conditioning by endogenous glucocorticoid levels.",2019,"Groups did not differ in their mean reduction in pain sensation, thus the placebo effect was not affected by differences in cortisol levels during the conditioning of placebo effects.","['healthy male and female subjects', 'Overall 77 participants']","['placebo', 'Placebo', 'Endogenous cortisol and conditioned placebo', 'placebo preconditioning']","['Cortisol levels', 'pain analgesia', 'cortisol levels', 'pain sensation']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",77.0,0.35453,"Groups did not differ in their mean reduction in pain sensation, thus the placebo effect was not affected by differences in cortisol levels during the conditioning of placebo effects.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland. Electronic address: jens.gaab@unibas.ch.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bürgin', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Urech', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bratschi', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Lorena Bartolomé', 'Initials': 'LB', 'LastName': 'Garcia', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Hauke', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Bitter', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bohny', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Switzerland.'}, {'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Bentz', 'Affiliation': 'Division of Cognitive Neuroscience, Faculty of Psychology, University of Basel, Switzerland; Psychiatric University Clinics, University of Basel, Switzerland.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2019.109739']
771,32282100,"EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes.","On June 28, 2018, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vyxeos, intended for the treatment of acute myeloid leukemia (AML). Vyxeos was designated as an orphan medicinal product on January 11, 2012. The applicant for this medicinal product was Jazz Pharmaceuticals Ireland Limited. Vyxeos is a liposomal formulation of a fixed combination of daunorubicin and cytarabine, antineoplastic agents that inhibit topoisomerase II activity and also cause DNA damage. The strength of Vyxeos is 5 units/mL, where 1 unit equals 1.0 mg cytarabine plus 0.44 mg daunorubicin. The marketing authorization holder Jazz Pharmaceuticals had found that this was an optimal ratio for the efficacy of the product. Study CLTR0310-301, a phase III, multicenter, randomized, trial of Vyxeos (daunorubicin-cytarabine) liposome injection versus standard 3+7 daunorubicin and cytarabine in patients aged 60-75 years with untreated high-risk (secondary) AML, showed a statistically significant difference between the two groups in overall survival (OS) with a median OS of 9.56 months in the daunorubicin-cytarabine arm compared with 5.95 months for standard chemotherapy (hazard ratio, 0.69; 95% confidence interval, 0.52-0.90; one-sided p = .003). The most common side effects were hypersensitivity including rash, febrile neutropenia, edema, diarrhea/colitis, mucositis, fatigue, musculoskeletal pain, abdominal pain, decreased appetite, cough, headache, chills, arrhythmia, pyrexia, sleep disorders, and hypotension. IMPLICATIONS FOR PRACTICE: Vyxeos has demonstrated a clinically significant improvement in overall survival compared with the standard of care 7+3 in the proposed population of patients with newly diagnosed acute myeloid leukemia (AML) with myelodysplasia-related changes and therapy-related AML. This is remarkable given the very poor prognosis of these patients and their unmet medical need. Secondary endpoints support the primary outcome, in particular an increased rate of hematopoietic stem cell transplantation, which is potentially the only curative treatment in AML.",2020,"The most common side effects were hypersensitivity including rash, febrile neutropenia, edema, diarrhea/colitis, mucositis, fatigue, musculoskeletal pain, abdominal pain, decreased appetite, cough, headache, chills, arrhythmia, pyrexia, sleep disorders, and hypotension.","['patients with newly diagnosed acute myeloid leukemia (AML) with myelodysplasia-related changes and therapy-related AML', 'Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes', 'patients aged 60-75\u2009years with untreated high-risk (secondary) AML']","['daunorubicin and cytarabine', 'daunorubicin and cytarabine, antineoplastic agents', 'daunorubicin-cytarabine', 'Vyxeos (daunorubicin-cytarabine) liposome', 'Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351', 'cytarabine plus 0.44 mg daunorubicin']","['overall survival', 'rate of hematopoietic stem cell transplantation, which is potentially the only curative treatment in AML', 'overall survival (OS', 'hypersensitivity including rash, febrile neutropenia, edema, diarrhea/colitis, mucositis, fatigue, musculoskeletal pain, abdominal pain, decreased appetite, cough, headache, chills, arrhythmia, pyrexia, sleep disorders, and hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1336735', 'cui_str': 'Treatment related acute myeloid leukaemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2825139', 'cui_str': 'Acute myeloid leukemia with myelodysplasia-related changes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C2346682', 'cui_str': 'CPX-351'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517459', 'cui_str': '0.44'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.117222,"The most common side effects were hypersensitivity including rash, febrile neutropenia, edema, diarrhea/colitis, mucositis, fatigue, musculoskeletal pain, abdominal pain, decreased appetite, cough, headache, chills, arrhythmia, pyrexia, sleep disorders, and hypotension.","[{'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Tzogani', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Karri', 'Initials': 'K', 'LastName': 'Penttilä', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Lapveteläinen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hemmings', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Freire', 'Affiliation': 'Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Márcia', 'Affiliation': 'Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Coppola', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Flores', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Barbachano', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Silvia Domingo', 'Initials': 'SD', 'LastName': 'Roige', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0785']
772,31039580,Quitting starts in the brain: a randomized controlled trial of app-based mindfulness shows decreases in neural responses to smoking cues that predict reductions in smoking.,"Current treatments for smoking yield suboptimal outcomes, partly because of an inability to reduce cue-induced smoking. Mindfulness training (MT) has shown preliminary efficacy for smoking cessation, yet its neurobiological target remains unknown. Our prior work with nonsmokers indicates that MT reduces posterior cingulate cortex (PCC) activity. In individuals who smoke, the PCC, consistently a main hub of the ""default mode network,"" activates in response to smoking cues. In this randomized controlled trial, we tested the effects of app-delivered MT on PCC reactivity to smoking cues and whether individual differences in MT-mediated PCC changes predicted smoking outcomes. Smoking cue-induced PCC reactivity was measured using functional magnetic resonance imaging at baseline and 1 month after receiving smartphone app-based MT (n = 33) vs. an active control (National Cancer Institute's QuitGuide, n = 34). Whether individual differences in treatment-related changes in PCC activity predicted smoking behavior was assessed. The MT group demonstrated a significant correlation between a reduction in PCC reactivity to smoking cues and a decline in cigarette consumption (r = 0.39, p = 0.02). No association was found in the control group (r = 0.08, p = 0.65). No effects of group alone were found in PCC or cigarette reduction. Post hoc analysis revealed this association is sex specific (women, r = 0.49, p = 0.03; men: r = -0.08, p = 0.79). This initial report indicates that MT specifically reduces smoking cue-induced PCC activity in a subject-specific manner, and the reduction in PCC activity predicts a concurrent decline in smoking. These findings link the hypothesized behavioral effects of MT for smoking to neural mechanisms particularly in women. This lays the groundwork for identifying individuals who may benefit from targeted digital therapeutic treatments such as smartphone-based MT, yielding improved clinical outcomes.",2019,No effects of group alone were found in PCC or cigarette reduction.,[],"['app-delivered MT', 'MT', 'smartphone app-based MT', 'Mindfulness training (MT']","['smoking cue-induced PCC activity', 'posterior cingulate cortex (PCC) activity', 'PCC reactivity to smoking cues and a decline in cigarette consumption', 'Smoking cue-induced PCC reactivity']",[],"[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}]",,0.0279824,No effects of group alone were found in PCC or cigarette reduction.,"[{'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, 02478, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Datko', 'Affiliation': 'Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, 149 Thirteenth St. #2301, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine, 121S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Druker', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Neal', 'Affiliation': 'University of Oklahoma-Tulsa School of Community Medicine, Tulsa, OK, 74135, USA.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Ohashi', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, 02478, USA.'}, {'ForeName': 'Hanif', 'Initials': 'H', 'LastName': 'Benoit', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Remko', 'Initials': 'R', 'LastName': 'van Lutterveld', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine, 121S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Judson A', 'Initials': 'JA', 'LastName': 'Brewer', 'Affiliation': 'Mindfulness Center, Brown University School of Public Health and Warren Alpert School of Medicine, 121S Main St, Providence, RI, 02903, USA. judson_brewer@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0403-y']
773,31060042,Emotion-based brain mechanisms and predictors for SSRI and CBT treatment of anxiety and depression: a randomized trial.,"Mechanisms and predictors for the successful treatment of anxiety and depression have been elusive, limiting the effectiveness of existing treatments and curtailing the development of new interventions. In this study, we evaluated the utility of three widely used neural probes of emotion (experience, regulation, and perception) in their ability to predict symptom improvement and correlate with symptom change following two first-line treatments-selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). Fifty-five treatment-seeking adults with anxiety and/or depression were randomized to 12 weeks of SSRI or CBT treatment (ClinicalTrials.gov identifier: NCT01903447). Functional magnetic resonance imaging (fMRI) was used to examine frontolimbic brain function during emotion experience, regulation, and perception, as probed by the Emotion Regulation Task (ERT; emotion experience and regulation) and emotional face assessment task (EFAT; emotion perception). Brain function was then related to anxiety and depression symptom change. Results showed that both SSRI and CBT treatments similarly attenuated insula and amygdala activity during emotion perception, and greater treatment-related decrease in insula and amygdala activity was correlated with greater reduction in anxiety symptoms. Both treatments also reduced amygdala activity during emotion experience but brain change did not correlate with symptom change. Lastly, greater pre-treatment insula and amygdala activity during emotion perception predicted greater anxiety and depression symptom improvement. Thus, limbic activity during emotion perception is reduced by both SSRI and CBT treatments, and predicts anxiety and depression symptom improvement. Critically, neural reactivity during emotion perception may be a non-treatment-specific mechanism for symptom improvement.",2019,"Results showed that both SSRI and CBT treatments similarly attenuated insula and amygdala activity during emotion perception, and greater treatment-related decrease in insula and amygdala activity was correlated with greater reduction in anxiety symptoms.",['Fifty-five treatment-seeking adults with anxiety and/or depression'],"['SSRI or CBT', 'serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT', 'Functional magnetic resonance imaging (fMRI', 'SSRI and CBT']","['Brain function', 'limbic activity during emotion perception', 'anxiety and depression symptom improvement', 'Emotion Regulation Task (ERT; emotion experience and regulation) and emotional face assessment task (EFAT; emotion perception', 'anxiety and depression symptom change', 'anxiety symptoms', 'insula and amygdala activity', 'insula and amygdala activity during emotion perception', 'amygdala activity']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0162758', 'cui_str': '5-HT Uptake Inhibitors'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}]",55.0,0.0131036,"Results showed that both SSRI and CBT treatments similarly attenuated insula and amygdala activity during emotion perception, and greater treatment-related decrease in insula and amygdala activity was correlated with greater reduction in anxiety symptoms.","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA. sgorka2@uic.edu.'}, {'ForeName': 'Christina B', 'Initials': 'CB', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Klumpp', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Kennedy', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Shankman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Departments of Psychiatry and Family Medicine and Public Health, University of California-San Diego, La Jolla, CA, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0407-7']
774,32285486,The effectiveness of a pressure injury prevention program for nursing assistants in private for-profit nursing homes: A cluster randomized controlled trial.,"AIM


To examine the effectiveness of a pressure injury prevention program for private for-profit nursing homes.
DESIGN


This study was a two-arm cluster randomized controlled trial. Ten private for-profit nursing homes made up the clusters.
METHODS


The participants were nursing home residents who aged 60 or above regardless of whether or not having pre-existing pressure injuries and also three types of nursing home assistants who provided direct care to the residents from 10 private for-profit nursing homes. These 10 nursing homes were randomly assigned to either the experimental or the control group. There were 477 and 536 resident participants and 51 and 62 nursing assistant participants in the experimental and control groups, respectively. The residents were the study participants and the nursing assistant participants were the interveners. The experimental group had the pressure injury prevention program implemented while the control group received the usual care. The primary study outcome which was the pressure injury incidence was analysed by GEE. Significance was set at a p-value of ≤.05. The data were collected between September 2017-March 2018.
RESULT


There were significant interactive effects of time and group on the incidence of pressure injuries (p = .0015) and on the skill performance of the nursing assistant participants (p < .0001).
CONCLUSIONS


An evidence-based pressure injury prevention program reduced the development of the pressure injuries and improved the skill performance of the nursing assistant participants. It is highly recommended that private for-profit nursing homes with high proportion of non-professional nursing assistants and insufficient nurses adopt this program for improving the prevention care of pressure injuries.
IMPACT


This research has an impact on prevention care of pressure injury in private for-profit nursing homes with high proportion non-professional nursing assistants which have the similar characteristics as the nursing homes studied in various regions and countries.
TRIAL REGISTRATION


The Controlled Trial registration ID is NCT02270385.",2020,"There were significant interactive effects of time and group on the incidence of pressure injuries (p=0.0015) and on the skill performance of the nursing assistant participants (p<0.0001).
","['Nursing Assistants in Private For-profit Nursing Homes', 'private for-profit nursing homes', 'nursing assistant participants', 'private for-profit nursing homes with high proportion non-professional nursing assistants', 'participants were nursing home residents who aged 60 or above regardless of whether or not having pre-existing pressure injuries and also three types of nursing home assistants who provided direct care to the residents from ten private for-profit nursing homes', 'ten nursing homes', 'There were 477 and 536 resident participants and 51 and 62 nursing assistant participants in the experimental and control groups respectively']","['pressure injury prevention program implemented while the control group received the usual care', 'Pressure Injury Prevention Program', 'pressure injury prevention program']","['skill performance', 'pressure injury incidence', 'incidence of pressure injuries']","[{'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",10.0,0.0327689,"There were significant interactive effects of time and group on the incidence of pressure injuries (p=0.0015) and on the skill performance of the nursing assistant participants (p<0.0001).
","[{'ForeName': 'Enid W-Y', 'Initials': 'EW', 'LastName': 'Kwong', 'Affiliation': 'School of Nursing, Putian University, Putian, Fujian Province, China.'}, {'ForeName': 'Liang Y', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Putian University, Putian, Fujian Province, China.'}, {'ForeName': 'Rick Y-C', 'Initials': 'RY', 'LastName': 'Kwan', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Journal of advanced nursing,['10.1111/jan.14391']
775,32280092,"Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial.","BACKGROUND


Deterioration of ionized calcium (Ca2+) handling in neurons could lead to neurodegenerative disease. Magnesium (Mg) antagonizes Ca during many physiologic activities, including energy metabolism and catalyzation of demethylation from 5-methylcytosine(5-mC) to 5-hydroxymethylcytosine(5-hmC).
OBJECTIVE


To test the hypothesis that actively reducing the Ca:Mg intake ratio in the diet through Mg supplementation improves cognitive function, and to test whether this effect is partially mediated by modified cytosines in Apolipoprotein E (APOE).
METHODS


This study is nested within the Personalized Prevention of Colorectal Cancer Trial (PPCCT), a double-blind 2×2 factorial randomized controlled trial, which enrolled 250 participants from Vanderbilt University Medical Center. Target doses for both Mg and placebo arms were personalized.
RESULTS


Among those aged > 65 years old who consumed a high Ca:Mg ratio diet, we found that reducing the Ca:Mg ratio to around 2.3 by personalized Mg supplementation significantly improved cognitive function by 9.1% (p = 0.03). We also found that reducing the Ca:Mg ratio significantly reduced 5-mC at the cg13496662 and cg06750524 sites only among those aged > 65 years old (p values = 0.02 and 0.03, respectively). Furthermore, the beneficial effect of reducing the Ca:Mg ratio on cognitive function in those aged over 65 years was partially mediated by reductions in 5-mC levels (i.e., cg13496662 and cg06750524) in APOE (p for indirect effect = 0.05).
CONCLUSION


Our findings suggest that, among those age 65 and over with a high dietary Ca:Mg ratio, optimal Mg status may improve cognitive function partially through modifications in APOE methylation. These findings, if confirmed, have significant implications for the prevention of cognitive aging and Alzheimer's disease.Clinical Trial Registry number and website: #100106 https://clinicaltrials.gov/ct2/show/NCT03265483.",2020,"We also found that reducing the Ca:Mg ratio significantly reduced 5-mC at the cg13496662 and cg06750524 sites only among those aged > 65 years old (p values = 0.02 and 0.03, respectively).","['enrolled 250 participants from Vanderbilt University Medical Center', 'Among those aged\u200a>\u200a65 years old who consumed a high Ca']","['ionized calcium (Ca2', 'Magnesium (Mg) antagonizes Ca', 'placebo']","['5-mC levels', 'cognitive function', 'Ca:Mg ratio significantly reduced 5-mC', 'Ca:Mg ratio']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0049308', 'cui_str': '5-Methylcytosine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",250.0,0.121845,"We also found that reducing the Ca:Mg ratio significantly reduced 5-mC at the cg13496662 and cg06750524 sites only among those aged > 65 years old (p values = 0.02 and 0.03, respectively).","[{'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University School of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Borenstein', 'Affiliation': 'Department of Family Medicine and Public Health, Division of Epidemiology, University of California-San Diego School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Vanderbilt School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Vanderbilt School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Murff', 'Affiliation': 'Division of Geriatric Medicine, General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Bingshan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Department of Medicine, Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University School of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Medicine, Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University School of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191223']
776,32280093,Impact of 3-Day Combined Anodal Transcranial Direct Current Stimulation-Visuospatial Training on Object-Location Memory in Healthy Older Adults and Patients with Mild Cognitive Impairment.,"BACKGROUND


Associative object-location memory (OLM) is known to decline even in normal aging, and this process is accelerated in patients with mild cognitive impairment (MCI). Given the lack of curative treatment for Alzheimer's disease, activating cognitive resources during its preclinical phase might prevent progression to dementia.
OBJECTIVE


To evaluate the effects of anodal transcranial direct current stimulation (atDCS) combined with an associative episodic memory training on OLM in MCI patients and in healthy elderly (HE).
METHODS


In a single-blind cross-over design, 16 MCI patients and 32 HE underwent a 3-day visuospatial OLM training paired with either 20 min or 30 s (sham) atDCS (1 mA, right temporoparietal cortex). Effects on immediate (training success) and long-term memory (1-month) were investigated by conducting Mixed Model analyses. In addition, the impact of combined intervention on within-session (online) and on between-session (offline) performance were explored.
RESULTS


OLM training+atDCS enhanced training success only in MCI patients, but not HE (difference n.s.). Relative performance gain was similar in MCI patients compared to HE under atDCS. No beneficial effect was found after 1-month. Exploratory analyses suggested a positive impact on online, but a negative effect on offline performance in MCI patients. In both groups, exploratory post-hoc analyses indicated an association between initially low-performers and greater benefit from atDCS.
CONCLUSION


Cognitive training in MCI may be enhanced by atDCS, but further delineation of the impact of current brain state, as well as temporal characteristics of multi-session atDCS-training application, may be needed to induce longer-lasting effects.",2020,"RESULTS


OLM training+atDCS enhanced training success only in MCI patients, but not HE (difference n.s.).","['patients with mild cognitive impairment (MCI', 'Healthy Older Adults and Patients with Mild Cognitive Impairment', '16 MCI patients and 32 HE underwent a', 'MCI patients', 'MCI patients and in healthy elderly (HE']","['3-day visuospatial OLM training paired with either 20\u200amin or 30\u200as (sham) atDCS', 'Cognitive training', 'anodal transcranial direct current stimulation (atDCS) combined with an associative episodic memory training', '3-Day Combined Anodal Transcranial Direct Current Stimulation-Visuospatial Training', 'Associative object-location memory (OLM', 'OLM training+atDCS']","['Relative performance gain', 'training success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0327004', 'cui_str': 'Olm'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0586905,"RESULTS


OLM training+atDCS enhanced training success only in MCI patients, but not HE (difference n.s.).","[{'ForeName': 'Angelica Vieira Cavalcanti', 'Initials': 'AVC', 'LastName': 'de Sousa', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Neurocure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Grittner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Center for Stroke Research, Berlin, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Rujescu', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic, Martin-Luther-University Halle-Wittenberg, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Külzow', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Neurocure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Neurocure Cluster of Excellence, Berlin, Germany.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191234']
777,32282572,Effects of trunk stabilization training robot on postural control and gait in patients with chronic stroke: a randomized controlled trial.,"Our study aimed to confirm the therapeutic effects of using a trunk stabilization training robot (3DBT-33) in patients with chronic stroke. A total of 38 patients with chronic stroke were randomly assigned to either an experimental or a control group. The robot group (n = 19) received 30 min of trunk stability robot training in addition to conventional physical therapy, while the control group (n = 19) received a similar conventional physical therapy as the robot group. All participants were assessed using the following: the Functional Ambulation Categories (FAC), timed up and go (TUG) test, Berg Balance Scale (BBS), Korean Modified Barthel Index (K-MBI), and Fugl-Meyer Assessment of Lower Extremity (FMA-LE). There were statistically significant improvements in all parameters at follow-up assessment after 4 weeks of intervention (P < 0.05). There were statistically significant differences in the FMA-LE, K-MBI, and BBS between the robot and control groups (P < 0.05). There was no significant difference in FAC (P = 0.935) and TUG (P = 0.442). Minimal detectable change was more significantly observed in the FMA-LE and BBS than in FAC, TUG, and K-MBI. The findings in the present study showed that trunk stabilization rehabilitation training using a rehabilitation robot in patients with chronic stroke was effective in improving the balance and functions in the lower extremities.",2020,"There were statistically significant differences in the FMA-LE, K-MBI, and BBS between the robot and control groups (P < 0.05).","['patients with chronic stroke', '38 patients with chronic stroke']","['30\u2009min of trunk stability robot training in addition to conventional physical therapy, while the control group (n\u2009=\u200919) received a similar conventional physical therapy as the robot group', 'trunk stabilization training robot', 'trunk stabilization training robot (3DBT-33', 'trunk stabilization rehabilitation training']","['postural control and gait', 'FAC', 'Functional Ambulation Categories (FAC), timed up and go (TUG) test, Berg Balance Scale (BBS), Korean Modified Barthel Index (K-MBI), and Fugl-Meyer Assessment of Lower Extremity (FMA-LE', 'FMA-LE and BBS', 'FMA-LE, K-MBI, and BBS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",38.0,0.0121343,"There were statistically significant differences in the FMA-LE, K-MBI, and BBS between the robot and control groups (P < 0.05).","[{'ForeName': 'Ji Hong', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Hyun Yong', 'Initials': 'HY', 'LastName': 'Seong', 'Affiliation': 'Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Gyeongsangnam.'}, {'ForeName': 'Sung Hwa', 'Initials': 'SH', 'LastName': 'Ko', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Woo-Ri', 'Initials': 'WR', 'LastName': 'Jo', 'Affiliation': 'Translational Research and Clinical Trials Center for Medical Devices, Chonbuk National University Hospital, Jeonju.'}, {'ForeName': 'Hyun-Ju', 'Initials': 'HJ', 'LastName': 'Sohn', 'Affiliation': 'Department of Rehabilitation Medicine, Medwill Hospital.'}, {'ForeName': 'Young Hyun', 'Initials': 'YH', 'LastName': 'Ahn', 'Affiliation': 'Department of Rehabilitation Medicine, Medwill Hospital.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Son', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Ho-Yeon', 'Initials': 'HY', 'LastName': 'Seo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Yeong-Ran', 'Initials': 'YR', 'LastName': 'Son', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Seong-Jun', 'Initials': 'SJ', 'LastName': 'Mun', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'Myoung-Hwan', 'Initials': 'MH', 'LastName': 'Ko', 'Affiliation': 'Translational Research and Clinical Trials Center for Medical Devices, Chonbuk National University Hospital, Jeonju.'}, {'ForeName': 'Yong-Il', 'Initials': 'YI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000399']
778,30867551,Intranasal naloxone rapidly occupies brain mu-opioid receptors in human subjects.,"Nasal spray formulations of naloxone, a mu-opioid receptor (MOR) antagonist, are currently used for the treatment of opioid overdose. They may have additional therapeutic utility also in the absence of opioid agonist drugs, but the onset and duration of action at brain MORs have been inadequately characterized to allow such projections. This study provides initial characterization of brain MOR availability at high temporal resolution following intranasal (IN) naloxone administration to healthy volunteers in the absence of a competing opioid agonist. Fourteen participants were scanned twice using positron emission tomography (PET) and [ 11 C]carfentanil, a selective MOR agonist radioligand. Concentrations of naloxone in plasma and MOR availability (relative to placebo) were monitored from 0 to 60 min and at 300-360 min post naloxone. Naloxone plasma concentrations peaked at ~20 min post naloxone, associated with slightly delayed development of brain MOR occupancy (half of peak occupancy reached at ~10 min). Estimated peak occupancies were 67 and 85% following 2 and 4 mg IN doses, respectively. The estimated half-life of occupancy disappearance was ~100 min. The rapid onset of brain MOR occupancy by IN naloxone, evidenced by the rapid onset of its action in opioid overdose victims, was directly documented in humans for the first time. The employed high temporal-resolution PET method establishes a model that can be used to predict brain MOR occupancy from plasma naloxone concentrations. IN naloxone may have therapeutic utility in various addictions where brain opioid receptors are implicated, such as gambling disorder and alcohol use disorder.",2019,Naloxone plasma concentrations peaked at ~20 ,"['healthy volunteers', 'human subjects', 'Fourteen participants were']","['naloxone', 'scanned twice using positron emission tomography (PET) and [ 11 C]carfentanil, a selective MOR agonist radioligand', 'intranasal (IN) naloxone', 'naloxone, a mu-opioid receptor (MOR) antagonist', 'Intranasal naloxone']","['Naloxone plasma concentrations', 'brain MOR occupancy', 'Estimated peak occupancies', 'plasma and MOR availability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0441633'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0066908', 'cui_str': 'Receptors, mu'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",14.0,0.0381696,Naloxone plasma concentrations peaked at ~20 ,"[{'ForeName': 'Jarkko', 'Initials': 'J', 'LastName': 'Johansson', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland. Jarkko.johansson@umu.se.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Hirvonen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'Clinical Research Services Turku - CRST Ltd, Turku, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ekblad', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Valtteri', 'Initials': 'V', 'LastName': 'Kaasinen', 'Affiliation': 'Division of Clinical Neurosciences, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Rajasilta', 'Affiliation': 'Institute of Biomedicine, University of Turku and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Semi', 'Initials': 'S', 'LastName': 'Helin', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Tuisku', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Sirén', 'Affiliation': 'Institute of Biomedicine, University of Turku and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Pennanen', 'Affiliation': 'Clinical Research Services Turku - CRST Ltd, Turku, Finland.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Opiant Pharmaceuticals Inc., Santa Monica, CA, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Crystal', 'Affiliation': 'Opiant Pharmaceuticals Inc., Santa Monica, CA, USA.'}, {'ForeName': 'Petri J', 'Initials': 'PJ', 'LastName': 'Vainio', 'Affiliation': 'Institute of Biomedicine, University of Turku and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Alho', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Clinical Research Services Turku - CRST Ltd, Turku, Finland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0368-x']
779,31732300,Efficacy of lianhuaqingwen granules in the management of chronic rhinosinusitis without nasal polyps.,"OBJECTIVES


Chronic rhinosinusitis (CRS) is a complicated disease with clinical symptoms that are impacted by the absence or presence of nasal polyps (CRSsNP or CRSwNP). Understanding of the different treatments of CRS is very significant in selecting appropriate therapies and preventing exacerbation relevant to this chronic inflammation. This study was aimed to evaluate the effect of Chinese traditional medicine lianhuaqingwen granules on CRSsNP.
MATERIALS AND METHODS


CRSsNP patients were enrolled and randomized into placebo or lianhuaqingwen (LHQW) granules treatment group (placebo or LHQW group). Their clinical symptoms were scored using Visual Analog Scale (VAS) and Sino-Nasal Outcome Test (SNOT)-22. Nitric oxide (NO) from nasal cavity and sinus and nasal resistance were also examined. Then, nasal biopsy samples and nasal lavage fluid (NLF) were obtained from these patients, and histologic characteristics of nasal mucosa and T cell subpopulations patterns in the NLF were evaluated. Finally, inflammatory mediators in the NLF were assessed in both groups.
RESULTS


One hundred and forty patients with CRSsNP finished this one-month study. VAS and SNOT-22 scores and nasal resistance were all decreased distinctly after the treatment of LHQW, but not after placebo. However, the nasal NO concentration was increased in LHQW administration group in comparison with placebo group. There were significant differences in above parameters between these two treatments. Histologic changes in nasal mucosa were improved only in LHQW group. CD4 +  and CD8 +  T cells were all downregulated in the LHQW treatment group, but not in placebo group. Inflammatory mediators from the NLF were decreased in LHQW treatment group compared to placebo group. Furthermore, there were significant changes between these two groups in CD4 +  and CD8 +  T cell subpopulations and concentrations of inflammatory substances.
CONCLUSION


These findings demonstrate that LHQW granules treatment may control the inflammation in nasal mucosa and result in the improvement of CRSsNP. This Chinese medicine might become a promising therapy in the management of this disease.",2020,"CD4 +  and CD8 +  T cells were all downregulated in the LHQW treatment group, but not in placebo group.","['chronic rhinosinusitis without nasal polyps', 'Chronic rhinosinusitis (CRS', 'CRSsNP', 'One hundred and forty patients with CRSsNP finished this one-month study']","['CRS', 'placebo', 'placebo or lianhuaqingwen (LHQW) granules treatment group (placebo or LHQW', 'lianhuaqingwen granules']","['VAS and SNOT-22 scores and nasal resistance', 'Histologic changes in nasal mucosa', 'nasal NO concentration', 'nasal biopsy samples and nasal lavage fluid (NLF', 'CD4 +  and CD8 +  T cell subpopulations and concentrations of inflammatory substances', 'Visual Analog Scale (VAS) and Sino-Nasal Outcome Test', 'Inflammatory mediators', 'CD4 +  and CD8 +  T cells', 'Nitric oxide (NO) from nasal cavity and sinus and nasal resistance']","[{'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0027430', 'cui_str': 'Nasal Polyps'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0027428', 'cui_str': 'Nasal Mucosa'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0586656', 'cui_str': 'Nasal biopsy sample (specimen)'}, {'cui': 'C0206289', 'cui_str': 'Nasal Washings'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure (body structure)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]",140.0,0.0443106,"CD4 +  and CD8 +  T cells were all downregulated in the LHQW treatment group, but not in placebo group.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Huashan Hospital North of Fudan University, Shanghai, China. Electronic address: linlinhsn@aliyun.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Dai', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Huashan Hospital North of Fudan University, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Ren', 'Affiliation': 'Department of Pathology, Huashan Hospital North of Fudan University, Shanghai, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Huashan Hospital North of Fudan University, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Huashan Hospital North of Fudan University, Shanghai, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Huashan Hospital North of Fudan University, Shanghai, China.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2019.102311']
780,32278330,The effect of two different irrigation needles on post-operative pain after pulpectomy in primary molar teeth: A randomized clinical study.,"BACKGROUND


Post-operative pain (PP) following pulpectomy is of concern for endodontic patients and dentists.
AIM


This study evaluated the intensity of PP following pulpectomy in primary maxillary molars, using two irrigation needles.
DESIGN


One hundred patients in ages ranging from 6-9 years requiring pulpectomy for asymptomatic primary teeth with non-vital pulp were included in the study. The participants were randomly assigned to two groups of 50 patients each, according to the type of irrigation needle used, that is, a conventional open-ended needle and a double side-vented needle. The teeth were obturated and then permanently restored. The presence of PP was assessed after six, 12, 24, 48, and 72 hours, and finally after one week, using a four-point pain intensity scale. The PP scores were then statistically analysed.
RESULTS


In 6, 12, and 24 hours time intervals, patients who had their teeth irrigated with the open-ended needle exhibited more intense PP than those who had their teeth irrigated with a double side-vented needle (P < .05). After 48 hours, 72 hours, and 1 week, however there was no significant difference between the groups (P > .05).
CONCLUSIONS


Side-vented needles may be preferred in order to decrease PP at the first 24 hours after pulpectomy in primary molars.",2020,"However, after 48h,72h and one week, there was no significant difference between the groups (P>0.05).
","['One hundred patients in ages ranging from 6 to 9 years requiring pulpectomy for asymptomatic primary teeth with non-vital pulp were included in the study', 'primary molar teeth', 'endodontic patients and dentists']","['conventional open-ended needle and a double side-vented needle', 'pulpectomy', 'irrigation needles']","['PP scores', 'postoperative pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0442741', 'cui_str': 'Non-vital'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227108', 'cui_str': 'Structure of deciduous molar tooth'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0181988', 'cui_str': 'Medication transfer needle, vented'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0418295,"However, after 48h,72h and one week, there was no significant difference between the groups (P>0.05).
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Topçuoğlu', 'Affiliation': 'Private Practice in Pedodontics, Kayseri, Turkey.'}, {'ForeName': 'Hüseyin Sinan', 'Initials': 'HS', 'LastName': 'Topçuoğlu', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Delikan', 'Affiliation': 'Department of Pedodontics Dentistry, Nuh Naci Yazgan University, Kayseri, Turkey.'}, {'ForeName': 'Seçil', 'Initials': 'S', 'LastName': 'Çalişkan', 'Affiliation': 'Department of Pedodontics Dentistry, Eskişehir Osmangazi University, Eskişehir, Turkey.'}]",International journal of paediatric dentistry,['10.1111/ipd.12652']
781,32279227,Efficacy of Postbiotics in a PRP-Like Cosmetic Product for the Treatment of Alopecia Area Celsi: A Randomized Double-Blinded Parallel-Group Study.,"INTRODUCTION


Alopecia areata (AA), also known as 'area Celsi', is the second most common form of hair loss affecting the scalp. Newly proposed treatments for AA include low-level light therapy, biologics such as Janus kinase inhibitors and autologous platelet-rich plasma (PRP), which is a well-known ""elixir"" for hair growth. Bioactive peptides developed through biotechnological applications have been used to overcome the limitations of PRP. More recently, the involvement of microbiota in hair growth disorders, in AA in particular, has been reported, and the usefulness of microbial metabolites, i.e. postbiotics, has been suggested.
METHODS


This study was a randomized double-blinded parallel-group study in which 160 persons of both sexes affected by AA and aged between 18 and 60 years were enrolled. The subjects were randomly assigned to a treatment group (group 1), receiving the TR-PRP plus-Celsi cosmetic product, and a placebo group (group 2). The SALT (Severity of Alopecia Tool) score was determined in both groups at baseline and after 2 and 3 months of treatment, and the results compared between groups.
RESULTS


The subjects in group 1 showed a significant change from baseline in SALT score at 2 months of treatment (61.04% ± 3.45%; p < 0.0001), with a further improvement at the end of treatment (3 months) (69.56% ± 4.32%; p < 0.0001). No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
CONCLUSIONS


The results of this study provide further proof of the efficacy of bioactive peptides that mimick the growth factors present in PRP in subjects affected by AA. They also add to our knowledge of the link between microbiota and hair growth disorders, emphasizing the importance of studies on the microbial community and microbial metabolites as a novel therapeutic approach.",2020,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","['Alopecia Area Celsi', '160 persons of both sexes affected by AA and aged between 18 and 60\xa0years were enrolled']","['Postbiotics', 'PRP-Like Cosmetic Product', 'TR-PRP plus-Celsi cosmetic product, and a placebo']","['SALT (Severity of Alopecia Tool) score', 'SALT score']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.108524,"No significant changes from baseline were reported for the subjects in group 2 (T1: 26.45% ± 3.64%; T3: 27.63% ± 7.61%).
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy. fabio.rinaldi@studiorinaldi.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Trink', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Human Advanced Microbiome Project (HMAP), Giuliani SpA, Milan, Italy.'}]",Dermatology and therapy,['10.1007/s13555-020-00369-9']
782,32277977,The influence of prolonged strength training upon muscle and fat in healthy and chronically diseased older adults.,"BACKGROUND


Physical muscle function and brain hippocampus size declines with age, accelerating after the age of 60. Strength training over a few months improves physical function, but less is known about how long-term strength training affects physical function and hippocampus volume. Therefore, we aimed to investigate the effect of 1-year strength training of two different intensities upon muscle mass, function, and hippocampus volume in retirement-age individuals.
METHODS


In this multidisciplinary randomized controlled trial (clinicaltrials.gov: NCT02123641), participants were allocated to either a) supervised, heavy resistance training (HRT, n = 149, 3/wk), b) moderate intensity resistance training (MIT, n = 154, 3/wk) or c) non-exercise activities (CON, n = 148). 451 participants were randomized (62-70 yrs., women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n = 143, 144 and 132; HRT, MIT and CON). Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed.
FINDINGS


Of the participants (HRT + MIT), 83% completed training at least 2/week. Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only. Further, chair-stand performance improved in all groups, whereas hippocampus volume decreased in all groups over time with no influence of strength training.
INTERPRETATION


Together, the results indicate that leg extensor power did not respond to long-term supervised strength training, but this type of training in a mixed group of healthy and chronically diseased elderly individuals can be implemented with good compliance and induces consistent changes in physiological parameters of muscle strength, muscle mass and abdominal fat.",2020,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","['retirement-age individuals', ' women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n\u202f=\u202f143, 144 and 132; HRT, MIT and CON', '451 participants were randomized (62-70\u202fyrs', 'healthy and chronically diseased older adults']","['heavy resistance training (HRT, n\u202f=\u202f149, 3/wk), b) moderate intensity resistance training (MIT, n\u202f=\u202f154, 3/wk) or c) non-exercise activities (CON, n\u202f=\u202f148', 'prolonged strength training', 'Strength training']","['Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed', 'hippocampus volume', 'increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36', 'Leg extensor power', 'physical function', 'chair-stand performance', 'isometric knee extensor strength']","[{'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",451.0,0.032446,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark. Electronic address: anne.theil.gylling@regionh.dk.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Garde', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Nina Linde', 'Initials': 'NL', 'LastName': 'Reislev', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kasper Winther', 'Initials': 'KW', 'LastName': 'Andersen', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Technology, University College Copenhagen, Sigurdsgade 26, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Dideriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kenneth Hudlebusch', 'Initials': 'KH', 'LastName': 'Mertz', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Monika Lucia', 'Initials': 'ML', 'LastName': 'Bayer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.110939']
783,31981294,Electrophysiological correlates of action observation treatment in children with cerebral palsy: A pilot study.,"Action Observation Treatment (AOT) has been shown to be effective in the functional recovery of several clinical populations. However, little is known about the neural underpinnings of the clinical efficacy of AOT in children with Cerebral Palsy (CP). Using electroencephalography (EEG), we recorded µ rhythm desynchronization as an index of sensorimotor cortex modulation during a passive action observation task before and after AOT. The relationship between sensorimotor modulation and clinical outcomes was also assessed. Eight children with CP entered the present randomized controlled crossover pilot study in which the experimental AOT preceded or followed a control Videogame Observation Treatment (VOT). Results provide further evidence of the clinical efficacy of AOT for improving hand motor function in CP, as assessed with the Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL). The novel finding is that AOT increases µ rhythm desynchronization at scalp locations corresponding to the hand representation areas. This effect is associated to functional improvement assessed with the MUUL. These preliminary findings, although referred to as a small sample, suggest that AOT may affect upper limb motor recovery in children with CP and modulate the activation of sensorimotor areas, offering a potential neurophysiological correlate to support the clinical utility of AOT.",2019,"Results provide further evidence of the clinical efficacy of AOT for improving hand motor function in CP, as assessed with the Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL).","['children with CP', 'Eight children with CP', 'children with Cerebral Palsy (CP', 'children with Cerebral Palsy']","['AOT', 'Action Observation Treatment (AOT', 'control Videogame Observation Treatment (VOT', 'electroencephalography (EEG']",['Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2732438', 'cui_str': 'Melbourne assessment of unilateral upper limb function'}, {'cui': 'C0222045'}]",8.0,0.0195631,"Results provide further evidence of the clinical efficacy of AOT for improving hand motor function in CP, as assessed with the Assisting Hand Assessment (AHA) and Melbourne Assessment of Unilateral Upper Limb Function Scale (MUUL).","[{'ForeName': 'Ermanno', 'Initials': 'E', 'LastName': 'Quadrelli', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Anzani', 'Affiliation': 'Child Neuropsychiatry Unit, ASST dei Sette Laghi, Varese, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ferri', 'Affiliation': 'Child Neuropsychiatry Unit, ASST dei Sette Laghi, Varese, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bolognini', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Maravita', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Zambonin', 'Affiliation': 'Child Neuropsychiatry Unit, ASST dei Sette Laghi, Varese, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Turati', 'Affiliation': 'Department of Psychology, Milan Center for Neuroscience, University of Milano-Bicocca, Milano, Italy.'}]",Developmental neurobiology,['10.1002/dneu.22734']
784,32275771,The Effects of Weak and Strong CYP3A Induction by Rifampicin on the Pharmacokinetics of Five Progestins and Ethinylestradiol Compared to Midazolam.,"It is known that co-administration of CYP3A inducers may decrease the effectiveness of oral contraceptives containing progestins as mono-preparations or combined with ethinylestradiol. In a randomized clinical drug-drug interaction study, we investigated the effects of CYP3A induction on the pharmacokinetics of commonly used progestins and ethinylestradiol. Rifampicin was used to induce CYP3A. The progestins chosen as victim drugs were levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products, and drospirenone combined with ethinylestradiol. Postmenopausal women (n = 12-14 per treatment group) received, in fixed sequence, a single dose of the victim drug plus midazolam without rifampicin, with rifampicin 10 mg/day (weak induction), and with rifampicin 600 mg/day (strong induction). The effects on progestin exposure were compared with the effects on midazolam exposure (as a benchmark). Unbound concentrations were evaluated for drugs binding to sex hormone binding globulin. Weak CYP3A induction, as confirmed by a mean decrease in midazolam exposure by 46%, resulted in minor changes in progestin exposure (mean decreases: 15-37%). Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%). Namely, the magnitude of the observed induction effects varied from weak to strong. Our data might provide an impetus to revisit the currently applied clinical recommendations for oral contraceptives, especially for levonorgestrel and norethindrone-containing products, and they might give an indication as to which progestin could be used, if requested, by women taking weak CYP3A inducers-although it is acknowledged that the exact exposure-response relationship for contraceptive efficacy is currently unclear for most progestins.",2020,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).",['Postmenopausal women (n=12-14 per treatment group'],"['rifampicin', 'Rifampicin', 'levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products and drospirenone combined with ethinylestradiol', 'CYP3A induction', 'ethinylestradiol', 'victim drug plus midazolam without rifampicin, with rifampicin 10 mg/d (weak induction), and with rifampicin 600 mg/d (strong induction', 'midazolam', 'CYP3A']",[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0028356', 'cui_str': 'Norethindrone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",[],,0.0299347,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).","[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Wiesinger', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Rottmann', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Nowotny', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Riecke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Gashaw', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Brudny-Klöppel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fricke', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Höchel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Friedrich', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1848']
785,32277388,Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,"INTRODUCTION


Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia.
METHODS


In this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp.
RESULTS


All screened patients (N = 100) were enrolled and randomized to TP (n = 33), RP1 (n = 33), or RP2 (n = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
CONCLUSIONS


Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations.
TRIAL REGISTRATION


Clinical Trial Registry of India; CTRI/2018/11/016431.",2020,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","['Indian men with androgenetic alopecia', 'men with androgenetic alopecia who are sensitive to alcoholic formulations', 'Patients with androgenetic alopecia treated with', 'All screened patients (N\u2009=\u2009100', '18\xa0years with androgenetic alopecia', 'patients aged\u2009≥', 'Indian Men']","['minoxidil', 'alcohol-based minoxidil topical solutions', 'TP', 'Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions', 'minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in']","['hydration and reduced redness of the scalp', 'mean (SD) score for redness', 'mean score of scaling', 'mean hydration, mean redness, and mean scaling on scalp', 'mean (SD) hydration', 'Androgenetic Alopecia']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0332324', 'cui_str': 'Sensitive'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0991555', 'cui_str': 'Cutaneous solution'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",100.0,0.0681424,"After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups.
","[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00374-y']
786,32272848,Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial.,"BACKGROUND


This study aimed to compare echocardiographic findings in low-risk patients with severe aortic stenosis after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
METHODS


The PARTNER 3 trial (Placement of Aortic Transcatheter Valves) randomized 1000 patients with severe aortic stenosis and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline and at 30 days and 1 year after the procedure were analyzed by a consortium of 2 echocardiography core laboratories.
RESULTS


The percentage of moderate or severe aortic regurgitation (AR) was low and not statistically different between the TAVR and SAVR groups at 30 days (0.8% versus 0.2%;  P =0.38). Mild AR was more frequent after TAVR than SAVR at 30 days (28.8% versus 4.2%;  P <0.001). At 1 year, mean transvalvular gradient (13.7±5.6 versus 11.6±5.0 mm Hg;  P =0.12) and aortic valve area (1.72±0.37 versus 1.76±0.42 cm 2 ;  P =0.12) were similar in TAVR and SAVR. The percentage of severe prosthesis-patient mismatch at 30 days was low and similar between TAVR and SAVR (4.6 versus 6.3%;  P =0.30). Valvulo-arterial impedance (Z va ), which reflects total left ventricular hemodynamic burden, was lower with TAVR than SAVR at 1 year (3.7±0.8 versus 3.9±0.9 mm Hg/mL/m 2 ;  P <0.001). Tricuspid annulus plane systolic excursion decreased and the percentage of moderate or severe tricuspid regurgitation increased from baseline to 1 year in SAVR but remained unchanged in TAVR. Irrespective of treatment arm, high Z va  and low tricuspid annulus plane systolic excursion, but not moderate to severe AR or severe prosthesis-patient mismatch, were associated with increased risk of the composite end point of mortality, stroke, and rehospitalization at 1 year.
CONCLUSIONS


In patients with severe aortic stenosis and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate or severe AR compared with SAVR but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe prosthesis-patient mismatch, and left ventricular mass regression were similar in TAVR and SAVR. SAVR was associated with significant deterioration of right ventricular systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Z va  and low tricuspid annulus plane systolic excursion were associated with worse outcome at 1 year whereas AR and severe prosthesis-patient mismatch were not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02675114.",2020,"The percentage of severe prosthesis-patient mismatch (PPM) at 30 days was low and similar between TAVR and SAVR (4.6 vs. 6.3%, p=0.30).","['Low-Risk Patients', '1000 patients with severe AS and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR', 'low risk patients with severe aortic stenosis (AS) following surgical (SAVR) or']","['transcatheter aortic valve replacement (TAVR', 'Transcatheter Versus Surgical Aortic Valve Replacement']","['RV systolic function and greater tricuspid regurgitation', 'mean transvalvular gradient', 'Valvulo-arterial impedance', 'percentage of moderate/severe tricuspid regurgitation', 'Tricuspid annulus plane systolic excursion (TAPSE', 'risk of the composite endpoint of mortality, stroke and re-hospitalization', 'Transprosthetic gradients, valve areas, percentage of severe PPM, and LV mass regression', 'percentage of moderate/severe aortic regurgitation (AR', 'percentage of severe prosthesis-patient mismatch (PPM', 'aortic valve area', 'mild AR']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429869', 'cui_str': 'Arterial impedance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443327', 'cui_str': 'Tricuspid'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3888927', 'cui_str': 'TAPSE'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428817', 'cui_str': 'Aortic valve area'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",1000.0,0.0905065,"The percentage of severe prosthesis-patient mismatch (PPM) at 30 days was low and similar between TAVR and SAVR (4.6 vs. 6.3%, p=0.30).","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Salaun', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Abdellaziz', 'Initials': 'A', 'LastName': 'Dahou', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.D., E.A., M.C.A., M.B.L., R.T.H.).'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Avenatti', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.D., E.A., M.C.A., M.B.L., R.T.H.).'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Guzzetti', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Mohamed-Salah', 'Initials': 'MS', 'LastName': 'Annabi', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Oumhani', 'Initials': 'O', 'LastName': 'Toubal', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bernier', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Beaudoin', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Ong', 'Affiliation': ""St Michael's Hospital, University of Toronto, Canada (G.O.).""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Ternacle', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Krapf', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (P.P., E.S., E.G., M.-S.A., O.T., M.B., J.B., J.T., L.K.).'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta, GA (V.H.T.).'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA (R.M.).'}, {'ForeName': 'Susheel K', 'Initials': 'SK', 'LastName': 'Kodali', 'Affiliation': 'Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York (S.K.K., M.C.A., C.R.S., M.B.L., R.T.H.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (M.R.).'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, OH (S.R.K.).'}, {'ForeName': 'S Chris', 'Initials': 'SC', 'LastName': 'Malaisrie', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL (S.C.M.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City (D.J.C.).'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Leipsic', 'Affiliation': ""St Paul's Hospital, Vancouver, Canada (J.L., P.B., J.G.W.).""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Blanke', 'Affiliation': ""St Paul's Hospital, Vancouver, Canada (J.L., P.B., J.G.W.).""}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': 'NYU-Langone Medical Center, New York, NY (M.R.W.).'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'McCabe', 'Affiliation': 'University of Washington, Seattle (J.M.M.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'Baylor Scott & White Healthcare, Plano, TX (D.L.B., M.J.M.).'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Babaliaros', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA (V.B.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Goldman', 'Affiliation': 'Lankenau Medical Center, Wynnewood, PA (S.G.).'}, {'ForeName': 'Wilson Y', 'Initials': 'WY', 'LastName': 'Szeto', 'Affiliation': 'University of Pennsylvania, Philadelphia (W.Y.S.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (P.G.).'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Pershad', 'Affiliation': 'Banner University Medical Center, Phoenix, AZ (A.P.).'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.D., E.A., M.C.A., M.B.L., R.T.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Edwards Lifesciences, Irvine, CA (K.X., E.R.).'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rogers', 'Affiliation': 'Edwards Lifesciences, Irvine, CA (K.X., E.R.).'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Webb', 'Affiliation': ""St Paul's Hospital, Vancouver, Canada (J.L., P.B., J.G.W.).""}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Smith', 'Affiliation': 'Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York (S.K.K., M.C.A., C.R.S., M.B.L., R.T.H.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Healthcare, Plano, TX (D.L.B., M.J.M.).'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.D., E.A., M.C.A., M.B.L., R.T.H.).'}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.D., E.A., M.C.A., M.B.L., R.T.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044574']
787,32271650,The Distance Teaching Practice of Combined Mode of Massive Open Online Course Micro-Video for Interns in Emergency Department During the COVID-19 Epidemic Period.,"Objective:   To observe and analyze the application effect of the combined mode of Massive Open Online Course (MOOC) micro-video during the COVID-19 epidemic period in the distance teaching practice of interns in the emergency department.   Materials and Methods:   The subjects of this study were 60 trainee nurses who conducted emergency nursing practice in Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology from January 1 to February 29, 2020. At the time of the COVID-19 outbreak in Wuhan, they were divided into two groups: (1) the experimental group (combined mode of MOOC micro-video) and (2) the control group (traditional theory teaching combined with clinical practice teaching). The differences of theoretical and practical examination scores and teaching satisfaction between the two groups were compared.   Results:   There was no significant difference in theoretical, practical, and total examination scores between the two groups, but in terms of teaching satisfaction, the overall satisfaction, the degree of easy understanding, the evaluation of teachers and learning results in the experimental group were higher than those in the control group, with statistical difference ( p  < 0.05).   Conclusion:   Compared with the traditional teaching methods, the effect of combined mode of MOOC micro-video in emergency nursing practice is the same as that of traditional teaching methods, but the satisfaction is higher, so it is more suitable to be used in nursing practice during the COVID-19 epidemic period, so as to effectively reduce the cross-infection between doctors, nurses, and teaching staff.",2020,"There was no significant difference in theoretical, practical, and total examination scores between the two groups, but in terms of teaching satisfaction, the overall satisfaction, the degree of easy understanding, the evaluation of teachers and learning results in the experimental group were higher than those in the control group, with statistical difference ( p  < 0.05).   ","['60 trainee nurses who conducted emergency nursing practice in Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology from January 1 to February 29, 2020']","['control group (traditional theory teaching combined with clinical practice teaching', 'Massive Open Online Course (MOOC) micro-video']","['theoretical, practical, and total examination scores', 'teaching satisfaction, the overall satisfaction, the degree of easy understanding, the evaluation of teachers and learning results', 'theoretical and practical examination scores and teaching satisfaction']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085125', 'cui_str': 'Nursing, Emergency'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",60.0,0.0226421,"There was no significant difference in theoretical, practical, and total examination scores between the two groups, but in terms of teaching satisfaction, the overall satisfaction, the degree of easy understanding, the evaluation of teachers and learning results in the experimental group were higher than those in the control group, with statistical difference ( p  < 0.05).   ","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sufang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yaru', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0079']
788,32272284,Omalizumab Re-Treatment and Step-Up in Patients with Chronic Spontaneous Urticaria: OPTIMA Trial.,"BACKGROUND


Omalizumab shows greater clinical benefit with 300 mg dose than with the 150 mg dose.
OBJECTIVE


To determine outcomes postwithdrawal, relapse, and re-treatment in omalizumab responders, and from stepping up to 300 mg after insufficient symptom control with 150 mg.
METHODS


This was a prospective, randomized (3:4), open-label, noncomparator study (clinicaltrials.gov: NCT02161562). A total of 314 adult patients with chronic spontaneous urticaria and symptomatic on H 1 -antihistamines were enrolled between August 1, 2014, and November 6, 2015. Patients received 150 mg/300 mg omalizumab, every 4 weeks for 24 weeks. Omalizumab 150 mg dose could be stepped up to 300 mg between week 8 and week 24, if the 7-day sum of the daily Urticaria Activity Score (UAS7) was more than 6. If patients relapsed after treatment withdrawal at week 24, they could be re-treated with the same dose on which omalizumab was started. Patients on 300 mg could extend treatment by 12 weeks if they did not achieve symptom control on 300 mg in the initial dosing phase. The primary end point was the proportion of well-controlled patients who relapsed postwithdrawal, and achieved symptom control at the end of re-treatment. Symptom control was assessed using UAS7 (UAS7 ≤ 6 = well controlled).
RESULTS


Overall, 115 of 314 patients had adequate symptom control at week 24 (end of the initial dosing period) and 56 were re-treated after relapse postwithdrawal; 87.8% (95% CI, 78.6%-96.9%) regained symptomatic control (UAS7 ≤ 6). Most (141 of 178) patients initially treated with 150 mg required step-up to 300 mg, which resulted in a 9.5-point (95% CI, 7.6-11.3) improvement in UAS7 over the mean change observed initially on 150 mg.
CONCLUSIONS


Step-up to 300 mg helps a greater proportion of patients achieve symptom control, and re-treatment with omalizumab is as effective as initial therapy.",2020,"Symptom control was assessed using the 7-day sum of daily Urticaria Activity Score (UAS7; UAS7 ≤6 = well-controlled).
","['314 adult patients with chronic spontaneous/idiopathic urticaria (CSU) and symptomatic on H 1 -antihistamines were enrolled between August 1, 2014 and November 6, 2015', 'Patients with Chronic Spontaneous Urticaria']","['omalizumab', 'Omalizumab', 'Omalizumab Retreatment and Step-Up']","['7-day sum of daily Urticaria Activity Score', 'adequate symptom control', 'UAS7 scores', 'proportion of well-controlled patients who relapsed post-withdrawal, and achieved symptom control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0157741', 'cui_str': 'Idiopathic urticaria'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",314.0,0.0925635,"Symptom control was assessed using the 7-day sum of daily Urticaria Activity Score (UAS7; UAS7 ≤6 = well-controlled).
","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: gsussman@rogers.com.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Hébert', 'Affiliation': ""Department of Medicine, Centre Hospitalier de l'Université Laval, Québec, QC, Canada.""}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Gulliver', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St John's, NL, Canada.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Institute for Dermatology, Markham, ON, Canada.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa Medical School, Ottawa, ON, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Center for Dermatology, Queen's University and Probity Medical Research, Peterborough, ON, Canada.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chambenoit', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Khalil', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Frederica', 'Initials': 'F', 'LastName': 'DeTakacsy', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vieira', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Rihakova', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.022']
789,31968003,Investigating cumulative effects of pre-performance routine interventions in beach volleyball serving.,"Pre-performance routines (PPRs) can be used in certain sports to minimize the effects of choking under pressure. This study aimed to investigate the cumulative effectiveness of PPR interventions on the accuracy of beach volleyball serves. Fifty-four beach volleyball players were randomly assigned to one of three PPR intervention groups or a control group. Participants performed 10 serves at a target on the opposite side of the beach volleyball court (pretest), were educated on a PPR intervention, and then completed 10 serves at the target under pressure that was induced through videotaping and ego-relevant instructions (posttest). The results indicated no difference in post-test serving accuracy among the intervention groups and the wait-list control group and no difference in effectiveness between cumulative and isolated PPR use. A possible explanation may be the inefficiency of the pressure manipulation. However, the null results related to isolated and cumulative PPR use under general (i.e., no pressure) conditions are still an important research finding. Future research should investigate the effectiveness of cumulative and other PPRs in other sports in general and under pressure.",2020,Fifty-four beach volleyball players were randomly assigned to one of three PPR intervention groups or a control group.,"['Participants performed 10 serves at a target on the opposite side of the beach volleyball court (pretest), were educated on a', 'beach volleyball serving', 'Fifty-four beach volleyball players']","['Pre-performance routines (PPRs', 'PPR interventions', 'pre-performance routine interventions', 'PPR intervention']",['post-test serving accuracy'],"[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0302608,Fifty-four beach volleyball players were randomly assigned to one of three PPR intervention groups or a control group.,"[{'ForeName': 'V Vanessa', 'Initials': 'VV', 'LastName': 'Wergin', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Beckmann', 'Affiliation': 'Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gröpel', 'Affiliation': 'Division of Sport Psychology, Department of Sport Science, University of Vienna, Austria.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mesagno', 'Affiliation': 'School of Health and Life Sciences, Federation University Australia, Ballarat, Australia.'}]",PloS one,['10.1371/journal.pone.0228012']
790,29371479,EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma.,"On May 20, 2016, a conditional marketing authorization valid through the European Union (EU) was issued for daratumumab as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who had demonstrated disease progression on the last therapy. The review of daratumumab was conducted under the EMA's accelerated assessment program for drugs that are of major interest for public health, especially from the point of view of therapeutic innovation.Daratumumab monotherapy achieved an overall response rate of 29.2% (95% confidence interval [CI] 20.8 to 38.9) in patients with multiple myeloma who had received at least three prior lines of therapy (including a PI and IMiD) or were double refractory to a PI and an IMiD (Study MMY2002). In patients with multiple myeloma relapsed from or refractory to two or more different prior therapies, including IMiDs (e.g., thalidomide, lenalidomide) and PI, an overall response was observed in 15 patients (35.7%, 95% CI: 21.6 to 52.0) (Study GEN501).On April 28, 2017, the therapeutic indication was extended to include the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This was based on two subsequent phase III studies of daratumumab in combination with lenalidomide/low-dose dexamethasone (MMY3003) and bortezomib/low dose dexamethasone (MMY3004).The most common side effects (grade 3-4) associated with daratumumab included neutropenia (37%), thrombocytopenia (23%), anemia (16%), pneumonia (10%), lymphopenia (8%), infusion-related reactions (6%), upper respiratory tract infection (5%), and fatigue (5%).The objective of this study was to summarize the scientific review done by the CHMP of the application leading to regulatory approval in the EU. The full scientific assessment report and product information, including the Summary of Product Characteristics (SmPC), are available on the EMA website (www.ema.europa.eu).
IMPLICATIONS FOR PRACTICE


A conditional Marketing authorization was issued in the European Union for daratumamb as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, based on the response rate data from two single-agent studies. Darzalex, a novel monoclonal antibody targeted against CD38, demonstrated a durable response rate in a heavily pre-treated population with limited treatment options based on the response rate data from two single-agent studies. The addition of daratumumab to lenalidomide and dexamethasone (study MMY3003), or bortezomib and dexamethasone (MMY3004), demonstrated a positive effect on progression-free survival in patients with multiple myeloma who had received at least one prior therapy. Following submission of the controlled data of the MMY3003 and MMY3004 studies, the efficacy and safety of daratumumab was confirmed and the approval of daratumumab was converted to standard approval.",2018,Daratumumab monotherapy achieved an overall response rate of 29.2% (95% confidence interval [CI] 20.8 to 38.9) in patients with multiple myeloma who had received at least three prior lines of therapy (including a PI and IMiD) or were double refractory to a PI and an IMiD (Study MMY2002).,"['adult patients with multiple myeloma who have received at least one prior therapy', 'adult patients with relapsed and refractory multiple myeloma', 'patients with multiple myeloma who had received at least one prior therapy', 'Adult Patients with Multiple Myeloma', 'adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who had demonstrated disease progression on the last therapy']","['dexamethasone (study MMY3003), or bortezomib and dexamethasone (MMY3004', 'lenalidomide/low-dose dexamethasone (MMY3003) and bortezomib/low dose dexamethasone', 'lenalidomide and dexamethasone, or bortezomib and dexamethasone', 'Darzalex']","['overall response rate', 'progression-free survival', 'neutropenia', 'lymphopenia', 'thrombocytopenia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1443643', 'cui_str': 'Proteasome Endopeptidase Complex Inhibitors'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4058940', 'cui_str': 'Darzalex'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",,0.045831,Daratumumab monotherapy achieved an overall response rate of 29.2% (95% confidence interval [CI] 20.8 to 38.9) in patients with multiple myeloma who had received at least three prior lines of therapy (including a PI and IMiD) or were double refractory to a PI and an IMiD (Study MMY2002).,"[{'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Tzogani', 'Affiliation': 'European Medicines Agency, London, United Kingdom kyriaki.tzogani@ema.europa.eu.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Penninga', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Schougaard Christiansen', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Hovgaard', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Sinan B', 'Initials': 'SB', 'LastName': 'Sarac', 'Affiliation': 'Danish Medicines Agency, Copenhagen, Denmark.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Camarero Jimenez', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garcia', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lafuente', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Sancho-López', 'Affiliation': 'Instituto de Investigación Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Salmonson', 'Affiliation': 'Läkemedelsverket, Medicinal Products Agency, Uppsala, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gisselbrecht', 'Affiliation': 'Hospital Saint Louis, Paris, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, London, United Kingdom.'}]",The oncologist,['10.1634/theoncologist.2017-0328']
791,32268942,"Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial.","PURPOSE


The BIOFLOW-VI (Biotronik-Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions-VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China.
METHODS


A total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial.
FINDINGS


The primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of -0.02 mm (95% CI, -0.06 to 0.03; P = 0.44; P noninferiority  < 0.0001). At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50). No definite or probable stent thrombosis had occurred in any of the 2 treatment arms.
IMPLICATIONS


The randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985.",2020,"At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50).","['440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions', 'Chinese Population', 'Subjects']","['Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent', 'durable polymer everolimus-eluting stent (DP-EES', 'BP-SES', 'DP-EES', 'ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES']","['probable stent thrombosis', 'target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization', '9-month in-stent late lumen loss (LLL']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1261077', 'cui_str': 'Structure of lower lobe of left lung'}]",440.0,0.165546,"At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50).","[{'ForeName': 'Chongjian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China. Electronic address: yangyjfw@126.com.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.014']
792,32274554,Distinct genetic subtypes of adiposity and glycemic changes in response to weight-loss diet intervention: the POUNDS Lost trial.,"PURPOSE


Obesity is a heterogeneous condition and distinct adiposity subtypes may differentially affect type 2 diabetes risk. We assessed relations between genetically determined subtypes of adiposity and changes in glycemic traits in a dietary intervention trial.
METHODS


The four genetic subtypes of adiposity including waist-hip ratio-increase only (WHRonly+), body mass index-increase only (BMIonly+), WHR-increase and BMI-increase (BMI+WHR+), and WHR-decrease and BMI-increase (BMI+WHR-) were assessed by polygenetic scores (PGSs), calculated based on 159 single nucleotide polymorphisms related to BMI and/or WHR. We examined the associations between the four PGSs and changes in fasting glucose, insulin, β-cell function (HOMA-B) and insulin resistance (HOMA-IR) in 692 overweight participants (84% white Americans) who were randomly assigned to one of four weight-loss diets in a 2-year intervention trial.
RESULTS


Higher BMI+WHR-PGS was associated with a greater decrease in 2-year changes in waist circumference in white participants (P = 0.002). We also found significant interactions between WHRonly+PGS and dietary protein in 2-year changes in fasting glucose and HOMA-B (P = 0.0007 and < 0.0001, respectively). When consuming an average-protein diet, participants with higher WHRonly+PGS showed less increased fasting glucose (β = - 0.46, P = 0.006) and less reduction in HOMA-B (β = 0.02, P = 0.005) compared with lower WHRonly+PGS. Conversely, eating high-protein diet was associated with less decreased HOMA-B among individuals with lower than higher WHRonly+PGS (β = - 0.02, P = 0.006).
CONCLUSIONS


Distinct genetically determined adiposity subtypes may differentially modify the effects of weight-loss diets on improving glucose metabolism in white Americans. This trial was registered at clinicaltrials.gov as NCT00072995.",2020,Higher BMI+WHR-PGS was associated with a greater decrease in 2-year changes in waist circumference in white participants (P = 0.002).,"['white Americans', '692 overweight participants (84% white Americans']",[],"['HOMA-B', 'adiposity including waist-hip ratio-increase only (WHRonly+), body mass index-increase only (BMIonly+), WHR-increase and BMI-increase (BMI+WHR+), and WHR-decrease and BMI-increase', 'glucose metabolism', 'fasting glucose', '2-year changes in waist circumference', 'fasting glucose, insulin, β-cell function (HOMA-B) and insulin resistance (HOMA-IR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231254', 'cui_str': 'Increased body mass index'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",692.0,0.0182223,Higher BMI+WHR-PGS was associated with a greater decrease in 2-year changes in waist circumference in white participants (P = 0.002).,"[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Dianjianyi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Pei', 'Affiliation': 'Department of Public Health Laboratory Sciences, West China School of Public Health, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1724, New Orleans, LA, USA. lqi1@tulane.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02244-x']
793,31173362,"Overall survival and histology-specific subgroup analyses from a phase 3, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma.","BACKGROUND


We performed a randomized phase 3 study of trabectedin versus dacarbazine in previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS).
METHODS


Patients were randomized 2:1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every 3 weeks. The primary objective was overall survival (OS). Secondary objectives were progression-free survival, objective response rate, safety, and patient-reported outcomes, all previously reported and demonstrating superior disease control with trabectedin. Results of the final OS analysis in preplanned subgroups of patients with LPS/LMS are presented.
RESULTS


At the time of the final OS analysis, 577 patients had been assigned randomly, including 423 (73%) with LMS and 154 (27%) with LPS. The median duration of treatment exposure was higher in the trabectedin arm compared with the dacarbazine arm (4 vs 2 cycles), as was the proportion of patients receiving an extended number of therapy courses (≥6 cycles: 42% vs 22%). This pattern was consistent across histological subgroups: the median number of treatment cycles (4 vs 2 for both subgroups) and proportion of patients with ≥6 treatment cycles (LMS, 43% vs 24%; LPS, 40% vs 16%). Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49). Sensitivity analyses of OS suggest confounding by post-study anticancer therapies, which were utilized in most patients in both treatment arms (71% vs 69%, respectively).
CONCLUSION


The final OS results demonstrated comparable survival between LPS/LMS patients receiving trabectedin or dacarbazine, which is consistent with the interim analysis results. Both LPS and LMS demonstrated improved disease control with trabectedin.",2019,"Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49).","['Patients', 'previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS', 'patients with advanced liposarcoma or leiomyosarcoma']","['LPS and LMS', 'dacarbazine', 'trabectedin versus dacarbazine', 'trabectedin', 'trabectedin or dacarbazine']","['survival', 'OS', 'progression-free survival, objective response rate, safety, and patient-reported outcomes', 'overall survival (OS', 'Overall survival', 'final median OS', 'median duration of treatment exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma (disorder)'}, {'cui': 'C0023269', 'cui_str': 'LMS - Leiomyosarcoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",577.0,0.194281,"Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49).","[{'ForeName': 'Shreyaskumar', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Damon R', 'Initials': 'DR', 'LastName': 'Reed', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kaiser', 'Affiliation': 'Lutheran General Advanced Care Center, Park Ridge, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Charlson', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': 'Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rushing', 'Affiliation': 'Simon Cancer Center, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Livingston', 'Affiliation': 'Blumenthal Cancer Center, Carolinas HealthCare System, Charlotte, North Carolina.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Seth', 'Affiliation': 'SUNY Upstate University Hospital, Syracuse, New York.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Forscher', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Georgia Cancer Specialists, Northside Hospital Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Sant P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Center, Santa Monica, California.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Trilok', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Knoblauch', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Martee L', 'Initials': 'ML', 'LastName': 'Hensley', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Mount Sinai Medical Center, New York, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Harvard Medical School, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32117']
794,24671929,Interventions for preoperative smoking cessation.,"BACKGROUND


Smokers have a substantially increased risk of postoperative complications. Preoperative smoking intervention may be effective in decreasing this incidence, and surgery may constitute a unique opportunity for smoking cessation interventions.
OBJECTIVES


The objectives of this review are to assess the effect of preoperative smoking intervention on smoking cessation at the time of surgery and 12 months postoperatively, and on the incidence of postoperative complications.
SEARCH METHODS


We searched the Cochrane Tobacco Addiction Group Specialized Register in January 2014.
SELECTION CRITERIA


Randomized controlled trials that recruited people who smoked prior to surgery, offered a smoking cessation intervention, and measured preoperative and long-term abstinence from smoking or the incidence of postoperative complications or both outcomes.
DATA COLLECTION AND ANALYSIS


The review authors independently assessed studies to determine eligibility, and discussed the results between them.
MAIN RESULTS


Thirteen trials enrolling 2010 participants met the inclusion criteria. One trial did not report cessation as an outcome. Seven reported some measure of postoperative morbidity. Most studies were judged to be at low risk of bias but the overall quality of evidence was moderate due to the small number of studies contributing to each comparison.Ten trials evaluated the effect of behavioural support on cessation at the time of surgery; nicotine replacement therapy (NRT) was offered or recommended to some or all participants in eight of these. Two trials initiated multisession face-to-face counselling at least four weeks before surgery and were classified as intensive interventions, whilst seven used a brief intervention. One further study provided an intensive intervention to both groups, with the intervention group additionally receiving a computer-based scheduled reduced smoking intervention. One placebo-controlled trial examined the effect of varenicline administered one week preoperatively followed by 11 weeks postoperative treatment, and one placebo-controlled trial examined the effect of nicotine lozenges from the night before surgery as an adjunct to brief counselling at the preoperative evaluation. There was evidence of heterogeneity between the effects of trials using intensive and brief interventions, so we pooled these separately. An effect on cessation at the time of surgery was apparent in both subgroups, but the effect was larger for intensive intervention (pooled risk ratio (RR) 10.76; 95% confidence interval (CI) 4.55 to 25.46, two trials, 210 participants) than for brief interventions (RR 1.30; 95% CI 1.16 to 1.46, 7 trials, 1141 participants). A single trial did not show evidence of benefit of a scheduled reduced smoking intervention. Neither nicotine lozenges nor varenicline were shown to increase cessation at the time of surgery but both had wide confidence intervals (RR 1.34; 95% CI 0.86 to 2.10 (1 trial, 46 participants) and RR 1.49; 95% CI 0.98 to 2.26 (1 trial, 286 participants) respectively). Four of these trials evaluated long-term smoking cessation and only the intensive intervention retained a significant effect (RR 2.96; 95% CI 1.57 to 5.55, 2 trials, 209 participants), whilst there was no evidence of a long-term effect following a brief intervention (RR 1.09; 95% CI 0.68 to 1.75, 2 trials, 341 participants). The trial of varenicline did show a significant effect on long-term smoking cessation (RR 1.45; 95% CI 1.01 to 2.07, 1 trial, 286 participants).Seven trials examined the effect of smoking intervention on postoperative complications. As with smoking outcomes, there was evidence of heterogeneity between intensive and brief behavioural interventions. In subgroup analyses there was a significant effect of intensive intervention on any complications (RR 0.42; 95% CI 0.27 to 0.65, 2 trials, 210 participants) and on wound complications (RR 0.31; 95% CI 0.16 to 0.62, 2 trials, 210 participants). For brief interventions, where the impact on smoking had been smaller, there was no evidence of a reduction in complications (RR 0.92; 95% CI 0.72 to 1.19, 4 trials, 493 participants) for any complication (RR 0.99; 95% CI 0.70 to 1.40, 3 trials, 325 participants) for wound complications. The trial of varenicline did not detect an effect on postoperative complications (RR 0.94; 95% CI 0.52 to 1.72, 1 trial, 286 participants).
AUTHORS' CONCLUSIONS


There is evidence that preoperative smoking interventions providing behavioural support and offering NRT increase short-term smoking cessation and may reduce postoperative morbidity. One trial of varenicline begun shortly before surgery has shown a benefit on long-term cessation but did not detect an effect on early abstinence or on postoperative complications. The optimal preoperative intervention intensity remains unknown. Based on indirect comparisons and evidence from two small trials, interventions that begin four to eight weeks before surgery, include weekly counselling and use NRT are more likely to have an impact on complications and on long-term smoking cessation.",2014,"In subgroup analyses there was a significant effect of intensive intervention on any complications (RR 0.42; 95% CI 0.27 to 0.65, 2 trials, 210 participants) and on wound complications (RR 0.31; 95% CI 0.16 to 0.62, 2 trials, 210 participants).","['Thirteen trials enrolling 2010 participants met the inclusion criteria', 'recruited people who smoked prior to surgery, offered a smoking cessation intervention, and measured preoperative and long-term abstinence from smoking or the incidence of postoperative complications or both outcomes']","['Preoperative smoking intervention', 'nicotine lozenges', 'placebo', 'nicotine replacement therapy (NRT', 'smoking intervention', 'varenicline', 'intervention group additionally receiving a computer-based scheduled reduced smoking intervention', 'preoperative smoking intervention']","['postoperative morbidity', 'postoperative complications', 'smoking cessation', 'long-term smoking cessation', 'complications', 'wound complications']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1253423', 'cui_str': 'Nicotine Oral Lozenge'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1096106'}]",46.0,0.336552,"In subgroup analyses there was a significant effect of intensive intervention on any complications (RR 0.42; 95% CI 0.27 to 0.65, 2 trials, 210 participants) and on wound complications (RR 0.31; 95% CI 0.16 to 0.62, 2 trials, 210 participants).","[{'ForeName': 'Thordis', 'Initials': 'T', 'LastName': 'Thomsen', 'Affiliation': 'Abdominal Centre, 3133, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark, 2100.'}, {'ForeName': 'Nete', 'Initials': 'N', 'LastName': 'Villebro', 'Affiliation': ''}, {'ForeName': 'Ann Merete', 'Initials': 'AM', 'LastName': 'Møller', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002294.pub4']
795,30860948,Effect of Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer: The Randomized Phase III NRG Oncology RTOG 0521 Trial.,"PURPOSE


Radiotherapy (RT) plus long-term androgen suppression (AS) are a standard treatment option for patients with high-risk localized prostate cancer. We hypothesized that docetaxel chemotherapy (CT) could improve overall survival (OS) and clinical outcomes among patients with high-risk prostate cancer.
PATIENTS AND METHODS


The multicenter randomized NRG Oncology RTOG 0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009. Patients were randomly assigned to receive standard long-term AS plus RT with or without adjuvant CT.
RESULTS


A total of 612 patients were enrolled; 563 were evaluable. Median prostate-specific antigen was 15.1 ng/mL; 53% had a Gleason score 9 to 10 cancer; 27% had cT3 to cT4 disease. Median follow-up was 5.7 years. Treatment was well tolerated in both arms. Four-year OS rate was 89% (95% CI, 84% to 92%) for AS + RT and 93% (95% CI, 90% to 96%) for AS + RT + CT (hazard ratio [HR], 0.69; 90% CI, 0.49 to 0.97; one-sided  P  = .034). There were 59 deaths in the AS + RT arm and 43 in the AS + RT + CT arm, with fewer deaths resulting from prostate cancer in the AS + RT + CT arm versus AS + RT (23  v  16 deaths, respectively). Six-year rate of distant metastasis was 14% for AS + RT and 9.1% for AS + RT + CT, (HR, 0.60; 95% CI, 0.37 to 0.99; two-sided  P  = .044). Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided  P  = .043).
CONCLUSION


For patients with high-risk nonmetastatic prostate cancer, CT with docetaxel improved OS from 89% to 93% at 4 years, with improved disease-free survival and reduction in the rate of distant metastasis. The trial suggests that docetaxel CT may be an option to be discussed with selected men with high-risk prostate cancer.",2019,"Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided  P  = .043).
","['A total of 612 patients were enrolled; 563 were evaluable', '0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009', 'selected men with high-risk prostate cancer', 'Localized High-Risk Prostate Cancer', 'patients with high-risk localized prostate cancer', 'patients with high-risk prostate cancer']","['Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy', 'docetaxel', 'AS + RT + CT', 'docetaxel chemotherapy (CT', 'standard long-term AS plus RT with or without adjuvant CT', 'Radiotherapy (RT) plus long-term androgen suppression (AS', 'docetaxel CT']","['tolerated', 'overall survival (OS) and clinical outcomes', 'Six-year disease-free survival rate', 'Median prostate-specific antigen', 'Six-year rate of distant metastasis', 'OS rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1269798', 'cui_str': 'pM category'}]",612.0,0.103851,"Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided  P  = .043).
","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': '1 Sutter Medical Group and Sutter Cancer Centers, Sacramento, CA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': '2 NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': '4 Tulane University Health Services Center, New Orleans, LA.'}, {'ForeName': 'Leonard G', 'Initials': 'LG', 'LastName': 'Gomella', 'Affiliation': '5 Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Mahul B', 'Initials': 'MB', 'LastName': 'Amin', 'Affiliation': '6 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': '7 University of California Davis Medical Center, Sacramento, CA.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': '8 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Garzotto', 'Affiliation': '9 Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Pervez', 'Affiliation': '10 Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Balogh', 'Affiliation': '11 Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Rodrigues', 'Affiliation': '12 London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': '13 McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': '14 The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': '15 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Raquibul', 'Initials': 'R', 'LastName': 'Hannan', 'Affiliation': '16 University of Texas Southwestern Medical School, Dallas, TX.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Horwitz', 'Affiliation': '17 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': '18 Christiana Care Health Services Community Clinical Oncology Program, Newark, DE.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Peters', 'Affiliation': '19 Northeast Radiation Oncology Center, Dunmore, PA.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': '20 University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': '21 Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': '6 Cedars-Sinai Medical Center, Los Angeles, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02158']
796,30865548,Mutational Analysis of Patients With Colorectal Cancer in CALGB/SWOG 80405 Identifies New Roles of Microsatellite Instability and Tumor Mutational Burden for Patient Outcome.,"PURPOSE


CALGB/SWOG 80405 was a randomized phase III trial that found no statistically significant difference in overall survival (OS) in patients with first-line metastatic colorectal cancer treated with chemotherapy plus either bevacizumab or cetuximab. Primary tumor DNA from 843 patients has been used to discover genetic markers of OS.
PATIENTS AND METHODS


Gene mutations were determined by polymerase chain reaction. Microsatellite status was determined by genotyping of microsatellites. Tumor mutational burden (TMB) was determined by next-generation sequencing. Cox proportional hazard models were used, with adjusting factors. Interaction of molecular alterations with either the bevacizumab or the cetuximab arms was tested.
RESULTS


Patients with high TMB in their tumors had longer OS than did patients with low TMB (hazard ratio [HR], 0.73 [95% CI, 0.57 to 0.95];  P  = .02). In patients with microsatellite instability-high (MSI-H) tumors, longer OS was observed in the bevacizumab arm than in the cetuximab arm (HR, 0.13 [95% CI, 0.06 to 0.30]; interaction  P  < .001 for interaction between microsatellite status and the two arms). Patients with  BRAF  mutant tumors had shorter OS than did patients with wild-type (WT) tumors (HR, 2.01 [95% CI, 1.49 to 2.71];  P  < .001). Patients with extended  RAS  mutant tumors had shorter OS than did patients with WT tumors (HR, 1.52 [95% CI, 1.26 to 1.84];  P  < .001). Patients with triple-negative tumors (WT for  NRAS / KRAS / BRAF ) had a median OS of 35.9 months (95% CI, 33.0 to 38.8 months) versus 22.2 months (95% CI, 19.6 to 24.4 months ) in patients with at least one mutated gene in their tumors ( P  < .001).
CONCLUSION


In patients with metastatic colorectal cancer treated in first line, low TMB, and  BRAF  and  RAS  mutations are negative prognostic factors. Patients with MSI-H tumors benefited more from bevacizumab than from cetuximab, and studies to confirm this effect of MSI-H are warranted.",2019,"In patients with microsatellite instability-high (MSI-H) tumors, longer OS was observed in the bevacizumab arm than in the cetuximab arm (HR, 0.13","['Patients with MSI-H tumors', 'patients with metastatic colorectal cancer', '843 patients', 'Patients with  BRAF', 'Patients With Colorectal Cancer in CALGB/SWOG 80405', 'patients with first-line metastatic colorectal cancer treated with']","['bevacizumab', 'chemotherapy plus either bevacizumab or cetuximab']","['longer OS', 'Tumor mutational burden (TMB', 'median OS', 'shorter OS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0725974,"In patients with microsatellite instability-high (MSI-H) tumors, longer OS was observed in the bevacizumab arm than in the cetuximab arm (HR, 0.13","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': '2 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Xueping', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': '3 Genentech, South San Francisco, CA.'}, {'ForeName': 'Tyler J', 'Initials': 'TJ', 'LastName': 'Zemla', 'Affiliation': '2 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': '4 Duke University, Durham, NC.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tam', 'Affiliation': '3 Genentech, South San Francisco, CA.'}, {'ForeName': 'Shilpi', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': '3 Genentech, South San Francisco, CA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': '5 West Virginia University Cancer Institute, Morgantown, WV.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': '6 Dana-Farber/Partners CancerCare, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': '7 Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': '1 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': '8 Southeast Clinical Oncology Research Consortium, Winston-Salem, NC.'}, {'ForeName': 'Blasé', 'Initials': 'B', 'LastName': 'Polite', 'Affiliation': '9 University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': '10 University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': '11 USC Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Kabbarah', 'Affiliation': '3 Genentech, South San Francisco, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01798']
797,30985930,Work-related medical rehabilitation in patients with cancer-Postrehabilitation results from a cluster-randomized multicenter trial.,"BACKGROUND


Effective multidisciplinary rehabilitation programs supporting the return to work have become increasingly relevant for cancer survivors. In Germany, inpatient work-related medical rehabilitation programs consider treatment modules of work-related diagnostics, work-related functional capacity training, psychosocial groups, and intensified social counseling. The authors tested the effectiveness of a work-related medical rehabilitation program compared with conventional medical rehabilitation using a cluster-randomized multicenter trial (German Clinical Trial Register: DRKS00007770).
METHODS


In total, 484 patients with cancer were recruited at 4 rehabilitation centers. Patients at a center who started their rehabilitation in the same week represented a cluster. These clusters were randomly assigned using computer-generated randomization schedules either to an intervention group (IG) or to a control group (CG). The primary outcome was role functioning. Secondary outcomes were other quality-of-life domains and the return to work.
RESULTS


In total, 425 patients (210 in the IG) were included in the analysis at the 3-month follow-up. There was no significant difference between the IG and CG in role functioning (b = 3.55; 95% CI, -1.18 to 8.29; P = .142). Participants in the IG reported better physical functioning (b = 5.99; 95% CI, 3.33-8.65; P < .001), less physical fatigue (b = -5.09; 95% CI, -9.62 to -0.56; P = .028), and less pain (b = -6.24; 95% CI, -11.24 to -1.23; P = .015).
CONCLUSIONS


Work-related medical rehabilitation had no effect on the primary outcome compared with conventional medical rehabilitation but may enhance physical functioning and reduce physical fatigue and pain.",2019,"Participants in the IG reported better physical functioning (b = 5.99; 95% CI, 3.33-8.65; P < .001), less physical fatigue (b = -5.09; 95% CI, -9.62 to -0.56; P = .028), and less pain","['Patients at a center who started their rehabilitation in the same week represented a cluster', '484 patients with cancer were recruited at 4 rehabilitation centers', 'patients with cancer-Postrehabilitation', '425 patients (210 in the IG']","['work-related medical rehabilitation program', 'conventional medical rehabilitation']","['pain', 'physical functioning and reduce physical fatigue and pain', 'physical functioning', 'physical fatigue', 'quality-of-life domains and the return to work']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}]",484.0,0.150378,"Participants in the IG reported better physical functioning (b = 5.99; 95% CI, 3.33-8.65; P < .001), less physical fatigue (b = -5.09; 95% CI, -9.62 to -0.56; P = .028), and less pain","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fauser', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lubeck, Lubeck, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychology and Methods, Jacobs University Bremen, Bremen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Beinert', 'Affiliation': 'Department of Oncology, Paracelsus-Klinik am See, Bad Gandersheim, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schmielau', 'Affiliation': 'Department of Oncology, AMEOS Reha Klinikum, Ratzeburg, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Biester', 'Affiliation': 'Department of Oncology, MediClin Rose Klinik, Horn-Bad Meinberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Krüger', 'Affiliation': 'Department of Oncology, Klinik Bavaria, Freyung, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Presl', 'Affiliation': 'Department of Oncology, Klinik Bavaria, Freyung, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bethge', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lubeck, Lubeck, Germany.'}]",Cancer,['10.1002/cncr.32131']
798,31946656,Evaluation of the impact of extrinsic rewards on user engagement in a health promotion context.,"Despite the many mHealth solutions available, it remains unclear what their success factors are. Specifically, there has been controversy on the effectiveness of extrinsic rewards. This study evaluates two design elements of an mHealth solution - i.e., social proof and tangible rewards - and their impact on user engagement. During a four-week campaign, a sample of 143 university staff members engaged in a health promotion campaign. Participants were randomly distributed over one of three treatment groups. It was found that the introduction of a sufficiently meaningful, unexpected, and customized extrinsic reward can engage participants significantly more in a health promotion context.",2019,"It was found that the introduction of a sufficiently meaningful, unexpected, and customized extrinsic reward can engage participants significantly more in a health promotion context.",['143 university staff members engaged in a health promotion campaign'],[],[],"[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]",[],[],,0.0176109,"It was found that the introduction of a sufficiently meaningful, unexpected, and customized extrinsic reward can engage participants significantly more in a health promotion context.","[{'ForeName': 'Raoul C Y', 'Initials': 'RCY', 'LastName': 'Nuijten', 'Affiliation': ''}, {'ForeName': 'Pieter M E', 'Initials': 'PME', 'LastName': 'Van Gorp', 'Affiliation': ''}, {'ForeName': 'Uzay', 'Initials': 'U', 'LastName': 'Kaymak', 'Affiliation': ''}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Simons', 'Affiliation': ''}, {'ForeName': 'Astrid D A M', 'Initials': 'ADAM', 'LastName': 'Kemperman', 'Affiliation': ''}, {'ForeName': 'Pauline E W', 'Initials': 'PEW', 'LastName': 'Van den Berg', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,['10.1109/EMBC.2019.8856296']
799,31067356,Risk-based treatment for patients with first relapse or progression of rhabdomyosarcoma: A report from the Children's Oncology Group.,"BACKGROUND


The purpose of this study was to evaluate risk and response-based multi-agent therapy for patients with rhabdomyosarcoma (RMS) at first relapse.
METHODS


Patients with RMS and measurable disease at first relapse with unfavorable-risk (UR) features were randomized to a 6-week phase 2 window with 1 of 2 treatment schedules of irinotecan with vincristine (VI) (previously reported). Those with at least a partial response to VI continued to receive 44 weeks of multi-agent chemotherapy including the assigned VI regimen. UR patients who did not have measurable disease at study entry, did not have a radiographic response after the VI window, or declined VI window therapy received 31 weeks of multi-agent chemotherapy including tirapazamine (TPZ) at weeks 1, 4, 10, 19, and 28. Favorable-risk (FR) patients received 31 weeks of the same multi-agent chemotherapy without VI and TPZ.
RESULTS


One hundred thirty-six eligible patients were enrolled. For 61 patients not responding to VI, the 3-year failure-free survival (FFS) and overall survival (OS) rates were 17% (95% confidence interval [CI], 8%-29%) and 24% (13%-37%), respectively. For 30 UR patients not treated with VI, the 3-year FFS and OS rates were 21% (8%-37%) and 39% (20%-57%), respectively. FR patients had 3-year FFS and OS rates of 79% (47%-93%) and 84% (50%-96%), respectively. There were no unexpected toxicities.
CONCLUSIONS


Patients with UR RMS at first relapse or disease progression have a poor prognosis when they are treated with this multi-agent therapy, whereas FR patients have a higher chance of being cured with second-line therapy.",2019,"For 61 patients not responding to VI, the 3-year failure-free survival (FFS) and overall survival (OS) rates were 17% (95% confidence interval [CI], 8%-29%) and 24% (13%-37%), respectively.","['Patients with RMS and measurable disease at first relapse with unfavorable-risk (UR) features', 'patients with first relapse or progression of rhabdomyosarcoma', 'patients with rhabdomyosarcoma (RMS) at first relapse', 'One hundred thirty-six eligible patients were enrolled']","['multi-agent chemotherapy including tirapazamine (TPZ', 'irinotecan with vincristine (VI']","['3-year FFS and OS rates', '3-year failure-free survival (FFS) and overall survival (OS) rates', 'toxicities', 'radiographic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0208407', 'cui_str': '3-Amino-1,2,4-benzotriazine-1,4-dioxide'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]",136.0,0.16764,"For 61 patients not responding to VI, the 3-year failure-free survival (FFS) and overall survival (OS) rates were 17% (95% confidence interval [CI], 8%-29%) and 24% (13%-37%), respectively.","[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Saban Research Institute, Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Lyden', 'Affiliation': 'Department of Preventive and Societal Medicine, University of Nebraska, Omaha, Nebraska.'}, {'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Breitfeld', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Walterhouse', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Donaldson', 'Affiliation': 'Department of Radiation Oncology, Stanford University, Stanford, California.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Parham', 'Affiliation': ""Department of Pathology, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Department of Preventive and Societal Medicine, University of Nebraska, Omaha, Nebraska.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.""}]",Cancer,['10.1002/cncr.32122']
800,31219558,A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa.,"CONTEXT


Anorexia nervosa (AN) is a psychiatric illness with considerable morbidity and no approved medical therapies. We have shown that relative androgen deficiency in AN is associated with greater depression and anxiety symptom severity.
OBJECTIVE


To determine whether low-dose testosterone therapy is an effective endocrine-targeted therapy for AN.
DESIGN


Double-blind, randomized, placebo-controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Ninety women, 18 to 45 years, with AN and free testosterone levels below the median for healthy women.
INTERVENTION


Transdermal testosterone, 300 μg daily, or placebo patch for 24 weeks.
MAIN OUTCOME MEASURES


Primary end point: body mass index (BMI). Secondary end points: depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors.
RESULTS


Mean BMI increased by 0.0 ± 1.0 kg/m2 in the testosterone group and 0.5 ± 1.1 kg/m2 in the placebo group (P = 0.03) over 24 weeks. At 4 weeks, there was a trend toward a greater decrease in HAM-D score (P = 0.09) in the testosterone vs placebo group. At 24 weeks, mean HAM-D and HAM-A scores decreased similarly in both groups [HAM-D: -2.9 ± 4.9 (testosterone) vs -3.0 ± 5.0 (placebo), P = 0.72; HAM-A: -4.5 ± 5.3 (testosterone) vs -4.3 ± 4.4 (placebo), P = 0.25]. There were no significant differences in eating disorder scores between groups. Testosterone therapy was safe and well tolerated with no increase in androgenic side effects compared with placebo.
CONCLUSION


Low-dose testosterone therapy for 24 weeks was associated with less weight gain-and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms-compared with placebo in women with AN.",2019,"CONCLUSIONS


Low-dose testosterone therapy for 24 weeks was associated with less weight gain - and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms - compared to placebo in women with AN.","['women with anorexia nervosa', '90 women, 18-45 years, with AN and free testosterone levels below the median for healthy women']","['testosterone', 'placebo', 'low-dose testosterone therapy', 'Testosterone therapy', 'Transdermal testosterone', 'placebo patch']","['HAM-D score', 'eating disorder scores', 'depression, anxiety, or disordered eating symptoms ', 'weight gain ', 'depression symptom severity [Hamilton Depression Rating Scale (HAM-D)], anxiety symptom severity [Hamilton Anxiety Rating Scale (HAM-A)], and eating disorder psychopathology and behaviors', 'mean HAM-D and HAM-A scores', 'Mean BMI', 'androgenic side effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",90.0,0.738216,"CONCLUSIONS


Low-dose testosterone therapy for 24 weeks was associated with less weight gain - and did not lead to sustained improvements in depression, anxiety, or disordered eating symptoms - compared to placebo in women with AN.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kimball', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schorr', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erinne', 'Initials': 'E', 'LastName': 'Meenaghan', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Bachmann', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Kamryn T', 'Initials': 'KT', 'LastName': 'Eddy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Kreiger-Benson', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Herzog', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Koman', 'Affiliation': 'Walden Behavioral Care, Waltham, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Keane', 'Affiliation': 'Walden Behavioral Care, Waltham, Massachusetts.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'Cambridge Eating Disorder Center, Cambridge, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klibanski', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Karen K', 'Initials': 'KK', 'LastName': 'Miller', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00828']
801,31656181,Factors associated with diarrhea and acute respiratory infection in children under two years of age in rural Bangladesh.,"BACKGROUND


Diarrhea and acute respiratory infection (ARI) are major causes of child mortality. We aimed to identify risk factors associated with diarrhea and ARI among children under 2 years of age in rural northern Bangladesh.
METHOD


We collected information on diarrhea and ARI in the previous 14 days and the previous 6 months at 6, 12, 18 and 24 months of age as part of a longitudinal, cluster randomized effectiveness trial, the Rang-Din Nutrition Study which enrolled 4011 pregnant women at ≤20 gestational weeks. Women and their children were followed up until 2 years postpartum. Information on household socioeconomic status, type of toilet, garbage disposal system, food insecurity, number of under-five children in the household, type of family, maternal characteristics and child characteristics was collected at baseline and/or at 6, 12, 18 and 24 months postpartum. Data on newborn health and feeding behaviors were collected within 72 h of delivery. Associations between potential risk factors and morbidity prevalence outcomes were assessed using logistic regression controlling for potential confounders.
RESULTS


Out of 3664 live born children, we collected information from ~ 3350 children at 6, 12, 18 and 24 months of age. Diarrhea in the previous 14 days, and in the previous 6 months, was associated with maternal depression score and food insecurity; diarrhea in the previous 6 months was also associated with family type (nuclear vs. joint). ARI in the previous 14 days was associated with maternal depression score, type of toilet and garbage disposal, household food insecurity and sex. Cough or nasal discharge in the past 6 months was associated with maternal depression score, type of toilet and garbage disposal, household food insecurity, sex and perceived overall physical condition of the infant after birth.
CONCLUSION


Maternal depression and food insecurity appear to be important risk factors for diarrhea and respiratory infection among children under 2 years of age in this setting. These findings suggest that policies and programs that include strategies to address maternal mental health and household food insecurity may contribute to improved child health.
TRIAL REGISTRATION


The trial was registered with the US National Institutes of Health at ClinicalTrials.gov, # NCT01715038 , with registration completed October 26, 2012.",2019,"ARI in the previous 14 days was associated with maternal depression score, type of toilet and garbage disposal, household food insecurity and sex.","['3664 live born children, we collected information from ~\u20093350 children at 6, 12, 18 and 24\u2009months of age', 'children under 2 years of age in rural northern Bangladesh', 'children under two years of age in rural Bangladesh', '4011 pregnant women at ≤20 gestational weeks']",[],"['Diarrhea', 'maternal depression score, type of toilet and garbage disposal, household food insecurity and sex', 'maternal depression score and food insecurity; diarrhea', 'maternal depression score, type of toilet and garbage disposal, household food insecurity, sex and perceived overall physical condition of the infant after birth', 'Cough or nasal discharge', 'household socioeconomic status, type of toilet, garbage disposal system, food insecurity, number of under-five children in the household, type of family, maternal characteristics and child characteristics', 'newborn health and feeding behaviors', 'diarrhea and ARI', 'diarrhea and acute respiratory infection']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1140607', 'cui_str': 'Toilets'}, {'cui': 'C0017095', 'cui_str': 'Garbages'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}]",3350.0,0.0875717,"ARI in the previous 14 days was associated with maternal depression score, type of toilet and garbage disposal, household food insecurity and sex.","[{'ForeName': 'Md Barkat', 'Initials': 'MB', 'LastName': 'Ullah', 'Affiliation': 'Department of Nutrition, University of California, One Shields Ave., Davis, CA, 95616, USA. mullah@ucdavis.edu.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, One Shields Ave., Davis, CA, 95616, USA.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, 225 Morgan Hall, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Md Showkat A', 'Initials': 'MSA', 'LastName': 'Khan', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Zakia', 'Initials': 'Z', 'LastName': 'Siddiqui', 'Affiliation': 'Health System and Population Studies Division, ICDDR,B, Dhaka, Bangladesh.'}, {'ForeName': 'Mokbul', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Rina Rani', 'Initials': 'RR', 'LastName': 'Paul', 'Affiliation': 'Care Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, One Shields Ave., Davis, CA, 95616, USA.'}]",BMC pediatrics,['10.1186/s12887-019-1738-6']
802,30991881,Water-Based Aerobic and Resistance Training as a Treatment to Improve the Lipid Profile of Women With Dyslipidemia: A Randomized Controlled Trial.,"Background : Regular exercise is recommended for the treatment of dyslipidemia. The aquatic environment presents some beneficial characteristics for patients suffering from dyslipidemia. However, it is unknown which modality promotes better results. This study aims to compare the effects of water-based aerobic training (WA) and water-based resistance training (WR) on lipid profile of dyslipidemic elderly women.  Methods : Sixty-nine dyslipidemic elderly women participated in this 3-arm randomized controlled clinical trial with groups in parallel. The interventions were WA, WR, and control group, with 2 weekly sessions for 10 weeks. Total cholesterol (TC), triglycerides, low-density lipoprotein, high-density lipoprotein (HDL) levels, and TC/HDL ratio, were determined before and after interventions.  Results : Intention-to-treat analysis showed that WA and WR participants obtained similar decreases in TC (-10.0% and -9.6%, respectively), triglycerides (-13.4% and -15.7%, respectively), low-density lipoprotein (-16.1% and -16.9%, respectively), TC/HDL (-16.9% and -23.4%, respectively) and increases in HDL (7.6% and 16.9%, respectively). The control group maintained their TC and low-density lipoprotein levels unchanged, whereas triglycerides and TC/HDL were increased (3.6% and 11.3%, respectively), and HDL decreases 4.8%.  Conclusions : WA and WR improve similarly the lipid profile of dyslipidemic elderly women, representing interesting nonpharmacological tools in the treatment of dyslipidemia.",2019,"Intention-to-treat analysis showed that WA and WR participants obtained similar decreases in TC (-10.0% and -9.6%, respectively), triglycerides (-13.4% and -15.7%, respectively), low-density lipoprotein (-16.1% and -16.9%, respectively), TC/HDL (-16.9% and -23.4%, respectively) and increases in HDL (7.6% and 16.9%, respectively).","['Sixty-nine dyslipidemic elderly women', 'patients suffering from dyslipidemia', 'dyslipidemic elderly women', 'Women With Dyslipidemia']","['WR', 'Water-Based Aerobic and Resistance Training', 'water-based aerobic training (WA) and water-based resistance training (WR', ' ', 'Regular exercise']","['triglycerides', 'triglycerides and TC/HDL', 'TC', 'Total cholesterol (TC), triglycerides, low-density lipoprotein, high-density lipoprotein (HDL) levels, and TC/HDL ratio', 'TC/HDL', 'TC and low-density lipoprotein levels', 'HDL', 'low-density lipoprotein']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",69.0,0.0486947,"Intention-to-treat analysis showed that WA and WR participants obtained similar decreases in TC (-10.0% and -9.6%, respectively), triglycerides (-13.4% and -15.7%, respectively), low-density lipoprotein (-16.1% and -16.9%, respectively), TC/HDL (-16.9% and -23.4%, respectively) and increases in HDL (7.6% and 16.9%, respectively).","[{'ForeName': 'Rochelle R', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Adriana C K', 'Initials': 'ACK', 'LastName': 'Buttelli', 'Affiliation': ''}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Coconcelli', 'Affiliation': ''}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'Vieira', 'Affiliation': ''}, {'ForeName': 'Alex de O', 'Initials': 'AO', 'LastName': 'Fagundes', 'Affiliation': ''}, {'ForeName': 'Juliano B', 'Initials': 'JB', 'LastName': 'Farinha', 'Affiliation': ''}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': ''}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Luiz F M', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0602']
803,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES


Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS


The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS


56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION


XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2019,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
804,32267058,"Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.","Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are recommended for glycaemic management in patients with type 2 diabetes (T2D). Oral semaglutide, the first oral GLP-1RA, has recently been approved for clinical use, based on the results of the randomized, Phase 3a Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) clinical trials. The PIONEER programme tested oral semaglutide in patients with T2D of duration ranging from 3.5 to 15 years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients. Outcomes (glycated haemoglobin [HbA1c] and body weight reduction, plus other relevant efficacy and safety endpoints) were tested against both placebo and active standard-of-care medications. A separate trial evaluated the cardiovascular safety of oral semaglutide in patients with T2D at high cardiovascular risk. Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA1c and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose. Oral semaglutide provided significantly better efficacy than placebo and commonly used glucose-lowering medications from the dipeptidyl peptidase-4 inhibitor (sitagliptin) and sodium-glucose co-transporter-2 inhibitor (empagliflozin) classes, as well as the subcutaneous GLP-1RAs liraglutide and dulaglutide. Oral semaglutide was well tolerated in line with the known safety profile of GLP-1RAs, with transient gastrointestinal events being the most common side effects reported. Cardiovascular safety was demonstrated for oral semaglutide in patients with cardiovascular disease or high cardiovascular risk. The results of the PIONEER programme suggest that oral semaglutide is efficacious and well tolerated for glycaemic control of T2D. The availability of oral semaglutide may help to broaden treatment choice and facilitate adoption of earlier GLP-1RA treatment in the paradigm of T2D management.",2020,"Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA 1c  and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose.","['patients with type 2 diabetes (T2D', 'patients with type 2 diabetes', 'patients with cardiovascular disease or high cardiovascular risk', 'patients with T2D at high cardiovascular risk', 'patients with T2D of duration ranging from 3.5 to 15\u2009years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients']","['Glucagon-like peptide-1 receptor agonists (GLP-1RAs', 'once-daily oral semaglutide', 'placebo', 'oral semaglutide']","['Efficacy, safety and cardiovascular outcomes', 'Outcomes (glycated haemoglobin', 'Cardiovascular safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}]",,0.0294568,"Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA 1c  and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose.","[{'ForeName': 'Tina K', 'Initials': 'TK', 'LastName': 'Thethi', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'Diabetes Centre Bochum-Hattingen, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14054']
805,32267624,Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial).,"OBJECTIVE


To investigate whether laparoscopic sacrohysteropexy (LSH) is non-inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse.
DESIGN


Multicentre randomised controlled, non-blinded non-inferiority trial.
SETTING


Five non-university teaching hospitals in the Netherlands, one university hospital in Belgium.
POPULATION


126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery.
METHODS


Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%.
MAIN OUTCOME MEASURES


Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life.
RESULTS


Laparoscopic sacrohysteropexy was non-inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference -1.7%, 95% CI: -7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP.
CONCLUSION


Laparoscopic sacrohysteropexy was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent.
TWEETABLE ABSTRACT


Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short-term outcomes.",2020,"CONCLUSION


LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up.","['uterine prolapse stage 2 or higher', 'Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse', '5 non-university teaching hospitals in the Netherlands, one university hospital in Belgium', '126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery']","['LSH', 'Hysteropexy', 'laparoscopic sacrohysteropexy versus sacrospinous hysteropexy', 'laparoscopic sacrohysteropexy (LSH']","['surgical failure', 'dyspareunia', 'Overall anatomical recurrences and quality of life', 'anatomical recurrence (any compartment), functional outcome and quality of life', 'Dyspareunia', 'bothersome symptoms of overactive bladder (OAB) and faecal incontinence', 'bothersome OAB and faecal incontinence', 'surgical failure rate', 'surgical failure, defined as reoccurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperative']","[{'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}]","[{'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3164185', 'cui_str': 'Sacrohysteropexy'}]","[{'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",126.0,0.455185,"CONCLUSION


LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up.","[{'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'van IJsselmuiden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'Amj', 'Initials': 'A', 'LastName': 'van Oudheusden', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'van de Pol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vollebregt', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Radder', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Housmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Smj', 'Initials': 'S', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deprest', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Hwf', 'Initials': 'H', 'LastName': 'van Eijndhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala, Zwolle, The Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16242']
806,30696335,Enhancing Motor Competence and Physical Activity in Kindergarten.,"BACKGROUND


This study aimed at evaluating the effect of the ""Walk,"" an 8-month physical activity (PA) program led by classroom and physical education teachers, on the motor competence (MC) and PA of 5- to 6-year-old children.
METHODS


A total of 143 children (mean age = 61.51 [1.85] mo) participated in the study and were randomly assigned to the experimental and control groups. Children's MC was assessed by the Körperkoordination Test für Kinder (KTK), and PA was objectively measured by Omron HJ-720IT-E2 pedometers. Measurements were performed at baseline, midintervention, and postintervention. A 1-sample t test computed at baseline step counts revealed that children presented significantly lower PA than recommended for their age (P < .001). To examine the effect of the intervention on children's MC and PA, several repeated-measures analyses of variance were utilized on (1) KTK item scores and (2) pedometer data.
RESULTS


The results revealed that the Walk project led to practically significant changes in the experimental group compared with the control group in both MC (P < .001, η 2  > .14 for all KTK items) and PA (P < .001, η 2  = .23).
CONCLUSIONS


This study highlights the efficacy of a PA project, involving both classroom and physical education teachers, for the enhancement of children's MC and PA.",2019,"The results revealed that the Walk project led to practically significant changes in the experimental group compared with the control group in both MC (P < .001, η 2  > .14 for all KTK items) and PA (P < .001, η 2  = .23).
","['Kindergarten', '143 children (mean age\u2009=\u200961.51 [1.85]\xa0mo) participated in the study']","['Walk,"" an 8-month physical activity (PA) program led by classroom and physical education teachers']","['Körperkoordination Test für Kinder (KTK), and PA', 'Enhancing Motor Competence and Physical Activity']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",143.0,0.0295486,"The results revealed that the Walk project led to practically significant changes in the experimental group compared with the control group in both MC (P < .001, η 2  > .14 for all KTK items) and PA (P < .001, η 2  = .23).
","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Aivazidis', 'Affiliation': ''}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Venetsanou', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Aggeloussis', 'Affiliation': ''}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Gourgoulis', 'Affiliation': ''}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kambas', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0260']
807,30696336,The Effect of an Exercise Intervention During Early Lactation on Bone Mineral Density During the First Year Postpartum.,"BACKGROUND


During lactation, women may lose up to 10% of bone mineral density (BMD) at trabecular-rich sites. Previous studies show that resistance exercise may slow BMD; however, the long-term effects of exercise on BMD during lactation have not been reported.
OBJECTIVE


To evaluate the effect of two 16-week exercise interventions (4- to 20-wk postpartum) in lactating women at 1-year postpartum on lumbar spine, total body, and hip BMD.
METHODS


To increase sample size at 1-year postpartum, two 16-week exercise interventions were combined for analysis. At 4-week postpartum, 55 women were randomized to intervention group (weight bearing aerobic exercise and resistance exercise) or control group (no exercise) for 16-week, with a 1-year postpartum follow-up. BMD was measured by dual-energy X-ray absorptiometry. Repeated-measures analysis of covariance was used to test for time and group differences for BMD controlling for prolactin concentration and dietary calcium at 1-year postpartum.
RESULTS


Change in lumbar spine BMD was significantly different over time and between groups from 4-week to 1-year postpartum, when controlling for prolactin concentration and dietary calcium. There were no significant differences between groups in total body and hip BMD.
CONCLUSION


These results suggest that resistance exercise may slow bone loss during lactation, resulting in higher BMD levels at 1-year postpartum.",2019,"There were no significant differences between groups in total body and hip BMD.
","['lactating women at 1-year postpartum on lumbar spine, total body, and hip BMD', '55 women']","['resistance exercise', 'intervention group (weight bearing aerobic exercise and resistance exercise) or control group (no exercise', 'exercise interventions (4- to 20-wk postpartum', 'Exercise Intervention']","['Bone Mineral Density', 'prolactin concentration and dietary calcium', 'BMD', 'lumbar spine BMD', 'total body and hip BMD']","[{'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",55.0,0.0631082,"There were no significant differences between groups in total body and hip BMD.
","[{'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Colleran', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hiatt', 'Affiliation': ''}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Wideman', 'Affiliation': ''}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Lovelady', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0232']
808,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE


To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS


Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS


Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION


Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
809,30764729,Increasing Employees' Health by Workplace Physical Activity Counseling: The Mediating Role of Step-Based Physical Activity Behavior Change.,"BACKGROUND


This study evaluated the effects of a 3-month workplace physical activity (PA) intervention on employees' health-related fitness and well-being. Moreover, mediational pathways were examined.
METHODS


A longitudinal, quasi-experimental trial was evaluated in Belgian employees. The intervention group (IG: n = 246) received 3-months individualized, tailored PA counseling, consisting of face-to-face counseling and follow-up e-mail and telephone contacts. The reference group (n = 54) received no PA counseling. Outcome measures (assessed at baseline, 3 mo [short term], and 9 mo [long term]) included body composition, cardiorespiratory fitness, well-being, and step-based PA.
RESULTS


With no changes in the reference group, the IG showed short-term improvements in body mass index (-0.24 kg/m 2 , P < .001), body fat (-0.88%, P < .001), waist circumference (-1.47 cm, P < .001), and muscle percentage (+0.47%, P < .001). Moreover, with respect to cardiorespiratory fitness, IG participants improved on perceived exertion, both in the short term (-0.91, P < .001) and long term (-0.83, P < .001). Furthermore, perceived physical well-being increased in the IG, both in the short term (+0.57, P < .001) and long term (+0.57, P < .001). The observed intervention effects on body composition, perceived exertion, and well-being were mediated by (increases in) step-based PA.
CONCLUSIONS


Workplace PA counseling programs have the potential to enhance employees' health-related fitness and well-being. Importantly, step-based PA behavior change was found to contribute to the postintervention improvements.",2019,"Moreover, with respect to cardiorespiratory fitness, IG participants improved on perceived exertion, both in the short term (-0.91, P < .001) and long term (-0.83, P < .001).","['A longitudinal, quasi-experimental trial was evaluated in Belgian employees', ""employees' health-related fitness and well-being""]","['no PA counseling', 'workplace physical activity (PA) intervention', '3-months individualized, tailored PA counseling, consisting of face-to-face counseling and follow-up e-mail and telephone contacts', 'Workplace PA counseling programs']","['body composition, perceived exertion, and well-being', 'muscle percentage', 'body mass index ', 'waist circumference', '9\xa0mo [long term]) included body composition, cardiorespiratory fitness, well-being, and step-based PA', 'body fat']","[{'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",,0.0155331,"Moreover, with respect to cardiorespiratory fitness, IG participants improved on perceived exertion, both in the short term (-0.91, P < .001) and long term (-0.83, P < .001).","[{'ForeName': 'Anass', 'Initials': 'A', 'LastName': 'Arrogi', 'Affiliation': ''}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Schotte', 'Affiliation': ''}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': ''}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Boen', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Seghers', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0148']
810,32253543,Energy replacement diminishes the postprandial triglyceride-lowering effect from accumulated walking in older women.,"PURPOSE


Dietary replacement of an acute exercise-induced energy deficit offsets the postprandial triglyceride (TG)-lowering effect of exercise in young boys and middle-aged men. It is unclear whether these findings are observed when exercise is accumulated in older adults. This study examined the effect of accumulating short bouts of exercise, with and without dietary replacement of an exercise-induced energy deficit, on postprandial TG in older women.
METHODS


Seventeen older women (≥ 65 years) underwent three, 8-h trials: (1) control, (2) accumulated walking and (3) accumulated walking with energy replacement. During the control trial, participants rested for 8 h. The accumulated walking trials comprised twenty 1.5 min brisk walking bouts performed at a pre-determined self-selected pace separated by 15 min seated rest. In each trial, participants consumed a standardised breakfast and lunch. The breakfast in the accumulated walking with energy replacement trial included replacement of the energy deficit (0.62 MJ, 149 kcal) induced by exercise. Venous blood samples were collected fasted and at 2, 4, 6 and 8 h after breakfast.
RESULTS


Time-averaged postprandial serum TG concentrations over 8 h were lower after accumulated walking than control and accumulated walking with energy replacement (mean ± SD: 1.46 ± 0.93 vs 1.71 ± 1.01 vs 1.60 ± 0.98 mmol/L, respectively: main effect of trial p = 0.017). There was little difference between control and accumulated walking with energy replacement.
CONCLUSIONS


Replacing the energy expenditure induced by accumulating 30 min of brisk walking in short (1.5 min) bouts diminishes the postprandial TG-lowering effect in older women.",2020,"There was little difference between control and accumulated walking with energy replacement.
","['young boys and middle-aged men', 'older women', 'Seventeen older women (≥', 'older adults']","['control, (2) accumulated walking and (3) accumulated walking with energy replacement', 'acute exercise-induced energy deficit offsets the postprandial triglyceride (TG)-lowering effect of exercise', 'accumulating short bouts of exercise, with and without dietary replacement of an exercise-induced energy deficit', 'min brisk walking bouts performed at a pre-determined self-selected pace separated by 15\xa0min seated rest']","['Venous blood samples', 'postprandial TG-lowering effect', 'postprandial triglyceride-lowering effect', 'Time-averaged postprandial serum TG concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.0628431,"There was little difference between control and accumulated walking with energy replacement.
","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan. m.miyashita@waseda.jp.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Hamada', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Fujihira', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Nagayama', 'Affiliation': 'Graduate School of Sport Sciences, Waseda University, Tokorozawa, Saitama, 359-1192, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Organization for University Research Initiatives, Waseda University, Singapore, 139651, Singapore.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Burns', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, 637616, Singapore.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, LE11 3TU, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02234-z']
811,32035412,Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas.,"BACKGROUND


Latinas have high rates of sedentary behavior and related health disparities, but it is unknown if interventions to increase physical activity will also reduce sedentary time. The current study examined changes in objectively measured sedentary time among Latinas in a randomized controlled trial of a physical activity intervention.
METHODS


Spanish-speaking Latinas (N = 202) were randomized to an exercise or wellness group and wore an accelerometer at baseline, 6 months, and 12 months.
RESULTS


Participants were sedentary on an average of 8.86 hours per day (SD = 2.60) at baseline. The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02). The intervention effect on sedentary behavior remained after controlling for moderate to vigorous physical activity. Additionally, time spent in moderate to vigorous physical activity was positively associated with more sedentary time (P = .04).
CONCLUSION


An intervention to increase moderate to vigorous physical activity resulted in greater sedentary time, raising concerns regarding compensation and highlighting the need for interventions to address both physical activity and sedentary behavior to improve public health.",2020,"The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02).","['Sedentary Time in Spanish-Speaking Latinas', 'Spanish-speaking Latinas (N = 202']","['Physical Activity Intervention', 'physical activity intervention', 'exercise or wellness group and wore an accelerometer at baseline, 6 months, and 12 months']","['sedentary time', 'sedentary behavior', 'time spent in moderate to vigorous physical activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",202.0,0.0457501,"The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02).","[{'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': ''}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': ''}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': ''}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0112']
812,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
813,32253054,"Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults.","PURPOSE


The triple combination therapy budesonide/glycopyrrolate/formoterol fumarate in a metered dose inhaler (BGF MDI), formulated by using innovative co-suspension delivery technology, is a new inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist fixed-dose combination for the maintenance treatment of COPD. For some patients, the use of an MDI may be optimized with a spacer. This Phase I study assessed the effect of a spacer on lung exposure, total systemic exposure, and safety of BGF MDI 320/36/9.6 μg in healthy subjects.
METHODS


This randomized, open-label, crossover study assessed the pharmacokinetic and safety profiles of BGF MDI in healthy adult subjects who received a single dose of BGF MDI 320/36/9.6 μg (administered as 2 inhalations with 160/18/4.8 μg per actuation) in 4 regimens: without spacer and no charcoal; with spacer and no charcoal; without spacer and with charcoal; and with spacer and with charcoal. Primary objectives were to assess total systemic exposure (without charcoal) and lung exposure (with charcoal) of budesonide, glycopyrronium, and formoterol administered as BGF MDI with and without a spacer. Safety was also assessed.
FINDINGS


In total, 56 subjects were randomized (mean age, 29.9 years; 60.7% male, 17.9% former smokers). For systemic exposure (without charcoal), the spacer/without spacer ratio, expressed as a percentage (intrasubject %CV) of C max  and AUC 0-tlast , respectively, was 152.0 (47.5) and 132.8 (43.6) for budesonide, 240.6 (80.2) and 154.7 (73.4) for glycopyrronium, and 165.6 (50.7) and 98.6 (53.8) for formoterol. For lung exposure (with charcoal), the spacer/without spacer ratio percentage (%CV) of C max  and AUC 0-tlast , respectively, was 183.6 (65.9) and 198.4 (71.5) for budesonide, 262.0 (91.8) and 373.9 (120.7) for glycopyrronium, and 222.9 (56.3) and 385.2 (147.0) for formoterol. Subjects who were judged to have suboptimal inhalation technique without a spacer (those in the lowest drug exposure quartile based on AUC 0-tlast ) had the greatest increase in both total systemic and lung exposure when a spacer was used versus no spacer. Subjects in the highest quartile had a minimal change in both total systemic and lung exposure when the spacer was used. Treatment-emergent adverse events (TEAEs) (all mild/moderate) reported by >1 subject per regimen were headache, cough, and dizziness. One subject withdrew because of TEAEs of headache and presyncope (neither considered treatment-related).
IMPLICATIONS


Drug delivery can be improved for subjects with suboptimal MDI inhalation technique when using a spacer device with BGF MDI triple therapy. ClinicalTrials.gov identifier: NCT03311373.",2020,Subjects in the highest quartile had a minimal change in both total systemic and lung exposure when the spacer was used.,"['healthy subjects', '56 subjects were randomized (mean age, 29.9 years', 'subjects with suboptimal MDI inhalation technique', 'Subjects who were judged to have suboptimal inhalation technique without a spacer (those in the lowest drug exposure quartile based on AUC 0-tlast ', 'healthy adult subjects who received a single dose of', 'Healthy Adults']","['budesonide', 'Budesonide/Glycopyrrolate/Formoterol Fumarate', 'BGF MDI 320/36/9.6\xa0μg (administered as 2 inhalations with 160/18/4.8\xa0μg per actuation) in 4 regimens: without spacer and no charcoal; with spacer and no charcoal; without spacer and with charcoal; and with spacer and with charcoal', 'BGF MDI triple therapy', 'budesonide/glycopyrrolate/formoterol fumarate', 'BGF MDI']","['lung exposure, total systemic exposure, and safety', 'total systemic exposure (without charcoal) and lung exposure (with charcoal) of budesonide, glycopyrronium, and formoterol administered as BGF MDI with and without a spacer', 'total systemic and lung exposure', 'Safety', 'headache, cough, and dizziness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",56.0,0.050227,Subjects in the highest quartile had a minimal change in both total systemic and lung exposure when the spacer was used.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, NC, USA. Electronic address: paul.dorinsky1@astrazeneca.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'DePetrillo', 'Affiliation': 'Pharmaron, Baltimore, MD, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gillen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.012']
814,32267071,A pragmatic study of mid-mixture insulin and basal insulin treatment in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic medications: A lesson from real-world experience.,"BACKGROUND


Chinese guidelines for the treatment of type 2 diabetes (T2D) recommend basal or premixed insulins as insulin starters after failed oral antihyperglycaemic medication (OAM). This pragmatic study compared effectiveness and safety of add-on basal insulin analog (BI) and mid-mixture insulin analog (MMI; 50:50 premixed insulin) as starter insulin regimens in Chinese patients with T2D in a real-world setting.
MATERIALS AND METHODS


This was a multicentre, open-label, randomized, parallel, pragmatic trial. Patients receiving OAMs were randomized 1:1 to BI (n = 410) or MMI (n = 404) for 24 weeks. Insulin titration and OAM adjustment were determined by investigators following usual standard-of-care. The primary outcome was change in glycated haemoglobin (HbA1c) from baseline.
RESULTS


Least-squares mean changes in HbA1c from baseline to week 24 were -2.00% and -2.15% for BI and MMI groups, respectively (P = .13). The MMI group demonstrated a greater reduction in concomitant OAM therapies used than BI group (53.8% vs. 35.3%, respectively; P < .001). Very limited daily insulin dose increments were observed from baseline to week 24 in both BI and MMI groups (2.5 U/day and 1.8 U/day, respectively). Although both insulin analogs were well-tolerated without severe hypoglycaemia, small weight gains were seen with both treatments. Higher total hypoglycaemia rates were noticed with the MMI group, while nocturnal hypoglycaemia events were comparable.
CONCLUSIONS


In real-world settings, BI and MMI provided similar improvement in glucose control without conceding hypoglycaemia. The BI group received a greater number of OAMs in real-world settings. Limited insulin dose titration was observed, while more adjustments occurred with OAM usage.",2020,"The MMI group demonstrated greater reduction in concomitant OAM therapies used than BI group (53.8% vs 35.3%, respectively; P < 0.001).","['Patients receiving OAMs', 'Chinese patients with T2D in a real-world setting', 'patients with type 2 diabetes uncontrolled with oral antihyperglycemic medications']","['basal insulin analog (BI) and mid-mixture insulin analog (MMI; 50/50 premixed insulin', 'mid-mixture insulin and basal insulin treatment', 'MMI']","['tolerated without severe hypoglycemia, small weight gains', 'Insulin titration and OAM adjustment', 'glycated hemoglobin (HbA1c', 'concomitant OAM therapies', 'nocturnal hypoglycemia events', 'total hypoglycemia rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.0741634,"The MMI group demonstrated greater reduction in concomitant OAM therapies used than BI group (53.8% vs 35.3%, respectively; P < 0.001).","[{'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Yujin', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, First Hospital, affiliate with Henan University of Science and Technology, Luoyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Hubei Provincial, Clinical Research Center for Diabetes and Metabolic Disorders, Tongji Medical College, Union Hospital, Huazhong University of Science and Technology, Wuhan, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14052']
815,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
816,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
817,31589864,Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse.,"BACKGROUND


Sacrocolpopexy is a commonly performed procedure for repair of apical compartment prolapse. A Y-shaped mesh is attached to the prolapsed cervix or vagina and suspended to the anterior longitudinal ligament of the sacrum. In addition to conventional laparoscopic and multi-port robotic routes, the robotic laparoendoscopic single-site approach has emerged as a viable, feasible, and widely applicable minimally invasive approach to sacrocolpopexy.
OBJECTIVE


To compare robotic laparoendoscopic single-site with multi-port robotic sacrocolpopexy for women with either utero-vaginal or vaginal apical prolapse.
MATERIALS AND METHODS


In this single-center randomized controlled trial, 70 women at Pelvic Organ Prolapse Quantitative stages 2-4 were assigned randomly to undergo sacrocolpopexy by robotic laparoendoscopic single-site or multi-port robotic approaches from August 2017 to November 2018. Of 35 women randomized to each group, 32 underwent sacrocolpopexy. Operating time was the primary outcome of the trial. Secondary outcomes included intraoperative bleeding, length of hospitalization, pain during the first postoperative 24 hours (according to a 0-10 visual analogue scale), need for analgesics, and intraoperative and postoperative adverse events. At 6 weeks and 6 months after surgery, patients underwent a physical examination according to Pelvic Organ Prolapse Quantitative measurements, to assess the anatomical success of the surgery. The Pelvic Floor Distress Inventory-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual-12 questionnaires were administered prior to surgery and at 6-month follow-up. The Patient Scar Assessment Questionnaire and the Activity Assessment Scale were administered at 6 weeks and 6 months after the surgery. Exclusion criteria included contraindication to general anesthesia, a history of prior sacrocolpopexy, suspicious adnexal masses, suspicious thickened endometrium, and morbid obesity (body mass index of 40 kg/m 2  or more).
RESULTS


The mean age of the patients was 58.4 years. More than half of the patients (54%) had stage III prolapse. Mean total operative times were 181.3 ± 32.6 and 157.5 ± 42 minutes for robotic laparoendoscopic single-site and multi-port robotic sacrocolpopexy, respectively; the difference was 23.8 minutes (95% confidence interval, 4.2-43.4, P = .018). The mean differences in duration between the procedures were as follows: 29.8 minutes, 95% confidence interval, 9.2-50.4, P = .005 for anesthesia time; 33.1 minutes, 95% confidence interval, 16.5-49.7, P < .0001 for console time; 8.6 minutes, 95% confidence interval, 1.1-16.3, P = .025 for supracervical hysterectomy time; 8.3 minutes, 95% confidence interval, 1.8-14.8, P = 0.03 for mesh suturing and fixation to the promontory; and 4.7 minutes, 95% confidence interval, 1.5-7.7, P = .004 for peritoneum suturing. Statistically significant differences were not observed between the groups in regard to estimated blood loss, intraoperative complications, and demand for analgesics during hospital stay. Quality-of-life parameters were similar. Patients' assessments of their scars were more favorable in the robotic laparoendoscopic single-site group.
CONCLUSION


For sacrocolpopexy, the operative time was longer for the robotic laparoendoscopic single-site than for the multi-port robotic approach. Both approaches are feasible, and short-term outcomes, quality-of-life parameters, and anatomic repair are comparable. Our results are generalizable only to the specific robotic platforms used in the study.",2020,"Statistically significant differences were not observed between the groups in estimated blood loss, intraoperative complications and the demand for analgesics during hospital stay.","['Exclusion criteria included: contraindication for general anesthesia, a history of prior sacrocolpopexy, suspicious adnexal masses, suspicious thickened endometrium and morbid obesity (body mass index of 40 kg/m 2  or more', 'women with either utero-vaginal or vaginal apical prolapse', '70 women at Pelvic Organ Prolapse Quantitative stages 2-4', '35 women randomized to each group, 32 underwent']","['conventional laparoscopic and multi-port robotic routes', 'Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy', 'robotic laparoendoscopic single-site with multi-port robotic sacrocolpopexy', 'sacrocolpopexy', 'sacrocolpopexy by robotic laparoendoscopic single-site or multi-port robotic approaches']","['intraoperative bleeding, length of hospitalization, pain during the first postoperative 24 hours (according to a 0-10 visual analogue scale), the need for analgesics, intraoperative and postoperative adverse events', 'Mean total operative times', 'Patient Scar Assessment Questionnaire and the Activity Assessment Scale', 'operative time', 'stage III prolapse', 'Pelvic Floor Distress Inventory-20 and Pelvic Organ Prolapse/Urinary Incontinence', 'blood loss, intraoperative complications and the demand for analgesics during hospital stay', 'Quality-of-life parameters']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",10.0,0.171174,"Statistically significant differences were not observed between the groups in estimated blood loss, intraoperative complications and the demand for analgesics during hospital stay.","[{'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Matanes', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Boulus', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Lauterbach', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Amit', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Weiner', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel. Electronic address: l_lior@rambam.health.gov.il.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.09.048']
818,32248552,Effect of periodontal therapy on adipokine biomarkers in overweight.,"AIM


The aim of this study was to evaluate the effect of non-surgical periodontal therapy on circulating levels of the systemic inflammation-associated biomarkers orosomucoid (ORM), high-sensitivity C-reactive protein (hsCRP), chemerin, and retinol-binding protein 4 (RBP4) in overweight or normal-weight patients with periodontitis at 27.5 months after therapy.
MATERIALS AND METHODS


This exploratory subanalysis includes patients from the ABPARO-trial (ClinicalTrials.gov NCT00707369). The per-protocol collective provided untreated periodontitis patients with high (≥28 kg/m 2  ) or moderate (21-24 kg/m 2  ) BMI. Out of the per-protocol collective, 80 patients were randomly selected and stratified for BMI group, sex, and treatment group (antibiotics/placebo), resulting in 40 overweight and normal-weight patients. Patients received non-surgical periodontal therapy and maintenance at 3-month intervals. Plasma samples from baseline and 27.5 months following initial treatment were used to measure the concentrations of ORM, hsCRP, chemerin, and RBP4.
RESULTS


At the 27.5-month examination, ORM and hsCRP decreased noticeably in the overweight group (ORM: p = .001, hsCRP: p = .004) and normal-weight patients (ORM: p = .007, hsCRP: p < .001). Chemerin decreased in the overweight group (p = .048), and RBP4 concentrations remained stable.
CONCLUSION


Non-surgical periodontal therapy reduced systemically elevated inflammation-associated biomarkers in periodontitis patients. These improvements were more pronounced in overweight patients than in normal-weight patients.",2020,"Chemerin decreased in the overweight group (p=0.048), and RBP4 concentrations remained stable.
","['40 overweight and normal-weight patients', 'overweight', '80 patients', 'patients from the ABPARO-trial (ClinicalTrials', 'overweight or normal-weight patients with periodontitis at 27.5 months after therapy', 'untreated periodontitis patients with high (≥ 28 kg/m 2  ) or moderate (21-24 kg/m 2  ) BMI', 'periodontitis patients']","['periodontal therapy', 'non-surgical periodontal therapy', 'hsCRP', 'BMI group, sex, and treatment group (antibiotics/placebo']","['RBP4 concentrations', 'concentrations of ORM, hsCRP, chemerin, and RBP4', 'ORM and hsCRP', 'adipokine biomarkers', 'Chemerin', 'circulating levels of the systemic inflammation-associated biomarkers orosomucoid (ORM), high-sensitivity C-reactive protein (hsCRP), chemerin, and retinol-binding protein 4 (RBP4']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1438309', 'cui_str': 'RBP4 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0574158', 'cui_str': 'Oromo language'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029297', 'cui_str': 'Alpha-1- acid glycoprotein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",80.0,0.0345811,"Chemerin decreased in the overweight group (p=0.048), and RBP4 concentrations remained stable.
","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Matern', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Koch', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Petersmann', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kocher', 'Affiliation': 'Unit of Periodontology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eickholz', 'Affiliation': 'Department of Periodontology, Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Lorenz', 'Affiliation': 'Department of Periodontology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ti-Sun', 'Initials': 'TS', 'LastName': 'Kim', 'Affiliation': 'Section of Periodontology, Department of Conservative Dentistry, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Meyle', 'Affiliation': 'Department of Periodontology, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Kaner', 'Affiliation': 'Departments of Periodontology and Synoptic Dentistry, Charite-Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gravemeier', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Harks', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ehmke', 'Affiliation': 'Department of Periodontology and Operative Dentistry, University Hospital Münster, Münster, Germany.'}]",Journal of clinical periodontology,['10.1111/jcpe.13288']
819,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT


Spinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.
PURPOSE


To introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.
STUDY DESIGN


Secondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).
METHODS


Functional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.
RESULTS


In Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (r RM 2  = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.
CONCLUSIONS


The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
820,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
821,31820339,"A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera ® ) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).","BACKGROUND


Biosimilars are highly similar to the licensed biologic (""reference product""), with no clinically meaningful differences in safety, purity, or potency between the two products.
OBJECTIVE


This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a rituximab biosimilar]) versus rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU).
PATIENTS AND METHODS


Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1 were randomized (1:1) to PF-05280586 or rituximab-EU (375 mg/m 2  intravenously [once weekly for 4 weeks at days 1, 8, 15, and 22]), stratified using the Follicular Lymphoma International Prognostic Index 2 classification. The primary endpoint was overall response rate (ORR) at week 26 (percentage of subjects achieving complete response [CR] or partial response [PR]). Therapeutic equivalence was concluded if the two-sided 95% confidence interval (CI) for the difference in ORR between groups was within the prespecified margin (± 16%). Secondary endpoints included progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD.
RESULTS


A total of 394 subjects were randomized: PF-05280586 (n = 196) or rituximab-EU (n = 198). ORR at week 26 was 75.5% (PF-05280586) versus 70.7% (rituximab-EU), for a difference of 4.66%; 95% CI (- 4.16 to 13.47), which was entirely within the prespecified equivalence margin. Rates of CR were 29.3% (PF-05280586) versus 31.0% (rituximab-EU). Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively. Safety, immunogenicity, and mean serum concentrations were similar between groups.
CONCLUSIONS


The efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU were similar up to week 52 in subjects with previously untreated CD20-positive LTB-FL.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02213263 and EudraCT (2014-000132-41).",2020,"Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.","['Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1', 'subjects with previously untreated CD20-positive LTB-FL', 'A total of 394 subjects', 'Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL']","['rituximab-EU', 'PF-05280586 or rituximab-EU', 'Rituximab Reference Product (MabThera ® ', 'rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU', 'PF-05280586 (a Rituximab Biosimilar', 'PF-05280586']","['Therapeutic equivalence', 'Rates of CR', 'progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD', 'efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD', 'overall response rate (ORR', 'Estimated 1-year PFS rates', 'complete response [CR] or partial response [PR', 'Safety, immunogenicity, and mean serum concentrations', 'ORR', 'efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU']","[{'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C1664181', 'cui_str': 'LTB protein, human'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1314901', 'cui_str': 'Mabthera'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",394.0,0.51071,"Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute and Research Center, US Oncology, 520 Country Club Rd, Eugene, OR, 97401, USA.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli Studi di Perugia, S.C. Oncoematologia-A.O. Santa Maria, 05100, Terni, Italy.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Third Internal Medicine, Faculty of Medicine, Yamagata University, 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan.'}, {'ForeName': 'Tahira', 'Initials': 'T', 'LastName': 'Khan', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA. Tahira.Khan@pfizer.com.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Robbins', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Alcasid', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, 19426, PA, USA.'}, {'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Rosenberg', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Aurer', 'Affiliation': 'University Hospital Centre Zagreb, Kišpatićeva ul. 12, 10000, Zagreb, Croatia.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00398-7']
822,32249668,Cognitively Challenging Agility Boot Camp Program for Freezing of Gait in Parkinson Disease.,"Introduction . It is well documented that freezing of gait (FoG) episodes occur in situations that are mentally challenging, such as dual tasks, consistent with less automatic control of gait in people with Parkinson disease (PD) and FoG. However, most physical rehabilitation does not include such challenges. The purpose was to determine (1) feasibility of a cognitively challenging Agility Boot Camp-Cognitive (ABC-C) program and (2) effects of this intervention on FoG, dual-task cost, balance, executive function, and functional connectivity.  Methods . A total of 46 people with PD and FoG enrolled in this randomized crossover trial. Each participant had 6 weeks of ABC-C and Education interventions. Outcome measures were the following: FoG, perceived and objective measures; dual-task cost on gait; balance; executive function; and right supplementary motor area (SMA)-pedunculopontine nucleus (PPN) functional connectivity. Effect sizes were calculated.  Results . ABC-C had high compliance (90%), with a 24% dropout rate. Improvements after exercise, revealed by moderate and large effect sizes, were observed for subject perception of FoG after exercise, dual-task cost on gait speed, balance, cognition (Scales for Outcomes in Parkinson's disease-Cognition), and SMA-PPN connectivity.  Conclusions . The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity. The study provided effect sizes to help design future studies with more participants and longer duration to fully determine the potential to improve FoG.",2020,"The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity.","['people with Parkinson disease (PD) and FoG', '46 people with PD and FoG enrolled']","['cognitively challenging Agility Boot Camp-Cognitive (ABC-C) program', 'Cognitively Challenging Agility Boot Camp Program']","['FoG, balance, dual-task cost, executive function, and brain connectivity', ""subject perception of FoG after exercise, dual-task cost on gait speed, balance, cognition (Scales for Outcomes in Parkinson's disease-Cognition), and SMA-PPN connectivity"", 'FoG, dual-task cost, balance, executive function, and functional connectivity', 'FoG, perceived and objective measures; dual-task cost on gait; balance; executive function; and right supplementary motor area (SMA)-pedunculopontine nucleus (PPN) functional connectivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450030', 'cui_str': 'Fog'}]","[{'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C1527386', 'cui_str': 'Peripheral line feeding'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0262306', 'cui_str': 'Nucleus Tegmentalis Pedunculopontinus'}]",46.0,0.0271566,"The ABC-C for people with PD and FoG is a feasible exercise program that has potential to improve FoG, balance, dual-task cost, executive function, and brain connectivity.","[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'King', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Smulders', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Harker', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Lapidus', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Carlson-Kuhta', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Brett W', 'Initials': 'BW', 'LastName': 'Fling', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Peterson', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320909331']
823,32006325,"Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers.","BACKGROUND AND OBJECTIVE


Exenatide promotes insulin secretion and inhibits postprandial glucagon secretion. Polyethylene glycolated exenatide injection (PB-119), a derivative obtained by modification of exenatide, is more stable in metabolic behavior than exenatide in vivo. Our study aimed to evaluate the safety, tolerability and pharmacokinetic characteristics of polyethylene glycolated exenatide as a single subcutaneous injection in healthy volunteers.
METHODS


Seventy subjects were randomly assigned to 8 incremental dosage groups (2, 5, 10, 25, 50, 100, 200 and 400 µg). The 2- to 50-µg groups had 8 subjects in each group (the ratio of test preparation to placebo was 3:1), and the 100- to 400-µg groups had 10 subjects in each group (the ratio of test preparation to placebo was 4:1). All the subjects received a single subcutaneous injection of polyethylene glycolated exenatide and placebo according to the dosage groups. The tolerability test was conducted in the 2- to 10-µg groups. The pharmacokinetic test was carried out in the 25- to 400-µg groups, and plasma samples were collected to determine the pharmacokinetics of polyethylene glycolated exenatide. After medication, the vital signs of the subjects were monitored, and laboratory tests and electrocardiogram tests were carried out regularly in all the subjects.
RESULTS


All 70 subjects completed the experiment. Except for the 5-µg and 10-µg groups, the safety and tolerability tests showed no adverse reactions in the 2-µg to 50-µg groups. Several subjects in the 100-µg and 200-µg groups had tolerable gastrointestinal tract reactions, and all subjects in the 400-µg group experienced adverse reactions, mainly gastrointestinal tract reactions and liver dysfunction. The pharmacokinetics of polyethylene glycolated exenatide was studied in 36 subjects, which showed slow absorption, a mean peak time of 20-40 h, and a mean elimination half-life of 51-64 h.
CONCLUSION


The administration of polyethylene glycolated exenatide injection at a single dose of 2-200 µg is safe and tolerable for healthy volunteers. Once-weekly polyethylene glycolated exenatide injection can be recommended.
CLINICAL TRIALS REGISTRATION


The study was registered at clinicaltrials.gov (No. NCT02084251).",2020,"Except for the 5-µg and 10-µg groups, the safety and tolerability tests showed no adverse reactions in the 2-µg to 50-µg groups.","['healthy volunteers', 'Seventy subjects', '36 subjects, which showed slow absorption, a mean peak time of 20-40\xa0h, and a mean elimination half-life of 51-64\xa0h.\nCONCLUSION', 'Healthy Volunteers', 'All 70 subjects completed the experiment']","['Polyethylene glycolated exenatide injection (PB-119', 'Single Dose Polyethylene', 'polyethylene glycolated exenatide', 'polyethylene glycolated exenatide injection', 'placebo', 'Glycolated Exenatide Injection (PB-119', 'polyethylene glycolated exenatide and placebo']","['Safety, Tolerability and Pharmacokinetics', 'tolerability test', 'safety and tolerability tests', 'adverse reactions, mainly gastrointestinal tract reactions and liver dysfunction', 'tolerable gastrointestinal tract reactions', 'adverse reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0220840', 'cui_str': 'glycolate'}, {'cui': 'C4026823', 'cui_str': 'exenatide Injection [Bydureon]'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}]",70.0,0.0344652,"Except for the 5-µg and 10-µg groups, the safety and tolerability tests showed no adverse reactions in the 2-µg to 50-µg groups.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Cai-Yun', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. LY52850@163.com.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Wei', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ya-Hong', 'Initials': 'YH', 'LastName': 'Xia', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ji-Hong', 'Initials': 'JH', 'LastName': 'Tian', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Institute of Clinical Pharmacology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00605-9']
824,32052313,"Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study.","OBJECTIVES


The aims were to demonstrate pharmacokinetic (PK) similarity between DRL_RI, a proposed rituximab biosimilar, and two reference innovator products (Rituxan ®  [RTX-US] and MabThera ®  [RTX-EU]) and compare their pharmacodynamics (PD), efficacy, safety, and immunogenicity in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration.
METHODS


In this randomized, double-blind, parallel-group study, 276 patients with moderate-to-severe active RA were randomized to receive DRL_RI, RTX-US, or RTX-EU on days 1 and 15. The primary PK end points included area under the concentration-time curve from time 0 to 336 h after first infusion (AUC 0-14 days, first infusion ), AUC from day 1 through week 16 (AUC 0-∞, entire course ), and AUC from time 0 to time of last quantifiable concentration after the second dose (AUC 0-t, second infusion ). Secondary end points included other PK parameters, such as maximum concentration (C max ), time to C max  after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity at week 24 and 52; and B cell recovery until week 52. AUC from time 0 to time of last quantifiable concentration after the first dose and over the entire course from day 1 through week 16 (AUC 0-t, entire course ) was analyzed as an exploratory end point.
RESULTS


The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54). PD outcomes (peripheral blood B-cell depletion and mean change in Disease Activity Score [28 joints]-C-reactive protein), efficacy, safety, and immunogenicity were also comparable between DRL_RI and the reference products.
CONCLUSION


DRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.
CLINICAL TRIALS REGISTRATION NUMBER


ClinicalTrials.gov identifier: NCT02296775.",2020,"The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54).","['276 patients with moderate-to-severe active RA', 'rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration', 'Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis']","['DRL_RI Versus Reference Rituximab', 'DRL_RI, RTX-US, or RTX-EU']","['mean change in Disease Activity Score [28\xa0joints]-C-reactive protein), efficacy, safety, and immunogenicity', 'Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity', 'PK parameters, such as maximum concentration (C max ), time to C max  after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity', 'efficacy, PD, safety, and immunogenicity', 'PD outcomes (peripheral blood B-cell depletion and', 'geometric mean ratios (GMRs', 'pharmacodynamics (PD), efficacy, safety, and immunogenicity', 'area under the concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",276.0,0.255532,"The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54).","[{'ForeName': 'Vikram Muralidhar', 'Initials': 'VM', 'LastName': 'Haridas', 'Affiliation': 'Sushruta Multispeciality Hospital, Hubballi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Katta', 'Affiliation': 'Katta Hospital, S.R. Kalla Memorial General Hospital, Jaipur, India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Nalawade', 'Affiliation': 'Inamdar Multispecialty Hospital, Pune, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kharkar', 'Affiliation': 'Govt Medical College and Hospital, Medical Square, Nagpur, India.'}, {'ForeName': 'Vyacheslav', 'Initials': 'V', 'LastName': 'Zhdan', 'Affiliation': 'M.V.Sklifosovskyi Poltava Regional Hospital, Poltava, Ukraine.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Garmish', 'Affiliation': 'SI NSC M.D. Strazhesko Institute of Cardiology, NAMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lopez-Lazaro', 'Affiliation': ""Clinical Sciences, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland. llopezlazaro@drreddys.com.""}, {'ForeName': 'Sonica Sachdeva', 'Initials': 'SS', 'LastName': 'Batra', 'Affiliation': ""Medical Sciences, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad, 500090, India.""}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kankanwadi', 'Affiliation': ""Development, Biologics, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland.""}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00406-1']
825,31669738,Enhanced recovery after surgery at cesarean delivery to reduce postoperative length of stay: a randomized controlled trial.,"OBJECTIVE


Our objective was to determine whether an enhanced recovery after surgery pathway at the time of cesarean birth would permit a reduction in postoperative length of stay and improve postoperative patient satisfaction compared to standard perioperative care.
MATERIALS AND METHODS


Patients undergoing nonemergent cesarean delivery at ≥37 weeks of gestation were randomized to enhanced recovery after surgery or standard care. Enhanced recovery after surgery involved multiple evidence-based interventions bundled into 1 protocol. The primary outcome was discharge on postoperative day 2. Secondary outcome variables included pain medication requirements, breastfeeding rates, and various measures of patient satisfaction.
RESULTS


From September 27, 2017, to May 2, 2018, a total of 58 women were randomized to enhanced recovery after surgery and 60 women to standard care. The groups were similar in medical comorbidities and in demographic and perioperative characteristics. Enhanced recovery after surgery was not associated with a significantly increased rate of postoperative day 2 discharges when compared with standard care (8.6% vs 3.3%, respectively; odds ratio, 2.74; 95% confidence interval, 0.51-14.70), but it was associated with a significantly reduced postoperative length of stay when compared with standard care, with a median length of stay of 73.5 hours (interquartile range, 71.08-76.62) vs 75.5 hours (interquartile range, 72.86-76.84) from surgery, difference in median length of stay (-1.92; 95% confidence interval, -3.80 to -0.29). Enhanced recovery after surgery was not associated with a reduction in postoperative narcotic use (117.16 ± 54.17 vs 119.38 ± 47.98 morphine milligram equivalents; mean difference, -2.22; 95% confidence interval, -20.86 to 16.42). More subjects randomized to the enhanced recovery after surgery protocol reported breastfeeding at discharge (67.2% vs 48.3%; P = .046). When patients were surveyed 6 weeks postpartum, those in the enhanced recovery after surgery group were more likely to feel that their expectations were met and that they had achieved their postoperative milestones earlier, and to report continued breastfeeding.
CONCLUSION


Enhanced recovery after surgery at cesarean delivery was not associated with an increase in the number of women discharged on postoperative day 2, but that may have been related to factors other than patients' medical readiness for discharge. Evidence that enhanced recovery after surgery at cesarean delivery may have the potential to improve outcomes such as day of discharge is suggested by the observed reduction in overall postoperative length of stay, improved patient satisfaction, and an increase in breastfeeding rates. Even better results may accrue with more provider and patient experience with enhanced recovery after surgery.",2020,"ERAS was not associated with a reduction in postoperative narcotic use, 117.16 ± 54.17 vs. 119.38 ± 47.98 morphine milligram equivalents (Mean difference: -2.22, 95% CI -20.86-16.42).","['Patients undergoing nonemergent cesarean delivery at ≥ 37 weeks of gestation', 'From September 27, 2017 to May 2, 2018, 58 women']","['ERAS or SC', 'ERAS']","['discharge on postoperative day 2 (POD#2', 'postoperative length of stay (LOS', 'Postoperative Length of Stay', 'pain medication requirements, breastfeeding rates and various measures of patient satisfaction', 'rate of POD#2 discharges', 'breastfeeding rates', 'median LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",58.0,0.216052,"ERAS was not associated with a reduction in postoperative narcotic use, 117.16 ± 54.17 vs. 119.38 ± 47.98 morphine milligram equivalents (Mean difference: -2.22, 95% CI -20.86-16.42).","[{'ForeName': 'Nickolas C', 'Initials': 'NC', 'LastName': 'Teigen', 'Affiliation': 'Georgia Perinatal Consultants, Atlanta, GA. Electronic address: nickolas.teigen@gmail.com.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Department of Obstetrics & Gynecology, Kaiser Permanente Southern California, Downey, CA.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Doulaveris', 'Affiliation': ""Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.""}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Abdissa', 'Initials': 'A', 'LastName': 'Negassa', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Anesthesia, New York University, New York, NY.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Bernstein', 'Affiliation': ""Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine / Montefiore Medical Center, Bronx, NY.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.10.009']
826,31939063,"Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial.","OBJECTIVE


Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade ® ) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study.
METHODS


In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566). From weeks 54 to 78, all patients received open-label treatment with PF-SZ-IFX (TP3; n = 505). Efficacy, safety, and immunogenicity data were analyzed during TP3.
RESULTS


Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group). The incidence of treatment-emergent adverse events was 28.9%, 29.4%, and 30.2%, respectively. The proportion of patients who were antidrug antibody (ADA) positive and neutralizing antibody positive (as a percentage of ADA-positive patients) was stable and comparable between groups.
CONCLUSIONS


Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54.
TRIAL REGISTRATION NUMBER


NCT02222493.",2020,"Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group).","['patients with moderate-to-severe active RA', 'patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78\xa0weeks or who switched from reference infliximab (Remicade ® ) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study', 'Patients with Rheumatoid Arthritis']","['PF-SZ-IFX or IFX-EU, each with methotrexate', 'infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX', 'Infliximab (IFX', 'open-label treatment with PF-SZ-IFX (TP3']","['efficacy, safety, and immunogenicity', 'incidence of treatment-emergent adverse events', 'Efficacy', 'Efficacy, safety, and immunogenicity data', 'long-term efficacy, safety, and immunogenicity', 'antidrug antibody (ADA) positive and neutralizing antibody positive']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0723012', 'cui_str': 'Remicade'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0075032', 'cui_str': 'TP3'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1609515', 'cui_str': 'Neutralising antibodies positive'}]",650.0,0.0748742,"Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group).","[{'ForeName': 'Stanley B', 'Initials': 'SB', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA. arthdoc@aol.com.'}, {'ForeName': 'Sebastiao C', 'Initials': 'SC', 'LastName': 'Radominski', 'Affiliation': 'Universidade Federal do Paraná, Rua General Carneiro, 181-Alto Da Glória, Curitiba, PR, 80060-900, Brazil.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Toho University, 2-22-36, Ohashi Meguro-ku, Tokyo, 153-8515, Japan.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tee', 'Affiliation': 'Department of Medicine, Medical Center Manila, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cronenberger', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, La Jolla, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hackley', 'Affiliation': 'Pfizer R&D UK, Ltd, Sandwich, Kent, UK.'}, {'ForeName': 'Muhammad I', 'Initials': 'MI', 'LastName': 'Rehman', 'Affiliation': 'Pfizer Inc, Andover, MA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'von Richter', 'Affiliation': 'Biopharmaceuticals, Hexal AG (a Sandoz company), Holzkirchen, Germany.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'Schlosspark-Klinik University Medicine, Heubnerweg 2, 14059, Berlin, Germany.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00403-z']
827,32250534,"Effect of liraglutide on food consumption, appetite sensations and eating behaviours in overweight people with type 1 diabetes.","AIMS


To investigate the effects of 24 weeks of treatment with liraglutide added to basal/bolus insulin on energy intake, appetite sensations and eating behaviours in overweight/obese participants with type 1 diabetes (T1D).
METHODS


In a double-blinded crossover fashion, 15 participants were randomly assigned (1:1) to receive placebo or liraglutide for 24 weeks including a 1-month titration period from 0.6 to 1.2 to 1.8 mg, in addition to their insulin. The treatment was followed by a 1-month wash-out period. Participants were then assigned to the other treatment for another 24 weeks. Food intake was measured, visual analogue scales and Three-Factor Eating Questionnaires were completed. Paired rank tests were used to compare the variables.
RESULTS


When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates. Their appetite sensations were modified: fasting desire to eat, hunger and prospective food consumption were significantly reduced. The sensation of fullness was prolonged for a few hours after a standardized breakfast. Restraint and disinhibition were significantly reduced by liraglutide.
CONCLUSIONS


In this randomized clinical trial, the addition of liraglutide to basal/bolus insulin therapy for 24 weeks in overweight/obese individuals with T1D significantly improved their food consumption, appetite sensations and eating behaviours.",2020,"When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates.","['overweight/obese participants with type 1 diabetes', '24\u2009weeks in overweight/obese individuals with type 1 diabetes', 'overweight subjects with type 1 diabetes']","['placebo or liraglutide', 'liraglutide added to basal/bolus insulin', 'liraglutide to basal/bolus insulin therapy', 'liraglutide']","['fasting desire to eat, hunger and prospective food consumption', 'food consumption, appetite sensations and eating behaviours', 'visual analogue scales and Three Factor Eating Questionnaires', 'Restraint and disinhibition', 'energy intake, appetite sensations and eating behaviours', 'sensation of fullness', 'Food intake', 'total intake and % fat and increased carbohydrates']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",15.0,0.14227,"When treated with liraglutide, participants modified their ad libitum food consumption with decreased total intake and % fat and increased carbohydrates.","[{'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Dubé', 'Affiliation': 'Diabetes Research Unit, CHU de Québec-Université Laval, Québec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': ""D'Amours"", 'Affiliation': 'Diabetes Research Unit, CHU de Québec-Université Laval, Québec, Canada.'}, {'ForeName': 'S John', 'Initials': 'SJ', 'LastName': 'Weisnagel', 'Affiliation': 'Diabetes Research Unit, CHU de Québec-Université Laval, Québec, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14050']
828,32151822,A 4-item PRECISE-DAPT score for dual antiplatelet therapy duration decision-making.,"The originally-proposed PRECISE-DAPT score is a 5-item risk score supporting decision-making for dual antiplatelet therapy 1  duration after PCI. It is unknown if a simplified version of the score based on 4 factors (age, hemoglobin, creatinine clearance, prior bleeding), and lacking white-blood cell count, retains potential to guide DAPT duration. The 4-item PRECISE-DAPT was used to categorize 10,081 patients who were randomized to short (3-6 months) or long (12-24 months) DAPT regimen according to high (HBR defined by PRECISE-DAPT ≥25 points) or non-high bleeding risk (PRECISE-DAPT<25) status. Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11). Only non-HBR patients experienced lower net clinical adverse events (NACE) with longer DAPT (p int  = 0.043). A 4-item simplified version of the PRECISE-DAPT score retains the potential to categorize patients who benefit from prolonged DAPT without concomitant bleeding liability from those who do not.",2020,"Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11).","['10,081 patients who were randomized to short (3-6 months) or long (12-24 months']",['DAPT'],"['ischemic risks', 'net clinical adverse events (NACE', 'bleeding rates in HBR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],"[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0200107,"Long treatment duration was associated with higher bleeding rates in HBR (ARD +2.22% [95% CI +0.53 to +3.90]) but not in non-HBR patients (ARD +0.25% [-0.14 to +0.64]; p int  = 0.026), and associated with lower ischemic risks in non-HBR (ARD -1.44% [95% CI -2.56 to -0.31]), but not in HBR patients (ARD +1.16% [-1.91 to +4.22]; p int  = 0.11).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Clinical and Experimental Medicine, Policlinic ""G. Martino"", University of Messina, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam, The Netherlands.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.'}, {'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Feres', 'Affiliation': 'Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital.'}, {'ForeName': 'Ewout W', 'Initials': 'EW', 'LastName': 'Steyerberg', 'Affiliation': 'Erasmus University Medical Center, s-Gravendijkwal 230, Rotterdam, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital. Electronic address: marco.valgimigli@insel.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.014']
829,32193044,Etomidate plus fentanyl for anesthesia in pediatric strabotomy.,"Considering the side effects of etomidate, it requires additional anesthetics to reduce the side effects and improve efficacy. Ketamine is often used as an adjunct anesthetic. We hypothesized that etomidate combined with fentanyl was more effective than etomidate combined with ketamine in the anesthesia of pediatric strabotomy. To prove our hypothesis, a prospective randomized controlled clinical study was performed, in which 35 children with strabotomy received etomidate plus ketamine (group A) for anesthesia induction and maintenance and 35 children with strabotomy received etomidate combined with fentanyl (group B). Mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS), anesthesia effect, and emergence agitation and pain were observed before anesthesia induction (T1), after anesthesia induction (T2), at the beginning of the operation (T3), after 10-min operation (T4), and at the end of the operation (T5). Children in group B had significantly lower MAP and HR from T3 to T5, decreased BIS from T2 to T4, better anesthesia effect, and smaller emergence agitation and pain scores at 10 min after entering into postanesthesia care unit (PACU) compared with group A (p < 0.05). The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05). In conclusion, etomidate combined with fentanyl plays a good efficacy in anesthesia of pediatric strabotomy compared with etomidate plus ketamine.",2020,The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05).,"['35 children with strabotomy received', 'anesthesia in pediatric strabotomy', 'group A) for anesthesia induction and maintenance and 35 children with strabotomy received']","['etomidate combined with fentanyl', 'etomidate plus ketamine', 'ketamine', 'Etomidate plus fentanyl', 'etomidate', 'Ketamine']","['mean emergence agitation score', 'anesthesia effect, and smaller emergence agitation and pain scores', 'MAP and HR', 'Mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS), anesthesia effect, and emergence agitation and pain were observed before anesthesia induction (T1), after anesthesia induction (T2), at the beginning of the operation (T3']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0948673', 'cui_str': 'Strabotomy'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",35.0,0.0530917,The mean emergence agitation score in group B was significantly lower than that in group A when the maximum emergence in group B was at 20 min after entering into PACU (p < 0.05).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Outpatient, Maternal and Child Health Hospital of Panzhihua, Panzhihua, Sichuan Province, China. Electronic address: huyanmc3h@163.com.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, The Affiliated Hospital of Panzhihua University, Panzhihua, Sichuan Province, China.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The 19th Metallurgical Hospital of Panzhihua, Panzhihua, Sichuan Province, China.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109666']
830,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION


Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS


In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION


We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
831,32250167,ENGINE: a Phase III randomized placebo controlled study of enzastaurin/R-CHOP as frontline therapy in high-risk diffuse large B-cell lymphoma patients with the genomic biomarker DGM1.,"While combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) cures most patients with diffuse large B-cell lymphoma (DLBCL), those with high-risk international prognostic index disease have inferior survival. Enzastaurin as a potent inhibitor of PKC-β and PI3K/AKT pathway suppressor has been tested in many clinical trials including two key studies in DLBCL: Phase III maintenance study (Preventing Relapse in Lymphoma Using Daily Enzastaurin [PRELUDE]) and a first-line Phase II study (S028). DNA extracted from PRELUDE patients' blood samples was retrospectively genotyped identifying a novel genetic biomarker, DGM1 that showed high correlation with response to enzastaurin. A similar finding observed in the S028 study suggested that addition of enzastaurin to R-CHOP may significantly improve outcomes as frontline therapy for high-risk DGM1 positive DLBCL patients. ENGINE is a global, multicenter, placebo-controlled and randomized study to compare the effect of R-CHOP/enzastaurin as frontline treatment in high-risk DLBCL patients. The primary end point for this study is overall survival in patients who are DGM1 positive. Clinical Trial Registration Identifier: NCT03263026.",2020,"DNA extracted from PRELUDE patients' blood samples was retrospectively genotyped identifying a novel genetic biomarker, DGM1 that showed high correlation with response to enzastaurin.","['high-risk diffuse large B-cell lymphoma patients with the genomic biomarker DGM1', 'patients with diffuse large B-cell lymphoma (DLBCL', 'high-risk DLBCL patients']","['placebo', 'R-CHOP/enzastaurin', 'enzastaurin/R-CHOP', 'rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP', 'Enzastaurin']",['overall survival'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C1327830', 'cui_str': 'enzastaurin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.1211,"DNA extracted from PRELUDE patients' blood samples was retrospectively genotyped identifying a novel genetic biomarker, DGM1 that showed high correlation with response to enzastaurin.","[{'ForeName': 'Grzegorz S', 'Initials': 'GS', 'LastName': 'Nowakowski', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing, PR China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, PR China.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Brody', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The Second Hospital of Dalian Medical University, Dalian, PR China.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maly', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing, PR China.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Rizvi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Yongping', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Affliliated Cancer Hospital of Zhengzhou University, Zhengzhou, PR China.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Lansigan', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Jing', 'Affiliation': 'Peking University Third Hospital, Beijing, PR China.'}, {'ForeName': 'Junning', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, PR China.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Lue', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Han', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Jivani', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heineman', 'Affiliation': 'Denovo Biopharma LLC, San Diego, CA, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Smith', 'Affiliation': 'University of Washington/Fred Hutchinson Cancer Center, Seattle, WA, USA.'}]","Future oncology (London, England)",['10.2217/fon-2020-0176']
832,32135337,Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects.,"BACKGROUND


Studies assessing the impact of sleep restriction (SR) on blood pressure (BP) are limited by short study length, extreme SR (<4 hours a night), and lack of attention to psychological distress as a possible mediator.
METHODS


A community-based cohort was assembled with 237 women (age 34.1 ± 13.5 years; body mass index 25.4 ± 5.4 kg/m 2 ), and a randomized, crossover, intervention study was conducted in 41 women (24 completed: age 30.2 ± 6.5 years; body mass index 24.3 ± 2.8 kg/m 2 ) to determine the causal effect of SR on BP. Sleep was maintained as usual (HS) or reduced by 1.5 hours a night (SR) for 6 weeks. In the cohort, associations between sleep and psychosocial factors were evaluated using multivariable models adjusted for demographic and clinical confounders. In the intervention study, in-office BP was measured weekly; ambulatory BP was measured at end point. Psychological factors were assessed at baseline and end point. Mixed-model analyses with total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect) were performed.
RESULTS


Among the community cohort, higher perceived stress, stressful events and distress, and lower resilience were associated with shorter sleep, worse sleep quality, and greater insomnia symptoms (P < .05). In the intervention, systolic BP increased as TST decreased (TST × week interaction, [coefficient ± standard error] -0.0097 ± 0.0046, P = .036). Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS. Psychological distress variables were not affected by TST and did not mediate the effects of SR on BP.
CONCLUSIONS


These results suggest that SR influences CVD risk in women via mechanisms independent of psychological stressors.",2020,"Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS.","['41 women (24 completed: age 30.2\u202f±\u202f6.5 years; body mass index 24.3\u202f±\u202f2.8 kg/m 2 ', 'premenopausal women with no indication of mediation by psychological effects', 'A community-based cohort was assembled with 237 women (age 34.1\u202f±\u202f13.5 years; body mass index 25.4\u202f±\u202f5.4 kg/m 2 ']","['Mild sleep restriction', 'sleep restriction (SR']","['mean arterial pressure', 'total sleep time (TST, main predictor), week and fraction of time spent in physical activity (covariates), and subject (random effect', '24-hour ambulatory blood pressure', 'shorter sleep, worse sleep quality, and greater insomnia symptoms', 'Psychological factors', 'blood pressure (BP', 'Wake ambulatory diastolic blood pressure', 'stress, stressful events and distress', 'ambulatory BP', 'Sleep', 'Psychological distress variables', 'systolic BP increased as TST']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0521090', 'cui_str': 'No indication of (contextual qualifier) (qualifier value)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",237.0,0.0291203,"Wake ambulatory diastolic blood pressure (-0.059 ± 0.022, P = .021) and mean arterial pressure (-0.067 ± 0.023, P = .018) were higher after SR versus HS.","[{'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'St-Onge', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY; Institute of Human Nutrition, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, NY. Electronic address: ms2554@cumc.columbia.edu.'}, {'ForeName': 'Ayanna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Aggarwal', 'Affiliation': 'Sleep center of excellence, Department of Medicine, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Jasmine L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Institute of Human Nutrition, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, NY; Tulane Medical Center, New Orleans, LA.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Spruill', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2020.02.006']
833,32217365,PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure: Results of the PRIME-HF Trial.,"BACKGROUND


Ivabradine is guideline-recommended to reduce heart failure (HF) hospitalization in patients with stable chronic HF with reduced ejection fraction (EF). Ivabradine initiation following acute HF has had limited evaluation, and there are few randomized data in US patients. The PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) study was conducted to address predischarge ivabradine initiation in stabilized acute HF patients.
METHODS


PRIME-HF was an investigator-initiated, randomized, open-label study of predischarge initiation of ivabradine versus usual care. Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min. Ivabradine was acquired per routine care. The primary end point was the proportion of patients on ivabradine at 180 days. Additional end points included heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension).
RESULTS


Overall, 104 patients (36% women, 64% African American) were randomized, and the study was terminated early because of funding limitations. At 180 days, 21 of 52 (40.4%) of patients randomized to predischarge initiation were treated with ivabradine compared with 6 of 52 (11.5%) randomized to usual care (odds ratio 5.19, 95% CI 1.88-14.33, P = .002). The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011). Patient-reported outcomes, β-blocker use/dose, and safety events were similar (all P > .05).
CONCLUSIONS


Ivabradine initiation prior to discharge among stabilized HF patients increased ivabradine use at 180 days and lowered heart rates without reducing β-blockers or increasing adverse events. As the trial did not achieve the planned enrollment, additional studies are needed.",2020,"The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011).","['Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min', '104 patients (36% women, 64% African American', 'patients with stable chronic HF with reduced ejection fraction (EF', 'stabilized acute HF patients', 'Heart Failure']","['ivabradine versus usual care', 'Ivabradine', 'ivabradine']","['safety events', 'heart failure (HF) hospitalization', 'proportion of patients on ivabradine', 'heart rate', 'heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.204552,"The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. Electronic address: robert.mentz@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Gudaye', 'Initials': 'G', 'LastName': 'Tasissa', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'New York Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Cole', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Heart and Vascular Institute, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Mahazarin', 'Initials': 'M', 'LastName': 'Ginwalla', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Old', 'Affiliation': 'Sentara Cardiovascular Research Institute, Norfolk, VA.'}, {'ForeName': 'Abraham S', 'Initials': 'AS', 'LastName': 'Salacata', 'Affiliation': 'Great Lakes Heart Center of Alpena, Alpena, MI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bigelow', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University School of Medicine, Durham, NC; Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2019.12.024']
834,31086222,"The Effect of Iranian Propolis on Glucose Metabolism, Lipid Profile, Insulin Resistance, Renal Function and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial.","Propolis is a natural product with many biological properties including hypoglycemic activity and modulating lipid profile. The present study was designed to evaluate the effect of Iranian propolis extract on glucose metabolism, Lipid profile, Insulin resistance, renal and liver function as well as inflammatory biomarkers in patients with type 2 diabetes mellitus (T2DM). A double-blind, placebo-controlled clinical trial was conducted. The duration of the study lasted 90 days. Patients with T2DM were recruited and randomly divided into an Iranian propolis group (1000 mg/day) (n = 50) and a placebo group (n = 44). There was a significant decrease in the serum levels of glycosylated hemoglobin (HbA1c), 2-hour post prandial (2hpp), insulin, homeostasis model assessment-insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), High sensitive C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α). However, there was a notable elevation in the serum HDL-C in the propolis group compared with the placebo group. In addition, a notable reduction in serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations in the propolis group was observed. Iranian propolis has beneficial effects on reducing post prandial blood glucose, serum insulin, insulin resistance, and inflammatory cytokines. It is also a useful treatment for preventing the liver and renal dysfunction, as well as, elevating HDL-C concentrations in patients with T2DM.",2019,"In addition, a notable reduction in serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations in the propolis group was observed.","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with T2DM', 'patients with T2DM']","['Iranian Propolis', 'placebo', 'Iranian propolis extract']","['serum levels of glycosylated hemoglobin (HbA1c), 2-hour post prandial (2hpp), insulin, homeostasis model assessment-insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), High sensitive C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α', 'glucose metabolism, Lipid profile, Insulin resistance, renal and liver function', 'post prandial blood glucose, serum insulin, insulin resistance, and inflammatory cytokines', 'serum HDL-C', 'serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations', 'Glucose Metabolism, Lipid Profile, Insulin Resistance, Renal Function and Inflammatory Biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.127932,"In addition, a notable reduction in serum liver transaminase (ALT and AST) and blood urea nitrogen (BUN) concentrations in the propolis group was observed.","[{'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Zakerkish', 'Affiliation': 'Diabetes research center, Health research institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jenabi', 'Affiliation': 'Department of Pharmacology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Zaeemzadeh', 'Affiliation': 'Department of Pharmacology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. zaeemzadeh_n@yahoo.com.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Hemmati', 'Affiliation': 'Medicinal Plant Research Center, School of pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Neisi', 'Affiliation': 'Department of Virology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Scientific reports,['10.1038/s41598-019-43838-8']
835,32239968,Preterm Infants Fed Cow's Milk-Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk.,"Objective:  An increasingly common practice is to feed preterm infants a base diet comprising only human milk (HM), usually fortified with a cow's milk (CM)-derived fortifier (CMDF). We evaluated the safety of CMDF in a diet of 100% mother's own milk (MOM) against a HM-derived fortifier (HMDF). To date, this has received little research attention.  Study Design:  We reanalyzed a 12-center randomized trial, originally comparing exclusive HM feeding, including MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1. However, for the current study, we performed a subgroup analysis ( n  = 114) selecting only infants receiving 100% MOM base diet plus fortification, and fed no DM or PTF. This allowed for an isolated comparison of fortifier type: CMDF versus HMDF to evaluate the primary outcomes: necrotizing enterocolitis (NEC) and a severe morbidity index of NEC surgery or death; and several secondary outcomes.  Results:  CMDF and HMDF groups had similar baseline characteristics. CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p  = 0.038), NEC surgery or death (RR 5.1,  p  = 0.014); and reduced head circumference gain ( p  = 0.04).  Conclusions:  In neonates fed, as currently recommended with a MOM-based diet, the safety of CMDF when compared to HMDF has been little researched. We conclude that available evidence points to an increase in adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death.",2020,"CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p  = 0.038), NEC surgery or death (RR 5.1,  p  = 0.014); and reduced head circumference gain ( p  = 0.04).  ",[],"['CMDF', 'MOM base diet plus fortification, and fed no DM or PTF', 'MOM, donor milk (DM), and HMDF, versus a CM exposed group fed MOM, preterm formula (PTF), and CMDF1']","['adverse outcomes with CMDF, including NEC and severe morbidity comprising NEC surgery or death', 'NEC surgery or death', 'head circumference gain']",[],"[{'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",114.0,0.181336,"CMDF was associated with higher risk of NEC; relative risk (RR) 4.2 ( p  = 0.038), NEC surgery or death (RR 5.1,  p  = 0.014); and reduced head circumference gain ( p  = 0.04).  ","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Health, University College, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Department of Medicine and University of California, San Francisco, California, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Abrams', 'Affiliation': 'Department of Pediatrics, Dell Medical School, The University of Texas, Austin, Texas, USA.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0133']
836,32170769,Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: CALGB/Alliance 50403.,"Immunochemotherapy followed by autologous transplant (ASCT) in CALGB/Alliance 59909 achieved a median progression-free survival (PFS) in mantle cell lymphoma (MCL) of 5 years, but late recurrences occurred. We evaluated tolerability and efficacy of adding post-transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB/Alliance 50403, a randomized phase II trial. Following augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg/m 2  IV days 1, 4, 8, 11 of a 3-week cycle for four cycles) or BM (1.6 mg/m 2  IV once weekly × 4 every 8 weeks for 18 months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4 years (P < .001). The 8-year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%-71.5%) and 64.4% (95% 51.8%-79.0%), respectively. Progression-free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD-negative post-induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long-term follow up suggests a PFS benefit from the addition of BC or BM post- transplant.",2020,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","['151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized']","['Immunochemotherapy and Autologous Stem Cell Transplantation', 'Immunochemotherapy followed by autologous transplant (ASCT', 'adding post-transplant bortezomib consolidation (BC) or maintenance (BM', 'Bortezomib Consolidation or Maintenance', 'augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab']","['8-year PFS estimates', 'Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow', 'PFS and OS', 'toxicity', 'median progression-free survival (PFS', 'PFS', 'tolerability and efficacy', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",151.0,0.0888476,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'Medicine/Hematology-Oncology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Fulton', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pettinger', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'LaCasce', 'Affiliation': 'Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Yi Tian', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurd', 'Affiliation': 'Hematology-Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Alliance Statistics and Data Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hernandez-Ilizaliturri', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine, Weill Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Hematology-Oncology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.25783']
837,32179258,Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial.,"BACKGROUND


Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease.
METHODS


Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
CONCLUSIONS


The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.",2020,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","['Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter', 'Approximately 3,830 patients', 'coronary artery disease patients', 'patients with coronary artery disease']","['Quantitative flow ratio-guided strategy versus angiography-guided strategy', 'angiography-guided strategy will undergo PCI based on angiography', 'QFR-guided versus an angiography-guided PCI strategy', 'QFR-guided or an angiography-guided strategy', 'Quantitative flow ratio (QFR', 'percutaneous coronary intervention (PCI', 'QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy']","['efficacy and cost-effectiveness', 'individual components of MACE and cost-effectiveness end points', '1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization', '1-year MACE excluding periprocedural myocardial infarction']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}]",3830.0,0.0747895,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Daixin', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: qsbfw@sina.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: bxu@citmd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.015']
838,31914147,"Generalizing findings from a randomized controlled trial to a real-world study of the iLookOut, an online education program to improve early childhood care and education providers' knowledge and attitudes about reporting child maltreatment.","In recent years, real-world studies (RWS) are gaining increasing interests, because they can generate more realistic and generalizable results than randomized controlled clinical trials (RCT). In 2017, we published a RCT in 741 early childhood care and education providers (CCPs). It is the Phase I of our iLookOut for Child Abuse project (iLookOut), an online, interactive learning module about reporting suspected child maltreatment. That study demonstrated that in a RCT setting, the iLookOut is efficient at improving CCPs' knowledge of and attitudes towards child maltreatment reporting. However, the generalizability of that RCT's results in a RWS setting remains unknown. To address this question, we design and conduct this large RWS in 11,065 CCPs, which is the Phase II of the iLookOut. We hypothesize replication of the earlier RCT findings, i.e., the iLookOut can improve CCPs' knowledge of and attitudes toward child maltreatment reporting in a real world setting. In addition, this RWS also explores whether demographic factors affect CCPs' performance. Results of this RWS confirmed the generalizability of the previous RCT's results in a real world setting. It yielded similar effect sizes for knowledge and attitudes as were found in the earlier RCT. Cohen's d for knowledge improvement was 0.95 in that RCT, 0.96 in this RWS; Cohen's d for attitude improvement was 0.98 in that RCT, 0.80 in this RWS. Also, we found several significant differences in knowledge and attitude improvement with regard to age, race, education, and employment status. In conclusion, iLookOut improves knowledge and attitudes of CCPs about child maltreatment prevention and reporting in a real-world setting. The generalizability of the initial RCT findings to this RWS provides strong evidence that the iLookout will be effective in other real world settings. It can be a useful model for other interventions aimed at preventing child maltreatment. Clinical trial registration for the original RCT: NCT02225301 (ClinicalTrials.gov Identifier).",2020,"In conclusion, iLookOut improves knowledge and attitudes of CCPs about child maltreatment prevention and reporting in a real-world setting.",['741 early childhood care and education providers (CCPs'],[],"['knowledge and attitude improvement with regard to age, race, education, and employment status', 'attitude improvement', 'knowledge improvement']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242271', 'cui_str': 'Employment status (observable entity)'}]",741.0,0.0405628,"In conclusion, iLookOut improves knowledge and attitudes of CCPs about child maltreatment prevention and reporting in a real-world setting.","[{'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Health Promotion, New York University College of Dentistry, New York City, New York, United States of America.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Panlilio', 'Affiliation': 'Department of Educational Psychology, Counseling and Special Education, Pennsylvania State University, University Park, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Verdiglione', 'Affiliation': 'Departments of Humanities, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Lehman', 'Affiliation': 'Departments of Population Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamm', 'Affiliation': 'Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fiene', 'Affiliation': 'Departments of Psychology & Human Development Research Center, Pennsylvania State University, Middletown, Pennsylvania, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dore', 'Affiliation': 'Departments of Humanities, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Bard', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Grable', 'Affiliation': 'Departments of Psychology & Human Development Research Center, Pennsylvania State University, Middletown, Pennsylvania, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Levi', 'Affiliation': 'Departments of Humanities & Pediatrics, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0227398']
839,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
840,31978126,Comparison of balance changes after inspiratory muscle or Otago exercise training.,"The inspiratory muscles contribute to balance via diaphragmatic contraction and by increasing intra-abdominal pressure. We have shown inspiratory muscle training (IMT) improves dynamic balance significantly with healthy community-dwellers. However, it is not known how the magnitude of balance improvements following IMT compares to that of an established balance program. This study compared the effects of 8-week of IMT for community-dwellers, to 8-week of the Otago exercise program (OEP) for care-residents, on balance and physical performance outcomes. Nineteen healthy community-dwellers (74 ± 4 years) were assigned to self-administered IMT. Eighteen, healthy care-residents (82 ± 4 years) were assigned to instructor-led OEP. The IMT involved 30 breaths twice-daily at ~50% of maximal inspiratory pressure (MIP). The OEP group undertook resistance and mobility exercises for ~60 minutes, twice-weekly. Balance and physical performance were assessed using the mini Balance Evaluation System Test (mini-BEST) and time up and go (TUG). After 8-week, both groups improved balance ability significantly (mini-BEST: IMT by 24 ± 34%; OEP by 34 ± 28%), with no between-group difference. Dynamic balance sub-tasks improved significantly more for the IMT group (P < 0.01), than the OEP group and vice versa for static balance sub-tasks (P = 0.01). The IMT group also improved MIP (by 66 ± 97%), peak inspiratory power (by 31 ± 12%) and TUG (by -11 ± 27%); whereas the OEP did not. IMT and OEP improved balance ability similarly, with IMT eliciting greater improvement in dynamic balance, whilst OEP improved static balance more than IMT. Unlike IMT, the OEP did not provide additional benefits in inspiratory muscle function and TUG performance. Our findings suggest that IMT offers a novel method of improving dynamic balance in older adults, which may be more relevant to function than static balance and potentially a useful adjunct to the OEP in frailty prevention.",2020,"Dynamic balance sub-tasks improved significantly more for the IMT group (P < 0.01), than the OEP group and vice versa for static balance sub-tasks (P = 0.01).","['healthy community-dwellers', 'community-dwellers', 'Nineteen healthy community-dwellers (74 ± 4 years', 'older adults', 'Eighteen, healthy care-residents (82 ± 4 years']","['OEP', 'Otago exercise program (OEP', 'Otago exercise training', 'inspiratory muscle training (IMT', 'self-administered IMT', 'instructor-led OEP', 'IMT and OEP', 'IMT']","['Balance and physical performance', 'Dynamic balance sub-tasks', 'dynamic balance', 'mini Balance Evaluation System Test (mini-BEST) and time up and go (TUG', 'inspiratory muscle function and TUG performance', 'dynamic balance, whilst OEP improved static balance', 'peak inspiratory power', 'MIP', 'balance ability']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2607857'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance (observable entity)'}]",19.0,0.0173829,"Dynamic balance sub-tasks improved significantly more for the IMT group (P < 0.01), than the OEP group and vice versa for static balance sub-tasks (P = 0.01).","[{'ForeName': 'Francesco Vincenzo', 'Initials': 'FV', 'LastName': 'Ferraro', 'Affiliation': 'Department of Human Sciences and Public Health, Bournemouth University, Bournemouth, England, United Kingdom.'}, {'ForeName': 'James Peter', 'Initials': 'JP', 'LastName': 'Gavin', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Thomas William', 'Initials': 'TW', 'LastName': 'Wainwright', 'Affiliation': 'Department of Human Sciences and Public Health, Bournemouth University, Bournemouth, England, United Kingdom.'}, {'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'McConnell', 'Affiliation': 'The Burrow, Christchurch, New Zealand.'}]",PloS one,['10.1371/journal.pone.0227379']
841,31995576,Do genetic ancestry tests increase racial essentialism? Findings from a randomized controlled trial.,"Genetic ancestry testing is a billion-dollar industry, with more than 26 million tests sold by 2018, which raises concerns over how it might influence test-takers' understandings of race. While social scientists argue that genetic ancestry tests may promote an essentialist view of race as fixed and determining innate abilities, others suggest it could reduce essentialist views by reinforcing a view of race as socially constructed. Essentialist views are a concern because of their association with racism, particularly in its most extreme forms. Here we report the first randomized controlled trial of genetic ancestry testing conducted to examine potential causal relationships between taking the tests and essentialist views of race. Native-born White Americans were randomly assigned to receive Admixture and mtDNA tests or no tests. While we find no significant average effect of genetic ancestry testing on essentialism, secondary analyses reveal that the impact of these tests on racial essentialism varies by type of genetic knowledge. Within the treatment arm, essentialist beliefs significantly declined after testing among individuals with high genetic knowledge, but increased among those with the least genetic knowledge. Additional secondary analysis show that essentialist beliefs do not change based on the specific ancestries reported in test-takers' results. These results indicate that individuals' interpretations of genetic ancestry testing results, and the links between genes and race, may depend on their understanding of genetics.",2020,Additional secondary analysis show that essentialist beliefs do not change based on the specific ancestries reported in test-takers' results.,['Native-born White Americans'],['Admixture and mtDNA tests or no tests'],['essentialist beliefs'],"[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0012929', 'cui_str': 'mtDNA'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}]",,0.0457147,Additional secondary analysis show that essentialist beliefs do not change based on the specific ancestries reported in test-takers' results.,"[{'ForeName': 'Wendy D', 'Initials': 'WD', 'LastName': 'Roth', 'Affiliation': 'Department of Sociology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Şule', 'Initials': 'Ş', 'LastName': 'Yaylacı', 'Affiliation': 'Department of Sociology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Jaffe', 'Affiliation': 'Department of Sociology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Richardson', 'Affiliation': 'Department of Sociology, University of British Columbia, Vancouver, BC, Canada.'}]",PloS one,['10.1371/journal.pone.0227399']
842,30839402,Huperzine-A response to cognitive impairment and task switching deficits in patients with Alzheimer's disease.,"BACKGROUND


Alzheimer's Disease (AD) is associated with cognitive decline due to various pathological mechanisms. There are several acetylcholinesterase inhibitor compounds which can improve cognition, but Huperzine-A is a natural sesquiterpene alkaloid extracted from Chinese herb (Huperzia Serrata) which has rapid action.
METHODS


Double blind study was conducted. Participants included 50 patients with AD and 50 healthy individuals. Patients were recruited from Civil and BV hospital Bahawalpur and Nishter hospital Multan, Pakistan during May 2017 until February 2018 who were stable on Huperzine-A medication. Patients were tested twice. First, at the time of diagnosis to determine baseline scores. Second, post eight weeks of Huperzine-A treatment. Healthy individuals had single testing session. Participants completed Addenbrooke's Cognitive Examination and Trail Making Test.
RESULTS


Patients with AD showed cognitive and task switching deficits in contrast with healthy individuals. There was significant improvement in cognition and task switching abilities post Huperzine-A treatment compared with baseline performance.
CONCLUSION


Huperzine-A is effective in reducing cognitive and task switching deficits in patients with AD.",2019,"There was significant improvement in cognition and task switching abilities post Huperzine-A treatment compared with baseline performance.
","[""patients with Alzheimer's disease"", 'Patients were recruited from Civil and BV hospital Bahawalpur and Nishter hospital Multan, Pakistan during May 2017 until February 2018 who were stable on Huperzine-A medication', 'Participants included 50 patients with AD and 50 healthy individuals', 'Healthy individuals had single testing session', 'patients with AD']","['Huperzine-A', 'Huperzine']","['cognition and task switching abilities', 'cognitive and task switching deficits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0063033', 'cui_str': 'huperzine A'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0063033', 'cui_str': 'huperzine A'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",50.0,0.0802604,"There was significant improvement in cognition and task switching abilities post Huperzine-A treatment compared with baseline performance.
","[{'ForeName': 'Amara', 'Initials': 'A', 'LastName': 'Gul', 'Affiliation': 'Department of Applied Psychology, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}, {'ForeName': 'Jehan', 'Initials': 'J', 'LastName': 'Bakht', 'Affiliation': 'Institute of Biotechnology and Genetic Engineering, The University of Agriculture, Peshawar, Pakistan.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Mehmood', 'Affiliation': 'Department of Applied Psychology, The Islamia University of Bahawalpur, Bahawalpur, Pakistan.'}]",Journal of the Chinese Medical Association : JCMA,['10.1016/j.jcma.2018.07.004']
843,31420361,Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biomarkers in High-Risk Women: A Pilot Study.,"Interventions that relieve vasomotor symptoms while reducing risk for breast cancer would likely improve uptake of chemoprevention for perimenopausal and postmenopausal women. We conducted a pilot study with 6 months of the tissue selective estrogen complex bazedoxifene (20 mg) and conjugated estrogen (0.45 mg; Duavee) to assess feasibility and effects on risk biomarkers for postmenopausal breast cancer. Risk biomarkers included fully automated mammographic volumetric density (Volpara), benign breast tissue Ki-67 (MIB-1 immunochemistry), and serum levels of progesterone, IGF-1, and IGFBP3, bioavailable estradiol and testosterone. Twenty-eight perimenopausal and postmenopausal women at increased risk for breast cancer were enrolled: 13 in cohort A with baseline Ki-67 < 1% and 15 in cohort B with baseline Ki-67 of 1% to 4%. All completed the study with > 85% drug adherence. Significant changes in biomarkers, uncorrected for multiple comparisons, were a decrease in mammographic fibroglandular volume ( P  = 0.043); decreases in serum progesterone, bioavailable testosterone, and IGF-1 ( P  < 0.01), an increase in serum bioavailable estradiol ( P  < 0.001), and for women from cohort B a reduction in Ki-67 ( P  = 0.017). An improvement in median hot flash score from 15 at baseline to 0 at 6 months, and menopause-specific quality-of-life total, vasomotor, and sexual domain scores were also observed ( P  < 0.001). Given the favorable effects on risk biomarkers and patient reported outcomes, a placebo-controlled phase IIB trial is warranted.",2019,"An improvement in median hot flash score from 15 at baseline to 0 at 6 months, and menopause specific quality of life total, vasomotor and sexual domain scores were also observed (p< 0.001).","['postmenopausal breast cancer', '28 peri- and post-menopausal women at increased risk for breast cancer', 'High Risk Women']","['Bazedoxifene and Conjugated Estrogen (Duavee®', 'tissue selective estrogen complex bazedoxifene (20 mg) and conjugated estrogen (0.45 mg) (Duavee®']","['median hot flash score', 'serum bioavailable estradiol', 'menopause specific quality of life total, vasomotor and sexual domain scores', 'serum progesterone, bioavailable testosterone, and IGF-1 (p<0.01', 'mammographic fibroglandular volume', 'automated mammographic volumetric density (Volpara®), benign breast tissue Ki-67 (MIB-1 immunochemistry), and serum levels of progesterone, IGF-1 and IGFBP3, bioavailable estradiol and testosterone']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C2346970', 'cui_str': 'bazedoxifene'}, {'cui': 'C0014938', 'cui_str': 'conjugated estrogens'}, {'cui': 'C3692336', 'cui_str': 'Duavee'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C4068884', 'cui_str': '0.45'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0806069', 'cui_str': 'Bioavailable estradiol'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone (substance)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0020986', 'cui_str': 'Immunochemistry'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",,0.0371583,"An improvement in median hot flash score from 15 at baseline to 0 at 6 months, and menopause specific quality of life total, vasomotor and sexual domain scores were also observed (p< 0.001).","[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Nye', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Onalisa', 'Initials': 'O', 'LastName': 'Winblad', 'Affiliation': 'Department of Diagnostic Radiology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Christy R', 'Initials': 'CR', 'LastName': 'Hagan', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Merit L', 'Initials': 'ML', 'LastName': 'Goodman', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0315']
844,26820670,Surgery versus medical therapy for heavy menstrual bleeding.,"BACKGROUND


Heavy menstrual bleeding significantly impairs the quality of life of many otherwise healthy women. Perception of heavy menstrual bleeding is subjective and management usually depends upon what symptoms are acceptable to the individual. Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy. Medical treatment options include oral medication and a hormone-releasing intrauterine device (LNG-IUS).
OBJECTIVES


To compare the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding.
SEARCH METHODS


We searched the following databases from inception to January 2016: Cochrane Gynaecology and Fertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and clinical trials registers (clinical trials.gov and ICTRP). We also searched the reference lists of retrieved articles.
SELECTION CRITERIA


Randomised controlled trials (RCTs) comparing conservative surgery or hysterectomy versus medical therapy (oral or intrauterine) for heavy menstrual bleeding.
DATA COLLECTION AND ANALYSIS


Two review authors independently selected the studies, assessed their risk of bias and extracted the data. Our primary outcomes were menstrual bleeding, satisfaction rate and adverse events. Where appropriate we pooled the data to calculate pooled risk ratios (RRs) or mean differences, with 95% confidence intervals (CIs), using a fixed-effect model. We assessed heterogeneity with the I(2) statistic and evaluated the quality of the evidence using GRADE methods.
MAIN RESULTS


We included 15 parallel-group RCTs (1289 women). Surgical interventions included hysterectomy and endometrial resection or ablation. Medical interventions included oral medication and the levonorgestrel-releasing intrauterine device (LNG-IUS). The overall quality of the evidence for different comparisons ranged from very low to moderate. The main limitations were lack of blinding, attrition and imprecision. Moreover, it was difficult to interpret long-term study findings as many women randomised to medical interventions subsequently underwent surgery. Surgery versus oral medicationSurgery (endometrial resection) was more effective in controlling bleeding at four months (RR 2.66, 95% CI 1.94 to 3.64, one RCT, 186 women, moderate quality evidence) and also at two years (RR 1.29, 95% CI 1.06 to 1.57, one RCT, 173 women, low quality evidence). There was no evidence of a difference between the groups at five years (RR 1.14, 95% CI 0.97 to 1.34, one RCT, 140 women, very low quality evidence).Satisfaction with treatment was higher in the surgical group at two years (RR 1.40, 95% CI 1.13 to 1.74, one RCT, 173 women, moderate quality evidence), but there was no evidence of a difference between the groups at five years (RR 1.13, 95% CI 0.94 to 1.37, one RCT, 114 women, very low quality evidence). There were fewer adverse events in the surgical group at four months (RR 0.26, 95 CI 0.15 to 0.46, one RCT, 186 women). These findings require cautious interpretation, as 59% of women randomised to the oral medication group had had surgery within two years and 77% within five years. Surgery versus LNG-IUSWhen hysterectomy was compared with LNG-IUS, the hysterectomy group were more likely to have objective control of bleeding at one year (RR 1.11, 95% CI 1.05 to 1.19, one RCT, 223 women, moderate quality evidence). There was no evidence of a difference in quality of life between the groups at five or 10 years, but by 10 years 46% of women originally assigned to LNG-IUS had undergone hysterectomy. Adverse effects associated with hysterectomy included surgical complications such as bladder or bowel perforation and vesicovaginal fistula. Adverse effects associated with LNG-IUS were ongoing bleeding and hormonal symptoms.When conservative surgery was compared with LNG-IUS, at one year the surgical group were more likely to have subjective control of bleeding (RR 1.19, 95% CI 1.07 to 1.32, five RCTs, 281 women, low quality evidence, I(2) = 15%). Satisfaction rates were higher in the surgical group at one year (RR 1.16, 95% CI 1.04, to 1.28, six RCTs, 442 women, I(2) = 27%), but this finding was sensitive to the choice of statistical model and use of a random-effects model showed no conclusive evidence of a difference between the groups. There was no evidence of a difference between the groups in satisfaction rates at two years (RR 0.93, 95% CI 0.81 to 1.08, two RCTs, 117 women, I(2) = 1%).At one year there were fewer adverse events (such as bleeding and spotting) in the surgical group (RR 0.36, 95% CI 0.15 to 0.82, three RCTs, moderate quality evidence). It was unclear what proportion of women assigned to LNG-IUS underwent surgery over long-term follow-up, as there were few data beyond one year.
AUTHORS' CONCLUSIONS


Surgery, especially hysterectomy, reduces menstrual bleeding more than medical treatment at one year. There is no conclusive evidence of a difference in satisfaction rates between surgery and LNG-IUS, though adverse effects such as bleeding and spotting are more likely to occur with LNG-IUS. Oral medication suits a minority of women in the long term, and the LNG-IUS device provides a better alternative to surgery in most cases. Although hysterectomy is a definitive treatment for heavy menstrual bleeding, it can cause serious complications for a minority of women. Most women may be well advised to try a less radical treatment as first-line therapy. Both LNG-IUS and conservative surgery appear to be safe, acceptable and effective.",2016,"Satisfaction rates were higher in the surgical group at one year (RR 1.16, 95% CI 1.04, to 1.28, six RCTs, 442 women, I(2) = 27%), but this finding was sensitive to the choice of statistical model and use of a random-effects model showed no conclusive evidence of a difference between the groups.","['15 parallel-group RCTs (1289 women', 'heavy menstrual bleeding', 'otherwise healthy women']","['surgery versus medical therapy', 'Surgery versus oral medicationSurgery (endometrial resection', 'conservative surgery or hysterectomy versus medical therapy (oral or intrauterine', 'Surgery versus medical therapy', 'Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy', 'Surgical interventions included hysterectomy and endometrial resection or ablation', 'levonorgestrel-releasing intrauterine device (LNG-IUS', 'hormone-releasing intrauterine device (LNG-IUS', 'LNG-IUSWhen hysterectomy']","['quality of life', 'satisfaction rates', 'menstrual bleeding', 'overall quality', 'effectiveness, safety and acceptability', 'adverse events (such as bleeding and spotting', 'controlling bleeding', 'adverse events', 'menstrual bleeding, satisfaction rate and adverse events', 'surgical complications such as bladder or bowel perforation and vesicovaginal fistula', 'bleeding and hormonal symptoms', 'subjective control of bleeding', 'objective control of bleeding', 'Satisfaction rates']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection (procedure)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0021902', 'cui_str': 'IUD, Hormone Releasing'}]","[{'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C0042582', 'cui_str': 'Vesico-Vaginal Fistulae'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.182222,"Satisfaction rates were higher in the surgical group at one year (RR 1.16, 95% CI 1.04, to 1.28, six RCTs, 442 women, I(2) = 27%), but this finding was sensitive to the choice of statistical model and use of a random-effects model showed no conclusive evidence of a difference between the groups.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marjoribanks', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Auckland, Park Rd, Grafton, Auckland, New Zealand, 1003.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lethaby', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003855.pub3']
845,27964966,Three weeks of parent-administered physiotherapy for very preterm infants improves motor performance at 37 weeks more than usual care [commentary].,,2017,,[],[],['motor performance'],[],[],[],,0.0671851,,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Spittle', 'Affiliation': ""Department of Physiotherapy, University of Melbourne, Australia; Victorian Infant Brain Studies, Murdoch Children's Research Institute, Melbourne, Australia.""}]",Journal of physiotherapy,['10.1016/j.jphys.2016.10.006']
846,32233208,[Compound Amino Acid Capsules combined with clomiphene for severe oligospermia].,"Objective


To study the effect of Compound Amino Acid Capsules (CAAC) combined with clomiphene in the treatment of severe oligospermia.
METHODS


A total of 104 patients with severe oligospermia admitted to our Center of Reproductive Medicine from January to September 2018 were randomly assigned to a trial (n = 60) and a control group (n = 44), the former treated by oral administration of CAAC combined with clomiphene and the latter with clomiphene only, both for 12 weeks. Comparisons were made between the two groups of patients in the sperm concentration, and the percentages of progressively motile sperm (PMS) and total motile sperm (TMS) before and after 4, 8 and 12 weeks of medication as well as the pregnancy rate during the treatment.
RESULTS


Compared with the baseline, the trial group showed significant elevation at 4, 8 and 12 weeks in sperm concentration (［3.13 ± 1.29］ vs ［12.06 ± 2.24］, ［22.10 ± 2.65］ and ［28.13 ± 3.59］ ×10⁶/ml, P < 0.01), PMS (［14.03 ± 2.49］% vs ［21.05 ± 3.14］%, ［29.08 ± 4.70］% and ［35.08 ± 3.70］%, P < 0.01) and TMS (［20.10 ± 4.05］% vs ［27.10 + 4.87］%, ［36.09 ± 5.64］% and ［45.04 ± 6.69］%, P < 0.01), and so did the control group in sperm concentration (［3.27 ± 1.46］ vs ［10.21 ± 2.35］, ［19.89 ± 2.74］ and ［25.23 ± 3.69］ ×10⁶/ml, P < 0.01), PMS (［13.32 ± 3.12］% vs ［17.02 ± 3.26］%, ［22.13 ± 3.70］% and ［27.18 ± 2.54］%, P < 0.01) and TMS (［21.30 ± 4.87］% vs ［24.22 ± 5.07］%, ［30.03 ± 5.33］% and ［35.05 ± 5.69］%, P < 0.01), even more significant in the trial than in the control group at the three time points after medication (P < 0.01). The pregnancy rate was markedly higher in the former than in the latter group at 4 (1.72% vs 0.53%, P < 0.01), 8 (4.21% vs 2.87%, P < 0.01) and 12 weeks (8.32% vs 6.32%, P < 0.01). No adverse reactions were observed in neither of the two groups during the treatment.
CONCLUSIONS


CAAC combined with clomiphene can significantly improve the semen parameters of the patients with severe oligospermia, with no obvious adverse events.",2019,"Compared with the baseline, the trial group showed significant elevation at 4, 8 and 12 weeks in sperm concentration (［3.13 ± 1.29］ vs ［12.06 ± 2.24］, ［22.10 ± 2.65］ and ［28.13 ± 3.59］ ×10⁶/ml, P < 0.01), PMS (［14.03 ± 2.49］% vs ［21.05 ± 3.14］%, ［29.08 ± 4.70］% and ［35.08 ± 3.70］%, P < 0.01) and TMS (［20.10 ± 4.05］% vs ［27.10 + 4.87］%, ［36.09 ± 5.64］% and ［45.04 ± 6.69］%, P < 0.01), and so did the control group in sperm concentration (［3.27 ± 1.46］ vs ［10.21 ± 2.35］, ［19.89 ± 2.74］ and ［25.23 ± 3.69］ ×10⁶/ml, P < 0.01), PMS (［13.32 ± 3.12］% vs ［17.02 ± 3.26］%, ［22.13 ± 3.70］% and ［27.18 ± 2.54］%, P < 0.01) and TMS (［21.30 ± 4.87］% vs ［24.22 ± 5.07］%, ［30.03 ± 5.33］% and ［35.05 ± 5.69］%, P < 0.01), even more significant in the trial than in the control group at the three time points after medication (P < 0.01).","['104 patients with severe oligospermia admitted to our Center of Reproductive Medicine from January to September 2018', 'patients with severe oligospermia', 'severe oligospermia']","['clomiphene', 'Compound Amino Acid Capsules (CAAC) combined with clomiphene', 'CAAC combined with clomiphene and the latter with clomiphene']","['pregnancy rate', 'percentages of progressively motile sperm (PMS) and total motile sperm (TMS', 'adverse reactions']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028960', 'cui_str': 'Oligoasthenoteratozoospermia'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}]","[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0642815', 'cui_str': 'CAAC'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",104.0,0.0460896,"Compared with the baseline, the trial group showed significant elevation at 4, 8 and 12 weeks in sperm concentration (［3.13 ± 1.29］ vs ［12.06 ± 2.24］, ［22.10 ± 2.65］ and ［28.13 ± 3.59］ ×10⁶/ml, P < 0.01), PMS (［14.03 ± 2.49］% vs ［21.05 ± 3.14］%, ［29.08 ± 4.70］% and ［35.08 ± 3.70］%, P < 0.01) and TMS (［20.10 ± 4.05］% vs ［27.10 + 4.87］%, ［36.09 ± 5.64］% and ［45.04 ± 6.69］%, P < 0.01), and so did the control group in sperm concentration (［3.27 ± 1.46］ vs ［10.21 ± 2.35］, ［19.89 ± 2.74］ and ［25.23 ± 3.69］ ×10⁶/ml, P < 0.01), PMS (［13.32 ± 3.12］% vs ［17.02 ± 3.26］%, ［22.13 ± 3.70］% and ［27.18 ± 2.54］%, P < 0.01) and TMS (［21.30 ± 4.87］% vs ［24.22 ± 5.07］%, ［30.03 ± 5.33］% and ［35.05 ± 5.69］%, P < 0.01), even more significant in the trial than in the control group at the three time points after medication (P < 0.01).","[{'ForeName': 'Yi-Gang', 'Initials': 'YG', 'LastName': 'Bao', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital of Jilin University, Changchun, Jilin 130041, China.'}, {'ForeName': 'Lian-Wen', 'Initials': 'LW', 'LastName': 'Zheng', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital of Jilin University, Changchun, Jilin 130041, China.'}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Dai', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital of Jilin University, Changchun, Jilin 130041, China.'}, {'ForeName': 'Gui-Jie', 'Initials': 'GJ', 'LastName': 'Wu', 'Affiliation': 'Center of Reproductive Medicine, The Second Hospital of Jilin University, Changchun, Jilin 130041, China.'}]",Zhonghua nan ke xue = National journal of andrology,[]
847,32078353,"Outreach and Inreach Strategies for Colorectal Cancer Screening Among Latinos at a Federally Qualified Health Center: A Randomized Controlled Trial, 2015-2018.","Objectives.  To compare usual care, inreach consisting of one-on-one education, mailed outreach offering a fecal immunochemical test (FIT), and a combination of outreach and inreach for promoting colorectal cancer (CRC) screening. Methods.  We conducted a 4-arm randomized controlled trial from 2015 to 2018 at a US federally qualified health center near the California-Mexico border primarily serving low-income Hispanics/Latinos. A total of 673 individuals aged 50 to 75 years not up to date with screening were assigned to 1 of the 4 intervention groups. The primary outcome was CRC screening through 6 months follow-up. Results.  A total of 671 patients were included in intention-to-screen analyses. Their mean age was 59.9 years, 48.9% were male, and 86.3% were primarily Spanish-speaking. Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85;  P  < .001 for all comparisons except  P  = .793 for outreach vs combination). Conclusions.  Among individuals at high risk for noncompletion, inreach with one-on-one education nearly doubled, and outreach offering mailed FIT alone or in combination with inreach nearly tripled screening compared with usual care. Mailed FIT outreach was superior to inreach for promoting screening.",2020,"Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85;  P  < .001 for all comparisons except  P  = .793 for outreach vs combination).","['Colorectal Cancer Screening Among Latinos at a Federally Qualified Health Center', '2015 to 2018 at a US federally qualified health center near the California-Mexico border primarily serving low-income Hispanics/Latinos', '2015-2018', '673 individuals aged 50 to 75 years not up to date with screening', '671 patients were included in intention-to-screen analyses', 'Their mean age was 59.9 years, 48.9% were male, and 86.3% were primarily Spanish-speaking']","['usual care, inreach consisting of one-on-one education, mailed outreach offering a fecal immunochemical test (FIT), and a combination of outreach and inreach']",['CRC screening through 6 months follow-up'],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",671.0,0.143398,"Screening was 27.5% for usual care (95% confidence interval [CI] = 0.21, 0.34), 52.7% for inreach (95% CI = 0.45, 0.60), 77.2% for outreach (95% CI = 0.71, 0.83), and 78.9% for combination of inreach and outreach (95% CI = 0.73, 0.85;  P  < .001 for all comparisons except  P  = .793 for outreach vs combination).","[{'ForeName': 'Sheila F', 'Initials': 'SF', 'LastName': 'Castañeda', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Balambal', 'Initials': 'B', 'LastName': 'Bharti', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Marielena', 'Initials': 'M', 'LastName': 'Rojas', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mercado', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Adriana M', 'Initials': 'AM', 'LastName': 'Bearse', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Camacho', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Manuel Song', 'Initials': 'MS', 'LastName': 'Lopez', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Muñoz', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Shawne', 'Initials': 'S', 'LastName': ""O'Connell"", 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Talavera', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Sheila F. Castañeda and Gregory A. Talavera are with the Department of Psychology, San Diego State University, Chula Vista, CA. Balambal Bharti, Lin Liu, and Samir Gupta are with the Moores Cancer Center, University of California, San Diego, La Jolla. Marielena Rojas, Silvia Mercado, Adriana M. Bearse, Jasmine Camacho, Manuel Song Lopez, and Fatima Muñoz are with San Ysidro Health, San Diego, CA. Shawne O'Connell is with Kimochi Inc, San Francisco, CA.""}]",American journal of public health,['10.2105/AJPH.2019.305524']
848,32237995,Attending After-School Physical Activity Club 2 Days a Week Attenuated an Increase in Percentage Body Fat and a Decrease in Fitness Among Adolescent Girls at Risk for Obesity.,"PURPOSE


To evaluate the effect of a 17-week intervention, including an after-school physical activity (PA) club 3 d/wk, on moderate-to-vigorous physical activity (MVPA), body mass index (BMI)  z  score, percentage body fat (%BF), and cardiorespiratory fitness (CRF) among fifth to eighth grade girls having a BMI  z  score ≥0, and explore whether intervention outcomes varied by club attendance (1 vs 2 vs 3 d/wk).
DESIGN


Secondary analysis of data from a group randomized controlled trial (N = 1519, 10- to 15-year-old girls: n = 753 intervention; n = 766 control).
SETTING


Twenty-four Midwestern US schools (n = 12 intervention; n = 12 control).
SAMPLE


Subsample (n = 1194 girls) from trial's intervention (n = 593 girls) and control (n = 601 girls) groups having BMI  z  scores ≥0.
MEASURES


Moderate-to-vigorous physical activity (min/h), BMI  z  score, %BF, and CRF ( V ˙ O 2max : mL/kg/min) were estimated at baseline and postintervention.
ANALYSIS


Linear mixed-effect models.
RESULTS


Intervention group gained less %BF ( B  = -0.35,  P  = .016), and their CRF decreased less ( B  = 0.22,  P = . 010) than the control. Marginally significant findings showed girls attending the club an average of 1 d/wk had greater increases in %BF ( B  = 0.33,  P  = .087) and MVPA ( B  = 0.20,  P = . 083) and a greater decrease in CRF ( B  = -0.20,  P = . 061) than girls attending 3 d/wk. No differences occurred between girls who attended 2 versus 3 d/wk for any outcomes.
CONCLUSIONS


The intervention attenuated an increase in %BF and a decrease in CRF among girls at risk for obesity from baseline to postintervention. Offering the after-school PA club 2 d/wk may be adequate for achieving outcomes.",2020,"RESULTS


Intervention group gained less %BF ( B  = -0.35,  P  = .016), and their CRF decreased less ( B  = 0.22,  P = .","['Adolescent Girls at Risk for Obesity', ""SAMPLE\n\n\nSubsample (n = 1194 girls) from trial's intervention (n = 593 girls) and"", 'N = 1519, 10- to 15-year-old girls: n = 753 intervention; n = 766 control', 'control (n = 601 girls) groups having BMI  z  scores ≥0', 'Twenty-four Midwestern US schools (n = 12 intervention; n = 12 control']",[],"['Percentage Body Fat', 'Fitness', 'Moderate-to-vigorous physical activity (min/h), BMI  z  score, %BF, and CRF ( V', 'BF', 'CRF', 'MVPA', 'moderate-to-vigorous physical activity (MVPA), body mass index (BMI)  z  score, percentage body fat (%BF), and cardiorespiratory fitness (CRF']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0252926,"RESULTS


Intervention group gained less %BF ( B  = -0.35,  P  = .016), and their CRF decreased less ( B  = 0.22,  P = .","[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Center for Family Health, Jackson, MI, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120915679']
849,32237005,A behavioral economics-based telehealth intervention to improve aspirin adherence following hospitalization for acute coronary syndrome.,"PURPOSE


A significant number of patients with acute coronary syndrome (ACS) are nonadherent to aspirin after hospital discharge, with an associated increased risk of subsequent cardiovascular events. The purpose of this pilot study was to test the efficacy of a telehealth intervention based on behavioral economics to improve aspirin adherence following hospitalization for ACS.
METHODS


We enrolled 130 participants (c¯X = 58 ± 10.7 years of age, 38% female, 45% black) from two hospitals. Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications. Consenting participants were randomized to the intervention or usual care group. The intervention group was eligible to receive up to $50 per month if they took their medicine daily, with $2 per day deducted if a dose was missed. All participants received an electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin, which was used to measure adherence calculated as the proportion of prescribed drug taken using the EM device. Based on the skewness in the adherence distribution, quantile regression was used to evaluate the effect of the intervention on median adherence over time.
RESULTS


After 90 days, adherence fell in the control group but remained high in the intervention group (median adherence 81% vs 90%, P = .18). Rehospitalization was higher in the control group (24% vs 13%, P = .17).
CONCLUSION


A loss aversion behavioral economics-based telehealth intervention is a promising approach to improving aspirin adherence following hospitalization for ACS.",2020,"Rehospitalization was higher in the control group (24% vs 13%, P = .17).
","['acute coronary syndrome', 'Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications', 'patients with acute coronary syndrome (ACS', '130 participants (c¯X = 58\u2009±\u200910.7\u2009years of age, 38% female, 45% black) from two hospitals', 'Consenting participants']","['aspirin', 'intervention or usual care group', 'behavioral economics-based telehealth intervention', 'electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin', 'telehealth intervention']","['Rehospitalization', 'aspirin adherence', 'median adherence over time', 'adherence fell']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",130.0,0.040123,"Rehospitalization was higher in the control group (24% vs 13%, P = .17).
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jaskowiak-Barr', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Daus', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Kimmel', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.4988']
850,31389246,Inferior Turbinate Reduction: Diode LASER or Conventional Partial Turbinectomy?,"Hypertrophy of inferior nasal turbinate is one of the most common causes for nasal obstruction (NO). As diode laser has proven to be as effective as any other lasers, our objective was to study various primary outcomes of its use of diode laser like improvement in NO, intraoperative bleeding, postoperative pain, and rapidity of healing. The study was undertaken to compare the various outcomes by diode laser turbinate reduction (LTR) and conventional partial inferior turbinectomy (PIT). A nonrandomized controlled trial was conducted on 2 groups: One group (30 cases) underwent LTR and PIT was performed in the other group (30 cases). The improvement in NO was measured postoperatively up to 6 months. Intraoperative bleeding was measured and postoperative pain scores were assessed each day up to fifth postoperative day. Lastly, rapidity of healing was evaluated until 6 months. Subjective relief of NO was 90.8% in LTR group, whereas it was 65% in PIT group at 6-month follow-up, which was statistically significant ( P  < .05). Pain scores were higher until 5 days in PIT group compared to LTR group ( P  = .0001). Intraoperative bleeding mean scores (milliliters) were 8.03 in LTR group compared to 23.29 in PIT group ( P  = .00001). Rapidity of healing was faster in LTR group with mean scores of 3.03 weeks in comparison to PIT group where it was 6.33 weeks ( P  = .00001). Compared to the conventional technique, the outcomes were better with diode laser and caused less morbidity.",2019,Intraoperative bleeding mean scores (milliliters) were 8.03 in LTR group compared to 23.29 in PIT group ( P  = .00001).,['Inferior Turbinate Reduction'],"['diode laser', 'LTR', 'LTR and PIT', 'Diode LASER', 'diode laser turbinate reduction (LTR) and conventional partial inferior turbinectomy (PIT']","['Rapidity of healing', 'Lastly, rapidity of healing', 'intraoperative bleeding, postoperative pain, and rapidity of healing', 'Intraoperative bleeding mean scores (milliliters', 'morbidity', 'Pain scores', 'Intraoperative bleeding', 'Subjective relief of NO', 'postoperative pain scores']","[{'cui': 'C0225434', 'cui_str': 'Inferior turbinated bone'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C1266928', 'cui_str': 'Nasal Concha'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0161872', 'cui_str': 'Turbinectomy (procedure)'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439242', 'cui_str': 'cm3'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",,0.0299385,Intraoperative bleeding mean scores (milliliters) were 8.03 in LTR group compared to 23.29 in PIT group ( P  = .00001).,"[{'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Doreyawar', 'Affiliation': '1 Department of ENT, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.'}, {'ForeName': 'Raveendra P', 'Initials': 'RP', 'LastName': 'Gadag', 'Affiliation': '1 Department of ENT, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.'}, {'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Dandinarasaiah', 'Affiliation': '1 Department of ENT, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.'}, {'ForeName': 'Shivalingappa B', 'Initials': 'SB', 'LastName': 'Javali', 'Affiliation': '2 Department of Community Medicine, USM-KLE International Medical College, Nehru Nagar, Belagavi, Karnataka, India.'}, {'ForeName': 'Nagaraj', 'Initials': 'N', 'LastName': 'Maradi', 'Affiliation': '1 Department of ENT, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.'}, {'ForeName': 'Deekshit', 'Initials': 'D', 'LastName': 'Shetty', 'Affiliation': '1 Department of ENT, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.'}]","Ear, nose, & throat journal",['10.1177/0145561319839795']
851,32229139,The short-term effect of dark chocolate flavanols on cognition in older adults: A randomized controlled trial (FlaSeCo).,"BACKGROUND


Cocoa flavanols in the diet have had positive effects on cognition, blood lipid levels, and glucose metabolism.
METHODS


Cognitively healthy older adults aged 65-75 years were recruited for an eight-week randomized, double-blind controlled trial to investigate the effectiveness of cocoa flavanols on cognitive functions. At baseline, nutrient and polyphenol intakes from diet were assessed with three-day food diaries. The intervention group received 50 g dark chocolate containing 410 mg of flavanols per day, and the control group 50 g dark chocolate containing 86 mg of flavanols per day, for eight weeks. Cognition was assessed with Verbal Fluency (VF) and the Trail Making Test (TMT) A and B as the main outcome measures. Changes in blood lipids and glucose were also measured.
RESULTS


The older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74). They were highly educated with a mean 14.9 years of education (SD 3.6). No differences in changes in cognition were seen between groups. The mean change (± SEs) in the time to complete the TMT A and B in the intervention group was -4.6 s (-7.1 to -2.1) and -16.1 s (-29.1 to -3.1), and in the controls -4.4 s (-7.0 to -1.9) and -12.5 s (-22.8 to -2.1)(TMT A p = 0.93; TMT B p = 0.66). No difference was apparent in the changes in blood lipids, glucose levels, or body weight between the groups.
CONCLUSIONS


The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.",2020,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"['older adults', 'healthy older adults', 'older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74', 'Cognitively healthy older adults aged 65-75\u202fyears', 'They were highly educated with a mean 14.9\u202fyears of education (SD 3.6']","['cocoa flavanols', '50\u202fg dark chocolate containing 410\u202fmg of flavanols per day, and the control group 50\u202fg dark chocolate containing 86\u202fmg of flavanols', 'dark chocolate flavanols', '2.1)(TMT']","['mean change (± SEs', 'blood lipids and glucose', 'Verbal Fluency (VF) and the Trail Making Test (TMT', 'cognitive functions', 'changes in cognition', 'cognition, blood lipid levels, and glucose metabolism', 'blood lipids, glucose levels, or body weight']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0857756', 'cui_str': 'Highly educated'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0700198,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland. Electronic address: merja.suominen@gery.fi.'}, {'ForeName': 'M M L', 'Initials': 'MML', 'LastName': 'Laaksonen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Salmenius-Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Hongisto', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tuukkanen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}]",Experimental gerontology,['10.1016/j.exger.2020.110933']
852,32233922,"Speech-Language Pathologists' Comfort Level With Use of Term ""Stuttering"" During Evaluations.","Purpose Speech-language pathologists (SLPs) anecdotally report concern that their interactions with a child who stutters, including even the use of the term ""stuttering,"" might contribute to negative affective, behavioral, and cognitive consequences. This study investigated SLPs' comfort in providing a diagnosis of ""stuttering"" to children's parents/caregivers, as compared to other commonly diagnosed developmental communication disorders. Method One hundred forty-one school-based SLPs participated in this study. Participants were randomly assigned to one of two vignettes detailing an evaluation feedback session. Then, participants rated their level of comfort disclosing diagnostic terms to parents/caregivers. Participants provided rationale for their ratings and answered various questions regarding academic and clinical experiences to identify factors that may have influenced ratings. Results SLPs were significantly less likely to feel comfortable using the term ""stuttering"" compared to other communication disorders. Thematic responses revealed increased experience with a specific speech-language population was related to higher comfort levels with using its diagnostic term. Additionally, knowing a person who stutters predicted greater comfort levels as compared to other clinical and academic experiences. Conclusions SLPs were significantly less comfortable relaying the diagnosis ""stuttering"" to families compared to other speech-language diagnoses. Given the potential deleterious effects of avoidance of this term for both parents and children who stutter, future research should explore whether increased exposure to persons who stutter of all ages systematically improves comfort level with the use of this term.",2020,"Conclusions SLPs were significantly less comfortable relaying the diagnosis ""stuttering"" to families compared to other speech-language diagnoses.",['Method One hundred forty-one school-based SLPs participated in this study'],['evaluation feedback session'],"[""Speech-Language Pathologists' Comfort Level"", 'comfort levels']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}]",141.0,0.0196745,"Conclusions SLPs were significantly less comfortable relaying the diagnosis ""stuttering"" to families compared to other speech-language diagnoses.","[{'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Byrd', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Texas at Austin.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Werle', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Texas at Austin.'}, {'ForeName': 'Kenneth O', 'Initials': 'KO', 'LastName': 'St Louis', 'Affiliation': 'Department of Communication Sciences and Disorders, West Virginia University, Morgantown.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00081']
853,32240835,Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial.,"BACKGROUND & AIMS


Sufficient bowel preparation is crucial for successful screening and surveillance colonoscopy. However, rates of inadequate preparation are still high. We investigated the effects of reinforced patient education using a smartphone application software (APP) for colonoscopy preparation in participants in a CRC screening program.
METHODS


We performed a prospective, endoscopist-blinded study of 500 patients undergoing split-dose bowel preparation for CRC screening or surveillance colonoscopies at multiple centers in Germany, from November 2017 through January 2019. Participants (n = 500) were given oral and written instructions during their initial appointment and then randomly assigned (1:1) to groups that received reinforced education starting 3 days before the colonoscopy (APP group) or no further education (controls). The primary outcome was quality of bowel preparation according to the Boston bowel preparation scale. Secondary outcomes included polyp and adenoma detection rates, compliance with low-fiber diet, split-dose laxative intake, perceived discomfort from the preparation procedure.
RESULTS


The mean Boston bowel preparation scale score was significantly higher in the APP-group (7.6 ± 0.1) than in the control group (6.7 ± 0.1) (P < .0001). The percentage of patients with insufficient bowel preparation was significantly lower in the APP group (8%) than in the control group (17%) (P = .0023). The adenoma detection rate was significantly higher in the APP group (35% vs 27% in controls) (P = .0324). Use of the APP was accompanied by a lower level of non-compliance with correct laxative intake (P =.0080) and diet instructions (P = .0089). The APP group reported a lower level of discomfort during preparation (P < .0001).
CONCLUSIONS


In a randomized trial, reinforcing patient education with a smartphone application optimized bowel preparation in the 3 days before colonoscopy, increasing bowel cleanliness, adenoma detection, and compliance in patients undergoing CRC screening or surveillance. ClinicalTrials.gov no: NCT03290157.",2020,The adenoma detection rate was significantly higher in the APP group (35% vs 27% in controls),"['Colorectal Cancer Screening Colonoscopies', '500 patients undergoing split-dose bowel preparation for CRC screening or surveillance colonoscopies at multiple centers in Germany, from November 2017 through January 2019', 'participants in a CRC screening program', 'patients undergoing CRC screening or surveillance']","['Smartphone Application to Reinforce Education', 'APP', 'reinforced patient education using a smartphone application software (APP', 'reinforced education starting 3 days before the colonoscopy (APP group) or no further education (controls']","['polyp and adenoma detection rates, compliance with low-fiber diet, split-dose laxative intake, perceived discomfort from the preparation procedure', 'level of discomfort', 'quality of bowel preparation according to the Boston bowel preparation scale', 'adenoma detection rate', 'mean Boston bowel preparation scale score', 'percentage of patients with insufficient bowel preparation']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1882982', 'cui_str': 'Screening colonoscopy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0578818', 'cui_str': 'In further education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0344356', 'cui_str': 'Restricted fiber diet'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0548441', 'cui_str': 'Preparation for procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]",500.0,0.138809,The adenoma detection rate was significantly higher in the APP group (35% vs 27% in controls),"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Walter', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm. Electronic address: Benjamin.walter@uniklinik-ulm.de.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Frank', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Ludwig', 'Affiliation': 'Gastroenterologische Schwerpunktpraxis, Dornstadt.'}, {'ForeName': 'Nektarios', 'Initials': 'N', 'LastName': 'Dikopoulos', 'Affiliation': 'Gastroenterologische Schwerpunktpraxis, Dornstadt.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mayr', 'Affiliation': 'Medizinische Klinik II, Krankenhaus Landshut-Achdorf, Landshut.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Neu', 'Affiliation': 'Medizinische Klinik II, Krankenhaus Landshut-Achdorf, Landshut.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Institut für Epidemiologie und Medizinische Biometrie, Universitätsklinik Ulm, Ulm.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hann', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Meier', 'Affiliation': 'Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie, Ludwigsburg.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Caca', 'Affiliation': 'Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie, Ludwigsburg.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinik Ulm, Ulm.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Meining', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.051']
854,32241042,[Clinical study of cell sheets containing allogeneic keratinocytes and fibroblasts for the treatment of partial-thickness burn wounds].,"Objective:  To evaluate the efficacy and safety of cell sheets containing allogeneic keratinocytes and fibroblasts in the treatment of partial-thickness burn wounds.  Methods:  The cell sheets containing allogeneic keratinocytes and fibroblasts were constructed using polyurethane biofilm as carrier. Then gross observation and histological observation were conducted. From April 2016 to December 2017, Changhai Hospital of Naval Medical University recruited patients with acute partial-thickness burn wounds that met the inclusion criteria for this prospective and positively self-controlled clinical trial. Recruitment of 40 acute partial-thickness burn wounds were planned with each selected single wound being not smaller than 10 cm×10 cm and not more than 5% total body surface area (TBSA). Each wound was equally divided into two areas, which were recruited into cell sheet group and conventional treatment group according to the random number table. The wounds in cell sheet group were covered by cell sheet and then sterile gauze as secondary dressings. Depending on the wound healing and exudation, the sterile gauze was replaced every 1 to 3 day (s) after the treatment was started, and the cell sheet was replaced every 7 days (namely dressing changing). The wounds in conventional treatment group were covered by sulfadiazine silver cream gauze and then dressed with sterile gauze, with the dressings changed every 2 to 3 days depending on wound exudation. On treatment day 5, 7, 10, and 14, the wound healing rates in the two groups were calculated. The complete wound healing time, the total number of dressing changes, and the status of wound infection during treatment were recorded. The Visual Analogue Scale was used to score the pain at the first dressing change. Scar formation of patients was followed up for 6 to 12 months after injury. Safety indicators including vital signs, laboratory examination indexes, and adverse reactions during treatment were observed. Data were statistically analysed with Wilcoxon rank sum test and Bonferroni correction.  Results:  (1) Each prepared cell sheet had a diameter of about 8 cm and was about 49 cm(2) in size, containing 2 or 3 layers of keratinocytes and fibroblasts. (2) A total of 43 patients were enrolled, of whom 3 patients dropped out of the study. Of the 40 patients who completed the treatment, there were 22 males and 18 females who were aged 1 to 57 year (s), with total burn area of 2% to 26% TBSA. (3) On treatment day 5, 7, 10, and 14, the wound healing rates in cell sheet group were significantly higher than those in conventional treatment group ( Z =4.205, 4.258, 3.495, 2.521,  P <0.05 or  P <0.01). The complete wound healing time in cell sheet group was 7 (6, 8) days, which was significantly shorter than 11 (7, 14) days in conventional treatment group ( Z =4.219,  P <0.01). The total number of wound dressing changes in cell sheet group was 1 (1, 2) times, which was significantly less than 6 (4, 7) times in conventional treatment group ( Z =5.464,  P <0.01). (4) The wounds in cell sheet group in 31 patients healed before the first dressing change. The pain score of wounds in the first dressing change in cell sheet group of 9 patients was 1 (0, 1) point, while the pain score of wounds in the first dressing change in conventional treatment group of 40 patients was 2 (1, 3) points. There was no obvious infection in the wounds in both groups of 40 patients before the wound healing. Nine patients completed the follow-up after the trial. In 6 patients, no scar formation was observed in cell sheet group or conventional treatment group. The color of wounds in cell sheet group was consistent with normal skin, and there was only a small amount of pigment deposition in the wounds of conventional treatment group. Three patients developed pigment deposition only in the wounds of cell sheet group but obvious scars in conventional treatment group. (5) The abnormal fluctuations of vital signs including body temperature, blood pressure, heart rate, respiratory rate, and laboratory examination indexes of all patients during treatment were alleviated through the process of burn wound healing. No obvious adverse reactions or abnormalities related to the treatment were observed.  Conclusions:  The cell sheet containing allogeneic keratinocytes and fibroblasts can reduce the number of dressing changes, accelerate wound epithelialization, shorten wound healing time, reduce pain during dressing change in the treatment of partial-thickness burn wounds, and it may reduce scar hyperplasia after wound healing because of accelerating wound epithelization. Its clinical application is simple, safe, and effective.",2020,No obvious adverse reactions or abnormalities related to the treatment were observed.  ,"['From April 2016 to December 2017, Changhai Hospital of Naval Medical University recruited patients with acute partial-thickness burn wounds that met the inclusion criteria for this prospective and positively self-controlled clinical trial', '40 acute partial-thickness burn wounds', '40 patients who completed the treatment, there were 22 males and 18 females who were aged 1 to 57 year (s), with total burn area of 2% to 26% TBSA', 'partial-thickness burn wounds', '2) A total of 43 patients were enrolled, of whom 3 patients dropped out of the study']","['sulfadiazine silver cream gauze', 'cell sheets containing allogeneic keratinocytes and fibroblasts']","['complete wound healing time', 'Visual Analogue Scale', 'vital signs, laboratory examination indexes, and adverse reactions', 'Scar formation', 'pain score of wounds', 'wound healing time, reduce pain', 'scar formation', 'wound healing rates', 'efficacy and safety', 'complete wound healing time, the total number of dressing changes, and the status of wound infection', 'pigment deposition', 'total number of wound dressing changes', 'abnormal fluctuations of vital signs including body temperature, blood pressure, heart rate, respiratory rate, and laboratory examination indexes', 'scar hyperplasia']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332687', 'cui_str': 'Second degree burn injury'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte'}, {'cui': 'C0016030', 'cui_str': 'Fibroblast'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}]",43.0,0.0215668,No obvious adverse reactions or abnormalities related to the treatment were observed.  ,"[{'ForeName': 'Y N', 'Initials': 'YN', 'LastName': 'Jiang', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Zheng', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Hu', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Shi', 'Affiliation': 'Jiaofa Herui Biotechnology (Rizhao) Company Limited, Shanghai 200129, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'Z F', 'Initials': 'ZF', 'LastName': 'Xia', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Xiao', 'Affiliation': 'Burn Institute of PLA, Department of Burn Surgery, Changhai Hospital, Naval Medical University, Shanghai 200433, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20191113-00426']
855,30929618,Cost-Effectiveness of Preventing Depression Among At-Risk Youths: Postintervention and 2-Year Follow-Up.,"OBJECTIVE


Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care.
METHODS


A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs.
RESULTS


Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher.
CONCLUSIONS


CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted.",2019,CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline.,"['316 youths, ages 13-17, randomly assigned to CBP or usual care', 'Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder']","['cognitive-behavioral prevention program (CBP) versus usual care', 'CBP']","['depression-free days (DFDs), quality-adjusted life years (QALYs), and costs', 'Cost-Effectiveness of Preventing Depression', 'incremental cost-effectiveness ratio (ICER', 'cost-effectiveness']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",316.0,0.043429,CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline.,"[{'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Lynch', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Beardslee', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'V Robin', 'Initials': 'VR', 'LastName': 'Weersing', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Tracy R G', 'Initials': 'TRG', 'LastName': 'Gladstone', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Porta', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Brent', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Mark', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Lynn L', 'Initials': 'LL', 'LastName': 'DeBar', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Garber', 'Affiliation': ""Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon (Lynch, Dickerson, Clarke, DeBar); Judge Baker Children's Center, Harvard University, Boston (Beardslee); San Diego State University (SDSU)-University of California, San Diego, Joint Doctoral Program in Clinical Psychology, SDSU, San Diego (Weersing); Wellesley Centers for Women, Wellesley College, Wellesley, Massachusetts (Gladstone); Department of Psychiatry, University of Pittsburgh, Pittsburgh (Porta); Department of Child and Adolescent Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh (Brent); Behavioral Health Financing, RTI International, Research Triangle Park, North Carolina (Mark); Department of Psychology (Hollon) and Department of Psychiatry (Garber), Vanderbilt University, Nashville, Tennessee.""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800144']
856,30938760,Fructose Consumption Contributes to Hyperinsulinemia in Adolescents With Obesity Through a GLP-1-Mediated Mechanism.,"CONTEXT


The consumption of high-fructose beverages is associated with a higher risk for obesity and diabetes. Fructose can stimulate glucagon-like peptide 1 (GLP-1) secretion in lean adults, in the absence of any anorexic effect.
OBJECTIVE


We hypothesized that the ingestion of glucose and fructose may differentially stimulate GLP-1 and insulin response in lean adolescents and adolescents with obesity.
DESIGN


We studied 14 lean adolescents [four females; 15.9 ± 1.6 years of age; body mass index (BMI), 21.8 ± 2.2 kg/m2] and 23 adolescents with obesity (five females; 15.1 ± 1.6 years of age; BMI, 34.5 ± 4.6 kg/m2). Participants underwent a baseline oral glucose tolerance test to determine their glucose tolerance and estimate insulin sensitivity and β-cell function [oral disposition index (oDIcpep)]. Eligible subjects received, in a double-blind, crossover design, 75 g of glucose or fructose. Plasma was obtained every 10 minutes for 60 minutes for the measures of glucose, insulin, and GLP-1 (radioimmunoassay) and glucose-dependent insulinotropic polypeptide (GIP; ELISA). Incremental glucose and hormone levels were compared between lean individuals and those with obesity by a linear mixed model. The relationship between GLP-1 increment and oDIcpep was evaluated by regression analysis.
RESULTS


Following the fructose challenge, plasma glucose excursions were similar in both groups, yet the adolescents with obesity exhibited a greater insulin (P < 0.001) and GLP-1 (P < 0.001) increase than did their lean peers. Changes in GIP were similar in both groups. After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group. The GLP-1 increment during 60 minutes from fructose drink was correlated with a lower oDIcpep (r2 = 0.22, P = 0.009).
CONCLUSION


Fructose, but not glucose, ingestion elicits a higher GLP-1 and insulin response in adolescents with obesity than in lean adolescents. Fructose consumption may contribute to the hyperinsulinemic phenotype of adolescent obesity through a GLP-1-mediated mechanism.",2019,"After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group.","['Adolescents With Obesity Through a GLP-1-Mediated Mechanism', 'lean adolescents and adolescents with obesity', 'lean adults', '14 lean adolescents [four females; 15.9 ± 1.6 years of age; body mass index (BMI), 21.8 ± 2.2 kg/m2] and 23 adolescents with obesity (five females; 15.1 ± 1.6 years of age; BMI, 34.5 ± 4.6 kg/m2', 'Eligible subjects', 'adolescents with obesity than in lean adolescents']","['Fructose consumption', 'Fructose', 'glucose or fructose', 'Fructose Consumption']","['Changes in GIP', 'glucose tolerance and estimate insulin sensitivity and β-cell function [oral disposition index (oDIcpep', 'GLP-1 response', 'glucose, insulin, and GLP-1 (radioimmunoassay) and glucose-dependent insulinotropic polypeptide (GIP; ELISA', 'Incremental glucose and hormone levels', 'plasma glucose excursions']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}]","[{'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",14.0,0.0386522,"After glucose ingestion, the GLP-1 response (P < 0.001) was higher in the lean group.","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Galderisi', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Van Name', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Department of Pediatrics, Pediatrics Endocrinology and Diabetes Section, Yale School of Medicine, New Haven, Connecticut.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00161']
857,31308004,A Randomized Phase II Trial of Pioglitazone for Lung Cancer Chemoprevention in High-Risk Current and Former Smokers.,"Lung cancer chemoprevention, especially in high-risk former smokers, has great potential to reduce lung cancer incidence and mortality. Thiazolidinediones prevent lung cancer in preclinical studies, and diabetics receiving thiazolidinediones have lower lung cancer rates which led to our double-blind, randomized, phase II placebo-controlled trial of oral pioglitazone in high-risk current or former smokers with sputum cytologic atypia or known endobronchial dysplasia. Bronchoscopy was performed at study entry and after completing 6 months of treatment. Biopsies were histologically scored, and primary endpoint analysis tested worst biopsy scores (Max) between groups; Dysplasia index (DI) and average score (Avg) changes were secondary endpoints. Biopsies also received an inflammation score. The trial accrued 92 subjects (47 pioglitazone, 45 placebo), and 76 completed both bronchoscopies (39 pioglitazone, 37 placebo). Baseline dysplasia was significantly worse for current smokers, and 64% of subjects had mild or greater dysplasia at study entry. Subjects receiving pioglitazone did not exhibit improvement in bronchial dysplasia. Former smokers treated with pioglitazone exhibited a slight improvement in Max, while current smokers exhibited slight worsening. While statistically significant changes in Avg and DI were not observed in the treatment group, former smokers exhibited a slight decrease in both Avg and DI. Negligible Avg and DI changes occurred in current smokers. A trend toward decreased Ki-67 labeling index occurred in former smokers with baseline dysplasia receiving pioglitazone. While pioglitazone did not improve endobronchial histology in this high-risk cohort, specific lesions showed histologic improvement, and further study is needed to better characterize responsive dysplasia.",2019,"While statistically significant changes in Avg and DI were not observed in the treatment group, former smokers exhibited a slight decrease in both Avg and DI.","['Lung Cancer Chemoprevention in High Risk Current and Former Smokers', 'smokers with sputum cytologic atypia or known endobronchial dysplasia', '92 subjects (47']","['thiazolidinediones', 'pioglitazone, 45 placebo', 'Thiazolidinediones', 'pioglitazone', 'bronchoscopies (39 pioglitazone, 37 placebo', 'Pioglitazone']","['bronchial dysplasia', 'Ki-67 labeling index', 'worst biopsy scores (Max) between groups; Dysplasia index (DI) and average score (Avg) changes', 'Avg and DI', 'endobronchial histology', 'Negligible Avg and DI changes', 'Baseline dysplasia']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0333865', 'cui_str': 'Atypical cell present'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}]","[{'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C1112356', 'cui_str': 'Bronchial dysplasia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0332269', 'cui_str': 'Negligible (qualifier value)'}]",92.0,0.146426,"While statistically significant changes in Avg and DI were not observed in the treatment group, former smokers exhibited a slight decrease in both Avg and DI.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Keith', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, Eastern Colorado VA Healthcare System, Rocky Mountain Regional VA Medical Center, Aurora, Colorado. Robert.keith@ucdenver.edu.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Merrick', 'Affiliation': 'Division of Pathology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Bunn', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Bagwell', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Lori D', 'Initials': 'LD', 'LastName': 'Dwyer-Nield', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Jackson', 'Affiliation': 'Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Geraci', 'Affiliation': 'Department of Medicine, IU School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'York E', 'Initials': 'YE', 'LastName': 'Miller', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, Eastern Colorado VA Healthcare System, Rocky Mountain Regional VA Medical Center, Aurora, Colorado.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0006']
858,31086250,Effects of diaphragmatic myofascial release on gastroesophageal reflux disease: a preliminary randomized controlled trial.,"The purpose of this study is to investigate whether implementing a myofascial release (MFR) protocol designed to restore the myofascial properties of the diaphragm has any effect on the symptoms, quality of life, and consumption of proton pump inhibitors (PPI) drugs by patients with non-erosive gastroesophageal reflux disease (GERD). We randomized 30 patients with GERD into a MFR group or a sham group. Changes in symptomatology and quality of life were measured with the Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index. Need of PPIs was measured as the milligrams of drug intake over the 7 days prior to each assessment. All variables were assessed at baseline, one week and 4 weeks after the end of the treatment. At week 4, patients receiving MFR showed significant improvements in symptomatology (mean difference-1.1; 95% CI: -1.7 to -0.5), gastrointestinal quality of life (mean difference 18.1; 95% CI: 4.8 to 31.5), and PPIs use (mean difference-97 mg; 95% CI: -162 to -32), compared to the sham group. These preliminary findings indicate that the application of the MFR protocol we used in this study decreased the symptoms and PPIs usage and increased the quality of life of patients with non-erosive GERD up to four weeks after the end of the treatment.",2019,Changes in symptomatology and quality of life were measured with the Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index.,"['30 patients with GERD into a MFR group or a sham group', 'patients with non-erosive gastroesophageal reflux disease (GERD']","['diaphragmatic myofascial release', 'proton pump inhibitors']","['Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index', 'gastroesophageal reflux disease', 'quality of life', 'gastrointestinal quality of life', 'symptomatology and quality of life', 'symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1264663', 'cui_str': 'Mass fraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0445143', 'cui_str': 'Non-erosive (qualifier value)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0034380'}]",30.0,0.0395616,Changes in symptomatology and quality of life were measured with the Reflux Disease Questionnaire and the Gastrointestinal Quality of Life Index.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Martínez-Hurtado', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Arguisuelas', 'Affiliation': 'Department of Physiotherapy, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Almela-Notari', 'Affiliation': 'Department of Gastroenterology, Hospital General de Castellón, Castellón, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Cortés', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barrasa-Shaw', 'Affiliation': 'Department of Surgery, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Campos-González', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Department of Medicine, Universidad Cardenal Herrera-CEU, CEU Universities, Valencia, Spain. juanfran@uchceu.es.'}]",Scientific reports,['10.1038/s41598-019-43799-y']
859,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
860,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6']
861,30900796,"Comment on ""a comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes"".",,2019,,['insulin-naïve patients with type 2 diabetes'],['degludec and insulin glargine 300 U/mL'],[],"[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]",[],,0.0125941,,"[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jourdan', 'Affiliation': 'Health Economics and Value Assessment, Sanofi, Paris, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13711']
862,30939922,"Rationale and Design of EMPOWER, a Pragmatic Randomized Trial of Automated Hovering in Patients With Congestive Heart Failure.","BACKGROUND


Congestive heart failure is a major cause of morbidity, mortality, and cost. Disease management programs have shown promise but lack firm evidence of effectiveness and scalability. We describe the motivation, design, and planned analyses of EMPOWER (Electronic Monitoring of Patients Offers Ways to Enhance Recovery), a randomized clinical trial of an innovative intervention incorporating behavioral economic principles with remote monitoring technology embedded within a healthcare system.
METHODS AND RESULTS


EMPOWER is an ongoing, pragmatic, randomized clinical trial comparing usual care to an automated hovering intervention that includes patient-level incentives for daily weight monitoring and diuretic adherence combined with automated feedback into the clinical care pathway, enabling real-time response to concerning clinical symptoms. Identification of eligible patients began in May 2016, and implementation of the intervention is feasible. Trial processes are embedded into existing clinical pathways. The primary outcome is time to readmission for any cause. Cost-effectiveness analyses are planned to evaluate the healthcare costs and health outcomes of the approach.
CONCLUSIONS


The EMPOWER trial incorporates leading-edge approaches in human motivation, derived from behavioral economics, with contemporary technology to provide scale and exception handling at low cost. The trial is also implemented within the naturalized environment of a health system, as much as possible taking advantage of the existing journeys of patients and workflows of clinicians. A goal of this pragmatic design is to limit resource utilization and also to test an intervention that would need minimal modification to be translated from research into a new way of practice.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov . Unique identifier: NCT02708654.",2019,Disease management programs have shown promise but lack firm evidence of effectiveness and scalability.,['Patients With Congestive Heart Failure'],['automated hovering intervention that includes patient-level incentives for daily weight monitoring and diuretic adherence combined with automated feedback into the clinical care pathway'],['time to readmission for any cause'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0513836', 'cui_str': 'Weight monitoring (regime/therapy)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.117057,Disease management programs have shown promise but lack firm evidence of effectiveness and scalability.,"[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'Lee R', 'Initials': 'LR', 'LastName': 'Goldberg', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'Louise B', 'Initials': 'LB', 'LastName': 'Russell', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Norton', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Iannotte', 'Affiliation': 'Departments of Medicine and Health Policy and Medical Ethics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA (S.J.M., K.G.V., D.A.A., L.R.G., L.B.R., L.A.N., L.G.I.).'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, New York University School of Medicine, New York, NY (A.B.T.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.118.005126']
863,32227244,Isradipine Versus Placebo in Early Parkinson Disease.,,2020,,['Early Parkinson Disease'],['Isradipine Versus Placebo'],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0516642,,[],Annals of internal medicine,['10.7326/P20-0004']
864,32227247,Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.,"Background


Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD).
Objective


To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.
Design


Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).
Setting


57 Parkinson Study Group sites in North America.
Participants


Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.
Intervention


5 mg of immediate-release isradipine twice daily or placebo for 36 months.
Measurements


The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication ""ON"" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures.
Results


336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness.
Limitation


The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects.
Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
Primary Funding Source


National Institute of Neurological Disorders and Stroke.",2020,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","['336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study', 'Participants\n\n\nPatients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment', 'Setting\n\n\n57 Parkinson Study Group sites in North America', 'Early Parkinson Disease']","['dihydropyridine calcium-channel blocker', 'placebo', 'dihydropyridine calcium-channel blockers', 'isradipine', 'Intervention\n\n\n5 mg of immediate-release isradipine twice daily or placebo', 'Isradipine Versus Placebo']","[""Unified Parkinson's Disease Rating Scale (UPDRS) parts"", 'time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures', 'total UPDRS score', 'edema and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",336.0,0.515182,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2534']
865,30882927,Influence of blood storage age on immune and coagulation parameters in critically ill transfused patients.,"BACKGROUND


Several retrospective studies have suggested that transfusion with red blood cells (RBCs) stored for longer periods is associated with increased mortality. The Age of Blood Evaluation (ABLE) study randomized subjects to receive fresh vs. standard issue RBC units and showed no difference in the primary or secondary endpoints of mortality or change in multi-organ dysfunction syndrome (MODS) score.
METHODS


In this study a subset of 100 ABLE subjects were enrolled to measure coagulation and immune parameters. Samples were collected pre-transfusion and on days 2, 6, 28, and 180 post-transfusion. Levels of 16 coagulation parameters, regulatory and functional T cells, 25 cytokines, and 16 markers of extracellular vesicles (EVs) were determined.
RESULTS


Changes from baseline in levels of protein C, factor V, and EVs expressing phosphatidyl serine and CTLA-4 (CD152) differed between recipients of fresh and standard storage age RBC units, with the vast majority of coagulation and EV markers and all cytokines tested showing no difference between study arms. Although most analytes showed no difference between subjects in the fresh and standard arms of the study, 6 coagulation parameters, 15 cytokines, and 7 EV parameters changed significantly in the period post-transfusion.
DISCUSSION


Transfusion of fresh vs. standard issue RBC units does not result in substantial changes in coagulation or immune parameters, up to day 35 of RBC storage. Furthermore, significant changes in multiple coagulation and immune parameters are detectable post-transfusion, though causality cannot be determined based on the current study.",2019,"DISCUSSION


Transfusion of fresh vs. standard issue RBC units does not result in substantial changes in coagulation or immune parameters, up to day 35 of RBC storage.","['critically ill transfused patients', '100 ABLE subjects']",[],"['levels of protein C, factor V, and EVs expressing phosphatidyl serine and CTLA-4 (CD152', 'Levels of 16 coagulation parameters, regulatory and functional T cells, 25 cytokines, and 16 markers of extracellular vesicles (EVs', 'mortality or change in multi-organ dysfunction syndrome (MODS) score', 'multiple coagulation and immune parameters']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0611128', 'cui_str': 'protein C (synaptosomal)'}, {'cui': 'C0015498', 'cui_str': 'Factor 5'}, {'cui': 'C0031623', 'cui_str': 'Phosphatidyl Serines'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0342953', 'cui_str': 'Organ dysfunction syndrome (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}]",,0.0354424,"DISCUSSION


Transfusion of fresh vs. standard issue RBC units does not result in substantial changes in coagulation or immune parameters, up to day 35 of RBC storage.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Norris', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Schechtman', 'Affiliation': 'Department of Biostatistics, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Inglis', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Adelman', 'Affiliation': 'Department of Biostatistics, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Heitman', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vilardi', 'Affiliation': 'Department of Surgery, University of California, San Francisco, California.'}, {'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Nareg H', 'Initials': 'NH', 'LastName': 'Roubinian', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Danesh', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Guiltinan', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Keating', 'Affiliation': 'Vitalant Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Surgery, University of California, San Francisco, California.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri.'}]",Transfusion,['10.1111/trf.15250']
866,32227625,Personalized application of three different concentrations of iodinated contrast media in coronary computed tomography angiography.,"No study has evaluated the impact of different iodinated contrast media on coronary contrast enhancement, using an injection protocol according to body surface area (BSA). Thus, the present study aimed to examine the usefulness and safety of personalized application of different iodine concentrations of contrast media in coronary computed tomographic (CT) angiography with a 2nd dual-source CT scanner in eliminating differences in coronary contrast enhancement based on a BSA-adapted injection protocol of contrast media. A total of 270 enrolled participants were randomly assigned to three groups: ioversol 320, ioversol 350 and iopromide 370 (n = 90 per group). The three groups were administered contrast media at a BSA-adjusted volume and flow rate with a fixed injection time of 15 seconds, and they subsequently received a 30-mL saline flush. All patients were scanned with a prospective electrocardiogram-gated protocol in a craniocaudal direction using a second-generation 128-slice dual-source CT system. The three iodinated contrast media used in coronary CT angiography exhibited similar diagnostic quality and safety. No significant differences were found in the contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects among the three groups. The three contrast media used in coronary CT angiography with 320, 350 and 370 mg/mL iodine, respectively, have comparable diagnostic quality and safety. However, more large-scale, multinational, multi-centre and prospective trials are warranted.",2020,"No significant differences were found in the contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects among the three groups.",['A total of 270 enrolled participants'],"['contrast media in coronary computed tomographic (CT) angiography with a 2nd dual-source CT scanner', 'electrocardiogram-gated protocol in a craniocaudal direction using a second-generation 128-slice dual-source CT system', 'ioversol 320, ioversol 350 and iopromide', '30-mL saline flush', 'iodinated contrast media in coronary computed tomography angiography', 'coronary CT angiography']","['diagnostic quality and safety', 'contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0063817', 'cui_str': 'iopromide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",270.0,0.0175523,"No significant differences were found in the contrast enhancement degrees, image quality scores, radiation doses and incidences of adverse effects among the three groups.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Hao', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Shandong Institute of Innovation, Suzhou Institute of Biomedical Engineering and Technology Affiliated with Chinese Academy of Sciences, Jinan, China.'}, {'ForeName': 'Guoxiang', 'Initials': 'G', 'LastName': 'Hao', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmaceutical Sciences of Shandong University, Jinan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Jinan Central Hospital Affiliated with Shandong First Medical University and Shandong University, Jinan, China.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Jinan Central Hospital Affiliated with Shandong First Medical University and Shandong University, Jinan, China.'}, {'ForeName': 'Qingjie', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'First Hospital Affiliated with Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Yuguo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Aifeng', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Brigham and Women's Hospital Affiliated with Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, The State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.'}]",Journal of cellular and molecular medicine,['10.1111/jcmm.15196']
867,30770517,Cyclophosphamide for Systemic Sclerosis-related Interstitial Lung Disease: A Comparison of Scleroderma Lung Study I and II.,"OBJECTIVE


To compare safety and efficacy outcomes between the cyclophosphamide (CYC) arms of Scleroderma Lung Study (SLS) I and II.
METHODS


Participants enrolled in the CYC arms of SLS I (n = 79) and II (n = 69) were included. SLS I and II randomized participants to oral CYC for 1 year and followed patients for an additional year off therapy (in SLS II, patients received placebo in Year 2). Eligibility criteria for SLS I and II were nearly identical. Outcomes included the forced vital capacity (FVC%)-predicted and DLCO%-predicted (measured every 3 mos) and quantitative radiographic extent of interstitial lung disease (measured at 1 and 2 yrs for SLS I and SLS II, respectively). Joint models were created to evaluate the treatment effect on the course of the FVC/DLCO over 2 years while controlling for baseline disease severity.
RESULTS


SLS I and II CYC participants had similar baseline characteristics. After adjusting for baseline disease severity, there was no difference in the course of the FVC%-predicted (p = 0.535) nor the DLCO%-predicted (p = 0.172) between the SLS I and II CYC arms. In both groups, treatment with CYC led to a significant improvement in the FVC%-predicted from 3 to 12 months, but no significant improvement beyond this point. Treatment with CYC had no effect on the DLCO for either group.
CONCLUSION


Treatment with 1 year of oral CYC led to similar improvements in lung function in both SLS I and II, although the effects were not sustained following cessation of CYC. These results suggest that increasing the duration of ILD therapy may improve outcomes for patients with systemic sclerosis-ILD.",2019,"In both groups, treatment with CYC led to a significant improvement in the FVC%-predicted from 3 to 12 months, but no significant improvement beyond this point.","['patients with systemic sclerosis-ILD', 'Systemic Sclerosis-related Interstitial Lung Disease', 'Participants enrolled in the CYC arms of SLS I (n = 79) and II (n = 69) were included']","['placebo', 'DLCO', 'oral CYC', 'SLS', 'Cyclophosphamide', 'cyclophosphamide (CYC']","['lung function', 'forced vital capacity (FVC%)-predicted and DLCO%-predicted (measured every 3 mos) and quantitative radiographic extent of interstitial lung disease', 'FVC%-predicted', 'safety and efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",69.0,0.0521788,"In both groups, treatment with CYC led to a significant improvement in the FVC%-predicted from 3 to 12 months, but no significant improvement beyond this point.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway. evolkmann@mednet.ucla.edu.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Myung', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Hoffmann-Vold', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}]",The Journal of rheumatology,['10.3899/jrheum.180441']
868,31540617,Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.,"BACKGROUND


There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease.
METHODS


In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat.
RESULTS


Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU.
CONCLUSION


ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.",2019,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","['patients with HIV and liver disease', 'January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score\u202f>\u202f1.45']","['ISAT', 'Integrated stepped alcohol treatment', 'health handout plus routine care', 'integrated stepped alcohol treatment (ISAT', 'ISAT and TAU']","['liver biomarkers', 'Abstinence rates', 'proportion with an undetectable HIV viral load', 'alcohol use, HIV, and liver outcomes', 'VACS Index scores', 'FIB-4 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",95.0,0.155409,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY 13244, United States of America.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America; College of Public Health, University of Georgia, Athens, GA 30602, United States of America.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System, UT Southwestern, Dallas, TX 75216, United States of America.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'D.C. VAMC, George Washington University School of Medicine and Health Sciences, Washington, DC 20422, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey VAMC, Baylor College of Medicine, Houston, TX 77030, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'VA NY Harbor Healthcare System, New York University School of Medicine, New York, NY 10010, United States of America.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States of America.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.007']
869,31307055,Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial.,"Background


Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
Objective


To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps.
Design


Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355).
Setting


30 Japanese institutions.
Patients


Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp.
Intervention


Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy.
Measurements


The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP).
Results


A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.
Limitation


An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously.
Conclusion


Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP.
Primary Funding Source


Japanese Gastroenterological Association.",2019,"Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
","['Patients\n\n\nPatients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp', '184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment', 'patients undergoing polypectomy', 'subcentimeter colorectal polyps', 'Patients on Anticoagulants With Subcentimeter Polyps', 'Setting\n\n\n30 Japanese institutions']","['Continuous Anticoagulation and Cold Snare Polypectomy Versus', 'HB+HSP', 'Heparin Bridging and Hot Snare Polypectomy', 'anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP', 'Cold snare polypectomy (CSP', 'HB+HSP or CA+CSP', 'CA+CSP']","['incidence of polypectomy-related major bleeding, and procedure time and hospitalization', 'incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis', 'incidence of polypectomy-related major bleeding', 'mean procedure time for each polyp and the hospitalization period']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0183362', 'cui_str': 'Snare, device (physical object)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0085148', 'cui_str': 'Hemostasis, Endoscopic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}]",30.0,0.0950026,"Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP).
","[{'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan (Y.T.).'}, {'ForeName': 'Katsuhiro', 'Initials': 'K', 'LastName': 'Mabe', 'Affiliation': 'National Hospital Organization Hakodate National Hospital, Hakodate, Japan (K.M.).'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Shimodate', 'Affiliation': 'Kurashiki Central Hospital, Kurashiki, Japan (Y.S.).'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yoshii', 'Affiliation': 'Sapporo Medical Center Nippon Telegraph and Telephone East Corporation, Sapporo, Japan (S.Y.).'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Japan (S.Y.).'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Iwatate', 'Affiliation': 'Sano Hospital, Kobe, Japan (M.I.).'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Kyoto Second Red Cross Hospital, Kyoto, Japan (T.K.).'}, {'ForeName': 'Kinichi', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Shizuoka Cancer Center, Suntogun, Shizuoka, Japan (K.H.).'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagaike', 'Affiliation': 'Suita Municipal Hospital, Suita, Japan (K.N.).'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Ikezawa', 'Affiliation': 'Akashi Medical Center, Akashi, Japan (N.I.).'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Osaka City General Hospital, Osaka, Japan (T.Y.).'}, {'ForeName': 'Yoriaki', 'Initials': 'Y', 'LastName': 'Komeda', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka-Sayama, Japan (Y.K.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Asai', 'Affiliation': 'Tane General Hospital, Osaka, Japan (S.A.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Utsunomiya Memorial Hospital, Tochigi, Japan (Y.A.).'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Akamatsu', 'Affiliation': 'Japanese Red Cross Society Wakayama Medical Center, Wakayama, Japan (T.A.).'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Sakakibara', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan (Y.S.).'}, {'ForeName': 'Hisatomo', 'Initials': 'H', 'LastName': 'Ikehara', 'Affiliation': 'Nihon University School of Medicine, Tokyo, Japan (H.I.).'}, {'ForeName': 'Yuzuru', 'Initials': 'Y', 'LastName': 'Kinjo', 'Affiliation': 'Naha City Hospital, Naha, Japan (Y.K.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ohta', 'Affiliation': 'Kansai Rosai Hospital, Amagasaki, Japan (T.O.).'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kitamura', 'Affiliation': 'Nara City Hospital, Nara, Japan (Y.K.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shono', 'Affiliation': 'Kumamoto University, Kumamoto, Japan (T.S.).'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Osaka General Medical Center, Osaka, Japan (T.I.).'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ohda', 'Affiliation': 'Hyogo College of Medicine, Nishinomiya, Japan (Y.O.).'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Tochigi Cancer Center, Utsunomiya, Japan (N.K.).'}, {'ForeName': 'Tokuma', 'Initials': 'T', 'LastName': 'Tanuma', 'Affiliation': 'Teine Keijinkai Hospital, Sapporo, Japan (T.T.).'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Sapporo Higashi Tokushukai Hospital, Sapporo, Japan (R.S.).'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan (T.S.).'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan (N.H.).'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Chino', 'Affiliation': 'Cancer Institute Hospital, Tokyo, Japan (A.C.).'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Kyoto Prefectural University of Medicine, Osaka, Japan (H.I.).'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Nojima', 'Affiliation': 'The University of Tokyo, Tokyo, Japan (M.N.).'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Uraoka', 'Affiliation': 'National Hospital Organization Tokyo Medical Center, Tokyo, Japan (T.U.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0026']
870,31757262,Randomized placebo-controlled trial of galantamine in individuals with cocaine use disorder.,"No pharmacotherapies are approved for the treatment of cocaine use disorder (CUD). Galantamine, a cholinesterase inhibitor, has shown initial promise for cocaine use reduction in methadone-maintained individuals with CUD and cognitive improvement in abstinent individuals with past CUD. However, galantamine has not previously tested in individuals with current CUD and no comorbid opioid use disorder or methadone maintenance. The goal of this 13-week, double-blind, placebo-controlled, randomized controlled trial was to test the efficacy of galantamine (8 mg or 16 mg/day; extended release (ER)) for reducing cocaine use and improving cognitive function in individuals with cocaine use disorder (CUD). Ninety-three treatment-seeking cocaine users were randomized to placebo (n = 32), 8 mg/day galantamine (n = 31) or 16 mg/day galantamine (n = 30). The medication was well-tolerated with minimal reports of side-effects. However, there were no significant treatment group differences in cocaine use outcomes (as measured by self-report or urines). The 16 mg galantamine group had a greater improvement in working memory capacity (Backwards Digit Span), but there were no other significant treatment group differences on key cognitive outcomes. These findings did not provide support for the efficacy of galantamine as a treatment for cocaine use in this sample of individuals with CUD.",2019,"The 16 mg galantamine group had a greater improvement in working memory capacity (Backwards Digit Span), but there were no other significant treatment group differences on key cognitive outcomes.","['Ninety-three treatment-seeking cocaine users', 'individuals with cocaine use disorder (CUD', 'abstinent individuals with past CUD', 'individuals with current CUD and no comorbid opioid use disorder or methadone maintenance', 'individuals with CUD', 'individuals with cocaine use disorder']","['placebo', 'Galantamine', 'galantamine', 'galantamine (n\u202f=\u202f31) or 16\u202fmg/day galantamine']","['key cognitive outcomes', 'working memory capacity (Backwards Digit Span']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0239076', 'cui_str': 'Cocaine user (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0582802', 'cui_str': 'Digit'}]",93.0,0.0432834,"The 16 mg galantamine group had a greater improvement in working memory capacity (Backwards Digit Span), but there were no other significant treatment group differences on key cognitive outcomes.","[{'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Babuscio', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America; VA Connecticut Healthcare System, West Haven, CT, United States of America. Electronic address: Mehmet.Sofuoglu@yale.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.009']
871,31855161,"Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial.","STUDY OBJECTIVES


We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD).
METHODS


This 14-week randomized, placebo-controlled, crossover design clinical trial administered an all-day active or control lighting intervention to 46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout). The study employed wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior.
RESULTS


The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention). The active intervention also resulted in significantly greater active versus control differences in intradaily variability. As for secondary outcomes, the active intervention resulted in significant improvements in Cornell Scale for Depression in Dementia scores (mean ± SEM: 10.30 ± 1.02 at baseline, 7.05 ± 0.67 after active intervention) and significantly greater active versus control differences in Cohen-Mansfield Agitation Inventory scores (mean ± SEM: -5.51 ± 1.03 for the active intervention, -1.50 ± 1.24 for the control intervention).
CONCLUSIONS


A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia living in controlled environments.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov, title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia, URL: https://clinicaltrials.gov/ct2/show/NCT01816152, identifier: NCT01816152.",2019,"The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention).","['Older Adults With Alzheimer Disease and Related Dementias', '46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout', 'persons with Alzheimer disease and related dementias (ADRD', 'patients with dementia living in controlled environments', 'Persons With Dementia, URL']","['lighting intervention', 'control lighting intervention', 'Tailored Lighting Intervention', 'placebo']","['sleep, mood, and behavior', 'Pittsburgh Sleep Quality Index scores', 'Sleep Quality, Rest-Activity, Mood, and Behavior', 'Cornell Scale for Depression in Dementia scores', 'Cohen-Mansfield Agitation Inventory scores', 'sleep quality, mood, and behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0014409', 'cui_str': 'Environment, Controlled'}, {'cui': 'C3541384', 'cui_str': 'Uniform resource locator (foundation metadata concept)'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023700', 'cui_str': 'Illumination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4545801', 'cui_str': 'PSQI (Pittsburgh Sleep Quality Index) score'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.252138,"The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention).","[{'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Plitnick', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Roohan', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Sahin', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kalsher', 'Affiliation': 'Cognitive Science Department, School of Humanities, Arts and Social Sciences, Rensselaer Polytechnic Institute, Troy, New York, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Rea', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, Troy, New York, United States.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8078']
872,24504983,Safety of regular formoterol or salmeterol in adults with asthma: an overview of Cochrane reviews.,"BACKGROUND


For adults with asthma that is poorly controlled on inhaled corticosteroids (ICS), guidelines suggest adding a long-acting beta2-agonist (LABA). The LABA can be taken together with ICS in a single (combination) inhaler. Improved symptom control can be assessed in the individual; however, the long-term risk of hospital admission or death requires evidence from randomised controlled trials. Clinical trials record these safety outcomes as non-fatal and fatal serious adverse events (SAEs), respectively.
OBJECTIVES


To assess the risk of serious adverse events in adults with asthma treated with regular maintenance formoterol or salmeterol compared with placebo, or when randomly assigned in combination with regular ICS, compared with the same dose of ICS.
METHODS


We included Cochrane reviews on the safety of regular formoterol and salmeterol from a June 2013 search of the Cochrane Database of Systematic Reviews. We carried out a search for additional trials in September 2013 and incorporated the new data. All reviews were independently assessed for inclusion and for quality (using the AMSTAR tool). We extracted from each review data from trials recruiting adults (participants older than 12 or 18 years of age).We combined the results from reviews on formoterol and salmeterol to assess the safety of twice-daily regular LABA as a class effect, both as monotherapy versus placebo and as combination therapy versus the same dose of ICS.We did not combine the results of direct and indirect comparisons of formoterol and salmeterol, or carry out a network meta-analysis, because of concerns over transitivity assumptions that posed a threat to the validity of indirect comparisons.
MAIN RESULTS


We identified six high-quality, up-to-date Cochrane reviews. Of these, four reviews (89 trials with 61,366 adults) related to the safety of regular formoterol or salmeterol as monotherapy or combination therapy. Two reviews assessed safety from trials in which adults were randomly assigned to formoterol versus salmeterol. These included three trials with 1116 participants given monotherapy (all prescribed background ICS) and 10 trials with 8498 adults receiving combination therapy. An additional search for trials in September 2013 identified five new included studies contributing data from 693 adults with asthma treated with combination formoterol/fluticasone in comparison with the same dose of inhaled fluticasone, as well as from 447 adults for whom formoterol monotherapy was compared with placebo.No trials reported separate results in adolescents. Overall, risks of bias for the primary outcomes were assessed as low. Death of any causeNone of the reviews found a significant increase in death of any cause from direct comparisons; however, none of the reviews could exclude the possibility of a two-fold increase in mortality on regular formoterol or salmeterol (as monotherapy vs placebo or as combination therapy versus ICS) in adults with asthma. Pooled mortality results from direct comparisons were as follows: formoterol monotherapy (odds ratio (OR) 4.49, 95% confidence interval (CI) 0.24 to 84.80, 13 trials, N = 4824), salmeterol monotherapy (OR 1.33, 95% CI 0.85 to 2.08, 10 trials, N = 29,128), formoterol combination (OR 3.56, 95% CI 0.79 to 16.03, 25 trials, N = 11,271) and salmeterol combination (OR 0.90, 95% CI 0.31 to 2.6, 35 trials, N = 13,447). In each case, we did not detect heterogeneity, and the quality of evidence was rated as moderate. Absolute differences in mortality were very small, translating into an increase of 7 per 10,000 over 26 weeks on any monotherapy (95% CI 2 less to 23 more) and 3 per 10,000 over 32 weeks on any combination therapy (95% CI 3 less to 17 more).Very few deaths were reported in the combination therapy trials, and combination therapy trial designs were different from those of monotherapy trials. Therefore we could not use indirect evidence to assess whether regular combination therapy was safer than regular monotherapy.Only one death occurred in the monotherapy trials comparing formoterol versus salmeterol, so evidence was insufficient to compare mortality. Non-fatal serious adverse events of any causeDirect evidence showed that non-fatal serious adverse events were increased in adults receiving salmeterol monotherapy (OR 1.14, 95% 1.01 to 1.28, I(2) = 0%,13 trials, N = 30,196) but were not significantly increased in any of the other reviews: formoterol monotherapy (OR 1.26, 95% CI 0.78 to 2.04, I(2) = 15%, 17 trials, N = 5758), formoterol combination (OR 0.99, 95% CI 0.77 to 1.27, I(2) = 0%, 25 trials, N = 11,271) and salmeterol combination (OR 1.15, 95% CI 0.91 to 1.44, I(2) = 0%, 35 trials, N = 13,447). This represents an absolute increase on any monotherapy of 43 per 10,000 over 26 weeks (95% CI 6 more to 85 more) and 16 per 10,000 over 32 weeks (95% CI 22 less to 60 more) on any combination therapy.Direct comparisons of formoterol and salmeterol detected no significant differences between risks of all non-fatal events in adults (as monotherapy or as combination therapy).
AUTHORS' CONCLUSIONS


Available evidence from the reviews of randomised trials cannot definitively rule out an increased risk of fatal serious adverse events when regular formoterol or salmeterol was added to an inhaled corticosteroid (as background or as randomly assigned treatment) in adults or adolescents with asthma.An increase in non-fatal serious adverse events of any cause was found with salmeterol monotherapy, and the same increase cannot be ruled out when formoterol or salmeterol was used in combination with an inhaled corticosteroid, although possible increases are small in absolute terms.However, if the addition of formoterol or salmeterol to an inhaled corticosteroid is found to improve symptomatic control, it is safer to give formoterol or salmeterol in the form of a combination inhaler (as recommended by the US Food and Drug Administration (FDA)). This prevents the substitution of LABA for an inhaled corticosteroid if symptom control is improved on LABA.The results of three large ongoing trials in adults and adolescents are awaited; these will provide more information on the safety of combination therapy under less supervised conditions and will report separate results for the adolescents included.",2014,"formoterol monotherapy (odds ratio (OR) 4.49, 95% confidence interval (CI) 0.24 to 84.80, 13 trials, N = 4824), salmeterol monotherapy (OR 1.33, 95% CI 0.85 to 2.08, 10 trials, N = 29,128), formoterol combination (OR 3.56, 95% CI 0.79 to 16.03, 25 trials, N = 11,271) and salmeterol combination (OR 0.90, 95% CI 0.31 to 2.6, 35 trials, N = 13,447).","['adults or adolescents with asthma', 'adults (participants older than 12 or 18 years of age).We combined the results from reviews on', 'in comparison with the same dose of inhaled fluticasone, as well as from 447 adults for whom', '1116 participants given monotherapy (all prescribed background ICS) and 10 trials with 8498 adults receiving combination therapy', 'September 2013 identified five new included studies contributing data from 693 adults with asthma treated with', 'adults with asthma treated with regular maintenance formoterol or', 'adults with asthma']","['salmeterol', 'placebo', 'regular formoterol and salmeterol', 'salmeterol monotherapy', 'inhaled corticosteroid', 'regular formoterol or salmeterol', 'formoterol or salmeterol', 'combination formoterol/fluticasone', 'formoterol', 'ICS', 'formoterol monotherapy', 'formoterol versus salmeterol', 'formoterol or salmeterol as monotherapy or combination therapy', 'formoterol and salmeterol']","['death', 'risks of all non-fatal events', 'mortality', 'non-fatal serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",693.0,0.722865,"formoterol monotherapy (odds ratio (OR) 4.49, 95% confidence interval (CI) 0.24 to 84.80, 13 trials, N = 4824), salmeterol monotherapy (OR 1.33, 95% CI 0.85 to 2.08, 10 trials, N = 29,128), formoterol combination (OR 3.56, 95% CI 0.79 to 16.03, 25 trials, N = 11,271) and salmeterol combination (OR 0.90, 95% CI 0.31 to 2.6, 35 trials, N = 13,447).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cates', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, UK, SW17 0RE.""}, {'ForeName': 'L Susan', 'Initials': 'LS', 'LastName': 'Wieland', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Oleszczuk', 'Affiliation': ''}, {'ForeName': 'Kayleigh M', 'Initials': 'KM', 'LastName': 'Kew', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010314.pub2']
873,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
874,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
875,32154586,"Relations Between Acute Effects of Alcohol on Response Inhibition, Impaired Control over Alcohol Use, and Alcohol-Related Problems.","BACKGROUND


Alcohol consistently impairs response inhibition in the laboratory, and alcohol impairment of response inhibition may lead to excess consumption or increases in intoxicated risk behavior, both of which contribute to risk for alcohol-related problems. To our knowledge, no prior studies have examined relations between alcohol impairment of response inhibition and either impaired control over alcohol (i.e., inability to adhere to predetermined drinking limits) or real-world alcohol-related problems. The current study addressed this gap in the literature.
METHODS


Young adult social drinkers (N = 215, 76% male) participated in a between-subjects, placebo-controlled alcohol challenge study and completed self-reports approximately 2 weeks later. Multilevel models were used to examine the hypothesis that alcohol impairment of response inhibition would indirectly lead to alcohol-related problems through impaired control over alcohol use.
RESULTS


Greater alcohol-induced impairment of response inhibition and impaired control over alcohol use were both significant predictors of alcohol-related problems. However, greater alcohol-induced response inhibition was not a significant predictor of impaired control over alcohol use.
CONCLUSIONS


To our knowledge, this is the first study demonstrating relationships between alcohol impairment of response inhibition and real-world alcohol-related problems and the first to address relationships between alcohol impairment of response inhibition and impaired control over alcohol use. These results suggest that impaired control over alcohol use may result from deficits in the trait ability to control behavior rather than deficits in alcohol-induced response inhibition. Regardless, results suggest that alcohol impairment of response inhibition and impaired control over alcohol are both worthwhile intervention targets.",2020,"However, greater alcohol-induced response inhibition was not a significant predictor of impaired control over alcohol use.
","['Young adult social drinkers (N=215, 76% Male) participated in a between-subjects, placebo-controlled alcohol challenge study and completed self-reports approximately two weeks later']",['Alcohol'],"['Response Inhibition, Impaired Control over Alcohol Use, and Alcohol-Related Problems', 'response inhibition']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0117678,"However, greater alcohol-induced response inhibition was not a significant predictor of impaired control over alcohol use.
","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Corbin', 'Affiliation': 'Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Berey', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jack T', 'Initials': 'JT', 'LastName': 'Waddell', 'Affiliation': 'Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Leeman', 'Affiliation': 'University of Florida, Gainesville, Florida.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14322']
876,32220636,Impact of rapid microbial identification on clinical outcomes in bloodstream infection: the RAPIDO randomized trial.,"OBJECTIVES


Bloodstream infection has a high mortality rate. It is not clear whether laboratory-based rapid identification of the organisms involved would improve outcome.
METHODS


The RAPIDO trial was an open parallel-group multicentre randomized controlled trial. We tested all positive blood cultures from hospitalized adults by conventional methods of microbial identification and those from patients randomized (1:1) to rapid diagnosis in addition to matrix-assisted desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) performed directly on positive blood cultures. The only primary outcome was 28-day mortality. Clinical advice on patient management was provided to members of both groups by infection specialists.
RESULTS


First positive blood culture samples from 8628 patients were randomized, 4312 into rapid diagnosis and 4136 into conventional diagnosis. After prespecified postrandomization exclusions, 2740 in the rapid diagnosis arm and 2810 in the conventional arm were included in the mortality analysis. There was no significant difference in 28-day survival (81.5% 2233/2740 rapid vs. 82.3% 2313/2810 conventional; hazard ratio 1.05, 95% confidence interval 0.93-1.19, p 0.42). Microbial identification was quicker in the rapid diagnosis group (median (interquartile range) 38.5 (26.7-50.3) hours after blood sampling vs. 50.3 (47.1-72.9) hours after blood sampling, p < 0.01), but times to effective antimicrobial therapy were no shorter (respectively median (interquartile range) 24 (2-78) hours vs. 13 (2-69) hours). There were no significant differences in 7-day mortality or total antibiotic consumption; times to resolution of fever, discharge from hospital or de-escalation of broad-spectrum therapy or 28-day Clostridioides difficile incidence.
CONCLUSIONS


Rapid identification of bloodstream pathogens by MALDI-TOF MS in this trial did not reduce patient mortality despite delivering laboratory data to clinicians sooner.",2020,"Microbial identification was quicker in the rapid diagnosis group (median 38·5 vs 50·3 hours after blood sampling, IQR 26·7-50·3 vs 47·1-72·9, p<0·01) but times to effective antimicrobial therapy were no shorter (median 24 hours (IQR 2-78) vs 13 hours (IQR 2-69)).","['bloodstream infection', '8,628 patients were randomised, 4,312 into rapid diagnosis, 4,136 into conventional']",['rapid microbial identification'],"['28-day survival', '7-day mortality or total antibiotic consumption; times to resolution of fever, discharge from hospital or de-escalation of broad spectrum therapy; or 28-day Clostridioides difficile incidence', 'Microbial identification', '28-day mortality']","[{'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",8628.0,0.527018,"Microbial identification was quicker in the rapid diagnosis group (median 38·5 vs 50·3 hours after blood sampling, IQR 26·7-50·3 vs 47·1-72·9, p<0·01) but times to effective antimicrobial therapy were no shorter (median 24 hours (IQR 2-78) vs 13 hours (IQR 2-69)).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'MacGowan', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. Electronic address: alasdair.macgowan@nbt.nhs.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grier', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stoddart', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reynolds', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Smartt', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': 'Department of Microbiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Department of Clinical Microbiology, UCLH NHS Foundation Trust, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelsey', 'Affiliation': 'Department of Medical Microbiology, Whittington Hospital, Whittington NHS Trust, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Steer', 'Affiliation': 'Department of Microbiology, Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'F K', 'Initials': 'FK', 'LastName': 'Gould', 'Affiliation': 'Department of Medical Microbiology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, England, UK.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Perry', 'Affiliation': 'Department of Medical Microbiology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, England, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Howe', 'Affiliation': 'Department of Microbiology, Public Health Wales, Cardiff University Hospital of Wales, Cardiff, Wales, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Department of Microbiology, Public Health Wales, Cardiff University Hospital of Wales, Cardiff, Wales, UK.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.01.030']
877,32223116,Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.,"BACKGROUND


The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied.
METHODS


We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.
RESULTS


Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31).
CONCLUSIONS


In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).",2020,"Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02).","['patients undergoing TAVI who were receiving', 'patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications']","['oral anticoagulation plus clopidogrel', 'transcatheter aortic-valve implantation (TAVI', 'Anticoagulation with or without Clopidogrel', 'oral anticoagulation', 'clopidogrel', 'clopidogrel or to receive clopidogrel']","['bleeding events', 'bleeding', 'bleeding and non-procedure-related bleeding', 'composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority', 'Bleeding', 'Most bleeding', 'serious bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]",,0.389161,"Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02).","[{'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Nijenhuis', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Brouwer', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Holvoet', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Christophe L F', 'Initials': 'CLF', 'LastName': 'Dubois', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Frambach', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'De Bruyne', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Gert K', 'Initials': 'GK', 'LastName': 'van Houwelingen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan A S', 'Initials': 'JAS', 'LastName': 'Van Der Heyden', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Toušek', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van der Kley', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Buysschaert', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Ferdinande', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roosen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Peper', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Frederick W F', 'Initials': 'FWF', 'LastName': 'Thielen', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Veenstra', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Dean R P P', 'Initials': 'DRPP', 'LastName': 'Chan Pin Yin', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Swaans', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Benno J W M', 'Initials': 'BJWM', 'LastName': 'Rensing', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""van 't Hof"", 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Timmers', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (V.J.N., J. Brouwer, J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) - all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) - all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915152']
878,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
879,32220129,Outcomes With the Use of Bag-Valve-Mask Ventilation During Out-of-hospital Cardiac Arrest in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


While emergency medical services (EMS) often use endotracheal intubation (ETI) or supraglottic airways (SGA), some patients receive only bag-valve-mask (BVM) ventilation during out-of-hospital cardiac arrests (OHCA). Our objective was to compare patient characteristics and outcomes for BVM ventilation to advanced airway management (AAM) in adults with OHCA.
METHODS


Using data from the Pragmatic Airway Resuscitation Trial, we identified patients receiving AAM (ETI or a SGA), BVM ventilation only (BVM-only), and BVM ventilation as a rescue after at least one failed attempt at advanced airway placement (BVM-rescue). The outcomes were return of spontaneous circulation (ROSC), 72-hour survival, survival to hospital discharge, neurologically intact survival (Modified Rankin Scale ≤ 3), and the presence of aspiration on a chest radiograph. Comparisons were made using generalized mixed-effects models while adjusting for age, sex, initial rhythm, EMS-witnessed status, bystander cardiopulmonary resuscitation, response time, study cluster, and advanced life support first on scene.
RESULTS


Of 3,004 patients enrolled, there were 282 BVM-only, 2,129 AAM, and 156 BVM-rescue patients with complete covariates. Shockable initial rhythms (34% vs. 18.6%) and EMS-witnessed arrests (21.6% vs. 11.3%) were more likely in BVM-only than AAM but similar between BVM-rescue and AAM. Compared to AAM, BVM-only patients had similar ROSC (odds ratio [OR] = 1.29, 95% confidence interval [CI] = 0.96 to 1.73), but higher 72-hour survival (OR = 1.96, 95% CI = 1.42 to 2.69), survival to discharge (OR = 4.47, 95% CI = 3.03 to 6.59), and neurologically intact survival (OR = 7.05, 95% CI = 4.40 to 11.3). Compared to AAM, BVM-rescue patients had similar ROSC (OR = 0.73, 95% CI = 0.47 to 1.12) and 72-hour survival (OR = 1.08, 95% CI = 0.66 to 1.77) but higher survival to discharge (OR = 2.15, 95% CI = 1.17 to 3.95) and neurologically intact survival (OR = 2.64, 95% CI = 1.20 to 5.81). Aspiration incidence was similar.
CONCLUSIONS


Bag-valve-mask-only ventilation is associated with improved OHCA outcomes. Despite similar rates of ROSC and 72-hour survival, BVM-rescue ventilation was associated with improved survival to discharge and neurologically intact survival compared to successful AAM.",2020,"Despite similar rates of ROSC and 72-hour survival, BVM-rescue ventilation was associated with improved survival to discharge and neurologically intact survival compared to successful AAM.","['adults with OHCA', '3,004 patients enrolled, there were 282 BVM-only, 2,129 AAM, and 156 BVM-rescue patients with complete covariates', 'patients receiving AAM (ETI or a SGA), BVM ventilation only (BVM-only), and BVM ventilation as a rescue after at least one failed attempt at advanced airway placement (BVM-rescue']","['BVM ventilation to advanced airway management (AAM', 'Bag-Valve-Mask Ventilation', 'bag-valve-mask (BVM) ventilation', 'endotracheal intubation (ETI) or supraglottic airways (SGA', 'Bag-valve-mask-only ventilation']","['ROSC and 72-hour survival, BVM-rescue ventilation', 'OHCA outcomes', 'survival to discharge and neurologically intact survival', 'return of spontaneous circulation (ROSC), 72-hour survival, survival to hospital discharge, neurologically intact survival (Modified Rankin Scale\xa0≤\xa03), and the presence of aspiration on a chest radiograph', 'Aspiration incidence', 'Shockable initial rhythms', '72-hour survival', 'neurologically intact survival', 'survival to discharge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0150126', 'cui_str': 'Airway Control'}, {'cui': 'C1960845', 'cui_str': 'Bag valve mask ventilation (procedure)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic (qualifier value)'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",3004.0,0.145676,"Despite similar rates of ROSC and 72-hour survival, BVM-rescue ventilation was associated with improved survival to discharge and neurologically intact survival compared to successful AAM.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Stephens', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Texas Southwest Medical Center, Dallas, TX.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'University of Texas Southwest Medical Center, Dallas, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Juan C J', 'Initials': 'JCJ', 'LastName': 'Puyana', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13927']
880,31370975,A randomized pilot trial of two parenting interventions for fathers in residential substance use disorder treatment.,"Residential substance misuse treatment programs for men typically do not integrate treatment for intimate partner violence (IPV) or parenting despite significant overlap between substance misuse, IPV and child maltreatment. A randomized trial compared two fatherhood focused interventions in 6-month residential substance misuse treatment programs. Fathers for Change (F4C) is an integrated intervention targeting IPV and child maltreatment. Dads 'n' Kids (DNK) is a psychoeducational intervention focused on child development and behavioral parenting skills. Sixty-two fathers were randomly assigned to F4C or DNK. They received 12 weeks of individual treatment while in the residential facility and were offered 4 aftercare sessions following discharge. They were assessed prior to treatment, at the time of residential discharge, following completion of the intervention booster sessions, and 3 months following intervention. Overall, both groups showed significant reductions in affect dysregulation, anger, and IPV. F4C fathers showed significantly greater decreases in affect dysregulation problems. There were no significant differences between groups on IPV but men who received F4C may have been less likely to use substances after leaving residential treatment. Integration of fatherhood focused interventions were possible and welcomed by residents at the facilities. F4C showed some benefit over DNK in terms of affect dysregulation symptoms and substance use relapse.",2019,There were no significant differences between groups on IPV but men who received F4C may have been less likely to use substances after leaving residential treatment.,"[""Dads 'n' Kids (DNK"", 'Sixty-two fathers', 'fathers in residential substance use disorder treatment']","['parenting interventions', 'F4C or DNK', 'F4C']","['affect dysregulation, anger, and IPV']","[{'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",,0.0485155,There were no significant differences between groups on IPV but men who received F4C may have been less likely to use substances after leaving residential treatment.,"[{'ForeName': 'Carla Smith', 'Initials': 'CS', 'LastName': 'Stover', 'Affiliation': 'Yale University School of Medicine, Child Study Center, New Haven, CT, USA; University of South Florida, Department of Mental Health Law and Policy, Tampa, FL, USA. Electronic address: carla.stover@yale.edu.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'McMahon', 'Affiliation': 'Yale University School of Medicine, Department of Psychiatry, New Haven, CT, USA; Yale University School of Medicine, Child Study Center, New Haven, CT, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'University of South Florida, Department of Mental Health Law and Policy, Tampa, FL, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.003']
881,31053215,Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans.,"STUDY OBJECTIVES


To examine the efficacy of imagery rehearsal (IR) combined with cognitive behavioral therapy for insomnia (CBT-I) compared to CBT-I alone for treating recurrent nightmares in military veterans with posttraumatic stress disorder (PTSD).
METHODS


In this randomized controlled study, 108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares were randomized to six sessions of IR + CBT-I (n = 55) or CBT-I (n = 53). Primary outcomes were measured with the Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ).
RESULTS


Improvement with treatment was significant (29% with reduction in nightmare frequency and 22% with remission). Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval = -0.87 to 0.63; likelihood ratio chi square = 4.7(3),  P  = .2); NDQ: 1.5, 95% confidence interval = -1.4 to 4.4; likelihood ratio chi square = 7.3,  P  = .06).
CONCLUSIONS


Combining IR with CBT-I conferred no advantage overall. Further research is essential to examine the possibly greater benefit of adding IR to CBT-I for some subgroups of veterans with PTSD.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans; Identifier: NCT00691626; URL: https://clinicaltrials.gov/ct2/show/NCT00691626.",2019,"Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval =","['108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares', 'Posttraumatic Nightmares in Combat Veterans', 'military veterans with posttraumatic stress disorder (PTSD']","['IR + CBT-I (n = 55) or CBT', 'imagery rehearsal (IR) combined with cognitive behavioral therapy', 'CBT-I alone', 'Imagery Rehearsal', 'Cognitive Behavioral Therapy (CBT']",['Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ'],"[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",108.0,0.0549086,"Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval =","[{'ForeName': 'Gerlinde C', 'Initials': 'GC', 'LastName': 'Harb', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Cook', 'Affiliation': 'Yale University and National Center for PTSD, New Haven, Connecticut.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Phelps', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Melbourne, Australia.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Gehrman', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Forbes', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Melbourne, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Localio', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Harpaz-Rotem', 'Affiliation': 'Yale University and National Center for PTSD, New Haven, Connecticut.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7770']
882,31112475,Positron Emission Tomography Score Has Greater Prognostic Significance Than Pretreatment Risk Stratification in Early-Stage Hodgkin Lymphoma in the UK RAPID Study.,"PURPOSE


Accurate stratification of patients is an important goal in Hodgkin lymphoma (HL), but the role of pretreatment clinical risk stratification in the context of positron emission tomography (PET) -adapted treatment is unclear. We performed a subsidiary analysis of the RAPID trial to assess the prognostic value of pretreatment risk factors and PET score in determining outcomes.
PATIENTS AND METHODS


Patients with stage IA to IIA HL and no mediastinal bulk underwent PET assessment after three cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine; 143 PET-positive patients (PET score, 3 to 5) received a fourth doxorubicin, bleomycin, vinblastine, and dacarbazine cycle and involved-field radiotherapy, and 419 patients in complete metabolic remission were randomly assigned to receive involved-field radiotherapy (n = 208) or no additional treatment (n = 211). Cox regression was used to investigate the association between PET score and pretreatment risk factors with HL-specific event-free survival (EFS).
RESULTS


High PET score was associated with inferior EFS, before ( P  < .001) and after adjustment ( P  = .01) for baseline risk stratification. Only patients with a postchemotherapy PET score of 5 (uptake ≥ three times maximum liver uptake) had an increased risk of progression or HL-related death (hazard ratio, 9.4  v  score of 3; 95% CI, 2.8 to 31.3 and hazard ratio, 6.7  v  score of 4; 95% CI, 1.4 to 31.7). Patients with a PET score of 5 also had inferior progression-free and overall survival. There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all  P  > .4).
CONCLUSION


In RAPID, a positive PET scan did not carry uniform prognostic weight; only a PET score of 5 was associated with inferior outcomes. This suggests that in future trials involving patients without B symptoms or mediastinal bulk, a score of 5 rather than a positive PET result should be used to guide treatment escalation in early-stage HL.",2019,"There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all  P  > .4).
","['Patients with stage IA to IIA HL and no mediastinal bulk underwent PET assessment after three cycles of', '143 PET-positive patients (PET score, 3 to 5) received a fourth', '419 patients in complete metabolic remission']","['doxorubicin, bleomycin, vinblastine, and dacarbazine', 'receive involved-field radiotherapy (n = 208) or no additional treatment', 'doxorubicin, bleomycin, vinblastine, and dacarbazine cycle and involved-field radiotherapy']","['postchemotherapy PET score of 5 (uptake ≥ three times maximum liver uptake', 'inferior progression-free and overall survival', 'Positron Emission Tomography Score', 'risk of progression or HL-related death (hazard ratio', 'PET score and pretreatment risk factors with HL-specific event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457150', 'cui_str': 'Stage Ia'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",,0.216386,"There was no association between European Organisation for Research and Treatment of Cancer or German Hodgkin Study Group risk group and EFS, before or after adjusting for PET score (all  P  > .4).
","[{'ForeName': 'Sally F', 'Initials': 'SF', 'LastName': 'Barrington', 'Affiliation': ""1 King's College London and Guy's and St Thomas' PET Centre, Kings College London, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Phillips', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Counsell', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': '3 University of Sheffield and Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': ""4 St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': '5 Cancer Research UK Centre, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Townsend', 'Affiliation': '6 University College Hospital London, London, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Culligan', 'Affiliation': '7 Aberdeen Royal Infirmary, Aberdeen, United Kingdom.'}, {'ForeName': 'Bilyana', 'Initials': 'B', 'LastName': 'Popova', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clifton-Hadley', 'Affiliation': '2 Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McMillan', 'Affiliation': '8 Nottingham City Hospitals National Health Service (NHS) Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': '9 Mount Vernon Hospital, Middlesex, United Kingdom.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': ""O'Doherty"", 'Affiliation': ""1 King's College London and Guy's and St Thomas' PET Centre, Kings College London, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Illidge', 'Affiliation': '10 Institute of Cancer Sciences and the Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': '10 Institute of Cancer Sciences and the Christie NHS Foundation Trust, University of Manchester, Manchester, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01799']
883,32212354,Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial.,"BACKGROUND


Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment.
MATERIAL AND METHODS


In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death.
RESULTS


Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01).
CONCLUSION


PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition. Clinical trial identification number. NCT02151214 IMPLICATIONS FOR PRACTICE: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.",2020,"In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm.","['patients with advanced cancer and malnutrition', '148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent', 'patients with advanced cancer cachexia and no intestinal impairment', 'patients with advanced cancer', 'patients with advanced cancer cachexia and without intestinal impairment', 'Patients with Advanced Cancer Cachexia']","['Parenteral Nutrition', 'Parenteral nutrition', 'parenteral nutrition (PN) over oral feeding (OF', 'optimized nutritional care with or without supplemental PN', 'parenteral nutrition']","['physical functioning', 'overall survival', 'HRQoL nor survival', 'serious adverse events', 'HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death', 'HRQoL DFS', 'Cancer QLQ-C15-PAL questionnaire', 'quality of life nor survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}]",148.0,0.277114,"In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm.","[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bouleuc', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life in Oncology Unit (INSERM Unité Mixte de Recherche [UMR] 1098), Centre Hospitalier Universitaire (CHU) Besançon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Cornet', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Ghislain', 'Initials': 'G', 'LastName': 'Grodard', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': 'Medical Oncology Department, Centre Hospitalier Universitaire (CHU) Besançon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dubroeucq', 'Affiliation': 'Department of Supportive Care, Institut Jean Godinot, Reims, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Crétineau', 'Affiliation': 'Department of Supportive Care, Institut de cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Frasie', 'Affiliation': 'Department of Supportive Care, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gamblin', 'Affiliation': 'Department of Supportive Care, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Chvetzoff', 'Affiliation': 'Department of Supportive Care, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Favier', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': 'Medical Oncology Department, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP), Créteil, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Grach', 'Affiliation': 'Department of Supportive Care, Centre François-Baclesse, Caen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Raynard', 'Affiliation': 'Tranversal Unit of Nutrition, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Salas', 'Affiliation': 'Medical Oncology Department, Centre Hospitalier (CH) La Timone, Marseille, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Capodano', 'Affiliation': 'Department of Supportive Care, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Pazart', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Aubry', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}]",The oncologist,['10.1634/theoncologist.2019-0856']
884,31278414,Validity of bladder volume measurement by ultrasound in women postpartum.,"INTRODUCTION


Vaginal birth increases the risk of urinary retention and overdistention of the bladder. To avoid unnecessary discomfort by catheterization, it is preferable to use ultrasound for diagnosis of these conditions. The aim of this study was to determine the validity of transabdominal ultrasound and a portable ultrasound system, Biocon-700, to measure bladder volume in women postpartum.
METHODS


Fifty women were included in this method comparison study. Within 48 h of giving birth, their bladder volume was measured in randomized order with both transabdominal ultrasound and Biocon-700. After urination, participants were scanned with Biocon-700 to measure residual bladder volume, and finally the bladder was emptied by catheterization. The total bladder volume was calculated as the voided volume plus the catheterized volume.
RESULTS


Biocon-700 measured 43.4 ml ± 117.4 ml (mean ± SD) lower than the total bladder volume, while volumes measured by transabdominal ultrasound were 117.8 ml ± 110.0 ml (mean ± SD) lower. Linear regression showed significant proportional bias in both methods. The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
CONCLUSIONS


Neither transabdominal ultrasound nor the portable ultrasound system, Biocon-700, can be used to measure bladder volume precisely after vaginal delivery. However, both ultrasound methods can be used as screening tools to prevent overdistention of the bladder, and Biocon-700 can furthermore be used to screen women for a residual bladder volume > 150 ml.",2020,"The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
","['Fifty women', 'women postpartum']","['transabdominal ultrasound and a portable ultrasound system, Biocon-700', 'transabdominal ultrasound and Biocon-700']",['total bladder volume'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429770', 'cui_str': 'Bladder volume (observable entity)'}]",50.0,0.0404696,"The Biocon-700 could detect a residual bladder volume > 150 ml with a positive predictive value of 66.7% and a negative predictive value of 100%.
","[{'ForeName': 'Josefine Tangen', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark. j.tangenjensen@gmail.com.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Klarskov', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jeannet', 'Initials': 'J', 'LastName': 'Lauenborg', 'Affiliation': 'Department of Obstetrics and Gynecology, Herlev Hospital, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}]",International urogynecology journal,['10.1007/s00192-019-04037-1']
885,31553945,Parent Perceptions on a Walking School Bus Program Among Low-Income Families: A Qualitative Study.,"BACKGROUND


The walking school bus (WSB) is a promising intervention to increase walking to school and physical activity in school-age children. The aim of this qualitative study was to assess parent perceptions of a WSB program that was part of a randomized controlled trial to inform future programs.
METHODS


The authors interviewed 45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route. The authors performed a qualitative analysis of the interview transcripts and coded interview segments into 4 broad categories as follows: facilitators, barriers, general positive sentiments, and proposals.
RESULTS


Most parents spoke of the benefits of the WSB program; in particular, parents frequently applauded exercise/physical health benefits. Of the barriers, the most frequently cited was time, with work schedule and commute changes leading some families to walk less frequently.
CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models. Parents made several suggestions to improve the program, including better recruitment methods, logistical improvements, and a platform for communicating with other parents.",2019,"CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","['school-age children', '45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route', 'Low-Income Families']",['walking school bus (WSB'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336816', 'cui_str': 'School bus, device (physical object)'}]",[],45.0,0.0365653,"CONCLUSIONS


Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Teller', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ''}, {'ForeName': 'Nasira', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Waite', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ickes', 'Affiliation': ''}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0637']
886,30849296,Long-Term Effects of Randomization to a Weight Loss Intervention in Older Adults: A Pilot Study.,"Randomized, controlled trials (RCTs) show intentional weight loss improves body composition and physical function in older adults; however, the long-term benefits (and risks) are unknown. We conducted a pilot study to assess the feasibility of recalling prior RCT participants to examine the long-term effects of intentional weight loss on body composition and physical function. A weighted, random sample of 60 older adults who were randomized to caloric restriction plus exercise (CR + EX) or exercise (EX) only in 5 prior RCTs (mean age at randomization, 67.3 years; 69% women, 80% white) were invited to participate. Follow-up was obtained on 89% (42 clinic visits, 10 phone interviews, 1 death) an average of 3.5 years (range, 2.2-5.8 years) after RCT completion. Despite greater weight, fat and lean mass loss during the RCT (mean difference in change (95% CI): -4.19 (-7.52, -0.86), -2.75 (-5.10, -0.40), and -2.32 (-3.69, -0.95) kg, respectively) in those randomized to CR + EX, long-term changes in weight (2.05 (-2.35, 6.45) kg) and body composition (1.80 (-1.56, 5.17) and 0.03 (-2.20, 2.26) kg for fat and lean mass, respectively) from baseline and physical function at long-term follow-up (mean difference in 400-m walk and SPPB (95% CI): 23.2 (-19.3, 65.6) sec and -0.03 (-1.02, 0.96) points, respectively) were similar in CR + EX and EX only. Although improvements in weight and body composition following intentional weight loss may not be sustained long-term, physical function does not appear to be negatively impacted. A larger study is needed to confirm these results.",2019,"Despite greater weight, fat and lean mass loss during the RCT (mean difference in change (95% CI): -4.19 (-7.52, -0.86), -2.75 (-5.10, -0.40), and -2.32 (-3.69, -0.95) kg, respectively) in those randomized to CR + EX, long-term changes in weight (2.05 (-2.35, 6.45) kg) and body composition (1.80 (-1.56, 5.17) and 0.03 (-2.20, 2.26) kg for fat and lean mass, respectively) from baseline and physical function at long-term follow-up (mean difference in 400-m walk and SPPB (95% CI): 23.2 (-19.3, 65.6) sec and -0.03 (-1.02, 0.96) points, respectively) were similar in CR + EX and EX only.","['60 older adults', 'only in 5 prior RCTs (mean age at randomization, 67.3\u2009years; 69% women, 80% white) were invited to participate', 'Older Adults', 'older adults']","['caloric restriction plus exercise (CR\u2009+\u2009EX) or exercise (EX', 'Weight Loss Intervention', 'intentional weight loss']","['weight and body composition', 'body composition', 'weight, fat and lean mass loss', 'body composition and physical function', 'weight']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",60.0,0.132403,"Despite greater weight, fat and lean mass loss during the RCT (mean difference in change (95% CI): -4.19 (-7.52, -0.86), -2.75 (-5.10, -0.40), and -2.32 (-3.69, -0.95) kg, respectively) in those randomized to CR + EX, long-term changes in weight (2.05 (-2.35, 6.45) kg) and body composition (1.80 (-1.56, 5.17) and 0.03 (-2.20, 2.26) kg for fat and lean mass, respectively) from baseline and physical function at long-term follow-up (mean difference in 400-m walk and SPPB (95% CI): 23.2 (-19.3, 65.6) sec and -0.03 (-1.02, 0.96) points, respectively) were similar in CR + EX and EX only.","[{'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Lyles', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'a Sticht Center on Aging, Wake Forest School of Medicine , Winston-Salem , NC , USA.'}]",Journal of nutrition in gerontology and geriatrics,['10.1080/21551197.2019.1572570']
887,30939090,Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303.,"PURPOSE


Alliance/CALGB 50303 (NCT00118209), an intergroup, phase III study, compared dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as frontline therapy for diffuse large B-cell lymphoma.
PATIENTS AND METHODS


Patients received six cycles of DA-EPOCH-R or R-CHOP. The primary objective was progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety.
RESULTS


Between 2005 and 2013, 524 patients were registered; 491 eligible patients were included in the final analysis. Most patients (74%) had stage III or IV disease; International Prognostic Index (IPI) risk groups included 26% IPI 0 to 1, 37% IPI 2, 25% IPI 3, and 12% IPI 4 to 5. At a median follow-up of 5 years, PFS was not statistically different between the arms (hazard ratio, 0.93; 95% CI, 0.68 to 1.27;  P  = .65), with a 2-year PFS rate of 78.9% (95% CI, 73.8% to 84.2%) for DA-EPOCH-R and 75.5% (95% CI, 70.2% to 81.1%) for R-CHOP. OS was not different (hazard ratio, 1.09; 95% CI, 0.75 to 1.59;  P  = .64), with a 2-year OS rate of 86.5% (95% CI, 82.3% to 91%) for DA-EPOCH-R and 85.7% (95% CI, 81.4% to 90.2%) for R-CHOP. Grade 3 and 4 adverse events were more common ( P  < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9%  v  10.7%, respectively), febrile neutropenia (35.0%  v  17.7%, respectively), mucositis (8.4%  v  2.1%, respectively), and neuropathy (18.6%  v  3.3%, respectively). Five treatment-related deaths (2.1%) occurred in each arm.
CONCLUSION


In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups.",2019,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","['524 patients were registered; 491 eligible patients were included in the final analysis', 'Between 2005 and 2013', 'diffuse large B-cell lymphoma', 'Patients received six cycles of', 'Diffuse Large B-Cell Lymphoma']","['Dose-Adjusted EPOCH-R Compared With R-CHOP', 'etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'DA-EPOCH-R or R-CHOP']","['febrile neutropenia', 'PFS or OS', 'mucositis', 'stage III or IV disease; International Prognostic Index', 'progression-free survival (PFS); secondary clinical objectives included response rate, overall survival (OS), and safety', 'Grade 3 and 4 adverse events', 'infection', '2-year PFS rate', 'neuropathy', '2-year OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C4520227', 'cui_str': 'Dose-adjusted EPOCH'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}]",524.0,0.170783,"Grade 3 and 4 adverse events were more common ( P < .001) in the DA-EPOCH-R arm than the R-CHOP arm, including infection (16.9% v 10.7%, respectively), febrile neutropenia (35.0% v 17.7%, respectively), mucositis (8.4% v 2.1%, respectively), and neuropathy (18.6% v 3.3%, respectively).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': '4 Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mei-Yin C', 'Initials': 'MC', 'LastName': 'Polley', 'Affiliation': '5 Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': '3 Duke University, Durham, NC.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '6 MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': '7 University of Rochester, Rochester, NY.'}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': '2 National Cancer Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nina D', 'Initials': 'ND', 'LastName': 'Wagner-Johnston', 'Affiliation': '1 Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': '8 The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Abramson', 'Affiliation': '9 Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': '10 Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': '11 Northwestern University, Chicago, IL.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': '12 University of Wisconsin, Madison, WI.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': '13 Univeristy of Washington, Seattle, WA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': '15 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Richards', 'Affiliation': '16 University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '17 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': '14 Cornell University Medical College, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01994']
888,25407135,Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis.,"BACKGROUND


Surgical removal of the tonsils, with or without adenoidectomy (adeno-/tonsillectomy), is a common ENT operation, but the indications for surgery are controversial. This is an update of a Cochrane review first published in The Cochrane Library in Issue 3, 1999 and previously updated in 2009.
OBJECTIVES


To assess the effectiveness of tonsillectomy (with and without adenoidectomy) in children and adults with chronic/recurrent acute tonsillitis in reducing the number and severity of episodes of tonsillitis or sore throat.
SEARCH METHODS


We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 30 June 2014.
SELECTION CRITERIA


Randomised controlled trials comparing tonsillectomy (with or without adenoidectomy) with non-surgical treatment in adults and children with chronic/recurrent acute tonsillitis.
DATA COLLECTION AND ANALYSIS


We used the standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS


This review includes seven trials with low to moderate risk of bias: five undertaken in children (987 participants) and two in adults (156 participants). An eighth trial in adults (40 participants) was at high risk of bias and did not provide any data for analysis. Good information about the effectiveness of adeno-/tonsillectomy is only available for the first year following surgery in children and for a shorter period (five to six months) in adults.We combined data from five trials in children; these trials included children who were 'severely affected' (based on the specific 'Paradise' criteria) and less severely affected. Children who had an adeno-/tonsillectomy had an average of three episodes of sore throats (of any severity) in the first postoperative year, compared to 3.6 episodes in the control group; a difference of 0.6 episodes (95% confidence interval (CI) -1 to -0.1; moderate quality evidence). One of the three episodes in the surgical group was the 'predictable' one that occurred in the immediate postoperative period.When we analysed only episodes of moderate/severe sore throat, children who had been more severely affected and had adeno-/tonsillectomy had on average 1.1 episodes of sore throat in the first postoperative year, compared with 1.2 episodes in the control group (low quality evidence). This is not a significant difference but one episode in the surgical group was that occurring immediately after surgery.Less severely affected children had more episodes of moderate/severe sore throat after surgery (1.2 episodes) than in the control group (0.4 episodes: difference 0.8, 95% CI 0.7 to 0.9), but again one episode was the predictable postoperative episode (moderate quality evidence).Data on the number of sore throat days is only available for moderately affected children and is consistent with the data on episodes. In the first year after surgery children undergoing surgery had an average of 18 days of sore throat (of which some - between five and seven on average - will be in the immediate postoperative period), compared with 23 days in the control group (difference 5.1 days, 95% CI 2.2 to 8.1; moderate quality evidence).When we pooled the data from two studies in adults (156 participants), there were 3.6 fewer episodes (95% CI 7.9 fewer to 0.70 more; low quality evidence) in the group receiving surgery within six months post-surgery. However, statistical heterogeneity was significant. The pooled mean difference for number of days with sore throat in a follow-up period of about six months was 10.6 days fewer in favour of the group receiving surgery (95% CI 5.8 fewer to 15.8 fewer; low quality evidence). However, there was also significant statistical heterogeneity in this analysis and the number of days with postoperative pain (which appeared to be on average 13 to 17 days in the two trials) was not included. Given the short duration of follow-up and the differences between studies, we considered the evidence for adults to be of low quality.Two studies in children reported that there was ""no statistically significant difference"" in quality of life outcomes, but the data could not be pooled. One study reported no difference in analgesics consumption. We found no evidence for prescription of antibiotics.Limited data are available from the included studies to quantify the important risks of primary and secondary haemorrhage.
AUTHORS' CONCLUSIONS


Adeno-/tonsillectomy leads to a reduction in the number of episodes of sore throat and days with sore throat in children in the first year after surgery compared to (initial) non-surgical treatment. Children who were more severely affected were more likely to benefit as they had a small reduction in moderate/severe sore throat episodes. The size of the effect is very modest, but there may be a benefit to knowing the precise timing of one episode of pain lasting several days - it occurs immediately after surgery as a direct consequence of the procedure. It is clear that some children get better without any surgery, and that whilst removing the tonsils will always prevent 'tonsillitis', the impact of the procedure on 'sore throats' due to pharyngitis is much less predictable.Insufficient information is available on the effectiveness of adeno-/tonsillectomy versus non-surgical treatment in adults to draw a firm conclusion.The impact of surgery, as demonstrated in the included studies, is modest. Many participants in the non-surgical group improve spontaneously (although some people randomised to this group do in fact undergo surgery). The potential 'benefit' of surgery must be weighed against the risks of the procedure as adeno-/tonsillectomy is associated with a small but significant degree of morbidity in the form of primary and secondary haemorrhage and, even with good analgesia, is particularly uncomfortable for adults.",2014,Many participants in the non-surgical group improve spontaneously (although some people randomised to this group do in fact undergo surgery).,"['adults and children with chronic/recurrent acute tonsillitis', 'children (987 participants) and two in adults (156 participants', 'adults (40 participants', 'children and adults with chronic/recurrent acute tonsillitis in reducing the number and severity of episodes of tonsillitis or sore throat', ""children; these trials included children who were 'severely affected' (based on the specific 'Paradise' criteria) and less severely affected"", 'chronic/recurrent acute tonsillitis']","['Tonsillectomy or adenotonsillectomy versus non-surgical treatment', 'adeno-/tonsillectomy', 'tonsillectomy (with and without adenoidectomy', 'tonsillectomy (with or without adenoidectomy) with non-surgical treatment', 'adenoidectomy (adeno-/tonsillectomy']","['analgesics consumption', 'episodes of sore throats', 'quality of life outcomes', 'number of days with postoperative pain', 'number of days with sore throat', 'sore throat', 'moderate quality', 'episodes of moderate/severe sore throat']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0339868', 'cui_str': 'Recurrent acute tonsillitis (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.242293,Many participants in the non-surgical group improve spontaneously (although some people randomised to this group do in fact undergo surgery).,"[{'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'UK Cochrane Centre, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK, OX2 7LG.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Glasziou', 'Affiliation': ''}, {'ForeName': 'Lee Yee', 'Initials': 'LY', 'LastName': 'Chong', 'Affiliation': ''}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Venekamp', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001802.pub3']
889,32401072,The role of dance/movement therapy in the treatment of negative symptoms in schizophrenia: a mixed methods pilot study.,"Background:  Optimizing psychosocial functioning by reducing the severity of negative symptoms are important outcomes for individuals with schizophrenia. Movement-based interventions could be uniquely capable of addressing the non-verbal nature of negative symptoms. Aims:  To examine the treatment effects of a 10-week group dance/movement therapy program on negative symptoms and psychosocial functioning of individuals diagnosed with schizophrenia. Methods:  A mixed methods intervention design (with explanatory intent) was used in which a randomized controlled trial was followed by semi-structured exit interviews. Participants diagnosed with schizophrenia ( N  = 31) were randomized to two conditions: treatment as usual (TAU) and dance/movement therapy (DMT). Before and after the program participants reported on negative symptoms and psychosocial functioning outcomes. Fifteen participants completed interviews. Results:  Quantitative data showed no improvement nor worsening of clinical status in the DMT group. Qualitative data suggested that participation in DMT had a physical impact, resulted in enhanced interpersonal connectivity, sense of integration, emotional support, and symptom management. Conclusions:  Qualitative but not quantitative findings suggest that DMT has potential to enhance psychosocial functioning and to reduce severity of negative symptoms for schizophrenia.",2020,"Qualitative data suggested that participation in DMT had a physical impact, resulted in enhanced interpersonal connectivity, sense of integration, emotional support, and symptom management.","['individuals with schizophrenia', 'Participants diagnosed with schizophrenia ( N \u2009=\u200931', 'individuals diagnosed with schizophrenia', 'Fifteen participants completed interviews', 'negative symptoms in schizophrenia']","['DMT', '10-week group dance/movement therapy program', 'usual (TAU) and dance/movement therapy (DMT']","['negative symptoms and psychosocial functioning', 'negative symptoms and psychosocial functioning outcomes', 'worsening of clinical status', 'enhanced interpersonal connectivity, sense of integration, emotional support, and symptom management']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",31.0,0.111952,"Qualitative data suggested that participation in DMT had a physical impact, resulted in enhanced interpersonal connectivity, sense of integration, emotional support, and symptom management.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Bryl', 'Affiliation': 'Creative Arts Therapies Department, College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Bradt', 'Affiliation': 'Creative Arts Therapies Department, College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Cechnicki', 'Affiliation': 'Community Psychiatry Department, Jagiellonian University, Cracow, Poland.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Doctoral Nursing Programs, College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'K Mark', 'Initials': 'KM', 'LastName': 'Sossin', 'Affiliation': 'Psychology Department, Dyson College of Arts and Sciences, Pace University, New York, NY, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goodill', 'Affiliation': 'Creative Arts Therapies Department, College of Nursing and Health Professions, Drexel University, Philadelphia, PA, USA.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2020.1757051']
890,32401086,Is it possible to extract lower third molars with infiltration anaesthesia techniques using articaine? A double-blind randomized clinical trial.,"Objective:  To compare the efficacy and safety of inferior alveolar nerve blocks (IANB) with additional buccal infiltration (standard technique) and of buccal and lingual anaesthetic infiltration (experimental technique) for lower third molar (L3M) extractions. Study design:  A randomised, double-blind clinical trial involving 129 L3M extractions was conducted. In the IANB group, an IANB was performed using the conventional approach, followed by a buccal injection in the extraction area. In the infiltration group (INF), an infiltration was performed in the buccal and lingual areas of the lower second molar. A 4% articaine solution was employed in all cases. The main outcome variable was anaesthetic efficacy. Other variables like intraoperative and postoperative pain, onset time and adverse events were also recorded. Descriptive and bivariate analyses of the data were made. Results:  120 patients were randomised. The IANB group showed significantly higher anaesthetic efficacy than the INF group (64.4 vs. 45.8%) (odds ratio = 0.47; 95% confidence interval = 0.22-0.97;  p  = 0.042). No complications were observed. Conclusions:  IANB with additional buccal infiltration is more suitable than the experimental technique for achieving adequate analgesia in L3M extractions. Moreover, the standard method is safe and provides a shorter onset time and lower initial postoperative pain levels.",2020,The IANB group showed significantly higher anaesthetic efficacy than the INF group (64.4 vs. 45.8%) (odds ratio = 0.47; 95% confidence interval = 0.22-0.97;  p  = 0.042).,"['129 L3M extractions', '120 patients were randomised', 'lower third molar (L3M) extractions']","['articaine solution', 'articaine', 'inferior alveolar nerve blocks (IANB) with additional buccal infiltration (standard technique) and of buccal and lingual anaesthetic infiltration (experimental technique']","['anaesthetic efficacy', 'postoperative pain, onset time and adverse events']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",129.0,0.328667,The IANB group showed significantly higher anaesthetic efficacy than the INF group (64.4 vs. 45.8%) (odds ratio = 0.47; 95% confidence interval = 0.22-0.97;  p  = 0.042).,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Sofos', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Soriano-Pons', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Octavi', 'Initials': 'O', 'LastName': 'Camps-Font', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sanmarti-García', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cosme', 'Initials': 'C', 'LastName': 'Gay-Escoda', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Valmaseda-Castellón', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1760348']
891,32401099,Internet-based therapy with FearFighter for anxiety disorders: a randomised clinical trial.,"Background:  Internet-based cognitive behavioural self-help psychotherapy (ICBT) can be an important alternative or supplement to ordinary face-to-face therapy. Aim:  To assess effectiveness of ICBT for adults with an anxiety disorder. Methods:  Sixty-four participants were randomised to 9 weeks with the FearFighter ICBT program ( n  = 32) or no intervention ( n  = 32). Outcomes included complete remission, severity of symptoms and occurrence of adverse events. Results:  No difference ( p  = 1.00) in remission between groups following 10 weeks of intervention nor at 37 weeks follow-up was found. There was significant reduction in the severity of symptoms ( p  < 0.05) at end of intervention of ICBT compared to the control group, while the reduction in symptoms at 37 weeks follow-up was equal for the two groups. Two participants in the ICBT group and none in the control group reported adverse events. Conclusion:  We found no difference in remission, but a reduction of symptoms in the ICBT group compared with the control group at end of intervention. At six months follow-up the two groups showed the same level in the reduction of symptoms.  Trial registration:  Clinicaltrials.gov: NCT02499055. Registered 01 July 2015.",2020,"There was significant reduction in the severity of symptoms ( p  < 0.05) at end of intervention of ICBT compared to the control group, while the reduction in symptoms at 37 weeks follow-up was equal for the two groups.","['Methods:  Sixty-four participants', 'anxiety disorders', 'adults with an anxiety disorder']","['ICBT', 'Internet-based therapy with FearFighter', ':  Internet-based cognitive behavioural self-help psychotherapy (ICBT', 'FearFighter ICBT program ( n \u2009=\u200932) or no intervention']","['severity of symptoms', 'complete remission, severity of symptoms and occurrence of adverse events', 'adverse events', 'reduction of symptoms']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",64.0,0.0505465,"There was significant reduction in the severity of symptoms ( p  < 0.05) at end of intervention of ICBT compared to the control group, while the reduction in symptoms at 37 weeks follow-up was equal for the two groups.","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Gentofte, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lindschou', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Gentofte, Denmark.'}, {'ForeName': 'Jan Hein', 'Initials': 'JH', 'LastName': 'Dybkjaer', 'Affiliation': 'Student Counselling Service, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Gentofte, Denmark.'}]",Nordic journal of psychiatry,['10.1080/08039488.2020.1755363']
892,30995174,Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer.,"PURPOSE


The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma.
PATIENTS AND METHODS


A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33-based high-intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles.
RESULTS


The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9%  v  4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated.
CONCLUSION


Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.",2019,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","['High-Intermediate and High-Risk Early Stage Endometrial Cancer', 'The median age of the 601 patients was 63 years, and 74% had stage I disease', 'high-intermediate and high-risk early-stage endometrial carcinoma', 'eligible patients with endometrial cancer', 'Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage']","['Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin', 'vaginal cuff brachytherapy and chemotherapy (VCB/C', 'pelvic radiation therapy (RT', 'Pelvic RT alone', 'VCB followed by intravenous paclitaxel 175 mg/m 2  (3 hours) plus carboplatin']","['recurrence-free survival (RFS', 'Pelvic or para-aortic nodal recurrences', 'RFS or overall survival', '60-month overall survival', '60-month RFS', 'Vaginal and distant recurrence rates', 'Acute toxicity']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0854674', 'cui_str': 'Brachytherapy to vagina'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.213594,"The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52).","[{'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Randall', 'Affiliation': '1 University of Kentucky, Lexington, KY.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'McMeekin', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'von Gruenigen', 'Affiliation': '4 Summa Health System, Akron, OH.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': '2 NRG Oncology Statistical and Data Center, Buffalo, NY.'}, {'ForeName': 'Catheryn M', 'Initials': 'CM', 'LastName': 'Yashar', 'Affiliation': '5 University of California San Diego, San Diego, CA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '3 University of Oklahoma School of Medicine, Oklahoma City, OK.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': '6 Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': '7 Ohio State University, Columbus, OH.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '8 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': '9 Mercer University, Savannah, GA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutherford', 'Affiliation': '10 Yale University, New Haven, CT.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""11 Women's Cancer Center of Nevada, Las Vegas, NV.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Terada', 'Affiliation': '12 University of Hawaii, Honolulu, HI.'}, {'ForeName': 'Penny R', 'Initials': 'PR', 'LastName': 'Anderson', 'Affiliation': '13 Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Brewster', 'Affiliation': '14 University of North Carolina Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': '15 Loyola University, Chicago, IL.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Aghajanian', 'Affiliation': '16 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': '17 University of Texas Southwestern Medical Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01575']
893,32210365,Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial.,"BACKGROUND


The cancer vaccine Vx-001, which targets the universal tumour antigen TElomerase Reverse Transcriptase (TERT), can mount specific Vx-001/TERT 572  CD8 + cytotoxic T cells; this immune response is associated with improved overall survival (OS) in patients with advanced/metastatic non-small cell lung cancer (NSCLC).
METHODS


A randomised, double blind, phase 2b trial, in HLA-A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy were randomised to receive either Vx-001 or placebo. The primary endpoint of the trial was OS.
RESULTS


Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the placebo and the Vx-001 arm, respectively) were analysed for efficacy. There was not treatment-related toxicity >grade 2. The study did not meet its primary endpoint (median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86) whereas the median Time to Treatment Failure (TTF) was 3.5 and 3.6 months, respectively. Disease control for >6months was observed in 30 (33.7%) and 26 (25.7%) patients treated with Vx-001 and placebo, respectively. There was no documented objective CR or PR. Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
CONCLUSION


Vx-001 could induce specific CD8 +  immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001.
CLINICAL TRIAL REGISTRATION


NCT01935154.",2020,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","['patients with advanced/metastatic non-small cell lung cancer (NSCLC', 'patients with stage IV non-small cell lung cancer', 'Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the', 'A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy']","['htert (vx-001) cancer vaccine', 'HLA', 'placebo', 'Vx-001 or placebo', 'chemotherapy maintenance immunotherapy']","['objective CR or PR', 'overall survival (OS', 'median Time to Treatment Failure (TTF', 'specific CD8 +  immune response', 'Long lasting TERT-specific immune response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1958472', 'cui_str': 'Vx001 cpd'}, {'cui': 'C0376659', 'cui_str': 'Vaccines, Tumor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",221.0,0.621622,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'S.G. Moscati Hospital, Avellino, Italy. cgridelli@libero.it.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institutui, Oncologic I. Chircuta, Cluz-Napoca, Romania.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Fundacion Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Mazowieckie Centrum, Otwock, Poland.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bover', 'Affiliation': 'Son Llatzer Hospital, Palma de Mallorca, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario Málaga, Instituto de Investigaciones Biomédicas (IBIMA), Málaga, Spain.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kentepozidis', 'Affiliation': '251 General Airforce Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zarogoulidis', 'Affiliation': 'Papanikolaou General Hospital, Exohi, Greece.'}, {'ForeName': 'Charalabos', 'Initials': 'C', 'LastName': 'Kalofonos', 'Affiliation': 'University Hospital of Patras, Rio, Greece.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kazarnowisz', 'Affiliation': 'Oddzial Onkologiiz Pododdziatem, Olsztyn, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korozan', 'Affiliation': 'Hospicjum Dutkiewicza SAC, Gdansk, Poland.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'de Las Penas', 'Affiliation': 'Hospital Provincial de Castellon, Castellon, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creui Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'A.O.U. di Pisa Hospital, Pisa, Italy.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius Hospital, Oldenburg, Germany.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bournakis', 'Affiliation': 'University Hospital ""Aretaieion"", Athens, Greece.'}, {'ForeName': 'Parvis', 'Initials': 'P', 'LastName': 'Sadjadian', 'Affiliation': 'Johannes Wesling Klinikum, Minden, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Kotsakis', 'Affiliation': 'Dpt of Medical Oncology, University General Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Chinet', 'Affiliation': 'Hopital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Kostantinos N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'General Hospital of Thoracic Diseases \'\'Sotiria"", Athens, Greece.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Correale', 'Affiliation': 'University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gallou', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Jeanne- Menez', 'Initials': 'JM', 'LastName': 'Jamet', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Eleni- Kyriaki', 'Initials': 'EK', 'LastName': 'Vetsika', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Kosmatopoulos', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-020-0785-y']
894,32401286,Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial.,"Importance


Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.
Objective


To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.
Design, Setting, and Participants


This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.
Interventions


Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.
Main Outcomes and Measures


Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.
Results


Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.
Conclusions and Relevance


In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02314065.",2020,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"['Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50', '204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period', 'primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care', 'Health Anxiety']","['Face-to-face cognitive behavior therapy (CBT', 'internet-delivered CBT or to individual face-to-face CBT', 'Internet vs Face-to-Face Cognitive Behavior Therapy']","['initial symptom level, recruitment path, or patient treatment preference', 'health anxiety symptoms', 'net societal cost', '1-sided 95% CI upper limits', 'number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.102247,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Björkander', 'Affiliation': 'Gustavsberg Academic Primary Care Clinic, Gustavsberg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0940']
895,32401305,Commentary on: A Randomized Controlled Trial of Three Noninvasive Analgesic Techniques for the Prevention of Pain During Facial Injections.,,2020,,[],[],[],[],[],[],,0.177472,,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Westmead Private Hospital, Westmead NSW, Australia.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa044']
896,32401335,Breast shield design impacts milk removal dynamics during pumping: a randomised controlled non-inferiority trial.,"INTRODUCTION


While many studies have investigated the importance of optimising pumping patterns for milk removal, the influence of breast shield design on milk removal has not been the focus of extensive investigation. This study aimed to determine the effectiveness of breast shields with either a 105° or a 90° flange opening angle on breast drainage and milk volume expressed during pumping.
MATERIAL AND METHODS


This study was a cross-over, randomised controlled non-inferiority trial (Registration; NCT03091985). Mothers (n=49) of breastfeeding infants participated in the study over two study sessions. Participants were randomly assigned to pump both breasts simultaneously for 15 minutes with either the 105° or 90° breast shield in the first session, and the other shield in the second session. Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields were assessed after 15 minutes of pumping. Intention-to-treat and per protocol analyses were performed to determine if the 105° breast shield was non-inferior to the 90° breast shield for breast drainage and volume expressed. Perceived comfort was assessed via questionnaire.
RESULTS


The 105° breast shield was both non-inferior and superior compared to the standard 90° shield for breast drainage (intention-to-treat, 3.87% (0.01 - 7.72), p=.049) and volume expressed (intention-to-treat, 9.14 mL (1.37 - 16.91), p=.02). In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
CONCLUSIONS


Expressing with the 105° breast shield was more efficient, effective and comfortable compared to the 90° shield. Breast shield design can significantly impact pumping outcomes, and an opening angle of 105° improves both the dynamics and comfort of milk removal.",2020,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
",['Mothers (n=49) of breastfeeding infants participated in the study over two study sessions'],[],"['Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields', 'feeling more comfortable (p<.001) and as having an improved fit to the breast', 'Perceived comfort']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0222605', 'cui_str': 'Both breasts'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0633338,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
","[{'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Sakalidis', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Ivarsson', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Haynes', 'Affiliation': 'Clinical Trials Unit (CTU) Bern, Faculty of Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Jäger', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Nania G', 'Initials': 'NG', 'LastName': 'Schärer-Hernández', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Leon R', 'Initials': 'LR', 'LastName': 'Mitoulas', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Prime', 'Affiliation': 'Medela AG, Baar, Switzerland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13897']
897,32401339,Program of Active Consumer Engagement in Self-Management in Epilepsy: Replication and extension of a self-management randomized controlled trial.,"OBJECTIVE


The Program of Active Consumer Engagement in Self-Management in Epilepsy (PACES) is an evidenced-based self-management intervention for adults with epilepsy. Prior randomized controlled trial (RCT) data show that PACES reduces depression and improves self-management, self-efficacy, and quality of life for 6 months postprogram. The objective of this study was to replicate a PACES RCT with key extensions: more diverse patient pool from community-based epilepsy centers; option for telephone-based participation; and longer follow-up (12 months with booster support for intervention group), to examine duration of impact and inform dissemination and implementation.
METHODS


Participants were adults with chronic epilepsy (n = 101) without serious mental illness or substantive intellectual impairment, recruited from three epilepsy centers. Participants were randomly assigned to intervention or waitlist control groups. Outcomes included the Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), Quality of Life in Epilepsy-31, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7, administered at baseline, postintervention (8 weeks), and 6 and 12 months postintervention. Intervention was an 8-week group of five to eight adults co-led by a psychologist and trained peer with epilepsy that met once per week by teleconference or in person at a hospital for 60-75 minutes. Topics included medical, psychosocial, cognitive, and self-management aspects of epilepsy, as well as community integration and epilepsy-related communication. Treatment group provided program evaluation.
RESULTS


PACES participants (n = 49) improved relative to controls (n = 52) on the ESES (P < .022) and overall distress composite (P = .008). At 6 months, PACES participants remained improved on the ESES (P = .008) and composite (P = .001), and were improved on the ESMS (P = .005). At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018). Attrition was low (<6% in each group), and all program satisfaction ratings exceeded 4.0/5.0.
SIGNIFICANCE


A consumer-generated epilepsy self-management program with broad psychosocial and medical emphasis can be effectively delivered by telephone or in person and facilitates long-term epilepsy self-management, adjustment, and coping up to 1 year after treatment.",2020,"At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018).","['Participants were adults with chronic epilepsy (n\xa0=\xa0101) without serious mental illness or substantive intellectual impairment, recruited from three epilepsy centers', 'Epilepsy', 'adults with epilepsy']","['PACES', 'adults co-led by a psychologist and trained peer with epilepsy that met once per week by teleconference or in person at a hospital for 60-75\xa0minutes']","['depression and improves self-management, self-efficacy, and quality of life', 'ESMS', 'overall distress composite of combined measures', 'Attrition', 'Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), Quality of Life in Epilepsy-31, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7', 'overall distress composite', 'ESES']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",101.0,0.0591539,"At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018).","[{'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Johnson', 'Affiliation': 'Health Promotion Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Fraser', 'Affiliation': 'Health Promotion Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lashley', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Department of Neurological Surgery, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Brandling-Bennett', 'Affiliation': 'UW Medicine, Valley Medical Center, Renton, Washington, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Caylor', 'Affiliation': 'Swedish Neuroscience Institute, Seattle, Washington, USA.'}, {'ForeName': 'Tessala', 'Initials': 'T', 'LastName': 'Warheit-Niemi', 'Affiliation': 'Neurology Vocational Services Unit, University of Washington, Seattle, Washington, USA.'}]",Epilepsia,['10.1111/epi.16530']
898,32401380,"Comparison of therapeutic efficacy of topical treatment with phenytoin and fluocinolone on cutaneous lichen planus: a randomized, double-blind trial.",,2020,,['cutaneous lichen planus'],['phenytoin and fluocinolone'],[],"[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0023646', 'cui_str': 'Lichen planus'}]","[{'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0060507', 'cui_str': 'fluocinolone'}]",[],,0.633,,"[{'ForeName': 'Mozhdeh', 'Initials': 'M', 'LastName': 'Sepaskhah', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Hemmatian Boroujeni', 'Affiliation': 'Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Javaheri', 'Affiliation': 'Department of Dermatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bagheri', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Dermatologic therapy,['10.1111/dth.13578']
899,32401385,"Comparison of the efficiency of two different PPI formula in treatment of atypical GERD patients, a prospective randomized study.","BACKGROUND AND AIM


The prospective, open-label, randomized study aims to compare the efficacy of lansoprazole, a fast orally-disintegrating proton pump inhibitor (PPI) and dexlansoprazole, a dual delayed release PPI in patients with atypical symptoms of gastro-esophageal reflux disease (GERD).
METHODS


Patients with atypical GERD symptoms with a total Reflux Symptom Index (RSI) score >10 were eligible for enrollment. From Feb. 2018 to Dec. 2019, 232 subjects were randomly assigned (1:1 ratio) to receive oral lansoprazole, Takepron® OD 30 mg, once daily before breakfast or oral dexlansoprazole, Dexilant® 60 mg, once daily before breakfast for 8 weeks. The primary endpoint is to compare the symptoms response rate after 8-week PPI therapy between the two groups.
RESULTS


There were 232 study subjects enrolling in this study. After 8-week PPI therapy, dexlansoprazole treated group had a significantly higher response rate than lansoprazole treated group in cough (76.5 % vs. 38.0 %) and globus (69.7 % vs. 30.8 %)(p all< 0.05 by intention to treat). Multivariate logistic regression analysis showed that use of dexlansoprazole, presence of dyslipidemia and typical GERD symptoms (acid reflux and heartburn) were predictors for symptom response for cough; use of dexlansoprazole and presence of erosive esophagitis were predictors for symptom response for globus (p all < 0.05). No predictor for therapy response to hoarseness was noted.
CONCLUSIONS


There is a higher response rate for cough and globus symptoms in atypical GERD patients after a 8-week PPI therapy with dexlansoprazole rather than lansoprazole. (NCT03418337).",2020,There is a higher response rate for cough and globus symptoms in atypical GERD patients after a 8-week PPI therapy with dexlansoprazole rather than lansoprazole.,"['From Feb. 2018 to Dec. 2019, 232 subjects', 'atypical GERD patients', '232 study subjects enrolling in this study', 'patients with atypical symptoms of gastro-esophageal reflux disease (GERD', 'Patients with atypical GERD symptoms with a total Reflux Symptom Index (RSI) score >10 were eligible for enrollment']","['PPI formula', 'oral lansoprazole, Takepron® OD 30 mg, once daily before breakfast or oral dexlansoprazole, Dexilant®', 'lansoprazole']","['dyslipidemia and typical GERD symptoms (acid reflux and heartburn', 'symptoms response rate', 'response rate', 'response rate for cough and globus symptoms']","[{'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C1174766', 'cui_str': 'Takepron'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast'}, {'cui': 'C2348248', 'cui_str': 'dexlansoprazole'}, {'cui': 'C2609580', 'cui_str': 'Dexilant'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0017650', 'cui_str': 'Feeling of lump in throat'}]",232.0,0.0220918,There is a higher response rate for cough and globus symptoms in atypical GERD patients after a 8-week PPI therapy with dexlansoprazole rather than lansoprazole.,"[{'ForeName': 'Xi-Hsuan', 'Initials': 'XH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jiing-Chyuan', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Po-Hsiang', 'Initials': 'PH', 'LastName': 'Ting', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Tien-En', 'Initials': 'TE', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15093']
900,31295363,"Higher dietary protein intake preserves lean body mass, lowers liver lipid deposition, and maintains metabolic control in participants with long-chain fatty acid oxidation disorders.","Medical nutrition therapy for long-chain fatty acid oxidation disorders (LC-FAODs) currently emphasizes fasting avoidance, restricted dietary long-chain fatty acid intake, supplementation with medium chain triglycerides, and increased carbohydrate intake. We hypothesize that increasing dietary protein intake relative to carbohydrate intake would preserve metabolic control yet induce physical benefits including reduced hepatic lipogenesis. Therefore, we compared two dietary approaches with similar fat intake but different carbohydrate to protein ratios in participants diagnosed with LC-FAODs. Thirteen participants were enrolled and randomized into either a high-protein (PRO) or a high-carbohydrate (CHO) diet for 4 months. Baseline and 4-month assessments included body composition, ectopic lipid deposition, and resting energy expenditure. End of study assessments also included total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity. At the end of the dietary intervention, both groups had similar energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads. Neither dietary group experienced worsening symptoms related to their LC-FAOD. Compared to the CHO group, the PRO group exhibited increased blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass while the CHO group lost lean mass. In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass. We propose that a modest increase in dietary protein along with fasting avoidance and fat restriction may improve body composition and energy expenditure in patients with LC-FAODs.",2019,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","['participants with long-chain fatty acid oxidation disorders', 'Thirteen participants', 'participants diagnosed with LC-FAODs', 'patients with LC-FAODs']","['high-protein (PRO) or a high-carbohydrate (CHO) diet', 'CHO', 'Medical nutrition therapy']","['total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity', 'blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass', 'body composition and energy expenditure', 'lean body mass, lowers liver lipid deposition', 'energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads', 'worsening symptoms', 'body composition, ectopic lipid deposition, and resting energy expenditure']","[{'cui': 'C0522095', 'cui_str': 'Long chain fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet (finding)'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",13.0,0.0245497,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Gillingham', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Elizondo', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Behrend', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Matern', 'Affiliation': 'Biochemical Genetics Laboratory, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Schoeller', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12155']
901,31196815,Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial.,"BACKGROUND


Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE-TIMI 58 cardiovascular outcomes trial, which included patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.
METHODS


In DECLARE-TIMI 58, patients with type 2 diabetes, HbA 1c  6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min were randomly assigned (1:1) to 10 mg dapagliflozin or placebo once daily. A prespecified secondary cardiorenal composite outcome was defined as a sustained decline of at least 40% in estimated glomerular filtration rate [eGFR] to less than 60 mL/min per 1·73m 2 , end-stage renal disease (defined as dialysis for at least 90 days, kidney transplantation, or confirmed sustained eGFR <15mL/min per 1·73 m 2 ), or death from renal or cardiovascular causes; a prespecified renal-specific composite outcome was the same but excluding death from cardiovascular causes. In this renal analysis, we report findings for the components of these composite outcomes, subgroup analysis of these composite outcomes, and changes in eGFR at different timepoints. DECLARE-TIMI 58 is registered with ClinicalTrials.gov, number NCT01730534.
FINDINGS


The trial took place between April 25, 2013, and Sept 18, 2018; median follow-up was 4·2 years (IQR 3·9-4·4). Of the 17 160 participants who were randomly assigned, 8162 (47·6%) had an eGFR of at least 90 mL/min per 1·73 m 2 , 7732 (45·1%) had an eGFR of 60 to less than 90 mL/min per 1·73 m 2 , and 1265 (7·4%) had an eGFR of less than 60 mL/min per 1·73 m 2  at baseline (one participant had missing data for eGFR); 6974 (40·6%) had established atherosclerotic cardiovascular disease and 10 186 (59·4%) had multiple risk factors. As previously reported, the cardiorenal secondary composite outcome was significantly reduced with dapagliflozin versus placebo (hazard ratio [HR] 0·76, 95% CI 0·67-0.87; p<0·0001); excluding death from cardiovascular causes, the HR for the renal-specific outcome was 0·53 (0·43-0·66; p<0·0001). We identified a 46% reduction in sustained decline in eGFR by at least 40% to less than 60 mL/min per 1·73 m 2  (120 [1·4% vs 221 [2·6%]; HR 0·54 [95% CI 0·43-0·67]; p<0·0001). The risk of end-stage renal disease or renal death was lower in the dapagliflozin group than in the placebo group (11 [0·1%] vs 27 [0·3%]; HR 0·41 [95% CI 0·20-0·82]; p=0·012). Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =0·72). 6 months after randomisation, the mean decrease in eGFR was larger in the dapagliflozin group than in the placebo group. The mean change equalised by 2 years, and at 3 and 4 years the mean decrease in eGFR was less with dapagliflozin than with placebo.
INTERPRETATION


Dapagliflozin seemed to prevent and reduce progression of kidney disease compared with placebo in this large and diverse population of patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function.
FUNDING


AstraZeneca.",2019,"Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =","['patients with type 2 diabetes, HbA 1c  6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min', 'patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function', 'patients with type 2 diabetes', 'patients with established atherosclerotic cardiovascular disease', 'patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function', 'Of the 17\u2008160 participants']","['dapagliflozin versus placebo', 'placebo', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'dapagliflozin or placebo', 'SGLT2 inhibitor dapagliflozin', 'dapagliflozin']","['glomerular filtration rate [eGFR', 'multiple risk factors', 'mean decrease in eGFR', 'sustained decline in eGFR', 'cardiorenal and renal-specific composite outcomes', 'risk of end-stage renal disease or renal death', 'eGFR', 'established atherosclerotic cardiovascular disease', 'development and progression of kidney disease', 'presence or absence of established atherosclerotic cardiovascular disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",17160.0,0.449725,"Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction =0·97; renal-specific outcome p interaction =0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction =0·67; renal-specific outcome p interaction =","[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: ofrim@hadassah.org.il.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Eri T', 'Initials': 'ET', 'LastName': 'Kato', 'Affiliation': 'Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30180-9']
902,32203207,Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial.,"BACKGROUND


Cardiotoxicity is the most significant adverse event associated with trastuzumab (T), the main component of HER2-positive breast cancer (BC) treatment. Less is known about the cardiotoxicity of dual HER2 blockade with T plus lapatinib (L), although this regimen is used in the metastatic setting.
METHODS


This is a sub-analysis of the ALTTO trial comparing adjuvant treatment options for patients with early HER2-positive BC. Patients randomised to either T or concomitant T + L were eligible. Cardiac events (CEs) rates were compared according to treatment arm.
RESULTS


With 6.9 years of median follow-up (FU) and 4190 patients, CE were observed in 363 (8.6%): 166 (7.9%) of patient in T + L arm vs. 197 (9.3%) in T arm (OR = 0.85 [95% CI, 0.68-1.05]). During anti-HER2 treatment 270 CE (6.4%) occurred while 93 (2.2%) were during FU (median time to onset = 6.6 months [IQR = 3.4-11.7]). While 265 CEs were asymptomatic (73%), 94 were symptomatic (26%) and four were cardiac deaths (1%). Recovery was observed in 301 cases (83.8%). Identified cardiac risk factors were: baseline LVEF < 55% (vs > 64%, OR 3.1 [95% CI 1.54-6.25]), diabetes mellitus (OR 1.85 [95% CI 1.25-2.75]), BMI > 30 kg/m 2  (vs < 25 mg/kg 2 , OR 2.21 [95% CI 1.40-3.49]), cumulative dose of doxorubicin ≥240 mg/m 2  (OR 1.36 [95% CI 1.01-1.82]) and of epirubicin≥ 480 mg/m 2  (OR 2.33 [95% CI 1.55-3.51]).
CONCLUSIONS


Dual HER2 blockade with T + L is a safe regimen from a cardiac perspective, but cardiac-focused history for proper patient selection is crucial.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT00490139 (registration date: 22/06/2007); EudraCT Number: 2006-000562-36 (registration date: 04/05/2007); Sponsor Protocol Number: BIG2-06 /EGF106708/N063D.",2020,"Cardiac events (CEs) rates were compared according to treatment arm.
","['patients with early HER2-positive BC', 'patients with HER2-positive breast cancer treated in the']","['trastuzumab (T', 'adjuvant lapatinib', 'T or concomitant T\u2009+\u2009L', 'doxorubicin']","['diabetes mellitus', 'Cardiac events (CEs) rates', 'Recovery', 'cardiac deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}]",,0.264623,"Cardiac events (CEs) rates were compared according to treatment arm.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eiger', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Noam F', 'Initials': 'NF', 'LastName': 'Pondé', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science, Kingussie, United Kingdom.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group (BIG), Brussels, Belgium.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Amylou', 'Initials': 'A', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Istenhegyi Géndiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Rodeheffer', 'Affiliation': 'Cardiovascular Department, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ewer', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Suter', 'Affiliation': 'Department of Cardiology, lnselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium. evandro.azambuja@bordet.be.""}]",British journal of cancer,['10.1038/s41416-020-0786-x']
903,32036679,Adolescent Mothers' Perceptions of a Mobile Phone-Based Peer Support Intervention.,"BACKGROUND


Postpartum depression (PPD) is prevalent among adolescent mothers and is associated with negative maternal and infant outcomes. Peer support can improve health outcomes among adult and adolescent populations and involves the provision of informational, emotional, and appraisal support delivered by a peer.
PURPOSE


To describe adolescent mothers' perceptions of a mobile phone-based peer support (MPPS) intervention designed to prevent PPD.
METHODS


This analysis draws on data from the MPPS intervention group of a pilot randomized controlled trial of pregnant adolescents 17 to 24 years old ( n  = 16). Maternal perceptions of the intervention were measured using the validated Peer Support Evaluation Inventory at 12 weeks postpartum.
RESULTS


Participants acknowledged receiving supportive actions including emotional (91%), informational (66%), and appraisal (64%) support. Participants perceived positive relationship qualities with their peer mentor such as trustworthiness (94%), acceptance (75%), empathy (81%), and commitment (81%) and felt their peer mentor possessed social competence (91%) and social skills (91%). Overall, 100% of participants were satisfied with their peer support experience and would recommend this type of support to a friend.
CONCLUSION


Participants perceived their experience with the MPPS intervention positively, which lends support to MPPS as an acceptable way to provide support to adolescent mothers.",2020,"Peer support can improve health outcomes among adult and adolescent populations and involves the provision of informational, emotional, and appraisal support delivered by a peer.
","[""Adolescent Mothers' Perceptions of a"", 'adult and adolescent populations', 'adolescent mothers', 'pregnant adolescents 17 to 24\u2009years old ( n \u2009=\u200916']","['mobile phone-based peer support (MPPS) intervention', 'MPPS intervention', 'Mobile Phone-Based Peer Support Intervention']","['social competence', 'social skills', 'health outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0595357,"Peer support can improve health outcomes among adult and adolescent populations and involves the provision of informational, emotional, and appraisal support delivered by a peer.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Chyzzy', 'Affiliation': 'Daphne Cockwell School of Nursing, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'LaRon E', 'Initials': 'LE', 'LastName': 'Nelson', 'Affiliation': 'Yale University School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vigod', 'Affiliation': ""Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Cindy-Lee', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}]",The Canadian journal of nursing research = Revue canadienne de recherche en sciences infirmieres,['10.1177/0844562120904591']
904,31479006,Individual Response to Standardized Exercise: Total and Abdominal Adipose Tissue.,"PURPOSE


(1) Determine the effect of exercise amount and intensity on the proportion of individuals for whom the adipose tissue (AT) response is above the minimal clinically important difference (MCID); and (2) Examine whether clinically meaningful anthropometric changes reflect individual AT responses above the MCID.
METHODS


Men (n = 41) and women (n = 62) (52.7 ± 7.6 yr) were randomized to control (n = 20); low amount low intensity (n = 24); high amount low intensity (n = 30); and high amount high intensity (n = 29) treadmill exercise for 24 wk. The AT changes were measured by MRI. 90% confidence intervals for each individual's observed response were calculated as the observed score ±1.64 × TE (technical error of measurement).
RESULTS


For visceral AT, HAHI and HALI had a greater proportion of individuals whose AT change and 90% confidence interval were beyond the MCID compared to controls (P < 0.006). For all other AT depots, all exercise groups had significantly more individuals whose changes were beyond the MCID compared with controls. Of those who achieved a waist circumference or body weight reduction ≥ the MCID, 76% to 93% achieved abdominal, abdominal subcutaneous, and visceral AT changes ≥ the MCID.
CONCLUSIONS


Increasing exercise amount and/or intensity may increase the proportion of individuals who achieve clinically meaningful visceral AT reductions. Waist circumference or body weight changes beyond a clinically meaningful threshold are predictive of clinically meaningful abdominal adiposity changes.",2020,"For all other AT depots, all exercise groups had significantly more individuals whose changes were beyond the MCID compared to controls.",['Men (n=41) and women (n=62) (52.7 ± 7.6 years'],"['low amount low intensity (LALI, N=24); high amount low intensity (HALI, N=30); and high amount high intensity (HAHI, N=29) treadmill exercise', 'Standardized Exercise']","['Total and Abdominal Adipose Tissue', 'waist circumference (WC) or body weight reduction ≥ the MCID']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0270552,"For all other AT depots, all exercise groups had significantly more individuals whose changes were beyond the MCID compared to controls.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Brennan', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON, CANADA.""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': 'Kingston General Health Research Institute, Kingston, Ontario, CANADA.'}, {'ForeName': 'Theresa E', 'Initials': 'TE', 'LastName': 'Cowan', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON, CANADA.""}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Clarke', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON, CANADA.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': 'Institute of Nutraceuticals and Functional Foods, Laval University, Quebec City, Quebec, CANADA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ross', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, ON, CANADA.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002140']
905,32400733,Comparison of proximal femoral nail (PFN) and dynamic hip screw (DHS) for the treatment of AO type A2 and A3 pertrochanteric fractures of femur.,"Objective


To compare the dynamic hip screw with proximal femoral nail for the treatment of Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fractures of femur.
METHODS


The randomised controlled single-blind study was conducted at the Mayo Hospital, Lahore, Pakistan, from September 2015 to September 2017, and comprised patients aged 40-75 years with Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fracture. The patients randomised into two equal groups. In Group A, patients were treated by closed reduction and internal fixation with dynamic hip screw, while those in Group B were treated by closed reduction and internal fixation by proximal femoral nail. Follow-up was done at 2nd, 6th and 12th weeks, and at 6th, 9th and 12th month post-operatively. Variables evaluated were frequency of union, surgical time, approximate amount of blood loss and complications. The functional assessment was done by using Harris hip score. SPSS 20 was used for data analysis.
RESULTS


Of the 68 patients, there were 34(50%) in each group. The mean age of patients in Group A was 60.88±12.49 years and in Group B it was 59.32±2.39 years. The mean surgery time in Group A was 58.71±7.84 minutes and in Group B 35.35±5.48 minutes (p<0.05). Mean blood loss was 273.82±30.0ml and 149.79±21.3ml in Group A and B respectively (p<0.05). The mean Harris hip score after 12 months in Groups A and B were 81.83±23.01 and 87.62±17.28 respectively. Infection was seen in 2(5.9%) patients in Group A and 1(2.9%) in Group B.
Conclusion


Proximal femoral nail provided equivalent functional outcome compared to dynamic hip screw with lesser blood loss and surgical time.",2020,The mean Harris hip score after 12 months in Groups A and B were 81.83±23.01 and 87.62±17.28 respectively.,"['Mayo Hospital, Lahore, Pakistan, from September 2015 to September 2017, and comprised patients aged 40-75 years with Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fracture', 'AO type A2 and A3 pertrochanteric fractures of femur', 'Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fractures of femur', '68 patients']","['dynamic hip screw with proximal femoral nail', 'proximal femoral nail (PFN) and dynamic hip screw (DHS', 'closed reduction and internal fixation by proximal femoral nail', 'dynamic hip screw', 'closed reduction and internal fixation with dynamic hip screw']","['blood loss and surgical time', 'mean Harris hip score', 'mean surgery time', 'Mean blood loss', 'frequency of union, surgical time, approximate amount of blood loss and complications', 'Infection']","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0281883', 'cui_str': 'Pertrochanteric fracture'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C1306879', 'cui_str': 'Trochanteric fracture of neck of femur'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0082226', 'cui_str': 'eIF-5A-deoxyhypusine synthase'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0213097,The mean Harris hip score after 12 months in Groups A and B were 81.83±23.01 and 87.62±17.28 respectively.,"[{'ForeName': 'Khaqan', 'Initials': 'K', 'LastName': 'Adeel', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Rana Dilawaiz', 'Initials': 'RD', 'LastName': 'Nadeem', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Ranjit Kumar', 'Initials': 'RK', 'LastName': 'Sah', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Mohy-Ud-Din', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, King Edward Medical University, Lahore, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.295426']
906,32400736,Improving dimensional stability of dental amalgam by using Nano Zinc Oxide.,"OBJECTIVE


To investigate the dimensional stability of dental amalgam after the incorporation of zinc oxide nano powder.
METHODS


The experimental study was conducted at the Hamdard University Dental Hospital and the Pakistan Council of Scientific and Industrial Research laboratories, Karachi, from January to June, 2018. Direct precipitation method was used in which analytical grade sodium hydroxide and zinc nitrate hex hydrate were used without any further purification. The sample was randomly divided into two groups. The control group A had 0 wt.% of nano zinc oxide, while the experimental group was further divided into 2 subgroups, with group B containing samples having 3 wt.% and group C 5 wt.% of nano zinc oxide. Delayed expansion was checked using electron micrometer. Data was analysed using SPSS 22.
RESULTS


Of the 180 samples, there were 90(50%) in control group A, and 45(25%) each in experimental groups B and C. Subgroup B showed significantly more linear expansion than subgroup C. Subgroups B and C achieved their entire linear expansion after 24 hours.
CONCLUSIONS


There was improvement in the dimensional stability of dental amalgam after the incorporation of nano particles of zinc oxide.",2020,"each in experimental groups B and C. Subgroup B showed significantly more linear expansion than subgroup C. Subgroups B and C achieved their entire linear expansion after 24 hours.
","['Hamdard University Dental Hospital and the Pakistan Council of Scientific and Industrial Research laboratories, Karachi, from January to June, 2018', 'Of the 180 samples']","['zinc oxide nano powder', 'Nano Zinc Oxide', 'nano zinc oxide']","['Delayed expansion', 'dimensional stability of dental amalgam', 'linear expansion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3164440', 'cui_str': 'Dental hospital'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0022886', 'cui_str': 'Laboratory Research'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0011324', 'cui_str': 'Amalgams, Dental'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",,0.020958,"each in experimental groups B and C. Subgroup B showed significantly more linear expansion than subgroup C. Subgroups B and C achieved their entire linear expansion after 24 hours.
","[{'ForeName': 'Abdur', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Department of Science of Dental Material, Hamdard College of Medicine and Dentistry, Hamdard University, Karachi.'}, {'ForeName': 'Nimrah', 'Initials': 'N', 'LastName': 'Khalil', 'Affiliation': 'Science of Dental Material, Dr Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Pakistan.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Saleem', 'Affiliation': 'Operative Dentistry, Hamdard College of Medicine and Dentistry, Hamdard University, Karachi, Pakistan.'}, {'ForeName': 'Nadeem Hafeez', 'Initials': 'NH', 'LastName': 'Khokhar', 'Affiliation': 'Hamdard College of Medicine and Dentistry, Karachi, Pakistan.'}, {'ForeName': 'Syed Junaid', 'Initials': 'SJ', 'LastName': 'Mehmood', 'Affiliation': 'Polymer and Plastic Section PCSIR Labs Complex, Karachi, Pakistan.'}, {'ForeName': 'Abdul Frahim', 'Initials': 'AF', 'LastName': 'Khan', 'Affiliation': 'ACRC-Polymer and Plastic Section, PCSIR labs complex, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.10690']
907,32400741,Effectiveness of positive psychotherapy for young adults with depressive Symptoms.,"OBJECTIVE


To analyse the level of happiness and depressive symptoms before and after positive psychotherapy..
METHODS


The experimental study was conducted from February 2018to March 2018 in Shahpur Sadar town of Sargodha district in the Punjab province of Pakistan at Govt. College, and comprised female young adults with depressive symptoms. The participants were subjected to 8 sessions (one baseline and seven other) of group positive psychotherapy. On the basis of repeated measure design, data was collected using the depression subscale of Depression Anxiety Stress Scale-21, Positive Psychotherapy Inventory, and Values in Action Inventory before, during and after therapy administration. SPSS 23 was used for data analysis.
RESULTS


Of the 250 subjects assessed, 30(12%) aged 18-20 years were selected for therapy sessions as they had some level of depression; 15(50%) mild and 15(50%) moderate. Mean happiness level increased with each session from baseline value of 20.63±4.61 to post-therapy 50.67±4.63 (p<0.05). Depression level decreased from baseline value of 15.47±3.42 with each session to post-therapy 4.53±1.10 (p<0.05).
CONCLUSIONS


Positive psychotherapy sessions were found to be effective in decreasing depression among female young adults.",2020,Mean happiness level increased with each session from baseline value of 20.63±4.61 to post-therapy 50.67±4.63 (p<0.05).,"['young adults with depressive Symptoms', 'Of the 250 subjects assessed, 30(12%) aged 18-20 years were selected for therapy sessions as they had some level of depression; 15(50', 'February 2018to March 2018 in Shahpur Sadar town of Sargodha district in the Punjab province of Pakistan at Govt', 'female young adults with depressive symptoms', 'female young adults']","['Positive psychotherapy sessions', 'positive psychotherapy']","['Depression level', 'level of happiness and depressive symptoms', 'depression subscale of Depression Anxiety Stress Scale-21, Positive Psychotherapy Inventory, and Values in Action Inventory', 'Mean happiness level']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.104325,Mean happiness level increased with each session from baseline value of 20.63±4.61 to post-therapy 50.67±4.63 (p<0.05).,"[{'ForeName': 'Arooj Fatima', 'Initials': 'AF', 'LastName': 'Mazhar', 'Affiliation': 'Department of Psychology, University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Naveed', 'Initials': 'MN', 'LastName': 'Riaz', 'Affiliation': 'Department of Psychology, University of Sargodha, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.16572']
908,32400903,Severe and enduring anorexia nervosa: No easy solutions.,"There is currently no evidence-based definition of severe and enduring anorexia nervosa (SE-AN) with which to reliably inform clinical practice and research. Indeed, data on the effect of AN severity and duration on treatment outcome are inconsistent. A large group of patients with SE-AN are repeatedly unsuccessfully managed with the available eating disorders treatments and have no access to adequate treatment for their illness. Cognitive behavioral therapy (CBT) adapted for SE-AN has been designed to enhance quality of life and reduce harm rather than promoting weight gain in such patients, and has had some success. However, a percentage of patients with SE-AN achieves remission, or at least returns to a normal weight range, with available evidence-based treatments for eating disorders, such as enhanced CBT (CBT-E). It would therefore be worth conducting a large-scale randomized controlled trial comparing CBT adapted for SE-AN with CBT-E to assess their relative acceptability; efficacy, including their effect on quality of life and medical stability; cost-effectiveness; and the treatment response moderators that might allow better matching of patients with SE-AN to a treatment oriented either to harm reduction or to change.",2020,"It would therefore be worth conducting a large-scale randomized controlled trial comparing CBT adapted for SE-AN with CBT-E to assess their relative acceptability; efficacy, including their effect on quality of life and medical stability; cost-effectiveness; and the treatment response moderators that might allow better matching of patients with SE-AN to a treatment oriented either to harm reduction or to change.",['Severe and enduring anorexia nervosa'],"['Cognitive behavioral therapy (CBT', 'CBT']",['quality of life and medical stability; cost-effectiveness'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0280831,"It would therefore be worth conducting a large-scale randomized controlled trial comparing CBT adapted for SE-AN with CBT-E to assess their relative acceptability; efficacy, including their effect on quality of life and medical stability; cost-effectiveness; and the treatment response moderators that might allow better matching of patients with SE-AN to a treatment oriented either to harm reduction or to change.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Dalle Grave', 'Affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital, Garda, Italy.'}]",The International journal of eating disorders,['10.1002/eat.23295']
909,30303626,"Evaluation of the Safety, Tolerability, and Pharmacokinetics of GSK2269557 (Nemiralisib) Administered Via Dry Powder Inhaler to Healthy Japanese Subjects.","The aim of the study was to assess the safety, tolerability, and pharmacokinetics of single and repeat doses of nemiralisib administered via a dry powder inhaler to healthy Japanese subjects. This was a single-center, double-blind, randomized, placebo-controlled, parallel, single- and repeat-ascending-dose study. Thirty-six healthy Japanese male subjects were randomized to receive either 1 dose strength of nemiralisib or placebo. The study consisted of a screening period, a single-dose session (session 1), a repeat-dose session (session 2), a 10-day washout period between the sessions, and then a follow-up visit 10 ± 1 days after the last dose of session 2. No serious adverse events were reported. No clinically significant abnormalities were found in clinical laboratory results, vital signs, or spirometry results. Generally, exposure (maximum observed plasma concentration [C max  ] and area under the concentration-time curve [AUC]) increased with dose in an approximately proportional manner. Plasma T max  was achieved rapidly at approximately 0.08 hours, and the terminal elimination half-life (T 1/2  ) was approximately 40 hours. T max  and T 1/2  did not change between days or doses in the single- and repeat-dose sessions. Following 10 daily doses of 200, 500, and 700 μg nemiralisib, accumulation was observed, and the ratios (session 2, day 10:session 1) for Ro(AUC 0-24  ) and R(C max  ) were 2.4-3.0 and 1.5-1.7, respectively. Steady state was achieved by 6-7 days, based on trough observed plasma drug concentration (C trough  ) values.",2019,T max  and T 1/2  did not change between days or doses in the single- and repeat-dose sessions.,"['Healthy Japanese Subjects', 'healthy Japanese subjects', 'Thirty-six healthy Japanese male subjects']","['GSK2269557 (Nemiralisib) Administered Via Dry Powder Inhaler', 'nemiralisib administered via a dry powder inhaler', 'placebo', 'nemiralisib or placebo']","['plasma concentration [C max  ] and area under the concentration-time curve [AUC', 'Safety, Tolerability, and Pharmacokinetics', 'clinical laboratory results, vital signs, or spirometry results', 'Plasma T max', 'Steady state', 'safety, tolerability, and pharmacokinetics', 'serious adverse events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4078792', 'cui_str': 'GSK2269557'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3853847', 'cui_str': 'Dry Powder Inhaler'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518766'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",36.0,0.18882,T max  and T 1/2  did not change between days or doses in the single- and repeat-dose sessions.,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ino', 'Affiliation': 'Medicines Development (Clinical Pharmacology Office), Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Clinical Pharmacology Modelling and Simulation, Medicine's Research Centre, GlaxoSmithKline, Stevenage, Hertfordshire, UK.""}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Terao', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Medicines Development (Clinical Pharmacology Office), Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Harue', 'Initials': 'H', 'LastName': 'Igarashi', 'Affiliation': 'Pre-Clinical Development, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Pharma Research & Development, Respiratory TAU, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Yotaro', 'Initials': 'Y', 'LastName': 'Numachi', 'Affiliation': 'Medicines Development, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.614']
910,32400728,Effects of static stretching as compared to autogenic inhibition and reciprocal inhibition muscle energy techniques in the management of mechanical neck pain: a randomized controlled trial.,"OBJECTIVE


To compare the effects of static stretching with autogenic inhibition and reciprocal inhibition muscle energy techniques on pain, disability and range of motion in patients with mechanical neck pain.
METHODS


A parallel design randomised controlled trial was conducted at Fauji Foundation Hospital and Railway-General Hospital, Rawalpindi, Pakistan, from April to November, 2017, and comprised of patients aged 18-70 years with neck pain of moderate intensity scoring 4-8 on numeric pain rating scale with limited or painful range of motion. The patients were randomly allocated via lottery method into static stretching group, autogenic inhibition muscle energy technique group and reciprocal inhibition muscle energy technique group. All the subjects received five consecutive treatments sessions. Outcome measurements included numeric pain rating scale score, neck disability index score and goniometry for cervical range of motion. Data was collected at baseline and after first and fifth sessions, and was analysed using SPSS 21.
RESULTS


Of the 78 subjects, there were 26(33.3%) in each of the three groups. Of them 7 were lost to follow-up and the study was completed by 71(91%) subjects. The overall mean age was 41.55±11.89 years (p>0.05). There was no significant difference between the groups at baseline (p>0.05). However, at first and second follow-up, there was a significant difference (p<0.05) between the groups in terms of immediate and short-term relief, except for immediate effects related to range of motion (p=0.056).
CONCLUSIONS


Significant difference existed among static stretching, autogenic inhibition and reciprocal inhibition groups in terms of pain, disability and range of motion in patients with mechanical neck pain.",2020,"CONCLUSIONS


Significant difference existed among static stretching, autogenic inhibition and reciprocal inhibition groups in terms of pain, disability and range of motion in patients with mechanical neck pain.","['Fauji Foundation Hospital and Railway-General Hospital, Rawalpindi, Pakistan, from April to November, 2017, and comprised of patients aged 18-70 years with neck pain of moderate intensity scoring 4-8 on numeric pain rating scale with limited or painful range of motion', 'patients with mechanical neck pain', 'mechanical neck pain', '78 subjects']","['static stretching', 'static stretching with autogenic inhibition and reciprocal inhibition muscle energy techniques', 'static stretching group, autogenic inhibition muscle energy technique group and reciprocal inhibition muscle energy technique group', 'autogenic inhibition and reciprocal inhibition muscle energy techniques']","['pain, disability and range of motion', 'numeric pain rating scale score, neck disability index score and goniometry for cervical range of motion']","[{'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0683266', 'cui_str': 'Reciprocal inhibition'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]",,0.0566313,"CONCLUSIONS


Significant difference existed among static stretching, autogenic inhibition and reciprocal inhibition groups in terms of pain, disability and range of motion in patients with mechanical neck pain.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Osama', 'Affiliation': 'Foundation University Institute of Rehabilitation Sciences FUIRS, Islamabad, Pakistan.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Shakil Ur Rehman', 'Affiliation': 'Riphah College Of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.9596']
911,32207217,The effect of adaptation theory-based therapeutic approach on adolescents anger management.,"PROBLEM


Anger is usually defined as psychometric, rather than a theoretical model and generally, anger treatments have been developed for handling incompatible anger. Roy Adaptation Model-based intervention not only focuses on problematic behaviors but also on healthy behaviors and to evaluate the individual with a holistic perspective. The research aim was the examination of the effect of the Roy adaptation theory-based, cognitive-behavioral approach program on adolescent's anger management.
METHODS


In this study, the pretest-posttest control group experimental design, interview, and observation techniques were used. Carried out in a vocational training center, with 60 participants (experimental group 30 and control group 30), who meet the research criteria. The semi-structured interview forms, the state-trait anger expression inventory, multidimensional anger scale, and brief symptom inventory were used for data collection. Results have been evaluated to the 95% confidence interval and p < .05 significance level. In data analysis; descriptive statistics, Pearson's χ 2  test, Mann-Whitney U test, and Wilcoxon Sign tests were used.
FINDINGS


There was a significant difference in anger management levels of the experimental group after the adaptation theory-based therapeutic approach program.
CONCLUSION


Study results showed that the adaptation-base therapeutic approach is effective in adolescent's anger management. This program will contribute to theoretical and practical studies and field experts.",2020,"There was a significant difference in anger management levels of the experimental group after the adaptation theory-based therapeutic approach program.
","[""adolescent's anger management"", 'adolescents anger management']","['Roy adaptation theory-based, cognitive-behavioral approach program', 'adaptation theory-based therapeutic approach', 'Roy Adaptation Model-based intervention']",['anger management levels'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557992', 'cui_str': 'Anger Management Training'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0557992', 'cui_str': 'Anger Management Training'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0187487,"There was a significant difference in anger management levels of the experimental group after the adaptation theory-based therapeutic approach program.
","[{'ForeName': 'Satı', 'Initials': 'S', 'LastName': 'Doğan', 'Affiliation': 'Department of Psychiatric Mental Health Nursing, Faculty of Nursing, Izmir, Turkey.'}, {'ForeName': 'Olcay', 'Initials': 'O', 'LastName': 'Çam', 'Affiliation': 'Department of Psychiatric Mental Health Nursing, Faculty of Nursing, Izmir, Turkey.'}]","Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc",['10.1111/jcap.12268']
912,32401418,Impact of pulsed electromagnetic field therapy on vascular function and blood pressure in hypertensive individuals.,"The present study investigated the impact of 12 weeks of pulsed electromagnetic field (PEMF) therapy on peripheral vascular function, blood pressure (BP), and nitric oxide in hypertensive individuals. Thirty hypertensive individuals (SBP > 130 mm Hg and/or MAP > 100 mm Hg) were assigned to either PEMF group (n = 15) or control group (n = 15). During pre-assessment, participants underwent measures of flow-mediated dilation (FMD), BP, and blood draw for nitric oxide (NO). Subsequently, they received PEMF therapy 3x/day for 12 weeks and, at conclusion, returned to the laboratory for post-assessment. Fifteen participants from the PEMF group and 11 participants from the control group successfully completed the study protocol. After therapy, the PEMF group demonstrated significant improvements in FMD and FMD NOR  (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively). Moreover, SBP, DBP, and MAP were reduced, but the control group did not (P = .04, .04, and .03, respectively). There were no significant alterations in NO in both groups (P > .05). Twelve weeks of PEMF therapy may improve BP and vascular function in hypertensive individuals. Additional studies are needed to identify the mechanisms by which PEMF affects endothelial function.",2020,"After therapy, the PEMF group demonstrated significant improvements in FMD and FMD NOR  (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively).","['Fifteen participants from the PEMF group and 11 participants from the control group successfully completed the study protocol', '100\xa0mm\xa0Hg', 'hypertensive individuals', 'Thirty hypertensive individuals (SBP\xa0>\xa0130\xa0mm']","['PEMF therapy', 'pulsed electromagnetic field (PEMF) therapy', 'pulsed electromagnetic field therapy', 'PEMF']","['flow-mediated dilation (FMD), BP, and blood draw for nitric oxide (NO', 'FMD and FMD NOR', 'SBP, DBP, and MAP', 'BP and vascular function', 'peripheral vascular function, blood pressure (BP), and nitric oxide', 'vascular function and blood pressure']","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",30.0,0.0517984,"After therapy, the PEMF group demonstrated significant improvements in FMD and FMD NOR  (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively).","[{'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Stewart', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Wheatley-Guy', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Johnson', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Win K', 'Initials': 'WK', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Chul-Ho', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13877']
913,31837710,Functional assessments of foot strength: a comparative and repeatability study.,"BACKGROUND


Evaluating the strength of the small muscles of the foot may be useful in a variety of clinical applications but is challenging from a methodology standpoint. Previous efforts have focused primarily on the functional movement of toe flexion, but clear methodology guidelines are lacking. A novel foot doming test has also been proposed, but not fully evaluated. The purposes of the present study were to assess the repeatability and comparability of several functional foot strength assessment techniques.
METHODS


Forty healthy volunteers were evaluated across two testing days, with a two-week doming motion practice period between them. Seven different measurements were taken using a custom toe flexion dynamometer (seated), custom doming dynamometer (standing), and a pressure mat (standing). Measurements from the doming dynamometer were evaluated for reliability (ICCs) and a learning effect (paired t-tests), while measurements from the toe flexion dynamometer and pressure mat were evaluated for reliability and comparability (correlations). Electromyography was also used to descriptively assess the extent of muscle isolation in all measurements.
RESULTS


Doming showed excellent within-session reliability (ICCs > 0.944), but a clear learning effect was present, with strength (p < 0.001) and muscle activity increasing between sessions. Both intrinsic and extrinsic muscles were engaged during this test. All toe flexion tests also showed excellent reliability (ICCs > 0.945). Seated toe flexion tests using the dynamometer were moderately correlated to standing toe flexion tests on a pressure mat (r > 0.54); however, there were some differences in muscle activity. The former may better isolate the toe flexors, while the latter appeared to be more functional for many pathologies. On the pressure mat, reciprocal motion appeared to display slightly greater forces and reliability than isolated toe flexion.
CONCLUSIONS


This study further refines potential methodology for foot strength testing. These devices and protocols can be duplicated in the clinic to evaluate and monitor rehabilitation progress in clinical populations associated with foot muscle weakness.",2019,"RESULTS


Doming showed excellent within-session reliability (ICCs > 0.944), but a clear learning effect was present, with strength (p < 0.001) and muscle activity increasing between sessions.",['Forty healthy volunteers'],"['Electromyography', 'custom toe flexion dynamometer (seated), custom doming dynamometer (standing), and a pressure mat (standing']","['muscle activity', 'standing toe flexion tests', 'reliability (ICCs) and a learning effect', 'Seated toe flexion tests']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}]",40.0,0.0201527,"RESULTS


Doming showed excellent within-session reliability (ICCs > 0.944), but a clear learning effect was present, with strength (p < 0.001) and muscle activity increasing between sessions.","[{'ForeName': 'Dustin A', 'Initials': 'DA', 'LastName': 'Bruening', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA. dabruening@byu.edu.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Ridge', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Jacobs', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Olsen', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Dallin W', 'Initials': 'DW', 'LastName': 'Griffin', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Drew H', 'Initials': 'DH', 'LastName': 'Ferguson', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Kirk E', 'Initials': 'KE', 'LastName': 'Bassett', 'Affiliation': 'Mechanical Engineering Department, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'A Wayne', 'Initials': 'AW', 'LastName': 'Johnson', 'Affiliation': 'Exercise Sciences Department, Brigham Young University, Provo, UT, USA.'}]",BMC musculoskeletal disorders,['10.1186/s12891-019-2981-6']
914,31910674,Promising Results From a Video-Feedback Interaction Guidance Intervention for Improving Maternal-Infant Interaction Quality of Depressed Mothers: A Feasibility Pilot Study.,"BACKGROUND


Mothers and infants affected by postpartum depression are known to have (1) reduced quality interactions and (2) elevated cortisol levels, both of which are linked to negative developmental outcomes in children. Parent training promoting sensitive and responsive maternal-infant interactions may help optimize development in children of mothers with postpartum depression.
OBJECTIVES


This pilot study tested a video-feedback interaction guidance intervention designed to improve maternal-infant interaction, depressive symptoms, and cortisol patterns of depressed mothers and their infants.
METHOD


An experimental, pre-test, post-test design was employed to randomly assign mothers with postpartum depression to intervention ( n  = 6) and control ( n  = 6) conditions. Intervention mothers received three video-feedback sessions during home visits, provided at three-week intervals. Control participants received three home visits on the same schedule.
RESULTS


Significant differences favoring the intervention group were observed in maternal-infant interaction quality, especially maternal sensitivity and cognitive growth fostering activities, and in reduced infant diurnal cortisol.
CONCLUSION


Professionally guided video-feedback intervention appears to support improvements in interactions between depressed mothers and their infants and optimizes infants' diurnal cortisol patterns. The findings from this feasibility pilot study have been used to support a large-scale follow-up exploration.",2020,"RESULTS


Significant differences favoring the intervention group were observed in maternal-infant interaction quality, especially maternal sensitivity and cognitive growth fostering activities, and in reduced infant diurnal cortisol.
","['depressed mothers and their infants', 'children of mothers with postpartum depression', 'Depressed Mothers']","['video-feedback interaction guidance intervention', 'Parent training promoting sensitive and responsive maternal-infant interactions', 'video-feedback sessions', 'Video-Feedback Interaction Guidance Intervention']","['maternal-infant interaction, depressive symptoms, and cortisol patterns', 'maternal-infant interaction quality, especially maternal sensitivity and cognitive growth fostering activities, and in reduced infant diurnal cortisol']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",,0.0234434,"RESULTS


Significant differences favoring the intervention group were observed in maternal-infant interaction quality, especially maternal sensitivity and cognitive growth fostering activities, and in reduced infant diurnal cortisol.
","[{'ForeName': 'Panagiota D', 'Initials': 'PD', 'LastName': 'Tryphonopoulos', 'Affiliation': 'Arthur Labatt Family School of Nursing, Western University, FIMS and Nursing Building, London, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Letourneau', 'Affiliation': 'Faculty of Nursing, Cumming School of Medicine (Pediatrics, Psychiatry & Community Health Sciences), University of Calgary, Calgary, Alberta, Canada.'}]",The Canadian journal of nursing research = Revue canadienne de recherche en sciences infirmieres,['10.1177/0844562119892769']
915,32000509,Effect of the Attachment and Child Health Parent Training Program on Parent-Child Interaction Quality and Child Development.,"BACKGROUND


Exposure to chronic stressors (poverty, addiction, family violence) in early life can derail children's development. Interventions focused on parental reflective function may promote parents' abilities to regulate their feelings and behaviors toward their children and buffer the impact of chronic stressors on children's development by nurturing high-quality parent-child interaction.
PURPOSE


To test the effectiveness of parental reflective function-focused intervention entitled Attachment and Child Health on parent-child interaction and child development.
METHODS


We conducted two pilots with vulnerable mothers and children <36 months. Randomized controlled trial (n = 20) and quasi-experimental (n = 10) methods tested the effect of Attachment and Child Health on parent-child interaction via Parent-Child Interaction Teaching Scale (PCITS) and on child development via Ages and Stages Questionnaire (ASQ-3) and Ages and Stages Questionnaire-Social Emotional (ASQSE). We employed analysis of covariance and t-tests to examine the outcomes.
RESULTS


For randomized controlled trial, we found significant improvements in PCITS parent total, combined total, and cognitive growth fostering scores, and ASQ-3 personal-social scores post-intervention. For quasi-experimental study, we found significant improvements in PCITS combined total, sensitivity to cues, response to child's distress, and responsiveness to caregiver scores.
CONCLUSION


Incorporating Attachment and Child Health contributed to effective programming for vulnerable families with young children.",2020,"For quasi-experimental study, we found significant improvements in PCITS combined total, sensitivity to cues, response to child's distress, and responsiveness to caregiver scores.
","['pilots with vulnerable mothers and children <36\u2009months', 'vulnerable families with young children']","['parental reflective function-focused intervention entitled Attachment and Child Health', 'Attachment and Child Health Parent Training Program']","['Parent-Child Interaction Quality and Child Development', ""PCITS combined total, sensitivity to cues, response to child's distress, and responsiveness to caregiver scores"", 'PCITS parent total, combined total, and cognitive growth fostering scores, and ASQ-3 personal-social scores', 'effect of Attachment and Child Health on parent-child interaction via Parent-Child Interaction Teaching Scale (PCITS) and on child development via Ages and Stages Questionnaire (ASQ-3) and Ages and Stages Questionnaire-Social Emotional (ASQSE']","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557118', 'cui_str': 'Family with young children'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",,0.0304167,"For quasi-experimental study, we found significant improvements in PCITS combined total, sensitivity to cues, response to child's distress, and responsiveness to caregiver scores.
","[{'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Anis', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Letourneau', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Benzies', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ewashen', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Hart', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, Canada.'}]",The Canadian journal of nursing research = Revue canadienne de recherche en sciences infirmieres,['10.1177/0844562119899004']
916,32200512,Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials.,"INTRODUCTION


Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of moderate-to-severe plaque psoriasis. Our objective was to evaluate the long-term efficacy and safety of ixekizumab in moderate-to-severe plaque psoriasis through 5 years.
METHODS


Data were integrated from the UNCOVER-1 and UNCOVER-2, randomized, double-blinded, phase-3 trials. Patients who continuously received the labeled ixekizumab dose, were static Physician's Global Assessment (sPGA) (0,1) responders at Week 12 and completed 60 weeks of treatment could enter the long-term extension (LTE) period. Patients could escalate to every-2-week dosing per investigator opinion. Efficacy and health outcomes included proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI ≤ 5/ ≤ 3/ ≤ 2/ ≤ 1 and Dermatology Life Quality Index (DLQI) (0,1). Results exclude patients who escalated to every-2-week dosing. A modified non-responder imputation method was used to account for missing data. Supplemental analyses include patients who escalated to every-2-week dosing and observed and multiple imputation results. Exposure-adjusted safety outcomes are also reported.
RESULTS


Of 206 patients who entered the LTE periods, 172 completed treatment. At Week 60, PASI 75/90/100 responses were 94.7%, 85.0% and 62.1%, respectively, and at year 5 were 90.3%, 71.3% and 46.3%, respectively. Similarly, meaningful responses were achieved for the other efficacy and health measures. Among patients with PASI 100 through 5 years, 92% achieved DLQI (0,1), indicating no impact of skin disease on quality of life. During the LTE period, exposure-adjusted incidence rates were 31.4 per 100 patient-years for treatment-emergent adverse events and 6.8 per 100 patient-years for serious adverse events. No deaths were reported. No new or unexpected safety findings were noted.
CONCLUSIONS


The results demonstrate 80 mg ixekizumab maintains long-term efficacy and a safety profile consistent with previous data in patients with moderate-to-severe plaque psoriasis through 5 years of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, UNCOVER-1: NCT01474512, UNCOVER-2: NCT01597245.",2020,"No new or unexpected safety findings were noted.
","['206 patients who entered the LTE periods, 172 completed treatment', 'moderate-to-severe plaque psoriasis through 5\xa0years', 'patients with moderate-to-severe plaque psoriasis through 5\xa0years of treatment', 'Through 5 Years in Moderate-to-Severe Psoriasis']","['ixekizumab', 'Ixekizumab', ""labeled ixekizumab dose, were static Physician's Global Assessment (sPGA""]","['exposure-adjusted incidence rates', 'Efficacy and Safety', 'PASI 75/90/100 responses', 'quality of life', 'proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100, sPGA (0,1) and (0), absolute PASI\u2009≤\u20095', 'Dermatology Life Quality Index (DLQI) (0,1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",206.0,0.0947104,"No new or unexpected safety findings were noted.
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, St. Louis, MO, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': 'Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Guenther', 'Affiliation': 'Guenther Dermatology Research Centre, London, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SkiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'ElMaraghy', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Crane', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shrom', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. shrom_david_stanley@lilly.com.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada.'}]",Dermatology and therapy,['10.1007/s13555-020-00367-x']
917,31435774,Gabapentin for the management of chronic pelvic pain in women.,"BACKGROUND


Chronic pelvic pain (CPP) is a frequent presenting symptom in gynaecology outpatient clinics. Neuromodulator pharmacological agents could be an option for treatment based on its efficacy in treating chronic pain in other conditions.
PURPOSE


This study aimed at evaluating the efficacy of oral Gabapentin to alleviate pain in women with CPP.
METHODS


In a randomized double-blinded placebo-controlled trial, 60 women suffering from chronic pelvic pain were randomly divided into two equal arms. The study group received Gabapentin 300 mg three times daily initially (900 mg), with 300 mg weekly incremental dose till pain was controlled, severe side effects occurred or maximum daily dose of 2700 mg was reached. The Primary outcome was the pain score improvement of CPP, defined as a 30% reduction in the pain score assessed by the 10-cm Visual Analogue Scale compared to baseline score.
RESULTS


In Gabapentin group, pain was significantly reduced at 12 and 24 weeks (mean = 5.12 ± 0.67 and 3.72 ± 0.69, respectively) than in placebo group (mean = 5.9 ± 0.92 and 5.5 ± 1.13, respectively); this difference was significant. At 24 weeks, there was significantly higher proportion of patients reporting 30% or more reduction in pain scores; 19 out of 20 patients (95%) in Gabapentin group compared to 8 out of 14 patients (57.1%) in placebo group. The relative risk for pain after gabapentin treatment was 0.5 with 95% confidence interval = 0.34 to 0.75 and number needed to treat = 3 (p = 0.007). Regarding adverse effects there was significantly higher incidence of dizziness with Gabapentin (26.1%) compared to placebo (3.3%).
CONCLUSION


Chronic pelvic pain in women may be treated sufficiently with Gabapentin.
TRIAL REGISTRATION


The trial was registered in ClinicalTrials.gov registry with clinical trial registration number: NCT02918760.",2019,The relative risk for pain after gabapentin treatment was 0.5 with 95% confidence interval = 0.34 to 0.75 and number needed to treat = 3 (p = 0.007).,"['60 women suffering from chronic pelvic pain', 'chronic pelvic pain in women', 'gynaecology outpatient clinics', 'women with CPP']","['placebo', 'Gabapentin']","['Chronic pelvic pain', 'pain', 'relative risk for pain', 'pain score improvement of CPP', 'dizziness', 'pain score assessed by the 10-cm Visual Analogue Scale', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0047123', 'cui_str': 'CPP'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.716219,The relative risk for pain after gabapentin treatment was 0.5 with 95% confidence interval = 0.34 to 0.75 and number needed to treat = 3 (p = 0.007).,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'AbdelHafeez', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reda', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt. reda.ahmed@yandex.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'El-Zeneiny', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Mokhles', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University Hospitals, Maternity Hospital, Ain Shams University, Abbaseya square, Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05272-z']
918,31647902,Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial.,"BACKGROUND & AIMS


There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis.
METHODS


For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 μs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes.
RESULTS


During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life.
CONCLUSIONS


In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.",2020,Vomiting scores increased significantly when the device was on in patients with delayed (P<.01) or normal gastric emptying (P=.05).,"['patients with refractory vomiting, with or without gastroparesis', '172 patients (66% women; mean age 45±12 years; 133 with gastroparesis) with chronic (more than 12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or post-surgical', 'patients with and without diabetes']","['gastric electrical stimulation device', 'GES', 'gastric electrical stimulation (GES', 'Gastric Electrical Stimulation']","['quality of life', 'vomiting score ranging from 0 (daily vomiting) to 4 (no vomiting) and the quality of life, assessed by the GIQLI scoring system', 'Gastric emptying', 'Vomiting scores', 'vomiting scores', 'changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes', 'frequency of refractory vomiting', 'normal gastric emptying']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0152020', 'cui_str': 'Gastric Stasis'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0034380'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0476288', 'cui_str': 'Digestive symptom (finding)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]",149.0,0.26277,Vomiting scores increased significantly when the device was on in patients with delayed (P<.01) or normal gastric emptying (P=.05).,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ducrotte', 'Affiliation': 'Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': 'Paris-HP Louis Mourier Hospital, Colombes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bonaz', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Fontaine', 'Affiliation': 'Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Bruley Des Varannes', 'Affiliation': 'Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Digestive Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Caiazzo', 'Affiliation': 'Lille University Hospital, Lille, France.'}, {'ForeName': 'Jean Charles', 'Initials': 'JC', 'LastName': 'Grimaud', 'Affiliation': 'Marseille University Hospital, Marseille, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Mion', 'Affiliation': 'Lyon Hôpital E. Herriot, Lyon, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Hadjadj', 'Affiliation': 'Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Paul Elie', 'Initials': 'PE', 'LastName': 'Valensi', 'Affiliation': 'Paris-HP Jean Verdier Hospital, Bondy, France.'}, {'ForeName': 'Lucine', 'Initials': 'L', 'LastName': 'Vuitton', 'Affiliation': 'Besancon University Hospital, Besancon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'Corbeil-Essonnes Central Hospital, Corbeil-Essonnes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ropert', 'Affiliation': 'Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Altwegg', 'Affiliation': 'Montpellier University Hospital-Lapeyronie, Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pouderoux', 'Affiliation': 'Nimes University Hospital, Nimes, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Dorval', 'Affiliation': 'Tours University Hospital, Tours, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dapoigny', 'Affiliation': 'Clermont-Ferrand University Hospital, Clermont Ferrand, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Duboc', 'Affiliation': 'Paris-HP Louis Mourier Hospital, Colombes, France.'}, {'ForeName': 'Pierre Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Steve Consultants, Oullins, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Donnadieu', 'Affiliation': 'Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gourcerol', 'Affiliation': 'Rouen University Hospital-Inserm UMR 1073/Inserm CIC-CRB 1404, Rouen, France. Electronic address: guillaume.gourcerol@chu-rouen.fr.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'Nancy University Hospital, Nancy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2019.10.018']
919,32123524,Benefits of Adhering to the Canadian Physical Activity Guidelines for Adults with Multiple Sclerosis Beyond Aerobic Fitness and Strength.,"Background


The Canadian Physical Activity Guidelines for Adults with Multiple Sclerosis (PAGs) were released in 2013 but have yet to be validated. We aimed to test the effectiveness of the PAGs in improving fitness, mobility, fatigue symptoms, and quality of life (QOL) in a large cohort of adults with multiple sclerosis (MS).
Methods


As part of an ongoing randomized controlled trial examining implementation of the PAGs, participants were randomized to either a direct referral group (physician referral to an exercise program following the PAGs; n = 42) or a control group (provided a print copy of the PAGs; n = 37). Physical activity behavior was assessed through weekly physical activity logs. Fitness, mobility, fatigue symptoms, and QOL were assessed at baseline and after 16 weeks. Participants were categorized as either PAG adherers (n = 30) or nonadherers (n = 49) to the PAGs based on achieving the weekly exercise recommendations at least 75% of the time.
Results


Adherence to the PAGs was twice as high in the referral group compared with the control group. Adherers experienced significantly greater improvements in peak oxygen consumption (29%), strength (7%-18%), mobility (16%), fatigue symptoms (-36%), and QOL (17%-22%) compared with nonadherers ( P  < .05).
Conclusions


Following the PAGs for at least 12 of 16 weeks results in improvements in fitness, mobility, fatigue symptoms, and QOL, confirming their effectiveness for improving health in people with MS.",2020,"Adherers experienced significantly greater improvements in peak oxygen consumption (29%), strength (7%-18%), mobility (16%), fatigue symptoms (-36%), and QOL (17%-22%) compared with nonadherers ( P  < .05).
","['Adults with Multiple Sclerosis Beyond Aerobic Fitness and Strength', 'adults with multiple sclerosis (MS', 'Adults with Multiple Sclerosis (PAGs', 'Participants were categorized as either PAG adherers (n = 30) or nonadherers (n = 49) to the PAGs based on achieving the weekly exercise recommendations at least 75% of the time']","['direct referral group (physician referral to an exercise program following the PAGs; n = 42) or a control group (provided a print copy of the PAGs', 'Canadian Physical Activity Guidelines']","['fitness, mobility, fatigue symptoms, and quality of life (QOL', 'strength', 'peak oxygen consumption', 'Physical activity behavior', 'fatigue symptoms', 'Fitness, mobility, fatigue symptoms, and QOL', 'fitness, mobility, fatigue symptoms, and QOL', 'mobility', 'QOL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C3251841', 'cui_str': 'poly(((mu3-(5,6-eta)-kappaO(2)-kappaO(2)-(1S,2S,3R,4R)-3-carboxy-7-oxabicyclo(2.2.1)hept-5-ene-2-carboxylato)silver(I)) monohydrate)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3251841', 'cui_str': 'poly(((mu3-(5,6-eta)-kappaO(2)-kappaO(2)-(1S,2S,3R,4R)-3-carboxy-7-oxabicyclo(2.2.1)hept-5-ene-2-carboxylato)silver(I)) monohydrate)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0499105,"Adherers experienced significantly greater improvements in peak oxygen consumption (29%), strength (7%-18%), mobility (16%), fatigue symptoms (-36%), and QOL (17%-22%) compared with nonadherers ( P  < .05).
","[{'ForeName': 'Karissa L', 'Initials': 'KL', 'LastName': 'Canning', 'Affiliation': ''}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': ''}]",International journal of MS care,['10.7224/1537-2073.2018-061']
920,32186926,The Effect of Tidal Model-Based Psychiatric Nursing Approach on the Resilience of Women Survivors of Violence.,"This study examined the effect of a psychiatric nursing approach based on the Tidal Model. The outcome variable was resilience in women survivors of violence. The experimental and descriptive study was conducted with a control group and a pretest post-test procedure. The research was carried out with 13 women in the intervention and 14 women in the control group. Resilience Scale for Adults Turkish Version (RSA) was used. Seven one to one sessions were performed with the intervention group. Inter-group comparison of pre- and post-test variation showed significant variations in favor of the intervention group in perception of the future and RSA scale total scores. Consequently the resilience of the intervention group increased, and they had a more positive, target-focused view of the future.",2020,"Consequently the resilience of the intervention group increased, and they had a more positive, target-focused view of the future.","['13 women in the intervention and 14 women in the control group', 'Adults', 'Women Survivors of Violence']","['psychiatric nursing approach', 'Tidal Model-Based Psychiatric Nursing Approach']","['perception of the future and RSA scale total scores', 'women survivors of violence', 'Resilience Scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]","[{'cui': 'C0033870', 'cui_str': 'Mental Health Nursing'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]",,0.0213507,"Consequently the resilience of the intervention group increased, and they had a more positive, target-focused view of the future.","[{'ForeName': 'Emel Öztürk', 'Initials': 'EÖ', 'LastName': 'Turgut', 'Affiliation': 'Mental Health and Psychiatric Nursing Department, Ege University Faculty of Nursing, İzmir, Turkey.'}, {'ForeName': 'Mahire Olcay', 'Initials': 'MO', 'LastName': 'Çam', 'Affiliation': 'Mental Health and Psychiatric Nursing Department, Ege University Faculty of Nursing, İzmir, Turkey.'}]",Issues in mental health nursing,['10.1080/01612840.2019.1672222']
921,32400732,The effects of traditional massage on spasticity of children with cerebral palsy: a randomized controlled trial.,"OBJECTIVE


To examine the effects of traditional massage on spasticity of children with cerebral palsy.
METHODS


The randomised control trial was conducted at the National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from September 2016 to August 2018, and comprised children with spastic cerebral palsy aged 2-10 years who were randomly allocated to control and intervention groups. Both the groups received routine physical therapy once daily, five times a week for three months. The intervention group additionally received traditional massage. Spasticity was evaluated using the Modified Ashworth Scale at baseline, and after 6th and 12th weeks of intervention. Data analysed using SPSS 20..
RESULTS


Of the 86 subjects enrolled, 75(87.2%) completed the study; 37(49.3%) in the control group with a mean age of 6.81±2.31 years, and 38(50.6%) in the intervention group with a mean age of 7.05±2.47 years. There were 25(68%) boys among the controls and 22(58%) in the intervention group. There was no statistically significant difference in baseline scores between the groups (p>0.05). At 6th week, reduction in scores was statistically significant in the right upper limb (p<0.05), and in the right lower limb (p<0.05) after the 12th week.
CONCLUSIONS


Traditional massage was found to have significant effect on the right side compared to the routine physical therapy for reduction of spasticity in children with cerebral palsy.",2020,"At 6th week, reduction in scores was statistically significant in the right upper limb (p<0.05), and in the right lower limb (p<0.05) after the 12th week.
","['Of the 86 subjects enrolled, 75(87.2%) completed the study; 37(49.3%) in the control group with a mean age of 6.81±2.31 years, and 38(50.6%) in the intervention group with a mean age of 7.05±2.47 years', 'children with cerebral palsy', 'National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from September 2016 to August 2018, and comprised children with spastic cerebral palsy aged 2-10 years']","['traditional massage', 'routine physical therapy']","['Spasticity', 'baseline scores']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",86.0,0.017663,"At 6th week, reduction in scores was statistically significant in the right upper limb (p<0.05), and in the right lower limb (p<0.05) after the 12th week.
","[{'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Mahmood', 'Affiliation': 'National Institute of Rehabilitation Medicine (NIRM), Islamabad, Pakistan.'}, {'ForeName': 'Shaista', 'Initials': 'S', 'LastName': 'Habibullah', 'Affiliation': 'National Institute of Rehabilitation Medicine (NIRM), Islamabad, Pakistan.'}, {'ForeName': 'Muhammad Naveed', 'Initials': 'MN', 'LastName': 'Babur', 'Affiliation': 'Isra Institute of Rehabilitation Sciences, Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.24442']
922,32401106,Effect of elastic abdominal binder on pain and functional recovery after caesarean delivery: a randomised controlled trial.,"The Elastic abdominal binder has been widely employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilisation. However, these proposed benefits have not been properly examined in women following caesarean delivery. We aimed to examine the effects of post-caesarean elastic abdominal binder use on recovery by comparing post-operative pain, mobility and quality of life. Pregnant women undergoing caesarean delivery were randomly assigned into two groups: abdominal binder (90 patients) and control (90 patients). The primary outcomes included the daily visual analogue scale pain scores and the distance from the six-minute walk test. Baseline characteristics were similar between the groups. There was no significant difference in pain scores and six-minute walking distance between the study groups. There was no significant between-group difference in quality-of-life dimensions, overall health status, and post-operative complication. The positive effects of elastic abdominal binder use following caesarean delivery could not be demonstrated in this study.Impact statement What is already known on this subject?  Elastic abdominal binder is commonly used after laparotomy to support incision. There was evidence to support the benefit of abdominal binder in reducing psychological distress during the first five days following laparotomy for other indications. From limited number of studies addressing caesarean section, the evidence for the benefits of the binder on pain, symptom distress, and change in haemoglobin level is conflicting. What do the results of this study add?  In contrast to the results of the previous study, the beneficial effects of abdominal binder on pain reduction, functional recovery, and quality of life following caesarean delivery could not be demonstrated in this study. What are the implications of these findings for clinical practice and/or further research?  The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population. Further studies in other population with different characteristics may be worthwhile.",2020,"The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population.","['Pregnant women undergoing caesarean delivery', 'after caesarean delivery']","['elastic abdominal binder', 'abdominal binder']","['pain reduction, functional recovery, and quality of life', 'quality of life', 'operative pain, mobility and quality of life', 'quality-of-life dimensions, overall health status, and post-operative complication', 'daily visual analogue scale pain scores and the distance from the six-minute walk test', 'pain and functional recovery', 'psychological distress', 'pain scores and six-minute walking distance']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0179303', 'cui_str': 'Abdominal binder'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.188427,"The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population.","[{'ForeName': 'Wisit', 'Initials': 'W', 'LastName': 'Chankhunaphas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kittipat', 'Initials': 'K', 'LastName': 'Charoenkwan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1631768']
923,32401118,Benefits of a Self-Management Program for the Couple Living With Parkinson's Disease: A Pilot Study.,"The goal of this pilot study was to explore health benefits for couples participating together in an existing community-based self-management workshop for Parkinson's disease (PD). A quasi-experimental two-wave design explored the effects of the  Strive to Thrive  program in comparison to a wait-list control condition. Preliminary data ( n  = 39 couples) showed that spouses in the intervention group had greater engagement in mental relaxation techniques at 7 weeks than those in the control condition (large effect size). Small effects were observed for increases in aerobic activity and mental relaxation for the adult with PD, increases in strength-based activities and self-efficacy for spouses, declines in depressive symptoms for spouses, and decreases in protective buffering for both adults with PD and spouses. The program showed potential for existing community-based programs to benefit couples living with chronic illness.",2020,Preliminary data ( n  = 39 couples) showed that spouses in the intervention group had greater engagement in mental relaxation techniques at 7 weeks than those in the control condition (large effect size).,"[""couples participating together in an existing community-based self-management workshop for Parkinson's disease (PD"", ""Couple Living With Parkinson's Disease""]",['Self-Management Program'],"['aerobic activity and mental relaxation', 'health benefits', 'greater engagement in mental relaxation techniques', 'strength-based activities and self-efficacy']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",39.0,0.0249277,Preliminary data ( n  = 39 couples) showed that spouses in the intervention group had greater engagement in mental relaxation techniques at 7 weeks than those in the control condition (large effect size).,"[{'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Lyons', 'Affiliation': 'Boston College, Chestnut Hill, MA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Zajack', 'Affiliation': 'University of Nevada, Las Vegas, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Greer', 'Affiliation': ""Parkinson's Resources of Oregon, Beaverton, USA.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Chaimov', 'Affiliation': ""Parkinson's Resources of Oregon, Beaverton, USA.""}, {'ForeName': 'Nathan F', 'Initials': 'NF', 'LastName': 'Dieckmann', 'Affiliation': 'Oregon Health & Science University, Portland, USA.'}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Carter', 'Affiliation': 'Oregon Health & Science University, Portland, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820918136']
924,32401144,"Rich environments, dull experiences: how environment can exacerbate the effect of constraint on the experience of boredom.","We examined the hypothesis that boredom is likely to occur when opportunity costs are high; that is, when there is a high potential value of engaging in activities other than the researcher-assigned activity. To this end, participants were either placed in a room with many possible affordances (e.g. a laptop, puzzle, etc.;  affordances condition; n = 121 ), or they were ushered into an empty room ( control condition; n = 107 ). In both conditions participants were instructed to entertain themselves with only their thoughts (hence, participants in the affordances condition were to refrain from engaging with the available options). As predicted, participants in the affordances condition reported higher levels of boredom compared with those in the control condition. Results suggest that under some conditions, environments that afford alternative activities may be  more  boring than those that are void of such activities.",2020,"As predicted, participants in the affordances condition reported higher levels of boredom compared with those in the control condition.",[],[],['levels of boredom'],[],[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}]",,0.021607,"As predicted, participants in the affordances condition reported higher levels of boredom compared with those in the control condition.","[{'ForeName': 'Andriy A', 'Initials': 'AA', 'LastName': 'Struk', 'Affiliation': 'Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Abigail A', 'Initials': 'AA', 'LastName': 'Scholer', 'Affiliation': 'Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Danckert', 'Affiliation': 'Department of Psychology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Seli', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}]",Cognition & emotion,['10.1080/02699931.2020.1763919']
925,32401221,A Mobile Health App for the Collection of Functional Outcomes After Inpatient Stroke Rehabilitation: Pilot Randomized Controlled Trial.,"BACKGROUND


Monitoring the functional status of poststroke patients after they transition home is significant for rehabilitation. Mobile health (mHealth) technologies may provide an opportunity to reach and follow patients post discharge. However, the feasibility and validity of functional assessments administered by mHealth technologies are unknown.
OBJECTIVE


This study aimed to evaluate the feasibility, validity, and reliability of functional assessments administered through the videoconference function of a mobile phone-based app compared with administration through the telephone function in poststroke patients after rehabilitation hospitalization.
METHODS


A randomized controlled trial was conducted in a rehabilitation hospital in Southeast China. Participants were randomly assigned to either a videoconference follow-up (n=60) or a telephone follow-up (n=60) group. We measured the functional status of participants in each group at 2-week and 3-month follow-up periods. Half the participants in each group were followed by face-to-face home visit assessments as the gold standard. Validity was assessed by comparing any score differences between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Reliability was assessed by computing agreements between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Feasibility was evaluated by the levels of completion, satisfaction, comfort, and confidence in the 2 groups.
RESULTS


Scores obtained from the videoconference follow-up were similar to those of the home visit assessment. However, most scores collected from telephone administration were higher than those of the home visit assessment. The agreement between videoconference follow-up and home visit assessments was higher than that between telephone follow-up and home visit assessments at all follow-up periods. In the telephone follow-up group, completion rates were 95% and 82% at 2-week and 3-month follow-up points, respectively. In the videoconference follow-up group, completion rates were 95% and 80% at 2-week and 3-month follow-up points, respectively. There were no differences in the completion rates between the 2 groups at all follow-up periods (X 2 1 =1.6, P=.21 for 2-week follow-up; X 2 1 =1.9, P=.17 for 3-month follow-up). Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up). The videoconference follow-up group demonstrated higher satisfaction than the telephone follow-up group at 3-month follow-up (X 2 3 =13.9; P=.03).
CONCLUSIONS


The videoconference follow-up assessment of functional status demonstrates higher validity and reliability, as well as higher confidence and satisfaction perceived by patients, than the telephone assessment. The videoconference assessment provides an efficient means of assessing functional outcomes of patients after hospital discharge. This method provides a novel solution for clinical trials requiring longitudinal assessments.
TRIAL REGISTRATION


chictr.org.cn: ChiCTR1900027626; http://www.chictr.org.cn/edit.aspx?pid=44831&htm=4.",2020,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","['patients after hospital discharge', 'rehabilitation hospital in Southeast China', 'poststroke patients after rehabilitation hospitalization']","['videoconference follow-up (n=60) or a telephone follow-up', 'mobile phone-based app compared with administration through the telephone function']","['Reliability', 'completion rates', 'higher satisfaction', 'levels of completion, satisfaction, comfort, and confidence', 'higher confidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0461705,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Shanjia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Guanli', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Chetwyn C H', 'Initials': 'CCH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, HongKong, Hong Kong.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Alex W K', 'Initials': 'AWK', 'LastName': 'Wong', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, United States.'}]",JMIR mHealth and uHealth,['10.2196/17219']
926,32401225,Social Media Interventions for Risky Drinking Among Adolescents and Emerging Adults: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use.
OBJECTIVE


This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences.
METHODS


This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups.
RESULTS


We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT.
CONCLUSIONS


The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16688.",2020,Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions.,"['955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey', 'Risky Drinking Among Adolescents and Emerging Adults', '955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT', 'Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males', 'adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C']","['Social Media Interventions', ""bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing"", 'social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control', 'social media intervention']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],955.0,0.0843012,Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions.,"[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Schneeberger', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Bourque', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'Department of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Irvine, CA, United States.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amy Sb', 'Initials': 'AS', 'LastName': 'Bohnert', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Zimmerman', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/16688']
927,32199011,The association of systemic inflammatory markers with indicators of stress and cardiac necrosis in patients undergoing aortic valve replacement and revascularization surgeries.,"The aim was to investigate: changes of inflammatory, stress and cardiac response in patients undergoing open heart surgeries up to five days after the procedure; the association between inflammatory, stress and cardiac response and whether changes in a certain marker can predict short-term patient outcome. Ninety patients were divided into three groups, 30 participants each (on-pump,off-pump revascularization and valve replacement group). The following markers were measured:complete blood count, CRP, IL-6, IL-10, leptin, resistin, monocyte chemoattractant protein-1 (MCP-1), cortisol, CK and hsTnT in 5 points. Resistin increased in all three groups. Lower IL-10 levels were found after the surgery and higher levels of leptin and MCP-1 in the off-pump than in the on-pump group. Off-pump group had higher values of IL-6, IL-10, leptin, resistin and MCP-1 and lower levels of CK and hsTnT 24 after surgery than the on-pump group. We found significant correlation between MCP-1 and resistin. The difference between resistin at time points 2 and 3 significantly predicted transfusion needs; while the difference between CRP and resistin before and at the end of the surgery together with the difference between leukocytes at the end and 24 hours after the surgery predicted the use of inotropic agents/vasopressors. Cardiac surgeries cause an increase of inflammatory, stress and cardiac markers. Only resistin correlated with MCP-1 which confirms the link between resistin secreted form infiltrated macrophages and enhanced release of MCP-1.",2020,"Off-pump group had higher values of IL-6, IL-10, leptin, resistin and MCP-1 and lower levels of CK and hsTnT 24 after surgery than the on-pump group.","['patients undergoing aortic valve replacement and revascularization surgeries', 'Ninety patients were divided into three groups, 30 participants each (on-pump,off-pump revascularization and valve replacement group', 'patients undergoing open heart surgeries']",[],"['Resistin', 'leptin and MCP-1', 'IL-6, IL-10, leptin, resistin and MCP-1 and lower levels of CK', 'inflammatory, stress and cardiac response', 'complete blood count, CRP, IL-6, IL-10, leptin, resistin, monocyte chemoattractant protein-1 (MCP-1), cortisol, CK and hsTnT in 5 points', 'Lower IL-10 levels', 'inflammatory, stress and cardiac markers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}]",[],"[{'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}]",90.0,0.0413009,"Off-pump group had higher values of IL-6, IL-10, leptin, resistin and MCP-1 and lower levels of CK and hsTnT 24 after surgery than the on-pump group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saracevic', 'Affiliation': 'Department of Medical Laboratory Diagnostics, University Hospital ""Sveti Duh"", Zagreb, Croatia. andrea.saracevic@gmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Medved', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hrabric Vlah', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kozmar', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bilic-Zulle', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Simundic', 'Affiliation': ''}]",Physiological research,[]
928,32185745,Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial.,"INTRODUCTION


The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).
METHODS


All subjects received open-label RCI (80 U) twice weekly for 12 weeks (part 1); only those with low disease activity [LDA; i.e., Disease Activity Score 28 joint count and erythrocyte sedimentation rate (DAS28-ESR) < 3.2] were randomly assigned to receive either RCI (80 U) or placebo twice weekly during the 12-week double-blind period (part 2). The primary efficacy endpoint was the proportion of subjects who achieved LDA at week 12. Secondary efficacy endpoints included proportions of subjects who maintained LDA during weeks 12 through 24 and achieved Clinical Disease Activity Index (CDAI) ≤ 10 at weeks 12 and 24. Safety was assessed via adverse event reports.
RESULTS


Of the 259 enrolled subjects, 235 completed part 1; 154 subjects (n = 77 each for RCI and placebo) entered part 2, and 127 (RCI, n = 71; placebo, n = 56) completed. At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI ≤ 10 (both p < 0.0001). At week 24, 47 (61.0%) RCI-treated and 32 (42.1%) placebo-treated subjects maintained LDA (p = 0.019); 66 (85.7%) RCI-treated and 50 (65.8%) placebo-treated subjects maintained CDAI ≤ 10 (p = 0.004). No unexpected safety signals were observed.
CONCLUSIONS


RCI was effective and generally safe in patients with active RA despite corticosteroid/DMARD therapy. By week 12, > 60% of patients achieved LDA, which was maintained with 12 additional weeks of treatment. Most patients who achieved LDA maintained it for 3 months after RCI discontinuation.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02919761.",2020,"No unexpected safety signals were observed.
","['subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs', 'Active Rheumatoid Arthritis', 'patients with active RA despite corticosteroid/DMARD therapy', '259 enrolled subjects, 235 completed part 1; 154 subjects (n\u2009=\u200977 each for RCI and']","['repository corticotropin injection (RCI', 'placebo', 'open-label RCI', 'Repository Corticotropin Injection', 'RCI']","['proportion of subjects who achieved LDA', 'Clinical Disease Activity Index (CDAI', 'efficacy and safety', 'proportions of subjects who maintained LDA', 'LDA']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",259.0,0.441859,"No unexpected safety signals were observed.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, 8144 Walnut Hill Lane, Suite 810, Dallas, TX, 75231, USA. rfleischmann@arthdocs.com.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Division of Rheumatology, David Geffen School of Medicine, University of California Los Angeles, Peter Morton Medical Building, 200, UCLA Medical Plaza, Suite 365-B, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Connolly-Strong', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, 1425 US-206, Bedminster, NJ, 07921, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Brasington', 'Affiliation': 'Division of Rheumatology, Washington University School of Medicine, 4921 Parkview Place, Suite C, 5th Floor, St. Louis, MO, 63110, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00199-3']
929,32202203,Do Patients With Parkinson's Disease With Freezing of Gait Respond Differently Than Those Without to Treadmill Training Augmented by Virtual Reality?,"Background . People with Parkinson's disease and freezing of gait (FOG+) have more falls, postural instability and cognitive impairment compared with FOG-.  Objective . To conduct a secondary analysis of the V-TIME study, a randomized, controlled investigation showing a greater reduction of falls after virtual reality treadmill training (TT + VR) compared with usual treadmill walking (TT) in a mixed population of fallers. We addressed whether these treadmill interventions led to similar gains in FOG+ as in FOG-.  Methods . A total of 77 FOG+ and 44 FOG- were assigned randomly to TT + VR or TT. Participants were assessed pre- and posttraining and at 6 months' follow-up. Main outcome was postural stability assessed by the Mini Balance Evaluation System Test (Mini-BEST) test. Falls were documented using diaries. Other outcomes included the New Freezing of Gait Questionnaire (NFOG-Q) and the Trail Making Test (TMT-B).  Results . Mini-BEST scores and the TMT-B improved in both groups after training ( P  = .001), irrespective of study arm and FOG subgroup. However, gains were not retained at 6 months. Both FOG+ and FOG- had a greater reduction of falls after TT + VR compared with TT ( P  = .008). NFOG-Q scores did not change after both training modes in the FOG+ group.  Conclusions . Treadmill walking (with or without VR) improved postural instability in both FOG+ and FOG-, while controlling for disease severity differences. As found previously, TT + VR reduced falls more than TT alone, even among those with FOG. Interestingly, FOG itself was not helped by training, suggesting that although postural instability, falls and FOG are related, they may be controlled by different mechanisms.",2020,"Mini-BEST scores and the TMT-B improved in both groups after training ( P  = .001), irrespective of study arm and FOG subgroup.","['A total of 77 FOG+ and 44 FOG', ""Patients With Parkinson's Disease With Freezing of Gait Respond"", 'mixed population of fallers', ""People with Parkinson's disease and freezing of gait (FOG""]","['virtual reality treadmill training (TT + VR', 'TT + VR', 'usual treadmill walking (TT', 'Treadmill walking (with or without VR', 'TT + VR or TT']","['postural instability', 'NFOG-Q scores', 'postural stability assessed by the Mini Balance Evaluation System Test (Mini-BEST) test', 'reduction of falls after TT + VR', 'Mini-BEST scores and the TMT-B', 'New Freezing of Gait Questionnaire (NFOG-Q) and the Trail Making Test (TMT-B']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}]",77.0,0.088833,"Mini-BEST scores and the TMT-B improved in both groups after training ( P  = .001), irrespective of study arm and FOG subgroup.","[{'ForeName': 'Esther M J', 'Initials': 'EMJ', 'LastName': 'Bekkers', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Alcock', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Nieuwhof', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pelosin', 'Affiliation': 'University of Genoa, Genoa, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Avanzino', 'Affiliation': 'University of Genoa, Genoa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cereatti', 'Affiliation': 'University of Sassari, Sassari, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Della Croce', 'Affiliation': 'University of Sassari, Sassari, Italy.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320912756']
930,32186050,Influence of the quickness and duration of De Qi on the analgesic effect of acupuncture in primary dysmenorrhea patients with a cold and dampness stagnation pattern.,"OBJECTIVE


To investigate the influence of the quickness and duration of De Qi (or Qi arrival) on the analgesic effect of acupuncture in primary dysmenorrhea patients with a cold and dampness stagnation pattern.
METHODS


Sixty-eight patients were randomly assigned to the De Qi group (deep needling with thick needles and manipulation, n = 17) or the non-De Qi group (shallow needling with thin needles and no manipulation, n = 51). Both groups underwent needling at Sanyinjiao (SP 6) for 30 min. The visual analogue scale was used to measure the degree of menstrual pain, and the Acupuncture De Qi Clinical Assessment Scale was used to assess De Qi. Only data from patients who experienced actual De Qi were included in the analysis.
RESULTS


Thirty-nine patients experienced actual De Qi. Patients who experienced actual De Qi in the De Qi group (n = 14) felt De Qi more rapidly (P = 0.028) and for a longer duration (P = 0.04) than patients who experienced actual De Qi in the non-De Qi group (n = 25). Both groups showed a reduction in the visual analogue scale score for pain after treatment. The analgesic effect did not significantly differ between the two groups. The occurrence time of De Qi showed a significant negative correlation with pain reduction at 20 and 30 min after needle removal (P < 0.05). There was no correlation between the duration of De Qi and the therapeutic effect.
CONCLUSION


In primary dysmenorrhea patients with a cold and dampness stagnation pattern, quicker onset of De Qi when needling Sanyinjiao (SP 6) achieves a better analgesic outcome. However, a longer duration of De Qi does not affect the degree of analgesia. Compared with minimal acupuncture, active acupuncture stimulation achieves a more rapid onset and longer duration of De Qi.",2019,The analgesic effect did not significantly differ between the two groups.,"['Sixty-eight patients', 'primary dysmenorrhea patients with a cold and dampness stagnation pattern']","['acupuncture', 'De Qi (or Qi arrival', 'minimal acupuncture, active acupuncture stimulation', 'De Qi group (deep needling with thick needles and manipulation, n = 17) or the non-De Qi group (shallow needling with thin needles and no manipulation']","['analgesic effect', 'quicker onset of De Qi', 'visual analogue scale', 'duration of De Qi and the therapeutic effect', 'rapid onset and longer duration of De Qi', 'visual analogue scale score for pain', 'actual De Qi', 'pain reduction', 'occurrence time of De Qi', 'degree of menstrual pain, and the Acupuncture De Qi Clinical Assessment Scale']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1527144'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",68.0,0.0325102,The analgesic effect did not significantly differ between the two groups.,"[{'ForeName': 'Nijuan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Liangxiao', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Guiwen', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Minyi', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Shangqing', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'School of Acupuncture Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Liangxiao', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'the Key Unit of State Administration of Traditional Chines Medicine, Evaluation of Characteristic Acupuncture Therapy, Beijing 100029, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
931,32186047,Effect of herb-partitioned moxibustion for primary dysmenorrhea: a randomized clinical trial.,"OBJECTIVE


To observe the effect of herb-partitioned moxibustion (HPM) for primary dysmenorrhea.
METHODS


Six hundred and forty patients were randomized assigned (1∶1) to HPM group and control group. Duration of treatment was 3 months with 3 month follow-up. The primary outcome was pain relief measured by visual analogue scale (VAS). The second outcomes were Cox Menstrual Symptom Scale (CMSS), menstrual pain duration and frequency of analgesics usage. The exploratory outcome included quality of life, RESULTS: After the 3-month treatment and follow-ups, the pain intensity measured by VAS was significantly reduced in both groups compared with baseline (P < 0.05), and it was significantly decreased in HPM group than that of control group (P < 0.001). The higher proportion of participants in the HPM group had a decrease of at least 50% in VAS at the end of treatment, as compared with the control group (P < 0.001). At the 3rd and 6th month, the menstrual pain duration, CMSS score and frequency of analgesics usage in HPM group were significantly lower than those of control group (P < 0.05). After 3 month treatment and follow-ups,the scores of physical, psychological, social and environmental domains were significantly increased than baseline in both groups (P < 0.05), and the sores of physical, psychological and environmental domains were significantly higher in HPM group than those of control group (P < 0.05) .
CONCLUSION


Herb-partitioned moxibustion reduced menstrual pain and improved quality of life, these were sustained for up to 3 months after treatment. Further research is needed to understand long term effect and the mechanism of the intervention.",2019,"After 3 month treatment and follow-ups,the scores of physical, psychological, social and environmental domains were significantly increased than baseline in both groups (P < 0.05), and the sores of physical, psychological and environmental domains were significantly higher in HPM group than those of control group (P < 0.05) .
","['Six hundred and forty patients', 'primary dysmenorrhea']","['Herb-partitioned moxibustion', 'herb-partitioned moxibustion (HPM', 'HPM group and control group', 'herb-partitioned moxibustion', 'HPM']","['sores of physical, psychological and environmental domains', 'scores of physical, psychological, social and environmental domains', 'quality of life', 'menstrual pain duration, CMSS score and frequency of analgesics usage', 'menstrual pain and improved quality of life', 'pain intensity measured by VAS', 'pain relief measured by visual analogue scale (VAS', 'Cox Menstrual Symptom Scale (CMSS), menstrual pain duration and frequency of analgesics usage', 'VAS']","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}]","[{'cui': 'C0019240', 'cui_str': 'Herb (substance)'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1455785', 'cui_str': 'Sore sensation quality'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}]",640.0,0.04434,"After 3 month treatment and follow-ups,the scores of physical, psychological, social and environmental domains were significantly increased than baseline in both groups (P < 0.05), and the sores of physical, psychological and environmental domains were significantly higher in HPM group than those of control group (P < 0.05) .
","[{'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecology, Second Affiliated Hospital, Liaoning University of Traditional Chinese Medicine, Shenyang 110034, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
932,30852132,"Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.","BACKGROUND


The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect.
METHODS


DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m 2 , and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825-853 kcal per day formula diet for 12-20 weeks), stepped food reintroduction (2-8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA 1c  less than 6·5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing.
FINDINGS


The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio [aOR] 7·49, 95% CI 2·05 to 27·32; p=0·0023) and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes (aOR 25·82, 8·25 to 80·84; p<0·0001). The adjusted mean difference between the control and intervention groups in change in bodyweight was -5·4 kg (95% CI -6·9 to -4·0; p<0·0001) and in HbA 1c  was -4·8 mmol/mol (-8·3 to -1·4 [-0·44% (-0·76 to -0·13)]; p=0·0063), despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
INTERPRETATION


The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss.
FUNDING


Diabetes UK.",2019,"Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
","['remission of type 2 diabetes', 'participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss', ""individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m 2 , and not receiving insulin between July 25, 2014, and Aug 5, 2016""]","['primary care-led weight-management intervention', 'computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size', 'withdrawal of antidiabetes and antihypertensive drugs, total diet replacement']","['intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes', 'weight loss', 'Sustained remission', 'remission of diabetes', 'Serious adverse events']","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.122103,"Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22).
","[{'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wilma S', 'Initials': 'WS', 'LastName': 'Leslie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Barnes', 'Affiliation': 'Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Brosnahan', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thom', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCombie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sviatlana', 'Initials': 'S', 'LastName': 'Zhyzhneuskaya', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Mrabeh', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Rodrigues', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Rehackova', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Adamson', 'Affiliation': 'Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Falko F', 'Initials': 'FF', 'LastName': 'Sniehotta', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Ross', 'Affiliation': 'Counterweight Ltd, London, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'McIlvenna', 'Affiliation': 'College of Medical, Veterinary & Life Sciences, and General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular and Medical Science, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kean', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Claudia-Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Science, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK. Electronic address: roy.taylor@newcastle.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30068-3']
933,32176565,Omega 3 Supplementation Can Regulate Inflammatory States in Gas Station Workers: A Double-Blind Placebo-Controlled Clinical Trial.,"Environmental exposure to diesel particulate matter and commercial gasoline in gas station workers might induce oxidative stress and changes in the balance of the immune system. In this study, the immunomodulatory impacts of omega 3 fatty acid (ω3FA) supplement were assessed on inflammatory and anti-inflammatory markers in gas station workers in a double-blind placebo-controlled clinical trial. Fifty-three men working in gas stations were treated with ω3FA ( n  = 29) or placebo ( n  = 24) for 60 days. C-reactive protein, interleukin-12 (IL-12), transforming growth factor β (TGF-β), interferon γ (IFN-γ), tumor necrosis factor α, IL-10, and IL-17 levels were measured by enzyme-linked immunosorbent assay method before and after the completion of the trial. The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001). Moreover, the levels of inhibitory cytokines including TGF-β and IL-10 significantly were increased in ω3FA group ( P  < 0.001). Overall, ω3FA nutritional supplementation can be useful in reducing inflammatory immune responses and maintaining immune tolerance in people with high exposure to inflammation-inducing factors. [Figure: see text].",2020,The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001).,"['Fifty-three men working in gas stations', 'Gas Station Workers', 'people with high exposure to inflammation-inducing factors']","['omega 3 fatty acid (ω3FA) supplement', 'placebo', 'Environmental exposure to diesel particulate matter and commercial gasoline', 'ω3FA', 'Placebo']","['inflammatory and anti-inflammatory markers', 'levels of inhibitory cytokines including TGF-β and IL-10', 'α, IL-10, and IL-17 levels', 'C-reactive protein, interleukin-12 (IL-12), transforming growth factor β (TGF-β), interferon γ (IFN-γ), tumor necrosis factor', 'concentrations of IFN-γ and IL-17']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0562311', 'cui_str': 'Petrol station'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014412', 'cui_str': 'Environmental Exposure'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0017113', 'cui_str': 'Gasoline'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",53.0,0.436733,The concentrations of IFN-γ and IL-17 were significantly decreased in ω3FA group compared with the placebo group ( P  < 0.001).,"[{'ForeName': 'Shoresh', 'Initials': 'S', 'LastName': 'Barkhordari', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Mirmosayyeb', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mansourian', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hosseininasab', 'Affiliation': 'Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Ramezani', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Mehdi', 'Initials': 'MM', 'LastName': 'Amin', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parinaz', 'Initials': 'P', 'LastName': 'Poursafa', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Esmaeil', 'Affiliation': 'Environment Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kelishadi', 'Affiliation': 'Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research,['10.1089/jir.2019.0220']
934,31712421,Distinct effects of orexin receptor antagonist and GABA A  agonist on sleep and physical/cognitive functions after forced awakening.,"The majority of patients with insomnia are treated with hypnotic agents. In the present study, we evaluated the side-effect profile of an orexin receptor antagonist and γ-aminobutyric acid A (GABA A ) receptor agonist on physical/cognitive functions upon forced awakening. This double-blind, randomized, placebo-controlled, cross-over study was conducted on 30 healthy male subjects. Fifteen minutes before bedtime, the subjects took a pill of suvorexant (20 mg), brotizolam (0.25 mg), or placebo and were forced awake 90 min thereafter. Physical- and cognitive-function tests were performed before taking the pill, after forced awakening, and the next morning. Polysomnographic recordings revealed that the efficacies of the hypnotic agents in prolonging total sleep time (∼30 min) and increasing sleep efficiency (∼6%) were comparable. When the subjects were allowed to go back to sleep after the forced awakening, the sleep latency was shorter under the influence of hypnotic agents (∼2 min) compared to the placebo trial (24 min), and the rapid eye movement latency was significantly shorter under suvorexant (98.8, 81.7, and 48.8 min for placebo, brotizolam, and suvorexant, respectively). Although brotizolam significantly impaired the overall physical/cognitive performance (sum of  z  score) compared with placebo upon forced awakening, there was no significant difference in the total  z  score of performance between suvorexant and placebo. Notably, the score for static balance with the eyes open was higher under suvorexant compared to brotizolam administration. The energy expenditure was lower under suvorexant and brotizolam compared with the placebo. The effect size of brotizolam ( d  = 0.24) to reduce the energy expenditure was larger than that of suvorexant ( d  < 0.01).",2019,"Although brotizolam significantly impaired the overall physical/cognitive performance (sum of  z  score) compared with placebo upon forced awakening, there was no significant difference in the total  z  score of performance between suvorexant and placebo.",['30 healthy male subjects'],"['orexin receptor antagonist and γ-aminobutyric acid A', 'hypnotic agents', 'placebo', 'brotizolam', 'pill of suvorexant', 'orexin receptor antagonist and GABA']","['sleep and physical/cognitive functions', 'energy expenditure', 'total sleep time (∼30 min) and increasing sleep efficiency', 'static balance', 'overall physical/cognitive performance', 'rapid eye movement latency', 'total  z  score of performance']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}, {'cui': 'C0220780', 'cui_str': 'Aminobutyric Acid'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0054151', 'cui_str': 'brotizolam'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034673'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",90.0,0.116882,"Although brotizolam significantly impaired the overall physical/cognitive performance (sum of  z  score) compared with placebo upon forced awakening, there was no significant difference in the total  z  score of performance between suvorexant and placebo.","[{'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Physical Education, Health, and Sport Sciences, University of Tsukuba, 305-8574 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Insung', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Fusae', 'Initials': 'F', 'LastName': 'Kawana', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Yajima', 'Affiliation': 'Faculty of Health and Nutrition, Tokyo Seiei College, 124-8530 Tokyo, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Fukusumi', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, 305-8574 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Satoh', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Kumpei', 'Initials': 'K', 'LastName': 'Tokuyama', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kokubo', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yanagisawa', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 305-8575 Tsukuba, Ibaraki, Japan; yanagisawa.masa.fu@u.tsukuba.ac.jp.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1907354116']
935,32186013,"Jiawei Xiaoyao capsule treatment for mild to moderate major depression with anxiety symptoms: a randomized, double-blind, double-dummy, controlled, multicenter, parallel-treatment trial.","OBJECTIVE


To assess the efficacy and safety of Jiawei Xiaoyao (JWXY) capsules on mild to moderate depression with anxiety symptoms, a randomized, double-blind, double-dummy controlled, multicenter, parallel-treatment trial was carried out among 210 outpatients with mild to moderate depression and anxiety symptoms from three hospitals in Beijing China.
METHODS


Participants were randomized into the JWXY group or the sertraline group. Each group received JWXY treatment and sertraline placebo, or sertraline and JWXY placebo for 8 weeks. Main outcomes were measured using the Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA) and the Clinical Global Impression Scale.
RESULTS


JWXY and sertraline had the equivalent effect on HAMD at every interview point. JWXY was more effective at reducing the HAMA scores at the 2nd and 12th week, HAMD sleep disturbance subscale scores at the 8th and 12th week, and HAMA somatic anxiety subscale scores at the 12th week. The rate of adverse events in the two groups was the same.
CONCLUSION


For mild to moderate depression with anxiety symptoms, JWXY could be as effective as sertraline in alleviating depressive symptoms. For anxiety symptoms, JWXY may be effective more quickly and with longer lasting effects than sertraline. In particular, it may also improve quality of sleep and somatic anxiety symptoms. JWXY is safe and cheaper than conventional antidepressants, and may be the first alternative choice for depression with anxiety symptoms.",2019,"JWXY was more effective at reducing the HAMA scores at the 2nd and 12th week, HAMD sleep disturbance subscale scores at the 8th and 12th week, and HAMA somatic anxiety subscale scores at the 12th week.","['mild to moderate major depression with anxiety symptoms', '210 outpatients with mild to moderate depression and anxiety symptoms from three hospitals in Beijing China', 'mild to moderate depression with anxiety symptoms', 'Participants']","['Jiawei Xiaoyao (JWXY) capsules', 'sertraline', 'JWXY', 'Jiawei Xiaoyao capsule treatment', 'JWXY treatment and sertraline placebo, or sertraline and JWXY placebo']","['HAMA scores', 'Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA) and the Clinical Global Impression Scale', 'HAMD sleep disturbance subscale scores', 'HAMA somatic anxiety subscale scores', 'quality of sleep and somatic anxiety symptoms', 'rate of adverse events']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1869284', 'cui_str': 'xiao-yao'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",210.0,0.369208,"JWXY was more effective at reducing the HAMA scores at the 2nd and 12th week, HAMD sleep disturbance subscale scores at the 8th and 12th week, and HAMA somatic anxiety subscale scores at the 12th week.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Su', 'Affiliation': 'Department of Scientific Research, Beijing Hospital of Traditional Chinese Medicine,Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'China Press of Traditional Chinese Medicine, Beijing 100013, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Guang An Men Hospital, China Academy of Chinese Medical Sciences Beijing 100053, China.'}, {'ForeName': 'Xindong', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Chinese Medicine, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China.'}, {'ForeName': 'Zhenyun', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Dongfang Hospital of BeijingUniversity of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Pathophysiology and Allergy Research Vienna General Hospital, Vienna A-1090, Austria.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
936,32186016,"Effect of electrically stimulating acupoint, Zusanli (ST 36), on patient's recovery after laparoscopic colorectal cancer resection: a randomized controlled trial.","OBJECTIVE


To investigate the effect of transcutaneous electrical acupoint stimulation (TEAS) on enhanced recovery after surgery (ERAS) in laparoscopic colorectal cancer resection and its clinical significance.
METHODS


Sixty-four patients undergoing laparoscopic colorectal resection were randomly divided into two groups, the control group (group A) and the TEAS group (group B). Patients in the TEAS group received electroacupuncture stimulation of bilateral Zusanli (ST 36) at 30 min before anesthesia to the end of surgery. The patients in the control group were not given the stimulation. Perioperative anesthesia management of the two groups were performed according to the ERAS guidelines, and postoperative patient-controlled intravenous analgesia (PCIA) was used. The amount of remifentanil used in the two groups was observed and recorded, and the visual analogue scale (VAS) of the 4, 12, 24 and 48 h after surgery in the two groups was recorded. Moreover, postoperative anal exhaust time, postoperative feeding time, postoperative first ambulation time and postoperative hospital stay length were compared between the two groups.
RESULTS


Compared with group A, the VAS score of group B decreased significantly at 48 h after operation (P < 0.05). The postoperative anal exhaust time in group B was significantly shorter than that of group A (P < 0.05). There was no significant difference between the two groups with regards to remifentanil consumption, postoperative feeding time, postoperative first ambulation time and postoperative hospital stay (all P > 0.05).
CONCLUSION


TEAS can promote the recovery of postoperative gastrointestinal function and reduce the pain intensity 48 h after surgery, thus satisfying the need of early postoperative analgesia.",2019,The postoperative anal exhaust time in group B was significantly shorter than that of group A (P < 0.05).,"['Sixty-four patients undergoing laparoscopic colorectal resection', ""patient's recovery after laparoscopic colorectal cancer resection"", 'laparoscopic colorectal cancer resection']","['surgery (ERAS', 'electrically stimulating acupoint, Zusanli (ST 36', 'remifentanil', 'electroacupuncture stimulation of bilateral Zusanli', 'TEAS', 'transcutaneous electrical acupoint stimulation (TEAS']","['postoperative anal exhaust time, postoperative feeding time, postoperative first ambulation time and postoperative hospital stay length', 'VAS score', 'postoperative anal exhaust time', 'pain intensity', 'remifentanil consumption, postoperative feeding time, postoperative first ambulation time and postoperative hospital stay', 'recovery of postoperative gastrointestinal function', 'visual analogue scale (VAS']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0231226', 'cui_str': 'Exhausting (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",64.0,0.0177849,The postoperative anal exhaust time in group B was significantly shorter than that of group A (P < 0.05).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510000, China.'}, {'ForeName': 'Wenfei', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Anesthesiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510000, China.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510000, China.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510000, China.'}, {'ForeName': 'Tingyu', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510000, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
937,32186028,"Effect of cream, prepared with Tripterygium wilfordii Hook F and other four medicinals, on joint pain and swelling in patients with rheumatoid arthritis: a double-blinded, randomized, placebo controlled clinical trial.","OBJECTIVE


To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis (RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh).
METHODS


Patients were 1∶1 randomized to add-on TwHF cream twice a day or placebo for 4 weeks. The primary endpoint was achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score (DAS28) improvement and safety profiles. Statistical analyses were performed using intention to treat analysis (ITT) set.
RESULTS


A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3% (12/35) in TwHF cream group and 11.4% (4/35) in placebo group (P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1% (6/35) comparing to it in placebo group with 2.9% (1/35) (P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed.
CONCLUSION


On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.",2019,"The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048).","['patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis', 'Patients', '70 active RA patients were enrolled', 'patients with active RA']","['TwHF cream twice a day or placebo', 'cream', 'placebo', 'Tripterygium wilfordii Hook F and other four medicinals', 'TwHF cream', 'Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh']","['higher ACR50 responder proportion', 'DAS28- CRP', 'DAS28-ESR', 'achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20', 'tender joint count', ""Physician's global assessment"", 'ACR20', 'substantive adverse events', 'joint pain and swelling', 'ACR50, 28-joint count Disease Activity Score (DAS28) improvement and safety profiles', 'swollen joint count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0077273', 'cui_str': 'Tripterygium wilfordii'}, {'cui': 'C0181209', 'cui_str': 'Hook (attribute)'}, {'cui': 'C0257081', 'cui_str': 'mangxiao'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}]",70.0,0.433217,"The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048).","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Xiaopo', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Department of Rheumatology, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences,Beijing 100053, China.""}, {'ForeName': 'Chengchung', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
938,30547234,"Correction to: Cardiovascular, muscular, and skeletal adaptations to recreational team handball training: a randomized controlled trial with young adult untrained men.",The author would like to correct the errors in the publication of the original article. The corrected details are given below for your reading.,2019,The corrected details are given below for your reading.,['young adult untrained men'],[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],[],,0.0276968,The corrected details are given below for your reading.,"[{'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Hornstrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark. thornstrup@nexs.ku.dk.'}, {'ForeName': 'F T', 'Initials': 'FT', 'LastName': 'Løwenstein', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'E W', 'Initials': 'EW', 'LastName': 'Helge', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Póvoas', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, University Institute of Maia, ISMAI, 4475-690, Maia, Portugal.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fristrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Andersen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gliemann', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nybo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, 3450, Odense, Denmark.'}]",European journal of applied physiology,['10.1007/s00421-018-4050-5']
939,32186121,Whole body vibration and auriculotherapy improve handgrip strength in individuals with knee osteoarthritis.,"OBJECTIVE


To verify the action of non-pharmacological interventions, whole body vibration exercise (WBVE) and auriculotherapy (AT) on the management of knee osteoarthritis (KOA) analyzing the handgrip strength (HS).
METHODS


One hundred twelve participants with KOA were allocated in (a) WBVE group with peak-to-peak displacement of 2.5 to 7.5 mm, frequency from 5 up to 14 Hz, acceleration peak from 0.12 up to 2.95 g (2 d/weekly for 5 weeks), (b) AT group, points of both ears (Kidney, Knee-correspondent point and Shenmen) were stimulated with seeds, (c) WBVE + AT group and (d) respective control groups. HS was assessed in all the participants, in acute and cumulative responses.
RESULTS


The intervention with WBVE alone and combined with AT improved (P < 0.05), in a cumulative response, the HS.
CONCLUSION


WBVE alone or combined with AT might promote biological effects that interfere with the HS in individuals with KOA.",2019,"The intervention with WBVE alone and combined with AT improved (P < 0.05), in a cumulative response, the HS.
CONCLUSION


WBVE alone or combined with AT might promote biological effects that interfere with the HS in individuals with KOA.","['individuals with knee osteoarthritis', 'individuals with KOA', 'One hundred twelve participants with KOA']","['Whole body vibration and auriculotherapy', 'whole body vibration exercise (WBVE) and auriculotherapy (AT', 'WBVE alone and combined with AT']","['HS', 'handgrip strength']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C2350276', 'cui_str': 'Auriculotherapies'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",[],112.0,0.0374085,"The intervention with WBVE alone and combined with AT improved (P < 0.05), in a cumulative response, the HS.
CONCLUSION


WBVE alone or combined with AT might promote biological effects that interfere with the HS in individuals with KOA.","[{'ForeName': 'Moreira-Marconi', 'Initials': 'MM', 'LastName': 'Eloá', 'Affiliation': 'Postgraduate Program in Clinical and Experimental Physiopathology, University of the State of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Dionello', 'Initials': 'D', 'LastName': 'Carla F', 'Affiliation': 'Department of Biophysics and Biometrics, Laboratory of Mechanical Vibrations and Integrative Practices-LAVIMPI, Institute of Biology Roberto Alcantara Gomes, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Morel', 'Initials': 'M', 'LastName': 'Danielle S', 'Affiliation': 'Department of Biophysics and Biometrics, Laboratory of Mechanical Vibrations and Integrative Practices-LAVIMPI, Institute of Biology Roberto Alcantara Gomes, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Sá-Caputo', 'Initials': 'SC', 'LastName': 'Danubia C', 'Affiliation': 'Department of Biophysics and Biometrics, Laboratory of Mechanical Vibrations and Integrative Practices-LAVIMPI, Institute of Biology Roberto Alcantara Gomes, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Sousa-Goncalves', 'Initials': 'SG', 'LastName': 'Cintia R', 'Affiliation': ''}, {'ForeName': 'Paineiras-Domingos', 'Initials': 'PD', 'LastName': 'Laisa L', 'Affiliation': 'Department of Biophysics and Biometrics, Laboratory of Mechanical Vibrations and Integrative Practices-LAVIMPI, Institute of Biology Roberto Alcantara Gomes, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Teixeira-Silva', 'Initials': 'TS', 'LastName': 'Ygor', 'Affiliation': 'Department of Biophysics and Biometrics, Laboratory of Mechanical Vibrations and Integrative Practices-LAVIMPI, Institute of Biology Roberto Alcantara Gomes, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Mario José Dos Santos', 'Affiliation': 'Pereira, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil- Department of Biophysics and Biometrics, Institute of Biology Roberto Alcantara Gomes- Department of Physiological Sciences Mario, Bernardo-Filho, Department of Biophysics and Biometrics, Laboratory of Mechanical Vibrations and Integrative Practices-LAVIMPI, Institute of Biology Roberto Alcantara Gomes, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
940,32186161,Effects of Huangban Bianxing One decoction combined with ranibizumab on treating exudative age-related macular degeneration.,"OBJECTIVE


To evaluate the clinical efficacy and safety of Chinese medicine formula Huangban Bianxing One decoction (HBOD) combined with ranibizumab for treating exudative age-related macular degeneration (AMD) patients.
METHODS


Totally 75 cases with exudative AMD (75 eyes) were enrolled in this study and randomly divided into two groups to receive either HBOD with ranibizumab or only ranibizumab. Early treatment diabetic retinopathy study (ETDRS) letters for the best corrected visual acuity, center macular thickness (CMT), height of the lesion, fundus hemorrhage area, fundus fluorescein leakage area as the main outcomes and safety indexes were estimated and compared before and after treatment for 3 or 6 months.
RESULTS


Comparing with the before treatment, ETDRS letter scores of both groups after treatment at month 3 obtained a greater improvement (P < 0.05), but the significant improvement only existed in the HBOD+ranibizumab group at month 6 (P < 0.01), and better than the ranibizumab group (P < 0.05). At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01). The hemorrhage area and fluorescein leakage area of the HBOD+ranibizumab group were also significantly reduced and also smaller than those of the ranibizumab group at month 6 (P < 0.01 or P < 0.05). During treatment, no significant adverse events relating to HBOD or ranibizumab treatment were elucidated.
CONCLUSION


HBOD combined with ranibizumab can improve visual acuity and reduce hemorrhage and fluorescein leakage of patients with exudative AMD. These results also indicated that HBOD may function as an effective and safe adjuvant drug for exudative AMD.",2019,"At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01).","['treating exudative age-related macular degeneration', 'patients with exudative AMD', 'exudative age-related macular degeneration (AMD) patients', 'Totally 75 cases with exudative AMD (75 eyes']","['HBOD with ranibizumab or only ranibizumab', 'HBOD + ranibizumab', 'Chinese medicine formula Huangban Bianxing One decoction (HBOD) combined with ranibizumab', 'ranibizumab', 'Huangban Bianxing One decoction combined with ranibizumab']","['hemorrhage area and fluorescein leakage area', 'CMT and lesion height', 'visual acuity and reduce hemorrhage and fluorescein leakage', 'corrected visual acuity, center macular thickness (CMT), height of the lesion, fundus hemorrhage area, fundus fluorescein leakage area', 'ETDRS letter scores']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",75.0,0.0232739,"At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Deng', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
941,32052503,Serum hepatitis B virus RNA predicts response to peginterferon treatment in HBeAg-positive chronic hepatitis B.,"Hepatitis B virus (HBV) RNA in serum is a novel biomarker that reflects cccDNA activity. We investigated whether HBV RNA can predict serological response to peginterferon (PEG-IFN) treatment. Serum HBV RNA levels were retrospectively measured at weeks 0, 12, 24 and 52 of therapy and after treatment discontinuation (week 78) in 266 HBeAg-positive chronic HBV patients who had participated in a global randomized controlled trial (HBV99-01 study). Patients received 52 weeks PEG-IFN monotherapy (n = 136) or PEG-IFN and lamivudine (n = 130). The primary end point was HBeAg loss 24 weeks after PEG-IFN discontinuation. At baseline, the mean serum level of HBV RNA was 6.8 (SD 1.2) log c/mL. HBV RNA levels declined to 4.7 (1.7) log c/mL after one year of PEG-IFN therapy alone and to 3.3 (1.2)log c/mL after combination therapy. From week 12 onward, HBV RNA level was significantly lower in patients who achieved HBeAg loss at the end of follow-up as compared to those who did not, regardless of treatment allocation (week 12:4.4 vs 5.1 log c/mL, P = .01; week 24:3.7 vs 4.9 log c/mL, P < .001). The performance of a multivariable model based on HBV RNA level was comparable at week 12 (AUC 0.68) and 24 (AUC 0.72) of therapy. HBV RNA level above 5.5 log c/mL at week 12 showed negative predictive values of 93/67/90/64% for HBV genotypes A/B/C/D for the prediction of HBeAg loss. In conclusion, HBV RNA in serum declines profoundly during PEG-IFN treatment. Early on-treatment HBV RNA level may be used to predict nonresponse.",2020,HBV RNA level above 5.5 log c/mL at week 12 showed negative predictive values of 93/67/90/64% for HBV genotypes,"['266 HBeAg-positive chronic HBV patients who had participated', 'HBeAg-positive chronic hepatitis B']","['orPEG-IFN and lamivudine', 'peginterferon', 'Hepatitis B virus (HBV) RNA', 'HBV RNA', 'PEG-IFN monotherapy']","['Serum HBV RNA levels', 'mean serum level of HBV RNA', 'HBV RNA levelwas', 'HBeAg loss 24 weeks after PEG-IFN discontinuation', 'HBV RNA level', 'mL.HBV RNA levels']","[{'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",,0.0431353,HBV RNA level above 5.5 log c/mL at week 12 showed negative predictive values of 93/67/90/64% for HBV genotypes,"[{'ForeName': 'Margo J H', 'Initials': 'MJH', 'LastName': 'van Campenhout', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'van Bömmel', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Section of Hepatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pfefferkorn', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Section of Hepatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Janett', 'Initials': 'J', 'LastName': 'Fischer', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Section of Hepatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Deichsel', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Section of Hepatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Boonstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anneke J', 'Initials': 'AJ', 'LastName': 'van Vuuren', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'Department of Gastroenterology and Rheumatology, Section of Hepatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Bettina E', 'Initials': 'BE', 'LastName': 'Hansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}]",Journal of viral hepatitis,['10.1111/jvh.13272']
942,30569759,"Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials.","Objective:  To compare the effectiveness and safety of the fluocinolone acetonide (FAc) intravitreal implant between the observational Iluvien Clinical Evidence study in the United Kingdom (ICE-UK) and the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) randomized controlled trials (RCTs) in people with diabetic macular edema (DME). Clinical Trials Registration: NCT00344968.  Methods:  This study selected patients randomized to receive 0.2 µg/day FAc insert (FAc treated eyes) or sham injection (control eyes) from the FAME RCTs, and patients' first FAc treated eye and non-FAc treated fellow (control) eye from the ICE-UK study. Outcomes included change in visual acuity (VA), central foveal thickness (CFT), and intraocular pressure (IOP).  Results:  After 12 months follow-up, mean change in VA was 5.0 letters improvement ( p  < .001) and 1.6 letters improvement ( p  = .003) in FAME FAc treated and control eyes, and 3.8 letters ( p  = .012) and  - 2.1 letters ( p  = .056) in ICE-UK FAc treated and control eyes, respectively. Mean change in CFT was  - 144 µm ( p  < .001) vs  - 72 µm ( p  < .001) in FAME FAc treated and control eyes and  - 113 µm ( p  < .001) vs  - 13 µm ( p  < .001) in ICE-UK FAc treated and control eyes. For eyes with a follow-up of 12 months, 77 (22.3%) and 15 (8.6%) FAME FAc treated and control eyes and 25 (18.7%) and six (4.3%) ICE-UK FAc treated and control eyes required emergent IOP-lowering therapy.  Conclusions:  Statistically significant improvements in VA 12 months after FAc implantation were observed in both the real-world study and in the RCTs. The improvement in VA and CFT in the RCTs was marginally greater than in the real-world study; however, recruits in the real-world study had more severe visual morbidity at baseline. Whilst there were many changes in the care of people with DME over this time, these data all support the value of treatment with FAc intravitreal implant.",2019,Mean change in CFT was  - 144 µm ( p  < .001) vs  - 72 µm ( p  < .001) in FAME FAc treated and control eyes and  - 113 µm ( p  < .001) vs  - 13 µm ( p  < .001) in ICE-UK FAc treated and control eyes.,"['patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials', 'Diabetic Macular Edema (FAME', 'people with diabetic macular edema (DME']","[""0.2\u2009µg/day FAc insert (FAc treated eyes) or sham injection (control eyes) from the FAME RCTs, and patients' first FAc treated eye and non-FAc treated fellow (control) eye from the ICE-UK study"", 'Fluocinolone Acetonide', 'fluocinolone acetonide (FAc) intravitreal implant', 'fluocinolone intravitreal implant', 'ICE-UK FAc']","['change in visual acuity (VA), central foveal thickness (CFT), and intraocular pressure (IOP', 'severe visual morbidity', 'VA', 'effectiveness and safety', 'VA and CFT', 'Mean change in CFT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0641456', 'cui_str': 'DMES'}]","[{'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016298', 'cui_str': 'Fluocinolone Acetonide'}, {'cui': 'C1299681', 'cui_str': 'Intravitreal implant'}, {'cui': 'C0060507', 'cui_str': 'fluocinolone'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0823898,Mean change in CFT was  - 144 µm ( p  < .001) vs  - 72 µm ( p  < .001) in FAME FAc treated and control eyes and  - 113 µm ( p  < .001) vs  - 13 µm ( p  < .001) in ICE-UK FAc treated and control eyes.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Holden', 'Affiliation': 'a Global Pharmacoepidemiology , Pharmatelligence , Cardiff , UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Kapik', 'Affiliation': 'b Alimera Sciences , Alpharetta , GA , USA.'}, {'ForeName': 'Annette B', 'Initials': 'AB', 'LastName': 'Beiderbeck', 'Affiliation': 'c Alimera Sciences Ophthalmologie GmbH , Berlin , Germany.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Currie', 'Affiliation': 'a Global Pharmacoepidemiology , Pharmatelligence , Cardiff , UK.'}]",Current medical research and opinion,['10.1080/03007995.2018.1560779']
943,32186106,Effects of Gua Sha therapy on weightlifting training: a randomized trial.,"OBJECTIVE


To evaluate the effect of Gua Sha therapy on weightlifting training.
METHODS


The sample size was calculated by conducting a pilot study. A total of 44 male weightlifters were randomly assigned to either the Gua Sha group (n = 15), sham scraping group (n = 14), or control group (n = 14). The participants in the Gua Sha group and sham scraping group received 16 sessions of Gua Sha therapy during normal weightlifting training for 8 weeks. No treatment was applied to participants in the control group. The effectiveness of Gua Sha therapy was evaluated by measuring weightlifting ability, the rating of perceived exertion (RPE) of snatch and clean and jerk (85% of 1 repetition maximum), and creatinine kinase (CK), blood urea nitrogen (BUN), and immunoglobulin A levels.
RESULTS


Gua Sha therapy treatment significantly increased weightlifting ability in participants in the Gua Sha group (P < 0.01). The RPE values of snatch and clean and jerk were significantly lower in the Gua Sha group and sham scraping groups compared with the control group (P < 0.05). CK levels were lower and immunoglobulin A levels were significantly higher in the Gua Sha group compared with sham scraping group and control group (both P < 0.05). BUN levels tended to be reduced only in the Gua Sha group. A close correlation between CK levels and the RPE was found in the Gua Sha group.
CONCLUSION


Gua Sha therapy can facilitate weightlifting ability, reduce the RPE, and inhibit muscle injury by promoting recovery from fatigue caused by normal weightlifting training. Gua Sha therapy could be an effective treatment to complement normal weightlifting training.",2019,CK levels were lower and immunoglobulin A levels were significantly higher in the Gua Sha group compared with sham scraping group and control group (both P < 0.05).,"['weightlifting training', '44 male weightlifters']","['Gua Sha therapy', 'sham scraping group']","['CK levels and the RPE', 'weightlifting ability', 'weightlifting ability, the rating of perceived exertion (RPE) of snatch and clean and jerk (85% of 1 repetition maximum), and creatinine kinase (CK), blood urea nitrogen (BUN), and immunoglobulin A levels', 'BUN levels', 'CK levels', 'RPE values of snatch and clean and jerk']","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184933', 'cui_str': 'Scraping (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C1704276', 'cui_str': 'Spasmodic movement (finding)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0202083', 'cui_str': 'Immunoglobulin A measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",44.0,0.0392475,CK levels were lower and immunoglobulin A levels were significantly higher in the Gua Sha group compared with sham scraping group and control group (both P < 0.05).,"[{'ForeName': 'Xingze', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Physical Education and Training, Shanghai University of Sport, Shanghai, 200438, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Houyong', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Research Center of Physical Education and Health Education in Gannan Normal University, Ganzhou City, Jiangxi Province 341000, China.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Research Center of Physical Education and Health Education in Gannan Normal University, Ganzhou City, Jiangxi Province 341000, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, The 8th Medical Center of Chinese PLA General Hospital Xiao Xitian Clinic, Beijing 100082, China.'}, {'ForeName': 'Jinsheng', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
944,32186107,Effect of adjuvant therapy with electroacupuncture on bone turnover markers and interleukin 17 in patients with rheumatoid arthritis.,"OBJECTIVE


To evaluate the effect of electroacupuncture as an adjuvant treatment with first-line medications on bone metabolism biomarkers and interleukin-17 (IL-17) in the peripheral blood of patients with rheumatoid arthritis (RA).
METHODS


Sixty RA patients were randomized into three groups. The control group was treated with methotrexate plus leflunomide (MTX+LEF), the acupuncture group was treated with simple needling plus MTX + LEF, and the patients in the electroacupuncture (EA) group were treated with EA plus MTX + LEF. EA or acupuncture was applied every other day for a total of 10 times over a treatment period of 8 weeks.
RESULTS


In all three treatment groups, serum levels of the bone metabolism markers PICP, N-MID, and B-ALP were elevated and the concentrations of the inflammatory markers β-CTx, IL-17, CRP, and TRACP-5b were reduced after treatment. These differences were significant for the EA group but not the other groups (P < 0.05).
CONCLUSION


EA could effectively reduce the suffering and improve the quality of life of RA patients. It is a promising adjuvant therapy for enhancing the effectiveness of clinical therapeutics.",2019,"In all three treatment groups, serum levels of the bone metabolism markers PICP, N-MID, and B-ALP were elevated and the concentrations of the inflammatory markers β-CTx, IL-17, CRP, and TRACP-5b were reduced after treatment.","['patients with rheumatoid arthritis (RA', 'Sixty RA patients', 'patients with rheumatoid arthritis']","['methotrexate plus leflunomide (MTX+LEF', 'EA', 'acupuncture', 'EA plus MTX + LEF', 'electroacupuncture', 'EA or acupuncture', 'electroacupuncture (EA', 'simple needling plus MTX + LEF']","['bone turnover markers', 'bone metabolism biomarkers and interleukin-17 (IL-17', 'quality of life', 'concentrations of the inflammatory markers β-CTx, IL-17, CRP, and TRACP-5b', 'serum levels of the bone metabolism markers PICP, N-MID, and B-ALP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0034380'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0297331', 'cui_str': 'TRAcP'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0072052', 'cui_str': 'CPP-I'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}]",60.0,0.0620938,"In all three treatment groups, serum levels of the bone metabolism markers PICP, N-MID, and B-ALP were elevated and the concentrations of the inflammatory markers β-CTx, IL-17, CRP, and TRACP-5b were reduced after treatment.","[{'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Department of Traditional Chinese Medicine Integrated TCM and Western Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.'}, {'ForeName': 'Xuejing', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Traditional Chinese Medicine Integrated TCM and Western Medicine, Yunyang Hospital, Chongqing, 404500, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Department of Traditional Chinese Medicine Integrated TCM and Western Medicine, Yunyang Hospital, Chongqing, 404500, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine Integrated TCM and Western Medicine, Yunyang Hospital, Chongqing, 404500, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'Department of Traditional Chinese Medicine Integrated TCM and Western Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Traditional Chinese Medicine Integrated TCM and Western Medicine, First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
945,32186108,Effect of hand-ear acupuncture on chronic low-back pain: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of hand-ear acupuncture on chronic low-back pain (cLBP).
METHODS


This was an open, randomized and controlled trial in The General Hospital of Western Theater Command, Sichuan Province. The trial was registered with ClinicalTrials.gov, NCT02260284. All the 152 participates with cLBP were randomly assigned to hand-ear acupuncture (n = 54), standard acupuncture (n = 50), or usual care groups (n = 48). Eighteen treatments were provided over 7 weeks. Back-related dysfunction and symptom severity were assessed by the Roland-Morris Disability Questionnaire (RMDQ) and the Visual Analogue Scale (VAS), which were collected at baseline, 2 months and 6 months post to the treatment.
RESULTS


At 6 months, the RMDQ scores improved by 7.74 points of hand-ear acupuncture group. Significant improvement of VAS and RMDQ was observed in hand-ear acupuncture group (P < 0.001), but no significant changes of RMDQ were observed in both standard acupuncture group and usual care group. We also observed an overall efficacy rate of 88.89% in hand-ear acupuncture group, as evaluated by Diagnosis and Curative Effect Standard for Symptom pattern of Traditional Chinese Medicine, which was much higher than 45.84% in the usual care group (H = 16.000, P < 0.001).
CONCLUSION


Both of the hand-ear acupuncture and standard acupuncture modes have beneficial and persistent effectiveness against cLBP compared with the usual care. Furthermore, hand-ear acupuncture is significantly more effective than the standardized acupuncture, especially in the long term.",2019,"Significant improvement of VAS and RMDQ was observed in hand-ear acupuncture group (P < 0.001), but no significant changes of RMDQ were observed in both standard acupuncture group and usual care group.","['General Hospital of Western Theater Command, Sichuan Province', '152 participates with cLBP', 'chronic low-back pain']","['standard acupuncture', 'hand-ear acupuncture']","['RMDQ scores', 'Roland-Morris Disability Questionnaire (RMDQ) and the Visual Analogue Scale (VAS', 'overall efficacy rate', 'Back-related dysfunction and symptom severity', 'chronic low-back pain (cLBP', 'RMDQ', 'VAS and RMDQ']","[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]",152.0,0.128255,"Significant improvement of VAS and RMDQ was observed in hand-ear acupuncture group (P < 0.001), but no significant changes of RMDQ were observed in both standard acupuncture group and usual care group.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Graduate College, The People's Liberation Army Naval Medical University, Shanghai 200433, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Traditional Chinese Medicine Department, The General Hospital of Western Theater Command, Chengdu 610083, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Traditional Chinese Medicine Department, The General Hospital of Western Theater Command, Chengdu 610083, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'Traditional Chinese Medicine Department, The General Hospital of Western Theater Command, Chengdu 610083, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""The People's Liberation Army 32357 troops, Chengdu 611630, China.""}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Traditional Chinese Medicine Department, The General Hospital of Western Theater Command, Chengdu 610083, China.'}, {'ForeName': 'Yonghe', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Traditional Chinese Medicine Department, The General Hospital of Western Theater Command, Chengdu 610083, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
946,32186030,Effect of acupuncture therapies combined with usual medical care on knee osteoarthritis.,"OBJECTIVE


To observe the effect of acupuncture or electroacupuncture (EA) combined with usual medical care for treating knee osteoarthritis (KOA) .
METHODS


A total of 90 patients with KOA were randomly allocated to 3 groups: usual care group (UC group, n = 30) was treated by pharmacological treatment of non-steroidal anti-inflammatory drugs (NSAIDs) and drugs for activating blood circulation (Ds-ABC), acupuncture (AP) combined with usual care group (UC group) (AP + UC group, n = 30) and EA combined with UC group (EA + UC group, n = 30). The primary outcome measurements included pain visual analogue scale/score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) and its subscales. Secondary outcome measurement was Assessment of Quality of Life instrument version of the 36-item Short Form Health Survey (AQoL-SF36).
RESULTS


By the end of the 1st week, AP + UC group and EA + UC group exhibited statistically significant improvements in primary outcome measures, except for WOMAC stiffness, compared with the UC group (P < 0.05). Moreover, the energy/fatigue domain of AQoL-SF36 in the AP + UC group showed better results than UC group (P < 0.05). By the end of the 2nd week, all the primary outcome measures revealed that either the AP + UC or EA + UC group demonstrating remarkable advantages compared with the UC group (P < 0.05). The social functioning and general health domains of AQoL-SF36 in the two acupuncture-intervention groups were improved significantly than UC group (P < 0.05). We also found the energy/fatigue and emotional wellbeing domains of AQoL-SF36 in the EA + UC group demonstrated better results than UC group (P < 0.05).
CONCLUSION


AP or EA combined with usual care is more effective than usual care alone for the treatment of KOA, the intervention of electric current in the process of acupuncture may improve more domains of AQoL-SF36 in KOA patients.",2019,The social functioning and general health domains of AQoL-SF36 in the two acupuncture-intervention groups were improved significantly than UC group (P < 0.05).,"['90 patients with KOA', 'knee osteoarthritis', 'KOA patients']","['usual care group (UC group, n = 30) was treated by pharmacological treatment of non-steroidal anti-inflammatory drugs (NSAIDs) and drugs for activating blood circulation (Ds-ABC), acupuncture (AP) combined with usual care group (UC group) (AP + UC group, n = 30) and EA combined with UC group (EA + UC', 'acupuncture or electroacupuncture (EA) combined with usual medical care', 'acupuncture therapies combined with usual medical care']","['energy/fatigue and emotional wellbeing domains of AQoL-SF36', 'pain visual analogue scale/score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) and its subscales', 'social functioning and general health domains of AQoL-SF36', 'energy/fatigue domain of AQoL-SF36', 'WOMAC stiffness', 'Quality of Life instrument version of the 36-item Short Form Health Survey (AQoL-SF36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0005775', 'cui_str': 'Blood Circulation'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",90.0,0.0458715,The social functioning and general health domains of AQoL-SF36 in the two acupuncture-intervention groups were improved significantly than UC group (P < 0.05).,"[{'ForeName': 'Lele', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Haixin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
947,32186033,Efficacy and safety of electroacupuncture in treatment of lumbar disc herniation: a protocol for a cohort study.,"OBJECTIVE


To compare the efficacy of electroacupuncture (deep needling) and general orthopedics in treatment of lumbar disc herniation (LDH), and to evaluate its long-term efficacy.
METHODS


This trial is a prospective cohort study. A total of 175 participants will be observed. The exposure group is obtained from department of acupuncture and moxibustion and the control group is from orthopedic department in hospital. Patients in exposed group will receive electroacupuncture in Dachangshu (BL 25), Guanyuanshu (BL 26), L4 Jiaji points (EX-B2 L4), L5 Jiaji points (EX-B2 L5) and S1 Jiaji points (EX-B2 S1) in the affected side once a day, 6 times as a treatment course for two courses (12 times). Patients in control group will receive orthopedic conventional therapy. In acute period, the treatment is mannitol injection (250 mL∶50 g) 200 mL, i.v., q.d.; 0.9% sodium chloride injection 250 mL, vitamin C injection 2 g, Dexamethasone sodium phosphate injection 10 mg, i.v., q.d.; sterile water for injection 2 mL, adenosine cobalt amine injection 1 mg, i.m., q.d., 12 d. In remission period, the treatment is Voltaren (Diclofenac diethyl lamine emulsion) external, q.d., 12 d. The researchers do not give any other intervention and record the relevant information only.
RESULTS


Modified Japanese Orthopaedic Association Scores, Visual Analogue Scale/Score, the Short Form-36 Quality-of-Life Questionnaire and Oswestry Disability Questionnaire and the second outcome measures (Adverse Event Questionnaire and Relapse Questionnaire) are measured before treatment, after the sixth treatment, and after the twelfth treatment. The follow-up periods are 3 months after the twelfth treatment, 6 months after the twelfth treatment, 1 year after the twelfth treatment.
CONCLUSION


This study will provide clinical researchers with the evidence on the safety and long-term efficacy of electroacupuncture in patients with Lumbar disc herniation.",2019,"Modified Japanese Orthopaedic Association Scores, Visual Analogue Scale/Score, the Short Form-36 Quality-of-Life Questionnaire and Oswestry Disability Questionnaire and the second outcome measures (Adverse Event Questionnaire and Relapse Questionnaire) are measured before treatment, after the sixth treatment, and after the twelfth treatment.","['lumbar disc herniation (LDH', '175 participants will be observed', 'patients with Lumbar disc herniation', 'lumbar disc herniation']","['adenosine cobalt amine injection', 'electroacupuncture (deep needling', 'acupuncture and moxibustion', 'sodium chloride injection 250 mL, vitamin C injection 2 g, Dexamethasone sodium phosphate injection', 'mannitol injection', 'Voltaren (Diclofenac diethyl lamine emulsion', 'electroacupuncture', 'electroacupuncture in Dachangshu (BL 25), Guanyuanshu (BL 26), L4 Jiaji points (EX-B2 L4), L5 Jiaji points (EX-B2 L5) and S1 Jiaji points (EX-B2 S1', 'orthopedic conventional therapy']","['Modified Japanese Orthopaedic Association Scores, Visual Analogue Scale/Score, the Short Form-36 Quality-of-Life Questionnaire and Oswestry Disability Questionnaire and the second outcome measures (Adverse Event Questionnaire and Relapse Questionnaire', 'Efficacy and safety']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0002508', 'cui_str': 'Amines'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C4282818', 'cui_str': 'Sodium Chloride Injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C4238438', 'cui_str': 'Mannitol Injection [Osmitrol]'}, {'cui': 'C0699958', 'cui_str': 'Voltaren'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",175.0,0.0473429,"Modified Japanese Orthopaedic Association Scores, Visual Analogue Scale/Score, the Short Form-36 Quality-of-Life Questionnaire and Oswestry Disability Questionnaire and the second outcome measures (Adverse Event Questionnaire and Relapse Questionnaire) are measured before treatment, after the sixth treatment, and after the twelfth treatment.","[{'ForeName': 'Yaru', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Yuanxiang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': ''}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
948,32186048,Effect of acupuncture on blood pressure control in hypertensive patients.,"OBJECTIVE


To study the effect of acupuncture on blood pressure (BP) control in hypertensive patients.
METHODS


A total of 80 out-patients with primary hypertension at the family medicine unit and the social security unit were randomly and equally divided into an acupuncture plus medication group and a control group that received only medication. Patients of the acupuncture group were treated with acupuncture stimulation of Yinlinquan (SP 9), Zusanli (ST 36), Taichong (LR 3), Hegu (LI 4), Quchi (LI 11), Neiguan (PC 6) for 30 min, once per week, continuously for eight weeks. In addition, both groups received amlodipine (5 mg) once daily, continuously for eight weeks. Systolic BP (SBP), diastolic BP (DBP) and mean arterial BP (mABP) were recorded. Data were analyzed by Mann-Whitney U test.
RESULTS


SBP of the 40 cases in the acupuncture group significantly improved compared to the medication only group [Z =－ 4.265, P (2-tailed) = 0.001] and DBP of acupuncture group was lower than that of the control group (Z =－ 2.813, P = 0.005). mABP of acupuncture group was the marked improvement in the reduction of blood pressure to that of medication group in controlling blood pressure. (Z = －2.416, P = 0.016).
CONCLUSION


These results indicate that the effectiveness of acupuncture with the acupuncture group is superior to the only medication group in the control of hypertension.",2019,"RESULTS


SBP of the 40 cases in the acupuncture group significantly improved compared to the medication only group [Z =－ 4.265, P (2-tailed) = 0.001] and DBP of acupuncture group was lower than that of the control group (Z =－ 2.813, P = 0.005).","['80 out-patients with primary hypertension at the family medicine unit and the social security unit', 'hypertensive patients']","['acupuncture', 'amlodipine', 'acupuncture stimulation of Yinlinquan (SP 9), Zusanli (ST 36), Taichong (LR 3), Hegu (LI 4), Quchi (LI 11), Neiguan (PC 6', 'acupuncture plus medication group and a control group that received only medication']","['Systolic BP (SBP), diastolic BP (DBP) and mean arterial BP (mABP', 'blood pressure control', 'DBP', 'blood pressure (BP) control', 'blood pressure']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",80.0,0.018063,"RESULTS


SBP of the 40 cases in the acupuncture group significantly improved compared to the medication only group [Z =－ 4.265, P (2-tailed) = 0.001] and DBP of acupuncture group was lower than that of the control group (Z =－ 2.813, P = 0.005).","[{'ForeName': 'Termklinchan', 'Initials': 'T', 'LastName': 'Vilaval', 'Affiliation': 'Thai Traditional and Alternative Medicine Unit, Department of Family Medicine, Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi 11120, Thailand.'}, {'ForeName': 'Wasin', 'Initials': 'W', 'LastName': 'Sasinan', 'Affiliation': 'Thai Traditional and Alternative Medicine Unit, Department of Family Medicine, Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi 11120, Thailand.'}, {'ForeName': 'Choesomboon', 'Initials': 'C', 'LastName': 'Mayuree', 'Affiliation': 'Thai Traditional and Alternative Medicine Unit, Department of Family Medicine, Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi 11120, Thailand.'}, {'ForeName': 'Praditbatuka', 'Initials': 'P', 'LastName': 'Chananun', 'Affiliation': 'Thai Traditional and Alternative Medicine Unit, Department of Family Medicine, Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi 11120, Thailand.'}, {'ForeName': 'Sukareechai', 'Initials': 'S', 'LastName': 'Somchai', 'Affiliation': 'Thai Traditional and Alternative Medicine Unit, Department of Family Medicine, Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi 11120, Thailand.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
949,32186049,Effect of a modified Banxia Xiexin decoction plus chemotherapy on stage Ⅲ colon cancer.,"OBJECTIVE


To investigate the effect of a modified Banxia Xiexin decoction (MBXD) plus chemotherapy on postoperative adverse reaction in patients with stage Ⅲ colon cancer in patients whose symptoms were identified as cold-heat complicated pattern in terms of the theory of Traditional Chinese Medicine (TCM).
METHODS


A prospective non-randomized control study of patients with stage Ⅲ colon cancer in Beijing Shijitan Hospital and Guang'anmen Hospital between January 2012 and December 2013. A total of 80 patients were divided into experimental group (MBXD + chemotherapy) and control group (chemotherapy). The adverse reactions, life quality and disease-free survival (DFS) were compared between the two groups.
RESULTS


The cold-heat complex pattern was released in 94.3% of patients in experimental group whereas 62.2% in control group (P < 0.05). Life quality was improved in 24 vs 14 cases, stabilized in 9 vs 14 cases whereas decreased in 2 vs 15 cases in experimental group and control group, respectively (P < 0.05). The average DFS was 22.371 months in experimental group, while 13.932 months in control group (P < 0.05).
CONCLUSION


MBXD combined with chemotherapy may significantly relieve clinical symptoms, reduce chemotherapy associated adverse effects, improve life quality, and prolong DFS of patients with stage Ⅲ colon cancer (cold-heat complicated pattern).",2019,The cold-heat complex pattern was released in 94.3% of patients in experimental group whereas 62.2% in control group (P < 0.05).,"['patients with stage Ⅲ colon cancer in patients whose symptoms were identified as cold-heat complicated pattern in terms of the theory of Traditional Chinese Medicine (TCM', ""patients with stage Ⅲ colon cancer in Beijing Shijitan Hospital and Guang'anmen Hospital between January 2012 and December 2013"", '80 patients', 'stage Ⅲ colon cancer']","['modified Banxia Xiexin decoction plus chemotherapy', 'experimental group (MBXD + chemotherapy) and control group (chemotherapy', 'MBXD combined with chemotherapy', 'modified Banxia Xiexin decoction (MBXD) plus chemotherapy']","['postoperative adverse reaction', 'Life quality', 'cold-heat complex pattern', 'adverse reactions, life quality and disease-free survival (DFS', 'life quality', 'average DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1869339', 'cui_str': 'Xiexin decoction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",80.0,0.0178541,The cold-heat complex pattern was released in 94.3% of patients in experimental group whereas 62.2% in control group (P < 0.05).,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of oncological surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Guangzhong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of oncological surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of oncological surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of oncological surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Hua', 'Affiliation': ""Department of oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Xingzhong', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Traditional Chinese Medicine, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
950,30914464,FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma.,"In November 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). Approval was based on ECHELON-2, a randomized, double-blind, actively controlled trial that compared BV+CHP with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in 452 patients with newly diagnosed, CD30-expressing PTCL. Efficacy was based on independent review facility-assessed progression-free survival (PFS). The median PFS was 48.2 months with BV+CHP versus 20.8 months with CHOP, resulting in a hazard ratio (HR) of 0.71 (95% confidence interval [CI]: 0.54-0.93). The trial also demonstrated improvement in overall survival (HR 0.66; 95% CI: 0.46-0.95), complete response rate (68% vs. 56%), and overall response rate (83% vs. 72%) with BV+CHP. The most common adverse reactions (incidence ≥20%) observed ≥2% more with BV+CHP were nausea, diarrhea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anemia. Peripheral neuropathy rates were similar (52% with BV+CHP, 55% with CHOP). Through the Real-Time Oncology Review pilot program, which allows FDA early access to key data, FDA granted this approval less than 2 weeks after official submission of the application. IMPLICATIONS FOR PRACTICE: This is the first U.S. Food and Drug Administration approval for treatment of patients with newly diagnosed peripheral T-cell lymphomas (PTCL). Improvement in progression-free and overall survival over cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy, which has been the standard of care for decades, is unprecedented. The new regimen represents a major advance for the frontline treatment of patients with CD30-expressing PTCL.",2019,"The trial also demonstrated improvement in overall survival (HR 0.66; 95% CI: 0.46-0.95), complete response rate (68% vs. 56%), and overall response rate (83% vs. 72%) with BV+CHP.","['adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL', 'patients with newly diagnosed peripheral T-cell lymphomas (PTCL', 'patients with CD30-expressing PTCL', '452 patients with newly diagnosed, CD30-expressing PTCL']","['cyclophosphamide, doxorubicin, and prednisone (CHP', 'cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy', 'BV+CHP with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP', 'BV+CHP']","['Efficacy', 'complete response rate', 'nausea, diarrhea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anemia', 'Peripheral neuropathy rates', 'progression-free and overall survival', 'review facility-assessed progression-free survival (PFS', 'overall response rate', 'median PFS', 'overall survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206180', 'cui_str': 'CD30+ Anaplastic Large-Cell Lymphoma'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1175474', 'cui_str': 'PtCl(2)(OH)(2)(dimethylamine) (isopropylamine)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",452.0,0.17326,"The trial also demonstrated improvement in overall survival (HR 0.66; 95% CI: 0.46-0.95), complete response rate (68% vs. 56%), and overall response rate (83% vs. 72%) with BV+CHP.","[{'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Richardson', 'Affiliation': 'Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA nicholas.richardson@fda.hhs.gov.'}, {'ForeName': 'Yvette L', 'Initials': 'YL', 'LastName': 'Kasamon', 'Affiliation': 'Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'R Angelo', 'Initials': 'RA', 'LastName': 'de Claro', 'Affiliation': 'Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Blumenthal', 'Affiliation': 'Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Ann T', 'Initials': 'AT', 'LastName': 'Farrell', 'Affiliation': 'Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0098']
951,31348336,Long-Term Follow-Up of Longevity and Diffusion Pattern of Hyaluronic Acid in Nasolabial Fold Correction through High-Frequency Ultrasound.,"BACKGROUND


Injectable hyaluronic acid fillers have been widely applied in the clinical treatment of facial wrinkles. However, further information and clinical evidence concerning dermal changes and hyaluronic acid filler longevity after injection and diffusion pattern are limited.
METHODS


The authors evaluated the longevity and diffusion pattern of two hyaluronic acid fillers generated by different cross-linking technologies used in the treatment of nasolabial folds using high-frequency ultrasound. Forty-one subjects were treated with Restylane 2 and the remaining 41 were treated with Dermalax DEEP. Wrinkle severity rating scale score and high-frequency ultrasound evaluation of nasolabial folds were performed before and after the injection of hyaluronic acid filler. The ultrasound images were acquired and analyzed to determine dermal thickness and the shape and distribution of hyaluronic acid filler.
RESULTS


At 2 and 24 weeks from baseline, increased dermal thickness induced by hyaluronic acid filler treatment was not significantly different between groups. At 48 weeks after injection, increased dermal thicknesses of the Restylane 2 group (0.14 ± 0.12 mm) were much lower than those of the Dermalax DEEP group (0.20 ± 0.13 mm). Ultrasound examination revealed that hyaluronic acid materials form well-demarcated and hypoechogenic areas. Restylane 2 tended to form a more diffuse pattern, with multiple smaller bubbles, whereas Dermalax DEEP developed into a more localized configuration, with larger clumps.
CONCLUSIONS


This study is the first long-term assessment of nasolabial fold correction that reveals the performance of different hyaluronic acid materials in vivo and validates high-frequency ultrasound as a simple and rapid modality. Hyaluronic acid fillers generated by different cross-linking technologies display differential diffusion patterns in skin tissues.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2019,"At 2 and 24 weeks from baseline, increased dermal thickness induced by hyaluronic acid filler treatment was not significantly different between groups.",[],"['Dermalax DEEP', 'hyaluronic acid filler', 'Hyaluronic acid fillers', 'hyaluronic acid fillers', 'Hyaluronic Acid']","['dermal thicknesses', 'Wrinkle severity rating scale score and high-frequency ultrasound evaluation of nasolabial folds', 'dermal thickness']",[],"[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}]",41.0,0.029878,"At 2 and 24 weeks from baseline, increased dermal thickness induced by hyaluronic acid filler treatment was not significantly different between groups.","[{'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': ""Beijing and Tianjin, People's Republic of China From the Department of Dermatology, Peking Union Medical College Hospital, and the Institute of Biomedical Engineering, Chinese Academy of Medical Sciences and Peking Union Medical College.""}, {'ForeName': 'Qian-Nan', 'Initials': 'QN', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Hong-Zhong', 'Initials': 'HZ', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ya-Gang', 'Initials': 'YG', 'LastName': 'Zuo', 'Affiliation': ''}, {'ForeName': 'Lan-Qin', 'Initials': 'LQ', 'LastName': 'Fu', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000005848']
952,32178858,Psychomotor Recovery Following Remimazolam-induced Sedation and the Effectiveness of Flumazenil as an Antidote.,"PURPOSE


Remimazolam tosylate (HR-7056) is a novel ester-type benzodiazepine with ultrafast onset of effect. The compound is being developed for sedation induction and maintenance during anesthesia. It was approved for procedural anesthesia in December 2019 by the National Medical Products Administration of China. Previous studies have reported on remimazolam's effects on consciousness and cognition. Although the time to full psychomotor recovery after remimazolam-mediated sedation is critical for decisions regarding hospital discharge, relevant clinical evidence is still lacking. This study investigated the residual psychomotor effects of remimazolam and their recovery from sedating treatment in 2 simulated clinical settings: (1) single-dose administration for sedation initiation; and (2) constant rate infusion for sedation maintenance.
METHODS


A single-ascending-dose, parallel-group, midazolam-controlled study and a 2-way crossover study evaluating the reversal effect of flumazenil versus placebo after a 2-h constant rate infusion were conducted with HR-7056 in 87 Chinese healthy volunteers; the studies used a double-blind, randomized trial design. A battery of psychomotor tests was administered before dosing and several times postdose over 4-6 h. Pharmacokinetic, sedation, and safety assessments were performed throughout the studies.
FINDINGS


After bolus infusion, the Bispectral Index score decreased in a concentration-dependent manner with HR-7056, accompanied by a sharp drop of Modified Observer's Assessment of Alertness/Sedation score. The recovery of consciousness was much faster with HR-7056 than with midazolam. During the constant rate infusion, the Bispectral Index score was maintained between 40 and 60 with an average plasma remimazolam concentration of ~1000 ng/mL. Subjects' performance in saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall was significantly impaired after single-dose midazolam and after constant rate infusion of remimazolam. The end-of-infusion injection of flumazenil shortened the median time to full alertness to 3.5 min and effectively reversed psychomotor and cardiovascular dysfunction.
IMPLICATIONS


The study results showed quicker psychomotor recovery from sedation in the remimazolam-treated group. The moderate and short-lasting residual effect of remimazolam after 2-h conscious sedation proposes a need for psychomotor assessment(s) before hospital discharge. ClinicalTrials.gov identifiers: NCT01970072 and NCT03444480.",2020,"ng/mL. Subjects' performance in saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall was significantly impaired after single-dose midazolam and after constant rate infusion of remimazolam.","['December 2019 by the National Medical Products Administration of China', '87 Chinese healthy volunteers']","['HR-7056', 'midazolam', 'flumazenil versus placebo', 'Flumazenil', 'remimazolam', 'Remimazolam-Induced Sedation', 'flumazenil']","['saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall', 'Bispectral Index score', ""Modified Observer's Assessment of Alertness/Sedation score"", 'median time to full alertness', 'Psychomotor Recovery', 'recovery of consciousness']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0034158', 'cui_str': 'Pursuit, Smooth'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",87.0,0.179989,"ng/mL. Subjects' performance in saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall was significantly impaired after single-dose midazolam and after constant rate infusion of remimazolam.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China; Clinical Trial Center, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. Electronic address: connie_6096@126.com.'}, {'ForeName': 'Nuoer', 'Initials': 'N', 'LastName': 'Sang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Kaicheng', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China. Electronic address: connie_6096@126.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.006']
953,31348363,Minced Skin Grafting for Promoting Wound Healing and Improving Donor-Site Appearance after Split-Thickness Skin Grafting: A Prospective Half-Side Comparative Trial.,"BACKGROUND


Minced skin grafting is a procedure that involves mincing of the harvested skin and grafting it back onto the wounds. The authors aimed to investigate whether minced skin grafting reduces the healing time and improves the sequential postoperative appearance of donor sites.
METHODS


A single-center, two-treatment, half-side comparative study was performed. The split-thickness skin remaining after grafting was minced until pasty. The small pasty graft mass was uniformly spread on half of the entire donor site. Minced skin grafting was not performed on the other side. The data from 30 patients were used for analysis.
RESULTS


The average time to complete healing of the donor sites in the minced skin grafting and control groups was 9.4 ± 2.5 and 12.4 ± 3.6 days, respectively. The difference in the healing time between the two groups was statistically significant (p < 0.001). Three blinded surgeons used a scale to grade photographs according to the degree of conspicuous donor sites in comparison with the normal skin around the donor sites. All observers reported that the differences in donor-site appearance between the minced skin grafting and control groups were statistically significant at postoperative months 1 and 2, and two observers reported that the differences in donor-site appearance were significant at months 4, 6, and 12. The differences in the number of patients with donor-site dyspigmentation between the minced skin grafting and control groups at 12 months were statistically significant (p < 0.05).
CONCLUSION


This prospective half-side comparative trial demonstrates that minced skin grafting promotes wound healing and improves donor-site appearance after split-thickness skin grafting.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2019,"All observers reported that the differences in donor-site appearance between the minced skin grafting and control groups were statistically significant at postoperative months 1 and 2, and two observers reported that the differences in donor-site appearance were significant at months 4, 6, and 12.",['30 patients were used for analysis'],"['Minced Skin Grafting', 'Split-Thickness Skin Grafting', 'minced skin grafting']","['number of patients with donor-site dyspigmentation', 'healing time', 'wound healing and improves donor-site appearance', 'small pasty graft mass', 'donor-site appearance', 'average time to complete healing of the donor sites']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin transplantation'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0173587,"All observers reported that the differences in donor-site appearance between the minced skin grafting and control groups were statistically significant at postoperative months 1 and 2, and two observers reported that the differences in donor-site appearance were significant at months 4, 6, and 12.","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Miyanaga', 'Affiliation': 'Ishikawa, Japan From the Department of Plastic Surgery, Kanazawa Medical University.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Kishibe', 'Affiliation': ''}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': ''}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': ''}, {'ForeName': 'Fumiya', 'Initials': 'F', 'LastName': 'Kinoshita', 'Affiliation': ''}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000005868']
954,31348529,Vitamin D supplementation for women during pregnancy.,"BACKGROUND


Vitamin D supplementation during pregnancy may be needed to protect against adverse pregnancy outcomes. This is an update of a review that was first published in 2012 and then in 2016.
OBJECTIVES


To examine whether vitamin D supplementation alone or in combination with calcium or other vitamins and minerals given to women during pregnancy can safely improve maternal and neonatal outcomes.
SEARCH METHODS


For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (12 July 2018), contacted relevant organisations (15 May 2018), reference lists of retrieved trials and registries at clinicaltrials.gov and WHO International Clinical Trials Registry Platform (12 July 2018). Abstracts were included if they had enough information to extract the data.
SELECTION CRITERIA


Randomised and quasi-randomised trials evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy in comparison to placebo or no intervention.
DATA COLLECTION AND ANALYSIS


Two review authors independently i) assessed the eligibility of trials against the inclusion criteria, ii) extracted data from included trials, and iii) assessed the risk of bias of the included trials. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS


We included 30 trials (7033 women), excluded 60 trials, identified six as ongoing/unpublished trials and two trials are awaiting assessments.Supplementation with vitamin D alone versus placebo/no interventionA total of 22 trials involving 3725 pregnant women were included in this comparison; 19 trials were assessed as having low-to-moderate risk of bias for most domains and three trials were assessed as having high risk of bias for most domains. Supplementation with vitamin D alone during pregnancy probably reduces the risk of pre-eclampsia (risk ratio (RR) 0.48, 95% confidence interval (CI) 0.30 to 0.79; 4 trials, 499 women, moderate-certainty evidence) and gestational diabetes (RR 0.51, 95% CI 0.27 to 0.97; 4 trials, 446 women, moderate-certainty evidence); and probably reduces the risk of having a baby with low birthweight (less than 2500 g) (RR 0.55, 95% CI 0.35 to 0.87; 5 trials, 697 women, moderate-certainty evidence) compared to women who received placebo or no intervention. Vitamin D supplementation may make little or no difference in the risk of having a preterm birth < 37 weeks compared to no intervention or placebo (RR 0.66, 95% CI 0.34 to 1.30; 7 trials, 1640 women, low-certainty evidence). In terms of maternal adverse events, vitamin D supplementation may reduce the risk of severe postpartum haemorrhage (RR 0.68, 95% CI 0.51 to 0.91; 1 trial, 1134 women, low-certainty evidence). There were no cases of hypercalcaemia (1 trial, 1134 women, low-certainty evidence), and we are very uncertain as to whether vitamin D increases or decreases the risk of nephritic syndrome (RR 0.17, 95% CI 0.01 to 4.06; 1 trial, 135 women, very low-certainty evidence). However, given the scarcity of data in general for maternal adverse events, no firm conclusions can be drawn.Supplementation with vitamin D and calcium versus placebo/no interventionNine trials involving 1916 pregnant women were included in this comparison; three trials were assessed as having low risk of bias for allocation and blinding, four trials were assessed as having high risk of bias and two had some components having a low risk, high risk, or unclear risk. Supplementation with vitamin D and calcium during pregnancy probably reduces the risk of pre-eclampsia (RR 0.50, 95% CI 0.32 to 0.78; 4 trials, 1174 women, moderate-certainty evidence). The effect of the intervention is uncertain on gestational diabetes (RR 0.33,% CI 0.01 to 7.84; 1 trial, 54 women, very low-certainty evidence); and low birthweight (less than 2500 g) (RR 0.68, 95% CI 0.10 to 4.55; 2 trials, 110 women, very low-certainty evidence) compared to women who received placebo or no intervention. Supplementation with vitamin D and calcium during pregnancy may increase the risk of preterm birth < 37 weeks in comparison to women who received placebo or no intervention (RR 1.52, 95% CI 1.01 to 2.28; 5 trials, 942 women, low-certainty evidence). No trial in this comparison reported on maternal adverse events.Supplementation with vitamin D + calcium + other vitamins and minerals versus calcium + other vitamins and minerals (but no vitamin D)One trial in 1300 participants was included in this comparison; it was assessed as having low risk of bias. Pre-eclampsia was not assessed. Supplementation with vitamin D + other nutrients may make little or no difference in the risk of preterm birth < 37 weeks (RR 1.04, 95% CI 0.68 to 1.59; 1 trial, 1298 women, low-certainty evidence); or low birthweight (less than 2500 g) (RR 1.12, 95% CI 0.82 to 1.51; 1 trial, 1298 women, low-certainty evidence). It is unclear whether it makes any difference to the risk of gestational diabetes (RR 0.42, 95% CI 0.10 to 1.73) or maternal adverse events (hypercalcaemia no events; hypercalciuria RR 0.25, 95% CI 0.02 to 3.97; 1 trial, 1298 women,) because the certainty of the evidence for both outcomes was found to be very low.
AUTHORS' CONCLUSIONS


We included 30 trials (7033 women) across three separate comparisons. Our GRADE assessments ranged from moderate to very low, with downgrading decisions based on limitations in study design, imprecision and indirectness.Supplementing pregnant women with vitamin D alone probably reduces the risk of pre-eclampsia, gestational diabetes, low birthweight and may reduce the risk of severe postpartum haemorrhage. It may make little or no difference in the risk of having a preterm birth < 37 weeks' gestation. Supplementing pregnant women with vitamin D and calcium probably reduces the risk of pre-eclampsia but may increase the risk of preterm births < 37 weeks (these findings warrant further research). Supplementing pregnant women with vitamin D and other nutrients may make little or no difference in the risk of preterm birth < 37 weeks' gestation or low birthweight (less than 2500 g). Additional rigorous high quality and larger randomised trials are required to evaluate the effects of vitamin D supplementation in pregnancy, particularly in relation to the risk of maternal adverse events.",2019,"Vitamin D supplementation may make little or no difference in the risk of having a preterm birth < 37 weeks compared to no intervention or placebo (RR 0.66, 95% CI 0.34 to 1.30; 7 trials, 1640 women, low-certainty evidence).","['30 trials (7033 women) across three separate comparisons', 'women during pregnancy in comparison to placebo or no intervention', '1916 pregnant women', 'gestational diabetes (RR 0.33', 'women during pregnancy', '3725 pregnant women', 'Supplementing pregnant women with', '1300 participants', '30 trials (7033 women), excluded 60 trials, identified six as ongoing/unpublished trials and two trials are awaiting assessments']","['vitamin D alone versus placebo', 'vitamin D supplementation', 'vitamin D and calcium', 'vitamin D + calcium + other vitamins and minerals versus calcium + other vitamins and minerals', 'placebo', 'supplementation with vitamin D alone or in\xa0combination\xa0with other\xa0micronutrients', 'vitamin D', 'vitamin D supplementation alone or in combination with calcium or other vitamins and minerals', 'vitamin D ', 'vitamin D and calcium versus placebo/no interventionNine', 'Vitamin D supplementation']","['risk of nephritic syndrome', 'risk of gestational diabetes', 'gestational diabetes', 'risk of pre-eclampsia, gestational diabetes, low birthweight', 'eclampsia', 'maternal adverse events', 'risk of preterm birth', 'risk of pre-eclampsia', 'risk of severe postpartum haemorrhage', 'risk of having a baby with low birthweight']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C4517449', 'cui_str': 'Zero point three three'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0268732', 'cui_str': 'Nephritic syndrome (disorder)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",1300.0,0.758436,"Vitamin D supplementation may make little or no difference in the risk of having a preterm birth < 37 weeks compared to no intervention or placebo (RR 0.66, 95% CI 0.34 to 1.30; 7 trials, 1640 women, low-certainty evidence).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Department of Dietetics and Nutrition, Robert Stempel College of Public Health and Social Work, Florida International University, 11200 SW 8th Street, AHC 5 - 323, Miami, Florida, USA, 33199.'}, {'ForeName': 'Lia K', 'Initials': 'LK', 'LastName': 'Kostiuk', 'Affiliation': ''}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Peña-Rosas', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008873.pub4']
955,32092167,A randomized controlled trial of a lifestyle intervention with longitudinal follow-up on ovarian dysmorphology in women with polycystic ovary syndrome.,"OBJECTIVE


Effects of lifestyle modification on reproductive function in polycystic ovary syndrome (PCOS) remain poorly elucidated. We compared the effects of a pulse-based diet (lentils, beans, split peas and chickpeas) with Therapeutic Lifestyle Changes (TLC) diet on ultrasonographic markers of ovarian morphology, hyperandrogenism and menstrual irregularity in PCOS.
DESIGN


Randomized controlled trial.
PATIENTS


Women with PCOS (18-35 years).
MEASUREMENTS


Thirty women randomized to the pulse-based and 31 to TLC groups completed a 16-week intervention without energy restriction. Groups performed aerobic exercise (minimum of 5 days/wk; 45 minutes/d) and received health counselling (monthly) and longitudinal follow-up. Follicle numbers per ovary (FNPO, 2-9 mm), ovarian volume (OV), free androgen index (FAI) and menstrual cycle length were measured pre- and postintervention.
RESULTS


Follicle numbers per ovary (mean change ± SD, -10 ± 15), OV (-2.7 ± 4.8 mL), FAI (-3 ± 2) and menstrual cycle length (-13 ± 47 days) decreased over time in both groups (All: P < .01), without group-by-time interactions (All: P ≥ .13). Attrition rate was 33.7% and comparable between groups (P = .94). Adherence to diet intervention negatively correlated with changes in FNPO (r=-0.54), OV (r=-0.35) and FAI (r = -.29) in pooled groups (All: P ≤ .04). Groups maintained reduced OV, FNPO, FAI and menstrual cycles 6 months postintervention; however, decreased FNPO and FAI at 16 weeks tended to revert to baseline levels 12 months postintervention in both groups (All: P ≤ .05).
CONCLUSIONS


Both interventions improved ovarian dysmorphology, hyperandrogenism and menstrual irregularity in PCOS, and no diet appeared to be superior at improving reproductive outcomes. Our observations highlight the importance of longitudinal surveillance for sustainable adherence to newly adopted healthy lifestyle behaviours and reproductive health in PCOS (ClinicalTrials.gov identifier, NCT01288638).",2020,"-13±47d) decreased over time in both groups (All: P<0.01), without group-by-time interactions (All: P≥0.13).","['polycystic ovary syndrome (PCOS', 'Thirty women randomized to the pulse-based and 31 to TLC groups completed a 16-week', 'Women with PCOS (18-35yrs', 'women with polycystic ovary syndrome']","['pulse-based diet (lentils, beans, split-peas, and chickpeas) with Therapeutic Lifestyle Changes (TLC) diet', 'health counseling (monthly) and longitudinal follow-up', 'lifestyle intervention', 'aerobic exercise', 'lifestyle modification', 'intervention without energy-restriction']","['OV, FNPO, FAI, and menstrual cycles', 'ovarian dysmorphology, hyperandrogenism, and menstrual irregularity in PCOS', 'FNPO and FAI', 'changes in FNPO (r=-0.54), OV (r=-0.35), and FAI', 'Attrition rate', 'ultrasonographic markers of ovarian morphology, hyperandrogenism, and menstrual irregularity in PCOS', 'FNPO (mean change±SD, -10±15), OV (-2.7±4.8mL), FAI (-3±2), and menstrual cycle length ', 'Follicle numbers per ovary (FNPO, 2-9 mm), ovarian volume (OV), free androgen index (FAI), and menstrual cycle length']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0950052', 'cui_str': 'Chickpea'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenism'}, {'cui': 'C0156404', 'cui_str': 'Irregular Menses'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4517451', 'cui_str': 'Zero point three five'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}]",30.0,0.123291,"-13±47d) decreased over time in both groups (All: P<0.01), without group-by-time interactions (All: P≥0.13).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kazemi', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Pierson', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'McBreairty', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Chizen', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}]",Clinical endocrinology,['10.1111/cen.14179']
956,31350629,Correction to: Comparative evaluation of Icon® resin infiltration and Clinpro™ XT varnish on colour and fluorescence changes of white spot lesions: a randomized controlled trial.,"In the publication of this article [1], there is an error in the Materials and methods section.",2019,"In the publication of this article [1], there is an error in the Materials and methods section.",['white spot lesions'],['Clinpro™ XT varnish'],[],"[{'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0042359', 'cui_str': 'Varnish'}]",[],,0.0865117,"In the publication of this article [1], there is an error in the Materials and methods section.","[{'ForeName': 'Annapurna', 'Initials': 'A', 'LastName': 'Kannan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Sri Ramachandra Institute of Higher Education and Research, Chennai, India. annapurnakannan@gmail.com.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Dental Sciences, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.'}]",Progress in orthodontics,['10.1186/s40510-019-0283-z']
957,32078356,Breakfast in the Classroom Initiative and Students' Breakfast Consumption Behaviors: A Group Randomized Trial.,"Objectives.  To identify the effect of a Breakfast in the Classroom (BIC) initiative on the foods and drinks students consume in the morning. Methods.  Sixteen public schools in Philadelphia, Pennsylvania, that provide universal breakfast participated in a group randomized trial to examine the effects of BIC with complementary nutrition promotion between 2013 and 2016. Control schools (n = 8) offered breakfast in the cafeteria before school. Baseline data were collected from 1362 students in grades 4 to 6. Endpoint data were collected after 2.5 years. Students self-reported the foods and drinks they consumed in the morning. Results.  At endpoint, there was no effect of the intervention on breakfast skipping. Nearly 30% of intervention students consumed breakfast foods or drinks from multiple locations, as compared with 21% of control students. A greater proportion of intervention students than control students consumed 100% juice, and a smaller proportion consumed sugar-sweetened beverages and foods high in saturated fat and added sugar. Conclusions.  A BIC initiative led to improvements in the types of foods and drinks students consumed in the morning. However, the program did not reduce breakfast skipping and increased the number of locations where students ate.",2020,"A greater proportion of intervention students than control students consumed 100% juice, and a smaller proportion consumed sugar-sweetened beverages and foods high in saturated fat and added sugar.","['1362 students in grades 4 to 6', ""Breakfast in the Classroom Initiative and Students' Breakfast Consumption Behaviors"", 'Sixteen public schools in Philadelphia, Pennsylvania, that provide universal breakfast participated']",[],['breakfast skipping'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]",[],"[{'cui': 'C4553621', 'cui_str': 'With breakfast'}]",,0.0326703,"A greater proportion of intervention students than control students consumed 100% juice, and a smaller proportion consumed sugar-sweetened beverages and foods high in saturated fat and added sugar.","[{'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Bauer', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Weeks', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Polonsky', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Davey', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Abel', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Ruth', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Dale', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Katherine W. Bauer and Heidi M. Weeks are with the Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor. Gary D. Foster is with WW International (formerly known as Weight Watchers), New York, NY. Heather M. Polonsky and Jennifer O. Fisher are with the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA. Adam Davey is with the College of Health Sciences and the Department of Behavioral Health and Nutrition, University of Delaware, Newark. Sandy Sherman, Michelle L. Abel, and Lauren C. Dale are with The Food Trust, Philadelphia. Karen J. Ruth is with the Fox Chase Cancer Center, Temple Health, Philadelphia.'}]",American journal of public health,['10.2105/AJPH.2019.305511']
958,32072695,"Orally administered mixed carotenoids protect human skin against ultraviolet A-induced skin pigmentation: A double-blind, placebo-controlled, randomized clinical trial.","BACKGROUND


Photoprotection of human skin is determined as the capacity of sunscreens to prevent ultraviolet (UV) B radiation-induced erythema and UVA radiation-induced pigmentation. It is unequivocal that, in addition to sunscreens, oral supplementation with carotenoids can protect human skin against UVB radiation-induced erythema. It is not known if this is also the case for UVA radiation-induced pigmentation.
OBJECTIVE


To clinically evaluate the photoprotective effects of daily supplementation with carotenoids against UVA radiation-induced pigmentation.
METHODS


In this double-blind, placebo-controlled trial, 60 subjects (Fitzpatrick types II-IV) were randomized to receive Nutrilite™ Multi Carotene supplement or placebo for 12 weeks. UVB-induced minimal erythemal dose (MED), UVA-induced minimal persistent pigmentation dose (MPPD) and skin carotenoid levels were measured at baseline, 4, 8, and 12 weeks of intervention. Skin color was evaluated by expert clinical graders and by colorimetry. Carotenoid levels in the skin were measured by the Biozoom ®  device.
RESULTS


In the intervention group, a significant increase in comparison with the placebo group was observed in (a) skin carotenoid levels, (b) UVB-induced MED, and (c) UVA-induced MPPD values obtained by colorimetry.
CONCLUSION


Daily supplementation with carotenoids protects human skin against both UVB-induced erythema and UVA-induced pigmentation.",2020,"In the intervention group, a significant increase in comparison with the placebo group was observed in (i) skin carotenoid levels, (ii) UVB-induced MED and (iii) UVA-induced MPPD values obtained by colorimetry.
","['60 subjects (Fitzpatrick types II-IV', 'induced skin pigmentation']","['carotenoids against UVA radiation-induced pigmentation', 'placebo', 'mixed carotenoids protect human skin against Ultraviolet A', 'UVB-induced Minimal Erythemal dose (MED', 'Nutrilite™ Multi Carotene supplement or placebo']","[' UVA-induced Minimal Persistent Pigmentation Dose (MPPD) and skin carotenoid levels', 'Carotenoid levels', 'i) skin carotenoid levels, (ii) UVB-induced MED and (iii) UVA-induced MPPD values', 'Skin color']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1269684', 'cui_str': 'Skin pigmented'}]","[{'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037290', 'cui_str': 'Skin Tone'}]",60.0,0.224159,"In the intervention group, a significant increase in comparison with the placebo group was observed in (i) skin carotenoid levels, (ii) UVB-induced MED and (iii) UVA-induced MPPD values obtained by colorimetry.
","[{'ForeName': 'Sudhir M', 'Initials': 'SM', 'LastName': 'Baswan', 'Affiliation': 'Global Discovery R&D, Amway Corporation, Ada, MI, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marini', 'Affiliation': 'IUF - Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Klosner', 'Affiliation': 'Nutrilite Health Institute R&D, Amway Corporation, Buena Park, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaenicke', 'Affiliation': 'IUF - Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Leverett', 'Affiliation': 'Global Discovery R&D, Amway Corporation, Ada, MI, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': 'Nutrilite Health Institute R&D, Amway Corporation, Buena Park, CA, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gellenbeck', 'Affiliation': 'Nutrilite Health Institute R&D, Amway Corporation, Buena Park, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Krutmann', 'Affiliation': 'IUF - Leibniz Research Institute for Environmental Medicine, Düsseldorf, Germany.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12541']
959,31353231,Impact of lipoprotein apheresis on thrombotic parameters in patients with refractory angina and raised lipoprotein(a): Findings from a randomized controlled cross-over trial.,"BACKGROUND


Raised lipoprotein(a) [Lp(a)] is a cardiovascular risk factor common in patients with refractory angina. The apolipoprotein(a) component of Lp(a) exhibits structural homology with plasminogen and can enhance thrombosis and impair fibrinolysis.
OBJECTIVES


The objective of the study was to assess the effect of lipoprotein apheresis on markers of thrombosis and fibrinolysis in patients with high Lp(a).
METHODS


In a prospective, single-blind, crossover trial, 20 patients with refractory angina and raised Lp(a) > 50 mg/dL were randomized to three months of weekly lipoprotein apheresis or sham. Blood taken before and after apheresis/sham was assessed using the Global Thrombosis Test, to assess time taken for in vitro thrombus formation (occlusion time) and endogenous fibrinolysis (lysis time), as well as von Willebrand Factor, fibrinogen, D-dimer, thrombin/anti-thrombin III complex, prothrombin fragments 1 + 2, and thrombin generation assays.
RESULTS


Lp(a) was significantly reduced by apheresis (100.2 [interquartile range {IQR}, 69.6143.0] vs 24.8 [17.2,34.0] mg/dL, P = .0001) but not by sham (P = .0001 between treatment arms). Apheresis prolonged occlusion time (576 ± 116 s vs 723 ± 142 s, P < .0001) reflecting reduced platelet reactivity and reduced lysis time (1340 [1128, 1682] s vs 847 [685,1302] s, P = .0006) reflecting enhanced fibrinolysis, without corresponding changes with sham. Apheresis, but not sham, reduced von Willebrand Factor (149 [89.0, 164] vs 64.2 [48.5, 89.8] IU/dL, P = .0001), and fibrinogen (3.12 ± 0.68 vs 2.20 ± 0.53 g/L, P < .0001), and increased prothrombin fragments 1 + 2 (158.16 [128.77, 232.09] vs 795.12 [272.55, 1201.00] pmol/L, P = .0006). There was no change in D-dimer, thrombin/anti-thrombin III complex, or thrombin generation assay with apheresis or sham.
CONCLUSION


Lipoprotein apheresis reduces Lp(a) and improves some thrombotic and fibrinolytic parameters in patients with refractory angina.",2019,"Apheresis prolonged occlusion time (576 ± 116 s vs 723 ± 142 s, P < .0001) reflecting reduced platelet reactivity and reduced lysis time (1340 [1128, 1682] s vs 847","['patients with refractory angina and raised lipoprotein(a', '20 patients with refractory angina and raised Lp(a)\xa0', 'patients with refractory angina', 'patients with high Lp(a']","['Raised lipoprotein(a) [Lp(a', 'lipoprotein apheresis or sham', 'lipoprotein apheresis', 'Lipoprotein apheresis']","['thrombotic parameters', 'prothrombin fragments', 'reduced von Willebrand Factor', 'platelet reactivity and reduced lysis time', 'thrombotic and fibrinolytic parameters', 'time taken for in\xa0vitro thrombus formation (occlusion time) and endogenous fibrinolysis (lysis time), as well as von Willebrand Factor, fibrinogen, D-dimer, thrombin/anti-thrombin III complex, prothrombin fragments 1\xa0+\xa02, and thrombin generation assays', 'Apheresis prolonged occlusion time', 'Lp(a', 'D-dimer, thrombin/anti-thrombin III complex, or thrombin generation assay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",,0.436947,"Apheresis prolonged occlusion time (576 ± 116 s vs 723 ± 142 s, P < .0001) reflecting reduced platelet reactivity and reduced lysis time (1340 [1128, 1682] s vs 847","[{'ForeName': 'Tina Z', 'Initials': 'TZ', 'LastName': 'Khan', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Deepa J', 'Initials': 'DJ', 'LastName': 'Arachchillage', 'Affiliation': 'Department of Haematology, Royal Brompton and Imperial College Healthcare NHS Trust and Imperial College London, London, UK.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Ahnström', 'Affiliation': 'Department of Haematology, Royal Brompton and Imperial College Healthcare NHS Trust and Imperial College London, London, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pottle', 'Affiliation': 'Cardiology Department, Harefield Hospital, Harefield, UK.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Barbir', 'Affiliation': 'Cardiology Department, Harefield Hospital, Harefield, UK. Electronic address: M.Barbir@rbht.nhs.uk.'}, {'ForeName': 'Dudley J', 'Initials': 'DJ', 'LastName': 'Pennell', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.06.009']
960,31294868,Rejuvenation of RBCs: validation of a manufacturing method suitable for clinical use.,"BACKGROUND


Rejuvenation of stored red blood cells (RBCs) increases levels of adenosine 5'-triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG) to those of fresh cells. This study aimed to optimize and validate the US-approved process to a UK setting for manufacture and issue of rejuvenated RBCs for a multicenter randomized controlled clinical trial in cardiac surgery.
STUDY DESIGN AND METHODS


Rejuvenation of leukoreduced RBC units involved adding a solution containing pyruvate, inosine, phosphate, and adenine (Rejuvesol, Zimmer Biomet), warming at 37°C for 60 minutes, then ""manual"" washing with saline adenine glucose mannitol solution. A laboratory study was conducted on six pools of ABO/D-matched units made the day after donation. On Days 7, 21, and 28 of 4 ± 2°C storage, one unit per pool was rejuvenated and measured over 96 hours for volume, hematocrit, hemolysis, ATP, 2,3-DPG, supernatant potassium, lactate, and purines added (inosine) or produced (hypoxanthine) by rejuvenation. Subsequently, an operational validation (two phases of 32 units each) was undertaken, with results from the first informing a trial component specification applied to the second. Rejuvenation effects were also tested on crossmatch reactivity and RBC antigen profiles.
RESULTS


Rejuvenation raised 2,3-DPG to, and ATP above, levels of fresh cells. The final component had potassium and hemolysis values below those of standard storage Days 7 and 21, respectively, containing 1.2% exogenous inosine and 500 to 1900 μmoles/unit of hypoxanthine. The second operational validation met compliance to the trial component specification. Rejuvenation did not adversely affect crossmatch reactivity or RBC antigen profiles.
CONCLUSION


The validated rejuvenation process operates within defined quality limits, preserving RBC immunophenotypes, enabling manufacture for clinical trials.",2019,"Rejuvenation did not adversely affect crossmatch reactivity or RBC antigen profiles.
",['Rejuvenation of leukoreduced RBC units involved adding a'],"['solution containing pyruvate, inosine, phosphate, and adenine (Rejuvesol, Zimmer Biomet), warming at 37°C for 60\u2009minutes, then ""manual"" washing with saline adenine glucose mannitol solution']","['crossmatch reactivity or RBC antigen profiles', 'Rejuvenation effects', 'crossmatch reactivity and RBC antigen profiles', ""adenosine 5'-triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG"", 'volume, hematocrit, hemolysis, ATP, 2,3-DPG, supernatant potassium, lactate, and purines added (inosine) or produced (hypoxanthine']","[{'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0244104', 'cui_str': 'Pyruvate'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0001407', 'cui_str': 'Adenine'}, {'cui': 'C0085898', 'cui_str': 'Biomet'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}]","[{'cui': 'C0855279', 'cui_str': 'Crossmatch'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0045399', 'cui_str': '2,3-Bisphosphoglycerate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}]",,0.0403322,"Rejuvenation did not adversely affect crossmatch reactivity or RBC antigen profiles.
","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Smethurst', 'Affiliation': 'Component Development Laboratory, NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jolley', 'Affiliation': 'Component Development Laboratory, NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Braund', 'Affiliation': 'Manufacturing & Development, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Proffitt', 'Affiliation': 'Component Development Laboratory, NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lynes', 'Affiliation': 'Red Cell Immunohaematology, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hazell', 'Affiliation': 'Red Cell Immunohaematology, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Mellor', 'Affiliation': 'Manufacturing & Development, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Ridgwell', 'Affiliation': 'IBGRL Protein Development & Production Unit, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Procter', 'Affiliation': 'Quality Monitoring, NHS Blood and Transplant, London, United Kingdom.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': 'Clinical Trials Unit, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Marinaki', 'Affiliation': ""Purine Research Laboratory, St Thomas' Hospital, London, United Kingdom.""}, {'ForeName': 'Helen V', 'Initials': 'HV', 'LastName': 'New', 'Affiliation': 'Clinical Directorate, NHS Blood and Transplant, London, United Kingdom.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, Glenfield General Hospital, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Edmondson', 'Affiliation': 'Manufacturing & Development, NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cardigan', 'Affiliation': 'Component Development Laboratory, NHS Blood and Transplant, Cambridge, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15426']
961,30696554,A randomised clinical study comparing the effect of Steareth 30 and SLS containing toothpastes on oral epithelial integrity (desquamation).,"OBJECTIVE


To compare the clinical effect of toothpastes containing Steareth 30 and SLS (sodium lauryl sulphate) surfactants on oral epithelial integrity (desquamation) using a new Oral Mucosal Sloughing Index (OMSI).
METHODS


30 volunteers participated in a single centre, double-blind, randomised, crossover clinical study. After a lead-in, subjects were allocated to the first test toothpaste, which was applied to the maxilla via a cap splint, followed by whole mouth brushing with the respective toothpaste and rinsing with the toothpaste slurry. Soft desquamation (lesion status) was assessed using a novel Oral Mucosal Sloughing Index (OMSI). Soft tissue status was measured at baseline (prior to test product use), 30 min following test product application and 4 days later following ""at home"" use of test toothpaste. After a wash out period, soft tissue assessment and product use were repeated for the remaining toothpaste.
RESULTS


Using the OMSI, 30 min post-application, significantly fewer lesion counts (all sites) were observed for the Steareth 30 toothpaste compared to SLS toothpaste (p < 0.0001). Additionally, 30 min after toothpaste use, the average lesion severity score was significantly lower for the Steareth 30 toothpaste compared to SLS toothpaste (p < 0.0001). There were no significant differences in lesion status at baseline or following 4 days of ""at home"" use of the toothpastes. No product related adverse events were reported.
CONCLUSION


Using an Oral Mucosal Sloughing Index for assessment, application of a toothpaste containing Steareth 30 generated significantly less transient soft tissue desquamation (fewer lesion counts and lower severity) than a toothpaste containing SLS.
CLINICAL SIGNIFICANCE


Treatment with a toothpaste containing Steareth 30 surfactant generated fewer transient soft tissue lesions (lower desquamation) compared to a toothpaste containing SLS surfactant.",2019,"There were no significant differences in lesion status at baseline or following 4 days of ""at home"" use of the toothpastes.",['30 volunteers participated in a single centre'],"['SLS toothpaste', 'Steareth 30 and SLS containing toothpastes', 'toothpastes containing Steareth 30 and SLS (sodium lauryl sulphate) surfactants', 'maxilla via a cap splint, followed by whole mouth brushing with the respective toothpaste and rinsing with the toothpaste slurry']","['lesion counts', 'Soft desquamation (lesion status', 'transient soft tissue lesions', 'lesion status', 'adverse events', 'transient soft tissue desquamation', 'novel Oral Mucosal Sloughing Index (OMSI', 'average lesion severity score', 'oral epithelial integrity (desquamation', 'Soft tissue status']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1725493', 'cui_str': 'steareth-30'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037506', 'cui_str': 'sodium lauryl sulfate'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0237849', 'cui_str': 'Scaling of skin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0853332', 'cui_str': 'Desquamation mouth'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",30.0,0.0397253,"There were no significant differences in lesion status at baseline or following 4 days of ""at home"" use of the toothpastes.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Unilever Oral Care, Quarry Road East, Bebington, Wirral, CH63 3JW, UK. Electronic address: alison.green@unilever.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Crichard', 'Affiliation': 'Birmingham Dental Hospital and School of Dentistry, 5 Mill Pool Way, Birmingham, B5 7EG, UK. Electronic address: S.D.Crichard@bham.ac.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ling-Mountford', 'Affiliation': 'Birmingham Dental Hospital and School of Dentistry, 5 Mill Pool Way, Birmingham, B5 7EG, UK. Electronic address: N.A.Ling@bham.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milward', 'Affiliation': 'Birmingham Dental Hospital and School of Dentistry, 5 Mill Pool Way, Birmingham, B5 7EG, UK. Electronic address: m.r.milward@bham.ac.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hubber', 'Affiliation': 'Birmingham Dental Hospital and School of Dentistry, 5 Mill Pool Way, Birmingham, B5 7EG, UK. Electronic address: N.Hubber@bham.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Platten', 'Affiliation': 'Unilever Oral Care, Quarry Road East, Bebington, Wirral, CH63 3JW, UK. Electronic address: Suzanne.Platten@Unilever.com.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Hindustan Unilever Limited Research Centre, Main Road, Whitefield, Bangalore 560 066, India. Electronic address: AshokKumar.Gupta@unilever.com.'}, {'ForeName': 'I L C', 'Initials': 'ILC', 'LastName': 'Chapple', 'Affiliation': 'Birmingham Dental Hospital and School of Dentistry, 5 Mill Pool Way, Birmingham, B5 7EG, UK. Electronic address: i.l.c.chapple@bham.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2018.11.005']
962,31118178,Economic evaluation of a phase III international randomised controlled trial of very early mobilisation after stroke (AVERT).,"OBJECTIVES


While very early mobilisation (VEM) intervention for stroke patients was shown not to be effective at 3 months, 12 month clinical and economical outcomes remain unknown. The aim was to assess cost-effectiveness of a VEM intervention within a phase III randomised controlled trial (RCT).
DESIGN


An economic evaluation alongside a RCT, and detailed resource use and cost analysis over 12 months post-acute stroke.
SETTING


Multi-country RCT involved 58 stroke centres.
PARTICIPANTS


2104 patients with acute stroke who were admitted to a stroke unit.
INTERVENTION


A very early rehabilitation intervention within 24 hours of stroke onset METHODS: Cost-utility analyses were undertaken according to pre-specified protocol measuring VEM against usual care (UC) based on 12 month outcomes. The analysis was conducted using both health sector and societal perspectives. Unit costs were sourced from participating countries. Details on resource use (both health and non-health) were sourced from cost case report form. Dichotomised modified Rankin Scale (mRS) scores (0 to 2 vs 3 to 6) and quality adjusted-life years (QALYs) were used to compare the treatment effect of VEM and UC. The base case analysis was performed on an intention-to-treat basis and 95% CI for cost and QALYs were estimated by bootstrapping. Sensitivity analysis were conducted to examine the robustness of base case results.
RESULTS


VEM and UC groups were comparable in the quantity of resource use and cost of each component. There were no differences in the probability of achieving a favourable mRS outcome (0.030, 95% CI -0.022 to 0.082), QALYs (0.013, 95% CI -0.041 to 0.016) and cost (AUD1082, 95% CI -$2520 to $4685 from a health sector perspective or AUD102, 95% CI -$6907 to $7111, from a societal perspective including productivity cost). Sensitivity analysis achieved results with mostly overlapped CIs.
CONCLUSIONS


VEM and UC were associated with comparable costs, mRS outcome and QALY gains at 12 months. Compared with to UC, VEM is unlikely to be cost-effective. The long-term data collection during the trial also informed resource use and cost of care post-acute stroke across five participating countries.
TRIAL REGISTRATION NUMBER


ACTRN12606000185561; Results.",2019,"There were no differences in the probability of achieving a favourable mRS outcome (0.030, 95% CI -0.022 to 0.082), QALYs (0.013, 95% CI -0.041 to 0.016) and cost (AUD1082, 95% CI -$2520 to $4685 from a health sector perspective or AUD102, 95% CI -$6907 to $7111, from a societal perspective including productivity cost).","['2104 patients with acute stroke who were admitted to a stroke unit', 'Multi-country RCT involved 58 stroke centres', 'stroke patients']","['VEM intervention', 'While very early mobilisation (VEM) intervention']","['costs, mRS outcome and QALY gains', 'quantity of resource use and cost of each component', 'Unit costs', 'Dichotomised modified Rankin Scale (mRS) scores', 'probability of achieving a favourable mRS outcome', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2104.0,0.173003,"There were no differences in the probability of achieving a favourable mRS outcome (0.030, 95% CI -0.022 to 0.082), QALYs (0.013, 95% CI -0.041 to 0.016) and cost (AUD1082, 95% CI -$2520 to $4685 from a health sector perspective or AUD102, 95% CI -$6907 to $7111, from a societal perspective including productivity cost).","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sheppard', 'Affiliation': 'Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wu', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ellery', 'Affiliation': 'Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health, Box Hill, Victoria, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-026230']
963,31109356,Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial.,"After publication of the original article [1], the authors have notified us that their originally submitted Table 1 was mistakenly replaced with Fig. 3 during editing. The original article has been corrected.The publisher apologizes to the readers for the inconvenience caused.",2019,The publisher apologizes to the readers for the inconvenience caused.,[],['Tamponade dressings versus no tamponade after hemorrhoidectomy'],[],[],"[{'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]",[],,0.0280281,The publisher apologizes to the readers for the inconvenience caused.,"[{'ForeName': 'Mike Ralf', 'Initials': 'MR', 'LastName': 'Langenbach', 'Affiliation': 'Klinik für Allgemein-/Viszeralchirurgie und Koloproktologie, Helios St. Elisabeth Klinik Josefstr. 3, 46045, Oberhausen, Germany.'}, {'ForeName': 'Dörthe', 'Initials': 'D', 'LastName': 'Seidel', 'Affiliation': 'Institut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke, Ostmerheimerstraße 200 Haus 38, 51109, Köln, Germany. doerthe.seidel@uni-wh.de.'}]",Trials,['10.1186/s13063-019-3358-8']
964,31019377,Correction to: Randomized community trial on nosocomial infection control educational module for nurses in public hospitals in Yemen: a study protocol.,[This corrects the article DOI: 10.1186/s12912-019-0333-3.].,2019,[This corrects the article DOI: 10.1186/s12912-019-0333-3.].,['nurses in public hospitals in Yemen'],['nosocomial infection control educational module'],[],"[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C0205721', 'cui_str': 'Infections, Hospital'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]",[],,0.0779861,[This corrects the article DOI: 10.1186/s12912-019-0333-3.].,"[{'ForeName': 'Gamil', 'Initials': 'G', 'LastName': 'Alrubaiee', 'Affiliation': ""Department of Applied Medical Sciences, Faculty of Medical Sciences, Al-Razi University, Sana'a, Yemen.""}, {'ForeName': 'Anisah', 'Initials': 'A', 'LastName': 'Baharom', 'Affiliation': '2Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan, Malaysia.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Faisal', 'Affiliation': '2Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan, Malaysia.'}, {'ForeName': 'Kadir Shahar', 'Initials': 'KS', 'LastName': 'Hayati', 'Affiliation': '2Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan, Malaysia.'}, {'ForeName': 'Shaffe Mohd', 'Initials': 'SM', 'LastName': 'Daud', 'Affiliation': '3Department of Foundations of Education, Faculty of Educational Studies, Universiti Putra Malaysia, Seri Kembangan, Malaysia.'}, {'ForeName': 'Huda Omer', 'Initials': 'HO', 'LastName': 'Basaleem', 'Affiliation': '4Department of Community Medicine and Public Health, Faculty of Medicine and Health Sciences, University of Aden, Aden, Yemen.'}]",BMC nursing,['10.1186/s12912-019-0340-4']
965,31034300,"FLT3 Inhibitor Maintenance After Allogeneic Transplantation: Is a Placebo-Controlled, Randomized Trial Ethical?",,2019,,[],"['Placebo', 'FLT3 Inhibitor Maintenance', 'Allogeneic Transplantation']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}]",[],,0.106653,,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Levis', 'Affiliation': '1 Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Yi-Bin', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': '2 Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hamadani', 'Affiliation': '3 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': '3 Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': '1 Johns Hopkins University, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00321']
966,31350784,When Expectancies Are Violated: A Functional Magnetic Resonance Imaging Study.,"Positive and negative expectancies drive behavioral and neurobiological placebo and nocebo effects, which in turn can have profound effects on patient improvement or worsening. However, expectations of events and outcomes are often not met in daily life and clinical practice. It is currently unknown how this affects placebo and nocebo effects. We have demonstrated that the violation of expectancies, such as when there is a discrepancy between what is expected and what is actually presented, reduces both placebo and nocebo effects while causing an extinction of placebo effects. The reduction of placebo and nocebo effects was paralleled by an activation of the left inferior parietal cortex, a brain region that redirects attention when discrepancies between sensory and cognitive events occur. Our findings highlight the importance of expectancy violation in shaping placebo and nocebo effects and open up new avenues for managing positive and negative expectations in clinical trials and practices.",2019,"The reduction of placebo and nocebo effects was paralleled by an activation of the left inferior parietal cortex, a brain region that redirects attention when discrepancies between sensory and cognitive events occur.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.290615,"The reduction of placebo and nocebo effects was paralleled by an activation of the left inferior parietal cortex, a brain region that redirects attention when discrepancies between sensory and cognitive events occur.","[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland Baltimore School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Department of Pain and Translational Symptom Science, University of Maryland Baltimore School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Dominic E', 'Initials': 'DE', 'LastName': 'Nathan', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Robinson', 'Affiliation': 'University College London Institute of Cognitive Neuroscience, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1587']
967,31067138,"Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study.","PURPOSE


Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression-free survival (PFS) and delayed new disease in patients with oligometastatic non-small-cell lung cancer (NSCLC) that did not progress after front-line systemic therapy. Herein, we present the longer-term overall survival (OS) results accompanied by additional secondary end points.
PATIENTS AND METHODS


This multicenter, randomized, phase II trial enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy. Patients were randomly assigned (1:1) to maintenance therapy or observation (MT/O) or to LCT to all active disease sites. The primary end point was PFS; secondary end points were OS, toxicity, and the appearance of new lesions. All analyses were two sided, and  P  values less than .10 were deemed significant.
RESULTS


The Data Safety and Monitoring Board recommended early trial closure after 49 patients were randomly assigned because of a significant PFS benefit in the LCT arm. With an updated median follow-up time of 38.8 months (range, 28.3 to 61.4 months), the PFS benefit was durable (median, 14.2 months [95% CI, 7.4 to 23.1 months] with LCT  v  4.4 months [95% CI, 2.2 to 8.3 months] with MT/O;  P  = .022). We also found an OS benefit in the LCT arm (median, 41.2 months [95% CI, 18.9 months to not reached] with LCT  v  17.0 months [95% CI, 10.1 to 39.8 months] with MT/O;  P  = .017). No additional grade 3 or greater toxicities were observed. Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034). Of the 20 patients who experienced progression in the MT/O arm, nine received LCT to all lesions after progression, and the median OS was 17 months (95% CI, 7.8 months to not reached).
CONCLUSION


In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O.",2019,Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034).,"['patients with oligometastatic non-small-cell lung cancer (NSCLC', '49 patients', 'Patients With Oligometastatic Non-Small-Cell Lung Cancer', 'enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy']","['maintenance therapy or observation (MT/O) or to LCT', 'LCT', 'Maintenance Therapy or Observation', 'local consolidative therapy (LCT) with radiotherapy']","['OS benefit', 'Survival after progression', 'progression-free survival (PFS', 'OS, toxicity, and the appearance of new lesions', 'longer-term overall survival (OS', 'median OS', 'PFS benefit', 'toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",49.0,0.136817,Survival after progression was longer in the LCT group (37.6 months with LCT  v  9.4 months with MT/O;  P  = .034).,"[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Gomez', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': '2 London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Louie', 'Affiliation': '2 London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Doebele', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Ferdinandos', 'Initials': 'F', 'LastName': 'Skoulidis', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Laurie E', 'Initials': 'LE', 'LastName': 'Gaspar', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Don L', 'Initials': 'DL', 'LastName': 'Gibbons', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kavanagh', 'Affiliation': '3 University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Sepesi', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00201']
968,31446979,Predicting pathologic response to neoadjuvant chemoradiation in resectable stage III non-small cell lung cancer patients using computed tomography radiomic features.,"OBJECTIVE


The use of a neoadjuvant chemoradiation followed by surgery in patients with stage IIIA NSCLC is controversial and the benefit of surgery is limited. There are currently no clinically validated biomarkers to select patients for such an approach. In this study we evaluate computed tomography (CT) derived intratumoral and peritumoral texture and nodule shape features in their ability to predict major pathological response (MPR). MPR being defined as ≤10% of residual viable tumor, assessed at the time of surgery.
MATERIAL AND METHODS


Ninety patients with stage III NSCLC treated with chemoradiation prior to surgical resection were selected. The patients were divided randomly into two equal sets, one for training and one for independent testing. The radiomic texture and shape features were extracted from within the nodule (intra) and from the parenchymal regions immediately surrounding the nodule (peritumoral). A univariate regression analysis was performed on the image and clinicopathologic variables and then included into a multivariable logistic regression (MLR) for binary outcome prediction of MPR. The radiomic signature risk-score was generated by using a multivariate Cox regression model and association of the signature with OS and DFS was also evaluated.
RESULTS


Thirteen stable and predictive intratumoral and peritumoral radiomic texture features were found to be predictive of MPR. The MLR classifier yielded an AUC of 0.90 ± 0.025 within the training set and a corresponding AUC = 0.86 in prediction of MPR within the test set. The radiomic signature was also significantly associated with OS (HR = 11.18, 95% CI = 3.17, 44.1; p-value = 0.008) and DFS (HR = 2.78, 95% CI = 1.11, 4.12; p-value = 0.0042) in the testing set.
CONCLUSION


Texture features extracted within and around the lung tumor on CT images appears to be associated with the likelihood of MPR, OS and DFS to chemoradiation.",2019,Thirteen stable and predictive intratumoral and peritumoral radiomic texture features were found to be predictive of MPR.,"['Ninety patients with stage III NSCLC treated with chemoradiation prior to surgical resection were selected', 'patients with stage IIIA NSCLC', 'resectable stage III non-small cell lung cancer patients using computed tomography radiomic features']","['neoadjuvant chemoradiation', 'computed tomography (CT']","['pathologic response', 'radiomic signature risk-score']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",13.0,0.0231974,Thirteen stable and predictive intratumoral and peritumoral radiomic texture features were found to be predictive of MPR.,"[{'ForeName': 'Mohammadhadi', 'Initials': 'M', 'LastName': 'Khorrami', 'Affiliation': 'Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Prantesh', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Hematology/Oncology, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, OH, USA.'}, {'ForeName': 'Kaustav', 'Initials': 'K', 'LastName': 'Bera', 'Affiliation': 'Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Alilou', 'Affiliation': 'Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Thawani', 'Affiliation': 'Maimonides Medical Center, 4802 10th Ave, Brooklyn, NY 11219, USA.'}, {'ForeName': 'Pradnya', 'Initials': 'P', 'LastName': 'Patil', 'Affiliation': 'Department of Solid Tumor Oncology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Ahmad', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Sudish', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Stephans', 'Affiliation': 'Department of Radiation Oncology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Pinfu', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, USA.'}, {'ForeName': 'Vamsidhar', 'Initials': 'V', 'LastName': 'Velcheti', 'Affiliation': 'Department of Hematology and Oncology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Madabhushi', 'Affiliation': 'Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH, USA; Louis Stokes Cleveland Veterans Administration Medical Center, OH, USA. Electronic address: anant.madabhushi@case.edu.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.06.020']
969,32109255,"A randomized controlled study incorporating an electromechanical gait machine, the Hybrid Assistive Limb, in gait training of patients with severe limitations in walking in the subacute phase after stroke.","Early onset, intensive and repetitive, gait training may improve outcome after stroke but for patients with severe limitations in walking, rehabilitation is a challenge. The Hybrid Assistive Limb (HAL) is a gait machine that captures voluntary actions and support gait motions. Previous studies of HAL indicate beneficial effects on walking, but these results need to be confirmed in blinded, randomized controlled studies. This study aimed to explore effects of incorporating gait training with HAL as part of an inpatient rehabilitation program after stroke. Thirty-two subacute stroke patients with severe limitations in walking were randomized to incorporated HAL training (4 days/week for 4 weeks) or conventional gait training only. Blinded assessments were carried out at baseline, after the intervention, and at 6 months post stroke. The primary outcome was walking independence according to the Functional Ambulation Categories. Secondary outcomes were the Fugl-Meyer Assessment, 2-Minute Walk Test, Berg Balance Scale, and the Barthel Index. No significant between-group differences were found regarding any primary or secondary outcomes. At 6 months, two thirds of all patients were independent in walking. Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048). This study found no difference between groups for any outcomes despite the extra resources required for the HAL training, but highlights the substantial improvements in walking seen when evidence-based rehabilitation is provided to patients, with severe limitations in walking in the subacute stage after stroke. In future studies potential subgroups of patients who will benefit the most from electromechanically-assisted gait training should be explored.",2020,"Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048).","['Thirty-two subacute stroke patients with severe limitations in walking', 'patients with severe limitations in walking in the subacute phase after stroke']","['HAL', 'electromechanical gait machine, the Hybrid Assistive Limb, in gait training', 'conventional gait training only', 'Hybrid Assistive Limb (HAL', 'HAL training', 'gait training with HAL']","['Fugl-Meyer Assessment, 2-Minute Walk Test, Berg Balance Scale, and the Barthel Index', 'walking independence according to the Functional Ambulation Categories']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}]",32.0,0.0927106,"Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048).","[{'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Wall', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Borg', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Vreede', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Palmcrantz', 'Affiliation': 'Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0229707']
970,32159243,Peer mentorship as an adjunct intervention for the treatment of eating disorders: A pilot randomized trial.,"OBJECTIVE


Peer mentorship has been shown to be helpful for other mental health conditions, but it has been understudied for patients with eating disorders. The goal of the present study was to evaluate the feasibility and efficacy of peer mentorship for individuals with eating disorders by conducting a randomized controlled trial (RCT).
TRIAL DESIGN


Parallel three-arm pilot RCT with 1:1:1 allocation to peer mentorship, social support mentorship (active comparison intervention), and waiting list.
METHOD


Sixty outpatients with anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED) were randomly assigned to a condition. Outcome measures, including eating disorder symptoms and general psychopathology, were completed at baseline, mid-, and postintervention.
RESULTS


Session attendance and acceptability ratings were higher in peer mentorship than social support mentorship. More participants in social support mentorship (39%) dropped out compared to peer mentorship (5%). In intent-to-treat analysis, peer mentorship showed greater reductions in body dissatisfaction and anxiety compared with both control groups. Compared with social support mentorship, peer mentorship had greater reductions in depression. Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN. Peer mentorship did not impact body mass index or reentry into higher level of care.
DISCUSSION


This pilot RCT provides preliminary evidence that peer mentorship is effective for some cognitive and behavioral symptoms of eating disorders as an adjunct to outpatient treatment. Additional studies are needed to evaluate the efficacy of peer mentorship in absence of treatment.",2020,"Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN.","['eating disorders', 'patients with eating disorders', 'Sixty outpatients with anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED', 'individuals with eating disorders']","['social support mentorship', 'peer mentorship, social support mentorship (active comparison intervention), and waiting list', 'peer mentorship', 'Peer mentorship', 'social support mentorship, peer mentorship']","['acceptability ratings', 'eating disorder symptoms and general psychopathology', 'body dissatisfaction and anxiety', 'binge eating days', 'feasibility and efficacy', 'depression']","[{'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0037438'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",60.0,0.0469861,"Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Ranzenhofer', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Mylene', 'Initials': 'M', 'LastName': 'Wilhelmy', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Annabella', 'Initials': 'A', 'LastName': 'Hochschild', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Sanzone', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23258']
971,31076850,"A prospective double-blind, randomized, placebo-controlled study to evaluate the efficacy of silodosin 8 mg as an on-demand, reversible, nonhormonal oral contraceptive for males: a pilot study.","PURPOSE


As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study.
METHODS


In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872.
RESULTS


The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up.
CONCLUSIONS


Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.",2020,None of the participants dropped out due to adverse events.,"['healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited', 'males', 'January 2017 to December 2017 with sample size 63']","['placebo', 'silodosin', 'silodosin 8\xa0mg and placebo', 'silodosin 8\xa0mg 3\xa0h prior to heterosexual vaginal intercourse', 'Silodosin']","['total reversible azoospermia, hence prevented unintended pregnancies', 'dropout rate due to adverse events', 'adverse events', 'Reversible azoospermia', 'number of unintended pregnancies in their female partners']","[{'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1870115', 'cui_str': 'silodosin'}, {'cui': 'C2366233', 'cui_str': 'silodosin 8 MG [Rapaflo]'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0004509', 'cui_str': 'Azoospermia'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",,0.230471,None of the participants dropped out due to adverse events.,"[{'ForeName': 'Gajanan S', 'Initials': 'GS', 'LastName': 'Bhat', 'Affiliation': ""Sexual Medicine, TSS Shripad Hegde Kadave Institute of Medical Sciences, A-1, Doctor's Quarters, Sirsi, Karnataka, 581402, India. gajubhatru@gmail.com.""}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Shastry', 'Affiliation': 'Department of Urology, Andrology and Sexual Medicine, TSS Shripad Hegde Kadave Institute of Medical Sciences, Sirsi, Karnataka, India.'}]",World journal of urology,['10.1007/s00345-019-02806-7']
972,31082898,Somatostatin as Inflow Modulator in Liver-transplant Recipients With Severe Portal Hypertension: A Randomized Trial.,"OBJECTIVE


To investigate the safety and efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing liver transplantation (LT) (ClinicalTrials.gov number,01290172).
BACKGROUND


In LT, portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial LT.
METHODS


Thirty-three patients undergoing LT for ESLD and CSPH were randomized double-blindly to receive somatostatin or placebo (2:1). The study drug was administered intraoperatively as 5-mL bolus (somatostatin: 500 μg), followed by a 2.5 mL/h infusion (somatostatin: 250 μg/h) for 5 days. Hepatic and systemic hemodynamics were measured, along with liver function tests and clinical outcomes. The ischemia-reperfusion injury (IRI) was analyzed through histological and protein expression analysis.
RESULTS


Twenty-nine patients (18 receiving somatostatin, 11 placebo) were included in the final analysis. Ten patients responded to somatostatin bolus, with a significant decrease in hepatic venous portal gradient (HVPG) and portal flow of -28.3% and -29.1%, respectively. At graft reperfusion, HVPG was lower in patients receiving somatostatin (-81.7% vs -58.8%; P = 0.0084), whereas no difference was observed in the portal flow (P = 0.4185). Somatostatin infusion counteracted the decrease in arterial flow (-10% vs -45%; P = 0.0431). There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival.
CONCLUSIONS


Somatostatin infusion during LT in patients with CSPH is safe, reduces the HVPG, and preserves the arterial inflow to the graft. This study establishes the efficacy of somatostatin as a liver inflow modulator.",2019,"There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival.
","['Liver-transplant Recipients With Severe Portal Hypertension', 'patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing liver transplantation (LT) (ClinicalTrials.gov number,01290172', 'Thirty-three patients undergoing LT for ESLD and CSPH', 'Twenty-nine patients (18 receiving somatostatin, 11']","['somatostatin or placebo', 'Somatostatin', 'somatostatin', 'placebo']","['hepatic venous portal gradient (HVPG) and portal flow', 'ischemia-reperfusion injury (IRI', 'severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival', 'portal flow', 'graft function and survival', 'Hepatic and systemic hemodynamics', 'arterial flow']","[{'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0765956', 'cui_str': '4-(3-chlorophenylsulfanyl)piperidine hydrochloride'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}]","[{'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0429856', 'cui_str': 'Arterial flow (observable entity)'}]",33.0,0.558437,"There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival.
","[{'ForeName': 'Roberto Ivan', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Vanlander', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University, Naples, Italy.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Van Limmen', 'Affiliation': 'Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'Scudeller', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Heyse', 'Affiliation': 'Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'De Baerdemaeker', 'Affiliation': 'Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Croo', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Voet', 'Affiliation': 'Department of Sonography, Ghent University Hospital Medical School, Ghent, Belgium.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Praet', 'Affiliation': 'Department of Anatomopathology, Ghent University Hospital Medical School, Ghent, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hoorens', 'Affiliation': 'Department of Anatomopathology, Ghent University Hospital Medical School, Ghent, Belgium.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Antoniali', 'Affiliation': 'Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Codarin', 'Affiliation': 'Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tell', 'Affiliation': 'Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Reynaert', 'Affiliation': 'Department of Basic Biomedical Sciences, Liver Cell Biology Laboratory, Vrije Universiteit Brussel (VUB), Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Colle', 'Affiliation': 'Department of Internal Medicine, Ghent University Hospital Medical School, Ghent. Belgium.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Sainz-Barriga', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}]",Annals of surgery,['10.1097/SLA.0000000000003062']
973,30975106,Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial.,"BACKGROUND


Effects of obesity prevention interventions in early childhood are only meaningful if they are sustained over time, but long-term follow-up studies are rare. The school-based cluster-randomised Healthy School Start (HSS) trial aimed at child health promotion and obesity prevention through parental support was carried out in 31 pre-school classes (378 families) in disadvantaged areas in Sweden during 2012-2013. Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline. This study aimed to evaluate the long-term effectiveness 4 years post-intervention.
METHODS


Data were collected from 215 children in March-June 2017. Child dietary intake, screen time, and physical activity were measured through parental-proxy questionnaires. Child height and weight were measured by the research group. Group effects were examined using Poisson, linear, logistic, and quantile regression for data on different levels. Analyses were done by intention to treat, per protocol, and sensitivity analyses using multiple imputation.
RESULTS


No between-group effects on dietary intake, screen time, physical activity, or BMI-sds were found for the entire group at the four-year follow-up. In girls, a significant subgroup-effect was found favouring intervention compared to controls with a lower intake of unhealthy foods, but this was not sustained in the sensitivity analysis. In boys, a significant sub-group effect was found where the boys in the intervention group beyond the 95th percentile had significantly higher BMI-sds compared to boys in the control group. This effect was sustained in the sensitivity analysis. Analyses per protocol showed significant intervention effects regarding a lower intake of unhealthy foods and drinks in the children with a high intervention dose compared to controls.
CONCLUSIONS


Four years after the intervention, only sub-group effects were found, and it is unlikely that the HSS intervention had clinically meaningful effects on the children. These results suggest that school-based prevention programmes need to be extended for greater long-term effectiveness by e.g. integration into school routine practice. In addition, results showed that children with a high intervention dose had better long-term outcomes compared to controls, which emphasises the need for further work to increase family engagement in interventions.
TRIAL REGISTRATION


ISRCTN, ISRCTN39690370, retrospectively registered March 1, 2013, http://www.isrctn.com/ISRCTN39690370 .",2019,"Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline.","['Data were collected from 215 children in March-June 2017', '31 pre-school classes (378 families) in disadvantaged areas in Sweden during 2012-2013', 'children with obesity at baseline']","['HSS intervention', 'obesity prevention interventions']","['BMI-sds', 'intake of unhealthy foods and drinks, and lower BMI-sds', 'dietary intake, screen time, physical activity, or BMI-sds', 'Child height and weight', 'Child dietary intake, screen time, and physical activity']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0524819', 'cui_str': 'Food and Beverages'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}]",215.0,0.0335627,"Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline.","[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Norman', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden. asa.norman@ki.se.'}, {'ForeName': 'Zangin', 'Initials': 'Z', 'LastName': 'Zeebari', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}, {'ForeName': 'Liselotte Schäfer', 'Initials': 'LS', 'LastName': 'Elinder', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.'}]",BMC pediatrics,['10.1186/s12887-019-1467-x']
974,31485282,Comparison of Auto- and Fixed-Continuous Positive Airway Pressure on Air Leak in Patients with Obstructive Sleep Apnea: Data from a Randomized Controlled Trial.,"Auto-CPAP may cause sleep fragmentation due to variations in pressure and unintentional leaks. The aim of this study was to compare air leak between fixed-CPAP and auto-CPAP after 4 months of CPAP treatment. This study is an ancillary analysis of a randomized, double-blind, parallel, controlled trial over 4 months, comparing fixed- and auto-CPAP in newly diagnosed patients with OSA. The following data were extracted from the CPAP devices: mean and 90th percentile pressure, residual apnea-hypopnea index, mean CPAP use, and amount of leak. Within each arm, patients were also randomly allocated to use of one of the three different brands of devices. Since the leak was reported differently for each device, median leak value was determined for each brand and leaks were classified as ""above the median"" or ""below the median"". Data from 269 patients were analyzed. The univariate analysis showed that tobacco consumption, CPAP level, and oronasal masks were associated with leaks above the median value but not the type of CPAP. The multivariate analysis showed that only CPAP level and oronasal masks were associated with leaks below the median. There were no differences in the types of mask used between fixed- and auto-CPAP. There was no impact of the type of CPAP on leaks or the type of interface used. We used a method based on the median leak value to standardize comparisons across devices which report leaks with different definitions.",2019,"The univariate analysis showed that tobacco consumption, CPAP level, and oronasal masks were associated with leaks above the median value but not the type of CPAP.","['Patients with Obstructive Sleep Apnea', 'newly diagnosed patients with OSA', '269 patients were analyzed']","['Auto- and Fixed-Continuous Positive Airway Pressure', 'fixed-CPAP and auto-CPAP', 'fixed- and auto-CPAP']","['air leak', '90th percentile pressure, residual apnea-hypopnea index, mean CPAP use, and amount of leak', 'CPAP level and oronasal masks', 'Air Leak', 'median leak value', 'tobacco consumption, CPAP level, and oronasal masks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}]",269.0,0.108667,"The univariate analysis showed that tobacco consumption, CPAP level, and oronasal masks were associated with leaks above the median value but not the type of CPAP.","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Lebret', 'Affiliation': 'HP2, INSERM U1042, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Marie-Caroline', 'Initials': 'MC', 'LastName': 'Rotty', 'Affiliation': 'IMAG, CNRS, Montpellier University, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Argento', 'Affiliation': 'AGIR à dom. Association, Meylan, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pepin', 'Affiliation': 'HP2, INSERM U1042, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'HP2, INSERM U1042, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Arbib', 'Affiliation': 'Cabinet de Pneumologie, Échirolles, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Jaffuel', 'Affiliation': 'APARD Groupe Adène, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'IMAG, CNRS, Montpellier University, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'HP2, INSERM U1042, Grenoble Alpes University, Grenoble, France.'}]",Canadian respiratory journal,['10.1155/2019/6310956']
975,32171183,Efficacy of kinesio taping in early stage breast cancer associated lymphedema: A randomized single blinded study.,"This study was designed to evaluate the effectiveness of kinesio taping compared to compression garment in treatment of early stage breast cancer-associated lymphedema (BCAL). Patients between 18-70-years old who had unilateral stage 1 BCAL were randomized into group I kinesio taping (KT) and group II compression garment (CG) for this single blinded study. KT was applied with a lymphatic correction technique in three-four day intervals for four weeks. At the end of the fourth week, patients were suggested to wear CGs. Patients in group II were treated daily for 23-hours in CGs. Education, preventive measures, and exercises were given to both groups. All patients were evaluated before the treatment (T0), immediate post treatment (T1), and three months after treatment (T2). Circumference differences were measured between the extremities with a nonelastic tape at five levels. Additionally, shoulder range of motion (ROM) was measured, and pain, heaviness, and sensation of tightness were evaluated with a visual analog scale (VAS). Thirty-five patients with stage 1 BCAL were included and randomized to the KT (n= 16) and CG (n= 19) groups. Demographic data and baseline clinical characteristics were similar. Both groups had reductions in all levels of arm circumference differences at immediate post-treatment and three months after treatment. Pain, tightness, and heaviness scores significantly decreased for both groups at immediate post-treatment and third month. Patients in the KT group had significantly lower pain sores than patients in the CG group. Results demonstrated that both modalities had similar effects in the treatment of early stage BCAL. For patients with early stage BCAL, KT can be an alternative treatment to CG for patients who have difficulties in obtaining and wearing CGs.",2019,Patients in the KT group had significantly lower pain sores than patients in the CG group.,"['Thirty-five patients with stage 1 BCAL', 'early stage breast cancer associated lymphedema', 'early stage breast cancer-associated lymphedema (BCAL', 'Patients between 18-70-years old who had unilateral stage 1 BCAL']","['kinesio taping (KT) and group II compression garment (CG', 'compression garment', 'kinesio taping']","['Pain, tightness, and heaviness scores', 'pain sores', 'pain, heaviness, and sensation of tightness', 'shoulder range of motion (ROM', 'Circumference differences', 'visual analog scale (VAS']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1455785', 'cui_str': 'Sore sensation quality'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",35.0,0.0504707,Patients in the KT group had significantly lower pain sores than patients in the CG group.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ozsoy-Unubol', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanal-Toprak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bahar-Ozdemir', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Akyuz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}]",Lymphology,[]
976,32171186,Inclusion of targeted skin products in the pre-surgical treatment regimen of peripheral lymphedema & lipedema.,"Advanced lymphedema is associated with a number of adverse skin changes including color, thickening of the epidermis, dryness, and hyperkeratosis. These changes are related to prolonged lymph stasis and contribute to an increased risk of infection. Similarly, lipedema is associated with skin thickening and appearance of nodular adipose deposition. Skin care is essential in both conditions. We examined whether inclusion of targeted skin products for 2 weeks to an established pre-surgical conservative treatment program was associated with beneficial effects on the skin condition in 150 patients with lymphedema and lipedema. Patients were randomly assigned to control or one of two treatment groups. All three groups (and for both lymphedema and lipedema) demonstrated a significant reduction in softness. Dimpling/ redness was significantly reduced in the targeted skin product groups for both patients with lymphedema or lipedema. Only patients with lipedema demonstrated a significant reduction in dryness/ hyperkeratosis following targeted skin product treatment. This study demonstrates that short-term use of targeted skin products in both patients with lymphedema and lipedema can be of benefit and further studies are needed to replicate these results and explore possible mechanisms.",2019,Dimpling/ redness was significantly reduced in the targeted skin product groups for both patients with lymphedema or lipedema.,"['patients with lymphedema and lipedema', 'peripheral lymphedema & lipedema', '150 patients with lymphedema and lipedema']",[],"['Dimpling/ redness', 'skin thickening and appearance of nodular adipose deposition', 'dryness/ hyperkeratosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0398370', 'cui_str': 'Lipoedemas'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]",[],"[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0241165', 'cui_str': 'Thick skin (finding)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}]",150.0,0.0155258,Dimpling/ redness was significantly reduced in the targeted skin product groups for both patients with lymphedema or lipedema.,"[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Campisi', 'Affiliation': 'Department of Plastic Surgery, University School of Catania, Sicily, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Harvey Medicine and Surgery Course, University of Pavia, Pavia, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'di Summa', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, University Hospital of Lausanne, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Scarabosio', 'Affiliation': 'Medical Student, Campus BioMedico, Rome, Italy.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Campisi', 'Affiliation': 'Dermatology Section of Chirurgia Laser Genova Medical Center, Genoa, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Campisi', 'Affiliation': 'Lymphatic Surgery & Microsurgery, University of Genoa, School of Medical Sciences & Pharmaceutics, Department of Surgery, Genoa, Italy.'}]",Lymphology,[]
977,32163927,The Effects of Interrupting Sitting Time on Affect and State Anxiety in Children of Healthy Weight and Overweight: A Randomized Crossover Trial.,"PURPOSE


Sedentary time relates to higher anxiety and more negative affect in children. This study assessed whether interrupting sitting over 3 hours is sufficient to influence state anxiety, positive affect, or negative affect, and tested weight status as a moderator.
METHODS


Analyses were the second (preplanned) purpose of a larger study. Children (N = 61; age: mean [SD] = 9.5 [1.3]; 43% healthy weight) completed 2 experimental conditions: continuous sitting for 3 hours and sitting for 3 hours interrupted with walking for 3 minutes in every 30 minutes. State anxiety, positive affect, and negative affect were reported at pretest and posttest. Multilevel models for repeated measures assessed whether experimental condition predicted posttest scores.
RESULTS


Experimental condition was unrelated to posttest state anxiety or positive affect. Weight status moderated how experimental condition influenced posttest negative affect (P = .003). Negative affect was lower in the children of healthy weight after interrupted sitting (vs continuous sitting; β = -0.8; 95% confidence interval, -1.5 to 0.0, P = .05), but it was higher in the children with overweight/obesity after interrupted sitting (vs continuous sitting; β = 0.6; 95% confidence interval, 0.0 to 1.2, P = .06).
CONCLUSIONS


Interrupting sitting acutely reduced negative affect in children of healthy weight, but not in children with overweight. Further research is needed to better understand the potential emotional benefits of sitting interruptions in youth.",2020,"Negative affect was lower in the children of healthy weight after interrupted sitting (vs continuous sitting; β = -0.8; 95% confidence interval, -1.5 to 0.0, P = .05), but it was higher in the children with overweight/obesity after interrupted sitting (vs continuous sitting; β = 0.6; 95% confidence interval, 0.0 to 1.2, P = .06).
","['Children of Healthy Weight and Overweight', 'Children (N = 61; age: mean [SD] = 9.5 [1.3]; 43% healthy weight', 'children']",['Sitting Time'],"['healthy weight', 'State Anxiety', 'State anxiety, positive affect, and negative affect']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.0249378,"Negative affect was lower in the children of healthy weight after interrupted sitting (vs continuous sitting; β = -0.8; 95% confidence interval, -1.5 to 0.0, P = .05), but it was higher in the children with overweight/obesity after interrupted sitting (vs continuous sitting; β = 0.6; 95% confidence interval, 0.0 to 1.2, P = .06).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zink', 'Affiliation': 'University of Southern California.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Berrigan', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Miranda M', 'Initials': 'MM', 'LastName': 'Broadney', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Faizah', 'Initials': 'F', 'LastName': 'Shareef', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Papachristopoulou', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Brady', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Shanna B', 'Initials': 'SB', 'LastName': 'Bernstein', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brychta', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Jacob D', 'Initials': 'JD', 'LastName': 'Hattenbach', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Ira L', 'Initials': 'IL', 'LastName': 'Tigner', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Courville', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Drinkard', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Smith', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Rosing', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Wolters', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'National Institutes of Health.'}, {'ForeName': 'Britni R', 'Initials': 'BR', 'LastName': 'Belcher', 'Affiliation': 'University of Southern California.'}]",Pediatric exercise science,['10.1123/pes.2019-0169']
978,32164142,[Application of test-negative design in vaccine efficacy evaluation].,"Vaccine efficacy can be assessed by a randomized placebo-control trial prior to marketing. However, after the marketing of a vaccine, if a placebo-randomized control trial is used to evaluate the efficacy of the vaccine, ethical issues will arise. Therefore, the evaluation of the efficacy of a vaccine after marketing has become a difficult problem in the public health field. In recent years, the research method of test-negative design has been widely used in the world for the evaluations of the efficacies of different post-marketing vaccines, such as influenza vaccine, rotavirus vaccine, cholera vaccine, pneumonia vaccine and EV71 vaccine. However, there are limited reports in the domestic literature on the test-negative design. Therefore, we summarize the basic principles, application steps, advantages and disadvantages of the test-negative design to provide theoretical methods and basis for the future study of test-negative design in China.",2020,"In recent years, the research method of test-negative design has been widely used in the world for the evaluations of the efficacies of different post-marketing vaccines, such as influenza vaccine, rotavirus vaccine, cholera vaccine, pneumonia vaccine and EV71 vaccine.",[],['placebo'],['Vaccine efficacy'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]",,0.134509,"In recent years, the research method of test-negative design has been widely used in the world for the evaluations of the efficacies of different post-marketing vaccines, such as influenza vaccine, rotavirus vaccine, cholera vaccine, pneumonia vaccine and EV71 vaccine.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health, Nanjing Medical University, Nanjing 211166, China.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Jin', 'Affiliation': 'Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.'}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Center for Global Health, Nanjing Medical University, Nanjing 211166, China; Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China; National Health Commission Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.'}]",Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi,['10.3760/cma.j.issn.0254-6450.2020.02.024']
979,32102946,Vitamin D Pathway and Other Related Polymorphisms and Risk of Prostate Cancer: Results from the Prostate Cancer Prevention Trial.,"Vitamin D may influence prostate cancer risk, but evidence is inconsistent. We conducted a nested case-control study in the Prostate Cancer Prevention Trial (PCPT). Cases ( n  = 1,128) and controls ( n  = 1,205) were frequency matched on age, first-degree relative with prostate cancer, and PCPT treatment arm (finasteride/placebo); African-Americans were oversampled and case/control status was biopsy confirmed. We selected 21 SNPs in vitamin D-related genes  (VDR, GC, C10orf88, CYP2R1, CYP24A1, CYP27B1, DHCR7 , and  NADSYN1 ) to test genotype and genotype-treatment interactions in relation to prostate cancer. We also tested mean serum 25(OH)D differences by minor allele distributions and tested for serum 25(OH)D-genotype interactions in relation to prostate cancer risk. Log-additive genetic models (Bonferroni-corrected within genes) adjusted for age, body mass index, PSA, and family history of prostate cancer revealed a significant interaction between treatment arm and  GC /rs222016 (finasteride OR = 1.37, placebo OR = 0.85;  P   interaction  < 0.05),  GC /rs222014 (finasteride OR = 1.36, placebo OR = 0.85;  P   interaction  < 0.05), and  CYP27B1 /rs703842 (finasteride OR = 0.76, placebo OR = 1.10;  P   interaction  < 0.05) among Caucasians, and  C10orf88 /rs6599638 (finasteride OR = 4.68, placebo OR = 1.39;  P   interaction  < 0.05) among African-Americans.  VDR/ rs1544410 and  CYP27B1 /rs703842 had significant treatment interactions for high-grade disease among Caucasians (finasteride OR = 0.81, placebo OR = 1.40;  P   interaction  < 0.05 and finasteride OR = 0.70, placebo OR = 1.28;  P   interaction  < 0.05, respectively). Vitamin D-related SNPs influenced serum 25(OH)D, but gene-serum 25(OH)D effect modification for prostate cancer was marginally observed only for  CYP24A1 /rs2248359. In conclusion, evidence that vitamin D-related genes or gene-serum 25(OH)D associations influence prostate cancer risk is modest. We found some evidence for gene-finasteride interaction effects for prostate cancer in Caucasians and African-Americans. Results suggest only minimal associations of vitamin D with total or high-grade prostate cancer.",2020,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","['Cases (n=1,128) and controls (n=1,205) were frequency matched on age, first-degree relative with prostate cancer and', 'African-Americans were oversampled and', 'prostate cancer in Caucasians and African-Americans', 'African Americans']","['placebo', 'Vitamin D-related SNPs', 'PCPT treatment arm (finasteride/placebo', 'Vitamin D', 'finasteride', 'CYP27B1/rs703842 (finasteride OR=0.76, placebo', 'GC/rs222014 (finasteride']",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0000340', 'cui_str': '25-Hydroxyvitamin D2 1-hydroxylase'}]",[],1205.0,0.071002,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Torkko', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Cathee', 'Initials': 'C', 'LastName': 'Till', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Adrie', 'Initials': 'A', 'LastName': 'van Bokhoven', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. mneuhous@fredhutch.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0413']
980,30498791,Effect of high-intensity versus low-intensity praziquantel treatment on HIV disease progression in HIV and  Schistosoma mansoni  co-infected patients: a randomised controlled trial.,"Background:  It has been hypothesised that  Schistosoma  co-infection exacerbates HIV progression, and hence anthelminthic intervention in co-infected individuals will delay it. We evaluated effects of high-intensity versus low-intensity praziquantel treatment of schistosomiasis on HIV disease progression among co-infected patients from fishing populations around Lake Victoria, Uganda.  Methods : Between August 2012 and September 2015, we conducted an open-label randomised, controlled trial. Adults, antiretroviral therapy-naïve, CD4 counts ≥350 cells/μl, HIV and  S. mansoni  co-infected, were randomised 1:1 to praziquantel (40mg/kg) given quarterly (starting at enrolment) or annually (starting 12 weeks after enrolment; such that low-intensity participants were still untreated when sampled at 12 weeks). A non-randomised HIV-positive  S. mansoni- negative comparison group was recruited. The primary outcome was mean change in plasma viral load at 12 and 60 weeks.  Results:  In total 363 participants (high-intensity 113, low-intensity 113, comparison group 137) were recruited; 96 (85.0%), 97 (85.8%) and 107 (78.1%) completed 60 weeks of follow up, respectively. Adjusting for baseline age and viral load, the geometric mean ratio (aGMR [95%CI]) viral load for high-intensity vs low-intensity groups at 12 weeks was 0.90 [0.65, 1.25] p=0.55 and at 60 weeks 1.88 [0.78, 4.53] p=0.16. Results in the comparison group were similar to trial arms. High-intensity, compared to low-intensity, treatment resulted in substantially lower  S. mansoni  prevalence at all follow up visits (p<0.05).  Conclusions:  In communities with a high burden of both  S. mansoni  and HIV infection, high-intensity treatment of  S. mansoni  does not delay HIV progression despite relevant benefit for parasite clearance.  Trial registration:  ISRCTN15371662 (17/11/2016).",2018,"High-intensity, compared to low-intensity, treatment resulted in substantially lower  S. mansoni  prevalence at all follow up visits (p<0.05).  ","['HIV disease progression in HIV and  Schistosoma mansoni  co-infected patients', 'Between August 2012 and September 2015', 'schistosomiasis on HIV disease progression among co-infected patients from fishing populations around Lake Victoria, Uganda', 'Adults, antiretroviral therapy-naïve, CD4 counts ≥350 cells/μl, HIV and  S. mansoni  co-infected', 'In total 363 participants (high-intensity 113, low-intensity 113, comparison group 137) were recruited; 96 (85.0%), 97 (85.8%) and 107 (78.1%) completed 60 weeks of follow up, respectively']","['HIV-positive  S. mansoni', 'high-intensity versus low-intensity praziquantel', 'praziquantel', 'high-intensity versus low-intensity praziquantel treatment']","['mean change in plasma viral load', 'geometric mean ratio (aGMR [95%CI]) viral load for high-intensity']","[{'cui': 'C1141957', 'cui_str': 'HIV disease progression'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]",363.0,0.396496,"High-intensity, compared to low-intensity, treatment resulted in substantially lower  S. mansoni  prevalence at all follow up visits (p<0.05).  ","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Abaasa', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, Keppel Street, WC1E 7HT, UK.'}, {'ForeName': 'Gershim', 'Initials': 'G', 'LastName': 'Asiki', 'Affiliation': 'MRC UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Obuku Ekii', 'Affiliation': 'MRC UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Wanyenze', 'Affiliation': 'MRC UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Pala', 'Affiliation': 'MRC UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Govert', 'Initials': 'G', 'LastName': 'J van Dam', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Paul L A M', 'Initials': 'PLAM', 'LastName': 'Corstjens', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hughes', 'Affiliation': 'MRC UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Rue du Bugnon, 46, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Rue du Bugnon, 46, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, Keppel Street, WC1E 7HT, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, Keppel Street, WC1E 7HT, UK.'}, {'ForeName': 'Anatoli', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'MRC UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda.'}]",Wellcome open research,['10.12688/wellcomeopenres.14683.2']
981,30969846,"Patient-Reported Outcome Results From the Open-Label, Randomized Phase III Myeloma X Trial Evaluating Salvage Autologous Stem-Cell Transplantation in Relapsed Multiple Myeloma.","PURPOSE


Salvage autologous stem-cell transplantation (sASCT) in patients with multiple myeloma (MM) relapsing after a prior autologous stem-cell transplantation leads to increased remission duration and overall survival. We report a comprehensive study on patient-reported outcomes, including quality of life (QoL) and pain in sASCT.
METHODS


Patients were randomly assigned to either sASCT or nontransplantation consolidation (NTC). Pain and QoL were assessed as secondary outcomes using validated QoL instruments (European Organisation for Research and Treatment of Cancer QLQ-C30 and myeloma-specific module, QLQ-MY20; the Brief Pain Inventory [Short Form]; and the Leeds Assessment of Neuropathic Symptoms and Signs [Self-Assessment] scale).
RESULTS


A total of 288 patients (> 96%) consented to the QoL substudy. The median follow-up was 52 months. The European Organisation for Research and Treatment of Cancer QLQ-C30 Global health status scores were higher (better) in the NTC group at 100 days after random assignment ( P  = .0496), but not at later time points. Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P  = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment. Patients reporting lower concerns about adverse effects of treatment after sASCT had a time to progression advantage.
CONCLUSION


Patients with sASCT with relapsed MM demonstrated a comparative reduction in QoL and greater impact of treatment adverse effects lasting for 6 months and up to 2 years for pain, after which patients who had received sASCT reported better outcomes. Patients who experienced lower adverse effects after sASCT had longer time to progression and overall survival, showing the need to improve symptom management peritransplantation. To our knowledge, this study provides the most comprehensive picture of QoL before and after sASCT in patients with relapsed MM.",2019,"Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P  = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment.","['patients with relapsed MM', 'Patients', 'patients with multiple myeloma (MM) relapsing after a prior autologous stem-cell transplantation', '288 patients (> 96%) consented to the QoL substudy']","['Salvage Autologous Stem-Cell Transplantation', 'Salvage autologous stem-cell transplantation (sASCT', 'NTC', 'sASCT', 'sASCT or nontransplantation consolidation (NTC']","['Pain and QoL', 'validated QoL instruments (European Organisation for Research and Treatment of Cancer QLQ-C30 and myeloma-specific module, QLQ-MY20; the Brief Pain Inventory [Short Form]; and the Leeds Assessment of Neuropathic Symptoms and Signs [Self-Assessment] scale', 'remission duration and overall survival', 'Cancer QLQ-C30 Global health status scores', 'longer time to progression and overall survival', 'quality of life (QoL) and pain in sASCT', 'Pain interference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0222045'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034380'}]",288.0,0.108635,"Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P  = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment.","[{'ForeName': 'Sam H', 'Initials': 'SH', 'LastName': 'Ahmedzai', 'Affiliation': '1 The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Snowden', 'Affiliation': '2 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Andrew John', 'Initials': 'AJ', 'LastName': 'Ashcroft', 'Affiliation': '3 Pinderfields Hospital, Mid-Yorks NHS Trust, Wakefield, United Kingdom.'}, {'ForeName': 'David Allan', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': '5 Nottingham City Hospitals, Nottingham City, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hockaday', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Jamie D', 'Initials': 'JD', 'LastName': 'Cavenagh', 'Affiliation': '6 Barts Health NHS Trust and The London NHS Trust, London, United Kingdom.'}, {'ForeName': 'Debo', 'Initials': 'D', 'LastName': 'Ademokun', 'Affiliation': '7 Ipswich Hospital NHS Trust, Ipswich, United Kingdom.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tholouli', 'Affiliation': '8 Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Allotey', 'Affiliation': '9 Royal Derby Hospital, Derby, United Kingdom.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Dhanapal', 'Affiliation': '10 Medway Maritime Hospital, Gillingham, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': '11 University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': '12 University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cavet', 'Affiliation': '13 The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Hunter', 'Affiliation': '14 Plymouth Hospitals Trust, Plymouth, United Kingdom.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Bird', 'Affiliation': '15 University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': '16 University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Parrish', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Treen C M', 'Initials': 'TCM', 'LastName': 'Morris', 'Affiliation': ""17 Queen's University, Belfast, United Kingdom.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': '4 University of Leeds, Leeds, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01006']
982,30859755,Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study.,"Frailty is associated with increased mortality both before and after liver transplantation (LT). There are no standardized exercise programs, in particular home-based exercise programs (HBEPs), for patients awaiting LT. The aim was to investigate the feasibility of such a program in patients awaiting LT. Patients were randomly selected from the Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises. Feasibility was based on patient eligibility (≥66% of waiting list), target recruitment (≥90% of n = 20), safety (no related serious adverse events), and adherence (≥66% adherence to 6-week HBEP). Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS]) were taken at baseline and at 6 and 12 weeks. 18 patients (50% male; median age, 55 years) were recruited. All domains of the study feasibility criteria were met. ISWT improved after 6 weeks (50 m; P ≤ 0.01) and 12 weeks (210 m; P ≤ 0.01), despite withdrawal of the telephone health calls. Similarly, improvements were seen in ADS (2700/day; P ≤ 0.01) and the SPPBT (2.5; P = 0.02) after 12 weeks. There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04). In conclusion, a 12-week HBEP, incorporating both easy-to-apply resistance and aerobic exercises, is safe and feasible in patients awaiting LT. Measures of aerobic and functional capacity demonstrate trends toward improvement that warrant further investigation in a randomized controlled trial.",2019,"There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04).","['patients awaiting LT', '18 patients (50% male; median age, 55 years) were recruited', 'Patients Awaiting Liver Transplantation']","['Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises', 'Home-Based Exercise']","['ISWT', 'Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS', 'HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.0341438,"There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04).","[{'ForeName': 'Felicity Rhian', 'Initials': 'FR', 'LastName': 'Williams', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vallance', 'Affiliation': 'Department of Physiotherapy, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faulkner', 'Affiliation': 'Department of Anaesthesia, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Towey', 'Affiliation': 'Department of Dietetics, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Durman', 'Affiliation': 'Advanced Personal Trainer, Virgin Active Solihull, Solihull, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kyte', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Elsharkawy', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thamara', 'Initials': 'T', 'LastName': 'Perera', 'Affiliation': 'Liver Transplant Unit, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Holt', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Lord', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Matthew James', 'Initials': 'MJ', 'LastName': 'Armstrong', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25442']
983,30794284,Should we provide outreach rehabilitation to very old people living in Nursing Care Facilities after a hip fracture? A randomised controlled trial.,"OBJECTIVE


to determine whether a 4-week postoperative rehabilitation program delivered in Nursing Care Facilities (NCFs) would improve quality of life and mobility compared with receiving usual care.
DESIGN


parallel randomised controlled trial with integrated health economic study.
SETTING


NCFs, in Adelaide South Australia.
SUBJECTS


people aged 70 years and older who were recovering from hip fracture surgery and were walking prior to hip fracture.
MEASUREMENTS


primary outcomes: mobility (Nursing Home Life-Space Diameter (NHLSD)) and quality of life (DEMQOL) at 4 weeks and 12 months.
RESULTS


participants were randomised to treatment (n = 121) or control (n = 119) groups. At 4 weeks, the treatment group had better mobility (NHLSD mean difference -1.9; 95% CI: -3.3, -0.57; P = 0.0055) and were more likely to be alive (log rank test P = 0.048) but there were no differences in quality of life. At 12 months, the treatment group had better quality of life (DEMQOL sum score mean difference = -7.4; 95% CI: -12.5 to -2.3; P = 0.0051), but there were no other differences between treatment and control groups. Quality adjusted life years (QALYs) gained over 12 months were 0.0063 higher per participant (95% CI: -0.0547 to 0.0686). The resulting incremental cost effectiveness ratios (ICERs) were $5,545 Australian dollars per unit increase in the NHLSD (95% CI: $244 to $15,159) and $328,685 per QALY gained (95% CI: $82,654 to $75,007,056).
CONCLUSIONS


the benefits did not persist once the rehabilitation program ended but quality of life at 12 months in survivors was slightly higher. The case for funding outreach home rehabilitation in NCFs is weak from a traditional health economic perspective.
TRIAL REGISTRATION


ACTRN12612000112864 registered on the Australian and New Zealand Clinical Trials Registry. Trial protocol available at https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 361980.",2019,"At 4 weeks, the treatment group had better mobility (NHLSD mean difference -1.9; 95% CI: -3.3, -0.57; P = 0.0055) and were more likely to be alive (log rank test P = 0.048) but there were no differences in quality of life.","['people aged 70 years and older who were recovering from hip fracture surgery and were walking prior to hip fracture', 'NCFs, in Adelaide South Australia']",['postoperative rehabilitation program delivered in Nursing Care Facilities (NCFs'],"['Quality adjusted life years (QALYs) gained', 'mobility (Nursing Home Life-Space Diameter (NHLSD)) and quality of life (DEMQOL', 'quality of life and mobility', 'better mobility', 'quality of life', 'incremental cost effectiveness ratios (ICERs']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}]","[{'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}]","[{'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.168625,"At 4 weeks, the treatment group had better mobility (NHLSD mean difference -1.9; 95% CI: -3.3, -0.57; P = 0.0055) and were more likely to be alive (log rank test P = 0.048) but there were no differences in quality of life.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation, Aged and Extended Care, Flinders University, Finders Medical Centre, Level 4 Rehabilitation Building, Flinders Drive, Bedford Park SA, Australia.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Killington', 'Affiliation': 'Rehabilitation, Aged and Extended Care, Flinders University, Finders Medical Centre, Level 4 Rehabilitation Building, Flinders Drive, Bedford Park SA, Australia.'}, {'ForeName': 'Enwu', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Rehabilitation, Aged and Extended Care, Flinders University, Finders Medical Centre, Level 4 Rehabilitation Building, Flinders Drive, Bedford Park SA, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, University of Sydney, Royal North Shore Hospital, St Leonards NSW, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kurrle', 'Affiliation': 'Cognitive Decline Partnership Centre, University of Sydney, Hornsby Ku-ring-gai Hospital, Hornsby NSW, Australia.'}, {'ForeName': 'Billingsley', 'Initials': 'B', 'LastName': 'Kaambwa', 'Affiliation': 'Health Economics Unit, Flinders University, Health Sciences Building, Sturt Road, Bedford Park SA, Australia.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Davies', 'Affiliation': 'Rehabilitation, Aged and Extended Care, Flinders University, Finders Medical Centre, Level 4 Rehabilitation Building, Flinders Drive, Bedford Park SA, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Nutrition and Dietetics, College of Nursing and Health Sciences, Flinders University, Bedford Park SA, Australia.'}, {'ForeName': 'Mellick', 'Initials': 'M', 'LastName': 'Chehade', 'Affiliation': 'Centre for Orthopaedic Trauma and Research, University of Adelaide, Adelaide SA, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'Health and Social Care Economics Group, Flinders University, Sturt Road, Bedford Park SA, Australia.'}]",Age and ageing,['10.1093/ageing/afz005']
984,30583740,"Correction to: Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.",After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].,2018,After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].,['temporomandibular disorder'],['Photobiomodulation versus light-emitting diode (LED) therapy'],[],"[{'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.113831,After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].,"[{'ForeName': 'Luciana G', 'Initials': 'LG', 'LastName': 'Langella', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Paula F C', 'Initials': 'PFC', 'LastName': 'Silva', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Costa-Santos', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Marcela L L', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Alessandro M', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Kristianne P S', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Raquel A', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Nove de Julho University, 235/249 Vergueiro Street, Liberdade, São Paulo, 01504-001, Brazil. sandra.skb@gmail.com.'}]",Trials,['10.1186/s13063-018-3089-2']
985,29341071,Anticholinergic medication for antipsychotic-induced tardive dyskinesia.,"BACKGROUND


Antipsychotic (neuroleptic) medication is used extensively to treat people with serious mental illnesses. However, it is associated with a wide range of adverse effects, including movement disorders. Because of this, many people treated with antipsychotic medication also receive anticholinergic drugs in order to reduce some of the associated movement side-effects. However, there is also a suggestion from animal experiments that the chronic administration of anticholinergics could cause tardive dyskinesia.
OBJECTIVES


To determine whether the use or the withdrawal of anticholinergic drugs (benzhexol, benztropine, biperiden, orphenadrine, procyclidine, scopolamine, or trihexylphenidyl) are clinically effective for the treatment of people with both antipsychotic-induced tardive dyskinesia and schizophrenia or other chronic mental illnesses.
SEARCH METHODS


We retrieved 712 references from searching the Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (16 July 2015 and 26 April 2017). We also inspected references of all identified studies for further trials and contacted authors of trials for additional information.
SELECTION CRITERIA


We included reports identified in the search if they were controlled trials dealing with people with antipsychotic-induced tardive dyskinesia and schizophrenia or other chronic mental illness who had been randomly allocated to (a) anticholinergic medication versus placebo (or no intervention), (b) anticholinergic medication versus any other intervention for the treatment of tardive dyskinesia, or (c) withdrawal of anticholinergic medication versus continuation of anticholinergic medication.
DATA COLLECTION AND ANALYSIS


We independently extracted data from included trials and we estimated risk ratios (RR) with 95% confidence intervals (CIs). We assumed that people who left early had no improvement. We assessed risk of bias and created a 'Summary of findings' table using GRADE.
MAIN RESULTS


The previous version of this review included no trials. We identified two trials that could be included from the 2015 and 2017 searches. They randomised 30 in- and outpatients with schizophrenia in the USA and Germany. Overall, the risk of bias was unclear, mainly due to poor reporting: allocation concealment was not described; generation of the sequence was not explicit; studies were not clearly blinded; and outcome data were not fully reported.Findings were sparse. One study reported on the primary outcomes and found that significantly more participants allocated to procyclidine (anticholinergic) had not improved to a clinically important extent compared with those allocated to isocarboxazid (MAO-inhibitor) after 40 weeks' treatment (1 RCT, n = 20; RR 4.20, 95% CI 1.40 to 12.58; very low quality evidence); that there was no evidence of a difference in the incidence of any adverse effects (1 RCT, n = 20; RR 0.33, 95% CI 0.02 to 7.32; very low quality evidence); or acceptability of treatment (measured by participants leaving the study early) (1 RCT, n = 20; RR 0.33, 95% CI 0.02 to 7.32; very low quality evidence). The other trial compared anticholinergic withdrawal with anticholinergic continuation and found no evidence of a difference in the incidence of acceptability of treatment (measured by participants leaving the study early) (1 RCT, n = 10; RR 2.14, 95% CI 0.11 to 42.52; very low quality evidence).No trials reported on social confidence, social inclusion, social networks, or personalised quality of life - outcomes designated important to patients. No studies comparing either i. anticholinergics with placebo or no treatment, or ii. studies of anticholinergic withdrawal, were found that reported on the primary outcome 'no clinically important improvement in TD symptoms and adverse events'.
AUTHORS' CONCLUSIONS


Based on currently available evidence, no confident statement can be made about the effectiveness of anticholinergics to treat people with antipsychotic-induced tardive dyskinesia. The same applies for the withdrawal of such medications. Whether the withdrawal of anticholinergics may benefit people with antipsychotic-induced TD should be evaluated in a parallel-group, placebo-controlled randomised trial, with adequate sample size and at least 6 weeks of follow-up.",2018,"Overall, the risk of bias was unclear, mainly due to poor reporting: allocation concealment was not described; generation of the sequence was not explicit; studies were not clearly blinded; and outcome data were not fully reported.","[""712 references from searching the Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (16 July 2015 and 26 April 2017"", 'people with antipsychotic-induced tardive dyskinesia and schizophrenia or other chronic mental illness who had been randomly allocated to (a', 'people with both antipsychotic-induced tardive dyskinesia and schizophrenia or other chronic mental illnesses', 'people with antipsychotic-induced tardive dyskinesia', 'outpatients with schizophrenia in the USA and Germany', 'people with serious mental illnesses']","['placebo', 'anticholinergic medication versus placebo (or no intervention), (b) anticholinergic medication versus any other intervention for the treatment of tardive dyskinesia, or (c) withdrawal of anticholinergic medication versus continuation of anticholinergic medication', 'Antipsychotic (neuroleptic) medication', 'anticholinergic drugs (benzhexol, benztropine, biperiden, orphenadrine, procyclidine, scopolamine, or trihexylphenidyl', 'procyclidine (anticholinergic', 'anticholinergics']","['tardive dyskinesia', 'low quality evidence); or acceptability of treatment', 'TD symptoms and adverse events', 'social confidence, social inclusion, social networks, or personalised quality of life - outcomes', 'incidence of any adverse effects']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C3714760', 'cui_str': 'TD - Tardive dyskinesia'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental illness'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714760', 'cui_str': 'TD - Tardive dyskinesia'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0041009', 'cui_str': 'Trihexyphenidyl'}, {'cui': 'C0005098', 'cui_str': 'benzatropine'}, {'cui': 'C0005578', 'cui_str': 'Biperiden'}, {'cui': 'C0029309', 'cui_str': 'Orphenadrine'}, {'cui': 'C0033254', 'cui_str': 'Procyclidine'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}]","[{'cui': 'C3714760', 'cui_str': 'TD - Tardive dyskinesia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.240917,"Overall, the risk of bias was unclear, mainly due to poor reporting: allocation concealment was not described; generation of the sequence was not explicit; studies were not clearly blinded; and outcome data were not fully reported.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bergman', 'Affiliation': 'Cochrane Response, Cochrane, St Albans House, 57-59 Haymarket, London, UK, SW1Y 4QX.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Soares-Weiser', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD000204.pub2']
986,30262813,Effects of daily consumption of the probiotic Bifidobacterium animalis subsp. lactis CECT 8145 on anthropometric adiposity biomarkers in abdominally obese subjects: a randomized controlled trial.,"BACKGROUND


The effects of probiotic Bifidobacterium animalis subsp. lactis CECT 8145 (Ba8145) and those of its heat-killed form (h-k Ba8145) on human anthropometric adiposity biomarkers are unknown.
OBJECTIVE


To assess the effect of Ba8145 and h-k Ba8145 ingestion on anthropometric adiposity biomarkers.
DESIGN


Randomized, parallel, double-blind, placebo-controlled trial with abdominally obese individuals. Participants (n = 135) consumed 1 capsule/day containing 10 10  colony forming unit (CFU) of Ba8145, 10 10  CFU of h-k Ba8145, or placebo (maltodextrin) for 3 months.
RESULTS


Ba8145 ingestion decreased waist circumference, waist circumference/height ratio, and Conicity index (P < 0.05) versus its baseline. Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment. Ba8145 decreased the body mass index compared with baseline and placebo group (P < 0.05). The decrease in visceral fat area after Ba8145 treatments reached significance (P < 0.05) only after h-k Ba8145. When analyses by gender were performed, significance remained only for women. Diastolic blood pressure and HOMA index decreased (P < 0.05) after h-k Ba8145. Gut microbiome analyses showed an increase in Akkermansia spp. after Ba8145 treatment, particularly in the live form, which was inversely related to weight (P = 0.003).
CONCLUSIONS


In abdominally obese individuals, consumption of Ba8145, both as viable and mainly as heat-killed cells, improves anthropometric adiposity biomarkers, particularly in women. An increase in the gut Akkermansia genus appears as a possible mechanism involved. Our results support Ba8145 probiotic as a complementary strategy in obesity management.",2019,Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment.,"['abdominally obese subjects', 'abdominally obese individuals']","['probiotic Bifidobacterium animalis subsp', 'lactis CECT', 'placebo (maltodextrin', 'placebo', 'Ba8145 and h-k Ba8145 ingestion']","['Diastolic blood pressure and HOMA index', 'visceral fat area', 'anthropometric adiposity biomarkers', 'waist circumference, waist circumference/height ratio, and Conicity index', 'body mass index', 'Akkermansia spp']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1490589', 'cui_str': 'Genus Akkermansia (organism)'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}]",,0.269698,Changes versus the placebo group reached significance (P < 0.05) after the h-k Ba8145 treatment.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain. rosamaria.valls@urv.cat.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Calderón-Pérez', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Companys', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pla-Pagà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Luján', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ortega', 'Affiliation': 'Departament de Medicina i Cirurgia, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Caimari', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Empar', 'Initials': 'E', 'LastName': 'Chenoll', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Genovés', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martorell', 'Affiliation': 'Biopolis SL/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Codoñer', 'Affiliation': 'Lifesequencing/Archer Daniels Midland. R&D Department (ADM Nutrition). C/Catedrático Agustín Escardino Benlloch 9, 46980-Paterna, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ramón', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Eurecat, Centre Tecnològic de Catalunya, Unitat de Nutrició i Salut, Reus, Spain.'}]",International journal of obesity (2005),['10.1038/s41366-018-0220-0']
987,32150750,"Immunogenicity, Safety, and Efficacy of a Standalone Universal Influenza Vaccine, FLU-v, in Healthy Adults: A Randomized Clinical Trial.","Background


FLU-v is a broad-spectrum influenza vaccine that induces antibodies and cell-mediated immunity.
Objective


To compare the safety, immunogenicity, and exploratory efficacy of different formulations and dosing regimens of FLU-v versus placebo.
Design


Randomized, double-blind, placebo-controlled, single-center phase 2b clinical trial. (ClinicalTrials.gov: NCT02962908; EudraCT: 2015-001932-38).
Setting


The Netherlands.
Participants


175 healthy adults aged 18 to 60 years.
Intervention


0.5-mL subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo) (2:2:1:1 ratio).
Measurements


Vaccine-specific cellular responses at days 0, 42, and 180 were assessed via flow cytometry and enzyme-linked immunosorbent assay. Solicited information on adverse events (AEs) was collected for 21 days after vaccination. Unsolicited information on AEs was collected throughout the study.
Results


The AEs with the highest incidence were mild to moderate injection site reactions. The difference between A-FLU-v and A-placebo in the median fold increase in secreted interferon-γ (IFN-γ) was 38.2-fold (95% CI, 4.7- to 69.7-fold; P = 0.001) at day 42 and 25.0-fold (CI, 5.7- to 50.9-fold; P < 0.001) at day 180. The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α), 7.0-fold (CI, 3.5- to 18.0-fold; P < 0.001) for interleukin-2 (IL-2), and 1.7-fold (CI, 0.1- to 4.0-fold; P = 0.004) for CD107a. At day 180, differences were 2.1-fold (CI, 0.0- to 6.0-fold; P = 0.030) for IFN-γ and 5.7-fold (CI, 2.0- to 15.0-fold; P < 0.001) for IL-2, with no difference for TNF-α or CD107a. No differences were seen between NA-FLU-v and NA-placebo.
Limitation


The study was not powered to evaluate vaccine efficacy against influenza infection.
Conclusion


Adjuvanted FLU-v is immunogenic and merits phase 3 development to explore efficacy.
Primary Funding Source


SEEK and the European Commission Directorate-General for Research and Innovation, European Member States within the UNISEC (Universal Influenza Vaccines Secured) project.",2020,"The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α),","['Participants\n\n\n175 healthy adults aged 18 to 60 years', 'Healthy Adults']","['Standalone Universal Influenza Vaccine, FLU', 'Intervention\n\n\n0.5-mL', 'placebo', 'FLU-v versus placebo', 'subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo']","['safety, immunogenicity, and exploratory efficacy', 'Immunogenicity, Safety, and Efficacy', 'adverse events (AEs', 'secreted interferon-γ (IFN-γ']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4505399', 'cui_str': 'Universal Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]",175.0,0.648406,"The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α),","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Dille', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'de Groen', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Oftung', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Hubert G M', 'Initials': 'HGM', 'LastName': 'Niesters', 'Affiliation': 'University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands (H.G.N.).'}, {'ForeName': 'Md Atiqul', 'Initials': 'MA', 'LastName': 'Islam', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands, and Shahjalal University of Science and Technology, Sylhet, Bangladesh (M.A.I.).'}, {'ForeName': 'Lisbeth Meyer', 'Initials': 'LM', 'LastName': 'Næss', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Hungnes', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Nuhoda', 'Initials': 'N', 'LastName': 'Aldarij', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Demi L', 'Initials': 'DL', 'LastName': 'Idema', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Ana Fernandez', 'Initials': 'AF', 'LastName': 'Perez', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Henderik W', 'Initials': 'HW', 'LastName': 'Frijlink', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Groeneveld', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Eelko', 'Initials': 'E', 'LastName': 'Hak', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}]",Annals of internal medicine,['10.7326/M19-0735']
988,32173464,"Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Second-Line Treatment of Patients With NSCLC: Results From an Expansion Cohort of a Phase 1 Trial.","INTRODUCTION


The safety and efficacy of bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β) receptor II (a TGF-β ""trap"") fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1), was evaluated in patients with advanced NSCLC.
METHODS


This expansion cohort of NCT02517398, an ongoing, phase 1, open-label trial, includes 80 patients with advanced NSCLC that progressed after platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment and those who also have not received previous immunotherapy. Patients were randomized at a one-to-one ratio to receive either bintrafusp alfa 500 mg or the recommended phase 2 dosage of 1200 mg every 2 weeks. The primary end point was the best overall response (by Response Evaluation Criteria in Solid Tumors 1.1 as adjudicated by independent review committee) and was assessed by the objective response rate (ORR).
RESULTS


A total of 80 patients were randomized to receive bintrafusp alfa 500 or 1200 mg (n = 40 each). Median follow-up was 51.9 weeks (IQR, 19.6-74.0). The ORR in all patients was 21.3% (17 of 80). The ORR was 17.5% (seven of 40) and 25.0% (10 of 40) for the 500 mg dose and the 1200 mg dose (recommended phase 2 dose), respectively. At the 1200 mg dose, patients with PD-L1-positive and PD-L1-high (≥80% expression on tumor cells) had ORRs of 36.0% (10 of 27) and 85.7% (six of seven), respectively. Treatment-related adverse events occurred in 55 of the 80 patients (69%) and were graded as greater than or equal to 3 in 23 of the 80 patients (29%). Of the 80 patients, eight (10%) had a treatment-related adverse event that led to treatment discontinuation; no treatment-related deaths occurred.
CONCLUSIONS


Bintrafusp alfa had encouraging efficacy and manageable tolerability in patients with NSCLC previously treated with platinum.",2020,Treatment-related adverse events (TRAEs) occurred in 55/80 patients (69%) and were grade ≥3 in 23/80 patients (29%).,"['Eighty patients', 'patients with advanced non-small cell lung cancer (NSCLC', '80 patients with advanced NSCLC that progressed following platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment who also have not received prior immunotherapy', 'patients with non-small cell lung cancer']",[],"['adverse events (TRAEs', 'objective response rate (ORR', 'ORR', 'overall response', 'efficacy and manageable tolerability', 'safety and efficacy']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.165194,Treatment-related adverse events (TRAEs) occurred in 55/80 patients (69%) and were grade ≥3 in 23/80 patients (29%).,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'HI2O-CNIO Haematological Malignancies Clinical Research Unit (Hospital Universitario 12 de Octubre-CNIO), Universidad Complutense & Ciberonc, Madrid, Spain. Electronic address: lpazares@seom.org.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Clinical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Medical Oncology Department, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Dae Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Deparment of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Flor', 'Affiliation': 'Servicio de Oncología Médica, Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': 'Unit of Immunotherapy and Anticancer Innovative Therapeutics, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Alvarez', 'Affiliation': 'Department of Medical Oncology, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Dussault', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts; a business of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Helwig', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Laureen S', 'Initials': 'LS', 'LastName': 'Ojalvo', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts; a business of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.03.003']
989,31087123,Prospective comparative study between the effect of CIDEX ®  OPA and STERRAD NX on the durability of digital flexible ureteroscope.,"PURPOSE


We compared the effect of chemical disinfection (CIDEX ®  OPA) and low-temperature hydrogen peroxide gas plasma (STERRAD NX) on two brand new digital flexible ureteroscope (DFU) (Flex-Xc) using subjective and objective parameters.
METHODS


Over 11-month period, all flexible ureteroscopic procedures that fulfill the inclusion criteria were done by two brand new flexible ureteroscopes and were prospectively evaluated. Intraoperative data included total operative time, laser power and duration, stone criteria and subjective evaluation of the procedure as well as visibility and maneuverability scores were reported. The end point of the study was when the scope was deemed by the surgeon as unable to perform the procedure; when leak test is positive.
RESULTS


A total of 88 patients were randomized either for the first flexible ureteroscope disinfected using Cidex ®  OPA (n = 59, 67%) or second ureteroscope sterilized with Sterrad NX (n = 29, 33%). Intraoperative, the first DFU was significantly used with a total operative time of approximately 49 h compared to the second one (p < 0.001). In the same context, laser power parameters were significantly different among the two groups (p = 0.003). The subjective evaluation of the procedure, maneuverability, visibility scores, laser duration, stone burden and post-operative infection rate were statistically insignificant between both groups. At the end point of the study, the deflection in up and downward directions for both DFU were measured.
CONCLUSIONS


The durability and longevity of the DFU is strongly related to the sterilization method. Our findings suggest that CIDEX ®  OPA should prioritize Sterrad in sterilization of DFU.",2020,"In the same context, laser power parameters were significantly different among the two groups (p = 0.003).",['88 patients'],"['second ureteroscope sterilized with Sterrad NX', 'CIDEX ®  OPA and STERRAD NX', 'chemical disinfection (CIDEX ® \xa0OPA) and low-temperature hydrogen peroxide gas plasma (STERRAD NX']","['total operative time', 'total operative time, laser power and duration, stone criteria and subjective evaluation of the procedure as well as visibility and maneuverability scores', 'durability and longevity of the DFU', 'subjective evaluation of the procedure, maneuverability, visibility scores, laser duration, stone burden and post-operative infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0184213', 'cui_str': 'Ureteroscopes'}, {'cui': 'C0878318', 'cui_str': 'Cidex'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0009264', 'cui_str': 'Cold'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023980', 'cui_str': 'Length of Life'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",88.0,0.0237341,"In the same context, laser power parameters were significantly different among the two groups (p = 0.003).","[{'ForeName': 'Saeed H', 'Initials': 'SH', 'LastName': 'Al Qahtani', 'Affiliation': 'Department of Urology, King Abdul Aziz Hospital, Al Ahsa, 31982, Saudi Arabia.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Abdelhamied', 'Affiliation': 'Department of Urology, Cairo University, Cairo, 11562, Egypt. haythamuro@yahoo.com.'}, {'ForeName': 'Abdulrahman H', 'Initials': 'AH', 'LastName': 'AlMuhrij', 'Affiliation': 'Department of Urology, King Abdul Aziz Hospital, Al Ahsa, 31982, Saudi Arabia.'}, {'ForeName': 'Mizyad Y', 'Initials': 'MY', 'LastName': 'Al Rawashada', 'Affiliation': 'Department of Urology, Al Moosa Specialized Hospital, Al Ahsa, 31982, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Al Askar', 'Affiliation': 'Department of Urology, King Abdul Aziz Hospital, Al Ahsa, 31982, Saudi Arabia.'}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Urology, Minia University, El Minia, 61511, Egypt.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Fath El-Bab', 'Affiliation': 'Department of Urology, Minia University, El Minia, 61511, Egypt.'}, {'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Galal', 'Affiliation': 'Department of Urology, Minia University, El Minia, 61511, Egypt.'}, {'ForeName': 'Mahmoud S', 'Initials': 'MS', 'LastName': 'Eladawy', 'Affiliation': 'Department of Urology, Fayoum University, El Fayoum, 64511, Egypt.'}]",World journal of urology,['10.1007/s00345-019-02800-z']
990,31098658,Impact of previous SWL on ureterorenoscopy outcomes and optimal timing for ureterorenoscopy after SWL failure in proximal ureteral stones.,"PURPOSE


We aimed to evaluate the impact of previous unsuccessful shock wave lithotripsy (SWL) therapy on ureterorenoscopy (URS) outcomes in proximal ureteral stones and to define whether there is any optimal timing for safe URS after SWL.
METHODS


The patients who underwent URS for proximal ureteral stones between the years 2015 and 2018 in eight centers were included. Patients were divided into two groups according to previous SWL history; group 1 consisted of patients without SWL before URS for the stone [SWL (-)] and group 2 consisted of patients with a previous SWL for the stone [SWL (+)]. Demographics, operation outcomes and stone characteristics were compared between these two groups. Regarding the complication and success rates, optimal timing for URS after SWL for the stone was calculated with receiver operator characteristics curve analysis.
RESULTS


Totally 638 patients were included (group 1: 466 patients and group 2: 172 patients). The operation and hospitalization times, rate of ureteral stenting and complications were significantly higher in group 2. Stone free status was similar between the groups. Optimal timing for URS after SWL was calculated as 16.5 days (AUC = 0.657, p = 0.012) with a sensitivity of 68% and specificity of 72%, regarding the complication rates. Complication rates were significantly higher in patients who were operated before 16.5 days (27.7% vs 6.5%, p < 0.001).
CONCLUSIONS


The optimal timing; 2-3 weeks delay of the URS procedure after unsuccessful SWL may decrease complication rates according to our results.",2020,"The operation and hospitalization times, rate of ureteral stenting and complications were significantly higher in group 2.","['patients who underwent URS for proximal ureteral stones between the years 2015 and 2018 in eight centers were included', 'proximal ureteral stones', 'Totally 638 patients were included (group 1: 466 patients and group 2: 172 patients']",['unsuccessful shock wave lithotripsy (SWL) therapy'],"['Complication rates', 'complication rates', 'Stone free status', 'operation and hospitalization times, rate of ureteral stenting and complications', 'Demographics, operation outcomes and stone characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}]","[{'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",638.0,0.0348816,"The operation and hospitalization times, rate of ureteral stenting and complications were significantly higher in group 2.","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Irer', 'Affiliation': 'Department of Urology, Izmir Metropolitan Municipality Esrefpasa Hospital, Izmir, Turkey.'}, {'ForeName': 'Mehmet Oguz', 'Initials': 'MO', 'LastName': 'Sahin', 'Affiliation': 'Department of Urology, Manisa State Hospital, Manisa, Turkey.'}, {'ForeName': 'Oguzcan', 'Initials': 'O', 'LastName': 'Erbatu', 'Affiliation': 'Department of Urology, Celal Bayar University School of Medicine, Manisa, Turkey.'}, {'ForeName': 'Alperen', 'Initials': 'A', 'LastName': 'Yildiz', 'Affiliation': 'Department of Urology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Sakir', 'Initials': 'S', 'LastName': 'Ongun', 'Affiliation': 'Department of Urology, Balikesir University School of Medicine, Balıkesir, Turkey.'}, {'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Cinar', 'Affiliation': 'Department of Urology, Bulent Ecevit University School of Medicine, Zonguldak, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Cihan', 'Affiliation': 'Department of Urology, Nigde Omer Halisdemir University School of Medicine, Nigde, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sahin', 'Affiliation': 'Department of Urology, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Sen', 'Affiliation': 'Department of Urology, Manisa State Hospital, Manisa, Turkey. sen_volkan@yahoo.com.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Ucer', 'Affiliation': 'Department of Urology, Celal Bayar University School of Medicine, Manisa, Turkey.'}, {'ForeName': 'Fuat', 'Initials': 'F', 'LastName': 'Kizilay', 'Affiliation': 'Department of Urology, Ege University School of Medicine, Izmir, Turkey.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Bozkurt', 'Affiliation': 'Department of Urology, Dokuz Eylul University School of Medicine, Izmir, Turkey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",World journal of urology,['10.1007/s00345-019-02809-4']
991,31335641,Efficacy of a transdiagnostic emotion-focused exposure treatment for chronic pain patients with comorbid anxiety and depression: a randomized controlled trial.,"The comorbidity between chronic pain and emotional problems has proven difficult to address with current treatment options. This study addresses the efficacy of a transdiagnostic emotion-focused exposure treatment (""hybrid"") for chronic pain patients with comorbid emotional problems. Adults (n = 115) with chronic musculoskeletal pain and functional and emotional problems were included in a 2-centre, parallel randomized controlled, open-label trial comparing this treatment to an active control condition receiving a guided Internet-delivered pain management treatment based on CBT principles (iCBT). The hybrid treatment (n = 58, 10-16 sessions) integrates exposure in vivo for chronic pain based on the fear-avoidance model with an emotion-regulation approach informed by procedures in Dialectical Behavior Therapy. The iCBT (n = 57; 8 treatment modules) addresses topics such as pain education, coping strategies, relaxation, problem solving, stress, and sleep management using standard CBT techniques. Patient-reported outcomes were assessed before and after treatment as well as at a 9-month primary end point. Across conditions, 78% participants completed post-treatment and 81% follow-up assessment. Intent-to-treat analyses showed that the hybrid had a significantly better post-treatment outcome on pain catastrophizing (d = 0.39) and pain interference (d = 0.63) and significantly better follow-up outcomes on depression (d = 0.43) and pain interference (d = 0.51). There were no differences on anxiety and pain intensity. Observed proportions of clinically significant improvement favoured the hybrid on all but one comparison, but no statistically significant differences were observed. We conclude that the hybrid emotion-focused treatment may be considered an acceptable, credible, and efficacious treatment option for chronic pain patients with comorbid emotional problems.",2019,Intent-to-treat analyses showed that the hybrid had a significantly better post-treatment outcome on pain catastrophizing (d = 0.39) and pain interference (d = 0.63) and significantly better follow-up outcomes on depression (d = 0.43) and pain interference (d = 0.51).,"['chronic pain patients with comorbid emotional problems', 'chronic pain patients with comorbid anxiety and depression', 'Adults (n = 115) with chronic musculoskeletal pain and functional and emotional problems']","['fear-avoidance model with an emotion-regulation approach informed by procedures in Dialectical Behavior Therapy', 'transdiagnostic emotion-focused exposure treatment (""hybrid', 'transdiagnostic emotion-focused exposure treatment', 'iCBT', 'active control condition receiving a guided Internet-delivered pain management treatment based on CBT principles (iCBT']","['pain interference', 'pain catastrophizing', 'anxiety and pain intensity']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0619666,Intent-to-treat analyses showed that the hybrid had a significantly better post-treatment outcome on pain catastrophizing (d = 0.39) and pain interference (d = 0.63) and significantly better follow-up outcomes on depression (d = 0.43) and pain interference (d = 0.51).,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Boersma', 'Affiliation': 'Center for Health and Medical Psychology, School of Law, Psychology and Social Work, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Södermark', 'Affiliation': 'Department of Medical and Health Sciences, Pain and Rehabilitation Centre, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hesser', 'Affiliation': 'Department of Behavioural Sciences and Learning, Division of Psychology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ida K', 'Initials': 'IK', 'LastName': 'Flink', 'Affiliation': 'Center for Health and Medical Psychology, School of Law, Psychology and Social Work, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Gerdle', 'Affiliation': 'Department of Medical and Health Sciences, Pain and Rehabilitation Centre, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Linton', 'Affiliation': 'Center for Health and Medical Psychology, School of Law, Psychology and Social Work, Örebro University, Örebro, Sweden.'}]",Pain,['10.1097/j.pain.0000000000001575']
992,29270687,"Correction to: Efficacy and safety of rotigotine in elderly patients with Parkinson's disease in comparison with the non-elderly: a post hoc analysis of randomized, double-blind, placebo-controlled trials.","Unfortunately, the online published article has errors in Table 1 and Table 2. The corrected tables are given in the following page.",2018,"Unfortunately, the online published article has errors in Table 1 and Table 2.","[""elderly patients with Parkinson's disease in comparison with the non-elderly""]","['rotigotine', 'placebo']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.404068,"Unfortunately, the online published article has errors in Table 1 and Table 2.","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Hospital, Shitsukawa, Toon, Ehime, Japan. nomoto@m.ehime-u.ac.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kondo', 'Affiliation': 'Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Sakurai', 'Affiliation': 'Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan.'}]",Journal of neurology,['10.1007/s00415-017-8706-6']
993,29572628,Correction to: Comparison between submucosal tunneling endoscopic resection and video-assisted thoracoscopic enucleation for esophageal submucosal tumors originating from the muscularis propria layer: a randomized controlled trial.,"In the original article, there are two errors in Table 3: 1. There were 8 patients undergoing VATE suffer from moderate fever, not 9. 2. In the fourth line of outcomes, saying ""pneumothorax, moderate fever and moderate fever,"" ""moderate fever"" was repeated.",2018,"There were 8 patients undergoing VATE suffer from moderate fever, not 9. 2.",['esophageal submucosal tumors originating from the muscularis propria layer'],['submucosal tunneling endoscopic resection and video-assisted thoracoscopic enucleation'],"['saying ""pneumothorax, moderate fever and moderate fever,"" ""moderate fever']","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0225358', 'cui_str': 'Detrusor Urinae'}]","[{'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",8.0,0.0814478,"There were 8 patients undergoing VATE suffer from moderate fever, not 9. 2.","[{'ForeName': 'Ningli', 'Initials': 'N', 'LastName': 'Chai', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Enqiang', 'Initials': 'E', 'LastName': 'Linghu', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China. linghuenqiang@vip.sina.com.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ""Department of Thoracic Surgery, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Zhenjuan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Fuxing Road 28. Haidian District, Beijing, People's Republic of China.""}]",Surgical endoscopy,['10.1007/s00464-018-6147-7']
994,31153977,Retrieval of individual patient data depended on study characteristics: a randomized controlled trial.,"OBJECTIVES


The aim of the study was to examine the effect of providing a financial incentive to authors of randomized clinical trials (RCTs) to obtain individual patient data (IPD).
STUDY DESIGN AND SETTING


Parallel-group RCT with authors identified in the RCTs eligible for two systematic reviews. The authors were randomly allocated to the intervention (financial incentive with several contact approaches) or control group (using the same contact approaches). Studied outcomes are proportion of authors who provided IPD, time to obtain IPD, and completeness of IPD received.
RESULTS


Of the 129 authors contacted, 37 authors suggested or contacted a person or funder providing relevant details or showed interest to collaborate, whereas 45 authors directed us to contact a person or funder, lacked resources or time, did not have ownership or approval to share the IPD, or claimed IPD was too old. None of the authors shared their IPD. We contacted 17 sponsors and received two complete IPD datasets from one sponsor. The time to obtain IPD was >1 year after a sponsor's positive response. Common barriers included study identification, data ownership, limited data access, and required IPD licenses.
CONCLUSION


IPD sharing may depend on study characteristics, including funding type, study size, study risk of bias, and treatment effect, but not on providing a financial incentive.",2019,The time to obtain IPD was >,['Parallel-group RCT with authors identified in the RCTs eligible for two systematic reviews'],['intervention (financial incentive with several contact approaches) or control group'],"['proportion of authors who provided IPD, time to obtain IPD, and completeness of IPD received', 'time to obtain IPD']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1955832', 'cui_str': 'Systematic Review'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}]",,0.173825,The time to obtain IPD was >,"[{'ForeName': 'Areti Angeliki', 'Initials': 'AA', 'LastName': 'Veroniki', 'Affiliation': ""Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece; Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Surgery & Cancer, Institute of Reproductive and Developmental Biology, Faculty of Medicine, Imperial College, London, UK. Electronic address: averonik@cc.uoi.gr.""}, {'ForeName': 'Huda M', 'Initials': 'HM', 'LastName': 'Ashoor', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Susan P C', 'Initials': 'SPC', 'LastName': 'Le', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Rios', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Stewart', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, Northern Ireland Hub for Trials Methodology Research, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Mavridis', 'Affiliation': 'Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece; Paris Descartes University, Sorbonne Paris Cité, Faculté de Médecine, Paris, France.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Straus', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Geriatric Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Tricco', 'Affiliation': ""Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Epidemiology Division, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.""}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.031']
995,31170515,"Factors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study.","OBJECTIVES


Recruitment to pragmatic trials is often difficult, and little is known about factors associated with key participation and treatment decisions. These were explored in the Prostate cancer testing and Treatment (ProtecT) study.
STUDY DESIGN AND SETTING


Baseline sociodemographic, patient-reported outcome, clinical history, and prostate cancer biopsy data were collected for all patients eligible to take part in the ProtecT trial, in a comprehensive cohort design. Men who rejected randomization specified a preferred option and were followed up identically to the randomized cohort. Factors associated with participation decisions, patient preferences, and reasons for changing treatment were explored.
RESULTS


Of 2,664 men with clinically localized prostate cancer, 997 (37%) rejected randomization. Their treatment preferences and subsequent treatment choices/changes in both randomized and treatment choice cohorts were strongly associated with prostate cancer risk features: toward active monitoring for low-risk disease and toward radical options with higher risk prostate cancer. Among many factors measured, only a small number of weak associations were found for occupation groups and some patient symptoms. Similar percentages changed from the random allocation and initially stated preference.
CONCLUSION


The comprehensive cohort design provided new insights into trial recruitment and participation decisions. Opportunities to improve recruitment by supporting recruiters with equipoise and patient preferences were identified.",2019,Their treatment preferences and subsequent treatment choices/changes in both randomized and treatment choice cohorts were strongly associated with prostate cancer risk features: toward active monitoring for low-risk disease and toward radical options with higher risk prostate cancer.,"['Men who rejected randomization specified a preferred option and were followed up identically to the randomized cohort', 'Baseline sociodemographic, patient-reported outcome, clinical history, and prostate cancer biopsy data were collected for all patients eligible to take part in the ProtecT trial, in a comprehensive cohort design', '2,664 men with clinically localized prostate cancer, 997 (37%) rejected randomization']",[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}]",[],[],2664.0,0.0522736,Their treatment preferences and subsequent treatment choices/changes in both randomized and treatment choice cohorts were strongly associated with prostate cancer risk features: toward active monitoring for low-risk disease and toward radical options with higher risk prostate cancer.,"[{'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK. Electronic address: jenny.donovan@bristol.ac.uk.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Opmeer', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, Bristol BS8 2PR, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.036']
996,31403168,Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial.,"STUDY OBJECTIVES


Insomnia and obstructive sleep apnea (OSA) commonly co-occur which makes OSA difficult to treat with continuous positive airway pressure (CPAP). We conducted a randomized controlled trial in participants with OSA and co-occurring insomnia to test the hypothesis that initial treatment with cognitive and behavioral therapy for insomnia (CBT-i), versus treatment as usual (TAU) would improve insomnia symptoms and increase subsequent acceptance and use of CPAP.
METHODS


One hundred and forty-five participants with OSA (apnea-hypopnea index ≥ 15) and comorbid insomnia were randomized to either four sessions of CBT-i, or TAU, before commencing CPAP therapy until 6 months post-randomization. Primary between-group outcomes included objective average CPAP adherence and changes in objective sleep efficiency by 6 months. Secondary between-group outcomes included rates of immediate CPAP acceptance/rejection, and changes in; sleep parameters, insomnia severity, and daytime impairments by 6 months.
RESULTS


Compared to TAU, participants in the CBT-i group had 61 min greater average nightly adherence to CPAP (95% confidence interval [CI] = 9 to 113; p = 0.023, d = 0.38) and higher initial CPAP treatment acceptance (99% vs. 89%; p = 0.034). The CBT-i group showed greater improvement of global insomnia severity, and dysfunctional sleep-related cognitions by 6 months (both: p < 0.001), and greater improvement in sleep impairment measures immediately following CBT-i. There were no between-group differences in sleep outcomes, or daytime impairments by 6 months.
CONCLUSIONS


In OSA participants with comorbid insomnia, CBT-i prior to initiating CPAP treatment improves CPAP use and insomnia symptoms compared to commencing CPAP without CBT-i. OSA patients should be evaluated for co-occurring insomnia and considered for CBT-i before commencing CPAP therapy.
CLINICAL TRIAL


Treating comorbid insomnia with obstructive sleep apnea (COMSIA) study: A new treatment strategy for patients with combined insomnia and sleep apnea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.",2019,"Compared to TAU, participants in the CBT-i group had 61-minutes greater average nightly adherence to CPAP (95%CI: 9, 113; p = 0.023, d = 0.38) and higher initial CPAP treatment acceptance (99 vs 89%; p = 0.034).","['145 participants with OSA (apnea-hypopnea index ≥ 15) and co-morbid insomnia', 'participants with OSA and co-occurring insomnia to test the hypothesis that initial treatment with', 'Insomnia and obstructive sleep apnea (OSA', 'obstructive sleep apnea participants with co-morbid insomnia']","['cognitive and behavioral therapy for insomnia (CBT-i), versus treatment as usual (TAU', 'Cognitive and behavioral therapy', 'CBT-i, or TAU', 'continuous positive airway pressure therapy']","['rates of immediate CPAP acceptance/rejection, and changes in; sleep parameters, insomnia severity, and daytime impairments by 6-months', 'global insomnia severity, and dysfunctional sleep-related cognitions', 'insomnia symptoms', 'sleep outcomes, or daytime impairments', 'average nightly adherence to CPAP', 'higher initial CPAP treatment acceptance', 'objective average CPAP adherence and changes in objective sleep efficiency', 'sleep impairment measures', 'CPAP use and insomnia symptoms']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",145.0,0.10112,"Compared to TAU, participants in the CBT-i group had 61-minutes greater average nightly adherence to CPAP (95%CI: 9, 113; p = 0.023, d = 0.38) and higher initial CPAP treatment acceptance (99 vs 89%; p = 0.034).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sweetman', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Catcheside', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Antic', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Science Research (ISSR), University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ching Li', 'Initials': 'CL', 'LastName': 'Chai-Coetzer', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Douglas', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': ""O'grady"", 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunn', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Thoracic Program, The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'College of Education Psychology and Social Work, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health: A Centre of Research Excellence, College of Medicine and Public Health, Flinders University of South Australia, Bedford Park, South Australia, Australia.'}]",Sleep,['10.1093/sleep/zsz178']
997,30496003,Effect of Remediating Blighted Vacant Land on Shootings: A Citywide Cluster Randomized Trial.,"Objectives.  To determine if remediating blighted vacant urban land reduced firearm shooting incidents resulting in injury or death. Methods.  We conducted a cluster randomized controlled trial in which we assigned 541 randomly selected vacant lots in Philadelphia, Pennsylvania, to 110 geographically contiguous clusters and randomly assigned these clusters to a greening intervention, a less-intensive mowing and trash cleanup intervention, or a no-intervention control condition. The random assignment to the trial occurred in April and June 2013 and lasted until March 2015. In a difference-in-differences analysis, we assessed whether the 2 treatment conditions relative to the control condition reduced firearm shootings around vacant lots. Results.  During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings. There was no evidence that the interventions displaced shootings into adjacent areas. Conclusions.  Remediating vacant land with inexpensive, scalable methods, including greening or minimal mowing and trash cleanup, significantly reduced shootings that result in serious injury or death. Public Health Implications.  Cities should experiment with place-based interventions to develop effective firearm violence-reduction strategies. Trial Registration.  This trial was registered with the International Standard Randomized Controlled Trial Number (study ID ISRCTN92582209; http://www.isrctn.com/ISRCTN92582209).",2019,"During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings.","['541 randomly selected vacant lots in Philadelphia, Pennsylvania, to 110 geographically contiguous clusters and randomly assigned these clusters to a', 'on Shootings']","['Remediating Blighted Vacant Land', 'greening intervention, a less-intensive mowing and trash cleanup intervention, or a no-intervention control condition']",[],"[{'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205283', 'cui_str': 'Contiguous (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0017095', 'cui_str': 'Garbages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],541.0,0.318924,"During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Moyer', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'MacDonald', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ridgeway', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Branas', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}]",American journal of public health,['10.2105/AJPH.2018.304752']
998,31122975,School-based physical activity intervention for older adolescents: rationale and study protocol for the Burn 2 Learn cluster randomised controlled trial.,"INTRODUCTION


This trial aims to investigate the impact of a school-based physical activity programme, involving high-intensity interval training (HIIT), on the physical, mental and cognitive health of senior school students.
METHODS AND ANALYSIS


The Burn 2 Learn (B2L) intervention will be evaluated using a two-arm parallel group cluster randomised controlled trial with allocation occurring at the school level (to treatment or wait-list control). Schools will be recruited in two cohorts from New South Wales, Australia. The trial will aim to recruit ~720 senior school students (aged 16-18 years) from 20 secondary schools (ie, 10 schools per cohort). A range of implementation strategies will be provided to teachers (eg, training, equipment and support) to facilitate the delivery of HIIT sessions during scheduled classes. In phase I and II (3 months each), teachers will facilitate the delivery of at least two HIIT sessions/week during lesson-time. In phase III (6 months), students will be encouraged to complete sessions outside of lesson-time (teachers may continue to facilitate the delivery of B2L sessions during lesson-time). Study outcomes will be assessed at baseline, 6 months (primary end point) and 12 months. Cardiorespiratory fitness (shuttle run test) is the primary outcome. Secondary outcomes include: vigorous physical activity, muscular fitness, cognition and mental health. A subsample of students will (i) provide hair samples to determine their accumulated exposure to stressful events and (ii) undergo multimodal MRI to examine brain structure and function. A process evaluation will be conducted (ie, recruitment, retention, attendance and programme satisfaction).
ETHICS AND DISSEMINATION


This study has received approval from the University of Newcastle (H-2016-0424) and the NSW Department of Education (SERAP: 2017116) human research ethics committees.
TRIAL REGISTRATION NUMBER


ACTRN12618000293268; Pre-results.",2019,"In phase I and II (3 months each), teachers will facilitate the delivery of at least two HIIT sessions/week during lesson-time.","['senior school students', '720\u2009senior school students (aged 16-18 years) from 20 secondary schools (ie, 10 schools per cohort', 'older adolescents', 'Schools will be recruited in two cohorts from New South Wales, Australia']","['school-based physical activity programme, involving high-intensity interval training (HIIT', 'School-based physical activity intervention']","['Cardiorespiratory fitness', 'vigorous physical activity, muscular fitness, cognition and mental health']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.128649,"In phase I and II (3 months each), teachers will facilitate the delivery of at least two HIIT sessions/week during lesson-time.","[{'ForeName': 'Angus A', 'Initials': 'AA', 'LastName': 'Leahy', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Eather', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Smith', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, Massachusetts, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Centre for Rehab Innovations(CRI), School of Biomedical Sciences and Pharmacy and the Priority Research Centre for Stroke and Brain Injury, Hunter Medical Research Institute (HMRI), University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Institute for Positive Psychology and Education, Faculty of Health Sciences, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noetel', 'Affiliation': 'Institute for Positive Psychology and Education, Faculty of Health Sciences, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Holliday', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Tatsuya T', 'Initials': 'TT', 'LastName': 'Shigeta', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Costigan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Walker', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Valkenborghs', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Prajwal', 'Initials': 'P', 'LastName': 'Gyawali', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': 'Auckland University of Technology, Human Potential Centre, Auckland, New Zealand.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Kennedy', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-026029']
999,30971318,Correction to: Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial.,"After publication of the original article [1], the authors have notified us that the Trial registration number NCT03274713 should be replaced by NCT03366363 in the Abstract section of the paper.",2019,"After publication of the original article [1], the authors have notified us that the Trial registration number NCT03274713 should be replaced by NCT03366363 in the Abstract section of the paper.",['knee osteoarthritis'],['electro-acupuncture and manual acupuncture versus sham acupuncture'],[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],,0.248792,"After publication of the original article [1], the authors have notified us that the Trial registration number NCT03274713 should be replaced by NCT03366363 in the Abstract section of the paper.","[{'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Tian-Qi', 'Initials': 'TQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Yu-Zheng', 'Initials': 'YZ', 'LastName': 'Du', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Xiqing District, Tianjin, China.'}, {'ForeName': 'Zhi-Shun', 'Initials': 'ZS', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Xicheng District, Beijing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Xicheng District, Beijing, China.'}, {'ForeName': 'Xiao-Gang', 'Initials': 'XG', 'LastName': 'Yu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese and Western Medicine, Haidian District, Beijing, China.'}, {'ForeName': 'Chun-Sheng', 'Initials': 'CS', 'LastName': 'Jia', 'Affiliation': 'Hebei University of Chinese Medicine, Shijiazhuang, Heibei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Dongcheng District, Beijing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of orthopedics, Institute of Acupuncture and Moxibustion, China Academy Of Chinese Medicine Sciences, Dongcheng District, Beijing, China.'}, {'ForeName': 'Ya-Quan', 'Initials': 'YQ', 'LastName': 'Hou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.'}, {'ForeName': 'Jia-Kai', 'Initials': 'JK', 'LastName': 'Shao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.'}, {'ForeName': 'Zhang-Sheng', 'Initials': 'ZS', 'LastName': 'Yu', 'Affiliation': 'Department of Bioinformatics and Biostatistics, SJTU-Yale Joint Center for Biostatistics, Shanghai Jiao Tong University, Minhang District, Shanghai, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China. lcz623780@126.com.'}]",Trials,['10.1186/s13063-019-3338-z']
1000,31740368,Colchicine's effects on lipoprotein particle concentrations in adults with metabolic syndrome: A secondary analysis of a randomized controlled trial.,"BACKGROUND


Colchicine has received renewed interest for its potential beneficial effects in secondary prevention of cardiovascular disease. This was presumed to be primarily because of its anti-inflammatory effects; however, limited data exist regarding colchicine's impact on other cardiovascular risk factors.
OBJECTIVE


The aim of this study was to examine if colchicine's anti-inflammatory actions would lead to reduced circulating concentrations of oxidized low-density lipoprotein (oxLDL) in metabolically unhealthy individuals. We also examined if colchicine would improve concentrations of other atherogenic lipoprotein subfractions.
METHODS


This is a secondary analysis of a double-blind, randomized, placebo-controlled pilot study in which 40 adults with metabolic syndrome were randomized to colchicine 0.6 mg or placebo twice daily for 3 months. Blood samples were collected in the fasted state. OxLDL was measured using enzyme-linked immunosorbent assay. Nuclear magnetic resonance spectroscopy was used to measure other lipoprotein particle subfraction concentrations.
RESULTS


Compared with placebo, colchicine reduced markers of inflammation, including C-reactive protein, erythrocyte sedimentation rate, and GlycA (P < .01). Concentrations of oxLDL (P = .019) and small LDL (P = .022) appeared significantly increased in the colchicine arm. Colchicine had no significant effect on other lipoprotein subfractions or lipoprotein particle sizes (all P > .05).
CONCLUSION


Although colchicine may have benefit in secondary prevention of cardiovascular disease in at-risk individuals, we found no evidence that these effects are because of improvements in circulating atherogenic lipoprotein particle concentrations. Further studies are needed to confirm whether colchicine increases circulating oxLDL and small LDL levels in adults with metabolic syndrome. If true, additional research is warranted to elucidate the mechanisms underlying these associations.",2019,"Colchicine had no significant effect on other lipoprotein subfractions or lipoprotein particle sizes (all P > .05).
","['adults with metabolic syndrome', '40 adults with metabolic syndrome', 'metabolically unhealthy individuals']","[""Colchicine's"", 'colchicine 0.6\xa0mg or placebo', 'Colchicine', 'placebo, colchicine', 'oxLDL', 'placebo', 'colchicine']","['lipoprotein particle concentrations', 'circulating atherogenic lipoprotein particle concentrations', 'Blood samples', 'lipoprotein subfractions or lipoprotein particle sizes', 'small LDL', 'markers of inflammation, including C-reactive protein, erythrocyte sedimentation rate, and GlycA (P']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C2718493', 'cui_str': 'Colchicine 0.6 MG [Colcrys]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",40.0,0.656291,"Colchicine had no significant effect on other lipoprotein subfractions or lipoprotein particle sizes (all P > .05).
","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA; Johns Hopkins Community Physicians at Howard County General Hospital, Johns Hopkins Medicine, Columbia, MD, USA; Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: ademido1@jhmi.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wolska', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sierra R', 'Initials': 'SR', 'LastName': 'Wilson', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sorokin', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Brady', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research (DIR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.10.011']
1001,31481069,Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: observations from TECOS.,"BACKGROUND


To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).
METHODS


TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses.
RESULTS


During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95% CI 0.81-1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15%) died subsequently, with 66 (11%) being CV deaths, and 57 (10%) experiencing hHF. The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83-1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes.
CONCLUSIONS


In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models. Trial registration clinicaltrials.gov no. NCT00790205.",2019,"The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83-1.82, P = 0.31).","['591 patients with a', '14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care', 'patients with diabetes']","['Sitagliptin', 'DPP-4i sitagliptin', 'placebo', 'Sitagliptin (TECOS']","['nonfatal MI', 'composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF', 'risk of cardiovascular death or hospitalization', 'subsequent risk of CV death or hHF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",616.0,0.284571,"The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83-1.82, P = 0.31).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Division of Diabetology, Medical Department I, St. Josef-Hospital (Ruhr-University), Bochum, Germany. michael.nauck@rub.de.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Pieper', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Timo E', 'Initials': 'TE', 'LastName': 'Strandberg', 'Affiliation': 'Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Riefflin', 'Affiliation': 'Practise Internal Medicine/Diabetology, Husby, Germany.'}, {'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Delibasi', 'Affiliation': 'Department of Internal Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Coronary Care and Cardiovascular Research at the Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'Don Beaven Medical Research Center, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0921-2']
1002,31070106,Perceived Causes of Personal versus Witnessed Overdoses among People who Inject Opioids.,"Background:  Studies show that people who inject drugs (PWID) underestimate their overdose risk. We sought to explore this phenomenon by comparing how PWID perceive causes of personal overdoses compared to witnessed overdoses.  Methods:  We analyzed 40 interviews from participants enrolled in a randomized-controlled behavioral intervention to reduce overdose among at-risk PWID in San Francisco from 2014 to 2016. Subjects were current illicit opioid injectors with opioid use disorder, had received take-home naloxone, and had overdosed within five years. Interviews were audio-recorded and transcribed verbatim. Using thematic content analysis, three analysts coded the interviews and measured interrater reliability. The analysts developed a codebook of a priori and inductively generated codes, and applied it to all interviews. Coding discrepancies were discussed.  Results : We used two theoretical frameworks - actor observer bias (AOB) and intragroup stigma - to analyze participants' descriptions of personal and witnessed overdoses. AOB suggests individuals may assign responsibility of their actions to external factors, while assigning responsibility for others' actions to internal mechanisms. Intragroup stigma describes the process whereby people perpetuate stigma within their own group. Related to these concepts, two principal themes were used to describe personal overdose: (1) drug volatility and (2) ascribing blame to others, and witnessed overdoses: (1) greed and (2) inexperience/foolishness.  Conclusion/Importance:  The differences in perceived causes of personal versus witnessed overdose align with AOB and intragroup stigma. Understanding how these theories shape overdose experiences may improve behavioral interventions by introducing peer based supports and encouraging PWIDs to employ evidence-based safety precautions when using opioids.",2019,We used two theoretical frameworks - actor observer bias (AOB) and intragroup stigma - to analyze participants' descriptions of personal and witnessed overdoses.,"['people who inject drugs (PWID) underestimate their overdose risk', '40 interviews from participants enrolled in a randomized-controlled behavioral intervention to reduce overdose among at-risk PWID in San Francisco from 2014 to 2016', 'Subjects were current illicit opioid injectors with opioid use disorder, had received take-home naloxone, and had overdosed within five years']",[],[],"[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332266', 'cui_str': 'Illicit (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0181342', 'cui_str': 'Injector'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],[],,0.0337546,We used two theoretical frameworks - actor observer bias (AOB) and intragroup stigma - to analyze participants' descriptions of personal and witnessed overdoses.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Behar', 'Affiliation': 'San Francisco Department of Public Health , San Francisco , California , USA.'}, {'ForeName': 'Jamie Suki', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Santa Clara University , Santa Clara , California , USA.'}, {'ForeName': 'Kennedy', 'Initials': 'K', 'LastName': 'Countess', 'Affiliation': 'San Francisco Department of Public Health , San Francisco , California , USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'San Francisco Department of Public Health , San Francisco , California , USA.'}, {'ForeName': 'Glenn-Milo', 'Initials': 'GM', 'LastName': 'Santos', 'Affiliation': 'San Francisco Department of Public Health , San Francisco , California , USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Coffin', 'Affiliation': 'San Francisco Department of Public Health , San Francisco , California , USA.'}]",Substance use & misuse,['10.1080/10826084.2019.1609988']
1003,31068212,Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial.,"After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the ""PROTHOR Investigators"" table.",2019,"After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the ""PROTHOR Investigators"" table.",[],['Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation'],[],[],"[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0559312', 'cui_str': 'Single-Lung Ventilation'}]",[],,0.0944464,"After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the ""PROTHOR Investigators"" table.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kiss', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. thomas.kiss@uniklinikum-dresden.de.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wittenstein', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Birr', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cinnella', 'Affiliation': 'Department of Anesthesia and Intensive Care, OO Riuniti Hospital, University of Foggia, Foggia, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cohen', 'Affiliation': 'Department of Anesthesiology, The Mount Sinai Hospital, New York, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'El Tahan', 'Affiliation': 'Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Falcão', 'Affiliation': 'Federal University of São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gregoretti', 'Affiliation': 'UOC Anestesia e Rianimazione A.O.Universitaria ""P. Giaccone"", Dipartimento Di.Chir.On.S, Università degli Studi di Palermo, Palermo, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Granell', 'Affiliation': 'Hospital General Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hachenberg', 'Affiliation': 'University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jankovic', 'Affiliation': 'Clinic for Anesthesia and Intensive Therapy, Clinical Center Nis, School of Medicine, University of Nis, Nis, Serbia.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Karzai', 'Affiliation': 'Zentralklinik Bad Berka, Bad Berka, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Krassler', 'Affiliation': 'Thoracic Center Coswig, Coswig, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Loop', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine Clinic, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Licker', 'Affiliation': 'University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Marczin', 'Affiliation': 'Section of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Mills', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Sheffield Teaching Hospitals, Sheffield University, Sheffield, UK.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Murrell', 'Affiliation': 'Department of Anesthesiology, Weill Cornell Medicine, New York, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Neskovic', 'Affiliation': 'Military Medical Academy, Belgrade, Serbia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Nisnevitch-Savarese', 'Affiliation': 'Penn State Hershey Anesthesiology & Perioperative Medicine, Hershey, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rossaint', 'Affiliation': 'Department of Anaesthesiology, University Hospital Aachen, Aachen, Germany.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'A Serpa', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': 'Department of Critical Care, Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Severgnini', 'Affiliation': ""Dipartimento di Biotecnologie e Scienze della Vita, Università degli Studi dell'Insubria, Varese, Italy.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Szegedi', 'Affiliation': 'Department of Anesthesiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vegh', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Voyagis', 'Affiliation': 'Department of Anaesthesia, Postoperative ICU, Pain Relief & Palliative Care Clinic, ""Sotiria"" Chest Diseases Hospital, Athens, Greece.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'M Gama', 'Initials': 'MG', 'LastName': 'de Abreu', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Senturk', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3371-y']
1004,30733182,Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial.,"BACKGROUND


Strategies are needed to prevent and control type 2 diabetes and intermediate hyperglycaemia, which together affect roughly a third of adults in Bangladesh. We aimed to assess the effects of mHealth and community mobilisation on the prevalence of intermediate hyperglycaemia and diabetes among the general adult population in rural Bangladesh, and to assess the effect of these interventions on the incidence of type 2 diabetes among people with intermediate hyperglycaemia within the study population.
METHODS


DMagic was a three-arm, cluster-randomised trial of participatory community mobilisation, mHealth mobile phone messaging, and usual care (control) in 96 villages (population roughly 125 000) in Bangladesh. Community mobilisation involved 18 monthly group meetings, led by lay facilitators, applying a participatory learning and action (PLA) cycle focused on diabetes prevention and control. mHealth involved twice-weekly voice messages over 14 months promoting behaviour change to reduce diabetes risk. The primary outcomes were the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the overall population at the end of the intervention implementation period, and 2-year cumulative incidence of type 2 diabetes in a cohort with intermediate hyperglycaemia at baseline. Primary outcomes were assessed through fasting blood glucose concentrations and 2-h oral glucose tolerance tests among a cross-section of adults aged 30 years and older and a cohort of individuals identified with intermediate hyperglycaemia. Prevalence findings are based on a cross-sectional survey at the end of the study; incidence findings are based on 2-year follow-up survey of a cohort of individuals identified with intermediate hyperglycaemia through a cross-sectional survey at baseline. We also assessed the cost-effectiveness of the interventions. This trial is registered with the ISRCTN registry, number ISRCTN41083256, and is completed.
FINDINGS


The study took place between June 27, 2015, and June 28, 2018, with the PLA intervention running in 32 villages from June, 2016, to December, 2017, and the mHealth intervention running in 32 villages from Oct 21, 2016, to Dec 24, 2017. End-of study prevalence was assessed in 11 454 individuals and incidence in 2100 individuals. There was a large reduction in the combined prevalence of type 2 diabetes and intermediate hyperglycaemia in the PLA group compared with the control group at the end of the study (adjusted [for stratification, clustering, and wealth] odds ratio [aOR] 0·36 [0·27-0·48]), with an absolute reduction of 20·7% (95% CI 14·6-26·7). Among 2470 adults with intermediate hyperglycaemia at baseline, 2100 (85%) were followed-up at 2 years. The 2-year cumulative incidence of diabetes in this cohort was significantly lower in the PLA group compared with control (aOR 0·39, 0·24-0·65), representing an absolute incidence reduction of 8·7% (3·5-14·0). There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43). The incremental cost-effectiveness ratios for PLA were INT$316 per case of intermediate hyperglycaemia or type 2 diabetes prevented and $6518 per case of type 2 diabetes prevented among individuals with intermediate hyperglycaemia.
INTERPRETATION


Our data provide strong evidence to support the use of community mobilisation based on PLA to prevent type 2 diabetes in this rural Bangladeshi population. Despite raising knowledge and awareness of diabetes, the mHealth intervention did not change disease outcomes in our population. Replication studies in other populations should be a priority.
FUNDING


UK Medical Research Council.",2019,"There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43).","['2470 adults with intermediate hyperglycaemia at baseline, 2100 (85%) were followed-up at 2 years', '96 villages (population roughly 125\u2008000) in Bangladesh', 'June 27, 2015, and June 28, 2018, with the PLA intervention running in 32 villages from June, 2016, to December, 2017, and the mHealth intervention running in 32 villages from Oct 21, 2016, to Dec 24, 2017', 'intermediate hyperglycaemia and diabetes among the general adult population in rural Bangladesh', 'people with intermediate hyperglycaemia within the study population', '11\u2008454 individuals and incidence in 2100 individuals', 'adults aged 30 years and older and a cohort of individuals identified with intermediate hyperglycaemia']","['mHealth and community mobilisation', 'mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic', 'Community mobilisation involved 18 monthly group meetings, led by lay facilitators, applying a participatory learning and action (PLA) cycle focused on diabetes prevention and control', 'participatory community mobilisation, mHealth mobile phone messaging, and usual care (control', 'PLA']","['incremental cost-effectiveness ratios', '2-year cumulative incidence of diabetes', 'combined prevalence of type 2 diabetes and intermediate hyperglycaemia', 'fasting blood glucose concentrations and 2-h oral glucose tolerance tests', 'diabetes risk', 'cost-effectiveness', '2-year cumulative incidence of type 2 diabetes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2470.0,0.0494623,"There was no evidence of effect of mHealth on combined prevalence of intermediate hyperglycaemia and diabetes (aOR 0·93, 0·74-1·16) or the incidence of diabetes (1·02, 0·73-1·43).","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fottrell', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK. Electronic address: e.fottrell@ucl.ac.uk.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kuddus', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Sanjit Kumer', 'Initials': 'SK', 'LastName': 'Shaha', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Jennings', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Kohenour', 'Initials': 'K', 'LastName': 'Akter', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tasmin', 'Initials': 'T', 'LastName': 'Nahar', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Haghparast-Bidgoli', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'A K Azad', 'Initials': 'AKA', 'LastName': 'Khan', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Costello', 'Affiliation': 'UCL Institute for Global Health, Faculty of Population Health Sciences, University College London, London, UK.'}, {'ForeName': 'Kishwar', 'Initials': 'K', 'LastName': 'Azad', 'Affiliation': 'Diabetic Association of Bangladesh, Dhaka, Bangladesh.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30001-4']
1005,30184165,Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial.,"Background


Doravirine (DOR), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI), is active against wild-type Human Immunodeficiency Virus (HIV)-1 and the most common NNRTI-resistant variants, and has a favorable and unique in vitro resistance profile.
Methods


DRIVE-AHEAD is a phase 3, double-blind, non-inferiority trial. Antiretroviral treatment-naive adults with ≥1000 HIV-1 RNA copies/mL were randomized (1:1) to once-daily, fixed-dose DOR at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate (TDF) at 300 mg (DOR/3TC/TDF) or to efavirenz at 600 mg, emtricitabine at 200 mg, and TDF at 300 mg (EFV/FTC/TDF) for 96 weeks. The primary efficacy endpoint was the proportion of participants with <50 HIV-1 RNA copies/mL at week 48 (Food and Drug Administration snapshot approach; non-inferiority margin 10%).
Results


Of the 734 participants randomized, 728 were treated (364 per group) and included in the analyses. At week 48, 84.3% (307/364) of DOR/3TC/TDF recipients and 80.8% (294/364) of EFV/FTC/TDF recipients achieved <50 HIV-1 RNA copies/mL (difference 3.5%, 95% CI, -2.0, 9.0). DOR/3TC/TDF recipients had significantly lower rates of dizziness (8.8% vs 37.1%), sleep disorders/disturbances (12.1% vs 25.2%), and altered sensorium (4.4% vs 8.2%) than EFV/FTC/TDF recipients. Mean changes in fasting low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) were significantly different between DOR/3TC/TDF and EFV/FTC/TDF (-1.6 vs +8.7 mg/dL and -3.8 vs +13.3 mg/dL, respectively).
Conclusions


In HIV-1 treatment-naive adults, DOR/3TC/TDF demonstrated non-inferior efficacy to EFV/FTC/TDF at week 48 and was well tolerated, with significantly fewer neuropsychiatric events and minimal changes in LDL-C and non-HDL-C compared with EFV/FTC/TDF.
Clinical Trials Registration


NCT02403674.",2019,"In HIV-1 treatment-naive adults, DOR/3TC/TDF demonstrated non-inferior efficacy to EFV/FTC/TDF at week 48 and was well tolerated, with significantly fewer neuropsychiatric events and minimal changes in LDL-C and non-HDL-C compared with EFV/FTC/TDF.
","['Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection', 'Antiretroviral treatment-naive adults with ≥1000 HIV-1 RNA copies/mL', '734 participants randomized']","['Tenofovir Disoproxil Fumarate', 'Doravirine/Lamivudine', 'TDF', 'Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate', '\n\n\nDoravirine (DOR), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI', 'lamivudine at 300 mg, and tenofovir disoproxil fumarate (TDF) at 300 mg (DOR/3TC/TDF) or to efavirenz at 600 mg, emtricitabine at 200 mg, and TDF at 300 mg (EFV/FTC/TDF']","['sleep disorders/disturbances', 'neuropsychiatric events', 'fasting low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C', 'rates of dizziness', 'altered sensorium']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C2928676', 'cui_str': 'efavirenz / emtricitabine / tenofovir disoproxil'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",734.0,0.290548,"In HIV-1 treatment-naive adults, DOR/3TC/TDF demonstrated non-inferior efficacy to EFV/FTC/TDF at week 48 and was well tolerated, with significantly fewer neuropsychiatric events and minimal changes in LDL-C and non-HDL-C compared with EFV/FTC/TDF.
","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Squires', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'University of Paris Diderot, Hôpital Saint-Louis, Assitance Publique Hôpitaux de Paris, France.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Wing-Wai', 'Initials': 'WW', 'LastName': 'Wong', 'Affiliation': 'Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Sussmann', 'Affiliation': 'Asistencia Cientifica de Alta Complejidad SAS, Bogota, Colombia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Desmond Tutu HIV Foundation, Cape Town, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lupinacci', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sklar', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Bach-Yen', 'Initials': 'BY', 'LastName': 'Nguyen', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Martin', 'Affiliation': 'Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy540']
1006,32151511,Efficacy of Bilateral Transversus Thoracis Muscle Plane Block in Pediatric Patients Undergoing Open Cardiac Surgery.,"OBJECTIVES


Adequate pain management is crucial for pediatric patients undergoing open cardiac surgery. The aim of the present study was to investigate the effect of a bilateral transversus thoracis muscle plane (TTP) block on open cardiac surgery outcomes.
SETTING


First Affiliated Hospital of Nanchang University.
PARTICIPANTS


Patients ages 6 to 60 months undergoing cardiac surgical procedures were included.
INTERVENTIONS


A group of 100 children were randomly allocated to receive either bilateral TTP block (TTP group) or no nerve block.
MEASUREMENTS AND MAIN RESULTS


The primary endpoint was postoperative pain, which was measured with the Modified Objective Pain Score. The secondary outcome measures included intraoperative and postoperative fentanyl consumption; time to extubation; time to first feces; length of stay in the intensive care unit; length of hospital stay; and possible complications such as ropivacaine allergy, pneumothorax, hematomas, infections, and injuries to the internal mammary artery and vein. The TTP group had a significantly lower Modified Objective Pain Score until 24 hours after extubation than the no nerve block group. The TTP group reported significantly less fentanyl consumption. Time to extubation and lengths of stay in the intensive care unit and hospital were significantly decreased in the TTP group.
CONCLUSION


Bilateral TTP blocks provide effective analgesia and accelerate recovery in pediatric patients.",2020,The TTP group had a significantly lower Modified Objective Pain Score until 24 hours after extubation than the no nerve block group.,"['A group of 100 children', 'First Affiliated Hospital of Nanchang University', 'pediatric patients undergoing open cardiac surgery', 'pediatric patients', 'Undergoing Open Cardiac Surgery', 'Pediatric Patients', 'Patients ages 6 to 60 months undergoing cardiac surgical procedures were included']","['Bilateral Transversus Thoracis Muscle Plane Block', 'bilateral TTP block (TTP group) or no nerve block', 'Bilateral TTP blocks', 'bilateral transversus thoracis muscle plane (TTP) block', 'TTP']","['postoperative pain, which was measured with the Modified Objective Pain Score', 'fentanyl consumption', 'Time to extubation and lengths of stay in the intensive care unit and hospital', 'intraoperative and postoperative fentanyl consumption; time to extubation; time to first feces; length of stay in the intensive care unit; length of hospital stay; and possible complications such as ropivacaine allergy, pneumothorax, hematomas, infections, and injuries to the internal mammary artery and vein', 'Modified Objective Pain Score']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018821', 'cui_str': 'Surgical Procedures, Heart'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0226276', 'cui_str': 'Internal Mammary Artery'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",100.0,0.0855439,The TTP group had a significantly lower Modified Objective Pain Score until 24 hours after extubation than the no nerve block group.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Shibiao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Biming', 'Initials': 'B', 'LastName': 'Zhan', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Jiangxi, China. Electronic address: drzhanbiming@163.com.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.02.005']
1007,31221222,"Correction to: Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial.","Following publication of the original article [1], we have been notified that the tagging of one of the author names was done incorrectly in the XML version of the paper. Original and corrected tagging can be seen below.",2019,"Following publication of the original article [1], we have been notified that the tagging of one of the author names was done incorrectly in the XML version of the paper.",['severe neuropathic or mixed pain in children from age 3 months to 18\u2009years - evaluation'],"['Gabapentin', 'morphine']",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.0481452,"Following publication of the original article [1], we have been notified that the tagging of one of the author names was done incorrectly in the XML version of the paper.","[{'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'de Leeuw', 'Affiliation': ""Department of Anesthesia and Pain Medicine, Erasmus MC-Sophia Children's Hospital, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. t.deleeuw@erasmusmc.nl.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mangiarini', 'Affiliation': 'Consorzio per Valutazione Biologiche e Farmacologiche, Pavia, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lundin', 'Affiliation': 'Fondazione Penta Onlus, Padova, Italy.'}, {'ForeName': 'Florentia', 'Initials': 'F', 'LastName': 'Kaguelidou', 'Affiliation': 'Department of Pediatric Pharmacology and Pharmacogenetics, AP-HP, Hôpital Robert Debré, F-75019, Paris, France.'}, {'ForeName': 'Tjitske', 'Initials': 'T', 'LastName': 'van der Zanden', 'Affiliation': ""Intensive Care and Department of Paediatric Surgery, Erasmus MC-Sophia Children's Hospital, Dr. Molewaterplein, 40 3015 GD, Rotterdam, The Netherlands.""}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': ""Intensive Care and Department of Paediatric Surgery, Erasmus MC-Sophia Children's Hospital, Dr. Molewaterplein, 40 3015 GD, Rotterdam, The Netherlands.""}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ceci', 'Affiliation': 'Consorzio per Valutazione Biologiche e Farmacologiche, Pavia, Italy.'}, {'ForeName': 'Saskia N', 'Initials': 'SN', 'LastName': 'de Wildt', 'Affiliation': ""Intensive Care and Department of Paediatric Surgery, Erasmus MC-Sophia Children's Hospital, Dr. Molewaterplein, 40 3015 GD, Rotterdam, The Netherlands.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3519-9']
1008,31428820,Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial.,"PURPOSE


Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.
METHODS


Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.
RESULTS


In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs.
CONCLUSION


Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.",2019,"pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage.",['HER2-positive early breast cancer'],"['trastuzumab', 'adjuvant CT-P6 or trastuzumab', 'CT-P6 versus reference trastuzumab', 'CT-P6 and trastuzumab']","['efficacy and safety', 'pCR and breast pCR rates', 'Efficacy and safety', 'pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0244191,"pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage.","[{'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, 160 E 34th Street, New York, 10016, USA.'}, {'ForeName': 'Y V', 'Initials': 'YV', 'LastName': 'Baranau', 'Affiliation': 'Department of Oncology, Belarusian State Medical University, 220013, Minsk, Belarus.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Baryash', 'Affiliation': 'Department of Oncology, Belarusian State Medical University, 220013, Minsk, Belarus.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manikhas', 'Affiliation': 'City Clinical Oncology Dispensary, Saint Petersburg, 198255, Russian Federation.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'GBUZ Saint Petersburg Clinical Research Center of Specialised Types of Care (Oncology), Saint Petersburg, 197758, Russian Federation.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dzagnidze', 'Affiliation': 'S. Khechinashvili University Clinic, Ltd, 0177, Tbilisi, Georgia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zhavrid', 'Affiliation': 'N.N. Alexandrov National Cancer Centre of Belarus, 223040, Minsk Region, Belarus.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boliukh', 'Affiliation': 'Vinnytsya Regional Clinical Oncology Dispensary, Vinnytsia, 21029, Ukraine.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital, Moscow, 143423, Russian Federation.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Wojewodzkie Centrum Onkologii, 80-219, Gdańsk, Poland.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Eniu', 'Affiliation': 'Cancer Institute ""Ion Chiricuta"", 400015, Cluj-Napoca, Romania.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Li', 'Affiliation': ""St. Luke's Medical Center, 1102, Quezon City, Philippines.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Rusyn', 'Affiliation': 'Transcarpathian Regional Clinical Oncology Dispensary, Transcarpathian, 88000, Ukraine.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tiangco', 'Affiliation': 'The Medical City, Ortigas Avenue, Pasig City, Philippines.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'CELLTRION, Inc., Incheon, 22014, Republic of Korea.'}, {'ForeName': 'S Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'CELLTRION, Inc., Incheon, 22014, Republic of Korea.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'CELLTRION, Inc., Incheon, 22014, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stebbing', 'Affiliation': 'Division of Cancer, Imperial Centre for Translational and Experimental Medicine, Du Cane Road, London, W12 0HS, UK. j.stebbing@imperial.ac.uk.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03920-4']
1009,30747908,"SUMMIT-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain.","NKTR-181, a new molecular entity, mu-opioid receptor agonist with an inherently slow rate of central nervous system (CNS) entry, was designed to provide analgesia while reducing abuse potential. This phase 3, enriched-enrollment, randomized-withdrawal trial evaluated the analgesic efficacy, safety, and tolerability of NKTR-181 in patients with chronic low-back pain (CLBP). Adults with moderate-to-severe CLBP refractory to nonopioid analgesics achieving an analgesic NKTR-181 dosage (100-400 mg twice daily) during the open-label titration period were randomized to continued NKTR-181 treatment, double-blind, or switched to placebo. The study was conducted at 55 sites in the United States. Of 1189 patients exposed to NKTR-181 during the titration period, 610 were randomized to NKTR-181 100 to 400 mg every 12 hours or placebo for 12 weeks. The primary outcome measure was change in weekly pain score (scale, 0-10) at 12 weeks from randomization baseline. Secondary outcome measures included responder rates defined by ≥30% and ≥50% improvement in pain score from screening to 12 weeks. Among 610 randomized patients, the mean pain score decreased from 6.73 to 2.32 during open-label titration. After randomization, the least-squares mean change in pain score was +0.92 for NKTR-181 vs +1.46 for placebo (P = 0.002). The ≥30%-improvement responder rate of NKTR-181 vs placebo was 71.2% vs 57.1% (P < 0.001), and the ≥50%-improvement responder rate was 51.1% vs 37.9% (P = 0.001). NKTR-181 was well tolerated with a low incidence (<3%) of CNS-related adverse events during the randomized treatment phase. In patients with moderate-to-severe CLBP, NKTR-181 demonstrated significant analgesic efficacy and a favorable safety/tolerability profile, with a low incidence of CNS adverse events.",2019,NKTR-181 was well tolerated with a low incidence (<3%) of CNS-related adverse events during the randomized treatment phase.,"['chronic low-back pain', 'Adults with moderate-to-severe CLBP refractory to nonopioid analgesics achieving an analgesic NKTR-181 dosage (100-400 mg twice daily) during the open-label titration period', 'patients with chronic low-back pain (CLBP', '1189 patients exposed to NKTR-181 during the titration period, 610 were randomized to']","['NKTR-181 100 to 400 mg every 12 hours or placebo', 'NKTR-181', 'placebo']","['analgesic efficacy', 'analgesic efficacy, safety, and tolerability', 'mean pain score', 'responder rates defined by ≥30% and ≥50% improvement in pain score', '≥30%-improvement responder rate of NKTR-181', '≥50%-improvement responder rate', 'pain score', 'change in weekly pain score']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0242937', 'cui_str': 'Non-Opioid Analgesics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4547855', 'cui_str': 'NKTR-181'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C4547855', 'cui_str': 'NKTR-181'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4547855', 'cui_str': 'NKTR-181'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]",610.0,0.384422,NKTR-181 was well tolerated with a low incidence (<3%) of CNS-related adverse events during the randomized treatment phase.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Markman', 'Affiliation': 'Department of Neurosurgery, Translational Pain Research Program, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gudin', 'Affiliation': 'Pain Management and Palliative Care Center, Englewood Hospital and Medical Center, Englewood, NJ, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Carolinas Pain Institute, The Center for Clinical Research, Winston-Salem, NC, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Argoff', 'Affiliation': 'Department of Neurology, Albany Medical Center, Albany, NY, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rowbotham', 'Affiliation': 'Sutter Health, CPMC Research Institute, San Francisco, CA, United States.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Agaiby', 'Affiliation': 'Clinical Investigation Specialists Inc, Kenosha, WI, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, AZ, United States.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Tufts University School of Medicine, Department of Anesthesia, Boston, MA, United States.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Doberstein', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, United States.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, United States.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Siddhanti', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Gold Coast Research, LLC, Plantation, FL, United States.'}]",Pain,['10.1097/j.pain.0000000000001517']
1010,30756094,Economic evaluation plan of a randomised controlled trial of intra-nodular injection of anti-TNF and placebo among patients with early Dupuytren's disease: Repurposing Anti-TNF for Treating Dupuytren's Disease (RIDD).,"Dupuytren's disease (DD) is a common fibroproliferative condition of the palmar and digital fascia of the hand; however, there is currently no approved treatment for early stage DD. The objective of this paper is to describe the methods applied to assess the cost-effectiveness of adalimumab injections compared to usual care for controlling the progression of early stage DD in the Repurposing Anti-TNF for Treating Dupuytren's Disease (RIDD) trial. Measure of effectiveness and resource use will be obtained from a randomised clinical trial, carried out in three healthcare centres, and recruiting a minimum of 138 patients aged 18 years and above with a diagnosis of early stage DD. Resource use and utility measures (quality-adjusted life years) will be collected at 3, 6, 9, 12 (primary outcome endpoint) and 18 months post-randomisation. A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs. The analysis will be performed from a health system (National Health Service and personal social services) perspective. Sensitivity analysis will be conducted to assess the robustness of the results. RIDD is the first randomised controlled trial with an economic evaluation conducted among patients with early stage DD. The protocol described here records our intent to conduct both a within-trial CUA alongside the RIDD study and a lifetime CUA using decision-analytic modelling.",2018,"A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs.","[""patients with early Dupuytren's disease"", 'three healthcare centres, and recruiting a minimum of 138 patients aged 18 years and above with a diagnosis of early stage DD', 'patients with early stage DD']","['intra-nodular injection of anti-TNF and placebo', 'adalimumab injections']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4082974', 'cui_str': ""Dupuytren's Disease""}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019255', 'cui_str': 'adalimumab Injection'}]",[],138.0,0.175632,"A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs.","[{'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Pinedo-Villanueva', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Nanchahal', 'Affiliation': 'Kennedy Institute of Rheumatology, University of Oxford, Oxford, OX3 7FY, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.14936.2']
1011,30806453,Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial.,"BACKGROUND


antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions.
OBJECTIVE


we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions.
DESIGN


a 2-armed 12-month cluster-randomised controlled trial.
SETTING


nursing homes in East, North and West Germany.
METHODS


all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation.
RESULTS


the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9-21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038-2.532).
CONCLUSIONS


the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02295462.",2019,"CONCLUSIONS


the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes.
","['nursing homes (EPCentCare', 'persons with dementia although guidelines clearly prioritise non-pharmacological interventions', '37 nursing homes with', 'German nursing homes', 'nursing homes in East, North and West Germany', 'n = 1,153 residents (intervention group: n = 493; control group: n = 660']","['person-centred care', 'educational interventions on person-centred care and a continuous supervision programme']","['antipsychotic medication', 'quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation', 'proportion of residents receiving at least one antipsychotic prescription']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0017482', 'cui_str': 'Germany, Federal Republic of'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517845', 'cui_str': '660'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0034380'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",1153.0,0.177903,"CONCLUSIONS


the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes.
","[{'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Richter', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Almuth', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Langner', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Balzer', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Wolschon', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Silies', 'Affiliation': 'Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sönnichsen', 'Affiliation': 'Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Löscher', 'Affiliation': 'Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Haastert', 'Affiliation': 'mediStatistica, Neuenrade, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Wolf', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fleischer', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}]",Age and ageing,['10.1093/ageing/afz016']
1012,30243810,"Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial.","OBJECTIVE


Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other.
DESIGN


Randomized controlled trial.
SETTING


Academic medical centers.
PATIENTS


We plan to randomize 276 persisting PUL-diagnosed women who are 18 years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2 years for fertility and patient satisfaction outcomes.
INTERVENTIONS


Randomization will be 1:1:1 ratio between expectant management, uterine evacuation and empiric use of methotrexate. After randomization to initial management plan, all patients will be followed by their clinicians until resolution of the PUL. The clinician will determine whether there is a change in management, based on clinical symptoms, and/or serial human chorionic gonadotropin (hCG) concentrations and/or additional ultrasonography.
MAIN OUTCOME


The primary outcome measure in each of the 3 treatment arms is the uneventful clinical resolution of a persistent PUL without change from the initial management strategy. Secondary outcome measures include: number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility.
CONCLUSION


This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.",2018,This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.,"['women who have persisting pregnancy of unknown location', 'women with a persisting pregnancy of unknown location', 'Academic medical centers', '276 persisting PUL-diagnosed women who are 18\u202fyears or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2\u202fyears for fertility and patient satisfaction outcomes']",['methotrexate'],"[' number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility', 'uneventful clinical resolution of a persistent PUL without change from the initial management strategy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3495853', 'cui_str': 'Pregnancy of unknown location'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392534', 'cui_str': 'Ruptured ectopic pregnancy (disorder)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4034144', 'cui_str': 'Methotrexate Injection'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449197', 'cui_str': 'PUL (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.229722,This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.,"[{'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. Electronic address: kbarnhart@obgyn.upenn.edu.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stephenson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City, OK, United States.'}, {'ForeName': 'Wahid A', 'Initials': 'WA', 'LastName': 'Youssef', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, United States.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Reproductive Sciences Branch, Eunice Kennedy Shriver NICHD, Rockville, MD, United States.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.009']
1013,32149480,Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study.,"Dysfunctional frontal cortical areas associated with clinical features are observed in children with autism spectrum disorder (ASD). This study attempted to identify any potential therapeutic effects of bilateral anodal transcranial direct current stimulation (tDCS) applied over the left and right prefrontal and motor areas on the clinical characteristics of children with ASD. Fifty children with confirmed ASD medical diagnoses were divided equally and randomly into a tDCS treatment group and a control group. The tDCS treatment group underwent 10 sessions (20-min durations, five per week) of bilateral anodal tDCS stimulation applied simultaneously over the left and right prefrontal and motor areas, whereas the control group underwent the same procedures but with the use of sham tDCS stimulation. Total scores and sub-scores of autism treatment evaluation checklist (ATEC) (language and communication; sociability; sensory awareness; and behavioral, health, and physical conditions) were measured before and after the tDCS treatment sessions of both groups. There were significant decreases in total ATEC scores (P = 0.014), sociability sub-scores (P = 0.021), and behavioral, health, and physical condition sub-scores (P = 0.011) in the tDCS treatment group. No significant changes were observed in total ATEC scores and sub-scores in the control group. In conclusion, compared to the control group, bilateral anodal tDCS showed potential therapeutic effects on children with ASD in terms of improvements in sociability, behavior, health, and physical conditions with no reported side effects. Autism Res 2020, 13: 828-836. © 2020 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Dysfunctional frontal cortical areas are associated with clinical features in children with autism spectrum disorder (ASD). Transcranial direct current stimulation (tDCS) is found to be a safe, noninvasive method to stimulate cortical regions and thus have therapeutic effects on children with ASD. © 2020 International Society for Autism Research, Wiley Periodicals, Inc.",2020,"There were significant decreases in total ATEC scores (P = 0.014), sociability sub-scores (P = 0.021), and behavioral, health, and physical condition sub-scores (P = 0.011) in the tDCS treatment group.","['children with autism spectrum disorder (ASD', 'Fifty children with confirmed ASD medical diagnoses', 'Children with Autism', 'Spectrum Disorders', 'children with ASD']","['tDCS', 'Transcranial direct current stimulation (tDCS', 'bilateral anodal transcranial direct current stimulation (tDCS', 'Bilateral Anodal Transcranial Direct Current Stimulation', 'bilateral anodal tDCS stimulation']","['sociability, behavior, health, and physical conditions with no reported side effects', 'Total scores and sub-scores of autism treatment evaluation checklist (ATEC) (language and communication; sociability; sensory awareness; and behavioral, health, and physical conditions', 'sociability sub-scores', 'total ATEC scores', 'total ATEC scores and sub-scores', 'behavioral, health, and physical condition sub-scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0558182', 'cui_str': 'Ability to interact with others (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",50.0,0.0150227,"There were significant decreases in total ATEC scores (P = 0.014), sociability sub-scores (P = 0.021), and behavioral, health, and physical condition sub-scores (P = 0.011) in the tDCS treatment group.","[{'ForeName': 'Hikmat', 'Initials': 'H', 'LastName': 'Hadoush', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences at Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nazzal', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences at Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Nihad A', 'Initials': 'NA', 'LastName': 'Almasri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Khalil', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences at Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Alafeef', 'Affiliation': 'Department of Biomedical Engineering, Jordan University of Science and Technology, Irbid, Jordan.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2290']
1014,31823314,Translating CKD Research into Primary Care Practice: a Group-Randomized Study.,"BACKGROUND


Chronic kidney disease (CKD) is common in the primary care setting. Early interventions may prevent progression of renal disease and reduce risk for cardiovascular complications, yet quality gaps have been documented. Successful approaches to improve identification and management of CKD in primary care are needed.
OBJECTIVE


To assess whether implementation of a primary care improvement model results in improved identification and management of CKD DESIGN: 18-month group-randomized study PARTICIPANTS: 21 primary care practices in 13 US states caring for 107,094 patients INTERVENTIONS: To promote implementation of CKD improvement strategies, intervention practices received clinical quality measure (CQM) reports at least quarterly, hosted an on-site visit and 2 webinars, and sent clinician/staff representatives to a ""best practice"" meeting. Control practices received CQM reports at least quarterly.
MAIN MEASURES


Changes in practice adherence to a set of 11 CKD CQMs KEY RESULTS: We observed significantly greater improvements among intervention practices for annual screening for albuminuria in patients with diabetes or hypertension (absolute change 22% in the intervention group vs. - 2.6% in the control group, p < 0.0001) and annual monitoring for albuminuria in patients with CKD (absolute change 21% in the intervention group vs. - 2.0% in the control group, p < 0.0001). Avoidance of NSAIDs in patients with CKD declined in both intervention and control groups, with a significantly greater decline in the control practices (absolute change - 5.0% in the intervention group vs. - 10% in the control group, p < 0.0001). There were no other significant changes found for the other CQMs. Variable implementation of CKD improvement strategies was noted across the intervention practices.
CONCLUSIONS


Implementation of a primary care improvement model designed to improve CKD identification and management resulted in significantly improved care on 3 out of 11 CQMs. Incomplete adoption of improvement strategies may have limited further improvement. Improving CKD identification and management likely requires a longer and more intensive intervention.",2020,"Avoidance of NSAIDs in patients with CKD declined in both intervention and control groups, with a significantly greater decline in the control practices (absolute change - 5.0% in the intervention group vs. - 10% in the control group, p < 0.0001).","['Chronic kidney disease (CKD', ' 21 primary care practices in 13 US states caring for 107,094 patients', 'patients with CKD']",[],"['annual monitoring for albuminuria', 'control practices']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0267615,"Avoidance of NSAIDs in patients with CKD declined in both intervention and control groups, with a significantly greater decline in the control practices (absolute change - 5.0% in the intervention group vs. - 10% in the control group, p < 0.0001).","[{'ForeName': 'Cara B', 'Initials': 'CB', 'LastName': 'Litvin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. litvincb@musc.edu.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Ruth G', 'Initials': 'RG', 'LastName': 'Jenkins', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Wessell', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lynne S', 'Initials': 'LS', 'LastName': 'Nemeth', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Ornstein', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05353-4']
1015,30770931,"The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants: Substudy of a Cluster-randomized Trial.","BACKGROUND


Oral vaccines have lower efficacy in developing compared to developed countries. Poor water, sanitation, and hygiene (WASH) may contribute to reduced oral vaccine immunogenicity.
METHODS


We conducted a cluster-randomized 2 × 2 factorial trial in rural Zimbabwe. Pregnant women and their infants were eligible if they lived in clusters randomized to (1) standard of care (52 clusters); (2) improved infant feeding (53 clusters); (3) WASH: ventilated improved pit latrine, 2 hand-washing stations, liquid soap, chlorine, infant play space, and hygiene counseling (53 clusters); or (4) feeding plus WASH (53 clusters). This substudy compared oral rotavirus vaccine (RVV) seroconversion (primary outcome), and seropositivity and geometric mean titer (GMT) (secondary outcomes), in WASH vs non-WASH infants by intention-to-treat analysis.
RESULTS


We included 801 infants with documented RVV receipt and postvaccine titer measurements (329 from 84 WASH clusters; 472 from 102 non-WASH clusters); 328 infants with prevaccination titers were included in the primary outcome. Thirty-three of 109 (30.3%) infants in the WASH group seroconverted following rotavirus vaccination, compared to 43 of 219 (19.6%) in the non-WASH group (absolute difference, 10.6% [95% confidence interval {CI}, .54%-20.7%]; P = .031). In the WASH vs non-WASH groups, 90 of 329 (27.4%) vs 107 of 472 (22.7%) were seropositive postvaccination (absolute difference, 4.7% [95% CI, -1.4% to 10.8%]; P = .130), and antirotavirus GMT was 18.4 (95% CI, 15.6-21.7) U/mL vs 14.9 (95% CI, 13.2-16.8) U/mL (P = .072).
CONCLUSIONS


Improvements in household WASH led to modest but significant increases in seroconversion to RVV in rural Zimbabwean infants.
CLINICAL TRIALS REGISTRATION


NCT01824940.",2019,"In the WASH versus non-WASH groups, 90/329 (27.4%) versus 107/472 (22.7%) were seropositive post-vaccination (absolute difference 4.7% (","['rural Zimbabwean infants', 'Pregnant women and their infants were eligible if they lived in clusters randomized to: 1', 'Zimbabwean infants', '801 infants with documented rotavirus vaccine receipt and post-vaccine titre measurements (329 from 84 WASH clusters; 472 from 102 non-WASH clusters); 328 infants with pre-vaccination titres']","['improved water, sanitation and hygiene', 'Standard-of-care (52 clusters); 2) Improved infant feeding (53 clusters); 3) WASH: ventilated improved pit latrine, two hand-washing stations, liquid soap, chlorine, infant play space, hygiene counseling (53 clusters); or 4) Feeding+WASH', 'WASH versus non-WASH', 'rotavirus vaccine', 'WASH']","['oral rotavirus vaccine immunogenicity', 'seropositive post-vaccination', 'seroconversion to oral rotavirus vaccine', 'seroconversion', 'seropositivity and geometric mean titre (GMT', 'Poor water, sanitation and hygiene (WASH']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C3266595', 'cui_str': 'Pit latrine'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}]",801.0,0.419867,"In the WASH versus non-WASH groups, 90/329 (27.4%) versus 107/472 (22.7%) were seropositive post-vaccination (absolute difference 4.7% (","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Ohio.""}, {'ForeName': 'Florence D', 'Initials': 'FD', 'LastName': 'Majo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Naume V', 'Initials': 'NV', 'LastName': 'Tavengwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz140']
1016,30782695,Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska.,"INTRODUCTION


The population in rural Alaska experiences a disproprionately high burden of infection-mediated hearing loss. While the state mandates school hearing screening, many children with hearing loss are not identified or are lost to follow-up before ever receiving treatment. A robust, tribally owned healthcare system exists in Alaska, but children with hearing loss must first be identified and referred for existing infrastructure to be used. This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss.
METHODS AND ANALYSIS


Comparative effectiveness community randomised trial testing digital innovations to improve school hearing screening and referral in 15 communities in the Norton Sound region of northwest Alaska, with data collection from October 2017 to February 2020. All children (K-12) attending school in Bering Strait School District with parental informed consent and child assent will be eligible (target recruitment n=1500). Participating children will undergo both the current school hearing screen and new mobile health (mHealth) screen, with screening test validity evaluated against an audiometric assessment. Communities will be cluster randomised to continue the current primary care referral process or receive telemedicine referral for follow-up diagnosis and treatment. The primary outcome will be time to International Statistical Classification of Diseases, 10th Revision, ear/hearing diagnosis from screening date, measured in days. Secondary outcomes will include: sensitivity and specificity of current school and mHealth screening protocols measured against a benchmark audiometric assessment (air and bone conduction audiometry, tympanometry and digital otoscopy); hearing loss prevalence; hearing-related quality of life; and school performance (AIMSweb). Intention-to-treat analysis will be used.
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound and Duke University and is registered on clinicaltrials.gov. Results will be distributed with equal emphasis on scientific and community dissemination.
TRIAL REGISTRATION NUMBER


NCT03309553; Pre-results.",2019,"This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss.
","['childhood hearing loss in rural Alaska', 'All children (K-12) attending school in Bering Strait School District with parental informed consent and child assent will be eligible (target recruitment n=1500', 'school hearing screening and referral in 15 communities in the Norton Sound region of northwest Alaska, with data collection from October 2017 to February 2020']",[],"['time to International Statistical Classification of Diseases, 10th Revision, ear/hearing diagnosis from screening date, measured in days', ' sensitivity and specificity of current school and mHealth screening protocols measured against a benchmark audiometric assessment (air and bone conduction audiometry, tympanometry and digital otoscopy); hearing loss prevalence; hearing-related quality of life; and school performance (AIMSweb']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557295', 'cui_str': 'Attending school (finding)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0005935', 'cui_str': 'Bone Conduction Hearing'}, {'cui': 'C0004286', 'cui_str': 'Audiometry'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0847244', 'cui_str': 'Otoscopy'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0034380'}]",,0.128385,"This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss.
","[{'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Emmett', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Samantha Kleindienst', 'Initials': 'SK', 'LastName': 'Robler', 'Affiliation': 'Department of Audiology, Norton Sound Health Corporation, Nome, Alaska, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labrique', 'Affiliation': 'Departments of International Health and Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Gallo', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hofstetter', 'Affiliation': 'Norton Sound Health Corporation, Nome, Alaska, USA.'}]",BMJ open,['10.1136/bmjopen-2018-023078']
1017,30720582,Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial.,"Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP. This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas. If trial stimulation was successful, a multicolumn SCS system was implanted. Outcomes were assessed at baseline (before randomization) and at 1, 3, 6, and 12 months after randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ≥50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability, and health-related quality of life (HRQoL). The results are posted at ClinicalTrials.gov under registration number NCT01697358. In the intent-to-treat analysis, there were more responders in the SCS group than in the OMM group (13.6%, 15/110 vs 4.6%, 5/108, difference 9% with 95% confidence interval 0.6%-17.5%, P = 0.036) at 6 months. The SCS group improved in all secondary outcomes compared with the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention. Adding multicolumn SCS to OMM improved pain relief, HRQoL, and function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.",2019,"In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention.","['failed back surgery syndrome patients', 'back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas']","['Multicolumn spinal cord stimulation', 'OMM', 'Spinal cord stimulation (SCS']","['SCS-related adverse events', 'pain relief, HRQoL, and function', 'neuropathic leg pain', 'HRQoL', 'surgical reintervention', 'proportion of patients with ≥50% reduction in LBP (responder', 'change in pain intensity, functional disability, and health-related quality of life (HRQoL']","[{'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}]",,0.15533,"In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'Department of Neurosurgery, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Surajit', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Neurosurgery, Nottingham University Hospital, Nottingham, United Kingdom.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'International Spine, Pain and Performance Center, Washington, DC, United States.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, United Kingdom.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Annemans', 'Affiliation': 'Interuniversity Centre for Health Economics Research, Ghent University, Brussels University, Ghent and Brussels, Belgium.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Clinical Research, Medtronic, Minneapolis, MN, United States.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Clinical Research, Medtronic, Minneapolis, MN, United States.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Van den Abeele', 'Affiliation': 'Department of Clinical Research, Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'North', 'Affiliation': 'The Neuromodulation Foundation, Inc, Baltimore, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001510']
1018,30221589,Moderators and predictors of outcomes in telephone delivered compared to face-to-face cognitive behaviour therapy for paediatric obsessive-compulsive disorder: preliminary evidence from a non-inferiority RCT.,"This study provides a preliminary exploration of factors which differentially predict treatment response to telephone-delivered cognitive behavioural therapy (TCBT) compared to face-to-face CBT (CBT) in a randomised non-inferiority controlled trial of 72 children (aged 11-18 years) with obsessive-compulsive disorder (OCD). Potential moderator variables, their interaction with treatment group (CBT, TCBT) and baseline levels of OCD severity were entered into separate regression models where the primary outcome measure was the post-intervention Children's Yale-Brown Obsessive-Compulsive Scale total score (CYBOCS). Separate regressions were also used to test associations between predictors and outcome controlling for pretreatment CYBOCS. Only pretreatment level of parent-rated child peer problems moderated the effects of the two interventions on CYBOCS severity at post-treatment. After controlling for baseline CYBOCS, only family accommodation rated by mothers predicted poorer outcomes in both groups. While CBT and TCBT may be equally effective for adolescents with OCD, the current results tentatively suggest that higher baseline level of peer problems strengthened the response to therapy for youth receiving TCBT and the predictor analyses reinforce the importance of directly addressing family accommodation during CBT for paediatric OCD regardless of delivery mode. Limitations of the current findings and directions for future work are discussed.",2019,Only pretreatment level of parent-rated child peer problems moderated the effects of the two interventions on CYBOCS severity at post-treatment.,"['paediatric obsessive-compulsive disorder', '72 children (aged 11-18\xa0years) with obsessive-compulsive disorder (OCD', 'adolescents with OCD']","['telephone delivered compared to face-to-face cognitive behaviour therapy', 'telephone-delivered cognitive behavioural therapy (TCBT', 'face-to-face CBT (CBT', 'TCBT']","['CYBOCS severity', 'Yale-Brown Obsessive-Compulsive Scale total score (CYBOCS']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",72.0,0.0408965,Only pretreatment level of parent-rated child peer problems moderated the effects of the two interventions on CYBOCS severity at post-treatment.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'a Research School of Psychology, Australian National University , Canberra , Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'b School of Psychology, Australian Catholic University , Brisbane , Australia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'd Great Ormond Street Institute of Child Health, University College London , London , United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'e Department of Clinical Neuroscience, Karolinska Institutet , Stockholm , Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lovell', 'Affiliation': 'f Division of Nursing, Midwifery & Social Work, School of Health Sciences, University of Manchester , Manchester , United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Krebs', 'Affiliation': 'g Kings College London, Institute of Psychiatry , London , United Kingdom.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lang', 'Affiliation': 'g Kings College London, Institute of Psychiatry , London , United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': 'g Kings College London, Institute of Psychiatry , London , United Kingdom.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""O'Kearney"", 'Affiliation': 'a Research School of Psychology, Australian National University , Canberra , Australia.'}]",Cognitive behaviour therapy,['10.1080/16506073.2018.1513555']
1019,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES


To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS


This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS


Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2  provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION


Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2  provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
1020,31397022,The impact of an epilepsy nurse competency framework on the costs of supporting adults with epilepsy and intellectual disability: findings from the EpAID study.,"BACKGROUND


The development of a nurse-led approach to managing epilepsy in adults with an intellectual disability (ID) offers the potential of improved outcomes and lower costs of care. We undertook a cluster randomised trial to assess the impact on costs and outcomes of the provision of ID nurses working to a designated epilepsy nurse competency framework. Here, we report the impact of the intervention on costs.
METHOD


Across the United Kingdom, eight sites randomly allocated to the intervention recruited 184 participants and nine sites allocated to treatment as usual recruited 128 participants. Cost and outcome data were collected mainly by telephone interview at baseline and after 6 months. Total costs at 6 months were compared from the perspective of health and social services and society, with adjustments for pre-specified participant and cluster characteristics at baseline including costs. Missing data were imputed using multiple imputation. Uncertainty was quantified by bootstrapping.
RESULTS


The intervention was associated with lower per participant costs from a health and social services perspective of -£357 (2014/2015 GBP) (95% confidence interval -£986, £294) and from a societal perspective of -£631 (95% confidence interval -£1473, £181). Results were not sensitive to the exclusion of accommodation costs.
CONCLUSIONS


Our findings suggest that the competency framework is unlikely to increase the cost of caring for people with epilepsy and ID and may reduce costs.",2019,"The intervention was associated with lower per participant costs from a health and social services perspective of -£357 (2014/2015 GBP) (95% confidence interval -£986, £294) and from a societal perspective of -£631 (95% confidence interval -£1473, £181).","['184 participants and nine sites allocated to treatment as usual recruited 128 participants', 'Across the United Kingdom', 'adults with epilepsy and intellectual disability', 'adults with an intellectual disability (ID']",['epilepsy nurse competency framework'],"['Total costs', 'costs']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}]","[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",184.0,0.0835545,"The intervention was associated with lower per participant costs from a health and social services perspective of -£357 (2014/2015 GBP) (95% confidence interval -£986, £294) and from a societal perspective of -£631 (95% confidence interval -£1473, £181).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pennington', 'Affiliation': ""Department of Health Services and Population Research, King's Health Economics, PO24, David Goldberg Centre, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ring', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Redley', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': ""King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hook', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Platt', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': ""King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pullen', 'Affiliation': 'Epilepsy Action, New Antsey House, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mander', 'Affiliation': 'NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Donaldson', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rowe', 'Affiliation': 'Finance and Contracts, NHS Wakefield Clinical Commissioning Group, Wakefield, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Cambridge, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Irvine', 'Affiliation': 'School of Nursing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12679']
1021,31241527,"A Prospective, Randomized, Controlled Trial Comparing Conservative Treatment With Trunk Stabilization Exercise to Standard Hip Muscle Exercise for Treating Femoroacetabular Impingement: A Pilot Study.","OBJECTIVE


To assess the efficacy of conservative management of women with femoroacetabular impingement (FAI) using trunk stabilization.
DESIGN


Randomized controlled trial (level of evidence: I).
SUBJECTS


Twenty FAI female patients who met the inclusion FAI criteria.
METHODS


A prospective, randomized, controlled study was performed on 20 female patients with symptomatic FAI comprising 2 groups (10 hips in trunk stabilization exercise group vs 10 hips in control group). We evaluated hip range of motion, isometric muscle strength using a handheld dynamometer (μ-TasMF-01; Anima, Co), and patient-reported outcome measures, including modified Harris hip score, Vail hip score, and international hip outcome tool 12 (iHOT12) before and at 4 weeks and 8 weeks after the intervention.
RESULTS


There was a significant improvement in the range of motion of hip flexion in the trunk training group detected as early as 4 weeks after the intervention compared with the control group (P < 0.05). Hip abductor strength significantly improved in the trunk training group at 4 weeks after the intervention, whereas it did not improve in the control group (P < 0.05). Vail hip score and iHOT12 were significantly increased at 8 weeks after the intervention in the trunk training group compared with the control group (iHOT12: 78.7 ± 22.4 vs 53.0 ± 22.3; P < 0.01, Vail hip score: 81.6 ± 18.5 vs 61.1 ± 11.6; P < 0.05). There was no significant difference in the modified Harris hip score between both the groups at 4 and 8 weeks after the intervention.
CONCLUSIONS


The addition of trunk stabilization exercise to a typical hip rehabilitation protocol improves short-term clinical outcomes and may augment nonoperative and postoperative rehabilitation.",2019,"There was no significant difference in the modified Harris hip score between both the groups at 4 and 8 weeks after the intervention.
","['20 female patients with symptomatic FAI comprising 2 groups (10 hips in trunk stabilization exercise group vs 10 hips in control group', 'Treating Femoroacetabular Impingement', 'women with femoroacetabular impingement (FAI) using trunk stabilization', 'Twenty FAI female patients who met the inclusion FAI criteria']","['trunk stabilization exercise', 'Trunk Stabilization Exercise to Standard Hip Muscle Exercise']","['Vail hip score and iHOT12', 'Hip abductor strength', 'modified Harris hip score', 'modified Harris hip score, Vail hip score, and international hip outcome tool 12 (iHOT12', 'range of motion of hip flexion']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2936290', 'cui_str': 'Femoroacetabular Impingement Syndrome'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",20.0,0.0542395,"There was no significant difference in the modified Harris hip score between both the groups at 4 and 8 weeks after the intervention.
","[{'ForeName': 'Michihisa', 'Initials': 'M', 'LastName': 'Aoyama', 'Affiliation': 'AR-Ex Medical Group, Tokyo Arthroscopy Center, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Orthopaedic Surgery, Wakamatsu Hospital, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Utsunomiya', 'Affiliation': 'Department of Orthopaedic Surgery, Wakamatsu Hospital, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Shiho', 'Initials': 'S', 'LastName': 'Kanezaki', 'Affiliation': 'Department of Orthopaedic Surgery, Wakamatsu Hospital, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'AR-Ex Medical Group, Tokyo Arthroscopy Center, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Watanuki', 'Affiliation': 'AR-Ex Medical Group, Tokyo Arthroscopy Center, Tokyo, Japan.'}, {'ForeName': 'Dean K', 'Initials': 'DK', 'LastName': 'Matsuda', 'Affiliation': 'DISC Sports and Spine, Marina Del Rey, California.'}, {'ForeName': 'Soshi', 'Initials': 'S', 'LastName': 'Uchida', 'Affiliation': 'Department of Orthopaedic Surgery, Wakamatsu Hospital, University of Occupational and Environmental Health, Kitakyushu, Japan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000516']
1022,30542662,"Design and protocol for a pragmatic randomised study to optimise screening, prevention and care for tuberculosis and HIV in Malawi (PROSPECT Study).","Background:  Adults seeking diagnosis and treatment for tuberculosis (TB) and HIV in low-resource settings face considerable barriers and have high pre-treatment mortality. Efforts to improve access to prompt TB treatment have been hampered by limitations in TB diagnostics, with considerable uncertainty about how available and new tests can best be implemented.  Design and methods:  The PROSPECT Study is an open, three-arm pragmatic randomised study that will investigate the effectiveness and cost-effectiveness of optimised HIV and TB diagnosis and linkage to care interventions in reducing time to TB diagnosis and prevalence of undiagnosed TB and HIV in primary care in Blantyre, Malawi. Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration) will be randomly allocated to one of three groups: (i) standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage. We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness.  Conclusions:  The PROSPECT Study will provide urgently-needed evidence under ""real-life"" conditions to inform clinicians and policy makers on how best to improve TB/HIV diagnosis and treatment in Africa.  Clinical trial registration:  NCT03519425 (08/05/2018).",2018,"We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening.","['adults with TB symptoms', 'Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration']","['optimised HIV and TB diagnosis and linkage to care interventions', 'standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage']","['prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness', 'time to TB treatment initiation', 'time to TB diagnosis and prevalence of undiagnosed TB and HIV']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.163433,"We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacPherson', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Lalloo', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Marriott', 'Initials': 'M', 'LastName': 'Nliwasa', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre , Malawi.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Department of Public Health and Policy, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Joekes', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Dama', 'Initials': 'D', 'LastName': 'Phiri', 'Affiliation': 'Radiology Department, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Bertie', 'Initials': 'B', 'LastName': 'Squire', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre , Malawi.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Pai', 'Affiliation': 'McGill International TB Centre, McGill University, Montreal , Canada.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.14598.3']
1023,30088145,A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment.,"Intimate partner victimization (IPV) during the perinatal period is associated with adverse outcomes for the woman, her developing fetus, and any children in her care. Maternal mental health concerns, including depression and anxiety, are prevalent during the perinatal period particularly among women experiencing IPV. Screening and interventions for IPV targeting women seeking mental health treatment are lacking. In the current study, we examine the feasibility, acceptability, and the preliminary efficacy of a brief, motivational computer-based intervention, SURE (Strength for U in Relationship Empowerment), for perinatal women with IPV seeking mental health treatment. The study design was a two-group, randomized controlled trial with 53 currently pregnant or within 6-months postpartum women seeking mental health treatment at a large urban hospital-based behavioral health clinic for perinatal women. Findings support the acceptability and feasibility of the SURE across a number of domains including content, delivery, and retention. All participants (100%) found the information and resources in SURE to be helpful. Our preliminary results found the degree of IPV decreased significantly from baseline to the 4-month follow-up for the SURE condition (paired t-test, p < 0.001), while the control group was essentially unchanged. Moreover, there was a significant reduction in emotional abuse for SURE participants (p = 0.023) relative to participants in the control condition. There were also reductions in physical abuse although non-significant (p = 0.060). Future work will test SURE in a larger, more diverse sample. ClinicalTrials.gov Identifier: NCT02370394.",2019,"Moreover, there was a significant reduction in emotional abuse for SURE participants (p = 0.023) relative to participants in the control condition.","['53 currently pregnant or within 6-months postpartum women seeking mental health treatment at a large urban hospital-based behavioral health clinic for perinatal women', 'victimized perinatal women seeking mental health treatment', 'perinatal women with IPV seeking mental health treatment', 'women experiencing IPV']","['Intimate partner victimization (IPV', 'computer-based brief intervention', 'motivational computer-based intervention, SURE (Strength for U in Relationship Empowerment']","['degree of IPV', 'emotional abuse', 'physical abuse']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse (event)'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}]",53.0,0.0491485,"Moreover, there was a significant reduction in emotional abuse for SURE participants (p = 0.023) relative to participants in the control condition.","[{'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA. czlotnick@butler.org.'}, {'ForeName': 'Golfo', 'Initials': 'G', 'LastName': 'Tzilos Wernette', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': 'Department of Medicine at Women and Infants Hospital, Providence, RI, USA.'}]",Archives of women's mental health,['10.1007/s00737-018-0895-1']
1024,32151439,Behavior-Specific Cognitions Moderate Rural Women's Responsiveness to Web-Based Interventions for Weight Loss.,"OBJECTIVE


To examine whether baseline behavior-specific cognitions moderated the effects of 2 Web-based interventions with enhanced features on weight loss success in rural women.
DESIGN


Secondary analysis of behavior-specific cognition data from a community-based, randomized controlled trial, as potential moderators of weight loss over 30 months.
PARTICIPANTS


Women, overweight or obese, from rural communities, aged 40-69 years (n = 200).
INTERVENTIONS


Theory-based Web interventions, with enhanced features of either peer-led Web discussion or professional e-mail counseling.
MAIN OUTCOME MEASURES


Benefits and barriers to healthy eating and activity; self-efficacy and interpersonal support for healthy eating and activity using validated surveys; and weight.
ANALYSIS


Longitudinal multilevel models.
RESULTS


Women in the professional e-mail counseling group were more likely to lose weight if they perceived fewer barriers to and higher self-efficacy for healthy eating and activity. Greater weight loss in the peer-led discussion group was observed for women with lower self-efficacy and higher perceptions of barriers. Interpersonal support did not moderate the effects of the interventions.
CONCLUSIONS AND IMPLICATIONS


Although women in 2 different Web-enhanced interventions achieved similar weight loss, their baseline perceptions of behavior-specific cognitions moderated their relationship with the type of intervention and weight loss success. These findings, although exploratory, may assist in matching women to Web interventions that would best maximize weight loss success. Further research is needed.",2020,Greater weight loss in the peer-led discussion group was observed for women with lower self-efficacy and higher perceptions of barriers.,"['Women in the professional e-mail counseling group', 'rural women', 'Women, overweight or obese, from rural communities, aged 40-69 years (n\u202f=\u202f200']","['Theory-based Web interventions, with enhanced features of either peer-led Web discussion or professional e-mail counseling']","['weight loss', 'weight loss success', 'Greater weight loss', 'Benefits and barriers to healthy eating and activity; self-efficacy and interpersonal support for healthy eating and activity using validated surveys; and weight']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0736969,Greater weight loss in the peer-led discussion group was observed for women with lower self-efficacy and higher perceptions of barriers.,"[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE. Electronic address: kevin.kupzyk@unmc.edu.'}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Pullen', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Hageman', 'Affiliation': 'Physical Therapy Education, College of Allied Health Professions, University of Nebraska Medical Center, Omaha, NE.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.02.003']
1025,31738927,Acute Ventilatory Support During Whole-Body Hybrid Rowing in Patients With High-Level Spinal Cord Injury: A Randomized Controlled Crossover Trial.,"BACKGROUND


High-level spinal cord injury (SCI) results in profound spinal and supraspinal deficits, leading to substantial ventilatory limitations during whole-body hybrid functional electrical stimulation (FES)-rowing, a form of exercise that markedly increases the active muscle mass via electrically induced leg contractions. This study tested the effect of noninvasive ventilation (NIV) on ventilatory and aerobic capacities in SCI.
METHODS


This blinded, randomized crossover study enrolled 19 patients with SCI (level of injury ranging from C4 to T8). All patients were familiar with FES-rowing and had plateaued in their training-related increases in aerobic capacity. Patients performed two FES-rowing peak exercise tests with NIV or without NIV (sham).
RESULTS


NIV increased exercise tidal volume (peak, 1.50 ± 0.31 L vs 1.36 ± 0.34 L; P < .05) and reduced breathing frequency (peak, 35 ± 7 beats/min vs 38 ± 6 beats/min; P < .05) compared with the sham test, leading to no change in alveolar ventilation but a trend toward increased oxygen uptake efficiency (P = .06). In those who reached peak oxygen consumption (Vo 2 peak) criteria (n = 13), NIV failed to significantly increase Vo 2 peak (1.73 ± 0.66 L/min vs 1.78 ± 0.59 L/min); however, the range of responses revealed a correlation between changes in peak alveolar ventilation and Vo 2 peak (r = 0.89; P < .05). Furthermore, those with higher level injuries and shorter time since injury exhibited the greatest increases in Vo 2 peak.
CONCLUSIONS


Acute NIV can successfully improve ventilatory efficiency during FES exercise in SCI but may not improve Vo 2 peak in all patients. Those who benefit most seem to be patients with cervical SCI within a shorter time since injury.
TRIAL REGISTRY


ClinicalTrials.gov; Nos.: NCT02865343 and NCT03267212; URL: www.clinicaltrials.gov.",2020,Acute NIV can successfully improve ventilatory efficiency during FES exercise in SCI but may not improve VO 2 peak in all patients.,"['patients with high-level spinal cord injury', 'Nineteen patients with SCI (C4-T8']","['Acute ventilatory support during whole-body hybrid rowing', 'non-invasive ventilation (NIV', 'FES-rowing peak exercise tests with NIV or Sham']","['oxygen uptake efficiency', 'exercise tidal volume', 'VO2peak', 'reduced breathing frequency', 'ventilatory efficiency', 'alveolar ventilation (VA', 'aerobic capacity', 'ventilatory and aerobic capacities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V), function (observable entity)'}]",,0.189248,Acute NIV can successfully improve ventilatory efficiency during FES exercise in SCI but may not improve VO 2 peak in all patients.,"[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston MA; Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA. Electronic address: ivivodtzev@partners.org.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA.'}, {'ForeName': 'Felipe X', 'Initials': 'FX', 'LastName': 'Cepeda', 'Affiliation': 'Universidade Nove de Julho, São Paulo, SP, Brazil.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston MA; Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital, Cambridge, MA.'}]",Chest,['10.1016/j.chest.2019.10.044']
1026,31783823,Oral esketamine for treatment-resistant depression: rationale and design of a randomized controlled trial.,"BACKGROUND


There is an urgent need to develop additional treatment strategies for patients with treatment-resistant depression (TRD). The rapid but short-lived antidepressant effects of intravenous (IV) ketamine as a racemic mixture have been shown repeatedly in this population, but there is still a paucity of data on the efficacy and safety of (a) different routes of administration, and (b) ketamine's enantiomers esketamine and arketamine. Given practical advantages of oral over IV administration and pharmacodynamic arguments for better antidepressant efficacy of esketamine over arketamine, we designed a study to investigate repeated administration of oral esketamine in patients with TRD.
METHODS


This study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks. The methods support examination of the efficacy, safety, tolerability, mechanisms of action, and economic impact of oral esketamine in patients with TRD.
DISCUSSION


This is the first RCT investigating repeated oral esketamine administration in patients with TRD. If shown to be effective and tolerated, oral esketamine administration poses important advantages over IV administration.
TRIAL REGISTRATION


Dutch Trial Register, NTR6161. Registered 21 October 2016.",2019,"This study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks.","['patients with TRD', 'patients with treatment-resistant depression (TRD']","['daily oral esketamine versus placebo', 'placebo', 'oral esketamine', 'Oral esketamine', 'intravenous (IV) ketamine']","['efficacy, safety, tolerability, mechanisms of action, and economic impact of oral esketamine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2825616'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524059', 'cui_str': 'mode of action'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2825616'}]",,0.312752,"This study features a triple-blind randomized placebo-controlled trial (RCT) comparing daily oral esketamine versus placebo as add-on to regular antidepressant medications for a period of 6 weeks, succeeded by a follow-up of 4 weeks.","[{'ForeName': 'Sanne Y', 'Initials': 'SY', 'LastName': 'Smith-Apeldoorn', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands. s.y.apeldoorn@umcg.nl.'}, {'ForeName': 'Jolien K E', 'Initials': 'JKE', 'LastName': 'Veraart', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Kamphuis', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Antoinette D I', 'Initials': 'ADI', 'LastName': 'van Asselt', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Aan Het Rot', 'Affiliation': 'Department of Psychology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schoevers', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2359-1']
1027,30753368,"Impact of Rotavirus Vaccine Introduction in Children Less Than 2 Years of Age Presenting for Medical Care With Diarrhea in Rural Matlab, Bangladesh.","BACKGROUND


Following the conclusion of a human rotavirus vaccine (HRV) cluster-randomized, controlled trial (CRT) in Matlab, Bangladesh, HRV was included in Matlab's routine immunization program. We describe the population-level impact of programmatic rotavirus vaccination in Bangladesh in children <2 years of age.
METHODS


Interrupted time series were used to estimate the impact of HRV introduction. We used diarrheal surveillance collected between 2000 and 2014 within the 2 service delivery areas (International Centre for Diarrhoeal Disease Research, Bangladesh [icddr,b] service area [ISA] and government service area [GSA]) of the Matlab Health and Demographic Surveillance System, administered by icddr,b. Age group-specific incidence rates were calculated for both rotavirus-positive (RV+) and rotavirus-negative (RV-) diarrhea diagnoses of any severity presenting to the hospital. We used 2 models to assess the impact within each service area: Model 1 used the pre-vaccine time period in all villages (HRV- and control-only) and Model 2 combined the pre-vaccine time period and the CRT time period, using outcomes from control-only villages.
RESULTS


Both models demonstrated a downward trend in RV+ diarrheal incidences in the ISA villages during 3.5 years of routine HRV use, though only Model 2 was statistically significant. Significant impacts of HRV on RV+ diarrhea incidences in GSA villages were not observed in either model. Differences in population-level impacts between the 2 delivery areas may be due to the varied rotavirus vaccine coverage and presentation rates to the hospital.
CONCLUSIONS


This study provides initial evidence of the population-level impact of rotavirus vaccines in children <2 years of age in Matlab, Bangladesh. Further studies are needed of the rotavirus vaccine impact after the nationwide introduction in Bangladesh.",2019,Significant impact of HRV on RV+ diarrhea incidence in GSA villages was not observed in either model.,"['children <2 years of age in Matlab, Bangladesh', 'children less than 2 years of age presenting for medical care with diarrhea in rural Matlab, Bangladesh', 'Diarrheal surveillance collected between 2000 and 2014 within the two service delivery areas (icddr,b service area [ISA] and government service area [GSA]) of the', 'Bangladesh in children <2 years of age']","['programmatic rotavirus vaccination', 'Matlab Health and Demographic Surveillance System administered by icddr', 'rotavirus vaccine introduction', 'Rotarix vaccine (HRV', 'HRV', 'rotavirus vaccines']","['rotavirus-positive (RV+) and rotavirus-negative (RV-) diarrhea', 'RV+ diarrheal incidence', 'RV+ diarrhea incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}]","[{'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2.0,0.0570139,Significant impact of HRV on RV+ diarrhea incidence in GSA villages was not observed in either model.,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schwartz', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Ahasan-Ul H', 'Initials': 'AH', 'LastName': 'Basunia', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Abu Syed Golam', 'Initials': 'ASG', 'LastName': 'Faruque', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Mustafizur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Sugimoto', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rowhani-Rahbar', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, Washington.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz133']
1028,30659257,The influence of 15-week exercise training on dietary patterns among young adults.,"BACKGROUND/OBJECTIVES


Little is currently known about how exercise may influence dietary patterns and/or food preferences. The present study aimed to examine the effect of a 15-week exercise training program on overall dietary patterns among young adults.
SUBJECTS/METHODS


This study consisted of 2680 young adults drawn from the Training Intervention and Genetics of Exercise Response (TIGER) study. Subjects underwent 15 weeks of aerobic exercise training, and exercise duration, intensity, and dose were recorded for each session using computerized heart rate monitors. In total, 4355 dietary observations with 102 food items were collected using a self-administered food frequency questionnaire before and after exercise training (n = 2476 at baseline; n = 1859 at 15 weeks). Dietary patterns were identified using a Bayesian sparse latent factor model. Changes in dietary pattern preferences were evaluated based on the pre/post-training differences in dietary pattern scores, accounting for the effects of gender, race/ethnicity, and BMI.
RESULTS


Within each of the seven dietary patterns identified, most dietary pattern scores were decreased following exercise training, consistent with increased voluntary regulation of food intake. A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β: -0.1280; 95% credible interval: -0.1877, -0.0637) patterns, while a higher intensity of exercise was linked to an increased preference for the prudent pattern (β: 0.0623; 95% credible interval: 0.0159, 0.1111). Consequently, a higher dose of exercise was related to a decreased preference for the snacking pattern (β: -0.0023; 95% credible interval: -0.0042, -0.0004) and an increased preference for the prudent pattern (β: 0.0029; 95% credible interval: 0.0009, 0.0048).
CONCLUSIONS


The 15-week exercise training appeared to motivate young adults to pursue healthier dietary preferences and to regulate their food intake.",2019,"A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β:","['2680 young adults drawn from the Training Intervention and Genetics of Exercise Response (TIGER) study', 'young adults']","['15-week exercise training program', 'aerobic exercise training, and exercise duration, intensity, and dose were recorded for each session using computerized heart rate monitors', '15-week exercise training']","['voluntary regulation of food intake', 'dietary pattern preferences', 'overall dietary patterns', 'dietary pattern scores']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4355.0,0.0292461,"A longer duration of exercise was associated with decreased preferences for the western (β: -0.0793; 95% credible interval: -0.1568, -0.0017) and snacking (β:","[{'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Sinead A', 'Initials': 'SA', 'LastName': 'Williamson', 'Affiliation': 'Departments of Information, Risk, & Operations Management and Statistics & Data Science, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Vazquez', 'Affiliation': 'Department of Epidemiology & Biostatistics and Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Bray', 'Affiliation': 'Department of Nutritional Sciences, The University of Texas at Austin, Austin, TX, USA. mbray@austin.utexas.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0299-3']
1029,30526364,Web-based CBT for the prevention of anxiety symptoms among medical and health science graduate students.,"Medical and health science graduate students report greater anxiety problems than the general population, but they are less likely to seek treatment due to cultural and logistical barriers. One preventative approach that overcomes these barriers is web-based cognitive behavioral therapy (webCBT). It is unknown whether webCBT is effective for preventing anxiety escalation within this population. A randomized controlled trial was conducted, comparing the effects of webCBT versus a control group (CG). Medical university students (n=594;  M age=27; 67% female; 80% Caucasian) completed online baseline measures and four assigned online activities. Measures were re-administered after approximately three months. There was a small interaction effect between time of assessment and treatment condition. Anxiety severity was lower in the webCBT ( M [ SD ]=2.88[3.36]) versus CG condition ( M [ SD ]=3.69 [3.35]) at follow-up. This effect was moderate for students with mild, versus minimal, anxiety at baseline. The proportion of students with possible anxiety disorder was lower in the webCBT (4.5%) versus CG (8.5%) condition, and the proportion of mildly anxious students with a clinically significant increase in symptoms was lower in the webCBT (10%) versus CG (20%) condition. WebCBT may aid in preventing anxiety escalation in this population, particularly for at-risk students who report mild anxiety symptoms.",2019,Anxiety severity was lower in the webCBT (M[SD]=2.88[3.36]) versus CG condition (M[SD]=3.69 [3.35]) at follow-up.,"['Medical university students (n=594; Mage=27; 67% female; 80% Caucasian', 'medical and health science graduate students']","['webCBT', 'Web-based CBT', 'WebCBT']","['Anxiety severity', 'symptoms', 'anxiety problems', 'proportion of students with possible anxiety disorder']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]",,0.0305785,Anxiety severity was lower in the webCBT (M[SD]=2.88[3.36]) versus CG condition (M[SD]=3.69 [3.35]) at follow-up.,"[{'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Howell', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC) , Charleston , SC , USA.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Rheingold', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC) , Charleston , SC , USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Uhde', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC) , Charleston , SC , USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC) , Charleston , SC , USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2018.1533575']
1030,31464192,"Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial.","BACKGROUND


IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems.
OBJECTIVE


This study aimed to examine the effect of 2 methods of maintaining engagement with the IntelliCare platform, coaching, and receipt of weekly recommendations to try different apps on depression, anxiety, and app use.
METHODS


A total of 301 participants with depression or anxiety were randomized to 1 of 4 treatments lasting 8 weeks and were followed for 6 months posttreatment. The trial used a 2X2 factorial design (coached vs self-guided treatment and weekly app recommendations vs no recommendations) to compare engagement metrics.
RESULTS


The median time to last use of any app during treatment was 56 days (interquartile range 54-57), with 253 participants (84.0%, 253/301) continuing to use the apps over a median of 92 days posttreatment. Receipt of weekly recommendations resulted in a significantly higher number of app use sessions during treatment (overall median=216; P=.04) but only marginal effects for time to last use (P=.06) and number of app downloads (P=.08). Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08). Participants showed significant reductions in the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) across all treatment arms (P s<.001). Coached treatment led to larger GAD-7 reductions than those observed for self-guided treatment (P=.03), but the effects for the PHQ-9 did not reach significance (P=.06). Significant interaction was observed between receiving recommendations and time for the PHQ-9 (P=.04), but there were no significant effects for GAD-7 (P=.58).
CONCLUSIONS


IntelliCare produced strong engagement with apps across all treatment arms. Coaching was associated with stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02801877; https://clinicaltrials.gov/ct2/show/NCT02801877.",2019,"Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08).",['301 participants with depression or anxiety'],['Coaching and Receipt of App Recommendations'],"['median time to last use', 'stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes', 'larger GAD-7 reductions', 'Depression, Anxiety, and Engagement', 'Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]",301.0,0.258999,"Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08).","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Schueller', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, Irvine, CA, United States.'}, {'ForeName': 'Kathryn Noth', 'Initials': 'KN', 'LastName': 'Tomasino', 'Affiliation': 'Department of Gastroenterology, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Nameyeh', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Karr', 'Affiliation': 'Audacious Software, Chicago, IL, United States.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Vergara', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'Lattie', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, IL, United States.'}]",Journal of medical Internet research,['10.2196/13609']
1031,30906526,N-terminal pro-brain natriuretic peptide: a potential follow-up biomarker of mandibular advancement device efficacy on cardiac function in obstructive sleep apnea.,"Interrelationships between obstructive sleep apnea (OSA) and cardiovascular diseases are now recognized, but some underlying pathophysiological mechanisms remain controversial. Circulating cardiac biomarkers are diagnostic tools that can help understand them, in particular the N-terminal pro-brain natriuretic peptide (NT-proBNP), a marker of myocardial stretch, and a potential indicator of subclinical cardiac stress in OSA. Continuous positive airway pressure (CPAP), the first-line treatment of moderate to severe OSA, may be considered as uncomfortable, resulting in poor adherence, and reduced effectiveness. In this case, mandibular advancement devices (MAD) are an effective alternative therapy, more comfortable, and generally well accepted, with higher compliance. To date, few studies have compared the cardiovascular effects of CPAP and MAD. From recent literature reviews, it emerges that both therapies are effective in blood pressure reduction. However, the effects of MAD on other cardiovascular outcomes are conflicting, in particular as regards to its impact on circulating cardiac biomarkers. In a recent ancillary study from a randomized controlled trial, Recoquillon  et al  concluded that two months of MAD treatment had no effect on NT-proBNP plasma levels in patients with severe OSA. The present discussion analyses this result from a biological, statistical, and analytical standpoint, in light of results from other studies evaluating natriuretic peptides in MAD-treated OSA, with the aim to support further longitudinal studies designed with a high methodological quality.",2018,"In this case, mandibular advancement devices (MAD) are an effective alternative therapy, more comfortable, and generally well accepted, with higher compliance.","['patients with severe OSA', 'obstructive sleep apnea']","['MAD', 'mandibular advancement devices (MAD', 'Continuous positive airway pressure (CPAP']","['NT-proBNP plasma levels', 'blood pressure reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0175505,"In this case, mandibular advancement devices (MAD) are an effective alternative therapy, more comfortable, and generally well accepted, with higher compliance.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Monneret', 'Affiliation': 'Department of Biochemistry and Molecular Biology, South Lyon Hospital Group, Hospices Civils de Lyon, Pierre-Bénite, 69495, France.'}]",F1000Research,['10.12688/f1000research.17081.2']
1032,30679315,"A Phase II Randomized Trial of Panitumumab, Erlotinib, and Gemcitabine Versus Erlotinib and Gemcitabine in Patients with Untreated, Metastatic Pancreatic Adenocarcinoma: North Central Cancer Treatment Group Trial N064B (Alliance).","LESSONS LEARNED


Dual epidermal growth factor receptor (EGFR)-directed therapy with erlotinib and panitumumab in combination with gemcitabine was superior to gemcitabine and erlotinib, but the clinical relevance is uncertain given the limited role of gemcitabine monotherapy.A significantly longer overall survival was observed in patients receiving the dual EGFR-directed therapy.The dual EGFR-directed therapy resulted in increased toxicity.
BACKGROUND


Gemcitabine is active in patients with advanced pancreatic adenocarcinoma. The combination of erlotinib, an oral epidermal growth factor receptor (EGFR) inhibitor, and gemcitabine was shown to modestly prolong overall survival when compared with gemcitabine alone. The North Central Cancer Treatment Group (now part of Alliance for Clinical Trials in Oncology) trial N064B compared gemcitabine plus erlotinib versus gemcitabine plus combined EGFR inhibition with erlotinib and panitumumab.
METHODS


Eligible patients with metastatic adenocarcinoma of the pancreas were randomized to either gemcitabine 1,000 mg/m 2  on days 1, 8, and 15 of a 28-day cycle with erlotinib 100 mg p.o. daily (Arm A) or the same combination with the addition of panitumumab 4 mg/kg on days 1 and 15 of a 28-day cycle (Arm B). The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, the confirmed response rate, and toxicity. Comparison between arms for the primary endpoint was done with a one-sided log-rank test, and a  p  value less than .20 was considered statistically significant. Response rate comparison was done with Fisher's exact test. All other reported  p  values are two-sided.
RESULTS


A total of 92 patients were randomized, 46 to each arm. The median overall survival was 4.2 months in Arm A and 8.3 months in Arm B (hazard ratio, 0.817; 95% confidence interval [CI], 0.530-1.260;  p  = .1792). The progression-free survival was 2.0 months in Arm A and 3.6 months in Arm B (hazard ratio, 0.843; 95% CI, 0.555-1.280;  p  = .4190). A partial confirmed response was seen in 8.7% of patients on Arm A and 6.5% on Arm B ( p  = .9999). No patients had a complete response. Grade 3 and higher nonhematologic toxicities were more common in patients on Arm B compared with those on Arm A (82.6% vs. 52.2%;  p  = .0018).
CONCLUSION


Dual EGFR-directed therapy resulted in a significant prolongation of overall survival in patients with advanced adenocarcinoma of the pancreas but was associated with substantially increased toxicities. Dual EGFR-directed therapy in combination with gemcitabine alone cannot be recommended for further study, as single-agent gemcitabine is no longer considered an appropriate therapy for otherwise fit patients with metastatic pancreatic cancer.",2019,"Grade 3 and higher nonhematologic toxicities were more common in patients on Arm B compared with those on Arm A (82.6% vs. 52.2%;  p  = .0018).
","['Eligible patients with metastatic adenocarcinoma of the pancreas', 'Patients with Untreated, Metastatic Pancreatic Adenocarcinoma', 'patients with metastatic pancreatic cancer', 'patients with advanced adenocarcinoma of the pancreas', 'patients with advanced pancreatic adenocarcinoma', '92 patients were randomized, 46 to each arm']","['gemcitabine', 'Gemcitabine', 'panitumumab', 'erlotinib, an oral epidermal growth factor receptor (EGFR) inhibitor, and gemcitabine', 'gemcitabine and erlotinib', 'Panitumumab, Erlotinib, and Gemcitabine Versus Erlotinib and Gemcitabine', 'erlotinib 100 mg p.o', 'gemcitabine plus erlotinib versus gemcitabine plus combined EGFR inhibition with erlotinib and panitumumab']","['progression-free survival', 'toxicity', 'Grade 3 and higher nonhematologic toxicities', 'toxicities', 'median overall survival', 'progression-free survival, the confirmed response rate, and toxicity', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1632291', 'cui_str': 'erlotinib 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]",92.0,0.111791,"Grade 3 and higher nonhematologic toxicities were more common in patients on Arm B compared with those on Arm A (82.6% vs. 52.2%;  p  = .0018).
","[{'ForeName': 'Thorvardur R', 'Initials': 'TR', 'LastName': 'Halfdanarson', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA halfdanarson.thorvardur@mayo.edu.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Foster', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Kim', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Smyrk', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'McCullough', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Mayo Clinic, Scottsdale, Arizona, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Ames', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jeffrry P', 'Initials': 'JP', 'LastName': 'Jaffe', 'Affiliation': 'Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}]",The oncologist,['10.1634/theoncologist.2018-0878']
1033,30602344,Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan.,"OBJECTIVE


Few individuals with mood disorders have access to evidence-based collaborative chronic care models (CCMs) because most patients are seen in small-group practices (<20 providers) with limited capacity to deliver CCMs. In this single-blind randomized controlled trial, we determined whether a CCM delivered nationally in a U.S. health plan improved 12-month outcomes among enrollees with mood disorders compared with usual care.
METHODS


Aetna insurance enrollees (N=238), mostly females (66.1%) with a mean age of 41.1 years, who were recently hospitalized for unipolar major depression or bipolar disorder provided informed consent, completed baseline assessments, and were randomly assigned to usual care or CCM. The CCM included 10 sessions of the Life Goals self-management program and brief contacts by phone by a care manager to determine symptom status. Primary outcomes were changes over 12 months in depression symptoms (nine-item Patient Health Questionnaire [PHQ-9]) and mental health-related quality of life (Short Form-12).
RESULTS


Adjusted mean PHQ-9 scores were lower by 2.34 points (95% confidence level [CL]=-4.18 to -0.50, p=0.01), indicating improved symptoms, and adjusted mean SF-12 mental health scores were higher by 3.21 points (CL=-.97 to 7.38, p=0.10), indicating better quality of life, among participants receiving CCM versus usual care.
CONCLUSIONS


Individuals receiving CCM compared with usual care had improved clinical outcomes, although substantial attrition may limit the impact of health plan-level delivery of CCMs. Further research on the use of health plan-level interventions, such as CCMs, as alternatives to practice-based models is warranted.",2019,"Adjusted mean PHQ-9 scores were lower by 2.34 points (95% confidence level [CL]=-4.18 to -0.50, p=0.01), indicating improved symptoms, and adjusted mean SF-12 mental health scores were higher by 3.21 points (CL=-.97 to 7.38, p=0.10), indicating better quality of life, among participants receiving CCM versus usual care.
","['\n\n\nAetna insurance enrollees (N=238), mostly females (66.1%) with a mean age of 41.1 years, who were recently hospitalized for unipolar major depression or bipolar disorder provided informed consent, completed baseline assessments', 'enrollees with mood disorders compared with usual care']","['usual care or CCM', 'CCM', 'Collaborative Care Intervention']","['Adjusted mean PHQ-9 scores', 'improved symptoms, and adjusted mean SF-12 mental health scores', 'clinical outcomes', 'changes over 12 months in depression symptoms (nine-item Patient Health Questionnaire [PHQ-9]) and mental health-related quality of life (Short Form-12', 'quality of life']","[{'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.126561,"Adjusted mean PHQ-9 scores were lower by 2.34 points (95% confidence level [CL]=-4.18 to -0.50, p=0.01), indicating improved symptoms, and adjusted mean SF-12 mental health scores were higher by 3.21 points (CL=-.97 to 7.38, p=0.10), indicating better quality of life, among participants receiving CCM versus usual care.
","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Kilbourne', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Prenovost', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Liebrecht', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}, {'ForeName': 'Hyong', 'Initials': 'H', 'LastName': 'Un', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'Center for Clinical Management Research, U.S. Department of Veterans Affairs (VA) Ann Arbor Healthcare System, Ann Arbor, Michigan (Kilbourne, Kim); Department of Psychiatry, University of Michigan Medical School, North Campus, Ann Arbor (Kilbourne, Prenovost, Liebrecht); Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor (Eisenberg); Aetna Healthcare, Blue Bell, Pennsylvania (Un); Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, and Department of Psychiatry, Harvard Medical School, Boston (Bauer).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800336']
1034,30964804,How Can Programs Better Support Female Sex Workers to Avoid HIV Infection in Zimbabwe? A Prevention Cascade Analysis.,"BACKGROUND


""HIV prevention cascades"" have been proposed to support programs by identifying gaps in demand for, access to, and capability to adhere to HIV prevention tools, but there are few empirical examples to guide development. We apply a prevention cascade framework to examine prevention coverage and factors associated with condoms and/or PrEP adherence among female sex workers.
SETTING


Seven sites across Zimbabwe.
METHODS


Seven respondent-driven sampling surveys from the intervention sites of a pragmatic cluster-randomized trial in Zimbabwe in 2016 were analyzed, and 611/1439 women testing HIV-negative included. We operationalized key components of an HIV prevention cascade including demand, supply, and capability to adhere to 2 tools for HIV prevention: condoms and pre-exposure prophylaxis (PrEP). We used adjusted logistic regression to identify determinants of adherence to condoms and PrEP in turn, examining the effect of adherence to one tool on adherence to the other.
RESULTS


There were 343/611, 54.7%, women reporting adherence to condoms and/or PrEP, leaving almost half uncovered. Although women were aware that condoms prevented HIV and reported good access to them, only 45·5% reported full adherence to condom use. For PrEP, a new technology, there were gaps along all 3 domains of demand, supply, and adherence. Alcohol use decreased adherence to PrEP and condoms. Younger and newer entrants to sex work were less likely to take PrEP every day.
CONCLUSIONS


HIV prevention programming among female sex workers in Zimbabwe could consider increasing awareness of PrEP alongside supply, alcohol use interventions, and approaches to engaging younger women.",2019,"There were 343/611, 54.7%, women reporting adherence to condoms and/or PrEP, leaving almost half uncovered.","['Seven respondent-driven sampling surveys from the intervention sites of a pragmatic cluster-randomized trial in Zimbabwe in 2016 were analyzed, and 611/1439 women testing HIV-negative included', 'female sex workers in Zimbabwe', 'female sex workers', 'Seven sites across Zimbabwe']",[],[],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],[],,0.0362943,"There were 343/611, 54.7%, women reporting adherence to condoms and/or PrEP, leaving almost half uncovered.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fearon', 'Affiliation': 'Department of Social and Environmental Health Research, Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, Faculty of Population Health Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Sibongile', 'Initials': 'S', 'LastName': 'Mtetwa', 'Affiliation': 'Centre for Sexual Health and HIV AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Sungai T', 'Initials': 'ST', 'LastName': 'Chabata', 'Affiliation': 'Centre for Sexual Health and HIV AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Phillis', 'Initials': 'P', 'LastName': 'Mushati', 'Affiliation': 'Centre for Sexual Health and HIV AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cambiano', 'Affiliation': 'Institute for Global Health, Faculty of Population Health Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Busza', 'Affiliation': 'Department of Social and Environmental Health Research, Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Napierala', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA.""}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Baral', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Weir', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rice', 'Affiliation': 'Department of Social and Environmental Health Research, Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'Centre for Sexual Health and HIV AIDS Research (CeSHHAR) Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'Department of Social and Environmental Health Research, Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001980']
1035,30651398,S-1 plus Raltitrexed for Refractory Metastatic Colorectal Cancer: A Phase II Trial.,"LESSONS LEARNED


The upregulation of dihydropyrimidine dehydrogenase (DPD) and thymidylate synthase (TS) are important mechanisms of resistance to 5-fluorouracil (5-FU) in metastatic colorectal cancer (mCRC) after long exposure to 5-FU.S-1 (containing a DPD inhibitor) combined with raltitrexed (a TS inhibitor) showed a moderate effect, which needs further study as a third- or later-line therapy in mCRC.
BACKGROUND


5-fluorouracil (5-FU) is a fundamental drug in the treatment of metastatic colorectal cancer (mCRC). Patients with mCRC are often exposed to 5-FU and/or its analogues for a long time because of its central role in treatment regimens. The upregulation of dihydropyrimidine dehydrogenase (DPD) and/or thymidylate synthase (TS) are important mechanisms of resistance of 5-FU. To evaluate the efficacy and safety of S-1 (containing a DPD inhibitor) and raltitrexed (a TS inhibitor) for refractory mCRC, a one-center, single-arm, prospective phase II trial was conducted.
METHODS


Patients who had mCRC that had progressed after treatment with fluoropyrimidine, irinotecan, and oxaliplatin and who had at least one measurable lesion were eligible for this trial. Patients received oral S-1 (80-120 mg for 14 days every 3 weeks) plus an intravenous infusion of raltitrexed (3 mg/m 2  on day 1 every 3 weeks). The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.
RESULTS


In total, 46 patients were enrolled. Three patients did not complete the first assessment because of adverse events and unwillingness, leaving tumor response evaluation available in 43 patients. Of 43 evaluable patients, the ORR was 13.9% and disease control rate was 58.1%. In the intention-to-treat population ( n  = 46), the ORR was 13.0% and disease control rate was 54.3%. Median PFS and median OS were 107 days (95% confidence interval [CI], 96.3-117.7) and 373 days (95% CI, 226.2-519.8), respectively. Most of the adverse effects were mild to moderate.
CONCLUSION


S-1 combined with raltitrexed for refractory mCRC showed moderate effect, and it is worthy of further study as third- or later-line therapy in mCRC.",2019,"Of 43 evaluable patients, the ORR was 13.9% and disease control rate was 58.1%.","['Patients with mCRC', '46 patients were enrolled', 'Refractory Metastatic Colorectal Cancer', 'Patients who had mCRC that had progressed after treatment with', 'and who had at least one measurable lesion were eligible for this trial', 'metastatic colorectal cancer (mCRC']","['S-1 (containing a DPD inhibitor) and raltitrexed (a TS inhibitor', 'oral S-1', 'fluoropyrimidine, irinotecan, and oxaliplatin', '5-FU', '5-fluorouracil (5-FU', 'S-1 plus Raltitrexed']","['upregulation of dihydropyrimidine dehydrogenase (DPD) and thymidylate synthase (TS', 'progression-free survival (PFS), overall survival (OS), and toxicity', 'disease control rate', 'Median PFS and median OS', 'objective response rate (ORR', 'efficacy and safety', 'ORR', 'upregulation of dihydropyrimidine dehydrogenase (DPD) and/or thymidylate synthase (TS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0677667', 'cui_str': 'raltitrexed'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0058126', 'cui_str': 'Dihydrouracil Dehydrogenase (NADP)'}, {'cui': 'C0040085', 'cui_str': 'Thymidylate Synthetase'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",46.0,0.096997,"Of 43 evaluable patients, the ORR was 13.9% and disease control rate was 58.1%.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Biotherapy, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Zhi-Ping', 'Initials': 'ZP', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'De-Yun', 'Initials': 'DY', 'LastName': 'Luo', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Hong-Feng', 'Initials': 'HF', 'LastName': 'Gou', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Yi', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Bi', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Oncology, Cancer Center, and the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China liujiyan1972@163.com.""}]",The oncologist,['10.1634/theoncologist.2018-0901']
1036,30475668,Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial.,"PURPOSE


Luminal breast cancer has a long natural history, with recurrences continuing beyond 10 years after diagnosis. We analyzed long-term follow-up (LTFU) of efficacy outcomes and adverse events in the Breast International Group (BIG) 1-98 study reported after a median follow-up of 12.6 years.
PATIENTS AND METHODS


BIG 1-98 is a four-arm, phase III, double-blind, randomized trial comparing adjuvant letrozole versus tamoxifen (either treatment received for 5 years) and their sequences (2 years of one treatment plus 3 years of the other) for postmenopausal women with endocrine-responsive early breast cancer. When pharmaceutical company sponsorship ended at 8.4 years of median follow-up, academic partners initiated an observational, LTFU extension collecting annual data on survival, disease status, and adverse events. Information from Denmark was from the Danish Breast Cancer Cooperative Group Registry. Intention-to-treat analyses are reported.
RESULTS


Of 8,010 enrolled patients, 4,433 were alive and not withdrawn at an LTFU participating center, and 3,833 (86%) had at least one LTFU report. For the monotherapy comparison of letrozole versus tamoxifen, we found a 9% relative reduction in the hazard of a disease-free survival event with letrozole (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.01). HRs for other efficacy end points were similar to those for disease-free survival. Efficacy of letrozole versus tamoxifen for contralateral breast cancer varied significantly over time (0- to 5-, 5- to 10-, and > 10-year HRs, 0.62, 0.47, and 1.35, respectively; treatment-by-time interaction P = .005), perhaps reflecting a longer carryover effect of tamoxifen. Reporting of specific long-term adverse events seemed more effective with national registry than with case-record reporting of clinical follow-up.
CONCLUSION


Efficacy end points continued to show trends favoring letrozole. Letrozole reduced contralateral breast cancer frequency in the first 10 years, but this reversed beyond 10 years. This study illustrates the value of extended follow-up in trials of luminal breast cancer.",2019,HRs for other efficacy end points were similar to those for disease-free survival.,"['postmenopausal women with endocrine-responsive early breast cancer', 'Postmenopausal Women With Hormone Receptor-Positive Breast Cancer', 'BIG 1-98 is a four-arm, phase III', '8,010 enrolled patients']","['Letrozole', 'adjuvant letrozole versus tamoxifen', 'Adjuvant Letrozole and Tamoxifen Alone', 'tamoxifen', 'letrozole']","['contralateral breast cancer', 'disease-free survival', 'contralateral breast cancer frequency']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C1096616', 'cui_str': 'Contralateral breast cancer'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",8010.0,0.0891941,HRs for other efficacy end points were similar to those for disease-free survival.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': '1 Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': '2 Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': '3 European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Maj-Britt', 'Initials': 'MB', 'LastName': 'Jensen', 'Affiliation': '4 Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': '4 Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""5 Institut Jules Bordet and L'Université Libre de Bruxelles, Brussels, Belgium.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': '6 KU Leuven, Leuven, Belgium.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': '7 National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Erik Hugger', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': '8 Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': '9 Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bonnefoi', 'Affiliation': '10 Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Vernon J', 'Initials': 'VJ', 'LastName': 'Harvey', 'Affiliation': '11 Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Spazzapan', 'Affiliation': '12 CRO National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tondini', 'Affiliation': '13 Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': '14 Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Veyret', 'Affiliation': '15 Centre de Cancérolgie Henri Becquerel, Rouen, France.'}, {'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': '16 ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Gianni', 'Affiliation': '17 Ospedale Infermi di Rimini, AUSL della Romagna, Ravenna, Italy.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rochlitz', 'Affiliation': '18 Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kralidis', 'Affiliation': '19 Kantonsspital, Aarau, Switzerland.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': '20 University Hospital Vaud University Hospital Center, Lausanne, Switzerland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': '21 Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart-Gebhart', 'Affiliation': ""5 Institut Jules Bordet and L'Université Libre de Bruxelles, Brussels, Belgium.""}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': '22 Hospital of Prato-AUSL Toscana Centro, Prato, Italy.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': '2 Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': '25 University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': '3 European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': '1 Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': '2 Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00440']
1037,30321906,Very early versus delayed mobilisation after stroke.,"BACKGROUND


Very early mobilisation (VEM) is performed in some stroke units and recommended in some acute stroke clinical guidelines. However, it is unclear whether very early mobilisation independently improves outcome after stroke.
OBJECTIVES


To determine whether very early mobilisation (started as soon as possible, and no later than 48 hours after onset of symptoms) in people with acute stroke improves recovery (primarily the proportion of independent survivors) compared with usual care.
SEARCH METHODS


We searched the Cochrane Stroke Group Trials Register (last searched 31 July 2017). We also systematically searched 19 electronic databases including; CENTRAL; 2017, Issue 7 in the Cochrane Library (searched July 2017), MEDLINE Ovid (1950 to August 2017), Embase Ovid (1980 to August 2017), CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to August 2017) , PsycINFO Ovid (1806 to August 2017), AMED Ovid (Allied and Complementary Medicine Database), SPORTDiscus EBSCO (1830 to August 2017). We searched relevant ongoing trials and research registers (searched December 2016), the Chinese medical database, Wanfangdata (searched to November 2016), and reference lists, and contacted researchers in the field.
SELECTION CRITERIA


Randomised controlled trials (RCTs) of people with acute stroke, comparing an intervention group that started out-of-bed mobilisation within 48 hours of stroke, and aimed to reduce time-to-first mobilisation, with or without an increase in the amount or frequency (or both) of mobilisation activities, with usual care, where time-to-first mobilisation was commenced later.
DATA COLLECTION AND ANALYSIS


Two review authors independently selected trials, extracted data, assessed risk of bias, and applied the GRADE approach to assess the quality of the evidence. The primary outcome was death or poor outcome (dependency or institutionalisation) at the end of scheduled follow-up. Secondary outcomes included death, dependency, institutionalisation, activities of daily living (ADL), extended ADL, quality of life, walking ability, complications (e.g. deep vein thrombosis), patient mood, and length of hospital stay. We also analysed outcomes at three-month follow-up.
MAIN RESULTS


We included nine RCTs with 2958 participants; one trial provided most of the information (2104 participants). The median (range) delay to starting mobilisation after stroke onset was 18.5 (13.1 to 43) hours in the VEM group and 33.3 (22.5 to 71.5) hours in the usual care group. The median difference within trials was 12.7 (4 to 45.6) hours. Other differences in intervention varied between trials; in five trials, the VEM group were also reported to have received more time in therapy, or more mobilisation activity.Primary outcome data were available for 2542 of 2618 (97.1%) participants randomized and followed up for a median of three months. VEM probably led to similar or slightly more deaths and participants who had a poor outcome, compared with delayed mobilisation (51% versus 49%; odds ratio (OR) 1.08, 95% confidence interval (CI) 0.92 to 1.26; P = 0.36; 8 trials; moderate-quality evidence). Death occurred in 7% of participants who received delayed mobilisation, and 8.5% of participants who received VEM (OR 1.27, 95% CI 0.95 to 1.70; P = 0.11; 8 trials, 2570 participants; moderate-quality evidence), and the effects on experiencing any complication were unclear (OR 0.88; 95% CI 0.73 to 1.06; P = 0.18; 7 trials, 2778 participants; low-quality evidence). Analysis using outcomes collected only at three-month follow-up did not alter the conclusions.The mean ADL score (measured at end of follow-up, with the 20-point Barthel Index) was higher in those who received VEM compared with the usual care group (mean difference (MD) 1.94, 95% CI 0.75 to 3.13, P = 0.001; 8 trials, 9 comparisons, 2630/2904 participants (90.6%); low-quality evidence), but there was substantial heterogeneity (93%). Effect sizes were smaller for outcomes collected at three-month follow-up, rather than later.The mean length of stay was shorter in those who received VEM compared with the usual care group (MD -1.44, 95% CI -2.28 to -0.60, P = 0.0008; 8 trials, 2532/2618 participants (96.7%); low-quality evidence). Confidence in the answer was limited by the variable definitions of length of stay. The other secondary outcome analyses (institutionalisation, extended activities of daily living, quality of life, walking ability, patient mood) were limited by lack of data.Sensitivity analyses by trial quality: none of the outcome conclusions were altered if we restricted analyses to trials with the lowest risk of bias (based on method of randomization, allocation concealment, completeness of follow-up, and blinding of final assessment), or information about the amount of mobilisation.Sensitivity analysis by intervention characteristics: analyses restricted to trials where the mean VEM time-to-first mobilisation was less than 24 hours, showed an odds of death of 1.35 (95% CI 0.99 to 1.83; P = 0.06; I² = 25%; 5 trials). Analyses restricted to the trials that clearly reported a more prolonged out-of-bed activity showed a similar primary outcome (OR 1.14; 0.96 to 1.35; P = 0.13; I² = 28%; 5 trials), and odds of death (OR 1.27; 0.93 to 1.73; P = 0.13; I² = 0%; 4 trials) to the main analysis.Exploratory network meta-analysis (NMA): we were unable to analyze by the amount of therapy, but low-quality evidence indicated that time-to-first mobilisation at around 24 hours was associated with the lowest odds of death or poor outcome, compared with earlier or later mobilisation.
AUTHORS' CONCLUSIONS


VEM, which usually involved first mobilisation within 24 hours of stroke onset, did not increase the number of people who survived or made a good recovery after their stroke. VEM may have reduced the length of stay in hospital by about one day, but this was based on low-quality evidence. Based on the potential hazards reported in the single largest RCT, the sensitivity analysis of trials commencing mobilisation within 24 hours, and the NMA, there was concern that VEM commencing within 24 hours may carry an increased risk, at least in some people with stroke. Given the uncertainty around these effect estimates, more detailed research is still required.",2018,"VEM probably led to similar or slightly more deaths and participants who had a poor outcome, compared with delayed mobilisation (51% versus 49%; odds ratio (OR) 1.08, 95% confidence interval (CI) 0.92 to 1.26; P = 0.36; 8 trials; moderate-quality evidence).","['people with acute stroke', '2958 participants; one trial provided most of the information (2104 participants', ' 2017, Issue 7 in the Cochrane Library (searched July 2017), MEDLINE Ovid (1950 to August 2017), Embase Ovid (1980 to August 2017), CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to August 2017) , PsycINFO Ovid (1806 to August 2017), AMED Ovid ']","['VEM', 'Exploratory network meta-analysis (NMA']","['Death', 'moderate-quality evidence', 'death, dependency, institutionalisation, activities of daily living (ADL), extended ADL, quality of life, walking ability, complications (e.g. deep vein thrombosis), patient mood, and length of hospital stay', 'median (range) delay to starting mobilisation after stroke onset', 'mean length of stay', 'extended activities of daily living, quality of life, walking ability, patient mood', 'delayed mobilisation', 'mobilisation activity', 'mean ADL score', 'length of stay in hospital', 'death or poor outcome (dependency or institutionalisation', 'time-to-first mobilisation', 'mean VEM time-to-first mobilisation', 'odds of death']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0023621', 'cui_str': 'Libraries'}, {'cui': 'C0025141', 'cui_str': 'MEDLINE'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}]","[{'cui': 'C4277638', 'cui_str': 'Mixed Treatment Meta-Analysis'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",9.0,0.301221,"VEM probably led to similar or slightly more deaths and participants who had a poor outcome, compared with delayed mobilisation (51% versus 49%; odds ratio (OR) 1.08, 95% confidence interval (CI) 0.92 to 1.26; P = 0.36; 8 trials; moderate-quality evidence).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'Academic Section of Geriatric Medicine, ICAMS, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, Glasgow, UK, G31 2ER.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Collier', 'Affiliation': ''}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Bate', 'Affiliation': ''}, {'ForeName': 'Matthew Nt', 'Initials': 'MN', 'LastName': 'Thuy', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006187.pub3']
1038,29850764,Understanding Why Pictorial Cigarette Pack Warnings Increase Quit Attempts.,"BACKGROUND


Our randomized trial found that pictorial cigarette pack warnings elicited more quit attempts than text-only warnings.
PURPOSE


In the current study, we sought to identify psychological mechanisms that explain why pictorial cigarette pack warnings change behavior.
METHODS


In 2014 and 2015, we recruited 2,149 adult smokers in NC and CA, USA. We randomly assigned smokers to receive on their cigarette packs for 4 weeks either a text-only warning (one of the USA's current warnings on the side of cigarette packs) or a pictorial warning (one of the USA's proposed text warnings with pictures on the top half of the front and back of cigarette packs).
RESULTS


Pictorial warnings increased attention to, reactions to, and social interactions about cigarette pack warnings (all p < .05). However, pictorial warnings changed almost no belief or attitude measures. Mediators of the impact of pictorial warnings included increased attention, negative affect, social interactions, thinking about the warning and harms of smoking, and intentions to quit (all p < .05). Analyses also found that pictorial warnings led to greater avoidance of the warnings, which was associated with more quit attempts (p < .05).
CONCLUSIONS


Pictorial warnings increased quit attempts by eliciting aversive reactions and by keeping the message vividly in smokers' minds. Contrary to predictions from several theories of health behavior, the warnings exerted little of their influence through changes in beliefs and attitudes and none of their influence through changes in risk perception. We propose the Tobacco Warnings Model based on these findings.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov identifier: NCT02247908; https://clinicaltrials.gov/ct2/show/NCT02247908.",2019,"CONCLUSIONS


Pictorial warnings increased quit attempts by eliciting aversive reactions and by keeping the message vividly in smokers' minds.","['In 2014 and 2015, we recruited 2,149 adult smokers in NC and CA, USA']","[""cigarette packs for 4 weeks either a text-only warning (one of the USA's current warnings on the side of cigarette packs) or a pictorial warning (one of the USA's proposed text warnings with pictures on the top half of the front and back of cigarette packs""]","['quit attempts', 'attention, negative affect, social interactions, thinking about the warning and harms of smoking, and intentions to quit', 'attention to, reactions to, and social interactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",2149.0,0.0165742,"CONCLUSIONS


Pictorial warnings increased quit attempts by eliciting aversive reactions and by keeping the message vividly in smokers' minds.","[{'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Parada', 'Affiliation': 'Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marcella H', 'Initials': 'MH', 'LastName': 'Boynton', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay032']
1039,31926883,Long-term Results of Trimethoprim-Sulfamethoxazole Versus Placebo to Reduce the Risk of Recurrent Toxoplasma gondii Retinochoroiditis.,"PURPOSE


To compare the effects of 1 year of treatment with trimethoprim-sulfamethoxazole (TMP-SMZ) vs placebo in reducing the risk of recurrence of toxoplasmic retinochoroiditis during a 6-year follow-up period.
DESIGN


Randomized, double-masked clinical trial.
METHODS


This cohort included 141 subjects recruited in Campinas, Brazil. The inclusion criterion was unilateral active recurrent toxoplasmic retinochoroiditis. All subjects were treated with 1 dose of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, subjects were randomly assigned to group 1 (1 TMP-SMZ dose every other day for 311 days) or group 2 (1 identical placebo tablet containing starch with no active ingredients every other day for 311 days). Between the second and sixth years of follow-up appointments, none of the subjects received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow-up and recurrent toxoplasmic retinochoroiditis in the 6 years of follow-up.
RESULTS


The cumulative probability of recurrence 1, 2, 3, 4, 5, and 6 years after the initial infection was, respectively, 13.0% (9/69), 17.4% (12/69), 20.3% (14/69), 23.2% (16/69), 26.1% (18/69), and 27.5% (19/69) in the placebo group and 0%, 0%, 0%, 0%, 0%, and 1.4% (1/72) in the TMP-SMZ group (P < .001; log-rank test). There were 3 cases (3/69; 4.3%) of multiple recurrences in the same individual in the placebo group. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female subjects.
CONCLUSIONS


TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis and may provide long-term benefits.",2020,No treatment-limiting toxicity or side effects were observed in either group.,"['female subjects', '141 subjects recruited in Campinas, Brazil']","['trimethoprim-sulfamethoxazole (TMP-SMZ', 'placebo tablet containing starch with no active ingredients', 'trimethoprim-sulfamethoxazole', 'placebo', 'TMP-SMZ']","['cumulative probability of recurrence', 'risk of recurrent Toxoplasma gondii retinochoroiditis', 'toxicity or side effects', 'unilateral active recurrent toxoplasmic retinochoroiditis', 'risk of recurrence of toxoplasmic retinochoroiditis', 'recurrent toxoplasmic retinochoroiditis within the first year of follow up and recurrent toxoplasmic retinochoroiditis']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0625823', 'cui_str': 'TMPS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040557', 'cui_str': 'Toxoplasma gondii'}, {'cui': 'C0008513', 'cui_str': 'Chorioretinitis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",141.0,0.225952,No treatment-limiting toxicity or side effects were observed in either group.,"[{'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Fernandes Felix', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil. Electronic address: joaopaulofelix@hotmail.com.'}, {'ForeName': 'Rodrigo Pessoa', 'Initials': 'RP', 'LastName': 'Cavalcanti Lira', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil; Federal University of Pernambuco (UFPE), Recife, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Hermano Lucio Gomes de', 'Initials': 'HLG', 'LastName': 'Assis Filho', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Alexandre Brito', 'Initials': 'AB', 'LastName': 'Cosimo', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mauricio Abujamra', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Leite Arieta', 'Affiliation': 'State University of Campinas (UNICAMP), Campinas, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.025']
1040,31981733,Serious Asthma Outcomes and Asthma Exacerbations with Maintenance on Inhaled Corticosteroid (Mometasone Furoate)/Long-Acting Beta Agonist (Formoterol) Combination Compared to Step Down to Mometasone Monotherapy.,"BACKGROUND


Because of historical safety concerns with the use of long-acting β-agonists (LABA) in asthma, step-down from inhaled corticosteroid (ICS)/LABA combination therapy to ICS monotherapy is recommended once asthma control is achieved.
OBJECTIVE


To evaluate the benefit/risk question about whether patients with asthma who achieve disease control on fixed-dose ICS/LABA combination therapy, such as mometasone furoate/formoterol fumarate (MF/F), should continue with this therapy or be stepped down to ICS monotherapy, such as MF.
METHODS


Using data from 8447 clinically stable patients with persistent asthma in the Safety Pharma Investigation of Respiratory Outcomes trial who had been receiving a stable dose of ICS/LABA for ≥4 weeks, this post hoc analysis evaluated the risk of serious asthma outcomes (SAOs) (adjudicated hospitalization, intubation, or death) and asthma exacerbation (AEX) (composite of hospitalizations ≥24 hours, emergency visits <24 hours requiring systemic corticosteroid, or systemic corticosteroid for ≥3 consecutive days) in participants randomized to remain on ICS/LABA (MF/F) or step down to ICS (MF) for 26 weeks.
RESULTS


There was no significant difference in SAO risk among patients maintained on ICS/LABA with MF/F compared with those who stepped down from ICS/LABA to MF (hazard ratio [HR], 1.03 [95% confidence interval (CI): 0.61, 1.75], P = .913). The risk of AEX was significantly lower in patients maintained on ICS/LABA with MF/F compared with those who stepped down from ICS/LABA to MF (HR, 0.87 [95% CI: 0.78, 0.98], P = .020).
CONCLUSIONS


In this post hoc analysis of a large clinical trial dataset, maintenance on ICS/LABA with MF/F is not associated with an increased risk of SAOs and also significantly reduces the risk of AEX compared with step-down from ICS/LABA to MF.",2020,There was no significant difference in SAO risk among patients maintained on ICS/,"['Using data from 8,447 clinically stable patients with persistent asthma in the SPIRO trial who had been receiving a stable dose of ICS', 'asthma patients who achieve disease control on fixed-dose ICS/LABA combination therapy, such as MF/F']","['Inhaled Corticosteroid (Mometasone Furoate)/Long-Acting Beta Agonist (Formoterol) Combination', 'ICS/LABA (MF/F) or step-down to ICS (MF']","['risk of AEX', 'risk of SAOs', 'SAO risk', 'risk of SAOs (adjudicated hospitalization, intubation, or death) and AEX (composite of hospitalizations ≥ 24 h, emergency visits']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]",8447.0,0.206373,There was no significant difference in SAO risk among patients maintained on ICS/,"[{'ForeName': 'Cindy L J', 'Initials': 'CLJ', 'LastName': 'Weinstein', 'Affiliation': 'Respiratory and Immunology Clinical Development, Merck & Co., Inc., Kenilworth, NJ. Electronic address: cindy.l.weinstein@merck.com.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ryan', 'Affiliation': 'Clinical Sciences, Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Drug Safety, Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Tulin', 'Initials': 'T', 'LastName': 'Shekar', 'Affiliation': 'Biostatistics, Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Gates', 'Affiliation': 'Biostatistics, Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lane', 'Affiliation': 'The Professional Respiratory Centre, Tallaght Hospital, Dublin, Ireland.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Agache', 'Affiliation': 'Faculty of Medicine, Transylvania University, Brasov, Romania.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Nathan', 'Affiliation': 'Asthma and Allergy Associates and Research Center, Colorado Springs, Colo.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.01.021']
1041,31965834,"Effect of multi-strain probiotic (UB0316) in weight management in overweight/obese adults: a 12-week double blind, randomised, placebo-controlled study.","This clinical trial was carried out to assess the effects of multi-strain probiotic capsule (UB0316:  Lactobacillus salivarius  UBLS-22,  Lactobacillus casei  UBLC-42,  Lactobacillus plantarum , UBLP-40,  Lactobacillus acidophilus  UBLA-34,  Bifidobacterium breve  UBBr-01,  Bacillus coagulans  Unique IS2 5×10 9  cfu each and fructo-oligosaccharide, 100 mg) on overweight/obesity-related parameters. Ninety subjects (age, 30-65 years; body mass index (BMI), 25-32 kg/m 2 ) were randomised into two groups, i.e. UB0316 (probiotic) and placebo (excipient maltodextrin). They were instructed to take 2 capsules (UB0316 or placebo) per day after meals for 12 weeks. Primary (BMI), and secondary (waist-to-hip ratio: WHR; body weight, body fat; sugar and lipid profile) endpoint measures were evaluated at scheduled visits. Vital signs, physical investigations, quality of life, physician/subjects global assessment and adverse events were also recorded. A total of 71 subjects completed the scheduled study visits and analysis thereof showed that a 12-week UB0316 supplementation significantly reduced BMI (95% CI: -0.64, -0.27;  P =0.0001), body weight (95% CI: -1.16, -0.50;  P <0.0001), and WHR (95% CI: -0.06, -0.01;  P =0.007) from the baseline, compared to placebo. Fat, blood lipid and sugar profile changes were non-significant. UB0316 significantly improved quality of life of overweight/obese individuals. Furthermore, no severe adverse events or abnormal findings were noted during vital, blood and physical examinations. In conclusion, this 12-week trial demonstrates that UB0316 is effective in reducing BMI, body weight and WHR in overweight/obese adults.",2019,"Fat, blood lipid and sugar profile changes were non-significant. UB0316 significantly improved quality of life of overweight/obese individuals.","['overweight/obese adults', 'Ninety subjects (age, 30-65 years; body mass index (BMI), 25-32 kg/m 2 ']","['UB0316 (probiotic) and placebo (excipient maltodextrin', 'placebo', 'UB0316', 'multi-strain probiotic (UB0316', 'multi-strain probiotic capsule (UB0316:  Lactobacillus salivarius', 'capsules (UB0316 or placebo']","['Primary (BMI), and secondary (waist-to-hip ratio: WHR; body weight, body fat; sugar and lipid profile) endpoint measures', 'WHR', 'Vital signs, physical investigations, quality of life, physician/subjects global assessment and adverse events', 'quality of life of overweight/obese individuals', 'Fat, blood lipid and sugar profile changes', 'BMI', 'body weight', 'UBLS-22,  Lactobacillus casei  UBLC-42,  Lactobacillus plantarum , UBLP-40,  Lactobacillus acidophilus  UBLA-34,  Bifidobacterium', 'BMI, body weight and WHR']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015237', 'cui_str': 'Excipients'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0518766'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034380'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005768'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",71.0,0.0850599,"Fat, blood lipid and sugar profile changes were non-significant. UB0316 significantly improved quality of life of overweight/obese individuals.","[{'ForeName': 'M Ratna', 'Initials': 'MR', 'LastName': 'Sudha', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana 500078, India.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Ahire', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana 500078, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jayanthi', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana 500078, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tripathi', 'Affiliation': 'Life Veda Treatment and Research Centre, Worli, Mumbai 400030, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nanal', 'Affiliation': 'Nanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai 400016, India.'}]",Beneficial microbes,['10.3920/BM2019.0052']
1042,31955502,Adjudication rather than experience of data abstraction matters more in reducing errors in abstracting data in systematic reviews.,"BACKGROUND


During systematic reviews, ""data abstraction"" refers to the process of collecting data from reports of studies. The data abstractors' level of experience may affect the accuracy of data abstracted. Using data from a randomized crossover trial in which different data abstraction approaches were compared, we examined the association between abstractors' level of experience and accuracy of data abstraction.
METHODS


We classified abstractors as ""more experienced"" if they had authored three or more published systematic reviews, and ""less experienced"" otherwise. Each abstractor abstracted data related to study design, baseline characteristics, and outcomes/results from six articles. We considered two types of errors: incorrect abstraction and errors of omission. We estimated the proportion of errors by level of experience using a binomial generalized linear mixed model.
RESULTS


We used data from 25 less experienced and 25 more experienced data abstractors. Overall error proportions were similar for less experienced abstractors (21%) and more experienced abstractors (19%). Compared with less experienced abstractors, more experienced abstractors had a lower odds of errors for data items related to outcomes/results (adjusted odds ratio [OR] = 0.53; 95% CI, 0.34-0.82) and potentially for data items related to study design (adjusted OR = 0.83; 95% CI, 0.64-1.09) but a potentially higher odds of errors for items related to baseline characteristics (adjusted OR = 1.42; 95% CI, 0.97-2.06).
CONCLUSION


Experience of data abstraction matters little. Errors are reduced by adjudication but still remain high for data items related to outcomes/results.",2020,"Compared with less experienced abstractors, more experienced abstractors had a lower odds of errors for data items related to outcomes/results (adjusted odds ratio [OR] = 0.53; 95% CI 0.34, 0.82) and potentially for data items related to study design (adjusted OR = 0.83; 95% CI 0.64, 1.09), but a potentially higher odds of errors for items related to baseline characteristics (adjusted OR = 1.42; 95% CI 0.97, 2.06).
",[],[],['Overall error proportions'],[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0973295,"Compared with less experienced abstractors, more experienced abstractors had a lower odds of errors for data items related to outcomes/results (adjusted odds ratio [OR] = 0.53; 95% CI 0.34, 0.82) and potentially for data items related to study design (adjusted OR = 0.83; 95% CI 0.64, 1.09), but a potentially higher odds of errors for items related to baseline characteristics (adjusted OR = 1.42; 95% CI 0.97, 2.06).
","[{'ForeName': 'Jian-Yu', 'Initials': 'JY', 'LastName': 'E', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Saldanha', 'Affiliation': 'Center for Evidence Synthesis in Health, Department of Health Services, Policy, and Practice (Primary), Department of Epidemiology (Secondary), Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Canner', 'Affiliation': 'Center for Outcomes Research, Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Schmid', 'Affiliation': 'Center for Evidence Synthesis in Health, Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jimmy T', 'Initials': 'JT', 'LastName': 'Le', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Colorado Denver, Aurora, Colorado.'}]",Research synthesis methods,['10.1002/jrsm.1396']
1043,30144630,"Competency Based Approach to Community Health (COACH): The methods of a family-centered, community-based, individually adaptive obesity randomized trial for pre-school child-parent pairs.","Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children. COACH focuses on improving personal agency for health behavior change by tailoring content to overcome contextual barriers. The intervention focuses on diet, physical activity, sleep, media use, and engaged parenting. The content is individually adapted based on routine assessments of competency in specific health behaviors using a mobile health platform and novel measurement tools developed by our team. In response to these regular assessments, health coaches provide tailored health behavior change strategies to help families focus on the areas where they decide to improve the most. The intervention consists of a 15-week group-based intensive phase, with weekly sessions delivered by health coaches in community centers. Following weekly sessions, a 3-month maintenance phase of the intervention consists of twice monthly coaching calls for participants to focus on individual health goals for their families. The primary outcome of the trial is child body mass index trajectory over 1 year. Secondary outcomes include parent body mass index change, child waist circumference, child diet, child physical activity, and other psychosocial mediators of child health behavior change. The control arm consists of a school readiness intervention, delivered by the Nashville Public Library. By applying a personalized approach to child behavior change, in the setting of both family and community, COACH aims to develop sustainable solutions for childhood obesity by supporting healthy childhood growth in low-income, minority preschool children.",2018,"Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children.","['childhood obesity among Latino pre-school children', 'pre-school child-parent pairs']","['behavioral intervention', 'school readiness intervention, delivered by the Nashville Public Library', 'Competency-Based Approaches to Community Health (COACH', 'Competency Based Approach to Community Health (COACH']","['child body mass index trajectory over 1\u202fyear', 'parent body mass index change, child waist circumference, child diet, child physical activity, and other psychosocial mediators of child health behavior change']","[{'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0023621', 'cui_str': 'Libraries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0218485,"Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, USA. Electronic address: Bill.Heerman@vanderbilt.edu.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Escarfuller', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Teeters', 'Affiliation': 'School of Education, University of Colorado Boulder, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Slesur', 'Affiliation': 'School of Medicine, Vanderbilt University, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, Vanderbilt University, USA.'}, {'ForeName': 'Ally', 'Initials': 'A', 'LastName': 'Qi', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Singer-Gabella', 'Affiliation': 'Peabody College of Education and Human Development, Vanderbilt University, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.08.006']
1044,31980132,Moderators of treatment efficacy in individualized metacognitive training for psychosis (MCT+).,"BACKGROUND AND OBJECTIVES


Individualized Metacognitive Training (MCT+) is a manualized intervention designed to improve delusional severity by reducing delusion-associated cognitive biases such as jumping-to-conclusions. Increased interest in personalized medicine stipulates the identification of patients who are more likely to benefit from specialized interventions. The present study aimed to explore baseline moderators of MCT+ efficacy on delusions and overall positive symptoms in psychosis.
METHODS


We analyzed data from a randomized rater-blind controlled trial, in which 92 patients with psychotic disorders and current or past delusions were randomly assigned to either MCT+ or CogPack®, a cognitive remediation software. Baseline moderator variables consisted of jumping-to-conclusions, cognitive insight, quality of life, self-esteem, selective attention, and patients' attitudes towards their symptoms. Linear mixed-effects models were applied to investigate specific moderators of MCT+ efficacy.
RESULTS


In MCT+ relative to CogPack, presence of a jumping-to-conclusions bias, a lowered decision threshold, and low self-esteem were associated with larger improvements in delusional severity and/or overall positive symptoms over time. Subjective reasoning style and insight, as well as subjective attitudes towards psychosis, did not moderate the treatment efficacy of MCT+ relative to CogPack.
LIMITATIONS


Participation of both treatment groups in group MCT as a part of standard care, possibly leading to additional effects on delusional severity.
CONCLUSIONS


Patients with low self-esteem and those who are prone to jumping-to-conclusions seem to particularly benefit from MCT+. Our results can help inform clinical practice as they provide specific criteria for selecting patients for whom MCT+ is most appropriate.",2020,"Subjective reasoning style and insight, as well as subjective attitudes towards psychosis, did not moderate the treatment efficacy of MCT+ relative to CogPack.
","['psychosis (MCT', 'psychosis', '92 patients with psychotic disorders and current or past delusions']","['individualized metacognitive training', 'MCT+\xa0or CogPack®, a cognitive remediation software', 'MCT', 'Individualized Metacognitive Training (MCT']","['delusional severity', 'delusional severity and/or overall positive symptoms', ""cognitive insight, quality of life, self-esteem, selective attention, and patients' attitudes towards their symptoms""]","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0034380'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",92.0,0.0637505,"Subjective reasoning style and insight, as well as subjective attitudes towards psychosis, did not moderate the treatment efficacy of MCT+ relative to CogPack.
","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Leanza', 'Affiliation': 'University of Basel Psychiatric Hospital, Center for Psychotic Disorders, University of Basel, Switzerland; University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology, Basel, Switzerland. Electronic address: letizia.leanza@unibas.ch.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Studerus', 'Affiliation': 'University of Basel, Department of Psychology, Division of Personality and Developmental Psychology, Basel, Switzerland.'}, {'ForeName': 'Vasilis P', 'Initials': 'VP', 'LastName': 'Bozikas', 'Affiliation': '2nd Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Andreou', 'Affiliation': 'University of Basel Psychiatric Hospital, Center for Psychotic Disorders, University of Basel, Switzerland.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101547']
1045,31967678,Hyperthermic intraperitoneal chemotherapy for ovarian cancer: The heat is on.,"Patients with advanced epithelial ovarian cancer have a high incidence of peritoneal disease recurrence despite maximal efforts to surgically remove all visible tumor plus intravenous chemotherapy. The administration of intraperitoneal chemotherapy that specifically targets the peritoneal surface has been investigated in previous trials, but questions about the design of these studies has prevented this treatment from being widely adopted in clinical practice. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a single intraoperative approach that also targets the peritoneal surface. A randomized phase 3 trial showed significant benefit in recurrence-free and overall survival when HIPEC was added to interval cytoreductive surgery (CRS) in patients who were not eligible for primary surgery because of the extent of their disease (OVHIPEC trial; NCT00426257). The trial showed no important differences in toxicity or patient-reported outcomes between the study groups. The extent of surgery and the number of bowel resections were also similar between the 2 study groups, and the effect of HIPEC was homogeneous across the levels of predefined and post hoc subgroups. Nevertheless, the design and the results of the OVHIPEC trial were critically assessed, and this resembles the reluctance to adopt the positive results of the earlier intraperitoneal chemotherapy studies. This overview discusses the design and results of the OVHIPEC trial. The evidence that is currently available points to a clinically relevant and cost-effective benefit of HIPEC added to interval CRS for patients with stage III ovarian cancer who are not eligible for primary surgery. Ongoing collaborative research will provide further evidence regarding the role of HIPEC in ovarian cancer.",2019,The trial showed no important differences in toxicity or patient-reported outcomes between the study groups.,"['patients with stage III ovarian cancer who are not eligible for primary surgery', 'Patients with advanced epithelial ovarian cancer', 'ovarian cancer']","['intraperitoneal chemotherapy', 'Hyperthermic intraperitoneal chemotherapy (HIPEC', 'HIPEC', 'interval cytoreductive surgery (CRS', 'Hyperthermic intraperitoneal chemotherapy']","['number of bowel resections', 'recurrence-free and overall survival', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.245509,The trial showed no important differences in toxicity or patient-reported outcomes between the study groups.,"[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': 'Department of Gynecology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Willemien J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': 'Department of Gynecology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Cancer,['10.1002/cncr.32505']
1046,31967685,Hyperthermic intraperitoneal chemotherapy does not improve survival in advanced ovarian cancer.,"Despite its widespread use, until recently, there was no randomized evidence for hyperthermic intraperitoneal chemotherapy (HIPEC) versus surgery without HIPEC for ovarian cancer. Recently, a Dutch study (OVHIPEC) reported benefits in both progression-free survival (PFS) and overall survival (OS) gained from the use of HIPEC at the time of interval debulking surgery (IDS) for stage III ovarian carcinoma, whereas a Korean randomized trial failed to show a benefit of HIPEC for patients with ovarian cancer undergoing primary debulking surgery or IDS. In colorectal cancer, 2 randomized trials failed to show an improvement in survival with HIPEC. In addition to these contradictory results, there are a number of aspects of the Dutch OVHIPEC trial in ovarian cancer that can be criticized. Some criticisms include a reduction of the number of patients needed to be randomized because of too slow accrual; much lower PFS and OS in both arms than expected according to the statistical plan; the small size of the study, with imbalances between the 2 arms (eg, more low-grade tumors in the HIPEC arm); the timing of randomization before the start of IDS; the lack of clear inclusion criteria for neoadjuvant chemotherapy; and the heterogeneity of the results, with the largest effect shown at the smaller centers. Furthermore, it is questionable whether the adverse events were reported completely. In conclusion, data about HIPEC for ovarian cancer in general are not convincing, and they do not change the standard of care, which remains for ovarian cancer surgery and intravenous chemotherapy.",2019,"In conclusion, data about HIPEC for ovarian cancer in general are not convincing, and they do not change the standard of care, which remains for ovarian cancer surgery and intravenous chemotherapy.","['patients with ovarian cancer undergoing primary debulking surgery or IDS', 'advanced ovarian cancer']","['Hyperthermic intraperitoneal chemotherapy', 'HIPEC', 'hyperthermic intraperitoneal chemotherapy (HIPEC) versus surgery without HIPEC']","['survival with HIPEC', 'survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.328531,"In conclusion, data about HIPEC for ovarian cancer in general are not convincing, and they do not change the standard of care, which remains for ovarian cancer surgery and intravenous chemotherapy.","[{'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Chiva', 'Affiliation': 'Department of Gynecologic Oncology, MD Anderson Cancer Center, Madrid, Spain.'}]",Cancer,['10.1002/cncr.32496']
1047,31462258,Positive association between baseline brachial-ankle pulse wave velocity and the risk of new-onset diabetes in hypertensive patients.,"BACKGROUND


There is no clearly defined temporal relationship between arterial stiffness and diabetes. We aimed to investigate the prospective association between baseline brachial-ankle pulse wave velocity (baPWV) and the risk of new-onset diabetes during follow-up, and examined whether there were effect modifiers, in hypertensive patients.
METHODS


We included 2429 hypertensive patients with all the pertinent data but without diabetes at the baseline, who were part of the China Stroke Primary Prevention Trial (CSPPT), a randomized, double-blind, actively controlled trial conducted in 32 communities in Anhui and Jiangsu provinces in China. The primary outcome was new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose (FG) ≥ 126.0 mg/dL at the exit visit.
RESULTS


During a median follow-up duration of 4.5 years, 287 (11.8%) participants developed diabetes. There was a significant positive association between baseline baPWV and the risk of new-onset diabetes (per SD increment; OR, 1.33; 95% CI 1.13, 1.56). Consistently, when baPWV was assessed as quartiles, a significantly higher risk of new-onset diabetes was found in participants in quartiles 2-4 (≥ 15.9 m/s; OR, 1.80; 95% CI 1.22, 2.65) compared with those in quartile 1 (< 15.9 m/s). The positive association was consistent in participants with (per SD increment; OR, 1.29; 95% CI 1.06, 1.56) or without (per SD increment; OR, 1.40; 95% CI 1.15, 1.71) impaired fasting glucose (IFG, FG ≥ 100.8 and < 126.0 mg/dL, P-interaction = 0.486).
CONCLUSIONS


In this sample of hypertensive patients, we found a significant positive association between baseline baPWV and the risk of new-onset diabetes. Clinical trial registration Trial registration: NCT00794885 (clinicaltrials.gov). Retrospectively registered November 20, 2008.",2019,"The positive association was consistent in participants with (per SD increment; OR, 1.29; 95% CI 1.06, 1.56) or without (per SD increment; OR, 1.40; 95% CI 1.15, 1.71) impaired fasting glucose (IFG, FG ≥ 100.8 and < 126.0 mg/dL, P-interaction = 0.486).
","['2429 hypertensive patients with all the pertinent data but without diabetes at the baseline, who were part of the China Stroke Primary Prevention Trial (CSPPT), a randomized, double-blind, actively controlled trial conducted in 32 communities in Anhui and Jiangsu provinces in China', 'hypertensive patients']",['baseline brachial-ankle pulse wave velocity (baPWV'],"['new-onset diabetes, defined as physician-diagnosed diabetes or use of glucose-lowering drugs during follow-up, or fasting glucose (FG)\u2009≥', 'baseline baPWV and the risk of new-onset diabetes', 'risk of new-onset diabetes', 'fasting glucose', 'diabetes']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.408897,"The positive association was consistent in participants with (per SD increment; OR, 1.29; 95% CI 1.06, 1.56) or without (per SD increment; OR, 1.40; 95% CI 1.15, 1.71) impaired fasting glucose (IFG, FG ≥ 100.8 and < 126.0 mg/dL, P-interaction = 0.486).
","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Youbao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Guobao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Genfu', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'Health Management College, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, 100083, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, E4132, Baltimore, MD, 21205-2179, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. xipingxu126@126.com.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Center for Kidney Disease; The State Key Laboratory for Organ Failure Research; Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. pharmaqin@126.com.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0915-0']
1048,29947729,Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time.,"BACKGROUND


Pictorial cigarette warning labels are thought to increase risk knowledge, but experimental research has not examined longer-term effects on memory for health risks named in text.
PURPOSE


To investigate memory-consolidation predictions that high- versus low-emotion warnings would support better long-term memory for named cigarette health risks and to test a mediational model of warning-label effects through memory on risk perceptions and quit intentions.
METHODS


A combined sample of U.S.-representative adult smokers, U.S.-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers were randomly assigned to a warning-label condition (High-emotion pictorial, Low-emotion pictorial, Text-only) in which they were exposed four times to nine warning labels and reported emotional reactions and elaboration. Memory of warning-label risk information, smoking risk perceptions, and quit intentions were assessed immediately after exposures or 6 weeks later.
RESULTS


Recall of warning-label text was low across the samples and supported memory-consolidation predictions. Specifically, immediate recall was highest for Low-emotion warnings that elicited the least emotion, but recall also declined the most over time in this condition, leaving its 6-week recall lowest; 6-week recall was similar for High-emotion and Text-only warnings. Greater recall was associated with higher risk perceptions and greater quit intentions and mediated part of warning-label effects on these important smoking outcomes. High-emotion warnings had additional non-memory-related effects on risk perceptions and quit intentions that were superior to text-only warnings.
CONCLUSIONS


High- but not Low-emotion pictorial warning labels may support the Food and Drug Administration's primary goal to ""effectively convey the negative health consequences of smoking.""
CLINICALTRIALS.GOV IDENTIFIER


NCT03375840.",2019,Greater recall was associated with higher risk perceptions and greater quit intentions and mediated part of warning-label effects on these important smoking outcomes.,"['A combined sample of U.S.-representative adult smokers, U.S.-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers']","['high- versus low-emotion warnings', 'warning-label condition (High-emotion pictorial, Low-emotion pictorial, Text-only) in which they were exposed four times to nine warning labels and reported emotional reactions and elaboration']","['risk perceptions and quit intentions', 'Memory of warning-label risk information, smoking risk perceptions, and quit intentions', 'risk perceptions and greater quit intentions and mediated part of warning-label effects']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1521910', 'cui_str': 'Teens'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0174988,Greater recall was associated with higher risk perceptions and greater quit intentions and mediated part of warning-label effects on these important smoking outcomes.,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Shoots-Reinhard', 'Affiliation': 'Department of Psychology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Evans', 'Affiliation': 'Department of Psychology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Shoben', 'Affiliation': 'College of Public Health, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Klein', 'Affiliation': 'College of Public Health, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Mary Kate', 'Initials': 'MK', 'LastName': 'Tompkins', 'Affiliation': 'Department of Psychology, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Romer', 'Affiliation': 'Annenberg Public Policy Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tusler', 'Affiliation': 'Department of Psychology, Ohio State University, Columbus, OH, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay050']
1049,29506034,Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.,"BACKGROUND


VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine.
OBJECTIVES


To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement.
METHODS


In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment.
RESULTS


LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment.
CONCLUSIONS


Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.
LEVEL OF EVIDENCE: 4


",2019,"CONCLUSIONS


Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.
","['124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment', 'lip and perioral enhancement']","['lidocaine', 'VYC-15L', 'VYC-15L (Juvéderm Volbella XC']","['Safety and Effectiveness', 'responder rate', 'safe and effective for lip and perioral enhancement', 'FACE-Q scores', 'FACE-Q Satisfaction', 'LFS responder rates', 'LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales', 'safety diaries', 'Severe injection site responses']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0457008', 'cui_str': 'Perioral (qualifier value)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C2351894', 'cui_str': 'Juvéderm'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0457008', 'cui_str': 'Perioral (qualifier value)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424488', 'cui_str': 'Lip line (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}]",124.0,0.0477686,"CONCLUSIONS


Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rivkin', 'Affiliation': 'David Geffen/UCLA School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Weinkle', 'Affiliation': 'Affiliate Clinical Professor of Dermatology, University of South Florida, Tampa, FL.'}, {'ForeName': 'Bhushan', 'Initials': 'B', 'LastName': 'Hardas', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Weiss', 'Affiliation': 'Department of Dermatology, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dee Anna', 'Initials': 'DA', 'LastName': 'Glaser', 'Affiliation': 'Department of Dermatology, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Biesman', 'Affiliation': 'Centre for Laser and Facial Surgery, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schumacher', 'Affiliation': 'Associate Director of Clinical Development at Allergan plc.'}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Murphy', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjy019']
1050,31960537,Nurse-led psychological intervention reduces anxiety symptoms and improves quality of life following percutaneous coronary intervention for stable coronary artery disease.,"OBJECTIVE


To study the effect of nurse-led counselling on the anxiety symptoms and the quality of life following percutaneous coronary intervention for stable coronary artery disease.
DESIGN


Randomised control trial.
SETTING


Rural and remote China.
PARTICIPANTS


Rural and remote patients were consecutively recruited from a medical centre located in China between January and December 2014.
INTERVENTIONS


The control group received standard pre-procedure information from a ward nurse on the processes of the hospitalisation and percutaneous coronary intervention, and post-procedural care. The intervention group received a structured 30-minute counselling session the day before and 24 hours after the percutaneous coronary intervention, by nurse consultants with qualifications in psychological therapies and counselling. The health outcomes were assessed by a SF-12 scale and the Seattle Angina Questionnaire at 6 and 12 months after percutaneous coronary intervention. The anxiety and depression symptoms were evaluated by a Zung anxiety and depression questionnaire.
MAIN OUTCOME MEASURES


Cardiac outcomes, quality of life and mental health status.
RESULTS


Eighty patients were randomly divided into control (n = 40) and intervention groups (n = 40). There was a significant increase in the scores of the three domains of Seattle Angina Questionnaire 12 months after percutaneous coronary intervention in the intervention group (P < .01). The mental health and physical health scores also increased (P < .01). In the control group, the mean scores of Zung self-rating anxiety scale 12 months following percutaneous coronary intervention were higher than the baseline scores, and higher than in the intervention group (P < .01).
CONCLUSIONS


Counselling by a clinician qualified in psychological therapies and counselling significantly reduces anxiety symptoms and improves quality of life.",2020,There was a significant increase in the scores of the three domains of Seattle Angina Questionnaire 12 months after percutaneous coronary intervention in the intervention group (P < .01).,"['Eighty patients', 'Rural and remote China', 'Rural and remote patients were consecutively recruited from a medical centre located in China between January and December 2014', 'stable coronary artery disease']","['Nurse-led psychological intervention', 'structured 30-minute counselling session the day before and 24\xa0hours after the percutaneous coronary intervention, by nurse consultants with qualifications in psychological therapies and counselling', 'percutaneous coronary intervention', 'standard pre-procedure information from a ward nurse on the processes of the hospitalisation and percutaneous coronary intervention, and post-procedural care', 'nurse-led counselling']","['quality of life', 'Zung anxiety and depression questionnaire', 'mean scores of Zung self-rating anxiety scale', 'anxiety symptoms and the quality of life', 'mental health and physical health scores', 'anxiety symptoms', 'Cardiac outcomes, quality of life and mental health status', 'anxiety and depression symptoms', 'Seattle Angina Questionnaire', 'SF-12 scale and the Seattle Angina Questionnaire']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}]",80.0,0.0350921,There was a significant increase in the scores of the three domains of Seattle Angina Questionnaire 12 months after percutaneous coronary intervention in the intervention group (P < .01).,"[{'ForeName': 'Zongxia', 'Initials': 'Z', 'LastName': 'Chang', 'Affiliation': ""Department of Cardiology and Nursing, Liaocheng People's Hospital, Liaocheng City, China.""}, {'ForeName': 'Ai-Qing', 'Initials': 'AQ', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology and Nursing, Liaocheng People's Hospital, Liaocheng City, China.""}, {'ForeName': 'Ai-Xia', 'Initials': 'AX', 'LastName': 'Zhou', 'Affiliation': ""Department of Cardiology and Nursing, Liaocheng People's Hospital, Liaocheng City, China.""}, {'ForeName': 'Tong-Wen', 'Initials': 'TW', 'LastName': 'Sun', 'Affiliation': 'Henan Key Laboratory of Critical Care Medicine, Department of General ICU, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Long-le', 'Initials': 'LL', 'LastName': 'Ma', 'Affiliation': 'Henan Key Laboratory of Critical Care Medicine, Department of General ICU, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Fergus W', 'Initials': 'FW', 'LastName': 'Gardiner', 'Affiliation': 'The Royal Flying Doctor Service, Canberra, ACT, Australia.'}, {'ForeName': 'Le-Xin', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology and Nursing, Liaocheng People's Hospital, Liaocheng City, China.""}]",The Australian journal of rural health,['10.1111/ajr.12587']
1051,31863911,Children Monosensitized to Can f 5 Show Different Reactions to Male and Female Dog Allergen Extract Provocation: A Randomized Controlled Trial.,"BACKGROUND


Dog dander consists of several allergenic molecules including Can f 5, which is a protein expressed in the prostate of male dogs.
OBJECTIVE


To investigate whether children monosensitized to Can f 5 show different reactions to provocation tests with male versus female dog dander in a double-blind randomized clinical trial.
METHODS


Twenty-two children (15-18 years) with a history of dog sensitization were enrolled from the COpenhagen Prospective Studies on Asthma in Childhood 2000  mother-child cohort. Skin prick test, specific IgE levels to dog dander (e5), and dog components Can f 1, 2, 3, and 5 were first assessed. We subsequently performed skin prick test and conjunctival allergen provocation test using dog dander collected separately from male and female dogs.
RESULTS


Seven of the 22 children were monosensitized to Can f 5. Eight were sensitized to a mix of the dog components, and 7 were no longer sensitized to dog. Of the children monosensitized to Can f 5, all had a positive skin prick test result to male dog extract and 1 of 7 was also positive to female dog extract (P = .01). Furthermore, 5 of 7 had a positive conjunctival allergen provocation test result to male dog extract and 1 of 7 also reacted to the female dog extract (P = .03). There was no difference between reactions to male and female dog extract provocation in children sensitized to a mix of the dog components.
CONCLUSIONS


Children monosensitized to Can f 5 show different reactions to male and female dog extract provocation using both skin prick test and conjunctival allergen provocation test, suggesting tolerance to female dogs.",2020,"There was no difference between reactions to male- and female dog extract provocation in children sensitized to a mix of the dog components.
","['Twenty-two children (15-18yrs) with a history of dog sensitization were enrolled from the COPSAC 2000  mother-child cohort', '22 children were mono-sensitized to Can f', 'dog dander collected separately from male and female dogs', 'female dogs']",['skin prick and conjunctival allergen provocation test'],"['Skin prick test, specific IgE levels', 'positive skin prick test']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0440458', 'cui_str': 'Dog dander (substance)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",22.0,0.0549966,"There was no difference between reactions to male- and female dog extract provocation in children sensitized to a mix of the dog components.
","[{'ForeName': 'Ann-Marie Malby', 'Initials': 'AM', 'LastName': 'Schoos', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo Lund', 'Initials': 'BL', 'LastName': 'Chawes', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Bloch', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stokholm', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Bønnelykke', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Kristensen', 'Affiliation': 'Thermo Fisher Scientific, Allerød, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Bisgaard', 'Affiliation': 'COpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: bisgaard@copsac.com.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.12.012']
1052,31783602,Effect of Vitamin D Supplementation on Faecal Microbiota: A Randomised Clinical Trial.,"In animal studies, vitamin D supplementation has been shown to improve gut microbiota and intestinal inflammation. However, limited evidence exists on the effect of vitamin D supplementation on the human gut microbiota. We examined the effect of vitamin D supplementation on faecal microbiota in 26 vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) ≤50 nmol/L), overweight or obese (BMI ≥25 kg/m 2 ) otherwise healthy adults. Our study was ancillary to a community based double-blind randomised clinical trial, conducted between 2014 and 2016. The participants provided stool samples at baseline and after 100,000 international units (IU) loading dose of cholecalciferol followed by 4000 IU daily or matching placebo for 16 weeks. Faecal microbiota was analysed using 16S rRNA sequencing; V6-8 region. There was no significant difference in microbiome α-diversity between vitamin D and placebo groups at baseline and follow-up (all  p  > 0.05). In addition, no clustering was found based on vitamin D supplementation at follow-up ( p  = 0.3). However, there was a significant association between community composition and vitamin D supplementation at the genus level ( p  = 0.04). The vitamin D group had a higher abundance of genus  Lachnospira , and lower abundance of genus  Blautia  (linear discriminate analysis >3.0). Moreover, individuals with 25(OH)D >75 nmol/L had a higher abundance of genus  Coprococcus  and lower abundance of genus  Ruminococcus  compared to those with 25(OH)D <50 nmol/L. Our findings suggest that vitamin D supplementation has some distinct effects on faecal microbiota. Future studies need to explore whether these effects would translate into improved clinical outcomes.",2019,"The vitamin D group had a higher abundance of genus  Lachnospira , and lower abundance of genus  Blautia  (linear discriminate analysis >3.0).","['26 vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) ≤50 nmol/L), overweight or obese (BMI ≥25 kg/m 2 ) otherwise healthy adults', 'Faecal Microbiota']","['vitamin D supplementation', 'Vitamin D Supplementation', 'cholecalciferol followed by 4000 IU daily or matching placebo', 'placebo', 'vitamin D']","['faecal microbiota', 'vitamin D supplementation', 'Faecal microbiota', 'microbiome α-diversity', 'abundance of genus  Lachnospira , and lower abundance of genus  Blautia', 'community composition and vitamin D supplementation', 'gut microbiota and intestinal inflammation']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0317586', 'cui_str': 'Lachnospira'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2658870', 'cui_str': 'Blautia species'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}]",26.0,0.411561,"The vitamin D group had a higher abundance of genus  Lachnospira , and lower abundance of genus  Blautia  (linear discriminate analysis >3.0).","[{'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Naderpoor', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3168 Australia.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Mousa', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3168 Australia.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Fernanda Gomez Arango', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, QLD 4101, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Barrett', 'Affiliation': 'Mater Research Institute, The University of Queensland, South Brisbane, QLD 4101, Australia.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Dekker Nitert', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, QLD 4101, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'de Courten', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, VIC 3168 Australia.'}]",Nutrients,['10.3390/nu11122888']
1053,31205170,The Effect of Core Stabilization Exercises on Trunk-Pelvis Three-Dimensional Kinematics During Gait in Non-Specific Chronic Low Back Pain.,"STUDY DESIGN


Controlled clinical trial study.
OBJECTIVE


This study aimed to evaluate the effect of core stabilization exercise program (CSEP) on trunk-pelvis kinematics during gait in non-specific chronic low back pain (NCLBP).
SUMMARY OF BACKGROUND DATA


NCLBP is a major public burden with variety of dysfunction including gait variability.
METHODS


Thirty participants (15 NCLBP and 15 healthy) were included in this study via the convenience sampling method. NCLBP group were intervened via the 16 sessions CSEP 3 days for 6 weeks and trunk-pelvis kinematics (angular displacement, waveform pattern [CVp], and offset variability [CVo]) during gait, pain, disability were evaluated before and after the intervention.
RESULTS


No significant differences in displacement and CVo in three planes were found between NCLBP and healthy groups. Independent t test was revealed that significant differences in CVp in the sagittal, frontal, and transverse planes were found between healthy and NCLBP in pre intervention. No significant changes in displacement and CVo were found as the result of intervention in NCLBP. Pain and disability decreased significantly after intervention. Paired t test revealed that the CSEP increased the frontal (P = 0.04) and transverse planes (P = 0.02) pattern variability significantly. However, there was a significant difference between groups in the sagittal plane CVp after intervention (sagittal plane CVp in healthy vs. NCLBP in post-CSE: mean difference = 14.1; P = 0.04).
CONCLUSION


Considering the role of the deep trunk muscles in gait, and their common deconditioning in CLBP, a CSEP intervention may increase trunk-pelvis kinematic pattern variability. These results suggest CSEP may specifically increase transverse and frontal plane variability, indicating improved motor pattern replication through this movement planes.
LEVEL OF EVIDENCE


2.",2019,Paired t test revealed that the CSEP increased the frontal (P = 0.04) and transverse planes (P = 0.02) pattern variability significantly.,"['non-specific chronic low back pain (NCLBP', 'Thirty participants (15 NCLBP and 15 healthy', 'Trunk-Pelvis Three-Dimensional Kinematics During Gait in Non-Specific Chronic Low Back Pain']","['NCLBP', 'CSEP', 'Core Stabilization Exercises', 'core stabilization exercise program (CSEP']","['transverse planes', 'transverse and frontal plane variability', 'CVp in the sagittal, frontal, and transverse planes', 'Pain and disability', 'displacement and CVo', 'sagittal plane CVp']","[{'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205106', 'cui_str': 'Horizontal plane'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C4551585', 'cui_str': 'Frontal plane'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}]",30.0,0.0440965,Paired t test revealed that the CSEP increased the frontal (P = 0.04) and transverse planes (P = 0.02) pattern variability significantly.,"[{'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences and Health services, Semnan, Iran.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Parhampour', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Pourahmadi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Sayyed Hamed', 'Initials': 'SH', 'LastName': 'Fazeli', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Ismail Ebrahimi', 'Initials': 'IE', 'LastName': 'Takamjani', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Akbari', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Tehran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Dadgoo', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}]",Spine,['10.1097/BRS.0000000000002981']
1054,31860172,Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine.,"INTRODUCTION


In the era of HIV treatment as prevention (TasP), evidence-based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community-based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine.
METHODS


Conducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community-based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention-control condition (n = 55). All individual positive affect intervention and attention-control sessions were delivered during three months of community-based CM where participants received financial incentives for stimulant abstinence. The 5-session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention-control condition consisted of neutral writing exercises and self-report measures.
RESULTS


Men randomized to the positive affect intervention displayed significantly lower log 10  HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15-month follow-up. There were concurrent, statistically significant intervention-related increases in positive affect as well as decreases in the self-reported frequency of stimulant use at six and twelve months.
CONCLUSIONS


Delivering a positive affect intervention during community-based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.",2019,"Men randomized to the positive affect intervention displayed significantly lower log 10  HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition.","['sexual minority men living with HIV who use methamphetamine', 'sexual minority men who use', 'Conducted in San Francisco', 'sexual minority men who use stimulants such as methamphetamine', 'From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use']","['positive affect intervention (n\xa0=\xa055) or attention-control condition', 'methamphetamine', 'positive affect intervention', 'neutral writing exercises and self-report measures', 'community-based contingency management (CM']","['log 10  HIV viral load', 'HIV viral load']","[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",,0.110968,"Men randomized to the positive affect intervention displayed significantly lower log 10  HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition.","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Evans', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gόmez', 'Affiliation': 'Berkeley School of Social Welfare, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Jain', 'Affiliation': 'San Diego School of Medicine, University of California, La Jolla, CA, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Shoptaw', 'Affiliation': 'Departments of Family Medicine and Psychiatry, Los Angeles David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Coffin', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Discepola', 'Affiliation': 'San Francisco AIDS Foundation, San Francisco, CA, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'San Francisco AIDS Foundation, San Francisco, CA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Woods', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, CA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25436']
1055,31082897,Low Ligation of Inferior Mesenteric Artery in Laparoscopic Anterior Resection for Rectal Cancer Reduces Genitourinary Dysfunction: Results From a Randomized Controlled Trial (HIGHLOW Trial).,"OBJECTIVES


The aim of the present study was to compare the incidence of genitourinary (GU) dysfunction after elective laparoscopic low anterior rectal resection and total mesorectal excision (LAR + TME) with high or low ligation (LL) of the inferior mesenteric artery (IMA). Secondary aims included the incidence of anastomotic leakage and oncological outcomes.
BACKGROUND


The criterion standard surgical approach for rectal cancer is LAR + TME. The level of artery ligation remains an issue related to functional outcome, anastomotic leak rate, and oncological adequacy. Retrospective studies failed to provide strong evidence in favor of one particular vascular approach and the specific impact on GU function is poorly understood.
METHODS


Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian nonacademic hospitals were randomized to high ligation (HL) or LL of IMA after meeting the inclusion criteria. GU function was evaluated using a standardized survey and uroflowmetric examination. The trial was registered under the ClinicalTrials.gov Identifier NCT02153801.
RESULTS


A total of 214 patients were randomized to HL (n = 111) or LL (n = 103). GU function was impaired in both groups after surgery. LL group reported better continence and less obstructive urinary symptoms and improved quality of life at 9 months postoperative. Sexual function was better in the LL group compared to HL group at 9 months. Urinated volume, maximum urinary flow, and flow time were significantly (P < 0.05) in favor of the LL group at 1 and 9 months from surgery. The ultrasound measured post void residual volume and average urinary flow were significantly (P < 0.05) better in the LL group at 9 months postoperatively. Time of flow worsened in both groups at 9 months compared to baseline. There was no difference in anastomotic leak rate (8.1% HL vs 6.7% LL). There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups.
CONCLUSIONS


LL of the IMA in LAR + TME results in better GU function preservation without affecting initial oncological outcomes. HL does not seem to increase the anastomotic leak rate.",2019,"There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups.
","['Rectal Cancer Reduces Genitourinary Dysfunction', 'in 6 Italian nonacademic hospitals', '214 patients', 'Between June 2014 and December 2016, patients who underwent']","['LL', 'elective laparoscopic low anterior rectal resection and total mesorectal excision (LAR + TME) with high or low ligation (LL', 'HL', 'Laparoscopic Anterior Resection', 'high ligation (HL) or LL of IMA', 'Low Ligation of Inferior Mesenteric Artery', 'elective laparoscopic LAR + TME']","['incidence of genitourinary (GU) dysfunction', 'GU function', 'Time of flow worsened', 'anastomotic leak rate', 'ultrasound measured post void residual volume and average urinary flow', 'Urinated volume, maximum urinary flow, and flow time', 'better continence and less obstructive urinary symptoms and improved quality of life', 'Sexual function', 'incidence of anastomotic leakage and oncological outcomes', 'blood loss, surgical times, postoperative complications, and initial oncological outcomes']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1273429', 'cui_str': 'Ligation of inferior mesenteric artery'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",214.0,0.0892984,"There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups.
","[{'ForeName': 'Giulio M', 'Initials': 'GM', 'LastName': 'Mari', 'Affiliation': 'Laparoscopic and Oncological General Surgery Department, ASST Monza, Desio Hospital, Desio MB, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Crippa', 'Affiliation': 'General Surgery Residency Program, University of Milan, Milan, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cocozza', 'Affiliation': 'ASST Sette Laghi, Surgical Oncology and Minimally Invasive Unit, Varese, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Berselli', 'Affiliation': 'ASST Sette Laghi, Surgical Oncology and Minimally Invasive Unit, Varese, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Livraghi', 'Affiliation': 'ASST Sette Laghi, Surgical Oncology and Minimally Invasive Unit, Varese, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Carzaniga', 'Affiliation': 'General Surgery Department, ASST Lecco, San Leopoldo Mandic Hospital, Merate LC, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Valenti', 'Affiliation': 'General Surgery Department, Humanitas Gavazzeni, Bergamo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Roscio', 'Affiliation': 'Division of General Surgery, ASST Sette Laghi, Galmarini Hospital, Tradate VA, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Division of Oncologic and Mini-invasive General Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mazzola', 'Affiliation': 'Division of Oncologic and Mini-invasive General Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Magistro', 'Affiliation': 'Division of Oncologic and Mini-invasive General Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Origi', 'Affiliation': 'Division of Oncologic and Mini-invasive General Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Forgione', 'Affiliation': 'Division of Oncologic and Mini-invasive General Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Zuliani', 'Affiliation': 'Humanitas Mater Domini Clinical Institute, General Surgery, Castellanza VA, Italy.'}, {'ForeName': 'Ildo', 'Initials': 'I', 'LastName': 'Scandroglio', 'Affiliation': 'Division of General Surgery, ASST Valle Olona, Busto Arsizio General Hospital, Busto Arsizio VA, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Pugliese', 'Affiliation': 'AIMS Academy, Milan, Italy.'}, {'ForeName': 'Andrea T M', 'Initials': 'ATM', 'LastName': 'Costanzi', 'Affiliation': 'Laparoscopic and Oncological General Surgery Department, ASST Monza, Desio Hospital, Desio MB, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Maggioni', 'Affiliation': 'Laparoscopic and Oncological General Surgery Department, ASST Monza, Desio Hospital, Desio MB, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000002947']
1056,31082899,Negative Pressure Wound Therapy for Surgical-site Infections: A Randomized Trial.,"OBJECTIVE


This study seeks to evaluate the efficacy of negative pressure wound therapy for surgical-site infection (SSI) after open pancreaticoduodenectomy.
BACKGROUND


Despite improvement in infection control, SSIs remain a common cause of morbidity after abdominal surgery. SSI has been associated with an increased risk of reoperation, prolonged hospitalization, readmission, and higher costs. Recent retrospective studies have suggested that the use of negative pressure wound therapy can potentially prevent this complication.
METHODS


We conducted a single-center randomized, controlled trial evaluating surgical incision closure during pancreaticoduodenectomy using negative pressure wound therapy in patients at high risk for SSI. We randomly assigned patients to receive negative pressure wound therapy or a standard wound closure. The primary end point of the study was the occurrence of a postoperative SSI. We evaluated the economic impact of the intervention.
RESULTS


From January 2017 through February 2018, we randomized 123 patients at the time of closure of the surgical incision. SSI occurred in 9.7% (6/62) of patients in the negative pressure wound therapy group and in 31.1% (19/61) of patients in the standard closure group (relative risk = 0.31; 95% confidence interval, 0.13-0.73; P = 0.003). This corresponded to a relative risk reduction of 68.8%. SSIs were found to independently increase the cost of hospitalization by 23.8%.
CONCLUSIONS


The use of negative pressure wound therapy resulted in a significantly lower risk of SSIs. Incorporating this intervention in surgical practice can help reduce a complication that significantly increases patient harm and healthcare costs.",2019,"SSI occurred in 9.7% (6/62) of patients in the negative pressure wound therapy group and in 31.1% (19/61) of patients in the standard closure group (relative risk = 0.31; 95% confidence interval, 0.13-0.73; P = 0.003).","['From January 2017 through February 2018, we randomized 123 patients at the time of closure of the surgical incision', 'Surgical-site Infections', 'patients at high risk for SSI']","['Negative Pressure Wound Therapy', 'surgical incision closure during pancreaticoduodenectomy using negative pressure wound therapy', 'negative pressure wound therapy or a standard wound closure', 'negative pressure wound therapy']","['risk of SSIs', 'occurrence of a postoperative SSI', 'SSI', 'cost of hospitalization', 'risk of reoperation, prolonged hospitalization, readmission, and higher costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",123.0,0.0975065,"SSI occurred in 9.7% (6/62) of patients in the negative pressure wound therapy group and in 31.1% (19/61) of patients in the standard closure group (relative risk = 0.31; 95% confidence interval, 0.13-0.73; P = 0.003).","[{'ForeName': 'Ammar A', 'Initials': 'AA', 'LastName': 'Javed', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Teinor', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Burkhart', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hundt', 'Affiliation': 'Department of Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Cameron', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Makary', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Frederic E', 'Initials': 'FE', 'LastName': 'Eckhauser', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Wolfgang', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Weiss', 'Affiliation': 'The John L. Cameron Division of Hepatobiliary and Pancreatic Surgery, The Johns Hopkins Hospital, Baltimore, MD.'}]",Annals of surgery,['10.1097/SLA.0000000000003056']
1057,31136052,Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection.,"BACKGROUND & AIMS


Tenofovir disoproxil fumarate (TDF) is a first-line treatment for chronic hepatitis B (CHB). We aimed to describe the efficacy and safety profiles of TDF treatment for up to 10 years in a well-described cohort of CHB patients.
METHODS


Hepatitis B e antigen (HBeAg)-negative and HBeAg-positive patients from two randomised, double-blind trials (ClinicalTrials.gov: NCT00117676 and NCT00116805) completed 48 weeks of randomised treatment with TDF or adefovir dipivoxil. A subset of these patients was then eligible to receive open-label TDF treatment for up to 10 years. At Year 10, patients were assessed for virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety and tolerability.
RESULTS


Of 641 randomised and treated patients, 585 (91%) entered the open-label extension phase with 203 (32%) patients completing Year 10 of the study. At Year 10, 118/118 (100%) of HBeAg-negative patients and 78/80 (98%) of HBeAg-positive patients with available data achieved hepatitis B virus (HBV) DNA < 69 IU/mL, while 88/106 (83%) and 60/77 (78%) patients achieved ALT normalisation, respectively. Of the 23 patients with HBeAg status available at Year 10, 12 (52%) and six (27%) experienced HBeAg loss and seroconversion, respectively. No resistance to TDF was documented up to Year 10. In the period between Year 8 and Year 10, the safety profile of TDF was similar to previous reports, with few patients experiencing renal- or bone-related adverse events.
CONCLUSIONS


Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.",2019,"Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.","['chronic hepatitis B (CHB', 'up to 10\xa0years in a well-described cohort of CHB patients', 'Of 641', 'randomised and treated patients, 585 (91%) entered the open-label extension phase with 203 (32%) patients completing Year 10 of the study', 'chronic hepatitis B virus infection', 'Hepatitis B e antigen ']","['Tenofovir disoproxil fumarate (TDF', 'TDF or adefovir dipivoxil', 'TDF', 'tenofovir disoproxil fumarate treatment', 'open-label TDF']","['HBeAg loss and seroconversion', 'efficacy and safety profiles', 'virological suppression', 'virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety and tolerability', 'hepatitis B virus (HBV) DNA', 'safety profile of TDF']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}]",23.0,0.106675,"Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Marcellin', 'Affiliation': 'Viral Hepatitis Research Unit, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wong', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sievert', 'Affiliation': 'Gastroenterology and Hepatology Unit, Monash Health and Monash University, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buggisch', 'Affiliation': 'Liver Unit, IFI-Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Liver Unit, IFI-Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flisiak', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University Bialystok, Bialystok, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kaita', 'Affiliation': 'Viral Hepatitis Investigative Unit, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Zahari', 'Initials': 'Z', 'LastName': 'Krastev', 'Affiliation': 'Clinic of Gastroenterology, St Ivan Rilsky University Hospital, Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Liver Unit, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cathcart', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Crans', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Marjoleine', 'Initials': 'M', 'LastName': 'Op den Brouw', 'Affiliation': 'Gilead Sciences Europe Ltd, Uxbridge, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Jump', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Flaherty', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Liver Unit, Hospital Universitario Vall d'Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain.""}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14155']
1058,31505228,A Phase 3 Randomized Study of Remestemcel-L versus Placebo Added to Second-Line Therapy in Patients with Steroid-Refractory Acute Graft-versus-Host Disease.,"Uncontrolled studies have suggested that bone marrow-derived mesenchymal stem cells (MSCs) may be effective against acute graft-versus-host disease (aGVHD). We conducted a multicenter, randomized study to assess the efficacy of using ex vivo cultured adult human MSC (remestemcel-L) in addition to second-line therapy to treat steroid-refractory aGVHD (NCT00366145). In total, 260 patients, 6 months to 70 years of age, were enrolled from August 2006 to May 2009 and were randomized 2:1 to receive 8 intravenous infusions of remestemcel-L or placebo, given over 4 weeks, in addition to second-line therapy according to institutional standards. Four additional infusions over 4 weeks were indicated for patients with incomplete response at day 28. Randomization was stratified by aGVHD grade. Efficacy and safety were assessed through 180 days of follow-up, with the primary endpoint being durable complete response (DCR), defined as complete resolution of aGVHD symptoms for any period of at least 28 days after beginning treatment. Remestemcel-L did not meet the primary endpoint of greater DCR in the intent-to-treat population (35% versus 30%; P = 0.42). In post hoc analyses, patients with liver involvement who received at least 1 infusion of remestemcel-L had a higher DCR, and higher overall complete or partial response rate (OR) than those who received placebo (29% versus 5%; P = .047). Among high-risk patients (aGVHD grades C and D), remestemcel-L demonstrated significantly higher OR at day 28 than placebo (58% versus 37%; P = 0.03). Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05). Similar rates of adverse events were observed between treatment groups. Remestemcel-L was safe and well tolerated. Results of this study did not demonstrate superior DCR compared with placebo when added to standard of care. The favorable clinical responses seen in some patient subsets may warrant further investigation.",2020,"Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05).","['260 patients, 6 months to 70 years of age, were enrolled from August 2006 to May 2009', 'Patients with Steroid-Refractory Acute Graft-versus-Host Disease']","['placebo', 'ex vivo cultured adult human MSC (remestemcel-L', 'Remestemcel-L versus Placebo Added to Second-Line Therapy', 'intravenous infusions of remestemcel-L or placebo']","['overall complete or partial response rate (OR', 'adverse events', 'durable complete response (DCR), defined as complete resolution of aGVHD symptoms', 'Efficacy and safety', 'safe and well tolerated']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",260.0,0.32227,"Furthermore, pediatric patients had a higher OR with MSCs compared with placebo (64% versus 23%; P = .05).","[{'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Department of Stem Cell and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: pkebriae@mdanderson.org.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Daly', 'Affiliation': 'Tom Baker Cancer Center, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Uberti', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Soiffer', 'Affiliation': 'Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Emory University Bone Marrow and Stem Cell Transplant Center, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burke', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Skerrett', 'Affiliation': 'Mesoblast, New York, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shpall', 'Affiliation': 'Department of Stem Cell and Cellular Therapy, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.08.029']
1059,30445644,Efficacy of a free-play intervention to increase physical activity during childcare: a randomized controlled trial.,"The primary aim of this study was to assess the efficacy of a childcare-based intervention in increasing child physical activity by allowing children unrestricted access to outdoor areas for free-play when structured activity is not taking place. A randomized controlled trial was conducted in six childcare services. Intervention services provided children unrestricted access outdoors for active free-play, while control services provided their usual scheduled periods of outdoor play. Consent was obtained from 231 children. Child moderate to vigorous activity (MVPA), the primary trial outcome, was assessed via accelerometer at baseline and 3 months post baseline. Intervention effects were examined using Generalised Linear Mixed Models. Controlling for child age, gender and baseline outcome measure, at follow-up there were no significant differences between groups in minutes of MVPA in-care (mean difference: 4.85; 95% CI: -3.96, 13.66; P = 0.28), proportion of wear time in-care spent in MVPA (mean difference: 1.52%; 95% CI: -0.50, 3.53; P = 0.14) or total physical activity in-care (mean difference in counts per minute: 23.18; 95% CI: -4.26, 50.61; P = 0.10), nor on measures of child cognition (P = 0.45-0.91). It was concluded that interventions addressing multiple aspects of the childcare and home environment might provide the greatest potential to improve child physical activity.",2019,"Controlling for child age, gender and baseline outcome measure, at follow-up there were no significant differences between groups in minutes of MVPA in-care (mean difference: 4.85; 95% CI: -3.96, 13.66; P = 0.28), proportion of wear time in-care spent in MVPA (mean difference: 1.52%; 95% CI: -0.50, 3.53; P = 0.14) or total physical activity in-care (mean difference in counts per minute: 23.18; 95% CI: -4.26, 50.61; P = 0.10), nor on measures of child cognition (P = 0.45-0.91).","['231 children', 'six childcare services', 'childcare']","['free-play intervention', 'childcare-based intervention']","['proportion of wear time in-care spent in MVPA', 'child cognition', 'total physical activity in-care', 'Child moderate to vigorous activity (MVPA', 'child physical activity', 'physical activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",231.0,0.173929,"Controlling for child age, gender and baseline outcome measure, at follow-up there were no significant differences between groups in minutes of MVPA in-care (mean difference: 4.85; 95% CI: -3.96, 13.66; P = 0.28), proportion of wear time in-care spent in MVPA (mean difference: 1.52%; 95% CI: -0.50, 3.53; P = 0.14) or total physical activity in-care (mean difference in counts per minute: 23.18; 95% CI: -4.26, 50.61; P = 0.10), nor on measures of child cognition (P = 0.45-0.91).","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Jannah', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Parmenter', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Lubna Abdul', 'Initials': 'LA', 'LastName': 'Razak', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'School of Education, Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Clinton-McHarg', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'Hunter New England Population Health, Wallsend, NSW, Australia.'}]",Health education research,['10.1093/her/cyy041']
1060,31947043,The Effects of Anti-gravity Treadmill Training on Gait Characteristics in Children with Cerebral Palsy.,"Cerebral palsy is a disorder that affects muscle tone, movement and motor skills. Most of the children with cerebral palsy (CP) are not able to walk or can walk in incorrect pattern and are dependent on assistive devices. Recently an antigravity treadmill has been found to be beneficial as a new therapeutic approach. Thus, we aimed to investigate the effects of antigravity treadmill training (AlterG) on gait characteristic in children with cerebral palsy. We provided a 45-minute training program, 3 times a week for 8 weeks for six CP children as our experimental group. Our control group was a group consisted of four CP children who took typical occupational therapy, accordingly. All subjects in both AlterG and control groups were evaluated at the gait lab before and after 8 weeks training. Gait patterns were characterized using spatiotemporal parameters and dynamic balance features. We also evaluated the popular clinical gait measures including walking speed and endurance, and mobility and balance.Our results demonstrated that spatiotemporal, dynamic balance and clinical features all improved more after 8 weeks AlterG training rather than control group ones. These findings suggest that AlterG training can be considered as an effective approach for improving walking ability and gait characteristics in children with cerebral palsy.",2019,"Our results demonstrated that spatiotemporal, dynamic balance and clinical features all improved more after 8 weeks AlterG training rather than control group ones.","['children with cerebral palsy', 'Children with Cerebral Palsy', 'children with cerebral palsy (CP']","['CP children who took typical occupational therapy', 'antigravity treadmill', 'antigravity treadmill training (AlterG', 'AlterG training', 'Anti-gravity Treadmill Training']","['walking ability and gait characteristics', 'walking speed and endurance, and mobility and balance', 'Gait Characteristics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0126112,"Our results demonstrated that spatiotemporal, dynamic balance and clinical features all improved more after 8 weeks AlterG training rather than control group ones.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotfian', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dadashi', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Rafieenazari', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rasteh', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molavi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirbagheri', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,['10.1109/EMBC.2019.8856660']
1061,31486158,Effect of Oral Versus Intramuscular Vitamin D Replacement on Oxidative Stress and Outcomes in Traumatic Mechanical Ventilated Patients Admitted to Intensive Care Unit.,"BACKGROUND


This study aimed to evaluate the safety and efficacy of 2 forms of vitamin D supplementation on oxidative stress and weaning from the ventilator in patients with traumatic injury and vitamin D deficiency.
METHODS


Seventy-two patients were randomly divided into 3 groups: receiving 50,000 IU pearl cholecalciferol daily for 6 days, 1 intramuscular injection of 300,000 IU of cholecalciferol, or a control group that did not receive any supplement. Duration of mechanical ventilation, body composition, and biochemical biomarkers were measured before and after the intervention.
RESULT


At the end of the study, the mean serum 25(OH)D increased in the intervention groups compared with the control group (P < .05). The interleukin 6, erythrocyte sedimentation rate, C-reactive protein levels, Sequential Organ Failure Assessment score, duration of mechanical ventilation, and length of intensive care unit admission significantly decreased; however, total antioxidant capacity concentration did not differ significantly between the 2 intervention groups. Among the body composition variables, extracellular water ratio changes were statically different in oral vitamin D group compared with the control group (P = .001). No side effects were reported with the supplements.
CONCLUSIONS


Vitamin D administration improved clinical signs and biochemical biomarkers in a small group of patients with traumatic injury. Well-designed multicenter clinical studies with longer intervention duration are necessary for this field.",2020,"Among the body composition variables, extracellular water ratio changes were statically different in oral vitamin D group compared with the control group (P = .001).","['patients with traumatic injury', 'Seventy-two patients', 'Traumatic Mechanical Ventilated Patients Admitted to Intensive Care Unit', 'patients with traumatic injury and vitamin D deficiency']","['Oral Versus Intramuscular Vitamin D Replacement', '50,000\u2009IU pearl cholecalciferol', 'vitamin D supplementation', 'Vitamin D', 'cholecalciferol, or a control group that did not receive any supplement']","['mean serum 25(OH)D', 'Duration of mechanical ventilation, body composition, and biochemical biomarkers', 'side effects', 'interleukin 6, erythrocyte sedimentation rate, C-reactive protein levels, Sequential Organ Failure Assessment score, duration of mechanical ventilation, and length of intensive care unit admission', 'extracellular water ratio changes', 'total antioxidant capacity concentration', 'Oxidative Stress and Outcomes', 'clinical signs and biochemical biomarkers', 'oxidative stress', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263723', 'cui_str': 'Injuries'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.0619495,"Among the body composition variables, extracellular water ratio changes were statically different in oral vitamin D group compared with the control group (P = .001).","[{'ForeName': 'Mohammad Amin Valizade', 'Initials': 'MAV', 'LastName': 'Hasanloei', 'Affiliation': 'Clinical Research Development Unit, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Rahimlou', 'Affiliation': 'Department of Nutrition, School of Para-medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Afsoon', 'Initials': 'A', 'LastName': 'Eivazloo', 'Affiliation': 'Clinical Research Development Unit, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Shahryar', 'Initials': 'S', 'LastName': 'Sane', 'Affiliation': 'Clinical Research Development Unit, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Ayremlou', 'Affiliation': 'Clinical Research Development Unit, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hashemi', 'Affiliation': 'Clinical Research Development Unit, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10404']
1062,31231970,Inter-Relations between Partner-Provided Support and Self-Efficacy: A Dyadic Longitudinal Analysis.,"BACKGROUND


Existing evidence indicates that social support may enhance recipients' self-efficacy (enabling hypothesis) or that self-efficacy facilitates support receipt (cultivation hypothesis). However, less is known about the time-lagged support-self-efficacy relationship in couples. Our aim was to disentangle reciprocal interrelations among stable and time-varying components of support provision and self-efficacy in couples over time.
METHODS


We conducted secondary analyses of a published randomised controlled trial with six assessments, spanning 1 year and N = 338 heterosexual couples (age range: 18-80 years). Women's and men's reports on physical activity-specific provided support and physical activity-specific self-efficacy were analysed.
RESULTS


Based on the actor-partner interdependence model, we compared nested random intercepts cross-lagged panel models. The final model revealed no gender effects. Stable levels of both partners' support provision and self-efficacy were positively associated. At the time-varying level, one partner's self-efficacy predicted the other partner's support provision later on. No lagged-association emerged for the opposite predictive direction.
CONCLUSIONS


Partners' stable shares of provided support and self-efficacy were interrelated, whereas higher time-varying self-efficacy of one partner seemed to activate support provision from the other partner, confirming the cultivation hypothesis but not the enabling hypothesis.",2019,"Women's and men's reports on physical activity-specific provided support and physical activity-specific self-efficacy were analysed.
","['spanning 1\xa0year and N\xa0=\xa0338 heterosexual couples (age range: 18-80\xa0years', 'couples over time']",[],"['physical activity-specific provided support and physical activity-specific self-efficacy', 'Self-Efficacy', ""Stable levels of both partners' support provision and self-efficacy""]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",338.0,0.0226642,"Women's and men's reports on physical activity-specific provided support and physical activity-specific self-efficacy were analysed.
","[{'ForeName': 'Diana Hilda', 'Initials': 'DH', 'LastName': 'Hohl', 'Affiliation': 'Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schultze', 'Affiliation': 'Goethe Universität, Frankfurt am Main, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Heuse', 'Affiliation': 'University of Applied Sciences Europe, Campus Berlin, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Luszczynska', 'Affiliation': 'SWPS University of Social Sciences and Humanities, Wroclaw, Poland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Knoll', 'Affiliation': 'Freie Universität Berlin, Berlin, Germany.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12166']
1063,31837079,Improved Display of Hepatic Arterial Anatomy Using Differential Subsampling With Cartesian Ordering (DISCO) With Gadoxetic Acid-Enhanced MRI: Comparison With Single Arterial Phase MRI and Computed Tomographic Angiography.,"BACKGROUND


In clinical practice arterial anatomy evaluation is often determined using computed tomographic angiography (CTA); the effect of enhanced MRI has been neglected.
PURPOSE


To evaluate whether multiple arterial phase (MAP) images from patients who underwent differential subsampling with Cartesian ordering (DISCO) acquisition would improve the hepatic arterial display compared with single arterial phase (SAP) and CTA.
STUDY TYPE


A prospective, randomized trial.
SUBJECTS


In all, 130 patients (mean age, 55.81 ± 9.43 years; range, 35-78 years) including 89 men and 41 women.
FIELD STRENGTH/SEQUENCE


3.0T, DISCO, liver acquisition with volume acceleration-flexible (LAVA-Flex), CTA.
ASSESSMENT


A simple randomization was conducted and the study was subdivided into study part I (DISCO vs. SAP) and study part II (DISCO vs. CTA). Ten hepatic arterial segments were independently evaluated by three readers in the axial plane and the quality of hepatic arterial display was assessed using a four-point scale.
STATISTICAL TESTS


Kendall's W-test, χ 2  test, Mann-Whitney U-test, and Kruskal-Wallis one-way analysis of variance (ANOVA) test.
RESULTS


Excellent interobserver agreement was obtained for hepatic arterial display (all Kendall's W values >0.80). For study part I, the mean arterial display scores for the common hepatic artery (CHA), proper hepatic artery (PHA), left hepatic artery (LHA), right hepatic artery (RHA), left gastric artery (LGA), and gastroduodenal artery (GDA) obtained with DISCO were higher than that obtained with SAP imaging (all P < 0.01). For study part II, comparable image quality for CHA (P = 0.798), PHA (P = 0.440), LHA (P = 0.211), RHA (P = 0.775) LGA (P = 0.468), and GDA (P = 0.801) was obtained with DISCO and CTA.
DATA CONCLUSION


The use of MAP acquisition with DISCO is superior to the use of SAP in hepatic arterial display and compares favorably with CTA; in the future, DISCO possibly can replace the latter ionization-related method to provide a more comprehensive evaluation of the liver arterial vessels.
LEVEL OF EVIDENCE


1 Technical Efficacy Stage: 1 J. Magn. Reson. Imaging 2020;51:1766-1776.",2020,Excellent interobserver agreement was obtained for hepatic arterial display (all Kendall's W values >0.80).,"['In all, 130 patients (mean age, 55.81\u2009±\u20099.43\u2009years; range, 35-78\u2009years) including 89 men and 41 women', 'patients who underwent differential subsampling with Cartesian ordering (DISCO) acquisition']","['Differential Subsampling With Cartesian Ordering (DISCO', 'liver acquisition with volume acceleration-flexible (LAVA-Flex), CTA', 'Gadoxetic Acid-Enhanced MRI', 'computed tomographic angiography (CTA', 'Single Arterial Phase MRI and Computed Tomographic Angiography']","['hepatic arterial display', 'quality of hepatic arterial display', 'mean arterial display scores for the common hepatic artery (CHA), proper hepatic artery (PHA), left hepatic artery (LHA), right hepatic artery (RHA), left gastric artery (LGA), and gastroduodenal artery (GDA) obtained with DISCO']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C3489483', 'cui_str': 'Gadoxetic acid'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0226300', 'cui_str': 'Structure of common hepatic artery'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery (body structure)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0226298', 'cui_str': 'Left Gastric Artery'}, {'cui': 'C0226311', 'cui_str': 'Structure of gastroduodenal artery'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]",130.0,0.0315587,Excellent interobserver agreement was obtained for hepatic arterial display (all Kendall's W values >0.80).,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hehan', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zixing', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaocheng', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'GE Healthcare China, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27020']
1064,31106922,"The impact of behavioural skills training on the knowledge, skills and well-being of front line staff in the intellectual disability sector: a clustered randomised control trial.","BACKGROUND


Staff with varying backgrounds and educational qualifications can be effectively trained to implement procedures in line with evidence-based practice. Behavioural skills training (BST) is a competency-based training model used to effectively educate a broad selection of professionals, including front line staff, in a range of work-related skills. However, BST has yet to be evaluated in a large group-based experiment.
METHODS


This study involved a parallel cluster randomised control trial. Six service sites, with a total of 54 participants, were randomised to the intervention condition using the 'coin toss' method. The intervention condition used BST to coach intellectual disability staff in reinforcement, systematic prompting, functional communication training and task analysis. Six service sites, with a total of 50 participants, were also randomised to a control condition in which generalised training in behavioural interventions was restricted. Recruited service sites were randomly assigned to the intervention condition (N = 6, n = 54) or the control condition (N = 6, n = 50) at one point in time, immediately after recruitment and before baseline testing took place. Allocations were stratified by service type (residential or day) and geographical region. One member of the research team allocated service sites using the 'coin toss' method, and another member, blind to the allocations, decided which experimental arm would receive the intervention and which would be designated as control. It was not possible to mask the intervention from participants, but they were recruited prior to randomisation.
RESULTS


Participants in the intervention condition demonstrated statistically significant improvements in their knowledge scores over the study period. Participants in the control condition showed no change or a statistically significant decrease in their knowledge scores. No statistically significant changes to well-being were observed for either group. There was clear evidence of knowledge maintenance, as well as skill acquisition and subsequent generalisation to the workplace environment, among participants in the intervention condition. Participants also evaluated the BST intervention positively.
CONCLUSIONS


Results support BST as a method for disseminating evidence-based practice to front line staff working with adults with intellectual and developmental disabilities.",2019,Participants in the control condition showed no change or a statistically significant decrease in their knowledge scores.,"['Six service sites, with a total of 54 participants', 'adults with intellectual and developmental disabilities', 'Six service sites, with a total of 50 participants', 'intellectual disability sector', 'Recruited service sites']","['BST', 'behavioural skills training', 'Behavioural skills training (BST']",['knowledge scores'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",54.0,0.051257,Participants in the control condition showed no change or a statistically significant decrease in their knowledge scores.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gormley', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Healy', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': ""O'Regan"", 'Affiliation': 'Behavioural Department, Rehab Group, Dublin 4, Ireland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Grey', 'Affiliation': 'College of Natural and Health Sciences, Zayed University, Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bracken', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12630']
1065,29468670,Housing Interventions and the Chronic and Acute Risks of Family Homelessness: Experimental Evidence for Education.,"This study considers risk associated with family homelessness for school functioning and experimental evidence on the effects of different housing interventions over time. Students in homeless families (N = 172; M age   = 7.31; SD = 4.15) were randomized to housing interventions that focus on acute risks (community-based rapid rehousing), chronic risks (permanent subsidy), or usual care (UC). A matched group of low-income, housed students served as an additional reference for effects on attendance, school mobility, and reading and math achievement across 4 years. Findings partially support the chronic-risk hypothesis that family homelessness interferes with achievement through its relation to deep poverty. Children randomly assigned to UC perform as well or better than children assigned to housing interventions in this municipality.",2019,Children randomly assigned to UC perform as well or better than children assigned to housing interventions in this municipality.,['Students in homeless families (N\xa0=\xa0172; M age  \xa0=\xa07.31; SD\xa0=\xa04.15'],"['housing interventions that focus on acute risks (community-based rapid rehousing), chronic risks (permanent subsidy), or usual care (UC']","['attendance, school mobility, and reading and math achievement']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0425241', 'cui_str': 'Homeless family (finding)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",,0.0387559,Children randomly assigned to UC perform as well or better than children assigned to housing interventions in this municipality.,"[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Cutuli', 'Affiliation': 'University of Minnesota, Twin Cities.'}, {'ForeName': 'Janette E', 'Initials': 'JE', 'LastName': 'Herbers', 'Affiliation': 'University of Minnesota, Twin Cities.'}]",Child development,['10.1111/cdev.13041']
1066,31433496,Transplantation in adults with relapsed/refractory acute lymphoblastic leukemia who are treated with blinatumomab from a phase 3 study.,"BACKGROUND


Blinatumomab, a bispecific T-cell-engaging (BiTE®) immuno-oncology therapy, demonstrated superior overall survival versus standard-of-care chemotherapy (SOC) in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL) in the phase 3 TOWER study. Herein, the authors reported clinical features and outcomes for those patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) after treatment with blinatumomab.
METHODS


In the TOWER study, adults with R/R ALL were randomized 2:1 to receive blinatumomab or SOC. Study treatment consisted of 2 cycles of induction with blinatumomab or SOC followed by consolidation and maintenance therapy. At any time after the first cycle, patients who were eligible for HSCT could proceed to HSCT.
RESULTS


Of the 97 patients who underwent HSCT during the study, baseline characteristics generally were comparable and donor types were similar between the patients treated with blinatumomab (65 patients) and those receiving SOC (32 patients). There was no evidence to suggest that the survival benefit of HSCT differed between the patients treated with blinatumomab and those receiving SOC (P = .68). On the basis of descriptive statistics, a survival benefit of HSCT versus no HSCT was not observed in patients who achieved complete remission with full, partial, or incomplete hematologic recovery with blinatumomab (odds ratio, 1.17; 95% CI, 0.54-2.53). The best outcomes were achieved in patients with no prior salvage therapy and with minimal residual disease response to blinatumomab regardless of on-study HSCT status.
CONCLUSIONS


Survival was found to be driven by response to study treatment and by salvage status regardless of on-study HSCT status. These data should be interpreted with caution because the current study was not designed to prospectively assess survival outcomes associated with HSCT after blinatumomab.
LAY SUMMARY


Evidence before this study: Blinatumomab is associated with superior morphologic and molecular response rates and superior overall outcome when compared with standard of care chemotherapy in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Added value of this study: The best outcomes with blinatumomab were observed in patients who achieved minimal residual disease remission in first salvage treatment regardless of subsequent allogeneic stem cell transplantation (HSCT). Implications of all the available evidence: Patients achieving CR/CRh/CRi following blinatumomab can have a durable response with or without HSCT.",2019,"The best outcomes were achieved in patients with no prior salvage therapy and with minimal residual disease response to blinatumomab regardless of on-study HSCT status.
","['97 patients who underwent HSCT during the study', 'patients who achieved minimal residual disease remission in first salvage treatment regardless of subsequent allogeneic stem cell transplantation (HSCT', 'adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia', 'adults with relapsed/refractory acute lymphoblastic leukemia who are treated with blinatumomab from a phase 3 study', 'adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL', 'adults with R/R ALL']","['blinatumomab or SOC followed by consolidation and maintenance therapy', 'standard-of-care chemotherapy (SOC', 'HSCT', 'care chemotherapy', 'blinatumomab or SOC', 'blinatumomab', 'allogeneic hematopoietic stem cell transplantation (HSCT']",['survival benefit of HSCT'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0085405', 'cui_str': 'Salvage Treatment'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3853839', 'cui_str': 'blinatumomab'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C3853839', 'cui_str': 'blinatumomab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}]",65.0,0.0856182,"The best outcomes were achieved in patients with no prior salvage therapy and with minimal residual disease response to blinatumomab regardless of on-study HSCT status.
","[{'ForeName': 'Elias J', 'Initials': 'EJ', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Department of Medicine, Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'Department of Hematology, Lyon-Sud Hospital, Pierre-Benite, France.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Department of Hematology and Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Department of Haematology, Wurzburg University, Wurzburg, Germany.'}, {'ForeName': 'Qui', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Franklin', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Forman', 'Affiliation': 'Gehr Family Center for Leukemia Research, City of Hope, Duarte, California.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Stein', 'Affiliation': 'Gehr Family Center for Leukemia Research, City of Hope, Duarte, California.'}]",Cancer,['10.1002/cncr.32335']
1067,31267576,Predonation fears identify young donors at risk for vasovagal reactions.,"BACKGROUND


Extending existing research on the relationship between predonation fear of having blood drawn and risk for vasovagal reactions among young donors, this study assessed the predictive power of specific donation-related fears.
STUDY DESIGN AND METHODS


After the health screening, high school whole blood donors (59.5% female) were randomly assigned into one of three groups. Group 1 (n = 881) answered a control question about their prior night's sleep. Group 2 (n = 911) answered the sleep question and a question about fear of having blood drawn. Group 3 (n = 924) answered the sleep question, the fear of having blood drawn question, and four questions about specific donation-related fears (seeing blood, needles, pain, and fainting).
RESULTS


The proportion of vasovagal reactions did not differ significantly among the groups, indicating that asking one or more fear questions before donation did not promote reactions. Fearful donors were more likely to have a vasovagal reaction, even after controlling for other important demographic and health predictors, with odds ratios ranging from 2.17 (95% confidence interval [CI], 1.44-3.27) for fear of fainting to 3.50 (95% CI, 2.34-5.23) for fear of seeing blood. Hours of sleep was not significantly related to vasovagal reaction risk.
CONCLUSION


Predonation fear identifies donors who are more likely to experience a vasovagal reaction and does so without increasing the risk of such reactions. Accordingly, fear should be assessed during screening to identify those who could benefit from instruction in anxiety management and who might require greater attention to help prevent donor injury.",2019,"The proportion of vasovagal reactions did not differ significantly among the groups, indicating that asking one or more fear questions before donation did not promote reactions.","['After the health screening, high school whole blood donors (59.5% female', 'young donors at risk for vasovagal reactions']","[""control question about their prior night's sleep""]","['sleep question, the fear of having blood drawn question, and four questions about specific donation-related fears (seeing blood, needles, pain, and fainting', 'proportion of vasovagal reactions', 'sleep question and a question about fear of having blood drawn', 'fear of fainting', 'vasovagal reaction risk', 'vasovagal reaction']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0375876', 'cui_str': 'Whole blood donor (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005768'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",924.0,0.0162926,"The proportion of vasovagal reactions did not differ significantly among the groups, indicating that asking one or more fear questions before donation did not promote reactions.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conatser', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Lux', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Erickson', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa.'}]",Transfusion,['10.1111/trf.15424']
1068,31209960,When words hurt: Verbal suggestion prevails over conditioning in inducing the motor nocebo effect.,"Perception and behavior are strongly influenced by the verbal information conveyed by other individuals (e.g., verbal suggestion) and by learning (e.g., conditioning). This influence is well represented by the placebo and nocebo effects, in which positive verbal suggestion associated with positive conditioning induces beneficial outcomes (placebo effect), while the opposite is true for the negative counterpart (nocebo effect). It is still unclear whether verbal suggestion and conditioning exert distinctive roles in influencing perception, behavior and motor system activity when they occur in opposite directions. To this purpose, fifty-three healthy volunteers were assigned to four groups characterized by either congruent or incongruent verbal suggestion and conditioning. Participants were asked to perform a force motor task by pressing a piston as strongly as possible. Transcranial magnetic stimulation over the primary motor cortex was used to record motor evoked potentials (MEP) and cortical silent period (CSP) from the muscle involved in the task. We found that negative verbal suggestion counteracted positive conditioning and induced sense of weakness, effort, and force decrements. MEP amplitude was stable, whereas the CSP duration shortened in all the groups throughout the procedure, indicating the involvement of cortical inhibitory circuits, independently of the type of verbal suggestion or conditioning. Our findings highlight a prevalent role of verbal suggestion over conditioning in determining a worsening (nocebo effect) but not an improvement (placebo effect) of motor performance. These results suggest that words associated with treatments should be chosen carefully to avoid negative outcomes, especially in sports and clinical settings.",2019,"MEP amplitude was stable, whereas the CSP duration shortened in all the groups throughout the procedure, indicating the involvement of cortical inhibitory circuits, independently of the type of verbal suggestion or conditioning.",['fifty-three healthy volunteers'],"['Transcranial magnetic stimulation', 'congruent or incongruent verbal suggestion and conditioning', 'placebo']","['CSP duration', 'motor evoked potentials (MEP) and cortical silent period (CSP', 'MEP amplitude']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}]",53.0,0.0360446,"MEP amplitude was stable, whereas the CSP duration shortened in all the groups throughout the procedure, indicating the involvement of cortical inhibitory circuits, independently of the type of verbal suggestion or conditioning.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Corsi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Emadi Andani', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Sometti', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tinazzi', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",The European journal of neuroscience,['10.1111/ejn.14489']
1069,31379118,Efficacy and safety of magnesium isoglycyrrhizinate injection in patients with acute drug-induced liver injury: A phase II trial.,"BACKGROUND


Drug-induced liver injury (DILI) is the most common reason for a drug to be withdrawn from the market. Apart from stopping the offending drug, no regimens are available for treating idiosyncratic DILI in clinical practice.
METHODS


We carried out a randomized, double-blind, multidoses, active drug controlled, multicentre phase II trial to assess the safety and efficacy of the study drug, magnesium isoglycyrrhizinate (MgIG), as compared to tiopronin, a standard therapy for DILI in China. The primary outcome was the proportion of alanine aminotransferase (ALT) normalization at week 4 after study drug administration. Logistic regression was used to examine the odds of ALT normalization between low dose (Group A) and high dose (Group B) vs active control (Group C).
RESULTS


One hundred and seventy-four eligible subjects were randomized and enrolled into three groups: 59 in group A, 56 in group B and 59 in group C. It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively. The results from the univariate logistic model showed that the odds of ALT normalized among subjects in Group A were about 3.6 times greater (OR = 3.55, 95% CI: 1.47-8.57, P = .0049) than subjects in Group C. Similar effect was observed among subjects in Group B (OR = 3.83, 95% CI: 1.54-9.55, P = .0039).
CONCLUSIONS


This trial provided preliminary evidence that MgIG is an effective and safe treatment for patients with acute DILI.",2019,"It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively.","['One hundred and seventy-four eligible subjects', 'patients with acute drug-induced liver injury', 'DILI in China', 'patients with acute DILI']","['magnesium isoglycyrrhizinate injection', 'magnesium isoglycyrrhizinate (MgIG', 'MgIG']","['proportion of alanine aminotransferase (ALT) normalization', 'ALT level', 'proportions of ALT normalization', 'Efficacy and safety', 'safety and efficacy']","[{'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860207', 'cui_str': 'Drug-Induced Liver Injury'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1958566', 'cui_str': 'magnesium isoglycyrrhizinate'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",174.0,0.243078,"It was shown that group A and group B lowered ALT level even at early stage of study drug administration; when compared with Group C (61.02%), the proportions of ALT normalization at week 4 were significantly greater in Group A (84.75%, P = .0029) and Group B (85.71%, P = .0037) respectively.","[{'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhenghua', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Mengqiu', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Division of Tuberculosis, Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Division of Tumor, Zhejiang Provincial Tumor Hospital, Hangzhou, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Liver Disease Center of Naval 905 Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Division of Tumor, Shanghai Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Zhongshun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Division of Tuberculosis, Nanjing Chest Hospital, Nanjing, China.'}, {'ForeName': 'Fujian', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Division of Tuberculosis, Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine, Hangzhou, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Unimed Scientific Inc., Wuxi, China.'}, {'ForeName': 'Hong-Mei', 'Initials': 'HM', 'LastName': 'Gu', 'Affiliation': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd, Nanjing, China.'}, {'ForeName': 'Yingxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jieting', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Minde', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14204']
1070,31294822,Muscle fibre activation is unaffected by load and repetition duration when resistance exercise is performed to task failure.,"KEY POINTS


Performing resistance exercise with heavier loads is often proposed to be necessary for the recruitment of larger motor units and activation of type II muscle fibres, leading to type II fibre hypertrophy. Indirect measures [surface electromyography (EMG)] have been used to support this thesis, although we propose that lighter loads lifted to task failure (i.e. volitional fatigue) result in the similar activation of type II fibres. In the present study, participants performed resistance exercise to task failure with heavier and lighter loads with both a normal and longer repetition duration (i.e. time under tension). Type I and type II muscle fibre glycogen depletion was determined by neither load, nor repetition duration during resistance exercise performed to task failure. Surface EMG amplitude was not related to muscle fibre glycogen depletion or anabolic signalling; however, muscle fibre glycogen depletion and anabolic signalling were related. Performing resistance exercise to task failure, regardless of load lifted or repetition duration, necessitates the activation of type II muscle fibres.
ABSTRACT


Heavier loads (>60% of maximal strength) are considered to be necessary during resistance exercise (RE) to activate and stimulate hypertrophy of type II fibres. Support for this proposition comes from observation of higher surface electromyography (EMG) amplitudes during RE when lifting heavier vs. lighter loads. We aimed to determine the effect of RE, to task failure, with heavier vs. lighter loads and shorter or longer repetition durations on: EMG-derived variables, muscle fibre activation, and anabolic signalling. Ten recreationally-trained young men performed four unilateral RE conditions randomly on two occasions (two conditions, one per leg per visit). Muscle biopsies were taken from the vastus lateralis before and one hour after RE. Broadly, total time under load, number of repetitions, exercise volume, EMG amplitude (at the beginning and end of each set) and total EMG activity were significantly different between conditions (P < 0.05); however, neither glycogen depletion (in both type I and type II fibres), nor phosphorylation of relevant signalling proteins showed any difference between conditions. We conclude that muscle fibre activation and subsequent anabolic signalling are independent of load, repetition duration and surface EMG amplitude when RE is performed to task failure. The results of the present study provide evidence indicating that type I and type II fibres are activated when heavier and lighter loads are lifted to task failure. We propose that our results explain why RE training with higher or lower loads, when loads are lifted to task failure, leads to equivalent muscle hypertrophy and occurs in both type I and type II fibres.",2019,"Surface EMG amplitude was not related to muscle fibre glycogen depletion or anabolic signalling; however, muscle fibre glycogen depletion and anabolic signalling were related.",['Ten recreationally-trained young men'],['Indirect measures [surface electromyography (EMG'],"['total EMG activity', 'total time under load, number of repetitions, exercise volume, EMG amplitude', 'glycogen depletion']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0333670', 'cui_str': 'Glycogen depletion (morphologic abnormality)'}]",,0.0241337,"Surface EMG amplitude was not related to muscle fibre glycogen depletion or anabolic signalling; however, muscle fibre glycogen depletion and anabolic signalling were related.","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Morton', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sonne', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farias Zuniga', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ibrahim Y Z', 'Initials': 'IYZ', 'LastName': 'Mohammad', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Keir', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim R', 'Initials': 'JR', 'LastName': 'Potvin', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}]",The Journal of physiology,['10.1113/JP278056']
1071,31910101,Effects of Supplemental Vitamin D on Muscle Performance and Quality of Life in Graves' Disease: A Randomized Clinical Trial.,"Background:  Vitamin D deficiency has been proposed to have a role in the development and course of Graves' disease (GD). Muscle weakness and quality of life (QoL) impairments are shared features of GD and vitamin D deficiency. We aimed at investigating whether vitamin D supplementation would improve restoration of muscle performance and thyroid-related QoL in GD and at describing the effect of anti-thyroid medication (ATD) on these outcomes.  Methods:  In a double-blinded clinical trial, hyperthyroid patients with a first-time diagnosis of GD were randomized to vitamin D 70 μg (2800 IU)/day or matching placebo as add-on to standard ATD. At baseline and after 3 and 9 months of intervention, we assessed isometric muscle strength, muscle function tests, postural stability, body composition, and QoL-impairment by using the ThyPRO questionnaire. Linear mixed modeling was used to analyze between-group differences. (The DAGMAR study clinicaltrials.gov ID NCT02384668).  Results:  Nine months of vitamin D supplementation caused an attenuation of muscle strength increment in all muscle measures investigated, significant at knee extension 60° where the increase was 24% lower ( p  = 0.04) in the vitamin D group compared with placebo. Compared with placebo, vitamin D supplementation tended to reduce gain of lean body mass (-24%,  p  = 0.08). Vitamin D supplementation significantly impeded alleviation of Composite QoL and the same trend was observed for the Overall QoL-Impact and Impaired Daily Life scales. In response to ATD, all measures improved significantly. The increase in muscle strength ranged from 25% to 40% ( p all  < 0.001), and increment of lean body mass was 10% ( p  < 0.001). Large changes were observed in all QoL scales.  Conclusions:  Nine months of vitamin D supplementation caused unfavorable effects on restoration of muscle performance. In contrast, ATD treatment was associated with marked improvement in all measures of muscle performance and thyroid-related QoL. In patients with newly diagnosed GD, high-dose vitamin D supplementation should not be recommended to improve muscle function, but ATD is of major importance to alleviate muscle impairment.",2020,"Nine months of vitamin D supplementation caused an attenuation of muscle strength increment in all muscle groups investigated, significant at knee extension 60° where the increase was 24% smaller (p=0.04) in the vitamin D group compared with placebo.","['hyperthyroid patients with a first time diagnosis of GD', ""Graves' disease""]","['anti-thyroid medication (ATD', 'placebo, vitamin D supplementation', 'vitamin D 70 mcg (2800 IU)/day or matching placebo', 'Vitamin D supplementation', 'vitamin D supplementation', 'supplemental vitamin D', 'placebo', ' Vitamin D deficiency', 'vitamin D']","['lean body mass', 'Muscle weakness and quality of life (QoL) impairments', 'gain of lean body mass', 'alleviation of Composite QoL', 'Overall QoL-Impact and Impaired Daily Life scales', 'muscle performance and thyroid-related QoL', 'muscle strength', 'attenuation of muscle strength increment', 'muscle performance and quality of life', 'restoration of muscle performance', 'restoration of muscle performance and thyroid-related QoL in GD', 'isometric muscle strength, muscle function tests, postural stability, body composition, and QoL-impairment using ThyPRO']","[{'cui': 'C0020550', 'cui_str': 'Hyperthyroid'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0018213', 'cui_str': 'Graves Disease'}]","[{'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C4517680', 'cui_str': 'Two thousand eight hundred'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}, {'cui': 'C0034380'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0222045'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.389076,"Nine months of vitamin D supplementation caused an attenuation of muscle strength increment in all muscle groups investigated, significant at knee extension 60° where the increase was 24% smaller (p=0.04) in the vitamin D group compared with placebo.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Grove-Laugesen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Per Karkov', 'Initials': 'PK', 'LastName': 'Cramon', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Malmstroem', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ebbehoj', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Department of Internal Medicine, Gentofte and Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Klavs Würgler', 'Initials': 'KW', 'LastName': 'Hansen', 'Affiliation': 'Medical Department, Regional Hospital Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rejnmark', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0634']
1072,31544330,Cost-effectiveness analysis of cabozantinib as second-line therapy in advanced hepatocellular carcinoma.,"BACKGROUND


In the CELESTIAL trial for patients with advanced hepatocellular carcinoma (HCC), cabozantinib showed improved survival compared with placebo but comes at a price. We aimed to investigate the cost-effectiveness of cabozantinib for sorafenib-resistant HCC from the payer's perspective of the USA, UK and China.
METHODS


We developed Markov models to simulate the patients pre-treated with first-line sorafenib following the CELESTIAL trial. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated for the treatment with cabozantinib or best supportive care. The list price for drugs was acquired from the Red Book, the British National Formulary, West China hospital and reported literature. Adverse events, utilities weights, and transition likelihood between states were sourced from the published randomized phase III trial. A willing-to-pay threshold was set $150 000/QALY in the USA, $70 671/QALY (£50 000/QALY) in the UK and $26 481/QALY (3x GDP per capita) in China. Deterministic and probabilistic sensitivity analyses were developed to test the models' uncertainty.
RESULTS


In the base case, treatment with cabozantinib increased effectiveness by 0.13 QALYs, resulting in an ICER vs best supportive care of $833 497/QALY in the USA, $304 177/QALY in the UK and $156 437/QALY in China. The models were most sensitive to assumptions about transitions to progression with both cabozantinib and best supportive care, the utility associated with being progression free. These results were robust across a range of scenarios and sensitivity analyses, including deterministic and probabilistic analyses.
CONCLUSIONS


Cabozantinib at its current cost would not be a cost-effective treatment option for patients with sorafenib-resistant HCC from the payer's perspective in the USA, UK or China. Substantial discounts are necessary to meet conventional cost-effectiveness thresholds.",2019,"In the base case, treatment with cabozantinib increased effectiveness by 0.13 QALYs, resulting in an ICER vs best supportive care of $833 497/QALY in the USA, $304 177/QALY in the UK and $156 437/QALY in China.","['advanced hepatocellular carcinoma', 'patients with advanced hepatocellular carcinoma (HCC', ""patients with sorafenib-resistant HCC from the payer's perspective in the USA, UK or China""]","['placebo', 'cabozantinib as second-line therapy', 'cabozantinib for sorafenib-resistant HCC']","['Adverse events, utilities weights, and transition likelihood', 'Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER', 'survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0534339,"In the base case, treatment with cabozantinib increased effectiveness by 0.13 QALYs, resulting in an ICER vs best supportive care of $833 497/QALY in the USA, $304 177/QALY in the UK and $156 437/QALY in China.","[{'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hutton', 'Affiliation': 'Department of Health Management and Policy, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Guiqi', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiuji', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14257']
1073,31247117,"A Clinical Drug-Drug Interaction Study Assessing a Novel Drug Transporter Phenotyping Cocktail With Adefovir, Sitagliptin, Metformin, Pitavastatin, and Digoxin.","A new probe drug cocktail containing substrates of important drug transporters was tested for mutual interactions in a clinical trial. The cocktail consisted of (predominant transporter; primary phenotyping metric): 10 mg adefovir-dipivoxil (OAT1; renal clearance (CL R  )), 100 mg sitagliptin (OAT3; CL R  ), 500 mg metformin (several renal transporters; CL R  ), 2 mg pitavastatin (OATP1B1; clearance/F), and 0.5 mg digoxin (intestinal P-gp, renal P-gp, and OATP4C1; peak plasma concentration (C max  ) and CL R  ). Using a randomized six-period, open change-over design, single oral doses were administrated either concomitantly or separately to 24 healthy male and female volunteers. Phenotyping metrics were evaluated by noncompartmental analysis and compared between periods by the standard average bioequivalence approach (boundaries for ratios 0.80-1.25). Primary metrics supported the absence of relevant interactions, whereas secondary metrics suggested that mainly adefovir was a victim of minor drug-drug interactions (DDIs). All drugs were well tolerated. This cocktail may be another useful tool to assess transporter-based DDIs in vivo.",2019,All drugs were well tolerated.,['24 healthy male and female volunteers'],"['adefovir-dipivoxil (OAT1; renal clearance [CL R  ]), 100 mg sitagliptin (OAT3; CL R  ), 500 mg metformin (several renal transporters; CL R  ), 2 mg pitavastatin (OATP1B1; clearance/F) and 0.5 mg digoxin (intestinal P-gp, renal P-gp and OATP4C1; C max  and CL R  ', 'Adefovir, Sitagliptin, Metformin, Pitavastatin and Digoxin']",['tolerated'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0050175', 'cui_str': 'adefovir'}]",[],24.0,0.04956,All drugs were well tolerated.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Trueck', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Chih-Hsuan', 'Initials': 'CH', 'LastName': 'Hsin', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Scherf-Clavel', 'Affiliation': 'Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Schaeffeler', 'Affiliation': 'Dr. Margarete-Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Lenssen', 'Affiliation': 'Hospital Pharmacy, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Gazzaz', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Gersie', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Taubert', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Quasdorff', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kinzig', 'Affiliation': 'Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Sörgel', 'Affiliation': 'Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Stoffel', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Fuhr', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, Department I of Pharmacology, Cologne, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1564']
1074,31198990,An automated motivational interview promotes donation intention and self-efficacy among experienced whole blood donors.,"BACKGROUND


Interventions intended to motivate donors to return can be costly and time consuming. The current study examined the effect of a Web-based automated interview, informed by motivational interviewing and self-determination theory, on donor intention, motivation, and behavior in a sample of highly experienced donors.
STUDY DESIGN AND METHODS


Approximately 1 week after donating, 1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female) participated in a study in which they were randomly assigned to either a donor motivational interview (n = 544) or knowledge interview (n = 633). Measures of donor motivation and psychological need support were obtained before the interviews, and again at postinterview assessments conducted approximately 2 days later and 7 weeks later. Blood center records were used to assess repeat donation attempts for 1 year after the interviews.
RESULTS


Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up. Among women only, the motivational interview was associated with greater competence and relatedness increases at both follow-up assessments.
CONCLUSION


An automated motivational interview appears to be a feasible way to promote donation intention and self-efficacy. Although the observed effects were small among highly experienced donors, we are currently assessing the potential effect of this intervention among less experienced donors.",2019,"Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up.","['1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female']",['donor motivational interview (n = 544) or knowledge interview'],['donation intention and self-efficacy'],"[{'cui': 'C0375876', 'cui_str': 'Whole blood donor (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0142229,"Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up.","[{'ForeName': 'Irina E', 'Initials': 'IE', 'LastName': 'Livitz', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Fox', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Ankawi', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'P Maxwell', 'Initials': 'PM', 'LastName': 'Slepian', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Kessler', 'Affiliation': 'New York Blood Center, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rebosa', 'Affiliation': 'New York Blood Center, New York, New York.'}, {'ForeName': 'Beth H', 'Initials': 'BH', 'LastName': 'Shaz', 'Affiliation': 'New York Blood Center, New York, New York.'}]",Transfusion,['10.1111/trf.15402']
1075,31631501,Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years.,"The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroids. After completing SIMCER at 6 months after transplant, 65 EVR-treated patients and 78 TAC-treated patients entered CERTITUDE. At month 24 after transplant, 34/65 (52.3%) EVR-treated patients remained calcineurin inhibitor (CNI) free. Mean estimated glomerular filtration rate (eGFR) was significantly higher with EVR versus TAC during months 3-12. At month 24, eGFR values were 83.6 versus 75.3 mL/minute/1.73 m 2  , respectively (P = 0.90) and adjusted mean change in eGFR from randomization was -8.0 versus -13.5 mL/minute/1.73 m 2  (P = 0.15). At month 24, 45.9%, 31.1%, and 23.0% of EVR-treated patients had chronic kidney disease stages 1, 2, and 3, respectively, versus 25.7%, 45.7%, and 28.6% of TAC-treated patients (P = 0.05). Treated biopsy-proven acute rejection affected 4 EVR-treated patients and 2 TAC patients during months 6-24. Adverse events led to study discontinuation in 15.4% and 7.7% of EVR-treated and TAC-treated patients, respectively. Grade 3 or 4 hematological events were rare in both groups. A CNI-free EVR-based maintenance regimen appears feasible in approximately half of liver transplant patients. It preserves renal function effectively with good efficacy without compromising safety or hematological tolerance.",2019,"Mean estimated GFR was significantly higher with everolimus versus tacrolimus during months 3-12; at month 24, values were 83.6 versus 75.3mL/min/1.73m 2  , respectively (p=0.089) and adjusted mean change in estimated GFR from randomization was -8.0 versus -13.5 mL/min/1.73m 2  (p=0.15).","['after liver transplantation', 'liver transplant patients who completed the SIMCER trial', 'liver transplant patients']","['CNI-free everolimus-based maintenance regimen', 'tacrolimus', 'tacrolimus to everolimus', 'everolimus versus tacrolimus', 'everolimus with stepwise tacrolimus withdrawal or to standard tacrolimus, both with basiliximab induction, mycophenolic acid ± steroids']","['safety or hematological tolerance', 'Mean estimated GFR', 'Grade 3 or 4 hematological events']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",65.0,0.0229432,"Mean estimated GFR was significantly higher with everolimus versus tacrolimus during months 3-12; at month 24, values were 83.6 versus 75.3mL/min/1.73m 2  , respectively (p=0.089) and adjusted mean change in estimated GFR from randomization was -8.0 versus -13.5 mL/min/1.73m 2  (p=0.15).","[{'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Saliba', 'Affiliation': 'Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': 'Hôpital Henri Mondor, AP-HP, Créteil, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Dharancy', 'Affiliation': 'CHRU de Lille, Lille, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dumortier', 'Affiliation': 'Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Yvon', 'Initials': 'Y', 'LastName': 'Calmus', 'Affiliation': 'Hôpital Pitié Salpêtrière, AP-HP, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': ""Hôpital l'Archet 2, Nice, France.""}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Hôpital Rangueil, Toulouse, France.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Salamé', 'Affiliation': 'Hôpital Trousseau, Chambray les Tours, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Neau-Cransac', 'Affiliation': 'Hôpital Haut Levèque, Bordeaux, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vanlemmens', 'Affiliation': 'Hôpital Jean Minjoz, Besançon, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Durand', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Pageaux', 'Affiliation': 'Hôpital Saint Eloi, Montpellier, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Leroy', 'Affiliation': 'Hôpital Albert Michallon, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hardwigsen', 'Affiliation': 'Hôpital la Timone, Marseille, France.'}, {'ForeName': 'Hakam', 'Initials': 'H', 'LastName': 'Gharbi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Masson', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Tindel', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'Hôpital Pitié Salpêtrière, AP-HP, Paris, France.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25664']
1076,31647139,Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial.,"BACKGROUND


The present study investigated the effects of fat-protein (CFP) counting in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.
METHODS


In this single centre, cross-over, randomised, controlled study, control meal (SM: standard meal using a carbohydrate counting method) and three test meals (HPM: high protein meal using a carbohydrate counting method; HPFM-a: high protein-fat meal using a carbohydrate counting method; HPFM-b: high protein-fat meal using a carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 min), late (120-240 min) and total (0-240 min) glucose response in 30 patients with T1D, aged 16-18 years.
RESULTS


The glucose levels of 0-90 min did not change after different meal consumptions (P > 0.05), whereas 120-240 min glucose levels were higher after HPFM-a consumption compared to HPFM-b consumption (P < 0.05). There were no significant differences between meals with respect to the early postprandial glucose response (0-120 min) (P = 0.405). In late response (120-240 min), HPFM-b [area under the curve (AUC) = 20 609 (582) mg dL -1   × dk] was significantly lower than SM [AUC = 24 092 (9015) mg dL -1   × dk], HPM [AUC = 24 072 (5853) mg dL -1   × dk] and HPFM-a [AUC = 25 986 (6979) mg dL -1   × dk] (P = 0.032).
CONCLUSIONS


Meal-related insulin dosing based on carbohydrate plus fat/protein counting has given positive results in the postprandial glycaemic profile as a result of lower postprandial glycaemic levels compared to conventional carbohydrate counting in patients with T1D after a high protein-fat meal.",2020,There were no significant differences between meals with respect to the early postprandial glucose response (0-120 min),"['patients with type 1 diabetes (T1D) on basal-bolus insulin therapy', '609 (582', '6979', '20', '30 patients with T1D, aged 16-18\xa0years', '24', '24\xa0072\xa0(5853', '986', 'adolescents with type 1 diabetes', '092']","['fat-protein (CFP', 'HPFM-a [AUC\xa0=\xa025', 'control meal (SM: standard meal using a carbohydrate counting method) and three test meals (HPM: high protein meal using a carbohydrate counting method; HPFM-a: high protein-fat meal using a carbohydrate counting method; HPFM-b: high protein-fat meal using a carbohydrate and fat-protein counting method', 'mg dL -1']","['postprandial glycaemic levels', 'glucose levels', 'HPFM-b [area under the curve (AUC)\xa0', 'early postprandial glucose response', 'blood glucose profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0444664', 'cui_str': 'Standard meal (finding)'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0208392,There were no significant differences between meals with respect to the early postprandial glucose response (0-120 min),"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kaya', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Science, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kurtoğlu', 'Affiliation': 'Department of Paediatric Endocrinology and Neonatology, Memorial Private Hospital, Kayseri, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gökmen Özel', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Health Science, Hacettepe University, Ankara, Turkey.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12711']
1077,31702486,Evaluation of Pharmacokinetic Interaction of Cilostazol with Metoclopramide after Oral Administration in Human.,"BACKGROUND


Metoclopramide is mainly metabolized by CYP2D6, CYP3A4, CYP2C19, and CYP1A2 enzymes, while cilostazol is also metabolized by CYP3A4, CYP2C19, and CYP1A2 enzymes.
AIM


This study evaluates the effect of cilostazol on the pharmacokinetics of oral metoclopramide.
METHODS


This was a randomized, two-phase cross-over pharmacokinetic study separated by a 4-week wash-out time period, 12 healthy non-smoking volunteers received metoclopramide 20 mg as a single oral dose and after 4 weeks, cilostazol 100 mg twice daily for 4 days then with metoclopramide 20 mg on test day. Serial blood samples were analyzed by using a validated high-performance liquid chromatography-ultraviolet method to determine maximum plasma drug concentration (Cmax), time to reach (Tmax), and area under the curve (AUC0-∞) of metoclopramide.
RESULTS


Cilostazol increased the mean Cmax, AUC0-∞ and half-life (T1/2) of metoclopramide by 6%, 27% and by 0.79 %, respectively. In addition, Tmax of metoclopramide was delayed by cilostazol.
CONCLUSION


The results showed delayed Tmax of metoclopramide by cilostazol, which could lead to the conclusion that cilostazol affects the absorption of metoclopramide. Both drugs when necessary to administer together must not be administered at the same time especially when given in gastroparesis patients.",2019,"RESULTS


Cilostazol increased the mean Cmax, AUC0-∞ and half-life (T1/2) of metoclopramide by 6%, 27% and by 0.79 %, respectively.","['12 healthy non-smoking volunteers', 'Human', 'gastroparesis patients']","['metoclopramide', 'cilostazol', 'Metoclopramide', 'Cilostazol with Metoclopramide']","['maximum plasma drug concentration (Cmax), time to reach (Tmax), and area under the curve (AUC0-∞) of metoclopramide', 'mean Cmax, AUC0-∞ and half-life', 'delayed Tmax']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0152020', 'cui_str': 'Gastric Stasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",12.0,0.0379914,"RESULTS


Cilostazol increased the mean Cmax, AUC0-∞ and half-life (T1/2) of metoclopramide by 6%, 27% and by 0.79 %, respectively.","[{'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Kaukab', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan.'}, {'ForeName': 'Syed Nisar', 'Initials': 'SN', 'LastName': 'Hussain Shah', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan.'}, {'ForeName': 'Zelal', 'Initials': 'Z', 'LastName': 'Kharaba', 'Affiliation': 'Department of Clinical Pharmacy, Al-Ain University, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Murtaza', 'Affiliation': 'Department of Pharmacy, COMSATS University Islamabad, Lahore Campus, Lahore 54000, Pakistan.'}, {'ForeName': 'Abubaker Ali', 'Initials': 'AA', 'LastName': 'Saad', 'Affiliation': 'Department of Cardiology, Chaudhary Pervaiz Elahi Institute of Cardiology, Multan, Pakistan.'}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Department of Statistics, Bahauddin Zakariya University, Multan, Pakistan.'}]",Current drug metabolism,['10.2174/1389200220666191105115805']
1078,31278996,Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up.,"OBJECTIVE


To report on the 32-week outcome of the Brief Behavioral Therapy (BBT) for Pediatric Anxiety and Depression in Primary Care clinical trial.
METHOD


A total of 185 youths aged 8 to 17 years with anxiety and/or depression identified through 9 pediatric primary care (PPC) settings in San Diego and Pittsburgh were randomized to receive Assisted Referral to Care (ARC) or up to 12 sessions of BBT over 16 weeks. The primary outcome was clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score of ≤2. Secondary outcomes included interview-rated functioning, depression, and anxiety. Here, we report on outcomes at 32 weeks after randomization. All analyses with primary outcomes are corrected for multiple comparisons using the false discovery rate procedure.
RESULTS


At 32 weeks, BBT was superior to ARC with respect to response (67.5% versus 43.1%, q = 0.03, number needed to treat [NNT] = 5) and functioning (d = 0.49, q = 0.04). BBT was superior to ARC with respect to its impact on anxiety (f = 0.21) but not depressive symptoms (f = 0.05). These findings persisted after controlling for the number of sessions received. Ethnicity moderated the impact of BBT on outcome (NNT for Hispanic youths = 2), because of a much lower response rate to ARC in Hispanic than in non-Hispanic youths (16.7% versus 49.2%, p = 0.04).
CONCLUSION


BBT is a promising intervention that can be effectively delivered in PPC and may be particularly effective for Hispanic patients. Further work is indicated to improve its impact on depressive symptoms and to test BBT against other treatments delivered in pediatric primary care.
CLINICAL TRIAL REGISTRATION INFORMATION


Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care; http://clinicaltrials.gov; NCT01147614.",2019,BBT was superior to ARC with respect to its impact on anxiety (f=0.21) but not depressive symptoms (f=0.05).,"['PPC) settings in San Diego and Pittsburgh', 'Hispanic patients', 'Pediatric Anxiety and Depression in Primary Care', '185 youth aged 8-17 with anxiety and/or depression identified through 9 pediatric primary care']","['Brief Behavioral Therapy (BBT', 'Brief Behavioral Therapy', 'Assisted Referral to Care (ARC', 'BBT']","['interview-rated functioning, depression, and anxiety', 'False Discovery Rate technique', 'clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score ≤ 2', 'anxiety']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",185.0,0.0469208,BBT was superior to ARC with respect to its impact on anxiety (f=0.21) but not depressive symptoms (f=0.05).,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Brent', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA; University of Pittsburgh School of Medicine, PA. Electronic address: brentda@upmc.edu.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Porta', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, CO.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'California State University, Long Beach, CA.'}, {'ForeName': 'Karen T G', 'Initials': 'KTG', 'LastName': 'Schwartz', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA.'}, {'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Lynch', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Iyengar', 'Affiliation': 'University of Pittsburgh, PA.'}, {'ForeName': 'V Robin', 'Initials': 'VR', 'LastName': 'Weersing', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.06.009']
1079,31899602,Ubrogepant Is Not Associated With Clinically Meaningful Elevations of Alanine Aminotransferase in Healthy Adult Males.,"Ubrogepant is a novel, oral calcitonin gene-related peptide (CGRP) receptor antagonist intended for the acute treatment of migraine attacks. Ubrogepant has a chemical structure distinct from previous small-molecule CGRP receptor antagonists that were associated with elevated serum alanine aminotransferase (ALT) in clinical trials. Here, we report overall and hepatic safety data from two placebo-controlled phase I trials of ubrogepant, spray-dried oral compressed tablet (SD-OCT) in healthy male volunteers. Trial A was a pharmacokinetic (PK) trial of single (100-400 mg) and multiple (40-400 mg) ascending doses. Trial B was a dedicated hepatic safety trial assessing daily use of ubrogepant 150 mg for 28 days. Serum ALT (as hepatotoxicity biomarker) and PK data are reported. Ubrogepant was well-tolerated in both trials, with a low incidence of adverse events that did not differ greatly from placebo. Changes in mean ALT levels were minimal and similar to placebo. Over 28 days of treatment, the mean percentage change in ALT from baseline was < 5% at all time points. No participant in either trial demonstrated ALT ≥ 3× upper limit of normal at any time. Ubrogepant SD-OCT demonstrated linear PK appropriate for acute treatment of migraine, with rapid uptake (time of maximum plasma concentration (t max  ): 2-3 hours) and no accumulation with daily use. Overall, there was no evidence of ubrogepant-associated hepatotoxicity with daily doses up to 400 mg for 10 days or with daily ubrogepant 150 mg for 28 days. Supratherapeutic dosing is a useful strategy for characterizing hepatic safety in early drug development.",2020,No participant in either trial demonstrated ALT ≥ ,"['Healthy Adult Males', 'healthy male volunteers']","['placebo', 'ubrogepant, spray-dried oral compressed tablet (SD-OCT', 'Supratherapeutic']","['adverse events', 'mean ALT levels', 'Serum ALT']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.337401,No participant in either trial demonstrated ALT ≥ ,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ankrom', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Phung', 'Initials': 'P', 'LastName': 'Bondiskey', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Chi-Chung', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Palcza', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marissa F', 'Initials': 'MF', 'LastName': 'Dockendorf', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Matthews', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Panebianco', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Reynders', 'Affiliation': 'MSD, Brussels, Belgium.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, New Jersey, USA.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Mesens', 'Affiliation': 'SGS Life Science Services, Antwerp, Belgium.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kraft', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Marcantonio', 'Affiliation': 'Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.12728']
1080,31124826,"Compatibility of Nonoriginal Abutments With Implants: Evaluation of Microgap at the Implant-Abutment Interface, With Original and Nonoriginal Abutments.","PURPOSE


The purpose of this study was to evaluate the fit of nonoriginal abutments to implants at the implant abutment junction.
MATERIALS AND METHODS


Twenty titanium implants from a single manufacturer were randomly divided into 2 groups of ten each. Ten titanium premachined original abutments (group I) and ten titanium premachined nonoriginal abutments (from different manufacturer-group II) were connected to the implants with the recommended manufacturer torque level and then embedded into autopolymerizing clear acrylic resin blocks. After overnight curing, these blocks were vertically sectioned using water jet sectioning machine and evaluated under scanning electron microscope following the sequential cleaning procedures. The microgap at the implant-abutment interface for all the samples was measured using pixel counting software and subjected to statistical analysis using nonparametric Mann-Whitney U test.
RESULTS


The mean microgap at the implant-abutment interface at the external, middle, and internal points was 1.597, 1.399, and 1.831 µm, respectively, for group I and 2.395, 2.488, and 3.339 µm, respectively, for group II samples. Nonparametric Mann-Whitney U test showed statistically significant difference between 2 groups at the midpoint for the nonoriginal abutments compared with the original ones.
CONCLUSION


Within the limitations of the study, the mean microgap at the implant-abutment interface at the platform level at the external, middle, and internal points for both original abutments and nonoriginal abutments was found to be within clinically acceptable limits.",2019,"Nonparametric Mann-Whitney U test showed statistically significant difference between 2 groups at the midpoint for the nonoriginal abutments compared with the original ones.
",['Twenty titanium implants from a single manufacturer'],['titanium premachined nonoriginal abutments'],[],"[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}]",[],,0.0215137,"Nonparametric Mann-Whitney U test showed statistically significant difference between 2 groups at the midpoint for the nonoriginal abutments compared with the original ones.
","[{'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Duraisamy', 'Affiliation': 'Senior Lecturer, Department of Prosthodontics, Saveetha Dental College and Hospital, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, India.'}, {'ForeName': 'Chitra Shankar', 'Initials': 'CS', 'LastName': 'Krishnan', 'Affiliation': 'Professor, Department of Prosthodontics, Ragas Dental College and Hospital, Chennai, India.'}, {'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Ramasubramanian', 'Affiliation': 'Reader, Department of Prosthodontics, Ragas Dental College and Hospital, Chennai, India.'}, {'ForeName': 'Jayakrishnakumar', 'Initials': 'J', 'LastName': 'Sampathkumar', 'Affiliation': 'Professor, Department of Prosthodontics, Ragas Dental College and Hospital, Chennai, India.'}, {'ForeName': 'Saravanakumar', 'Initials': 'S', 'LastName': 'Mariappan', 'Affiliation': 'Professor, Department of Prosthodontics, Ragas Dental College and Hospital, Chennai, India.'}, {'ForeName': 'Azhagarasan', 'Initials': 'A', 'LastName': 'Navarasampatti Sivaprakasam', 'Affiliation': 'Professor and Head, Department of Prosthodontics, Ragas Dental College and Hospital, Chennai, India.'}]",Implant dentistry,['10.1097/ID.0000000000000885']
1081,31525829,The efficacy of intermittent pneumatic compression as a substitute for manual lymphatic drainage in complete decongestive therapy in the treatment of breast cancer related lymphedema.,"The aim of this study is to evaluate the efficacy of intermittent pneumatic compression (IPC) as a substitute for manual lymphatic drainage (MLD) in complete decongestive therapy (CDT) for treatment of advanced stages of breast cancer-related lymphedema. In this randomized, single-blind, controlled study, 46 patients with breast cancer-related lymphedema were divided into 2 groups. Both MLD with compression bandage (CB) group (n=24) and IPC with CB group (n=22) received treatment 3 days a week for 5 weeks. Home exercise program was also given to all patients. At the end of the 5th week, patients were treated with a daily 23-hour compression garment and home exercise routines. Assessments were taken at baseline, the fifth week, and the third month. Arm circumference was measured at 5 different areas, shoulder range of motion (ROM) was evaluated with a goniometer, pain, and tightness, and heaviness sensations were assessed with visual analog scale. Both groups had similar demographic and clinical characteristics (p<0.05). There were no significant differences between groups and both groups showed significant improvement (p<0.05) in the five measurement levels of the arm circumference at the fifth week and third month. Similarly, shoulder ROM, pain, tightness, and heaviness sensations improved in both groups (p<0.05). Both MLD and IPC as a component of CDT were found successful at 5 weeks and 3 months without superiority to each other.",2019,There were no significant differences between groups and both groups showed significant improvement (p<0.05) in the five measurement levels of the arm circumference at the fifth week and third month.,"['breast cancer related lymphedema', '46 patients with breast cancer-related lymphedema', 'advanced stages of breast cancer-related lymphedema']","['intermittent pneumatic compression (IPC', 'intermittent pneumatic compression', 'Home exercise program', 'MLD with compression bandage (CB', 'decongestive therapy (CDT', 'daily 23-hour compression garment and home exercise routines']","['goniometer, pain, and tightness, and heaviness sensations', 'shoulder ROM, pain, tightness, and heaviness sensations']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic Leukoencephalopathy'}, {'cui': 'C0677875', 'cui_str': 'Compression Wraps'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0581912', 'cui_str': 'Heaviness sensation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",46.0,0.0196682,There were no significant differences between groups and both groups showed significant improvement (p<0.05) in the five measurement levels of the arm circumference at the fifth week and third month.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanal-Toprak', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ozsoy-Unubol', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bahar-Ozdemir', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Akyuz', 'Affiliation': 'Marmara Üniversitesi Eğitim Arastirma Hastanesi Fiziksel Tip ve Rehabilitasyon Anabilim Dali, Pendik/Istanbul, Turkey.'}]",Lymphology,[]
1082,31829138,Induction of labor compared to expectant management in term nulliparas with a latent phase of labor of more than 8 hours: a randomized trial.,"BACKGROUND


Prolonged latent phase of labor is associated with adverse maternal and neonatal outcomes. Preliminary data indicate that labor induction for prolonged latent phase may reduce cesarean delivery. We performed a study powered to Cesarean delivery to evaluate labor induction compared to expectant management in full term nulliparas hospitalized for persistent contractions but non-progressive to established labor after an overnight stay.
METHODS


From 2015 and 2017, nulliparas, ≥ 39 weeks' gestation with prolonged latent phase of labor (persistent contractions after overnight hospitalization > 8 h), cervical dilation ≤3 cm, intact membranes and reassuring cardiotocogram were recruited. Participants were randomized to immediate induction of labor (with vaginal dinoprostone or amniotomy or oxytocin as appropriate) or expectant management (await labor for at least 24 h unless indicated intervention as directed by care provider). Primary outcome measure was Cesarean delivery.
RESULTS


Three hundred eighteen women were randomized (159 to each arm). Data from 308 participants were analyzed. Cesarean delivery rate was 24.2% (36/149) vs. 23.3%, (37/159) RR 1.0 95% CI 0.7-1.6; P = 0.96 in induction of labor vs. expectant arms. Interval from intervention to delivery was 17.1 ± 9.9 vs. 40.1 ± 19.8 h; P < 0.001, intervention to active labor 9.6 ± 10.2 vs. 29.6 ± 18.5 h; P < 0.001, active labor to delivery 7.6 ± 3.6 vs. 10.5 ± 7.2 h; P < 0.001, intervention to hospital discharge 2.4 ± 1.2 vs. 2.9 ± 1.4 days; P < 0.001 and dinoprostone use was 19.5% (29/149) vs. 8.2% (13/159) RR 2.4 95% CI 1.3-4.4; P = 0.01 in IOL compared with expectant arms respectively. Intrapartum oxytocin use, epidural analgesia and uterine hyperstimulation syndrome, postpartum hemorrhage, patient satisfaction on allocated intervention, during labor and delivery and baby outcome were not significantly different across trial arms.
CONCLUSIONS


Induction of labor did not reduce Cesarean delivery rates but intervention to delivery and to hospital discharge durations are shorter. Patient satisfaction scores were similar. Induction of labor for prolonged latent phase of labor can be performed without apparent detriment to expedite delivery.
TRIAL REGISTRATION


Registered in Malaysia National Medical Research Register (NMRR-15-16-23,886) on 6 January 2015 and the International Standard Randomised Controlled Trials Number registry, registration number ISRCTN14099170 on 5 Nov 2015.",2019,RR 1.0 95% CI 0.7-1.6; P = 0.96 in induction of labor vs. expectant arms.,"['cervical dilation ≤3\u2009cm, intact membranes and reassuring cardiotocogram were recruited', 'full term nulliparas hospitalized for persistent contractions but non-progressive to established labor after an overnight stay', ""From 2015 and 2017, nulliparas, ≥ 39\u2009weeks' gestation with prolonged latent phase of labor (persistent contractions after overnight hospitalization"", 'term nulliparas with a latent phase of labor of more than 8\u2009hours', '308 participants were analyzed', 'Three hundred eighteen women']","['dinoprostone', 'labor (with vaginal dinoprostone or amniotomy or oxytocin as appropriate) or expectant management (await labor for at least 24\u2009h unless indicated intervention as directed by care provider']","['cesarean delivery', 'Intrapartum oxytocin use, epidural analgesia and uterine hyperstimulation syndrome, postpartum hemorrhage, patient satisfaction', 'Patient satisfaction scores', 'Cesarean delivery rate', 'Cesarean delivery', 'Cesarean delivery rates']","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes (finding)'}, {'cui': 'C0557055', 'cui_str': 'Reassuring (procedure)'}, {'cui': 'C0007207', 'cui_str': 'Cardiotocogram'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1384591', 'cui_str': 'Amniotomy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction (disorder)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}]",318.0,0.284043,RR 1.0 95% CI 0.7-1.6; P = 0.96 in induction of labor vs. expectant arms.,"[{'ForeName': 'Patrick Naveen', 'Initials': 'PN', 'LastName': 'Sargunam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lindy Li Mei', 'Initials': 'LLM', 'LastName': 'Bak', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peng Chiong', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia. pctan@um.edu.my.'}, {'ForeName': 'Narayanan', 'Initials': 'N', 'LastName': 'Vallikkannu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mat Adenan', 'Initials': 'MA', 'LastName': 'Noor Azmi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Syeda Nureena', 'Initials': 'SN', 'LastName': 'Zaidi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sandar Tin', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Zawiah', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2602-2']
1083,31840400,"Development of parallel measures to assess HIV stigma and discrimination among people living with HIV, community members and health workers in the HPTN 071 (PopART) trial in Zambia and South Africa.","INTRODUCTION


Integrating standardized measures of HIV stigma and discrimination into research studies of emerging HIV prevention approaches could enhance uptake and retention of these approaches, and care and treatment for people living with HIV (PLHIV), by informing stigma mitigation strategies. We sought to develop a succinct set of measures to capture key domains of stigma for use in research on HIV prevention technologies.
METHODS


From 2013 to 2015, we collected baseline data on HIV stigma from three populations (PLHIV (N = 4053), community members (N = 5782) and health workers (N = 1560)) in 21 study communities in South Africa and Zambia participating in the HPTN 071 (PopART) cluster-randomized trial. Forty questions were adapted from a harmonized set of measures developed in a consultative, global process. Informed by theory and factor analysis, we developed seven scales, with values ranging from 0 to 3, based on a 4-point agreement Likert, and calculated means to assess different aspects of stigma. Higher means reflected more stigma. We developed two measures capturing percentages of PLHIV who reported experiencing any stigma in communities or healthcare settings in the past 12 months. We validated our measures by examining reliability using Cronbach's alpha and comparing the distribution of responses across characteristics previously associated with HIV stigma.
RESULTS


Thirty-five questions ultimately contributed to seven scales and two experience measures. All scales demonstrated acceptable to very good internal consistency. Among PLHIV, a scale captured internalized stigma, and experience measures demonstrated that 22.0% of PLHIV experienced stigma in the community and 7.1% in healthcare settings. Three scales for community members assessed fear and judgement, perceived stigma in the community and perceived stigma in healthcare settings. Similarly, health worker scales assessed fear and judgement, perceived stigma in the community and perceived co-worker stigma in healthcare settings. A higher proportion of community members and health workers reported perceived stigma than the proportion of PLHIV who reported experiences of stigma.
CONCLUSIONS


We developed novel, valid measures that allowed for triangulation of HIV stigma across three populations in a large-scale study. Such comparisons will illuminate how stigma influences and is influenced by programmatic changes to HIV service delivery over time.",2019,"A higher proportion of community members and health workers reported perceived stigma than the proportion of PLHIV who reported experiences of stigma.
","['From 2013 to 2015', 'people living with HIV (PLHIV', 'HIV stigma from three populations (PLHIV (N\xa0=\xa04053), community members (N\xa0=\xa05782) and health workers (N\xa0=\xa01560)) in 21 study communities in South Africa and Zambia participating in the HPTN 071 (PopART) cluster-randomized trial', 'people living with HIV, community members and health workers in the HPTN 071 (PopART) trial in Zambia and South Africa']",[],"['HIV stigma and discrimination', 'stigma', 'fear and judgement, perceived stigma in the community and perceived stigma in healthcare settings', 'health worker scales assessed fear and judgement, perceived stigma in the community and perceived co-worker stigma in healthcare settings']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0222045'}]",3.0,0.0608849,"A higher proportion of community members and health workers reported perceived stigma than the proportion of PLHIV who reported experiences of stigma.
","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Stangl', 'Affiliation': 'International Center for Research on Women, Washington, DC, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Lilleston', 'Affiliation': 'International Center for Research on Women, Washington, DC, USA.'}, {'ForeName': 'Hlengani', 'Initials': 'H', 'LastName': 'Mathema', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Krishnaratne', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Sievwright', 'Affiliation': 'International Center for Research on Women, Washington, DC, USA.'}, {'ForeName': 'Nomhle', 'Initials': 'N', 'LastName': 'Bell-Mandla', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Redwaan', 'Initials': 'R', 'LastName': 'Vermaak', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Tila', 'Initials': 'T', 'LastName': 'Mainga', 'Affiliation': 'Zambart, School of Medicine, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Steinhaus', 'Affiliation': 'International Center for Research on Women, Washington, DC, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'SCHARP, Seattle, Washington, USA.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25421']
1084,30628462,Effects of occlusal splints on shoulder strength and activation.,"Introduction:  The use of oral appliances to enhance sports performance has been advocated by some authors, however, studies addressing the effectiveness of these strategies are inconclusive.  Methods:  Here we investigate the effects of dental occlusions on shoulder strength. Fourteen healthy male subjects (age = 21.67 ± 0.86 years) without temporomandibular joint (TMJ) disorder participated in this study. Isokinetic strength was evaluated in shoulder abduction/adduction and arm external/internal rotation tests. Three randomised conditions were assessed: (1) occlusal splint (OS), which repositioned the TMJ in centric relation; (2) placebo splint (PS); and (3) no-splint (N). The strength tests were performed at a speed of 60°/sec in concentric mode. Muscle activity was measured by surface electromyography (EMG) in the main muscles engaged in the movements.  Results:  Significant differences in peak torque between OS and both of the other experimental conditions were found in some of the analyzed variables. Moreover, there was significantly higher muscular EMG activation in the OS condition when compared to the other conditions for some of the tested muscles. These data suggest that splints may have a positive ergogenic effect on shoulder muscular strength in healthy male subjects.  Conclusion:  OS may provide an advantage for healthy subjects engaged in sports whereby shoulder and arm strength are important for performance. Key messages Occlusal splints in centric relation position have an ergogenic effect, by increasing strength and muscle activation on shoulder in healthy subjects. These results could have implications for sports or other physical activities were arm and shoulder strength are important.",2019,"Moreover, there was significantly higher muscular EMG activation in the OS condition when compared to the other conditions for some of the tested muscles.","['Fourteen healthy male subjects (age = 21.67\u2009±\u20090.86\xa0years) without temporomandibular joint (TMJ) disorder participated in this study', 'healthy subjects', 'healthy male subjects']","['placebo splint (PS); and (3) no-splint (N', 'occlusal splints']","['peak torque', 'muscular EMG activation', 'shoulder strength', 'Muscle activity', 'shoulder strength and activation', 'shoulder muscular strength', 'Isokinetic strength']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0162528', 'cui_str': 'Occlusal Splints'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",14.0,0.0233408,"Moreover, there was significantly higher muscular EMG activation in the OS condition when compared to the other conditions for some of the tested muscles.","[{'ForeName': 'Amândio', 'Initials': 'A', 'LastName': 'Dias', 'Affiliation': 'a Neuromuscular Research Lab, CIPER, Faculdade de Motricidade Humana , Universidade de Lisboa , Lisbon , Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Redinha', 'Affiliation': 'c Faculdade de Medicina Dentária , Universidade de Lisboa , Lisbon , Portugal.'}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Vaz', 'Affiliation': 'd Universidade Europeia , Lisbon , Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Cordeiro', 'Affiliation': 'f Escola Superior de Saúde Dr. Lopes Dias, Instituto Politécnico de Castelo Branco , Castelo Branco , Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Silva', 'Affiliation': 'e Department of Biomechanics , University of Nebraska at Omaha , Omaha , NE , USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pezarat-Correia', 'Affiliation': 'a Neuromuscular Research Lab, CIPER, Faculdade de Motricidade Humana , Universidade de Lisboa , Lisbon , Portugal.'}]",Annals of medicine,['10.1080/07853890.2019.1566766']
1085,31881995,"Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate).","BACKGROUND


Late-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial.
METHODS


Here we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8 weeks of individual treatment sessions twice per week and a follow-up period of 6 months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6 months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples.
DISCUSSION


This study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).",2019,Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects.,"['248 patients with LLD of both genders at 7 sites in Germany', 'people suffering from LLD', 'late life depression']","['cognitive behavioural therapy (CBT', 'Cognitive behavioural therapy', 'specific CBT intervention', 'Psychotherapy']","['change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up', 'severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0222045'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}]",248.0,0.124931,Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects.,"[{'ForeName': 'Forugh S', 'Initials': 'FS', 'LastName': 'Dafsari', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany. forugh.salimi-dafsari@uk-koeln.de.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Bewernick', 'Affiliation': 'Department of Neurodegenerative Diseases and Geriatric Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Biewer', 'Affiliation': 'Clinical Trials Centre Cologne, Gleueler Str 269, 50935, Cologne, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Christ', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Kerpener Str 62, 50931, Cologne, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5, 79104, Freiburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Froelich', 'Affiliation': 'Department of Geriatric Psychiatry Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, 68159, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Kerpener Str 62, 50931, Cologne, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Luppa', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, University of Leipzig, 01403, Leipzig, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Riedel-Heller', 'Affiliation': 'Institute of Social Medicine, Occupational Health and Public Health, University of Leipzig, 01403, Leipzig, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5, 79104, Freiburg, Germany.'}, {'ForeName': 'Magnus-Sebastian', 'Initials': 'MS', 'LastName': 'Vry', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5, 79104, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Neurodegenerative Diseases and Geriatric Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Eberhard Karls University, Schleichstraße 4, 72076, Tuebingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany.'}]",BMC psychiatry,['10.1186/s12888-019-2412-0']
1086,31831042,Prognostic impact of pathological complete remission after preoperative irradiation in patients with locally advanced head and neck squamous cell carcinoma: re-analysis of a phase 3 clinical study.,"PURPOSE


The purpose of this study was to determine the associations between pathological complete remission (pCR) and clinical outcomes in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) who received preoperative radiotherapy or chemoradiotherapy in a phase 3 clinical study.
METHODS


A total of 222 newly diagnostic stage III/IVM0 HNSCC patients were randomly assigned to a preoperative concurrent chemoradiotherapy group (n = 104) or preoperative radiotherapy alone group (n = 118). Over a mean follow-up of 59 months, 72 patients were defined as non-responders to preoperative therapy and subsequently underwent resection of the primary lesion with or without neck dissection. The relationship between the pathological tumor response of the primary lesion and treatment prognosis was analyzed. Kaplan-Meier and Cox regression multivariate analyses were performed to evaluate the impact of pCR on local control (LC), overall survival (OS), progression-free survival (PFS), and distant metastasis-free survival (DMFS).
RESULTS


Among the 72 non-responders, 25 patients, 10 in the chemotherapy group and 15 in the radiotherapy group, achieved pCR. The 5-year LC, OS, PFS, and DMFS of pCR patients and non-pCR patients were 93.2% vs. 67.7% (p = 0.007), 83.3% vs. 39.7% (p = 0.0006), 76.1% vs. 44.0% (p = 0.009), and 90.4% vs. 56.3% (p = 0.005), respectively. In multivariate analysis, pCR is also an independent prognostic factor in prognosis, with statistically significant differences.
CONCLUSION


pCR after preoperative radiotherapy or concurrent chemoradiotherapy is a good prognostic factor in locally advanced HNSCC.
TRIAL REGISTRATION


Number:ChiCTR-TRC-114004322 Date:05 Mar, 2014.",2019,"The 5-year LC, OS, PFS, and DMFS of pCR patients and non-pCR patients were 93.2% vs. 67.7% (p = 0.007), 83.3% vs. 39.7% (p = 0.0006), 76.1% vs. 44.0% (p = 0.009), and 90.4% vs. 56.3% (p = 0.005), respectively.","['222 newly diagnostic stage III/IVM0 HNSCC patients', 'patients with locally advanced head and neck squamous cell carcinoma', 'patients with locally advanced head and neck squamous cell carcinoma (HNSCC) who received']","['preoperative radiotherapy or concurrent chemoradiotherapy', 'pCR', 'preoperative concurrent chemoradiotherapy', 'preoperative irradiation', 'preoperative radiotherapy alone', 'preoperative radiotherapy or chemoradiotherapy', 'radiotherapy']","['pCR', 'local control (LC), overall survival (OS), progression-free survival (PFS), and distant metastasis-free survival (DMFS', '5-year LC, OS, PFS, and DMFS']","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",72.0,0.0807822,"The 5-year LC, OS, PFS, and DMFS of pCR patients and non-pCR patients were 93.2% vs. 67.7% (p = 0.007), 83.3% vs. 39.7% (p = 0.0006), 76.1% vs. 44.0% (p = 0.009), and 90.4% vs. 56.3% (p = 0.005), respectively.","[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. yijunlin1969@163.com.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shiping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhengang', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Head and Neck Surgery, National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Head and Neck Surgery, National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Head and Neck Surgery, National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]","Radiation oncology (London, England)",['10.1186/s13014-019-1428-4']
1087,31881954,"Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study.","BACKGROUND


Compulsory admission to psychiatric hospital is rising despite serious ethical concerns. Among measures to reduce compulsory admissions, Psychiatric Advance Directives (PAD) are the most promising, with intensive PAD (i.e. facilitated and shared) being the most effective. The aim of the study is to experiment Psychiatric Advance Directives in France.
METHODS


A multicentre randomized controlled trial and qualitative approach conducted from January 2019 to January 2021 with intent-to-treat analysis.
SETTING


Seven hospitals in three French cities: Lyon, Marseille, and Paris. Research assistants meet each participant at baseline, 6 months and 12 months after inclusion for face-to-face interviews.
PARTICIPANTS


400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12 months, with capacity to consent (MacCAT-CR), over 18 years old, and able to understand French.
INTERVENTIONS


The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity. Participants meet a facilitator, who is a peer support worker specially trained to help them. They are invited to nominate a healthcare agent, and to share the document with them, as well as with their psychiatrist. The Usual Care (UC) group (expected n = 200) receives routine care.
MAIN OUTCOMES AND MEASURES


The primary outcome is the rate of compulsory admissions to hospital during the 12-month follow-up. Secondary outcomes include quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs.
DISCUSSION


Implication of peer support workers in PAD, potential barriers of supported-decision making, methodological issues of evaluating complex interventions, evidence-based policy making, and the importance of qualitative evaluation in the context of constraint are discussed.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03630822. Registered 14th August 2018.",2019,The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity.,"['Seven hospitals in three French cities', '400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12\u2009months, with capacity to consent (MacCAT-CR), over 18\u2009years old, and able to understand French', 'people living with schizophrenia, bipolar I disorders, or schizoaffective disorders', 'January 2019 to January 2021 with intent-to-treat analysis']","['Psychiatric advance directives', 'Usual Care (UC) group (expected n\xa0=\u2009200) receives routine care']","['quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs', 'rate of compulsory admissions to hospital during the 12-month follow-up']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",400.0,0.0886275,The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity.,"[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France. aurelie.tinland@gmail.com.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Leclerc', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Mougeot', 'Affiliation': 'Centre Max Weber, UMR 5283 - Centre hospitalier Le Vinatier, Lyon, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Greacen', 'Affiliation': 'Mental Health and Social Sciences Research Unit, Paris Psychiatry and Neurosciences University Hospital Group, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Pontier', 'Affiliation': 'Department of Psychiatry, Sainte-Marguerite University Hospital, F-13009, Marseille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Franck', 'Affiliation': 'Resource center of psychosocial rehabilitation, Centre hospitalier Le Vinatier, UMR 5229, CNRS & Université Claude Bernard Lyon 1, Université de Lyon, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lançon', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Boucekine', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'School of medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, F-13005, Marseille Cedex 5, France.'}]",BMC psychiatry,['10.1186/s12888-019-2416-9']
1088,31856379,Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial.,"BACKGROUND


The present study aimed to assess the effect of a healthy diet, enriched or not with pecan nuts or extra-virgin olive oil, on the lipid profile of patients with stable coronary artery disease (CAD).
METHODS


This was a randomised clinical trial conducted for 12 weeks with patients aged between 40 and 80 years with stable CAD for more than 60 days. Individuals were randomised into groups [control group (CG) with 67 patients, pecan nut group (PNG) with 68 patients and olive oil group (OOG) with 69 patients]. The CG was prescribed a healthy diet according to the nutritional guidelines; the PNG was prescribed the same healthy diet plus 30 g day -1  of pecan nuts; and the OOG was prescribed a healthy diet plus 30 mL day -1  of extra-virgin olive oil.
RESULTS


In total, 204 subjects were submitted to an intention-to-treat analysis. After adjustment for baseline values and type of statin used, there was no difference regarding low-density lipoprotein (LDL)-cholesterol (primary outcome), high-density lipoprotein (HDL)-cholesterol, LDL-cholesterol/HDL-cholesterol ratio and HDL-cholesterol/triglycerides ratio according to groups. However, the PNG exhibited a significant reduction in non-HDL-cholesterol levels [PNG: 114.9 (31) mg dL -1  ; CG: 127 (33.6) mg dL -1  ; OOG: 126.6 (37.4) mg dL -1  ; P = 0.033] and in the total cholesterol/HDL-cholesterol ratio [PNG: 3.7 (0.7); CG: 4.0 (0.8); OOG: 4.0 (0.8); P = 0.044] compared to the CG and OOG.
CONCLUSIONS


Supplementing a healthy diet with 30 g day -1  of pecan nuts for 12 weeks did not improve LDL-cholesterol levels but may improve other lipid profile markers in patients with stable CAD.",2020,"However, the PNG exhibited a significant reduction in non-HDL-cholesterol levels [PNG: 114.9 (31) ","['patients with stable coronary artery disease (CAD', 'patients with stable CAD', 'patients with stable coronary artery disease', '204 subjects were submitted to an intention-to-treat analysis', '12\xa0weeks with patients aged between 40 and 80\xa0years with stable CAD for more than 60\xa0days']","['pecan nut group (PNG) with 68 patients and olive oil group (OOG', 'healthy diet enriched or not with pecan nuts or extra-virgin olive oil', 'OOG was prescribed a healthy diet plus 30\xa0mL day -1  of extra-virgin olive oil', 'dL', 'healthy diet, enriched or not with pecan nuts or extra-virgin olive oil', 'mg dL']","['non-HDL-cholesterol levels', 'low-density lipoprotein (LDL)-cholesterol (primary outcome), high-density lipoprotein (HDL)-cholesterol, LDL-cholesterol/HDL-cholesterol ratio and HDL-cholesterol/triglycerides ratio', 'total cholesterol/HDL-cholesterol ratio', 'LDL-cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0440289', 'cui_str': 'Pecan nut (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",204.0,0.0832412,"However, the PNG exhibited a significant reduction in non-HDL-cholesterol levels [PNG: 114.9 (31) ","[{'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Campos', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Portal', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Markoski', 'Affiliation': 'Graduate Program in Nutrition Sciences, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Quadros', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Â C', 'Initials': 'ÂC', 'LastName': 'Bersch-Ferreira', 'Affiliation': 'HCor Research Institute, Coracao Hospital (IP-HCor), São Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garavaglia', 'Affiliation': 'Graduate Program in Nutrition Sciences, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12727']
1089,31815632,The efficacy of managing fluid overload in chronic peritoneal dialysis patients by a structured nurse-led intervention protocol.,"BACKGROUND


Extracellular volume overload is a common problem in peritoneal dialysis (PD) patients and is associated with excessive mortality. We determine the effectiveness of treating PD patients with extracellular volume overload by a structured nurse-led intervention program.
METHODS


The hydration status of PD patients was screened by bioimpedance spectroscopy (BIS). Fluid overload was defined as overhydration volume ≥ 2 L. Patients were classified into Symptomatic and Asymptomatic Groups and were managed by a structured nurse-led intervention protocol that focused on education and motivation. Hypertonic cycles were given for short term symptom relief for the Symptomatic group. Patients were followed for 12 weeks for the change in volume status, blood pressure, knowledge and adherence as determined by standard questionnaires.
RESULTS


We recruited 103 patients (53 Symptomatic, 50 Asymptomatic Group. There was a significant reduction in overhydration volume 4 weeks after intervention, which was sustained by week 12; the overall reduction in overhydration volume was 0.96 ± 1.43 L at 4 weeks, and 1.06 ± 1.70 L at 12 weeks (p < 0.001 for both). The improvement was significant for both Symptomatic and Asymptomatic Groups. There was a concomitant reduction in systolic blood pressure in the Asymptomatic (146.9 ± 20.7 to 136.9 ± 19.5 mmHg, p = 0.037) but not Symptomatic group. The scores of knowledge, adherence to dietary control and advices on daily habit at week 4 were all significantly increased, and the improvement was sustained at week 12.
CONCLUSIONS


The structured nurse-led intervention protocol has a lasting benefit on the volume status of PD patients with extracellular volume overload. BIS screening allows prompt identification of volume overload in asymptomatic patients, and facilitates a focused effort on this high risk group.",2019,"The scores of knowledge, adherence to dietary control and advices on daily habit at week 4 were all significantly increased, and the improvement was sustained at week 12.
","['chronic peritoneal dialysis patients', '103 patients (53 Symptomatic, 50 Asymptomatic Group', 'PD patients with extracellular volume overload', 'asymptomatic patients', 'PD patients with extracellular volume overload by a structured nurse-led intervention program', 'peritoneal dialysis (PD) patients']",['BIS screening'],"['overhydration volume', 'systolic blood pressure', 'volume status, blood pressure, knowledge and adherence', 'scores of knowledge, adherence to dietary control and advices on daily habit']","[{'cui': 'C0455150', 'cui_str': 'Chronic peritoneal dialysis (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0392689', 'cui_str': 'Overhydration (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",53.0,0.0338042,"The scores of knowledge, adherence to dietary control and advices on daily habit at week 4 were all significantly increased, and the improvement was sustained at week 12.
","[{'ForeName': 'Man Ching', 'Initials': 'MC', 'LastName': 'Law', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Bonnie Ching-Ha', 'Initials': 'BC', 'LastName': 'Kwan', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Janny Suk-Fun', 'Initials': 'JS', 'LastName': 'Fung', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Kai Ming', 'Initials': 'KM', 'LastName': 'Chow', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Jack K C', 'Initials': 'JKC', 'LastName': 'Ng', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Pang', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Phyllis Mei-Shan', 'Initials': 'PM', 'LastName': 'Cheng', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': 'Chi Bon', 'Initials': 'CB', 'LastName': 'Leung', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Cheuk Chun', 'Initials': 'CC', 'LastName': 'Szeto', 'Affiliation': 'Carol and Richard Yu Peritoneal Dialysis Research Centre, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, SAR, China. ccszeto@cuhk.edu.hk.'}]",BMC nephrology,['10.1186/s12882-019-1596-3']
1090,31818266,"Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.","BACKGROUND


The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population.
METHODS


The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m 2 ), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m 2  (routine dialysis group) and 5 ml/min/1.73 m 2  or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods.
DISCUSSION


This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m 2 . With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial.
TRIAL REGISTRATION


The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.",2019,The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups.,"['progressive chronic kidney disease (CKD) patients', 'Chinese population', 'Eligible participants are 18-80\u2009years old, in stable CKD stages 4-5 (eGFR >\u20097\u2009ml/min /1.73', 'advanced CKD population']","['routine and deferred dialysis initiation (RADDI', 'routine dialysis intervention']","['difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events', 'hospitalization rate and other safety indices', 'mortality, comorbidities, and quality of life']","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C2317473', 'cui_str': 'CKD stage 4'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}]",,0.178398,The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups.,"[{'ForeName': 'Xinju', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lining', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiaonong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, Beijing Tongren Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Rihong', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Nephrology, Shaanxi Hospital of Traditional Chinese Medicine, Shaanxi, China.'}, {'ForeName': 'Caili', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Baotou Medical College, Baotou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Sichuan Academy of Medical Sciences, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Kidney disease center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Detian', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yuzhu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Beijing Haidian Hospital (Beijing Haidian Section of Peking University Third Hospital), Beijing, China.'}, {'ForeName': 'Wenling', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Department of Nephrology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Renal Division, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Department of Nephrology, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China. zuoli@bjmu.edu.cn.""}]",BMC nephrology,['10.1186/s12882-019-1627-0']
1091,31856771,Neurocognitive working mechanisms of the prevention of relapse in remitted recurrent depression (NEWPRIDE): protocol of a randomized controlled neuroimaging trial of preventive cognitive therapy.,"BACKGROUND


Major Depressive Disorder (MDD) is a psychiatric disorder with a highly recurrent character, making prevention of relapse an important clinical goal. Preventive Cognitive Therapy (PCT) has been proven effective in preventing relapse, though not for every patient. A better understanding of relapse vulnerability and working mechanisms of preventive treatment may inform effective personalized intervention strategies. Neurocognitive models of MDD suggest that abnormalities in prefrontal control over limbic emotion-processing areas during emotional processing and regulation are important in understanding relapse vulnerability. Whether changes in these neurocognitive abnormalities are induced by PCT and thus play an important role in mediating the risk for recurrent depression, is currently unclear. In the Neurocognitive Working Mechanisms of the Prevention of Relapse In Depression (NEWPRIDE) study, we aim to 1) study neurocognitive factors underpinning the vulnerability for relapse, 2) understand the neurocognitive working mechanisms of PCT, 3) predict longitudinal treatment effects based on pre-treatment neurocognitive characteristics, and 4) validate the pupil dilation response as a marker for prefrontal activity, reflecting emotion regulation capacity and therapy success.
METHODS


In this randomized controlled trial, 75 remitted recurrent MDD (rrMDD) patients will be included. Detailed clinical and cognitive measurements, fMRI scanning and pupillometry will be performed at baseline and three-month follow-up. In the interval, 50 rrMDD patients will be randomized to eight sessions of PCT and 25 rrMDD patients to a waiting list. At baseline, 25 healthy control participants will be additionally included to objectify cross-sectional residual neurocognitive abnormalities in rrMDD. After 18 months, clinical assessments of relapse status are performed to investigate which therapy induced changes predict relapse in the 50 patients allocated to PCT.
DISCUSSION


The present trial is the first to study the neurocognitive vulnerability factors underlying relapse and mediating relapse prevention, their value for predicting PCT success and whether pupil dilation acts as a valuable marker in this regard. Ultimately, a deeper understanding of relapse prevention could contribute to the development of better targeted preventive interventions.
TRIAL REGISTRATION


Trial registration: Netherlands Trial Register, August 18, 2015, trial number NL5219.",2019,"After 18 months, clinical assessments of relapse status are performed to investigate which therapy induced changes predict relapse in the 50 patients allocated to PCT.
","['25 healthy control participants', '75 remitted recurrent MDD (rrMDD) patients will be included', 'remitted recurrent depression (NEWPRIDE', '50 rrMDD patients']","['Preventive Cognitive Therapy (PCT', 'PCT', 'preventive cognitive therapy']","['pupil dilation response', 'Relapse']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression (disorder)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}]","[{'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",75.0,0.120185,"After 18 months, clinical assessments of relapse status are performed to investigate which therapy induced changes predict relapse in the 50 patients allocated to PCT.
","[{'ForeName': 'Rozemarijn S', 'Initials': 'RS', 'LastName': 'van Kleef', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands. r.s.van.kleef@umcg.nl.'}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': 'Department of Psychiatry and Urban Mental Health Institute, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'van Valen', 'Affiliation': 'Department of Geriatrics, Heidelberglaan 100, University Medical Center Utrecht, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Aleman', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands.'}, {'ForeName': 'Jan-Bernard C', 'Initials': 'JC', 'LastName': 'Marsman', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands.'}, {'ForeName': 'Marie-José', 'Initials': 'MJ', 'LastName': 'van Tol', 'Affiliation': 'Cognitive Neuroscience Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 2, 9713 AW, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2384-0']
1092,31883526,"Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya.","BACKGROUND


Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.
METHODS/DESIGN


We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up.
DISCUSSION


The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03466346, registered March 15, 2018.",2019,"We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer.","['Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD', '2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6\u2009months of fluoxetine prescribed by a nurse or clinical officer', 'Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other', 'adults with mental disorders', 'major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya']","['treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine', 'psychotherapy and/or medication']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020005', 'cui_str': 'Hospitals, County'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],2710.0,0.0328138,"We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Levy', 'Affiliation': 'Medical School, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Muthoni', 'Initials': 'M', 'LastName': 'Mathai', 'Affiliation': 'Department of Psychiatry, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Purba', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Linnet', 'Initials': 'L', 'LastName': 'Ongeri', 'Affiliation': 'Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Njuguna', 'Affiliation': 'Director of Mental Health, Kenyan Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Onyango', 'Affiliation': 'Kisumu County, Ministry of Health, Kisumu, Kenya.'}, {'ForeName': 'Dickens', 'Initials': 'D', 'LastName': 'Akena', 'Affiliation': 'Department of Psychiatry, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rota', 'Affiliation': 'University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Ammon', 'Initials': 'A', 'LastName': 'Otieno', 'Affiliation': 'University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Departments of Psychiatry and Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Hafsa', 'Initials': 'H', 'LastName': 'Lukwata', 'Affiliation': 'Division of Mental Health and Control of Substance Abuse, Ministry of Health -, Kampala, Uganda.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute for Health Policy Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, UC Global Health Institute, San Francisco, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bukusi', 'Affiliation': 'Department of Psychiatry, Kenyatta National Hospital, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burger', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Blum', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Division of Mental Health and Control of Substance Abuse, Ministry of Health -, Kampala, Uganda.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Meffert', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA, USA. Susan.Meffert@ucsf.edu.'}]",BMC psychiatry,['10.1186/s12888-019-2395-x']
1093,31329507,Effectiveness of Kinesio Taping on Anastomotic Regions in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Pilot Study.,"Background:  The purpose of the study was to investigate the effect of using Kinesio Taping ®  (KT) on anastomotic regions along with complex decongestive physiotherapy (CDP) in patients with breast cancer-related lymphedema (BCRL).  Methods and Results:  Patients with unilateral BCRL were divided into two groups in this randomized controlled study: Group 1 (CDP,  n  = 14) and Group 2 (CDP+ KT,  n  = 18). Assessment of limb size was quantified by using circumferential limb measurements and then calculated for each segment by using the frustum formula. CDP included manual lymphatic drainage, compression bandages, exercises, and skin care. KT was applied to lymphatic anastomosis. All patients received treatment for 1 hour per day, 5 days per week for 4 weeks. The outcome measure was difference in the reduction of limb volumes between the groups. There was a significant difference in both groups before and after treatment ( p  < 0.05), but there was no significant difference between the two groups regarding changes in limb volume ( p  > 0.05).  Conclusion:  The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.",2019,The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.,"['Patients with unilateral BCRL', 'Patients with Breast Cancer-Related Lymphedema', 'patients with breast cancer-related lymphedema (BCRL']","['complex decongestive physiotherapy (CDP', 'Kinesio Taping', 'Kinesio Taping ®  (KT']","['limb size', 'limb volume', 'reduction of limb volumes', 'manual lymphatic drainage, compression bandages, exercises, and skin care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0010724', 'cui_str': 'CDP'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0556834', 'cui_str': 'Manual Lymphatic Drainage'}, {'cui': 'C0677875', 'cui_str': 'Compression Wraps'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}]",,0.025077,The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.,"[{'ForeName': 'Gülbin', 'Initials': 'G', 'LastName': 'Ergin', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Health Science Faculty, European University of Lefke, Lefke, North Cyprus.'}, {'ForeName': 'Ertan', 'Initials': 'E', 'LastName': 'Şahinoğlu', 'Affiliation': 'Dr. İsmail Atabek Physical Therapy and Rehabilitation Center, İzmir, Turkey.'}, {'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Karadibak', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, İzmir, Turkey.'}, {'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Yavuzşen', 'Affiliation': 'Institute for Oncology, Dokuz Eylul University, İzmir, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0003']
1094,31335755,Ketamine/propofol admixture vs etomidate for intubation in the critically ill: KEEP PACE Randomized clinical trial.,"BACKGROUND


Periintubation hypotension is associated with poor outcomes in the critically ill. We aimed to determine if an admixture of ketamine and propofol for emergent endotracheal intubation in critically ill patients was superior to etomidate. Primary endpoint was the change in mean arterial pressure from baseline to 5 minutes postdrug administration.
METHODS


Emergent-use, stratified (shock status and unit type), multiunit, randomized, parallel-group superiority clinical trial was conducted at a tertiary academic medical center. Adult medical/surgical and transplant/oncologic intensive care unit patients undergoing emergent intubation were assigned randomly to receive either ketamine/propofol admixture (0.5 mg/kg of ketamine and propofol each) or reduced dose etomidate (0.15 mg/kg) for emergent intubation.
RESULTS


One hundred sixty participants were randomized, and 152 (79 ketamine/propofol admixture, 73 etomidate) were included in the intention-to-treat analysis. There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes postdrug administration (treatment difference [ketamine/propofol admixture-etomidate]: -2.1 mm Hg; 95% confidence interval, -6.9 mm Hg to +2.7 mm Hg; p = 0.385). In addition, no statistically significant difference was demonstrated in the change of mean arterial pressure from baseline at 10 minutes and 15 minutes postdrug administration, no statistical difference in the use of new-onset vasoactive agents or difficulty of intubation between groups. More patients in the etomidate group required non-red blood cell transfusions (16 [22%] vs. 8 [10%], p = 0.046). For patients who had adrenal testing performed, more patients in the etomidate group developed immediate adrenal insufficiency (13 [81%] of 16 vs. 5 [38%] of 13, p = 0.027). Serious adverse events were rare, 2 (3%) (cardiac arrest, hypotension) in ketamine/propofol admixture and 4 (5%) (hypertension, hypotension) in etomidate (p = 0.430).
CONCLUSION


In a heterogeneous critically ill population, ketamine/propofol admixture was not superior to a reduced dose of etomidate at preserving per-intubation hemodynamics and appears to be a safe alternative induction agent in the critically ill.
LEVEL OF EVIDENCE


Therapeutic/Care Management, level II.
TRIAL REGISTRY


ClinicalTrials.gov, NCT02105415, Ketamine/Propofol Admixture ""Ketofol"" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial, IRB 13-000506, Trial Registration: March 31, 2014.",2019,There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes post-drug administration [treatment difference (ketamine/propofol admixture - etomidate):,"['critically-ill patients', 'Adult medical/surgical and transplant/oncologic intensive care unit patients undergoing emergent intubation', 'Emergent-use, stratified (shock status and unit type), multi-unit, randomized, parallel-group superiority clinical trial was conducted at a tertiary academic medical center', 'One hundred and sixty participants were randomized and 152 (79']","['ketamine/propofol admixture, 73 etomidate', 'ketamine/propofol admixture [0.5 mg/kg of ketamine and propofol each] or reduced dose etomidate [0.15 mg/kg] for emergent intubation', 'KEtaminE/ProPofol Admixture vs Etomidate', 'etomidate', 'ketamine and propofol', 'ketamine/propofol admixture']","['mean arterial pressure change', 'immediate adrenal insufficiency', 'hypertension, hypotension', 'non-red blood cell transfusions', 'Serious adverse events', 'cardiac arrest, hypotension', 'mean arterial pressure']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0565912', 'cui_str': 'Unit type (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0001623', 'cui_str': 'Adrenal Insufficiency'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]",160.0,0.3358,There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes post-drug administration [treatment difference (ketamine/propofol admixture - etomidate):,"[{'ForeName': 'Nathan Jerome', 'Initials': 'NJ', 'LastName': 'Smischney', 'Affiliation': 'From the Department of Anesthesiology and Perioperative Medicine (N.J.S., W.T.N., D.R.B., B.P.), Division of Pulmonary and Critical Care Medicine (A.G.D.M., S.S.H., R.A.O., V.N.I., O.G., P.R.B.), Department of Biostatistics (D.R.S.), and Hemodynamic and Airway Management Group (HEMAIR) (N.J.S., D.R.B., O.G.), Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Wayne T', 'Initials': 'WT', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gallo De Moraes', 'Affiliation': ''}, {'ForeName': 'Sumedh S', 'Initials': 'SS', 'LastName': 'Hoskote', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pickering', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Oeckler', 'Affiliation': ''}, {'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Iyer', 'Affiliation': ''}, {'ForeName': 'Ognjen', 'Initials': 'O', 'LastName': 'Gajic', 'Affiliation': ''}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': ''}, {'ForeName': 'Philippe R', 'Initials': 'PR', 'LastName': 'Bauer', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002448']
1095,31331789,Alirocumab efficacy and safety by race and ethnicity: Analysis from 3 ODYSSEY phase 3 trials.,"BACKGROUND


Differences in lipid and cardiovascular risk profiles have been observed in African-American/black (AA/B), white (W), and Hispanic/Latino (H/L) individuals. Efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, may vary by race and ethnicity and has not been analyzed.
OBJECTIVE


This post hoc analysis evaluated alirocumab efficacy and safety vs control in 3 pooled ODYSSEY phase 3 trials (COMBO I, COMBO II, and LONG TERM) by race (AA/B [n = 154] vs W [n = 1982]) and ethnicity (H/L [n = 174] vs non-H/L [n = 3149]).
METHODS


Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin received alirocumab (75 mg up to 150 mg every 2 weeks [COMBO I & II] or 150 mg every 2 weeks [LONG TERM]) or control (placebo [COMBO I and LONG TERM] or ezetimibe [COMBO II]).
RESULTS


At baseline, LDL-C levels were similar across treatment groups; median lipoprotein(a) levels were higher in AA/B (33.0-120.0 mg/dL) vs W (7.1-66.3 mg/dL) and lower in H/L (5.0-38.3 mg/dL) vs non-H/L (7.7-69.0 mg/dL). At week 24, alirocumab significantly reduced LDL-C vs control. Alirocumab also reduced lipoprotein(a) compared with control across the subgroups. Treatment-emergent adverse events were similar between alirocumab (68.9-85.0%) and control (70.6-82.4%) regardless of race and ethnicity.
CONCLUSION


Alirocumab significantly reduced LDL-C and Lp(a) levels compared with control, regardless of race and ethnicity, with overall safety comparable to control across most of the racial and ethnic groups analyzed.",2019,"Alirocumab significantly reduced LDL-C and Lp(a) levels compared with control, regardless of race and ethnicity, with overall safety comparable to control across most of the racial and ethnic groups analyzed.","['African-American/black (AA/B), white (W), and Hispanic/Latino (H/L) individuals', 'Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin received']","['Alirocumab', 'ethnicity', 'COMBO I & II] or 150\xa0mg every 2\xa0weeks [LONG TERM]) or control (placebo [COMBO I and LONG TERM] or ezetimibe [COMBO II', 'alirocumab (75\xa0mg up to 150\xa0mg every 2\xa0weeks ', 'alirocumab']","['median lipoprotein(a) levels', 'LDL-C levels', 'Alirocumab efficacy and safety', 'reduced lipoprotein(a', 'alirocumab efficacy and safety', 'LDL-C and Lp(a) levels']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.0915647,"Alirocumab significantly reduced LDL-C and Lp(a) levels compared with control, regardless of race and ethnicity, with overall safety comparable to control across most of the racial and ethnic groups analyzed.","[{'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Ferdinand', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, LA, USA. Electronic address: kferdina@tulane.edu.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': 'Health Promotion and Disease Prevention, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Elassal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Deedwania', 'Affiliation': 'Division of Cardiology, University of California, San Francisco, CA, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.06.002']
1096,31329503,Postural Stability in Patients with Lower Limb Lymphedema.,"Background:  Impaired mobility and musculoskeletal dysfunctions are commonly seen in patients with lymphedema and can affect the balance system in patients in whom the lower limb is affected. This study aims at comparing postural stability between patients with lower limb lymphedema (LLL) and healthy subjects.  Methods and Results:  This controlled study included 36 patients with LLL (LLL group) and 36 healthy subjects (control group). Fall risk, stability index, and Fourier index measurements of Tetrax ®  Interactive Balance System were compared. There were no statistically significant differences between groups in terms of demographics parameters ( p  > 0.05). Some stability and Fourier index measurements were significantly higher in subjects in the LLL group than in the control group. However, the fall risk was not statistically different in patients with LLL than healthy subjects ( p  > 0.05).  Conclusion:  LLL may cause balance impairments. However, this impairment may not lead to increased fall risk. The evaluation of postural stability in LLL patients would be a useful addition to routine clinical practice due to the relationship between LLL and balance impairments.",2019,"However, the fall risk was not statistically different in patients with LLL than healthy subjects ( p  > 0.05).  ","['patients with lymphedema', 'patients with lower limb lymphedema (LLL) and healthy subjects', 'LLL patients', '36 patients with LLL (LLL group) and 36 healthy subjects (control group', 'Patients with Lower Limb Lymphedema']",['LLL'],"['Fall risk, stability index, and Fourier index measurements of Tetrax ®  Interactive Balance System', 'stability and Fourier index measurements', 'Postural Stability', 'Impaired mobility and musculoskeletal dysfunctions', 'fall risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0518456', 'cui_str': 'Physical mobility impairment'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",36.0,0.0227722,"However, the fall risk was not statistically different in patients with LLL than healthy subjects ( p  > 0.05).  ","[{'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Doruk Analan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Kaya', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Adana City Training and Research Hospital, Adana, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0004']
1097,31169350,Determination of optimal on-treatment diastolic blood pressure range using automated measurements in subjects with cardiovascular disease-Analysis of a SPRINT trial subpopulation.,"Automated office blood pressure measurement (AOBPM) is recommended for diagnosing hypertension; however, optimal treatment targets using this method are not established. Discrepancies between automated and office measurements of blood pressure have been described, producing uncertainty regarding the use of AOBPM in clinical practice. The Systolic Blood Pressure Intervention Trial (SPRINT) results improved our understanding of target AOBPM systolic blood pressure (SBP) levels; however, diastolic blood pressure (DBP) targets remain unknown. Therefore, we sought to determine the optimal on-treatment DBP range. The analysis was performed on the participants of the SPRINT trial who had hypertension and prior cardiovascular disease. We analyzed the data of 1470 participants (mean age 70.3 ± 9.3 years, 24.1% female) selected from the SPRINT trial database of National Heart, Lung and Blood Institute. The mean achieved SBP and DBP were 127.9 ± 10.7 and 68.3 ± 9.4 mm Hg, respectively. Most of the participants (57.4%) had a DBP lower than 70 mm Hg, while only 11.7% had DPB ≥80 mm Hg. Clinical composite endpoint was defined as myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure or death from cardiovascular causes. There were 159 (10.8%) clinical endpoint events. The participants with on-treatment AOBPM DBP range of 68.6-78.6 mm Hg showed the lowest hazard risk of a clinical composite endpoint. These results correspond to the office DBP range of 70-80 mm Hg recommended in ESC guidelines. This is the first attempt to determine the range of optimal DBP values using population-based AOBPM in patients with prior cardiovascular disease.",2019,Hg showed the lowest hazard risk of a clinical composite endpoint.,"['participants of the SPRINT trial who had hypertension and prior cardiovascular disease', '1470 participants (mean age 70.3\xa0±\xa09.3\xa0years, 24.1% female) selected from the SPRINT trial database of National Heart, Lung and Blood Institute', 'participants with on-treatment AOBPM DBP range of 68.6-78.6\xa0mm', 'subjects with cardiovascular disease-Analysis of a SPRINT trial subpopulation', 'patients with prior cardiovascular disease']",['Automated office blood pressure measurement (AOBPM'],"['diastolic blood pressure (DBP', 'DBP', 'mean achieved SBP and DBP', 'myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure or death from cardiovascular causes', 'AOBPM systolic blood pressure (SBP) levels']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0005768'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517855', 'cui_str': '68.6 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1470.0,0.0637285,Hg showed the lowest hazard risk of a clinical composite endpoint.,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sobieraj', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Siński', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13581']
1098,32027446,Once-Daily Oxycodone Prolonged-Release Tablets Are Resistant to Alcohol-Induced Dose Dumping: Results From a Randomized Trial in Healthy Volunteers.,"The objective of this study was to determine the effect of concomitant alcohol intake on the bioavailability of oxycodone from an oxycodone once-daily (OOD) formulation and an oxycodone twice-daily (OTD) formulation. A phase I, open-label, randomized, crossover alcohol interaction study in 20 healthy volunteers under fasting conditions was conducted. Participants received five treatments, OOD with 240 mL of 0%, 20%, or 40% alcohol; and OTD with 240 mL of 0% or 40% alcohol. Pharmacokinetic parameters did not differ between participants taking OOD with water or with 240 mL of 20% alcohol. There was a slight increase in overall oxycodone absorption from OOD with 40% alcohol but no increase in peak absorption. Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged-release profile. Although it is recommended that alcohol be avoided while taking opioids, there was no evidence of alcohol-induced dose dumping in these oxycodone formulations.",2020,Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged-release profile.,"['20 healthy volunteers under fasting conditions was conducted', 'healthy volunteers']","['oxycodone twice-daily (OTD) formulation', 'OOD with 240 mL of 0, 20, or 40% alcohol; and OTD with 240 mL of 0 or 40% alcohol']","['Pharmacokinetic parameters', 'peak absorption', 'overall oxycodone absorption', 'bioavailability of oxycodone']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",20.0,0.028047,Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged-release profile.,"[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Burger', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fraser', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}, {'ForeName': 'Martina Alice', 'Initials': 'MA', 'LastName': 'Maritz', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Faulkner', 'Affiliation': 'BioPharma Services Inc., Toronto, Ontario, Canada.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rey', 'Affiliation': 'Develco Pharma Schweiz AG, Pratteln, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12737']
1099,32108976,Improving Cancer Patients' Insurance Choices (I Can PIC): A Randomized Trial of a Personalized Health Insurance Decision Aid.,"BACKGROUND


Many cancer survivors struggle to choose a health insurance plan that meets their needs because of high costs, limited health insurance literacy, and lack of decision support. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial.
MATERIALS AND METHODS


Eligible individuals (18-64 years, diagnosed with cancer for ≤5 years, English-speaking, not Medicaid or Medicare eligible) were randomized to I Can PIC or an attention control health insurance worksheet. Primary outcomes included health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control. Secondary outcomes included knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up.
RESULTS


A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up. After viewing I Can PIC or the control, health insurance knowledge and a health insurance literacy item assessing confidence understanding health insurance were higher in the I Can PIC group. At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed. There were no significant differences between groups in other outcomes. Results did not change when controlling for health literacy and employment. Both groups reported having limited health insurance options.
CONCLUSION


I Can PIC can improve cancer survivors' health insurance knowledge and confidence using health insurance. System-level interventions are needed to lower financial toxicity and help patients manage care costs.
IMPLICATIONS FOR PRACTICE


Inadequate health insurance compromises cancer treatment and impacts overall and cancer-specific mortality. Uninsured or underinsured survivors report fewer recommended cancer screenings and may delay or avoid needed follow-up cancer care because of costs. Even those with adequate insurance report difficulty managing care costs. Health insurance decision support and resources to help manage care costs are thus paramount to cancer survivors' health and care management. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial. I Can PIC provides health insurance information, supports patients through managing care costs, offers a list of financial and emotional support resources, and provides a personalized cost estimate of annual health care expenses across plan types.",2020,"At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed.","['A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up', ""Cancer Patients' Insurance Choices (I Can PIC"", 'Eligible individuals (18-64\u2009years, diagnosed with cancer for ≤5\u2009years, English-speaking, not Medicaid or Medicare eligible']",['I Can PIC or an attention control health insurance worksheet'],"['health literacy and employment', 'health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control', 'knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]","[{'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",335.0,0.111716,"At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed.","[{'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Grant', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Nerissa P', 'Initials': 'NP', 'LastName': 'George', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Barker', 'Affiliation': 'Brown School and Center for Health Economics and Policy, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Kuroki', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'McBride', 'Affiliation': 'Brown School and Center for Health Economics and Policy, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Goodwin', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0703']
1100,31328670,Increased Activity in Patients with Cardiovascular Risk Factors Increases Heart Rate Variability.,"This study evaluated the effect of increased physical activity on high-frequency (HF) heart rate variability (HRV) during the first hour after sleep onset in patients with hypertension and/or stable angina pectoris. Physical activity and HF were measured using activity monitors and 24-hour Holter monitors at baseline and 6 months later. The physical activity increased in 28 patients (increase group) and decreased in 20 patients (decrease group) after 6 months. In this study, after 6 months, compared to the decreased physical activity group, the increased physical activity group showed a significant increase in the HF index during the first hour after sleep onset. Therefore, the increase in the HF index may have been due to the increase in physical activity. An increase in physical activity suggests that the quality of sleep early in the sleep cycle may be improved, which may affect the patient's prognosis.",2020,The physical activity increased in 28 patients (increase group) and decreased in 20 patients (decrease group) after 6 months.,['patients with hypertension and/or stable angina pectoris'],[],"['HF index', 'high-frequency (HF) heart rate variability (HRV', 'Physical activity and HF', 'physical activity', 'activity monitors and 24-hour Holter monitors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0182920', 'cui_str': 'Electrocardiographic monitor and recorder, device (physical object)'}]",,0.0192827,The physical activity increased in 28 patients (increase group) and decreased in 20 patients (decrease group) after 6 months.,"[{'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Nursing, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyachi', 'Affiliation': 'Chutoen General Medical Center, Kakegawa, Shizuoka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tamakoshi', 'Affiliation': 'Department of Nursing, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Negi', 'Affiliation': 'Negi Clinic, Inazawa, Aichi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Watanabe Medical Clinic, Chita, Aichi, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hirai', 'Affiliation': 'Department of Nursing, Sugiyama Jogakuen University, Nagoya, Aichi, Japan.'}]",Western journal of nursing research,['10.1177/0193945919864700']
1101,31319398,A Group Dynamics-Based Exercise Intervention to Improve Physical Activity Maintenance in Breast Cancer Survivors.,"BACKGROUND


To maintain increases in physical activity (PA), interventions that implement group dynamics principles and strategies with the intent of enhancing group cohesion may be advantageous. This study examined group cohesion and PA following a group dynamics-based PA intervention among breast cancer survivors.
METHODS


The study was designed as a pilot randomized controlled trial comparing an 8-week group dynamics-based intervention with an individually supervised intervention. Group cohesion was measured by the Physical Activity Group Environment Questionnaire, and PA was measured at baseline, post-intervention, and 3-month follow-up using a self-report questionnaire and pedometer.
RESULTS


Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555). At 3-month follow-up, 91.7% of participants in the group-dynamics-based intervention (n = 12) were classified as moderately active or greater, compared with 54.5% in the individually supervised intervention (n = 11).
CONCLUSIONS


These results suggest that, for breast cancer survivors, peer support and fostering group cohesion as part of an exercise program may help to support PA following the completion of a structured intervention. A larger trial with longer follow-up is needed to establish comparative efficacy for a group-dynamics-based exercise intervention to enhance long-term PA adherence in breast cancer survivors.",2019,"RESULTS


Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555).","['breast cancer survivors', 'Breast Cancer Survivors']","['Exercise Intervention', 'exercise intervention', 'PA following a group dynamics-based PA intervention']","['Physical Activity Group Environment Questionnaire, and PA', 'Physical Activity Maintenance']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.0254624,"RESULTS


Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leach', 'Affiliation': ''}, {'ForeName': 'Katie B', 'Initials': 'KB', 'LastName': 'Potter', 'Affiliation': ''}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Hidde', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0667']
1102,32084522,Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy.,"PURPOSE


A phase I clinical trial was designed to test the feasibility and toxicity of administering high-dose spatially fractionated radiation therapy to magnetic resonance imaging (MRI)-defined prostate tumor volumes, in addition to standard treatment.
METHODS AND MATERIALS


We enrolled 25 men with favorable to high-risk prostate cancer and 1 to 3 suspicious multiparametric MRI (mpMRI) gross tumor volumes (GTVs). The mpMRI-GTVs were treated on day 1 with 12 to 14 Gy via dose cylinders using a lattice extreme ablative dose technique. The entire prostate, along with the proximal seminal vesicles, was then treated to 76 Gy at 2 Gy/fraction. For some high-risk patients, the distal seminal vesicles and pelvic lymph nodes received 56 Gy at 1.47 Gy/fraction concurrently in 38 fractions. The total dose to the lattice extreme ablative dose cylinder volume(s) was 88 to 90 Gy (112-123 Gy in 2.0 Gy equivalents, assuming an α-to-β ratio of 3).
RESULTS


Dosimetric parameters were satisfactorily met. Median follow-up was 66 months. There were no grade 3 acute/subacute genitourinary or gastrointestinal adverse events. Maximum late genitourinary toxicity was grade 1 in 15 (60%), grade 2 in 4 (16%), and grade 4 in 1 (4%; sepsis after a posttreatment transurethral resection). Maximum late gastrointestinal toxicity was grade 1 in 11 (44%) and grade 2 in 4 (16%). Two patients experienced biochemical failure.
CONCLUSIONS


External beam radiation therapy delivered with an upfront spatially fractionated, stereotactic high-dose mpMRI-GTV boost is feasible and was not associated with any unexpected events. The technique is now part of a follow-up phase II randomized trial.",2020,"Maximum late GU toxicity was Grade 1 in 15 (60%), Grade 2 in 4 (16%), and Grade 4 in 1 (4%; sepsis after a post-treatment transurethral resection).",['We enrolled 25 men with favorable to high-risk prostate cancer and 1-3 suspicious multiparametric MRI (mpMRI) gross tumor volumes (GTVs'],"['MRI-GUIDED Prostate Cancer Lattice Extreme Ablative Dose (LEAD', 'BOOST Radiotherapy', 'Lattice Extreme Ablative Dose (LEAD) technique', 'PHASE']","['biochemical failure', 'grade 3 acute/subacute genitourinary (GU) or gastrointestinal (GI) adverse events', 'Maximum late GU toxicity', 'feasibility and toxicity', 'Maximum late GI toxicity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume (observable entity)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",25.0,0.038764,"Maximum late GU toxicity was Grade 1 in 15 (60%), Grade 2 in 4 (16%), and Grade 4 in 1 (4%; sepsis after a post-treatment transurethral resection).","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: apollack@med.miami.edu.'}, {'ForeName': 'Felix M', 'Initials': 'FM', 'LastName': 'Chinea', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bossart', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Deukwoo', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Departments of Public Health Sciences and Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Abramowitz', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynne', 'Affiliation': 'Departments of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Jorda', 'Affiliation': 'Departments of Pathology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Marples', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Biophysics Research Institute of America, Miami, Florida.'}, {'ForeName': 'Isildinha', 'Initials': 'I', 'LastName': 'Reis', 'Affiliation': 'Departments of Public Health Sciences and Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Studenski', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Casillas', 'Affiliation': 'Department of Radiology, University of Miami, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Stoyanova', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.052']
1103,31324597,"Pre-emptive intervention versus treatment as usual for infants showing early behavioural risk signs of autism spectrum disorder: a single-blind, randomised controlled trial.","BACKGROUND


Great interest exists in the potential efficacy of prediagnostic interventions within the autism spectrum disorder prodrome, but available evidence relates to children at high familial risk. We aimed to test the efficacy of a pre-emptive intervention designed for infants showing early behavioural signs of autism spectrum disorder.
METHODS


In this single-blind, randomised controlled trial done at two specialist centres in Australia, infants aged 9-14 months were enrolled if they were showing at least three early behavioural signs of autism spectrum disorder on the Social Attention and Communication Surveillance-Revised (SACS-R) 12-month checklist. Infants were randomly assigned (1:1) to receive a parent-mediated video-aided intervention (iBASIS-VIPP) or treatment as usual. Group allocation was done by minimisation, stratified by site, sex, age, and the number of SACS-R risk behaviours. Assessments were done at baseline (before treatment allocation) and at the 6 month endpoint. The primary outcome was Autism Observation Scale for Infants (AOSI), which measures early behavioural signs associated with autism spectrum disorder. Secondary outcomes were a range of infant and caregiver outcomes measured by Manchester Assessment of Caregiver-Infant interaction (MACI), Mullen Scales of Early Learning (MSEL), Vineland Adaptive Behaviour Scales, 2nd edition (VABS-2), MacArthur-Bates Communicative Development Inventory (MCDI), and Parenting Sense of Competence (PSOC) scale. This trial is registered with Australian New Zealand Clinical Trials Registry, number ANZCTR12616000819426.
FINDINGS


Between June 9, 2016, and March 30, 2018, 103 infants were randomly assigned, 50 to the iBASIS-VIPP group and 53 to the treatment-as-usual group. After the intervention, we observed no significant differences between groups on early autism spectrum disorder behavioural signs measured by the AOSI (difference estimate -0·74, 95% CI -2·47 to 0·98). We also observed no significant differences on secondary outcomes measuring caregiver non-directiveness (0·16, -0·33 to 0·65), caregiver sensitive responding (0·24, -0·15 to 0·63), and infant attentiveness (-0·19, -0·63 to 0·25) during parent-child interactions (MACI), as well as on researcher-administered measures of receptive (1·30, -0·48 to 3·08) and expressive language (0·54, -0·73 to 1·80), visual reception (0·31, -0·77 to 1·40), and fine motor skills (0·55, -0·32 to 1·41) using the MSEL. Compared with the treatment-as-usual group, the iBASIS-VIPP group had lower infant positive affect (-0·69, -1·27 to -0·10) on the MACI, but higher caregiver-reported receptive (37·17, 95% CI 10·59 to 63·75) and expressive vocabulary count (incidence rate ratio 2·31, 95% CI 1·22 to 4·33) on MCDI, and functional language use (difference estimate 6·43, 95% CI 1·06 to 11·81) on VABS. There were no significant group differences on caregiver-reported measures of MCDI infant gesture use (3·22, -0·60 to 7·04) and VABS social behaviour (3·28, -1·43 to 7·99). We observed no significant differences between groups on self-reported levels of parenting satisfaction (difference estimate 0·21, 95% CI -0·09 to 0·52), interest (-0·23, -0·62 to 0·16) and efficacy (-0·08, -0·38 to 0·22) on PSOC.
INTERPRETATION


A pre-emptive intervention for the autism spectrum disorder prodrome had no immediate treatment effect on early autism spectrum disorder symptoms, the quality of parent-child interactions, or researcher-administered measures of developmental skills. However, we found a positive effect on parent-rated infant communication skills. Ongoing follow-up of this infant cohort will assess longer-term developmental effects.
FUNDING


Western Australia Children's Research Fund, Autism Cooperative Research Centre, La Trobe University, and Angela Wright Bennett Foundation.",2019,"After the intervention, we observed no significant differences between groups on early autism spectrum disorder behavioural signs measured by the AOSI (difference estimate -0·74, 95% CI -2·47 to 0·98).","['infants showing early behavioural signs of autism spectrum disorder', 'infants showing early behavioural risk signs of autism spectrum disorder', 'Between June 9, 2016, and March 30, 2018', 'two specialist centres in Australia, infants aged 9-14 months were enrolled if they were showing at least three early behavioural signs of autism spectrum disorder on the Social Attention and Communication Surveillance-Revised (SACS-R) 12-month checklist', '103 infants']","['pre-emptive intervention', 'prediagnostic interventions', 'parent-mediated video-aided intervention (iBASIS-VIPP) or treatment as usual', 'Pre-emptive intervention', 'iBASIS-VIPP']","['parenting satisfaction', 'early autism spectrum disorder behavioural signs', 'MCDI, and functional language use', 'Autism Observation Scale for Infants (AOSI), which measures early behavioural signs associated with autism spectrum disorder', 'range of infant and caregiver outcomes measured by Manchester Assessment of Caregiver-Infant interaction (MACI), Mullen Scales of Early Learning (MSEL), Vineland Adaptive Behaviour Scales, 2nd edition (VABS-2), MacArthur-Bates Communicative Development Inventory (MCDI), and Parenting Sense of Competence (PSOC) scale', 'MCDI infant gesture use (3·22, -0·60 to 7·04) and VABS social behaviour', 'VABS', 'secondary outcomes measuring caregiver non-directiveness (0·16, -0·33 to 0·65), caregiver sensitive responding (0·24, -0·15 to 0·63), and infant attentiveness (-0·19, -0·63 to 0·25) during parent-child interactions (MACI), as well as on researcher-administered measures of receptive (1·30, -0·48 to 3·08) and expressive language (0·54, -0·73 to 1·80), visual reception (0·31, -0·77 to 1·40), and fine motor skills']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1444514', 'cui_str': 'Communication surveillance'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",103.0,0.392064,"After the intervention, we observed no significant differences between groups on early autism spectrum disorder behavioural signs measured by the AOSI (difference estimate -0·74, 95% CI -2·47 to 0·98).","[{'ForeName': 'Andrew J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia; Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia. Electronic address: andrew.whitehouse@telethonkids.org.au.'}, {'ForeName': 'Kandice J', 'Initials': 'KJ', 'LastName': 'Varcin', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Alvares', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Barbaro', 'Affiliation': 'Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bent', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Boutrus', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia; Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; School of Psychological Science, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Chetcuti', 'Affiliation': 'Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cooper', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Dimov', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Dissanayake', 'Affiliation': 'Cooperative Research Centre for Living with Autism (Autism CRC), Indooroopilly, QLD, Australia; Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Doyle', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Grant', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Iacono', 'Affiliation': 'La Trobe Rural Health School, Bendigo, VIC, Australia.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Maybery', 'Affiliation': 'School of Psychological Science, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pillar', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Renton', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, WA, Australia; Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Rowbottam', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sadka', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Segal', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Children's Neurosciences, Evelina London Children's Hospital, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, London, UK.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wakeling', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}, {'ForeName': 'Ming Wai', 'Initials': 'MW', 'LastName': 'Wan', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wray', 'Affiliation': 'Child and Adolescent Health Service, Child Development Service, West Perth, WA, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, University of Manchester, Manchester, UK; Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Greater Manchester Mental Health NHS Trust, Manchester, UK.'}, {'ForeName': 'Kristelle', 'Initials': 'K', 'LastName': 'Hudry', 'Affiliation': 'Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30184-1']
1104,31220283,Interval Walking Improves Glycemic Control and Body Composition After Cancer Treatment: A Randomized Controlled Trial.,"CONTEXT


Patients with colorectal cancer have increased risk of metabolic diseases including diabetes. Exercise training may counteract metabolic dysregulation, but the impact of exercise training on glycemic control, including postprandial glycemia, has never been explored in patients with colorectal cancer.
OBJECTIVE


To examine the effects of home-based interval walking on aerobic and metabolic fitness and quality of life in patients with colorectal cancer.
DESIGN


Randomized controlled trial.
SETTING


Clinical research center.
PARTICIPANTS


Thirty-nine sedentary (<150 minutes moderate-intensity exercise per week) patients with stage I to III colorectal cancer who had completed primary treatment.
INTERVENTION


Home-based interval walking 150 min/wk or usual care for 12 weeks.
MAIN OUTCOME MEASURES


Changes from baseline to week 12 in maximum oxygen uptake (VO2peak) by cardiopulmonary exercise test, glycemic control by oral glucose tolerance test (OGTT), body composition by dual-energy x-ray absorptiometry scan, blood biochemistry, and quality of life.
RESULTS


Compared with control, interval walking had no effect on VO2peak [mean between-group difference: -0.32 mL O2 · kg-1 · min-1 (-2.09 to 1.45); P = 0.721] but significantly improved postprandial glycemic control with lower glucose OGTT area under the curve [-126 mM · min (-219 to -33); P = 0.009], 2-hour glucose concentration [-1.1 mM (-2.2 to 0.0); P = 0.056], and improved Matsuda index [1.94 (0.34; 3.54); P = 0.01]. Also, interval walking counteracted an increase in fat mass in the control group [-1.47 kg (-2.74 to -0.19); P = 0.025].
CONCLUSION


A home-based interval-walking program led to substantial improvements in postprandial glycemic control and counteracted fat gain in posttreatment patients with colorectal cancer, possibly providing an effective strategy for prevention of secondary metabolic diseases.",2019,"Compared to control, interval-walking had no effect on VO2peak (mean between-group difference: -0.32ml O2*kg-1*min-1 [-2.09; 1.45], p = 0.721) but significantly improved post-prandial glycaemic control with lower glucose OGTT-area under the curve (-126 mM*min [-219; -33], p=0.009), 2-hour glucose concentration (-1.1 mM [-2.2;0.0], p=0.056), and improved Matsuda index +1.94 [0.34; 3.54], p=0.019.","['colorectal cancer patients', 'Colorectal cancer patients', 'post-treatment colorectal cancer patients', 'after Cancer Treatment', 'Thirty-nine sedentary (less than 150 min moderate intensity exercise per week), stage I-III colorectal cancer patients, who had completed primary treatment']","['exercise training', 'Home-based interval-walking 150 min per week or usual care for 12 weeks', 'Exercise training']","['VO2peak', 'fat mass', '2-hour glucose concentration', 'VO2peak by cardiopulmonary exercise test; glycemic control by oral glucose tolerance test (OGTT); body composition by DXA-scan; blood biochemistry, and quality of life', 'Interval-Walking Improves Glycaemic Control and Body Composition']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}, {'cui': 'C0005768'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0034380'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",39.0,0.0555946,"Compared to control, interval-walking had no effect on VO2peak (mean between-group difference: -0.32ml O2*kg-1*min-1 [-2.09; 1.45], p = 0.721) but significantly improved post-prandial glycaemic control with lower glucose OGTT-area under the curve (-126 mM*min [-219; -33], p=0.009), 2-hour glucose concentration (-1.1 mM [-2.2;0.0], p=0.056), and improved Matsuda index +1.94 [0.34; 3.54], p=0.019.","[{'ForeName': 'Jesper F', 'Initials': 'JF', 'LastName': 'Christensen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sundberg', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Osterkamp', 'Affiliation': 'Department of Surgical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thorsen-Streit', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anette B', 'Initials': 'AB', 'LastName': 'Nielsen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie K', 'Initials': 'CK', 'LastName': 'Olsen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sissal S', 'Initials': 'SS', 'LastName': 'Djurhuus', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Simonsen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schauer', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kell', 'Initials': 'K', 'LastName': 'Østerlind', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter-Martin', 'Initials': 'PM', 'LastName': 'Krarup', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Mosgaard', 'Affiliation': 'Department of Oncology, Herlev and Gentofte Hospital, Copenhagen University, Herlev, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Vistisen', 'Affiliation': 'Department of Oncology, Herlev and Gentofte Hospital, Copenhagen University, Herlev, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Tolver', 'Affiliation': 'Data Science Laboratory, Department of Mathematical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Hojman', 'Affiliation': 'Centre of Inflammation and Metabolism/, Rigshospitalet, Copenhagen, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00590']
1105,32125197,"Respiratory outcomes after a 1-year treatment of obstructive sleep apnoea with bibloc versus monobloc oral appliances: a multicentre, randomized equivalence trial.","Objective:  The benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that these types of appliances would be equally effective. Material and methods:  In this multicentre, randomized equivalence trial, patients with OSA received one type of bibloc or one type of monobloc treatment. At baseline, a 1-night polygraphy study was done, and this was repeated after 1 year. The outcome was any change in the apnoea-hypopnoea index (AHI) and the limits of equivalence between the two devices were set at ±5 AHI units. Results:  Of 302 patients, 146 were randomly assigned to bibloc and 156 to monobloc appliances. In 88 and 104 patients, respectively, there were significant reductions in the AHI ( p  < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups. The proportions of responders defined as having an AHI <10 were 68% and 65% for the bibloc and monobloc groups, respectively. Treatment-related adverse events were mild, transient and the dropouts were more frequent in the bibloc group. Conclusions:  Both types of treatments positively and significantly reduced respiratory disturbances, but at the 1-year follow-up, they were not significantly different in treating OSA, with a numerically greater reduction of the AHI value with the bibloc appliance. However, the higher proportion of treatment-related adverse events and higher proportion of dropouts among bibloc users should be balanced against the advantage of a greater reduction in the AHI.",2020,"In 88 and 104 patients, respectively, there were significant reductions in the AHI ( p  < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups.","['patients with OSA received one type of bibloc or one type of monobloc treatment', 'obstructive sleep apnoea (OSA', '302 patients, 146 were randomly assigned to bibloc and 156 to monobloc appliances']","['bibloc versus monobloc oral appliances', 'bibloc over monobloc appliances']","['apnoea-hypopnoea index (AHI) and the limits of equivalence', 'obstructive sleep apnoea', 'respiratory disturbances', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0243112'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",302.0,0.112638,"In 88 and 104 patients, respectively, there were significant reductions in the AHI ( p  < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups.","[{'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Tegelberg', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Nohlert', 'Affiliation': 'Centre for Clinical Research, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bornefalk-Hermansson', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Fransson', 'Affiliation': 'Postgraduate Dental Education Center and Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Isacsson', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Västmanland County Hospital, Västerås, Sweden.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1730436']
1106,31325345,Randomized controlled trial of the effectiveness of three different oral moisturizers in palliative care patients.,"Most patients in palliative care have problems with dry mouth caused by medication or as a direct result of their condition. Dry mouth may cause problems that affect the primary disease negatively and contribute to poorer quality of life in palliative patients. This randomized controlled trial compared the efficacy of three different oral moisturizers: 17% watery solution of glycerol; oxygenated glycerol triester (marketed as Aequasyal in Europe and as Aquoral in the USA); and a newly developed product, Salient. Of the three products, glycerol provided the best relief from xerostomia directly after application, but had no effect after 2 h. By contrast, the effects of Aequasyal and Salient were largely maintained over the same period. The findings for oral discomfort and pain and speech problems showed a similar pattern. Despite its poor effect after 2 h, patients preferred glycerol over Salient and Aequasyal, probably because of the unpleasant taste of Aequasyal and the consistency and mode of application of Salient. Within the limitations of this study, none of the three products tested was found to be clinically completely adequate. However, the glycerol solution was preferred by this group of patients, and its short-lived effect can be compensated for by frequent applications.",2019,"Of the three products, glycerol provided the best relief from xerostomia directly after application, but had no effect after 2 h.","['palliative patients', 'palliative care patients']",['oral moisturizers: 17% watery solution of glycerol; oxygenated glycerol triester'],['oral discomfort and pain and speech problems'],"[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0443350', 'cui_str': 'Watery (finding)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}]","[{'cui': 'C0399459', 'cui_str': 'Discomfort in mouth (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0395016', 'cui_str': 'Speech problem (finding)'}]",,0.053966,"Of the three products, glycerol provided the best relief from xerostomia directly after application, but had no effect after 2 h.","[{'ForeName': 'Siri F', 'Initials': 'SF', 'LastName': 'Kvalheim', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mihaela C', 'Initials': 'MC', 'LastName': 'Marthinussen', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Dagny F', 'Initials': 'DF', 'LastName': 'Haugen', 'Affiliation': 'Department of Clinical Medicine K1, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Gunhild V', 'Initials': 'GV', 'LastName': 'Strand', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Stein-Atle', 'Initials': 'SA', 'LastName': 'Lie', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}]",European journal of oral sciences,['10.1111/eos.12655']
1107,31310989,Effects of a Combined Upper- and Lower-Limb Plyometric Training Program on High-Intensity Actions in Female U14 Handball Players.,"PURPOSE


To analyze the effects of a 9-week plyometric training program on the sprint times (5, 10, 20, and 30 m), change-of-direction speed (modified T test and modified Illinois test), jumping (squat jump, countermovement jump, countermovement jump with arms, and horizontal 5-jump test), upper-body strength (right and left handgrip, back extensor strength, and medicine ball throw), and balance (Y and stork balance tests) of female handball players.
METHODS


Athletes were randomly divided into experimental (n = 21; age = 13.5 [0.3] y) and control (n = 20; age = 13.3 [0.3] y) groups. Training exercises and matches were performed together, but the experimental group replaced a part of their normal regimen by biweekly upper- and lower-limb plyometric training.
RESULTS


Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
CONCLUSIONS


A plyometric training program allows female junior handball players to improve important components of their physical performance.",2019,"Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
","['Female U14 Handball Players', 'female junior handball players', 'Athletes were randomly divided into experimental (n = 21; age = 13.5 [0.3]\xa0y) and control (n = 20; age = 13.3 [0.3] y) groups']","['plyometric training program', 'experimental group replaced a part of their normal regimen by biweekly upper- and lower-limb plyometric training', 'Combined Upper- and Lower-Limb Plyometric Training Program']","['left-leg stork balance', 'change of direction', 'vertical and horizontal jumping', 'upper-limb strength', 'change-of-direction speed (modified T test and modified Illinois test), jumping (squat jump, countermovement jump, countermovement jump with arms, and horizontal 5-jump test), upper-body strength (right and left handgrip, back extensor strength, and medicine ball throw), and balance (Y and stork balance tests) of female handball players']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]",,0.00907494,"Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
","[{'ForeName': 'Mehrez', 'Initials': 'M', 'LastName': 'Hammami', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Universidad de Los Lagos.'}, {'ForeName': 'Nawel', 'Initials': 'N', 'LastName': 'Gaamouri', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Gaith', 'Initials': 'G', 'LastName': 'Aloui', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'University of ""La Manouba"".'}]",Pediatric exercise science,['10.1123/pes.2018-0278']
1108,31310990,Effect of Breaks in Prolonged Sitting or Low-Volume High-Intensity Interval Exercise on Markers of Metabolic Syndrome in Adults With Excess Body Fat: A Crossover Trial.,"BACKGROUND


This study analyzed the effect of walking breaks or low-volume high-intensity interval exercise (LV-HIIE) on markers of metabolic syndrome relative to a day of prolonged sitting.
METHODS


Twenty-five adults with excess body fat participated in this crossover trial: (1) 10-hour sitting day (SIT), (2) LV-HIIE followed by a sitting day (EX+SIT), and (3) sitting day with 5-minute walking breaks for every 20 minutes (SIT+WB). Glucose and blood pressure (BP) were measured before and 1 hour after 4 meals and 2 hours after lunch. Triglycerides were measured at baseline, 2, and 3.5 hours after lunch. Generalized mixed models were used to identify differences in the area under the curve (AUC) of BP and incremental AUC (iAUC) of glucose and triglycerides among the sessions.
RESULTS


iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2). AUC-diastolic BP was lower in SIT+WB than SIT (β = -14.1 mm Hg·10 h; 95% confidence interval, -26.5 to -1.6) and EX+SIT (β = -14.5 mm Hg·10 h; 95% confidence interval, -26.9 to -2.1). There were no differences in triglycerides and systolic BP levels among the sessions.
CONCLUSION


Adults with excess body fat present lower glucose and diastolic BP during a day with breaks in sitting time compared with a prolonged sitting day with or without an LV-HIIE session.",2019,"RESULTS


iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2).","['Twenty-five adults with excess body fat participated in this crossover trial', 'Adults With Excess Body Fat']","['Breaks in Prolonged Sitting or Low-Volume High-Intensity Interval Exercise', 'walking breaks or low-volume high-intensity interval exercise (LV-HIIE']","['Glucose and blood pressure (BP', 'area under the curve (AUC) of BP and incremental AUC (iAUC) of glucose and triglycerides', 'AUC-diastolic BP', 'Triglycerides', 'glucose and diastolic BP', 'iAUC-glucose', 'triglycerides and systolic BP levels']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",25.0,0.111075,"RESULTS


iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2).","[{'ForeName': 'Yuri Alberto', 'Initials': 'YA', 'LastName': 'Freire', 'Affiliation': ''}, {'ForeName': 'Geovani de Araújo Dantas de', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': ''}, {'ForeName': 'Rodrigo Alberto Vieira', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'Luiz Fernando', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': ''}, {'ForeName': 'Ágnes Denise de Lima', 'Initials': 'ÁDL', 'LastName': 'Bezerra', 'Affiliation': ''}, {'ForeName': 'Ana Paula Trussardi', 'Initials': 'APT', 'LastName': 'Fayh', 'Affiliation': ''}, {'ForeName': 'José Cazuza de', 'Initials': 'JC', 'LastName': 'Farias Júnior', 'Affiliation': ''}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Boreskie', 'Affiliation': ''}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Duhamel', 'Affiliation': ''}, {'ForeName': 'Eduardo Caldas', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0492']
1109,31310991,Randomized Controlled Trial of Primary Health Care Strategies for the Promotion of Leisure-Time Physical Activity Among Older Brazilians.,"BACKGROUND


Physical activity promotion within primary health care is in the spotlight. However, few studies have evaluated the long-term effectiveness of possible interventions. This study aimed to compare the effectiveness of 3 primary health care interventions in increasing leisure-time physical activity among older Brazilians.
METHODS


Experimental study with 142 older residents of an ongoing urban cohort in São Paulo (Brazil). Participants were randomized into 3 groups: minimal intervention group, physician-based counseling group, and individual counseling and referral for physical activity programs group (CRG). We used the long version of the International Physical Activity Questionnaire to assess leisure-time physical activity at baseline, 4 years after baseline without any intervention, 3 months after intervention, and 6 months after intervention. Statistical analysis included repeated analysis of variance.
RESULTS


At baseline, 31% of the individuals were active, and this figure remained stable for a period of 4 years. Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively).
CONCLUSION


Results indicate that interventions with CRG are effective in producing sustained changes in physical activity among older Brazilians.",2019,"Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively).
","['142 older residents of an ongoing urban cohort in São Paulo (Brazil', 'Older Brazilians', 'older Brazilians']","['minimal intervention group, physician-based counseling group, and individual counseling and referral for physical activity programs group (CRG', '3 primary health care interventions']",['leisure-time physical activity for CRG'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0270923,"Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively).
","[{'ForeName': 'Francini Vilela', 'Initials': 'FV', 'LastName': 'Novais', 'Affiliation': ''}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Simoes', 'Affiliation': ''}, {'ForeName': 'Chester', 'Initials': 'C', 'LastName': 'Schmaltz', 'Affiliation': ''}, {'ForeName': 'Luiz R', 'Initials': 'LR', 'LastName': 'Ramos', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2017-0502']
1110,31310993,Feasibility of a Home-Based Balance Intervention in Middle-Aged Women Using Wii Fit Plus®.,"BACKGROUND


This study evaluated the feasibility and effectiveness of a home-based exercise intervention using the Wii Fit Plus®.
METHODS


A randomized, controlled trial of 24 women (age 53.6 [5.4] y) was used to assess compliance and changes in balance over 12 weeks. Balance was measured via the Berg Balance Scale and Frailty and Injuries: Cooperative Studies of Intervention Techniques-4 Scale at baseline and week 6 and week 12. Participant compliance to the intervention was captured via paper logs and the electronic record collected by the Wii Fit Plus®.
RESULTS


Participants in the intervention group were 95% compliant based on electronic records. There were no significant differences between groups for total score on either balance scale. There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position.
CONCLUSIONS


The results suggest that the Wii Fit Plus® is appropriate for home-based interventions in middle-aged women. Modest improvements in balance indicate that this may be an effective means to improve or maintain balance in older women. More research is needed to determine compliance and benefits to reducing fall risk in durations exceeding 12 weeks.",2019,"There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position.
","['middle-aged women', 'Participants in the intervention group were 95% compliant based on electronic records', 'older women', '24 women (age 53.6 [5.4]\xa0y', 'Middle-Aged Women Using Wii Fit Plus®']","['Home-Based Balance Intervention', 'home-based exercise intervention']","['average velocity', 'total score on either balance scale', 'maximum velocity y']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0222045'}]",,0.043176,"There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position.
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Wherry', 'Affiliation': ''}, {'ForeName': 'Cheryl Der', 'Initials': 'C', 'LastName': 'Ananian', 'Affiliation': ''}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Swan', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0265']
1111,31310994,Estimated Physical Activity in Adolescents by Wrist-Worn GENEActiv Accelerometers.,"BACKGROUND


Reports of physical activity (PA) measured via wrist-worn accelerometers in adolescents are limited. This study describes PA levels in adolescents at baseline of an obesity prevention and weight management trial.
METHODS


Adolescents (n = 930) at 8 high schools wore an accelerometer for 7 days, with average acceleration values of <50 mg, >150 mg, and >500 mg categorized as sedentary, moderate, and vigorous PA, respectively. In a 3-level mixed-effects generalized linear model, PA was regressed on sex, weight status, and day of week. Daily PA was nested within students, and students within schools, with random effects included for both.
RESULTS


Adolescents accumulated a median of 40 minutes daily of moderate to vigorous PA (MVPA). MVPA was significantly different for teens with obesity versus teens with normal weight (-5.4 min/d, P = .03); boys versus girls (16.3 min/d, P < .001); and Sundays versus midweek (-16.6 min/d, P < .001). Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status.
CONCLUSIONS


Interventions to increase PA in adolescents may benefit from focusing on increasing weekend PA and increasing MVPA in girls.",2019,"Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status.
","['Adolescents (n = 930) at 8 high schools wore an accelerometer for 7 days, with average acceleration values of <50\xa0mg, >150\xa0mg, and >500\xa0mg categorized as sedentary, moderate, and vigorous PA, respectively', 'adolescents at baseline of an obesity prevention and weight management trial', 'teens with obesity versus teens with normal weight (-5.4\xa0min']",['MVPA'],"['median of 40 minutes daily of moderate to vigorous PA (MVPA', 'Average sedentary time', 'Estimated Physical Activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",930.0,0.041892,"Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status.
","[{'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Elizabeth Yakes', 'Initials': 'EY', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Natalie H', 'Initials': 'NH', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Kuhlemeier', 'Affiliation': ''}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'McCauley', 'Affiliation': ''}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': ''}, {'ForeName': 'Alberta S', 'Initials': 'AS', 'LastName': 'Kong', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0344']
1112,31330502,Effects of Suspension Versus Traditional Resistance Training on Explosive Strength in Elementary School-Aged Boys.,"PURPOSE


The aim of this study was to determine the effects of an 8-week program of resistance training (RT) or suspension training (ST) on explosive strength in prepubescent boys.
METHODS


Fifty-seven boys aged 10-11 years were assigned to 2 training groups, RT or ST or a control group (no training program). Boys trained twice weekly for 8 weeks.
RESULTS


A significant interaction was reported with a large (P < .001, ηp2=.463), medium (P < .001, ηp2=.395), and small effect sized (P ≤ .001, ηp2=.218) in the 1-kg ball throw, 3-kg ball throw, and time-at-20-m test, respectively. There was no significant interaction in the countermovement vertical jump or the standing long jump. Changes from preintervention to postintervention for the 1-kg ball throw were 5.94% and 5.82% for the ST and RT, respectively, and 8.82% and 8.14% in the 3-kg ball throw for the ST and RT, respectively. The improvement in the 20-m sprint was 1.19% for the ST and 2.33% for the RT.
CONCLUSION


Traditional RT and ST seem to be effective methods for improving explosive strength in prepubescent boys. ST could be considered as an alternative modality to optimize explosive strength training in school-based programs.",2019,There was no significant interaction in the countermovement vertical jump or the standing long jump.,"['prepubescent boys', 'Fifty-seven boys aged 10-11 years', 'Elementary School-Aged Boys']","['Suspension Versus Traditional Resistance Training', 'resistance training (RT) or suspension training (ST', 'RT or ST or a control group (no training program']","['Explosive Strength', 'countermovement vertical jump or the standing long jump', 'explosive strength', '20-m sprint']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0167912,There was no significant interaction in the countermovement vertical jump or the standing long jump.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Marta', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Alves', 'Affiliation': 'Polytechnic Institute of Beja.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Esteves', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Natalina', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Aguado-Jimenez', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Alonso-Martínez', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Mário C', 'Initials': 'MC', 'LastName': 'Marques', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}]",Pediatric exercise science,['10.1123/pes.2018-0287']
1113,31323643,"Effects of Simulated Horseback Riding on Balance, Postural Sway, and Quality of Life in Older Adults With Parkinson's Disease.","The purpose of this study was to determine changes in balance, postural sway, and quality of life after 6 wk of simulated horseback riding in adults diagnosed with Parkinson's disease. Eight older adults completed two 60-min riding sessions weekly for 6 wk. Variables of balance, postural sway, and quality of life were measured 6 wks before and within 1 wk before and after the intervention. Berg Balance Scale scores decreased from baseline to preintervention (48.36 ± 5.97 vs. 45.86 ± 6.42, p = .050) and increased from preintervention to postintervention (45.86 ± 6.42 vs. 50.00 ± 4.38, p = .002). Cognitive impairment, a dimension of quality of life, improved from baseline to postintervention (37.5 ± 20.5 vs. 21.5 ± 14.4, p = .007). Six weeks of simulated horseback riding may improve balance and cognitive impairment in older adults with Parkinson's disease.",2019,"Berg Balance Scale scores decreased from baseline to preintervention (48.36 ± 5.97 vs. 45.86 ± 6.42, p = .050) and increased from preintervention to postintervention (45.86 ± 6.42 vs. 50.00 ± 4.38, p = .002).","[""older adults with Parkinson's disease"", ""adults diagnosed with Parkinson's disease"", ""Older Adults With Parkinson's Disease"", 'Eight older adults']","['Simulated Horseback Riding', 'simulated horseback riding']","['balance and cognitive impairment', 'Berg Balance Scale scores', 'Cognitive impairment, a dimension of quality of life', 'Balance, Postural Sway, and Quality of Life', 'Variables of balance, postural sway, and quality of life', 'balance, postural sway, and quality of life']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]",[],"[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",8.0,0.0392512,"Berg Balance Scale scores decreased from baseline to preintervention (48.36 ± 5.97 vs. 45.86 ± 6.42, p = .050) and increased from preintervention to postintervention (45.86 ± 6.42 vs. 50.00 ± 4.38, p = .002).","[{'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Goudy', 'Affiliation': ""Texas Woman's University.""}, {'ForeName': 'Brandon Rhett', 'Initials': 'BR', 'LastName': 'Rigby', 'Affiliation': ""Texas Woman's University.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Silliman-French', 'Affiliation': ""Texas Woman's University.""}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Becker', 'Affiliation': ""Texas Woman's University.""}]",Adapted physical activity quarterly : APAQ,['10.1123/apaq.2019-0008']
1114,31323644,Effects of a 12-Week Exercise Intervention on Subsequent Compensatory Behaviors in Adolescent Girls: An Exploratory Study.,"PURPOSE


Chronic exercise programs can induce adaptive compensatory behavioral responses through increased energy intake (EI) and/or decreased free-living physical activity in adults. These responses can negate the benefits of an exercise-induced energy deficit; however, it is unclear whether young people experience similar responses. This study examined whether exercise-induced compensation occurs in adolescent girls.
METHODS


Twenty-three adolescent girls, heterogeneous for weight status, completed the study. Eleven adolescent girls aged 13 years completed a 12-week supervised exercise intervention (EX). Twelve body size-matched girls comprised the nonexercise control group (CON). Body composition, EI, free-living energy expenditure (EE), and peak oxygen uptake (V˙O2) were measured repeatedly over the intervention.
RESULTS


Laboratory EI (EX: 9027, 9610, and 9243 kJ·d-1 and CON: 9953, 9770, and 10,052 kJ·d-1 at 0, 12, and 18 wk, respectively; effect size [ES] = 0.26, P = .46) and free-living EI (EX: 7288, 6412, and 5273, 4916 kJ·d-1 and CON: 7227, 7128, and 6470, 6337 kJ·d-1 at 0, 6, 12, and 18 wk, respectively; ES ≤ 0.26, P = .90) did not change significantly over time and were similar between groups across the duration of the study. Free-living EE was higher in EX than CON (13,295 vs 12,115 kJ·d-1, ES ≥ 0.88, P ≥ .16), but no significant condition by time interactions were observed (P ≥ .17).
CONCLUSION


The current findings indicate that compensatory changes in EI and EE behaviors did not occur at a group level within a small cohort of adolescent girls. However, analysis at the individual level highlights large interindividual variability in behaviors, which suggests a larger study may be prudent to extend this initial exploratory research.",2019,"Free-living EE was higher in EX than CON (13,295 vs 12,115 kJ·d-1, ES ≥ 0.88, P ≥ .16), but no significant condition by time interactions were observed (P ≥ .17).
","['adults', 'Twenty-three adolescent girls, heterogeneous for weight status, completed the study', 'Adolescent Girls', 'adolescent girls', 'Eleven adolescent girls aged 13 years']","['12-Week Exercise Intervention', 'nonexercise control group (CON', 'supervised exercise intervention (EX']","['Body composition, EI, free-living energy expenditure (EE), and peak oxygen uptake (V˙O2', 'Free-living EE', 'free-living EI', 'EI and EE behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",23.0,0.0208356,"Free-living EE was higher in EX than CON (13,295 vs 12,115 kJ·d-1, ES ≥ 0.88, P ≥ .16), but no significant condition by time interactions were observed (P ≥ .17).
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Massie', 'Affiliation': 'Loughborough University.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Smallcombe', 'Affiliation': 'Loughborough University.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tolfrey', 'Affiliation': 'Loughborough University.'}]",Pediatric exercise science,['10.1123/pes.2019-0012']
1115,31321427,The effect of medication cost transparency alerts on prescriber behavior.,"OBJECTIVE


The purpose of this study was to determine if medication cost transparency alerts provided at time of prescribing led ambulatory prescribers to reduce their use of low-value medications.
MATERIALS AND METHODS


Provider-level alerts were deployed to ambulatory practices of a single health system from February 2018 through April 2018. Practice sites included 58 primary care and 152 specialty care clinics totaling 1896 attending physicians, residents, and advanced practice nurses throughout western Washington. Prescribers in the randomly assigned intervention arm received a computerized alert whenever they ordered a medication among 4 high-cost medication classes. For each class, a lower cost, equally effective, and safe alternative was available. The primary outcome was the change in prescribing volume for each of the 4 selected medication classes during the 12-week intervention period relative to a prior 24-week baseline.
RESULTS


A total of 15 456 prescriptions for high-cost medications were written during the baseline period including 7223 in the intervention arm and 8233 in the control arm. During the intervention period, a decrease in daily prescribing volume was noted for all high-cost medications including 33% for clobetasol propionate (p < .0001), 59% for doxycycline hyclate (p < .0001), 43% for fluoxetine tablets (p < .0001), and a non-significant 3% decrease for high-cost triptans (p = .65). Prescribing volume for the high-cost medications overall decreased by 32% (p < .0001).
CONCLUSION


Medication cost transparency alerts in an ambulatory setting lead to more cost-conscious prescribing. Future work is needed to predict which alerts will be most effective.",2019,"Prescribing volume for the high-cost medications overall decreased by 32% (p < .0001).
","['prescriber behavior', '58 primary care and 152 specialty care clinics totaling 1896 attending physicians, residents, and advanced practice nurses throughout western Washington', 'Provider-level alerts were deployed to ambulatory practices of a single health system from February 2018 through April 2018']","['doxycycline', 'computerized alert whenever they ordered a medication among 4 high-cost medication classes', 'fluoxetine']","['change in prescribing volume for each of the 4 selected medication classes', 'high-cost triptans', 'daily prescribing volume']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1567966', 'cui_str': 'Triptans'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",58.0,0.0200453,"Prescribing volume for the high-cost medications overall decreased by 32% (p < .0001).
","[{'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Monsen', 'Affiliation': 'Center for Analytics and Informatics, Atrius Health, Newton, Massachusetts, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Liao', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Gaster', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Flynn', 'Affiliation': 'Department of Pharmacy Services, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Payne', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, Washington, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz025']
1116,31127818,Effect of Macronutrient Type and Gastrointestinal Release Site on PYY Response in Normal Healthy Subjects.,"BACKGROUND AND AIMS


Enteroendocrine L cells release satiety inducing hormones in response to stimulation by luminal macronutrients. We sought to profile the differential effect of macronutrient type and site of release on circulating concentrations of the L cell-derived enteroendocrine hormone peptide tyrosine tyrosine (amino acids 1 to 36) (PYY).
MATERIALS AND METHODS


Eight healthy volunteers were recruited to a randomized, double-blinded, six-way crossover study. At each visit, the participants consumed a 500-kcal drink containing carbohydrate, protein, or fat in either gastric or small intestinal release formulations. Plasma PYY concentrations and hunger ratings were assessed for 3 hours after consumption of the test drink. The food intake was recorded thereafter at an ad libitum lunch.
RESULTS


Microcapsular formulations targeting the distal small intestinal delivery of fat, but not carbohydrate or protein, markedly enhance PYY release relative to macronutrient delivery in gastric release formulations. Food intake at an ad libitum meal was lowest after consumption of the formulation releasing fat at the distal small intestine.
CONCLUSION


Targeting of fat to the distal small intestine in delayed release microcapsules enhanced PYY release and was associated with reductions in food intake.",2019,Targeting of fat to the distal small intestine in delayed release microcapsules enhances PYY release and is associated with reductions in food intake.,"['Eight healthy volunteers', 'Normal Healthy Subjects']","['500 kilocalorie drink containing either carbohydrate, protein or fat, in either gastric or small intestinal release formulations', 'Macronutrient Type and Gastrointestinal Release Site']","['Plasma PYY concentrations and hunger ratings', 'Food intake']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",8.0,0.121913,Targeting of fat to the distal small intestine in delayed release microcapsules enhances PYY release and is associated with reductions in food intake.,"[{'ForeName': 'Aisling M', 'Initials': 'AM', 'LastName': 'Mangan', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al Najim', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'McNamara', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Martin', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Andrius', 'Initials': 'A', 'LastName': 'Antanaitis', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sinéad B', 'Initials': 'SB', 'LastName': 'Bleiel', 'Affiliation': 'AnaBio Technologies Ltd., R&D Centre of Excellence and Production, Carrigtwohill, Ireland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kent', 'Affiliation': 'AnaBio Technologies Ltd., R&D Centre of Excellence and Production, Carrigtwohill, Ireland.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Neil G', 'Initials': 'NG', 'LastName': 'Docherty', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-01697']
1117,28753136,"Implementation of a Personalized, Cost-Effective Physical Therapy Approach (Coach2Move) for Older Adults: Barriers and Facilitators.","BACKGROUND AND PURPOSE


This article reports on a recent randomized clinical trial that showed a personalized approach to physical therapy (Coach2Move) by a physical therapist specialized in geriatrics (PTG) to be more cost-effective than usual physical therapy care in people with mobility problems (n = 130, mean age = 78 years).
METHODS


We used an explanatory mixed-methods sequential design alongside the randomized clinical trial to gain insight into (a) the contrast between the 2 interventions, (b) the fidelity of the Coach2Move delivery; (c) PTGs' experiences of Coach2Move; and (d) possible barriers and facilitators for future implementation. The study included 13 PTGs educated in the strategy and 13 physical therapists with expertise in geriatrics delivering the usual care. In total, 106 medical records were available for assessment: 57 (85%) Coach2Move, 49 (75%) usual care. Quantitative process indicators were used to analyze electronic medical records to determine contrasts in the phases of clinical reasoning. The fidelity of the delivery was tested using indicator scores focusing on 4 key elements of Coach2Move. In-depth interviews with Coach2Move therapists were thematically analyzed to explore experiences and facilitators/barriers related to implementation.
RESULTS AND DISCUSSION


Indicator scores showed significant and clinically relevant contrasts in all phases of clinical reasoning, with consistently higher scores among PTGs, except for the treatment plan. Moreover, the fidelity of Coach2Move delivery was more than 70% in all phases, except the evaluation phase (53%). Experiences of Coach2Move were positive. In particular, extended intake allowing motivational interviewing, physical examination and an in-depth problem analysis, and shared goal setting were considered valuable. Facilitators for implementation were the addition of a Coach2Move medical record, frequent coaching by the researcher, and readiness to change in the therapist. Barriers were (1) having to use 2 parallel electronic medical record systems, (2) having to clear the calendar to schedule an intake of 90 minutes, (3) fear of losing income, (4) the sense that patients do not want to change their lifestyle, and (5) not acknowledging that increasing physical activity is an important goal for older adults with mobility problems.
CONCLUSIONS


Physical therapy based on the Coach2Move strategy is substantially different from usual care. Future implementation should focus on increasing regular evaluation and feedback, taking into account individuals' contextual factors, and improving organizational facilities while mitigating income loss.",2019,"Moreover, the fidelity of Coach2Move delivery was more than 70% in all phases, except the evaluation phase (53%).","['In total, 106 medical records were available for assessment: 57 (85%) Coach2Move, 49 (75%) usual care', 'Older Adults', 'older adults with mobility problems', '13 PTGs educated in the strategy and 13 physical therapists with expertise in geriatrics delivering the usual care', 'people with mobility problems (n = 130, mean age = 78 years']","['personalized approach to physical therapy (Coach2Move) by a physical therapist specialized in geriatrics (PTG', 'Personalized, Cost-Effective Physical Therapy Approach (Coach2Move']",['fidelity of Coach2Move delivery'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",130.0,0.0336624,"Moreover, the fidelity of Coach2Move delivery was more than 70% in all phases, except the evaluation phase (53%).","[{'ForeName': 'Arjan J W', 'Initials': 'AJW', 'LastName': 'van de Sant', 'Affiliation': 'Physiotherapy Department, Pantein Healthcare, Boxmeer, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hoogeboom', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, IQ Healthcare, Nijmegen, the Netherlands.'}, {'ForeName': 'Maria W G', 'Initials': 'MWG', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, IQ Healthcare, Nijmegen, the Netherlands.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000140']
1118,30936281,Association Between Enthesitis and Health-related Quality of Life in Psoriatic Arthritis in Biologic-naive Patients from 2 Phase III Ustekinumab Trials.,"OBJECTIVE


Evaluate enthesitis, physical function, and health-related quality of life (HRQOL) among patients with psoriatic arthritis (PsA) who are naive to anti-tumor necrosis factor agents.
METHODS


In PSUMMIT 1 and 2, patients with PsA were randomized to placebo or ustekinumab 45 mg or 90 mg. Enthesitis was assessed at weeks 0 and 24 (Maastricht Ankylosing Spondylitis Enthesitis Score). Assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study Short Form-36 (SF-36) physical component summary/mental component summary (PCS/MCS), and American College of Rheumatology 20 (ACR20).
RESULTS


At Week 24, 21 had worsened enthesitis, 158 had improved enthesitis, and 412 had unchanged enthesitis. Improved enthesitis was associated with improvements in HAQ-DI and SF-36 MCS. Results were similar for ACR20 responders and nonresponders.
CONCLUSION


Improvement in enthesitis at Week 24 was associated with improvements in physical function/HRQOL regardless of ACR20 response.",2019,Improved enthesitis was associated with improvements in HAQ-DI and SF-36 MCS.,[],['placebo or ustekinumab'],"['HAQ-DI, SF-36 PCS/MCS, and ACR20', 'physical function/HRQoL regardless of ACR20 response', 'HAQ-DI and SF-36 MCS']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.0643364,Improved enthesitis was associated with improvements in HAQ-DI and SF-36 MCS.,"[{'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA. Iain.McInnes@glasgow.ac.uk.""}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Ritchlin', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'G James', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': ""From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.""}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of rheumatology,['10.3899/jrheum.180792']
1119,31175711,Short-term effects of perindopril-amlodipine vs perindopril-indapamide on blood pressure control in sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension: A double-blinded randomized controlled trial.,"Poor blood pressure (BP) control contributes to complications in sub-Saharan African (SSA) type 2 diabetic individuals. Experts have advocated the use of combination therapies for effective BP control in these patients. The suggested combinations should include a RAAS antagonist and either a CCB or a thiazide diuretic; however, their efficacy is yet to be established in SSA. We investigated the short-term effects of two combination therapies on BP control in SSA type 2 diabetic individuals. This was a double-blinded randomized controlled trial conducted at the Yaoundé Central Hospital (Cameroon) from October 2016 to May 2017. We included type 2 diabetic patients, newly diagnosed for hypertension. After baseline assessment and 24-hour ABPM, participants were allocated to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide for 42 days. Data analyses followed the intention-to-treat principle. We included fifteen participants (8 being females) in each group. Both combinations provided good circadian BP control after 6 weeks with similar efficacy. Twenty-four-hour SBP dropped from 144 to 145 mm Hg vs 128 to 126 mm Hg with perindopril-amlodipine and perindopril-indapamide, respectively (P = 0.003 for both groups). Twenty-four-hour DBP dropped from 85 to 78 mm Hg (P = 0.013) vs 89 to 79 mm Hg (P = 0.006) in the same respective groups. No significant adverse effect was reported. A fixed initial combination of perindopril-amlodipine or perindopril-indapamide achieved similar effective BP control after 6 weeks in SSA type 2 diabetic individuals with newly diagnosed hypertension. Therefore, these combinations can be used interchangeably in this indication.",2019,Twenty-four-hour DBP dropped from 85 to 78 mm Hg (P = 0.013) vs 89 to 79 mm Hg (P = 0.006) in the same respective groups.,"['sub-Saharan African (SSA) type 2 diabetic individuals', 'type 2 diabetic patients, newly diagnosed for hypertension', 'Yaoundé Central Hospital (Cameroon) from October 2016 to May 2017', 'fifteen participants (8 being females) in each group', 'Hg vs 128 to 126\xa0mm', 'SSA type 2 diabetic individuals', 'sub-Saharan type 2 diabetic individuals newly diagnosed for hypertension', 'SSA type 2 diabetic individuals with newly diagnosed hypertension']","['perindopril-amlodipine and perindopril-indapamide', 'perindopril-amlodipine vs perindopril-indapamide', 'perindopril\xa0+\xa0amlodipine or perindopril\xa0+\xa0indapamide', 'perindopril-amlodipine or perindopril-indapamide']","['blood pressure control', 'Poor blood pressure (BP', 'adverse effect', 'effective BP control']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",15.0,0.426857,Twenty-four-hour DBP dropped from 85 to 78 mm Hg (P = 0.013) vs 89 to 79 mm Hg (P = 0.006) in the same respective groups.,"[{'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Sobngwi', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Mfeukeu-Kuate', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Merveille', 'Initials': 'M', 'LastName': 'Kouam', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Aurel T', 'Initials': 'AT', 'LastName': 'Tankeu', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Nganou-Gnindjio', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Ba', 'Initials': 'B', 'LastName': 'Hamadou', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Etoa', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Ngassam', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nkamgna', 'Affiliation': 'National Obesity Center, Yaoundé Central Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Mesmin Y', 'Initials': 'MY', 'LastName': 'Dehayem', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'François F', 'Initials': 'FF', 'LastName': 'Kaze', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}, {'ForeName': 'Andre P', 'Initials': 'AP', 'LastName': 'Kengne', 'Affiliation': 'Non-Communicable Diseases Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Mbanya', 'Affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13557']
1120,29027564,"Correction to: Complete mucosal healing of distal lesions induced by twice-daily budesonide 2-mg foam promoted clinical remission of mild-to-moderate ulcerative colitis with distal active inflammation: double-blind, randomized study.","In Fig. 2(c) of this article, the length of the ""95% CI difference bars"" under the items labelled ""Left-sided and Pancolitis"" and ""Left-sided"" under the heading ""Disease type"" was corrected. The correct figure is shown in the following page.",2018,"2(c) of this article, the length of the ""95% CI difference bars"" under the items labelled ""Left-sided and Pancolitis"" and ""Left-sided"" under the heading ""Disease type"" was corrected.",['mild-to-moderate ulcerative colitis with distal active inflammation'],[],['clinical remission'],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0333361', 'cui_str': 'Polymorphonuclear leukocyte infiltration'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.132671,"2(c) of this article, the length of the ""95% CI difference bars"" under the items labelled ""Left-sided and Pancolitis"" and ""Left-sided"" under the heading ""Disease type"" was corrected.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Naganuma', 'Affiliation': 'Department of Gastroenterology and Hepatology, School of Medicine, Keio University, Shinanomachi 35, Shinjuku-ku, Tokyo, 160-0016, Japan. maknaganuma@gmail.com.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Aoyama', 'Affiliation': 'Gastrointestinal Endoscopy and Inflammatory Bowel Disease Center, Aoyama Medical Clinic, Hyogo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Tada', 'Affiliation': 'Tada Tomohiro Institute of Gastroenterology and Proctology, Saitama, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Research and Development Center for New Medical Frontiers, School of Medicine, Kitasato University, Kanagawa, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology and Hepatology, School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-017-1399-x']
1121,31255456,Clinical and radiological outcomes between biportal endoscopic decompression and microscopic decompression in lumbar spinal stenosis.,"BACKGROUND CONTEXT


Numerous minimal invasive techniques treating lumbar spinal stenosis have been introduced. Clinical results using biportal endoscopic spinal surgery has recently been introduced as a treatment option for lumbar spinal stenosis. The purpose of this study was to compare the clinical and radiologic outcome between microscopic unilateral laminotomy bilateral decompression and biportal endoscopic unilateral laminotomy bilateral decompression in patients with degenerative lumbar spinal stenosis.
METHOD


A total of 89 patients were evaluated for this study. Only single-level patients were enrolled for accurate comparison. Patients that underwent biportal endoscopic surgery were assigned to Group A, and patients that underwent microscopic surgery were designated Group B. Clinical outcomes were evaluated using modified Macnab criteria, Oswestry Disability Index, and Visual Analog Scale. Postoperative complications were checked until final follow up. Plain radiographs before and after surgery were compared to analyze the change of alignment.
RESULT


There was a significant difference between Group A and B in VAS of back on postoperative 2 months. Other clinical measurements except for postoperative 2 months VAS of back showed no significant difference. There were no significant differences between Group A and Group B regarding preoperative and postoperative radiological findings.
CONCLUSION


Two different decompression techniques preserve the spinal structure and exhibit a favorable clinical outcome and have the advantage of not causing postoperative instability in the short term follow up. Biportal endoscopic surgery may leads to less postoperative back pain than microscopic surgery, which may allow early ambulation and shorter hospitalization period.",2020,"There were no significant differences between Group A and Group B regarding preoperative and postoperative radiological findings.
","['lumbar spinal stenosis', 'patients with degenerative lumbar spinal stenosis', 'A total of 89 patients']","['biportal endoscopic surgery', 'Biportal endoscopic surgery', 'biportal endoscopic spinal surgery', 'microscopic unilateral laminotomy bilateral decompression and biportal endoscopic unilateral laminotomy bilateral decompression', 'biportal endoscopic decompression and microscopic decompression']","['postoperative back pain', 'modified Macnab criteria, Oswestry Disability Index, and Visual Analog Scale', 'Postoperative complications']","[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0410636', 'cui_str': 'Degenerative lumbar spinal stenosis (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",89.0,0.0358918,"There were no significant differences between Group A and Group B regarding preoperative and postoperative radiological findings.
","[{'ForeName': 'Woo-Kie', 'Initials': 'WK', 'LastName': 'Min', 'Affiliation': 'Department of Orthopedic Surgery, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Republic of Korea.'}, {'ForeName': 'Ju-Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Himnaera Hospital, Pusan, Republic of Korea. Electronic address: dspfuture@hanmail.net.'}, {'ForeName': 'Dae-Jung', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Himnaera Hospital, Pusan, Republic of Korea.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Chungnam National University, School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Orthopedic Surgery, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Republic of Korea.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2019.05.022']
1122,31287437,Intratympanic Steroid Treatment of Bell's Palsy in Patients with Comorbid Disease: A Preliminary Report.,"OBJECTIVES


This study evaluated the efficacy of intratympanic steroid injection (ITSI)as initial treatment and therecovery speed for Bell's palsy (BP)inpatients with diabetes mellitus (DM)and/or hypertension (HT).
MATERIALS AND METHODS


In total,90 patients with comorbid diseases diagnosed with BP received either ITSI (study group, n=61) or systemic steroid treatment (SST) (control group, n=29).The facial nerve function was assessed using the House-Brackmann (HB) grading system for up to 6 months or until complete recovery from BP. To investigate a relationship with the complete recovery time from BP, hematologic and baseline characteristic parameters were analyzed.
RESULTS


The complete recovery rate of the ITSI and SST groups was 47.5% and 44.8% at the 1st month, 70.5% and 89.7% at the 3rd month, and 96.7% and 100% at the 6th month of the study, respectively. Lymphocyte and neutrophil values were significantly associated with the complete recovery time from BP. No major adverse events from ITSI itself were noticed during the procedure and during the follow-up of the treatment.
CONCLUSION


Both treatment types have no superiorities over each other in initial treatment for BP in patients with comorbid diseases. ITSI is effective and safe and may avoid the unwanted side effects associated with systemic steroids inthese patients.",2020,"No major adverse events from ITSI itself were noticed during the procedure and during the follow-up of the treatment.
","['patients with comorbid diseases', 'Patients with Comorbid Disease', 'total,90 patients with comorbid diseases diagnosed with BP received either', ""Bell's palsy (BP)inpatients with diabetes mellitus (DM)and/or hypertension (HT""]","['systemic steroid treatment (SST) (control group, n=29).The facial nerve function was assessed using the House-Brackmann (HB) grading system', 'ITSI', 'intratympanic steroid injection (ITSI)as initial treatment']","['complete recovery rate', 'Lymphocyte and neutrophil values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376175', 'cui_str': 'Facial Paralysis, Idiopathic'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234290', 'cui_str': 'Seventh cranial nerve function (observable entity)'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.028857,"No major adverse events from ITSI itself were noticed during the procedure and during the follow-up of the treatment.
","[{'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Demir', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Genç', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Güven', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Mahmut Sinan', 'Initials': 'MS', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kara', 'Affiliation': 'Department of Otorhinolaryngology, Sakarya University School of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Ünal', 'Initials': 'Ü', 'LastName': 'Erkorkmaz', 'Affiliation': 'Department of Biostatistics, Sakarya University School of Medicine, Sakarya, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2019.5415']
1123,31277968,Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial.,"INTRODUCTION


Despite the importance of using penile injections as part of a penile rehabilitation program, men have difficulty complying with these programs.
AIM


To test a novel psychological intervention based on Acceptance and Commitment Therapy for erectile dysfunction (ACT-ED) to help men utilize penile injections.
METHODS


This pilot randomized controlled trial (RCT) recruited men who were beginning a standard care (SC) structured penile rehabilitation program following radical prostatectomy. The SC program instructed patients to use penile injections 2 to 3 times per week. Participants were randomized to SC+ACT-ED or SC+enhanced monitoring (EM). Over 4 months, patients in the SC+ACT-ED group received SC plus 4 ACT sessions and 3 ACT phone calls; those in the EM group received SC plus 7 phone calls from an experienced sexual medicine nurse practitioner. Participants were assessed at study entry and at 4 and 8 months. For this pilot study, the goal was to determine initial efficacy (ie, effect sizes, where d = 0.2 is small, d = 0.5 is medium, and d = 0.8 is large).
MAIN OUTCOME MEASURE


Primary outcomes were feasibility and use of penile injections. Secondary outcomes were ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret.
RESULTS


The 53 participants were randomized (ACT, n = 26; EM, n = 27). The study acceptance rate was 61%. At 4 months, the ACT-ED group utilized more penile injections per week (1.7) compared to the EM group (0.9) (d = 1.25; P = .001) and was more adherent to penile rehabilitation compared to the EM group (ACT, 44%; EM, 10%; relative risk [RR], 4.4; P = .02). These gains were maintained at 8 months for injections per week (ACT, 1.2; EM, 0.7; d = 1.08; P = .03) and approached significance for adherence (ACT, 18%; EM, 0%; P = .10). At 4 months, ACT-ED, compared to EM, reported moderate effects for greater satisfaction with ED treatment (d = 0.41; P = .22), greater sexual self-esteem (d = 0.54; P = .07) and sexual confidence (d = 0.48; P = .07), lower sexual bother (d = 0.43; P = .17), and lower prostate cancer treatment regret (d = 0.74; P = .02). At 8 months, moderate effects in favor of ACT-ED were maintained for greater sexual self-esteem (d = 0.40; P = .19) and less treatment regret (d = 0.47; P = .16).
CLINICAL IMPLICATIONS


ACT concepts may help men utilize penile injections and cope with the effects of ED.
STRENGTHS AND LIMITATIONS


Strengths include use of an innovative intervention utilizing ACT concepts and pilot RCT. Limitations include the pilot nature of the study (eg, small samples size, lack of statistical power).
CONCLUSION


ACT-ED is feasible and significantly increases the use of penile injections. ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret. Nelson CJ, Saracino RM, Napolitano S, et al. Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial. J Sex Med 2019; 19:1398-1408.",2019,ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret.,['53 participants'],"['standard care (SC) structured penile rehabilitation program following radical prostatectomy', 'Penile Injection Therapy-Based Rehabilitation', 'novel psychological intervention based on Acceptance and Commitment Therapy', 'SC+ACT-ED or SC+enhanced monitoring (EM']","['acceptance rate', 'ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret', 'lower prostate cancer treatment regret', 'treatment regret', 'adherent to penile rehabilitation', 'initial efficacy', 'sexual confidence', 'lower sexual bother', 'feasibility and use of penile injections', 'sexual self-esteem', 'greater sexual self-esteem']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",53.0,0.0701759,ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret.,"[{'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Electronic address: nelsonc@mskcc.org.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Saracino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Napolitano', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Pessin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Narus', 'Affiliation': 'Sexual and Reproductive Medicine Program, Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mulhall', 'Affiliation': 'Sexual and Reproductive Medicine Program, Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.013']
1124,31303572,Functional Magnetic Resonance Imaging Detects Between-Group Differences in Neural Activation Among Men with Delayed Orgasm Compared with Normal Controls: Preliminary Report.,"BACKGROUND


Mechanisms underlying delayed orgasm (DO) are poorly understood; however, known effects of psychotropic medications on sexual function provides a rationale for aberrant central nervous system signaling as a cause.
AIM


To compare brain activation between men with normal orgasm and those with lifelong DO during sexual stimulation using brain fMRI algorithms.
METHODS


3 subjects with self-reported life-long DO and 6 normal controls were included in this study. The International Index of Erectile Function, Male Sexual Health Questionnaire, and self-reported time to orgasm were used to assess sexual function. Subjects underwent a 3-T fMRI study while viewing 3 video clips: a neutral control (NC), a positive emotional control (EC), and a sexual condition (SC). Each video sequence was repeated 5 times, with 50-second clips presented in a randomized fashion. fMRI data were analyzed in a block design manner to determine areas of differential brain activation between groups. The Allen Brain Atlas of gene expression in the human brain was used to identify signaling pathways in the areas of differential fMRI activation between the DO and control groups.
OUTCOMES


The primary outcome was differential activation of fMRI neural activation between groups.
RESULTS


Analysis of differential activation in the SC compared with the NC and EC revealed increased activation in the right frontal operculum (P = .003), right prefrontal gyrus (P = .003), and inferior occipital gyrus (P = .003). Increased activation in the right fusiform gyrus of the occipital lobe and the right hippocampus (P = .0004) was seen in the DO group compared with controls. Using the Allen Atlas of Human Brain Expression, we identified corresponding neurotransmitter receptors to this region, including adenosine receptors, muscarinic and nicotinic cholinergic receptors, cannabinoid receptors, and dopamine receptors, among others.
CLINICAL IMPLICATIONS


Lifelong DO in men may be due to abnormal neurotransmitter signaling leading to poor progression of arousal due to aberrant processing of sexual cues. Identification of neurotransmitter pathways by fMRI will aid the development of pharmacotherapeutic agents.
STRENGTHS & LIMITATIONS


Strengths of this study include the novel application of functional neuroimaging to investigate the pathogenesis of DO. Limitations include the small sample size, making this study exploratory in nature.
CONCLUSION


This study revealed differences in brain activation on visualization of sexual stimuli in men with a history of DO compared with controls. Identified regions are rich in numerous neurotransmitter receptor subtypes and may be amenable to pharmacologic targeting to identify novel therapies for these men. Flannigan R, Heier L, Voss H, et al. Functional Magnetic Resonance Imaging Detects Between-Group Differences in Neural Activation Among Men with Delayed Orgasm Compared with Normal Controls: Preliminary Report. J Sex Med 2019:16;1246-1254.",2019,Increased activation in the right fusiform gyrus of the occipital lobe and the right hippocampus (P = .0004) was seen in the DO group compared with controls.,"['men with normal orgasm and those with lifelong DO during sexual stimulation using brain fMRI algorithms', 'Men with Delayed Orgasm Compared with Normal Controls', '3 subjects with self-reported life-long DO and 6 normal controls', 'men with a history of DO compared with controls']","['3-T fMRI study while viewing 3 video clips: a neutral control (NC), a positive emotional control (EC), and a sexual condition (SC']","['right prefrontal gyrus', 'brain activation', 'activation in the right frontal operculum', 'International Index of Erectile Function, Male Sexual Health Questionnaire, and self-reported time to orgasm', 'Neural Activation', 'differential activation of fMRI neural activation']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0002045'}, {'cui': 'C1112573'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1097281', 'cui_str': '3-(DMP)-T'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0149547', 'cui_str': 'Frontal operculum structure'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",,0.0505626,Increased activation in the right fusiform gyrus of the occipital lobe and the right hippocampus (P = .0004) was seen in the DO group compared with controls.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Flannigan', 'Affiliation': 'Department of Urology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Heier', 'Affiliation': 'Department of Radiology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Voss', 'Affiliation': 'Department of Radiology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'J Levi', 'Initials': 'JL', 'LastName': 'Chazen', 'Affiliation': 'Department of Radiology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Darius A', 'Initials': 'DA', 'LastName': 'Paduch', 'Affiliation': 'Department of Urology, Weill Cornell Medical College, New York, NY, USA; Consulting Research Services, Inc, North Bergen, NJ, USA. Electronic address: darius.paduch@mac.com.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.007']
1125,31283989,Effect of multichannel transcranial direct current stimulation to reduce hypertonia in individuals with prolonged disorders of consciousness: A randomized controlled pilot study.,"BACKGROUND


Spasticity management in severely brain-injured patients with disorders of consciousness (DOC) is a major challenge because it leads to complications and severe pain that can seriously affect quality of life.
OBJECTIVES


We aimed to determine the feasibility of a single session of transcranial direct current stimulations (tDCS) to reduce spasticity in chronic patients with DOC.
METHODS


We enrolled 14 patients in this double-blind, sham-controlled randomized crossover pilot study. Two cathodes were placed over the left and right primary motor cortex and 2 anodes over the left and right prefrontal cortex. Hypertonia of the upper limbs and level of consciousness were assessed by the Modified Ashworth Scale (MAS) and the Coma Recovery Scale-Revised (CRS-R). Resting state electroencephalography was also performed.
RESULTS


At the group level, spasticity was reduced in only finger flexors. Four responders (29%) showed reduced hypertonicity in at least 2 joints after active but not sham stimulation. We found no behavioural changes by the CRS-R total score. At the group level, connectivity values in beta2 were higher with active versus sham stimulation. Relative power in the theta band and connectivity in the beta band were higher for responders than non-responders after the active stimulation.
CONCLUSION


This pilot study highlights the potential benefit of using tDCS for reducing upper-limb hypertonia in patients with chronic DOC. Large-sample clinical trials are needed to optimize and validate the technique.",2019,"Relative power in the theta band and connectivity in the beta band were higher for responders than non-responders after the active stimulation.
","['patients with chronic DOC', 'severely brain-injured patients with disorders of consciousness (DOC', 'individuals with prolonged disorders of consciousness', 'chronic patients with DOC']","['tDCS', 'transcranial direct current stimulations (tDCS', 'multichannel transcranial direct current stimulation']","['connectivity values', 'CRS-R total score', 'reduced hypertonicity', 'Modified Ashworth Scale (MAS) and the Coma Recovery Scale-Revised (CRS-R', 'hypertonia', 'spasticity', 'Hypertonia of the upper limbs and level of consciousness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235396', 'cui_str': 'Hypertonicity'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0222045'}, {'cui': 'C0026826', 'cui_str': 'Hypermyotonia'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness (observable entity)'}]",2.0,0.164358,"Relative power in the theta band and connectivity in the beta band were higher for responders than non-responders after the active stimulation.
","[{'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Thibaut', 'Affiliation': 'Coma Science Group, University Hospital of Liège, Liège, Belgium; GIGA-Consciousness, University of Liège, Liège, Belgium. Electronic address: athibaut@ulg.ac.be.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Piarulli', 'Affiliation': 'Coma Science Group, University Hospital of Liège, Liège, Belgium; Department of Surgical, Medical and Molecular Pathology and Critical Care, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martens', 'Affiliation': 'Coma Science Group, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Chatelle', 'Affiliation': 'Coma Science Group, University Hospital of Liège, Liège, Belgium; GIGA-Consciousness, University of Liège, Liège, Belgium; Laboratory for NeuroImaging of Coma and Consciousness - Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Laureys', 'Affiliation': 'Coma Science Group, University Hospital of Liège, Liège, Belgium; GIGA-Consciousness, University of Liège, Liège, Belgium.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.05.009']
1126,31759938,"Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: Results of the randomized, controlled, open-label DE LAVAL study.","BACKGROUND


Lipoprotein apheresis (LA) can effectively lower lipoproteins but is an invasive procedure.
OBJECTIVE


The objective of this study was to evaluate whether evolocumab can reduce LA requirement in patients undergoing chronic LA.
METHODS


Patients on regular weekly or every-2-week LA and moderate- to high-intensity statin (if tolerated) with pre-LA low-density lipoprotein cholesterol (LDL-C) levels ≥2.6 mmol/L (100 mg/dL) to ≤4.9 mmol/L (190 mg/dL) were randomized to continue the same LA frequency, or discontinue LA and receive evolocumab 140 mg every-2-weeks subcutaneously for 6 weeks. At week 6, all patients received only open-label evolocumab for 18 weeks. The primary endpoint was LA avoidance at the end of 6 weeks based on achieving pre-LA LDL-C <2.6 mmol/L at week 4.
RESULTS


Thirty-nine patients (mean [SD] age 62 [10] years, 59% male, 82% with familial hypercholesterolemia) were randomized (evolocumab, n = 19; LA, n = 20). At the end of 6 weeks, more patients receiving evolocumab avoided LA than those receiving LA (84% vs 10%; treatment difference, 74% [95% CI: 45, 87]; P < .0001). Thirty patients (77%) did not require LA at 24 weeks. Evolocumab reduced pre-LA LDL-C by 50% from the baseline to week 4 compared with a 3% increase in the LA arm. Pre-LA LDL-C <1.8 mmol/L (70 mg/dL) was achieved by 10 patients (53%) receiving evolocumab and none receiving LA (week 4). Safety was comparable between arms.
CONCLUSION


Evolocumab treatment significantly reduced LA requirement in patients undergoing chronic LA. In addition, >50% of patients achieved LDL-C <1.8 mmol/L on evolocumab alone, demonstrating that in patients with pre-LA LDL-C ≤4.9 mmol/L, evolocumab may replace LA.",2019,Evolocumab reduced pre-LA LDL-C by 50% from the baseline to week 4 compared with a 3% increase in the LA arm.,"['Thirty-nine patients (mean [SD] age 62 [10] years, 59% male, 82% with familial hypercholesterolemia', 'patients undergoing chronic LA', 'patients undergoing chronic LA.\nMETHODS\n\n\nPatients on regular weekly or every-2-week LA and moderate- to high-intensity statin (if tolerated) with pre-LA low-density lipoprotein cholesterol (LDL-C) levels']","['discontinue LA and receive evolocumab 140\xa0mg every-2-weeks subcutaneously for 6\xa0weeks', 'Lipoprotein apheresis (LA', 'Evolocumab', 'evolocumab avoided LA', 'Pre-LA LDL-C', 'evolocumab']","['Safety', 'LA requirement', 'LA avoidance', 'lipoprotein apheresis requirement and lipid levels', 'Evolocumab reduced pre-LA LDL-C']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",39.0,0.0856299,Evolocumab reduced pre-LA LDL-C by 50% from the baseline to week 4 compared with a 3% increase in the LA arm.,"[{'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'Preventive Cardiology, Boca Raton, FL, USA. Electronic address: sjbaum@fpim.org.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Sampietro', 'Affiliation': 'Lipoapheresis Unit, Fondazione CNR Toscana Gabriele Monasterio, Pisa, Italy.'}, {'ForeName': 'Dev', 'Initials': 'D', 'LastName': 'Datta', 'Affiliation': 'Lipid Unit, University Hospital Llandough, Penarth, Cardiff, United Kingdom.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knusel', 'Affiliation': 'Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.'}, {'ForeName': 'Ransi', 'Initials': 'R', 'LastName': 'Somaratne', 'Affiliation': 'Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kurtz', 'Affiliation': 'Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hohenstein', 'Affiliation': 'Nephrological Center Villingen-Schwenningen, Villingen-Schwenningen, Germany; Extracorporeal Treatment and Lipoprotein Apheresis Center, Department of Internal Medicine III, University Hospital Carl Gustav Carus, Technische Universitaet, Dresden, Germany.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.10.003']
1127,31787586,National Lipid Association Scientific Statement on the use of icosapent ethyl in statin-treated patients with elevated triglycerides and high or very-high ASCVD risk.,"Representatives from the National Lipid Association (NLA) participated in the development of the 2018 American Heart Association/American College of Cardiology/Multisociety Guideline on the Management of Blood Cholesterol, which reaffirmed that lifestyle changes and statin treatment are therapeutic cornerstones for atherosclerotic cardiovascular disease (ASCVD) risk reduction. It also updated prior recommendations to incorporate newer data demonstrating ASCVD risk reduction with ezetimibe and proprotein convertase subtilisin kexin type 9 inhibitors as adjuncts to statin therapy for patients at high and very-high ASCVD risk. The 2018 Guideline was finalized shortly before full results were available from a randomized, placebo-controlled cardiovascular outcomes trial [Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT)] that examined the effects of icosapent ethyl (IPE) 4 g/d on major adverse cardiovascular events in selected high- or very high-risk, statin-treated patients with elevated triglycerides. The primary outcome variable of first major adverse cardiovascular event (cardiovascular death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina) was reduced by 25% (95% confidence interval 17%-32%, P < .001). REDUCE-IT served as the primary basis for the NLA's review of evidence for the use of IPE for ASCVD risk reduction. Based on this review, the NLA position is that for patients aged ≥45 years with clinical ASCVD, or aged ≥50 years with diabetes mellitus requiring medication plus ≥1 additional risk factor, with fasting triglycerides 135 to 499 mg/dL on high-intensity or maximally tolerated statin therapy (±ezetimibe), treatment with IPE is recommended for ASCVD risk reduction (evidence rating: class I; evidence level: B-R).",2019,IT served as the primary basis for the NLA's review of evidence for the use of IPE for ASCVD risk reduction.,"['patients at high and very-high ASCVD risk', 'statin-treated patients with elevated triglycerides and high or very-high ASCVD risk', 'patients aged ≥45\xa0years with clinical ASCVD, or aged ≥50\xa0years with diabetes mellitus requiring medication plus ≥1 additional risk factor, with fasting triglycerides 135 to 499\xa0mg/dL on high-intensity or maximally tolerated statin therapy (±ezetimibe), treatment with IPE is recommended for ASCVD risk reduction (evidence rating: class']","['placebo', 'icosapent ethyl (IPE) 4 g']","['first major adverse cardiovascular event (cardiovascular death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}]",2018.0,0.0487982,IT served as the primary basis for the NLA's review of evidence for the use of IPE for ASCVD risk reduction.,"[{'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Orringer', 'Affiliation': 'Miller School of Medicine, Cardiovascular Division, University of Miami, Miami, FL, USA. Electronic address: ceo20@med.miami.edu.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Jacobson', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'School of Public Health, Department of Applied Health Science, Indiana University, Bloomington, IN, USA; Midwest Biomedical Research, Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.10.014']
1128,31270101,Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial.,"BACKGROUND


Cigarette smoking increases the risk of chronic diseases; heating instead of burning tobacco can lower these risks, contributing to tobacco harm reduction. This study (with 984 adult American smokers) examined whether favorable changes occur in 8 co-primary endpoints (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL, sICAM-1, 11-DTX-B2, 8-epi-PGF2α) indicative of biological and functional effects when cigarette smokers switch to the heat-not-burn Tobacco Heating System 2.2 (THS). Additionally, these biomarkers of exposure (BoExp) were quantified: MHBMA, 3-HPMA, Total NNN, CEMA, 3-OH-B[a]P, HMPMA, Total 1-OHP, NEQ, and CO exhaled.
METHODS


Participants were randomized to continued smoking of their preferred cigarette brand ( n  = 496) or to using THS (IQOS brand;  n  = 488) for 6 months. THS has a maximum heating temperature of 350°C, delivering 1.21 mg nicotine/stick and 3.94 mg glycerin/stick under the Health Canada Intense smoking regimen.
RESULTS


The main outcome was a favorable change 6 months after baseline, with statistically significant improvements in 5 of 8 biomarkers of effect (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL) when smokers switched to THS compared with those who continued to smoke cigarettes. Likewise, BoExp were markedly reduced.
CONCLUSIONS


All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups.
IMPACT


Improvements in 5 of 8 biomarkers of effect are supportive of the research hypothesis, suggestive of disease risk reduction potential for smokers switching to THS instead of continuing to smoke cigarettes.",2019,"All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups.
","['Participants were randomized to continued smoking of their preferred cigarette brand (n = 488) or to using', '984 adult American smokers']","['THS (IQOS brand', 'THS', 'Heat-Not-Burn Tobacco Product']",['biological effects'],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",984.0,0.0149522,"All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups.
","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lüdicke', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland. frank.luedicke@pmi.com.'}, {'ForeName': 'S Michael', 'Initials': 'SM', 'LastName': 'Ansari', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lama', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Blanc', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Donelli', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Picavet', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Peitsch', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Weitkunat', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-18-0915']
1129,31268377,The effects of Psychoeducation on the Traumatic Perception of the Birth Phenomenon in women with Substance-use Disorders.,"Objective : The present study evaluates the traumatic perception of the birth phenomenon in women with substance-use disorders (SUD) and to investigate the effects of psychoeducation on this perception.  Material and Methods : The study was conducted between January and July 2017, and involved 60 women with SUD who were divided into two groups: intervention ( n  = 30) and control ( n  = 30). The study was carried out using the semi-experimental ""pre-post test matched group model,"" and the Traumatic Perception of Birth Psychoeducation Program (TPBPP) was applied.  Results : Traumatic birth perception was found to be decreased after TPBPP was applied in four modules to women with SUD.  Conclusion : TPBPP is an effective psychoeducation model in the reduction of the traumatic perception of birth in women with SUD.",2019,Conclusion : TPBPP is an effective psychoeducation model in the reduction of the traumatic perception of birth in women with SUD.,"['women with substance-use disorders (SUD', 'women with Substance-use Disorders', 'women with SUD', 'January and July 2017, and involved 60 women with SUD']","['Material and Methods ', 'Psychoeducation', 'TPBPP', 'Birth Psychoeducation Program (TPBPP']",['Traumatic birth perception'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",60.0,0.0160213,Conclusion : TPBPP is an effective psychoeducation model in the reduction of the traumatic perception of birth in women with SUD.,"[{'ForeName': 'Hacer', 'Initials': 'H', 'LastName': 'Yalnız Dilcen', 'Affiliation': 'Bartın University Faculty of Health Sciences, Midwifery Department , Turkey.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Genc', 'Affiliation': 'Faculty of Health Sciences , Midwifery Department, Ege University , Izmir , Turkey.'}]",Substance use & misuse,['10.1080/10826084.2019.1618335']
1130,31002442,An internet-delivered cognitive behavioural therapy pain management programme for spinal cord injury pain: A randomized controlled trial.,"BACKGROUND


Chronic pain is common after spinal cord injury (SCI) and dedicated SCI cognitive behavioural therapy pain management programmes (CBT-PMPs) have a growing evidence base to support their uptake clinically. The development of internet-delivered treatment options may overcome barriers to the access and uptake of centre-based programmes. This study examines such an approach on quality of lie (QoL), pain, mood and sleep.
METHODS


Adults with SCI pain (>3 months) were recruited and randomly assigned to the intervention or control group. The intervention comprised a six module CBT-PMP delivered once weekly. A blinded assessor determined changes in self-reported outcome measures post-intervention and at 3 months. Linear mixed models and effect sizes based on changes between groups were reported. Significance was set p < 0.05.
RESULTS


The recruitment rate was 32% (intervention n = 35, control n = 34), and the drop-out rate at 3 months was 26%. On average, participants accessed three (SD 2.1) of six modules. While no difference in QoL was reported, a significant group*time interaction was found for NRS of current pain (χ 2   = 8.22, p = 0.016), worst pain (χ 2   = 11.20, p = 0.004), and Brief Pain Inventory (interference) (χ 2   = 6.924, p = 0.031). Moderate to large effect sizes favouring the intervention were demonstrated at each time point for the pain metrics (Cohen's d: 0.38-0.84). At 3-month follow-up, 48% of the intervention group rated themselves improved or very much improved (p < 0.05).
CONCLUSIONS


This study demonstrates the potential of an internet-delivered SCI specific CBT-PMP in reporting significant statistical and clinical benefit in pain intensity and interference. Strategies to improve engagement are needed.",2019,Moderate to large effect sizes favouring the intervention were demonstrated at each time point for the pain metrics (Cohen's d: 0.38-0.84).,"['spinal cord injury pain', 'Adults with SCI pain (>3\xa0months']","['internet-delivered SCI specific CBT-PMP', 'SCI cognitive behavioural therapy pain management programmes (CBT-PMPs', 'internet-delivered cognitive behavioural therapy pain management programme']","['recruitment rate', 'quality of lie (QoL), pain, mood and sleep', 'worst pain', 'NRS of current pain', 'QoL', 'Brief Pain Inventory (interference']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.169439,Moderate to large effect sizes favouring the intervention were demonstrated at each time point for the pain metrics (Cohen's d: 0.38-0.84).,"[{'ForeName': 'Dearbhla', 'Initials': 'D', 'LastName': 'Burke', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Lennon', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Blake', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}, {'ForeName': 'Maeve', 'Initials': 'M', 'LastName': 'Nolan', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Sorcha', 'Initials': 'S', 'LastName': 'Barry', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Eimear', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Maye', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': ""O'Connor"", 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Maume', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Cheyne', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Sadb', 'Initials': 'S', 'LastName': 'Ní Ghiollain', 'Affiliation': 'The Spinal Cord System of Care Team, The National Rehabilitation Hospital, Dun Laoighire, County Dublin, Ireland.'}, {'ForeName': 'Brona M', 'Initials': 'BM', 'LastName': 'Fullen', 'Affiliation': 'UCD School of Public Health, Physiotherapy and Sports Science, Health Science Centre, University College Dublin, Dublin 4, Ireland.'}]","European journal of pain (London, England)",['10.1002/ejp.1402']
1131,31300595,Randomized comparison between perineural dexamethasone and dexmedetomidine for ultrasound-guided infraclavicular block.,"BACKGROUND


This randomized trial compared perineural dexamethasone (5 mg) and dexmedetomidine (100 µg) for ultrasound-guided infraclavicular brachial plexus block. We hypothesized that both adjuvants would result in similar durations of motor block and therefore designed the study as an equivalence trial (equivalence margin=3.0 hours).
METHODS


One hundred and twenty patients undergoing upper limb surgery with ultrasound-guided infraclavicular block (using 35 mL of lidocaine 1%-bupivacaine 0.25% with epinephrine 5 µg/mL) were randomly allocated to receive perineural dexamethasone (5 mg) or dexmedetomidine (100 µg). Patients and operators were blinded to the nature of the perineural adjuvant. After the performance of the block, a blinded observer assessed the success rate (defined as a minimal sensorimotor composite score of 14 out of 16 points at 30 min) as well as the incidence of surgical anesthesia (defined as the ability to complete surgery without local infiltration, supplemental blocks, intravenous opioids, or general anesthesia). Heart rate and blood pressure were recorded before the block as well as during the first 2 hours after its performance. Furthermore, the level of sedation (using the Ramsay Sedation Scale) was recorded in the postanesthesia care unit. Postoperatively, the blinded observer contacted patients with successful blocks to inquire about the duration of motor block, sensory block, and postoperative analgesia.
RESULTS


No intergroup differences were observed in terms of success rate and surgical anesthesia. Compared with dexmedetomidine, dexamethasone provided longer durations of motor block (17.4 (4.0) vs 14.3 (3.0) hours; p<0.001; 95% CI 1.7 to 4.5), sensory block (19.0 (4.0) vs 15.0 (3.2) hours; p<0.001; 95% CI 2.6 to 5.4), and analgesia (22.2 (3.6) vs 16.9 (3.9) hours; p<0.001; 95% CI 3.7 to 6.9). Dexmedetomidine resulted in lower heart rate and blood pressure after the performance of the block, as well as an increased level of sedation postoperatively.
CONCLUSION


Compared with dexmedetomidine (100 µg), dexamethasone (5 mg) results in longer sensorimotor block and analgesic durations, as well as a decreased level of patient sedation. Further studies are required to compare dexamethasone and dexmedetomidine using different doses, local anesthetic agents, and approaches to the brachial plexus.
TRIAL REGISTRATION NUMBER


NCT03610893.",2019,No intergroup differences were observed in terms of success rate and surgical anesthesia.,['One hundred and twenty patients undergoing upper limb surgery with'],"['lidocaine 1%-bupivacaine 0.25% with epinephrine', 'dexamethasone', 'perineural dexamethasone', 'ultrasound-guided infraclavicular block', 'dexmedetomidine, dexamethasone', 'Dexmedetomidine', 'dexmedetomidine', 'dexamethasone and dexmedetomidine', 'perineural dexamethasone and dexmedetomidine']","['success rate and surgical anesthesia', 'Heart rate and blood pressure', 'level of patient sedation', 'sensory block', 'success rate', 'longer sensorimotor block and analgesic durations', 'level of sedation (using the Ramsay Sedation Scale', 'duration of motor block, sensory block, and postoperative analgesia', 'longer durations of motor block', 'analgesia', 'lower heart rate and blood pressure']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",120.0,0.249534,No intergroup differences were observed in terms of success rate and surgical anesthesia.,"[{'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile julian.aliste@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Anesthesiology and Perioperative Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Orthopedic Surgery, University of Chile, Santiago, Chile.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Pain Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'De Q', 'Initials': 'DQ', 'LastName': 'Tran', 'Affiliation': 'Anesthesiology, McGill University, Montreal, Quebec, Canada.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2019-100680']
1132,31706905,Niacin for treatment of nonalcoholic fatty liver disease (NAFLD): novel use for an old drug?,"Niacin has been widely used clinically for over half a century for dyslipidemia. Recent new evidence indicates that niacin may be useful in the treatment of nonalcoholic fatty liver disease (NAFLD) and its sequential complications including nonalcoholic steatohepatitis and fibrosis. There is an urgent unmet need for a cost-effective solution for this public health problem affecting nearly one in three adults. Niacin inhibits and reverses hepatic steatosis and inflammation in animals and liver cell cultures. It prevents liver fibrosis in animals and decreases collagen in cultured human stellate cells. Its mechanism of action is by oxidative stress reduction and inhibition of diacylglycerol acyltransferase 2 and other possible targets. An uncontrolled clinical trial in 39 hypertriglyceridemic patients with steatosis showed reduction of liver fat by 47% and reductions in liver enzymes and C-reactive protein from the baseline when treated with niacin extended-release for 6 months These hypothesis-generating data indicate a novel repurposed use of niacin for NAFLD. Niacin beneficially affects NAFLD at 3 major stages directly and, by affecting steatosis, it indirectly decreases the cascade effect on inflammation and fibrosis. It offers the advantage potentially of combination with other drugs in development for evolving synergistically more intense and broader efficacy. In select patients, it may benefit frequently associated atherogenic dyslipidemia. A randomized placebo-controlled double-blind parallel trial (with niacin alone or in combination with another drug in development) to assess the safety and efficacy of niacin on steatosis, inflammation, and fibrosis in patients with nonalcoholic steatohepatitis/NAFLD is warranted.",2019,"Niacin beneficially affects NAFLD at 3 major stages directly and, by affecting steatosis, it indirectly decreases the cascade effect on inflammation and fibrosis.","['patients with nonalcoholic steatohepatitis', 'nonalcoholic fatty liver disease (NAFLD', '39 hypertriglyceridemic patients with steatosis']","['Niacin', 'niacin', 'placebo', 'niacin alone', 'NAFLD']","['steatosis, inflammation, and fibrosis', 'hepatic steatosis and inflammation', 'liver fat', 'atherogenic dyslipidemia', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4524040', 'cui_str': 'Atherogenic dyslipidaemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.144826,"Niacin beneficially affects NAFLD at 3 major stages directly and, by affecting steatosis, it indirectly decreases the cascade effect on inflammation and fibrosis.","[{'ForeName': 'Moti L', 'Initials': 'ML', 'LastName': 'Kashyap', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, Irvine, CA, USA; Atherosclerosis Research Center, Tibor Rubin Veterans Affairs Healthcare System, Long Beach, CA, USA. Electronic address: mkashyap@uci.edu.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Ganji', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, Irvine, CA, USA; Atherosclerosis Research Center, Tibor Rubin Veterans Affairs Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Naresh K', 'Initials': 'NK', 'LastName': 'Nakra', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, Irvine, CA, USA; Atherosclerosis Research Center, Tibor Rubin Veterans Affairs Healthcare System, Long Beach, CA, USA.'}, {'ForeName': 'Vaijinath S', 'Initials': 'VS', 'LastName': 'Kamanna', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, Irvine, CA, USA; Atherosclerosis Research Center, Tibor Rubin Veterans Affairs Healthcare System, Long Beach, CA, USA. Electronic address: vkamanna15@gmail.com.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.10.006']
1133,31299919,Effect of extended hours dialysis on markers of chronic kidney disease-mineral and bone disorder in the ACTIVE Dialysis study.,"BACKGROUND


Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD) is a significant cause of morbidity among haemodialysis patients and is associated with pathological changes in phosphate, calcium and parathyroid hormone (PTH). In the ACTIVE Dialysis study, extended hours dialysis reduced serum phosphate but did not cause important changes in PTH or serum calcium. This secondary analysis aimed to determine if changes in associated therapies may have influenced these findings and to identify differences between patient subgroups.
METHODS


The ACTIVE Dialysis study randomised 200 participants to extended hours haemodialysis (≥24 h/week) or conventional haemodialysis (≤18 h/week) for 12 months. Mean differences between treatment arms in serum phosphate, calcium and PTH; and among key subgroups (high vs. low baseline phosphate/PTH, region, time on dialysis, dialysis setting and frequency) were examined using mixed linear regression.
RESULTS


Phosphate binder use was reduced with extended hours (- 0.83 tablets per day [95% CI -1.61, - 0.04; p = 0.04]), but no differences in type of phosphate binder, use of vitamin D, dose of cinacalcet or dialysate calcium were observed. In adjusted analysis, extended hours were associated with lower phosphate (- 0.219 mmol/L [- 0.314, - 0.124; P < 0.001]), higher calcium (0.046 mmol/L [0.007, 0.086; P = 0.021]) and no change in PTH (0.025 pmol/L [- 0.107, 0.157; P = 0.713]). The reduction in phosphate with extended hours was greater in those with higher baseline PTH and dialysing at home.
CONCLUSION


Extended hours haemodialysis independently reduced serum phosphate levels with minimal change in serum calcium and PTH levels. With a few exceptions, these results were consistent across patient subgroups.
TRIAL REGISTRATION


Clinicaltrials.gov NCT00649298 . Registered 1 April 2008.",2019,"In the ACTIVE Dialysis study, extended hours dialysis reduced serum phosphate but did not cause important changes in PTH or serum calcium.","['200 participants to extended hours haemodialysis (≥24\u2009h/week) or', 'haemodialysis patients']","['extended hours dialysis', 'conventional haemodialysis']","['serum calcium and PTH levels', 'type of phosphate binder, use of vitamin D, dose of cinacalcet or dialysate calcium', 'chronic kidney disease-mineral and bone disorder', 'serum phosphate levels', 'serum phosphate, calcium and PTH']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4076240', 'cui_str': 'CKD-MBD'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}]",200.0,0.094788,"In the ACTIVE Dialysis study, extended hours dialysis reduced serum phosphate but did not cause important changes in PTH or serum calcium.","[{'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Zhan', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, 2 Yinghuayuan E St, Chaoyang Qu, Beijing Shi, 100096, China.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia.'}, {'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Sunshine Coast University Hospital, Birtinya, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Chenggang', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'School of Social Development and Public Policy, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Scaria', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia. mjardine@georgeinstitute.org.au.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, 2 Yinghuayuan E St, Chaoyang Qu, Beijing Shi, 100096, China. zhangling5@medmail.com.cn.'}]",BMC nephrology,['10.1186/s12882-019-1438-3']
1134,30653423,Randomized Phase II Trial Comparing Site-Specific Treatment Based on Gene Expression Profiling With Carboplatin and Paclitaxel for Patients With Cancer of Unknown Primary Site.,"PURPOSE


Although gene expression profiling is a promising diagnostic technique to determine the tissue of origin for patients with cancer of unknown primary site (CUP), no clinical trial has evaluated yet site-specific therapy directed by this approach compared with empirical chemotherapy. We therefore performed a randomized study to assess whether such site-specific therapy improves outcome compared with empirical chemotherapy in previously untreated patients with CUP.
PATIENTS AND METHODS


Comprehensive gene expression profiling was performed by microarray analysis, and an established algorithm was applied to predict tumor origin. Patients with CUP were randomly assigned (1:1) to receive standard site-specific therapy or empirical paclitaxel and carboplatin (PC). The primary end point was 1-year survival rate.
RESULTS


One hundred thirty patients were randomly assigned and had sufficient biopsy tissue for molecular analysis. Efficacy analysis was performed for 50 and 51 patients in the site-specific therapy and empirical PC arms, respectively. Cancer types most commonly predicted were pancreatic (21%), gastric (21%), and lymphoma (20%). The 1-year survival rate was 44.0% and 54.9% for site-specific treatment and empirical PC ( P = .264), respectively. Median overall and progression-free survival were 9.8 and 5.1 months, respectively, for site-specific treatment versus 12.5 and 4.8 months for empirical PC ( P = .896 and .550, respectively). Median overall survival (16.7 v 10.6 months; P = .116) and progression-free survival (5.5 v 3.9 months; P = .018) were better for predicted more-responsive than less-responsive tumor types.
CONCLUSION


Site-specific treatment that was based on microarray profiling did not result in a significant improvement in 1-year survival compared with empirical PC, although prediction of the original site seemed to be of prognostic value.",2019,"CONCLUSION


Site-specific treatment that was based on microarray profiling did not result in a significant improvement in 1-year survival compared with empirical PC, although prediction of the original site seemed to be of prognostic value.","['Patients with CUP', 'previously untreated patients with CUP', 'Patients With Cancer of Unknown Primary Site', 'patients with cancer of unknown primary site (CUP', 'One hundred thirty patients']","['empirical chemotherapy', 'site-specific therapy', 'standard site-specific therapy or empirical paclitaxel and carboplatin (PC', 'Carboplatin and Paclitaxel']","['Median overall and progression-free survival', 'progression-free survival', '1-year survival', '1-year survival rate', 'Median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",130.0,0.143825,"CONCLUSION


Site-specific treatment that was based on microarray profiling did not result in a significant improvement in 1-year survival compared with empirical PC, although prediction of the original site seemed to be of prognostic value.","[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': '1 Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': '1 Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': '3 Chiba University, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Arai', 'Affiliation': '3 Chiba University, Chiba, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': '4 Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Akiyoshi', 'Affiliation': '4 Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': '5 Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Onoe', 'Affiliation': '5 Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': '6 National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': '6 National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': '7 Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Toyoda', 'Affiliation': '7 Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Onozawa', 'Affiliation': '8 Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ono', 'Affiliation': '8 Shizuoka Cancer Center, Nagaizumi, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': '1 Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': '1 Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': '9 Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Ayano', 'Initials': 'A', 'LastName': 'Takeuchi', 'Affiliation': '10 Keio University, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': '11 Chuo University, Hachioji, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nishio', 'Affiliation': '1 Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': '1 Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00771']
1135,31767518,Pharmacokinetic and pharmacodynamic assessment of alirocumab in patients with familial hypercholesterolemia associated with proprotein convertase subtilisin/kexin type 9 gain-of-function or apolipoprotein B loss-of-function mutations.,"BACKGROUND


Familial hypercholesterolemia is characterized by high levels of low-density lipoprotein cholesterol (LDL-C), and causes of familial hypercholesterolemia include apolipoprotein B (APOB) loss-of-function mutations (LOFm) and proprotein convertase subtilisin/kexin type 9 (PCSK9) gain-of-function mutations (GOFm).
OBJECTIVE


The aim of this study was to compare the pharmacokinetics and pharmacodynamics of alirocumab between patients with APOB LOFm vs PCSK9 GOFm.
METHODS


Patients (6 APOB LOFm and 17 PCSK9 GOFm carriers) with LDL-C ≥70 mg/dL on maximally tolerated lipid-lowering therapies received alirocumab 150 mg at Weeks 0, 2, 4, and 6, placebo at Week 8, alirocumab at Week 10, placebo at Weeks 12 and 14, then completed a follow-up period at Week 22.
RESULTS


At Week 8, mean ± standard error (SE) alirocumab concentration was lower in APOB LOFm carriers compared with PCSK9 GOFm carriers (12.12 ± 1.81 vs 16.74 ± 2.53 mg/L). APOB LOFm carriers had higher mean ± SE total PCSK9 (6.56 ± 0.73 mg/L) and lower mean ± SE free PCSK9 (0.025 ± 0.016 mg/L) at Week 8 compared with PCSK9 GOFm carriers (4.21 ± 0.35 and 0.11 ± 0.035 mg/L for total and free PCSK9, respectively). Despite this observed greater PCSK9 suppression, mean ± SE percent LDL-C reduction was lower in APOB LOFm (55.3 ± 1.0%) compared with PCSK9 GOFm carriers (73.1 ± 0.9%). Treatment-emergent adverse events occurred in 16 patients (94.1%) in the PCSK9 GOFm group and 5 patients (83.3%) in the APOB LOFm group.
CONCLUSIONS


Overall, PCSK9 inhibition with alirocumab results in clinically meaningful reductions in LDL-C in both APOB LOFm and PCSK9 GOFm carriers, although reductions were greater in the PCSK9 GOFm carriers. The results indicate a possible underlying contributor to hypercholesterolemia other than PCSK9 in patients with APOB LOFm.
CLINICAL TRIAL REGISTRATION


NCT01604824; clinicaltrials.gov.",2019,"Treatment-emergent adverse events occurred in 16 patients (94.1%) in the PCSK9 GOFm group and 5 patients (83.3%) in the APOB LOFm group.
","['patients with familial hypercholesterolemia associated with proprotein convertase subtilisin/kexin type 9 gain-of-function or apolipoprotein B loss-of-function mutations', 'patients with APOB LOFm vs PCSK9 GOFm', 'Patients (6 APOB LOFm and 17 PCSK9 GOFm carriers) with LDL-C ≥70', 'patients with APOB LOFm']","['placebo', 'PCSK9 GOFm', 'alirocumab', 'alirocumab at Week 10, placebo']","['PCSK9 suppression, mean\xa0±\xa0SE percent LDL-C reduction', 'SE total PCSK9', 'Treatment-emergent adverse events', 'APOB LOFm', 'mean\xa0±\xa0standard error (SE) alirocumab concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C4505106', 'cui_str': 'Loss of Function Mutation'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.10362,"Treatment-emergent adverse events occurred in 16 patients (94.1%) in the PCSK9 GOFm group and 5 patients (83.3%) in the APOB LOFm group.
","[{'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Hopkins', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City, UT, USA. Electronic address: paul.hopkins@utah.edu.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Krempf', 'Affiliation': 'CHU de Nantes - Hôpital Nord Laennec, Saint-Herblain, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': 'Hôpital de la Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Donahue', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'A Thomas', 'Initials': 'AT', 'LastName': 'DiCioccio', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.10.007']
1136,30056223,Improving Response Rates and Representation of Hard-to-Reach Groups in Family Experience Surveys.,"OBJECTIVE


Most US hospitals conduct patient experience surveys by mail or telephone after discharge to assess patient/family centeredness of care. Pediatric response rates are usually very low, especially for black, Latino, and low-income respondents. We investigated whether day of discharge surveying using tablets improves response rates and respondent representativeness.
METHODS


This was a quasi-experimental study of parents of patients discharged from 4 units of a children's hospital. Parents were assigned to receive the Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) via an audio-enabled tablet before discharge or via mail at approximately 1 week postdischarge. Intervention and control conditions alternated by week. We compared response rates, child/respondent characteristics, and mean top-box scores between tablet and mail only arms.
RESULTS


Administering Child HCAHPS on a tablet was administratively feasible and did not interfere with the discharge process (median completion time, 12.4 minutes). The response rate was 71.1% (424 of 596) for tablet versus 16.3% (96 of 588) for mail only. Although the tablet response rate was higher in every subgroup, tablet respondents were more likely to be fathers (20.4% vs 6.4%; P = .006), more likely to have a high school education or less (17.5% vs 8.4%; P = .002), less likely to be white (56.8% vs 71.9%; P = .006), and more likely to be publicly insured (31.4% vs 19.8%; P = .02). Tablet scores were significantly higher than mail only scores for 3 of 17 measures.
CONCLUSIONS


The response rate for day of discharge tablet survey administration was >4-fold higher than with single-wave mail-only administration, with greater participation of hard-to-reach groups. These findings suggest tablet administration before discharge shows great promise for real-time feedback and QI and may transform the field of inpatient survey administration.",2019,"Tablet scores were significantly higher than mail only scores for 3 of 17 measures.
","[""parents of patients discharged from 4 units of a children's hospital""]","['Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) via an audio-enabled tablet before discharge or via mail at approximately 1 week postdischarge', 'Child HCAHPS']","['tablet response rate', 'Tablet scores', 'response rates, child/respondent characteristics, and mean top-box scores', 'response rate', 'Pediatric response rates', 'response rates and respondent representativeness']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]",,0.0557429,"Tablet scores were significantly higher than mail only scores for 3 of 17 measures.
","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Toomey', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital; Department of Pediatrics (SL Toomey and MA Schuster), Department of Health Care Policy (AM Zaslavsky), Harvard Medical School, Boston, Mass. Electronic address: sara.toomey@childrens.harvard.edu.""}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Elliott', 'Affiliation': 'Department of Pediatrics (SL Toomey and MA Schuster), Department of Health Care Policy (AM Zaslavsky), Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Zaslavsky', 'Affiliation': 'RAND Corporation (MN Elliott), Santa Monica, Calif.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Quinn', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Thomson', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital.""}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Onorato', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Schuster', 'Affiliation': ""Division of General Pediatrics, Department of Medicine (SL Toomey, J Quinn, DJ Klein, S Wagner, C Thomson, MWu, S Onorato, and MA Schuster), Boston Children's Hospital; Department of Pediatrics (SL Toomey and MA Schuster), Department of Health Care Policy (AM Zaslavsky), Harvard Medical School, Boston, Mass; Kaiser Permanente School of Medicine (MA Schuster), Pasadena, Calif.""}]",Academic pediatrics,['10.1016/j.acap.2018.07.007']
1137,31783739,"Effect of prenatal EPA and DHA on maternal and cord blood insulin sensitivity: a secondary analysis of the mothers, omega 3, and mental health study.","BACKGROUND


We sought to determine whether prenatal supplementation with the omega-3 fatty acids eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) would increase markers of insulin sensitivity in maternal or cord blood compared with placebo supplementation. A secondary aim was to evaluate the association of serum EPA and DHA fractions with adiponectin, leptin and the adiponectin:leptin ratio (ALR). We hypothesized that omega-3 fatty acid supplementation would increase markers of insulin sensitivity in maternal and umbilical cord plasma.
METHODS


We analyzed stored plasma samples collected from a prior 3-arm prospective, double-blinded, randomized controlled trial in which 126 women with singleton pregnancies between 12- and 20-weeks' gestation were randomized to receive: 1) an EPA-rich fish oil supplement, 2) a DHA-rich fish oil supplement, or 3) a soy oil placebo. Maternal venous blood samples were collected at 12-20 weeks gestation (before supplementation) and at 34-36 weeks gestation. At delivery, cord blood was collected. Samples were analyzed using sandwich enzyme-linked immunosorbent assay kits to quantify leptin and adiponectin levels which were utilized to calculate the ALR, a proxy measure for insulin sensitivity.
RESULTS


We found no difference in adiponectin, leptin, and the ALR between the treatment and placebo groups at baseline, after supplementation, or in umbilical cord blood. In regression analyses, higher maternal serum DHA fraction was associated with increased ALR before (p = 0.01) and after (p = 0.04) DHA supplementation. There was no association of EPA fraction with any measure of insulin sensitivity. Cord blood DHA fraction was significantly associated with cord plasma leptin (p = 0.02). Early pregnancy BMI was significantly associated with maternal leptin levels at baseline and in late pregnancy (p < 0.001) and was inversely associated with the ALR (p < 0.001). The ALR decreased significantly between the early and late pregnancy visits (p < 0.001). Pregnancy weight gain was inversely associated with the ALR (P. < 0.02).
CONCLUSIONS


EPA- and DHA- rich fish oil supplementation had no effect on plasma markers of insulin sensitivity. However, maternal serum DHA fraction was significantly associated with markers of insulin sensitivity.
TRIAL REGISTRATION


https://clinicaltrials.gov/, registration number NCT00711971, 7/7/2008.",2019,"In regression analyses, higher maternal serum DHA fraction was associated with increased ALR before (p = 0.01) and after (p = 0.04) DHA supplementation.","['mothers, omega 3, and mental health study', ""126 women with singleton pregnancies between 12- and 20-weeks' gestation""]","['omega-3 fatty acid supplementation', 'EPA- and DHA- rich fish oil supplementation', 'prenatal EPA and DHA', 'placebo', 'omega-3 fatty acids eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA', 'EPA-rich fish oil supplement, 2) a DHA-rich fish oil supplement, or 3) a soy oil placebo']","['insulin sensitivity in maternal and umbilical cord plasma', 'insulin sensitivity', 'maternal leptin levels', 'cord plasma leptin', 'plasma markers of insulin sensitivity', 'ALR', 'EPA fraction', 'Cord blood DHA fraction', 'maternal serum DHA fraction', 'maternal and cord blood insulin sensitivity', 'adiponectin, leptin, and the ALR', 'Early pregnancy BMI', 'Pregnancy weight gain', 'serum EPA and DHA fractions with adiponectin, leptin and the adiponectin:leptin ratio (ALR', 'Maternal venous blood samples']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",126.0,0.616342,"In regression analyses, higher maternal serum DHA fraction was associated with increased ALR before (p = 0.01) and after (p = 0.04) DHA supplementation.","[{'ForeName': 'Joey A', 'Initials': 'JA', 'LastName': 'England', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin, MSB 3.286, Houston, 77030, USA. joey.a.england@uth.tmc.edu.'}, {'ForeName': 'Joses', 'Initials': 'J', 'LastName': 'Jain', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico, 915 Camino de Salud NE, MSC10-5580, Albuquerque, 87131, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Holbrook', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico, 915 Camino de Salud NE, MSC10-5580, Albuquerque, 87131, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Schrader', 'Affiliation': 'Clinical and Translational Center, University of New Mexico, 915 Camino de Salud NE, MSC08-4635, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Clinical and Translational Center, University of New Mexico, 915 Camino de Salud NE, MSC08-4635, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Mozurkewich', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico, 915 Camino de Salud NE, MSC10-5580, Albuquerque, 87131, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2599-6']
1138,31254046,Adherence and effectiveness of a single instruction of pelvic floor exercises: a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS


In Brazil there are limited knowledge and education about preventative exercises for pelvic floor muscles (PFMs). We hypothesised that a single pelvic floor muscle exercise (PFME) session immediately postpartum would be effective in preventing urinary incontinence (UI) in a 3-month postpartum period with good adherence rates.
METHODS


Two hundred two women were approached for this randomised controlled trial and randomly assigned to two groups: the control group and experimental group. The intervention comprised a visual assessment of PFM contraction, a single PFME instruction session supervised by a physical therapist, and an educational approach through distribution of brochures about home-based PFME exercises (without supervision). Involuntary urinary loss and quality of life (QoL) were evaluated using the International Consultation on Incontinence Questionnaire Short Form (main outcome). Sociodemographic and clinical information was collected. Adherence and barriers were assessed via telephone/mobile phone surveys (secondary outcomes).
RESULTS


The adherence rate was 85.1%; only 37% of the women reported having some knowledge about PFME prior to participating in this study. The main barriers to PFME mentioned were forgetfulness (61.2%), lack of time (52.2%), and the need to take care of the baby (56.7%). One instruction session on postnatal PFME delivered in the immediate postpartum period was ineffective for improving urinary symptoms such as frequency of leakage (p = 0.821), amount of leakage (p = 0.746), and influence of leakage on QoL (p = 0.823). In addition, there was no difference in QoL 3 months post-partum (p = 0.872).
CONCLUSIONS


Although the proposed intervention did not prevent UI symptoms, the adherence rate to PFME was high.",2020,"In addition, there was no difference in QoL 3 months post-partum (p = 0.872).
",['Two hundred two women'],"['visual assessment of PFM contraction, a single PFME instruction session supervised by a physical therapist, and an educational approach through distribution of brochures about home-based PFME exercises (without supervision', 'single instruction of pelvic floor exercises', 'single pelvic floor muscle exercise (PFME) session immediately postpartum']","['Involuntary urinary loss and quality of life (QoL', 'Adherence and effectiveness', 'adherence rate', 'urinary symptoms such as frequency of leakage', 'adherence rate to PFME']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0262718', 'cui_str': 'Pelvic muscle exercises'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0429778', 'cui_str': 'Urinary loss (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0633055', 'cui_str': 'PFME'}]",202.0,0.0972799,"In addition, there was no difference in QoL 3 months post-partum (p = 0.872).
","[{'ForeName': 'Cinara', 'Initials': 'C', 'LastName': 'Sacomori', 'Affiliation': ""School of Kinesiology, Universidad Bernardo O'Higgins, Santiago, Chile.""}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Zomkowski', 'Affiliation': 'Physical Therapy Department, Universidade do Sul de Santa Catarina-UNISUL, Palhoça, Santa Catarina, Brazil. kamillazomkowski@gmail.com.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Dos Passos Porto', 'Affiliation': 'Physical Therapy Department, College of Health and Sport Science-CEFID, Santa Catarina State University-UDESC, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Fernando Luiz', 'Initials': 'FL', 'LastName': 'Cardoso', 'Affiliation': 'Physical Therapy Department, College of Health and Sport Science-CEFID, Santa Catarina State University-UDESC, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Fabiana Flores', 'Initials': 'FF', 'LastName': 'Sperandio', 'Affiliation': 'Physical Therapy Department, College of Health and Sport Science-CEFID, Santa Catarina State University-UDESC, Florianópolis, Santa Catarina, Brazil.'}]",International urogynecology journal,['10.1007/s00192-019-04032-6']
1139,31240723,Method of levels therapy for first-episode psychosis: The feasibility randomized controlled Next Level trial.,"OBJECTIVE


We aimed to determine the feasibility and acceptability of Method of Levels (MOL) for people experiencing first-episode psychosis (FEP) to inform decision making about the therapy's suitability for further testing in a larger clinical trial.
METHOD


A parallel group randomized controlled trial design was used. Participants (N = 36) were allocated to receive either treatment as usual (TAU) or TAU plus MOL. Recruitment and retention in the trial and the acceptability of the MOL intervention were the primary outcomes.
RESULTS


The recruitment target was met within the planned time frame. Retention in the trial at final follow-up was 97%, substantially higher than the 80% threshold prespecified as a successful feasibility outcome. Participant feedback provided initial evidence of the acceptability of the study design and intervention for this population.
CONCLUSION


Results support progressing to a larger trial of MOL for FEP. Recommendations for the design of future trials are provided.",2019,"Retention in the trial at final follow-up was 97%, substantially higher than the 80% threshold prespecified as a successful feasibility outcome.","['Participants (N\u2009=\u200936', 'first-episode psychosis', 'people experiencing first-episode psychosis (FEP']","['usual (TAU) or TAU plus MOL', 'Method of Levels (MOL']",[],"[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",[],,0.180563,"Retention in the trial at final follow-up was 97%, substantially higher than the 80% threshold prespecified as a successful feasibility outcome.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Griffiths', 'Affiliation': 'Division of Psychology and Mental Health, School of Psychological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Mansell', 'Affiliation': 'Division of Psychology and Mental Health, School of Psychological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Carey', 'Affiliation': 'Centre for Remote Health, Flinders University, Alice Springs, Northern Territory, Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Edge', 'Affiliation': 'Centre for Remote Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': 'Department of Biostatistics and Health Informatics, Institute of Psychiatry, London, UK.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Tai', 'Affiliation': 'Division of Psychology and Mental Health, School of Psychological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}]",Journal of clinical psychology,['10.1002/jclp.22820']
1140,31250356,Broccoli sprout supplementation in patients with advanced pancreatic cancer is difficult despite positive effects-results from the POUDER pilot study.,"Pancreatic ductal adenocarcinoma is a highly aggressive malignancy with short survival and limited therapeutic options. Broccoli sulforaphane is a promising new treatment due to the results of recent epidemiological, experimental and patient studies. Upon approval from the ethics committee and registration at ClinicalTrials.gov, 40 patients with palliative chemotherapy were placed into a placebo and treatment group in an unblinded fashion. Fifteen capsules with pulverized broccoli sprouts containing 90 mg/508 μmol sulforaphane and 180 mg/411 μmol glucoraphanin or methylcellulose were administered daily for up to 1 year. Twenty-nine patients were included in the treatment group and 11 patients were in the placebo group; these patients were followed for up to 1 year. The patient characteristics, overall survival and feasibility were assessed. Compared to those of the placebo group, the mean death rate was lower in the treatment group during the first 6 months after intake (day 30: 0%/18%, day 90: 0%/25%, and day 180: 25%/43%), and Kaplan-Meier analysis revealed a higher survival rate. There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year. We concluded from the Karnofsky index that the broccoli sprouts did not impact patient's self-care and overall abilities severely. The intake of 15 capsules daily was difficult for some patients, and the broccoli sprouts sometimes increased digestive problems, nausea and emesis. We did not obtain statistically significant results (p = 0.291 for the endpoint at day 180), but the knowledge about the feasibility is the basis for the development of new sulforaphane drugs.",2020,There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year.,"['40 patients with palliative chemotherapy', 'Twenty-nine patients were included in the treatment group and 11 patients were in the', 'patients with advanced pancreatic cancer']","['Broccoli sprout supplementation', 'pulverized broccoli sprouts containing 90\xa0mg/508\xa0μmol sulforaphane and 180\xa0mg/411\xa0μmol glucoraphanin', 'Broccoli sulforaphane', 'placebo']","['mean death rate', 'digestive problems, nausea and emesis', 'survival rate', 'overall survival and feasibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0330499', 'cui_str': 'Broccoli'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0768176', 'cui_str': 'beta-D-glucopyranose, 1-thio-, 1-(5-(methylsulfinyl)-N-(sulfooxy)pentanimidate)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",40.0,0.469328,There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year.,"[{'ForeName': 'Vladimir J', 'Initials': 'VJ', 'LastName': 'Lozanovski', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Polychronidis', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gross', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Gharabaghi', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Arianeb', 'Initials': 'A', 'LastName': 'Mehrabi', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schemmer', 'Affiliation': 'Division of Transplant Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Herr', 'Affiliation': 'Department of General, Visceral, and Transplant Surgery, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. i.herr@uni-heidelberg.de.'}]",Investigational new drugs,['10.1007/s10637-019-00826-z']
1141,30797692,Effects of Acupressure on Sleep Quality and Psychological Distress in Nursing Home Residents: A Randomized Controlled Trial.,"OBJECTIVE


To compare the efficacy of acupressure with sham acupressure in older-adult nursing home residents presenting with poor sleep quality and psychological distress.
DESIGN


Prospective, randomized, double-blind, sham-controlled trial.
SETTING AND PARTICIPANTS


Sixty-two nursing home residents with poor sleep quality and psychological distress participated in this study. Participants were randomly assigned to an experimental group (n = 31) receiving acupressure at true acupoints (Baihui, Juque, Neiguan, Tianzhu, and Yongchung) or control group (n = 31) receiving acupressure at sham points. All participants received 20 minutes of acupressure before sleeping 3 times a week for 8 weeks. All participants were blinded to group allocation.
MEASURES


Sleep quality and psychological distress were measured using the Pittsburgh Sleep Quality Index and the Kessler Psychological Distress scale, respectively. Both groups' outcomes were assessed by assessors blinded to group allocation at the baseline, the end of the intervention, and 1 month after the intervention.
RESULTS


The experimental group demonstrated significantly more improvement in sleep quality than did the control group at the end of the intervention (10.5 vs 13.3) and 1 month after the intervention (8.3 vs 14.2; both P ≤ .001). Moreover, the experimental group had lower psychological distress levels than did the control group at 1 month after the intervention (14.6 vs 17.9, P = .05). Furthermore, significant differences in mean sleep quality (F = 60.8, P < .001) and psychological distress (F = 24.6, P < .001) were observed in the experimental group between the measurements at baseline and after the intervention.
CONCLUSIONS


Acupressure at true acupoints improves sleep quality, reduces psychological distress, and provides more clinically beneficial effects compared with that at sham points. Future studies should examine whether these effects are maintained in the long term.",2019,"Furthermore, significant differences in mean sleep quality (F = 60.8, P < .001) and psychological distress (F = 24.6, P ","['Nursing Home Residents', 'older-adult nursing home residents presenting with poor sleep quality and psychological distress', 'Sixty-two nursing home residents with poor sleep quality and psychological distress participated in this study']","['acupressure', 'acupressure with sham acupressure', 'Acupressure', 'acupressure at true acupoints (Baihui, Juque, Neiguan, Tianzhu, and Yongchung) or control group (n\xa0=\xa031) receiving acupressure']","['psychological distress', 'Sleep Quality and Psychological Distress', 'sleep quality, reduces psychological distress', 'Pittsburgh Sleep Quality Index and the Kessler Psychological Distress scale', 'lower psychological distress levels', 'sleep quality', 'Sleep quality and psychological distress', 'mean sleep quality']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.145583,"Furthermore, significant differences in mean sleep quality (F = 60.8, P < .001) and psychological distress (F = 24.6, P ","[{'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Chen', 'Affiliation': 'Master Program in Long-Term Care, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Pei', 'Initials': 'TP', 'LastName': 'Yeh', 'Affiliation': 'School of Nursing, China Medical University, Taichung, Taiwan; Department of Nursing, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Yueh-Chen', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Department of Nursing, National Taichung University of Science and Technology, Taichung, Taiwan.'}, {'ForeName': 'Mei-Ju', 'Initials': 'MJ', 'LastName': 'Chi', 'Affiliation': 'Master Program in Long-Term Care, Taipei Medical University, Taipei, Taiwan; School of Gerontology Health Management, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Mei-Wen', 'Initials': 'MW', 'LastName': 'Chen', 'Affiliation': 'Lee General Hospital affiliated Chunghwa Nursing Home, Taiwan.'}, {'ForeName': 'Kuei-Ru', 'Initials': 'KR', 'LastName': 'Chou', 'Affiliation': 'School of Nursing, Taipei Medical University, Taipei, Taiwan; Psychiatric Research Center, Taipei Medical University Hospital, Taipei, Taiwan; Department of Nursing, Taipei Medical University- Shuang Ho Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yin-Yi', 'Initials': 'YY', 'LastName': 'Lien', 'Affiliation': 'Master Program in Long-Term Care, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Fen', 'Initials': 'CF', 'LastName': 'Yuan', 'Affiliation': ""Yuanli Lee's General Hospital, Lee's Medical Corporation, Taiwan. Electronic address: yuanhsc@livemail.tw.""}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.003']
1142,31799981,Irisin and troponin I expression in dialysis patients submitted to remote ischemic preconditioning: a pilot study.,"BACKGROUND


Renal replacement therapy continues to be related to high hospitalization rates and poor quality of life. All-cause morbidity and mortality in renal replacement therapy in greater than 20% per year, being 44 times greater when diabetes is present, and over 10 times that of the general population. Regardless of treatment, the 5-year survival is 40%, surpassing many types of cancers. Irisin is a hormone that converts white adipose tissue into beige adipose tissue, aggregating positive effects like fat mass control, glucose tolerance, insulin resistance, prevention of muscle loss, and reduction in systemic inflammation.
OBJECTIVES


To determine the serum levels of troponin I in hemodialysis patients submitted to remote ischemic preconditioning (RIPC) associated with irisin expression.
METHODS


This was a prospective, randomized, double-blind clinical trial with patients with chronic kidney disease submitted to hemodialysis for a 6-month period. Troponin I, IL-6, urea, TNF-α, and creatinine levels were determined from blood samples. The expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH were also evaluated by RT-PCR.
RESULTS


Samples from 14 hypertensive patients were analyzed, 9 (64.3%) of whom were type 2 diabetics, aged 44-64 years, and 50% of each sex. The difference between pre- and post-intervention levels of troponin I was not significant. No differences were verified between the RIPC and control groups, except for IL-6, although a significant correlation was observed between irisin and troponin I.
CONCLUSION


Remote ischemic preconditioning did not modify irisin or troponin I expression, independent of the time of collection.",2020,"The expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH were also evaluated by RT-PCR.
","['patients with chronic kidney disease submitted to hemodialysis for a 6-month period', '14 hypertensive patients were analyzed, 9 (64.3%) of whom were type 2 diabetics, aged 44-64 years, and 50% of each sex']","['remote ischemic preconditioning', 'remote ischemic preconditioning (RIPC']","['Irisin and troponin', 'serum levels of troponin', '5-year survival', 'irisin or troponin', 'expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH', 'Troponin I, IL-6, urea, TNF-α, and creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3496084', 'cui_str': 'Thioredoxin'}, {'cui': 'C0079904', 'cui_str': 'Nuclear Factor-Kappab'}, {'cui': 'C0074302', 'cui_str': 'Selenoproteins'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}]",,0.1188,"The expressions of irisin, thioredoxin, Nf-kb, GPX4, selenoprotein and GADPH were also evaluated by RT-PCR.
","[{'ForeName': 'Flávia de Sousa', 'Initials': 'FS', 'LastName': 'Gehrke', 'Affiliation': 'Departamento de Farmácia, Universidade Paulista, São Paulo, SP, Brasil.'}, {'ForeName': 'Mariana Carvalho', 'Initials': 'MC', 'LastName': 'Gouveia', 'Affiliation': 'Departamento de Nefrologia, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Carla Gabriela Marques', 'Initials': 'CGM', 'LastName': 'Barbosa', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, SP, Brasil.'}, {'ForeName': 'Neif', 'Initials': 'N', 'LastName': 'Murad', 'Affiliation': 'Departamento de Cardiologia, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Beatriz da Costa Aguiar Alves', 'Initials': 'BCAA', 'LastName': 'Reis', 'Affiliation': 'Laboratório de Análises Clínicas, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Fernando Luiz Affonso', 'Initials': 'FLA', 'LastName': 'Fonseca', 'Affiliation': 'Laboratório de Análises Clínicas, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}, {'ForeName': 'Edimar Cristiano', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Ciências Farmacêuticas, Universidade Federal de São Paulo, Diadema, SP, Brasil.'}, {'ForeName': 'Marcelo Rodrigues', 'Initials': 'MR', 'LastName': 'Bacci', 'Affiliation': 'Departamento de Nefrologia, Centro Universitário em Saúde do ABC, Santo André, SP, Brasil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-jbn-2019-0051']
1143,31142196,The effect of learning an individualized song on autobiographical memory recall in individuals with Alzheimer's disease: A pilot study.,"Numerous neuropsychological studies have investigated the effect of music on patients with Alzheimer's disease. Findings suggest that music can improve behavioral symptoms, but its potential effects on cognitive abilities of patients still require more investigation. In this 2 × 2 crossover study, we measured the impact of learning an individualized song on autobiographical memory recall and other cognitive abilities in 12 patients with mild to moderate Alzheimer's disease. For each patient, one favorite song of the patient and one autobiographical memory with positive valence were associated to create a new personalized song. This song was taught to the patient by a speech and language therapy student throughout 10 sessions. This training period and a non-training period were proposed in a counterbalanced order between participants. We tested participants' autobiographical recall and general cognitive abilities at three time points: at the start of the experiment, at crossover, and at the end of the experiment. After excluding one outlier, results showed a significant improvement in the retrieval of the autobiographical memory and in general cognitive abilities after song training compared to the non-training period. Overall, our findings suggest that the use of personalized songs may be a useful and motivating tool for addressing the decline of autobiographical memory and of cognitive functions in general in persons with Alzheimer's disease.",2019,"After excluding one outlier, results showed a significant improvement in the retrieval of the autobiographical memory and in general cognitive abilities after song training compared to the non-training period.","[""individuals with Alzheimer's disease"", ""persons with Alzheimer's disease"", ""12 patients with mild to moderate Alzheimer's disease"", ""patients with Alzheimer's disease""]",[],"['autobiographical memory recall', 'retrieval of the autobiographical memory and in general cognitive abilities', 'behavioral symptoms', 'autobiographical memory recall and other cognitive abilities', 'autobiographical recall and general cognitive abilities']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]",[],"[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",12.0,0.0634225,"After excluding one outlier, results showed a significant improvement in the retrieval of the autobiographical memory and in general cognitive abilities after song training compared to the non-training period.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Fraile', 'Affiliation': 'a Lyon Neuroscience Research Center, INSERM U1028 & CNRS UMR 5292 , Lyon I University , Lyon , France.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Bernon', 'Affiliation': 'a Lyon Neuroscience Research Center, INSERM U1028 & CNRS UMR 5292 , Lyon I University , Lyon , France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rouch', 'Affiliation': 'c Memory Resource and Research Center , University Hospital of Saint-Etienne , Saint-Etienne , France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Pongan', 'Affiliation': 'c Memory Resource and Research Center , University Hospital of Saint-Etienne , Saint-Etienne , France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Tillmann', 'Affiliation': 'a Lyon Neuroscience Research Center, INSERM U1028 & CNRS UMR 5292 , Lyon I University , Lyon , France.'}, {'ForeName': 'Yohana', 'Initials': 'Y', 'LastName': 'Lévêque', 'Affiliation': 'a Lyon Neuroscience Research Center, INSERM U1028 & CNRS UMR 5292 , Lyon I University , Lyon , France.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1617837']
1144,30674084,Comparing Gelfoam vs fat as a sealing material in stapedotomy: A prospective double-blind randomised clinical trial.,"OBJECTIVES


One research aspect of stapes surgery is various materials that are used to seal the oval window. Several materials are used to seal the oval window, for example adipose tissue, perichondrium, vein graft, gelatin sponge (Gelfoam), blood clot and soft connective tissue. Up to now, there has been no randomised clinical trial that has evaluated the effects of different types of sealing material on hearing outcomes after stapedotomy. Hence, the present study aimed to find out which of these materials; fat or Gelfoam was associated with better hearing outcome, when used as a sealing material.
DESIGN


This prospective, double-blind, randomised clinical trial was carried out on ears that had undergone stapedotomy.
SETTING


Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran.
PARTICIPANTS


A total of 176 primary stapedotomies were analysed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears.
MAIN OUTCOME MEASURES


Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated.
RESULTS


Total of 90.7% of all ears in the fat group and 87.8% of ears in Gelfoam group achieved postoperative air-bone gap (ABG) within 20 dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10 dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5-3 kHz. There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group. The occurrence of sensorineural hearing loss in different frequencies was not significant between the two groups (P > 0.05). In addition, there was no case of dead ear in either group.
CONCLUSIONS


We found similarity between hearing outcome in the Gelfoam and fat as sealing materials in stapedotomy. We believe that the first limitation of this study was the short-term follow-up in stapedotomy. The other issue is that one has to be cautious when using our result, which might not be applicable in larger fenestra stapedectomy.",2019,There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group.,"['A total of 176 primary stapedotomies were analysed', 'ears that had undergone stapedotomy', 'Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran']",['Gelfoam vs fat'],"['Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss', 'postoperative air-bone gap (ABG', 'sensorineural hearing loss']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0395740', 'cui_str': 'Small fenestra stapedectomy (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0086746', 'cui_str': 'Otology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",176.0,0.053421,There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Safoura', 'Initials': 'S', 'LastName': 'Aminpour', 'Affiliation': 'Department of Otolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13291']
1145,30921490,"A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment.","The pharmacokinetics and safety of a single oral dose of 200-mg plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD) in oral solution (Epidiolex in the United States; 100 mg/mL) were assessed in subjects with mild to severe hepatic impairment (n =  8 each for mild and moderate, n = 6 for severe) relative to matched subjects with normal hepatic function (n = 8). Blood samples were collected until 48 hours after dosing and evaluated by liquid chromatography and tandem mass spectrometry. Pharmacokinetic parameters (primarily maximum measured plasma concentration, area under the plasma concentration-time curve from time zero to time t, area under the concentration-time curve from time zero to infinity, time to maximum plasma concentration, and terminal half-life) of CBD and its major metabolites were derived using non-compartmental analysis. CBD was rapidly absorbed in all groups independent of hepatic function (median time to maximum plasma concentration, 2-2.8 hours). Exposure (area under the concentration-time curve from time zero to infinity) to total CBD slightly increased in subjects with mild hepatic impairment (geometric mean ratio [GMR], 1.48; 90% confidence interval [CI], 0.90-2.41). However, there were clinically relevant increases in subjects with moderate (GMR, 2.45; 90%CI, 1.50-4.01) and severe (GMR, 5.15; 90%CI, 2.94-9.00) hepatic impairment, relative to subjects with normal hepatic function. Exposure to the CBD metabolites (6-hydroxy-CBD and 7-hydroxy-CBD) also increased in subjects with moderate and severe hepatic impairment, but to a lesser extent than the parent drug. The 7-carboxy-CBD metabolite exposure was lower in subjects with severe hepatic impairment when compared with subjects with normal liver function. These findings indicate that dose modification is necessary in patients with moderate and severe hepatic impairment, and a lower starting dose and slower titration are necessary based on benefit-risk. CBD was well tolerated, and there were no serious adverse events reported during the trial.",2019,"CBD was rapidly absorbed in all groups independent of hepatic function (median time to maximum plasma concentration, 2-2.8 hours).","['patients with moderate and severe hepatic impairment', 'subjects with mild to severe hepatic impairment (n = \u20098 each for mild and moderate, n = 6 for severe) relative to matched subjects with normal hepatic function (n = 8', 'Subjects With Mild to Severe Hepatic Impairment', 'subjects with moderate and severe hepatic impairment']","['200-mg plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD', 'Cannabidiol (CBD']","['Pharmacokinetic parameters (primarily maximum measured plasma concentration, area under the plasma concentration-time curve from time zero to time t, area under the concentration-time curve from time zero to infinity, time to maximum plasma concentration, and terminal half-life) of CBD and its major metabolites', '7-carboxy-CBD metabolite exposure', 'total CBD', 'Blood samples', 'CBD', 'CBD metabolites (6-hydroxy-CBD and 7-hydroxy-CBD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0524527', 'cui_str': 'Drug Formulation'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0537479,"CBD was rapidly absorbed in all groups independent of hepatic function (median time to maximum plasma concentration, 2-2.8 hours).","[{'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'GW Research Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, United Kingdom.'}]",Journal of clinical pharmacology,['10.1002/jcph.1412']
1146,30978155,Intermittent Versus Continuous PEG-Asparaginase to Reduce Asparaginase-Associated Toxicities: A NOPHO ALL2008 Randomized Study.,"PURPOSE


Asparaginase is an essential drug in childhood acute lymphoblastic leukemia (ALL) therapy and is frequently given for months to obtain continuous asparagine depletion. We randomly assigned patients to continuous versus intermittent pegylated-asparaginase (PEG-asp) treatment, hypothesizing there would be decreased toxicity with unchanged efficacy.
METHODS


Children (median age, 4.2 years) treated for non-high-risk ALL according to the Nordic Society for Pediatric Hematology and Oncology ALL2008 protocol received five intramuscular PEG-asp injections (1,000 IU/m 2 ) every two weeks and were then randomly assigned to additional three doses (6-week intervals [experimental arm], n = 309) versus 10 doses (2-week intervals [standard arm], n = 316). The primary end point was noninferior (6% margin) disease-free survival. Toxicity reduction was a secondary end point. Occurrence of asparaginase-associated hypersensitivity, pancreatitis, osteonecrosis, and thromboembolism were prospectively registered.
RESULTS


After a median follow-up of 4.1 years, the 5-year disease-free survival was 92.2% (95% CI, 88.6 to 95.8) and 90.8% (95% CI, 87.0 to 94.6) in the experimental and standard arms, respectively. The 3-year cumulative incidence of any first asparaginase-associated toxicity (hypersensitivity [n = 13]; osteonecrosis [n = 29]; pancreatitis [n = 24]; thromboembolism [n = 17]) was 9.3% in the experimental arm and 18.1% in the standard arm ( P  = .001). Asparaginase-associated toxicity reduction was confirmed in sex- and risk-group-adjusted Cox regression analysis stratified by age (≥ 10 and < 10 years; hazard ratio, 0.48;  P  = .001). The experimental arm had the lowest incidences of all four toxicities, reaching significance for pancreatitis (6-month risk, 5.8%  v  1.3%;  P  = .002).
CONCLUSION


The excellent cure rates and reduced toxicity risk support the use of intermittent PEG-asp therapy after the first 10 weeks in future childhood ALL trials that apply prolonged PEG-asp therapy.",2019,"The experimental arm had the lowest incidences of all four toxicities, reaching significance for pancreatitis (6-month risk, 5.8%  v  1.3%;  P  = .002).
","['Children (median age, 4.2 years) treated for non-high-risk ALL according to the Nordic Society for Pediatric Hematology and Oncology ALL2008 protocol received five', 'childhood acute lymphoblastic leukemia (ALL']","['intramuscular PEG-asp injections', 'Intermittent Versus Continuous PEG-Asparaginase', 'continuous versus intermittent pegylated-asparaginase (PEG-asp']","['Toxicity reduction', '5-year disease-free survival', '3-year cumulative incidence of any first asparaginase-associated toxicity', 'excellent cure rates and reduced toxicity risk', 'Asparaginase-Associated Toxicities', 'noninferior (6% margin) disease-free survival', 'toxicity with unchanged efficacy', 'Occurrence of asparaginase-associated hypersensitivity, pancreatitis, osteonecrosis, and thromboembolism', 'toxicity reduction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1690538', 'cui_str': 'Pediatric hematology'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0647096', 'cui_str': 'monomethoxypolyethylene glycol-conjugated asparaginase'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}]",,0.0888222,"The experimental arm had the lowest incidences of all four toxicities, reaching significance for pancreatitis (6-month risk, 5.8%  v  1.3%;  P  = .002).
","[{'ForeName': 'Birgitte Klug', 'Initials': 'BK', 'LastName': 'Albertsen', 'Affiliation': '1 Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Grell', 'Affiliation': '2 University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Abrahamsson', 'Affiliation': '4 University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bendik', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': '5 Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Vettenranta', 'Affiliation': '6 Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Ólafur G', 'Initials': 'ÓG', 'LastName': 'Jónsson', 'Affiliation': '7 Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': '3 Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Benjamin O', 'Initials': 'BO', 'LastName': 'Wolthers', 'Affiliation': '3 Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': '8 Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': '2 University of Copenhagen, Copenhagen, Denmark.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01877']
1147,31240998,The differential influence of computerized neuropsychological assessment across psychopathology.,"Objective:  Novel technologies have transformed neuropsychological test administration so that research examining the equivalency of computerized versions of traditional tests is needed. This study examined the relationship between psychological symptom severity and performance on the Wisconsin Card Sorting Test (WCST) using the manual versus computerized administration. Method:  Eighty-five participants were randomly assigned to the manual or computerized WCST administration and also completed the Dot Counting Test, Depression Anxiety Stress Scales, and Short UPPS-P Impulsive Behavior Scale. Moderation analyses examined the effects of depressive, anxiety, and impulsivity symptom severity on WCST performance. Results:  For Perseverative Responses (PR), the methods of administration (MOAs) were equivalent regardless of psychological symptom severity. For failures to maintain set (FMS), MOA itself influenced performance, with participants making at least twice as many FMS on the computerized WCST. MOA also significantly moderated the relationship between FMS and impulsivity severity, including Lack of Perseverance, Sensation Seeking, and Positive Urgency. Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST. Conclusions:  Findings suggest that equivalence between the manual and computerized versions of the WCST depends on the WCST subscale and the type of psychological symptom. New normative data need to be developed for the computerized WCST, along with a more consistent method of scoring and interpreting WCST subscales.",2020,"Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST.  ",['Method:  Eighty-five participants'],"['manual or computerized WCST', 'Wisconsin Card Sorting Test (WCST) using the manual versus computerized administration']","['depressive, anxiety, and impulsivity symptom severity on WCST performance', 'FMS and impulsivity severity, including Lack of Perseverance, Sensation Seeking, and Positive Urgency', 'Results:  For Perseverative Responses (PR), the methods of administration (MOAs', 'Dot Counting Test, Depression Anxiety Stress Scales, and Short UPPS-P Impulsive Behavior Scale', 'WCST subscale and the type of psychological symptom']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517892', 'cui_str': '85'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",85.0,0.0192767,"Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST.  ","[{'ForeName': 'Shifali M', 'Initials': 'SM', 'LastName': 'Singh', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Soble', 'Affiliation': 'Department of Psychiatry, University of Illinois College of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, IL, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1631888']
1148,31215174,Effects of a Worksite Group Intervention to Promote Physical Activity and Health: The Role of Psychological Coaching.,"BACKGROUND


This study investigates whether a worksite physical activity (PA) promotion program consisting of both a ""practical"" PA component and a ""theoretical"" (psychological) coaching component (PA+C) is more effective than the same ""practical"" PA component alone.
METHODS


N = 213 employees were assigned to two groups by cluster-randomisation: one group received the ""MoVo-work"" program including a PA component and a coaching component (PA+C group). The other group received only the PA component (PA group). Assessment of PA and health was conducted at five time points.
RESULTS


Six weeks after program completion the percentage of physically active participants was significantly higher in the PA+C group compared to the PA group (68% vs. 45%; p = .01). At 12-month follow-up, the PA+C group showed a higher percentage of physically active participants and a better health status than the PA group on the descriptive level, but these differences did not reach statistical significance.
CONCLUSIONS


Results suggest that a PA promotion program including a psychological coaching component is more effective in evoking behavior change than a practical PA program alone. However, booster interventions are required to maintain the additional effects.",2019,"RESULTS


Six weeks after program completion the percentage of physically active participants was significantly higher in the PA+C group compared to the PA group (68% vs. 45%; p = .01).","['213 employees', 'N\xa0']","['worksite physical activity (PA) promotion program consisting of both a ""practical"" PA component and a ""theoretical"" (psychological) coaching component (PA+C', 'MoVo-work"" program including a PA component and a coaching component (PA+C group', 'PA promotion program', 'Worksite Group Intervention']",['health status'],"[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}]",213.0,0.0120403,"RESULTS


Six weeks after program completion the percentage of physically active participants was significantly higher in the PA+C group compared to the PA group (68% vs. 45%; p = .01).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Krebs', 'Affiliation': 'University of Freiburg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Baaken', 'Affiliation': 'Zentrum Beruf + Gesundheit, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'University of Freiburg, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Goehner', 'Affiliation': 'Catholic University of Applied Sciences, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'University of Freiburg, Germany.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12170']
1149,30875090,Effect of Intravenous Oxycodone Versus Sufentanil on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery.,"More than 30% of patients who undergo surgery will experience postoperative nausea and vomiting (PONV) if no prophylactic treatments are used. Although numerous studies have been performed to investigate the factors related to PONV, the effect of perioperative intravenous oxycodone on the incidence of PONV has not been well investigated. In this study, gynecological patients (grade I-II, aged 18-65 years, scheduled to undergo elective gynecological laparoscopic surgery under general anesthesia) were randomized to the oxycodone group or the sufentanil group. In the oxycodone group, patients received intravenous oxycodone for the induction and maintenance of anesthesia, as well as postoperative analgesia, while sufentanil was used in the sufentanil group. The primary outcome variable was the incidence of PONV. As secondary outcomes, time to first PONV, the rating of the most severe PONV, postoperative pain scores at different time points, hemodynamics, and side effects were evaluated. We found that, compared with sufentanil, oxycodone decreased the incidence of PONV by 13.5% (P = .041). The time to first vomiting was longer in the oxycodone group than in the sufentanil group. Postoperative pain scores at different time points and hemodynamics were comparable between the oxycodone and sufentanil groups. We concluded that the incidence of PONV in gynecological patients who underwent laparoscopic surgery was lower when using intravenous oxycodone for anesthesia induction, anesthesia maintenance, and postoperative analgesia than when using intravenous sufentanil. However, oxycodone and sufentanil provided the same stable hemodynamics during surgery and satisfactory postoperative analgesia.",2019,Postoperative pain scores at different time points and hemodynamics were comparable between the oxycodone and sufentanil groups.,"['Patients Undergoing Gynecological Laparoscopic Surgery', 'gynecological patients (grade I-II, aged 18-65 years, scheduled to undergo elective gynecological laparoscopic surgery under general anesthesia', 'gynecological patients who underwent']","['Oxycodone Versus Sufentanil', 'oxycodone', 'laparoscopic surgery', 'sufentanil', 'intravenous oxycodone', 'sufentanil, oxycodone', 'oxycodone and sufentanil']","['Postoperative Nausea and Vomiting', 'experience postoperative nausea and vomiting (PONV', 'incidence of PONV', 'Postoperative pain scores', 'time to first vomiting', 'time to first PONV, the rating of the most severe PONV, postoperative pain scores at different time points, hemodynamics, and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.139404,Postoperative pain scores at different time points and hemodynamics were comparable between the oxycodone and sufentanil groups.,"[{'ForeName': 'Bingdong', 'Initials': 'B', 'LastName': 'Tao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, Shanghai, China.'}]",Journal of clinical pharmacology,['10.1002/jcph.1408']
1150,30623568,Short-term efficacy of two breast pumps and impact on breastfeeding outcomes at 6 months in exclusively breastfeeding mothers: A randomised trial.,"The provision of breast pumps is a potential strategy to increase breastfeeding duration. This trial compared the effectiveness and acceptability of two breast pumps in mothers exclusively breastfeeding (EBF) their healthy term infant. It also tested whether provision of pumps versus vouchers of equivalent value influenced breastfeeding or attainment of mothers' goals at 3 and 6 months. Mothers were randomised at 3- to 4-week post-partum (Beijing [n = 30], Moscow [n = 34], London [n = 45], New York [n = 3]) to groups A (Philips single-electric pump, Natural bottle), B (Medela Swing single-electric pump, Calma bottle), or C (Control; vouchers). At 6 weeks, group A and B mothers expressed for 10 min/breast; milk weight and opinions of pump/bottle were recorded. Feeding practices were assessed using questionnaires at 3 and 6 months. Milk weight/flow pattern did not differ between groups. Pump A scored significantly better for ease-of-use, cushion-feel, need-to-lean-forward, pleasant, comfort. At 3 and 6 months, %EBF or meeting their goal was not significantly different; (3 months: 86%, 85%, 84%; 6 months: 20%, 15%, 26%; meeting goal 24%, 17%, 27% for A, B, and C). Expressed breast milk (EBM) provision was higher in groups A and B (3 months: 76%, 76%, 24% (p < 0.001); 6 months: 83%, 87%, 32% (p < 0.001); and negatively predicted EBF at 6 months (OR no EBM 5.07, 95% CI [1.56, 16.5]). The pumps were equally effective for milk expression at 6 weeks. Pump provision did not significantly influence breastfeeding practices or attainment of goals but resulted in higher EBM provision, which was associated with lower EBF but not other breastfeeding categories at 6 months.",2019,"Pump A scored significantly better for ease-of-use, cushion-feel, need-to-lean-forward, pleasant, comfort.","['mothers exclusively breastfeeding (EBF) their healthy term infant', 'n\xa0=\xa03', 'exclusively breastfeeding mothers']","['Moscow [n\xa0=\xa034], London [n\xa0=\xa045], New York']","['breastfeeding outcomes', 'Expressed breast milk (EBM) provision', 'EBF', 'effectiveness and acceptability', 'Milk weight/flow pattern']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0452739', 'cui_str': 'Expressed breast milk (substance)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0510971,"Pump A scored significantly better for ease-of-use, cushion-feel, need-to-lean-forward, pleasant, comfort.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': 'Childhood Nutrition Research Centre, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Childhood Nutrition Research Centre, UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lukoyanova', 'Affiliation': ""Department of Nutrition for Sick and Healthy Children, National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Beijing Children's Hospital Affiliated to Capital Medical University, Beijing, China.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Potak', 'Affiliation': ""Neonatal Perinatal Medicine, Cohen Children's Medical Center of New York at North Shore, Manhasset, New York, USA.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Borovik', 'Affiliation': ""Department of Nutrition for Sick and Healthy Children, National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Namazova-Baranova', 'Affiliation': ""Department of Nutrition for Sick and Healthy Children, National Medical Research Center of Children's Health of the Ministry of Health of the Russian Federation, Moscow, Russia.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schanler', 'Affiliation': ""Neonatal Perinatal Medicine, Cohen Children's Medical Center of New York at North Shore, Manhasset, New York, USA.""}]",Maternal & child nutrition,['10.1111/mcn.12779']
1151,31220875,Oral 5-aminosalicylic acid for maintenance of surgically-induced remission in Crohn's disease.,"BACKGROUND


Crohn's disease (CD) is a chronic inflammatory disorder that can involve any part of the gastrointestinal tract. 5-Aminosalicylates (5-ASAs) are locally acting, anti-inflammatory compounds that reduce inflammation of the colonic mucosa with release profiles that vary among various commercially available formulations. This updated Cochrane review summarizes current evidence on the use of 5-ASA formulations for maintenance of surgically-induced remission in CD.
OBJECTIVES


To assess the efficacy and safety of 5-ASA agents for the maintenance of surgically-induced remission in CD.
SEARCH METHODS


We searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register from inception to 16 July 2018. We also searched references, conference abstracts, and trials registers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) that included participants with CD in remission following surgery and compared 5-ASAs to no treatment, placebo or any other active intervention with duration of at least three months were considered for inclusion.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. The primary outcome was clinical relapse. Secondary outcomes included endoscopic recurrence, radiologic and surgical relapse, adverse events, serious adverse events and withdrawal due to adverse events.
MAIN RESULTS


Fourteen RCTs (1867 participants) were included in the review. Participants (15 to 70 years) were recruited from gastroenterology hospitals and medical clinics in Europe and North America and followed up between 3 and 72 months. The risk of bias was assessed as 'low' in one study, 'unclear' in seven and as 'high' in six.At 12 months, 36% (20/55) of participants in the 5-ASA group experienced clinical relapse compared to 51% (28/55) in the no treatment control group (RR 0.71, 95% CI 0.46 to 1.10; low certainty evidence). Moderate certainty evidence suggests that 5-ASAs are more effective for preventing clinical relapse than placebo. During a follow-up period of 12 to 72 months, 36% (131/361) of 5-ASA participants relapsed compared to 43% (160/369) of placebo participants (RR 0.83, 95% CI 0.72 to 0.96; I² = 0%; moderate certainty evidence). At 12 months, 17% (17/101) of the 4 g/day mesalamine group relapsed compared to 26% (27/105) of the 2.4 g/day group (RR 0.65, 95% CI 0.38 to 1.13; moderate certainty evidence). There was no evidence of a difference in clinical relapse rates when 5-ASA compounds were compared to purine antimetabolites. At 24 months, 61% (103/170) of mesalamine participants relapsed compared to 67% (119/177) of azathioprine participants (RR 0.90, 95% CI 0.76 to 1.07; I² = 28%; low certainty evidence). During 24 months, 50% (9/18) of 5-ASA participants had clinical relapse compared to 13% (2/16) of adalimumab participants (RR 4.0, 95% CI 1.01 to 15.84; low certainty evidence). The effects of sulphasalazine compared to placebo on clinical relapse rate is uncertain. After 18 to 36 months, 66% (95/143) of participants treated with sulphasalazine relapsed compared to 71% (110/155) in the placebo group (RR 0.88, 95% CI 0.56 to 1.38; I² = 38%; low certainty evidence).The effect of 5-ASA drugs on safety was uncertain. During 24 months follow-up, 4% (2/55) of 5-ASA participants experienced adverse events compared to none (0/55) in the no treatment control group (RR 5.00, 95% CI 0.25 to 101.81; very low certainty evidence). An equal proportion of 5-ASA participants (10%; 23/241) and placebo (9%; 20/225) groups experienced an adverse event during a follow-up of 3 to 72 months (RR 1.07, 95% CI 0.60 to 1.91; I² = 0%; low certainty evidence). Adverse event rates were similar in the 5-ASA and purine analogues groups. However, serious adverse events and withdrawals due to adverse events were more common in participants who received purine analogues than 5-ASA. At 52 weeks to 24 months, 52% (107/207) of 5-ASA participants had an adverse event compared to 47% (102/218) of purine analogue participants (RR 1.11, 95% CI 0.97 to 1.27, I² = 0%; low certainty evidence). Four per cent (6/152) of 5-ASA participants had a serious adverse event compared to 17% (27/159) of purine analogue participants (RR 0.30, 95% CI 0.11 to 0.80; very low certainty evidence). Eight per cent (17/207) of 5-ASA participants withdrew due to an adverse event compared to 19% (42/218) of purine analogue participants (RR 0.48, 95% CI 0.28 to 0.83; low certainty evidence). Adverse event rates were similar in high and low dose mesalamine participants. After 12 months, 2% (2/101) of 4 g/day mesalamine participants had an adverse event compared to 2% (2/105) of 2.4 g/day participants (RR 1.04, 95% CI 0.15 to 7.24; low certainty evidence). The proportion of participants who experienced adverse events over a 24 month follow-up in the mesalamine group was 78% (14/18) compared to 69% (11/16) of adalimumab participants (RR 1.13, 95% CI 0.75 to 1.71; very low certainty evidence). None (0/32) of the sulphasalazine participants had an adverse event at 18 months follow-up compared to 3% (1/34) of the placebo group (RR 0.35, 95% CI 0.01 to 8.38; very low certainty evidence). Commonly reported adverse events in the included studies were diarrhoea, nausea, increased liver function tests, pancreatitis, and abdominal pain.
AUTHORS' CONCLUSIONS


5-ASA preparations are superior to placebo for the maintenance of surgically-induced clinical remission in patients with CD (moderate certainty). The number needed to treat to prevent one relapse was 13 patients. The evidence for endoscopic remission is uncertain. The sulphasalazine class of 5-ASA agents failed to demonstrate superiority against placebo, 5-ASAs failed to demonstrate superiority compared to no treatment (very low and low certainty). The efficacy of two different doses of the same 5-ASA and the efficacy of 5-ASA compared to purine antimetabolites (azathioprine or 6-mercaptopurine) in maintaining surgically-induced remission of CD remains unclear. However, purine analogues lead to more serious adverse events and discontinuation due to adverse events. There is a low certainty that 5-ASA is inferior for maintaining surgically-induced remission of CD compared to biologics (anti TNF-ɑ). 5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.",2019,"5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.","[""Crohn's disease"", 'patients with CD (moderate certainty', 'Fourteen RCTs (1867 participants) were included in the review', ""Crohn's disease (CD"", 'Participants (15 to 70 years) were recruited from gastroenterology hospitals and medical clinics in Europe and North America and followed up between 3 and 72 months', 'participants with CD in remission following surgery and compared 5-ASAs to no treatment']","['sulphasalazine', 'placebo', '5-ASA formulations', 'purine antimetabolites (azathioprine or 6-mercaptopurine', 'adalimumab', 'Oral 5-aminosalicylic acid', '5-ASA', 'mesalamine', 'azathioprine']","['serious adverse event', 'adverse event', 'diarrhoea, nausea, increased liver function tests, pancreatitis, and abdominal pain', 'adverse events', 'clinical relapse', 'Adverse event rates', 'endoscopic recurrence, radiologic and surgical relapse, adverse events, serious adverse events and withdrawal due to adverse events', 'clinical relapse rate', 'clinical relapse rates', 'efficacy and safety']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232743', 'cui_str': 'Increased liver function (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.529653,"5-ASA formulations appear to be safe with no difference in the occurrence of adverse events or withdrawal when compared with placebo, no treatment or biologics.","[{'ForeName': 'Teuta', 'Initials': 'T', 'LastName': 'Gjuladin-Hellon', 'Affiliation': 'School of Medicine, University of Central Lancashire, Preston, Lancashire, UK, PR1 7BH.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Zipporah', 'Initials': 'Z', 'LastName': 'Iheozor-Ejiofor', 'Affiliation': ''}, {'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Akobeng', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008414.pub3']
1152,31241539,Effect of a Commercially Available Footwear Insole on Biomechanical Variables Associated With Common Running Injuries.,"OBJECTIVE


To determine whether Dr. Scholl's Active Series (DSAS) footwear insoles alter biomechanical variables associated with running injuries.
DESIGN


Randomized, controlled experiment.
SETTING


Sport medicine and biomechanics gait analysis laboratory.
PARTICIPANTS


Fifteen healthy adults.
INTERVENTIONS


The control condition was the participant's own athletic footwear. The experimental condition was the participant's own athletic footwear plus a DSAS insole. Participants completed running gait analysis trials with each condition.
MAIN OUTCOME MEASURES


Peak vertical loading rates (VLRs), peak ankle eversion velocities (AEVs), peak ankle eversion angles (AEAs), and knee abduction angular impulses (KAAIs) were calculated and compared between the control and DSAS conditions because these variables have been associated with plantar fasciitis (VLRs), tibial stress syndrome (AEVs, AEAs), and patellofemoral pain syndrome (KAAIs).
RESULTS


Dr. Scholl's Active Series insoles reduced VLRs across participants by 16% (P < 0.001) but had no consistent influence on AEVs, AEAs, or KAAIs. Participant-specific responses showed that most runners either experienced AEA and KAAI reductions or no change with the DSAS insole, whereas AEVs commonly increased with the DSAS insole.
CONCLUSIONS


Dr. Scholl's Active Series insoles demonstrate efficacy in reducing VLRs, which are associated with plantar fasciitis. Biomechanical changes to variables associated with tibial stress syndrome (AEVs, AEAs) and patellofemoral pain syndrome (KAAIs) were inconsistent.",2019,"RESULTS


Dr. Scholl's Active Series insoles reduced VLRs across participants by 16% (P < 0.001) but had no consistent influence on AEVs, AEAs, or KAAIs.",['Fifteen healthy adults'],[],"['AEVs, AEAs, or KAAIs', 'AEA and KAAI reductions', 'tibial stress syndrome (AEVs, AEAs) and patellofemoral pain syndrome (KAAIs', 'Peak vertical loading rates (VLRs), peak ankle eversion velocities (AEVs), peak ankle eversion angles (AEAs), and knee abduction angular impulses (KAAIs', 'Biomechanical Variables', 'plantar fasciitis (VLRs), tibial stress syndrome (AEVs, AEAs), and patellofemoral pain syndrome (KAAIs', 'VLRs']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]",[],"[{'cui': 'C0017301', 'cui_str': 'General Adaptation Syndrome'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral Pain Syndrome'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}]",15.0,0.0429867,"RESULTS


Dr. Scholl's Active Series insoles reduced VLRs across participants by 16% (P < 0.001) but had no consistent influence on AEVs, AEAs, or KAAIs.","[{'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Lewinson', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Stefanyshyn', 'Affiliation': 'Biomedical Engineering Program, Schulich School of Engineering, University of Calgary, Calgary, AB, Canada.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000536']
1153,31229087,Mamey sapote fruit and carotenoid formulations derived thereof are dietary sources of vitamin A - A comparative randomized cross-over study.,"Mamey sapote is a fruit rich in specific keto-carotenoids, namely sapotexanthin and cryptocapsin. Their chemical structure suggests their provitamin A activity, although their absorption and conversion to vitamin A remained to be demonstrated in humans. Besides structure-related factors, the fruit matrix might also hamper absorption and conversion efficiency. Therefore, we monitored carotenoid and vitamin A levels in triacylglycerol-rich lipoprotein (TRL) fractions in plasma of human participants after consumption of fresh sapote and a carotenoid-rich ""matrix-free"" formulation derived thereof. A randomized 2-way cross-over study was conducted to compare the post-prandial bioavailability of 0.8 mg sapotexanthin and 1.2-1.5 mg cryptocapsin from the above-mentioned test meals. Seven blood samples were drawn over 9.5 h after test meal consumption. Carotenoids and retinoids were quantitated in TRL fractions using HPLC-DAD. Sapotexanthin was absorbed by all participants from all meals, being ca. 36% more bioavailable from the ""matrix-free"" formulation (AUC median  = 73.4 nmol∙h/L) than from the fresh fruit (AUC median  = 54.0 nmol∙h/L; p ≤ 0.001). Cryptocapsin was only absorbed by 4 of 13 participants. The appearance of retinyl esters was observed in all participants independent of the test meal. Although the fruit matrix hampered carotenoid in vivo-bioavailability from sapote, the fruit clearly represents a valuable source of vitamin A for humans.",2019,"36% more bioavailable from the ""matrix-free"" formulation (AUC median  = 73.4 nmol∙h/L) than from the fresh fruit (AUC median  = 54.0 nmol∙h/L; p ≤ 0.001).",[],['sapotexanthin and 1.2-1.5\u202fmg cryptocapsin'],"['appearance of retinyl esters', 'triacylglycerol-rich lipoprotein (TRL) fractions', 'post-prandial bioavailability']",[],"[{'cui': 'C3180638', 'cui_str': 'sapotexanthin'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0807756', 'cui_str': 'Retinyl ester'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.0184025,"36% more bioavailable from the ""matrix-free"" formulation (AUC median  = 73.4 nmol∙h/L) than from the fresh fruit (AUC median  = 54.0 nmol∙h/L; p ≤ 0.001).","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Chacón-Ordóñez', 'Affiliation': 'Institute of Food Science and Biotechnology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Garbenstrasse 25, D-70599 Stuttgart, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Esquivel', 'Affiliation': 'School of Food Technology, University of Costa Rica, 2060 San Pedro, Costa Rica.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Quesada', 'Affiliation': 'Department of Biochemistry, School of Medicine, University of Costa Rica, 2060 San Pedro, Costa Rica.'}, {'ForeName': 'Randall R', 'Initials': 'RR', 'LastName': 'Jiménez', 'Affiliation': 'Institute of Evolutionary Ecology and Conservation Genomics, University of Ulm, Albert-Einstein Allee 11, 89069 Ulm, Germany.'}, {'ForeName': 'Aracelly', 'Initials': 'A', 'LastName': 'Cordero', 'Affiliation': 'School of Food Technology, University of Costa Rica, 2060 San Pedro, Costa Rica.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Carle', 'Affiliation': 'Institute of Food Science and Biotechnology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Garbenstrasse 25, D-70599 Stuttgart, Germany; Biological Science Department, King Abdulaziz University, P.O. Box 80257, Jeddah 21589, Saudi Arabia.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schweiggert', 'Affiliation': 'Institute of Food Science and Biotechnology, Chair Plant Foodstuff Technology and Analysis, University of Hohenheim, Garbenstrasse 25, D-70599 Stuttgart, Germany; Analysis and Technology of Plant-based Foods, Department of Beverage Research, Geisenheim University, D-65366 Geisenheim, Germany. Electronic address: Ralf.Schweiggert@hs-gm.de.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.04.009']
1154,31229188,Enhancing adolescent SBIRT with a peer-delivered intervention: An implementation study.,"PURPOSE


Innovations in adolescent prevention and early intervention strategies are needed to curb early substance use and bring public health models to scale, such as Screening, Brief Intervention, and Referral to Treatment (SBIRT). Young adults in recovery may have an important role to play in delivering these innovations. However, clinics, schools, and community programs may face barriers when implementing new prevention and early intervention approaches in their settings. The purpose of this study is to examine the feasibility, barriers, and facilitators of Project Amp, an innovative, four-session prevention and early intervention model to enhance SBIRT for adolescents.
METHODS


Three school-based programs and three health clinics were selected to implement SBIRT for adolescents and refer eligible adolescents (13-17 years old, moderate risk for substance use disorder) to the study intervention. Between three and six mentors (young adults, 18-28 years old, with lived experience of substance use recovery, also known as peers), were recruited at each site and trained in core skills to deliver the intervention. Study staff communicated with each setting throughout implementation and collected quantitative and qualitative data regarding facilitators and barriers to success. The qualitative data were analyzed to identify key strategies for success when implementing Project Amp.
RESULTS


Across the six sites, 71 practitioners including physicians, nurses, social workers, and counselors, completed training in SBIRT and 30 mentors were hired and trained for the study. Twenty completed sessions with adolescent participants. A total of 1192 adolescents were screened using the CRAFFT. Of those screened, 139 (12%) were eligible, 51 eligible youth (37%) enrolled in the study, and 28 enrolled youth (55%) completed the intervention. Five of the six sites were successfully able to integrate the SBIRT-based Project Amp model into their workflow. Facilitators and barriers for implementation were identified related to three critical factors: recruitment, readiness, and sustainability.
CONCLUSIONS


The Project Amp intervention can be conducted successfully in school and healthcare settings in conjunction with SBIRT, adding capacity to expand access to screening and early intervention in a developmentally appropriate way. However, the study yielded insights into adaptations for future implementation, such as a more streamlined model and centralized staff roles such as integrated roles for young peer mentors.",2019,"Across the six sites, 71 practitioners including physicians, nurses, social workers, and counselors, completed training in SBIRT and 30 mentors were hired and trained for the study.","['Three school-based programs and three health clinics were selected to implement SBIRT for adolescents and refer eligible adolescents (13-17\u202fyears old, moderate risk for substance use disorder) to the study intervention', 'adolescents', 'Young adults', '1192 adolescents', 'Twenty completed sessions with adolescent participants', 'Of those screened, 139 (12%) were eligible, 51 eligible youth (37%) enrolled in the study, and 28 enrolled youth (55%) completed the intervention', '71 practitioners including physicians, nurses, social workers, and counselors, completed training in SBIRT and 30 mentors were hired and trained for the study', 'Between three and six mentors (young adults, 18-28\u202fyears old, with lived experience of substance use recovery, also known as peers']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]",[],[],1192.0,0.0200122,"Across the six sites, 71 practitioners including physicians, nurses, social workers, and counselors, completed training in SBIRT and 30 mentors were hired and trained for the study.","[{'ForeName': 'Laura A Pannella', 'Initials': 'LAP', 'LastName': 'Winn', 'Affiliation': 'C4 Innovations, 200 Reservoir Street, Suite 202, Needham, MA 02494, United States of America. Electronic address: lwinn@c4innovates.com.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Paquette', 'Affiliation': 'C4 Innovations, 200 Reservoir Street, Suite 202, Needham, MA 02494, United States of America. Electronic address: kpaquette@c4innovates.com.'}, {'ForeName': 'Laura Rose W', 'Initials': 'LRW', 'LastName': 'Donegan', 'Affiliation': 'C4 Innovations, 200 Reservoir Street, Suite 202, Needham, MA 02494, United States of America. Electronic address: rdonegan@c4innovates.com.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'Wilkey', 'Affiliation': 'C4 Innovations, 200 Reservoir Street, Suite 202, Needham, MA 02494, United States of America. Electronic address: cwilkey@c4innovates.com.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Ferreira', 'Affiliation': 'C4 Innovations, 200 Reservoir Street, Suite 202, Needham, MA 02494, United States of America. Electronic address: kferreira@c4innovates.com.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.05.009']
1155,30724812,"Response to the Comment on ""Medial Open Transversus Abdominis Plane (MOTAP) Catheters Reduce Opioid Requirements and Improve Pain Control Following Open Liver Resection: a Multicenter, Blinded, Randomized Controlled Trial"".",,2019,,[],['Medial Open Transversus Abdominis Plane (MOTAP'],['Pain Control'],[],"[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",,0.121739,,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Karanicolas', 'Affiliation': 'Sunnybrook Health Sciences Centre, Department of Surgery, University of Toronto, Toronto, ON, Canada Pain Services, EDS Program, University Health Network, Research Chair University of Toronto Centre For the Study of Pain, Department of Anesthesia, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hance', 'Initials': 'H', 'LastName': 'Clarke', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000002882']
1156,31251694,Cost Effectiveness of Interval Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer on the Basis of a Randomized Phase III Trial.,"PURPOSE


In the randomized open-label phase III OVHIPEC trial, the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improved recurrence-free and overall survival in patients with stage III ovarian cancer. We studied the cost effectiveness of the addition of HIPEC to interval CRS in patients with ovarian cancer.
PATIENTS AND METHODS


We constructed a Markov health-state transition model to measure costs and clinical outcomes. Transition probabilities were derived from the OVHIPEC trial by fitting survival distributions. Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY), was calculated from a Dutch societal perspective, with a time horizon of 10 years. Univariable and probabilistic sensitivity analyses were conducted to evaluate the decision uncertainty.
RESULTS


Total health care costs were €70,046 (95% credibility interval [CrI], €64,016 to €76,661) for interval CRS compared with €85,791 (95% CrI, €78,766 to €93,935) for interval CRS plus HIPEC. The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group. The ICER amounted to €28,299/QALY. In univariable sensitivity analysis, the utility of recurrence-free survival and the number of days in the hospital affected the calculated ICER most.
CONCLUSION


On the basis of the trial data, treatment with interval CRS and HIPEC in patients with stage III ovarian cancer was accompanied by a substantial gain in QALYs. The ICER is below the willingness-to-pay threshold in the Netherlands, indicating interval CRS and HIPEC is cost effective for this patient population. These results lend additional support for reimbursing the costs of treating these patients with interval CRS and HIPEC in countries with comparable health care systems.",2019,"The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group.","['patients with stage III ovarian cancer', 'Stage III Ovarian Cancer', 'patients with ovarian cancer']","['interval CRS and HIPEC', 'Interval Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy', 'HIPEC to interval CRS', 'hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS']","['interval CRS', 'utility of recurrence-free survival', 'Transition probabilities', 'mean QALY', 'Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY', 'Total health care costs', 'recurrence-free and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.207322,"The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group.","[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Koole', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'van Lieshout', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Willemien J', 'Initials': 'WJ', 'LastName': 'van Driel', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'van Schagen', 'Affiliation': '6Erasmus University Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jacobien M', 'Initials': 'JM', 'LastName': 'Kieffer', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jules H', 'Initials': 'JH', 'LastName': 'Schagen van Leeuwen', 'Affiliation': '7St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk W R', 'Initials': 'HWR', 'LastName': 'Schreuder', 'Affiliation': '8UMC Utrecht Cancer Center, Utrecht, the Netherlands.'}, {'ForeName': 'Ralph H', 'Initials': 'RH', 'LastName': 'Hermans', 'Affiliation': '9Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': '5The Dutch Peritoneal Oncology Group, Eindhoven, the Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'van der Velden', 'Affiliation': '2Center for Gynecologic Oncology Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': '11University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Leon F A G', 'Initials': 'LFAG', 'LastName': 'Massuger', 'Affiliation': '12Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Arend G', 'Initials': 'AG', 'LastName': 'Aalbers', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Verwaal', 'Affiliation': '13Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Koen K', 'Initials': 'KK', 'LastName': 'Van de Vijver', 'Affiliation': '14University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Harten', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': '1The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00594']
1157,31800496,Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial.,"OBJECTIVE


The aim of this study was to evaluate the safety and feasibility of nonoperative treatment of acute nonperforated appendicitis in children during 5 years of follow-up.
METHODS


A 4-year follow-up of a previous randomized controlled pilot trial, including 50 children with acute nonperforated appendicitis, was performed. The patients were initially randomized to nonoperative treatment with antibiotics or appendectomy with 1-year follow-up previously reported. Data were extracted from the computerized notes and telephone interviews.The primary outcome was treatment failure, defined as need for a secondary intervention under general anesthesia, related to the previous diagnosis of acute nonperforated appendicitis.
RESULTS


The children were followed up for at least 5 years [median 5.3 (range 5.0-5.6)] after inclusion. There were no failures in the appendectomy group (0/26) and 11 failures in the nonoperative group (11/24). Nine failures had occurred during the first year after inclusion, 2 of whom had histologically confirmed appendicitis. There were 2 further patients with recurrent acute appendicitis 1 to 5 years after inclusion. Both these patients had uncomplicated laparoscopic appendectomies for histologically confirmed acute appendicitis. There were no losses to follow-up.
CONCLUSIONS


At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%). Treatment with antibiotics seems to be safe in the intermediate-term; none of the children previously treated nonoperatively re-presented with complicated appendicitis.",2020,"At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%).","['Acute Nonperforated Appendicitis in Children', '50 children with acute nonperforated appendicitis, was performed', 'acute nonperforated appendicitis in children during 5 years of follow-up']","['antibiotics', 'antibiotics or appendectomy', 'nonoperative treatment', 'Nonoperative Treatment Versus Appendectomy']","['recurrent acute appendicitis', 'safety and feasibility', 'acute appendicitis', 'treatment failure, defined as need for a secondary intervention under general anesthesia, related to the previous diagnosis of acute nonperforated appendicitis']","[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0162643'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis (contextual qualifier) (qualifier value)'}]",50.0,0.117108,"At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%).","[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Patkova', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Svenningsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Almström', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'Surgery Unit, UCL Institute of Child Health, London, United Kingdom, Department of Pediatric Surgery, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Wester', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Svensson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",Annals of surgery,['10.1097/SLA.0000000000003646']
1158,31779583,Efficacy and tolerability of sofosbuvir and daclatasvir for treatment of hepatitis C genotype 1 & 3 in patients undergoing hemodialysis- a prospective interventional clinical trial.,"BACKGROUND


There is paucity of data using direct anti-viral agents (DAA) in patients on maintenance hemodialysis (MHD) infected with HCV-genotype 1 & 3. Aim of the study was to evaluate DAA therapy in patients infected with HCV-genotype 1 & 3 on MHD.
METHODS


A prospective open label, parallel, non-randomized interventional trial was conducted in patients with Hepatitis-C on maintenance hemodialysis. Total of Sixty two (62) patients with hepatitis-C on maintenance hemodialysis were screened and 36 patients were enrolled and then equally allocated in 1:1 ratio to group 1 who received 400 mg daily sofosbuvir/ 60 mg daily daclatasvir and group 2 who received thrice a week 400 mg Sofosbuvir and daily 60 mg daclatasvir for 12 weeks. Patients with compensated cirrhosis received therapy for 24 weeks. Relevant data was obtained before, during and after therapy. HCV viral load was assessed at week 4, 8, at end of therapy and 12 weeks after treatment.
RESULTS


Eighteen (18) patients were allocated in each group. Three patients in group 1 withdrawn from the study after 2 weeks due to refusal to participate, while one withdrawn in group 2 due to development of adverse effect. Mean age of patients was 47.22 + 14.17 in group 1 and 53.89 + 14.11 in group 2. Genotype 3 was most common in group 1 patients, n = 12 (66.6%), and n = 11 (61.1%) in group 2. All patients in both groups achieved undetectable viral load at 12th week. As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%) patients achieved SVR (group 1 = 15/15; group 2 = 14/17).
CONCLUSION


Direct acting antiviral therapy using sofosbuvir and declatsavir is highly effective and tolerable in patients with HCV genotype 1 & 3 undergoing maintenance hemodialysis, especially when given daily.
TRIAL REGISTRATION


This trial is registered in WHO, International Clinical Trial Registry Platform, through Iranian Registry of Clinical Trials (IRCT) having IRCT ID: IRCT20170614034526N3, registered retrospectively on 2019-03-08.",2019,As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%),"['patients infected with HCV-genotype 1 & 3 on MHD', 'patients with Hepatitis-C on maintenance hemodialysis', 'patients with HCV genotype 1 & 3 undergoing maintenance hemodialysis', 'Total of Sixty two (62) patients with hepatitis-C on maintenance hemodialysis were screened and 36 patients', 'Eighteen (18) patients were allocated in each group', 'patients undergoing hemodialysis- a prospective interventional clinical trial', 'patients on maintenance hemodialysis\xa0(MHD) infected with HCV-genotype 1 & 3', 'Patients with compensated cirrhosis received therapy for 24\u2009weeks']","['direct anti-viral agents (DAA', 'sofosbuvir and daclatasvir', '400\u2009mg daily sofosbuvir/ 60\u2009mg daily daclatasvir and group 2 who received thrice a week 400\u2009mg Sofosbuvir and daily 60\u2009mg daclatasvir', 'SVR']","['Efficacy and tolerability', 'HCV viral load']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1868902', 'cui_str': 'HCV viral load'}]",,0.0684156,As per intention to treat analysis overall 29/36 (80.55%) patients achieved SVR (group 1 = 15/18; group 2 = 14/18) and as per-protocol analysis overall 29/32 (90.62%),"[{'ForeName': 'Shafiq Ur Rehman', 'Initials': 'SUR', 'LastName': 'Cheema', 'Affiliation': 'Department of Nephrology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan. shafiqcheema@yahoo.com.'}, {'ForeName': 'Muhammad Salman', 'Initials': 'MS', 'LastName': 'Rehman', 'Affiliation': 'Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Hussain', 'Affiliation': 'Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.'}, {'ForeName': 'Sidra Shafiq', 'Initials': 'SS', 'LastName': 'Cheema', 'Affiliation': 'Combined Military Hospital.L.M.C, Lahore, Pakistan.'}, {'ForeName': 'Nooman', 'Initials': 'N', 'LastName': 'Gilani', 'Affiliation': 'Department of Gastroenterology Jinnah Hospital & Allama Iqbal Medical College, Lahore, Pakistan.'}]",BMC nephrology,['10.1186/s12882-019-1631-4']
1159,31783827,Peer support for frequent users of inpatient mental health care in Uganda: protocol of a quasi-experimental study.,"BACKGROUND


Reducing readmissions among frequent users of psychiatric inpatient care could result in substantial cost savings to under-resourced mental health systems. Studies from high-income countries indicate that formal peer support can be an effective intervention for the reduction of readmissions among frequent users. Although in recent years formal peer support programmes have been established in mental health services in a few low- and middle-income countries (LMICs), they have not been rigorously evaluated.
METHODS


This protocol describes a quasi-experimental difference-in-differences study conducted as part of a broader evaluation of the Brain Gain II peer support programme based at Butabika National Referral Hospital in Kampala, Uganda. The primary objective is to investigate whether frequent users of psychiatric inpatient care who have access to a peer support worker (PSW+) experience a greater reduction in rehospitalisation rates and number of days spent in hospital compared to those who do not have access to a peer support worker (PSW-). Frequent users, defined as adults diagnosed with either a mental disorder or epilepsy who have had three or more inpatient stays at Butabika over the previous 24 months, are referred to Brain Gain II by hospital staff on five inpatient wards. Frequent users who normally reside in a district where peer support workers currently operate (Kampala, Jinja, Wakiso and Mukono) are eligible for formal peer support and enter the PSW+ group. Participants in the PSW+ group are expected to receive at least one inpatient visit by a trained peer support worker before hospital discharge and three to six additional visits after discharge. Frequent users from other districts enter the PSW- group and receive standard care. Participants' admissions data are extracted from hospital records at point of referral and six months following referral.
DISCUSSION


To the best of our knowledge, this will be the first quasi-experimental study of formal peer support in a LMIC and the first to assess change in readmissions, an outcome of particular relevance to policy-makers seeking cost-effective alternatives to institutionalised mental health care.",2019,Studies from high-income countries indicate that formal peer support can be an effective intervention for the reduction of readmissions among frequent users.,"['frequent users of inpatient mental health care in Uganda', ""Participants' admissions data are extracted from hospital records at point of referral and six months following referral"", 'frequent users of psychiatric inpatient care who have access to a peer support worker (PSW+) experience', 'Frequent users, defined as adults diagnosed with either a mental disorder or epilepsy who have had three or more inpatient stays at Butabika over the previous 24\u2009months, are referred to Brain Gain II by hospital staff on five inpatient wards', 'based at Butabika National Referral Hospital in Kampala, Uganda']",['Brain Gain II peer support programme'],[],"[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0019980', 'cui_str': 'Hospital Records'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric inpatient'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.0441697,Studies from high-income countries indicate that formal peer support can be an effective intervention for the reduction of readmissions among frequent users.,"[{'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, London, UK. grace.ryan@lshtm.ac.uk.'}, {'ForeName': 'Mauricia', 'Initials': 'M', 'LastName': 'Kamuhiirwa', 'Affiliation': 'Butabika National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mugisha', 'Affiliation': 'Butabika National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Baillie', 'Affiliation': 'East London National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Cerdic', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': 'Camden and Islington National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Newman', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Nkurunungi', 'Affiliation': 'Butabika Recovery College, Kampala, Uganda.'}, {'ForeName': 'Sujit D', 'Initials': 'SD', 'LastName': 'Rathod', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, London, UK.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Devries', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'De Silva', 'Affiliation': 'Department of Population Health, Wellcome Trust, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mpango', 'Affiliation': 'Butabika National Referral Hospital, Kampala, Uganda.'}]",BMC psychiatry,['10.1186/s12888-019-2360-8']
1160,31041591,"A Pilot, Randomized Study in Women of Nutrition-Related Clinical Chemistry at 6 Weeks after Roux en Y Gastric Bypass: Comparison of Two Nutrition Support Plans.","BACKGROUND


The current pilot study tested a twofold hypothesis: some nutrition-related chemical measures change by 6 weeks after Roux en Y Gastric Bypass (RNYGB); one of two nutrition support plans will prevent chemical signs of nutrition problems at 6 weeks better than the other. After RNYGB, nutrition support should begin right away. However, studies on nutritional status mostly examine subjects much later. In addition, little attention has been paid to optimizing nutrition support plans.
METHODS


Premenopausal females scheduled for RNYGB were given either a commercially available meal replacement product (2 servings/day) + other supplements or just a new meal replacement (2 servings/day). The latter included some nutrient versions that might enhance absorption. Blood and urine samples were taken before and 6 weeks after surgery.
RESULTS


In both groups, plasma vitamin D and B 12  did not change, plasma osteopontin and vascular endothelial growth factor rose, while plasma retinol binding protein and a bone resorption marker declined. Copper status changes differed between groups based on plasma ceruloplasmin. Iron status improved in both groups (ferritin to c-reactive protein ratios). With the new formulation, magnesium status may have improved, urinary potassium rose, and blood sugar fell. In the other group, a liver damage marker increased, while homocysteine decreased.
CONCLUSIONS


Nutrition-related parameters showed varying trends 6 weeks after RNYGB. Some of the trends were affected by the type of nutritional support provided.",2019,"In both groups, plasma vitamin D and B 12  did not change, plasma osteopontin and vascular endothelial growth factor rose, while plasma retinol binding protein and a bone resorption marker declined.","['Women of Nutrition-Related Clinical Chemistry at 6\xa0Weeks after Roux en Y Gastric Bypass', 'Premenopausal females scheduled for RNYGB were given either a']",['commercially available meal replacement product (2 servings/day)\u2009+\u2009other supplements or just a new meal replacement'],"['liver damage marker', 'Blood and urine samples', 'Iron status', 'plasma ceruloplasmin', 'urinary potassium rose, and blood sugar fell', 'plasma vitamin D and B 12  did not change, plasma osteopontin and vascular endothelial growth factor rose, while plasma retinol binding protein and a bone resorption marker']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0008000', 'cui_str': 'Chemistry, Clinical'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0151763', 'cui_str': 'Liver damage (disorder)'}, {'cui': 'C0005768'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0007841', 'cui_str': 'Ceruloplasmin Ferroxidase'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C2757028', 'cui_str': 'Retinol-Binding Proteins, Plasma'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}]",,0.0193467,"In both groups, plasma vitamin D and B 12  did not change, plasma osteopontin and vascular endothelial growth factor rose, while plasma retinol binding protein and a bone resorption marker declined.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'DiSilvestro', 'Affiliation': 'Medinutra LLC, 8050 Simfield Rd, Dublin, OH, 43016, USA. studies@columbus.rr.com.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Choban', 'Affiliation': 'Department of Surgery, Central Ohio Surgical Associates, Mt Carmel Health Center, Columbus, OH, USA.'}, {'ForeName': 'Fernando N', 'Initials': 'FN', 'LastName': 'Aguila', 'Affiliation': 'Department of Surgery, Central Ohio Surgical Associates, Mt Carmel Health Center, Columbus, OH, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Central Ohio Surgical Associates, Mt Carmel Health Center, Columbus, OH, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Joseph', 'Affiliation': 'Medinutra LLC, 8050 Simfield Rd, Dublin, OH, 43016, USA.'}]",Obesity surgery,['10.1007/s11695-019-03895-4']
1161,31579978,Efficacy and safety of oral silymarin in comparison with oral doxycycline and their combination therapy in the treatment of acne vulgaris.,"Two factors of oxidative stress and inflammatory processes are implicated in pathogenesis of acne vulgaris. Silymarin has antioxidant and anti-inflammatory activities. This study was done to evaluate the effect of oral silymarin in the treatment of acne vulgaris compared to doxycycline and also their combination therapy. This randomized controlled trial was performed on 60 patients with acne vulgaris were divided into three groups of 20 patients, including: Silymarin (Group 1), Doxycycline (Group 2), and both compounds (Group 3). The patients' response was monitored every month and the lesions were evaluated using photography and two methods of Global Acne Grading system (GAGS) and Acne Severity Index (ASI). According to the results, the response to silymarin was not significantly different with doxycycline in the GAGS index (p = .260), but was lower in the ASI (p = .021). In this study, the synergistic effects of silymarin and doxycycline combination have been investigated in comparison with doxycycline. Although the improvement was more favorable in combination group, there was no statistically significant difference (p = .9 in ASI and p = .5 in GAGS). The results of our study suggest that although the silymarin monotherapy is not as effective as doxycycline for the treatment of acne vulgaris, it can be a therapeutic option.",2019,"Although the improvement was more favorable in combination group, there was no statistically significant difference (P=0.9 in ASI and P=0.5 in GAGS).
","['60 patients with acne vulgaris', 'Acne Vulgaris']","['Silymarin', 'Doxycycline and their Combination Therapy', 'doxycycline', 'Doxycycline', 'silymarin and doxycycline', 'Oral Silymarin', 'oral silymarin']","['Global Acne Grading system (GAGS) and Acne Severity Index (ASI', 'Efficacy and Safety', 'GAGS index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.024309,"Although the improvement was more favorable in combination group, there was no statistically significant difference (P=0.9 in ASI and P=0.5 in GAGS).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shie Morteza', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Islamic Azad University, Pharmaceutical Sciences Branch, Tehran, Iran.'}, {'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Hayati', 'Affiliation': 'Islamic Azad University, Pharmaceutical Sciences Branch, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Namazi', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Abdollahimajd', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Dermatologic therapy,['10.1111/dth.13095']
1162,22592705,Metal protein attenuating compounds for the treatment of Alzheimer's dementia.,"BACKGROUND


Alzheimer's dementia (AD) may be caused by the formation of extracellular senile plaques comprised of beta-amyloid (Aß). In vitro and mouse model studies have demonstrated that metal protein attenuating compounds (MPACs) promote the solubilisation and clearance of Aß.
OBJECTIVES


To evaluate the efficacy of metal protein attenuating compounds (MPACs) for the treatment of cognitive impairment due to Alzheimer's dementia.
SEARCH METHODS


We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 29 July 2010 using the terms: Clioquinol OR PBT1 OR PBT2 OR ""metal protein"" OR MPACS OR MPAC.
SELECTION CRITERIA


Randomised double-blind trials in which treatment with an MPAC was administered to participants with Alzheimer's dementia in a parallel group comparison with placebo were included.
DATA COLLECTION AND ANALYSIS


Three review authors (RM, LJ, ELS) independently assessed the quality of trials according to the Cochrane Handbook for Systematic Reviews of Interventions.The primary outcome measure of interest was cognitive function (as measured by psychometric tests). The secondary outcome measures of interest were in the following areas: quality of life, functional performance, effect on carer, biomarkers, safety and adverse effects, and death.
MAIN RESULTS


Two MPAC trials were identified. One trial compared clioquinol (PBT1) with placebo in 36 patients and 32 had sufficient data for per protocol analysis. There was no statistically significant difference in cognition (as measured on the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)) between the active treatment and placebo groups at 36 weeks. The difference in mean change from baseline ADAS-Cog score in the clioquinol arm compared with the placebo arm at weeks 24 and 36 was a difference of 7.37 (95% confidence interval (CI) 1.51 to 13.24) and 6.36 (95% CI -0.50 to 13.23), respectively.There was no significant impact on non-cognitive symptoms or clinical global impression. One participant in the active treatment group developed neurological symptoms (impaired visual acuity and colour vision) which resolved on cessation of treatment and were possibly attributable to the drug.In the second trial a successor compound, PBT2, was compared with placebo in 78 participants with mild Alzheimer's dementia; all were included in the intention-to-treat analysis. There was no significant difference in the Neuropsychological Test Battery (NTB) composite, memory or executive scores between placebo and PBT2 in the least squares mean change from baseline at week 12. However, two executive function component tests of the NTB showed significant improvement over placebo in the PBT2 250 mg group from baseline to week 12: category fluency test (2.8 words, 95% CI 0.1 to 5.4; P = 0.041) and trail making part B (-48.0 s, 95% CI -83.0 to -13.0; P = 0.009). There was no significant effect on cognition on Mini-Mental State Examination (MMSE) or ADAS-Cog scales. PBT2 had a favourable safety profile.
AUTHORS' CONCLUSIONS


There is an absence of evidence as to whether clioquinol (PBT1) has any positive clinical benefit for patients with AD, or whether the drug is safe. We have some concerns about the quality of the study methodology; there was an imbalance in treatment and control groups after randomisation (participants in the active treatment group had a higher mean pre-morbid IQ) and the secondary analyses of results stratified by baseline dementia severity. The planned phase III trial of PBT1 has been abandoned and this compound has been withdrawn from development. The second trial of PBT2 was more rigorously conducted and showed that after 12 weeks this compound appeared to be safe and well tolerated in people with mild Alzheimer's dementia. Larger trials are now required to demonstrate cognitive efficacy.",2012,"There was no significant difference in the Neuropsychological Test Battery (NTB) composite, memory or executive scores between placebo and PBT2 in the least squares mean change from baseline at week 12.","[""people with mild Alzheimer's dementia"", '36 patients and 32 had sufficient data for per protocol analysis', ""Alzheimer's dementia (AD"", 'patients with AD', ""Alzheimer's dementia"", ""78 participants with mild Alzheimer's dementia"", ""participants with Alzheimer's dementia in a parallel group comparison with"", ""cognitive impairment due to Alzheimer's dementia""]","['placebo', 'PBT1', 'PBT2', 'clioquinol (PBT1) with placebo', 'clioquinol', 'Clioquinol OR PBT1 OR PBT2 OR ""metal protein"" OR MPACS OR MPAC', 'metal protein attenuating compounds (MPACs', 'MPAC']","['safe and well tolerated', 'quality of life, functional performance, effect on carer, biomarkers, safety and adverse effects, and death', 'cognition on Mini-Mental State Examination (MMSE) or ADAS', 'category fluency test', 'neurological symptoms (impaired visual acuity and colour vision', 'non-cognitive symptoms or clinical global impression', 'trail making part B ', 'Neuropsychological Test Battery (NTB) composite, memory or executive scores', 'cognition', ""Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog"", 'cognitive function (as measured by psychometric tests', 'mean change from baseline ADAS-Cog score']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021978', 'cui_str': 'Clioquinol'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C3853978'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0086032', 'cui_str': 'Daylight Vision'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",78.0,0.524838,"There was no significant difference in the Neuropsychological Test Battery (NTB) composite, memory or executive scores between placebo and PBT2 in the least squares mean change from baseline at week 12.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'UCL Mental Health Sciences Unit, University College Medical School, London, UK. e.sampson@ucl.ac.uk'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Jenagaratnam', 'Affiliation': ''}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD005380.pub4']
1163,22972099,Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.,"BACKGROUND


Both inhaled steroids (ICS) and long-acting beta(2)-agonists (LABA) are used in the management of chronic obstructive pulmonary disease (COPD). This updated review compared compound LABA plus ICS therapy (LABA/ICS) with the LABA component drug given alone.
OBJECTIVES


To assess the efficacy of ICS and LABA in a single inhaler with mono-component LABA alone in adults with COPD.
SEARCH METHODS


We searched the Cochrane Airways Group Specialised Register of trials. The date of the most recent search was November 2011.
SELECTION CRITERIA


We included randomised, double-blind controlled trials. We included trials comparing compound ICS and LABA preparations with their component LABA preparations in people with COPD.
DATA COLLECTION AND ANALYSIS


Two authors independently assessed study risk of bias and extracted data. The primary outcomes were exacerbations, mortality and pneumonia, while secondary outcomes were health-related quality of life (measured by validated scales), lung function, withdrawals due to lack of efficacy, withdrawals due to adverse events and side-effects. Dichotomous data were analysed as random-effects model odds ratios or rate ratios with 95% confidence intervals (CIs), and continuous data as mean differences and 95% CIs. We rated the quality of evidence for exacerbations, mortality and pneumonia according to recommendations made by the GRADE working group.
MAIN RESULTS


Fourteen studies met the inclusion criteria, randomising 11,794 people with severe COPD. We looked at any LABA plus ICS inhaler (LABA/ICS) versus the same LABA component alone, and then we looked at the 10 studies which assessed fluticasone plus salmeterol (FPS) and the four studies assessing budesonide plus formoterol (BDF) separately. The studies were well-designed with low risk of bias for randomisation and blinding but they had high rates of attrition, which reduced our confidence in the results for outcomes other than mortality.Primary outcomes There was low quality evidence that exacerbation rates in people using LABA/ICS inhalers were lower in comparison to those with LABA alone, from nine studies which randomised 9921 participants (rate ratio 0.76; 95% CI 0.68 to 0.84). This corresponds to one exacerbation per person per year on LABA and 0.76 exacerbations per person per year on ICS/LABA. Our confidence in this effect was limited by statistical heterogeneity between the results of the studies (I(2) = 68%) and a risk of bias from the high withdrawal rates across the studies. When analysed as the number of people experiencing one or more exacerbations over the course of the study, FPS lowered the odds of an exacerbation with an odds ratio (OR) of 0.83 (95% CI 0.70 to 0.98, 6 studies, 3357 participants). With a risk of an exacerbation of 47% in the LABA group over one year, 42% of people treated with LABA/ICS would be expected to experience an exacerbation. Concerns over the effect of reporting biases led us to downgrade the quality of evidence for this effect from high to moderate.There was no significant difference in the rate of hospitalisations (rate ratio 0.79; 95% CI 0.55 to 1.13, very low quality evidence due to risk of bias, statistical imprecision and inconsistency). There was no significant difference in mortality between people on combined inhalers and those on LABA, from 10 studies on 10,680 participants (OR 0.92; 95% CI 0.76 to 1.11, downgraded to moderate quality evidence due to statistical imprecision). Pneumonia occurred more commonly in people randomised to combined inhalers, from 12 studies with 11,076 participants (OR 1.55; 95% CI 1.20 to 2.01, moderate quality evidence due to risk of bias in relation to attrition) with an annual risk of around 3% on LABA alone compared to 4% on combination treatment. There were no significant differences between the results for either exacerbations or pneumonia from trials adding different doses or types of inhaled corticosteroid.Secondary outcomes ICS/LABA was more effective than LABA alone in improving health-related quality of life measured by the St George's Respiratory Questionnaire (1.58 units lower with FPS; 2.69 units lower with BDF), dyspnoea (0.09 units lower with FPS), symptoms (0.07 units lower with BDF), rescue medication (0.38 puffs per day fewer with FPS, 0.33 puffs per day fewer with BDF), and forced expiratory volume in one second (FEV(1)) (70 mL higher with FPS, 50 mL higher with BDF). Candidiasis (OR 3.75) and upper respiratory infection (OR 1.32) occurred more frequently with FPS than SAL. We did not combine adverse event data relating to candidiasis for BDF studies as the results were very inconsistent.
AUTHORS' CONCLUSIONS


Concerns over the analysis and availability of data from the studies bring into question the superiority of ICS/LABA over LABA alone in preventing exacerbations. The effects on hospitalisations were inconsistent and require further exploration. There was moderate quality evidence of an increased risk of pneumonia with ICS/LABA. There was moderate quality evidence that treatments had similar effects on mortality. Quality of life, symptoms score, rescue medication use and FEV(1) improved more on ICS/LABA than on LABA, but the average differences were probably not clinically significant for these outcomes. To an individual patient the increased risk of pneumonia needs to be balanced against the possible reduction in exacerbations.More information would be useful on the relative benefits and adverse event rates with combination inhalers using different doses of inhaled corticosteroids. Evidence from head-to-head comparisons is needed to assess the comparative risks and benefits of the different combination inhalers.",2012,There were no significant differences between the results for either exacerbations or pneumonia from trials adding different doses or types of inhaled corticosteroid.,"['people with COPD', 'Fourteen studies met the inclusion criteria, randomising 11,794 people with severe COPD', 'adults with COPD', 'chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease (COPD']","['Combined corticosteroid and long-acting beta(2)-agonist', 'LABA', 'LABA/ICS', 'mono-component LABA alone', 'ICS and LABA', 'LABA plus ICS inhaler (LABA/ICS', 'fluticasone plus salmeterol (FPS', 'LABA plus ICS therapy (LABA/ICS', 'inhaled steroids (ICS) and long-acting beta(2)-agonists (LABA']","['health-related quality of life (measured by validated scales), lung function, withdrawals due to lack of efficacy, withdrawals due to adverse events and side-effects', 'Candidiasis (OR 3.75) and upper respiratory infection', 'quality of evidence for exacerbations, mortality and pneumonia', 'forced expiratory volume in one second (FEV(1', 'risk of pneumonia with ICS/LABA', 'Pneumonia', 'Quality of life, symptoms score, rescue medication use and FEV(1', 'exacerbations, mortality and pneumonia', 'exacerbation rates', 'rescue medication', 'mortality', 'dyspnoea', 'health-related quality of life', 'rate of hospitalisations']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",11794.0,0.584317,There were no significant differences between the results for either exacerbations or pneumonia from trials adding different doses or types of inhaled corticosteroid.,"[{'ForeName': 'Luis Javier', 'Initials': 'LJ', 'LastName': 'Nannini', 'Affiliation': 'Pulmonary Section, Hospital E Peron, G. Baigorria, Argentina. nanninilj@cimero.org.ar.'}, {'ForeName': 'Toby J', 'Initials': 'TJ', 'LastName': 'Lasserson', 'Affiliation': ''}, {'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Poole', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006829.pub2']
1164,23076894,Vitamin K antagonists or low-molecular-weight heparin for the long term treatment of symptomatic venous thromboembolism.,"BACKGROUND


People with venous thromboembolism (VTE) are generally treated for five days with intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin (LMWH) followed by three months of vitamin K antagonist treatment. Treatment with vitamin K antagonists requires regular laboratory measurements and some patients have contraindications to treatment. This is an update of a review first published in 2000 and updated in 2002.
OBJECTIVES


To evaluate the efficacy and safety of long term treatment of VTE with LMWH compared to vitamin K antagonists.
SEARCH METHODS


For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched February 2012) and CENTRAL (2012, Issue 1).
SELECTION CRITERIA


Two authors evaluated trials independently for methodological quality.
DATA COLLECTION AND ANALYSIS


The review authors extracted data independently. Primary analysis included all trial participants randomised to the allocated treatment groups. Separate analyses were performed according to the quality of the trials and for subgroups such as trials initially using similar treatments in both trial arms and those that did not, trials concerning deep vein thrombosis (DVT) and pulmonary embolism (PE) and the different periods of follow-up.
MAIN RESULTS


All 15 trials, with a combined total of 3197 patients, fulfilling our criteria were combined in a meta-analysis. We found a non-statistically significant reduction in the risk of recurrent VTE between the two treatments (odds ratio (OR) 0.82, 95% CI 0.59 to 1.13). Analysis of pooled data for category I trials (those with a high methodological quality) showed a non-significant reduction in the odds of recurrent VTE favouring LMWH treatment (OR 0.80, 95% CI 0.54 to 1.18).For all trials combined, the difference in bleeding significantly favoured treatment with LMWH (OR 0.50, 95% CI 0.31 to 0.79). Considering only category I trials, a non-significant trend favouring LMWH remained (OR 0.62, 95% CI 0.36 to 1.07). No difference was observed in mortality (OR 1.06, 95% CI 0.74 to 1.54).
AUTHORS' CONCLUSIONS


LMWHs are possibly as effective as vitamin K antagonists in preventing symptomatic VTE after an episode of symptomatic deep venous thrombosis, but are much more expensive. Treatment with LMWH is significantly safer than treatment with vitamin K antagonists. LMWH may result in fewer episodes of bleeding and is possibly a safe alternative in some patients, especially those in geographically inaccessible areas, are reluctant to visit the thrombosis service regularly, or with contraindications to vitamin K antagonists. However, treatment with vitamin K antagonists remains the treatment of choice for the majority of patients.",2012,"No difference was observed in mortality (OR 1.06, 95% CI 0.74 to 1.54).
","['People with venous thromboembolism (VTE', '3197 patients, fulfilling our criteria were combined in a meta-analysis', 'symptomatic venous thromboembolism']","['Vitamin K antagonists or low-molecular-weight heparin', 'LMWH', 'VTE with LMWH', 'vitamin K antagonist treatment', 'intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin (LMWH', 'vitamin K antagonists']","['bleeding', 'LMWH', 'deep vein thrombosis (DVT) and pulmonary embolism (PE', 'risk of recurrent VTE', 'efficacy and safety', 'mortality']","[{'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",3197.0,0.116024,"No difference was observed in mortality (OR 1.06, 95% CI 0.74 to 1.54).
","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Andras', 'Affiliation': 'Department of Vascular Surgery, Freeman Hospital, Newcastle upon Tyne, UK. alinaro@hotmail.com.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Sala Tenna', 'Affiliation': ''}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Crawford', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002001.pub2']
1165,31227470,Managing Paratonia in Persons With Dementia: Short-term Effects of Supporting Cushions and Harmonic Techniques.,"OBJECTIVES


Paratonia, a form of hypertonia typically seen in dementia, is often associated with difficulties in positioning and daily care. No evidence-based therapy or clinical guideline for management is available. In this study, the short-term effect of harmonic techniques (HT) and supporting cushions (SC) on paratonia was explored.
DESIGN


This was a multicenter interventional clinical trial with AB/BA crossover design. Each intervention (SC or HT) was subsequently implemented over 1 week in each of the participants.
SETTING AND PARTICIPANTS


The study included 22 participants with moderate to severe paratonia from 9 different nursing homes in Flanders, Belgium.
METHODS


Measurements of biceps brachii and rectus femoris muscle tone (MyotonPRO), maximal elbow and knee extension (goniometer), and pain (Pain Assessment Checklist for Seniors With Limited Ability to Communicate) were performed on 3 different days within 1 week. The effect of HT on nursing care was evaluated with the Pain Assessment Checklist for Seniors With Limited Ability to Communicate and visual analog scale ratings of discomfort items.
RESULTS


After 30 minutes of positioning with SC, participants had lower biceps brachii muscle tone (P = .041) and higher maximal elbow extension (P = .006) than without SC. After a 30-minute session of HT, a significant increase in biceps brachii muscle tone (P = .032) and maximal extension of elbow (P < .001) and knee (P = .028) was found. Pain (P = .003) and discomfort (P = .001 to P = .019) during morning care were significantly lower when care was preceded by 30 minutes of HT.
CONCLUSIONS/IMPLICATIONS


This explorative study revealed beneficial short-term effects on range of motion for both SC and HT and a positive effect of SC on upper limb muscle tone. Beneficial effects of HT were found on resident's pain and caregiver's discomfort during care. The results of the present study are encouraging and can contribute to the development of evidence-based interventions for paratonia.",2019,"After 30 minutes of positioning with SC, participants had lower biceps brachii muscle tone (P = .041) and higher maximal elbow extension (P = .006) than without SC.","['22 participants with moderate to severe paratonia from 9 different nursing homes in Flanders, Belgium', 'Persons With Dementia']","['harmonic techniques (HT) and supporting cushions (SC', 'SC', 'Each intervention (SC or HT', 'HT']","['upper limb muscle tone', 'biceps brachii muscle tone', 'Pain', 'maximal extension of elbow', 'maximal elbow extension', 'biceps brachii and rectus femoris muscle tone (MyotonPRO), maximal elbow and knee extension (goniometer), and pain (Pain Assessment Checklist', 'discomfort', 'Pain Assessment Checklist']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231519', 'cui_str': 'Gegenhalten'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0180249', 'cui_str': 'Cushion'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",22.0,0.0535859,"After 30 minutes of positioning with SC, participants had lower biceps brachii muscle tone (P = .041) and higher maximal elbow extension (P = .006) than without SC.","[{'ForeName': 'Bieke', 'Initials': 'B', 'LastName': 'Van Deun', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium. Electronic address: bieke.vandeun@ugent.be.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Van Den Noortgate', 'Affiliation': 'Department of Geriatrics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Van Bladel', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'De Weerdt', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Cambier', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.04.031']
1166,22513949,Vitamin D supplementation for cystic fibrosis.,"BACKGROUND


Cystic fibrosis (CF) is a genetic disorder with multiorgan effects. In a subgroup with pancreatic insufficiency malabsorption of the fat soluble vitamins (A, D, E, K) may occur. Vitamin D is involved in calcium homeostasis and bone mineralisation and may have extraskeletal effects. This review examines the evidence for vitamin D supplementation in CF.
OBJECTIVES


To assess the effects of vitamin D supplementation on the frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity in the CF population.
SEARCH METHODS


We searched the Cochrane CF and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Most recent search: 15 February 2012.
SELECTION CRITERIA


Randomised and quasi-randomised controlled trials of vitamin D supplementation compared to placebo in the CF population regardless of exocrine pancreatic function.
DATA COLLECTION AND ANALYSIS


Both authors independently assessed the 'risk of bias' of each included trial and extracted outcome data (from published trial information) for assessment of bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events.
MAIN RESULTS


Three studies are included, although only data from two were available (41 adults and children with CF). One of these studies compared supplemental 800 international units (IU) vitamin D and placebo for 12 months in 30 osteopenic pancreatic insufficient adults; both groups continued 900 IU vitamin D daily. The other (abstract only) compared supplemental 1g calcium alone, 1600 IU vitamin D alone, 1600 IU vitamin D and 1g calcium and placebo in a double-blind randomised cross-over trial; only 11 children (vitamin D and placebo groups) after six-months supplementation are included; inclusion criteria, pancreatic sufficiency or disease status of participants are not defined. There were no significant differences in primary or secondary outcomes in either study. The studies are not directly comparable due to differences in supplementation, outcome reporting and possibly participant characteristics (eg severity of lung disease, growth and nutrition, pancreatic sufficiency). There were no adverse events in either study. The third study (abstract only) compared daily calcitriol (0.25 or 0.5 micrograms) with placebo in pancreatic insufficient children and young adults, only pre-intervention data were available.
AUTHORS' CONCLUSIONS


There is no evidence of benefit or harm in the limited number of small-sized published trials. Adherence to relevant CF guidelines on vitamin D should be considered until further evidence is available.",2012,There were no adverse events in either study.,"['pancreatic insufficient children and young adults, only pre-intervention data were available', '30 osteopenic pancreatic insufficient adults', '41 adults and children with CF', 'cystic fibrosis']","['vitamin D supplementation', 'placebo', 'daily calcitriol', 'Vitamin D', 'Vitamin D supplementation', '11 children (vitamin D and placebo', 'vitamin D and 1g calcium and placebo', 'supplemental 800 international units (IU) vitamin D and placebo']","['frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity', 'adverse events', 'bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events']","[{'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439453', 'cui_str': 'IU'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0242154', 'cui_str': 'Vitamin D toxicity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}]",,0.619612,There were no adverse events in either study.,"[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ferguson', 'Affiliation': 'Christchurch Hospital, Canterbury District Health Board, Private Bag 4710, Christchurch, New Zealand, 8014. janet.ferguson@actrix.co.nz.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007298.pub3']
1167,25386977,Garlic for the common cold.,"Background Garlic is alleged to have antimicrobial and antiviral properties that relieve the common cold, among other beneficial effects. There is widespread usage of garlic supplements. The common cold is associated with significant morbidity and economic consequences. On average, children have six to eight colds per year and adults have two to four.Objectives To determine whether garlic (Allium sativum) is effective for the prevention or treatment of the common cold, when compared to placebo, no treatment or other treatments.Search methods We searched CENTRAL (2014, Issue 7),OLDMEDLINE (1950 to 1965),MEDLINE (January 1966 to July week 5, 2014), EMBASE(1974 to August 2014) and AMED (1985 to August 2014).Selection criteria Randomised controlled trials of common cold prevention and treatment comparing garlic with placebo, no treatment or standard treatment.Data collection and analysis Two review authors independently reviewed and selected trials from searches, assessed and rated study quality and extracted relevant data.Main results In this updated review, we identified eight trials as potentially relevant from our searches. Again, only one trial met the inclusion criteria.This trial randomly assigned 146 participants to either a garlic supplement (with 180 mg of allicin content) or a placebo (once daily)for 12 weeks. The trial reported 24 occurrences of the common cold in the garlic intervention group compared with 65 in the placebo group (P value < 0.001), resulting in fewer days of illness in the garlic group compared with the placebo group (111 versus 366). The number of days to recovery from an occurrence of the common cold was similar in both groups (4.63 versus 5.63). Only one trial met the inclusion criteria, therefore limited conclusions can be drawn. The trial relied on self reported episodes of the common cold but was of reasonable quality in terms of randomisation and allocation concealment. Adverse effects included rash and odour. Authors' conclusions There is insufficient clinical trial evidence regarding the effects of garlic in preventing or treating the common cold. A single trial suggested that garlic may prevent occurrences of the common cold but more studies are needed to validate this finding. Claims of effectiveness appear to rely largely on poor-quality evidence.",2014,"To determine whether garlic (Allium sativum) is effective for the prevention or treatment of the common cold, when compared to placebo, no treatment or other treatments.",['146 participants to either a'],"['placebo', 'garlic (Allium sativum', 'garlic intervention', 'garlic with placebo, no treatment or standard treatment', 'garlic supplement', 'garlic', 'Garlic', ' Garlic']","['number of days to recovery', 'rash and odour']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0993630', 'cui_str': 'Allium sativum'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",146.0,0.769985,"To determine whether garlic (Allium sativum) is effective for the prevention or treatment of the common cold, when compared to placebo, no treatment or other treatments.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lissiman', 'Affiliation': 'Faculty of Medicine, Dentistry & Health Sciences, The University ofWestern Australia, Crawley, WA, 6009, Australia. libby.lissiman@gmail.com.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Bhasale', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006206.pub4']
1168,12917897,Nebulised anti-pseudomonal antibiotics for cystic fibrosis.,"BACKGROUND


Persistent infection by Pseudomonas aeruginosa contributes to lung damage, resulting in illness and death in people with cystic fibrosis (CF). Nebulised antibiotics are commonly used to treat this infection.
OBJECTIVES


To examine the evidence that nebulised anti-pseudomonal antibiotic treatment in people with CF reduces frequency of exacerbations of infection, improves lung function, quality of life and survival. To examine adverse effects of nebulised anti-pseudomonal antibiotic treatment.
SEARCH STRATEGY


Trials were identified from the Cochrane Cystic Fibrosis and Genetic Disorders Group clinical trials register. Companies that marketed nebulised anti-pseudomonal antibiotics were contacted for information on unpublished trials. Most recent search of the Group's trials register: August 2002.
SELECTION CRITERIA


Trials were selected if, nebulised anti-pseudomonal antibiotics treatment was used for four weeks or more in people with CF, allocation to treatment was randomised or quasi-randomised, and there was a placebo or a no placebo control group or another nebulised antibiotic comparison.
DATA COLLECTION AND ANALYSIS


For the first version of this review, two reviewers independently selected and judged the quality of, the trials to be included in the review. One reviewer extracted data from these trials and performed all tasks for the updated version of the review.
MAIN RESULTS


Out of 33 trials identified, there were 11, with 873 participants, that met the inclusion criteria. Ten trials with 758 participants compared a nebulised anti-pseudomonal antibiotic with placebo or usual treatment. One of these trials accounted for 68% of the total participants and seven of these trials used a cross-over design. Tobramycin was studied in four trials and follow up ranged from 1 to 32 months. Lung function, measured as forced expired volume in one second (FEV1) was better in the treated group than in control group in nine of these. Resistance to antibiotics increased more in the antibiotic treated group than in placebo group. Tinnitus and voice alteration were more frequent with tobramycin than placebo. One short-term trial of one month, with 115 participants, compared tobramycin and colistin, and showed a trend towards greater improvement in FEV1 in the tobramycin group.
REVIEWER'S CONCLUSIONS


Nebulised anti-pseudomonal antibiotic treatment improves lung function. However, more evidence, from longer duration trials, is needed to determine if this benefit is maintained as well as to determine the significance of development of antibiotic resistant organisms. There is insufficient evidence for recommendations about type of drug and dose regimens.",2003,"Lung function, measured as forced expired volume in one second (FEV1) was better in the treated group than in control group in nine of these.","['873 participants', 'people with CF', 'people with cystic fibrosis (CF', '758 participants', 'cystic fibrosis']","['tobramycin', 'placebo', 'Nebulised antibiotics', 'Tobramycin', 'nebulised anti-pseudomonal antibiotics treatment', 'nebulised anti-pseudomonal antibiotic treatment', 'nebulised anti-pseudomonal antibiotic with placebo or usual treatment', 'placebo or a no placebo control group or another nebulised antibiotic comparison', 'Nebulised anti-pseudomonal antibiotics']","['Tinnitus and voice alteration', 'FEV1', 'exacerbations of infection, improves lung function, quality of life and survival', 'lung function', 'Resistance to antibiotics', 'Lung function']","[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C1527340', 'cui_str': 'Voice Disturbance'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0034380'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",,0.242053,"Lung function, measured as forced expired volume in one second (FEV1) was better in the treated group than in control group in nine of these.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1169,31056676,Evidence in a Cluster Randomized Controlled Trial of Increased 2009 Pandemic Risk Associated With 2008-2009 Seasonal Influenza Vaccine Receipt.,,2019,,['2009 pandemic risk associated with 2008-09 seasonal influenza vaccine receipt'],[],[],"[{'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]",[],[],,0.236922,,"[{'ForeName': 'Danuta M', 'Initials': 'DM', 'LastName': 'Skowronski', 'Affiliation': 'Communicable Diseases and Immunization Services, British Columbia Centre for Disease Control, Vancouver.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'De Serres', 'Affiliation': 'Direction of Biological and Occupational Risks, Institut National de Santé Publique du Québec, Quebec, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz351']
1170,23235653,Sapropterin dihydrochloride for phenylketonuria.,"BACKGROUND


Phenylketonuria results from a deficiency of the enzyme phenylalanine hydroxylase. Dietary restriction of phenylalanine keeps blood phenylalanine concentration low. Most natural foods are excluded from diet and supplements are used to supply other nutrients. Recent publications report a decrease in blood phenylalanine concentration in some patients treated with sapropterin dihydrochloride. We examined the evidence for the use of sapropterin dihydrochloride to treat phenylketonuria.
OBJECTIVES


To assess the safety and efficacy of sapropterin dihydrochloride in lowering blood phenylalanine concentration in people with phenylketonuria.
SEARCH METHODS


We identified relevant trials from the Group's Inborn Errors of Metabolism Trials Register. Date of last search: 29 June 2012.We also searched ClinicalTrials.gov and Current controlled trials. Last search: 23 July 2012.We contacted the manufacturers of the drug (BioMarin Pharmaceutical Inc.) for information regarding any unpublished trials.
SELECTION CRITERIA


Randomized controlled trials comparing sapropterin with no supplementation or placebo in people with phenylketonuria due to phenylalanine hydroxylase deficiency.
DATA COLLECTION AND ANALYSIS


Two authors independently assessed trials and extracted outcome data.
MAIN RESULTS


Two placebo-controlled trials were included. One trial administered 10 mg/kg/day sapropterin in 89 children and adults with phenylketonuria whose diets were not restricted and who had previously responded to saproterin.This trial measured change in blood phenylalanine concentration. The second trial screened 90 children (4 to 12 years) with phenylketonuria whose diet was restricted, for responsiveness to sapropterin. Forty-six responders entered the placebo-controlled part of the trial and received 20 mg/kg/day sapropterin. This trial measured change in both phenylalanine concentration and protein tolerance. Both trials reported adverse events. The trials showed an overall low risk of bias; but both are Biomarin-sponsored. One trial showed a significant lowering in blood phenylalanine concentration in the sapropterin group (10 mg/kg/day), mean difference -238.80 μmol/L (95% confidence interval -343.09 to -134.51); a second trial (20 mg/kg/day sapropterin) showed a non-significant difference, mean difference -51.90 μmol/L (95% confidence interval -197.27 to 93.47). The second trial also reported a significant increase in phenylalanine tolerance, mean difference18.00 mg/kg/day (95% confidence interval 12.28 to 23.72) in the 20 mg/kg/day sapropterin group.
AUTHORS' CONCLUSIONS


There is evidence of short-term benefit from using sapropterin in some patients with sapropterin-responsive forms of phenylketonuria; blood phenylalanine concentration is lowered and protein tolerance increased. There are no serious adverse events associated with using sapropterin in the short term.There is no evidence on the long-term effects of sapropterin and no clear evidence of effectiveness in severe phenylketonuria.",2012,"The second trial also reported a significant increase in phenylalanine tolerance, mean difference18.00 mg/kg/day (95% confidence interval 12.28 to 23.72) in the 20 mg/kg/day sapropterin group.
","['Forty-six responders entered the', 'people with phenylketonuria due to phenylalanine hydroxylase deficiency', '89 children and adults with phenylketonuria whose diets were not restricted and who had previously responded to saproterin', '90 children (4 to 12 years) with phenylketonuria whose diet was restricted, for responsiveness to sapropterin', 'people with phenylketonuria']","['sapropterin dihydrochloride', 'Sapropterin dihydrochloride', 'sapropterin with no supplementation or placebo', 'placebo']","['phenylalanine tolerance', 'safety and efficacy', 'adverse events', 'phenylalanine concentration and protein tolerance', 'blood phenylalanine concentration']","[{'cui': 'C0751434', 'cui_str': 'Phenylalanine Hydroxylase Deficiency'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0048897', 'cui_str': 'Sapropterin'}]","[{'cui': 'C1996349', 'cui_str': 'Sapropterin dihydrochloride'}, {'cui': 'C0048897', 'cui_str': 'Sapropterin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005768'}]",90.0,0.518266,"The second trial also reported a significant increase in phenylalanine tolerance, mean difference18.00 mg/kg/day (95% confidence interval 12.28 to 23.72) in the 20 mg/kg/day sapropterin group.
","[{'ForeName': 'Usha Rani', 'Initials': 'UR', 'LastName': 'Somaraju', 'Affiliation': 'Department of Biochemistry and Genetics, Trinity School of Medicine, Kingstown, Saint Vincent and The Grenadines. dr_usha_rani@yahoo.com.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Merrin', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008005.pub3']
1171,23543536,Antibiotics for acute laryngitis in adults.,"BACKGROUND


This is an updated version of the original review published in Issue 2, 2007 of The Cochrane Library. Acute laryngitis is a common illness worldwide. Diagnosis is often made by case history alone and treatment is often directed toward controlling symptoms.
OBJECTIVES


To assess the effectiveness and safety of different antibiotic therapies in adults with acute laryngitis. A secondary objective was to report the rates of adverse events associated with these treatments.
SEARCH METHODS


We searched CENTRAL 2012, Issue 12, MEDLINE (January 1966 to January week 3, 2013), EMBASE (1974 to January 2013), LILACS (1982 to January 2013) and BIOSIS (1980 to January 2013).
SELECTION CRITERIA


Randomised controlled trials (RCTs) comparing any antibiotic therapy with placebo for acute laryngitis. The main outcome was objective voice scores.
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted and descriptively synthesised data.
MAIN RESULTS


Only two trials met the study inclusion criteria after extensive literature searches. One hundred participants were randomised to receive either penicillin V (800 mg twice a day for five days), or an identical placebo, in a study of acute laryngitis in adults. A tape recording of each patient reading a standardised text was obtained during the first visit, subsequently during re-examination after one and two weeks, and at follow-up after two to six months. No significant differences were found between the groups. The trial also measured symptoms reported by participants and found no significant differences.The second trial investigated erythromycin for treating acute laryngitis in 106 adults. The mean objective voice scores measured at the first visit, at re-examination after one and two weeks, and at follow-up after two to six months did not significantly differ between control and intervention groups. At one week there were significant beneficial differences in the severity of reported vocal symptoms as judged by the participants (P = 0.042). Comparing the erythromycin and placebo groups on subjective voice scores, the a priori risk ratio (RR) was 0.7 (95% confidence interval (CI) 0.51 to 0.96, P = 0.034) and the number needed to treat for an additional beneficial outcome (NNTB) was 4.5.
AUTHORS' CONCLUSIONS


Antibiotics appear to have no benefit in treating acute laryngitis. Erythromycin could reduce voice disturbance at one week and cough at two weeks when measured subjectively. We consider that these outcomes are not relevant in clinical practice. The implications for practice are that prescribing antibiotics should not be done in the first instance as they will not objectively improve symptoms.",2013,At one week there were significant beneficial differences in the severity of reported vocal symptoms as judged by the participants (P = 0.042).,"['January 1966 to January week 3, 2013), EMBASE (1974 to January 2013), LILACS (1982 to January 2013) and BIOSIS (1980 to January 2013', 'adults with acute laryngitis', 'acute laryngitis in adults', '106 adults', 'One hundred participants']","['penicillin V', 'antibiotic therapies', 'placebo', 'Erythromycin', 'erythromycin', 'erythromycin and placebo']","['voice disturbance', 'subjective voice scores', 'mean objective voice scores', 'rates of adverse events', 'objective voice scores', 'effectiveness and safety', 'priori risk ratio (RR', 'severity of reported vocal symptoms']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0456588', 'cui_str': '1974 (qualifier value)'}, {'cui': 'C0456590', 'cui_str': '1982 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001327', 'cui_str': 'Acute laryngitis (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0030840', 'cui_str': 'phenoxymethylpenicillin'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}]","[{'cui': 'C1527340', 'cui_str': 'Voice Disturbance'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.298854,At one week there were significant beneficial differences in the severity of reported vocal symptoms as judged by the participants (P = 0.042).,"[{'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Reveiz', 'Affiliation': 'Research Promotion and Development Team, Health Systems Based on Primary Health Care (HSS), Pan American Health Organization,Washington DC, USA. mmreveiz@hotmail.com'}, {'ForeName': 'Andrés Felipe', 'Initials': 'AF', 'LastName': 'Cardona', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004783.pub4']
1172,31093929,The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects.,"BACKGROUND


Oral insulin 338 is a novel tablet formulation of a long-acting basal insulin. This randomised, open-label, four-period crossover trial investigated the effect of timing of food intake on the single-dose pharmacokinetic properties of oral insulin 338.
METHODS


After an overnight fast, 44 healthy males received single fixed doses of oral insulin 338 administered 0, 30, 60 or 360 min before consuming a standardised meal (500 kcal, 57 energy percent [E%] carbohydrate, 13 E% fat, 30 E% protein). Blood samples for pharmacokinetic assessment were taken up to 288 h post-dose.
RESULTS


Total exposure (area under the concentration-time curve from time zero to infinity [AUC Ins338,0-∞ ]) and maximum concentration (C max,Ins338 ) of insulin 338 were both significantly lower for 0 versus 360 min post-dose fasting (ratio [95% confidence interval (CI)]: 0.36 [0.26-0.49], p < 0.001, and 0.35 [0.25-0.49], p < 0.001, respectively). There were no significant differences in AUC Ins338,0-∞  and C max,Ins338  for 30 or 60 versus 360 min post-dose fasting (ratio [95% CI] 30 versus 360 min: 0.85 [0.61-1.21], p = 0.36, and 0.86 [0.59-1.26], p = 0.42; ratio [95% CI] 60 versus 360 min: 0.96 [0.72-1.28], p = 0.77, and 0.99 [0.75-1.31], p = 0.95). The mean half-life was ~ 55 h independent of the post-dose fasting period. Oral insulin 338 was well-tolerated with no safety issues identified during the trial.
CONCLUSIONS


Oral insulin 338 pharmacokinetics are not affected by food intake from 30 min after dosing, implying that patients with diabetes mellitus do not need to wait more than 30 min after a morning dose of oral insulin 338 before having their breakfast. This is considered important for convenience and treatment compliance. CLINICALTRIALS.
GOV IDENTIFIER


NCT02304627.",2019,"There were no significant differences in AUC Ins338,0-∞  and C max,Ins338  for 30 or 60 versus 360 ","['Healthy Male Subjects', 'patients with diabetes mellitus', '44 healthy males']","['oral insulin 338 administered 0, 30, 60 or 360\xa0min before consuming a standardised meal', 'Food Intake']","['Total exposure (area under the concentration-time curve', 'mean half-life', 'Pharmacokinetics of Oral Basal Insulin']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",44.0,0.227668,"There were no significant differences in AUC Ins338,0-∞  and C max,Ins338  for 30 or 60 versus 360 ","[{'ForeName': 'Inge B', 'Initials': 'IB', 'LastName': 'Halberg', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. ibh@novonordisk.com.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lyby', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Wassermann', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraße 9, 41460, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil Mainz GmbH & Co. KG, Rheinstraße 4c, 55116, Mainz, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraße 9, 41460, Neuss, Germany.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00772-2']
1173,24563468,Metal protein attenuating compounds for the treatment of Alzheimer's dementia.,"BACKGROUND


Alzheimer's dementia (AD) may be caused by the formation of extracellular senile plaques comprised of beta-amyloid (Aß). In vitro and mouse model studies have demonstrated that metal protein attenuating compounds (MPACs) promote the solubilisation and clearance of Aß.
OBJECTIVES


To evaluate the efficacy of metal protein attenuating compounds (MPACs) for the treatment of cognitive impairment due to Alzheimer's dementia.
SEARCH METHODS


We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 29 July 2010 using the terms: Clioquinol OR PBT1 OR PBT2 OR ""metal protein"" OR MPACS OR MPAC.
SELECTION CRITERIA


Randomised double-blind trials in which treatment with an MPAC was administered to participants with Alzheimer's dementia in a parallel group comparison with placebo were included.
DATA COLLECTION AND ANALYSIS


Three review authors (RM, LJ, ELS) independently assessed the quality of trials according to the Cochrane Handbook for Systematic Reviews of Interventions.The primary outcome measure of interest was cognitive function (as measured by psychometric tests). The secondary outcome measures of interest were in the following areas: quality of life, functional performance, effect on carer, biomarkers, safety and adverse effects, and death.
MAIN RESULTS


Two MPAC trials were identified. One trial compared clioquinol (PBT1) with placebo in 36 patients and 32 had sufficient data for per protocol analysis. There was no statistically significant difference in cognition (as measured on the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)) between the active treatment and placebo groups at 36 weeks. The difference in mean change from baseline ADAS-Cog score in the clioquinol arm compared with the placebo arm at weeks 24 and 36 was a difference of 7.37 (95% confidence interval (CI) 1.51 to 13.24) and 6.36 (95% CI -0.50 to 13.23), respectively.There was no significant impact on non-cognitive symptoms or clinical global impression. One participant in the active treatment group developed neurological symptoms (impaired visual acuity and colour vision) which resolved on cessation of treatment and were possibly attributable to the drug.In the second trial a successor compound, PBT2, was compared with placebo in 78 participants with mild Alzheimer's dementia; all were included in the intention-to-treat analysis. There was no significant difference in the Neuropsychological Test Battery (NTB) composite or memory between placebo and PBT2 in the least squares mean change from baseline at week 12. However, two executive function component tests of the NTB showed significant improvement over placebo in the PBT2 250 mg group from baseline to week 12: category fluency test (2.8 words, 95% CI 0.1 to 5.4; P = 0.041) and trail making part B (-48.0 s, 95% CI -83.0 to -13.0; P = 0.009). In the executive factor Z score, the difference in least squares mean change from baseline at week 12 for PBT2 250 mg compared with placebo was 0·27 (0·01 to 0·53; p=0·042).There was no significant effect on cognition on Mini-Mental State Examination (MMSE) or ADAS-Cog scales. PBT2 had a favourable safety profile.
AUTHORS' CONCLUSIONS


There is an absence of evidence as to whether clioquinol (PBT1) has any positive clinical benefit for patients with AD, or whether the drug is safe. We have some concerns about the quality of the study methodology; there was an imbalance in treatment and control groups after randomisation (participants in the active treatment group had a higher mean pre-morbid IQ) and the secondary analyses of results stratified by baseline dementia severity. The planned phase III trial of PBT1 has been abandoned and this compound has been withdrawn from development. The second trial of PBT2 was more rigorously conducted and showed that after 12 weeks this compound appeared to be safe and well tolerated in people with mild Alzheimer's dementia. Larger trials are now required to demonstrate cognitive efficacy.",2014,There was no significant difference in the Neuropsychological Test Battery (NTB) composite or memory between placebo and PBT2 in the least squares mean change from baseline at week 12.,"[""people with mild Alzheimer's dementia"", '36 patients and 32 had sufficient data for per protocol analysis', ""Alzheimer's dementia (AD"", 'patients with AD', ""Alzheimer's dementia"", ""78 participants with mild Alzheimer's dementia"", ""participants with Alzheimer's dementia in a parallel group comparison with"", ""cognitive impairment due to Alzheimer's dementia""]","['placebo', 'PBT1', 'PBT2', 'clioquinol (PBT1) with placebo', 'clioquinol', 'Clioquinol OR PBT1 OR PBT2 OR ""metal protein"" OR MPACS OR MPAC', 'metal protein attenuating compounds (MPACs', 'MPAC']","['Neuropsychological Test Battery (NTB) composite or memory', 'safe and well tolerated', 'quality of life, functional performance, effect on carer, biomarkers, safety and adverse effects, and death', 'cognition on Mini-Mental State Examination (MMSE) or ADAS', 'category fluency test', 'neurological symptoms (impaired visual acuity and colour vision', 'non-cognitive symptoms or clinical global impression', 'trail making part B ', 'cognition', ""Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog"", 'cognitive function (as measured by psychometric tests', 'mean change from baseline ADAS-Cog score']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021978', 'cui_str': 'Clioquinol'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}]","[{'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0034380'}, {'cui': 'C3853978'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0086032', 'cui_str': 'Daylight Vision'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.519449,There was no significant difference in the Neuropsychological Test Battery (NTB) composite or memory between placebo and PBT2 in the least squares mean change from baseline at week 12.,"[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'Marie Curie Palliative Care Research Unit, University College, 67-73 Riding House Street, London, UK, W1W 7EJ.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Jenagaratnam', 'Affiliation': ''}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD005380.pub5']
1174,24848732,Oral herbal therapies for treating osteoarthritis.,"BACKGROUND


Medicinal plant products are used orally for treating osteoarthritis. Although their mechanisms of action have not yet been elucidated in full detail, interactions with common inflammatory mediators provide a rationale for using them to treat osteoarthritic complaints.
OBJECTIVES


To update a previous Cochrane review to assess the benefits and harms of oral medicinal plant products in treating osteoarthritis.
SEARCH METHODS


We searched electronic databases (CENTRAL, MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to 29 August 2013, unrestricted by language, and the reference lists from retrieved trials.
SELECTION CRITERIA


Randomised controlled trials of orally consumed herbal interventions compared with placebo or active controls in people with osteoarthritis were included. Herbal interventions included any plant preparation but excluded homeopathy or aromatherapy products, or any preparation of synthetic origin.
DATA COLLECTION AND ANALYSIS


Two authors used standard methods for trial selection and data extraction, and assessed the quality of the body of evidence using the GRADE approach for major outcomes (pain, function, radiographic joint changes, quality of life, withdrawals due to adverse events, total adverse events, and serious adverse events).
MAIN RESULTS


Forty-nine randomised controlled studies (33 interventions, 5980 participants) were included. Seventeen studies of confirmatory design (sample and effect sizes pre-specified) were mostly at moderate risk of bias. The remaining 32 studies of exploratory design were at higher risk of bias. Due to differing interventions, meta-analyses were restricted to Boswellia serrata (monoherbal) and avocado-soyabean unsaponifiables (ASU) (two herb combination) products.Five studies of three different extracts from Boswellia serrata were included. High-quality evidence from two studies (85 participants) indicated that 90 days treatment with 100 mg of enriched Boswellia serrata extract improved symptoms compared to placebo. Mean pain was 40 points on a 0 to 100 point VAS scale (0 is no pain) with placebo, enriched Boswellia serrata reduced pain by a mean of 17 points (95% confidence interval (CI) 8 to 26); number needed to treat for an additional beneficial outcome (NNTB) 2; the 95% CIs did not exclude a clinically significant reduction of 15 points in pain. Physical function was 33 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 0 to 100 point subscale (0 is no loss of function) with placebo, enriched Boswellia serrata improved function by 8 points (95% CI 2 to 14); NNTB 4. Assuming a minimal clinically important difference of 10 points, we cannot exclude a clinically important benefit in some people. Moderate-quality evidence (one study, 96 participants) indicated that adverse events were probably reduced with enriched Boswellia serrata (18/48 events versus 30/48 events with placebo; relative risk (RR) 0.60, 95% CI 0.39 to 0.92). Possible benefits of other Boswellia serrata extracts over placebo were confirmed in moderate-quality evidence from two studies (97 participants) of Boswellia serrata (enriched) 100 mg plus non-volatile oil, and low-quality evidence from small single studies of a 999 mg daily dose of Boswellia serrata extract and 250 mg daily dose of enrichedBoswellia serrata. It was uncertain if a 99 mg daily dose of Boswellia serrata offered benefits over valdecoxib due to the very low-quality evidence from a small single study. It was uncertain if there was an increased risk of adverse events or withdrawals with Boswellia serrata extract due to variable reporting of results across studies. The studies reported no serious adverse events. Quality of life and radiographic joint changes were not measured.Six studies examined the ASU product Piasclidine®. Moderate-quality evidence from four studies (651 participants) indicated that ASU 300 mg produced a small and clinically questionable improvement in symptoms, and probably no increased adverse events compared to placebo after three to 12 months treatment. Mean pain with placebo was 40.5 points on a VAS 0 to 100 scale (0 is no pain), ASU 300 mg reduced pain by a mean of 8.5 points (95% CI 1 to 16 points); NNTB 8. ASU 300 mg improved function (standardised mean difference (SMD) -0.42, 95% CI -0.73 to -0.11). Function was estimated as 47 mm (0 to 100 mm scale, where 0 is no loss of function) with placebo, ASU 300 mg improved function by a mean of 7 mm (95% CI 2 to 12 mm); NNTB 5 (3 to 19). There were no differences in adverse events (5 studies, 1050 participants) between ASU (53%) and placebo (51%) (RR 1.04, 95% CI 0.97 to 1.12); withdrawals due to adverse events (1 study, 398 participants) between ASU (17%) and placebo (15%) (RR 1.14, 95% CI 0.73 to 1.80); or serious adverse events (1 study, 398 participants) between ASU (40%) and placebo (33%) (RR 1.22, 95% CI 0.94 to 1.59). Radiographic joint changes, measured as change in joint space width (JSW) in two studies (453 participants) did not differ between ASU 300 mg treatment (-0.53 mm) and placebo (-0.65 mm); mean difference of -0.12 (95% CI -0.43 to 0.19). Moderate-quality evidence from a single study (156 participants) confirmed possible benefits of ASU 600 mg over placebo, with no increased adverse events. Low-quality evidence (1 study, 357 participants) indicated there may be no differences in symptoms or adverse events between ASU 300 mg and chondroitin sulphate. Quality of life was not measured.All other herbal interventions were investigated in single studies, limiting conclusions. No serious side effects related to any plant product were reported.
AUTHORS' CONCLUSIONS


Evidence for the proprietary ASU product Piasclidine® in the treatment of osteoarthritis symptoms seems moderate to high for short term use, but studies over a longer term and against an apparently active control are less convincing. Several other medicinal plant products, including extracts of Boswellia serrata, show trends of benefits that warrant further investigation in light of the fact that the risk of adverse events appear low.There is no evidence that Piasclidine® significantly improves joint structure, and limited evidence that it prevents joint space narrowing. Structural changes were not tested for with any other herbal intervention.Further investigations are required to determine optimum daily doses producing clinical benefits without adverse events.",2014,Physical function was 33 points on the Western Ontario and McMaster Universities Osteoarthritis Index,"['people with osteoarthritis were included', 'Forty-nine randomised controlled studies (33 interventions, 5980 participants) were included', 'plant preparation but excluded homeopathy or aromatherapy products, or any preparation of synthetic origin']","['oral medicinal plant products', 'Boswellia serrata extracts over placebo', 'Oral herbal therapies', 'ASU', 'placebo', 'valdecoxib', 'herbal interventions', 'ASU 600 mg over placebo', 'Boswellia serrata extract', 'placebo, ASU']","['moderate-quality evidence', 'Function', 'pain', 'Quality of life', 'change in joint space width (JSW', 'Physical function', 'adverse events', 'Radiographic joint changes', 'Mean pain', 'serious adverse events', 'major outcomes (pain, function, radiographic joint changes, quality of life, withdrawals due to adverse events, total adverse events, and serious adverse events', 'Moderate-quality evidence', 'symptoms or adverse events', 'Quality of life and radiographic joint changes']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0949854', 'cui_str': 'Herbal Preparations'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0684199', 'cui_str': 'Homeopathy'}, {'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032100', 'cui_str': 'Plants, Medicinal'}, {'cui': 'C2608032', 'cui_str': 'Boswellia serrata'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242388', 'cui_str': 'Herbal Therapy'}, {'cui': 'C0913246', 'cui_str': 'valdecoxib'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0224497', 'cui_str': 'Articular space (body structure)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",5980.0,0.761014,Physical function was 33 points on the Western Ontario and McMaster Universities Osteoarthritis Index,"[{'ForeName': 'Melainie', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'School of Health and Sport Sciences, Cluster for Health Improvement, University of the Sunshine Coast, Sippy Downs campus, Locked Bag 4, Maroochydore DC, Queensland, Australia, 4558.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Chrubasik', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD002947.pub2']
1175,22592718,WITHDRAWN: Effectiveness and safety of first-line tenofovir + emtricitabine + efavirenz for patients with HIV.,"BACKGROUND


The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to treatment, issues of adherence and viral resistance are major challenges limiting its success. There is a need for an effective and safe first-line regimen, to cope with the ever-increasing incidence of non-adherence and primary resistance. A more recent first-line treatment regimen consists of Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg).
OBJECTIVES


To evaluate the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011.
SELECTION CRITERIA


Randomized controlled trials evaluating the effects of TDF + FTC + EFV compared with other HAART regimens.
DATA COLLECTION AND ANALYSIS


Two reviewers independently assessed trial eligibility and risk of bias, and extracted data from the included study.
MAIN RESULTS


Only one study involving 517 antiretroviral-naive HIV infected adults was included in this review. Participants were randomly assigned to receive either a regimen of TDF (300 mg), FTC (200mg), and EFV (600mg ) once daily; or a regimen of fixed-dose zidovudine (AZT) (300 mg) and lamivudine (3TC) (150 mg) twice daily plus EFV (600mg) once daily. Significantly more patients in the TDF-FTC group reached and maintained HIV RNA levels of less than 50 copies per milliliter compared to the AZT- 3TC group (RR 1.13; 95% CI 1.02 to 1.25). Also, more participants in the TDF-FTC group had greater increase from baseline CD4 cell counts compared to the AZT-3TC group (190 vs. 158 cells per mm(3)). More patients in the AZT-3TC group than in the TDF-FTC group had adverse events resulting in discontinuation of the study drugs (9% vs. 4%, respectively; P = 0.02). There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
AUTHORS' CONCLUSIONS


Only one trial has shown beneficial effects and safety of TDF+ FTC + EFV as first-line treatment for patients with HIV. The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed.",2012,"There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
","['patients with HIV', '517 antiretroviral-naive HIV infected adults']","['FTC', 'first-line tenofovir + emtricitabine + efavirenz', 'lamivudine (3TC) (150 mg) twice daily plus EFV', 'TDF-FTC', 'TDF', 'AZT- 3TC', 'HAART', 'TDF+ FTC + EFV', 'zidovudine (AZT', 'EFV', 'TDF + FTC + EFV', 'Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg']","['maintained HIV RNA levels', 'adverse events', 'cause mortality', 'Effectiveness and safety', 'baseline CD4 cell counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0887947', 'cui_str': 'HAART'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",517.0,0.2,"There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
","[{'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Omeje', 'Affiliation': 'Community Medicine, UNTH/Comprehensive Health Centre, Obukpa, Nsukka, Enugu State, Nigeria. innocentomeje@yahoo.com'}, {'ForeName': 'Charles I', 'Initials': 'CI', 'LastName': 'Okwundu', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007276.pub3']
1176,31744476,A regional systems intervention for suicide prevention in the Netherlands (SUPREMOCOL): study protocol with a stepped wedge trial design.,"BACKGROUND


In the Netherlands, suicide rates showed a sharp incline and this pertains particularly to the province of Noord-Brabant, one of the southern provinces in the Netherlands. This calls for a regional suicide prevention effort.
METHODS/DESIGN


Study protocol. A regional suicide prevention systems intervention is implemented and evaluated by a stepped wedge trial design in five specialist mental health institutions and their adherent chain partners. Our system intervention is called SUPREMOCOL, which stands for Suicide Prevention by Monitoring and Collaborative Care, and focuses on four pillars: 1) recognition of people at risk for suicide by the development and implementation of a monitoring system with decision aid, 2) swift access to specialist care of people at risk, 3) positioning nurse care managers for collaborative care case management, and 4) 12 months telephone follow up. Eligible patients are persons attempting suicide or expressing suicidal ideation. Primary outcome is number of completed suicides, as reported by Statistics Netherlands and regional Public Health Institutes. Secondary outcome is number of attempted suicides, as reported by the regional ambulance transport and police. Suicidal ideation of persons registered in the monitoring system will, be assessed by the PHQ-9 and SIDAS questionnaires at baseline and 3, 6, 9 and 12 months after registration, and used as exploratory process measure. The impact of the intervention will be evaluated by means of the RE-AIM dimensions reach, efficacy, adoption, implementation, and maintenance. Intervention integrity will be assessed and taken into account in the analysis.
DISCUSSION


The present manuscript presents the design and development of the SUPREMOCOL study. The ultimate goal is to lower the completed suicides rate by 20%, compared to the control period and compared to other provinces in the Netherlands. Moreover, our goal is to provide specialist mental health institutions and chain partners with a sustainable and adoptable intervention for suicide prevention.
TRIAL REGISTRATION


Netherlands Trial Register under registration number NL6935 (5 April 2018). This is the first version of the study protocol (September 2019).",2019,A regional suicide prevention systems intervention is implemented and evaluated by a stepped wedge trial design in five specialist mental health institutions and their adherent chain partners.,"['Eligible patients are persons attempting suicide or expressing suicidal ideation', 'five specialist mental health institutions and their adherent chain partners']",[],"['number of attempted suicides, as reported by the regional ambulance transport and police', 'number of completed suicides, as reported by Statistics Netherlands and regional Public Health Institutes', 'Suicidal ideation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",,0.0605272,A regional suicide prevention systems intervention is implemented and evaluated by a stepped wedge trial design in five specialist mental health institutions and their adherent chain partners.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hofstra', 'Affiliation': 'Specialist Mental Health Institution, GGz Breburg, Tilburg, Netherlands. E.Hofstra@ggzbreburg.nl.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Elfeddali', 'Affiliation': 'Specialist Mental Health Institution, GGz Breburg, Tilburg, Netherlands.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Metz', 'Affiliation': 'Specialist Mental Health Institution, GGz Breburg, Tilburg, Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Bakker', 'Affiliation': 'Department of Methodology and Statistics, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Jacobus J', 'Initials': 'JJ', 'LastName': 'de Jong', 'Affiliation': 'Specialist Mental Health Institution, GGz Breburg, Tilburg, Netherlands.'}, {'ForeName': 'Chijs', 'Initials': 'C', 'LastName': 'van Nieuwenhuizen', 'Affiliation': 'Tranzo-Scientific Center for Care and Wellbeing, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'van der Feltz-Cornelis', 'Affiliation': 'Mental Health and Addiction Research Group, Department of Health Sciences, Hull York Medical School, University of York, York, UK.'}]",BMC psychiatry,['10.1186/s12888-019-2342-x']
1177,23152224,Rectal 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.,"BACKGROUND


5-Aminosalicylic acid (5-ASA) is a first-line therapy for inducing and maintaining remission of mild and moderately active ulcerative colitis (UC). When the proximal margin of inflammation is distal to the splenic flexure, 5-ASA therapy can be delivered as a rectal suppository, foam or liquid enema.
OBJECTIVES


The primary objective was to assess the efficacy and safety of rectal 5-ASA for maintaining remission of distal UC.
SEARCH METHODS


We searched MEDLINE (1966 to August 2012), the Cochrane Library (August 2012), abstracts from major gastroenterology meetings (1997-2011) and bibliographies of relevant publications to identify relevant studies.
SELECTION CRITERIA


Eligible studies were randomized controlled trials comparing rectal 5-ASA to placebo or another active treatment for a minimum duration of six months. Symptom scores needed to be assessed in at least one study outcome. Patients had to be at least 12 years of age with disease extent less than 60 cm from the anal verge or distal to the splenic flexure, as determined by barium enema, colonoscopy or sigmoidoscopy. Patients were expected to be in remission prior to the treatment trial.
DATA COLLECTION AND ANALYSIS


Study eligibility was independently assessed by three authors. Data were extracted using standardized forms by two independent reviewers, with inter-rater agreement assessed using Cohen's Kappa and disagreements resolved by consensus. In cases where clarification of study results or methodology was needed, corresponding authors were contacted. The methodological quality of each trial was assessed by the Cochrane risk of bias tool and by a 30-point scale developed and used previously by the authors. Pooled risk ratios (RR) and corresponding 95% confidence intervals (CI) for continued clinical, endoscopic and histologic remission were estimated for comparisons between rectal 5-ASA and placebo or oral 5-ASA, and for comparisons among 5-ASA doses. Heterogeneity was assessed using the Chi(2) test and visual inspection of forest plots. If no significant heterogeneity was identified (P > 0.10 for Chi(2)) a fixed-effect model (Mantel-Haenstzel) was used. If heterogeneity was significant, a random-effects model was used.
MAIN RESULTS


Nine studies (484 patients) met the pre-specified inclusion criteria (Kappa 1.00). Six studies were rated as low risk of bias. Three studies were rated as high risk of bias due to blinding (two open label and one single-blind). The total daily dose of rectal 5-ASA ranged from 0.5 g to 4 g, and dose frequency ranged from once to three times daily. 5-ASA was delivered as liquid enema in five studies or as a suppository in four studies. Follow-up ranged from 6 to 24 months. Rectal 5-ASA was significantly superior to placebo for maintenance of symptomatic remission over a period of 12 months.Sixty-two per cent of patients in the rectal 5-ASA group maintained symptomatic remission compared to 30% of patients in the placebo group (4 studies; 301 patients; RR 2.22, 95% CI 1.26 to 3.90; I(2) = 67%; P < 0.01). A GRADE analysis indicated that the overall quality of the evidence for the primary outcome was low due to imprecision (i.e. sparse data 144 events) and inconsistency (i.e. unexplained heterogeneity). Rectal 5-ASA was significantly superior to placebo for maintenance of endoscopic remission over a 12 month period. Seventy-five per cent of patients in the rectal 5-ASA group maintained endoscopic remission compared to 15% of patients in the placebo group (1 study; 25 patients; RR 4.88, 95% CI 1.31 to 18.18; P < 0.05). There was no statistically significant difference in the proportion of patients who experienced at least one adverse event. Sixteen per cent of patients in the rectal 5-ASA group experienced at least one adverse compared to 12% of placebo patients (2 studies; 160 patients; RR 1.35, 95% CI 0.63 to 2.89; I(2) = 0%; P = 0.44). The most commonly reported adverse events were anal irritation and abdominal pain. No statistically significant differences between rectal and oral 5-ASA were identified for either symptomatic or endoscopic remission over a period of six months. Eighty per cent of patients in the rectal 5-ASA group maintained symptomatic remission compared to 65% of patients in the oral 5-ASA group (2 studies; 69 patients; RR 1.24, 95% CI 0.92 to 1.66; I(2) = 0%; P = 0.15). A GRADE analysis indicated that the overall quality of the evidence for the primary outcome was low due to imprecision (i.e. sparse data 50 events) and high risk of bias (i.e. both studies in the pooled analysis were open label). Eighty per cent of patients in the rectal 5-ASA group maintained endoscopic remission compared to 70% of patients in the oral 5-ASA group (2 studies; 91 patients; RR 1.14, 95% CI 0.90 to 1.45; I(2) = 0%; P = 0.26). In two small trials, one comparing 2 g/day 5-ASA enemas to 4 g/day 5-ASA enemas and the other comparing 0.5 g/day 5-ASA suppositories to 1 g/day 5-ASA suppositories no dose response relationship was observed.
AUTHORS' CONCLUSIONS


The limited data available suggest that rectal 5-ASA is effective and safe for maintenance of remission of mild to moderately active distal UC. Well designed randomized trials are needed to establish the optimal dosing regimen for rectal 5-ASA, to compare rectal 5-ASA with rectal corticosteroids and to identify subgroups of patients who are more or less responsive to specific rectal 5-ASA regimens. The combination of oral and rectal 5-ASA appears to be more effective than either oral or rectal monotherapy for induction of remission. The efficacy of combination therapy for maintenance of remission has not been assessed and could be evaluated in future trials.",2012,No statistically significant differences between rectal and oral 5-ASA were identified for either symptomatic or endoscopic remission over a period of six months.,"['Eighty', 'ulcerative colitis', '1966 to August 2012), the Cochrane Library (August 2012), abstracts from major gastroenterology meetings (1997-2011) and bibliographies of relevant publications to identify relevant studies', 'Patients had to be at least 12 years of age with disease extent less than 60 cm from the anal verge or distal to the splenic flexure, as determined by barium enema, colonoscopy or sigmoidoscopy', 'patients who are more or less responsive to specific rectal 5-ASA regimens']","['placebo', '5-Aminosalicylic acid (5-ASA', 'Rectal 5-aminosalicylic acid', '5-ASA suppositories', 'rectal 5-ASA', '5-ASA', 'oral 5-ASA', 'rectal 5-ASA to placebo', 'oral and rectal 5-ASA', 'Rectal 5-ASA']","['Pooled risk ratios (RR) and corresponding 95% confidence intervals (CI) for continued clinical, endoscopic and histologic remission', 'rectal and oral 5-ASA', 'anal irritation and abdominal pain', 'symptomatic remission', 'Chi(2) test and visual inspection of forest plots', 'endoscopic remission', 'efficacy and safety', 'symptomatic or endoscopic remission']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0023621', 'cui_str': 'Libraries'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0005358', 'cui_str': 'Bibliography'}, {'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0227387', 'cui_str': 'Splenic Flexure'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0203075', 'cui_str': 'Barium Enema'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0037075', 'cui_str': 'Proctosigmoidoscopy'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C1735348', 'cui_str': 'Anal irritation'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0086312', 'cui_str': 'Forestlands'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.454054,No statistically significant differences between rectal and oral 5-ASA were identified for either symptomatic or endoscopic remission over a period of six months.,"[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Marshall', 'Affiliation': 'Division of Gastroenterology, McMaster University, Hamilton, Canada. marshllj@mcmaster.ca.'}, {'ForeName': 'Marroon', 'Initials': 'M', 'LastName': 'Thabane', 'Affiliation': ''}, {'ForeName': 'A Hillary', 'Initials': 'AH', 'LastName': 'Steinhart', 'Affiliation': ''}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ''}, {'ForeName': 'E Jan', 'Initials': 'EJ', 'LastName': 'Irvine', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004118.pub2']
1178,31219919,One Size Does Not Fit All: A Perspective on the American Society of Anesthesiologists Physical Status Classification for Pediatric Patients.,"BACKGROUND


The American Society of Anesthesiologists physical status (ASA-PS) classification system is used worldwide to classify patients based on comorbid conditions before general anesthesia. Despite its popularity, the ASA-PS classification system has been shown to have poor interrater reliability due to its subjective definitions, especially when applied to the pediatric population. We hypothesized that the clarification of ASA-PS definitions to better reflect pediatric conditions would improve the accuracy of ASA-PS applied to this population.
METHODS


A stratified, randomized sample of 120 pediatric surgical cases was collected from a tertiary-care pediatric hospital. A team of senior anesthesiologists reclassified ASA-PS within this patient sample using the suggested pediatric-specific ASA-PS definitions. Interrater reliability was measured using intraclass correlation (ICC) and Fleiss κ statistic. In addition, a qualitative study component using small focus groups of senior anesthesiologists identified areas of ambiguity within the ASA-PS system.
RESULTS


Among the 90 reclassifications within each ASA-PS group, 42.2% (n = 38) of ASA-PS I were upgraded to ASA-PS II, and 36.7% (n = 33) of ASA-PS II were upgraded to ASA-PS III. In addition, 28.9% (n = 26) of ASA-PS III were upgraded to ASA-PS IV, and 24.4% (n = 22) of ASA-PS IV were downgraded to III. ICC across the reclassified ASA-PS categories was 0.77 (95% confidence interval [CI], 0.71-0.83; P < .001) demonstrating strong overall agreement. Fleiss κ statistic was lowest in ASA-PS II and III patients (κ = 0.41 and κ = 0.30, respectively) indicating lower agreement beyond chance within these subgroups. Focus groups revealed common themes such as active sequelae of disease, active versus well-controlled presence of comorbidities, and the possible inclusion of functional limitations as important considerations.
CONCLUSIONS


The ASA-PS classification system has several benefits including ease-of-use, simplicity, and flexibility. However, revising the ASA-PS system to provide better guidance for pediatric patients could be valuable. While this study demonstrates good interrater reliability with the included ASA-PS pediatric definitions, further work is needed to clarify accurate assignment of ASA-PS within the midrange of the scale (ASA-PS II and III) and explore its implementation in other institutions.",2020,"Fleiss κ statistic was lowest in ASA-PS II and III patients (κ = 0.41 and κ = 0.30, respectively) indicating lower agreement beyond chance within these subgroups.","['senior anesthesiologists identified areas of ambiguity within the ASA-PS system', '120 pediatric surgical cases was collected from a tertiary-care pediatric hospital', 'pediatric patients', 'American Society of Anesthesiologists Physical Status Classification for Pediatric Patients']",['ASA-PS'],"['Interrater reliability', 'Fleiss κ statistic']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0647347', 'cui_str': 'ASA-PS'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450990', 'cui_str': 'American Society of Anesthesiologists physical status classification'}]","[{'cui': 'C0647347', 'cui_str': 'ASA-PS'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",120.0,0.0557776,"Fleiss κ statistic was lowest in ASA-PS II and III patients (κ = 0.41 and κ = 0.30, respectively) indicating lower agreement beyond chance within these subgroups.","[{'ForeName': 'Lynne R', 'Initials': 'LR', 'LastName': 'Ferrari', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Leahy', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Staffa', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Crofton', 'Affiliation': ""Complex Care Service, Division of General Pediatrics, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Methot', 'Affiliation': 'From the Department of Anesthesiology, Critical Care and Pain Medicine.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Berry', 'Affiliation': ""Complex Care Service, Division of General Pediatrics, Boston Children's Hospital, Boston, Massachusetts.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004277']
1179,30311014,Correction to: Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial.,The above article originally published with an error present in Discussion section and presented correctly in this article. The original article was corrected.,2018,The above article originally published with an error present in Discussion section and presented correctly in this article.,['psoriatic arthritis patients'],['certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs'],[],"[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0003191', 'cui_str': 'Anti-Rheumatic Drugs'}]",[],,0.0432419,The above article originally published with an error present in Discussion section and presented correctly in this article.,"[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'Division of Rheumatology, University of Utah School of Medicine, Salt Lake City, UT, USA. jessica.walsh@hsc.utah.edu.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nurminen', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center and University of Washington, Seattle, WA, USA.'}]",Clinical rheumatology,['10.1007/s10067-018-4311-z']
1180,31794102,Optical coherence tomographic (OCT) evaluation of intraoral non-ablative erbium: YAG laser (SMOOTH mode) in rejuvenation of nasolabial folds; A prospective randomized split face comparative pilot study.,"BACKGROUND


There are both few non-comparative studies investigating the efficacy of intraoral Er: YAG laser (SMOOTH mode) in rejuvenating nasolabial folds (NLFs) and lack of valid and objective wrinkles scales. In this prospective randomized split face comparative pilot study, we investigated the safety and efficacy of intraoral Er: YAG laser (SMOOTH MODE) compared with extraoral approach in rejuvenating NLFs using OCT as an objective evaluating tool.
MATERIALS AND METHODS


Twenty adult women with notable NLFs were randomized in this study. The patients received 5 monthly sessions of Er: YAG laser (SMOOTH mode) using intraoral approach on one side and extraoral approach on the other side. Outcome was evaluated 2 weeks and 4 months post-treatment by Global Aesthetic Improvement Scale (GAIS), OCT, and patients' satisfaction. Side effects were also evaluated.
RESULTS


Intraoral sides had significant increase in OCT evaluated dermal thickness at 4 months post-treatment (P = .03) without side effects compared with extraoral sides. Extraoral approach had significantly higher patients' satisfaction compared with intraoral approach at 2 weeks and 4 months post-treatment (P = .03, .02, respectively). Insignificant differences between both approaches were found regarding GAIS scoring, OCT evaluated epidermal thickness at 2 weeks and 4 months post-treatment, and OCT evaluated dermal thickness at 2 weeks post-treatment (P < .05).
CONCLUSION


Intraoral Er: YAG laser (SMOOTH mode) is safer and more effective than extraoral approach in rejuvenating NLFs. OCT is a promising objective tool for evaluating facial wrinkles. Further studies are still needed.",2020,"Extraoral approach had significantly higher patients' satisfaction compared with intraoral approach at 2 weeks and 4 months post-treatment (P = .03, .02, respectively).","['Twenty adult women with notable NLFs', 'rejuvenation of nasolabial folds']","['intraoral Er: YAG laser (SMOOTH MODE', 'Er: YAG laser (SMOOTH mode) using intraoral approach on one side and extraoral approach on the other side', 'Optical coherence tomographic (OCT) evaluation of intraoral non-ablative erbium: YAG laser (SMOOTH mode', 'intraoral Er: YAG laser (SMOOTH mode', 'OCT', 'Intraoral Er: YAG laser (SMOOTH mode']","['OCT evaluated dermal thickness', 'GAIS scoring, OCT evaluated epidermal thickness', ""patients' satisfaction"", 'Side effects', 'safety and efficacy', ""Global Aesthetic Improvement Scale (GAIS), OCT, and patients' satisfaction""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C0457903', 'cui_str': 'Erbium YAG Lasers'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0442089', 'cui_str': 'Extraoral approach (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}]",20.0,0.0362421,"Extraoral approach had significantly higher patients' satisfaction compared with intraoral approach at 2 weeks and 4 months post-treatment (P = .03, .02, respectively).","[{'ForeName': 'Nayera', 'Initials': 'N', 'LastName': 'Moftah', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Nevien', 'Initials': 'N', 'LastName': 'Samy', 'Affiliation': 'Medical Applications of Laser Department, National Institute of Laser Enhanced Sciences, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Riham S H M', 'Initials': 'RSHM', 'LastName': 'Allam', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Shaza A H', 'Initials': 'SAH', 'LastName': 'El Tagy', 'Affiliation': 'Dermatology and Venereology Department, Air Forces General Hospital, Cairo, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Abdelghani', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}]",Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI),['10.1111/srt.12816']
1181,31201653,The Impact of Integrating Physical Health into a Brief CBT Approach for Medically Ill Veterans.,"The current study explored the use and preliminary outcomes of physical health treatment elements integrated into a traditional brief cognitive behavioral therapy (bCBT) approach for medically ill veterans with depression and/or anxiety. Data were collected as part of a pragmatic randomized trial examining patient outcomes of bCBT versus an enhanced usual care condition. bCBT was delivered to participants by Veterans Health Administration (VA) mental health providers in the primary care setting. Using a skill-based approach, providers and participants selected modules from a list of intervention strategies. Modules included Taking Control of Your Physical Health, Using Thoughts to Improve Wellness, Increasing Pleasant Activities, and Learning How to Relax. Skill module use and impact on treatment completion and clinical outcomes were explored for participants randomized to bCBT who received at least one skill module (n = 127). Utilization data showed that participants and providers most commonly selected the physical health module for the first skill session. Receiving the ""physical health"" and ""thoughts"" modules earlier in treatment were associated with a higher likelihood of treatment completion (defined as four or more sessions). Preliminary outcome data suggest that the physical health skill module was equally effective or superior to other bCBT skill modules. Results suggest that incorporating physical health elements with a bCBT approach hold the potential to positively impact treatment engagement/completion and may result in improved outcomes for medically ill patient populations.",2020,"Receiving the ""physical health"" and ""thoughts"" modules earlier in treatment were associated with a higher likelihood of treatment completion (defined as four or more sessions).","['medically ill patient populations', 'participants by Veterans Health Administration (VA) mental health providers in the primary care setting', 'Medically Ill Veterans', 'medically ill veterans with depression and/or anxiety']","['Integrating Physical Health into a Brief CBT Approach', 'physical health treatment elements integrated into a traditional brief cognitive behavioral therapy (bCBT) approach', 'bCBT']","['Taking Control of Your Physical Health, Using Thoughts to Improve Wellness, Increasing Pleasant Activities, and Learning How to Relax']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C3834230', 'cui_str': 'Take Control'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}]",,0.0311226,"Receiving the ""physical health"" and ""thoughts"" modules earlier in treatment were associated with a higher likelihood of treatment completion (defined as four or more sessions).","[{'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Brandt', 'Affiliation': 'The Houston OCD Program, 708 E. 19th Street, Houston, TX, 77008, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Deavers', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Blvd. (152), Houston, TX, 77030, USA.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Hundt', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Fletcher', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cully', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, One Baylor Plaza, Houston, TX, 77030, USA. jcully@bcm.edu.'}]",Journal of clinical psychology in medical settings,['10.1007/s10880-019-09634-2']
1182,31752799,Change in smoking cessation stage over 1 year in patients with schizophrenia: a follow up study in Japan.,"BACKGROUND


We performed a follow up study about willingness and behaviors to quit smoking among smokers with schizophrenia in Japan.
METHODS


Participants were outpatients with schizophrenia aged 20-69 years who had been visiting the hospital for ≥1 year as of April 1, 2016, and had visited the hospital more than once in the previous 6 months. A baseline survey on smoking behaviors including current smoking status and smoking cessation stage, was administered in 420 participants that were randomly extracted from a patient pool (n = 680) in 2016, and a follow-up survey was administered in 2017. We calculated the distribution and change in smoking cessation stage, number of smokers and nonsmokers after 1 year, and quitting rate from a naturalistic 1-year smoking-cessation follow up.
RESULTS


The number of baseline respondents was 350; 113 current smokers and 68 former smokers. Among the 113 current smokers, 104 (92.0%) were followed for 1 year, 79 (70.0%) were interested in smoking cessation, and only 7 had received smoking cessation treatments at baseline. Among the tracked 104 participants, only 6 (5.8%) stopped smoking after 1 year. Among the 25 participants who had intentions to quit smoking within 6 months at baseline, 6 (24.0%) maintained their intention to quit smoking for 1 year, and 16 (64.0%) did not maintain their intention to quit smoking.
CONCLUSIONS


Our findings showed that many smokers with schizophrenia were interested in quitting smoking, but few patients received treatment and actually quit smoking. Timely intervention, including the option to receive smoking cessation treatment, is necessary for those patients with schizophrenia who smoke.
TRIAL REGISTRATION


UMIN Clinical Trials Registry (UMIN000023874, registered on August 31, 2016).",2019,"Among the 113 current smokers, 104 (92.0%) were followed for 1 year, 79 (70.0%) were interested in smoking cessation, and only 7 had received smoking cessation treatments at baseline.","['25 participants who had intentions to quit smoking within 6\u2009months at baseline, 6 (24.0%) maintained their intention to quit smoking for 1\u2009year, and 16 (64.0%) did not maintain their intention to quit smoking', 'smokers with schizophrenia in Japan', '420 participants that were randomly extracted from a patient pool (n\u2009=\u2009680) in 2016, and a follow-up survey was administered in 2017', 'patients with schizophrenia', '113 current smokers, 104 (92.0%) were followed for 1\u2009year, 79 (70.0%) were interested in smoking cessation, and only 7 had received smoking cessation treatments at baseline', 'Participants were outpatients with schizophrenia aged 20-69\u2009years who had been visiting the hospital for ≥1\u2009year as of April 1, 2016, and had visited the hospital more than once in the previous 6\u2009months', 'patients with schizophrenia who smoke']",['smoking cessation treatment'],['quitting smoking'],"[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3241966'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",104.0,0.0222755,"Among the 113 current smokers, 104 (92.0%) were followed for 1 year, 79 (70.0%) were interested in smoking cessation, and only 7 had received smoking cessation treatments at baseline.","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Higuchi', 'Affiliation': 'Taiyo Hills Hospital, 2200 Abe, Ochiaicho, Takahashi City, Okayama, 716-0061, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakaya', 'Affiliation': 'Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo, Sendai, 980-8573, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Health Care Research, Behavioral Sciences and Survivorship Research and Division of Cohort Consortium Research, Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Chinatsu', 'Initials': 'C', 'LastName': 'Hayashibara', 'Affiliation': 'Division of Occupational Therapy, Faculty of Care and Rehabilitation, Seijoh University, 2-172 Fukinodai, Tokai City, Aichi, 476-8588, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Ikuta', 'Initials': 'I', 'LastName': 'Shinkawa', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Yada', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kodama', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takenaka', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Kishi', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Kakeda', 'Affiliation': 'Department of Neuropsychiatry, Kochi Medical School, Kochi University, Kohasu, Oko-cho, Nankoku, Kochi, 783-8505, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital and Behavioral Sciences and Survivorship Research, Center for Public Health Sciences, National Cancer Center, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan. minagaki@med.shimane-u.ac.jp.'}]",BMC psychiatry,['10.1186/s12888-019-2351-9']
1183,31562049,"The Effects of Mold-Fermented Cheese on Brain-Derived Neurotrophic Factor in Community-Dwelling Older Japanese Women With Mild Cognitive Impairment: A Randomized, Controlled, Crossover Trial.","OBJECTIVES


To investigate the effects of mold-fermented cheese (MFC) on brain-derived neurotrophic factor (BDNF) in community-dwelling older Japanese women with mild cognitive impairment (MCI).
DESIGN


Randomized controlled crossover trial.
INTERVENTION


Participants were randomly assigned to 2 groups. The MFC group was provided with 33.4 g MFC (camembert cheese) daily for 3 months, and the non-MFC group was provided with the same amount of non-MFC (processed cheese made from mozzarella cheese and cream cheese) for 3 months. After the post-intervention analysis (primary analysis), there was a 3-month washout period, followed by a crossover period (secondary analysis).
SETTING AND PARTICIPANTS


Urban community in Tokyo, Japan. A total of 71 older women aged ≥70 years with MCI based on selected criteria in 689 community-dwelling women.
MEASURES


Face-to-face interviews were conducted to administer the Geriatric Depression Scale (GDS) and Mini-Mental State Examination (MMSE) and collect data on medical history. Physical function measures included grip strength, knee extension strength, and usual walking speed. Blood samples were obtained to determine the levels of albumin, vitamin D, high-sensitivity C-reactive protein, and BDNF.
RESULTS


Significant interactions were observed in BDNF after intervention of MFC intake in the secondary (F = 5.368, P = .024) and combined analyses (F = 4.354, P = .039) but not the primary analysis. There were no significant changes in the 3 categories of MMSE score (normal, MCI, moderate or severe cognitive impairment), GDS score, physical function, and blood indicators.
CONCLUSIONS AND IMPLICATIONS


Three months of MFC ingestion had beneficial effects on BDNF levels in community-dwelling older women with MCI; however, the BDNF increases did not translate into MMSE scores. Further study into the effects of interventions on cognitive function and depression in older people with MCI is necessary.",2019,"There were no significant changes in the 3 categories of MMSE score (normal, MCI, moderate or severe cognitive impairment), GDS score, physical function, and blood indicators.
","['older people with MCI', 'community-dwelling older women with MCI', 'Community-Dwelling Older Japanese Women With Mild Cognitive Impairment', 'Urban community in Tokyo, Japan', 'community-dwelling older Japanese women with mild cognitive impairment (MCI', '71 older women aged ≥70\xa0years with MCI based on selected criteria in 689 community-dwelling women']","['brain-derived neurotrophic factor (BDNF', 'MFC', 'mold-fermented cheese (MFC', 'Mold-Fermented Cheese']","['BDNF', 'levels of albumin, vitamin D, high-sensitivity C-reactive protein, and BDNF', 'Geriatric Depression Scale (GDS) and Mini-Mental State Examination (MMSE) and collect data on medical history', 'cognitive function and depression', 'BDNF levels', '3 categories of MMSE score (normal, MCI, moderate or severe cognitive impairment), GDS score, physical function, and blood indicators', 'grip strength, knee extension strength, and usual walking speed']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0369241', 'cui_str': 'Molds'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005768'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",689.0,0.0502416,"There were no significant changes in the 3 categories of MMSE score (normal, MCI, moderate or severe cognitive impairment), GDS score, physical function, and blood indicators.
","[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Institute of Gerontology, J.F. Oberlin University, Tokyo, Japan.'}, {'ForeName': 'Narumi', 'Initials': 'N', 'LastName': 'Kojima', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Osuka', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Tokui', 'Affiliation': 'R&D Division, Meiji Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Takasugi', 'Affiliation': 'R&D Division, Meiji Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Kawashima', 'Affiliation': 'R&D Division, Meiji Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Taketo', 'Initials': 'T', 'LastName': 'Yamaji', 'Affiliation': 'R&D Division, Meiji Co, Ltd, Tokyo, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hosoi', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Chang Won', 'Initials': 'CW', 'LastName': 'Won', 'Affiliation': 'Department of Family Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan. Electronic address: kimhk@tmig.or.jp.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.06.023']
1184,31793418,The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities.,"BACKGROUND


Peripheral neuropathy can significantly impact the quality of life for those who are affected, as therapies from the current treatment algorithm often fail to deliver adequate symptom relief. There has, however, been an increasing body of evidence for the use of cannabinoids in the treatment of chronic, noncancer pain. The efficacy of a topically delivered cannabidiol (CBD) oil in the management of neuropathic pain was examined in this four-week, randomized and placebocontrolled trial.
METHODS


In total, 29 patients with symptomatic peripheral neuropathy were recruited and enrolled. 15 patients were randomized to the CBD group with the treatment product containing 250 mg CBD/3 fl. oz, and 14 patients were randomized to the placebo group. After four weeks, the placebo group was allowed to crossover into the treatment group. The Neuropathic Pain Scale (NPS) was administered biweekly to assess the mean change from baseline to the end of the treatment period.
RESULTS


The study population included 62.1% males and 37.9% females with a mean age of 68 years. There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group. No adverse events were reported in this study.
CONCLUSION


Our findings demonstrate that the transdermal application of CBD oil can achieve significant improvement in pain and other disturbing sensations in patients with peripheral neuropathy. The treatment product was well tolerated and may provide a more effective alternative compared to other current therapies in the treatment of peripheral neuropathy.",2020,"There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group.","['patients with peripheral neuropathy', 'Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities', 'The study population included 62.1% males and 37.9% females with a mean age of 68 years', 'In total 29 patients with symptomatic peripheral neuropathy were recruited and enrolled', '15 patients']","['CBD', 'topically delivered cannabidiol (CBD) oil', 'placebo', 'CBD oil', 'Topical Cannabidiol Oil']","['neuropathic pain scale (NPS', 'intense pain, sharp pain, cold and itchy sensations', 'adverse events', 'pain and other disturbing sensations', 'neuropathic pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain (finding)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0634657,"There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group.","[{'ForeName': 'Dixon H', 'Initials': 'DH', 'LastName': 'Xu', 'Affiliation': 'PGY-2, Department of Podiatric Medicine and Surgery, Scripps Mercy Hospital, San Diego, CA 92103, United States.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Cullen', 'Affiliation': 'Podiatric Surgery Section Chief, Scripps Mercy Hospital, 4077 Fifth Ave, MER35, San Diego, CA, 92103, United States.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Microbiology, Immunology & Pathology, Des Moines University, Des Moines, IA, 50312, United States.'}, {'ForeName': 'Yujiang', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Microbiology, Immunology & Pathology, Des Moines University, Des Moines, IA, 50312, United States.'}]",Current pharmaceutical biotechnology,['10.2174/1389201020666191202111534']
1185,31752762,Efficacy of path-oriented psychological self-help interventions to improve mental health of empty-nest older adults in the Community of China.,"BACKGROUND


China has the world's largest aging population and the number of empty-nest older adults is on the rise. In comparison to the aging population in general, empty-nest older adults have a lower level of subjective well-being and poorer mental health status due to a lack of emotional support from their children. The aim of this study is to conduct an empirical study to evaluate the efficacy of the 'Path-oriented Psychological Self-help Intervention' (P-oPSI) led by nurses on the mental health of empty-nest older adults in the community, to provide a scientific foundation for improving their quality of life.
METHODS


A Quasi-Experimental controlled intervention study was conducted from 2015 to 2017. A total of 76 empty-nest older adults from 2 districts were recruited using a convenience sampling and assigned to 2 groups based on their residential communities in the city of Chifeng in the Inner Mongolia Autonomous Region, China. The wait list control group participated in a mental health lecture to gain knowledge and learn techniques of mental health promotion. The intervention group additionally received 1 month of training in a nurse-led 'P-oPSI' for a month. Both groups were followed-up for 3 months. Mental health status, coping styles, and psychological self-help ability of the participating empty nest older adults were assessed at the baseline, 1 month, and 3-months follow up, respectively. Two-way analysis of variance and a simple effect test were used to analyse the differences of the two groups.
RESULTS


The P-oPSI yielded a greater benefit for the mental health status, coping styles, and psychological self-help ability of the participants in the intervention group. Combined with a simple effect test, the scores of the mental health status, positive coping style, and psychological self-help ability of those in the intervention group significantly increased at 1 month after the baseline (F  mental health status  = 7.59, F  positive coping style  = 7.24, F  psychological self-help ability  = 7.07); and the sustainable effect of this program lasted for 3 months after the intervention (F  mental health status  = 13.24, F  positive coping style  = 10.42, F  psychological self-help ability  = 10.45), which reached statistical significance (P < 0.01).
CONCLUSIONS


The P-oPSI program significantly improved the level of mental health of empty-nest older adults in China. This intervention provides a new approach of self-management to improve mental health of older adults in community settings.
TRIAL REGISTRATION


chictr.org.cn: ChiCTR1900025552. Retrospectively registered 1 September 2019.",2019,"The P-oPSI yielded a greater benefit for the mental health status, coping styles, and psychological self-help ability of the participants in the intervention group.","['76 empty-nest older adults from 2 districts were recruited using a convenience sampling and assigned to 2 groups based on their residential communities in the city of Chifeng in the Inner Mongolia Autonomous Region, China', 'older adults in community settings', 'A Quasi-Experimental controlled intervention study was conducted from 2015 to 2017', 'empty-nest older adults', 'empty-nest older adults in the Community of China']","[""Path-oriented Psychological Self-help Intervention' (P-oPSI"", ""1 month of training in a nurse-led 'P-oPSI"", 'mental health lecture to gain knowledge and learn techniques of mental health promotion', 'path-oriented psychological self-help interventions']","['level of mental health', 'scores of the mental health status, positive coping style, and psychological self-help ability', 'Mental health status, coping styles, and psychological self-help ability', 'mental health status, coping styles, and psychological self-help ability', 'mental health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0373645,"The P-oPSI yielded a greater benefit for the mental health status, coping styles, and psychological self-help ability of the participants in the intervention group.","[{'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, 313000, Zhejiang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'AdventHealth Whole-Person Research, Orlando, FL, 32804, USA.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Binzhou Polytechnic, Binzhou, 256600, Shandong, China.'}, {'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Yu', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, 313000, Zhejiang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'School of Nursing, Harbin Medical University, DaQing Campus, Daqing, 163319, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, 433 First Avenue, New York, NY, 10010, USA. bei.wu@nyu.edu.'}]",BMC psychiatry,['10.1186/s12888-019-2327-9']
1186,30055336,A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial.,"Primary care offers a familiar and accessible clinical venue for patients with obesity to receive evidence-based lifestyle interventions for weight management. However, there are numerous barriers to the implementation of such programs in primary care, and previous primary care weight loss interventions demonstrate modest and temporary effects. Weight loss treatment delivered within primary care by peer coaches may offer a viable and effective alternative. The purpose of this trial is to test the effects of weight loss treatment that includes ongoing support from a peer coach (i.e., trained, salaried community health workers) as compared to self-directed treatment. Peer coach treatment will be delivered over 18 months and includes a combination of in-person, group-based office visits and individual telephone contacts. This weight loss trial will include 375 adults with obesity (BMI = 30-50 kg/m 2 ) randomized from 10 primary care practices. The primary outcome will be changes in body weight at month 18. Secondary outcomes will include key patient-centered outcomes, including quality-of-life, physical and social functioning, mood, and treatment satisfaction. The cost-effectiveness of the peer coach intervention will also be evaluated. If this novel intervention is effective, it could offer a practical and sustainable approach for the delivery of weight loss treatment in primary care that has the potential to improve clinical outcomes for patients, increase treatment options for primary care providers, and reduce obesity-related healthcare utilization and costs.",2018,"If this novel intervention is effective, it could offer a practical and sustainable approach for the delivery of weight loss treatment in primary care that has the potential to improve clinical outcomes for patients, increase treatment options for primary care providers, and reduce obesity-related healthcare utilization and costs.","['patients with obesity to receive evidence-based lifestyle interventions for weight management', '375 adults with obesity (BMI\u202f=\u202f30-50\u202fkg/m 2 ) randomized from 10 primary care practices']",['peer coach intervention'],"['changes in body weight', 'key patient-centered outcomes, including quality-of-life, physical and social functioning, mood, and treatment satisfaction', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",375.0,0.0481957,"If this novel intervention is effective, it could offer a practical and sustainable approach for the delivery of weight loss treatment in primary care that has the potential to improve clinical outcomes for patients, increase treatment options for primary care providers, and reduce obesity-related healthcare utilization and costs.","[{'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine, 1717 11th Avenue South, Birmingham, AL 35205, USA. Electronic address: gdutton@uabmc.edu.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine, 1717 11th Avenue South, Birmingham, AL 35205, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine, 1717 11th Avenue South, Birmingham, AL 35205, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisu', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine, 1717 11th Avenue South, Birmingham, AL 35205, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Richman', 'Affiliation': 'University of Alabama at Birmingham, Department of Surgery, 1922 7th Avenue South, Birmingham 35233, USA.'}, {'ForeName': 'Tamela', 'Initials': 'T', 'LastName': 'Turner', 'Affiliation': 'University of Alabama at Birmingham, Department of Family and Community Medicine, 930 20th Street South, Birmingham, AL 35294, USA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Phillips', 'Affiliation': 'University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine, 1717 11th Avenue South, Birmingham, AL 35205, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.015']
1187,30978535,Nonceliac Gluten and Wheat Sensitivity.,"Non-celiac gluten and/or wheat sensitivity (NCGS) is thought to be an immune-mediated reaction to gluten or other components of wheat (eg, fructans or amylase trypsin inhibitors) with intestinal and extraintestinal symptoms which improve once gluten and/or wheat is eliminated from the diet and after a diagnosis of celiac disease and wheat allergy have been excluded with appropriate testing. However, there is a great deal of skepticism within the scientific community questioning the existence of NCGS as a distinct clinical disorder. There are no strict diagnostic criteria and a placebo-controlled rechallenge trial has been recommended for diagnosis. In research settings, a double-blind placebo-controlled rechallenge trial has been recommended for diagnosis. There are limited studies estimating the prevalence of NCGS using this study design. The existing studies have variable results likely due to the lack of a uniform diagnostic criterion, a great deal of dependence on the patient's perception of symptoms and a large nocebo effect in existing studies. In clinical practice, a single blind placebo-controlled rechallenge trial has been recommended for diagnosis. The pathogenesis of NCGS is unclear and there is no known biomarker or diagnostic histologic lesion for this condition. It is important to adopt a multidisciplinary team approach to patients with suspected NCGS with involvement of the primary care doctor, gastroenterologist, pathologist and nutritionist who may play an important role in diagnosis and treatment. There may especially be a role in elimination of food containing high quantity of both gluten and fructans. Furthermore, patients should be educated on the nutritional implications of consuming a long-term gluten-free diet.",2019,"However, there is a great deal of skepticism within the scientific community questioning the existence of NCGS as a distinct clinical disorder.",[],"['placebo', 'celiac gluten and/or wheat sensitivity (NCGS']",['Nonceliac Gluten and Wheat Sensitivity'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.124943,"However, there is a great deal of skepticism within the scientific community questioning the existence of NCGS as a distinct clinical disorder.","[{'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas. Electronic address: anamk@bcm.edu.'}, {'ForeName': 'Milena Gould', 'Initials': 'MG', 'LastName': 'Suarez', 'Affiliation': 'Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Murray', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.04.009']
1188,31771601,A Phase I/II trial comparing autologous dendritic cell vaccine pulsed either with personalized peptides (PEP-DC) or with tumor lysate (OC-DC) in patients with advanced high-grade ovarian serous carcinoma.,"BACKGROUND


Most ovarian cancer patients are diagnosed at a late stage with 85% of them relapsing after surgery and standard chemotherapy; for this reason, new treatments are urgently needed. Ovarian cancer has become a candidate for immunotherapy by reason of their expression of shared tumor-associated antigens (TAAs) and private mutated neoantigens (NeoAgs) and the recognition of the tumor by the immune system. Additionally, the presence of intraepithelial tumor infiltrating lymphocytes (TILs) is associated with improved progression-free and overall survival of patients with ovarian cancer. The aim of active immunotherapy, including vaccination, is to generate a new anti-tumor response and amplify an existing immune response. Recently developed NeoAgs-based cancer vaccines have the advantage of being more tumor specific, reducing the potential for immunological tolerance, and inducing robust immunogenicity.
METHODS


We propose a randomized phase I/II study in patients with advanced ovarian cancer to compare the immunogenicity and to assess safety and feasibility of two personalized DC vaccines. After standard of care surgery and chemotherapy, patients will receive either a novel vaccine consisting of autologous DCs pulsed with up to ten peptides (PEP-DC), selected using an agnostic, yet personalized, epitope discovery algorithm, or a sequential combination of a DC vaccine loaded with autologous oxidized tumor lysate (OC-DC) prior to an equivalent PEP-DC vaccine. All vaccines will be administered in combination with low-dose cyclophosphamide. This study is the first attempt to compare the two approaches and to use NeoAgs-based vaccines in ovarian cancer in the adjuvant setting.
DISCUSSION


The proposed treatment takes advantage of the beneficial effects of pre-treatment with OC-DC prior to PEP-DC vaccination, prompting immune response induction against a wide range of patient-specific antigens, and amplification of pre-existing NeoAgs-specific T cell clones. Trial registration This trial is already approved by Swissmedic (Ref.: 2019TpP1004) and will be registered at http://www.clinicaltrials.gov before enrollment opens.",2019,Ovarian cancer has become a candidate for immunotherapy by reason of their expression of shared tumor-associated antigens (TAAs) and private mutated neoantigens (NeoAgs) and the recognition of the tumor by the immune system.,"['patients with ovarian cancer', 'patients with advanced high-grade ovarian serous carcinoma', 'ovarian cancer patients', 'patients with advanced ovarian cancer']","['cyclophosphamide', 'personalized DC vaccines', 'autologous dendritic cell vaccine pulsed either with personalized peptides (PEP-DC) or with tumor lysate (OC-DC', 'novel vaccine consisting of autologous DCs pulsed with up to ten peptides (PEP-DC', 'standard chemotherapy', 'DC vaccine loaded with autologous oxidized tumor lysate (OC-DC) prior to an equivalent PEP-DC vaccine']",['progression-free and overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0206701', 'cui_str': 'Cystadenocarcinoma, Serous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0913765,Ovarian cancer has become a candidate for immunotherapy by reason of their expression of shared tumor-associated antigens (TAAs) and private mutated neoantigens (NeoAgs) and the recognition of the tumor by the immune system.,"[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Sarivalasis', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Boudousquié', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Balint', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Stevenson', 'Affiliation': 'Swiss Institute of Bioinformatics, 1015, Lausanne, Switzerland.'}, {'ForeName': 'Philippe O', 'Initials': 'PO', 'LastName': 'Gannon', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Emanuela Marina', 'Initials': 'EM', 'LastName': 'Iancu', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Rossier', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Martin Lluesma', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Women-Mother-Child Department, Service of Gynecology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sempoux', 'Affiliation': 'Department of Pathology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Coukos', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'Laboratory of Biostatistics, School of Health Sciences, National and Kapodistrian, University of Athens, Athens, Greece.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Harari', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bassani-Sternberg', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Lana E', 'Initials': 'LE', 'LastName': 'Kandalaft', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland. Lana.Kandalaft@chuv.ch.'}]",Journal of translational medicine,['10.1186/s12967-019-02133-w']
1189,31782367,Short-term Effect of Fresh Pomegranate Juice on Serum Cortisol and Thyroxine in Patients with type 2 Diabetes.,"BACKGROUND


The effect of pomegranate juice on type 2 diabetic conditions has been determined in various occasions. However, such an effect on cortisol and thyroxine hormones, which are major controllers of energy metabolism, is not yet revealed.
OBJECTIVES


In this study, we intended to measure the short-term effect of fresh pomegranate juice on serum cortisol and thyroxine in patients with type 2 diabetes.
MATERIALS AND METHODS


This study was a randomized clinical trial in which 89 fasted patients with type 2 diabetes were supplemented with fresh pomegranate juice at a dose of 1.5 mL kg-1. Blood specimens were then collected before and at 1 and 3 hours after juice administration. Serum cortisol and thyroxine were assessed using commercial chemiluminescent-immunoassay kits.
RESULTS


Serum cortisol, but not thyroxine, was significantly (P < 0.0001) lower in patients with type 2 diabetes after ingesting fresh pomegranate juice. In addition, no significant correlation (r2 = 0.00003, P = 0.9569) was observed between cortisol response to fresh pomegranate juice and the level of fasting serum glucose in the recruited patients. Moreover, no significant difference (P = 0.9118) in cortisol response to fresh pomegranate juice was found between recruited males and females.
CONCLUSIONS


In conclusion, fresh pomegranate juice decreased serum cortisol, 1 hour after juice ingestion, but not serum thyroxine 3 hours after juice ingestion, in patients with type 2 diabetes. In addition, cortisol response to fresh pomegranate juice was found not to be affected by patients' gender and the level of fasting serum glucose.",2020,"RESULTS


Serum cortisol, but not thyroxine, was significantly (P &amp;lt; 0.0001) lower in patients with type 2 diabetes after ingesting fresh pomegranate juice.","['patients with type 2 diabetes', '89 patients with type 2 diabetes']",['fresh pomegranate juice'],"['Serum cortisol', 'level of fasting serum glucose', 'cortisol response to fresh pomegranate juice', 'cortisol response', 'Serum cortisol and thyroxine', 'serum cortisol and thyroxine', 'cortisol response to fresh pomegranate juice and the level of fasting serum glucose', 'serum cortisol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}]","[{'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}]",89.0,0.023162,"RESULTS


Serum cortisol, but not thyroxine, was significantly (P &amp;lt; 0.0001) lower in patients with type 2 diabetes after ingesting fresh pomegranate juice.","[{'ForeName': 'Saleem Ali', 'Initials': 'SA', 'LastName': 'Banihani', 'Affiliation': 'Department of Medical Laboratory Sciences, Jordan University of Science and Technology, Irbid 22110, Jordan.'}, {'ForeName': 'Seham M', 'Initials': 'SM', 'LastName': 'Makahleh', 'Affiliation': 'Department of Medical Laboratory Sciences, Jordan University of Science and Technology, Irbid 22110, Jordan.'}, {'ForeName': 'Zeyad J', 'Initials': 'ZJ', 'LastName': 'El-Akawi', 'Affiliation': 'Department of Physiology and Biochemistry, Jordan University of Science and Technology, Irbid 22110, Jordan.'}]",Current molecular medicine,['10.2174/1566524019666191129104153']
1190,31771921,Impact on cardiometabolic risk of a weight loss intervention with higher protein from lean red meat: Combined results of 2 randomized controlled trials in obese middle-aged and older adults.,"BACKGROUND


The recognized benefits of a higher protein diet on muscle mass and strength in older adults are tempered by concerns of the potentially negative cardiometabolic impact of dietary sources of animal protein.
OBJECTIVE


The aim of this study was to explore the cardiometabolic impact of 2 weight reduction diets: a higher protein diet, providing balanced portions of lean beef and pork throughout the day, vs. a diet following the Recommended Daily Allowance level of protein in obese middle-aged and older adults.
METHODS


Data from Measuring Eating, Activity and Strength: Understanding the Response-Using Protein and Protein Optimization in Women Enables Results-Using Protein were combined for the present analysis. Subjects were randomly assigned to a 6-month weight loss diet (500 kcal deficit) and prescribed a Recommended Daily Allowance level of protein (0.8 g protein/kg BW), control group, or a higher level of protein (1.2 g protein/kg BW), protein group. For the protein group, lean, high-quality protein was evenly distributed between meals or balanced throughout the day (30 g protein/meal). The following cardiometabolic markers were quantified by nuclear magnetic resonance spectroscopy: lipids, lipoproteins, GlycA, trimethylamine-N-oxide, betaine, branched-chain amino acids, and lipoprotein insulin resistance index scores.
RESULTS


In both groups (control [n = 27] and protein [n = 53]), there were significant (P ≤ .05) changes from baseline in weight loss (-6.2% and -7.2%), distance walked (+53.1 and +75.0 meters), and fasting plasma glucose (-7.5 and -6.2 mg/dL), respectively. At endpoint, protein group had significantly (P ≤ .05) lower triglycerides (-17.3 mg/dL), large very-low-density lipoprotein particle concentration (VLDL-P; -1.2 nmol/L), total low-density lipoprotein particle concentration (LDL-P; -67.8 nmol/L), small LDL-P (-59.4 nmol/L) and lipoprotein insulin resistance index (-5.9), whereas control group had significantly (P ≤ .05) lower GlycA (-13.1 μmol/L), total VLDL-P (-7.9 nmol/L), and small VLDL-P (-7.0 nmol/L). Differences between groups were observed for small VLDL-P (P = .02) and protein intake (P < .0001).
CONCLUSIONS


These findings suggest that a hypocaloric diet with either traditional (0.8 g/kg BW/d) or higher protein (1.2 g/kg BW/d; predominantly from lean red meat) content improves risk markers of cardiovascular disease and type II diabetes in obese middle-aged and older adults. Both diets were also associated with improved physical function, and neither had an adverse impact on cardiometabolic outcomes.",2019,"At endpoint, protein group had significantly (P ≤ .05) lower triglycerides (-17.3 mg/dL), large very-low-density lipoprotein particle concentration (VLDL-P; -1.2 nmol/L), total low-density lipoprotein particle concentration (LDL-P; -67.8 nmol/L), small LDL-P (-59.4 nmol/L) and lipoprotein insulin resistance index (-5.9), whereas control group had significantly (P ≤ .05) lower GlycA (-13.1 μmol/L), total VLDL-P (-7.9 nmol/L), and small VLDL-P","['obese middle-aged and older adults', 'obese middle-aged and older\xa0adults', 'older adults', 'Data from Measuring Eating, Activity and Strength', 'Women']","['weight reduction diets', '6-month weight loss diet (500\xa0kcal deficit) and prescribed a Recommended Daily Allowance level of protein', 'weight loss intervention with higher protein from lean red meat']","['small VLDL-P', 'total low-density lipoprotein particle concentration', 'fasting plasma glucose', 'total VLDL-P', 'physical function', 'lipoproteins, GlycA, trimethylamine-N-oxide, betaine, branched-chain amino acids, and lipoprotein insulin resistance index scores', 'risk markers of cardiovascular disease and type II diabetes', 'small LDL-P', 'protein intake', 'cardiometabolic outcomes', 'weight loss', 'large very-low-density lipoprotein particle concentration', 'lipoprotein insulin resistance index', 'distance walked', 'cardiometabolic risk', 'triglycerides']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012167', 'cui_str': 'Weight Reduction Diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowances'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0452848', 'cui_str': 'Red Meat'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0308859,"At endpoint, protein group had significantly (P ≤ .05) lower triglycerides (-17.3 mg/dL), large very-low-density lipoprotein particle concentration (VLDL-P; -1.2 nmol/L), total low-density lipoprotein particle concentration (LDL-P; -67.8 nmol/L), small LDL-P (-59.4 nmol/L) and lipoprotein insulin resistance index (-5.9), whereas control group had significantly (P ≤ .05) lower GlycA (-13.1 μmol/L), total VLDL-P (-7.9 nmol/L), and small VLDL-P","[{'ForeName': 'Kathryn N', 'Initials': 'KN', 'LastName': 'Porter Starr', 'Affiliation': 'Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA; Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Geriatric Research, Education, and Clinical Center, Durham VA Medical Center, Durham, NC, USA. Electronic address: kathryn.starr@dm.duke.edu.'}, {'ForeName': 'Margery A', 'Initials': 'MA', 'LastName': 'Connelly', 'Affiliation': 'Laboratory Corporation of America Holdings (LabCorp), Morrisville, NC, USA.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Orenduff', 'Affiliation': 'Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Shelley R', 'Initials': 'SR', 'LastName': 'McDonald', 'Affiliation': 'Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA; Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Geriatric Research, Education, and Clinical Center, Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA; Geriatric Research, Education, and Clinical Center, Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Department of Medicine and Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine and Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Connie W', 'Initials': 'CW', 'LastName': 'Bales', 'Affiliation': 'Center for the Study of Aging, Duke University School of Medicine, Durham, NC, USA; Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Geriatric Research, Education, and Clinical Center, Durham VA Medical Center, Durham, NC, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.09.012']
1191,31215092,Effect of vitamin D supplementation on total and free 25 hydroxyvitamin D and parathyroid hormone. An analysis of two randomized controlled trials.,"BACKGROUND


It is questionable as to whether total serum 25 hydroxyvitamin D (T25D) levels are lower in African Americans. We measured serum T25D, free 25hydroxyvitamin D (F25D) and serum parathyroid hormone (PTH) in African American and Caucasian women and studied the effect of vitamin D dosing to determine if differences by race or age occur.
METHODS


Healthy young and older Caucasian and African American women who were vitamin D insufficient were randomized in two clinical trials to escalating daily doses of vitamin D from 400 to 4800 IU and placebo for 12 months.
RESULTS


Baseline F25D and T25D were significantly lower in young but not older African American compared to Caucasian women. At baseline, the rate of change, or slope, in F25D with T25D was significantly greater in younger women than in older women, but difference in the rate of change in F25D with T25D is similar in African American and Caucasian women. After vitamin D supplementation, there was an increase in F25D, and the dose response was not significantly different by age or race. The ratio of F25D/T25D decreased in all groups once T25D exceeded ~60 nmol L -1  . There was a progressive decrease in serum PTH with increasing vitamin D doses and the per cent change was similar for F25D and T25D.
CONCLUSION


Serum F25D and T25D are lower in younger African American women, and since dietary vitamin D is similar in the groups, it is likely that the cause of low serum 25OHD in African American women is due to reduced UV exposure and reduced skin production of vitamin D.",2019,"The ratio of F25D/T25D decreased in all groups once T25D exceeded ~ 60nmol/L. There was a progressive decrease in serum PTH with increasing vitamin D doses and the percent change was similar for F25D and T25D.
CONCLUSION


","['African Americans', 'African American and Caucasian women', 'Healthy young and older Caucasian and African American women who were vitamin D insufficient', 'African American women', 'younger African American women']","['vitamin D', 'vitamin D supplementation', 'Vitamin D Supplementation', 'total serum 25 hydroxyvitamin D', 'vitamin D from 400 IU - 4800IU and placebo']","['F25D, and the dose response', 'Baseline F25D and T25D', 'T25D) levels', 'serum T25D, free 25hydroxyvitamin D (F25D), and serum parathyroid hormone (PTH', 'Total and Free 25 Hydroxyvitamin D and Parathyroid Hormone', 'serum PTH', 'ratio of F25D/T25D', 'Serum F25D and T25D', 'rate of change in F25D with T25D']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.198549,"The ratio of F25D/T25D decreased in all groups once T25D exceeded ~ 60nmol/L. There was a progressive decrease in serum PTH with increasing vitamin D doses and the percent change was similar for F25D and T25D.
CONCLUSION


","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Smith', 'Affiliation': 'Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gallagher', 'Affiliation': 'Bone Metabolism, Department Endocrinology, Creighton University School of Medicine, Omaha, NE, USA.'}]",Journal of internal medicine,['10.1111/joim.12950']
1192,30883517,Targeted Proteomic Analysis Detects Acute T Cell-Mediated Kidney Allograft Rejection in Belatacept-Treated Patients.,"BACKGROUND


There is an unmet need for reliable minimally invasive diagnostic biomarkers for immunological allograft monitoring and for the detection of acute kidney transplant rejection. Here, targeted proteomic analysis was applied to compare 92 proteins in sera of belatacept-treated patients who had biopsy-proven, acute T-cell-mediated rejection (aTCMR) with patients without aTCMR.
METHODS


Proximity extension immunoassay was used to measure 92 inflammation-related protein concentrations in the prerejection and rejection sera of 11 patients with aTCMR and 9 patients without aTCMR. This assay uses 2 matched oligonucleotide-labeled antibody probes for each protein and polymerase chain reaction to measure normalized protein expression values.
RESULTS


Five proteins (CD5, CD8A, NCR1, TNFRSF4, and TNFRSF9) were expressed significantly higher in samples with aTCMR compared with samples without aTCMR (adjusted P-value < 0.014) and had a good predictive capacity for aTCMR [area under the curve in a receiver-operator curve ranged from 0.83 to 0.91 (P < 0.014)]. These proteins are associated with CD8 cytotoxic T-cell and NK cell functions. Nonhierarchical clustering analysis showed distinct clustering of samples with aTCMR and samples without aTCMR. This clustering was not found in prerejection samples (1 month after transplantation). In prerejection samples, IFN-γ was expressed at a significantly lower level (normalized protein expression value median -0.15, interquartile range: -0.27 to 0.04) than in samples of patients without rejection (median 0.13, interquartile range: -0.07 to 0.15, adjusted P-value = 0.00367).
CONCLUSIONS


Targeted proteomic analysis with proximity extension immunoassay is a promising minimally invasive technique to diagnose aTCMR in kidney transplant recipients.",2019,"In prerejection samples, IFN-γ was expressed at a significantly lower level (normalized protein expression value median -0.15, interquartile range: -0.27 to 0.04) than in samples of patients without rejection (median 0.13, interquartile range: -0.07 to 0.15, adjusted P-value = 0.00367).
","['acute kidney transplant rejection', '92 proteins in sera of belatacept-treated patients who had biopsy-proven, acute T-cell-mediated rejection (aTCMR) with patients without aTCMR', 'kidney transplant recipients']","['aTCMR and 9 patients without aTCMR', 'aTCMR']","['CD8 cytotoxic T-cell and NK cell functions', 'Five proteins (CD5, CD8A, NCR1, TNFRSF4, and TNFRSF9']","[{'cui': 'C0238217', 'cui_str': 'Renal transplant rejection (disorder)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",11.0,0.0196707,"In prerejection samples, IFN-γ was expressed at a significantly lower level (normalized protein expression value median -0.15, interquartile range: -0.27 to 0.04) than in samples of patients without rejection (median 0.13, interquartile range: -0.07 to 0.15, adjusted P-value = 0.00367).
","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'van der Zwan', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Rotterdam Transplant Group, Erasmus MC, University Medical Center.'}, {'ForeName': 'Dennis A', 'Initials': 'DA', 'LastName': 'Hesselink', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Rotterdam Transplant Group, Erasmus MC, University Medical Center.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Clahsen-van Groningen', 'Affiliation': 'Department of Pathology, Rotterdam Transplant Group, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Carla C', 'Initials': 'CC', 'LastName': 'Baan', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Rotterdam Transplant Group, Erasmus MC, University Medical Center.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000587']
1193,30997650,Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis.,"BACKGROUND


The 24-h area under the concentration-time curve (AUC 24 )/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC 24 ; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs.
METHODS


An OSS for the prediction of AUC 24  of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment.
RESULTS


OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS 2-4-8  cannot be used for rifampicin in steady state conditions.
CONCLUSION


OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC 24  values of first-line anti-TB drugs in this population.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02121314).",2019,Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition.,['Patients with Tuberculosis'],"['rifampicin', 'isoniazid, rifampicin, ethambutol and pyrazinamide']",['concentration-time curve'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0518982,Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition.,"[{'ForeName': 'Antonia Morita I', 'Initials': 'AMI', 'LastName': 'Saktiawati', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Harkema', 'Affiliation': ', Groningen, The Netherlands.'}, {'ForeName': 'Althaf', 'Initials': 'A', 'LastName': 'Setyawan', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Population Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yanri W', 'Initials': 'YW', 'LastName': 'Subronto', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sumardi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Ymkje', 'Initials': 'Y', 'LastName': 'Stienstra', 'Affiliation': 'Department of Internal Medicine/Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rob E', 'Initials': 'RE', 'LastName': 'Aarnoutse', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Magis-Escurra', 'Affiliation': 'Department of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Groesbeek, The Netherlands.'}, {'ForeName': 'Jos G W', 'Initials': 'JGW', 'LastName': 'Kosterink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Tjip S', 'Initials': 'TS', 'LastName': 'van der Werf', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jan-Willem C', 'Initials': 'JC', 'LastName': 'Alffenaar', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Marieke G G', 'Initials': 'MGG', 'LastName': 'Sturkenboom', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands. m.g.g.sturkenboom@umcg.nl.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00763-3']
1194,31205211,Implementation of a prehospital air medical thawed plasma program: Is it even feasible?,"BACKGROUND


The Prehospital Air Medical Plasma (PAMPer) trial demonstrated a 30-day survival benefit among hypotensive trauma patients treated with prehospital plasma during air medical transport. We characterized resources, costs and feasibility of air medical prehospital plasma program implementation.
METHODS


We performed a secondary analysis using data derived from the recent PAMPer trial. Intervention patients received thawed plasma (5-day shelf life). Unused plasma units were recycled back to blood bank affiliates, when possible. Distribution method and capability of recycling varied across sites. We determined the status of plasma units deployed, utilized, wasted, and returned. We inventoried thawed plasma use and annualized costs for distribution and recovery.
RESULTS


The PAMPer trial screened 7,275 patients and 5,103 plasma units were deployed across 22 air medical bases during a 42-month period. Only 368 (7.2%) units of this total thawed plasma pool were provided to plasma randomized PAMPer patients. Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis. The estimated average annual cost of implementation of a thawed plasma program per air medical base at an average courier distance would be between US $24,343 and US $30,077, depending on the ability to recycle plasma and distance of courier delivery required.
CONCLUSION


A prehospital plasma program utilizing thawed plasma is resource intensive. Plasma waste can be minimized depending on trauma center and blood bank specific logistics. Implementation of a thawed plasma program can occur with financial cost. Products with a longer shelf life, such as liquid plasma or freeze-dried plasma, may provide a more cost-effective prehospital product relative to thawed plasma.
LEVEL OF EVIDENCE


Therapeutic, level III.",2019,"Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis.","['hypotensive trauma patients treated with prehospital plasma during air medical transport', '7,275 patients and 5,103 plasma units were deployed across 22 air medical bases over a 42-month time period']",[],['30-day survival benefit'],"[{'cui': 'C0857353', 'cui_str': 'Hypotensive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",7275.0,0.0353111,"Of the total plasma pool, 3,716 (72.8%) units of plasma were returned to the blood bank with the potential for transfusion prior to expiration and 1,019 (20.0%) thawed plasma units were deemed wasted for this analysis.","[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Adams', 'Affiliation': 'From the Division of Trauma and General Surgery, Department of Surgery (P.W.A., K.A.W., J.B.B., A.T.P., B.S.Z., M.D.N., J.L.S.), and Department of Emergency Medicine (F.X.G.), University of Pittsburgh Medical Center; Vitalant, and Department of Pathology (M.H.Y.), University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Surgery (B.J.D.), University of Tennessee Health Science Center, Knoxville; Department of Surgery (R.S.M.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery (B.G.H.), University of Louisville, Louisville, Kentucky; MetroHealth Medical Center (J.A.C.), Case Western Reserve University, Cleveland, Ohio; Department of Surgery (H.A.P.), University of Texas Southwestern, Parkland Hospital, Dallas; and Health Harris Methodist Hospital (W.R.W.), Fort Worth, Texas.'}, {'ForeName': 'Kayla A', 'Initials': 'KA', 'LastName': 'Warren', 'Affiliation': ''}, {'ForeName': 'Frank X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Yazer', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daily', 'Affiliation': ''}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Brain G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': ''}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': ''}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': ''}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Witham', 'Affiliation': ''}, {'ForeName': 'A Tyler', 'Initials': 'AT', 'LastName': 'Putnam', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002406']
1195,31689232,Once-weekly supervised combined training improves neurocognitive and psychobehavioral outcomes in young patients with type 1 diabetes mellitus.,"Background Previous studies investigating the beneficial effects of exercise in type 1 diabetes mellitus (T1DM) are relatively insufficient compared to studies on type 2 diabetes mellitus (T2DM), due to the fear of hypoglycemia. Recently, several researchers have reported that combined aerobic and resistance exercise prevents hypoglycemia during and after exercise. Furthermore, exercise has been shown to have beneficial effects on the psychological status of patients with various diseases. The aim of this study was to evaluate the effect of combined aerobic and resistance exercise in adolescents with T1DM. Methods Thirty-five type 1 diabetic patients were enrolled, and subjects were divided into either an exercise group or a control group. Thirty patients (20 patients in the exercise group, 10 patients in the control group) completed the study. The exercise program was performed for 1 h at a time, once a week, for 12 weeks. Study parameters were evaluated at baseline and 3 months after baseline evaluation. Results Combined aerobic and resistance exercise better controlled the body mass index (BMI), and also improved maximum muscular strength and maximum exercise intensity. On psychological tests, subjects' attention and quality of life showed improving tendency, while their stress and behavioral problems diminished. The number of exercise events increased in the training group, while the daily total insulin dose and glycated hemoglobin (HbA1c) level showed no significant changes. Conclusions A 12-week structured exercise program consisting of aerobic and resistance exercises improves cardiovascular, neurocognitive and psychobehavioral functions, and positively helps lifestyle modification in patients with T1DM.",2019,"Results Combined aerobic and resistance exercise better controlled the body mass index (BMI), and also improved maximum muscular strength and maximum exercise intensity.","['adolescents with T1DM', 'patients with T1DM', 'patients with various diseases', 'Thirty patients (20 patients in the exercise group, 10 patients in the control group) completed the study', 'young patients with type 1 diabetes mellitus', 'type 1 diabetes mellitus (T1DM', 'Methods Thirty-five type 1 diabetic patients']","['aerobic and resistance exercises', 'exercise group or a control group', 'Combined aerobic and resistance exercise', 'combined aerobic and resistance exercise']","['cardiovascular, neurocognitive and psychobehavioral functions', 'number of exercise events', 'daily total insulin dose and glycated hemoglobin (HbA1c) level', 'neurocognitive and psychobehavioral outcomes', 'maximum muscular strength and maximum exercise intensity', 'body mass index (BMI']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",35.0,0.018248,"Results Combined aerobic and resistance exercise better controlled the body mass index (BMI), and also improved maximum muscular strength and maximum exercise intensity.","[{'ForeName': 'Junghwan', 'Initials': 'J', 'LastName': 'Suh', 'Affiliation': ""Department of Pediatrics, Severance Children's Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Han Saem', 'Initials': 'HS', 'LastName': 'Choi', 'Affiliation': ""Department of Pediatrics, Severance Children's Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Ahreum', 'Initials': 'A', 'LastName': 'Kwon', 'Affiliation': ""Department of Pediatrics, Severance Children's Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Hyun Wook', 'Initials': 'HW', 'LastName': 'Chae', 'Affiliation': ""Department of Pediatrics, Severance Children's Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Soyong', 'Initials': 'S', 'LastName': 'Eom', 'Affiliation': 'Epilepsy Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ho-Seong', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ""Department of Pediatrics, Severance Children's Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.""}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2019-0120']
1196,31729973,Vitamin e-loaded membrane dialyzers reduce hemodialysis inflammaging.,"BACKGROUND


Inflammaging is a persistent, low-grade, sterile, nonresolving inflammatory state, associated with the senescence of the immune system. Such condition downregulates both innate and adaptive immune responses during chronic disorders as type II diabetes, cancer and hemodialysis, accounting for their susceptibility to infections, malignancy and resistance to vaccination. Aim of this study was to investigate hemodialysis inflammaging, by evaluating changes of several hemodialysis treatments on indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation.
METHODS


We conducted a randomized controlled observational crossover trial. Eighteen hemodialysis patients were treated with 3 different hemodialysis procedures respectively: 1) Low-flux bicarbonate hemodialysis, 2) Low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers, and 3) Hemodialfitration. The control group consisted of 14 hospital staff healthy volunteers. Blood samples were collected from all 18 hemodialysis patients just after the long interdialytic interval, at the end of each hemodialysis treatment period.
RESULTS


Hemodialysis kynurenine and kynurenine/L - tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients. At the end of the low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers period, L - tryptophan serum levels remained unchanged vs both low-flux bicarbonate hemodialysis and hemodialfitration. Kynurenine levels instead decreased, resulting in a significant reduction of kynurenine/L - tryptophan blood ratio and indoleamine 2,3-dioxygenase-1 activity, when matched to both low-flux bicarbonate hemodialysis and HDF respectively. Serum nitric oxide control group levels, were significantly lower when compared to all hemodialysis patient groups. Interestingly, low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers nitric oxide serum levels from venous line blood samples taken 60 min after starting the hemodialysis session were significantly lower vs serum taken simultaneously from the arterial blood line.
CONCLUSIONS


The treatment with more biocompatible hemodialysis procedure as low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers, reduced indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation when compared to both low-flux bicarbonate hemodialysis and hemodialfitration. These data suggest that low-flux bicarbonate hemodialysis with vitamin E - loaded dialyzers lowering hemodialysis inflammaging, could be associated to changes of proinflammatory signalling a regulated molecular level.
TRIAL REGISTRATION


NCT Number: NCT02981992; Other Study ID Numbers: 20100014090. First submitted: November 26, 2016. First posted: December 5, 2016. Last Update Posted: December 5, 2016.",2019,"tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients.","['14 hospital staff healthy volunteers', 'hemodialysis patients', 'Eighteen hemodialysis patients', 'Hemodialysis kynurenine and kynurenine/L\u2009']","['Low-flux bicarbonate hemodialysis, 2) Low-flux bicarbonate hemodialysis with vitamin E\u2009-\u2009loaded dialyzers, and 3) Hemodialfitration', 'Vitamin e-loaded membrane dialyzers']","['indoleamine 2,3-dioxygenase-1 activity', 'kynurenine/L\u2009-\u2009tryptophan blood ratio and indoleamine 2,3-dioxygenase-1 activity', 'indoleamine 2,3-dioxygenase-1 activity and nitric oxide formation', 'Serum nitric oxide control group levels', 'Blood samples', 'Kynurenine levels', 'tryptophan blood ratio levels']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C1564138', 'cui_str': 'Indoleamine-Pyrrole 2,3,-Dioxygenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0005768'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0140031,"tryptophan blood ratio levels were significantly higher, when compared to the control group, indicating an increased indoleamine 2,3-dioxygenase-1 activity in hemodialysis patients.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Sepe', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy. v.sepe@smatteo.pv.it.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Gregorini', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Rampino', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Esposito', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Coppo', 'Affiliation': 'Fondazione Ricerca Molinette, Regina Margherita Hospital 94, Piazza Polonia, 10126, Torino, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Università degli Studi di Perugia, Pharmaceutical Sciences, Branch of Via del Giochetto, building B, 2nd floor, 06123, Perugia, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Libetta', 'Affiliation': 'Unit of Nephrology and Dialysis, Transplantation; Fondazione IRCCS Policlinico «San Matteo», Viale Camillo Golgi 19, 27100, Pavia, Italy.'}]",BMC nephrology,['10.1186/s12882-019-1585-6']
1197,31775668,Save the children by treating their mothers (PriVileG-M-study) - study protocol: a sequentially randomized controlled trial of individualized psychotherapy and telemedicine to reduce mental stress in pregnant women and young mothers and to improve Child's health.,"BACKGROUND


As early as pregnancy, maternal mental stress impinges on the child's development and health. Thus, this may cause enhanced risk for premature birth, lowered fetal growth, and lower fetal birth weight as well as enhanced levels of the stress hormone cortisol and lowered levels of the bonding hormone oxytocin. Maternal stress further reduces maternal sensitivity for the child's needs which impairs the mother-child-interaction and bonding. Therefore, prevention and intervention studies on mental stress are necessary, beginning prenatally and applying rigorous research methodology, such as randomized controlled trials, to ensure high validity.
METHODS


A randomized controlled trial is used to assess the impact of psychotherapy and telemedicine on maternal mental stress and the child's mental and physical health. Mentally stressed pregnant women are randomized to an intervention (IG) and a not intervened control group. The IG receives an individualized psychotherapy starting prenatal and lasting for 10 months. Afterwards, a second randomization is used to investigate whether the use of telemedicine can stabilize the therapeutic effects. Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed. Psycho-biologically, the synchronicity of cortisol and oxytocin levels between mother and child are assessed as well as the peptidome of the colostrum and breast milk, which are assumed to be essential for the adaptation to the extra-uterine environment. All assessments are compared to an additional control group of healthy women. Finally, the results of the study will lead to the development of a qualification measure for health professionals to detect mental stress, to treat it with low-level interventions and to refer those women with high stress levels to mental health professionals.
DISCUSSION


The study aims to prevent the transgenerational transfer of psychiatric and somatic disorders from the mother to her child. The effects of the psychotherapy will be stabilized through telemedicine and long-term impacts on the child's and mothers' mental health are enhanced. The combination of psychotherapy, telemedicine and methodologies of ecological momentary assessment, video recording and bio banking are new in content-related and methodological manner.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00017065. Registered 02 May 2019. World Health Organization, Universal Trial Number: U1111-1230-9826. Registered 01 April 2019.",2019,"Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed.","['psychiatric and somatic disorders from the mother to her child', ""pregnant women and young mothers and to improve Child's health"", 'Mentally stressed pregnant women']","['psychotherapy, telemedicine and methodologies of ecological momentary assessment, video recording and bio banking', 'telemedicine', 'individualized psychotherapy and telemedicine', 'psychotherapy', 'psychotherapy and telemedicine', 'intervention (IG) and a not intervened control group']","['mental stress', ""maternal mental stress and the child's mental and physical health"", 'maternal sensitivity', 'transfer into daily life, maternal sensitivity and mother-child-bonding', 'synchronicity of cortisol and oxytocin levels']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439579', 'cui_str': 'Synchronicities (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0739938,"Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bischoff', 'Affiliation': 'Department of Health and Prevention, Institute of Psychology, University Greifswald, Greifswald, Germany. marie.bischoff1@uni-greifswald.de.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Howland', 'Affiliation': 'Department of Neonatology and Paediatric Intensive Care, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Klinger-König', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tomczyk', 'Affiliation': 'Department of Health and Prevention, Institute of Psychology, University Greifswald, Greifswald, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Health and Prevention, Institute of Psychology, University Greifswald, Greifswald, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zygmunt', 'Affiliation': 'Clinic and Polyclinic for Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Department of Neonatology and Paediatric Intensive Care, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van den Berg', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bethke', 'Affiliation': 'Department of Health, Nursing and Administration, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Corleis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Günther', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Liutkus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Stentzel', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Neumann', 'Affiliation': 'Department of Health, Nursing and Administration, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Penndorf', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ludwig', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hammer', 'Affiliation': 'Department of Functional Genomics, Interfaculty Institute for Genetics and Functional Genomics, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Winter', 'Affiliation': 'Integrated Research Biobank, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Grabe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}]",BMC psychiatry,['10.1186/s12888-019-2279-0']
1198,31123992,Prostacyclin Affects the Relation Between Brain Interstitial Glycerol and Cerebrovascular Pressure Reactivity in Severe Traumatic Brain Injury.,"BACKGROUND


Cerebral injury may alter the autoregulation of cerebral blood flow. One index for describing cerebrovascular state is the pressure reactivity (PR). Little is known of whether PR is associated with measures of brain metabolism and indicators of ischemia and cell damage. The aim of this investigation was to explore whether increased interstitial levels of glycerol, a marker of cell membrane damage, are associated with PR, and if prostacyclin, a membrane stabilizer and regulator of the microcirculation, may affect this association in a beneficial way.
MATERIALS AND METHODS


Patients suffering severe traumatic brain injury (sTBI) were treated according to an intracranial pressure (ICP)-targeted therapy based on the Lund concept and randomized to an add-on treatment with prostacyclin or placebo. Inclusion criteria were verified blunt head trauma, Glasgow Coma Score ≤ 8, age 15-70 years, and a first measured cerebral perfusion pressure of ≥ 10 mmHg. Multimodal monitoring was applied. A brain microdialysis catheter was placed on the worst affected side, close to the penumbra zone. Mean (glycerol mean ) and maximal glycerol (glycerol max ) during the 96-h sampling period were calculated. The mean PR was calculated as the ICP/mean arterial pressure (MAP) regression coefficient based on hourly mean ICP and MAP during the first 96 h.
RESULTS


Of the 48 included patients, 45 had valid glycerol and PR measurements available. PR was higher in the placebo group as compared to the prostacyclin group (p = 0.0164). There was a positive correlation between PR and the glycerol mean  (ρ = 0.503, p = 0.01) and glycerol max  (ρ = 0.490, p = 0.015) levels in the placebo group only.
CONCLUSIONS


PR is correlated to the glycerol level in patients suffering from sTBI, a relationship that is not seen in the group treated with prostacyclin. Glycerol has been associated with membrane degradation and may support glycerol as a biomarker for vascular endothelial breakdown. Such a breakdown may impair the regulation of cerebrovascular PR.",2019,PR was higher in the placebo group as compared to the prostacyclin group (p = 0.0164).,"['Severe Traumatic Brain Injury', 'Patients suffering severe traumatic brain injury (sTBI', 'Inclusion criteria were verified blunt head trauma, Glasgow Coma Score\u2009≤\u20098, age 15-70\xa0years, and a first measured cerebral perfusion pressure of\u2009≥']","['placebo', 'prostacyclin or placebo', 'prostacyclin', 'Prostacyclin', 'Glycerol', 'intracranial pressure (ICP)-targeted therapy']","['Mean (glycerol mean ) and maximal glycerol (glycerol max ', 'PR', 'ICP/mean arterial pressure (MAP) regression coefficient', 'glycerol max', 'autoregulation of cerebral blood flow', 'mean PR', 'glycerol mean  ']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0428713', 'cui_str': 'Cerebral Perfusion Pressure'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205911', 'cui_str': 'Prostaglandins I'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.102171,PR was higher in the placebo group as compared to the prostacyclin group (p = 0.0164).,"[{'ForeName': 'Lars-Owe D', 'Initials': 'LD', 'LastName': 'Koskinen', 'Affiliation': 'Department of Pharmacology and Clinical Neuroscience, Neurosurgery, Umeå University, 901 85, Umeå, Sweden. Lars-Owe.Koskinen@umu.se.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sundström', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hägglund', 'Affiliation': 'Department of Pharmacology and Clinical Neuroscience, Neurosurgery, Umeå University, 901 85, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Eklund', 'Affiliation': 'Department of Radiation Sciences, Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Olivecrona', 'Affiliation': 'Department of Pharmacology and Clinical Neuroscience, Neurosurgery, Umeå University, 901 85, Umeå, Sweden.'}]",Neurocritical care,['10.1007/s12028-019-00741-4']
1199,31783597,"Efficacy and Safety of New  Lactobacilli  Probiotics for Unconstipated Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.","Irritable bowel syndrome (IBS) is a common and chronic gastrointestinal disorder. Probiotics may have the potential to impact the management of IBS; however, the results of trials are conflicting. This study aimed to investigate whether a mixture of  lactobacilli  probiotics could improve abdominal symptoms in patients with unconstipated IBS. Fifty Vietnamese patients with unconstipated IBS were randomly assigned to either the probiotics or placebo groups. During the intervention, participants took the probiotic supplement, named Foodis Lactobacillus, or placebo capsule once a day. Patients recorded their subject global assessment (SGA) weekly and were assessed with the visual analogue scale (VAS) during the 4-week study period. Patients with SGA score of 2 points or more or a decrease of more than 30% in VAS score were considered responders. Patients who responded weekly for more than 2 of the 4 weeks were considered overall responders. There was no significant difference in demographic characteristics between the groups. Overall responder rates of improvement of global IBS symptoms assessed by SGA score were significantly higher in the probiotics group (80.8%) than in the placebo group (45.8%) ( p  = 0.009). The overall responder rates assessed by VAS score were also higher in the probiotics group (69.2%, 41.7%,  p  = 0.048). There were no adverse events in either group during the study period. Our findings suggest that the new combination of  Lactobacilli  appears to be promising in the relief of abdominal symptoms in Vietnamese patients with unconstipated IBS.",2019,Overall responder rates of improvement of global IBS symptoms assessed by SGA score were significantly higher in the probiotics group (80.8%) than in the placebo group (45.8%) ( p  = 0.009).,"['Unconstipated Irritable Bowel Syndrome', 'Vietnamese patients with unconstipated IBS', 'Fifty Vietnamese patients with unconstipated IBS', 'patients with unconstipated IBS']","['Placebo', 'mixture of  lactobacilli  probiotics', 'probiotics or placebo', 'placebo', 'New  Lactobacilli  Probiotics', 'probiotic supplement, named Foodis Lactobacillus, or placebo']","['subject global assessment (SGA', 'visual analogue scale (VAS', 'demographic characteristics', 'adverse events', 'Irritable bowel syndrome (IBS', 'overall responder rates assessed by VAS score', 'abdominal symptoms', 'relief of abdominal symptoms', 'Efficacy and Safety', 'global IBS symptoms assessed by SGA score', 'VAS score']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C1561452', 'cui_str': 'Vietnamese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.254719,Overall responder rates of improvement of global IBS symptoms assessed by SGA score were significantly higher in the probiotics group (80.8%) than in the placebo group (45.8%) ( p  = 0.009).,"[{'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Yeon Sil', 'Initials': 'YS', 'LastName': 'Jang', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Danbee', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Science and Technology, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Dong Kyung', 'Initials': 'DK', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Yang Won', 'Initials': 'YW', 'LastName': 'Min', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}]",Nutrients,['10.3390/nu11122887']
1200,31157575,Combined long-pulsed Nd-Yag laser and itraconazole versus itraconazole alone in the treatment of onychomycosis nails.,"Background:  Oral antifungal therapies are effective for onychomycosis but it was complicated by systemic effects. Effective and safe therapy is needed to improve esthetic appearance of nails. Objective:  The present study is an attempt to evaluate and compare the efficacy of of combined treatment of onychomycosis with 1,064-nm long-pulsed Nd-Yag laser and pulse itraconazole therapy versus pulse itraconazole alone. Methods:  Thirty onychomycosis patients were divided into two groups: Groups I and II. Patients of Group I are treated by itraconazole pulse therapy. Patients of Group II received six laser sessions with long-pulsed Nd:Yag laser and itraconazole pulse therapy. The investigators rated clearance using ""Onychomycosis Severity Index (OSI)"", photographs, and mycology at 6 and 9 months after treatment. Results:  Group I's clinical improvement response was excellent in two cases, good in six cases, moderate in five cases, and mild in two cases. Mycological improvement response was excellent in two cases, good in two cases, moderate in six cases, and mild in five cases (OSI before treatment was 13.4 ± 3.02 and after was 6.67 ± 3.6). Group II's clinical improvement response was excellent in 10, good in 3, moderate in 1, and mild in 1. Mycological improvement's response was excellent in two cases, good in two cases, moderate in six cases, and mild in five cases (OSI before treatment was 13.33 ± 3.11 and after was 5.07 ± 4.15). There were no adverse effects. The clinical response showed best results with Group II, but the mycological cure was equal in both groups. Conclusions:  The use of combined long-pulsed Nd-Yag laser and itraconazole pulse therapy gives the best clinical results and patient's satisfaction.",2020,There were no adverse effects.,"['onychomycosis nails', 'Thirty onychomycosis patients']","['combined long-pulsed Nd-Yag laser and itraconazole pulse therapy', 'itraconazole', 'Combined long-pulsed Nd-Yag laser and itraconazole', 'itraconazole pulse therapy', 'onychomycosis with 1,064-nm long-pulsed Nd-Yag laser and pulse itraconazole therapy versus pulse itraconazole alone', 'six laser sessions with long-pulsed Nd:Yag laser and itraconazole pulse therapy']","[""Mycological improvement's response"", 'Onychomycosis Severity Index (OSI)"", photographs, and mycology', 'adverse effects', 'Mycological improvement response', 'clinical improvement response', 'mycological cure', 'esthetic appearance of nails']","[{'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0392276', 'cui_str': 'Nd-YAG Lasers'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}]","[{'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1318471', 'cui_str': 'Mycology'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1286240', 'cui_str': 'Appearance of nail'}]",30.0,0.0101859,There were no adverse effects.,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamed Khater', 'Affiliation': 'Faculty of Medicine, Department of Venereology and Andrology, Zagazig University, Zagazig, Egypt\u200f.'}, {'ForeName': 'Fathia M', 'Initials': 'FM', 'LastName': 'Khattab', 'Affiliation': 'Faculty of Medicine, Department of Venereology and Andrology, Zagazig University, Zagazig, Egypt\u200f.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1623861']
1201,31067006,Usefulness of a salt check sheet for elementary school and junior high school children.,"There are no known methods to easily evaluate the dietary salt intake of children. We hypothesized that the salt check sheet, for which validity has been confirmed in both hypertensive outpatients and in the general population, can be used to assess dietary salt intake in children. We enrolled 188 healthy schoolchildren (mean age 11.2 ± 1.1 years, 53.2% boys) and asked them to answer both the salt check sheet and a brief self-administered dietary history questionnaire for Japanese schoolchildren aged 6-18 years (BDHQ15y). The mean total salt check-sheet score was 12.7 ± 4.0 points (range: 4-24 points), and the estimated daily salt intake from the BDHQ15y was 12.1 ± 3.7 g (range: 4.7-27.2 g). The total check-sheet score was significantly positively correlated with the estimated daily salt intake from the BDHQ15y (r = 0.408, P < 0.001). Thirty-one study participants were assigned to the ""low"" salt group (total score on the salt check sheet was 0-8 points), 78 participants to the ""medium"" salt group (9-13 points), and 79 participants to the ""high and very high"" salt group (≥14 points), and a comparison estimating daily salt intake from the BDHQ15y among the three groups was performed. Daily salt-intake levels tended to increase as the group of total check-sheet scores increased: ""low"" vs ""medium"" vs ""high and very high"" salt group levels were 9.5 ± 3.1 vs 11.6 vs 13.5 ± 3.9, respectively (P < 0.001). This demonstrates that the salt check sheet is a useful tool to easily assess dietary salt intake in children.",2019,"Daily salt-intake levels tended to increase as the group of total check-sheet scores increased: ""low"" vs ""medium"" vs ""high and very high"" salt group levels were 9.5 ± ","['children', 'Japanese schoolchildren aged 6-18\xa0years (BDHQ15y', 'hypertensive outpatients', 'elementary school and junior high school children', 'Thirty-one study participants', '188 healthy schoolchildren (mean age 11.2\xa0±\xa01.1\xa0years, 53.2% boys']","['low"" salt group (total score on the salt check sheet', 'salt check sheet and a brief self-administered dietary history questionnaire', 'salt check sheet', 'high and very high"" salt', 'medium"" salt']","['mean total salt check-sheet score', 'Daily salt-intake levels', 'total check-sheet score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0425401', 'cui_str': 'Dietary history (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",188.0,0.0116715,"Daily salt-intake levels tended to increase as the group of total check-sheet scores increased: ""low"" vs ""medium"" vs ""high and very high"" salt group levels were 9.5 ± ","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Higashiagatsuma-machi Local Health Center, Gunma, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Steel Memorial Yawata Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13549']
1202,31063679,Intraoperative Versus Extended Antibiotic Prophylaxis in Liver Transplant Surgery: A Randomized Controlled Pilot Trial.,"The appropriate duration of surgical antibiotic prophylaxis in orthotopic liver transplantation (OLT) in the presence of significant iatrogenic immunosuppression is unclear. We hypothesized that 72 hours of perioperative antibiotic prophylaxis would decrease rates of surgical site infection (SSI) in OLT patients when compared with intraoperative antibiotic prophylaxis alone. OLT recipients were randomized to receive either intraoperative antibiotics only (short antibiotics [SAs]) or 72 hours of perioperative antibiotics (extended antibiotics [EAs]). A total of 102 patients were randomized: 51 to the EA group and 51 to the SA group. Rates of SSI and nosocomial infection (NI) in the SA group were 19% and 17%, respectively, compared with 27% (SSI; P = 0.36) and 22% (NI; P = 0.47) in the EA group, although these differences were not statistically significant. Intensive care unit (ICU) length of stay (LOS), hospital LOS, 30-day mortality, and time to infection were also similar between the 2 groups. Patients developing infections had longer ICU LOS and hospital LOS and a higher association with reoperation, endoscopic retrograde cholangiopancreatography, and 30-day readmission. In conclusion, extending perioperative antibiotics to 72 hours from intraoperative dosing alone in OLT patients does not appear to decrease the incidence of SSI or NI. The results from this pilot trial with 60% power suggest that it is acceptable for OLT recipients to receive intraoperative antibiotic prophylaxis alone.",2019,"Rates of SSI and nosocomial infection (NI) in the SA group were 19% and 17%, respectively, compared with 27% (SSI; P = 0.36) and 22% (NI; P = 0.47) in the EA group, although these differences were not statistically significant.","['102 patients were randomized: 51 to the EA group and 51 to the SA group', 'Liver Transplant Surgery', 'OLT recipients', 'orthotopic liver transplantation (OLT']","['intraoperative antibiotics only (short antibiotics [SAs]) or 72\xa0hours of perioperative antibiotics (extended antibiotics [EAs', 'Intraoperative Versus Extended Antibiotic Prophylaxis']","['rates of surgical site infection (SSI', 'incidence of SSI or NI', 'reoperation, endoscopic retrograde cholangiopancreatography, and 30-day readmission', 'Rates of SSI and nosocomial infection (NI', 'ICU LOS and hospital LOS', 'Intensive care unit (ICU) length of stay (LOS), hospital LOS, 30-day mortality, and time to infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0205721', 'cui_str': 'Infections, Hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",102.0,0.137485,"Rates of SSI and nosocomial infection (NI) in the SA group were 19% and 17%, respectively, compared with 27% (SSI; P = 0.36) and 22% (NI; P = 0.47) in the EA group, although these differences were not statistically significant.","[{'ForeName': 'Puja S', 'Initials': 'PS', 'LastName': 'Berry', 'Affiliation': 'Department of Surgery, University of Virginia Medical Center, Charlottesville, VA.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Guidry', 'Affiliation': 'School of Medicine, Department of Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Surgery, University of Virginia Medical Center, Charlottesville, VA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Pelletier', 'Affiliation': 'Department of Surgery, University of Virginia Medical Center, Charlottesville, VA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Sawyer', 'Affiliation': 'Department of Surgery, Western Michigan University, Kalamazoo, MI.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25486']
1203,31658994,"Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation-Related Abscopal Responses.","Ipilimumab is effective for patients with melanoma, but not for those with less immunogenic tumors. We report a phase II trial of ipilimumab with concurrent or sequential stereotactic ablative radiotherapy to metastatic lesions in the liver or lung (NCT02239900). Ipilimumab (every 3 weeks for 4 doses) was given with radiotherapy begun during the first dose (concurrent) or 1 week after the second dose (sequential) and delivered as 50 Gy in 4 fractions or 60 Gy in 10 fractions to metastatic liver or lung lesions. In total, 106 patients received ≥1 cycle of ipilimumab with radiation. Median follow-up was 10.5 months. Median progression-free survival time was 2.9 months (95% confidence interval, 2.45-3.40), and median overall survival time was not reached. Rates of clinical benefit of nonirradiated tumor volume were 26% overall, 28% for sequential versus 20% for concurrent therapy ( P  = 0.250), and 31% for lung versus 14% for liver metastases ( P  = 0.061). The sequential lung group had the highest rate of clinical benefit at 42%. There were no differences in treatment-related adverse events between groups. Exploratory analysis of nontargeted lesions revealed that lesions receiving low-dose radiation were more likely to respond than those that received no radiation (31% vs. 5%,  P  = 0.0091). This phase II trial of ipilimumab with stereotactic radiotherapy describes satisfactory outcomes and low toxicities, lending support to further investigation of combined-modality therapy for metastatic cancers.",2019,Median progression-free survival time was 2.9 months (95% confidence interval 2.45-3.40) and median overall survival time was not reached.,"['patients with melanoma', 'Metastatic Disease']","['ipilimumab with concurrent or sequential stereotactic ablative radiation therapy', 'Ipilimumab with Stereotactic Radiation Therapy', 'Ipilimumab', 'ipilimumab with radiation']","['treatment-related adverse events', 'highest rate of clinical benefit', 'median overall survival time', 'Median progression-free survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C4552093', 'cui_str': 'Stereotactic Radiation Therapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",106.0,0.0296904,Median progression-free survival time was 2.9 months (95% confidence interval 2.45-3.40) and median overall survival time was not reached.,"[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. jwelsh@mdanderson.org.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Groot', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Naing', 'Affiliation': 'Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Hess', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vassiliki A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Taylor R', 'Initials': 'TR', 'LastName': 'Cushman', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Simon', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Rishab', 'Initials': 'R', 'LastName': 'Ramapriyan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Hampartsoum B', 'Initials': 'HB', 'LastName': 'Barsoumian', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maria Angelica', 'Initials': 'MA', 'LastName': 'Cortez', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Erminia', 'Initials': 'E', 'LastName': 'Massarelli', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Genitouirinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allison', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Raju', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Sherif G', 'Initials': 'SG', 'LastName': 'Shaaban', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Dadu', 'Affiliation': 'Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Cabanillas', 'Affiliation': 'Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Clark', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Gomez', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hahn', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ritsuko', 'Initials': 'R', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hong', 'Affiliation': 'Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Cancer immunology research,['10.1158/2326-6066.CIR-18-0793']
1204,30012355,"Rationale and design of a placebo controlled randomized trial to assess short term, high-dose oral cholecalciferol on select laboratory and genomic responses in African Americans with hypovitaminosis D.","Cardiovascular Disease (CVD) and related disorders remain a leading cause of health disparities and premature death for African Americans. Hypovitaminosis D is disproportionately prevalent in African Americans and has been linked to CVD and CVD risk factors including hypertension, diabetes and obesity. Thus, hypovitaminosis D may represent a common pathway influencing CV risk factors in a select subgroup of persons. The purpose of this paper is to report the study design of a prospective eight week prospective double-blind randomized, placebo-controlled trial (n = 330 allocated 2:1 to intervention vs. control) to assess the effect of placebo vs. high-dose oral cholecalciferol (100,000 IU vitamin D3 at baseline and week 2) on 6-week change of select biologic cardiometabolic risk factors (including parathyroid hormone to assess biologic activity, pro-inflammatory/pro-thrombotic/fibrotic markers, insulin sensitivity and vitamin D metabolites) and their relationship to vitamin D administration and modification by vitamin D receptor polymorphisms in overweight, hypertensive African Americans with hypovitaminosis D. Findings from this trial will present insights into potential causal links between vitamin D repletion and mechanistic pathways of CV disease, including established and novel genomic markers.",2018,"Hypovitaminosis D is disproportionately prevalent in African Americans and has been linked to CVD and CVD risk factors including hypertension, diabetes and obesity.","['African Americans with hypovitaminosis D', 'overweight, hypertensive African Americans with hypovitaminosis D', 'African Americans']","['placebo vs. high-dose oral cholecalciferol', 'cholecalciferol', 'placebo', 'vitamin D administration and modification by vitamin D receptor polymorphisms']","['biologic activity, pro-inflammatory/pro-thrombotic/fibrotic markers, insulin sensitivity and vitamin D metabolites']","[{'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0108082', 'cui_str': 'Cholecalciferol Receptors'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.263571,"Hypovitaminosis D is disproportionately prevalent in African Americans and has been linked to CVD and CVD risk factors including hypertension, diabetes and obesity.","[{'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Norris', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA. Electronic address: kcnorris@mednet.ucla.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Edwina Barnett', 'Affiliation': 'Jackson State University, Jackson, MS, USA.'}, {'ForeName': 'Yuan-Xiang', 'Initials': 'YX', 'LastName': 'Meng', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': 'Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Nicholas', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Gibbons', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD. USA.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Jackson State University, Jackson, MS, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.006']
1205,30998965,Video strategies improved health professional knowledge across different contexts: a helix counterbalanced randomized controlled study.,"OBJECTIVE


This study aimed to apply a novel helix counterbalanced randomized controlled trial design to evaluate the effectiveness of video vs. written knowledge translation strategies for improving health professional knowledge of evidence provided in scientific journal articles.
STUDY DESIGN AND SETTING


A Helix counterbalanced randomized controlled trial was used to compare the impact of delivering research information via video or written modalities compared to a no-information control across three health contexts. Interventions were delivered and data collected via an online survey to nursing and allied health professionals across five hospitals within a public health service in Melbourne, Australia. A knowledge test measuring alignment between respondent perceived benefit of the intervention and conclusions listed in the journal article was the primary outcome.
RESULTS


There were 119 participants recruited with n = 13 incomplete responses. Exposure to the video increased the likelihood of a knowledge test response that was aligned with the research evidence compared to the no-information control (OR 2.61; 95% CI 1.40, 4.89; P = 0.003), but this was not the case for exposure to the written modality (OR 1.39; 95% CI 0.75, 2.57; P = 0.294).
CONCLUSION


Providing video knowledge translation strategies to nursing and allied health professionals increases the likelihood they will understand the main findings from scientific journal articles.",2019,"Exposure to the video increased the likelihood of a knowledge test response that was aligned with the research evidence compared to the no-information control (OR 2.61; 95% CI 1.40, 4.89; P = 0.003), but this was not the case for exposure to the written modality (OR 1.39; 95% CI 0.75, 2.57; P = 0.294).
",['119 participants recruited with n\xa0=\xa013 incomplete responses'],['video vs. written knowledge translation strategies'],['health professional knowledge'],"[{'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C3494164', 'cui_str': 'Knowledge Translation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",119.0,0.218993,"Exposure to the video increased the likelihood of a knowledge test response that was aligned with the research evidence compared to the no-information control (OR 2.61; 95% CI 1.40, 4.89; P = 0.003), but this was not the case for exposure to the written modality (OR 1.39; 95% CI 0.75, 2.57; P = 0.294).
","[{'ForeName': 'Mitchell N', 'Initials': 'MN', 'LastName': 'Sarkies', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University Peninsula Campus, McMahons Road, Frankston, 3199 Victoria, Australia; Allied Health Research Unit, Monash Health Kingston Centre, 400 Warrigal Road, Cheltenham, 3092 Victoria, Australia. Electronic address: mitchell.sarkies@monash.edu.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Maloney', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Science, Monash University Peninsula Campus, McMahons Road, Frankston, 3199 Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Symmons', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University Peninsula Campus, McMahons Road, Frankston, 3199 Victoria, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.04.003']
1206,31209657,Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.,"BACKGROUND


Venetoclax is a selective B-cell lymphoma-2 (BCL-2) inhibitor approved for use as monotherapy or with rituximab in patients with chronic lymphocytic leukemia (CLL). The objectives of the current analysis of observed data from adult patients randomized to venetoclax-rituximab in the phase III MURANO study were to characterize venetoclax pharmacokinetics (PKs) using a Bayesian approach, evaluate whether a previously developed population PK model for venetoclax can describe the PKs of venetoclax when administered with rituximab, and to determine post hoc estimates of PK parameters for the exposure-response analysis.
METHODS


Parameter estimates and uncertainty estimated by a population PK model were used as priors. Additional covariate effects (CLL risk status, geographic region, and 17p deletion [del(17p)] status) were added to the model. The updated model was used to describe venetoclax PKs after repeated dosing in combination with rituximab, and to determine post hoc estimates of PK parameters for exposure-response analysis.
RESULTS


The PK analysis included 600 quantifiable venetoclax PK samples from 182 patients in the MURANO study. Model evaluation using standard diagnostic plots, visual predictive checks, and normalized prediction distribution error plots indicated no model deficiencies. There was no significant relationship between venetoclax apparent clearance (CL/F) and bodyweight, age, sex, mild and moderate hepatic and renal impairment, or coadministration of weak cytochrome P450 3A inhibitors. The chromosomal abnormality del(17p) and CLL risk status had no apparent effect on the PKs of venetoclax. A minimal increase in venetoclax CL/F (approximately 7%) was observed after coadministration with rituximab. CL/F was 30% lower in patients from Central and Eastern Europe (n = 60) or Asia (n = 4) compared with other regions (95% confidence interval [CI] 21-39%). Apparent central volume of distribution was 30% lower (95% CI 22-38%) in females (n = 56) compared with males (n = 126). No clinically significant impact of region or sex was observed on key safety and efficacy outcomes.
CONCLUSIONS


The Bayesian model successfully characterized venetoclax PKs over time and confirmed key covariates affecting PKs in the MURANO study. The model was deemed appropriate for further use in simulations and for generating individual patient PK parameters for subsequent exposure-response evaluation.",2019,The model was deemed appropriate for further use in simulations and for generating individual patient PK parameters for subsequent exposure-response evaluation.,"['600 quantifiable venetoclax PK samples from 182 patients in the MURANO study', 'Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia', 'patients with chronic lymphocytic leukemia (CLL']","['venetoclax-rituximab', 'Venetoclax in Combination with Rituximab', 'rituximab']","['venetoclax CL/F', 'venetoclax apparent clearance (CL/F) and bodyweight, age, sex, mild and moderate hepatic and renal impairment', 'Additional covariate effects (CLL risk status, geographic region, and 17p deletion [del(17p)] status', 'key safety and efficacy outcomes', 'Apparent central volume of distribution', 'CL/F']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",600.0,0.0410057,The model was deemed appropriate for further use in simulations and for generating individual patient PK parameters for subsequent exposure-response evaluation.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA. deng.rong@gene.com.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm, LLC, North Potomac, MD, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Kshirsagar', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Chunze', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Girish', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Freise', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Ahmed Hamed', 'Initials': 'AH', 'LastName': 'Salem', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital, Peter MacCallum Cancer Centre, and University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Amsterdam UMC, University of Amsterdam on behalf of HOVON CLL WG, Amsterdam, The Netherlands.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00788-8']
1207,31775685,The (cost) effectiveness of guided internet-based self-help CBT for dialysis patients with symptoms of depression: study protocol of a randomised controlled trial.,"BACKGROUND


Only a minority of dialysis patients with depressive symptoms are diagnosed and receive treatment. Depressive symptoms are highly prevalent in this population and are associated with adverse clinical outcomes. Underlying factors for this undertreatment may be the lack of evidence for the safety and effectivity of antidepressant medication, the reluctance of patients to adhere to antidepressant medication, the lack of mental healthcare provision in somatic healthcare environments and end-stage renal disease (ESRD) related physical limitations that complicate face-to-face psychotherapy. Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers. The aim of this study is to investigate the (cost) effectiveness of a guided Internet-based self-help intervention for symptoms of depression in dialysis patients.
METHODS


This study is a cluster randomized controlled trial (RCT) that investigates the effectiveness of a 5-week Internet-based self-help Problem Solving Therapy (PST) for depressive symptoms in dialysis patients. Depressive symptoms will be measured using the Beck Depression Inventory - second edition (BDI-II), with a cut-off score of ≥10. We aim to include 206 dialysis patients with depressive symptoms who will be cluster randomized to the intervention or the Care as Usual (CAU) control group. Secondary outcomes will include anxiety symptoms, quality of life, economic costs and clinical outcomes, such as inflammatory factors and hair cortisol levels. Assessments will take place at baseline (T0), 2 weeks after intervention (T1) and 6 months (T2), 12 months (T3) and 18 months (T4) after intervention. The control group will be measured at the same time points. Analysis will be based on the intention-to-treat principle. Mixed models will be used to assess the changes within each condition between pre-treatment and post-treatment.
DISCUSSION


If demonstrated to be (cost) effective, Internet-based PST will offer new possibilities to treat dialysis patients with depressive symptoms and to improve their quality of care.
TRIAL REGISTRATION


Dutch Trial Register: Trial NL6648 (NTR6834) (prospectively registered 13th November 2017).",2019,Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers.,"['depressive symptoms in dialysis patients', 'dialysis patients', '206 dialysis patients with depressive symptoms who will be cluster randomized to the intervention or the', 'dialysis patients with symptoms of depression', 'dialysis patients with depressive symptoms']","['Care as Usual (CAU) control group', '5-week Internet-based self-help Problem Solving Therapy (PST', 'guided internet-based self-help CBT', 'guided Internet-based self-help intervention', 'Guided Internet-based self-help treatment']","['anxiety symptoms, quality of life, economic costs and clinical outcomes, such as inflammatory factors and hair cortisol levels', 'Depressive symptoms']","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",206.0,0.165598,Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers.,"[{'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Nadort', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands. e.nadort@olvg.nl.'}, {'ForeName': 'Robbert W', 'Initials': 'RW', 'LastName': 'Schouten', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands.'}, {'ForeName': 'Friedo W', 'Initials': 'FW', 'LastName': 'Dekker', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Honig', 'Affiliation': 'Department of Psychiatry, OLVG, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Department of Amsterdam Public Health research institute, VUmc, Van der Boechorststraat 7, 1081 BT, Amsterdam, Netherlands.'}, {'ForeName': 'Carl E H', 'Initials': 'CEH', 'LastName': 'Siegert', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2363-5']
1208,30145268,Doxazosin for the treatment of co-occurring PTSD and alcohol use disorder: Design and methodology of a randomized controlled trial in military veterans.,"Posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD) are two of the most common mental health disorders affecting civilians as well as military populations. If left untreated, individuals with co-occurring PTSD/AUD are at increased risk for developing other mental health problems (e.g., depression, anxiety), physical health problems, reduced resiliency and military readiness, and vocational and social impairment. Substantial gaps in the treatment of co-occurring PTSD/AUD exist and there is a critical need to develop more effective pharmacological treatments. The current study addresses this gap in the literature by testing the efficacy and safety of doxazosin, a long-acting and selective alpha-1 adrenergic antagonist, as compared to placebo in reducing PTSD and AUD severity among U.S. military veterans. Noradrenergic dysregulation has been implicated in the development and maintenance of PTSD and AUD, and pilot studies examining doxazosin in PTSD-only or AUD-only samples have shown promise. This is the first study, however, to evaluate doxazosin in a comorbid PTSD/AUD sample. This paper describes the rationale, design and methodology of a randomized, double-blind, placebo-controlled trial of doxazosin (16 mg/day) delivered over 12 weeks among military veterans with current PTSD and AUD. In addition, functional magnetic resonance imaging (fMRI) is applied at pre- and post-treatment to investigate the underlying pathophysiology of comorbid PTSD/AUD and identify prognostic indicators of treatment outcome. This study is designed to accelerate research on co-occurring PTSD/AUD and provide empirical evidence to inform clinical practice.",2018,Substantial gaps in the treatment of co-occurring PTSD/AUD exist and there is a critical need to develop more effective pharmacological treatments.,"['co-occurring PTSD and alcohol use disorder', 'U.S. military veterans', 'military veterans', 'military veterans with current PTSD and AUD']","['functional magnetic resonance imaging (fMRI', 'doxazosin', 'placebo', 'Doxazosin']",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0324595,Substantial gaps in the treatment of co-occurring PTSD/AUD exist and there is a critical need to develop more effective pharmacological treatments.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Augur', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: augur@musc.edu.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Research and Development Service, South Texas Veterans Health Care System, South Texas Veterans Health Care System, San Antonio, TX, USA; Department of Psychology, University of Texas at San Antonio, San Antonio, TX, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Shirley', 'Affiliation': 'Department of Clinical Pharmacy and Outcomes Sciences, College of Pharmacy, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Henschel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA; Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA. Electronic address: brett.litz@va.gov.'}, {'ForeName': 'Allison K', 'Initials': 'AK', 'LastName': 'Hancock', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: hancocka@uthscsa.edu.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: roache@uthscsa.edu.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: mintz@uthscsa.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Wachen', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA; National Center for PTSD, VA Boston Healthcare System, Boston, MA, USA. Electronic address: jennifer.wachen@va.gov.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA; National Center for PTSD, VA Boston Healthcare System, Boston, MA, USA. Electronic address: terence.keane@va.gov.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradyk@musc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2018.08.009']
1209,31543373,Addition of marine omega-3 fatty acids to statins in familial hypercholesterolemia does not affect in vivo or in vitro endothelial function.,"BACKGROUND


Prestatin trials reported positive effects of omega-3 polyunsaturated fatty acids (n-3 PUFA) in cardiovascular disease, whereas recent studies and meta-analyses have not reproduced these results. The effect of n-3 PUFA in patients with familial hypercholesterolemia (FH), a group with particularly high risk of cardiovascular disease, is not well established.
OBJECTIVE


We investigated the effect of n-3 PUFA in the early stage of atherosclerosis in FH patients by evaluating in vivo (peripheral arterial tonometry [PAT]) and in vitro (plasma asymmetric dimethylarginine and E-selectin) endothelial function.
METHODS


This was a double-blind, placebo-controlled cross-over study with 34 FH patients on statin treatment (mean age 46.6 years). In random order, all individuals were treated for 3 months with high-dose n-3 PUFA (2 g, ×2) and 3 months placebo (olive oil, 2 g ×2), separated by a 3-month washout period. Anthropometric data, blood samples, and PAT were collected at 4 time points.
RESULTS


There were no significant changes in reactive hyperemia index measured by PAT after n-3 PUFA compared with placebo, median reactive hyperemia index after n-3 PUFA was 1.98 and after placebo 1.96 (P = .51). No significant changes were detected in the soluble endothelial marker asymmetric dimethylarginine (in 2 different assays) when comparing n-3 PUFA and placebo (P = .92 and .14, respectively). Finally, the level of E-selectin did not change significantly during the trial (P = .26).
CONCLUSION


Addition of n-3 PUFA to standard lipid-lowering treatment in genetically verified FH patients did not affect the in vivo endothelial function or soluble endothelial markers.",2019,"There were no significant changes in reactive hyperemia index measured by PAT after n-3 PUFA compared with placebo, median reactive hyperemia index after n-3 PUFA was 1.98 and after placebo 1.96 (P = .51).","['34 FH patients on statin treatment (mean age 46.6\xa0years', 'FH patients by evaluating in\xa0vivo', 'patients with familial hypercholesterolemia (FH), a group with particularly high risk of cardiovascular disease']","['peripheral arterial tonometry [PAT', 'n-3 PUFA and placebo', 'marine omega-3 fatty acids', 'placebo', 'n-3 PUFA', 'omega-3 polyunsaturated fatty acids (n-3 PUFA', 'placebo (olive oil']","['reactive hyperemia index', 'Anthropometric data, blood samples, and PAT', 'median reactive hyperemia index after n-3 PUFA', 'soluble endothelial marker asymmetric dimethylarginine', 'level of E-selectin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}]",,0.34091,"There were no significant changes in reactive hyperemia index measured by PAT after n-3 PUFA compared with placebo, median reactive hyperemia index after n-3 PUFA was 1.98 and after placebo 1.96 (P = .51).","[{'ForeName': 'Liv Nesse', 'Initials': 'LN', 'LastName': 'Hande', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway; Faculty of Health Sciences, University of Tromsø, Tromsø, Norway. Electronic address: livnessehande@gmail.com.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Thunhaug', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Enebakk', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Ludviksen', 'Affiliation': 'Research Laboratory, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pettersen', 'Affiliation': 'Research Laboratory, Nordland Hospital, Bodø, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hovland', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway; Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Knut Tore', 'Initials': 'KT', 'LastName': 'Lappegård', 'Affiliation': 'Division of Internal Medicine, Nordland Hospital, Bodø, Norway; Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.08.004']
1210,31218718,Effective ways to retain first-time blood donors: a field-trial study.,"BACKGROUND


Regular blood donors are the cornerstone of blood safety. Understanding the donors' behavior to donate blood improves blood donor retention programs. The purpose of this study is to evaluate the return rate of first-time blood donors following different interventions to identify effective ways to retain first-time donors.
STUDY DESIGN AND METHODS


The study was conducted on 1356 first-time blood donors at four main blood centers in Iran. The donors were randomly assigned based on different interventions (phone calls, educational letter, emotional letter, incentive, motivational meeting, and no intervention) to six groups. The return rate of donors was defined as a second attempt to donate within 6 months after the first donation. Return rate and 95% confidence intervals (CIs) were calculated and compared among different groups.
RESULTS


A total of 394 (29%) donors returned within 6 months for a second donation (95% CI, 0.26-0.31). The return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting, and control groups was 36% (95% CI, 0.31-0.42), 33.2% (95% CI, 0.27-0.38), 31.5% (95% CI, 0.25-0.37), 30% (95% CI, 0.22-0.38), 22% (95% CI, 0.17-0.27) and 22.1% (95% CI, 0.17-0.27), respectively.
CONCLUSIONS


This study provides evidence supporting the fact that more first-time blood donors can be motivated to donate again by implementing targeted interventions. It demonstrates that emotional letters, educational letters, and phone reminders were effective in improving the return rate of first-time donors.",2019,"The return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting, and control groups was 36% (95% CI, 0.31-0.42), 33.2% (95% CI, 0.27-0.38), 31.5% (95% CI, 0.25-0.37), 30% (95% CI, 0.22-0.38), 22% (95% CI, 0.17-0.27) and 22.1% (95% CI, 0.17-0.27), respectively.
",['1356 first-time blood donors at four main blood centers in Iran'],"['interventions (phone calls, educational letter, emotional letter, incentive, motivational meeting, and no intervention']","['return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting', 'return rate of donors', 'return rate of first-time donors', 'Return rate and 95% confidence intervals (CIs']","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",1356.0,0.0373074,"The return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting, and control groups was 36% (95% CI, 0.31-0.42), 33.2% (95% CI, 0.27-0.38), 31.5% (95% CI, 0.25-0.37), 30% (95% CI, 0.22-0.38), 22% (95% CI, 0.17-0.27) and 22.1% (95% CI, 0.17-0.27), respectively.
","[{'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Hashemi', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Maghsudlu', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Nasizadeh', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Esmaielifar', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Pourfathollah', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}]",Transfusion,['10.1111/trf.15404']
1211,31202641,Complementary low-density lipoprotein-cholesterol lowering and pharmacokinetics of adding bempedoic acid (ETC-1002) to high-dose atorvastatin background therapy in hypercholesterolemic patients: A randomized placebo-controlled trial.,"BACKGROUND


Bempedoic acid is an oral, once-daily, first-in-class medication being developed to treat hypercholesterolemia.
OBJECTIVE


The aim of the study was to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy of bempedoic acid added to stable high-intensity atorvastatin background therapy and multiple-dose plasma pharmacokinetics of atorvastatin alone and combined with steady-state bempedoic acid.
METHODS


This was a phase 2 study in patients with hypercholesterolemia (NCT02659397). Patients received once-daily open-label atorvastatin 80 mg for 4 weeks then were randomized 2:1 at baseline to receive double-blind bempedoic acid 180 mg (n = 45) or placebo (n = 23) plus open-label atorvastatin 80 mg for 4 weeks. Efficacy was assessed 4 weeks after randomization. Atorvastatin and metabolites' steady-state levels were analyzed before first dosing with bempedoic acid and after 2 weeks of treatment.
RESULTS


The 4-week stabilization phase with 80 mg atorvastatin resulted in approximately 40% lowering of LDL-C values from screening. The placebo-adjusted least squares mean lowering of LDL-C from baseline to Day 29 with bempedoic acid was 22% (P = .003). Placebo-adjusted reductions from baseline with bempedoic acid also were significant for total cholesterol (-10%; P = .014), non-high-density lipoprotein cholesterol (-13%; P = .015), apolipoprotein B (-15%; P = .004), and high-sensitivity C-reactive protein (-44%; P = .002). Point estimates of bempedoic acid effects on steady-state atorvastatin and ortho-hydroxy atorvastatin area under the curve were <30% and not clinically meaningful.
CONCLUSIONS


Bempedoic acid 180 mg added to stable high-dose atorvastatin therapy effectively lowers LDL-C in patients with hypercholesterolemia without causing clinically important increases in atorvastatin exposure.",2019,The 4-week stabilization phase with 80 mg atorvastatin resulted in approximately 40% lowering of LDL-C values from screening.,"['hypercholesterolemic patients', 'patients with hypercholesterolemia', 'patients with hypercholesterolemia (NCT02659397']","['Bempedoic acid 180\xa0mg added to stable high-dose atorvastatin therapy', 'placebo', 'once-daily open-label atorvastatin 80\xa0mg for 4\xa0weeks then were randomized 2:1 at baseline to receive double-blind bempedoic acid 180\xa0mg (n\xa0=\xa045) or placebo (n\xa0=\xa023) plus open-label atorvastatin 80\xa0mg for 4\xa0weeks', 'atorvastatin alone and combined with steady-state bempedoic acid', 'Placebo', 'atorvastatin background therapy', 'atorvastatin']","['Efficacy', ""Atorvastatin and metabolites' steady-state levels"", 'total cholesterol', 'non-high-density lipoprotein cholesterol', 'low-density lipoprotein cholesterol (LDL-C)-lowering efficacy', 'LDL-C values', 'LDL-C', 'high-sensitivity C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1124482', 'cui_str': 'atorvastatin 80 MG'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.223283,The 4-week stabilization phase with 80 mg atorvastatin resulted in approximately 40% lowering of LDL-C values from screening.,"[{'ForeName': 'Narendra D', 'Initials': 'ND', 'LastName': 'Lalwani', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA. Electronic address: nlalwani@esperion.com.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Hanselman', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'MacDougall', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Lulu R', 'Initials': 'LR', 'LastName': 'Sterling', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}, {'ForeName': 'Clay T', 'Initials': 'CT', 'LastName': 'Cramer', 'Affiliation': 'Esperion Therapeutics, Inc, Ann Arbor, MI, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.05.003']
1212,30947636,Effect of Mobile Health on In-person Service Use Among People With Serious Mental Illness.,"OBJECTIVE


This study examined whether mobile health (mHealth) affects the use of in-person services among people with serious mental illness.
METHODS


This randomized comparative effectiveness trial evaluated minutes of service use among 163 participants for 3 months before, during, and after exposure to mHealth or clinic-based care.
RESULTS


mHealth and clinic-based care participants used fewer services during the intervention (9% and 14%, respectively) and follow-up (2% and 12%) periods than during the preintervention phase. During treatment, mHealth treatment responders (participants who experienced recovery gains and maintained them at follow-up) reduced service use more than nonresponders (12% vs. 10%). Postintervention, service use by mHealth treatment responders continued to drop (an additional 11%), whereas service use by mHealth nonresponders increased by 8%.
CONCLUSIONS


mHealth and clinic-based illness management interventions may reduce the need for other in-person services among people with serious mental illness, particularly among mHealth users who experience sustained recovery.",2019,"Postintervention, service use by mHealth treatment responders continued to drop (an additional 11%), whereas service use by mHealth nonresponders increased by 8%.
","['163 participants for 3 months before, during, and after exposure to mHealth or clinic-based care', 'People With Serious Mental Illness', 'people with serious mental illness']","['mobile health (mHealth', 'Mobile Health']",['service use by mHealth nonresponders'],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",163.0,0.0749293,"Postintervention, service use by mHealth treatment responders continued to drop (an additional 11%), whereas service use by mHealth nonresponders increased by 8%.
","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Ben-Zeev', 'Affiliation': 'BRiTE Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Ben-Zeev, Buck, Hallgren); Health Services Research and Development, Puget Sound Veterans Affairs Healthcare System, Seattle (Buck); Dartmouth Institute, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, and Westat Inc., Rockville, Maryland (Drake).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'BRiTE Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Ben-Zeev, Buck, Hallgren); Health Services Research and Development, Puget Sound Veterans Affairs Healthcare System, Seattle (Buck); Dartmouth Institute, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, and Westat Inc., Rockville, Maryland (Drake).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hallgren', 'Affiliation': 'BRiTE Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Ben-Zeev, Buck, Hallgren); Health Services Research and Development, Puget Sound Veterans Affairs Healthcare System, Seattle (Buck); Dartmouth Institute, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, and Westat Inc., Rockville, Maryland (Drake).'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Drake', 'Affiliation': 'BRiTE Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Ben-Zeev, Buck, Hallgren); Health Services Research and Development, Puget Sound Veterans Affairs Healthcare System, Seattle (Buck); Dartmouth Institute, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, and Westat Inc., Rockville, Maryland (Drake).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800542']
1213,31166842,Re: Perioperative Oral Nutrition Supplementation Reduces Prevalence of Sarcopenia following Radical Cystectomy: Results of a Prospective Randomized Controlled Trial.,,2019,,['following Radical Cystectomy'],['Oral Nutrition Supplementation'],['Prevalence of Sarcopenia'],"[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}]",,0.102162,,"[{'ForeName': 'Ertugrul', 'Initials': 'E', 'LastName': 'Sefik', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Ibrahim Halil', 'Initials': 'IH', 'LastName': 'Bozkurt', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Basmaci', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, İzmir, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Celik', 'Affiliation': 'Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, İzmir, Turkey.'}]",The Journal of urology,['10.1097/JU.0000000000000373']
1214,31204264,Low-Intensity Shockwave Therapy (LiST) for Erectile Dysfunction: Is It Safe for Patients on Anticoagulant Medication?,"INTRODUCTION


A significant percentage of men with vasculogenic erectile dysfunction (ED) use antiplatelet therapy because they have a history of cardiovascular disease. However, the safety of this novel treatment modality in patients under antiplatelet treatment has been based on anecdotal cases, and published data are lacking. The aim of this study is to examine the safety of low-intensity shockwave therapy (LiST) on a group of patients under antiplatelet therapy who were treated with LiST.
METHODS


A pulled data analysis, conducted from November-December 2018, including 2 randomized clinical trials conducted at an Andrology outpatient clinic is presented. The 2 trials used the same design, the same shockwaves generator, as well as the same method of delivering the energy. The LiST protocol differed between the patients regarding LiST sessions number (6, 12, or 18), sessions frequency (1, 2, or 3 sessions/wk) and energy flux density used, which was either 0.05 or 0.1 mJ/mm 2 . The number of 5,000 pulses/session remained unchanged. For the purpose of the current study, patients receiving anticoagulant medication at the time of treatment and follow-up period were included in this analysis. All patients had a diagnosis of vasculogenic ED. According to the study protocol, after every treatment visit, as well as at 1 and 3 months after treatment, all patients reported any side effects or complications of the treatment; physical examination of the penis was performed before and after each treatment session, as well as at follow-up visits at 1 and 3 months. Penile ultrasonography was performed at baseline, as well as at 3 months' follow-up, at the same time with triplex ultrasonography by the same investigator.
RESULTS


138 patients were included in the 2 trials, whereas 135 (98%) of them finished the 3 months follow-up. 35 (25.3%) of them were under anticoagulant/antiplatelet medication during LiST. No bleeding events or any other side effects were reported.
STRENGTHS & LIMITATIONS


The main strength of this article is that it is the first report on the safety of LiST on the specific group of cardiovascular patients with ED under anticoagulant/antiplatelet therapy. However, it is a pulled data analysis, based on 2 randomized studies, which did not have safety of LiST as a primary outcome.
CONCLUSION


LiST seems to be a safe and well-tolerated treatment option for vasculogenic ED in patients on antiplatelet medication. Kalyvianakis D, Memmos D, Mykoniatis I, et al. Low-Intensity Shockwave Therapy (LiST) for Erectile Dysfunction: Is It Safe for Patients on Anticoagulant Medication? J Sex Med 2019;16:1478-1480.",2019,"No bleeding events or any other side effects were reported.
","['men with vasculogenic erectile dysfunction (ED', '138 patients were included in the 2 trials, whereas 135 (98%) of them finished the 3 months follow-up', 'A pulled data analysis, conducted from November-December 2018, including 2 randomized clinical trials conducted at an Andrology outpatient clinic is presented', 'Erectile Dysfunction', 'patients under antiplatelet therapy who were treated with LiST', 'All patients had a diagnosis of vasculogenic ED', 'patients receiving anticoagulant medication at the time of treatment and follow-up period']","['low-intensity shockwave therapy (LiST', 'Low-Intensity Shockwave Therapy (LiST']","['Penile ultrasonography', 'bleeding events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",138.0,0.0212945,"No bleeding events or any other side effects were reported.
","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kalyvianakis', 'Affiliation': '1(st) Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece; Institute for the Study of Urological Diseases, Thessaloniki, Greece.'}, {'ForeName': 'Dimirios', 'Initials': 'D', 'LastName': 'Memmos', 'Affiliation': '1(st) Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Mykoniatis', 'Affiliation': '1(st) Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece; Institute for the Study of Urological Diseases, Thessaloniki, Greece. Electronic address: g_mikoniatis@hotmail.com.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Kapoteli', 'Affiliation': '1(st) Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece; Institute for the Study of Urological Diseases, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Hatzichristou', 'Affiliation': '1(st) Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece; Institute for the Study of Urological Diseases, Thessaloniki, Greece.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.008']
1215,31773200,Effect of an exercise programme for reducing abdominal fat on overactive bladder symptoms in young overweight women.,"INTRODUCTION AND HYPOTHESIS


The effect of exercise in relation to overweight and overactive bladder (OAB) in young women has not been sufficiently supported by studies. The objective of our study was to reduce symptoms of OAB through a 3-month exercise programme in young overweight women with OAB. The sample consisted of 70 women (mean age 26.7 ± 4.8 years), 36 being treated and 34 in the control group.
METHODS


We used a body composition analyser with the assessment of skeletal muscle mass (SMM) (kg), body fat mass (BFM) (kg), body fat percentage (BFP) (%), visceral fat area (VFA) (cm²/level) and the waist/hip circumference index (WHR). OAB symptoms were evaluated using a voiding diary, the overactive bladder questionnaire (OAB-q) and the Patient Perception of Intensity of Urgency Scale (PPIUS). The intervention was a programme for the reduction of abdominal fat (PRAF), with elements of aerobic training, strengthening of the abdominal muscles and stretching.
RESULTS


In the OAB symptoms assessed through the voiding diary (number of voidings per 24 h, nocturia, mean voided volume) as well as in the OAB-q and PPIUS scales after training, significant differences were reported in favour of the treatment group [number of voidings per 24 h: treatment vs. control group, baseline 9.1 ± 0.3 vs. 8.6 ± 0.3, final 6.9 ± 0.2 vs. 8.1 ± 0.2, p < 0.0001; mean voided volume per 24 h (ml): treatment vs. control group, baseline 154.2 ± 9.1 vs. 162.2 ± 9.3, final 201.3 ± 9.3 vs. 164.1 ± 9.6, p < 0.0001] with a large effect size (ES). In the body composition analysis after training, significant differences were also reported in favour of the treatment group in the reduction of body mass index (BMI), BFP and VFA (p < 0.0001), with a large ES.
CONCLUSIONS


Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme. A reduction in OAB symptoms was also objectively confirmed following the PRAF exercise programme.",2020,"CONCLUSIONS


Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme.","['young overweight women', '70 women (mean age 26.7\u2009±\u20094.8\xa0years), 36 being treated and 34 in the control group', 'young overweight women with OAB', 'young women']","['exercise', 'aerobic training, strengthening of the abdominal muscles and stretching', 'exercise programme']","['OAB-q and PPIUS scales', 'BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference', 'reduction of body mass index (BMI), BFP and VFA', 'symptoms of OAB', 'overactive bladder symptoms', 'OAB symptoms assessed through the voiding diary (number of voidings per 24\xa0h, nocturia, mean voided volume', 'OAB symptoms', 'voiding diary, the overactive bladder questionnaire (OAB-q) and the Patient Perception of Intensity of Urgency Scale (PPIUS', 'skeletal muscle mass (SMM) (kg), body fat mass (BFM) (kg), body fat percentage (BFP) (%), visceral fat area (VFA) (cm²/level) and the waist/hip circumference index (WHR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0000739', 'cui_str': 'Abdominal Muscles'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0045933', 'cui_str': 'BFP'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}]",70.0,0.0334517,"CONCLUSIONS


Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme.","[{'ForeName': 'Magdaléna', 'Initials': 'M', 'LastName': 'Hagovska', 'Affiliation': 'Department of Physiatry, Balneology, and Medical Rehabilitation, Institution-Faculty of Medicine, PJ Safarik University, Rastislavova 43, 040 01, Kosice, Slovak Republic. magdalena.hagovska@upjs.sk.'}, {'ForeName': 'Ján', 'Initials': 'J', 'LastName': 'Švihra', 'Affiliation': 'Department of Urology, Institution-Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Bratislava, Slovak Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Buková', 'Affiliation': 'Institute of Physical Education and Sport, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Dračková', 'Affiliation': 'Institute of Physical Education and Sport, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Horbacz', 'Affiliation': 'Institute of Physical Education and Sport, PJ Safarik University, Kosice, Slovak Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Nagyová', 'Affiliation': 'Department of Social and Behavioural Medicine, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic.'}]",International urogynecology journal,['10.1007/s00192-019-04157-8']
1216,31377052,"Treatment effect of alirocumab according to age group, smoking status, and hypertension: Pooled analysis from 10 randomized ODYSSEY studies.","BACKGROUND


Age, smoking, hypercholesterolemia, and hypertension are major risk factors for atherosclerotic cardiovascular disease.
OBJECTIVE


We examined whether the effects of alirocumab on low-density lipoprotein cholesterol (LDL-C) differed according to age, hypertension, or smoking status.
METHODS


Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24-104 weeks' duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non-familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on ezetimibe and 1175 on placebo]). Most participants received concomitant maximum tolerated statin therapy. In 8 trials, the alirocumab dose was increased from 75 mg every 2 weeks (Q2W) to 150 mg Q2W at Week 12 if predefined risk-based LDL-C goals were not achieved at Week 8 (≥70 mg/dL in very high cardiovascular risk; ≥100 mg/dL in moderate or high cardiovascular risk). Two trials compared alirocumab 150 mg Q2W vs placebo. The efficacy and safety of alirocumab were assessed post hoc in subgroups stratified by age (<65, ≥65 to <75, ≥75 years) and baseline hypertension or smoking status.
RESULTS


Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control. Subgroup analyses confirmed no significant interactions in response to alirocumab between age group, hypertension, or smoking status. Overall rates of treatment-emergent adverse events were similar between alirocumab and control groups.
CONCLUSIONS


In this pooled analysis from 10 trials, alirocumab led to substantial LDL-C reductions vs control in every age group and regardless of hypertension or smoking status. Alirocumab was well tolerated in all subgroups.",2019,"RESULTS


Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control.","[""Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24-104\xa0weeks' duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non-familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on"", 'subgroups stratified by age (<65, ≥65 to <75, ≥75\xa0years) and baseline hypertension or smoking status']","['alirocumab 150\xa0mg Q2W vs placebo', 'ezetimibe and 1175 on placebo', 'alirocumab', 'Alirocumab']","['LDL-C', 'hypertension, or smoking status', 'efficacy and safety of alirocumab', 'Overall rates of treatment-emergent adverse events', 'low-density lipoprotein cholesterol (LDL-C', 'substantial LDL-C reductions', 'tolerated']","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.155133,"RESULTS


Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control.","[{'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. Electronic address: Frederick.raal@wits.ac.za.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Cardiology Division, State University of Campinas School of Medicine (FCM Unicamp), Campinas, Brazil.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Fonseca', 'Affiliation': 'Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Averna', 'Affiliation': 'Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialties (PROMISE), School of Medicine, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farnier', 'Affiliation': 'Department of Cardiology, Lipid Clinic, Point Médical, CHU Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Ferdinand', 'Affiliation': 'Department of Medicine, Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': 'Department of Cardiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Eliano Pio', 'Initials': 'EP', 'LastName': 'Navarese', 'Affiliation': 'Interventional Cardiology and Cardiovascular Medicine Research, Mater Dei Hospital, Bari, Italy; Cardiovascular Institute, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland; SIRIO MEDICINE Network, VA, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Lerch', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'L Veronica', 'Initials': 'LV', 'LastName': 'Lee', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Biostatistics and Programming, Chilly-Mazarin, France.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.06.006']
1217,31190322,Effect of Phenylephrine and Ephedrine on Cerebral (Tissue) Oxygen Saturation During Carotid Endarterectomy (PEPPER): A Randomized Controlled Trial.,"BACKGROUND


Short-acting vasopressor agents like phenylephrine or ephedrine can be used during carotid endarterectomy (CEA) to achieve adequate blood pressure (BP) to prevent periprocedural stroke by preserving the cerebral perfusion. Previous studies in healthy subjects showed that these vasopressors also affected the frontal lobe cerebral tissue oxygenation (rSO 2 ) with a decrease after administration of phenylephrine. This decrease is unwarranted in patients with jeopardized cerebral perfusion, like CEA patients. The study aimed to evaluate the impact of both phenylephrine and ephedrine on the rSO 2  during CEA.
METHODS


In this double-blinded randomized controlled trial, 29 patients with symptomatic carotid artery stenosis underwent CEA under volatile general anesthesia in a tertiary referral medical center. Patients were preoperative allocated randomly (1:1) for receiving either phenylephrine (50 µg; n = 14) or ephedrine (5 mg; n = 15) in case intraoperative hypotension occurred, defined as a decreased mean arterial pressure (MAP) ≥ 20% compared to (awake) baseline. Intraoperative MAP was measured by an intra-arterial cannula placed in the radial artery. After administration, the MAP, cardiac output (CO), heart rate (HR), stroke volume, and rSO 2  both ipsilateral and contralateral were measured. The timeframe for data analysis was 120 s before, until 600 s after administration.
RESULTS


Both phenylephrine (70 ± 9 to 101 ± 22 mmHg; p < 0.001; mean ± SD) and ephedrine (75 ± 11 mmHg to 122 ± 22 mmHg; p < 0.001) adequately restored MAP. After administration, HR did not change significantly over time, and CO increased 19% for both phenylephrine and ephedrine. rSO 2  ipsilateral and contralateral did not change significantly after administration at 300 and 600 s for either phenylephrine or ephedrine (phenylephrine 73%, 73%, 73% and 73%, 73%, 74%; ephedrine 72%, 73%, 73% and 75%, 74%, 74%).
CONCLUSIONS


Within this randomized prospective study, MAP correction by either phenylephrine or ephedrine showed to be equally effective in maintaining rSO 2  in patients who underwent CEA. Clinical Trial Registration ClincalTrials.gov, NCT01451294.",2019,Both phenylephrine (70 ± 9 to 101 ± 22 mmHg; p < 0.001; mean ± SD) and ephedrine (75 ± 11 mmHg to 122 ± 22 mmHg; p < 0.001) adequately restored MAP.,"['healthy subjects', 'patients who underwent CEA', '29 patients with symptomatic carotid artery stenosis underwent CEA under volatile general anesthesia in a tertiary referral medical center', 'Carotid Endarterectomy (PEPPER', 'patients with jeopardized cerebral perfusion, like CEA patients']","['phenylephrine and ephedrine', 'phenylephrine', 'phenylephrine or ephedrine', 'phenylephrine or ephedrine (phenylephrine', 'ephedrine', 'Phenylephrine and Ephedrine']","['MAP, cardiac output (CO), heart rate (HR), stroke volume, and rSO 2  both ipsilateral and contralateral', 'Cerebral (Tissue) Oxygen Saturation', 'frontal lobe cerebral tissue oxygenation', 'mean arterial pressure (MAP', 'time, and CO', 'Intraoperative MAP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3695086', 'cui_str': 'Symptomatic carotid artery stenosis (disorder)'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C0453397', 'cui_str': 'Piper nigrum'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation (observable entity)'}, {'cui': 'C0016733', 'cui_str': 'Frontal Cortex'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",29.0,0.552639,Both phenylephrine (70 ± 9 to 101 ± 22 mmHg; p < 0.001; mean ± SD) and ephedrine (75 ± 11 mmHg to 122 ± 22 mmHg; p < 0.001) adequately restored MAP.,"[{'ForeName': 'Leonie M M', 'Initials': 'LMM', 'LastName': 'Fassaert', 'Affiliation': 'Department of Vascular Surgery G04.129, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. l.m.m.fassaert@umcutrecht.nl.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'de Borst', 'Affiliation': 'Department of Vascular Surgery G04.129, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Claire W A', 'Initials': 'CWA', 'LastName': 'Pennekamp', 'Affiliation': 'Department of Vascular Surgery G04.129, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Jantine C', 'Initials': 'JC', 'LastName': 'Specken-Welleweerd', 'Affiliation': 'Department of Vascular Surgery G04.129, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Frans L', 'Initials': 'FL', 'LastName': 'Moll', 'Affiliation': 'Department of Vascular Surgery G04.129, University Medical Center Utrecht, University of Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'Wilton A', 'Initials': 'WA', 'LastName': 'van Klei', 'Affiliation': 'Department of Anesthesiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Rogier V', 'Initials': 'RV', 'LastName': 'Immink', 'Affiliation': 'Department of Medical Biology, Laboratory for Clinical Cardiovascular Physiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}]",Neurocritical care,['10.1007/s12028-019-00749-w']
1218,31784747,Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.,"OBJECTIVE


Recent results from the Cardiovascular Trial of the Testosterone Trials showed that testosterone treatment of older men with low testosterone was associated with greater progression of noncalcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the Testosterone Trial.
METHODS


The Cardiovascular part of the trial included 170 men aged 65 years or older with low testosterone. Participants received testosterone gel or placebo gel for 12 months. The primary outcome was change in NCP volume from baseline to 12 months, as determined by coronary computed tomography angiography (CCTA). We assayed several markers of cardiovascular risk and analyzed each marker individually in a model as predictive variables and change in NCP as the dependent variable.
RESULTS


Of 170 enrollees, 138 (73 testosterone, 65 placebo) completed the study and were available for the primary analysis. Of 10 markers evaluated, none showed a significant association with the change in NCP volume, but a significant interaction between treatment assignment and waist-hip ratio (WHR) (P = 0.0014) indicated that this variable impacted the testosterone effect on NCP volume. The statistical model indicated that for every 0.1 change in the WHR, the testosterone-induced 12-month change in NCP volume increased by 26.96 mm3 (95% confidence interval, 7.72-46.20).
CONCLUSION


Among older men with low testosterone treated for 1 year, greater WHR was associated with greater NCP progression, as measured by CCTA. Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.",2020,Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.,"['individuals in the T Trial', '170 men aged 65 years or older with low T. Participants received', 'older men', 'Older Men Treated with', '170 enrollees', 'older men with low T']","['Testosterone(T', 'T gel or placebo gel', 'Testosterone']","['change in NCP volume', 'waist-hip ratio', 'NCP volume', 'coronary computed tomography angiography (CCTA', 'testosterone effect on non-calcified plaque volume', 'non-calcified plaque volume', 'plaque progression', 'progression of non-calcified plaque (NCP']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",170.0,0.301467,Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.,"[{'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rine', 'Initials': 'R', 'LastName': 'Nakanishi', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juhwan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Nanette K', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': 'Department of Medicine, Division of Cardiology, Emory Heart and Vascular Center Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Alabama.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hamal', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Sheilds', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': 'Department of Family and Preventive Medicine, Division of Epidemiology, University of California, San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Cherukuri', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Cunningham', 'Affiliation': ""Departments of Medicine and Molecular & Cellular Biology, Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas.""}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alvin M', 'Initials': 'AM', 'LastName': 'Matsumoto', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Puget Sound Health System, and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molich', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Venkata M', 'Initials': 'VM', 'LastName': 'Alla', 'Affiliation': 'Division of Cardiovascular Diseases, Creighton University School of Medicine, Omaha, Nebraska.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Birudaraju', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Nezarat', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Kelash', 'Initials': 'K', 'LastName': 'Rai', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Shone', 'Initials': 'S', 'LastName': 'Almeida', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Roy', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sheikh', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Trad', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz242']
1219,30973790,Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.,"PURPOSE


Tamoxifen administered for 5 years at 20 mg/d is effective in breast cancer treatment and prevention, but toxicity has limited its broad use. Biomarker trials showed that 5 mg/d is not inferior to 20 mg/d in decreasing breast cancer proliferation. We hypothesized that a lower dose given for a shorter period could be as effective in preventing recurrence from breast intraepithelial neoplasia but have a lower toxicity than the standard dose.
PATIENTS AND METHODS


We conducted a multicenter randomized trial of tamoxifen, 5 mg/d or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ. The primary end point was the incidence of invasive breast cancer or ductal carcinoma in situ.
RESULTS


Five hundred women 75 years of age or younger were included. After a median follow-up of 5.1 years (interquartile range, 3.9-6.3 years), there were 14 neoplastic events with tamoxifen and 28 with placebo (11.6  v  23.9 per 1,000 person-years; hazard ratio, 0.48; 95% CI, 0.26 to 0.92;  P  = .02), which resulted in a 5-year number needed to treat of 22 (95% CI, 20 to 27). Tamoxifen decreased contralateral breast events by 75% (three  v  12 events; hazard ratio, 0.25; 95% CI, 0.07 to 0.88;  P  = .02). Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P  = .02). There were 12 serious adverse events with tamoxifen and 16 with placebo, including one deep vein thrombosis and one stage I endometrial cancer with tamoxifen and one pulmonary embolism with placebo.
CONCLUSION


Tamoxifen at 5 mg/d for 3 years can halve the recurrence of breast intraepithelial neoplasia with a limited toxicity, which provides a new treatment option in these disorders.",2019,Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P  = .02).,"['3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ', 'Five hundred women 75 years of age or younger were included', 'Breast Intraepithelial Neoplasia']","['Tamoxifen', 'Low-Dose Tamoxifen', 'placebo', 'Placebo', 'tamoxifen, 5 mg/d or placebo', 'tamoxifen']","['contralateral breast events', 'breast cancer proliferation', 'deep vein thrombosis and one stage I endometrial cancer', 'frequency of daily hot flashes', 'Local and Contralateral Recurrence', 'incidence of invasive breast cancer or ductal carcinoma in situ']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442834', 'cui_str': 'Atypical ductal hyperplasia (qualifier value)'}, {'cui': 'C0205417', 'cui_str': 'Lobular (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}]",,0.626096,Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P  = .02).,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Puntoni', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Aliana', 'Initials': 'A', 'LastName': 'Guerrieri-Gonzaga', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Caviglia', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Avino', 'Affiliation': '4 Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cortesi', 'Affiliation': '5 Azienda Ospedaliera-Universitaria Policlinico di Modena, Modena, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Taverniti', 'Affiliation': '6 Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pacquola', 'Affiliation': '7 Ospedale SS Antonio e Margherita-ASL AL, Tortona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falcini', 'Affiliation': '8 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Gulisano', 'Affiliation': '9 ULSS 6 Vicenza, Vicenza, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Digennaro', 'Affiliation': '10 IRCCS Istituto Tumori ""Giovanni Paolo II"", Bari, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cariello', 'Affiliation': '11 Azienda Unità Sanitaria Locale della Romagna, Ravenna, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Cagossi', 'Affiliation': '12 Ospedale Bernardino Ramazzini, Carpi, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Pinotti', 'Affiliation': '13 Azienda Socio-Sanitaria Territoriale Sette Laghi, Varese, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lazzeroni', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Serrano', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Branchi', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campora', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Petrera', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Buttiron Webber', 'Affiliation': '1 Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': '14 Azienda Ospedaliera-Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': '3 European Institute of Oncology IRCCS, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01779']
1220,31732649,Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).,,2020,,['relapsing-remitting MS'],['Cholecalciferol'],[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]",[],,0.0863181,,[],Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000648']
1221,30243812,Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients.,"Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2) a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known. This project took advantage of a unique opportunity to modify and disseminate the ACP health literacy intervention among patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices all had health coaches that could be leveraged to provide chronic disease self-management mostly via phone, but also at the point-of-care. Hence we conducted a patient-randomized, pragmatic clinical trial in 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.",2018,"While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known.","['patient-centered medical homes serving rural patients', 'patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH', 'rural clinics with limited resources that disproportionately care for patients with limited literacy', '6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes']",['ACP health literacy intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",[],6.0,0.025536,"While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known.","[{'ForeName': 'Kristie B', 'Initials': 'KB', 'LastName': 'Hadden', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR 72205-7199, USA. Electronic address: khadden@uams.edu.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Highway, Shreveport, LA 71130-3932, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Northwestern University, Division of General Internal Medicine and Geriatrics, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gan', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR 72205-7199, USA.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Hur', 'Affiliation': 'Northwestern University, Division of General Internal Medicine and Geriatrics, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Northwestern University, Department of Preventive Medicine, 680 N. Lake Shore Drive, Suite 1400, Chicago, IL 60611, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'McSweeney', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR 72205-7199, USA.'}, {'ForeName': 'Latrina Y', 'Initials': 'LY', 'LastName': 'Prince', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 W. Markham Street, Little Rock, AR 72205-7199, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Northwestern University, Division of General Internal Medicine and Geriatrics, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL 60611, USA.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Highway, Shreveport, LA 71130-3932, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.007']
1222,31185775,"The Effects of Virtual Kayak Paddling Exercise on Postural Balance, Muscle Performance, and Cognitive Function in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial.","Deterioration of physical and psychological health is an important issue in older adults aged 65 years or more. This study aimed to determine whether a virtual kayak paddling (VKP) exercise could improve postural balance, muscle performance, and cognitive function in older adults with mild cognitive impairment. Sixty participants were randomly assigned to the VKP ( n  = 30) or control group ( n  = 30). Participants in the VKP group performed the paddling exercise in a virtual environment for 60 min twice a week for 6 weeks, whereas those in the control group performed home exercises. Postural balance ( p  < .05), muscle performance ( p  < .05), and cognitive function ( p  < .05) were significantly improved in the VKP group and were superior to those in the control group ( p  < .05). Thus, the findings indicate that VKP exercise improves postural balance, muscle performance, and cognitive function in older adults with mild cognitive impairment.",2019,"Postural balance ( p  < .05), muscle performance ( p  < .05), and cognitive function ( p  < .05) were significantly improved in the VKP group and were superior to those in the control group ( p  < .05).","['older adults with mild cognitive impairment', 'older adults aged 65 years or more', 'Sixty participants', 'Older Adults with Mild Cognitive Impairment']","['control group performed home exercises', 'virtual kayak paddling (VKP) exercise', 'VKP', 'Virtual Kayak Paddling Exercise', 'VKP exercise', 'paddling exercise']","['cognitive function', 'Postural Balance, Muscle Performance, and Cognitive Function', 'Postural balance', 'postural balance, muscle performance, and cognitive function', 'muscle performance', 'Deterioration of physical and psychological health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4316800', 'cui_str': 'Kayaking'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",60.0,0.0205344,"Postural balance ( p  < .05), muscle performance ( p  < .05), and cognitive function ( p  < .05) were significantly improved in the VKP group and were superior to those in the control group ( p  < .05).","[{'ForeName': 'Wonjae', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0020']
1223,31189519,"Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.","BACKGROUND


Durability of glycaemic control might reduce disease burden and improve long-term outcomes. DUAL VIII investigated the durability of insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes with the use of a visit schedule that mirrored routine clinical practice.
METHODS


In this 104-week international, multicentre, open-label, phase 3b randomised controlled trial, insulin-naive patients aged 18 years and older, with HbA 1c  between 7·0-11·0% (53-97 mmol/mol), BMI of 20 kg/m 2  or higher, on stable doses of oral antidiabetic drugs, were recruited from outpatient clinics. Patients were randomly assigned 1:1, with a simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being an add-on to existing therapy. The internal safety committee, the independent external committee, and the personnel involved in defining the analysis sets were masked until the database was released for statistical analysis. Patients and all other investigators were not masked. In the IDegLira group, patients were given degludec 100 units/mL plus liraglutide 3·6 mg/mL in a 3 mL prefilled PDS290 pen for subcutaneous injection; in the IGlar U100 group, patients were given IGlar U100 solution, in a 3 mL prefilled Solostar pen for subcutaneous injection. Both treatments were given once daily at any time of day and it was recommended that the time of day remained the same throughout the trial. The primary endpoint was time from randomisation to need for treatment intensification (HbA 1c  ≥7·0% [53 mmol/mol] at two consecutive visits, including week 26). Once patients met this criterion, the trial product was permanently discontinued and patients were not withdrawn from trial but rather remained on follow-up for the entire treatment and follow-up period. The primary analysis was in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT02501161.
FINDINGS


From Jan 8, 2016, to Oct 3, 2018, 1345 patients were screened, of which 1012 (75·2%) were eligible and randomly assigned to either IDegLira (n=506) or IGlar U100 (n=506). 484 (96%) of 506 in the IDegLira group and 481 (95%) of 506 in the IGlar U100 group completed the trial. Baseline characteristics were similar and representative of patients eligible for basal insulin intensification (overall mean diabetes duration 10 years; HbA 1c  8·5% [69 mmol/mol]; fasting plasma glucose 10 mmol/L). Patients in the IDegLira group had significantly longer time until intensification was needed than those in the IGlar U100 group (median >2 years vs about 1 year). Fewer patients in the IDegLira group needed treatment intensification over 104 weeks than those in the IGlar U100 group (189 [37%] of 506 vs 335 [66%] of 506). The preplanned sensitivity analyses of the primary endpoint were in agreement with the primary analysis (hazard ratio 0·45 [95% CI 0·38-0·54]) in the proportional hazards regression model and the generalised log-rank test was also in favour of IDegLira (p<0·0001). No new or unexpected safety and tolerability issues were identified and there were no treatment-related deaths.
INTERPRETATION


In patients with uncontrolled type 2 diabetes on oral antidiabetic drugs, initial injectable therapy with IDegLira resulted in fewer patients reaching the treatment intensification criterion during 104 weeks versus IGlar U100, with longer durability of the treatment effect with IDegLira.
FUNDING


Novo Nordisk.",2019,Fewer patients in the IDegLira group needed treatment intensification over 104 weeks than those in the IGlar U100 group (189 [37%] of 506 vs 335 [66%] of 506).,"['patients with type 2 diabetes with the use of a visit schedule that mirrored routine clinical practice', 'patients with uncontrolled type 2 diabetes on oral antidiabetic drugs', 'From Jan 8, 2016, to Oct 3, 2018, 1345 patients were screened, of which 1012 (75·2%) were eligible and randomly assigned to either IDegLira (n=506) or IGlar U100 (n=506', 'type 2 diabetes (DUAL VIII', 'naive patients aged 18 years and older, with HbA 1c  between 7·0-11·0% (53-97 mmol/mol), BMI of 20 kg/m 2  or higher, on stable doses of oral antidiabetic drugs, were recruited from outpatient clinics', '484 (96%) of 506 in the IDegLira group and 481 (95%) of 506 in the IGlar U100 group completed the trial']","['liraglutide 3·6 mg/mL in a 3 mL prefilled PDS290 pen', 'simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being an add-on to existing therapy', 'insulin', 'insulin degludec plus liraglutide versus insulin glargine U100', 'insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100']","['time from randomisation to need for treatment intensification', 'longer time until intensification']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0445599', 'cui_str': 'VIII'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",1345.0,0.149931,Fewer patients in the IDegLira group needed treatment intensification over 104 weeks than those in the IGlar U100 group (189 [37%] of 506 vs 335 [66%] of 506).,"[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA; MedStar Health Research Institute, Hyattsville, MD, USA. Electronic address: varoda@bwh.harvard.edu.""}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'González-Galvez', 'Affiliation': 'Jalisco Institute of Research in Diabetes and Obesity SC, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Grøn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Halladin', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Institute for Clinical and Experimental Medicine and Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Jermendy', 'Affiliation': 'Bajcsy-Zsilinszky Hospital, Budapest, Hungary.'}, {'ForeName': 'Adri', 'Initials': 'A', 'LastName': 'Kok', 'Affiliation': 'Union and Clinton Hospitals in Alberton, Gauteng, South Africa.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sabbah', 'Affiliation': 'Hadassah University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silver', 'Affiliation': 'Southern New Hampshire Diabetes and Endocrinology, Nashua, NH, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30184-6']
1224,31189520,"Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial.","BACKGROUND


Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg.
METHODS


In this 52-week, multicentre, randomised, open-label, phase 3a trial, we recruited patients with type 2 diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA 1c  of 7·5-9·5% (58-80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily. To approximate treatment individualisation in clinical practice, oral semaglutide dose could be adjusted on the basis of prespecified HbA 1c  and tolerability criteria. Two efficacy-related estimands were prespecified: treatment policy (regardless of treatment discontinuation or use of rescue medication) and trial product (on treatment and without use of rescue medication) for participants randomly assigned to treatment. The primary endpoint was achievement of HbA 1c  of less than 7% (53 mmol/mol) at week 52 and the confirmatory secondary efficacy endpoint was change in bodyweight from baseline to week 52. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02849080, and European Clinical Trials Database, EudraCT number 2015-005593-38, and an open-label extension is ongoing.
FINDINGS


Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251). Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9). All participants were given at least one dose of their allocated study drug except for one participant in the sitagliptin group. From a mean baseline HbA 1c  of 8·3% (SD 0·6%; 67 mmol/mol [SD 6·4]), a greater proportion of participants achieved an HbA 1c  of less than 7% with oral semaglutide than did with sitagliptin (treatment policy estimand: 58% [134 of 230] vs 25% [60 of 238]; and trial product estimand: 63% [123 of 196] vs 28% [52 of 184]). The odds of achieving an HbA 1c  of less than 7% was significantly better with oral semaglutide than sitagliptin (treatment policy estimand: odds ratio [OR] 4·40, 95% CI 2·89-6·70, p<0·0001; and trial product estimand: 5·54, 3·54-8·68, p<0·0001). The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: -2·6 kg [SE 0·3] vs -0·7 kg [SE 0·2], estimated treatment difference [ETD] -1·9 kg, 95% CI -2·6 to -1·2; p<0·0001; and trial product estimand: -2·9 kg [SE 0·3] vs -0·8 kg [SE 0·3], ETD -2·2 kg, -2·9 to -1·5; p<0·0001). Adverse events occurred in 197 (78%) of 253 participants in the oral semaglutide group versus 172 (69%) of 250 in the sitagliptin group, and nausea was the most common adverse event with oral semaglutide (53 [21%]). Two deaths occurred in the sitagliptin group during the trial.
INTERPRETATION


Oral semaglutide, with flexible dose adjustment, based on efficacy and tolerability, provided superior glycaemic control and weight loss compared with sitagliptin, and with a safety profile consistent with subcutaneous GLP-1 receptor agonists.
FUNDING


Novo Nordisk A/S.",2019,"The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: -2·6 kg [SE 0·3] vs -0·7 kg [SE 0·2], estimated treatment difference [ETD]","['type 2 diabetes (PIONEER 7', 'Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251', 'patients with type 2 diabetes from 81 sites in ten countries', 'participants who received at least one dose of study drug', 'Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9', 'Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA 1c  of 7·5-9·5% (58-80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening']","['interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily', 'estimand: -2·9 kg [SE 0·3', 'oral semaglutide with sitagliptin 100 mg', 'oral semaglutide with flexible dose adjustment versus sitagliptin', 'sitagliptin']","['mean bodyweight', 'treatment difference [ETD', 'Adverse events', 'achievement of HbA 1c  of less', 'efficacy and tolerability', 'Efficacy and safety', 'efficacy and safety', 'nausea', 'Safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.19469,"The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: -2·6 kg [SE 0·3] vs -0·7 kg [SE 0·2], estimated treatment difference [ETD]","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria. Electronic address: thomas.pieber@medunigraz.at.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, GA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mertens', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases, Metabolism and Aging (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Christiansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Christin L', 'Initials': 'CL', 'LastName': 'Hertz', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Signe O R', 'Initials': 'SOR', 'LastName': 'Wallenstein', 'Affiliation': 'Novo Nordisk A/S, Aalborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30194-9']
1225,30776134,"Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of JNJ-61178104, a Novel Tumor Necrosis Factor-Alpha and Interleukin-17A Bispecific Antibody, in Healthy Subjects.","The safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of JNJ-61178104, a novel anti-tumor necrosis factor-alpha (TNFα) and anti-interleukin-17A (IL-17A) bispecific antibody, were investigated in a placebo-controlled, first-in-human study. Healthy subjects (n = 54) received a single dose of JNJ-61178104 by either intravenous infusion (0.1, 0.3, 1, 3, and 10 mg/kg) or subcutaneous injection (1 mg/kg). Blood samples for measurement of serum JNJ-61178104 concentrations, total IL-17A, total TNFα, and detection of antidrug antibodies were collected for up to 16 weeks after dosing and assessed using electrochemiluminescence immunoassays. PK parameters were calculated by noncompartmental analysis and estimated by nonlinear mixed-effects modeling. JNJ-61178104 was generally well tolerated in healthy subjects. For the intravenous cohorts, mean maximum concentration, and area under the concentration-time curve values increased in a dose-proportional manner. Mean clearance ranged from 6.73 to 9.99 mL/day/kg, mean volume of distribution at terminal phase after intravenous administration ranged from 51.0 to 91.9 mL/kg, and mean half-life ranged from 4.3 to 9.7 days following intravenous administration. After a single subcutaneous dose of 1 mg/kg, median time to maximum concentration was 4.0 days, mean bioavailability was 52.0% and mean half-life was 5.3 days. A linear 2-compartment population model with first-order elimination adequately characterized the pharmacokinetics with parameters consistent with noncompartmental analysis estimates. Body weight and antidrug antibodies were significant covariates on JNJ-61178104 clearance. The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups. All subjects who received active treatment were antidrug antibody positive after dosing with JNJ-61178104.",2019,The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups.,"['Healthy Subjects', 'Healthy subjects (n\xa0=\xa054', 'healthy subjects']",['subcutaneous injection'],"['Mean clearance', 'Blood samples for measurement of serum JNJ-61178104 concentrations, total IL-17A, total TNFα, and detection of antidrug antibodies', 'median time to maximum concentration', 'time to reach mean maximum serum total TNFα and total IL-17A concentrations', 'antidrug antibody positive', 'mean maximum concentration, and area under the concentration-time curve values', 'mean bioavailability', 'PK parameters', 'Body weight and antidrug antibodies', 'safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of JNJ-61178104, a novel anti-tumor necrosis factor-alpha (TNFα) and anti-interleukin-17A (IL-17A) bispecific antibody', 'Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0206492', 'cui_str': 'Bifunctional Antibodies'}]",,0.0411094,The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups.,"[{'ForeName': 'Derrick E', 'Initials': 'DE', 'LastName': 'Akpalu', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Frederick', 'Affiliation': 'Immunology Translational Medicine, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Ivo P', 'Initials': 'IP', 'LastName': 'Nnane', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Immunology Discovery, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Ort', 'Affiliation': 'Immunology Discovery, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'Biologics Development Sciences, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dogmanits', 'Affiliation': 'Biologics Development Sciences, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Raible', 'Affiliation': 'Immunology Translational Medicine, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1393']
1226,31106666,Predictive value of serum amyloid a levels for requirement of concomitant methotrexate in tocilizumab initiation: A  post hoc  analysis of the SURPRISE study.,"Objectives:  To identify predictive factors for remission by tocilizumab monotherapy in rheumatoid arthritis (RA) patients. Methods:  This is a  post hoc  analysis of the SURPRISE study, a 2-year randomized, controlled study comparing the efficacy of tocilizumab with (ADD-ON) and without methotrexate (SWITCH). The primary endpoint was DAS28-ESR remission (<2.6) at week 24. The change in modified total Sharp score from baseline to week 52 (ΔmTSS/year) was also assessed as an endpoint. The effect of clinical parameters at baseline on remission was estimated by logistic regression analysis. Results:  In SWITCH ( n  = 96), CRP, SAA, RF, and DAS28 at baseline showed predictive value for DAS28 remission in unadjusted analysis. Adjusted analysis confirmed SAA and DAS28 as predictive factors, with SAA having the highest value (ROC-AUC = 0.731). Furthermore, structural remission (ΔmTSS/year ≤ 0.5) rate was significantly higher in patients with SAA of < 50.0 μg/mL than other patients. In contrast, in ADD-ON ( n  = 98), only DAS28 showed predictive value for DAS28 remission. In patients with SAA < 50.0 μg/mL, both DAS28 remission and structural remission rate were comparable between SWITCH and ADD-ON. Conclusion:  RA patients with low SAA levels at baseline may benefit similarly from tocilizumab with and without methotrexate. Trial registration number:  NCT01120366.",2020,"Furthermore, structural remission (ΔmTSS/year ≤ 0.5) rate was significantly higher in patients with SAA of < 50.0 μg/mL than other patients.",['rheumatoid arthritis (RA) patients'],"['tocilizumab', 'tocilizumab with (ADD-ON) and without methotrexate (SWITCH', 'tocilizumab monotherapy']","['structural remission (ΔmTSS/year ≤\u20090.5) rate', 'low SAA levels', 'DAS28-ESR remission', 'DAS28 remission and structural remission rate']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.372353,"Furthermore, structural remission (ΔmTSS/year ≤ 0.5) rate was significantly higher in patients with SAA of < 50.0 μg/mL than other patients.","[{'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoo', 'Affiliation': 'Department of Internal Medicine, Utazu Hospital, Ehime, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Kobayashi-Haraoka', 'Affiliation': 'Division of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Department of Internal Medicine, Fukushima Red Cross Hospital, Fukushima, Japan.'}, {'ForeName': 'Yohko', 'Initials': 'Y', 'LastName': 'Murakawa', 'Affiliation': 'Department of Rheumatology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Hidekata', 'Initials': 'H', 'LastName': 'Yasuoka', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Hirata', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Nagasawa', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': ""Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyasaka', 'Affiliation': 'Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': ""Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yokota', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1621026']
1227,29556937,Correction to: Exploring the Effectiveness of a Peer-Mediated Model of the PEERS Curriculum: A Pilot Randomized Control Trial.,The original version of this article unfortunately contained a mistake.,2018,The original version of this article unfortunately contained a mistake.,[],['Peer-Mediated Model of the PEERS Curriculum'],[],[],"[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]",[],,0.0523967,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Matthews', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA. nmatthews@autismcenter.org.'}, {'ForeName': 'Beatriz C', 'Initials': 'BC', 'LastName': 'Orr', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Warriner', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'DeCarlo', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Sorensen', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Laflin', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3531-z']
1228,31033774,Log-Transformed Electromyography Amplitude-Power Output Relationship: Single-Leg Knee-Extensor Versus Single-Leg Cycle Ergometry.,"Noble, EB, Pilarski, JM, Vora, HK, Zuniga, JM, and Malek, MH. Log-transformed electromyography amplitude-power output relationship: single-leg knee-extensor versus single-leg cycle ergometry. J Strength Cond Res 33(5): 1311-1319, 2019-Comparing and contrasting motor unit recruitment and activation for the same muscles for multiple versus single-joint exercise may provide a better understanding of neuromuscular fatigue. The purpose of this study, therefore, is to compare the slope and y-intercept terms for the 3 superficial quadriceps femoris (QF) (vastus lateralis, rectus femoris, and vastus medialis) muscles derived from the log-transformed electromyography (EMG) amplitude-power output relationship between the single-leg knee-extensor ergometry (KE) and the single-leg cycle ergometry (CE). Ten healthy college-aged men who engaged in regular physical activity visited the laboratory on 2 occasions separated by 7 days to perform either single-leg CE or single-leg KE in a randomized order. For each visit, subjects performed incremental exercise until voluntary fatigue. Electromyography electrodes were placed on the superficial QF muscles. The slope and y-intercept terms, for each muscle, for the EMG amplitude versus power output relationship was examined using the log-transformed model for each subject's data. The results indicated no significant (p > 0.05) mean differences for either slope or y-intercept terms between exercise modes and across muscles. In addition, separate repeated-measures analyses of variance (ANOVAs) were used to determine mean differences for the slope and y-intercept values between the 3 muscles. In addition, separate 2 (mode: CE or KE) × intensity (intensity: 30, 60, and 90% of maximal workload) repeated-measures ANOVAs were conducted for each muscle. There was a significant (p < 0.05) mode × exercise intensity interaction for each muscle. Follow-up testing indicated that in most cases, the normalized EMG amplitude was significantly higher for single-leg KE than single-leg CE. These results indicated that incremental single-leg KE activates the superficial QF muscles significantly greater than single-leg CE.",2019,"Follow-up testing indicated that in most cases, the normalized EMG amplitude was significantly higher for single-leg KE than single-leg CE.",['Ten healthy college-aged men who engaged in regular physical activity visited the laboratory on 2 occasions separated by 7 days to perform either'],"['Log-transformed electromyography amplitude-power output relationship: single-leg knee-extensor versus single-leg cycle ergometry', 'Log-Transformed Electromyography Amplitude-Power Output Relationship: Single-Leg Knee-Extensor Versus Single-Leg Cycle Ergometry', 'Electromyography electrodes', 'single-leg CE or single-leg KE', 'single-leg knee-extensor ergometry (KE) and the single-leg cycle ergometry (CE', 'CE or KE']","['normalized EMG amplitude', 'superficial QF muscles', 'Noble, EB, Pilarski, JM, Vora, HK, Zuniga, JM, and Malek, MH']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",10.0,0.0161605,"Follow-up testing indicated that in most cases, the normalized EMG amplitude was significantly higher for single-leg KE than single-leg CE.","[{'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Noble', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Pilarski', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}, {'ForeName': 'Harshal K', 'Initials': 'HK', 'LastName': 'Vora', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Zuniga', 'Affiliation': 'Department of Biomechanics, University of Nebraska, Omaha, College of Education, Omaha, Nebraska.'}, {'ForeName': 'Moh H', 'Initials': 'MH', 'LastName': 'Malek', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000001950']
1229,31757266,Learning How to Ask - Does a one-day training increase trauma inquiry in routine substance use disorder practice? Results of a cluster-randomized controlled trial.,"AIMS


To examine the effectiveness of a one-day skills training program for increasing trauma inquiry in routine substance use disorder treatment.
DESIGN


Cluster-randomized two-armed controlled trial, with 12 substance use disorder (SUD) organizations operating 25 counseling centers, randomly assigned to training in trauma inquiry (13 counseling centers of 8 SUD organizations) or no training (12 counseling centers of 4 SUD organizations).
SETTING


SUD counseling centers in Northern Germany.
CASES


N = 5204 SUD counseling services.
INTERVENTION


The professionals assigned to the intervention group received a one-day training in trauma inquiry plus a 1.5-hour refresher session 3 months later. Professionals in the control group received no training.
MEASURES


Over a 12-month period, professionals documented for each counseling service whether they asked the client about four traumatic events: physical abuse, emotional abuse, sexual abuse and neglect.
ANALYSIS


Primary outcomes were rates of asking about physical abuse, sexual abuse, emotional abuse and neglect in the 6 months after training. These were compared across conditions, while adjusting for baseline probabilities in the 6 months before training, using mixed-effects logistic regression.
FINDINGS


In the 6 months after training, the rate of asking about physical abuse was 18% higher in the SUD counseling services of trained professionals, relative to services of untrained professionals (OR = 1.18, 95% CI = [1.01-1.37, p = .035]). No effect was found for asking about sexual abuse, emotional abuse and neglect.
CONCLUSION


A one-day training program in trauma inquiry, combined with a brief refresher session, was effective in increasing inquiries about physical abuse in routine counseling practice. The training was ineffective in increasing inquiries about sexual abuse, emotional abuse and neglect. The effectiveness of a one-day training of trauma inquiry might be increased by a longer training, or by combining it with additional elements, such as ongoing supervision.",2019,"In the 6 months after training, the rate of asking about physical abuse was 18% higher in the SUD counseling services of trained professionals, relative to services of untrained professionals (OR = 1.18, 95% CI = [1.01-1.37, p = .035]).","['12 substance use disorder (SUD) organizations operating 25 counseling centers', 'SUD counseling centers in Northern Germany']","['no training', 'one-day skills training program', 'training in trauma inquiry (13 counseling centers of 8 SUD organizations) or no training (12 counseling centers of 4 SUD organizations']","['rate of asking about physical abuse', 'asking about sexual abuse, emotional abuse and neglect', 'rates of asking about physical abuse, sexual abuse, emotional abuse and neglect']","[{'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0220885', 'cui_str': 'organization'}]","[{'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse (event)'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]",,0.0269313,"In the 6 months after training, the rate of asking about physical abuse was 18% higher in the SUD counseling services of trained professionals, relative to services of untrained professionals (OR = 1.18, 95% CI = [1.01-1.37, p = .035]).","[{'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Lotzin', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany; Center for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: A.Lotzin@uke.de.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Buth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany; Center for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sehner', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hiller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany; Center for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Marcus-Sebastian', 'Initials': 'MS', 'LastName': 'Martens', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany; Center for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': 'School of Psychology, University of East London, Water Lane, London E15 4LZ, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Cowlishaw', 'Affiliation': 'Phoenix Australia Centre for Posttraumatic Mental Health, Department of Psychiatry, The University of Melbourne, Australia; Population Health Sciences, University of Bristol, Beacon House, Queens Road, Bristol BS8 1QU, UK.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schäfer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany; Center for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.005']
1230,31760207,"Single Cupping Thearpy Session Improves Pain, Sleep, and Disability in Patients with Nonspecific Chronic Low Back Pain.","The objective of this study was to evaluate if a single session of real or placebo cupping therapy in patients with chronic low back pain would be enough to temporarily reduce pain intensity and functional disability, enhancing their mechanical threshold and reducing local skin temperature. The outcome measures were Brief Pain Inventory, pressure pain threshold, Roland-Morris disability questionnaire and low back skin temperature. This is an experimental clinical trial; after examination (AV0), patients were submitted to real or placebo cupping therapy (15 minutes, bilaterally at the points BL23 (Shenshu), BL24 (Qihaishu) and BL25 (Dachangshu) and were revaluated immediately after the session (AV1) and after one week (AV2). The patients showed a significant improvement in all pain severity items and sleep in the Brief Pain Inventory (p < 0.05) and a decrease in disability in Roland-Morris disability questionnaire (p < 0.001). No significant differences were found in pressure pain threshold or skin temperature. No significant differences were found in any outcome of the placebo cupping therapy group. Thus, the cupping therapy is effective in reducing low back pain and decreasing disability after one single session but not in changing skin mechanical threshold or temperature.",2020,The patients showed a significant improvement in all pain severity items and sleep in the BPI and a decrease in disability in RMDQ.,"['Patients With Nonspecific Chronic Low Back Pain', 'patients with chronic LBP']","['placebo cupping therapy', 'Single Cupping Therapy Session']","['disability in RMDQ', 'Pain, Sleep And Disability', 'pain severity items and sleep', 'PPT or skin temperature', 'Brief Pain Inventory (BPI), pressure pain threshold (PPT), Roland Morris disability questionnaire (RMDQ) and low back skin temperature']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0394663', 'cui_str': 'Cupping (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}]",,0.0480546,The patients showed a significant improvement in all pain severity items and sleep in the BPI and a decrease in disability in RMDQ.,"[{'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Volpato', 'Affiliation': 'Institute of Motricity Sciences, Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Izabela C A', 'Initials': 'ICA', 'LastName': 'Breda', 'Affiliation': 'Graduate Program of Biosciences Applied to Health (PPGB), Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Ravena C', 'Initials': 'RC', 'LastName': 'de Carvalho', 'Affiliation': 'Graduate Program of Biosciences Applied to Health (PPGB), Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Castro Moura', 'Affiliation': 'College of Nursing, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Laís L', 'Initials': 'LL', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program of Biosciences Applied to Health (PPGB), Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Marcelo L', 'Initials': 'ML', 'LastName': 'Silva', 'Affiliation': 'Institute of Motricity Sciences, Federal University of Alfenas, Alfenas, MG, Brazil.'}, {'ForeName': 'Josie R T', 'Initials': 'JRT', 'LastName': 'Silva', 'Affiliation': 'Institute of Motricity Sciences, Federal University of Alfenas, Alfenas, MG, Brazil. Electronic address: josie.resende@unifal-mg.edu.br.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2019.11.004']
1231,31174708,Is fidelity to motivational interviewing associated with alcohol outcomes in treatment-seeking 60+ year-old citizens?,"BACKGROUND


Part of the variability in treatment outcomes for Motivational Interviewing (MI) may be explained by differences in the fidelity to MI. The Motivational Interviewing Treatment Integrity manual version 4 (MITI 4) is an improved measure of fidelity to elements of MI. It is not known whether the fidelity to MI, as measured by the MITI 4, is related to treatment outcome.
OBJECTIVES


To examine whether fidelity to MI is associated with alcohol use outcomes - predictive validity of the MITI 4.
METHOD


Twenty percent of the recorded sessions at the Danish sites of the Elderly Study were randomly drawn and coded for fidelity to MI with the MITI 4. The Elderly Study was an international, randomized controlled trial, in which people 60 years or older with Alcohol Use Disorders received either four weeks of Motivational Enhancement Therapy (MET) or four weeks of MET combined with up to eight additional sessions of the Community Reinforcement Approach- Senior (MET+CRA-S). Elements of MI and summary scores of the MITI 4 were used as predictors in a mixed effects regression analysis. Treatment outcomes were use of alcohol and consequences of drinking at 26-weeks follow-up.
RESULTS


In total, 423 sessions representing 238 participants were randomly drawn and coded for fidelity to MI. Mean values of the treatment elements indicated high fidelity to MI, with higher fidelity to MI in the MET sessions, as compared to CRA-S sessions. None of the predictors in the multilevel model analyses were associated with outcome at follow-up. Exploratory analysis indicated reverse associations between one measure of MI-fidelity and drinking outcomes in the combined treatment (CRAS).
CONCLUSION


The fidelity of the MI intervention, received by participants in this study, did not predict better treatment outcomes. MI may be less effective in populations which are already committed to change behavior. As expected and validating for the MITI 4, fidelity to MI-elements was lower in the combination of MI with other treatment approaches. Additionally, the timing of MI in these combined settings might be important for effectiveness.",2019,"It is not known whether the fidelity to MI, as measured by the MITI 4, is related to treatment outcome.
","['In total, 423 sessions representing 238 participants were randomly drawn and coded for fidelity to MI', 'Twenty percent of the recorded sessions at the Danish sites of the Elderly Study were randomly drawn and coded for fidelity to MI with the MITI 4', 'people 60\u202fyears or older with Alcohol Use Disorders received either four weeks of']","['Motivational Interviewing (MI', 'Motivational Enhancement Therapy (MET) or four weeks of MET combined with up to eight additional sessions of the Community Reinforcement Approach- Senior (MET+CRA-S']","['alcohol and consequences of drinking at 26-weeks follow-up', 'MI-fidelity and drinking outcomes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",238.0,0.019676,"It is not known whether the fidelity to MI, as measured by the MITI 4, is related to treatment outcome.
","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Kramer Schmidt', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 18, entrance 220B, 5000 Odense C, Denmark. Electronic address: lkramer@health.sdu.dk.'}, {'ForeName': 'Theresa B', 'Initials': 'TB', 'LastName': 'Moyers', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, MSC11 6280, 1 University of New Mexico, Albuquerque, NM 87131, United States. Electronic address: tmoyers@unm.edu.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 18, entrance 220B, 5000 Odense C, Denmark; OPEN Odense Patient data Explorative Network, Denmark. Electronic address: ansnielsen@health.sdu.dk.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Andersen', 'Affiliation': 'Unit of Clinical Alcohol Research, University of Southern Denmark, J.B. Winsløwsvej 18, entrance 220B, 5000 Odense C, Denmark; Department of Mental Health, Region of Southern Denmark, Denmark. Electronic address: Kjeld.andersen@rsyd.dk.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.004']
1232,31174713,Treatment with injectable hydromorphone: Comparing retention in double blind and open label treatment periods.,"BACKGROUND


In a double-blind, non-inferiority randomized controlled trial injectable hydromorphone, a licensed short acting opioid analgesic, was shown to be as effective as diacetylmorphine for the treatment of severe opioid use disorder. An appropriate question is whether hydromorphone offered open-label can attract and retain patients.
METHODS


This is a retrospective study, using daily prescription data from the Crosstown Clinic in Vancouver, Canada. Treatment retention among participants who had the opportunity to receive open-label injectable hydromorphone for at least 90 consecutive days (n = 108) before having the choice of receiving open-label diacetylmorphine, was compared to their retention outcomes with double-blind injectable opioid agonist treatment (iOAT). McNemar tests analyzed differences in proportions; a conditional logistic model estimated exact odds ratios; Pairwise t-tests analyzed differences in total number of treatment days; and Kaplan-Meier curves and clustered log-rank tests compared time to first 30 continuous days without injectable treatment.
RESULTS


A total of 74 participants (68.5%) were retained in both open-label hydromorphone and double-blind iOAT. Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10). Participants attended a mean of 84.4 (SD = 15.8) days of iOAT in the trial and 80.5 (SD = 22.0) days in open-label hydromorphone (mean difference of -3.9; 95% CI = -8.9, 1.1). Kaplan-Meier curves and log-rank tests were not statistically significant.
CONCLUSION


As treatment with injectable hydromorphone expands across Canada, our study contributes in a unique manner by providing evidence that the high retention rates observed during the clinical trial were maintained when participants started open-label hydromorphone.",2019,"Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10).","['participants who had the opportunity to receive', 'Crosstown Clinic in Vancouver, Canada', 'A total of 74 participants (68.5%) were retained in both open-label', 'for at least 90 consecutive days (n\u202f=\u202f108) before having the choice of receiving']","['double-blind injectable opioid agonist treatment (iOAT', 'hydromorphone and double-blind iOAT', 'open-label diacetylmorphine', 'open-label injectable hydromorphone', 'diacetylmorphine', 'Open-label hydromorphone', 'hydromorphone']",['Kaplan-Meier curves and log-rank tests'],"[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",74.0,0.449354,"Open-label hydromorphone was not significantly associated with lower retention (OR = 0.5; 95% CI: 0.2, 1.1; p = .10).","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Oviedo-Joekes', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada. Electronic address: eugenia@cheos.ubc.ca.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Palis', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Guh', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Marchand', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Brissette', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Hôpital Saint-Luc, CHUM Montréal, Montréal, QC H2X 3J4, Canada.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'Providence Health Care, Providence Crosstown Clinic, 84 West Hastings Street, Vancouver, BC V6B 1G6, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': 'Providence Health Care, Providence Crosstown Clinic, 84 West Hastings Street, Vancouver, BC V6B 1G6, Canada.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Lock', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Aslam H', 'Initials': 'AH', 'LastName': 'Anis', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Marsh', 'Affiliation': 'Northern Ontario School of Medicine, 935 Ramsey Lake Road, Sudbury, ON P3E 2C6, Canada; Canadian Addiction Treatment Centres, 175 Commerce Valley West, Suite 300, Markham, Ontario L3T 7P6, Canada.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Schechter', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St. Paul's Hospital, 575-1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada; School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada.""}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.012']
1233,31170715,How Exercise Can Influence Oxidative Stress and Glucose Levels after Pancreatic Resection: A Randomised Controlled Trial.,"BACKGROUND


One of the most challenging operations is the resection of the pancreas, which is associated with high morbidity. Metabolic control during the perioperative period remains an issue that is sometimes difficult to manage.
OBJECTIVES


Exercise has a positive effect on glycaemic control. The objective of this trial was determining whether exercise has any benefit for oxidative stress and glucose levels.
METHOD


The study was an open-label, randomised clinical trial. It has been registered in the International Standard Randomised Controlled Trial registry. The patients were selected according to the Consolidated Standard of Reporting Trials criteria.
RESULTS


In total, 56 patients were assessed for eligibility. There was no statistical difference between the 2 groups (the exercise and the control one) regarding the disease characteristics, morbidity or influence of exercise on oxidative stress; however, the control of glucose was superior in the exercise group.
CONCLUSIONS


Exercise has a positive effect on glycaemic control in patients after pancreatic resection.",2020,"There was no statistical difference between the 2 groups (the exercise and the control one) regarding the disease characteristics, morbidity or influence of exercise on oxidative stress; however, the control of glucose was superior in the exercise group.
","['after Pancreatic Resection', 'patients after pancreatic resection']",[],"['disease characteristics, morbidity or influence of exercise on oxidative stress', 'Oxidative Stress and Glucose Levels']","[{'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",56.0,0.085786,"There was no statistical difference between the 2 groups (the exercise and the control one) regarding the disease characteristics, morbidity or influence of exercise on oxidative stress; however, the control of glucose was superior in the exercise group.
","[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Katsourakis', 'Affiliation': 'Department of Surgery, Agios Dimitrios General Hospital, Thessaloniki, Greece, tasoskatsourakis@hotmail.com.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vrabas', 'Affiliation': 'School of Physical Education and Sports Sciences at Serres, ""Aristotle"" University, Thessaloniki, Greece.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Dimitriadis', 'Affiliation': 'Department of Surgery, Papanikolaou University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Apostolidis', 'Affiliation': 'Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stamatis', 'Initials': 'S', 'LastName': 'Aggelopoulos', 'Affiliation': 'Department of Surgery, Papanikolaou University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Iosif', 'Initials': 'I', 'LastName': 'Chatzis', 'Affiliation': 'Department of Surgery, Agios Dimitrios General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Noussios', 'Affiliation': 'School of Physical Education and Sports Sciences at Serres, ""Aristotle"" University, Thessaloniki, Greece.'}]",Digestive surgery,['10.1159/000500910']
1234,31149934,Further Examination of the Pain Stages of Change Questionnaires Among Chronic Low Back Pain Patients: Long-term Predictive Validity of Pretreatment and Posttreatment Change Scores and Stability of Posttreatment Scores.,"OBJECTIVES


In order to maximize the therapeutic benefits of cognitive-behavioral therapy (CBT) for chronic pain, individuals need to be motivated to adopt a self-management approach. The Pain Stages of Change Questionnaire (PSOCQ) was developed to measure patients' readiness to adopt a self-management approach to chronic pain. The present study examined whether pretreatment and posttreatment PSOCQ change scores among chronic low back pain patients could predict 6- and 12-month follow-up outcomes, and the stability of posttreatment PSOCQ scores during follow-up.
METHODS


Participants were recruited from a VA primary care clinic. Data from 60 participants assigned to either regular CBT or a modified CBT (ie, PRIME CBT) condition were analyzed in the present study. Self-report measures including PSOCQ, pain severity, disability, and depressive symptom severity were administered at pretreatment, 10 weeks posttreatment, 6-month and follow-up assessments.
RESULTS


Multiple regression analyses showed that pretreatment and posttreatment changes in the Action/Maintenance scores significantly predicted pain severity at 6 months, and changes in the Precontemplation scores significantly predicted disability at 6 months. None of the PSOCQ change scores significantly predicted depressive symptom severity. Posttreatment Precontemplation and Action/Maintenance scores were quite stable, even at 12-month follow-up.
CONCLUSIONS


Changes in patients' attitudes toward adopting a pain self-management approach may serve as one of the therapeutic mechanisms and predict long-term function. This study also revealed that changed attitudes toward chronic pain self-management remain quite stable over time. Adoption of beliefs consistent with chronic pain self-management during treatment may promote sustained benefits.",2019,"Post-treatment Pre-contemplation and Action/Maintenance scores were quite stable, even at 12-month follow up.
","['chronic low back pain patients', '60 participants assigned to either', 'Participants were recruited from a VA primary care clinic', 'Chronic Low Back Pain Patients']","['cognitive behavioral therapy (CBT', 'regular CBT or a modified CBT']","['Pain Stages of Change Questionnaire (PSOCQ', 'Pain Stages of Change Questionnaires', 'PSOCQ, pain severity, disability, and depressive symptom severity', 'pain severity', 'depressive symptom severity']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",60.0,0.0256558,"Post-treatment Pre-contemplation and Action/Maintenance scores were quite stable, even at 12-month follow up.
","[{'ForeName': 'Chung Jung', 'Initials': 'CJ', 'LastName': 'Mun', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Otis', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Concato', 'Affiliation': 'Departments of Internal Medicine.'}, {'ForeName': 'M Carringotn', 'Initials': 'MC', 'LastName': 'Reid', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Burg', 'Affiliation': 'Departments of Internal Medicine.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Czlapinski', 'Affiliation': 'Pain Research, Informatics, Multimorbidities and Education (PRIME) Center, VA Connecticut Healthcare System.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Kerns', 'Affiliation': 'Pain Research, Informatics, Multimorbidities and Education (PRIME) Center, VA Connecticut Healthcare System.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000733']
1235,31146613,"The Novel Effects of a Hydrolyzed Polysaccharide Dietary Supplement on Immune, Hepatic, and Renal Function in Adults with HIV in a Randomized, Double-Blind, Placebo-Control Trial.","The primary objective of the study was to evaluate the effects of a hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC), on immune, hepatic, and renal function in HIV + individuals. A 6-month randomized double-blind placebo-controlled trial was utilized to conduct the intervention. Forty-seven HIV + individuals on stable antiretroviral therapy were enrolled and randomly assigned to one of the 2 study conditions ( n  = 22 RBAC and  n  = 25 placebo) and consumed 3 gram/day of either compound for 6 months. Participants were assessed at baseline and 3 and 6 months follow-up for CD4+ and CD8+, liver enzymes, and kidney function. No side effects were reported, and liver and kidney markers remained nearly completely within normal limits. The percentage change in CD4+ was similar for the placebo (+2.2%) and RBAC (+3.1%) groups at 6 months follow-up. The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%;  p  = 0.04). The CD4+/CD8+ ratio improved clinically in the RBAC group from 0.95 (SD = 0.62) at baseline to 1.07 (SD = 0.11) at 6 months, whereas it declined in the placebo group from 0.96 (SD = 0.80) at baseline to 0.72 (SD = 0.59) at 6 months. Our results showed a statistically significant decrease in CD8+ count and a clinically significant increase in CD4+/CD8+ ratio for the RBAC group compared to the placebo group. Thus, the results of this study suggest that the immunomodulatory and antisenescent activities of RBAC are promising for the HIV population.",2019,"The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%;  p  = 0.04).","['Adults with HIV', 'HIV\u2009+\u2009individuals', 'Forty-seven HIV\u2009+\u2009individuals on stable antiretroviral therapy']","['RBAC and  n \u2009=\u200925 placebo', 'placebo', 'hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC', 'Placebo', 'Hydrolyzed Polysaccharide Dietary Supplement']","['Immune, Hepatic, and Renal Function', 'CD8+ count', 'percentage change in CD8+ count', 'liver and kidney markers', 'CD4+ and CD8+, liver enzymes, and kidney function', 'CD4+/CD8+ ratio', 'immune, hepatic, and renal function', 'percentage change in CD4']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.387552,"The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%;  p  = 0.04).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Atlas', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Muhammad H', 'Initials': 'MH', 'LastName': 'Abbas', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Rasul', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Ashar', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Lantigua', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Michaud', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldberg', 'Affiliation': 'b Glow Health, PA , Bay Harbor Islands , FL , USA.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Lages', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Higuera', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fiallo', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'a Department of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Judi M', 'Initials': 'JM', 'LastName': 'Woolger', 'Affiliation': 'c Department of Medicine , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ciraula', 'Affiliation': 'c Department of Medicine , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'c Department of Medicine , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'c Department of Medicine , University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Konefal', 'Affiliation': 'd Department of Family Medicine and Community Health , University of Miami Miller School of Medicine , Miami , FL , USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1619010']
1236,31178278,"Prophylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery: The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial.","BACKGROUND


Prophylactic intra-aortic balloon counterpulsation (IABC) is commonly used in selected patients undergoing coronary artery bypass graft (CABG) surgery, but definitive evidence is lacking. The aim of the multicentre PINBALL Pilot randomised controlled trial (RCT) was to assess the feasibility of performing a definitive trial to address this question.
METHODS


Patients listed for CABG surgery with impaired left ventricular function and at least one additional risk factor for postoperative low cardiac output syndrome were eligible for inclusion if the treating surgical team was uncertain as to the benefit of prophylactic IABC. The primary outcome of feasibility was based on exceeding a pre-specified recruitment rate, protocol compliance and follow-up.
RESULTS


The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants. For 20/24 (83%) participants, preoperative IABC use occurred according to study assignment. Six (6)-month follow-up was available for all enrolled participants, [IABC 1 death (8%) vs. control 1 death (9%), p = 0.95].
CONCLUSION


The PINBALL Pilot recruitment rate was insufficient to demonstrate feasibility of a multicentre RCT of prophylactic IABC in high risk patients undergoing CABG surgery.",2020,The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants.,"['high risk patients undergoing CABG surgery', 'Patients listed for CABG surgery with impaired left ventricular function and at least one additional risk factor for postoperative low cardiac output syndrome', 'selected patients undergoing coronary artery bypass graft (CABG) surgery', 'High Risk Cardiac Surgery']","['Prophylactic intra-aortic balloon counterpulsation (IABC', 'Prophylactic Intra-Aortic Balloon Counterpulsation', 'prophylactic IABC']","['preoperative IABC use', 'feasibility was based on exceeding a pre-specified recruitment rate, protocol compliance and follow-up']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.478708,The recruitment rate of 0.5 participants per site per month did not meet the feasibility threshold of two participants per site per month and the study was stopped early after enrolment of 24 out of the planned sample size of 40 participants.,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Perth, WA, Australia; School of Medicine, University of Western Australia, Perth, WA, Australia. Electronic address: ed_litton@hotmail.com.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Bass', 'Affiliation': 'Malcolm Fischer Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Dickson', 'Affiliation': 'Department of cardiothoracic surgery, Westmead Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Hillis', 'Affiliation': 'School of Medicine, University of Western Australia, Perth, WA, Australia; Department of Cardiology, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Inskip', 'Affiliation': 'Intensive Care Unit, The St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Jacques', 'Affiliation': 'Intensive Care Unit, The St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McGiffin', 'Affiliation': 'Department of Cardiothoracic Surgery, The Alfred Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuiness', 'Affiliation': 'Department of Cardiothoracic Surgery, The Alfred Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Jennene', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Intensive Care Unit, The St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiovascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Playford', 'Affiliation': 'Department of Anaesthesia, Westmead Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne Vic, Australia.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiothoracic Surgery, Monash Health, Melbourne, Vic, Australia.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Solman', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne Vic, Australia.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Tran', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne Vic, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Yarad', 'Affiliation': 'Malcolm Fischer Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Delaney', 'Affiliation': 'Malcolm Fischer Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Heart, lung & circulation",['10.1016/j.hlc.2019.04.006']
1237,31053213,Effects of Two-Week Sleep Extension on Glucose Metabolism in Chronically Sleep-Deprived Individuals.,"STUDY OBJECTIVES


Sleep deprivation is known to be associated with insulin resistance and diabetes risk. This study investigated whether 2-week sleep extension in chronically sleep-deprived individuals would improve glucose metabolism.
METHODS


A crossover study was conducted in volunteers without diabetes who reported sleeping ≤ 6 h/night. They were randomized to maintain their habitual sleep or extend sleep time for 2 weeks, then crossed over after a washout period. Sleep was monitored by actigraphy. Oral glucose tolerance tests (75 g) with insulin levels was performed at the end of each period. Mixed-effect linear regression analysis, adjusting for sequence and period effects, was applied.
RESULTS


A total of 21 participants (19 females) with mean (standard deviation) age of 33.1 (6.1) years completed the protocol. Mean sleep duration during habitual sleep was 318.7 (44.3) minutes and the participants extended their sleep by 36.0 (45.2) minutes during sleep extension. The average washout period was 21 (11) days. There were no significant effects of sleep extension on any metabolic parameters. The per-protocol analysis included eight participants who could sleep more than 6 hours during sleep extension (mean sleep duration 396 [25] minutes, extended by 60.1 [28.5] minutes). Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference -0.50 [95% confidence interval [CI] -0.89, -0.11,  P  = .013]), early insulin secretion (insulinogenic index; mean difference 0.39 [95% CI 0.15, 0.63,  P  = .001]), and β-cell function (disposition index, mean difference 1.07 [95% CI 0.17, 1.97,  P  = .02]).
CONCLUSIONS


Sleep extension in chronically sleep-deprived individuals improved glucose metabolism in only those who could objectively extend their sleep to more than 6 h/night. Our findings suggest that a critical amount of sleep is needed to benefit metabolic outcomes.",2019,"Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference","['volunteers without diabetes who reported sleeping ≤ 6 h/night', 'Chronically Sleep-Deprived Individuals', 'eight participants who could sleep more than 6 hours during sleep extension (mean sleep duration 396 [25] minutes, extended by 60.1 [28.5] minutes', '21 participants (19 females) with mean (standard deviation) age of 33.1 (6.1) years completed the protocol', 'chronically sleep-deprived individuals']",['Two-Week Sleep Extension'],"['early insulin secretion (insulinogenic index', 'Sleep', 'Glucose Metabolism', 'Oral glucose tolerance tests', 'glucose metabolism', 'β-cell function (disposition index', 'Homeostatic Model Assessment of Insulin Resistance', 'Mean sleep duration during habitual sleep']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]",8.0,0.0585718,"Among these individuals, sleep extension improved Homeostatic Model Assessment of Insulin Resistance (adjusted mean difference","[{'ForeName': 'Apichart', 'Initials': 'A', 'LastName': 'So-Ngern', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Naricha', 'Initials': 'N', 'LastName': 'Chirakalwasan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Suwannee', 'Initials': 'S', 'LastName': 'Chanprasertyothin', 'Affiliation': 'Research Center, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Thakkinstian', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirimon', 'Initials': 'S', 'LastName': 'Reutrakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7758']
1238,31174993,"Adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Many patients with type 2 diabetes do not achieve sustained diabetes remission after metabolic (bariatric) surgery for the treatment of obesity. Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes. Our aim was to assess the safety and efficacy of liraglutide 1·8 mg in patients with persistent or recurrent type 2 diabetes after metabolic surgery.
METHODS


In the GRAVITAS randomised double-blind, placebo-controlled trial, we enrolled adults who had undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and had persistent or recurrent type 2 diabetes with HbA 1c  levels higher than 48 mmol/mol (6·5%) at least 1 year after surgery from five hospitals in London, UK. Participants were randomly assigned (2:1) via a computer-generated sequence to either subcutaneous liraglutide 1·8 mg once daily or placebo, both given together with a reduced-calorie diet, aiming for a 500 kcal per day deficit from baseline energy intake, and increased physical activity. The primary outcome was the change in HbA 1c  from baseline to the end of the study period at 26 weeks, assessed in patients who completed the trial. Safety was assessed in the safety analysis population, consisting of all participants who received either liraglutide or placebo. This trial is registered with EudraCT, number 2014-003923-23, and the ISRCTN registry, number ISRCTN13643081.
FINDINGS


Between Jan 29, 2016, and May 2, 2018, we assigned 80 patients to receive either liraglutide (n=53) or placebo (n=27). 71 (89%) participants completed the study and were included in the principal complete-cases analysis. In a multivariable linear regression analysis, with baseline HbA 1c  levels and surgery type as covariates, liraglutide treatment was associated with a difference of -13·3 mmol/mol (-1·22%, 95% CI -19·7 to -7·0; p=0·0001) in HbA 1c  change from baseline to 26 weeks, compared with placebo. Type of surgery had no significant effect on the outcome. 24 (45%) of 53 patients assigned to liraglutide and 11 (41%) of 27 assigned to placebo reported adverse effects: these were mainly gastrointestinal and in line with previous experience with liraglutide. There was one death during the study in a patient assigned to the placebo group, which was considered unrelated to study treatment.
INTERPRETATION


These findings support the use of adjunctive liraglutide treatment in patients with persistent or recurrent type 2 diabetes after metabolic surgery.
FUNDING


JP Moulton Foundation.",2019,"Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes.","['Between Jan 29, 2016, and May 2, 2018', 'patients with persistent or recurrent type 2 diabetes after metabolic surgery', 'enrolled adults who had undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and had persistent or recurrent type 2 diabetes with HbA 1c  levels higher than 48 mmol/mol (6·5%) at least 1 year after surgery from five hospitals in London, UK', 'patients with type 2 diabetes', 'patients with persistent or recurrent type 2 diabetes after metabolic surgery (GRAVITAS']","['placebo', 'subcutaneous liraglutide 1·8 mg once daily or placebo, both given together with a reduced-calorie diet', 'liraglutide or placebo', 'Liraglutide, a glucagon-like peptide-1 analogue', 'liraglutide', 'Adjunctive liraglutide']","['change in HbA 1c', 'safety and efficacy', 'adverse effects', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet (finding)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",80.0,0.725018,"Liraglutide, a glucagon-like peptide-1 analogue, improves glycaemic control and reduces bodyweight in patients with type 2 diabetes.","[{'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Pérez-Pevida', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Madhawi', 'Initials': 'M', 'LastName': 'Aldhwayan', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kamocka', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Emma Rose', 'Initials': 'ER', 'LastName': 'McGlone', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK; Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Chahal', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Batterham', 'Affiliation': 'Centre for Obesity Research, Rayne Institute, Department of Medicine, University College London, London, UK; Bariatric Centre for Weight Management and Metabolic Surgery and National Institute for Health Research Biomedical Research Centre, University College London Hospital, London, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McGowan', 'Affiliation': ""Diabetes and Endocrinology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': ""Surgery, St George's University Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Greener', 'Affiliation': 'Diabetes and Endocrinology, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ahmed R', 'Initials': 'AR', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery & Cancer, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Petrie', 'Affiliation': 'Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scholtz', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Bloom', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Tan', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London and Imperial College Healthcare NHS Trust, London, UK. Electronic address: t.tan@imperial.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30157-3']
1239,31169568,Gabapentin and Memantine for Treatment of Acquired Pendular Nystagmus: Effects on Visual Outcomes.,"BACKGROUND


The most common causes of acquired pendular nystagmus (APN) are multiple sclerosis (MS) and oculopalatal tremor (OPT), both of which result in poor visual quality of life. The objective of our study was to evaluate the effects of memantine and gabapentin treatments on visual function. We also sought to correlate visual outcomes with ocular motor measures and to describe the side effects of our treatments.
METHODS


This study was single-center cross-over trial. A total of 16 patients with chronic pendular nystagmus, 10 with MS and 6 with OPT were enrolled. Visual acuity (in logarithm of the minimum angle of resolution [LogMAR]), oscillopsia amplitude and direction, eye movement recordings, and visual function questionnaires (25-Item National Eye Institute Visual Functioning Questionnaire [NEI-VFQ-25]) were performed before and during the treatments (gabapentin: 300 mg 4 times a day and memantine: 10 mg 4 times a day).
RESULTS


A total of 29 eyes with nystagmus were evaluated. Median near monocular visual acuity improved in both treatment arms, by 0.18 LogMAR on memantine and 0.12 LogMAR on gabapentin. Distance oscillopsia improved on memantine and on gabapentin. Median near oscillopsia did not significantly change on memantine or gabapentin. Significant improvement in ocular motor parameters was observed on both treatments. Because of side effects, 18.8% of patients discontinued memantine treatment-one of them for a serious adverse event. Only 6.7% of patients discontinued gabapentin. Baseline near oscillopsia was greater among those with higher nystagmus amplitude and velocity.
CONCLUSIONS


This study demonstrated that both memantine and gabapentin reduce APN, improving functional visual outcomes. Gabapentin showed a better tolerability, suggesting that this agent should be used as a first-line agent for APN. Data from our investigation emphasize the importance of visual functional outcome evaluations in clinical trials for APN.",2020,"Median near monocular visual acuity improved in both treatment arms, by 0.18 LogMAR on memantine and 0.12 LogMAR on gabapentin.","['16 patients with chronic pendular nystagmus, 10 with MS and 6 with OPT were enrolled', 'Acquired Pendular Nystagmus', '29 eyes with nystagmus']","['Gabapentin and Memantine', 'memantine and gabapentin', 'Gabapentin', 'memantine', 'gabapentin']","['Baseline near oscillopsia', 'Median near oscillopsia', 'Distance oscillopsia', 'functional visual outcomes', 'Median near monocular visual acuity', 'visual function', 'Visual acuity (in logarithm of the minimum angle of resolution [LogMAR]), oscillopsia amplitude and direction, eye movement recordings, and visual function questionnaires (25-Item National Eye Institute Visual Functioning Questionnaire [NEI-VFQ-25', 'ocular motor parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0271388', 'cui_str': 'Pendular Nystagmus'}, {'cui': 'C1282963', 'cui_str': 'Acquired pendular nystagmus (disorder)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0422980', 'cui_str': 'Movement of visual image - finding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",16.0,0.125518,"Median near monocular visual acuity improved in both treatment arms, by 0.18 LogMAR on memantine and 0.12 LogMAR on gabapentin.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Nerrant', 'Affiliation': ""Hospices Civils de Lyon (EN, LA, FP-V, A-LV, AV, CT), Neuro-Ophthalmology and Neuro-Cognition Unit, Hôpital Neurologique Pierre Wertheimer, Bron, France; Lyon I University (EN, SV, JB, AV, CT), Lyon, France; Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation, Hôpital Neurologique Pierre Wertheimer, Bron, France; INSERM U1028 CNRS UMR5292 Lyon Neuroscience Center, Team ImpAct (AV, CT) and Observatoire Français de la Sclérose en Plaques (SV), Bron, France; Hospices Civils de Lyon (JB), Pôle Information Médicale Evaluation Recherche Unit, Equipe d'Accueil 4129, Bron, France; and Hospices Civils de Lyon (BC), Pharmacie Department, Hôpital Neurologique Pierre Wertheimer, Bron, France.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Abouaf', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pollet-Villard', 'Affiliation': ''}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Vie', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vukusic', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Berthiller', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Colombet', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vighetto', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Tilikete', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000807']
1240,31033612,Corrective Exercises Improve Movement Efficiency and Sensorimotor Function but Not Fatigue Sensitivity in Chronic Ankle Instability Patients: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effect of corrective exercises on functional movement patterns, sensorimotor function, self-reported function, and fatigue sensitivity in collegiate athletes with chronic ankle instability (CAI).
DESIGN


A randomized controlled trial.
SETTING


Laboratory of sports sciences.
PARTICIPANTS


Forty male volunteers were randomly assigned to the experimental group (age 21.2 ± 1.7 years, height 174.5 ± 6.1 cm, and weight 69.6 ± 6.9 kg) or the control group (age 20.9 ± 1.8 years, height 178.2 ± 6.6 cm, and weight 68.8 ± 8.1 kg).
INTERVENTION


Participants in the experimental group performed supervised corrective exercises 3 times per week for 8 weeks. Fatigue was induced with a progressive treadmill protocol before and after the 8-week intervention.
MAIN OUTCOME MEASURES


Outcomes included movement efficiency during 3 squat tasks, static and dynamic postural control, strength of the ankle musculature, joint position sense, and self-reported function with the Foot and Ankle Ability Measure subscales. These outcomes were assessed before and immediately after fatiguing treadmill running both before and after 8-weeks of corrective exercises.
RESULTS


Significant improvements in movement efficiency, sensorimotor function, and self-reported function were noted in the experimental group relative to the control group (P < 0.001), in a nonfatigued state. However, in a fatigued stated, the experimental intervention only improved static postural control (P = 0.016) relative to the control group.
CONCLUSIONS


These findings demonstrate that 8-weeks of corrective exercises were effective at enhancing movement efficiency, sensorimotor function, and self-reported function in collegiate athletes with CAI. However, this intervention program has limited abilities at reducing the effects of fatigue.",2019,"However, in a fatigued stated, the experimental intervention only improved static postural control (P = 0.016) relative to the control group.
","['Forty male volunteers were randomly assigned to the experimental group (age 21.2 ± 1.7 years, height 174.5 ± 6.1 cm, and weight 69.6 ± 6.9 kg) or the control group (age 20.9 ± 1.8 years, height 178.2 ± 6.6 cm, and weight 68.8 ± 8.1 kg', 'Laboratory of sports sciences', 'collegiate athletes with chronic ankle instability (CAI', 'Chronic Ankle Instability Patients']","['supervised corrective exercises', 'Corrective Exercises', 'corrective exercises']","['functional movement patterns, sensorimotor function, self-reported function, and fatigue sensitivity', 'static postural control', 'movement efficiency, sensorimotor function, and self-reported function', 'movement efficiency during 3 squat tasks, static and dynamic postural control, strength of the ankle musculature, joint position sense, and self-reported function with the Foot and Ankle Ability Measure subscales', 'Fatigue']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0589515', 'cui_str': 'Sensorimotor functions (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense, function (observable entity)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",40.0,0.0370412,"However, in a fatigued stated, the experimental intervention only improved static postural control (P = 0.016) relative to the control group.
","[{'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Bagherian', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Rahnama', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000511']
1241,31152598,Prolonged-Release Tacrolimus Is Less Susceptible to Interaction With the Strong CYP3A Inhibitor Voriconazole in Healthy Volunteers.,"The nature and extent of drug-drug interactions between oral drugs is affected by numerous modulators. The effect of the formulation (prolonged release (PR) vs. immediate release (IR)) of a victim drug during treatment with a CYP3A (cytochrome P450 enzyme 3A4) inhibitor is unknown but expected to be smaller with PR. We studied PR and IR tacrolimus during treatment with the strong CYP3A inhibitor voriconazole in 18 healthy volunteers in a pharmacokinetic, four-phase, crossover trial. The exposure increase was significantly smaller after PR tacrolimus than after IR tacrolimus (AUC (area under the curve) 2.62-fold vs. 6.02-fold, P < 0.001; C max  (maximum concentration) 2.02-fold vs. 2.7-fold, P = 0.026) and less variable (AUC increase 1.6 to 4.8-fold vs. 1.8 to 19-fold). CYP3A5 genotype, voriconazole exposure, and CYP3A4 phenotype (determined with a midazolam microdose) were not related to the relative change in tacrolimus exposure. Thus, when considering drug-drug interactions with CYP3A inhibitors, the formulation of orally administered victim drugs should also be considered.",2019,"The exposure increase was significantly smaller after PR tacrolimus than after IR tacrolimus (AUC (area under the curve) 2.62-fold vs. 6.02-fold, P ","['18 healthy volunteers', 'Healthy Volunteers']","['CYP3A inhibitor voriconazole', 'CYP3A Inhibitor Voriconazole', 'PR tacrolimus', 'PR and IR tacrolimus']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850056', 'cui_str': 'CYP3A Inhibitors'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],18.0,0.0436131,"The exposure increase was significantly smaller after PR tacrolimus than after IR tacrolimus (AUC (area under the curve) 2.62-fold vs. 6.02-fold, P ","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Huppertz', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Department of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Kathrin I', 'Initials': 'KI', 'LastName': 'Foerster', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Burhenne', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zorn', 'Affiliation': 'Central Laboratory, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Czock', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Heidelberg, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1529']
1242,31147190,Paravertebral Block Versus Intercostal Nerve Block in Non-Intubated Uniportal Video-Assisted Thoracoscopic Surgery: A Randomised Controlled Trial.,"BACKGROUND


Non-intubated uniportal video-assisted thoracoscopic surgery (VATS) has been reported to be safe and feasible for patients with various thoracic diseases, including those who have respiratory dysfunction. This study examined the anaesthetic and analgesic sparing effects of either paravertebral block or intercostal nerve block on the non-intubated technique with spontaneous ventilation in patients under general anaesthesia (GA) using a supraglottic airway device. The primary aim was to compare the anaesthetic sparing effect of paravertebral block versus intercostal nerve block in non-intubated GA with airway support via a supraglottic airway device during VATS surgery. The secondary aim was to compare the recovery characters and postoperative outcomes of the patients.
METHODS


The study included 105 patients with American Society of Anesthesiologists (ASA) physical status II-III who had video-assisted thoracoscopy without endotracheal intubation and using a laryngeal airway. The patients were divided into three groups; each group consisted of 35 patients. Group I (35 patients): control group received only GA. Group 2 (35 patients): received a single-shot paravertebral block before induction of the GA. Group 3 (35 patients): received thoracoscopic intercostal block infiltration after induction of anaesthesia from the third to the eighth intercostal nerve block, in addition to intrathoracic vagal block. Heart rate, mean arterial pressure (MAP), and oxygen saturation were recorded before induction of GA (T0), after induction of GA (T1), 20 minutes later (T2), and before the end of the surgical procedure (T3).
RESULTS


Heart rate was significantly lower in Groups 2 and 3 compared with Group 1, and lower in Group 2 compared with Group 3. The MAP was significantly lower in Groups 2 and 3 compared with Group 1, and there was no significant difference between Groups 2 and 3. Oxygen saturation was significantly higher in Group 2 and in Group 3 compared with Group 1 and there was no significance difference between Groups 2 and 3. Expiratory fraction of sevoflurane (Ef sevo) was significantly lower in Groups 2 and 3 compared with Group 1, with no difference between Group 2 and 3. Groups 2 and 3 had lower fentanyl requirements, time to spontaneous eye movement, time to spontaneous arm movement, time to purposeful movement, and time to laryngeal mask removal than Group 1.
CONCLUSIONS


Regional anaesthesia by either preoperative paravertebral block or thoracoscopic intercostal nerve block with ipsilateral vagal block provided an anaesthetic sparing effect, guided by lower Ef sevo concentration, with comparable bi-spectral index in patients undergoing uniportal thoracoscopic surgery.",2020,"Expiratory fraction of sevoflurane (Ef sevo) was significantly lower in Groups 2 and 3 compared with Group 1, with no difference between Group 2 and 3.","['non-intubated GA with airway support via a supraglottic airway device during VATS surgery', '105 patients with American Society of Anesthesiologists (ASA) physical status II-III who had video-assisted thoracoscopy without endotracheal intubation and using a laryngeal airway', 'patients under general anaesthesia (GA) using a supraglottic airway device', 'patients undergoing uniportal thoracoscopic surgery', 'patients with various thoracic diseases, including those who have respiratory dysfunction']","['thoracoscopic intercostal block infiltration', 'control group received only GA', 'Intubated Uniportal Video-Assisted Thoracoscopic Surgery', 'single-shot paravertebral block before induction of the GA', 'paravertebral block versus intercostal nerve block', 'spontaneous ventilation', 'Paravertebral Block Versus Intercostal Nerve Block', 'paravertebral block or intercostal nerve block', 'intubated uniportal video-assisted thoracoscopic surgery (VATS']","['Expiratory fraction of sevoflurane (Ef sevo', 'fentanyl requirements, time to spontaneous eye movement, time to spontaneous arm movement, time to purposeful movement, and time to laryngeal mask removal', 'Oxygen saturation', 'Heart rate', 'Heart rate, mean arterial pressure (MAP), and oxygen saturation']","[{'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2923055', 'cui_str': 'Video assisted thoracoscopy (procedure)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C3873831', 'cui_str': 'Laryngeal airway'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0039978', 'cui_str': 'Thoracic Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1260922', 'cui_str': 'Abnormal breathing (finding)'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4304660', 'cui_str': 'Uniportal video assisted thoracoscopic surgery (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",105.0,0.0729709,"Expiratory fraction of sevoflurane (Ef sevo) was significantly lower in Groups 2 and 3 compared with Group 1, with no difference between Group 2 and 3.","[{'ForeName': 'Mona Mohamed', 'Initials': 'MM', 'LastName': 'Mogahed', 'Affiliation': 'Department of Anaesthesiology, SICU and pain therapy, Tanta University, El Bahr Road, Egypt. Electronic address: monamogahedfr@hotmail.com.'}, {'ForeName': 'Mohamed Shafik', 'Initials': 'MS', 'LastName': 'Elkahwagy', 'Affiliation': 'Department of Cardiothoracic surgery, Tanta University, Egypt. Electronic address: m_elkahwagy2005@hotmail.com.'}]","Heart, lung & circulation",['10.1016/j.hlc.2019.04.013']
1243,31174710,Brief interventions for young adults who use drugs: The moderating effects of resilience and trauma.,"Among participants in an intervention clinical trial (N = 602), we examined resilience as a moderator of substance use outcomes by intervention condition and between participants with and without severe traumatic stress (STS). Eligibility included men and women ages 18-39 with recent multidrug use; drug treatment enrollees were excluded. Outcome measures were past 90-day frequencies of substance use and abstinence. Putative moderators were measured using the Resilience Research Centre's Adult Resilience Measure (RRC-ARM) and the Traumatic Stress Scale from the Global Appraisal of Individual Needs (GAIN). Analyses employed hierarchical linear models. High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity. Participants with low resilience scores had poorer outcomes, and those outcomes were largely unaffected by intervention condition. Participants without STS experienced the interventions similarly to the overall sample. Regardless of the level of resilience, however, participants with STS did not benefit from the interventions. The findings point to the importance of screening for both resilience and traumatic stress prior to intervention to maximize the impact of brief interventions for substance users, and also to link those needing more intensive approaches to additional services and professional care.",2019,"High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity.","['participants with and without severe traumatic stress (STS', 'young adults who use drugs', 'Eligibility included men and women ages 18-39 with recent multidrug use; drug treatment enrollees were excluded']",[],"['past 90-day frequencies of substance use and abstinence', ""Resilience Research Centre's Adult Resilience Measure (RRC-ARM) and the Traumatic Stress Scale""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]",[],"[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",,0.08346,"High resilience predicted better substance use outcomes, and the ordering of intervention effects for high resilience participants was stepwise by intervention condition intensity.","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Kurtz', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, 7255 NE 4(th) Avenue, Suite 112, Miami, FL 33138, USA. Electronic address: steven.kurtz@nova.edu.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Pagano', 'Affiliation': 'Department of Psychiatry, Division of Child Psychiatry, Case Western Reserve University, 10524 Euclid Avenue #1155A, Cleveland, OH 44106, USA. Electronic address: Maria.Pagano@case.edu.'}, {'ForeName': 'Mance E', 'Initials': 'ME', 'LastName': 'Buttram', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, 7255 NE 4(th) Avenue, Suite 112, Miami, FL 33138, USA. Electronic address: mance.buttram@nova.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ungar', 'Affiliation': 'Resilience Research Centre, Dalhousie University, Halifax, Canada. Electronic address: Michael.Ungar@Dal.Ca.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.03.009']
1244,31179505,Impact of force magnitude on effectiveness in cervical headgear therapy: a cephalometric analysis.,"AIM


The main aim of this study was to study the impact of different force magnitudes on effectiveness in cervical headgear (CHG) therapy.
MATERIALS AND METHODS


Forty patients were treated with CHG with light (L; 300 g) or heavy (H; 500 g) force in this controlled clinical trial. Patients were asked to wear CHG for 10 hours/day for 10 months. The inner bow of the CHG was expanded (3-4 mm) and the long outer bow bent (10-20 degree) upward in relation to the inner bow. Adherence to instructions and force magnitude in CHG use was monitored by electronic module (Smartgear, Swissorthodontics, Switzerland). Lateral cephalograms were taken before (T1) and after (T2) the treatment and studied with modified Pancherz analysis using a Planmeca Romexis Ceph module (Planmeca, Finland).
RESULTS


In both groups, skeletal and dental effects were seen. The only statistically significant difference in cephalometric analysis was the inclination of upper incisors at T1 (P = 0.010) and at T2 (P = 0.011). In both groups, a reduction in Sella-Nasion- point A (SNA) angle was found: L group T1 82.7degree (SD ± 3.6degree), T2 82.0degree (SD ± 3.5 degree) and H group T1 82.6 degree (SD ± 4.7 degree), T2 81.5 degree (SD ± 4.5 degree), but no statistically significant difference between the groups. Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002).
CONCLUSION


Children with lower force CHG seem to adhere better to instructions for CHG use. After 10 months of use, no statistically significant differences were found in dental or skeletal outcome. However, in the H group, the outcome was achieved with less daily hours of use.",2019,"Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002).
","['Children with lower force', 'Forty patients were treated with']",['CHG with light (L; 300 g) or heavy'],"['Sella-Nasion- point A (SNA) angle', 'cephalometric analysis', 'dental or skeletal outcome', 'skeletal and dental effects', 'CHG']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0934420', 'cui_str': 'Nasion'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0407698', 'cui_str': 'Orthodontic cephalogram (procedure)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}]",40.0,0.0479585,"Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002).
","[{'ForeName': 'Tuula H', 'Initials': 'TH', 'LastName': 'Talvitie', 'Affiliation': 'Oral and Maxillofacial Unit, Tampere University Hospital, Turku, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Helminen', 'Affiliation': 'Research, Development and Innovation Centre, Tampere University Hospital, Turku, Finland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Karsila', 'Affiliation': 'Turku Municipal Health Care Services, Dental Teaching Unit, Turku, Finland.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Varho', 'Affiliation': 'Turku Municipal Health Care Services, Dental Teaching Unit, Turku, Finland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Signorelli', 'Affiliation': 'Clinic for Orthodontics and Pediatric Dentistry, Center for Dental Medicine, University of Zurich, Switzerland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Department of Oral Development and Orthodontics, Research Unit of Oral Health Sciences.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Peltomäki', 'Affiliation': 'Oral and Maxillofacial Unit, Tampere University Hospital, Turku, Finland.'}]",European journal of orthodontics,['10.1093/ejo/cjz022']
1245,31170275,Histomorphometric Analysis of Maxillary Sinus Grafts: A Pilot Study.,"PURPOSE


This pilot study evaluated and compared the degree of new bone formation following maxillary sinus graft (MSG) using three different bone graft materials.
MATERIAL AND METHODS


Patients with an edentulous posterior maxilla (unilateral or bilateral) were included in this study and underwent a two-stage procedure. Each sinus was randomly assigned one of the three graft materials: anorganic bovine bone mineral (ABBM), anorganic equine bone mineral (AEBM), or mineralized cancellous bone allograft (MCBA). Bone core samples were obtained from the lateral wall of the grafted sites at least 8 months after MSG. Bone quality was evaluated during bone core retrieval. The samples were histomorphometrically analyzed using Kruskal-Wallis and Dunn-Bonferroni tests at the significance level of α = .05.
RESULTS


A total of 28 sinuses (14 unilateral and 7 bilateral) from 21 subjects, with a mean age of 61.5 (range, 33-75) years, were included in the study. Twenty-eight bone cores (ABBM [n = 9], AEBM [n = 9], and MCBA [n = 10]) were obtained at a mean healing time of 9.1 (range, 8-12) months. Six maxillary sinus membrane perforations (≤ 5 mm) were noted and repaired during surgery (21.4%). Histomorphometric analysis of the harvested bone cores revealed statistically significant differences in the percentage of vital bone (VB%), residual bone materials (RBM%), and connective tissue/marrow (CT%) among the different graft materials (Kruskal-Wallis; P < .05). The VB% in the MCBA group (32.0% ± 12.4%) was significantly greater than those in the ABBM (10.9% ± 8.9%) and AEBM (9.1% ± 5.9%) groups (P < .05). The RBM% in the MCBA group (5.5% ± 5.7%) was, however, significantly less than those in the ABBM (34.3% ± 12.1%) and AEBM (38.9% ± 5.3%) groups (P < .05). There were no significant differences in VB% and RBM% between ABBM and AEBM (P = 1.0). Newly formed bone and residual graft materials were integrated into the surrounding tissue with no sign of inflammation or foreign-body reaction.
CONCLUSION


Within the confines of the study, MCBA has significantly greater new bone formation than ABBM and AEBM. AEBM showed comparable histomorphometric results in all parameters (VB%, RBM%, CT%) to ABBM.",2019,"Newly formed bone and residual graft materials were integrated into the surrounding tissue with no sign of inflammation or foreign-body reaction.
","['Patients with an edentulous posterior maxilla (unilateral or bilateral', 'Maxillary Sinus Grafts', 'A total of 28 sinuses (14 unilateral and 7 bilateral) from 21 subjects, with a mean age of 61.5 (range, 33-75) years, were included in the study']","['graft materials: anorganic bovine bone mineral (ABBM), anorganic equine bone mineral (AEBM), or mineralized cancellous bone allograft (MCBA', 'MCBA', 'maxillary sinus graft (MSG']","['Bone quality', 'VB% and RBM% between ABBM and AEBM', 'percentage of vital bone (VB%), residual bone materials (RBM%), and connective tissue/marrow (CT', 'AEBM', 'mean healing time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material (attribute)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",6.0,0.0249123,"Newly formed bone and residual graft materials were integrated into the surrounding tissue with no sign of inflammation or foreign-body reaction.
","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': ''}, {'ForeName': 'Joseph Ky', 'Initials': 'JK', 'LastName': 'Kan', 'Affiliation': ''}, {'ForeName': 'Kitichai', 'Initials': 'K', 'LastName': 'Rungcharassaeng', 'Affiliation': ''}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Roe', 'Affiliation': ''}, {'ForeName': 'Jaime L', 'Initials': 'JL', 'LastName': 'Lozada', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.6218']
1246,31039052,Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma.,"PURPOSE


Anti-programmed death-1 (PD-1) monotherapy induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma (cHL), but complete remission (CR) is infrequently observed. As decitabine is known to boost T-cell function, we assessed the safety and efficacy of anti-PD-1 camrelizumab alone versus decitabine-primed camrelizumab in patients with relapsed/refractory cHL.
METHODS


This two-arm, open-label, phase II study enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy. Anti-PD-1 treatment-naïve patients were randomly assigned (1:2) to camrelizumab (200 mg) monotherapy or decitabine (10 mg/d, days 1 to 5) plus camrelizumab (200 mg, day 8) combination therapy every 3 weeks. Patients who were previously treated with anti-PD-1 were assigned combination therapy. Primary end point was CR rate and safety.
RESULTS


Overall, 86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months. In anti-PD-1-naïve patients, CR rate was 32% (six of 19 patients) with camrelizumab monotherapy versus 71% (30 of 42 patients) who were administered decitabine plus camrelizumab ( P  = .003). At the time of analysis, the response duration rate at 6 months was 76% on camrelizumab monotherapy versus 100% on decitabine plus camrelizumab. For patients who were previously treated with anti-PD-1, 28% achieved CR and 24% partial response after decitabine plus camrelizumab. Ten patients maintained a response at more than 6 months and 81% of responders were estimated to have a response at more than 1 year. For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
CONCLUSION


CR rate in patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade was significantly higher with decitabine plus camrelizumab than with camrelizumab alone. Decitabine plus camrelizumab may reverse resistance to PD-1 inhibitors in patients with relapsed/refractory cHL.",2019,"For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
","['Refractory Classical Hodgkin Lymphoma', 'patients with relapsed/refractory classic Hodgkin lymphoma (cHL', '86 patients were enrolled and evaluated for response, with a median follow-up of 14.9 months', 'Patients who were previously treated with anti-PD-1', 'enrolled patients with relapsed/refractory cHL who had received at least two lines of previous therapy', 'patients with relapsed/refractory cHL', 'Anti-PD-1 treatment-naïve patients']","['decitabine plus camrelizumab', 'Decitabine plus camrelizumab', 'camrelizumab monotherapy', 'open-label', 'camrelizumab', 'camrelizumab (200 mg) monotherapy or decitabine']","['safety and efficacy', 'response duration rate', 'CR rate and safety', 'PD-1 blockade', 'CR rate']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",86.0,0.043294,"For both treatments, the most common adverse events were clinically inconsequential cherry hemangiomas and leukocytopenia that were self-limiting.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Chunmeng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Mei', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Ku', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Meixia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'An', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Malcolm V', 'Initials': 'MV', 'LastName': 'Brock', 'Affiliation': '2 John Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': ""1 Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02151']
1247,31042410,"Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial.","PURPOSE


The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB).
PATIENTS AND METHODS


In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG - with LSG) in the mean number of histologically detected SLNs had to be greater than -0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases.
RESULTS


Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, -0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences.
CONCLUSION


We show that SLNB is equally effective irrespective of the surgeon's knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.",2019,One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG.,"['Early Breast Cancer', 'sentinel lymph node biopsy (SLNB', 'One thousand one hundred two evaluable patients', 'Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers', 'patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB']","['Lymphoscintigraphy', 'preoperative lymphoscintigraphy (LSG', 'SLNB']",['mean number of histologically detected SLNs'],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}]","[{'cui': 'C0412375', 'cui_str': 'Lymphoscintigraphy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]",1198.0,0.128431,One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG.,"[{'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kuemmel', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Holtschmidt', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': '2 University of Rostock, Rostock, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Von der Assen', 'Affiliation': '3 Niels-Stensen-Kliniken, Georgsmarienhütte, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': '4 University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Thill', 'Affiliation': '5 Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': '4 University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': '6 University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': '8 Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Lubitz', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jens Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': '9 Breast Center of the Charité, Berlin, Germany.'}, {'ForeName': 'Mattea', 'Initials': 'M', 'LastName': 'Reinisch', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hötzeldt', 'Affiliation': '11 Brustzentrum Asklepios Harzklinik, Goslar, Germany.'}, {'ForeName': 'Fenja', 'Initials': 'F', 'LastName': 'Seither', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Schwidde', 'Affiliation': '12 Die Frauenärztinnen Mülheim an der Ruhr, Mülheim, Germany.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Uhrhan', 'Affiliation': '13 Zentrum für Nuklearmedizin und Molekulare Bildgebung Essen, Essen, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': '14 Luisenkrankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Mulowski', 'Affiliation': '1 Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': '10 German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kuehn', 'Affiliation': '15 Clinic Esslingen, Esslingen, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02092']
1248,31722702,"Impact of the intervention program ""JolinchenKids - fit and healthy in daycare"" on energy balance related-behaviors: results of a cluster controlled trial.","BACKGROUND


The purpose of this study was to evaluate the multi-component health promotion program, JolinchenKids - fit and healthy in daycare, designed to promote physical activity (PA), healthy eating, and mental wellbeing among 3- to 6-year-old preschoolers.
METHODS


For this cluster controlled trial, 62 daycare facilities (DFs) from thirteen different federal states in Germany were recruited (31 intervention, 31 control DFs). Outcome measures were children's habitual PA, fruits and vegetable consumption, consumption of unsweetened beverages and snacks with parents as raters. Study nurses assessed children's body composition and motor skills. Data was collected at baseline and 12 months later. To track adherence to the implementation of intervention modules at individual DF groups, an implementation calendar was used from baseline to follow-up. Linear mixed models were used to investigate effects for survey, group and their interaction at the individual level while accounting for clustering.
RESULTS


Samples of 831 (baseline) and 641 (follow-up) children aged 4.3 ± 0.8 and 5.2 ± 0.8 years were analysed. More than half of the intervention DFs chose the nutrition or PA module for the first year of implementation while an implementation level of > 50% was only achieved in less than a third. A significant intervention effect (survey × group interaction) was found for the standing long jump favouring children at intervention DFs (β = 3.08; 95% Confidence interval [CI]: (0.09; 6.07)). No significant intervention effects were found for time spent on PA, total screen time, dietary habits, and body composition, i.e. body-mass-index and percentage of body fat.
CONCLUSIONS


Participation in JolinchenKids - fit and healthy in daycare led to improvements in some indicators for motor skills. However, other health outcomes and behaviours were not affected by program participation over the course of 1 year.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00011065 (Date of registration 16-09-2016).",2019,"No significant intervention effects were found for time spent on PA, total screen time, dietary habits, and body composition, i.e. body-mass-index and percentage of body fat.
","['62 daycare facilities (DFs) from thirteen different federal states in Germany were recruited (31 intervention, 31 control DFs', 'Samples of 831 (baseline) and 641 (follow-up) children aged 4.3\u2009±\u20090.8 and 5.2\u2009±\u20090.8\u2009years were analysed']","['intervention program ""JolinchenKids - fit and healthy in daycare']","['physical activity (PA), healthy eating, and mental wellbeing', 'time spent on PA, total screen time, dietary habits, and body composition, i.e. body-mass-index and percentage of body fat', ""children's body composition and motor skills"", ""children's habitual PA, fruits and vegetable consumption, consumption of unsweetened beverages and snacks with parents as raters""]","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",,0.0736359,"No significant intervention effects were found for time spent on PA, total screen time, dietary habits, and body composition, i.e. body-mass-index and percentage of body fat.
","[{'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Steenbock', 'Affiliation': 'Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstrasse 30, 28359, Bremen, Germany. steenbock@leibniz-bips.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Buck', 'Affiliation': 'Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstrasse 30, 28359, Bremen, Germany.'}, {'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Zeeb', 'Affiliation': 'Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstrasse 30, 28359, Bremen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rach', 'Affiliation': 'Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstrasse 30, 28359, Bremen, Germany.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Pischke', 'Affiliation': 'Centre for Health and Society, Medical Faculty, Institute of Medical Sociology, Heinrich Heine University Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}]",BMC pediatrics,['10.1186/s12887-019-1817-8']
1249,31162549,The Effects of Dapagliflozin on Systemic and Renal Vascular Function Display an Epigenetic Signature.,"CONTEXT


Mechanisms mediating the cardiovascular and renal protection exerted by SGLT2 inhibitors are still partially unknown. We investigated whether dapagliflozin modulates systemic and renal vascular function and structure, and induces epigenetic modifications.
SUBJECTS AND METHODS


Forty hypertensive patients with type 2 diabetes were randomly assigned to 4-week treatment with dapagliflozin 10 mg or hydrochlorothiazide (HCT) 12.5 mg. Routine analyses; plasma renin activity; aldosterone, catecholamine, and 24-hour urinary electrolyte levels; flow-mediated dilation (FMD) of the brachial artery; carotid-femoral pulse-wave velocity (PWV); augmentation index; and resistive index and dynamic renal resistive index (DRIN) were measured at baseline and after treatment. Circulating miRNAs (miRs) related to heart failure (miR30e-5p, miR199a-3p), endothelial dysfunction (miR27b and miR200b), and renal function (miR130b-3p, miR21-5p) were assessed and related to the effects of treatments.
RESULTS


Dapagliflozin and HCT marginally lowered blood pressure. Fasting glucose was lowered, whereas 24-hour diuresis, glycosuria, and osmolar clearance were increased by dapagliflozin (P < 0.001 for all), without affecting sodium excretion and glomerular filtration rate. Magnesium levels significantly increased after dapagliflozin treatment (P = 0.02). Neither dapagliflozin nor HCT modified FMD or PWV. DRIN did not vary in the dapagliflozin group, whereas it increased in the HCT group (P = 0.047 for time by treatment interaction). Both treatments induced variations in the expression of some miRs; dapagliflozin, but not HCT, significantly up-regulated miR30e-5p and downregulated miR199a-3p.
CONCLUSION


A putative epigenetic regulation of the protecting cardiovascular effect exerted by SGLT2 inhibitors was found. Dapagliflozin might exert nephroprotection by preserving renal vasodilating capacity.",2019,"Both treatments induced variations in the expression of some miRNA; dapagliflozin, but not hydrochlorothiazide, significantly up-regulated miR30e-5p and down-regulated miR199a-3p.
",['Forty hypertensive patients with type 2 diabetes'],"['Magnesium', 'dapagliflozin 10mg or hydrochlorothiazide', 'hydrochlorothiazide', 'dapagliflozin and hydrochlorothiazide', 'dapagliflozin']","['blood pressure', '24h diuresis, glycosuria and osmolar clearance', 'sodium excretion and glomerular filtration rate', 'plasma renin activity, aldosterone, catecholamines, 24 hour-urinary electrolytes, flow-mediated dilation of the brachial artery (FMD), carotid-femoral pulse-wave velocity (PWV), Augmentation Index (AIx) and baseline (RI) and dynamic renal resistive index (DRIN', 'heart failure (miR30e-5p, miR199a-3p), endothelial dysfunction (miR27b and miR200b) and renal function', 'DRIN', 'Fasting glucose']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0439351', 'cui_str': 'osmolar'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",40.0,0.0250506,"Both treatments induced variations in the expression of some miRNA; dapagliflozin, but not hydrochlorothiazide, significantly up-regulated miR30e-5p and down-regulated miR199a-3p.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Seghieri', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Giannini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dardano', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Taddei', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Ghiadoni', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00706']
1250,30182376,The impact of a primary health care intervention on infant feeding practices: a cluster randomised controlled trial in Brazil.,"BACKGROUND


Proper feeding practices in early life can enhance the full human potential development of children. We aimed to evaluate the impact of a primary health care intervention on infant feeding practices among children from low-income families.
METHODS


A cluster randomised controlled trial was conducted in Porto Alegre, Brazil. Healthcare centres were randomised into intervention (n = 9) and control (n = 11) groups. In intervention sites, health workers were trained in accordance with the national guidelines. Infant feeding practices were assessed in children at 6 months (n = 617) and 12 months (n = 516) of age. Feeding practice quality was assessed using the Infant and Child Feeding Index (ICFI). Additionally, we evaluated the introduction of nonrecommended foods.
RESULTS


At 6 months, the mean ICFI score was higher in the intervention group [MD = 0.22; 95% confidence interval (CI) = 0.24-1.11]. The prevalence of infants who met the recommendation for meat into the food-frequency score was higher in the intervention than the control group [relative risk (RR) = 1.63; 95% CI = 1.26-2.11]. At 12 months of age, the ICFI mean (MD = 0.23; 95% CI = 0.35-0.56) and the prevalence of children who met the recommendation for dietary diversity (RR = 1.11; 95% CI = 1.01-1.22) and meal frequency (RR = 4.68; 95% CI = 1.34-16.36) were higher in the intervention group, although only among children who had more than seven follow-up appointments during the first year of life. The children from intervention group had a significant delay for added sugar (MD = 0.51; 95% CI = 0.13-0.89), tea (mean = 0.47; 95% CI = 0.13-0.82), jelly (MD = 0.35; 95% CI = 0.11-0.58) and filled cookies (MD = 0.29; 95% CI = 0.06-0.52) compared to the control group.
CONCLUSIONS


The health workers' training was effective with respect to improving infant feeding practices.",2019,"At 6 months, the mean ICFI score was higher in the intervention group [MD = 0.22; 95% confidence interval (CI) = 0.24-1.11].","['children from low-income families', 'Healthcare centres', 'infant feeding practices']",['primary health care intervention'],"['significant delay for added sugar', 'filled cookies', 'dietary diversity', 'meal frequency', 'Feeding practice quality', 'mean ICFI score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C3853210', 'cui_str': 'Cookie (substance)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0567465', 'cui_str': 'Feeding practice (regime/therapy)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",617.0,0.135041,"At 6 months, the mean ICFI score was higher in the intervention group [MD = 0.22; 95% confidence interval (CI) = 0.24-1.11].","[{'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Ferreira', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Sangalli', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Leffa', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rauber', 'Affiliation': 'Faculdade de Saúde Pública, University of São Paulo, São Paulo, Brasil.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Vitolo', 'Affiliation': 'Nutrition Research Group (NUPEN), Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brasil.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12595']
1251,31125092,Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment.,"CONTEXT


Evidence for further nonvertebral fracture (NVF) reductions with long-term antiresorptive therapy in osteoporosis is lacking.
OBJECTIVE


To evaluate NVF risk reduction in subjects receiving ≤10 years of denosumab treatment.
DESIGN


Phase 3, randomized, placebo-controlled, 3-year Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial (NCT00089791) and its open-label 7-year extension (NCT00523341).
SETTING


One hundred seventy-two study centers worldwide.
PATIENTS


Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both).
INTERVENTIONS


Subjects randomly assigned 1:1 denosumab 60 mg SC Q6M (long-term) or placebo (crossover) in FREEDOM; eligible subjects could enroll in the extension to receive denosumab 60 mg SC Q6M.
MAIN OUTCOME MEASURES


NVF Exposure-adjusted subject incidence (per 100 subject-years) during denosumab treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3.
RESULTS


Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) = 0.72 (0.61 to 0.86); P < 0.001]; in long-term only were 1.98 (1.67 to 2.34) during years 1 to 3 and 1.44 (1.24 to 1.66) during years 4 to 10 [RR = 0.74 (0.60 to 0.93); P = 0.008]. combined osteonecrosis of the jaw and atypical femoral fracture rate was 0.06.
CONCLUSIONS


Long-term denosumab treatment, >3 and ≤10 years, was associated with further reductions in NVF rates compared with the first 3 years.",2019,"Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) =","['Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both', 'Osteoporosis', '4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) ', 'One hundred seventy-two study centers worldwide', 'subjects receiving ≤10 years of denosumab treatment', 'treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3']","['placebo', 'Denosumab', 'denosumab 60 mg SC Q6M (long-term) or placebo', 'denosumab 60 mg SC Q6M', 'denosumab']","['combined osteonecrosis of the jaw and atypical femoral fracture rate', 'Nonvertebral Fracture Reduction', 'NVF rates', 'NVF risk reduction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4517506', 'cui_str': '1.53'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",4074.0,0.03351,"Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) =","[{'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Butler', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Lakewood, Colorado.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Roux', 'Affiliation': 'Paris Descartes University, Paris, France.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Wagman', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, New Mexico.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00271']
1252,31145833,Association between advanced cancer patient-caregiver agreement regarding prognosis and hospice enrollment.,"BACKGROUND


Patients with advanced, incurable cancer who understand their illness is incurable are more likely to prefer hospice care at the end of life compared with patients who believe their illness is curable. To the authors' knowledge, it is unclear whether patient-caregiver agreement regarding perceived prognosis is associated with hospice enrollment.
METHODS


The current study examined the prospective relationship between patient-caregiver agreement concerning perceived prognosis and hospice enrollment in the last 30 days of life. Data were collected during a cluster randomized controlled trial examining a communication intervention for oncologists and patients with advanced cancer and their caregivers. At the time of study entry, patients and caregivers (141 dyads) were categorized as endorsing a ""good"" prognosis if they: 1) reported a >50% chance of surviving ≥2 years; or if they 2) predicted that the patient's quality of life 3 months into the future would be ≥7 on an 11-point scale.
RESULTS


Approximately one-fifth of dyads agreed on a poor prognosis whereas approximately one-half disagreed regarding prognosis. In approximately one-third of dyads, patients and caregivers both believed the patient's future quality of life would be good (34%) and that the patient would live for ≥2 years (30%). Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
CONCLUSIONS


Dyadic understanding of patients' projected life expectancy and future quality of life appears to be predictive of care received at the end of life. Improving rates of hospice enrollment may be best achieved with dyadic interventions.",2019,"Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
","['Patients with advanced, incurable cancer', 'oncologists and patients with advanced cancer and their caregivers']",['communication intervention'],"['life expectancy and future quality of life', 'life expectancy and poor future quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0034380'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",,0.12627,"Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Megan Johnson', 'Initials': 'MJ', 'LastName': 'Shen', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, University of California at Davis, Davis, California.'}, {'ForeName': 'Guibo', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': 'Department of Pediatrics, University of California at Davis, Davis, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Department of Psychology, Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}]",Cancer,['10.1002/cncr.32188']
1253,31051248,Telephone call reminders did not increase screening uptake more than SMS reminders: a recruitment study within a trial.,"OBJECTIVES


The aim of the study was to compare the response rates and costs of phone call vs. short message service (SMS) screening reminders to prospective randomized controlled trial (RCT) participants.
STUDY DESIGN AND SETTING


This study was a randomized evaluation within a large Australian diabetes prevention RCT. Participants were men aged 50-74 years, overweight or obese, without a previous type 2 diabetes diagnosis. Those eligible on a prescreening questionnaire who did not attend a further screening assessment within 4 weeks were randomized to receive an SMS or phone call reminder (N = 709). The primary outcome was attendance for further screening assessment within 8 weeks of prescreening.
RESULTS


Attendance was 18% (62/354) in the SMS reminder group, and 23% (80/355) in the phone reminder group, with no statistically significant difference in response according to reminder type (relative risk = 1.29, 95% confidence interval [CI]: 0.96-1.73, P = 0.09). The lower confidence limits for response to SMS (95% CI: 14-22%) and phone reminders (95% CI: 18-27%) did not include the 8-week attendance rate before this evaluation, 12%. Phone reminders cost substantially more than SMS reminders (AU$6.21 vs. AU$0.53 per reminder).
CONCLUSION


SMS reminders were as adequate a method as phone reminders to boost RCT screening uptake and were considerably more affordable.",2019,"Phone reminders cost substantially more than SMS reminders (AU$6.21 vs. AU$0.53 per reminder).
","['Participants were men aged 50-74\xa0years, overweight or obese, without a previous type 2 diabetes diagnosis', 'Those eligible on a prescreening questionnaire who did not attend a further screening assessment within 4\xa0weeks']","['phone call vs. short message service (SMS) screening reminders', 'Telephone call reminders', 'SMS or phone call reminder']","['attendance for further screening assessment within 8\xa0weeks of prescreening', '8-week attendance rate', 'screening uptake']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3178909'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",,0.322478,"Phone reminders cost substantially more than SMS reminders (AU$6.21 vs. AU$0.53 per reminder).
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bracken', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia. Electronic address: karen.bracken@ctc.usyd.edu.au.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Allan', 'Affiliation': 'Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'Anzac Research Institute and Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Health Research Institute, University of Canberra, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine, The Austin Hospital, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Handelsman', 'Affiliation': 'Anzac Research Institute and Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Warrick', 'Initials': 'W', 'LastName': 'Inder', 'Affiliation': 'Department of Diabetes and Endocrinology, Princess Alexandra Hospital, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stuckey', 'Affiliation': 'Keogh Institute of Medical Research and Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Bu B', 'Initials': 'BB', 'LastName': 'Yeap', 'Affiliation': 'Department of Endocrinology and Diabetes, Fiona Stanley Hospital and Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Freemasons Foundation Centre for Mens Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.04.009']
1254,30155772,"Correction to: Ginkgo biloba extract EGb 761 ®  versus pentoxifylline in chronic tinnitus: a randomized, double-blind clinical trial.","The article Ginkgo biloba extract EGb 761 ®  versus pentoxifylline in chronic tinnitus: a randomized, double-blind clinical trial, written by Klára Procházková, Ivan Šejna, Jan Skutil and Aleš Hahn, was originally published electronically on the publisher's internet portal (currently SpringerLink).",2018,"The article Ginkgo biloba extract EGb 761 ®  versus pentoxifylline in chronic tinnitus: a randomized, double-blind clinical trial, written by Klára Procházková, Ivan Šejna, Jan Skutil and Aleš Hahn, was originally published electronically on the publisher's internet portal (currently SpringerLink).",['chronic tinnitus'],['Ginkgo biloba extract EGb 761 ®  versus pentoxifylline'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}]","[{'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C1095795', 'cui_str': 'EGb 761'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]",[],,0.699958,"The article Ginkgo biloba extract EGb 761 ®  versus pentoxifylline in chronic tinnitus: a randomized, double-blind clinical trial, written by Klára Procházková, Ivan Šejna, Jan Skutil and Aleš Hahn, was originally published electronically on the publisher's internet portal (currently SpringerLink).","[{'ForeName': 'Klára', 'Initials': 'K', 'LastName': 'Procházková', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Kralovske Vinohrady, Šrobárova 50, 10034, Prague, Czech Republic. klara.prochazkova@gmail.com.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Šejna', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Kralovske Vinohrady, Šrobárova 50, 10034, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Skutil', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Kralovske Vinohrady, Šrobárova 50, 10034, Prague, Czech Republic.'}, {'ForeName': 'Aleš', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Kralovske Vinohrady, Šrobárova 50, 10034, Prague, Czech Republic.'}]",International journal of clinical pharmacy,['10.1007/s11096-018-0704-y']
1255,30892615,Changes in pharyngeal airway dimensions following incremental and maximum bite advancement during Herbst-rapid palatal expander appliance therapy in late adolescent and young adult patients: a randomized non-controlled prospective clinical study.,"OBJECTIVES


This was a parallel, assessor-blinded, randomized, non-controlled prospective trial with the objective to evaluate and compare the effects of maximum advancement (MA) and incremental advancement (IA) of mandible with cast-splint-type Herbst-rapid palatal expander (RPE) appliance on pharyngeal airway dimensions and hyoid bone position in skeletal Class II late adolescents and young adults.
MATERIALS AND METHODS


A total of 48 patients (19 male and 29 female, mean age: 15.45 ± 1.42 years) with skeletal Class II malocclusion were treated with cast-splint Herbst-RPE appliance. Inclusion criteria were skeletal Class II malocclusion, mandibular retrognathia, bilateral Class II molar and canine relationship, increased overjet, normal or decreased vertical dimensions, minimal crowding, and no missing teeth. Enrolled subjects were randomly allocated into two groups according to mandibular advancement type: IA and MA Herbst-RPE therapy. The outcome assessor was blinded. Advancement in MA group was adjusted until tête-à-tête incisor relationship or super Class I molar relationship was obtained. Initial forward movement in IA group was 4-5 mm and followed by bimonthly 2 mm of subsequent advancements. Skeletal, pharyngeal airway, and hyoid measurements were performed using lateral cephalometric films. Statistical significance was set at P value of less than 0.05.
RESULTS


Hypopharyngeal airway dimensions (P < 0.000), oropharyngeal airway dimensions (P < 0.001, P < 0.007), and PASmin values (P < 0.010, P < 0.009) were increased and soft palate angle (P < 0.018, P < 0.007) was decreased in MA and IA groups significantly. Hyoid bone measurements revealed a significant difference in H-Cv2 distance (MA: P < 0.002-P < 0.002; IA: P < 0.001-P < 0.043) and H-Cv3 distance (P < 0.005, P < 0.001) for both groups. However, all these changes did not differ among the MA and IA activation groups. ANB°, Wits, overjet, and overbite measurements decreased and SNB°, Co-Gn, Na-Me, ANS-Me, and S-Go increased with the treatment significantly in both mandibular advancement groups (P < 0.000-P < 0.040).
CONCLUSIONS


Herbst-RPE appliance provided a similar improvement in the oropharyngeal and hypopharyngeal airway dimensions and similar changes in sagittal and vertical hyoid position for both maximum and IA protocols in patients with skeletal Class II malocclusion.
TRIAL REGISTRATION


ISRCTN69743543.",2019,Hyoid bone measurements revealed a significant difference in H-Cv2 distance (MA: P < 0.002-P,"['skeletal Class II late adolescents and young adults', 'patients with skeletal Class II malocclusion', 'late adolescent and young adult patients', 'Inclusion criteria were skeletal Class II malocclusion, mandibular retrognathia, bilateral Class II molar and canine relationship, increased overjet, normal or decreased vertical dimensions, minimal crowding, and no missing teeth', '48 patients (19 male and 29 female, mean age: 15.45 ± 1.42 years) with skeletal Class II malocclusion']","['cast-splint Herbst-RPE appliance', 'maximum advancement (MA) and incremental advancement (IA) of mandible with cast-splint-type Herbst-rapid palatal expander (RPE) appliance', 'Herbst-RPE appliance', 'incremental and maximum bite advancement during Herbst-rapid palatal expander appliance therapy', 'mandibular advancement type: IA and MA Herbst-RPE therapy']","['oropharyngeal airway dimensions', 'H-Cv2 distance', 'Hypopharyngeal airway dimensions', 'PASmin values', 'H-Cv3 distance', 'soft palate angle', 'pharyngeal airway dimensions', 'oropharyngeal and hypopharyngeal airway dimensions']","[{'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3494422', 'cui_str': 'Retrognathias'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0042569', 'cui_str': 'Vertical Dimension'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0441308', 'cui_str': 'Cast splint (physical object)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0243112'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}]","[{'cui': 'C0150694', 'cui_str': 'Oropharyngeal airway'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0450811', 'cui_str': 'CV2 (body structure)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0450812', 'cui_str': 'CV3 (body structure)'}, {'cui': 'C0030219', 'cui_str': 'Velum Palatinum'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}]",48.0,0.0597592,Hyoid bone measurements revealed a significant difference in H-Cv2 distance (MA: P < 0.002-P,"[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Gul Amuk', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Erciyes University, Kayseri.'}, {'ForeName': 'Gokmen', 'Initials': 'G', 'LastName': 'Kurt', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bezmialem University, Istanbul.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Baysal', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Izmir Katip Çelebi University, Izmir.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Turker', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Mersin University, Turkey.'}]",European journal of orthodontics,['10.1093/ejo/cjz011']
1256,31133474,Physical Exercise Improves Function in Acutely Hospitalized Older Patients: Secondary Analysis of a Randomized Clinical Trial.,"OBJECTIVES


To evaluate the effects of an exercise intervention on physical function, maximal muscle strength, and muscle power in very old hospitalized patients.
DESIGN


In a randomized controlled trial, 130 hospitalized patients were allocated to an exercise intervention (n = 65) or a control group (n = 65). The intervention consisted of a multicomponent exercise training program performed during 5-7 consecutive days (2 sessions/d). The usual care group received habitual hospital care, which included physical rehabilitation when needed.
SETTING AND PARTICIPANTS


Acute care for elderly unit. Older adults age >75 years.
MEASURES


Physical function, assessed with the Short Physical Performance Battery test and the Gait Velocity Test (GVT), were the primary endpoints. The GVT was also administered under dual-task conditions (ie, verbal and arithmetic GVT). The functional tasks were recorded using an inertial sensor unit to determine the movement pattern. The secondary endpoints were maximal muscle strength and muscle power output.
RESULTS


The exercise intervention program provided significant benefits over usual care. At discharge (primary time point), the exercise group showed a mean increase of 1.7 points in the Short Physical Performance Battery scale (95% confidence interval [CI] 0.98, 2.42) and 0.14 m·s-1 in the GVT (95% CI 0.086, 0.194) over the usual care group. The intervention also improved the verbal (0.151; 95% CI 0.119, 0.184 vs -0.001; 95% CI -0.025, 0.033 in the control group) and arithmetic GVT (0.115; 95% CI 0.077, 0.153 vs -0.004; 95% CI -0.044, 0.035). Significant benefits were also observed in the intervention group in movement pattern, as well as in muscle strength and muscle power.
CONCLUSIONS AND IMPLICATIONS


An individualized multicomponent exercise training program improves physical function, maximal muscle strength, and muscle power in acutely hospitalized older patients. These findings support the importance of physical exercise for avoiding the loss of physical functional capacity that frequently occurs during hospitalization in older adults.",2019,"The intervention also improved the verbal (0.151; 95% CI 0.119, 0.184 vs -0.001; 95% CI -0.025, 0.033 in the control group) and arithmetic GVT (0.115; 95% CI 0.077, 0.153 vs -0.004; 95% CI -0.044, 0.035).","['very old hospitalized patients', 'Older adults age >75\xa0years', 'acutely hospitalized older patients', 'Acute care for elderly unit', '130 hospitalized patients', 'older adults', 'Acutely Hospitalized Older Patients']","['habitual hospital care, which included physical rehabilitation when needed', 'Physical Exercise', 'individualized multicomponent exercise training program', 'multicomponent exercise training program', 'exercise intervention', 'physical exercise', 'exercise intervention program']","['Short Physical Performance Battery test and the Gait Velocity Test (GVT', 'arithmetic GVT', 'Short Physical Performance Battery scale', 'physical function, maximal muscle strength, and muscle power', 'maximal muscle strength and muscle power output', 'muscle strength and muscle power']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}]",130.0,0.0569571,"The intervention also improved the verbal (0.151; 95% CI 0.119, 0.184 vs -0.001; 95% CI -0.025, 0.033 in the control group) and arithmetic GVT (0.115; 95% CI 0.077, 0.153 vs -0.004; 95% CI -0.044, 0.035).","[{'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain; Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain; Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain; Geriatric Department, Complejo Hospitalario de Navarra (CHN), Pamplona, Navarra, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Casas-Herrero', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain; Geriatric Department, Complejo Hospitalario de Navarra (CHN), Pamplona, Navarra, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucía', 'Affiliation': ""CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain; Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain; Research Institute of the Hospital 12 de Octubre ('i+12'), Madrid, Spain.""}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain; Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain; CIBER of Frailty and Healthy Aging (CIBERFES), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: mikel.izquierdo@gmail.com.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.04.001']
1257,31013172,Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma.,"PURPOSE


SARC024 is a phase II clinical trial of the multikinase inhibitor regorafenib in specific sarcoma subtypes, including advanced osteosarcoma. We hypothesized that regorafenib would improve progression-free survival (PFS) in patients with sarcoma and report the results of the osteosarcoma cohort.
PATIENTS AND METHODS


This trial enrolled patients with progressive metastatic osteosarcoma with measurable disease by RECIST who had received at least one prior line of therapy. Patients were randomly assigned at a ratio of one to one to regorafenib or placebo. Crossover was allowed at time of disease progression. PFS was the primary end point of the study, which was powered to detect a difference of at least 3 months in median PFS.
RESULTS


Forty-two patients from 12 centers were enrolled between September 2014 and May 2018. Median age was 37 years (range, 18 to 76 years). Patients had received an average of 2.3 prior therapy regimens. Ten patients receiving placebo crossed over to active drug at time of progression. Study enrollment was stopped early, after a data safety monitoring committee review. Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;  P  = .017). In the context of the crossover design, there was no statistically significant difference in overall survival. Fourteen (64%) of 22 patients initially randomly assigned to regorafenib experienced grade 3 to 4 events attributed to treatment, including one grade 4 colonic perforation.
CONCLUSION


The study met its primary end point, demonstrating activity of regorafenib in patients with progressive metastatic osteosarcoma. No new safety signals were observed. Regorafenib should be considered a treatment option for patients with relapsed metastatic osteosarcoma.",2019,"Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;  P  = .017).","['Patients With Metastatic Osteosarcoma', 'enrolled patients with progressive metastatic osteosarcoma with measurable disease by RECIST who had received at least one prior line of therapy', 'Median age was 37 years (range, 18 to 76 years', 'Forty-two patients from 12 centers were enrolled between September 2014 and May 2018', 'patients with relapsed metastatic osteosarcoma', 'patients with sarcoma', 'patients with progressive metastatic osteosarcoma']","['regorafenib or placebo', 'regorafenib', 'placebo', 'Regorafenib']","['activity of regorafenib', 'progression-free survival (PFS', 'PFS', 'overall survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278512', 'cui_str': 'Metastatic osteosarcoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",42.0,0.260789,"Median PFS was significantly improved with regorafenib versus placebo: 3.6 months (95% CI, 2.0 to 7.6 months) versus 1.7 months (95% CI, 1.2 to 1.8 months), respectively (hazard ratio, 0.42; 95% CI, 0.21 to 0.85;  P  = .017).","[{'ForeName': 'Lara E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': '1 Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bolejack', 'Affiliation': '2 Cancer Research and Biostatistics, Seattle, WA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': '1 Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Ganjoo', 'Affiliation': '3 Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Loggers', 'Affiliation': '4 Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Sant', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': '5 Sarcoma Oncology Research Center, Santa Monica, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Agulnik', 'Affiliation': '6 Northwestern University, Chicago, IL.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Livingston', 'Affiliation': '7 Levine Cancer Institute, Charlotte, NC.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Reed', 'Affiliation': '8 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Keedy', 'Affiliation': '9 Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rushing', 'Affiliation': '10 Indiana University, Bloomington, IN.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Okuno', 'Affiliation': '11 Mayo Clinic Rochester, Rochester, MN.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Reinke', 'Affiliation': '12 Sarcoma Alliance for Research Through Collaboration, Ann Arbor, MI.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Riedel', 'Affiliation': '13 Duke Cancer Institute, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': '14 Mayo Clinic Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""15 Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA.""}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': '16 Monter Cancer Center, Northwell Health, Lake Success, NY, and Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02374']
1258,31141176,The efficacy of a single imaginal exposure-writing assignment in reducing posttraumatic stress and depressive symptoms: A pilot study.,"OBJECTIVE


This online study examined the effects of a single imaginal exposure-writing assignment on posttraumatic stress (PTS) and comorbid depressive symptoms.
METHOD


Forty-six participants with PTS were allocated to either a single imaginal exposure-writing assignment, a nontrauma writing assignment, or to a nonwriting control condition, and were reassessed 2 and 5 weeks after baseline. Of the 49 participants, 36 were female, with an average age of 23. Participation was conducted through Qualtrics. Effects were assessed with the Posttraumatic Diagnostic Scale (PDS) and the Beck Depression Inventory-II (BDI-II).
RESULTS


PTS and depressive symptoms decreased over time regardless of the study condition.
CONCLUSIONS


We found no support for the efficacy of a single imaginal exposure-writing assignment in reducing PTS or comorbid depressive symptoms. Suggestions are given for future studies that attempt to identify a minimal dose of imaginal exposure writing for PTS.",2019,We found no support for the efficacy of a single imaginal exposure-writing assignment in reducing PTS or comorbid depressive symptoms.,"['49 participants, 36 were female, with an average age of 23', 'Forty-six participants with PTS']","['single imaginal exposure-writing assignment', 'single imaginal exposure-writing assignment, a nontrauma writing assignment, or to a nonwriting control condition']","['posttraumatic stress and depressive symptoms', 'depressive symptoms', 'Posttraumatic Diagnostic Scale (PDS) and the Beck Depression Inventory-II (BDI-II']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",46.0,0.0499802,We found no support for the efficacy of a single imaginal exposure-writing assignment in reducing PTS or comorbid depressive symptoms.,"[{'ForeName': 'Yvonne D', 'Initials': 'YD', 'LastName': 'Vinke', 'Affiliation': 'HSK, Mental Health Care Institution, Lelystad, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Truijens', 'Affiliation': 'Department of Psychology and Pedagogical Science, University of Ghent, Ghent, Belgium.'}, {'ForeName': 'Esmee', 'Initials': 'E', 'LastName': 'van Polanen Petel', 'Affiliation': 'PSYTREC, Mental Health Care Institution, Leusden, The Netherlands.'}, {'ForeName': 'Arnold A P', 'Initials': 'AAP', 'LastName': 'van Emmerik', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}]",Journal of clinical psychology,['10.1002/jclp.22802']
1259,31132908,Relevance of the assessment mode in the digital assessment of processing speed.,"Introduction : Many medical facilities and research institutes start using digital assessment methods to assess cognitive abilities, such as processing speed, instead of the traditional pen and paper versions. Even though many of the new digital assessment methods have shown to have a stable internal validity, the comparability of results across assessment modes is unclear. The study investigated whether results for assessing processing speed via (i) the traditional pen and paper version, (ii) a tablet and pen version, and (iii) a tablet and finger version are comparable.  Methods : In a within-subject design, each participant ( N = 30) completed the 90-number version by Oswald and Roth (1987) of the trail-making test (TMT) in three different assessment modes in randomized order. Each participant completed four TMT versions in each assessment mode (3 × 4 within-subject design).  Results : Repeated measures ANOVA and mixed-effects analyses adjusted for age, gender, mode order, and trial number reveal significantly faster test TMT completion times (about 5 s) for the tablet and pen version compared to the pen and paper and the tablet and finger version.  Conclusions : Our findings indicate that assessing processing speed can lead to different results with different digital versions depending on their setup, especially different input devices. Medical professionals and researchers who use digital assessment methods to assess cognitive abilities need to be aware of mode effects, even within the digital assessment domain, because the results may not be comparable and the available norms may not be applicable.",2019,"Repeated measures ANOVA and mixed-effects analyses adjusted for age, gender, mode order, and trial number reveal significantly faster test TMT completion times (about 5 s) for the tablet and pen version compared to the pen and paper and the tablet and finger version.  ",[],['90-number version by Oswald and Roth (1987) of the trail-making test (TMT'],[],[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}]",[],,0.0242617,"Repeated measures ANOVA and mixed-effects analyses adjusted for age, gender, mode order, and trial number reveal significantly faster test TMT completion times (about 5 s) for the tablet and pen version compared to the pen and paper and the tablet and finger version.  ","[{'ForeName': 'Francisca S', 'Initials': 'FS', 'LastName': 'Rodriguez', 'Affiliation': 'a Center for Cognitive Science , University of Kaiserslautern , Kaiserslautern , Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Spilski', 'Affiliation': 'a Center for Cognitive Science , University of Kaiserslautern , Kaiserslautern , Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'c Computer graphics & HCI, Department of Computer Science , University of Kaiserslautern , Kaiserslautern , Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hekele', 'Affiliation': 'a Center for Cognitive Science , University of Kaiserslautern , Kaiserslautern , Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lachmann', 'Affiliation': 'a Center for Cognitive Science , University of Kaiserslautern , Kaiserslautern , Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Ebert', 'Affiliation': 'a Center for Cognitive Science , University of Kaiserslautern , Kaiserslautern , Germany.'}, {'ForeName': 'Franca Alexandra', 'Initials': 'FA', 'LastName': 'Rupprecht', 'Affiliation': 'c Computer graphics & HCI, Department of Computer Science , University of Kaiserslautern , Kaiserslautern , Germany.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1616079']
1260,31119404,Correction to: An Anti-hyperventilation Instruction Decreases the Drop in End-tidal CO 2  and Symptoms of Hyperventilation During Breathing at 0.1 Hz.,"The original version of this article unfortunately contained an error in abstract section. The number of participants should be ""Forty-six participants"" instead of ""Thirty-six participants"". The correct sentence is as follows: Forty-six participants were randomly assigned to one of two groups: a group given an anti-hyperventilation instruction and a control group without such an instruction. The original article has been corrected.",2019,Forty-six participants were randomly assigned to one of two groups: a group given an anti-hyperventilation instruction and a control group without such an instruction.,['Forty-six participants'],['anti-hyperventilation instruction and a control group without such an instruction'],[],[],"[{'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],46.0,0.0264887,Forty-six participants were randomly assigned to one of two groups: a group given an anti-hyperventilation instruction and a control group without such an instruction.,"[{'ForeName': 'Mikołaj Tytus', 'Initials': 'MT', 'LastName': 'Szulczewski', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Stawki 5/7, 00-183, Warsaw, Poland. mikolaj.szulczewski@psych.uw.edu.pl.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-019-09441-3']
1261,31141079,SAFETY AND EFFICACY OF EUS-GUIDED COIL PLUS CYANOACRYLATE VERSUS CONVENTIONAL CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES: A RANDOMIZED CONTROLLED TRIAL.,"BACKGROUND


One of the most feared complications with the use of cyanoacrylate for treatment of gastric varices is the occurrence of potentially life-threatening systemic embolism. Thus, endoscopists are turning towards new techniques, including endoscopic coiling, as a potentially safer and more effective treatment option. However, no studies have been performed comparing the two techniques.
OBJECTIVE


This study aims to compare the safety and efficacy of endoscopic ultrasound guided coil and cyanoacrylate injection versus the conventional technique of injection of cyanoacrylate alone.
DESIGN


A pilot randomized controlled trial.
METHODS


Patients randomized into group I were treated with coil and cyanoacrylate, and those in group II with cyanoacrylate alone. Flow within the varix was evaluated immediately after the treatment session and one month following initial treatment. If thrombosis was confirmed, additional follow-up was performed 4 and 10 months following initial treatment. All patients underwent a thoracic computerized tomography scan after the procedure.
RESULTS


A total of 32 patients, 16 in each group, were followed for an average of 9.9 months (range 1-26 months). Immediately after the procedure, 6 (37.5%) group-I patients and 8 (50%) group-II patients presented total flow reduction in the treated vessel (P=0.476). After 30 days, 11 (73.3%) group-I patients and 12 (75%) group-II patients were found to have varix thrombosis. In both groups, the majority of patients required only one single session for varix obliteration (73.3% in group I versus 80% in group II). Asymptomatic pulmonary embolism occurred in 4 (25%) group-I patients and 8 (50%) group-II patients (P=0.144). No significant difference between the groups was observed.
CONCLUSION


There is no statistical difference between endoscopic ultrasound guided coils plus cyanoacrylate versus conventional cyanoacrylate technique in relation to the incidence of embolism. However, a greater tendency towards embolism was observed in the group treated using the conventional technique. Both techniques have similar efficacy in the obliteration of varices. Given the small sample size of our pilot data, our results are insufficient to prove the clinical benefit of the combined technique, and do not yet justify its use, especially in light of higher cost. Further studies with larger sample size are warranted.",2019,There is no statistical difference between endoscopic ultrasound guided coils plus cyanoacrylate versus conventional cyanoacrylate technique in relation to the incidence of embolism.,['OF GASTRIC VARICES'],"['endoscopic ultrasound guided coil and cyanoacrylate injection', 'thoracic computerized tomography scan', 'cyanoacrylate alone', 'coil and cyanoacrylate', 'conventional cyanoacrylate technique', 'cyanoacrylate']","['safety and efficacy', 'tendency towards embolism', 'varix obliteration', 'total flow reduction', 'varix thrombosis', 'Asymptomatic pulmonary embolism']","[{'cui': 'C0017145', 'cui_str': 'Gastric Varix'}]","[{'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylates'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0441633'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0332465', 'cui_str': 'Obliteration (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",32.0,0.0414168,There is no statistical difference between endoscopic ultrasound guided coils plus cyanoacrylate versus conventional cyanoacrylate technique in relation to the incidence of embolism.,"[{'ForeName': 'Maíra Ribeiro de Almeida', 'Initials': 'MRA', 'LastName': 'Lôbo', 'Affiliation': 'Universidade de São Paulo, Faculdade de Medicina, Departamento de Gastroenterologia, Hospital das Clínicas, Serviço de Endoscopia Gastrointestinal, São Paulo, SP, Brasil.'}, {'ForeName': 'Dalton Marques', 'Initials': 'DM', 'LastName': 'Chaves', 'Affiliation': 'Universidade de São Paulo, Faculdade de Medicina, Departamento de Gastroenterologia, Hospital das Clínicas, Serviço de Endoscopia Gastrointestinal, São Paulo, SP, Brasil.'}, {'ForeName': 'Diogo Turiani Hourneaux', 'Initials': 'DTH', 'LastName': 'DE Moura', 'Affiliation': 'Universidade de São Paulo, Faculdade de Medicina, Departamento de Gastroenterologia, Hospital das Clínicas, Serviço de Endoscopia Gastrointestinal, São Paulo, SP, Brasil.'}, {'ForeName': 'Igor Braga', 'Initials': 'IB', 'LastName': 'Ribeiro', 'Affiliation': 'Universidade de São Paulo, Faculdade de Medicina, Departamento de Gastroenterologia, Hospital das Clínicas, Serviço de Endoscopia Gastrointestinal, São Paulo, SP, Brasil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ikari', 'Affiliation': 'Universidade de São Paulo, Faculdade de Medicina, Hospital das Clinicas, Instituto do Coração, Diagnóstico por Imagem, São Paulo, SP, Brasil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'DE Moura', 'Affiliation': 'Universidade de São Paulo, Faculdade de Medicina, Departamento de Gastroenterologia, Hospital das Clínicas, Serviço de Endoscopia Gastrointestinal, São Paulo, SP, Brasil.'}]",Arquivos de gastroenterologia,['10.1590/S0004-2803.201900000-08']
1262,30995176,"Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.","PURPOSE


A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies.
PATIENTS AND METHODS


Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety.
RESULTS


The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases.
CONCLUSION


IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure.",2019,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","['patients with relapsed chronic lymphocytic leukemia (CLL', 'Patients With Relapsed Chronic Lymphocytic Leukemia', 'Patients', '110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study', 'patients with relapsed CLL']","['IDELA', 'Rituximab With or Without Idelalisib', 'IDELA monotherapy', 'placebo plus rituximab', 'IDELA-plus-rituximab (IDELA/R', 'idelalisib (IDELA) plus rituximab', 'rituximab', 'rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo']","['PFS and OS', 'grade and grade 3 or greater colitis', 'pneumonitis', 'progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety', 'diarrhea', 'median OS', 'ORR', 'median PFS', 'incidence of elevated hepatic aminotransferases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",110.0,0.412396,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': '1 Willamette Valley Cancer Institute and Research Center, US Oncology Research, Springfield, OR.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': '2 Stanford School of Medicine, Stanford, CA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': '3 Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '4 Georgetown University Hospital, Washington DC.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': '5 Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""6 St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': '7 Zucher School of Medicine at Hofstra/Northwell, New Hyde Park, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '8 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': '9 University of California, San Diego, Moores Cancer Center, La Jolla, CA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': '10 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': '11 Università Vita-Salute San Raffaele and Istituto Di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': '12 David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ervin', 'Affiliation': '13 Venice Regional Bayfront Health, Venice, FL.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lamanna', 'Affiliation': '14 Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': '15 Centre Hospitalier Lyon-Sud, Pierre Benite, France.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': '16 University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': '17 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': '18 Ulm University, Ulm, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': '21 University of California, Irvine, Orange, CA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': '18 Ulm University, Ulm, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01460']
1263,31140540,"The effect of perindopril on echocardiographic parameters, NYHA functional class and serum NT-proBNP values in patients with diastolic heart failure.","INTRODUCTION


Growing evidence has demonstrated that diastolic heart failure occurs in about half of heart failure (HF) patients. We investigated the effects of perindopril on echocardiographic parameters, New York Heart Association (NYHA) functional class and serum N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in patients with diastolic heart failure.
METHODS


In total, 108 diastolic heart failure patients aged ≥ 50 years, who had diastolic dysfunction with an ejection fraction ≥ 50%, were enrolled and randomised to one of the two study groups. Perindopril was initiated in the study group and the control group was given standard therapy. Echocardiographic parameters, NT-proBNP levels and NYHA classes were recorded. The patients were followed for 11 (three to 16) months. Eighty-eight patients completed the study.
RESULTS


Although diastolic parameters were not changed, A' (septal) velocity (10.8 vs 9.9 cm/s) and Sm (septal) velocity (8.5 vs 7.6 cm/s) were significantly increased in the perindopril compared to the control group. A significant increase in A' (septal) velocity (+0.61 vs -0.28 cm/s, p = 0.04) and a slight increase in Sm (septal) velocity (+0.99 vs 0.36 cm/s, p = 0.054) were noted in the perindopril group.
CONCLUSIONS


Tissue Doppler septal late diastolic velocities and septal systolic myocardial velocities increased in the perindopril group but NT-proBNP levels, and NYHA class was not changed in this study population.",2019,"A significant increase in A' (septal) velocity (+0.61 vs -0.28 cm/s, p = 0.04) and a slight increase in Sm (septal) velocity (+0.99 vs 0.36 cm/s, p = 0.054) were noted in the perindopril group.
","['patients with diastolic heart failure', '108 diastolic heart failure patients aged ≥ 50 years, who had diastolic dysfunction with an ejection fraction ≥ 50', 'Eighty-eight patients completed the study']","['perindopril', 'Perindopril']","['echocardiographic parameters, New York Heart Association (NYHA) functional class and serum N-terminal pro B-type natriuretic peptide (NT-proBNP) levels', ""A' (septal) velocity"", 'diastolic parameters', 'echocardiographic parameters, NYHA functional class and serum NT-proBNP values', 'Echocardiographic parameters, NT-proBNP levels and NYHA classes', 'Sm (septal) velocity', 'Tissue Doppler septal late diastolic velocities and septal systolic myocardial velocities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1135196', 'cui_str': 'Heart Failure, Diastolic'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0136123', 'cui_str': 'Perindopril'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",108.0,0.0247089,"A significant increase in A' (septal) velocity (+0.61 vs -0.28 cm/s, p = 0.04) and a slight increase in Sm (septal) velocity (+0.99 vs 0.36 cm/s, p = 0.054) were noted in the perindopril group.
","[{'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Yuksek', 'Affiliation': 'Department of Cardiology, Near East University Hospital, Nicosia, Cyprus.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Cerit', 'Affiliation': 'Department of Cardiology, Near East University Hospital, Nicosia, Cyprus. Email: drcerit@hotmail.com.'}, {'ForeName': 'Nihan Kahya', 'Initials': 'NK', 'LastName': 'Eren', 'Affiliation': 'Department of Cardiology, Izmir Ataturk Education and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Ergene', 'Affiliation': 'Department of Cardiology, 9 Eylul University Hospital, Izmir, Turkey.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-022']
1264,30706792,Effect of a Physical Activity Program on Serum Biochemical Parameters among the Elderly Women.,"BACKGROUND


The present study examined the efficacy of the walking program on biochemical parameters among the elderly women.
METHODS


A total of one hundred elderly women participated in this randomized clinical trial study. The intervention group attended a 24-week walking exercise meeting five times per week. The control group continued with their routine activities. The subjects were assessed in Fasting blood glucose (FBS) and lipid profile before and after 12 and 24 weeks of the program.
RESULTS


The mean age of the elderly participants in the study was 68.33 ± 4.55 years. The results of repeated measures ANOVA showed a significant difference between the intervention and the control group in FBS, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol after completing the program (for all p < 0.001).
CONCLUSION


The low-cost physical activity intervention could be effective for reducing chronic vascular disease risk factors among community-dwelling elderly women.",2019,"The results of repeated measures ANOVA showed a significant difference between the intervention and the control group in FBS, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol after completing the program (for all p < 0.001).
","['mean age of the elderly participants in the study was 68.33 ± 4.55 years', 'community dwelling elderly women', 'elderly women', 'A total of one hundred elderly women', 'Elderly Women']","['physical activity intervention', 'Physical Activity Program', '24-week walking exercise meeting five times per week', 'walking program']","['Serum Biochemical Parameters', 'chronic vascular disease risk factors', 'Fasting blood glucose (FBS) and lipid profile', 'FBS, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",100.0,0.0133992,"The results of repeated measures ANOVA showed a significant difference between the intervention and the control group in FBS, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol after completing the program (for all p < 0.001).
","[{'ForeName': 'Seyedeh Ameneh', 'Initials': 'SA', 'LastName': 'Motalebi', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Jamileh Amirzadeh', 'Initials': 'JA', 'LastName': 'Iranagh', 'Affiliation': 'Social Determinants of Health Research Centre (SDH), Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Reviews on recent clinical trials,['10.2174/1574887114666190201113809']
1265,31101480,Using Herbs and Spices to Increase Vegetable Intake Among Rural Adolescents.,"OBJECTIVE


To test whether adding herbs and spices to school lunch vegetables increases selection and intake compared with lightly salted control versions among rural adolescents.
DESIGN


This study compared intake of vegetables with herbs and spices with lightly salted controls (phase I) and tested whether 5 repeated exposures would increase students' intake of herb and spice seasoned vegetables (phase II).
PARTICIPANTS AND SETTING


A total of 600-700 students at a rural middle/high school (age 11-18 years).
INTERVENTION


In phase I, herbs and spices were added to 8 vegetables and outcomes were compared with 8 control recipes. In phase II, the impact of repeated exposure to herb and spice blends served on different vegetables was assessed.
MAIN OUTCOMES


Vegetable selection rates, weighed intake, and willingness to eat again.
ANALYSIS


Two-way ANOVAs tested effects of condition (herbs and spices vs control; before vs after exposure) and age (middle vs high school) on selection and intake.
RESULTS


In phase I, students ate more control than seasoned broccoli (P = .01), cauliflower (P = .006), and green beans (P = .01), and high schoolers generally consumed more seasoned vegetables than did middle schoolers (P < .03). In phase II, repeated exposure to herbs and spices increased reported willingness to eat again for seasoned broccoli (P = .003).
CONCLUSIONS AND IMPLICATIONS


In a short-term intervention, herbs and spices did not produce robust increases in school lunch vegetable intake among rural adolescents, but limited repeat exposure may increase students' willingness to consume these flavors. Additional work is needed to identify individual and school-level characteristics that affect students' willingness to select and consume vegetables with herbs and spices.",2019,"In a short-term intervention, herbs and spices did not produce robust increases in school lunch vegetable intake among rural adolescents, but limited repeat exposure may increase students' willingness to consume these flavors.","['Rural Adolescents', ""students' intake of herb and spice seasoned vegetables (phase II"", 'A total of 600-700 students at a rural middle/high school (age 11-18 years', 'rural adolescents']","['adding herbs and spices to school lunch vegetables', 'vegetables with herbs and spices with lightly salted controls']","['school lunch vegetable intake', 'Vegetable selection rates, weighed intake, and willingness to eat again', 'willingness to eat again for seasoned broccoli']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0453242', 'cui_str': 'Herbs and spices (substance)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0453242', 'cui_str': 'Herbs and spices (substance)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0330499', 'cui_str': 'Broccoli'}]",,0.0195961,"In a short-term intervention, herbs and spices did not produce robust increases in school lunch vegetable intake among rural adolescents, but limited repeat exposure may increase students' willingness to consume these flavors.","[{'ForeName': 'Juliana R', 'Initials': 'JR', 'LastName': 'Fritts', 'Affiliation': 'Department of Food Science, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Bermudez', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Hargrove', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Alla', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fort', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Qihan', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Cravener', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': ""D'Adamo"", 'Affiliation': 'Department of Family and Community Medicine, Department of Epidemiology and Public Health, Center for Integrative Medicine, University of Maryland, Baltimore, MD.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hayes', 'Affiliation': 'Department of Food Science, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'Department of Food Science, Pennsylvania State University, University Park, PA; Department of Nutritional Sciences, Pennsylvania State University, University Park, PA. Electronic address: klk37@psu.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.04.016']
1266,31101732,Reply to: Randomized controlled trial of a simplified adductor canal block performed for analgesia following total knee arthroplasty.,,2019,,['total knee arthroplasty'],['simplified adductor canal block'],[],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",[],,0.164333,,"[{'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Swenson', 'Affiliation': 'Department of Anesthesiology, University of Utah, Salt Lake City, Utah, USA Jeff.Swenson@hsc.utah.edu.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Davis', 'Affiliation': 'Department of Anesthesiology, University of Utah, Salt Lake City, Utah, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2019-100667']
1267,31108818,"Choosing a front-of-package warning label for Brazil: A randomized, controlled comparison of three different label designs.","INTRODUCTION


Warning labels (WLs) are the newest paradigm of nutrient-based, front-of-package labels (FOP) that have been consistently shown to be more effective at informing consumer purchases than other FOP labels. Their effectiveness may be attributed to their design and the consistency in the information they communicate. The present study assessed designs effects of WLs in improving understanding and perceptions among 2419 Brazilian adults.
METHODS


Participants were randomly assigned to one of four study arms in an online, randomized, controlled experiment: (1) the Triangular WL 'A lot of /Muito' (Muito); (2) Triangular WL 'High in/Alto em' (Alto); (3) the Chilean WL 'High in/Alto em' (Chile); and (4) a control condition (no WL). Participants responded to a series of questions, while viewing images of 9 products, that assessed their understanding of the nutrient content of the product, its healthfulness, and their intentions to purchase. All aggregate differences in responses between study arms were estimated using oneway-ANOVAs.
RESULTS


WLs were superior to the list of ingredients and the nutrition facts panel in improving participant understanding and perceptions of the nutrient profile of products, particularly in helping identify nutrients in excess. Alto was significantly better than the control at identifying which of the two products contained an excess of nutrients and at improving consumer understanding of nutrient content across different indicators. Alto, followed by Muito, was also better at communicating that fewer WLs signified a healthier product. The Muito WL was significantly more visible to participants than the Chile WL. There were no differences between study arms in shifting consumer purchase intentions.
CONCLUSIONS


In this study, WLs were an important addition to the current nutrition label. The triangular symbol, the white background and the signal word, 'High in/ Alto em' showed consistently better results than the signal word 'A lot of/ Muito' and the octagonal symbol. These design elements serve to make WLs more visible to consumers, capturing their attention and informing their food evaluations, and may have greater potential to influence appropriate for a Brazilian audience.",2019,Alto was significantly better than the control at identifying which of the two products contained an excess of nutrients and at improving consumer understanding of nutrient content across different indicators.,"['2419 Brazilian adults', 'Participants']","[""Triangular WL 'A lot of /Muito' (Muito); (2) Triangular WL 'High in/Alto em' (Alto); (3) the Chilean WL 'High in/Alto em' (Chile); and (4) a control condition (no WL""]",['Muito WL'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205119', 'cui_str': 'Triangular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],2419.0,0.054721,Alto was significantly better than the control at identifying which of the two products contained an excess of nutrients and at improving consumer understanding of nutrient content across different indicators.,"[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Khandpur', 'Affiliation': 'Center for Epidemiological Studies in Health and Nutrition (NUPENS), Faculty of Public Health, University of São Paulo, Brazil. Electronic address: neha.khandpur@usp.br.'}, {'ForeName': 'Laís Amaral', 'Initials': 'LA', 'LastName': 'Mais', 'Affiliation': ""Brazilian Institute for Consumer's Defense (IDEC), Brazil.""}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'de Morais Sato', 'Affiliation': 'Center for Epidemiological Studies in Health and Nutrition (NUPENS), Faculty of Public Health, University of São Paulo, Brazil.'}, {'ForeName': 'Ana Paula Bortoletto', 'Initials': 'APB', 'LastName': 'Martins', 'Affiliation': ""Brazilian Institute for Consumer's Defense (IDEC), Brazil.""}, {'ForeName': 'Carla Galvão', 'Initials': 'CG', 'LastName': 'Spinillo', 'Affiliation': 'Research Group of Digital and Information Design, Department of Design, Federal University of Paraná, Brazil.'}, {'ForeName': 'Carlos Felipe Urquizar', 'Initials': 'CFU', 'LastName': 'Rojas', 'Affiliation': 'Research Group of Digital and Information Design, Department of Design, Federal University of Paraná, Brazil.'}, {'ForeName': 'Mariana Tarricone', 'Initials': 'MT', 'LastName': 'Garcia', 'Affiliation': 'Health Institute, São Paulo State Health Secretariat, Brazil.'}, {'ForeName': 'Patrícia Constante', 'Initials': 'PC', 'LastName': 'Jaime', 'Affiliation': 'Center for Epidemiological Studies in Health and Nutrition (NUPENS), Faculty of Public Health, University of São Paulo, Brazil.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.01.008']
1268,31111344,Improving Compliance with Very Low Energy Diets (VLEDs) Prior to Bariatric Surgery-a Randomised Controlled Trial of Two Formulations.,"INTRODUCTION


Preoperative very low energy diets (VLEDs) improve access during bariatric surgery. Compliance with traditional VLED is variable, mainly due to gastrointestinal side effects. Formulite™ is a new formulation of VLED, with higher protein, soluble fibre and probiotics.
AIMS


To compare traditional VLED (Optifast™) with the new VLED (Formulite™) and assess compliance, weight loss, satisfaction, side effects and surgical access.
METHODS


This was a randomised double-blinded study involving patients scheduled for bariatric surgery. The primary outcome was compliance, assessed by urinary ketone concentration and proportion of patients in ketosis at 2 weeks. Secondary outcomes were weight loss, satisfaction and patient reported outcomes, gastrointestinal side effects and operative conditions.
RESULTS


There were 69 participants: 35 in the Formulite™ group and 34 in the Optifast™ group. Ketosis at 2 weeks was achieved in both groups (88.5% vs 83.3%, Formulite™ vs. Optifast™, p = 0.602). Urinary ketones were higher with Formulite™ (1.5 vs 15 mmol/L, p = 0.030). Total body weight loss percentage, hunger and operative conditions were similar in both groups. Formulite™ produced less flatulence (score 3 vs 2, p = 0.010) and emotional eating (score 2 vs 1, p = 0.037); however, Optifast™ ranked higher in terms of taste (score 4 vs 3, p = 0.001) and overall satisfaction (score 5 vs 7, p = 0.011).
CONCLUSIONS


Compliance over 2 weeks was high in both VLEDs with most subjects achieving ketosis. Overall satisfaction was moderately high, although variable. Whilst Formulite™ is a viable alternative to Optifast™, better formulations of VLED that addresses key adverse effects, whilst achieving ketosis, would be of significant value.",2019,"Urinary ketones were higher with Formulite™ (1.5 vs 15 mmol/L, p = 0.030).","['69 participants: 35 in the Formulite™ group and 34 in the Optifast™ group', 'patients scheduled for bariatric surgery']","['Preoperative very low energy diets (VLEDs', 'Very Low Energy Diets (VLEDs', 'traditional VLED (Optifast™) with the new VLED (Formulite™']","['overall satisfaction', 'Overall satisfaction', 'Urinary ketones', 'compliance, weight loss, satisfaction, side effects and surgical access', 'Ketosis', 'flatulence', 'emotional eating', 'Total body weight loss percentage, hunger and operative conditions', 'weight loss, satisfaction and patient reported outcomes, gastrointestinal side effects and operative conditions', 'urinary ketone concentration and proportion of patients in ketosis']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet (finding)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1287282', 'cui_str': 'Finding of ketone concentration, dipstick (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",69.0,0.140943,"Urinary ketones were higher with Formulite™ (1.5 vs 15 mmol/L, p = 0.030).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Davenport', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia.'}, {'ForeName': 'Yazmin', 'Initials': 'Y', 'LastName': 'Johari', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia.'}, {'ForeName': 'Alexandria', 'Initials': 'A', 'LastName': 'Klejn', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Laurie', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of General Surgery, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Geraldine J', 'Initials': 'GJ', 'LastName': 'Ooi', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Burton', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Brown', 'Affiliation': 'Monash University Department of Surgery, Central Clinical School, Monash University, Level 6, 99 Commercial Road, Melbourne, 3004, Australia. Wendy.Brown@med.monash.edu.au.'}]",Obesity surgery,['10.1007/s11695-019-03916-2']
1269,29799065,Correction to: No difference in mid-term survival and clinical outcome between patient-specific and conventional instrumented total knee arthroplasty: a randomized controlled trial.,"In the original article, one of the co-author's (W. van der Weegen) middle name has been missed in the publication of the article. The correct complete name should be W. van der Weegen.",2019,"In the original article, one of the co-author's (W. van der Weegen) middle name has been missed in the publication of the article.",['patient-specific and conventional instrumented total knee arthroplasty'],[],['mid-term survival and clinical outcome'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",[],"[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0358258,"In the original article, one of the co-author's (W. van der Weegen) middle name has been missed in the publication of the article.","[{'ForeName': 'M G M', 'Initials': 'MGM', 'LastName': 'Schotanus', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, H vd Hoffplein 1, 6162 AG, Sittard-Geleen, The Netherlands. martijnschotanus@hotmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Boonen', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Center, H vd Hoffplein 1, 6162 AG, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'van der Weegen', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Drumpt', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borghans', 'Affiliation': 'Department of Radiology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Department of Methodology and Statistics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van Rhijn', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Kort', 'Affiliation': ', Roosteren, The Netherlands.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-018-4986-3']
1270,31054907,Experience with HPV self-sampling and clinician-based sampling in women attending routine cervical screening in the Netherlands.,"Several countries offer HPV self-sampling for screening non-attendees. It is assumed that screening attendees also prefer self-sampling to clinician-based sampling, however, little research has been conducted with respect to this. Women participating in the IMPROVE-study were randomised (1:1) to self- or clinician-collected HPV testing, and HPV-positive women were retested using the other collection method. Three different questionnaires were sent out among a subset of participating women: Q1) HPV-positive women from both study groups were asked about their experiences with self-sampling and clinician-based sampling (n = 497); Q2) HPV-negative women from the self-sampling group were asked about their experiences with self-sampling (n = 2366); and Q3) HPV-negative women in the clinician-collection group were asked about their experiences with clinician-based sampling (n = 2092). Response rates ranged from 71.6 to 79.4%. Women reported significantly lower levels of shame, nervousness, discomfort and pain during self-sampling compared to clinician-based sampling. However, trust in correct sampling was significantly higher during clinician-based sampling. The majority of women in group Q1 preferred self-sampling (76.5%) to clinician-based sampling (11.9%) in future screening, while 11.6% of women reported to have no preference for either method. To conclude, women from a regular screening population have a positive attitude towards self-sampling but express some concerns with respect to accuracy. The majority prefers self-sampling to clinician-based sampling in future screening. Based on these results, a screening approach where women can choose for either self-sampling or clinician-based sampling seems highly justifiable.",2019,"The majority of women in group Q1 preferred self-sampling (76.5%) to clinician-based sampling (11.9%) in future screening, while 11.6% of women reported to have no preference for either method.","['women attending routine cervical screening in the Netherlands', 'Women participating in the IMPROVE-study were randomised (1:1) to self- or clinician-collected HPV testing, and HPV-positive women']","['HPV self-sampling and clinician-based sampling', 'self-sampling and clinician-based sampling (n\u202f=\u202f497); Q2) HPV-negative women from the self-sampling group were asked about their experiences with self-sampling (n\u202f=\u202f2366); and Q3) HPV-negative women in the clinician-collection group were asked about their experiences with clinician-based sampling']","['levels of shame, nervousness, discomfort and pain', 'Response rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0198113,"The majority of women in group Q1 preferred self-sampling (76.5%) to clinician-based sampling (11.9%) in future screening, while 11.6% of women reported to have no preference for either method.","[{'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Polman', 'Affiliation': 'Cancer Center Amsterdam, Department of Pathology, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: n.polman@vumc.nl.'}, {'ForeName': 'Yanne', 'Initials': 'Y', 'LastName': 'de Haan', 'Affiliation': 'Cancer Center Amsterdam, Department of Pathology, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke J', 'Initials': 'NJ', 'LastName': 'Veldhuijzen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniëlle A M', 'Initials': 'DAM', 'LastName': 'Heideman', 'Affiliation': 'Cancer Center Amsterdam, Department of Pathology, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Henrica C W', 'Initials': 'HCW', 'LastName': 'de Vet', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chris J L M', 'Initials': 'CJLM', 'LastName': 'Meijer', 'Affiliation': 'Cancer Center Amsterdam, Department of Pathology, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leon F A G', 'Initials': 'LFAG', 'LastName': 'Massuger', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Folkert J', 'Initials': 'FJ', 'LastName': 'van Kemenade', 'Affiliation': 'Department of Pathology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Preventive medicine,['10.1016/j.ypmed.2019.04.025']
1271,31096794,Combined therapy of plantar warts with topical bleomycin and microneedling: a comparative controlled study‏.,"Background:  The aim of this study was to assess the efficacy of combination between microneedling with dermapen and topical bleomycin in the treatment of plantar warts in comparison with intralesional bleomycin and intralesional saline (placebo). Methods:  Fifty-four patients were assigned into three groups, each containing 18 patients. The first group treated by micro-needling phenotype with topical bleomycin at 2 weeks interval, the second group received intralesional bleomycin at 3 weeks interval and the control group was intralesional saline for a maximum of four weeks. Results:  Complete clearance of warts in 16 patients in the micro-needling group (88.9%) versus 15 patients (83.3%) in the intralesional bleomycin group versus one patient (5.6%) in the control group‏. Conclusions:  Microneedling assisted topical bleomycin spraying seems to be a promising effective and noninvasive therapeutic modality for recalcitrant plantar warts that facilitates delivery and absorption of bleomycin into the lesion‏.",2020,"RESULTS


Complete clearance of warts in 16 patients in the micro-needling group (88.9%) versus 15 patients (83.3%) in the intralesional bleomycin group versus one patient (5.6%) in the control group‏.
CONCLUSIONS


","['Fifty-four patients were assigned into three groups, each containing 18 patients', 'plantar warts in comparison with']","['intralesional bleomycin', 'topical bleomycin and microneedling', 'intralesional bleomycin and intralesional saline (placebo', 'micro-needling phenotype with topical bleomycin', 'intralesional saline', 'topical bleomycin']",[],"[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042548', 'cui_str': 'Verruca plantaris (disorder)'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]",[],54.0,0.039798,"RESULTS


Complete clearance of warts in 16 patients in the micro-needling group (88.9%) versus 15 patients (83.3%) in the intralesional bleomycin group versus one patient (5.6%) in the control group‏.
CONCLUSIONS


","[{'ForeName': 'Hend D', 'Initials': 'HD', 'LastName': 'Gamil', 'Affiliation': 'Dermatology Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Nasr', 'Affiliation': 'Dermatology Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Fathia M', 'Initials': 'FM', 'LastName': 'Khattab', 'Affiliation': 'Dermatology Dermatology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Amira M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': 'Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1612837']
1272,30722059,"Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.","BACKGROUND


Lefamulin, a pleuromutilin antibiotic, is active against pathogens commonly causing community-acquired bacterial pneumonia (CABP). The Lefamulin Evaluation Against Pneumonia (LEAP 1) study was a global noninferiority trial to evaluate the efficacy and safety of lefamulin for the treatment of CABP.
METHODS


In this double-blind study, adults with CABP of Pneumonia Outcomes Research Team risk class ≥III were randomized 1:1 to receive lefamulin at 150 mg intravenously (IV) every 12 hours or moxifloxacin at 400 mg IV every 24 hours. After 6 doses, patients could be switched to an oral study drug if prespecified improvement criteria were met. If methicillin-resistant Staphylococcus aureus was suspected, either linezolid or placebo was added to moxifloxacin or lefamulin, respectively. The US Food and Drug Administration primary endpoint was an early clinical response (ECR) 96 ± 24 hours after the first dose of the study drug in the intent-to-treat (ITT) population (noninferiority margin, 12.5%). The European Medicines Agency co-primary endpoints were an investigator assessment of clinical response (IACR) 5-10 days after the last dose of the study drug in the modified ITT (mITT) and clinically evaluable (CE) populations (noninferiority margin, 10%).
RESULTS


There were 551 patients randomized (n = 276 lefamulin; n = 275 moxifloxacin). Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%, respectively; difference -2.9%, 95% confidence interval [CI] g -8.5 to 2.8) and IACR (mITT, 81.7% vs 84.2%, respectively; difference -2.6%, 95% CI -8.9 to 3.9; CE, 86.9% vs 89.4%, respectively; difference -2.5%, 95% CI -8.4 to 3.4). Rates of study drug discontinuation due to treatment-emergent adverse events were 2.9% for lefamulin and 4.4% for moxifloxacin.
CONCLUSIONS


Lefamulin was noninferior to moxifloxacin for the primary efficacy endpoints and was generally safe and well tolerated.
CLINICAL TRIALS REGISTRATION


NCT02559310.",2019,Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%; difference:,"['Community-Acquired Bacterial Pneumonia', '551 patients were randomized (n=276 lefamulin; n=275', 'adults with CABP of Pneumonia Outcomes Research Team risk class ≥III']","['linezolid or placebo', 'moxifloxacin', 'lefamulin', 'IV-to-Oral Lefamulin, a Pleuromutilin Antibiotic', 'lefamulin 150 mg intravenously (IV) q12h or moxifloxacin 400 mg IV q24h']","['Efficacy and Safety', 'safe and well tolerated', 'early clinical response (ECR', 'investigator assessment of clinical response (IACR']","[{'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0004626', 'cui_str': 'Pneumonia, Bacterial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035168'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0071283', 'cui_str': 'pleuromutilin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",551.0,0.472496,Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%; difference:,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': 'Summa Health, Akron, Ohio.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Das Consulting, Guerneville, California.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saviski', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Seltzer', 'Affiliation': 'Urogen Pharma, New York.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Paukner', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Talbot', 'Affiliation': 'Talbot Advisors LLC, Anna Maria, Florida.'}, {'ForeName': 'Leanne B', 'Initials': 'LB', 'LastName': 'Gasink', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz090']
1273,30337510,Acetaminophen reduces acute and persistent incisional pain after hysterectomy.,"OBJECTIVE


Acetaminophen is effective for acute surgical pain, but whether it reduces persistent incision pain remains unknown. We tested the primary hypothesis that patients given perioperative acetaminophen have less incisional pain three months after surgery. Our secondary hypotheses were that patients randomized to acetaminophen have less postoperative pain and analgesic consumption, and better functional recovery at three months.
METHODS


140 patients having abdominal hysterectomy were randomly assigned to: 1)intravenous acetaminophen (4 g/day for 72 postoperative hours); or, 2) saline placebo. The primary outcome was incisional pain visual analog scale (VAS) at three months after surgery. The secondary outcomes were (1, 2) postoperative VAS scores while laying and sitting and (3) total patient-controlled intravenous tramadol consumption during the initial 24 hours, (4) DN4 questionnaires and (5) SF-12 at three months after surgery.
RESULTS


The persistent incisional pain scores at three months were significantly lower in acetaminophen (median [Q1, Q3]: 0 [0, 0]) as compared with saline group (0 [0, 1]) (P = 0.002). Specifically, 89%, 9%, and 2% of acetaminophen patients with VAS pain score at three months of 0, 1, and 2 or more, as compared with 66%, 23%, and 10% in the saline group (odds ratio: 2.19 (95% CI: 1.33, 3.59), P = 0.002). Secondly, postoperative pain scores both laying and sitting were significantly lower in the acetaminophen group. Acetaminophen group had significantly better DN4 score and mental health related but not physical health related quality of life.
CONCLUSIONS


Our results suggest that acetaminophen reduces the risk and intensity of persistent incisional pain. However, there are other mechanisms by which acetaminophen might reduce persistent pain.
KEY WORDS


Anesthesia, acetaminophen, Persistent surgical pain, Postoperative acute pain.",2018,"The persistent incisional pain scores at three months were significantly lower in acetaminophen (median [Q1, Q3]: 0",['140 patients having abdominal hysterectomy'],"['perioperative acetaminophen', 'saline placebo', 'Acetaminophen', 'acetaminophen', '1)intravenous acetaminophen']","['surgical pain, Postoperative acute pain', 'postoperative pain and analgesic consumption, and better functional recovery', 'incisional pain', 'postoperative VAS scores while laying and sitting and (3) total patient-controlled intravenous tramadol consumption', 'incisional pain visual analog scale (VAS', 'DN4 score and mental health', 'risk and intensity of persistent incisional pain', 'persistent incisional pain scores', 'postoperative pain scores both laying and sitting', 'physical health related quality of life', 'VAS pain score']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.614004,"The persistent incisional pain scores at three months were significantly lower in acetaminophen (median [Q1, Q3]: 0","[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Koyuncu', 'Affiliation': ''}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Hakimoglu', 'Affiliation': ''}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Ugur', 'Affiliation': ''}, {'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Akkurt', 'Affiliation': ''}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Turhanoglu', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sessler', 'Affiliation': ''}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}]",Annali italiani di chirurgia,[]
1274,31092895,"Convenience, satisfaction, health-related quality of life of once-weekly 70 mg/m 2  vs. twice-weekly 27 mg/m 2  carfilzomib (randomized A.R.R.O.W. study).","We compared patient-reported outcomes (PROs) with once-weekly carfilzomib 70 mg/m 2  (Kd70 mg/m 2 ) vs. twice-weekly carfilzomib 27 mg/m 2  (Kd27 mg/m 2 ) plus dexamethasone in relapsed or refractory multiple myeloma (RRMM). Patient-reported convenience/satisfaction collected at Cycle 2, Day 1 was compared between groups using logistic regression. European Organization for Research and Treatment of Cancer QOL Questionnaire (QLQ-C30), MM-module (QLQ-MY20), and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) questionnaires were administered at baseline, then every other cycle. PROs were compared between groups using mixed models for repeated measures. Times from randomization to first deterioration (TTD) in scores were analyzed using Cox regression. PRO analyses included 469 patients. Once-weekly Kd70 mg/m 2  patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m 2 . The mixed models for repeated measures demonstrated no clinically meaningful differences in scores between treatment arms. Clinically meaningful deterioration in QLQ-C30 Global Health Status/QOL rates were 34.2% (once-weekly Kd70 mg/m 2 ) vs. 40.3% (twice-weekly Kd27 mg/m 2 ). TTD was longer for once-weekly Kd70 mg/m 2  vs. twice-weekly Kd27 mg/m 2  for QLQ-C30 fatigue (HR, 0.79; p = 0.035), QLQ-MY20 disease symptoms (HR, 0.67; p = 0.008), EQ-5D-5L index score (HR, 0.58; p = 0.002), and EQ-5D-5L Visual Analog Scale (HR, 0.75, p = 0.031). Once-weekly Kd70 mg/m 2  improved convenience/satisfaction, and reduced HRQOL deterioration vs. twice-weekly Kd27 mg/m 2 , supporting convenient, once-weekly Kd70 mg/m 2  dosing in RRMM.",2019,"Once-weekly Kd70 mg/m 2  patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m 2 .",['469 patients'],['carfilzomib 70 mg/m 2  (Kd70 mg/m 2 ) vs. twice-weekly carfilzomib 27 mg/m 2  (Kd27 mg/m 2 ) plus dexamethasone'],"['QLQ-C30 fatigue', 'QLQ-C30 Global Health Status/QOL rates', 'EQ-5D-5L index score', 'EQ-5D-5L Visual Analog Scale', 'QLQ-MY20 disease symptoms', 'Convenience, satisfaction, health-related quality of life', 'convenience/satisfaction, and reduced HRQOL deterioration', 'Cancer QOL Questionnaire (QLQ-C30), MM-module (QLQ-MY20), and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0626962,"Once-weekly Kd70 mg/m 2  patients reported greater convenience (odds ratio [OR], 4.98; p < 0.001) and satisfaction (OR, 2.41; p = 0.059) vs. twice-weekly Kd27 mg/m 2 .","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital, Nantes, France. philippe.moreau@chu-nantes.fr.'}, {'ForeName': 'Shaji', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Boccia', 'Affiliation': 'Center for Cancer and Blood Disorders, Bethesda, MD, USA.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University, Nagoya, Japan.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Clinic Heidelberg, Internal Medicine V and National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cocks', 'Affiliation': 'KCStats Consultancy, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trigg', 'Affiliation': 'Adelphi Values Ltd, Manchester, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Zahlten-Kumeli', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Yucel', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sumeet S', 'Initials': 'SS', 'LastName': 'Panjabi', 'Affiliation': 'Amgen, Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}]",Leukemia,['10.1038/s41375-019-0480-2']
1275,31739848,Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study.,"STUDY OBJECTIVES


Short sleep duration contributes to hypertension, yet few behavioral sleep extension interventions have been developed. The goal of our study was to evaluate the feasibility and preliminary efficacy of a technology assisted sleep extension intervention among individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes.
METHODS


Adults aged 30-65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night were randomized 2:1 to a 6-week technology assisted intervention versus a self-management control group. The intervention included a wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching. The control group was instructed to maintain their current sleep schedule. Data were analyzed using descriptive statistics and nonparametric statistics to evaluate differences in between groups as well as prepost changes within each group. We also conducted bivariate correlations to evaluate predictors of change in sleep and ABP.
RESULTS


A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years.) Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008). Participants in the intervention group completed 90% of the coaching sessions and rated the enjoyment of the intervention as 4 or 5 out of 5.
CONCLUSIONS


Technology assisted sleep extension intervention is feasible and well liked in this population. Results demonstrate the potential for this intervention to improve sleep duration, quality and 24-hour ABP.",2019,"Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008).","['Adults aged 30-65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night', 'Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension', 'A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years', 'individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes']","['Technology assisted sleep extension intervention', 'wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching', 'technology assisted intervention versus a self-management control group', 'Technology Assisted Behavior Intervention', 'technology assisted sleep extension intervention']","['sleep duration, quality and 24-hour ABP', 'total sleep time', 'Sleep', 'sleep disturbance', 'diastolic blood pressure', '24-hour systolic blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}]",16.0,0.0540268,"Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008).","[{'ForeName': 'Kelly Glazer', 'Initials': 'KG', 'LastName': 'Baron', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Duffecy', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'DeJuran', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Mathematics and Computer Science, Lake Forest University, Lake Forest, Illinois.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rothschild', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lane', 'Affiliation': 'Department of Internal Medicine, Rush University Medical Center, Chicago, Illinois.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8018']
1276,31740863,Effect of Mulligan spinal mobilization with arm movement along with neurodynamics and manual traction in cervical radiculopathy patients: A randomized controlled trial.,"OBJECTIVE


To determine the effect of Mulligan Spinal Mobilisation with Arm Movement along with neurodynamics and manual traction on pain, disablity and cervical range of motion in cervical radiculopathy patients.
METHODS


The randomised controlled trial (RCT) was conducted from August to December 2017 at the Railway General Hospital, Rawalpindi, Pakistan, and comprised cervical radiculopathy patients of either gender aged 20-60 years. They were randomised into two groups, with the experimental Group A getting treated with Spinal Mobilisation with Arm Movement along with neurodynamics and manual traction, while the control group B only getting treated with neurodynamics and manual traction. The pain, disability and cervical range of motion were assessed before and after treatment of 3 weeks using Numeric Pain Rating Scale, Neck Disability Index and Goniometry. Data was analyzed using SPSS 21.
RESULTS


Of the 31 patients, 19(61.3%) were females and 12(38.7%) were males. The overall mean age was 41.65±9.714 years. There were 15(48.4%) patients in Group A, and 16(51.6%) in Group B. Group A showed significantly better results in terms of pain, disability and cervical range of motion (p<0.05 each).
CONCLUSIONS


Patients treated with Spinal Mobilisation with Arm Movement along with neurodynamics and manual traction had better outcome compared to those who only got neurodynamics and manual traction.",2019,"The pain, disability and cervical range of motion were assessed before and after treatment of 3 weeks using Numeric Pain Rating Scale, Neck Disability Index and Goniometry.","['August to December 2017 at the Railway General Hospital, Rawalpindi, Pakistan, and comprised cervical radiculopathy patients of either gender aged 20-60 years', 'cervical radiculopathy patients', 'Of the 31 patients, 19(61.3%) were females and 12(38.7%) were males']","['Mulligan Spinal Mobilisation with Arm Movement along with neurodynamics and manual traction', 'Spinal Mobilisation with Arm Movement along with neurodynamics and manual traction, while the control group B only getting treated with neurodynamics and manual traction', 'Mulligan spinal mobilization with arm movement along with neurodynamics and manual traction']","['Numeric Pain Rating Scale, Neck Disability Index and Goniometry', 'pain, disablity and cervical range of motion', 'pain, disability and cervical range of motion']","[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",,0.110669,"The pain, disability and cervical range of motion were assessed before and after treatment of 3 weeks using Numeric Pain Rating Scale, Neck Disability Index and Goniometry.","[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Shafique', 'Affiliation': 'General Headquarter, Rawalpindi, Pakistan.'}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Shakil-Ur-Rehman', 'Affiliation': 'Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.297956.']
1277,31740867,Outcome of treatment of Zygomatic bone fracture by two point fixation versus three point fixation in Mayo Hospital Lahore.,"OBJECTIVE


To compare the outcome of two-point internal fixation versus three-point internal fixation for the treatment of zygoma fractures.
METHODS


The quassi-experimental study was conducted at the King Edward Medical University, Mayo Hospital, Lahore, Pakistan, from April to September 2016, and comprised patients with zygomatic bone fracture who were randomly divided into two groups. In Group A, patients were treated with two-point fixation and in Group B, patients were treated with three-point fixation. All patients were treated by the same consultant. Patients were followed up on first, third and sixth week postoperatively and malar height and mouth opening were recorded at the sixth week follow-up. Data was analysed using SPSS 17.
RESULTS


Of the 60 patients, there were 30(50%) in each of the two groups. There were 39(65%) males and 21(35%) females. The mean age in Group A was 29.56±9.89 years (range: 17-50 years), while in Group-B it was 29.45±8.68 years (range: 17-49 years). Mean malar height at 6th week post-operative follow up showed a significant reduction in Group B compared to Group A (p= 0.001). Significant improvement in mouth opening was seen in Group B compared to Group A (p= 0.034).
CONCLUSIONS


Three-point fixation was found to give more stable reduction compared to 2-point fixation for treating zygomatic bone fractures in terms of malar height and mouth opening.",2019,"CONCLUSIONS


Three-point fixation was found to give more stable reduction compared to 2-point fixation for treating zygomatic bone fractures in terms of malar height and mouth opening.","['There were 39(65%) males and 21(35%) females', 'Mayo Hospital Lahore', 'King Edward Medical University, Mayo Hospital, Lahore, Pakistan, from April to September 2016, and comprised patients with zygomatic bone fracture', 'The mean age in Group A was 29.56±9.89 years (range: 17-50 years), while in Group-B it was 29.45±8.68 years (range: 17-49 years', '60 patients']","['two-point internal fixation versus three-point internal fixation', 'Zygomatic bone fracture by two point fixation versus three point fixation']","['malar height and mouth opening', 'mouth opening', 'Mean malar height']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043539', 'cui_str': 'Malar Bone'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0043539', 'cui_str': 'Malar Bone'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0150841,"CONCLUSIONS


Three-point fixation was found to give more stable reduction compared to 2-point fixation for treating zygomatic bone fractures in terms of malar height and mouth opening.","[{'ForeName': 'Hafiz Nasir', 'Initials': 'HN', 'LastName': 'Mahmood', 'Affiliation': 'Department of Maxillofacial Surgery, King Edward Medical University, Mayo Hospital Lahore.'}, {'ForeName': 'Ashfaq Ur', 'Initials': 'AU', 'LastName': 'Rahim', 'Affiliation': 'Department of Maxillofacial Surgery, King Edward Medical University, Mayo Hospital Lahore.'}, {'ForeName': 'Waseem Ullah', 'Initials': 'WU', 'LastName': 'Khan', 'Affiliation': 'Department of Prosthodontics, Punjab Dental Hospital Lahore.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.298939.']
1278,31740859,Effects of Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques on mechanical back pain: a randomized control trial.,"OBJECTIVE


To determine effectiveness of sustained natural apophyseal glides with and without thoracic postural correction techniques on patients of chronic mechanical low back pain .
METHODS


The randomized control trial was conducted at the National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from November 1, 2015, to January 31, 2016, and comprised females aged 20-60 years experiencing mechanical low back pain for more than 03 months. They were randomly assigned to two equal groups. Group 1 was given Mulligan sustained natural apophyseal glides mobilization, while group2 was given the same along with thoracic postural correction techniques for 4 weeks, 3 sessions per week and one session per day. Outcome measures included Numeric Pain Rating Scale, Oswestry Disability Index and Goniometry of Lumbar Range of Motion. Data was analysed using SPSS 20.
RESULTS


Of the 40 patients, there were 20(50%) in each of the groups. Mean age of patients in group 1 was 41.30±10.45years, while in group 2 it was 35.12±9.04 years. Compared to the baseline readings, pain, functional independence and range of motion showed significant improvement (p<0.0001) postintervention in both groups. Mean scores in group 2 showed more improvement than group 1 (p<0.0001) in all variables.
CONCLUSIONS


The effectiveness of thoracic postural correction exercises along with sustained natural apophyseal glides was noted in patients with mechanical low back pain.",2019,"Compared to the baseline readings, pain, functional independence and range of motion showed significant improvement (p<0.0001) postintervention in both groups.","['National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from November 1, 2015, to January 31, 2016, and comprised females aged 20-60 years experiencing mechanical low back pain for more than 03 months', 'patients of chronic mechanical low back pain ', 'patients with mechanical low back pain', '40 patients']","['sustained natural apophyseal glides with and without thoracic postural correction techniques', 'Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques', 'thoracic postural correction exercises']","['Numeric Pain Rating Scale, Oswestry Disability Index and Goniometry of Lumbar Range of Motion', 'Mean scores', 'mechanical back pain', 'pain, functional independence and range of motion']","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0423682', 'cui_str': 'Low Back Pain, Mechanical'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0454281', 'cui_str': 'Posture correction (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0994839,"Compared to the baseline readings, pain, functional independence and range of motion showed significant improvement (p<0.0001) postintervention in both groups.","[{'ForeName': 'Syeda Qurra', 'Initials': 'SQ', 'LastName': 'Tul Ain', 'Affiliation': 'Riphah College Of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Shakil Ur Rehman', 'Affiliation': 'Riphah College Of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Misbah', 'Initials': 'M', 'LastName': 'Maryam', 'Affiliation': 'Riphah College Of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Sania Khawar', 'Initials': 'SK', 'LastName': 'Kiani', 'Affiliation': 'Riphah College Of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.274875.']
1279,31740860,Comparison between facilitator and peer assisted learning: an interventional study at Peshawar Medical College.,"OBJECTIVE


To compare peer-assisted learning with facilitator-assisted learning in small group format comprising undergraduate medical students.
METHODS


The interventional study was conducted from March to August 2016 at Peshawar Medical College, Peshawar, Pakistan, and comprised 2nd year medical students who were randomised into two groups; Group 1 was exposed to peer-assisted learning while Group 2 had facilitator-assisted learning. A validated multiple-choice questionnaire was used for data collection both before and after the intervention. SPSS 19 was used for data analysis.
RESULTS


Of the 80 subjects, there were 40(50%) in each of the two groups, and the groups had 20(50%) males and as many females each. Mean age of Group 1 was 18.90±0.68 years and in Group 2 it was 18.40±0.72 years. There was no significant difference between academic scores of the two groups (p=0.65). Within the groups, pre- and post-intervention test scores showed significant difference (p<0.05).
CONCLUSIONS


Peer-assisted learning was found to be as good as facilitator-assisted learning and it can be introduced as a method of effective teaching.",2019,"Within the groups, pre- and post-intervention test scores showed significant difference (p<0.05).
","['80 subjects', 'March to August 2016 at Peshawar Medical College, Peshawar, Pakistan, and comprised 2nd year medical students', 'small group format comprising undergraduate medical students']","['facilitator and peer assisted learning', 'peer-assisted learning while Group 2 had facilitator-assisted learning', 'peer-assisted learning with facilitator-assisted learning']",['academic scores'],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.0181118,"Within the groups, pre- and post-intervention test scores showed significant difference (p<0.05).
","[{'ForeName': 'Robina', 'Initials': 'R', 'LastName': 'Usman', 'Affiliation': 'Peshawar Medical College, Riphah International University, Islamabad.'}, {'ForeName': 'Brekhna', 'Initials': 'B', 'LastName': 'Jamil', 'Affiliation': 'Khyber Medical University, Peshawar.'}, {'ForeName': 'Nazish', 'Initials': 'N', 'LastName': 'Waheed', 'Affiliation': 'North West School of Medicine, Peshawar.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.286712.']
1280,31740862,Isoflurane alone versus small dose propofol with isoflurane for removal of laryngeal mask airway in children-a randomized controlled trial.,"OBJECTIVE


To compare the safety of laryngeal mask airway removal using two different deep anaesthesia techniques in paediatric patients.
METHODS


The Randomized Control Trial was conducted at Aga Khan University Hospital, Karachi, from April 2012 to November 2013, and comprised patients aged 2-10 years scheduled for infraumbilical surgeries. Anaesthesia was induced with sevoflurane and later it was maintained by is oflurane, oxygen and nitrous oxide. The laryngeal mask airway was removed in the intervention group-I at 0.4 minimum alveolar concentration of isoflurane with propofol 1mg/kg. In the control group-II, it was removed at 1.2 minimum alveolar concentration of isoflurane alone. SPSS 19 was used for data analysis.
RESULTS


Of the 50 patients, there were 25(50%) in each of the two groups. Overall, there were 46(92%) males and 4(8%) females. Incidence of airway obstruction and teeth clenching was significantly higher in group-II (p<0.05 each). Emergence duration was also significantly increased in group-II compared to group-I (p=0.001). The Post-Anaesthesia Care Unit stay timing was not significantly different between the groups (p=0.74).
CONCLUSIONS


Laryngeal mask airway removal under deep anaesthetic technique of low-dose propofol with isoflurane was found to be associated with minimal adverse airway events than isoflurane alone in paediatric patients.",2019,Incidence of airway obstruction and teeth clenching was significantly higher in group-II (p<0.05 each).,"['children', '50 patients', 'paediatric patients', 'Aga Khan University Hospital, Karachi, from April 2012 to November 2013, and comprised patients aged 2-10 years scheduled for infraumbilical surgeries']","['isoflurane', 'Isoflurane alone versus small dose propofol with isoflurane', 'isoflurane with propofol', 'laryngeal mask airway removal', 'sevoflurane']","['laryngeal mask airway', 'Incidence of airway obstruction and teeth clenching', 'Post-Anaesthesia Care Unit stay timing', 'Emergence duration', 'minimal adverse airway events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0424444', 'cui_str': 'Clenching teeth (finding)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1320715', 'cui_str': 'Airway event'}]",,0.0377691,Incidence of airway obstruction and teeth clenching was significantly higher in group-II (p<0.05 each).,"[{'ForeName': 'Dileep', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Gauhar', 'Initials': 'G', 'LastName': 'Afshan', 'Affiliation': 'Department of Anesthesia, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Zubair', 'Affiliation': 'Department of Anesthesia, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hamid', 'Affiliation': 'Department of Anesthesia, Aga Khan University, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.296240.']
1281,31739785,Randomised controlled trial of an intervention to improve parental knowledge and management practices of fever.,"BACKGROUND


We know that parents require resources which can assist them to improve fever knowledge and management practices. The purpose of this study, using an RCT, was to examine the effectiveness of an information leaflet at increasing parental knowledge of fever, specifically temperature definition.
METHODS


A prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate. An information leaflet for use in the trial was designed based on previous studies with parents. Parents in the intervention arm read an information leaflet on fever and management of fever in children, completed a short questionnaire at Time 1 (T1) and again 2 weeks after randomisation at Time 2 (T2). Parents in the control arm did not receive the fever information leaflet but completed the same questionnaire as the intervention arm at T1 and againat T2. The primary outcome was the correct definition of fever (higher than ≥38 °C).
RESULTS


A total of 100 parents participated in the study at T1. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1. 76% of the intervention arm correctly identified ""higher than ≥38°C"" as the temperature at which a fever is said to be present compared to 28% of the control arm. After 2 weeks, there was an increase of 6% of parents in the intervention arm (increase to 82.4%) who gave the correct temperature compared to just a 2.8% increase in the control arm (increase to 30.8%). Univariate logistic regression showed that parents in the intervention arm were significantly more likely to give the correct answer at both time-points (T1: OR 8.1; CI 95% 3.3-19.9: p < 0.01; T2: OR 10.5; CI 95% 3.4-32.0: p < 0.01).
CONCLUSIONS


Our RCT of this simple educational intervention has been shown to improve parental understanding of fever knowledge and correct management strategies. Education interventions providing simple, clear information is a key step to decreasing parental mismanagement of fever and febrile illness in children.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02903342, September 16, 2016, Retrospectively registered.",2019,A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1.,"['children', '100 parents participated in the study at T1', 'Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate']",[],"['fever information leaflet', 'parental knowledge and management practices of fever', 'correct definition of fever', 'correct temperature']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",100.0,0.13531,A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sahm', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Medicine, University College Cork, Cork, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mc Gillicuddy', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College, Cork, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'Trials Research and Methodologies Group (TRAMS), HRB Clinical Research Facility, Mercy University Hospital, Cork, Ireland. f.shiely@ucc.ie.'}]",BMC pediatrics,['10.1186/s12887-019-1808-9']
1282,31739859,Sleep/Wake Detection by Behavioral Response to Haptic Stimuli.,"STUDY OBJECTIVES


Actigraphy, the tool of choice for assessment of sleep phase disorders, is insensitive to movement-free waking. This study aimed to determine whether the detection of waking could be performed by recording instrumental responses to haptic stimuli delivered by a low-cost device.
METHODS


Twenty adults underwent 2 nights of laboratory polysomnography (PSG) while wearing a fingerless glove under which a stimulating actigraph (""Wakemeter"") was apposed to the palm. The Wakemeter, controlled by a tablet computer, delivered gentle, haptic stimuli every 10 minutes during the sleep period. If a stimulus was detected, the participant squeezed the Wakemeter. Stimulus times, response times and movements were streamed to the tablet. Concurrent PSG data were scored blind to stimuli and responses. Self-reported sleep quality ratings were collected each morning.
RESULTS


The Wakemeter was acceptable to 19 of 20 participants, and effects on self-reported and objective sleep were small. The probability of a response to the stimulus during a wake epoch was high regardless of movement. In contrast, actigraphy magnitude distributions were indistinguishable across epochs scored wake without movement versus sleep, confirming a known limitation of actigraphy. A simple method for calculating sleep efficiency from responses to the stimuli yielded estimates that were highly correlated with PSG-derived estimates (rho = .69, P < .001).
CONCLUSIONS


Behavioral responses to haptic stimuli detected epochs of movement-free wake during the sleep period and may augment actigraphy in the low-burden estimation of sleep efficiency. Acceptability of the method over longer recording periods remains to be established.",2019,"The Wakemeter was acceptable to 19 of 20 participants, and effects on self-reported and objective sleep were small.",['Twenty adults underwent 2 nights of'],"['laboratory polysomnography (PSG) while wearing a fingerless glove under which a stimulating actigraph (""Wakemeter']","['Stimulus times, response times and movements', 'self-reported and objective sleep', 'sleep quality ratings']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0206069', 'cui_str': 'Glove'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",20.0,0.0304956,"The Wakemeter was acceptable to 19 of 20 participants, and effects on self-reported and objective sleep were small.","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, California.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bäbler', 'Affiliation': 'Zühlke Engineering AG, Bogenschützenstrasse 9A, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maillart', 'Affiliation': 'University of Geneva, Geneva School of Economics and Management and Citizen Cyber Lab, Campus Biotech, Geneva, Switzerland.'}, {'ForeName': 'Afik', 'Initials': 'A', 'LastName': 'Faerman', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, California.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Woodward', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Healthcare System, Palo Alto, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8038']
1283,31079146,"Safety Comparison of Two Enterovirus 71 (EV71) Inactivated Vaccines in Yiwu, China.","The safety of two kinds of post-marketing enterovirus 71 (EV71) vaccine in China was evaluated in this study. Fourteen vaccination clinics were randomly assigned in a 1:1 ratio, and both children in two groups were administered according to a two-dose schedule (on a 0 and 28 day schedule). Written informed consent was obtained, and recipients in this study were observed for 30 min after inoculation in the clinic, and then followed via phone or on-site follow-up at day 3 and 30. No severe EV71-associated adverse event was reported. No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556). There was no significant difference in the occurrence of adverse events among recipients aged less than 24 months; however, the proportion of adverse events was higher in Group CAMS than in Group Sinovac among the subjects aged 24-35 months (5.3% vs. 2.5%, p < 0.001). The two kinds of EV71 vaccines showed satisfactory safety. Adverse events after vaccination were normal and acceptable.",2019,"No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556).","['Fourteen vaccination clinics', 'Yiwu, China']",['Two Enterovirus 71 (EV71) Inactivated Vaccines'],"['satisfactory safety', 'proportion of adverse events', 'Adverse events', 'occurrence of adverse events']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0338051', 'cui_str': 'Vaccination clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0379054,"No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556).","[{'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Fu', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Weibiao', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Lingqiao', 'Initials': 'L', 'LastName': 'Lou', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz004']
1284,30825454,Effective Tyrosinase Inhibition by Thiamidol Results in Significant Improvement of Mild to Moderate Melasma.,"Melasma is a pigmentary disorder characterized by hyperpigmented patchy skin in sun-exposed areas, especially the face. Treatment of melasma can be challenging because long-term therapy is required, reoccurrence is common, and existing therapies are insufficient and unsatisfactory. To investigate new treatment options, we performed an exploratory double-blinded, randomized split-face study to assess the efficacy of the tyrosinase inhibitor Thiamidol compared to hydroquinone in women with mild to moderate melasma. After 12 weeks, modified Melasma Area and Severity Index scores significantly improved on both the Thiamidol-treated and the hydroquinone-treated sides of the face. Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%). During treatment, no subjects displayed worsening of modified Melasma Area and Severity Index scores on the Thiamidol-treated side, while approximately 10% of the subjects showed a worsening of modified Melasma Area and Severity Index scores on the hydroquinone-treated side. All subjects routinely used sunscreens and consistent results were obtained in low and in high UV ambient conditions. Subjects rated the efficacy of the Thiamidol formulation significantly better with regard to overall decreased intensity of dark spots and their overall appearance throughout the study. Thiamidol was well-tolerated and well-perceived and represents an effective agent to reduce hyperpigmentation.",2019,"Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%).",['women with mild to moderate melasma'],"['hydroquinone', 'tyrosinase inhibitor Thiamidol']","['intensity of dark spots', 'modified Melasma Area and Severity Index scores', 'worsening of modified Melasma Area and Severity Index scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0020307', 'cui_str': 'Quinols'}, {'cui': 'C0041484', 'cui_str': 'Phenol Oxidase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.0190578,"Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%).","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Arrowitz', 'Affiliation': 'Beiersdorf Inc, Wilton, Connecticut, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Schoelermann', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Mann', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany.'}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Jiang', 'Affiliation': 'Thomas J. Stephens & Associates, Inc, Richardson, Texas, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Beiersdorf Inc, Wilton, Connecticut, USA.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Kolbe', 'Affiliation': 'Beiersdorf AG, Hamburg, Germany. Electronic address: Ludger.Kolbe@Beiersdorf.com.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.02.013']
1285,31082916,Impact of Breast Surgery in Primary Metastasized Breast Cancer: Outcomes of the Prospective Randomized Phase III ABCSG-28 POSYTIVE Trial.,"BACKGROUND


Conflicting evidence exists regarding the value of surgical resection of the primary in stage IV breast cancer patients.
OBJECTIVE


The prospective randomized phase III ABCSG-28 POSYTIVE trial evaluated median survival comparing primary surgery followed by systemic therapy to primary systemic therapy in de novo stage IV breast cancer.
METHODS


Between 2011 and 2015, 90 previously untreated stage IV breast cancer patients were randomly assigned to surgical resection of the primary tumor followed by systemic therapy (Arm A) or primary systemic therapy (Arm B) in Austria. Overall survival (OS) was defined as the primary study endpoint.
RESULTS


The trial was stopped early due to poor recruitment. Ninety patients (45 arm A, 45 arm B) were included; median follow-up was 37.5 months. Patients in the surgery arm had more cT3 breast cancer (22.2% vs 6.7%) and more cN2 staging (15.6% vs 4.4%). Both groups were well balanced with respect to the type of first-line systemic treatment. Median survival in arm A was 34.6 months, versus 54.8 months in the nonsurgery arm [hazard ratio (HR) 0.691, 95% confidence interval (95% CI) 0.358-1.333; P = 0.267]; time to distant progression was 13.9 months in the surgery arm and 29.0 months in the nonsurgery arm (HR 0.598, 95% CI 0.343-1.043; P = 0.0668).
CONCLUSION


The prospective phase III trial ABCSG-28 (POSYTIVE) could not demonstrate an OS benefit for surgical resection of the primary in breast cancer patients presenting with de novo stage IV disease.",2019,The prospective phase III trial ABCSG-28 (POSYTIVE) could not demonstrate an OS benefit for surgical resection of the primary in breast cancer patients presenting with de novo stage IV disease.,"['de novo stage IV breast cancer', '90 previously untreated stage IV breast cancer patients', 'Primary Metastasized Breast Cancer', 'breast cancer patients presenting with de novo stage IV disease', 'stage IV breast cancer patients', 'Ninety patients (45 arm A, 45 arm B) were included; median follow-up was 37.5 months', 'Between 2011 and 2015']","['surgical resection of the primary tumor followed by systemic therapy (Arm A) or primary systemic therapy', 'systemic therapy to primary systemic therapy', 'Breast Surgery']","['Median survival', 'Overall survival (OS', 'median survival', 'time to distant progression', 'cN2 staging', 'cT3 breast cancer']","[{'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",,0.118776,The prospective phase III trial ABCSG-28 (POSYTIVE) could not demonstrate an OS benefit for surgical resection of the primary in breast cancer patients presenting with de novo stage IV disease.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Fitzal', 'Affiliation': 'Department of Surgery, Medical University, Vienna, Austria.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Bjelic-Radisic', 'Affiliation': 'Department of Gynecology, Medical University, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Knauer', 'Affiliation': 'Breast Health Center, St Gallen, Austria.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Steger', 'Affiliation': 'Medical Oncology, Medical University, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hubalek', 'Affiliation': 'Department of Gynecology, Breast Health Center Hall, Tirol, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Medical Oncology, Medical University, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Singer', 'Affiliation': 'Gynecology, Medical University, Graz, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bartsch', 'Affiliation': 'German Breast Group, Breast Health Center Hall, Tirol, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schrenk', 'Affiliation': 'Department of Surgery, Medical University, Linz, Austria.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Soelkner', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Medical University, Linz, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Medical Oncology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000002771']
1286,31079163,Three days of training with a low-fidelity arthroscopy triangulation simulator box improves task performance in a virtual reality high-fidelity virtual knee arthroscopy simulator.,"PURPOSE


The aim of this work is to evaluate the effectiveness of training with the low-fidelity ArthroBox ®  regarding performance of different basic arthroscopy tasks using a validated high-fidelity virtual reality simulator of the knee.
METHODS


Nineteen volunteers (14 females and 5 males) without any previous experience in arthroscopy were randomly assigned either to the ArthroBox ®  training group (n =10) or the non-training group (n =9). The training group underwent a supervised ArthroBox  ®  training consisting of a daily 60-min session for three consecutive days. Both groups completed the basic and the final assessment using a validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™). The following three factors were measured in different exercises (explained in ""Materials and methods""): amount of time to finish the task, length of camera and scope path within the joint. Furthermore, the volunteers' demographics (age, sex, dexterity, video game experience, sport activities and profession) was assessed but showed no differences between the groups.
RESULTS


There were no significant differences between the training and non-training group regarding the above-mentioned demographic factors. However, the training group showed significant improvement from baseline to follow-up in most activities (e.g. task performance time in seconds, intra-articular camera and grasp distance in centimetres; see Table 1) in comparison to the non-training group.
CONCLUSIONS


The results from this study demonstrate that training for three consecutive days using a portable and versatile low-fidelity simulator significantly improves arthroscopy performance when using a validated high-fidelity virtual knee simulator. Arthroscopic triangulation training outside the operating theatre with a portable, low-cost simulator has proven to be a valuable educational tool to improve the arthroscopic skills of trainee surgeons.
LEVEL OF EVIDENCE


Diagnostic study, Level II.",2020,"Both groups completed the basic and the final assessment using a validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™).","['Nineteen volunteers (14 females and 5 males) without any previous experience in arthroscopy', 'virtual reality high-fidelity virtual knee arthroscopy simulator']","['validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™', 'ArthroBox ®  training group (n\u2009=10) or the non-training group']","['arthroscopy performance', 'most activities (e.g. task performance time in seconds, intra-articular camera and grasp distance', 'task performance']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",19.0,0.0404162,"Both groups completed the basic and the final assessment using a validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™).","[{'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Bouaicha', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland. samy.bouaicha@balgrist.ch.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Epprecht', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Jentzsch', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Ernstbrunner', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Rany', 'Initials': 'R', 'LastName': 'El Nashar', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rahm', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05526-y']
1287,31870338,"Impact of sunflower seed oil versus mustard seed oil on skin barrier function in newborns: a community-based, cluster-randomized trial.","BACKGROUND


Natural vegetable oils are widely used for newborn massage in many low resource settings. Animal models indicated that sunflower seed oil (SSO) can accelerate skin barrier recovery following damage, while other oils, including mustard oil (MO), may cause further skin barrier damage. The objective was to compare the effects of two SSO and MO used for routine massage on skin integrity in premature and full-term neonates.
METHODS


This community-based cluster randomized controlled trial included 995 neonates assigned to full body massage with sunflower seed oil (SSO, intervention) or mustard seed oil (MO, standard practice) from July 2012-May 2014 in Sarlahi, Nepal. Skin integrity measures were evaluated over 28 days, including skin condition (erythema, rash, dryness), skin surface pH, stratum corneum (SC) cohesion/protein concentration, and transepidermal water loss (TEWL). Overall means and rates of change in these skin measures were compared between oil groups using bivariate random-effects models.
RESULTS


500 and 495 live born neonates received repeated massage with MO and SSO, respectively. Skin pH decreased more quickly for SSO than MO in the first week of life, with a difference in mean daily reductions of 0.02 (95% CI: 0.002-0.040). Erythema, rash and dryness increased (worsened) over days 1-14 then decreased by day 28, with no significant oil group differences. TEWL increased over time, with no significant oil group differences. Gestational age did not modify the effect; the slightly faster decrease in skin pH among SSO infants was similar in magnitude between term and preterm infants.
CONCLUSIONS


Oil type may contribute to differences in skin integrity when neonates are massaged regularly. The more rapid acid mantle development observed for SSO may be protective for neonates in lower resource settings.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01177111); registered August 6th, 2010.",2019,"Gestational age did not modify the effect; the slightly faster decrease in skin pH among SSO infants was similar in magnitude between term and preterm infants.
","['newborns', '995 neonates assigned to', 'premature and full-term neonates', '500 and 495 live born neonates']","['routine massage', 'SSO and MO', 'full body massage with sunflower seed oil (SSO, intervention) or mustard seed oil (MO, standard practice', 'sunflower seed oil versus mustard seed oil', 'sunflower seed oil (SSO']","['skin condition (erythema, rash, dryness), skin surface pH, stratum corneum (SC) cohesion/protein concentration, and transepidermal water loss (TEWL', 'skin pH', 'Skin integrity measures', 'Skin pH', 'skin barrier function', 'Erythema, rash and dryness', 'skin integrity']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0556844', 'cui_str': 'Body massage (regime/therapy)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0453262', 'cui_str': 'Mustard seed (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0221921', 'cui_str': 'Stratum corneum structure'}, {'cui': 'C1304757', 'cui_str': 'Finding of protein concentration, dipstick (finding)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0232445', 'cui_str': 'Skin pH (observable entity)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",995.0,0.194995,"Gestational age did not modify the effect; the slightly faster decrease in skin pH among SSO infants was similar in magnitude between term and preterm infants.
","[{'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Summers', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Marty O', 'Initials': 'MO', 'LastName': 'Visscher', 'Affiliation': ""Skin Sciences Program, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Jeevan B', 'Initials': 'JB', 'LastName': 'Sherchand', 'Affiliation': 'Department of Microbiology, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj Rd, Kathmandu, 44600, Nepal.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, Washington, DC, USA.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, W5009, Baltimore, MD, 21205, USA. lmullany@jhu.edu.'}]",BMC pediatrics,['10.1186/s12887-019-1871-2']
1288,30986533,Established search filters may miss studies when identifying randomized controlled trials.,"OBJECTIVES


The authors were becoming increasingly aware of studies reporting randomized controlled trial (RCT), which reported trial phase but did not mention study design or randomization in the title or abstract. The objective of this study was to determine if established RCT literature search filters should include terms for trial phase.
STUDY DESIGN AND SETTING


This study is a case study. A search filter for trial phase (the P3 filter) was developed, and its sensitivity, efficiency, and value were determined when compared with two established RCT literature search filters (The Cochrane Highly Sensitive Search Strategies [HSSS] and the Royle and Waugh Brief RCT Search Strategy [BRSS]) in the year 2015-improved sensitivity was determined where the P3 filter identified studies missed by either of the established filters; efficiency was determined by the number needed to read; and the Cochrane risk of bias tool was used to determine study quality as a proxy for value.
RESULTS


Both established filters missed studies. The HSSS missed one RCT and four follow-up RCT studies. The BRSS missed one RCT and five follow-up RCT studies. Study quality was unclear.
CONCLUSION


Established RCT literature search filters may miss studies where trial phase is reported instead of terms for study design or randomization. The P3 filter can be incorporated to improve sensitivity.",2019,"A search filter for trial phase (the P3 filter) was developed, and its sensitivity, efficiency, and value were determined when compared with two established RCT literature search filters (The Cochrane Highly Sensitive Search Strategies [HSSS] and the Royle and Waugh Brief RCT Search Strategy [BRSS]) in the year 2015-improved sensitivity was determined where the P3 filter identified studies missed by either of the established filters; efficiency was determined by the number needed to read; and the Cochrane risk of bias tool was used to determine study quality as a proxy for value.
",[],[],[],[],[],[],,0.0965729,"A search filter for trial phase (the P3 filter) was developed, and its sensitivity, efficiency, and value were determined when compared with two established RCT literature search filters (The Cochrane Highly Sensitive Search Strategies [HSSS] and the Royle and Waugh Brief RCT Search Strategy [BRSS]) in the year 2015-improved sensitivity was determined where the P3 filter identified studies missed by either of the established filters; efficiency was determined by the number needed to read; and the Cochrane risk of bias tool was used to determine study quality as a proxy for value.
","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London WC1E 7HB, UK. Electronic address: ucjucc4@ucl.ac.uk.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Varley-Campbell', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London WC1E 7HB, UK.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Carter', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London WC1E 7HB, UK.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.04.002']
1289,31078486,Effects of the FIT-HIP Intervention for Fear of Falling After Hip Fracture: A Cluster-Randomized Controlled Trial in Geriatric Rehabilitation.,"OBJECTIVES


Fear of falling (FoF) is common after hip fracture and can impede functional recovery because of activity restriction. The Fear of falling InTervention in HIP fracture geriatric rehabilitation (FIT-HIP intervention) was designed to target FoF and consequently to improve mobility. The aim of this study was to evaluate the effect of the FIT-HIP intervention in patients with FoF in geriatric rehabilitation (GR) after hip fracture.
DESIGN, SETTING, AND PARTICIPANTS


This cluster-randomized controlled trial was performed in 11 post-acute GR units in the Netherlands (2016-2017). Six clusters were assigned to the intervention group, 5 to the usual care group. We included 78 patients with hip fracture and FoF (aged ≥65 years; 39 per group).
INTERVENTION(S)


The FIT-HIP intervention is a multicomponent cognitive behavioral intervention conducted by physiotherapists, embedded in usual care in GR. The FIT-HIP intervention was compared to usual care in GR.
MEASUREMENTS


FoF was assessed with the Falls Efficacy Scale-International (FES-I) and mobility, with the Performance Oriented Mobility Assessment (POMA). Data were collected at baseline, discharge, and 3 and 6 months postdischarge from GR. Primary endpoints were change scores at discharge. Linear mixed models were used to evaluate the treatment effect.
RESULTS


No significant between-group differences were observed for primary outcome measures. With the usual care group as reference, the FES-I estimated difference between mean change scores was 3.3 [95% confidence interval (CI) -1.0, 7.5, P = .13] at discharge from GR; -4.1 (95% CI -11.8, 3.6, P = .29) after 3 months; and -2.8 (95% CI -10.0, 4.4, P = .44) after 6 months. POMA estimated difference was -0.3 (95% CI -6.5, 5.8, P = .90).
CONCLUSION/IMPLICATIONS


The FIT-HIP intervention was not effective in reducing FoF. Possibly FoF (shortly) after hip fracture can to some extent be appropriate. This may imply the study was not able to accurately identify and accordingly treat FoF that is maladaptive (reflective of disproportionate anxiety).",2019,No significant between-group differences were observed for primary outcome measures.,"['After Hip Fracture', '11 post-acute GR units in the Netherlands (2016-2017', 'patients with FoF in geriatric rehabilitation (GR) after hip fracture', '78 patients with hip fracture and FoF (aged ≥65\xa0years; 39 per group']","['FIT-HIP Intervention', 'FIT-HIP intervention']","['Fear of Falling', 'change scores at discharge', 'Falls Efficacy Scale-International (FES-I) and mobility, with the Performance Oriented Mobility Assessment (POMA']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}]",78.0,0.0829924,No significant between-group differences were observed for primary outcome measures.,"[{'ForeName': 'Maaike N', 'Initials': 'MN', 'LastName': 'Scheffers-Barnhoorn', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: m.n.scheffers-barnhoorn@lumc.nl.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'van Eijk', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jolanda C M', 'Initials': 'JCM', 'LastName': 'van Haastregt', 'Affiliation': 'Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; Department of Family Medicine and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Romke', 'Initials': 'R', 'LastName': 'van Balen', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Gertrudis I J M', 'Initials': 'GIJM', 'LastName': 'Kempen', 'Affiliation': 'Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.03.009']
1290,31711451,Perioperative effects of caudal block on pediatric patients in laparoscopic upper urinary tract surgery: a randomized controlled trial.,"BACKGROUND


While caudal block has been widely used during pediatric lower limbs and lower abdominal surgeries, few studies to date have evaluated the perioperative effects of caudal block on pediatric patients in laparoscopic upper urinary tract surgery.
METHODS


Ninety-six pediatric patients, aged 6 months to 7 years, ASA grade I-II, scheduled to undergo laparoscopic upper urinary tract surgery, were randomized to a non-block group (no caudal block performed), an ROP1.0 group (patients received 1.0 mL/kg of 0.15% ropivacaine) and an ROP1.3 group (patients received 1.3 mL/kg of 0.15% ropivacaine). The primary outcome variable was perioperative fentanyl use. The secondary outcome variables were pain score, hemodynamic fluctuation, the number of patients needing rescue fentanyl and side effects.
RESULTS


Caudal block with 1.3 mL/kg of 0.15% ropivacaine significantly decreased perioperative fentanyl usage (ROP 1.3 vs. non-caudal block, P < 0.01; ROP 1.3 vs. ROP 1.0, P < 0.05). Moreover, patients in the ROP1.3 group, compared to those without, displayed more stable hemodynamics, lower pain score in the PACU and 8 h after operation, less demand for rescue fentanyl, shorter time of PACU stay.
CONCLUSIONS


Caudal block with 1.3 mL/kg of 0.15% ropivacaine reduced perioperative fentanyl use during laparoscopic upper urinary tract surgery on pediatric patients and produced good postoperative analgesia when compared with no caudal block and caudal block with 1.0 mL/kg of 0.15% ropivacaine.
TRIAL REGISTRATION


Clinical trial number: ChiCTR1800015549, chictr.org.cn.",2019,"Caudal block with 1.3 mL/kg of 0.15% ropivacaine significantly decreased perioperative fentanyl usage (ROP 1.3 vs. non-caudal block, P < 0.01; ROP 1.3 vs. ROP 1.0, P < 0.05).","['pediatric patients in laparoscopic upper urinary tract surgery', 'Ninety-six pediatric patients, aged 6\u2009months to 7\u2009years, ASA grade I-II, scheduled to undergo laparoscopic upper urinary tract surgery']","['ROP1.3 group (patients received 1.3\u2009mL/kg of 0.15% ropivacaine', 'non-block group (no caudal block performed), an ROP1.0 group (patients received 1.0\u2009mL/kg of 0.15% ropivacaine', 'ropivacaine', 'caudal block']","['stable hemodynamics, lower pain score', 'time of PACU stay', 'pain score, hemodynamic fluctuation, the number of patients needing rescue fentanyl and side effects', 'perioperative fentanyl', 'perioperative fentanyl usage', 'perioperative fentanyl use']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",96.0,0.248916,"Caudal block with 1.3 mL/kg of 0.15% ropivacaine significantly decreased perioperative fentanyl usage (ROP 1.3 vs. non-caudal block, P < 0.01; ROP 1.3 vs. ROP 1.0, P < 0.05).","[{'ForeName': 'Bingdong', 'Initials': 'B', 'LastName': 'Tao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, 36 Sanhao Street Heping District, Shenyang, 110004, Liaoning Province, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, 36 Sanhao Street Heping District, Shenyang, 110004, Liaoning Province, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, 36 Sanhao Street Heping District, Shenyang, 110004, Liaoning Province, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, 36 Sanhao Street Heping District, Shenyang, 110004, Liaoning Province, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, PICU, Shengjing Hospital, China Medical University, Shenyang, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Shengjing Hospital, China Medical University, 36 Sanhao Street Heping District, Shenyang, 110004, Liaoning Province, China. zhaoping_sj@icloud.com.'}]",BMC pediatrics,['10.1186/s12887-019-1812-0']
1291,30957391,The influence of mean arterial pressure on the efficacy and safety of dual antiplatelet therapy in minor stroke or transient ischemic attack patients.,"Mean arterial pressure (MAP) is the strongest predictor of stroke. The combination of clopidogrel and aspirin within 24 hours after onset has been suggested by the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) study to be superior to aspirin alone. However, it is not clear whether poststroke blood pressure has an influence on the efficacy and safety of dual antiplatelet treatment. We have performed a post hoc analysis from the CHANCE trial. Patients were stratified into three groups based on MAP levels. Among patients with MAP <102 mm Hg, there was no significant difference in stroke recurrence between the clopidogrel-aspirin group and the aspirin group (7.7% vs 7.5%; hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.73-1.45). However, compared to aspirin treatment, the clopidogrel-aspirin dual treatment was more effective at reducing the risk of stroke in patients with MAP ≥113 mm Hg (6.9% vs 12.3%, HR, 0.55; 95% CI, 0.39-0.78) or 102-113 mm Hg (9.5% vs 14.9%, HR, 0.62; 95% CI, 0.48-0.81). There was a significant interaction between MAP and antiplatelet therapy as it relates to stroke recurrence (P for interaction = 0.037), and a similar result was found for combined vascular events (P for interaction = 0.027). In conclusion, dual antiplatelet therapy may be more effective at reducing combined vascular events in patients with higher MAP after minor stroke or transient ischemic attack.",2019,"Hg (9.5% vs 14.9%, HR, 0.62; 95% CI, 0.48-0.81).","['patients with MAP <102\xa0mm', 'minor stroke or transient ischemic attack patients', 'patients with MAP ≥113\xa0mm', 'patients with higher MAP after minor stroke or transient ischemic attack']","['clopidogrel-aspirin', 'clopidogrel and aspirin', 'aspirin', 'dual antiplatelet therapy']","['stroke recurrence', 'risk of stroke', 'Mean arterial pressure (MAP', 'efficacy and safety', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0656201,"Hg (9.5% vs 14.9%, HR, 0.62; 95% CI, 0.48-0.81).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13527']
1292,30973207,A randomized controlled trial on the blood pressure-lowering effect of amlodipine and nifedipine-GITS in sustained hypertension.,"In a multicenter, randomized trial, we investigated whether the long half-time dihydropyridine calcium channel blocker amlodipine was more efficacious than the gastrointestinal therapeutic system (GITS) formulation of nifedipine in lowering ambulatory blood pressure (BP) in sustained hypertension (clinic systolic/diastolic BP 140-179/90-109 mm Hg and 24-hour systolic/diastolic BP ≥ 130/80 mm Hg). Eligible patients were randomly assigned to amlodipine 5-10 mg/day or nifedipine-GITS 30-60 mg/day. Ambulatory BP monitoring was performed for 24 hours at baseline and 4-week treatment and for 48 hours at 8-week treatment with a dose of medication missed on the second day. After 8-week treatment, BP was similarly reduced in the amlodipine (n = 257) and nifedipine-GITS groups (n = 248) for both clinic and ambulatory (24-hour systolic/diastolic BP 10.3/6.5 vs 10.9/6.3 mm Hg, P ≥ 0.24) measurements. However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P ≤ 0.04) between-group difference in 24-hour (-1.2 mm Hg) and daytime diastolic BP (-1.5 mm Hg). In conclusion, amlodipine and nifedipine-GITS were efficacious in reducing 24-hour BP. When a dose of medication was missed, amlodipine became more efficacious than nifedipine-GITS.",2019,"However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P ≤ 0.04) between-group difference in 24-hour (-1.2 mm Hg) and daytime diastolic BP (-1.5 mm Hg).","['Eligible patients', 'sustained hypertension (clinic systolic/diastolic BP 140-179/90-109\xa0mm', 'sustained hypertension']","['nifedipine-GITS', 'nifedipine', 'dihydropyridine calcium channel blocker amlodipine', 'amlodipine 5-10\xa0mg/day or nifedipine-GITS 30-60\xa0mg/day', 'amlodipine and nifedipine-GITS', 'amlodipine']","['daytime diastolic BP', '24-hour BP', 'ambulatory BP reductions', 'BP', 'ambulatory blood pressure (BP', 'Hg and 24-hour systolic/diastolic BP', 'Ambulatory BP monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",257.0,0.0861067,"However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P ≤ 0.04) between-group difference in 24-hour (-1.2 mm Hg) and daytime diastolic BP (-1.5 mm Hg).","[{'ForeName': 'Qi-Fang', 'Initials': 'QF', 'LastName': 'Huang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chang-Sheng', 'Initials': 'CS', 'LastName': 'Sheng', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Dou', 'Affiliation': 'Jiangsu Province Hospital for Governmental Employees, Nanjing, China.'}, {'ForeName': 'Mei-Sheng', 'Initials': 'MS', 'LastName': 'Zheng', 'Affiliation': 'Wuhu Chinese Medicine Hospital, Wuhu, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Zhu', 'Affiliation': 'Chongqing Hypertension Institute, Department of Hypertension and Endocrinology, Daping Hospital, The Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13543']
1293,31062455,Examining the effects of computerised cognitive training on levels of executive function in adults with Down syndrome.,"BACKGROUND


Individuals with Down syndrome (DS) are at much greater risk of developing Alzheimer's disease, and one of the early clinical symptoms of Alzheimer's disease is executive dysfunction. In the general population, cognitive training has shown some promising results in relation to maintaining or improving cognitive processes. There is currently a gap in the literature in relation to cognitive training for adults with DS.
METHODS


A quasi-experimental mixed factorial design with partial crossover was used involving an 8-week intervention period using a brain training programme. Participants were matched on age and then randomly assigned to either the intervention group or the delayed intervention group. Forty adults with DS, aged between 30 and 49 and with a mild or moderate level of intellectual disability, participated in the study. All participants completed baseline measures of executive function, using both neuropsychological assessments and an informant-rated measure of behavioural executive function. The intervention group first completed the training and then the delayed intervention group. Executive function assessments were repeated for both groups following the training.
RESULTS


The study aimed to examine whether a cognitive training programme could have an effect on levels of executive function. While conclusions are limited owing to small sample size, improvement was seen in neuropsychological assessments of executive function following cognitive training. Positive effects reflected in everyday behaviours were not as promising.
CONCLUSIONS


This study showed that, while it has not been previously an area of focus, individuals with DS can complete a computerised cognitive training programme. Furthermore, the results were promising with significant improvements found in neuropsychological assessments of executive function. These findings need further investigation with a larger sample size and would benefit from the use of a brain imaging component to strengthen the findings.",2019,"While conclusions are limited owing to small sample size, improvement was seen in neuropsychological assessments of executive function following cognitive training.","['adults with Down syndrome', 'adults with DS', 'Individuals with Down syndrome (DS', 'Forty adults with DS, aged between 30 and 49 and with a mild or moderate level of intellectual disability, participated in the study']","['computerised cognitive training', 'cognitive training programme', 'cognitive training', 'delayed intervention group']","['Executive function assessments', 'everyday behaviours', 'behavioural executive function', 'levels of executive function', 'neuropsychological assessments of executive function', 'executive function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",40.0,0.0519556,"While conclusions are limited owing to small sample size, improvement was seen in neuropsychological assessments of executive function following cognitive training.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'McGlinchey', 'Affiliation': 'Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'McCarron', 'Affiliation': 'Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holland', 'Affiliation': 'Cambridge Intellectual & Development Disabilities Research Group (CIDDRG), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'McCallion', 'Affiliation': 'School of Social Work, Temple University, Philadelphia, PA, USA.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12626']
1294,31055568,Usefulness of Preoperative Mechanical Bowel Preparation in Patients with Colon Cancer who Undergo Elective Surgery: A Prospective Randomized Trial Using Oral Antibiotics.,"BACKGROUND


To prevent surgical site infection (SSI) in colorectal surgery, the combination of mechanical bowel preparation (MBP), oral antibiotic bowel preparation (OABP), and the intravenous antibiotics have been proposed as standard treatment. We conducted an RCT comparing the incidence of SSI between MBP + OABP and OABP alone after receiving a single dose of intravenous antibiotics.
METHODS


The study group comprised 254 patients who underwent elective surgery for colon cancer. Patients were randomly assigned to receive MBP + OABP and intravenous antibiotics (MBP + OABP group) or to receive OABP and intravenous antibiotics (OABP alone group).
RESULTS


Overall, 125 patients in MBP + OABP group and 126 patients in OABP alone group were eligible. Incisional SSI occurred in 3 patients (2.4%) in MBP + OABP group, and 8 patients (6.3%) in the OABP-alone group. Organ/space SSI developed in 0 patients (0%) and in 4 patients (3.2%) in each group respectively. The OABP-alone group was thus not shown to be noninferior to the MBP + OABP group in the incidences of incisional SSI or organ/space SSI. Other infectious complications developed in 7 patients (5.6%) and in 6 patients (4.8%) in each group, indicating the non-inferiority of OABP alone to MBP + OABP.
CONCLUSIONS


MBP combined with oral antibiotics and intravenous antibiotics remains standard in elective colon cancer surgery.",2020,The OABP-alone group was thus not shown to be noninferior to the MBP + OABP group in the incidences of incisional SSI or organ/space SSI.,"['Patients with Colon Cancer who Undergo Elective Surgery', '254 patients who underwent elective surgery for colon cancer', '125 patients in MBP + OABP group and 126 patients in OABP alone group were eligible', 'elective colon cancer surgery']","['mechanical bowel preparation (MBP), oral antibiotic bowel preparation (OABP', 'Preoperative Mechanical Bowel Preparation', 'MBP + OABP', 'MBP + OABP and intravenous antibiotics (MBP + OABP group) or to receive OABP and intravenous antibiotics (OABP alone group', 'MBP combined with oral antibiotics and intravenous antibiotics', 'Oral Antibiotics']","['infectious complications', 'Incisional SSI', 'Organ/space SSI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",254.0,0.0748808,The OABP-alone group was thus not shown to be noninferior to the MBP + OABP group in the incidences of incisional SSI or organ/space SSI.,"[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan, sadahiro@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Kazutake', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Gota', 'Initials': 'G', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyakita', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogimi', 'Affiliation': 'Department of Surgery, Tokai University Hospital, Isehara, Japan.'}]",Digestive surgery,['10.1159/000500020']
1295,31077093,Improving Education About Breast Cancer for Medical Students in China.,"In traditional medical school curriculum of cancer education in China, there is a very limited amount of teaching about breast cancer. The current situation may result in indifference to breast cancer education among medical students. Case-based learning (CBL) is a popular teaching method based on clinical cases. To date, there are few research reports about the application and research of CBL in breast cancer education. The aim of this study is to explore the teaching effect about CBL combined with lecture-based learning (LBL) in breast cancer education. Questions of breast cancer in National Medical Licensing Examination (NMLE) from 2011 to 2018 were analyzed. The questions about breast cancer were used as the evaluation criteria for this study. In this pilot study, a total of 140 students were randomly divided into a lecture only group (control group) and a lecture plus CBL group (observation group). The students in the observation group had better academic performances and abilities of memory, understanding, and application. They also had higher favorable impressions of the learning experience. In conclusion, more active approaches yield more learning and are viewed more favorably. CBL plus lecture can significantly improve education about breast cancer among medical students, which may be an important message for the evolution of curriculum in Chinese medical schools.",2019,"The students in the observation group had better academic performances and abilities of memory, understanding, and application.","['breast cancer in National Medical Licensing Examination (NMLE) from 2011 to 2018 were analyzed', 'breast cancer education', 'Medical Students in China', '140 students']","['CBL plus lecture', 'Case-based learning (CBL', 'lecture only group (control group) and a lecture plus CBL', 'CBL combined with lecture-based learning (LBL']","['academic performances and abilities of memory, understanding, and application']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0242373', 'cui_str': 'Licensing'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",140.0,0.0127199,"The students in the observation group had better academic performances and abilities of memory, understanding, and application.","[{'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Xinmiao', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Jinfei', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China. jinfeng@cmu.edu.cn.""}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01536-z']
1296,31066177,"Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering.","Recent guidelines call for more intensive blood pressure (BP)-lowering and a less-stringent treatment-resistant hypertension (TRH) definition, both of which may increase the occurrence of this high-risk phenotype. We performed a post hoc analysis of 11 784 SPRINT and ACCORD-BP participants without baseline TRH, who were randomized to an intensive (<120 mm Hg) or standard (<140 mm Hg) systolic BP target. Incidence, prevalence, and predictors of TRH were compared using the updated definition (requiring ≥4 drugs to achieve BP < 130/80 mm Hg) during intensive treatment, vs the former definition (requiring ≥4 drugs to achieve BP < 140/90 mm Hg) during standard treatment. Incidence/prevalence of apparent refractory hypertension (RFH; uncontrolled BP despite ≥5 drugs) was similarly compared. Overall, 5702 and 6082 patients were included in the intensive and standard treatment cohorts, respectively. Crude TRH incidence using the updated definition under intensive treatment was 30.3 (95% CI, 29.3-31.4) per 100 patient-years, compared with 9.7 (95% CI, 9.2-10.2) using the prior definition under standard treatment. Point prevalence using the prior TRH definition at 1-year was 7.5% in SPRINT and 14% in ACCORD vs 22% and 36%, respectively, with the updated TRH definition. Significant predictors of incident TRH included number of baseline antihypertensive drugs, having diabetes, baseline systolic BP, and Black race. Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years). Implementation of the 2017 hypertension guideline, including lower BP goals for most individuals, is expected to substantially increase treatment burden and incident TRH among the hypertensive population.",2019,Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years).,"['5702 and 6082 patients were included in the intensive and standard treatment cohorts, respectively', '11\xa0784 SPRINT and ACCORD-BP participants without baseline TRH, who were randomized to an intensive (<120\xa0mm\xa0Hg) or standard (<140\xa0mm']",[],"['number of baseline antihypertensive drugs, having diabetes, baseline systolic BP, and Black race', 'Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering', 'Crude TRH incidence', 'Hg) systolic BP target', 'Incidence of apparent RFH', 'Incidence, prevalence, and predictors of TRH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}]",,0.131972,Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years).,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacotherapy & Translational Research, College of Pharmacy, Gainesville, Florida.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Almut G', 'Initials': 'AG', 'LastName': 'Winterstein', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, Gainesville, Florida.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy & Translational Research, College of Pharmacy, Gainesville, Florida.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13550']
1297,31062373,Influence of Calcineurin Inhibitor and Sex on Mycophenolic Acid Pharmacokinetics and Adverse Effects Post-Renal Transplant.,"Tacrolimus or cyclosporine is prescribed with mycophenolic acid posttransplant and contributes to interpatient variability in mycophenolic acid pharmacokinetics and response. Cyclosporine inhibits enterohepatic circulation of the metabolite mycophenolic acid glucuronide, which is not described with tacrolimus. This study investigated mycophenolic acid pharmacokinetics and adverse effects in stable renal transplant recipients and the association with calcineurin inhibitors, sex, and race. Mycophenolic acid and mycophenolic acid glucuronide area under the concentration-time curve from 0 to 12 hours (AUC 0-12h  ) and apparent clearance were determined at steady state in 80 patients receiving cyclosporine with mycophenolate mofetil and 67 patients receiving tacrolimus with mycophenolate sodium. Gastrointestinal adverse effects and hematologic parameters were evaluated. Statistical models evaluated mycophenolic acid pharmacokinetics and adverse effects. Mycophenolic acid AUC 0-12h  was 1.70-fold greater with tacrolimus (68.9 ± 30.9 mg·h/L) relative to cyclosporine (40.8 ± 17.6 mg·h/L); P < .001. Target mycophenolic acid AUC 0-12h  of 30-60 mg·h/L was achieved in 56.3% on cyclosporine compared with 34.3% receiving tacrolimus (P < .001). Mycophenolic acid clearance was 48% slower with tacrolimus (10.6 ± 4.7 L/h) relative to cyclosporine (20.5 ± 10.0 L/h); P < .001. Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P < .001). Race did not affect mycophenolic acid pharmacokinetics. Gastrointestinal adverse effect scores were 2.2-fold higher with tacrolimus (P < .001) and more prominent in women (P = .017). Lymphopenia was more prevalent with tacrolimus (52.2%) than cyclosporine (22.5%); P < 0.001. Calcineurin inhibitors and sex contributed to interpatient variability in mycophenolic acid pharmacokinetics and adverse effects post-renal transplant, which could be attributed to differences in enterohepatic circulation.",2019,Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P ,"['stable renal transplant recipients', '80 patients receiving', '17.6']","['tacrolimus with mycophenolate sodium', 'Calcineurin Inhibitor', 'cyclosporine', 'Calcineurin inhibitors', 'tacrolimus', 'cyclosporine with mycophenolate mofetil', 'Mycophenolic acid and mycophenolic acid glucuronide', 'mycophenolic acid pharmacokinetics', 'Tacrolimus or cyclosporine', 'Mycophenolic acid AUC', 'Cyclosporine']","['Lymphopenia', 'Gastrointestinal adverse effects and hematologic parameters', 'mycophenolic acid pharmacokinetics and adverse effects', 'Mycophenolic acid clearance', 'Enterohepatic circulation', 'mycophenolic acid pharmacokinetics', 'Target mycophenolic acid AUC', 'Gastrointestinal adverse effect scores', 'mycophenolic acid glucuronide AUC']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid 7-O-glucuronide'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0014362', 'cui_str': 'Entero-Hepatic Circulation'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid 7-O-glucuronide'}]",80.0,0.0689333,Enterohepatic circulation occurred less frequently with cyclosporine (45%) compared with tacrolimus (78%); P < 0.001; with a 2.9-fold greater mycophenolic acid glucuronide AUC 0-12h  to mycophenolic acid AUC 0-12h  ratio (P ,"[{'ForeName': 'Calvin J', 'Initials': 'CJ', 'LastName': 'Meaney', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Patcharaporn', 'Initials': 'P', 'LastName': 'Sudchada', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Consiglio', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Cooper', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}, {'ForeName': 'Rocco C', 'Initials': 'RC', 'LastName': 'Venuto', 'Affiliation': 'Department of Medicine; Nephrology Division, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Tornatore', 'Affiliation': 'Immunosuppressive Pharmacology Research Program, Translational Pharmacology Research Core, Buffalo, NY, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1428']
1298,31551154,Cytokines hold promise for human embryo culture in vitro: results of a randomized clinical trial.,"OBJECTIVE


To evaluate the effects of cytokine enrichment of culture medium on embryological and clinical outcomes after intracytoplasmic sperm injection (ICSI).
DESIGN


A randomized clinical trial.
SETTING


In vitro fertilization centers.
PATIENT(S)


This trial included 443 ICSI cycles randomized into two groups.
INTERVENTION(S)


This study evaluated the influence of integration of granulocyte-macrophage colony-stimulating factor, heparin-binding epidermal growth factor-like growth factor, and leukemia inhibitory factor into culture media on human embryo development after ICSI.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy rate per a randomized participant.
RESULT(S)


Cytokine enrichment of culture medium showed improvement in ongoing pregnancy rate compared with no cytokines (106/224 [47%] vs. 78/219 [36%]; absolute rate difference [ARD] = 12; 95% confidence interval [CI], 2.5-21). This integration of cytokines also showed better rates of live birth (101/224 [45%] vs. 71/219 [33%]; ARD = 13; 95% CI, 4-21) and cumulative live birth (132/224 [60%] vs. 97/219 [44%]; ARD = 12; 95% CI, 4-20) and lower rate of pregnancy loss (27/124 [22%] vs. 37/103 [36%]; ARD = -14; 95% CI, -26 to -2) than conventional medium. Embryos developed in the cytokine-supplemented medium showed better blastocyst formation, quality, cryopreservation, and use than control medium.
CONCLUSION(S)


Integration of cytokines into human embryo culture media showed improvement in embryological and clinical outcomes after ICSI. However, the long-term effect of cytokine enrichment of a medium is still unclear and warrants further studies with longitudinal follow-up.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02420886 at ClinicalTrials.gov.",2019,"Cytokine enrichment of culture medium showed improvement in ongoing pregnancy rate compared with no cytokines (106/224 [47%] vs. 78/219 [36%]; absolute rate difference [ARD] = 12; 95% confidence interval [CI], 2.5-21).","['443 ICSI cycles randomized into two groups', 'human embryo culture in\xa0vitro']","['granulocyte-macrophage colony-stimulating factor, heparin', 'intracytoplasmic sperm injection (ICSI']","['blastocyst formation, quality, cryopreservation, and use than control medium', 'embryological and clinical outcomes', 'rates of live birth', 'rate of pregnancy loss', 'cumulative live birth', 'ongoing pregnancy rate']","[{'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0010405', 'cui_str': 'Cryofixation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",443.0,0.510737,"Cytokine enrichment of culture medium showed improvement in ongoing pregnancy rate compared with no cytokines (106/224 [47%] vs. 78/219 [36%]; absolute rate difference [ARD] = 12; 95% confidence interval [CI], 2.5-21).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fawzy', 'Affiliation': 'IbnSina IVF Center, IbnSina Hospital, Sohag, Egypt; Banon IVF Center, Assiut, Egypt. Electronic address: drfawzy001@me.com.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Emad', 'Affiliation': 'IbnSina IVF Center, IbnSina Hospital, Sohag, Egypt; Banon IVF Center, Assiut, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Elsuity', 'Affiliation': 'IbnSina IVF Center, IbnSina Hospital, Sohag, Egypt; Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mahran', 'Affiliation': 'Banon IVF Center, Assiut, Egypt; Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Y', 'Initials': 'MY', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ahmed N', 'Initials': 'AN', 'LastName': 'Fetih', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Abdelghafar', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sabry', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nour', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Salah M', 'Initials': 'SM', 'LastName': 'Rasheed', 'Affiliation': 'Department of Obstetrics and Gynecology, Sohag University, Sohag, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.07.012']
1299,31057094,Short-time high-intensity exercise increases peripheral BDNF in a physical fitness-dependent way in healthy men.,"BDNF is associated with brain health and positively modulated by exercise; however, the influence of physical fitness status on BDNF is incipient. This study investigated the BDNF response after acute-exercise sessions performed at low, moderate, and high intensities and the relationship between physical fitness status and BDNF response. Twenty-eight men, divided according to physical fitness status (<50th or >50th percentile for VO 2max ), performed three randomised acute exercise sessions at low (90% of VT1), moderate (midpoint between VT1-VT2), and high (midpoint between VT2-W max ) intensities until exhaustion or for up to 60 min. Lactate and BDNF were determined pre and post-exercises. For BDNF, there were main effects of time ( p  = 0.003) and interaction ( p  < 0.001), showing an increase post high-intensity exercise ( p  < 0.001). Changes in BDNF presented differences between conditions ( p  < 0.001) with greater increase in high-intensity compared with the others ( p  = 0.003). For lactate, there were main effects of time ( p  < 0.001), condition ( p  < 0.001), and interaction ( p  < 0.001) with greater concentration in high-intensity. High-intensity exercise exhibited inverse correlation between the changes in BDNF and lactate (r=-0.38,  p  = 0.044). There was significant correlation between BDNF and VO 2max  for moderate ( r  = -0.57,  p  = 0.002) and a trend for high-intensity condition ( r  = -0.37,  p  = 0.050) and when evaluating BDNF according to physical fitness level, it was observed that subjects with lower physical fitness levels had greater increases in BDNF in short-time high-intensity exercise ( p  = 0.041). In conclusion, short-time high-intensity exercise seems to be more efficient in increasing BDNF concentration, and physical fitness level influences this response, as healthy individuals with lower physical fitness levels were more responsive.",2020,Changes in BDNF presented differences between conditions (p < 0.001) with greater increase in high-intensity compared with the others (p = 0.003).,"['healthy men', 'healthy individuals with lower physical fitness levels', 'Twenty-eight men, divided according to physical fitness status (<50th or >50th percentile for VO 2max ']","['BDNF', 'Short-time high-intensity exercise']","['high-intensity condition', 'BDNF', 'BDNF and VO 2max  for moderate', 'high-intensity', 'BDNF and lactate', 'Lactate and BDNF', 'BDNF response', 'increase post high-intensity exercise']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0198744,Changes in BDNF presented differences between conditions (p < 0.001) with greater increase in high-intensity compared with the others (p = 0.003).,"[{'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Postgraduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Fabrício Eduardo', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Immunometabolism of Skeletal Muscle and Exercise Research Group, Department of Physical Education, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Teixeira', 'Affiliation': 'Research center for Sport and Physical Activity (UID/PTD/04213/2016), Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Fábio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Postgraduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}]",European journal of sport science,['10.1080/17461391.2019.1611929']
1300,31058457,A self-monitoring urinary salt excretion level measurement device for educating young women about salt reduction: A parallel randomized trial involving two groups.,"To prevent and treat hypertension, it is important to restrict salt in one's diet since adolescence. However, an effective salt-reduction education system has yet to be established. Besides accurate evaluation, we believe that the frequent usage of a measurement device may motivate individuals to avoid high salt intake. The present study evaluated the use of a urinary salt excretion measurement device for salt-reduction education in a parallel randomized trial of two groups. The sample comprised 100 university students who provided consent to participate. A survey with 24-hour home urine collection and blood pressure measurement was conducted. Participants in the self-monitoring group measured their own urinary salt excretion level for 4 weeks, using the self-measurement device. Analyses were conducted on 51 participants in the control group and 49 in the self-monitoring group. At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels. After intervention, 24-hour urinary sodium/potassium ratio showed no change in the control group [baseline score: 4.1 ± 1.5; endline score: 4.2 ± 2.0; P = 0.723], but it decreased significantly in the self-monitoring group [baseline score: 4.0 ± 1.7; endline score: 3.5 ± 1.4; P = 0.044]. This change was significant even after adjusting for baseline and endline differences between groups using analysis of covariance (P = 0.045). The self-monitoring urinary salt excretion measurement device improved the 24-hour urinary sodium/potassium ratio. The device is a useful and practical tool for educating young individuals about dietary salt reduction.",2019,"At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels.","['educating young women about salt reduction', '100 university students who provided consent to participate', '51 participants in the control group and 49 in the self-monitoring group']","['urinary salt excretion measurement device for salt-reduction education', 'self-monitoring urinary salt excretion level measurement device']","['urinary salt excretion level', 'characteristics and 24-hour urinary salt excretion levels', '24-hour urinary sodium/potassium ratio']","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0201808', 'cui_str': 'Excretion measurement (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",51.0,0.0151328,"At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels.","[{'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Yasutake', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Nutritional Sciences, Nakamura Gakuen University, Fukuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Umeki', 'Affiliation': ""Department of Food of Health Sciences, International College of Arts and Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Horita', 'Affiliation': 'Department of Health and Nutrition Sciences, Faculty of Health and Nutrition Sciences, Nishikyushu University, Kanzaki, Japan.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Morita', 'Affiliation': ""Department of Food of Health Sciences, International College of Arts and Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Health Care Center, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ohe', 'Affiliation': 'Health Care Center, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Hypertension Center, Steel Memorial Yawata Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Munechika', 'Initials': 'M', 'LastName': 'Enjoji', 'Affiliation': 'Health Care Center, Fukuoka University, Fukuoka, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13545']
1301,31058977,"A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection.","BACKGROUND


Herpes simplex virus 2 (HSV2) causes genital herpes in >400 million persons worldwide.
METHODS


We conducted a randomized, double-blinded, placebo-controlled trial of a replication-defective HSV2 vaccine, HSV529. Twenty adults were enrolled in each of 3 serogroups of individuals: those negative for both HSV1 and HSV2 (HSV1-/HSV2-), those positive or negative for HSV1 and positive for HSV2 (HSV1±/HSV2+), and those positive for HSV1 and negative for HSV2 (HSV1+/HSV2-). Sixty participants received vaccine or placebo at 0, 1, and 6 months. The primary end point was the frequency of solicited local and systemic reactions to vaccination.
RESULTS


Eighty-nine percent of vaccinees experienced mild-to-moderate solicited injection site reactions, compared with 47% of placebo recipients (95% confidence interval [CI], 12.9%-67.6%; P = .006). Sixty-four percent of vaccinees experienced systemic reactions, compared with 53% of placebo recipients (95% CI, -17.9% to 40.2%; P = .44). Seventy-eight percent of HSV1-/HSV2- vaccine recipients had a ≥4-fold increase in neutralizing antibody titer after 3 doses of vaccine, whereas none of the participants in the other serogroups had such responses. HSV2-specific CD4+ T-cell responses were detected in 36%, 46%, and 27% of HSV1-/HSV2-, HSV1±/HSV2+, and HSV1+/HSV2- participants, respectively, 1 month after the third dose of vaccine, and CD8+ T-cell responses were detected in 14%, 8%, and 18% of participants, respectively.
CONCLUSIONS


HSV529 vaccine was safe and elicited neutralizing antibody and modest CD4+ T-cell responses in HSV-seronegative vaccinees.
CLINICAL TRIALS REGISTRATION


NCT01915212.",2019,"Sixty-four percent of vaccinees experienced systemic reactions compared with 53% of placebo recipients (p = 0.44, 95%CI -0.179, 0.402).","['Twenty adults each enrolled in three serogroups, HSV1 /HSV2 , HSV1 /HSV2 , and HSV1 /HSV2 , received', 'Adults With or Without HSV Infection', 'Herpes simplex virus 2 (HSV2) causes genital herpes in over 400 million persons worldwide']","['vaccine or placebo', 'placebo', 'HSV529 vaccine', 'HSV1 /HSV2 vaccine', 'Placebo', 'replication-defective HSV2 vaccine, HSV529']","['moderate solicited injection site reactions', 'HSV2-specific CD4+ T-cell responses', 'CD8+ T-cell responses', 'safe and elicited neutralizing antibody and modest CD4+ T-cell responses', 'systemic reactions', 'neutralizing antibody titer', 'frequency of solicited local and systemic reactions to vaccination']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0019348', 'cui_str': 'Herpes Simplex Virus Infection'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",20.0,0.700411,"Sixty-four percent of vaccinees experienced systemic reactions compared with 53% of placebo recipients (p = 0.44, 95%CI -0.179, 0.402).","[{'ForeName': 'Lesia K', 'Initials': 'LK', 'LastName': 'Dropulic', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Makinna C', 'Initials': 'MC', 'LastName': 'Oestreich', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Harlan L', 'Initials': 'HL', 'LastName': 'Pietz', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Laing', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, NIAID, NIH, Rockville.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Lumbard', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Garabedian', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.'}, {'ForeName': 'Siu Ping', 'Initials': 'SP', 'LastName': 'Turk', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Aiying', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Global Biostatistics and Programming, Pennsylvania.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Hornung', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, NIH, Frederick, Maryland.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Seshadri', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Malisa T', 'Initials': 'MT', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Hosken', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'New Vaccines Portfolio Strategy and Execution, Pennsylvania.'}, {'ForeName': 'Lee-Jah', 'Initials': 'LJ', 'LastName': 'Chang', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Koelle', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington.'}, {'ForeName': 'Kening', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Cohen', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz225']
1302,31050809,Characterizing red blood cell age exposure in massive transfusion therapy: the scalar age of blood index (SBI).,"BACKGROUND


The mortality of trauma patients requiring massive transfusion to treat hemorrhagic shock approaches 17% at 24 hours and 26% at 30 days. The use of stored RBCs is limited to less than 42 days, so older RBCs are delivered first to rapidly bleeding trauma patients. Patients who receive a greater quantity of older RBCs may have a higher risk for mortality.
METHODS AND MATERIALS


Characterizing blood age exposure requires accounting for the age of each RBC unit and the quantity of transfused units. To address this challenge, a novel Scalar Age of Blood Index (SBI) that represents the relative distribution of RBCs received is introduced and applied to a secondary analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized controlled trial (NCT01545232, https://clinicaltrials.gov/ct2/show/NCT01545232). The effect of the SBI is assessed on the primary PROPPR outcome, 24-hour and 30-day mortality.
RESULTS


The distributions of blood storage ages successfully maps to a parameter (SBI) that fully defines the blood age curve for each patient. SBI was a significant predictor of 24-hour and 30-day mortality in an adjusted model that had strong predictive ability (odds ratio, 1.15 [1.01-1.29], p = 0.029, C-statistic, 0.81; odds ratio, 1.14 [1.02-1.28], p = 0.019, C-statistic, 0.88, respectively).
CONCLUSION


SBI is a simple scalar metric of blood age that accounts for the relative distribution of RBCs among age categories. Transfusion of older RBCs is associated with 24-hour and 30-day mortality, after adjustment for total units and clinical covariates.",2019,"Transfusion of older RBCs is associated with 24-hour and 30-day mortality, after adjustment for total units and clinical covariates.",['trauma patients requiring massive transfusion'],"['SBI', 'stored RBCs']","['Blood Index', '24-hour and 30-day mortality', 'blood index (SBI', 'primary PROPPR outcome, 24-hour and 30-day mortality']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]",[],"[{'cui': 'C0005768'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",,0.092142,"Transfusion of older RBCs is associated with 24-hour and 30-day mortality, after adjustment for total units and clinical covariates.","[{'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Jones', 'Affiliation': 'Department of Acute, Chronic and Continuing Care, School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jose-Miguel', 'Initials': 'JM', 'LastName': 'Yamal', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Pittet', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': 'Department of Surgery, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Department of Surgery, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15334']
1303,31047902,Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial.,"BACKGROUND


Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes.
METHODS


SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA 1c  values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed.
FINDINGS


Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect -2·9 [95% CI -3·5 to -2·3]; p<0·0001) and fewer severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall (three vs 18; p=0·0036). The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76). No serious adverse device effects or episodes of diabetic ketoacidosis were reported.
INTERPRETATION


Insulin pump therapy with integrated CGM and a suspend-before-low feature reduced the frequency of sensor hypoglycaemic and severe hypoglycaemic events in hypoglycaemia-prone adults compared with use of continuous subcutaneous insulin infusion without real-time CGM. These results suggest that this technology could be beneficial in this high-risk population.
FUNDING


Medtronic International Trading Sàrl and Medtronic Canada.",2019,The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76).,"['hypoglycaemia-prone adults with type 1 diabetes', 'Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK', '12·5] years) and 76 to the intervention group (mean age 49·0', 'Between Dec 7, 2016, and March 27, 2018', '153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4', 'people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA 1c  values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4', 'hypoglycaemia-prone adults with type 1 diabetes (SMILE', 'hypoglycaemia-prone adults']","['insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard', 'MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group', 'suspend-before-low insulin pump technology']","['safety and efficacy', 'hypoglycaemic events', 'hypoglycaemia', 'hyperglycaemia', 'Efficacy and safety', 'severe hypoglycaemic events (instances requiring third-party assistance with carbohydrate or glucagon administration, or other resuscitative actions) overall', 'mean number of sensor hypoglycaemic events', 'serious adverse device effects or episodes of diabetic ketoacidosis']","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0342317', 'cui_str': 'Loss of hypoglycemic warning (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C1705537', 'cui_str': 'Suspended'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]",153.0,0.179194,The most common adverse events were hypoglycaemia (observed in ten [13%] of 77 participants in the control group vs four [5%] of 76 in the intervention group) and hyperglycaemia (observed in seven [9%] of 77 vs seven [9%] of 76).,"[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milan, Italy.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""Department of Internal Medicine, King's College Hospital, Diabetes Research Group, Weston Education Center, London, UK.""}, {'ForeName': 'Harold W', 'Initials': 'HW', 'LastName': 'de Valk', 'Affiliation': 'Department of Internal Medicine, University Medical Center, Utrecht, Netherlands.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': ""Department of Diabetology, Grenoble University Hospital, Service d'Endocrinologie, Pôle Digidune, Grenoble, France.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castañeda', 'Affiliation': 'Bakken Research Centre, Maastricht, Netherlands.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'de Portu', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Da Silva', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Roseline', 'Initials': 'R', 'LastName': 'Ré', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vorrink-de Groot', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Medtronic, Northridge, CA, USA.'}, {'ForeName': 'Francine R', 'Initials': 'FR', 'LastName': 'Kaufman', 'Affiliation': 'Medtronic, Northridge, CA, USA.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland. Electronic address: ohad.cohen@medtronic.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30150-0']
1304,31046527,Sustainable improvement of HbA 1c  and satisfaction with diabetes care after adding telemedicine in patients on adaptable insulin regimens: Results of the TeleDiabetes randomized controlled trial.,"This 2-year study evaluates whether tele-education adds to improvement and maintenance of good glycemic control and patient satisfaction. Adult patients were randomly assigned to study, getting immediate access to tele-education, or control group, getting this surplus education after 3 months. At several moments, clinical data were retrieved and patients completed questionnaires. Multivariate analyses of covariance and repeated measures analysis of variance were conducted. Implementation of tele-education in between face-to-face contacts improved glycemic control for both groups, which was maintained over a 2-year period. Tele-education did not have an influence on glucose measurements or on hypoglycemic events. Patients were satisfied with this tele-educational tool and appreciated use of personal messages. Further research should focus on the possible influence of ""life changes"" and influence on ""need for more tele-educational feedback,"" and consequently on the provision of (mobile) platforms adaptable to patient's (changing life) situations.",2020,"Implementation of tele-education in between face-to-face contacts improved glycemic control for both groups, which was maintained over a 2-year period.","['Adult patients', 'patients on adaptable insulin regimens']","['telemedicine', 'getting immediate access to tele-education, or control group, getting this surplus education']","['glycemic control', 'Sustainable improvement of HbA 1c  and satisfaction with diabetes care']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0216373,"Implementation of tele-education in between face-to-face contacts improved glycemic control for both groups, which was maintained over a 2-year period.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Buysse', 'Affiliation': 'Ghent University, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Coremans', 'Affiliation': 'AZ Nikolaas, Belgium.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Pouwer', 'Affiliation': 'University of Southern Denmark, Denmark.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ruige', 'Affiliation': 'AZ Nikolaas, Belgium.'}]",Health informatics journal,['10.1177/1460458219844369']
1305,31711513,Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results.,"BACKGROUND


Stem cell therapy is investigated as a treatment option for patients with ischemic heart disease. In this study, long-term safety and efficacy of autologous intra-myocardial injections of adipose-derived stromal cells (ASCs) was studied in patients with refractory angina.
METHODS


Sixty patients with coronary artery stenosis and preserved left ventricular ejection fraction were 2:1 randomised to intramyocardial injections of ASCs or saline and followed for 3 years.
RESULTS


For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period. However, in the same period, there was in the placebo group a significant decline in bicycle exercise time (437 ± 53 s to 383 ± 58 s, P = 0.001), the exercise performance measured in watt (87 ± 12 W to 80 ± 12 W, P = 0.019) and in METs (4.5 ± 0.4 to 4.1 ± 0.4, P = 0.002). Moreover, angina measured as CCS class was significantly reduced in the ASC group but not in the placebo group (2.5 ± 0.9 to 1.8 ± 1.2, P = 0.002 and 2.5 ± 0.8 to 2.1 ± 1.3, P = 0.186, respectively). However, no significant change was observed between the two groups.
CONCLUSIONS


Patients receiving ASCs had improved cardiac symptoms and unchanged exercise capacity, in opposition to deterioration in the placebo group. Trial registration ClinicalTrials.gov Identifier: NCT01449032. Registered 7 October 2011-Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT01449032?term=jens+kastrup&rank=7.",2019,"For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period.","['patients with refractory angina', 'Sixty patients with coronary artery stenosis and preserved left ventricular ejection fraction', 'patients with ischemic heart disease', 'patients with refractory angina (MyStromalCell Trial']","['placebo', 'Autologous adipose-derived stromal cell treatment', 'intramyocardial injections of ASCs or saline', 'autologous intra-myocardial injections of adipose-derived stromal cells (ASCs']","['CCS class', 'performance in METs', 'cardiac symptoms and unchanged exercise capacity', 'bicycle exercise time and the exercise performance', 'exercise performance', 'bicycle exercise time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0439587', 'cui_str': 'Exercise time (qualifier value)'}]",60.0,0.177572,"For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period.","[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Qayyum', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark. abbas.ali.qayyum@regionh.dk.'}, {'ForeName': 'Anders Bruun', 'Initials': 'AB', 'LastName': 'Mathiasen', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Gentofte University of Copenhagen, Kildegårdsvej 28, 2900, Hellerup, Denmark.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Haack-Sørensen', 'Affiliation': 'Cardiology Stem Cell Centre 9302, Rigshospitalet University of Copenhagen, Henrik Harpestrengsvej 4C, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ekblond', 'Affiliation': 'Cardiology Stem Cell Centre 9302, Rigshospitalet University of Copenhagen, Henrik Harpestrengsvej 4C, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark.'}]",Journal of translational medicine,['10.1186/s12967-019-2110-1']
1306,31728715,"A pilot study on intermittent every other days of 5-dose Filgrastim compared with single Pegfilgrastim in breast Cancer patients receiving adjuvant Docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy.","Aim To compare the efficacy and safety of intermittent every other days 5-dose filgrastim with single pegfilgrastim in patients with breast cancer receiving adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. Methods In this pilot study, Korean patients who had undergone complete resection for breast cancer and scheduled for adjuvant TAC chemotherapy were enrolled. Patients were randomized to receive either intermittent 5 doses of filgrastim (5 mcg/kg/day) or once-a-cycle pegfilgrastim (6 mg) as primary prophylaxis during the first three cycles of the TAC chemotherapy. Absolute neutrophil count (ANC) was analyzed as well. Results A total of 22 patients were randomly and equally divided into filgrastim or pegfilgrastim arms. Febrile neutropenia (FN) occurred in 1 patient in the pegfilgrastim arm (1 of 33 cycles) and none in the filgrastim arm. G3 neutropenia occurred in 1 patient (1 of 33 cycles) in the filgrastim arm and 2 patients (4 of 33 cycles) in the pegfilgrastim arm (P = 0.476). G4 neutropenia occurred in 11 patients (28 of 33 cycles) in the filgrastim arm and 9 patients (18 of 33 cycles) in the pegfilgrastim arm (P = 0.476). Except for on day 9 in cycle 3, there was no significant difference between the two groups in terms of ANC. Conclusion We observed no significant differences between the two methods of prophylaxis in terms of FN and G3/4 neutropenia incidence in patients receiving adjuvant TAC chemotherapy. Intermittent every other days 5-dose filgrastim may be available alternative to pegfilgrastim.",2020,"Except for on day 9 in cycle 3, there was no significant difference between the two groups in terms of ANC.","['patients with breast cancer receiving adjuvant', '22 patients', 'breast Cancer patients receiving', 'patients receiving adjuvant TAC chemotherapy', 'Korean patients who had undergone complete resection for breast cancer and scheduled for adjuvant TAC chemotherapy were enrolled']","['filgrastim or pegfilgrastim', 'single Pegfilgrastim', 'adjuvant Docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy', 'filgrastim with single pegfilgrastim', 'pegfilgrastim', 'TAC chemotherapy', 'filgrastim', 'Filgrastim', 'filgrastim (5 mcg/kg/day) or once-a-cycle pegfilgrastim', 'docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy']","['G3 neutropenia', 'efficacy and safety', 'Febrile neutropenia (FN', 'Absolute neutrophil count (ANC', 'G4 neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C1532561', 'cui_str': 'ug/kg/day'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",,0.0267571,"Except for on day 9 in cycle 3, there was no significant difference between the two groups in terms of ANC.","[{'ForeName': 'Byeong Seok', 'Initials': 'BS', 'LastName': 'Sohn', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Joo Hyuk', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Koh', 'Affiliation': 'Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Korea University Guro Hospital, Korea University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. sbkim3@amc.seoul.kr.'}]",Investigational new drugs,['10.1007/s10637-019-00863-8']
1307,31005604,"Feasibility of a Family Meal Intervention to Address Nutrition, Emotional Wellbeing, and Food Insecurity of Families With Adolescents.","OBJECTIVE


To assess the feasibility of a family meal intervention to address indicators of parent and adolescent nutrition and well-being and household food security.
METHODS


Nine adolescents and a parent/caregiver were recruited from a youth health clinic. Families were provided with meal plans, recipes, and ingredients for 5 meals weekly for 4 weeks. Participants completed baseline and follow-up surveys and open-ended interviews.
RESULTS


Overall, fidelity to the intervention was high among families; the frequency of family meals increased by approximately 2 meals/wk. Both parent/caregivers and adolescents reported improvements to nutrition (4 of 9 increased vegetable consumption for both) and most reported improvements to mental well-being. Household food insecurity also reduced during the intervention (means of 8.2 and 0.2 at baseline and follow-up, respectively).
CONCLUSIONS AND IMPLICATIONS


Providing families with meal plans, recipes, and ingredients is an acceptable way to increase weekly frequency of family meals. Future research may consider the family meal as a way to engage with families about broader concerns.",2019,"Overall, fidelity to the intervention was high among families; the frequency of family meals increased by approximately 2 meals/wk.","['Families With Adolescents', 'Nine adolescents and a parent/caregiver were recruited from a youth health clinic']","['Family Meal Intervention', 'family meal intervention']",['frequency of family meals'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]",9.0,0.0291702,"Overall, fidelity to the intervention was high among families; the frequency of family meals increased by approximately 2 meals/wk.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Utter', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand. Electronic address: j.utter@auckland.ac.nz.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Denny', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Farrant', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Cribb', 'Affiliation': 'Le Va, Manukau City, New Zealand.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.03.015']
1308,31012984,"Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials.","GLPG1690 is a novel autotaxin inhibitor in development for the treatment of idiopathic pulmonary fibrosis (IPF). We report phase 1 studies investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690 in healthy subjects. We performed a first-in-human randomized, double-blind, placebo-controlled trial of single (20, 60, 150, 300, 600, 1000, 1500 mg) and multiple (14 days: 150 mg twice daily; 600 and 1000 mg once daily) ascending oral doses of GLPG1690 (NCT02179502), and a randomized, open-label, crossover relative bioavailability study to compare the PK of tablet and capsule formulations of GLPG1690 600 mg and to assess the effect of food on PK of the tablet formulation (NCT03143712). Forty and 13 subjects were randomized in the first-in-human and relative bioavailability studies, respectively. GLPG1690 was well tolerated, with no dose-limiting toxicity at all single and multiple doses. GLPG1690 was rapidly absorbed and eliminated, with a median t max  and mean t 1/2  of approximately 2 and 5 hours, respectively. GLPG1690 exposure increased with increasing dose (mean C max  , 0.09-19.01 µg/mL; mean AUC 0-inf  , 0.501-168 µg·h/mL, following single doses of GLPG1690 20-1500 mg). PD response, evidenced by rapid reduction in plasma lysophosphatidic acid (LPA) C18:2 levels, increased with increasing GLPG1690 plasma levels, plateauing at approximately 80% reduction in LPA C18:2 at around 0.6 µg/mL GLPG1690. Tablet and capsule formulations had similar PK profiles, and no clinically significant food effect was observed when comparing tablets taken in fed and fasted states. The safety, tolerability, and PK/PD profiles of GLPG1690 support continued clinical development for IPF.",2019,GLPG1690 is a novel autotaxin inhibitor in development for the treatment of idiopathic pulmonary fibrosis (IPF).,"['Healthy Subjects', 'Forty and 13 subjects', 'healthy subjects', 'idiopathic pulmonary fibrosis (IPF']","['GLPG1690', 'placebo', 'Autotaxin Inhibitor GLPG1690']","['GLPG1690 plasma levels', 'PD response', 'plasma lysophosphatidic acid (LPA) C18:2 levels', 'safety, tolerability, and PK/PD profiles', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C4508131', 'cui_str': 'GLPG1690'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4508131', 'cui_str': 'GLPG1690'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024367', 'cui_str': 'Lysophosphatidic Acids'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.129943,GLPG1690 is a novel autotaxin inhibitor in development for the treatment of idiopathic pulmonary fibrosis (IPF).,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Aar', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Desrivot', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Dupont', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Heckmann', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Fieuw', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Stutvoet', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Fagard', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Van de Wal', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmer', 'Affiliation': 'Galapagos Biotech Limited, Cambridge, United Kingdom.'}]",Journal of clinical pharmacology,['10.1002/jcph.1424']
1309,29446830,Prior ingestion of exogenous ketone monoester attenuates the glycaemic response to an oral glucose tolerance test in healthy young individuals.,"KEY POINTS


The recent development of exogenous ketone supplements allows direct testing of the metabolic effects of elevated blood ketones without the confounding influence of widespread changes experienced with ketogenic diets or prolonged fasting. In the present study, we determined the effect of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester on the glycaemic response and insulin sensitivity index during a 2 h oral glucose tolerance test (OGTT) in humans. The results obtained show that consuming a ketone monoester supplement 30 min prior to an OGTT reduced the glycaemic response and markers of insulin sensitivity without affecting insulin secretion. The findings of the present study provides evidence that ketone supplements could have therapeutic potential for future application as a glucose-lowering nutritional supplement.
ABSTRACT


The main objectives of the present study were: (i) to determine whether acute ingestion of ketone monoester (K me  ); (R)-3-hydroxybutyl (R)-3-hydroxybutyrate impacts plasma glucose levels during a standardized oral glucose tolerance test (OGTT) and (ii) to compare changes in insulin concentrations and estimates of insulin sensitivity after acute K me  supplementation. Twenty healthy participants (n = 10 males/females) aged between 18 and 35 years took part in a randomized cross-over study. After an overnight fast, participants consumed a K me  supplement (ΔG®; TΔS Ltd, UK, Oxford, UK; 0.45 ml kg -1  body weight) or placebo (water) 30 min before completing a 75 g OGTT. Blood samples were collected every 15-30 min over 2.5 h. The participants and study personnel performing the laboratory analyses were blinded to the study condition. K me  acutely raised blood d-beta-hydroxybutyrate (β-OHB) to 3.2 ± 0.6 mm within 30 min with levels remaining elevated throughout the entire OGTT. Compared to placebo, K me  significantly decreased the glucose area under the curve (AUC; -17%, P = 0.001), non-esterified fatty acid AUC (-44%, P < 0.001) and C-peptide incremental AUC (P = 0.005), at the same time as improving oral glucose insulin sensitivity index by ∼11% (P = 0.001). In conclusion, a K me  supplement that acutely increased β-OHB levels up to ∼3 mm attenuated the glycaemic response to an OGTT in healthy humans. The reduction in glycaemic response did not appear to be driven by an increase in insulin secretion, although it was accompanied by improved markers of insulin sensitivity. These results suggest that ketone monoester supplements could have therapeutic potential in the management and prevention of metabolic diseases.",2018,"Compared to placebo, K me  significantly decreased the glucose area under the curve (AUC; -16%, P = 0.001), non-esterified fatty acid AUC (-44%, P ","['healthy humans', '10\xa0males/females) aged between 18 and 35\xa0years took part in a randomized cross-over study', 'Twenty healthy participants (n\xa0', 'healthy young individuals', 'humans']","['ketone monoester (K me  ); (R)-3-hydroxybutyl (R)-3-hydroxybutyrate', 'placebo', 'placebo (water', 'exogenous ketone supplements', 'R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester', 'exogenous ketone monoester']","['β-OHB levels', 'insulin secretion', 'Blood samples', 'glycaemic response and insulin sensitivity index', 'glycaemic response and markers of insulin sensitivity', 'oral glucose insulin sensitivity index', 'glycaemic response', 'C-peptide incremental AUC']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C3529323', 'cui_str': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",20.0,0.0631014,"Compared to placebo, K me  significantly decreased the glucose area under the curve (AUC; -16%, P = 0.001), non-esterified fatty acid AUC (-44%, P ","[{'ForeName': 'Étienne', 'Initials': 'É', 'LastName': 'Myette-Côté', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Neudorf', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rafiei', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiology, Anatomy, and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, Canada.'}]",The Journal of physiology,['10.1113/JP275709']
1310,31002578,Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study.,"PURPOSE


To evaluate the impact of two different intraperitoneal (IP) chemotherapy regimens on progression-free survival (PFS) among women with newly diagnosed advanced ovarian carcinoma.
METHODS


Eligible patients were randomly assigned to six cycles of IV paclitaxel 80 mg/m 2  once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m 2  once per week with IP carboplatin area under the curve 6 (IP carboplatin) versus once every 3 weeks IV paclitaxel 135 mg/m 2  over 3 hours day 1, IP cisplatin 75 mg/m 2  day 2, and IP paclitaxel 60 mg/m 2  day 8 (IP cisplatin). All participants received bevacizumab 15 mg/kg IV every 3 weeks in cycles 2 to 22.
RESULTS


A total of 1,560 participants were enrolled and had 84.8 months of follow-up. The median PFS duration was 24.9 months in the IV carboplatin arm, 27.4 months in the IP carboplatin arm, and 26.2 months in the IP cisplatin arm. For the subgroup of 1,380 patients with stage II/III and residual disease of 1 cm or less, median PFS was 26.9 (IV-carboplatin), 28.7 (IP-carboplatin), and 27.8 months (IP cisplatin), respectively. Median PFS for patients with stage II/III and no residual disease was 35.9, 38.8, and 35.5 months, respectively. Median overall survival for all enrolled was 75.5, 78.9, and 72.9 months, respectively, and median overall survival for stage II/III with no gross residual disease was 98.8 months, 104.8 months, and not reached. Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores (Gynecologic Oncology Group) were similar for all arms, but the mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores during chemotherapy were statistically worse in the IP cisplatin arm.
CONCLUSION


Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.",2019,"Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.","['1,560 participants were enrolled and had 84.8 months of follow-up', 'women with newly diagnosed advanced ovarian carcinoma', 'Advanced Ovarian Carcinoma', 'Eligible patients', '1,380 patients with stage II/III and residual disease of 1 cm or less']","['intraperitoneal (IP) chemotherapy regimens', 'bevacizumab', 'IV paclitaxel 80 mg/m 2  once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m 2  once per week with IP carboplatin area under the curve 6 (IP carboplatin', 'Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab', 'paclitaxel 135 mg/m 2  over 3 hours day 1, IP cisplatin 75 mg/m 2  day 2, and IP paclitaxel', 'IP cisplatin']","['Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores', 'progression-free survival (PFS', 'mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores', 'median PFS duration', 'duration of PFS', 'median overall survival', 'median PFS', 'Median overall survival', 'Median PFS']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029925'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1560.0,0.234568,"Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.","[{'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': '1 University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': '2 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': '3 University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': '4 The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': '2 Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'DiSilvestro', 'Affiliation': '5 Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': '6 Saitama Medical University International Medical Center, Hidaka-Shi, Japan.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': '7 The University of Arizona Cancer Center, Tucson, AZ.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': '8 The University of Arizona, Tucson, AZ.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': '3 University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': '9 The Ohio State University, Columbus, OH.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': '10 Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Le', 'Affiliation': '11 University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Davidson', 'Affiliation': '12 University of Colorado, Aurora, CO.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Gray', 'Affiliation': '13 University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Rose', 'Affiliation': '14 Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': '15 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Tashanna', 'Initials': 'T', 'LastName': 'Myers', 'Affiliation': '16 University of Connecticut, Storrs, CT.'}, {'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': '17 Duke University Health System, Durham, NC.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': '18 University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': '1 University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01568']
1311,31685913,Effects of modified aerobic training on muscle metabolism in individuals with peripheral arterial disease: a randomized clinical trial.,"The primary objective of this study was to compare the effects on muscle metabolism of two types of aerobic training, with and without a load on the lower limbs, in adults with peripheral arterial disease (PAD). A simple blind randomized clinical trial was conducted using two groups: conventional aerobic (CG) and modified aerobic with a load on the lower limbs (MG). Both groups underwent training by walking three times a week over a 12-week period. The ratings of muscle metabolism were determined after a treadmill test with constant velocity and inclination concomitant with the use of near infrared spectroscopy (NIRS). Altogether 40 individuals with PAD (CG = 65.45 ± 10.60 and MG = 63.10 ± 10.54) were included in the study. After the intervention, in both groups, there was a reduction in the relative time to recovery (p = 0.002), an improvement in the re-oxygenation rate (p = 0.017), an increased time of resistance after reaching the lowest muscle oxygen saturation (StO 2 ) (p < 0.001), an increase in the distance walked (p < 0.001), and an improvement of the walking economy relative to StO 2  (p < 0.001). After 12 weeks of training, an improvement in the deoxygenation rate was observed in both groups (p = 0.002), but with a greater magnitude in the CG (p = 0.017). Only the CG presented an increase in time to reach the lowest StO 2  on the treadmill after the intervention (p = 0.010). The traditional aerobic training was superior to the modified training in relation to the improvement of muscle metabolism in patients with PAD.",2019,"After 12 weeks of training, an improvement in the deoxygenation rate was observed in both groups (p = 0.002), but with a greater magnitude in the CG (p = 0.017).","['adults with peripheral arterial disease (PAD', 'individuals with peripheral arterial disease', 'Altogether 40 individuals with PAD (CG\u2009=\u200965.45\u2009±\u200910.60 and MG\u2009=\u200963.10\u2009±\u200910.54) were included in the study', 'patients with PAD']","['traditional aerobic training', 'modified aerobic training', 'aerobic training', 'conventional aerobic (CG) and modified aerobic with a load on the lower limbs (MG']","['muscle metabolism', 're-oxygenation rate', 'relative time to recovery', 'time of resistance after reaching the lowest muscle oxygen saturation', 'deoxygenation rate', 'time to reach the lowest StO', 'ratings of muscle metabolism', 'distance walked']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439564', 'cui_str': 'Relative time'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",40.0,0.0565781,"After 12 weeks of training, an improvement in the deoxygenation rate was observed in both groups (p = 0.002), but with a greater magnitude in the CG (p = 0.017).","[{'ForeName': 'Débora Pantuso', 'Initials': 'DP', 'LastName': 'Monteiro', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil.'}, {'ForeName': 'Giane Amorim', 'Initials': 'GA', 'LastName': 'Ribeiro-Samora', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil.'}, {'ForeName': 'Raquel Rodrigues', 'Initials': 'RR', 'LastName': 'Britto', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil.'}, {'ForeName': 'Danielle Aparecida Gomes', 'Initials': 'DAG', 'LastName': 'Pereira', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Avenida Presidente Antônio Carlos, 6627 - Pampulha, Belo Horizonte, MG, CEP 31270-901, Brazil. danielleufmg@gmail.com.'}]",Scientific reports,['10.1038/s41598-019-52428-7']
1312,30898329,Cost effectiveness of text messages to reduce methamphetamine use and HIV sexual risk behaviors among men who have sex with men.,"Methamphetamine use is highly prevalent among gay, bisexual, and other men who have sex with men (MSM) in the United States and has been associated with condomless anal intercourse (CAI), a common route of HIV infection. Text messaging is a very low-cost method of delivery for intervention content. This paper presents a cost-effectiveness analysis of a randomized controlled trial testing three nested methods of text message delivery designed to reduce methamphetamine use and HIV sexual risk behaviors among MSM (Project Tech Support2). From March 2014 to January 2016, 286 non-treatment seeking methamphetamine-using MSM were randomized into one of three study arms: 1) Interactive text message conversations with Peer Health Educators, plus five daily automated, unidirectional theory-based messages, plus a weekly self-monitoring text message assessment (TXT-PHE; n = 94); or, 2) Five daily automated, unidirectional theory-based messages plus a weekly self-monitoring text message assessment (TXT-Auto; n = 99); or, 3) The weekly self-monitoring text message assessment only (AO; n = 93). Methamphetamine use at nine months post-enrollment was lower than at baseline in all three arms. The addition of Peer Health Educators and/or theory-based text messages did not produce cost-effective reductions in methamphetamine use over the weekly AO text messages. However, both intervention arms outperformed the AO arm in reducing HIV risk behaviors, but the TXT-Auto arm dominated the TXT-PHE arm in achieving greater reductions in days of methamphetamine use and CAI at lower cost. The TXT-Auto arm achieved greater reductions in CAI than the attentional control at a cost in the base case of ~$37.50 per episode of CAI reduced per month. Sensitivity analyses showed that results were robust to a number of changes in assumptions. Interventions seeking to reduce methamphetamine use among non-treatment-seeking MSM may seek to add minimal attentional control-style text messages to their routines querying about recent methamphetamine use and/or high-risk sex. Interventions seeking to additionally reduce HIV sexual risk behaviors among non-treatment-seeking MSM, specifically engagement in CAI, may seek to additionally apply theory-based text messages.",2019,The addition of Peer Health Educators and/or theory-based text messages did not produce cost-effective reductions in methamphetamine use over the weekly AO text messages.,"['From March 2014 to January 2016, 286 non-treatment seeking methamphetamine-using MSM', 'men who have sex with men (MSM', 'men who have sex with men']","['Methamphetamine', 'Interactive text message conversations with Peer Health Educators, plus five daily automated, unidirectional theory-based messages, plus a weekly self-monitoring text message assessment (TXT-PHE; n\u202f=\u202f94); or, 2) Five daily automated, unidirectional theory-based messages plus a weekly self-monitoring text message assessment (TXT-Auto; n\u202f=\u202f99); or, 3) The weekly self-monitoring text message assessment']","['HIV sexual risk behaviors', 'methamphetamine use and HIV sexual risk behaviors', 'HIV risk behaviors']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1136362', 'cui_str': 'Health Educators'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047143', 'cui_str': 'tmdPHE'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.058227,The addition of Peer Health Educators and/or theory-based text messages did not produce cost-effective reductions in methamphetamine use over the weekly AO text messages.,"[{'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Reback', 'Affiliation': 'Friends Research Institute, Inc., 1419 N. La Brea Ave, Los Angeles, CA 90028, USA; David Geffen School of Medicine, Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles, USA; Center for HIV Identification, Prevention and Treatment Services, University of California, Los Angeles, 10880 Wilshire Blvd, Suite 1800, Los Angeles, CA 90024, USA. Electronic address: reback@friendsresearch.org.'}, {'ForeName': 'Jesse B', 'Initials': 'JB', 'LastName': 'Fletcher', 'Affiliation': 'Friends Research Institute, Inc., 1419 N. La Brea Ave, Los Angeles, CA 90028, USA.'}, {'ForeName': 'Arleen A', 'Initials': 'AA', 'LastName': 'Leibowitz', 'Affiliation': 'Center for HIV Identification, Prevention and Treatment Services, University of California, Los Angeles, 10880 Wilshire Blvd, Suite 1800, Los Angeles, CA 90024, USA; UCLA Luskin School of Public Affairs, University of California, Los Angeles, Los Angeles, CA, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.02.006']
1313,31721487,Impact of Pharmacogenomics on Clinical Outcomes for Patients Taking Medications With Gene-Drug Interactions in a Randomized Controlled Trial.,"OBJECTIVE


The objective of the Genomics Used to Improve DEpression Decisions (GUIDED) trial was to evaluate the utility of pharmacogenomic testing to improve outcomes among patients with major depressive disorder (MDD) who had not responded to at least 1 prior medication trial. The objective of the present analysis was to assess outcomes for the subset of patients expected to benefit from combinatorial pharmacogenomic testing because they were taking medications with predicted gene-drug interactions.
METHODS


Participants (enrolled from April 14, 2014, to February 10, 2017) had an inadequate response to at least 1 psychotropic medication in the current episode of MDD. Patients were randomized to treatment as usual (TAU) or the guided-care arm, in which clinicians had access to a combinatorial pharmacogenomic test report to inform medication selection. Patients and raters were blinded to study arm through week 8. The following outcomes were assessed using the 17-item Hamilton Depre​ssion Rating Scale (HDRS-17): symptom improvement (percent change in HDRS-17 score), response (≥ 50% decrease in HDRS-17 score), and remission (HDRS-17 score ≤ 7). In the GUIDED trial, the primary endpoint of symptom improvement did not reach significance in the intent-to-treat cohort (P = .069). Here, a post hoc analysis of patients who were taking medications subject to gene-drug interactions at baseline as predicted by combinatorial pharmacogenomic testing (N = 912) is presented.
RESULTS


Among participants taking medications subject to gene-drug interactions at baseline, outcomes at week 8 were significantly improved for those in the guided-care arm compared to TAU (symptom improvement: 27.1% versus 22.1%, P = .029; response: 27.0% versus 19.0%, P = .008; remission: 18.2% versus 10.7%, P = .003). When patients who switched medications were assessed, all outcomes were significantly improved in the guided-care arm compared to TAU (P = .011 for symptom improvement, P = .011 for response, P = .008 for remission).
CONCLUSIONS


By identifying and focusing on the patients with predicted gene-drug interactions, use of a combinatorial pharmacogenomic test significantly improved outcomes among patients with MDD who had at least 1 prior medication failure.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02109939​.",2019,"In the GUIDED trial, the primary endpoint of symptom improvement did not reach significance in the intent-to-treat cohort (P = .069).","['Participants (enrolled from April 14, 2014, to February 10, 2017) had an inadequate response to at least 1 psychotropic medication in the current episode of MDD', 'patients who were taking medications subject to gene-drug interactions at baseline as predicted by combinatorial pharmacogenomic testing (N = 912) is presented', 'Patients Taking Medications', 'patients with MDD who had at least 1 prior medication failure', 'patients with major depressive disorder (MDD) who had not responded to at least 1 prior medication trial']","['usual (TAU) or the guided-care arm, in which clinicians had access to a combinatorial pharmacogenomic test report to inform medication selection']","['17-item Hamilton Depre\u200bssion Rating Scale (HDRS-17): symptom improvement (percent change in HDRS-17 score), response (≥ 50% decrease in HDRS-17 score), and remission (HDRS-17 score ≤ 7']","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1290952', 'cui_str': 'Taking medication (observable entity)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Testing'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.18046,"In the GUIDED trial, the primary endpoint of symptom improvement did not reach significance in the intent-to-treat cohort (P = .069).","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, The Corporal Michael Crescenz VAMC, 3535 Market Street, Room 689, Philadelphia, PA 19104. thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry, and National Network of Depression Centers, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare, Worcester, Massachusetts, USA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Department of Psychiatry, Washington University School of Medicine, and the John Cochran Veteran's Administration Hospital, St Louis, Missouri, USA.""}, {'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'Division of Geriatric Psychiatry, McLean Hospital, Harvard Medical School, Belmont, Massachusetts, USA.'}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Mondimore', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine-Wichita, Wichita, Kansas, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc, Mason, Ohio, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Myriad Genetics, Inc, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jablonski', 'Affiliation': 'Assurex Health, Inc, Mason, Ohio, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry, and National Network of Depression Centers, Ann Arbor, Michigan, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12910']
1314,30715250,Safety and Efficacy of C-reactive Protein-guided Antibiotic Use to Treat Acute Respiratory Infections in Tanzanian Children: A Planned Subgroup Analysis of a Randomized Controlled Noninferiority Trial Evaluating a Novel Electronic Clinical Decision Algorithm (ePOCT).,"BACKGROUND


The safety and efficacy of using C-reactive protein (CRP) to decide on antibiotic prescription among febrile children at risk of pneumonia has not been tested.
METHODS


This was a randomized (1:1) controlled noninferiority trial in 9 primary care centers in Tanzania (substudy of the ePOCT trial evaluating a novel electronic decision algorithm). Children aged 2-59 months with fever and cough and without life-threatening conditions received an antibiotic based on a CRP-informed strategy (combination of CRP ≥80 mg/L plus age/temperature-corrected tachypnea and/or chest indrawing) or current World Health Organization standard (respiratory rate ≥50 breaths/minute). The primary outcome was clinical failure by day (D) 7; the secondary outcomes were antibiotic prescription at D0, secondary hospitalization, or death by D30.
RESULTS


A total of 1726 children were included (intervention: 868, control: 858; 0.7% lost to follow-up). The proportion of clinical failure by D7 was 2.9% (25/865) in the intervention arm vs 4.8% (41/854) in the control arm (risk difference, -1.9% [95% confidence interval {CI}, -3.7% to -.1%]; risk ratio [RR], 0.60 [95% CI, .37-.98]). Twenty of 865 (2.3%) children in the intervention arm vs 345 of 854 (40.4%) in the control arm received antibiotics at D0 (RR, 0.06 [95% CI, .04-.09]). There were fewer secondary hospitalizations and deaths in the CRP arm: 0.5% (4/865) vs 1.5% (13/854) (RR, 0.30 [95% CI, .10-.93]).
CONCLUSIONS


CRP testing using a cutoff of ≥80 mg/L, integrated into an electronic decision algorithm, was able to improve clinical outcome in children with respiratory infections while substantially reducing antibiotic prescription.
CLINICAL TRIALS REGISTRATION


NCT02225769.",2019,"There were fewer secondary hospitalizations and deaths in the CRP arm: 0.5% (4/865) versus 1.5% (13/854, RR 0.30, 0.100.93).
","['febrile children at risk of pneumonia', 'Tanzanian children', 'children with respiratory infections', 'Children aged 2-59 months with fever and cough and without acutely life-threatening conditions received an', '9 primary care centers in Dar es Salaam, Tanzania (as part of a study evaluating a novel electronic decision algorithm, ePOCT', 'Results\n\n\nFrom December 2014 to February 2016, 1726 children were included']","['C-reactive protein (CRP', 'C-reactive protein-guided antibiotic', 'novel electronic clinical decision algorithm (ePOCT', 'antibiotic based on a CRP-informed strategy (combination of CRP80mg/L plus age/temperature-corrected tachypnea and/or chest indrawing) or current WHO standard (respiratory rate ≥50']","['secondary hospitalizations and deaths', 'safety and efficacy', 'proportion of clinical failure', 'clinical failure by D7; the secondary outcomes were antibiotic prescription at D0, secondary hospitalization or death by D30']","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0002045'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",1726.0,0.381948,"There were fewer secondary hospitalizations and deaths in the CRP arm: 0.5% (4/865) versus 1.5% (13/854, RR 0.30, 0.100.93).
","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Keitel', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Samaka', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Masimba', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Hosiana', 'Initials': 'H', 'LastName': 'Temba', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Said', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kagoro', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tarsis', 'Initials': 'T', 'LastName': 'Mlaganile', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Sangu', 'Affiliation': 'City Council, Dar es Salaam, Tanzania.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Genton', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': ""D'Acremont"", 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz080']
1315,31574228,Effects of a Resuscitation Strategy Targeting Peripheral Perfusion Status versus Serum Lactate Levels among Patients with Septic Shock. A Bayesian Reanalysis of the ANDROMEDA-SHOCK Trial.,"Rationale:  A recent randomized controlled trial showed that a peripheral perfusion-guided resuscitation strategy was associated with lower mortality and less organ dysfunction when compared with lactate-guided resuscitation strategy in patients with septic shock, but the difference in the primary outcome, 28-day mortality, did not reach the proposed statistical significance threshold ( P  = 0.06). We tested different analytic methods to aid in the interpretation of these results. Objectives:  To reassess the results of the ANDROMEDA-SHOCK trial using both Bayesian and frequentist frameworks. Methods:  All patients recruited in ANDROMEDA-SHOCK were included. Both a  post hoc  Bayesian analysis and a mixed logistic regression analysis were performed. The Bayesian analysis included four different priors (optimistic, neutral, null, and pessimistic) for mortality endpoints. The probability of having a Sequential Organ Failure Assessment in the lowest quartile at 72 hours was assessed using Bayesian networks. Measurements and Main Results:  In the Bayesian analysis, the posterior probability that a peripheral perfusion-targeted resuscitation strategy is superior to lactate-targeted resuscitation at 28 days was above 90% for all priors; the probability of benefit at 90 days was above 90% for all but the pessimistic prior. Using an optimistic prior, posterior median odds ratios were 0.61 (95% credible interval, 0.41-0.90) and 0.68 (95% credible interval, 0.47-1.01) for 28-day and 90-day mortality, respectively. The comparable frequentist odds ratios for 28-day and 90-day mortality were 0.61 (95% confidence interval [CI], 0.38-0.92) and 0.70 (95% CI, 0.45-1.08), respectively. The odds that that patients in the peripheral perfusion-targeted resuscitation arm had Sequential Organ Failure Assessment scores in the lower quartile at 72 hours was 1.55 (95% CI, 1.02-2.37). Conclusions:  Peripheral perfusion-targeted resuscitation may result in lower mortality and faster resolution of organ dysfunction when compared with a lactate-targeted resuscitation strategy.",2020,"Using an optimistic prior, the Bayesian intervention odds ratio was 0.63 (95% credible interval 0.41-0.90) and 0.69 (95% credible interval 0.47-1.01) for 28-and 90-days mortality, respectively.","['patients with septic shock', 'Patients with Septic Shock', 'All patients recruited in the ANDROMEDA-Shock trial were included']","['peripheral perfusion-guided resuscitation strategy', 'Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels']","['frequentist odds ratios for 28-day and 90-day mortality', 'SOFA scores', 'probability of having a SOFA', 'lower mortality and faster resolution of organ dysfunction', 'lower mortality and less organ dysfunction', 'probability of benefit at 90-days', 'posterior probability that a peripheral perfusion-targeted resuscitation strategy is superior to lactate-targeted resuscitation at 28-days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0330433', 'cui_str': 'Andromeda (organism)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow (observable entity)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}]",,0.239825,"Using an optimistic prior, the Bayesian intervention odds ratio was 0.63 (95% credible interval 0.41-0.90) and 0.69 (95% credible interval 0.47-1.01) for 28-and 90-days mortality, respectively.","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Ospina-Tascón', 'Affiliation': 'Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICESI, Cali, Colombia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0968OC']
1316,30935872,"Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial.","BACKGROUND


Glucose management is challenging in patients who require nutritional support in hospital. We aimed to assess whether fully closed-loop insulin delivery would improve glycaemic control compared with conventional subcutaneous insulin therapy in inpatients receiving enteral or parenteral nutrition or both.
METHODS


We did a two-centre (UK and Switzerland), open-label, randomised controlled trial in adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy. Patients recruited from non-critical care surgical and medical wards were randomly assigned (1:1) using a computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice. Continuous glucose monitoring in the control group was masked to patients, ward staff, and investigators. Patients were followed up for a maximum of 15 days or until hospital discharge. The primary endpoint was the proportion of time that sensor glucose concentration was in target range (5·6-10·0 mmol/L), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01774565.
FINDINGS


Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22). The proportion of time that sensor glucose was in the target range was 68·4% [SD 15·5] in the closed-loop group and 36·4% [26·6] in the control group (difference 32·0 percentage points [95% CI 18·5-45·5; p<0·0001]). One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions. There were no adverse events related to study interventions in either group. No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either study group.
INTERPRETATION


Closed-loop insulin delivery is an effective treatment option to improve glycaemic control in patients receiving nutritional support in hospital.
FUNDING


Diabetes UK, Swiss National Science Foundation, National Institute for Health Research Cambridge Biomedical Research Centre, Wellcome Trust, and European Foundation for the Study of Diabetes.",2019,"One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions.","['patients who require nutritional support in hospital', 'Patients recruited from non-critical care surgical and medical wards', 'adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy', 'inpatients receiving enteral or parenteral nutrition or both', 'inpatients receiving nutritional support', 'Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22', 'patients receiving nutritional support in hospital']","['conventional subcutaneous insulin therapy', 'computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice', 'Fully closed-loop insulin delivery']","['severe hypoglycaemia or hyperglycaemia with ketonaemia', 'proportion of time that sensor glucose', 'proportion of time that sensor glucose concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0235430', 'cui_str': 'Ketoacidemia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}]",90.0,0.186561,"One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions.","[{'ForeName': 'Charlotte K', 'Initials': 'CK', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Martignoni', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wertli', 'Affiliation': 'Department of General Internal Medicine, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust Cambridge, Cambridge, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30061-0']
1317,31004521,Cognitive-behavioral therapy (CBT) for generalized anxiety disorder: Contrasting various CBT approaches in a randomized clinical trial.,"OBJECTIVE


Cognitive-behavior therapy (CBT) is considered the ""golden standard"" psychotherapy for generalized anxiety disorder (GAD) but, at this point, we have little information about differences among various CBT approaches.
METHOD


We conducted a randomized controlled trial to compare three CBT protocols for GAD: (a) Cognitive Therapy/Borkovec's treatment package; (b) Rational Emotive Behavior Therapy, and (c) Acceptance and Commitment Therapy/Acceptance-based behavioral therapy. A number of 75 patients diagnosed with GAD, aged between 20 and 51 (m = 27.13; standard deviation = 7.50), 60 women and 11 men, were randomized to the three treatment arms.
RESULTS


All treatments were associated with large pre-post intervention reductions in GAD symptoms and dysfunctional automatic thoughts, with no significant differences between groups. Correlation analyses showed similar associations between changes in symptoms and changes in dysfunctional automatic thoughts.
CONCLUSIONS


All three approaches appear to be similarly effective. Implications for the theoretical models underlying each of the three cognitive-behavior therapy approaches are discussed.",2019,"All treatments were associated with large pre-post intervention reductions in GAD symptoms and dysfunctional automatic thoughts, with no significant differences between groups.","['75 patients diagnosed with GAD, aged between 20 and 51 (m = 27.13; standard deviation = 7.50), 60 women and 11 men', 'generalized anxiety disorder']","[""CBT protocols for GAD: (a) Cognitive Therapy/Borkovec's treatment package; (b) Rational Emotive Behavior Therapy, and (c) Acceptance and Commitment Therapy/Acceptance-based behavioral therapy"", 'Cognitive-behavior therapy (CBT', 'Cognitive-behavioral therapy (CBT']","['dysfunctional automatic thoughts', 'GAD symptoms and dysfunctional automatic thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",60.0,0.0434947,"All treatments were associated with large pre-post intervention reductions in GAD symptoms and dysfunctional automatic thoughts, with no significant differences between groups.","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Stefan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babeş-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Ioana A', 'Initials': 'IA', 'LastName': 'Cristea', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babeş-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Szentagotai Tatar', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babeş-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'David', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy/International Institute for the Advanced Study of Psychotherapy and Applied Mental Health, Babeş-Bolyai University, No 37 Republicii Street, Cluj-Napoca, Romania.'}]",Journal of clinical psychology,['10.1002/jclp.22779']
1318,31014090,"Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women.","BACKGROUND


SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown.
METHODS AND RESULTS


SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services-linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups.
CONCLUSIONS


Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov . Unique identifier: NCT01406236.",2019,"Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients.","['958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15\u2009904 trial-eligible registry patients during trial enrollment', 'Women (Study of Access Site for Enhancement of PCI for Women', 'women undergoing cardiac catheterization or percutaneous coronary intervention (PCI']",[],"['bleeding and mortality, and post-PCI bleeding', 'Rates of Bleeding and Vascular Complications', 'rates of post-PCI bleeding', '30-day death and unplanned revascularization rates', 'bleeding and mortality', '30-day death and unplanned revascularization']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",24958.0,0.421933,"Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Rymer', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC (J.A.R., A.K., M.W.K., S.V.R).'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Division of Cardiology, Duke Clinical Research Institute, Durham, NC (L.A.K., D.M.W.).'}, {'ForeName': 'Ajar', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC (J.A.R., A.K., M.W.K., S.V.R).'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora (C.N.H., J.C.M.).'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Gilchrist', 'Affiliation': 'Department of Medicine, Penn State University, Hershey, PA (I.C.G.).'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Messenger', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora (C.N.H., J.C.M.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Department of Medicine, Stanford University, CA (R.A.H.).'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON (S.S.J.).'}, {'ForeName': 'Alice K', 'Initials': 'AK', 'LastName': 'Jacobs', 'Affiliation': 'Department of Medicine, Boston University, MA (A.K.J.).'}, {'ForeName': 'J Dawn', 'Initials': 'JD', 'LastName': 'Abbott', 'Affiliation': 'Division of Cardiovascular Medicine, Warren Alpert Medical School of Brown University and Lifespan Cardiovascular Institute, Providence, RI (J.D.A.).'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Division of Cardiology, Duke Clinical Research Institute, Durham, NC (L.A.K., D.M.W.).'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC (J.A.R., A.K., M.W.K., S.V.R).'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC (J.A.R., A.K., M.W.K., S.V.R).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.118.007086']
1319,27030386,Physical exercise training interventions for children and young adults during and after treatment for childhood cancer.,"BACKGROUND


A decreased physical fitness has been reported in patients and survivors of childhood cancer. This is influenced by the negative effects of the disease and the treatment of childhood cancer. Exercise training for adult cancer patients has frequently been reported to improve physical fitness. In recent years, literature on this subject has also become available for children and young adults with cancer, both during and after treatment. This is an update of the original review that was performed in 2011.
OBJECTIVES


To evaluate the effect of a physical exercise training intervention on the physical fitness (i.e. aerobic capacity, muscle strength, or functional performance) of children with cancer within the first five years from their diagnosis (performed either during or after cancer treatment), compared to a control group of children with cancer who did not receive an exercise intervention.To determine whether physical exercise within the first five years of diagnosis has an effect on fatigue, anxiety, depression, self efficacy, and HRQoL and to determine whether there are any adverse effects of the intervention.
SEARCH METHODS


We searched the electronic databases of Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and PEDro; ongoing trial registries and conference proceedings on 6 September 2011 and 11 November 2014. In addition, we performed a handsearch of reference lists.
SELECTION CRITERIA


The review included randomized controlled trials (RCTs) and clinical controlled trials (CCTs) that compared the effects of physical exercise training with no training, in people who were within the first five years of their diagnosis of childhood cancer.
DATA COLLECTION AND ANALYSIS


Two review authors independently identified studies meeting the inclusion criteria, performed the data extraction, and assessed the risk of bias using standardized forms. Study quality was rated by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) criteria.
MAIN RESULTS


Apart from the five studies in the original review, this update included one additional RCT. In total, the analysis included 171 participants, all during treatment for childhood acute lymphoblastic leukaemia (ALL).The duration of the training sessions ranged from 15 to 60 minutes per session. Both the type of intervention and intervention period varied in all the included studies. However, the control group always received usual care.All studies had methodological limitations, such as small numbers of participants, unclear randomization methods, and single-blind study designs in case of one RCT and all results were of moderate to very low quality (GRADE).Cardiorespiratory fitness was evaluated by the 9-minute run-walk test, timed up-and-down stairs test, the timed up-and-go time test, and the 20-m shuttle run test. Data of the 9-minute run-walk test and the timed up-and-down stairs test could be pooled. The combined 9-minute run-walk test results showed significant differences between the intervention and the control groups, in favour of the intervention group (standardized mean difference (SMD) 0.69; 95% confidence interval (CI) 0.02 to 1.35). Pooled data from the timed up-and-down stairs test showed no significant differences in cardiorespiratory fitness (SMD -0.54; 95% CI -1.77 to 0.70). However, there was considerable heterogeneity (I(2) = 84%) between the two studies on this outcome. The other two single-study outcomes, 20-m shuttle run test and the timed up-and-go test, also showed positive results for cardiorespiratory fitness in favour of the intervention group.Only one study assessed the effect of exercise on bone mineral density (total body), showing a statistically significant positive intervention effect (SMD 1.07; 95% CI 0.48 to 1.66). The pooled data on body mass index showed no statistically significant end-score difference between the intervention and control group (SMD 0.59; 95% CI -0.23 to 1.41).Three studies assessed flexibility. Two studies assessed ankle dorsiflexion. One study assessed active ankle dorsiflexion, while the other assessed passive ankle dorsiflexion. There were no statistically significant differences between the intervention and control group with the active ankle dorsiflexion test; however, in favour of the intervention group, they were found for passive ankle dorsiflexion (SMD 0.69; 95% CI 0.12 to 1.25). The third study assessed body flexibility using the sit-and-reach distance test, but identified no statistically significant difference between the intervention and control group.Three studies assessed muscle strength (knee, ankle, back and leg, and inspiratory muscle strength). Only the back and leg strength combination score showed statistically significant differences on the muscle strength end-score between the intervention and control group (SMD 1.41; 95% CI 0.71 to 2.11).Apart from one sub-scale of the cancer scale (Worries; P value = 0.03), none of the health-related quality of life scales showed a significant difference between both study groups on the end-score. For the other outcomes of fatigue, level of daily activity, and adverse events (all assessed in one study), there were no statistically significant differences between the intervention and control group.None of the included studies evaluated activity energy expenditure, time spent on exercise, anxiety and depression, or self efficacy as an outcome.
AUTHORS' CONCLUSIONS


The effects of physical exercise training interventions for childhood cancer participants are not yet convincing. Possible reasons are the small numbers of participants and insufficient study designs, but it can also be that this type of intervention is not as effective as in adult cancer patients. However, the first results show some positive effects on physical fitness in the intervention group compared to the control group. There were positive intervention effects for body composition, flexibility, cardiorespiratory fitness, muscle strength, and health-related quality of life (cancer-related items). These were measured by some assessment methods, but not all. However, the quality of the evidence was low and these positive effects were not found for the other assessed outcomes, such as fatigue, level of daily activity, and adverse events. There is a need for more studies with comparable aims and interventions, using a higher number of participants that also include diagnoses other than ALL.",2016,"There were no statistically significant differences between the intervention and control group with the active ankle dorsiflexion test; however, in favour of the intervention group, they were found for passive ankle dorsiflexion (SMD 0.69; 95% CI 0.12 to 1.25).","['171 participants, all during treatment for childhood acute lymphoblastic leukaemia (ALL).The duration of the training sessions ranged from 15 to 60 minutes per session', 'patients and survivors of childhood cancer', 'childhood cancer participants', '6 September 2011 and 11 November 2014', 'adult cancer patients', 'children and young adults during and after treatment for childhood cancer', 'people who were within the first five years of their diagnosis of childhood cancer', 'children and young adults with cancer', 'children with cancer within the first five years from their diagnosis (performed either during or after cancer treatment), compared to a control group of children with cancer who did not receive an']","['Physical exercise training interventions', 'physical exercise', 'exercise intervention', 'Exercise training', 'physical exercise training interventions', 'physical exercise training intervention', 'physical exercise training with no training']","['physical fitness (i.e. aerobic capacity, muscle strength, or functional performance', 'muscle strength end-score', 'active ankle dorsiflexion', 'cardiorespiratory fitness', 'health-related quality of life scales', 'physical fitness', 'Grading of Recommendation Assessment, Development and Evaluation (GRADE) criteria', 'body composition, flexibility, cardiorespiratory fitness, muscle strength, and health-related quality of life (cancer-related items', 'fatigue, level of daily activity, and adverse events', 'bone mineral density (total body', 'fatigue, anxiety, depression, self efficacy, and HRQoL', 'activity energy expenditure, time spent on exercise, anxiety and depression, or self efficacy', 'passive ankle dorsiflexion', 'muscle strength (knee, ankle, back and leg, and inspiratory muscle strength', 'body flexibility', 'ankle dorsiflexion']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3853978'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]",,0.0484501,"There were no statistically significant differences between the intervention and control group with the active ankle dorsiflexion test; however, in favour of the intervention group, they were found for passive ankle dorsiflexion (SMD 0.69; 95% CI 0.12 to 1.25).","[{'ForeName': 'Katja I', 'Initials': 'KI', 'LastName': 'Braam', 'Affiliation': 'Department of Pediatrics, Division of Oncology/Hematology, VU University Medical Center, PO Box 7057, Room 6 D 120, Amsterdam, Netherlands, 1007 MB.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'van der Torre', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Takken', 'Affiliation': ''}, {'ForeName': 'Margreet A', 'Initials': 'MA', 'LastName': 'Veening', 'Affiliation': ''}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'van Dulmen-den Broeder', 'Affiliation': ''}, {'ForeName': 'Gertjan J L', 'Initials': 'GJ', 'LastName': 'Kaspers', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008796.pub3']
1320,30753384,Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.,"BACKGROUND


Effective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness.
METHODS


From March 2014 through March 2017, a double-blind, placebo-controlled trial was conducted in 260 participants ≥1 year old hospitalized with influenza-like illness at 6 hospitals in Mexico. Participants were randomized 1:1 to NTZ (age ≥12 years, 600 mg twice daily; age 4-11 years and 1-3 years, 200 or 100 mg twice daily, respectively) or placebo for 5 days in addition to standard of care. The primary endpoint was time from first dose to hospital discharge. Influenza reverse-transcription polymerase chain reaction and Respifinder 22 multiplex test were used for virus detection.
RESULTS


Of 260 participants enrolled, 257 were randomized and took at least 1 dose of study treatment (intention-to-treat population): 130 in the NTZ group and 127 in the placebo group. The Kaplan-Meier estimate of the median duration of hospitalization was 6.5 (interquartile range [IQR], 4.0-9.0) days in the NTZ group vs 7.0 (IQR, 4.0-9.0) days in the placebo group (P = .56). Duration of hospitalization between the 2 treatments was similar in children (P = .29) and adults (P = .62), influenza A and B (P = .32), and other respiratory viruses. Seven (5.4%) and 6 (4.7%) participants in the NTZ and placebo groups, respectively, reported serious adverse events.
CONCLUSIONS


Treatment with NTZ did not reduce the duration of hospital stay in severe influenza-like illness. Further analyses based on age and evaluations by virus did not reveal any subgroups that appeared to benefit from NTZ.
CLINICAL TRIALS REGISTRATION


NCT02057757.",2019,"Duration of hospitalization between the two treatments was similar in children (P=0.29) and adults (P=0.62), influenza A and B (P=0.32) and other respiratory viruses.","['260 participants ≥ 1 year old hospitalized with influenza-like illness at six hospitals in Mexico', 'Severe Acute Respiratory Illness', '260 participants enrolled, 257 were randomized and took at least one dose of study treatment (ITT population): 130 in the NTZ group and 127 in the']","['placebo', 'nitazoxanide', 'NTZ and placebo', 'NTZ', 'Nitazoxanide (NTZ', 'Nitazoxanide']","['time from first dose to hospital discharge', 'median duration of hospitalization', 'severe adverse events', 'duration of hospital stay', 'Efficacy and Safety', 'Duration of hospitalization']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",260.0,0.687629,"Duration of hospitalization between the two treatments was similar in children (P=0.29) and adults (P=0.62), influenza A and B (P=0.32) and other respiratory viruses.","[{'ForeName': 'Ana E', 'Initials': 'AE', 'LastName': 'Gamiño-Arroyo', 'Affiliation': 'Hospital Infantil de México ""Dr Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'M Lourdes', 'Initials': 'ML', 'LastName': 'Guerrero', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Social and Scientific Systems, Inc, Silver Spring, Maryland.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Ramírez-Venegas', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Mexico City.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Llamosas-Gallardo', 'Affiliation': 'Instituto Nacional de Pediatría, Mexico City.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Galindo-Fraga', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sarbelio', 'Initials': 'S', 'LastName': 'Moreno-Espinosa', 'Affiliation': 'Hospital Infantil de México ""Dr Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Roldán-Aragón', 'Affiliation': 'Hospital General ""Dr Aurelio Valdivieso,"" Oaxaca, Mexico.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Araujo-Meléndez', 'Affiliation': 'Hospital Central ""Dr Ignacio Morones-Prieto,"" San Luis Potosi, Mexico.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Ibarra-González', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Martínez-López', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'García-Andrade', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kapushoc', 'Affiliation': 'Social and Scientific Systems, Inc, Silver Spring, Maryland.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Smolskis', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz100']
1321,31000379,"Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial.","BACKGROUND


Nasogastric tube insertion is a common but distressing procedure in young children. We aimed to compare the efficacy of topical local anaesthetic and vasoconstrictor nasal spray with placebo for distress related to nasogastric tube insertion.
METHODS


We did a prospective, randomised, controlled, double-blind, superiority trial in a single tertiary paediatric emergency department in Australia. Eligible participants were children aged 6 months to 5 years who were planned to have a nasogastric tube inserted as part of their emergency department treatment. Patients were assigned using computer-generated block randomisation to receive lidocaine and phenylephrine nasal spray (10 mg lidocaine and 1 mg phenylephrine for children weighing 6-12 kg; 20 mg lidocaine and 2 mg phenylephrine for children weighing >12 kg), or 0·9% sodium chloride placebo nasal spray, before nasogastric insertion. Guardians, observers, and proceduralists were all masked to the intervention. The primary outcome was procedure-related distress, measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale during the final attempt at nasogastric tube insertion. All patients were included in the primary analysis (intention-to-treat). FLACC scores were compared using the Wilcoxon rank-sum test, and categorical outcomes were compared using χ 2  or Fisher's exact tests as appropriate. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000092695.
FINDINGS


Between July 30, 2014, and Aug 17, 2017, 107 children in a convenience sample were randomly assigned to receive lidocaine and phenylephrine nasal spray (n=54) or placebo (n=53). Seven children did not receive study medication (six no longer required nasogastric tube insertion and one withdrew consent). 50 children received each intervention; all were included in the analysis. There was no difference in median FLACC score at time of nasogastric tube insertion (9 [IQR 7-10] for lidocaine and phenylephrine vs 9 [IQR 8-10] for placebo; median difference between groups -1, 95% CI -2·7 to 0·7, p=0·21). Adverse effects of the spray or nasogastric tube insertion (most commonly vomiting and gagging) occurred in 14 (28%) of those who received lidocaine and phenylephrine and 21 (42%) of those who received placebo.
INTERPRETATION


Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo. Further research addressing distress associated with nasogastric tube insertion in young children is needed.
FUNDING


Monash Health Senior Medical Staff Association, Australasian College for Emergency Medicine, Emergency Medicine Research Foundation.",2019,"INTERPRETATION


Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo.","['Eligible participants were children aged 6 months to 5 years who were planned to have a nasogastric tube inserted as part of their emergency department treatment', 'young children and infants', 'single tertiary paediatric emergency department in Australia', 'young children', '50 children received each intervention; all were included in the analysis', 'Between July 30, 2014, and Aug 17, 2017, 107 children in a convenience sample']","['lidocaine and 1 mg phenylephrine', 'placebo', 'phenylephrine', 'lidocaine', 'lidocaine and phenylephrine nasal spray', 'lidocaine and phenylephrine', 'Lidocaine and phenylephrine nasal spray', 'Nasogastric tube insertion', 'topical local anaesthetic and vasoconstrictor nasal spray with placebo', 'saline placebo nasal spray', 'lidocaine and 2 mg phenylephrine', 'Lidocaine and phenylephrine', '0·9% sodium chloride placebo nasal spray', 'nasogastric tube insertion']","['median FLACC score at time of nasogastric tube insertion', 'FLACC scores', 'procedure-related distress, measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale', 'vomiting and gagging', 'Adverse effects', 'pain and distress of nasogastric tube insertion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1248657', 'cui_str': 'Phenylephrine Nasal Spray'}, {'cui': 'C0204819', 'cui_str': 'Intubation, Nasogastric'}, {'cui': 'C0472473', 'cui_str': 'Local anesthesia, surface'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0204819', 'cui_str': 'Intubation, Nasogastric'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.707132,"INTERPRETATION


Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo.","[{'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Craig', 'Affiliation': ""Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Parkville, VIC, Australia. Electronic address: simon.craig@monash.edu.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Seith', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cheek', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, VIC, Australia; Emergency Department, Royal Children's Hospital, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Egerton-Warburton', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'West', 'Affiliation': 'Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia; Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30058-6']
1322,30253043,Relationship between three commonly used non-invasive fibrosis biomarkers and improvement in fibrosis stage in patients with non-alcoholic steatohepatitis.,"BACKGROUND & AIMS


Non-invasive biomarkers are needed for monitoring changes in liver histology in patients with non-alcoholic steatohepatitis (NASH). Obeticholic acid (OCA) was shown to improve fibrosis in patients with NASH in the FLINT trial; a post hoc analysis of these data was performed to determine the relationship between 3 non-invasive fibrosis markers and liver fibrosis improvement.
METHODS


In the Phase 2b FLINT trial, patients were randomised (1:1) to receive 25 mg OCA or placebo once daily for 72 weeks. Aspartate aminotransferase:platelet ratio index (APRI), fibrosis-4 (FIB-4) index and non-alcoholic fatty liver disease fibrosis score (NFS) were evaluated in serum at baseline and weeks 24, 48, 72 and 96. Liver biopsies were obtained at baseline and 72 weeks.
RESULTS


In patients with fibrosis improvement at week 24, scores were reduced by a median of 34% for APRI, 10% for FIB-4 and 4% for NFS. Reductions in APRI (P = 0.015) and FIB-4 (P = 0.036), but not NFS (P = 0.201) at week 24, significantly correlated with ≥1-stage improvement in histologic fibrosis at week 72. Reductions in APRI at week 72 were significantly correlated with fibrosis improvement at week 72 (P = 0.012). Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
CONCLUSIONS


Readily available non-invasive markers may predict improvement in liver fibrosis in patients with NASH. Upon external confirmation and further refinement in larger populations, these markers may serve as surrogate endpoints in NASH clinical trials.",2019,"Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
","['patients with non-alcoholic steatohepatitis (NASH', 'patients with NASH', 'patients with non-alcoholic steatohepatitis']","['OCA or placebo', 'Obeticholic acid (OCA', 'placebo', 'OCA']","['Liver biopsies', 'histologic fibrosis', 'FIB-4', 'fibrosis stage', 'fibrosis improvement', 'Reductions in APRI', 'liver fibrosis', 'Aspartate aminotransferase:platelet ratio index (APRI), fibrosis-4 (FIB-4) index and non-alcoholic fatty liver disease fibrosis score (NFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}]","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.337244,"Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
","[{'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Organ Transplant Center, Swedish Medical Center, Seattle, Washington.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Department of Internal Medicine, Saint Louis University, Saint Louis, Missouri.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Terrault', 'Affiliation': 'Departments of Medicine and Surgery, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Ferguson', 'Affiliation': 'Intercept Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.13974']
1323,31699072,Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial.,"BACKGROUND


The use and optimal duration of treatment with nebulized hypertonic saline (HS) in infants hospitalized for acute bronchiolitis is unclear. The objective was to compare the efficacy of 1 versus 3 days of nebulized 3% HS at 72 h of treatment. We conducted a blinded non-inferiority randomized controlled trial including infants aged less than 12 months old, hospitalized for a moderate bronchiolitis.
METHODS


Nebulisations of 3% HS for 1 day were followed by either the continuation of 3% HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d group) for 2 days Randomization was performed according to a predefined list with a 1:1 ratio, obtained with a random generator number with blocks.. Main outcome was mean Wang clinical severity score (CSS) after 72 h of treatment.
RESULTS


One hundred sixteen infants (HS1d n = 59 and HS3d n = 57), were included over two epidemic seasons from 2014 to 2016, but recruitement did not reach the planned sample size. The difference for the Wang CSS score in the HS3d vs HS1d group was 0.71 [IC 90% 0.1; 1.3], above the precluded value of 0.4 set in the protocol defining the non-inferiority of shorter treatment duration. Clinical remission was more rapidly obtained in the HS3d than in HS1d (2.3 ± 1.6 vs 2.9 ± 1.4 days, p = 0.04), with a non-significant tendency for less need of nutritional support and supplemental oxygen in HS3d group. Clinical worsening and treatment intolerance were similar in the 2 groups.
CONCLUSIONS


Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
TRIAL REGISTRATION


Clinical trials NCT02538458, October 2014.",2019,"Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
","['One hundred sixteen infants (HS1d n\u2009=\u200959 and HS3d n\u2009=\u200957', 'infants hospitalized for acute bronchiolitis', 'Nebulisations of 3', 'hospitalized bronchiolitis', 'infants aged less than 12\u2009months old, hospitalized for a moderate bronchiolitis']","['nebulized hypertonic saline (HS', 'HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d', 'Nebulized hypertonic saline']","['Clinical worsening and treatment intolerance', 'mean Wang clinical severity score (CSS', 'CSS score', 'Clinical remission']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute capillary bronchiolitis'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",116.0,0.404323,"Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
","[{'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Beal', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Métropole Savoie, FR-73000, Chambéry, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barbier', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Thoret', 'Affiliation': 'CIC U1406, INSERM, FR-38000, Grenoble, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Rubio', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Bonnet', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Roseline', 'Initials': 'R', 'LastName': 'Mazet', 'Affiliation': 'Department of Pharmacy, CHU Grenoble Alpes, FR-38000, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ego', 'Affiliation': 'CIC U1406, INSERM, FR-38000, Grenoble, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pin', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France. ipin@chu-grenoble.fr.'}]",BMC pediatrics,['10.1186/s12887-019-1804-0']
1324,31002449,"The relationships between worry, happiness and pain catastrophizing in the experience of acute pain.","BACKGROUND


The current study aimed to (a) evaluate the effects of an experimental manipulation of worry and happiness on pain perception and measures of worry about pain and pain catastrophizing and (b) determine if changes in situation-specific worry about pain and pain catastrophizing would be related to changes in acute pain.
METHODS


The study included 120 healthy, pain-free volunteers. Participants were exposed to four levels of noxious stimulation and asked to report on the pain intensity, worry about pain and pain catastrophizing they experienced during the stimulation procedures. They were then randomly assigned to either a Happy or a Worry condition, where they were exposed to emotion induction procedures. The noxious exposure procedures and measures of pain, pain-related worry and pain catastrophizing were then repeated.
RESULTS


Participants in the Worry condition reported significant increases in pain intensity, and those in the Happy condition reported significant decreases in pain intensity. Further, the Worry condition participants reported significant increases in both pain-related worry and pain catastrophizing, while the Happy condition showed the opposite effects. Finally, changes in worry about pain and pain catastrophizing were found to mediate the impact of the affect induction procedure on pain intensity.
CONCLUSIONS


The findings demonstrate that pain intensity, worry about pain and pain catastrophizing are all sensitive to changes in mood. The results have potential clinical implications.
SIGNIFICANCE


The current study shows that manipulation-induced changes in pain-related worry, pain catastrophizing, and affect have direct effects on the experience of acute pain. More broadly, the overlap of these three variables provides with anxiety and mood disorders offers the promise of new vistas for research and treatment of pain conditions by assessing and targeting the cognitions and behaviors that are common to worry and catastrophizing.",2019,"Finally, changes in worry about pain and pain catastrophizing were found to mediate the impact of the affect induction procedure on pain intensity.
","['120 healthy, pain-free volunteers']",['Happy or a Worry condition'],"['pain intensity, worry about pain and pain catastrophizing', 'pain, pain-related worry and pain catastrophizing', 'pain-related worry and pain catastrophizing', 'pain-related worry, pain catastrophizing', 'pain intensity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0321842,"Finally, changes in worry about pain and pain catastrophizing were found to mediate the impact of the affect induction procedure on pain intensity.
","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Lefebvre', 'Affiliation': 'Department of Psychology, Wofford College, Spartanburg, South Carolina.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}]","European journal of pain (London, England)",['10.1002/ejp.1405']
1325,30988413,Correction: Associations of measures of systemic blood flow used in a randomized trial of delayed cord clamping in preterm infants.,A correction to this paper has been published and can be accessed via a link at the top of the paper.,2019,A correction to this paper has been published and can be accessed via a link at the top of the paper.,['preterm infants'],"['Correction', 'delayed cord clamping']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]",[],,0.0312242,A correction to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Popat', 'Affiliation': ""Children's Hospital at Westmead, Westmead, NSW, Australia. himanshu.popat@health.nsw.gov.au.""}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Lucille', 'Initials': 'L', 'LastName': 'Sebastian', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Evans', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gill', 'Affiliation': 'Centre for Neonatal Education and Research, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kluckow', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sinhal', 'Affiliation': 'Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Koert', 'Initials': 'K', 'LastName': 'de Waal', 'Affiliation': ""John Hunter Children's Hospital, New Lambton, NSW, Australia.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tarnow-Mordi', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'University of Sydney, Camperdown, Australia.'}]",Pediatric research,['10.1038/s41390-019-0382-z']
1326,31369675,Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial.,"BACKGROUND


There is a lack of evidence based on longitudinal information in the field of Class II malocclusion management with cervical headgear (CH), especially in a randomized setting.
OBJECTIVES


The main objective of this study was to evaluate skeletal facial changes, particularly in vertical dimensions, after Kloehn-type CH treatment in children when the timing of treatment is altered.
TRIAL DESIGN


Prospective, parallel-group, randomized controlled trial.
METHODS


Screened children with Class II malocclusion were randomized in 1:1 ratio to two groups of equal size by sealed-envelope randomization: the early group (EG), where active CH treatment was started at the age of 7.8 years, and the late group (LG), where CH treatment was started at the age of 9.5 years. The active treatment was continued until normal Class I occlusion on first molars was achieved. Cephalograms were taken at three different time points. Changes in cephalometric measurements were compared between groups and genders. Blinding was applicable for outcome evaluation.
RESULTS


Of 67 randomized children, 56 completed the study. Upper face height increased during the CH treatment phase, as the parameter N-ANS increased significantly during the active treatments of EG (P < 0.05) and LG (P < 0.05). Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01). The Gonial angle decreased significantly in the early CH treatment group compared to the later treatment group (T0-T2: P < 0.01). CH improved the antero-posterior jaw relationship. No harms were encountered.
CONCLUSIONS


Although the upper face height increased, the mandible showed anterior rotation after CH treatment. The Gonial angle was significantly decreased in the EG compared to the LG. There were gender-specific differences in both sagittal and vertical dimensions when examining interrelations in dimensional changes. The differences found between the early and later treatment groups were not clinically important when the cephalometric results are considered.
CLINICAL REGISTRATION


ClinicalTrials.gov (NCT02010346).",2019,"Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01).","['Class II malocclusion management with cervical headgear (CH', 'Screened children with Class II malocclusion', '67 randomized children']","['Kloehn-type CH', 'cervical headgear treatment', 'equal size by sealed-envelope randomization: the early group (EG), where active CH treatment']","['Upper face height', 'Gonial angle', 'skeletal facial changes', 'Changes in cephalometric measurements', 'parameter NSL-PL']","[{'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2963529', 'cui_str': 'Gonial angle (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",67.0,0.0332818,"Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01).","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Julku', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pirilä-Parkkinen', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Tolvanen', 'Affiliation': 'Department of Community Dentistry, Institute of Dentistry, University of Turku, Finland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}]",European journal of orthodontics,['10.1093/ejo/cjz053']
1327,31722690,Does the treatment of anxiety in children with Attention-Deficit/Hyperactivity Disorder (ADHD) using cognitive behavioral therapy improve child and family outcomes? Protocol for a randomized controlled trial.,"BACKGROUND


Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care.
METHODS


This RCT is recruiting children aged 8-12 years (N = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child's parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression.
DISCUSSION


The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes.
TRIAL REGISTRATION


This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 (https://doi.org/10.1186/ISRCTN59518816). The trial was first registered 29/9/15 and last updated 15/1/19.",2019,Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities.,"['children with ADHD and comorbid anxiety compared with usual care', 'Eligible children', 'children aged 8-12\u2009years (N\u2009=\u2009228) from pediatrician practices in Victoria, Australia', 'Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social', 'children with ADHD', 'children with Attention-Deficit/Hyperactivity Disorder (ADHD', ""child's parent (Anxiety Disorders Interview Schedule for Children V""]","['cognitive-behavioral therapy (CBT', 'cognitive behavioral therapy', 'existing CBT intervention', '10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician']","['proportion of children meeting diagnostic criteria for an anxiety disorder', 'range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.122909,Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Vic, Australia. emma.sciberras@deakin.edu.au.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Efron', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Vic, Australia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Engel', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Vic, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Anderson', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Nicholson', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Vic, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schembri', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}]",BMC psychiatry,['10.1186/s12888-019-2276-3']
1328,31003626,Effect of a high-fat Mediterranean diet on bodyweight and waist circumference: a prespecified secondary outcomes analysis of the PREDIMED randomised controlled trial.,"BACKGROUND


Because of the high density of fat, high-fat diets are perceived as likely to lead to increased bodyweight, hence health-care providers are reluctant to recommend them to overweight or obese individuals. We assessed the long-term effects of ad libitum, high-fat, high-vegetable-fat Mediterranean diets on bodyweight and waist circumference in older people at risk of cardiovascular disease, most of whom were overweight or obese.
METHODS


PREDIMED was a 5 year parallel-group, multicentre, randomised, controlled clinical trial done in primary care centres affiliated to 11 hospitals in Spain. 7447 asymptomatic men (aged 55-80 years) and women (aged 60-80 years) who had type 2 diabetes or three or more cardiovascular risk factors were randomly assigned (1:1:1) with a computer-generated number sequence to one of three interventions: Mediterranean diet supplemented with extra-virgin olive oil (n=2543); Mediterranean diet supplemented with nuts (n=2454); or a control diet (advice to reduce dietary fat; n=2450). Energy restriction was not advised, nor was physical activity promoted. In 2016, we reported the 5 year changes in bodyweight and waist circumference, but because of a subsequently identified protocol deviation (including enrolment of household members without randomisation, assignment to a study group without randomisation of some participants at one of 11 study sites, and apparent inconsistent use of randomisation tables at another site; 866 [11·6%] participants were affected in total), we have withdrawn our previously published report and now report revised effect estimates based on reanalyses that do not rely exclusively on the assumption that all the participants were randomly assigned. In this analysis of the trial, we measured bodyweight and waist circumference at baseline and yearly for 5 years in the intention-to-treat population. The PREDIMED trial is registered with ISRCTN.com, number ISRCTN35739639.
FINDINGS


After a median 4·8 years (IQR 2·8-5·8) of follow-up, participants in all three groups had marginally reduced bodyweight and increased waist circumference. After multivariable adjustment, including adjustment for propensity scores and use of robust variance estimators, the difference in 5 year changes in bodyweight in the Mediterranean diet with olive oil group was -0·410 kg (95% CI -0·830 to 0·010; p=0·056) and in the nut group was -0·016 kg (-0·453 to 0·421; p=0·942), compared with the control group. The adjusted difference in 5 year changes in waist circumference was -0·466 cm (-1·109 to 0·176; p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) in the nut group, compared with the control group.
INTERPRETATION


A long-term intervention with an unrestricted-calorie, high-vegetable-fat Mediterranean diet was associated with no significant difference in bodyweight and some evidence of less gain in central adiposity compared with a control diet. These results lend support to advice not restricting intake of healthy fats for bodyweight maintenance.
FUNDING


Spanish Government, CIBERobn, Instituto de Salud Carlos III, Hojiblanca, Patrimonio Comunal Olivarero, California Walnut Commission, Borges SA, and Morella Nuts.",2019,"p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) in the nut group, compared with the control group.
","['primary care centres affiliated to 11 hospitals in Spain', '7447 asymptomatic men (aged 55-80 years) and women (aged 60-80 years) who had type 2 diabetes or three or more cardiovascular risk factors', 'older people at risk of cardiovascular disease, most of whom were overweight or obese']","['high-fat Mediterranean diet', 'ad libitum, high-fat, high-vegetable-fat Mediterranean diets', 'Mediterranean diet supplemented with extra-virgin olive oil (n=2543); Mediterranean diet supplemented with nuts (n=2454); or a control diet (advice to reduce dietary fat', 'Mediterranean diet with olive oil']","['waist circumference', 'central adiposity', 'bodyweight and increased waist circumference', 'bodyweight and waist circumference']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",7447.0,0.182165,"p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) in the nut group, compared with the control group.
","[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi Sunyer, University of Barcelona, Barcelona, Spain. Electronic address: restruch@clinic.ub.es.""}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine and Public Health, Universidad de Navarra-Institute of Health Research of Navarra, Pamplona, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, School of Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': ""Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Human Nutrition Department, Hospital Universitari Sant Joan, Institut d'Investigació Sanitària Pere Virgili, University Rovira i Virgili, Reus, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Cardiovascular and Nutrition Research Group, Institut de Recerca Hospital delMar, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Chiva-Blanch', 'Affiliation': ""Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi Sunyer, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Institute of Health Sciences, University of Balearic Islands and Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, University of Málaga, Málaga, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arós', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Cardiology, University Hospital of Alava, Vitoria, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Research Institute of Biomedical Research and Health Services and School of Medicine, University of Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Buil-Cosiales', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Primary Health Care Division, Institute of Health Research of Navarra, Pamplona, Spain.'}, {'ForeName': 'José V', 'Initials': 'JV', 'LastName': 'Sorlí', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, School of Medicine, University of Valencia, Valencia, Spain; Primary Care Division, Valencia Institute of Health, Burjassot, Valencia, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Muñoz', 'Affiliation': 'Primary Health Care Division, Institut Català de la Salut and Idiap-Jordi Gol, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora-Gallisá', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Primary Health Care Division, Institut Català de la Salut and Idiap-Jordi Gol, Tarragona, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Lamuela-Raventós', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Nutrition and Bromatology, School of Pharmacy, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Alimentación y Seguridad Alimentaria, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Serra-Mir', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Internal Medicine and Lipid Clinic, Department of Endocrinology and Nutrition, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Internal Medicine and Lipid Clinic, Department of Endocrinology and Nutrition, University of Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30074-9']
1329,31690740,Early evening light mitigates sleep compromising physiological and alerting responses to subsequent late evening light.,"The widespread use of electric light and electronic devices has resulted in an excessive exposure to light during the late-evening and at night. This late light exposure acutely suppresses melatonin and sleepiness and delays the circadian clock. Here we investigate whether the acute effects of late-evening light exposure on our physiology and sleepiness are reduced when this light exposure is preceded by early evening bright light. Twelve healthy young females were included in a randomised crossover study. All participants underwent three evening (18:30-00:30) sessions during which melatonin, subjective sleepiness, body temperature and skin blood flow were measured under different light conditions: (A) dim light, (B) dim light with a late-evening (22:30-23:30) light exposure of 750 lx, 4000 K, and (C) the same late-evening light exposure, but now preceded by early-evening bright light exposure (18.30-21.00; 1200 lx, 4000 K). Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim. Interestingly, these effects were reduced when the late-evening light was preceded by an early evening 2.5-hour bright light exposure. Thus daytime and early-evening exposure to bright light can mitigate some of the sleep-disruptive consequences of light exposure in the later evening.",2019,Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim.,['Twelve healthy young females'],['electric light and electronic devices'],"['melatonin levels and subjective sleepiness', 'subjective sleepiness, body temperature and skin blood flow', 'larger skin temperature gradients']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",12.0,0.029679,Late-evening light exposure reduced melatonin levels and subjective sleepiness and resulted in larger skin temperature gradients as compared to dim.,"[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Te Kulve', 'Affiliation': 'Department of Human Biology & Movement Sciences, NUTRIM, Maastricht University, Maastricht, The Netherlands. marijetekulve@gmail.com.'}, {'ForeName': 'Luc J M', 'Initials': 'LJM', 'LastName': 'Schlangen', 'Affiliation': 'Intelligent Lighting Institute, Department of Human Technology Interaction, Eindhoven University of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Wouter D', 'Initials': 'WD', 'LastName': 'van Marken Lichtenbelt', 'Affiliation': 'Department of Human Biology & Movement Sciences, NUTRIM, Maastricht University, Maastricht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-019-52352-w']
1330,31690824,Fear expression is suppressed by tyrosine administration.,"Animal studies have demonstrated that catecholamines regulate several aspects of fear conditioning. In humans, however, pharmacological manipulations of the catecholaminergic system have been scarce, and their primary focus has been to interfering with catecholaminergic activity after fear acquisition or expression had taken place, using L-Dopa, primarily, as catecholaminergic precursor. Here, we sought to determine if putative increases in presynaptic dopamine and norepinephrine by tyrosine administered before conditioning could affect fear expression. Electrodermal activity (EDA) of 46 healthy participants (24 placebo, 22 tyrosine) was measured in an instructed fear task. Results showed that tyrosine abolished fear expression compared to placebo. Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood. Therefore, the effect of tyrosine on fear expression cannot be attributed to these factors. Taken together, these findings provide evidence that the catecholaminergic system influences fear expression in humans.",2019,"Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood.","['46 healthy participants (24 placebo, 22 tyrosine) was measured in\xa0an instructed fear task']",['placebo'],"['Electrodermal activity (EDA', 'Fear expression', 'fear expression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",46.0,0.0189243,"Importantly, tyrosine did not affect EDA responses to the aversive stimulus (UCS) or alter participants' mood.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Soranzo', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aquili', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK. luca.aquili@shu.ac.uk.'}]",Scientific reports,['10.1038/s41598-019-52610-x']
1331,30991824,Psychoeducation for chronic cognitive impairment and reduced early readmissions amongst pulmonary inpatients.,"Patients with chronic pulmonary disease have been found to have among the highest rates of early (30 days) readmissions by the Center for Medicare and Medicaid Services. Proactive identification and psychoeducational intervention for the effect of chronic cognitive impairment on readmission have not been tested in this population. This is a pre-post quality improvement study for service-wide inpatient pulmonary readmission rates in chronic pulmonary disease. We examined the impact of screening patients for likely cognitive impairment and providing patients/families with psychoeducation regarding 'forgetfulness' on 30-day readmission rates on an inpatient pulmonary service. We observed a 50% decline in early readmissions (25.7% > 12.3%) for the inpatient pulmonary service after initiation of screening and psychoeducation of patients/families for improved adherence despite cognitive impairment ( t  = -2.53,  df = 17,  p  = 0.011). A randomly assigned, controlled clinical trial is warranted.",2019,"We observed a 50% decline in early readmissions (25.7% > 12.3%) for the inpatient pulmonary service after initiation of screening and psychoeducation of patients/families for improved adherence despite cognitive impairment (t = -2.53, df= 17, p = 0.011).","['chronic pulmonary disease', 'pulmonary inpatients', 'Patients with chronic pulmonary disease', ""screening patients for likely cognitive impairment and providing patients/families with psychoeducation regarding 'forgetfulness""]","['Psychoeducation', 'Proactive identification and psychoeducational intervention']","['30-day readmission rates', 'early readmissions', 'adherence despite cognitive impairment']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0542476', 'cui_str': 'Forgetful (finding)'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0599714,"We observed a 50% decline in early readmissions (25.7% > 12.3%) for the inpatient pulmonary service after initiation of screening and psychoeducation of patients/families for improved adherence despite cognitive impairment (t = -2.53, df= 17, p = 0.011).","[{'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Ketterer', 'Affiliation': 'Consultation/Liaison Psychiatry, Henry Ford Hospital , Detroit , MI , USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ouellette', 'Affiliation': 'Division of Pulmonary Medicine, Henry Ford Hospital , Detroit , MI , USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jennings', 'Affiliation': 'Henry Ford Hospital, Wayne State University , Detroit , MI , USA.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1601749']
1332,31002399,Reexamination of the chromium-51-labeled posttransfusion red blood cell recovery method.,"BACKGROUND


The chromium-51-labeled posttransfusion recovery (PTR) study has been the gold-standard test for assessing red blood cell (RBC) quality. Despite guiding RBC storage development for decades, it has several potential sources for error.
METHODS


Four healthy adult volunteers each donated an autologous, leukoreduced RBC unit, aliquots were radiolabeled with technetium-99m after 1 and 6 weeks of storage, and then infused. Subjects were imaged by single-photon-emission computed tomography immediately and 4 hours after infusion. Additionally, from subjects described in a previously published study, adenosine triphosphate levels in transfusates infused into 52 healthy volunteers randomized to a single autologous, leukoreduced, RBC transfusion after 1, 2, 3, 4, 5, or 6 weeks of storage were correlated with PTR and laboratory parameters of hemolysis.
RESULTS


Evidence from one subject imaged after infusion of technetium-99m-labeled RBCs suggests that, in some individuals, RBCs may be temporarily sequestered in the liver and spleen immediately following transfusion and then subsequently released back into circulation; this could be one source of error leading to PTR results that may not accurately predict the true quantity of RBCs cleared by intra- and/or extravascular hemolysis. Indeed, adenosine triphosphate levels in the transfusates correlated more robustly with measures of extravascular hemolysis in vivo (e.g., serum iron, indirect bilirubin, non-transferrin-bound iron) than with PTR results or measures of intravascular hemolysis (e.g., plasma free hemoglobin).
CONCLUSIONS


Sources of measurement error are inherent in the chromium-51 PTR method. Transfusion of an entire unlabeled RBC unit, followed by quantifying extravascular hemolysis markers, may more accurately measure true posttransfusion RBC recovery.",2019,"Indeed, adenosine triphosphate levels in the transfusates correlated more robustly with measures of extravascular hemolysis in vivo (e.g., serum iron, indirect bilirubin, non-transferrin-bound iron) than with PTR results or measures of intravascular hemolysis (e.g., plasma free hemoglobin).
","['52 healthy volunteers', 'Four healthy adult volunteers each donated an']","['autologous, leukoreduced RBC unit, aliquots were radiolabeled with technetium-99m', 'technetium-99m-labeled RBCs']","['adenosine triphosphate levels', 'red blood cell (RBC) quality']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0303611', 'cui_str': 'Technetium 99m'}]","[{'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",4.0,0.0214269,"Indeed, adenosine triphosphate levels in the transfusates correlated more robustly with measures of extravascular hemolysis in vivo (e.g., serum iron, indirect bilirubin, non-transferrin-bound iron) than with PTR results or measures of intravascular hemolysis (e.g., plasma free hemoglobin).
","[{'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Francis', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mahajan', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Rapido', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'La Carpia', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Soffing', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Chaitanya', 'Initials': 'C', 'LastName': 'Divgi', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Yeh', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Akiva', 'Initials': 'A', 'LastName': 'Mintz', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Lenhurst', 'Initials': 'L', 'LastName': 'Leslie', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Agrest', 'Affiliation': 'Nuclear Medicine, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Karafin', 'Affiliation': 'Versiti Medical Sciences Institute, Milwaukee, Wisconsin.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Ginzburg', 'Affiliation': 'Division of Hematology Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Beth H', 'Initials': 'BH', 'LastName': 'Shaz', 'Affiliation': 'New York Blood Center, New York, New York.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'BloodWorks Northwest, Seattle, Washington.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Amireault', 'Affiliation': 'Biologie Intégrée du Globule Rouge UMR_S1134, INSERM, Univ. Paris Diderot, Sorbonne Paris Cité, Univ. de la Réunion, Univ. des Antilles, Institut National de la Transfusion Sanguine, Laboratory of Excellence GR-Ex, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Buffet', 'Affiliation': 'Biologie Intégrée du Globule Rouge UMR_S1134, INSERM, Univ. Paris Diderot, Sorbonne Paris Cité, Univ. de la Réunion, Univ. des Antilles, Institut National de la Transfusion Sanguine, Laboratory of Excellence GR-Ex, Paris, France.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Zimring', 'Affiliation': 'BloodWorks Northwest, Seattle, Washington.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': ""D'Alessandro"", 'Affiliation': 'University of Colorado Denver-Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Pathology and Cell Biology, Columbia University Irving Medical Center-New York Presbyterian Hospital, New York, New York.'}]",Transfusion,['10.1111/trf.15310']
1333,31038809,Conditioning pain modulation reduces pain only during the first stimulation of the temporal summation of pain paradigm in healthy participants.,"BACKGROUND


Pro-nociceptive and anti-nociceptive mechanisms are commonly assessed in clinical and experimental pain studies, but their potential interaction is not well understood.
OBJECTIVES


Investigate the effect of conditioning pain modulation (CPM) on temporal summation of pain (TSP).
METHODS


Twenty healthy participants underwent cuff algometry assessment on the lower legs to establish the pressure pain tolerance threshold (PTT). For the TSP assessment, ten stimuli at the level of the PTT were delivered by computerised cuff inflations (1-s stimulation, 1-s break) while participants rated pain intensity on a 10-cm electronic visual analogue scale (VAS). This TSP paradigm was then repeated with a simultaneous conditioning stimulus induced by a cuff on the contralateral leg, inflated to a constant pressure corresponding to 30% (mild), 70% (moderate) or 100% (severe) of the PTT. These were assessed in a randomised order, with a fifteen-minute break between tests. A final TSP test without conditioning was reassessed at the end (post-recording).
RESULTS


An interaction between stimuli (1-10) and repetition (p < 0.05) was found for VAS scores. VAS scores for the first stimulus were decreased during 30%, 70%, and 100% conditioning intensities, compared to baseline and post-recordings (p < 0.05). There was a significant increase in TSP during conditioning (p < 0.05). There were no significant differences between baseline and post-recordings for any stimuli (p > 0.05).
CONCLUSIONS


The current study indicates that mild to severe stimuli administered by cuff algometry does not modulate summation effect of temporal summation of pain, which could indicate that pain facilitatory mechanisms are more potent compared with pain inhibitory mechanisms.
SIGNIFICANCE


Current knowledge on the interaction effect of pro and anti-nociceptive paradigms are the lacking. The current study indicates that conditioning pain modulation does not modulate the summation effect of temporal summation of pain, when evaluated by computerized pressure algometry. This finding was independent of the mild, moderate and severe painful conditioning intensities.",2019,An interaction between stimuli (1-10) and repetition (p < 0.05) was found for VAS scores.,"['Twenty healthy participants underwent', 'healthy participants']","['conditioning pain modulation (CPM', 'cuff algometry assessment']","['pain', 'pain intensity on a 10-cm electronic visual analogue scale (VAS', 'VAS scores', 'TSP', 'pressure pain tolerance threshold (PTT', 'temporal summation of pain (TSP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1533179', 'cui_str': 'Tsp'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}]",20.0,0.04558,An interaction between stimuli (1-10) and repetition (p < 0.05) was found for VAS scores.,"[{'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Holden', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Kristian Kjaer', 'Initials': 'KK', 'LastName': 'Petersen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Arendt-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1408']
1334,31704948,Statin Short-term Inhibition of Insulin Sensitivity and Secretion During Acute Phase of ST-Elevation Myocardial Infarction.,"Hyperglycemia during myocardial infarction (MI) has a strong and direct association with mortality. In stable patients and experimental models, statins favor the elevation of glycaemia. The present study investigated whether short-course treatment with statins during MI can influence glucose homeostasis and thus the clinical outcome. In this prospective study, euglycemic hyperinsulinemic clamp (EHC) was performed at second (D2) and sixth (D6) day after MI in patients randomized to simvastatin (S)10 or 80 mg/day during hospitalization (n = 27). In addition, patients (n = 550) were treated without (WS) or with simvastatin (S) at 20, 40 or 80 mg/day had HOMA2S on admission (D1) and fifth (D5) day after MI. According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025). Consistently, the changes in HOMA2S between D1 and D5 were 40 ± 145% (WS), 22 ± 117% (S20), 16 ± 61% (S40) and -2% ± 88% (S80) (p = 0.001). In conclusion, statin during the acute phase of MI reduces insulin sensitivity in a dose-dependent manner.",2019,"According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025).",[],"['simvastatin', 'euglycemic hyperinsulinemic clamp (EHC', 'simvastatin (S)10']","['insulin sensitivity', 'Hyperglycemia', 'Insulin Sensitivity and Secretion']",[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",550.0,0.0261715,"According to EHC, insulin sensitivity increased by 20 ± 60% in S10 and decreased by -6 ± 28% in S80 (p = 0.025).","[{'ForeName': 'Andrei C', 'Initials': 'AC', 'LastName': 'Sposito', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil. andreisposito@gmail.com.'}, {'ForeName': 'Luiz Sergio F', 'Initials': 'LSF', 'LastName': 'Carvalho', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Moura', 'Affiliation': 'Department of Medicine, Weill-Cornell Medical College, New York, New York, United States.'}, {'ForeName': 'Alessandra M', 'Initials': 'AM', 'LastName': 'Campos-Staffico', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Riobaldo M R', 'Initials': 'RMR', 'LastName': 'Cintra', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Nadruz', 'Affiliation': 'Faculty of Medical Sciences, State University of Campinas (Unicamp), Campinas, SP, Brazil.'}, {'ForeName': 'Osorio R', 'Initials': 'OR', 'LastName': 'Almeida', 'Affiliation': 'Hospital de Base do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Quinaglia E Silva', 'Affiliation': 'Hospital de Base do Distrito Federal, Brasília, Brazil.'}]",Scientific reports,['10.1038/s41598-019-52111-x']
1335,30992058,"Correction to: Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan.","Following publication of the original article [1], the authors reported an error in Table 2.",2019,"Following publication of the original article [1], the authors reported an error in Table 2.","['controlled phase III trial in Japan', 'patients with active rheumatoid arthritis and inadequate response to']","['Sarilumab plus methotrexate', 'methotrexate', 'placebo']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.238468,"Following publication of the original article [1], the authors reported an error in Table 2.","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan. tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Kazuteru', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Sanofi K.K, Opera City Tower 3-20-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 163-1488, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Sanofi K.K, Opera City Tower 3-20-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 163-1488, Japan.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hagino', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': 'Sanofi-Genzyme, 500 Kendall St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Toho University, 2-22-36 Ohashi, Meguro-ku, Tokyo, 153-8515, Japan.'}]",Arthritis research & therapy,['10.1186/s13075-019-1887-x']
1336,31583436,"A phase I delayed-start, randomized and pharmacodynamic study of metformin and chemotherapy in patients with solid tumors.","PURPOSE


Metformin activates AMP-related pathways leading to inactivation of mammalian target of rapamycin (mTOR) and suppression of its downstream effectors, crucial for cancer growth. Epidemiologic studies showed a reduced incidence and improved survival in cancer patients. We conducted a prospective phase I study to assess the safety of metformin in combination with chemotherapy in patients with solid tumors.
METHODS


We conducted a delayed-start randomized trial of non-diabetic patients in two stages. In Stage 1, we randomized patients to two arms: concurrent arm (metformin with chemo) vs. delayed arm (chemo alone). In Stage 2, patients in delayed arm were crossed over to receive metformin. Patients received metformin 500 mg twice daily with chemotherapy to define dose-limiting toxicities (DLTs) in both stages. Secondary endpoints assessed adverse events (AEs) and response rates. Translational correlates included effects of metformin on expression and phosphorylation of 5' adenosine monophosphate-activated protein kinase (AMPK) by western blot in PBMCs.
RESULTS


A total of 100 patients were enrolled (51 in delayed arm vs. 49 concurrent arm). Rate of DLTs in patients receiving metformin with chemotherapy was 6.1% vs. 7.8% in patients receiving chemotherapy alone. DLTs seen with addition of metformin included those associated with established chemo adverse events. No lactic acidosis or hypoglycemia occurred. Restaging showed stable disease in 46% at cessation of metformin. 28% of patients with measurable tumor markers showed improvement. AMPK phosphorylation showed a four- to sixfold increase in AMPK phosphorylation after metformin.
CONCLUSIONS


This is the largest phase I study of metformin combined with chemotherapy, which suggests that metformin can be given safely with chemotherapy, and offers a platform for future studies. Post-metformin increase in AMPK phosphorylation may potentially explain lack of disease progression in nearly half of our patients.
FUNDING


UL1 TR001064.
CLINICAL TRIAL INFORMATION


NCT01442870.",2019,No lactic acidosis or hypoglycemia occurred.,"['cancer patients', 'patients with solid tumors', '100 patients were enrolled (51 in delayed arm vs. 49 concurrent arm', 'non-diabetic patients in two stages']","['metformin with chemotherapy', 'metformin combined with chemotherapy', 'metformin', 'chemotherapy', 'metformin 500\xa0mg twice daily with chemotherapy', 'concurrent arm (metformin with chemo) vs. delayed arm (chemo alone', 'metformin and chemotherapy']","['Rate of DLTs', 'survival', 'lactic acidosis or hypoglycemia', 'AMPK phosphorylation', 'adverse events (AEs) and response rates']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1869036', 'cui_str': 'Lactic acidosis (SMQ)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.0465807,No lactic acidosis or hypoglycemia occurred.,"[{'ForeName': 'Mohammad Wasif', 'Initials': 'MW', 'LastName': 'Saif', 'Affiliation': 'Northwell Health Cancer Institute, 1111 Marcus Avenue, 2nd Floor, Lake Success, NY, 11042, USA. wsaif@northwell.edu.'}, {'ForeName': 'Shrikar', 'Initials': 'S', 'LastName': 'Rajagopal', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Caplain', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Grimm', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Serebrennikova', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Tsichlis', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martell', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03967-3']
1337,31040096,"Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial.","BACKGROUND


Bloodstream infection is associated with high mortality and serious morbidity in preterm babies. Evidence from clinical trials shows that antimicrobial-impregnated central venous catheters (CVCs) reduce catheter-related bloodstream infection in adults and children receiving intensive care, but there is a paucity of similar evidence for babies receiving neonatal intensive care.
METHODS


This open-label, parallel-group, pragmatic, randomised controlled trial was done in 18 neonatal intensive care units in England. Newborn babies who needed a peripherally inserted CVC (PICC) were allocated randomly (1:1) to receive either a PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC. Random allocation was done with a web-based program, which was centrally controlled to ensure allocation concealment. Randomisation sequences were computer-generated in random blocks of two and four, and stratified by site. Masking of clinicians to PICC allocation was impractical because rifampicin caused brown staining of the antimicrobial-impregnated PICC. However, participant inclusion in analyses and occurrence of outcome events were determined following an analysis plan that was specified before individuals saw the unblinded data. The primary outcome was the time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection between 24 h after randomisation and 48 h after PICC removal or death. We analysed outcome data according to the intention-to-treat principle. We excluded babies for whom a PICC was not inserted from safety analyses, as these analyses were done with groups defined by the PICC used. This trial is registered with ISRCTN, number 81931394.
FINDINGS


Between Aug 12, 2015, and Jan 11, 2017, we randomly assigned 861 babies (754 [88%] born before 32 weeks of gestation) to receive an antimicrobial-impregnated PICC (430 babies) or standard PICC (431 babies). The median time to PICC removal was 8·20 days (IQR 4·77-12·13) in the antimicrobial-impregnated PICC group versus 7·86 days (5·00-12·53) days in the standard PICC group (hazard ratio [HR] 1·03, 95% CI 0·89-1·18, p=0·73), with 46 (11%) of 430 babies versus 44 (10%) of 431 babies having a microbiologically confirmed bloodstream or CSF infection. The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63). Secondary outcomes relating to infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal were similar between the two groups, although rifampicin resistance in positive cultures of PICC tips was higher in the antimicrobial-impregnated PICC group (relative risk 3·51, 95% CI 1·16-10·57, p=0·018). 60 adverse events were reported from 49 (13%) patients in the antimicrobial-impregnated PICC group and 50 events from 45 (10%) babies in the standard PICC group.
INTERPRETATION


We found no evidence of benefit or harm associated with miconazole and rifampicin-impregnated PICCs compared with standard PICCs for newborn babies. Future research should focus on other types of antimicrobial impregnation of PICCs and alternative approaches for preventing infection.
FUNDING


UK National Institute for Health Research Health Technology Assessment programme.",2019,"The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63).","['Between Aug 12, 2015, and Jan 11, 2017', 'preterm babies', 'Newborn babies who needed a peripherally inserted CVC (PICC', 'adults and children receiving intensive care', '18 neonatal intensive care units in England', 'babies receiving neonatal intensive care', 'newborn babies']","['miconazole and rifampicin-impregnated PICCs', 'antimicrobial-impregnated PICC (430 babies) or standard PICC', 'Antimicrobial-impregnated central venous catheters', 'PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC', 'antimicrobial-impregnated central venous catheters (CVCs']","['median time to PICC removal', 'infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal', 'rifampicin resistance in positive cultures of PICC tips', '60 adverse events', 'time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection', 'bloodstream or CSF infection', 'time from random allocation to first bloodstream or CSF infection']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085559'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0021711', 'cui_str': 'Infant, Newborn, Intensive Care'}]","[{'cui': 'C0025942', 'cui_str': 'Miconazole'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007807'}]",,0.184959,"The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK; Health Data Research UK, London, UK. Electronic address: r.gilbert@ucl.ac.uk.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Donohue', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fraser', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Barts Health NHS Trust, London, UK; Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McGuire', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Oddie', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK; Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30114-2']
1338,30676464,Efficacy of Vein Visualization Devices for Peripheral Intravenous Catheter Placement in Preterm Infants: A Randomized Clinical Trial.,,2019,,['Preterm Infants'],['Vein Visualization Devices'],[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0042449', 'cui_str': 'Veins'}]",[],,0.314482,,[],The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000392']
1339,30992195,"Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


In patients with type 2 diabetes, intensive glucose control can be renoprotective and albuminuria-lowering treatments can slow the deterioration of kidney function. We assessed the albuminuria-lowering effect of the sodium-glucose co-transporter-2 inhibitor dapagliflozin with and without the dipeptidyl peptidase-4 inhibitor saxagliptin, and the effect of dapagliflozin-saxagliptin on glycaemic control in patients with type 2 diabetes and moderate-to-severe chronic kidney disease.
METHODS


In this double-blind, placebo-controlled trial (DELIGHT), we enrolled patients at 116 research centres in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain, Taiwan, and the USA. We included patients with a known history of type 2 diabetes, increased albuminuria (urine albumin-to-creatinine ratio [UACR] 30-3500 mg/g), an estimated glomerular filtration rate of 25-75 mL/min per 1·73 m 2 , and an HbA 1c  of 7·0-11·0% (53-97 mmol/mol), who had been receiving stable doses of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy and glucose-lowering treatment for at least 12 weeks. After a 4-week, single-blind placebo run-in period, participants were randomly assigned (1:1:1; via an interactive voice-web response system) to receive dapagliflozin (10 mg) only, dapagliflozin (10 mg) and saxagliptin (2·5 mg), or placebo once-daily for 24 weeks. Primary endpoints were change from baseline in UACR (dapagliflozin and dapagliflozin-saxagliptin groups) and HbA 1c  (dapagliflozin-saxagliptin group) at week 24 in all randomly allocated patients with available data (full analysis set). This study is registered with ClinicalTrials.gov, number NCT02547935 and is completed.
FINDINGS


The study took place between July 14, 2015, and May 18, 2018. 1187 patients were screened, of whom 461 were randomly assigned: 145 to the dapagliflozin group, 155 to the dapagliflozin-saxagliptin group, and 148 to the placebo group (13 patients were excluded because of data integrity issues). Dapagliflozin and dapagliflozin-saxagliptin reduced UACR versus placebo throughout the study period. At week 24, the difference (vs placebo; n=134 patients with available data) in mean UACR change from baseline was -21·0% (95% CI -34·1 to -5·2; p=0·011) for dapagliflozin (n=132) and -38·0% (-48·2 to -25·8; p<0·0001) for dapagliflozin-saxagliptin (n=139). HbA 1c  was reduced in the dapagliflozin-saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (-0·58% [-0·80 to -0·37; p<0·0001]). The numbers of patients with adverse events (79 [54%] in the dapagliflozin group, 104 [68%] in the dapagliflozin-saxagliptin group, and 81 [55%] in the placebo group) or serious adverse events (12 [8%], 12 [8%], and 16 [11%], respectively) were similar across groups. There were no new drug-related safety signals.
INTERPRETATION


Dapagliflozin with or without saxagliptin, given in addition to angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment, is a potentially attractive option to slow the progression of kidney disease in patients with type 2 diabetes and moderate-to-severe chronic kidney disease.
FUNDING


AstraZeneca.",2019,HbA 1c  was reduced in the dapagliflozin-saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (-0·58% [-0·80 to -0·37; p<0·0001]).,"['1187 patients were screened, of whom 461 were randomly assigned: 145 to the', 'patients with a known history of type 2 diabetes, increased albuminuria (urine albumin-to-creatinine ratio [UACR] 30-3500 mg/g), an estimated glomerular filtration rate of 25-75 mL/min per 1·73 m 2 , and an HbA 1c  of 7·0-11·0% (53-97 mmol/mol), who had been receiving stable doses of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy and glucose-lowering treatment for at least 12 weeks', 'enrolled patients at 116 research centres in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain, Taiwan, and the USA', 'patients with type 2 diabetes and moderate-to-severe chronic kidney disease', 'patients with type 2 diabetes', 'patients with type 2 diabetes and chronic kidney disease (DELIGHT']","['angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment', 'placebo', 'interactive voice-web response system) to receive dapagliflozin (10 mg) only, dapagliflozin', 'dapagliflozin and saxagliptin', 'saxagliptin (2·5 mg), or placebo', 'dapagliflozin-saxagliptin', 'Dapagliflozin and dapagliflozin-saxagliptin', 'saxagliptin', 'Dapagliflozin with or without saxagliptin', 'sodium-glucose co-transporter-2 inhibitor dapagliflozin with and without the dipeptidyl peptidase-4 inhibitor saxagliptin', 'dapagliflozin']","['numbers of patients with adverse events', 'HbA 1c', 'mean UACR change', 'serious adverse events', 'change from baseline in UACR (dapagliflozin and dapagliflozin-saxagliptin groups) and HbA 1c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",1187.0,0.421698,HbA 1c  was reduced in the dapagliflozin-saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (-0·58% [-0·80 to -0·37; p<0·0001]).,"[{'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Bergur', 'Initials': 'B', 'LastName': 'Stefánsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reyner', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Centre Copenhagen Gentofte, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Centre for Nephrology, University College London, London, UK.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology Department, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30086-5']
1340,30992406,Ultrasound-guided suprainguinal fascia iliaca compartment block versus periarticular infiltration for pain management after total hip arthroplasty: a randomized controlled trial.,,2019,,['pain management after total hip arthroplasty'],['Ultrasound-guided suprainguinal fascia iliaca compartment block versus periarticular infiltration'],[],"[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]",[],,0.0804575,,"[{'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Vermeylen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Algemeen Ziekenhuis Turnhout, Turnhout, Belgium kris.vermeylen@gmail.com.'}, {'ForeName': 'Ine', 'Initials': 'I', 'LastName': 'Leunen', 'Affiliation': 'Department of Anesthesia and Intensive Care, Algemeen Ziekenhuis Turnhout, Turnhout, Belgium.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2019-100519']
1341,30883055,Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.,"BACKGROUND


Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear.
METHODS


In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y 12  inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events.
RESULTS


Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group.
CONCLUSIONS


In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y 12  inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.).",2019,"Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events.","['patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI', 'patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y 12  inhibitor to receive', 'after Acute Coronary Syndrome or PCI in Atrial Fibrillation', 'patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y 12  inhibitor, an antithrombotic regimen that included apixaban, without', '4614 patients from 33 countries']","['apixaban', 'aspirin', 'placebo', 'Antithrombotic Therapy', 'apixaban or a vitamin K antagonist and to receive aspirin or matching placebo', 'vitamin K antagonist, aspirin', 'vitamin K antagonist']","['incidence of death or hospitalization and of ischemic events', 'incidence of ischemic events', 'death or hospitalization', 'Major or clinically relevant nonmajor bleeding', 'death or hospitalization and a composite of ischemic events', 'ischemic events', 'major or clinically relevant nonmajor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",4614.0,0.605675,"Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group (23.5% vs. 27.4%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events.","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heizer', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Amit N', 'Initials': 'AN', 'LastName': 'Vora', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Massaro', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Averkov', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Bahit', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hijazi', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sinnaeve', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': ""From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., G.H., A.N.V., T.M., C.B.G., J.H.A.); Bristol-Myers Squibb, Princeton, NJ (R.A., J.L.); Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.); Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.) - both in Canada; Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Vivantes Neukoelln Medical Center, Berlin (H.D.), and Heart Center Leipzig, Department of Internal Medicine-Cardiology, University of Leipzig, Leipzig (H.T.) - both in Germany; Pirogov Russian National Research Medical University, Moscow (O.A.); Instituto de Neurología Cognitiva (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); Hospital Israelita Albert Einstein, São Paulo (O.B.); Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland (A.B.); the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H.); the National Scientific Center, Strazhesko Institute of Cardiology, Kiev, Ukraine (A.P.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (P.S.); the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom (R.F.S.); and University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1817083']
1342,30985632,"Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study.","BACKGROUND


We evaluated single oral dose of delafloxacin versus single intramuscular ceftriaxone in participants with uncomplicated urogenital gonorrhea (primary objective). Secondary objectives included the efficacy, safety, and tolerability of delafloxacin versus ceftriaxone for uncomplicated urogenital, rectal, and/or pharyngeal gonorrhea.
METHODS


In this open-label, multicenter study, 460 participants at 25 study centers were randomized (2:1) to receive a single 900-mg oral dose of delafloxacin or 250-mg intramuscular ceftriaxone. Neisseria gonorrhoeae culture, nucleic acid amplification test, and clinical responses were evaluated. The primary efficacy end point was the urogenital microbiological cure in the urogenital microbiological intention-to-treat population; noninferiority (NI) was assessed using a 10% NI margin.
RESULTS


In the urogenital microbiological intention-to-treat population, urogenital cure rates for delafloxacin were 85.1% (194/228) versus 91.0% (91/100) for ceftriaxone (95% confidence interval, -13.18% to 1.36%). Because the lower bound of the confidence interval exceeded the prespecified -10% NI margin, delafloxacin did not demonstrate NI to ceftriaxone. Treatment failures were more often associated with N. gonorrhoeae with higher delafloxacin minimum inhibitory concentration (MIC) values. In microbiologically evaluable participants, failure occurred in 1 (0.6%) of 177 urogenital infections caused by isolates with delafloxacin MICs <0.008 μg/mL and 31 (64.6%) of 48 infections caused by isolates with delafloxacin MICs ≥0.008 μg/mL. Gastrointestinal adverse events were common with 900-mg of delafloxacin and typically included mild to moderate diarrhea, flatulence, nausea, and vomiting. The most common adverse event was diarrhea in both treatment groups.
CONCLUSIONS


A single 900-mg dose of delafloxacin is not a reliable treatment of uncomplicated urogenital gonorrhea. Treatment failures were common in infections caused by N. gonorrhoeae with delafloxacin MICs ≥0.008 μg/mL. Additional testing with alternative dosing regimens could be considered.ClinicalTrials.gov Identifier: NCT02015637.",2019,Treatment failures were more often associated with N. gonorrhoeae with higher delafloxacin minimum inhibitory concentration (MIC) values.,"['Uncomplicated Gonorrhea Treatment', '460 participants at 25 study centers', 'participants with uncomplicated urogenital gonorrhea (primary objective', 'uncomplicated urogenital gonorrhea']","['delafloxacin or 250-mg intramuscular ceftriaxone', 'Single-Dose Oral Delafloxacin', 'Ceftriaxone', 'delafloxacin', 'delafloxacin versus ceftriaxone', 'ceftriaxone']","['delafloxacin minimum inhibitory concentration (MIC) values', 'Gastrointestinal adverse events', 'failure', 'efficacy, safety, and tolerability', 'urogenital microbiological cure in the urogenital microbiological intention-to-treat population; noninferiority (NI', 'diarrhea', 'urogenital cure rates for delafloxacin', 'uncomplicated urogenital, rectal, and/or pharyngeal gonorrhea', 'Efficacy and Safety', 'moderate diarrhea, flatulence, nausea, and vomiting']","[{'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]","[{'cui': 'C2828290', 'cui_str': 'delafloxacin'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C2828290', 'cui_str': 'delafloxacin'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",460.0,0.189758,Treatment failures were more often associated with N. gonorrhoeae with higher delafloxacin minimum inhibitory concentration (MIC) values.,"[{'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Hook', 'Affiliation': ''}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Golden', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Taylor', 'Affiliation': 'Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Henry', 'Affiliation': 'Firma Clinical Research, Chicago, IL.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tseng', 'Affiliation': 'Firma Clinical Research, Chicago, IL.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Workowski', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Jerri', 'Initials': 'J', 'LastName': 'Swerdlow', 'Affiliation': 'Melinta Therapeutics, Lincolnshire, IL.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nenninger', 'Affiliation': 'Melinta Therapeutics, Lincolnshire, IL.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cammarata', 'Affiliation': 'Melinta Therapeutics, Lincolnshire, IL.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000971']
1343,27225981,Interventions for female pattern hair loss.,"BACKGROUND


Female pattern hair loss (FPHL), or androgenic alopecia, is the most common type of hair loss affecting women. It is characterised by progressive shortening of the duration of the growth phase of the hair with successive hair cycles, and progressive follicular miniaturisation with conversion of terminal to vellus hair follicles (terminal hairs are thicker and longer, while vellus hairs are soft, fine, and short). The frontal hair line may or may not be preserved. Hair loss can have a serious psychological impact on women.
OBJECTIVES


To determine the efficacy and safety of the available options for the treatment of female pattern hair loss in women.
SEARCH METHODS


We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (2015, Issue 6), MEDLINE (from 1946), EMBASE (from 1974), PsycINFO (from 1872), AMED (from 1985), LILACS (from 1982), PubMed (from 1947), and Web of Science (from 1945). We also searched five trial registries and checked the reference lists of included and excluded studies.
SELECTION CRITERIA


We included randomised controlled trials that assessed the efficacy of interventions for FPHL in women.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trial quality, extracted data and carried out analyses.
MAIN RESULTS


We included 47 trials, with 5290 participants, of which 25 trials were new to this update. Only five trials were at 'low risk of bias', 26 were at 'unclear risk', and 16 were at 'high risk of bias'.The included trials evaluated a wide range of interventions, and 17 studies evaluated minoxidil. Pooled data from six studies indicated that a greater proportion of participants (157/593) treated with minoxidil (2% and one study with 1%) reported a moderate to marked increase in their hair regrowth when compared with placebo (77/555) (risk ratio (RR) = 1.93, 95% confidence interval (CI) 1.51 to 2.47; moderate quality evidence). These results were confirmed by the investigator-rated assessments in seven studies with 1181 participants (RR 2.35, 95% CI 1.68 to 3.28; moderate quality evidence). Only one study reported on quality of life (QoL) (260 participants), albeit inadequately (low quality evidence). There was an important increase of 13.18 in total hair count per cm² in the minoxidil group compared to the placebo group (95% CI 10.92 to 15.44; low quality evidence) in eight studies (1242 participants). There were 40/407 adverse events in the twice daily minoxidil 2% group versus 28/320 in the placebo group (RR 1.24, 95% CI 0.82 to 1.87; low quality evidence). There was also no statistically significant difference in adverse events between any of the individual concentrations against placebo.Four studies (1006 participants) evaluated minoxidil 2% versus 5%. In one study, 25/57 participants in the minoxidil 2% group experienced moderate to greatly increased hair regrowth versus 22/56 in the 5% group (RR 1.12, 95% CI 0.72 to 1.73). In another study, 209 participants experienced no difference based on a visual analogue scale (P = 0.062; low quality evidence). The assessments of the investigators based on three studies (586 participants) were in agreement with these findings (moderate quality evidence). One study assessed QoL (209 participants) and reported limited data (low quality evidence). Four trials (1006 participants) did not show a difference in number of adverse events between the two concentrations (RR 1.02, 95% CI 0.91 to 1.20; low quality evidence). Both concentrations did not show a difference in increase in total hair count at end of study in three trials with 631 participants (mean difference (MD) -2.12, 95% CI -5.47 to 1.23; low quality evidence).Three studies investigated finasteride 1 mg compared to placebo. In the finasteride group 30/67 participants experienced improvement compared to 33/70 in the placebo group (RR 0.95, 95% CI 0.66 to 1.37; low quality evidence). This was consistent with the investigators' assessments (RR 0.77, 95% CI 0.31 to 1.90; low quality evidence). QoL was not assessed. Only one study addressed adverse events (137 participants) (RR 1.03, 95% CI 0.45 to 2.34; low quality evidence). In two studies (219 participants) there was no clinically meaningful difference in change of hair count, whilst one study (12 participants) favoured finasteride (low quality evidence).Two studies (141 participants) evaluated low-level laser comb therapy compared to a sham device. According to the participants, the low-level laser comb was not more effective than the sham device (RR 1.54, 95% CI 0.96 to 2.49; and RR 1.18, 95% CI 0.74 to 1.89; moderate quality evidence). However, there was a difference in favour of low-level laser comb for change from baseline in hair count (MD 17.40, 95% CI 9.74 to 25.06; and MD 17.60, 95% CI 11.97 to 23.23; low quality evidence). These studies did not assess QoL and did not report adverse events per treatment arm and only in a generic way (low quality evidence). Low-level laser therapy against sham comparisons in two separate studies also showed an increase in total hair count but with limited further data.Single studies addressed the other comparisons and provided limited evidence of either the efficacy or safety of these interventions, or were unlikely to be examined in future trials.
AUTHORS' CONCLUSIONS


Although there was a predominance of included studies at unclear to high risk of bias, there was evidence to support the efficacy and safety of topical minoxidil in the treatment of FPHL (mainly moderate to low quality evidence). Furthermore, there was no difference in effect between the minoxidil 2% and 5% with the quality of evidence rated moderate to low for most outcomes. Finasteride was no more effective than placebo (low quality evidence). There were inconsistent results in the studies that evaluated laser devices (moderate to low quality evidence), but there was an improvement in total hair count measured from baseline.Further randomised controlled trials of other widely-used treatments, such as spironolactone, finasteride (different dosages), dutasteride, cyproterone acetate, and laser-based therapy are needed.",2016,"Both concentrations did not show a difference in increase in total hair count at end of study in three trials with 631 participants (mean difference (MD) -2.12, 95% CI -5.47 to 1.23; low quality evidence).Three studies investigated finasteride 1 mg compared to placebo.","['female pattern hair loss in women', 'Female pattern hair loss (FPHL', 'female pattern hair loss', 'women', '47 trials, with 5290 participants, of which 25 trials were new to this update']","['placebo', 'topical minoxidil', 'spironolactone, finasteride (different dosages), dutasteride, cyproterone acetate, and laser-based therapy', 'LILACS', 'Finasteride', 'minoxidil', 'Low-level laser therapy', 'finasteride']","['moderate to greatly increased hair regrowth', 'visual analogue scale', 'total hair count', 'adverse events', 'change of hair count', 'quality of life (QoL', 'total hair count per cm²', 'number of adverse events', 'efficacy and safety', 'hair regrowth']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0056855', 'cui_str': 'Cyproterone Acetate'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",5290.0,0.525014,"Both concentrations did not show a difference in increase in total hair count at end of study in three trials with 631 participants (mean difference (MD) -2.12, 95% CI -5.47 to 1.23; low quality evidence).Three studies investigated finasteride 1 mg compared to placebo.","[{'ForeName': 'Esther J', 'Initials': 'EJ', 'LastName': 'van Zuuren', 'Affiliation': 'Department of Dermatology, Leiden University Medical Center, PO Box 9600, B1-Q, Leiden, Netherlands, 2300 RC.'}, {'ForeName': 'Zbys', 'Initials': 'Z', 'LastName': 'Fedorowicz', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schoones', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007628.pub4']
1344,30963443,Acute Effects of Electronic Cigarette Inhalation on the Vasculature and the Conducting Airways.,"The use of electronic cigarettes has increased exponentially since its introduction onto the global market in 2006. However, short- and long-term health effects remain largely unknown due to the novelty of this product. The present study examines the acute effects of e-cigarette aerosol inhalation, with and without nicotine, on vascular and pulmonary function in healthy volunteers. Seventeen healthy subjects inhaled electronic cigarette aerosol with and without nicotine on two separate occasions in a double-blinded crossover fashion. Blood pressure, heart rate, and arterial stiffness measured by pulse wave velocity and pulse wave analysis were assessed at baseline, and then at 0 h, 2 h, and 4 h following exposure. Dynamic spirometry and impulse oscillometry were measured following vascular assessments at these time points, as well as at 6 h following exposure. e-Cigarette aerosol with nicotine caused a significant increase in heart rate and arterial stiffness. Furthermore, e-cigarette aerosol-containing nicotine caused a sudden increase in flow resistance as measured by impulse oscillometry, indicating obstruction of the conducting airways. Both aerosols caused an increase in blood pressure. The present study indicates that inhaled e-cigarette aerosol with nicotine has an acute impact on vascular and pulmonary function. Thus, chronic usage may lead to long-term adverse health effects. Further investigation is warranted.",2019,Seventeen healthy subjects inhaled electronic cigarette aerosol with and without nicotine on two separate occasions in a double-blinded crossover fashion.,"['Seventeen healthy subjects inhaled', 'healthy volunteers']","['electronic cigarette aerosol with and without nicotine', 'nicotine', 'e-cigarette aerosol inhalation, with and without nicotine', 'electronic cigarettes', 'Electronic Cigarette Inhalation']","['heart rate and arterial stiffness', 'blood pressure', 'Blood pressure, heart rate, and arterial stiffness measured by pulse wave velocity and pulse wave analysis', 'flow resistance', 'Dynamic spirometry and impulse oscillometry']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}]",17.0,0.0337063,Seventeen healthy subjects inhaled electronic cigarette aerosol with and without nicotine on two separate occasions in a double-blinded crossover fashion.,"[{'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Antoniewicz', 'Affiliation': 'Division of Internal Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, 182 88, Stockholm, Sweden. lukasz.antoniewicz@ki.se.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Brynedal', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Hedman', 'Affiliation': 'Department of Public Health and Clinical Medicine, Occupational and Environmental Medicine, The OLIN Unit, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lundbäck', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Bosson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}]",Cardiovascular toxicology,['10.1007/s12012-019-09516-x']
1345,30975352,Diagnostic occlusion test for acquired esotropia.,"OBJECTIVE


To assess the effect of the 45-minute diagnostic occlusion test (DOT) on the measured esodeviation in patients with acquired esotropia.
METHODS


After the routine ophthalmic examination, 67 patients with acquired esotropia were randomly assigned to either the patch group (37 subjects) or the control group (30 subjects). For both groups the mean distance and near deviations before and after 45 minutes were compared.
RESULTS


The mean pre- and post-DOT measurement at distant target for the patch group was an esodeviation of 6.7 ± 7.5 prism diopters (PD) and 13.2 ± 11.7 PD, respectively. The 45-minute DOT induced an average increase of the esotropia of 6.4 ± 5.9 PD in the patch group (p = 0.0001). For the control group, the first and second mean measurement were similar, 9.2 ± 7.6 PD and 9.1 ± 6.5 PD, respectively (p = 0.103). The mean pre- and post-DOT esodeviation at near distance for the patch group were 10.1 ± 10.1 PD and 18.7 ± 13.7 PD (p = 0.001). Following the DOT, >5 PD change was noted in 26 (70.1%) from a near distance target (p = 0.001). For the control group, the mean near first and second measurements were 13.9 PD and 15.0 PD, respectively.
CONCLUSION


Performing DOT in acquired esodeviations may help to reveal the full deviation and ultimately decrease the risk of surgical undercorrection by eliminating tonic fusional divergence. The DOT can be applied clinically for acquired esotopia to accurately measure the angle of deviation.",2019,The mean pre- and post-DOT esodeviation at near distance for the patch group were 10.1 ± 10.1 PD and 18.7 ± 13.7 PD (p = 0.001).,"['patients with acquired esotropia', '67 patients with acquired esotropia']",['45-minute diagnostic occlusion test (DOT'],"['mean distance and near deviations', 'mean pre- and post-DOT esodeviation at near distance', 'mean pre- and post-DOT measurement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444629', 'cui_str': 'Basic esotropia'}]","[{'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C4551734', 'cui_str': 'Esodeviation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",67.0,0.0333125,The mean pre- and post-DOT esodeviation at near distance for the patch group were 10.1 ± 10.1 PD and 18.7 ± 13.7 PD (p = 0.001).,"[{'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'AlAli', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Sadik Taju', 'Initials': 'ST', 'LastName': 'Sherief', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'MacNeill', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Quann', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ont.. Electronic address: michael.wan@sickkids.ca.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Smith', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, University of Toronto, Toronto, Ont.'}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2018.04.005']
1346,30888090,Blinding is compromised for transcranial direct current stimulation at 1 mA for 20 min in young healthy adults.,"Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that is frequently used to study cortical excitability changes and their impact on cognitive functions in humans. While most stimulators are capable of operating in double-blind mode, the amount of discomfort experienced during tDCS may break blinding. Therefore, specifically designed sham stimulation protocols are being used. The ""fade-in, short-stimulation, fade-out"" (FSF) protocol has been used in hundreds of studies and is commonly believed to be indistinguishable from real stimulation applied at 1 mA for 20 min. We analysed subjective reports of 192 volunteers, who either received real tDCS (n = 96) or FSF tDCS (n = 96). Participants reported more discomfort for real tDCS and correctly guessed the condition above chance-level. These findings indicate that FSF does not ensure complete blinding and that better active sham protocols are needed.",2019,Participants reported more discomfort for real tDCS and correctly guessed the condition above chance-level.,"['young healthy adults', '192 volunteers, who either received', 'humans']","['FSF', 'real tDCS', 'Transcranial direct current stimulation (tDCS', 'FSF tDCS']",['discomfort for real tDCS'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",192.0,0.0929626,Participants reported more discomfort for real tDCS and correctly guessed the condition above chance-level.,"[{'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Turi', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Csifcsák', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Nya Mehnwolo', 'Initials': 'NM', 'LastName': 'Boayue', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aslaksen', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antal', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Groot', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Hawkins', 'Affiliation': 'School of Psychology, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Forstmann', 'Affiliation': 'Integrative Model-based Cognitive Neuroscience Research Unit, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Opitz', 'Affiliation': 'Department of Biomedical Engineering, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Thielscher', 'Affiliation': 'Department of Electrical Engineering, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mittner', 'Affiliation': 'Department of Psychology, University of Tromsø, Tromsø, Norway.'}]",The European journal of neuroscience,['10.1111/ejn.14403']
1347,31887743,Disease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis: A Randomized Controlled Trial.,"Background


MIV-711 is a novel selective cathepsin K inhibitor with beneficial effects on bone and cartilage in preclinical osteoarthritis models.
Objective


To evaluate the efficacy, safety, and tolerability of MIV-711 in participants with symptomatic, radiographic knee osteoarthritis.
Design


26-week randomized, double-blind, placebo-controlled phase 2a study with a 26-week open-label safety extension substudy. (EudraCT: 2015-003230-26 and 2016-001096-73).
Setting


Six European sites.
Participants


244 participants with primary knee osteoarthritis, Kellgren-Lawrence grade 2 or 3, and pain score of 4 to 10 on a numerical rating scale (NRS).
Intervention


MIV-711, 100 (n = 82) or 200 (n = 81) mg daily, or matched placebo (n = 77). Participants (46 who initially received 200 mg/d and 4 who received placebo) received 200 mg of MIV-711 daily during the extension substudy.
Measurements


The primary outcome was change in NRS pain score. The key secondary outcome was change in bone area on magnetic resonance imaging (MRI). Other secondary end points included cartilage thickness on quantitative MRI and type I and II collagen C-telopeptide biomarkers. Outcomes were assessed over 26 weeks.
Results


Changes in NRS pain scores with MIV-711 were not statistically significant (placebo, -1.4; MIV-711, 100 mg/d, -1.7; MIV-711, 200 mg/d, -1.5). MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels. Nine serious adverse events occurred in 6 participants (1 in the placebo group, 3 in the 100 mg group, and 2 in the 200 mg group); none were considered to be treatment-related.
Limitation


The trial was relatively short.
Conclusion


MIV-711 was not more effective than placebo for pain, but it significantly reduced bone and cartilage progression with a reassuring safety profile. This treatment may merit further evaluation as a disease-modifying osteoarthritis drug.
Primary Funding Source


Medivir.",2020,MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels.,"['Participants\n\n\n244 participants with primary knee osteoarthritis, Kellgren-Lawrence grade 2 or 3, and pain score of 4 to 10 on a numerical rating scale (NRS', 'Osteoarthritis', 'participants with symptomatic, radiographic knee osteoarthritis', 'Participants (46 who initially received 200 mg/d and 4 who received']","['placebo', 'Placebo', 'Novel Cathepsin K Inhibitor', 'MIV-711']","['Nine serious adverse events', 'medial femoral cartilage thinning', 'NRS pain score', 'cartilage thickness on quantitative MRI and type I and II collagen C-telopeptide biomarkers', 'medial femoral bone area progression', 'bone and cartilage progression', 'NRS pain scores', 'change in bone area on magnetic resonance imaging (MRI', 'efficacy, safety, and tolerability', 'bone and cartilage biomarker levels']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0284930', 'cui_str': 'Cathepsin X'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0534110', 'cui_str': '(125I)mIV'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",244.0,0.588212,MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels.,"[{'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom (P.G.C., S.R.K.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.).'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Kingsbury', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom (P.G.C., S.R.K.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.).'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Guillard', 'Affiliation': 'Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.).'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Rizoska', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Sjögren', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Graham', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Jansson', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Wadell', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bethell', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Öhd', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}]",Annals of internal medicine,['10.7326/M19-0675']
1348,30957170,"An Open-Label, Randomized, Active-Controlled Trial of 8 Versus 12 Weeks of Elbasvir/Grazoprevir for Treatment-Naive Patients With Chronic Hepatitis C Genotype 1b Infection and Mild Fibrosis (EGALITE Study): Impact of Baseline Viral Loads and NS5A Resistance-Associated Substitutions.","BACKGROUND


A 12-week grazoprevir/elbasvir regimen is highly effective against hepatitis C virus genotype 1 (HCV-1) infection. The efficacy of an 8-week regimen for treatment-naive HCV-1-infected patients with mild fibrosis has not been determined.
METHODS


Treatment-naive HCV-1b-infected patients with mild fibrosis were randomly assigned to receive 8 (n = 41) or 12 (n = 41) weeks of grazoprevir/elbasvir therapy. The primary end point was a sustained virologic response, defined as an HCV RNA level of < 12 IU/mL, at posttreatment week 12 (SVR12).
RESULTS


SVR12 was achieved by 87.8% of patients (36 of 41) in the 8-week arm and 100% (41 of 41) in the 8-week arm of the full-analysis population and by 90.0% (36 of 40) and 100% (41 of 41), respectively, in the per-protocol population (all P = .055). In the 8-week arm, a significantly lower SVR12 rate was observed among patients with a high HCV-1b load, defined as ≥1 500 000 IU/mL (79% vs 100%; P = .042), and among those with a baseline Y93H resistance-associated substitution (RAS) frequency of >15% in HCV nonstructural protein 5A (NS5A; 40.0% vs 97.1%; P = .004). Between-group analysis demonstrated that, among patient with a high HCV-1b load and a baseline Y93H RAS frequency of >15%, those in the 8-week arm had a substantially lower SVR12 rate than those in the 12-week arm (40.0% vs 100.0%). All 4 HCV-1b relapses had a Y93H RAS frequency of >99% at posttreatment week 12.
CONCLUSIONS


Twelve weeks of grazoprevir/elbasvir therapy is highly effective for treatment-naive patients with mild fibrosis. A truncated, 8-week grazoprevir/elbasvir regimen might be applied for those with low viral loads or without a significant NS5A RAS frequency.
CLINICAL TRIALS REGISTRATION


NCT03186365.",2019,"All four HCV-1b relapses had NS5A RAS Y93H> 99% at post-treatment week-12.
","['HCV-1b naïve patients with mild fibrosis', 'naïve patients with mild fibrosis', 'treatment-naïve chronic hepatitis C genotype 1b patients with mild fibrosis (EGALITE', 'HCV-1b naïve patients with mild fibrosis were randomized to 8 (n=41) or 12 (n=41) weeks of']","['NS5A resistance-associated substitution', 'grazoprevir/elbasvir', 'elbasvir/grazoprevir']","['SVR12 rate', 'SVR12', 'SVR12 (HCV RNA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4049394', 'cui_str': 'Chronic hepatitis C genotype 1b'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4080053', 'cui_str': 'grazoprevir'}, {'cui': 'C4080052', 'cui_str': 'elbasvir'}, {'cui': 'C4080453', 'cui_str': 'elbasvir / grazoprevir'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.0634156,"All four HCV-1b relapses had NS5A RAS Y93H> 99% at post-treatment week-12.
","[{'ForeName': 'Chung-Feng', 'Initials': 'CF', 'LastName': 'Huang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Chao-Hung', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital, ChiaYi.'}, {'ForeName': 'Pin-Nan', 'Initials': 'PN', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital.'}, {'ForeName': 'Ming-Jong', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung City.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei.'}, {'ForeName': 'Jia-Horng', 'Initials': 'JH', 'LastName': 'Kao', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei.'}, {'ForeName': 'Shih-Jer', 'Initials': 'SJ', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital-Yunlin Branch, Yunlin.'}, {'ForeName': 'Pei-Lun', 'Initials': 'PL', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Tainan.'}, {'ForeName': 'Jyh-Jou', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Tainan.'}, {'ForeName': 'Rong-Nan', 'Initials': 'RN', 'LastName': 'Chien', 'Affiliation': 'Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taipei.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Peng', 'Affiliation': 'Division of Hepatology and Gastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung.'}, {'ForeName': 'Chun-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taipei.'}, {'ForeName': 'Tsai-Yuan', 'Initials': 'TY', 'LastName': 'Hsieh', 'Affiliation': 'Department of Gastroenterology, Tri-service General Hospital, Taipei.'}, {'ForeName': 'Chun-Han', 'Initials': 'CH', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung City.'}, {'ForeName': 'Chia-Yen', 'Initials': 'CY', 'LastName': 'Dai', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Jee-Fu', 'Initials': 'JF', 'LastName': 'Huang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Wan-Long', 'Initials': 'WL', 'LastName': 'Chuang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz154']
1349,31712967,The Efficacy of a Gambling Prevention Program Among High-School Students.,"Youth problem gambling has become an emergent public health issue, and adolescents constitute a vulnerable age group for the development of gambling-related problems. Although there is research concerning the risk factors of youth problem gambling, rigorous evaluations of the effectiveness of preventive initiatives is still rare. The present study evaluated the efficacy of an integrative intervention to prevent youth problem gambling based on a multidimensional set of factors including gambling-related knowledge, misconceptions, attitudes, gambling frequency, amount of money spent, total hours spent gambling per week, and sensation seeking. A pre- and post-test design was performed with 111 Portuguese high-school students randomly assigned to two groups (experimental and control). The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week. The intervention was also effective in reducing the number of at-risk/problem gamblers during the study period. Furthermore, these findings were stable after a 6-week follow-up. Overall, the intervention program appeared to be effective in correcting some gambling-related behaviours, and provides suggestions for future interventions.",2020,"The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week.","['High-School Students', '111 Portuguese high-school students']","['Gambling Prevention Program', 'integrative intervention']","['number of at-risk/problem gamblers', 'correct knowledge about gambling, reducing misconceptions and attitudes']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0032730', 'cui_str': 'Portuguese (ethnic group)'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.018052,"The findings demonstrated that the intervention was effective in improving correct knowledge about gambling, reducing misconceptions and attitudes, and in decreasing the total hours spent gambling per week.","[{'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Calado', 'Affiliation': 'Department of Psychology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK. filipa.calado2013@my.ntu.ac.uk.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Liah', 'Initials': 'L', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'Department of Psychology, ISCTE - CIS/IUL - Lisbon University Institute, Avenida das Forças Armadas, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychology, Nottingham Trent University, 50 Shakespeare Street, Nottingham, NG1 4FQ, UK.'}]",Journal of gambling studies,['10.1007/s10899-019-09908-2']
1350,30887607,Anti-fracture efficacy of zoledronate in subgroups of osteopenic postmenopausal women: secondary analysis of a randomized controlled trial.,"BACKGROUND


We recently reported that the administration of zoledronate every 18 months to osteopenic older women reduces the incidence of fractures.
OBJECTIVE


Here, we present a more detailed analysis of that trial to determine whether baseline clinical characteristics impact on the anti-fracture efficacy of this intervention.
METHODS


This is a prospective, randomized, placebo-controlled, double-blind trial in osteopenic postmenopausal women aged ≥ 65 years, to determine the anti-fracture efficacy of zoledronate. 2000 women were recruited using electoral rolls and randomized to receive 4 infusions of either zoledronate 5 mg or normal saline, at 18-month intervals. Each participant was followed for 6 years. Calcium supplements were not supplied.
RESULTS


Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001). There were no significant interactions between baseline variables (age, anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk) and the treatment effect. In particular, the reduction in fractures appeared to be independent of baseline fracture risk, and numbers needed to treat (NNT) to prevent one woman fracturing were not significantly different across baseline fracture risk tertiles.
CONCLUSIONS


The present analyses indicate that the decrease in fracture numbers is broadly consistent across this cohort. The lack of relationship between NNTs and baseline fracture risk calls into question the need for BMD measurement and precise fracture risk assessment before initiating treatment in older postmenopausal women.",2019,"RESULTS


Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001).","['2000 women were recruited using electoral rolls', 'older postmenopausal women', 'subgroups of osteopenic postmenopausal women', 'osteopenic older women', 'osteopenic postmenopausal women aged\xa0≥']","['zoledronate 5\xa0mg or normal saline', 'zoledronate', 'Calcium supplements', 'placebo']","['Fragility fractures', 'fracture numbers', 'anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0302113', 'cui_str': 'Fragility, function (observable entity)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2000.0,0.521824,"RESULTS


Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001).","[{'ForeName': 'I R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Garratt', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Wiessing', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Bolland', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bastin', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Journal of internal medicine,['10.1111/joim.12901']
1351,31711168,Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial.,"Background


Weight regain after intentional loss is common. Most evidence-based weight management programs focus on short-term loss rather than long-term maintenance.
Objective


To evaluate the benefit of coaching in an electronic health record (EHR)-based weight maintenance intervention.
Design


Randomized controlled trial. (ClinicalTrials.gov: NCT01946191).
Setting


Practices affiliated with an academic medical center.
Participants


Adult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years.
Intervention


Participants were randomly assigned to EHR tools (tracking group) versus EHR tools plus coaching (coaching group). The EHR tools included weight, diet, and physical activity tracking flow sheets; standardized surveys; and reminders. The coaching group received 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.
Measurements


The primary outcome was weight change at 24 months. Secondary outcomes included 5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction.
Results


Among 194 randomly assigned participants (mean age, 53.4 years [SD, 12.2]; 143 [74%] women; 171 [88%] white), 157 (81%) completed the trial. Mean baseline weight and BMI were 85.8 kg (SD, 19.1) and 30.4 kg/m2 (SD, 5.9). At 24 months, mean weight regain (± SE) was 2.1 ± 0.62 kg and 4.9 ± 0.63 kg in the coaching and tracking groups, respectively. The between-group difference in weight change at 24 months was significant (-2.86 kg [95% CI, -4.60 to -1.11 kg]) in the linear mixed model. At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
Limitation


Single-site trial, which limits generalizability.
Conclusion


Among adults with intentional weight loss of at least 5%, use of EHR tools plus coaching resulted in less weight regain than EHR tools alone.
Primary Funding Source


Agency for Healthcare Research and Quality and National Institutes of Health.",2019,"At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
","['adults with', '194 randomly assigned participants (mean age, 53.4 years [SD, 12.2', '143 [74%] women; 171 [88%] white), 157 (81%) completed the trial', 'Participants\n\n\nAdult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years', 'Setting\n\n\nPractices affiliated with an academic medical center']","['Electronic Health Record-Based Coaching', 'EHR tools (tracking group) versus EHR tools plus coaching (coaching group', 'personalized coaching through the EHR patient portal, with 24 scheduled contacts']","['weight change', 'Mean baseline weight and BMI', '5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction', 'mean weight regain (±\xa0SE', 'weight loss', 'intentional weight loss', 'weight regain', 'Weight Maintenance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]",194.0,0.154702,"At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%.
","[{'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, Salt Lake City, Utah (M.B.C., R.H.).'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tudorascu', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Arnold', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Comer', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah, Salt Lake City, Utah (M.B.C., R.H.).'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Laurey R', 'Initials': 'LR', 'LastName': 'Simkin-Silverman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania (K.M.M., C.L.B., D.T., B.B.G., J.A., D.C., K.H., L.R.S., G.S.F.).'}]",Annals of internal medicine,['10.7326/M18-3337']
1352,31335642,Cortisol affects pain sensitivity and pain-related emotional learning in experimental visceral but not somatic pain: a randomized controlled study in healthy men and women.,"Despite growing interest in the role of stress mediators in pain chronicity, the effects of the stress hormone cortisol on acute pain remain incompletely understood. In a randomized, double-blind, placebo-controlled study with N = 100 healthy volunteers, we tested the effects of oral hydrocortisone (20 mg) in 2 widely used pain models for the visceral and somatic modality. Salivary cortisol was increased in the hydrocortisone group (time × group: P < 0.001). For the visceral modality, assessed using pressure-controlled rectal distensions, hydrocortisone decreased the pain threshold from before to after treatment (time × group: P = 0.011), an effect primarily driven by women (time × sex: P = 0.027). For the somatic modality, cutaneous heat pain thresholds remained unaffected by hydrocortisone. Hydrocortisone did not alter perceived pain intensity or unpleasantness of either modality. Conditioned pain-related fear in response to predictive cues was only observed for the visceral modality (time × modality: P = 0.026), an effect that was significantly reduced by hydrocortisone compared with placebo (time × group: P = 0.028). This is the first psychopharmacological study to support that acutely increased cortisol enhances pain sensitivity and impairs pain-related emotional learning within the visceral, but not the somatic pain modality. Stress-induced visceral hyperalgesia and deficits in emotional pain-related learning could play a role in the pathophysiology of chronic visceral pain.",2019,Salivary cortisol was increased in the hydrocortisone group (time × group: P < 0.001).,"['N = 100 healthy volunteers', 'healthy men and women']","['placebo', 'hydrocortisone', 'oral hydrocortisone', 'Hydrocortisone']","['pain intensity or unpleasantness', 'pain sensitivity and pain-related emotional learning', 'pain threshold', 'Conditioned pain-related fear in response to predictive cues', 'Salivary cortisol']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning (observable entity)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",100.0,0.227134,Salivary cortisol was increased in the hydrocortisone group (time × group: P < 0.001).,"[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Siebert', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Koenen', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Kleine-Borgmann', 'Affiliation': 'Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Icenhour', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]",Pain,['10.1097/j.pain.0000000000001579']
1353,30939096,"Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.","PURPOSE


The Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial demonstrated a 3-year disease-free survival (DFS) of 98.7%. In this planned secondary analysis, we report longer-term outcomes and exploratory results to characterize the biology of small HER2-positive tumors and genetic factors that may predispose to paclitaxel-induced peripheral neuropathy (TIPN).
PATIENTS AND METHODS


In this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m 2 ) with trastuzumab for 12 weeks, followed by trastuzumab for 9 months. The primary end point was DFS. Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS) were also analyzed. In an exploratory analysis, intrinsic subtyping by PAM50 (Prosigna) and calculation of the risk of recurrence score were performed on the nCounter analysis system on archival tissue. Genotyping was performed to investigate TIPN.
RESULTS


A total of 410 patients were enrolled from October 2007 to September 2010. After a median follow-up of 6.5 years, there were 23 DFS events. The 7-year DFS was 93% (95% CI, 90.4 to 96.2) with four (1.0%) distant recurrences, 7-year OS was 95% (95% CI, 92.4 to 97.7), and 7-year RFI was 97.5% (95% CI, 95.9 to 99.1). PAM50 analyses (n = 278) showed that most tumors were HER2-enriched (66%), followed by luminal B (14%), luminal A (13%), and basal-like (8%). Genotyping (n = 230) identified one single-nucleotide polymorphism,  rs3012437 , associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
CONCLUSION


With longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes. Distribution of PAM50 intrinsic subtypes in small HER2-positive tumors is similar to that previously reported for larger tumors.",2019,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","['patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received', '410 patients were enrolled from October 2007 to September 2010', 'patients with grade 2 or greater TIPN (10.4', 'patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer']","['adjuvant paclitaxel and trastuzumab', 'trastuzumab', 'paclitaxel']","['distant recurrences, 7-year OS', 'Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS', '7-year RFI', '3-year disease-free survival (DFS', 'DFS', '7-year DFS', 'risk of TIPN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",410.0,0.0620248,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Dillon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Ritterhouse', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Fuhrman', 'Affiliation': 'NanoString Technologies, Seattle, WA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baltay', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': '9Sarah Cannon Cancer Center, Nashville, TN.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'P Kelly', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor Clinic Lester and Sue Smith Breast Center, Houston, TX.'}, {'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Shapira', 'Affiliation': 'Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00066']
1354,30933282,Gastric Emptying in Patients With Well-Controlled Type 2 Diabetes Compared With Young and Older Control Subjects Without Diabetes.,"CONTEXT


Gastric emptying is a major determinant of postprandial glycemia and is often delayed in long-standing, complicated type 2 diabetes mellitus (T2DM). However, there is little information about gastric emptying in well-controlled T2DM.
OBJECTIVE


To evaluate the rate of gastric emptying in community-based patients with relatively well-controlled T2DM compared with young and older control subjects without diabetes.
PARTICIPANTS AND DESIGN


A total of 111 patients with T2DM managed by diet (n = 52) or metformin monotherapy (n = 59) (HbA1c 6.6 ± 0.1%/49.0 ± 0.9 mmol/mol), 18 age- and body mass index (BMI)-matched older subjects without diabetes, and 15 young healthy subjects consumed a standardized mashed potato meal (368.5 kcal) containing 100 μL 13C-octanoic acid. Gastric emptying (by breath test) and blood glucose were evaluated over 240 minutes.
RESULTS


Gastric emptying was slower in the older than in the young subjects without diabetes (2.3 ± 0.1 vs 3.0 ± 0.1 kcal/min, P = 0.0008). However, relative to the age- and BMI-matched subjects without diabetes, gastric emptying (2.8 ± 0.1 kcal/min) was faster in patients with T2DM (P = 0.0005). Furthermore, gastric emptying was faster in the metformin-treated (3.0 ± 0.1 kcal/min) than in the diet-controlled (2.7 ± 0.1 kcal/min) patients with T2DM (P = 0.011), although there were no differences in age, BMI, HbA1c, or the duration of known diabetes. The increments in blood glucose (at t = 30 and 60 minutes and the incremental area under the curve during t = 0 to 120 minutes) after the meal were related directly to the rate of gastric emptying in the subjects with T2DM regardless of treatment with or without metformin (P < 0.05 each).
CONCLUSIONS


Gastric emptying is slowed with aging but otherwise is relatively more rapid in patients with well-controlled T2DM. This provides a strong rationale for slowing gastric emptying to improve postprandial glycemic control in these patients.",2019,"Furthermore, gastric emptying was faster in the metformin-treated (3.0 ± 0.1 kcal/min) than in the diet-controlled (2.7 ± 0.1 kcal/min) patients with T2DM (P = 0.011), although there were no differences in age, BMI, HbA1c, or the duration of known diabetes.","['Patients', '111 patients with T2DM managed by diet (n = 52) or', 'n = 59) ', 'patients with well-controlled T2DM', 'community-based patients with relatively well-controlled T2DM compared with young and older control subjects without diabetes', '18 age- and body mass index (BMI)-matched older subjects without diabetes, and 15 young healthy subjects']","['standardized mashed potato meal (368.5 kcal) containing 100 μL 13C-octanoic acid', 'metformin monotherapy']","['Gastric Emptying', 'Gastric emptying (by breath test) and blood glucose', 'rate of gastric emptying', 'blood glucose', 'Furthermore, gastric emptying', 'postprandial glycemic control', 'Gastric emptying']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0054616', 'cui_str': 'caprylic acid'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",111.0,0.0156716,"Furthermore, gastric emptying was faster in the metformin-treated (3.0 ± 0.1 kcal/min) than in the diet-controlled (2.7 ± 0.1 kcal/min) patients with T2DM (P = 0.011), although there were no differences in age, BMI, HbA1c, or the duration of known diabetes.","[{'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Watson', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Xuyi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Zilin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence (CRE) in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2018-02736']
1355,30221597,Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.,"BACKGROUND


Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk.
METHODS


From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure).
RESULTS


Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
CONCLUSIONS


The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).",2018,"The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
","['From 2010 through 2014', '19,114 persons who were enrolled in the trial', 'older persons', 'enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability', 'older adults', 'Healthy Elderly']","['Aspirin', 'enteric-coated aspirin or placebo', 'aspirin', 'placebo']","['rate of cardiovascular disease', 'rate of major hemorrhage', 'risk of major hemorrhage', 'Cardiovascular Events and Bleeding', 'composite of death, dementia, or persistent physical disability', 'cardiovascular disease', 'major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",9525.0,0.34536,"The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Abhayaratna', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stocks', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Sharyn M', 'Initials': 'SM', 'LastName': 'Fitzgerald', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Trevaks', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Colin I', 'Initials': 'CI', 'LastName': 'Johnston', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Radziszewska', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jelinek', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Mobin', 'Initials': 'M', 'LastName': 'Malik', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Eaton', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Brauer', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Cloud', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mahady', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Satterfield', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grimm', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': ""From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1805819']
1356,30955977,"Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial.","BACKGROUND


First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival after treatment with pembrolizumab monotherapy in patients with a PD-L1 TPS of 1% or greater.
METHODS


This randomised, open-label, phase 3 study was done in 213 medical centres in 32 countries. Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater. Randomisation was computer generated, accessed via an interactive voice-response and integrated web-response system, and stratified by region of enrolment (east Asia vs rest of world), ECOG performance status score (0 vs 1), histology (squamous vs non-squamous), and PD-L1 TPS (≥50% vs 1-49%). Enrolled patients were randomly assigned 1:1 in blocks of four per stratum to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles or the investigator's choice of platinum-based chemotherapy for four to six cycles. Primary endpoints were overall survival in patients with a TPS of 50% or greater, 20% or greater, and 1% or greater (one-sided significance thresholds, p=0·0122, p=0·0120, and p=0·0124, respectively) in the intention-to-treat population, assessed sequentially if the previous findings were significant. This study is registered at ClinicalTrials.gov, number NCT02220894.
FINDINGS


From Dec 19, 2014, to March 6, 2017, 1274 patients (902 men, 372 women, median age 63 years [IQR 57-69]) with a PD-L1 TPS of 1% or greater were allocated to pembrolizumab (n=637) or chemotherapy (n=637) and included in the intention-to-treat population. 599 (47%) had a TPS of 50% or greater and 818 patients (64%) had a TPS of 20% or greater. As of Feb 26, 2018, median follow-up was 12·8 months. Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018). The median surival values by TPS population were 20·0 months (95% CI 15·4-24·9) for pembrolizumab versus 12·2 months (10·4-14·2) for chemotherapy, 17·7 months (15·3-22·1) versus 13·0 months (11·6-15·3), and 16·7 months (13·9-19·7) versus 12·1 months (11·3-13·3), respectively. Treatment-related adverse events of grade 3 or worse occurred in 113 (18%) of 636 treated patients in the pembrolizumab group and in 252 (41%) of 615 in the chemotherapy group and led to death in 13 (2%) and 14 (2%) patients, respectively.
INTERPRETATION


The benefit-to-risk profile suggests that pembrolizumab monotherapy can be extended as first-line therapy to patients with locally advanced or metastatic non-small-cell lung cancer without sensitising EGFR or ALK alterations and with low PD-L1 TPS.
FUNDING


Merck Sharp & Dohme.",2019,"Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018).","['213 medical centres in 32 countries', 'patients with locally advanced or metastatic non-small-cell lung cancer without sensitising EGFR or ALK alterations and with low PD-L1 TPS', 'patients with a PD-L1 TPS of 1% or greater', 'previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer', 'Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater', 'patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater', 'From Dec 19, 2014, to March 6, 2017, 1274 patients (902 men, 372 women, median age 63 years [IQR 57-69]) with a PD-L1 TPS of 1% or greater were allocated to', 'n=637) or chemotherapy (n=637) and included in the intention-to-treat population']","['platinum-based chemotherapy', 'Pembrolizumab versus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab']","['median surival values', 'ECOG performance status score', 'death', 'Overall survival', 'overall survival', 'overall and progression-free survival']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.437817,"Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018).","[{'ForeName': 'Tony S K', 'Initials': 'TSK', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, State Key Laboratory of South China, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China. Electronic address: tony@clo.cuhk.edu.hk.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guandong, China.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Kudaba', 'Affiliation': 'Department of Internal Diseases, Riga East Clinical University-Latvian Oncology Center, Riga, Latvia.'}, {'ForeName': 'Dariusz M', 'Initials': 'DM', 'LastName': 'Kowalski', 'Affiliation': 'Department of Lung Cancer and Chest Tumours, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Seoul, South Korea.'}, {'ForeName': 'Hande Z', 'Initials': 'HZ', 'LastName': 'Turna', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Castro', 'Affiliation': 'Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vichien', 'Initials': 'V', 'LastName': 'Srimuninnimit', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Konstantin K', 'Initials': 'KK', 'LastName': 'Laktionov', 'Affiliation': 'Department of Thoracic and Abdominal Oncology, N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lubiniecki', 'Affiliation': 'Global Clinical Development, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics and Research Design Statistics, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kush', 'Affiliation': 'Global Clinical Development, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Lopes', 'Affiliation': 'Department of Medical Oncology, Sylvester Comprehensive Cancer Center at the University of Miami, Miami, FL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)32409-7']
1357,30951609,Mental health stigma in depressed Latinos over the course of therapy: Results from a randomized controlled trial.,"OBJECTIVE


The current study examined the course, correlates, and predictors of mental health stigma among depressed, Spanish-speaking Latinos that were receiving treatment. This population faces significant disparities in mental health treatment and carries high levels of mental health stigma.
METHOD


The study utilized data generated from a randomized clinical trial (N = 46) that evaluated the efficacy of Behavioral Activation and Supportive Counseling for depression among Latinos.
RESULTS


Mental health stigma decreased over time; these decreases were more pronounced among individuals who were randomized to Supportive Counseling. Mental health stigma was positively associated with depressive symptoms and therapeutic alliance over time. Mental health stigma was not related to treatment attrition.
CONCLUSIONS


These preliminary findings indicate that mental health stigma continues to be relevant among individuals who are actively participating in treatment. Receiving mental health treatment may be sufficient to dispel some of the stigmatizing views endorsed by underserved clinical populations.",2019,"Mental health stigma was not related to treatment attrition.
",['individuals who are actively participating in treatment'],['Behavioral Activation and Supportive Counseling'],"['Mental health stigma', 'mental health stigma']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3697360', 'cui_str': 'Supportive counseling'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",,0.0479004,"Mental health stigma was not related to treatment attrition.
","[{'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': 'Department of Psychology, Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, Houston, Texas.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lejuez', 'Affiliation': 'Department of Psychology, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'MacPherson', 'Affiliation': 'School of Medicine, Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, Maryland.'}]",Journal of clinical psychology,['10.1002/jclp.22777']
1358,30951004,Influence of Cardiopulmonary Resuscitation Coaching and Provider Role on Perception of Cardiopulmonary Resuscitation Quality During Simulated Pediatric Cardiac Arrest.,"OBJECTIVES


We aimed to describe the impact of a cardiopulmonary resuscitation coach on healthcare provider perception of cardiopulmonary resuscitation quality during simulated pediatric cardiac arrest.
DESIGN


Prospective, observational study.
SETTING


We conducted secondary analysis of data collected from a multicenter, randomized trial of providers who participated in a simulated pediatric cardiac arrest.
SUBJECTS


Two-hundred pediatric acute care providers.
INTERVENTIONS


Participants were randomized to having a cardiopulmonary resuscitation coach versus no cardiopulmonary resuscitation coach. Cardiopulmonary resuscitation coaches provided feedback on cardiopulmonary resuscitation performance and helped to coordinate key tasks. All teams used cardiopulmonary resuscitation feedback technology.
MEASUREMENTS AND MAIN RESULTS


Cardiopulmonary resuscitation quality was collected by the defibrillator, and perceived cardiopulmonary resuscitation quality was collected by surveying participants after the scenario. We calculated the difference between perceived and measured quality of cardiopulmonary resuscitation and defined accurate perception as no more than 10% deviation from measured quality of cardiopulmonary resuscitation. Teams with a cardiopulmonary resuscitation coach were more likely to accurately estimate chest compressions depth in comparison to teams without a cardiopulmonary resuscitation coach (odds ratio, 2.97; 95% CI, 1.61-5.46; p < 0.001). There was no significant difference detected in accurate perception of chest compressions rate between groups (odds ratio, 1.33; 95% CI, 0.77-2.32; p = 0.32). Among teams with a cardiopulmonary resuscitation coach, the cardiopulmonary resuscitation coach had the best chest compressions depth perception (80%) compared with the rest of the team (team leader 40%, airway 55%, cardiopulmonary resuscitation provider 30%) (p = 0.003). No differences were found in perception of chest compressions rate between roles (p = 0.86).
CONCLUSIONS


Healthcare providers improved their perception of cardiopulmonary resuscitation depth with a cardiopulmonary resuscitation coach present. The cardiopulmonary resuscitation coach had the best perception of chest compressions depth.",2019,"There was no significant difference detected in accurate perception of chest compressions rate between groups (odds ratio, 1.33; 95% CI, 0.77-2.32; p = 0.32).","['providers who participated in a simulated pediatric cardiac arrest', 'Two-hundred pediatric acute care providers']","['cardiopulmonary resuscitation coach versus no cardiopulmonary resuscitation coach', 'cardiopulmonary resuscitation coach', 'Cardiopulmonary Resuscitation Coaching and Provider Role']","['cardiopulmonary resuscitation quality', 'cardiopulmonary resuscitation performance', 'Cardiopulmonary resuscitation quality', 'chest compressions depth perception', 'accurate perception of chest compressions rate', 'perception of chest compressions rate']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0035820', 'cui_str': 'Role'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0011586', 'cui_str': 'Stereopsis'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",200.0,0.0124319,"There was no significant difference detected in accurate perception of chest compressions rate between groups (odds ratio, 1.33; 95% CI, 0.77-2.32; p = 0.32).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine, Cumming School of Medicine, University of Calgary, KidSIM-ASPIRE Research Program, Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""KidSIM-ASPIRE Simulation Research Program, Alberta Children's Hospital, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Tofil', 'Affiliation': ""Children's of Alabama, University of Alabama at Birmingham, Birmingham, AL.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hunt', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davidson', 'Affiliation': ""KidSIM-ASPIRE Simulation Research Program, Alberta Children's Hospital, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chatfield', 'Affiliation': ""KidSIM-ASPIRE Simulation Research Program, Alberta Children's Hospital, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Duff', 'Affiliation': ""Stollery Children's Hospital, University of Alberta, Edmonton, AB, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001871']
1359,30924165,Pharmacokinetic and pharmacodynamic study of lenograstim for hematopoietic stem cell mobilization: a prospective randomized study for optimal apheresis.,"BACKGROUND


This study evaluated the correlation between the pharmacokinetics and pharmacodynamics of granulocyte colony-stimulating factor (lenograstim) and the impact of initiation time of apheresis on stem cell mobilization in patients with multiple myeloma.
STUDY DESIGN AND METHODS


Twenty-four patients with multiple myeloma were randomized into one of the two groups (early vs. late). Lenograstim at 10 μg/kg/day once daily was injected for at least 4 consecutive days. Apheresis was initiated 2 hours after the fourth dose of lenograstim in the early collection group and 16 hours after the fourth dose of lenograstim in the late collection group. Blood sampling for pharmacokinetics was performed within 30 minutes before, and 1, 2, 6, and 24 hours after the fourth dose of lenograstim.
RESULTS


Overall, the two groups (early vs. late, n = 10 vs. 14) exhibited similar baseline characteristics including age, sex, subtype of myeloma, stage distribution, and myeloma-associated symptoms. No correlation was found between plasma lenograstim concentration and peripheral blood (PB) CD34+ cell counts or hematopoietic progenitor cells. In the late collection group, the median number of apheresis procedures for minimal collection was significantly lower (early vs. late: 2 vs. 1; p = 0.04) and there was a higher number of total collected PB CD34+ cells in a single session of apheresis (1.4 vs. 3.1; p = 0.06). There were no differences in median overall PB stem cell collection efficiency.
CONCLUSION


Late collection positively impacted the number of apheresis procedures for minimal collection, with numerically improved PB stem cell collection efficiency at first apheresis in patients with multiple myeloma.",2019,"Late collection positively impacted the number of apheresis procedures for minimal collection, with numerically improved PB stem cell collection efficiency at first apheresis in patients with multiple myeloma.","['Twenty-four patients with multiple myeloma', 'hematopoietic stem cell mobilization', 'patients with multiple myeloma']","['granulocyte colony-stimulating factor (lenograstim', 'Lenograstim', 'lenograstim']","['PB stem cell collection efficiency', 'plasma lenograstim concentration and peripheral blood (PB) CD34+ cell counts or hematopoietic progenitor cells', 'median number of apheresis procedures for minimal collection', 'median overall PB stem cell collection efficiency', 'total collected PB CD34+ cells']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0218640', 'cui_str': 'lenograstim'}]","[{'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0218640', 'cui_str': 'lenograstim'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",24.0,0.0502225,"Late collection positively impacted the number of apheresis procedures for minimal collection, with numerically improved PB stem cell collection efficiency at first apheresis in patients with multiple myeloma.","[{'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dok Hyun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyu-Pyo', 'Initials': 'KP', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung Min', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Sun', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Cheolwon', 'Initials': 'C', 'LastName': 'Suh', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}]",Transfusion,['10.1111/trf.15265']
1360,30922152,Effects of Exercise Interventions on Habitual Physical Activity and Sedentary Behavior in Adolescents With Cerebral Palsy.,"PURPOSE


Exercise interventions have been shown to increase motor capacities in adolescents with cerebral palsy; however, how they affect habitual physical activity (HPA) and sedentary behavior is unclear. The main objective was to correlate changes in HPA with changes in mobility capacity following exercise interventions.
METHODS


A total of 54 participants (aged 12-20 y) with bilateral spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) levels II and III received 4 months of group progressive resistance training or treadmill training. Mobility measurements and HPA (averaged over 96 h) were made before and after interventions.
RESULTS


Averaged baseline mobility and HPA measures and improvements in each after both interventions were positively correlated in all participants. Percentage of sedentary/awake time decreased 2%, with significant increases in HPA measures of step count (16%), walk time (14%), and upright time (9%). Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.
CONCLUSIONS


Mobility capacity improved after these interventions and was clearly associated with improved HPA. The group progressive resistance training intervention seems preferable to improve HPA, perhaps related to greater social interaction and motivation provided by group training.",2019,"Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.  ","['Adolescents With Cerebral Palsy', '54 participants (aged 12-20\xa0y) with bilateral spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) levels II and III received 4 months of group', 'adolescents with cerebral palsy']","['Exercise Interventions', 'Exercise interventions', 'progressive resistance training intervention', 'progressive resistance training or treadmill training']","['HPA after group progressive resistance training', 'walk time', 'HPA measures of step count', 'Mobility capacity', 'upright time', 'Mobility measurements and HPA', 'motor capacities', 'mobility improvement', 'Habitual Physical Activity and Sedentary Behavior', 'Percentage of sedentary/awake time', 'Mobility measures and HPA changes', 'HPA']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3838784', 'cui_str': 'Bilateral spastic cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441926', 'cui_str': 'Level II (tumor staging)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",54.0,0.0127144,"Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.  ","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bar-Haim', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Aviram', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Shkedy Rabani', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Amro', 'Affiliation': 'Al-Quds University.'}, {'ForeName': 'Ibtisam', 'Initials': 'I', 'LastName': 'Nammourah', 'Affiliation': 'Cambridge Medical & Rehabilitation Center.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Al-Jarrah', 'Affiliation': 'Jordan University of Science and Technology.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Raanan', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Loeppky', 'Affiliation': 'VA Medical Center.'}, {'ForeName': 'Netta', 'Initials': 'N', 'LastName': 'Harries', 'Affiliation': 'Assaf Harofeh Medical Center.'}]",Pediatric exercise science,['10.1123/pes.2018-0254']
1361,31712590,Autonomic adaptations mediate the effect of hydration on brain functioning and mood: Evidence from two randomized controlled trials.,"Dehydration (water loss >2.0% of body weight) has significant negative effects on physical and mental performance. In two studies the effects of minor hypo-hydration (water loss <1.0% of body weight) on CNS function, mood and cardiovascular functioning were measured. Study 1: On two mornings twelve male participants were exposed to a temperature of 30 °C for four hours and either did or did not drink two 150 ml glasses of water during that time. Study 2: Fifty-six (25 M) individuals were exposed to the same 30 °C environment and randomly allocated to either drink (2 × 150 ml) or not drink. When not given water 0.59% (Study 1) and 0.55% (Study 2) bodyweight was lost. Participant's heart rate variability (HRV) was measured, and they rated their thirst and mood. In study 1, participants participated in an fMRI protocol during which they completed a modified version of the Paced Auditory Serial Addition Test (PASAT), at the end of which they rated its difficulty. Decreases in fMRI BOLD activity in the orbito-frontal cortex, ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex were observed when participants were hypo-hydrated. These deactivations were associated with reduced HRV, greater perceived effort, and more anxiety. In study 2 declines in HRV were found to mediate the effect of hypo-hydration on ratings of anxiety. These data are discussed in relation to a model that describes how autonomic regulatory and interoceptive processes may contribute to the affective consequences of minor hypo-hydration.",2019,"Decreases in fMRI BOLD activity in the orbito-frontal cortex, ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex were observed when participants were hypo-hydrated.","['participants participated in an fMRI protocol during which they completed a modified version of the', 'two mornings twelve male participants', 'Study 2: Fifty-six (25\u2009M) individuals were exposed to the same 30\u2009°C environment and randomly allocated to either']","['temperature of 30\u2009°C for four hours and either did or did not drink two 150', 'hydration', 'Paced Auditory Serial Addition Test (PASAT', 'drink (2\u2009×\u2009150\u2009ml) or not drink']","['reduced HRV, greater perceived effort, and more anxiety', 'CNS function, mood and cardiovascular functioning', ""Participant's heart rate variability (HRV"", 'Dehydration', 'ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex', 'fMRI BOLD activity', 'physical and mental performance']","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0566278', 'cui_str': 'Does not drink (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0020663', 'cui_str': 'Preoptico-Hypothalamic Area'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",2.0,0.0770728,"Decreases in fMRI BOLD activity in the orbito-frontal cortex, ventral cingulate gyrus, dorsal cingulate cortex, hypothalamus, amygdala, right striatum, post-central gyrus and superior parietal cortex were observed when participants were hypo-hydrated.","[{'ForeName': 'Hayley A', 'Initials': 'HA', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK. h.a.young@swansea.ac.uk.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cousins', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Fletcher', 'Affiliation': 'PepsiCo, 100 Summit Lake Drive, Valhalla, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benton', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, SA2 8PP, Wales, UK.'}]",Scientific reports,['10.1038/s41598-019-52775-5']
1362,30941442,Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


The aim of this study was to evaluate the effectiveness of perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program in pregnant women above the age of 35 years to prevent perineal tear and episiotomy.
METHODS


A randomized parallel assignment study involved two groups of pregnant women at the obstetrics outpatient clinic 4 weeks prior to their due date. The first group (n = 200) was educated to do digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program. The second group (n = 200) received only the prevention education program. Occurrence of perineal laceration was reported at time of delivery as a primary outcome. Statistical analysis was done using the IBM SPSS computer program (Statistical Package for the Social Sciences; IBM Corp, Armonk, NY, USA), release 22 for Microsoft Windows.
RESULTS


Delivery was significantly less complicated by perineal tear, episiotomy and postnatal pain in the first than in the second group (p < 0.05). Grades of perineal tear were mostly of first and second degree in the first group compared with the second group. We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
CONCLUSIONS


Performing antenatal digital perineal massage and PFMT in addition to health education is recommended to reduce perineal complications.",2020,"We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
","['pregnant women above the age of 35 years to prevent perineal tear and episiotomy', 'two groups of pregnant women at the obstetrics outpatient clinic 4\xa0weeks prior to their due date', 'pregnant women older than 35\xa0years']","['prevention education program', 'perineal massage, pelvic floor muscle training (PFMT) and a pelvic floor dysfunction (PFD) prevention educational program', 'digital perineal massage and pelvic floor muscle training and received an educational PFD prevention program', 'Perineal massage and training reduce perineal trauma']","['Grades of perineal tear', 'Occurrence of perineal laceration', 'perineal tear, episiotomy and postnatal pain', 'hospital stay']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery (observable entity)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction (disorder)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0341226,"We found a significantly lower need for analgesia and fewer ampoules required during the hospital stay in the first group (p < 0.001, 0.002, respectively).
","[{'ForeName': 'Amira S', 'Initials': 'AS', 'LastName': 'Dieb', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt. amirasaied2026@gmail.com.'}, {'ForeName': 'Amira Y', 'Initials': 'AY', 'LastName': 'Shoab', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Gabr', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdallah', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Shaban', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Attia', 'Affiliation': 'Department of Obstetrics and Gynecology, Kasr AlAini Hospital, Faculty of Medicine, Cairo University, ElSaraya Street, Manial, Cairo, P.O. Box 11956, Egypt.'}]",International urogynecology journal,['10.1007/s00192-019-03937-6']
1363,30935260,Can we consider silymarin as a treatment option for vitiligo? A double-blind controlled randomized clinical trial of phototherapy plus oral  Silybum marianum  product versus phototherapy alone.,"Introduction:  Vitiligo is a chronic skin disorder caused by destruction of the skin melanocytes, which presents as a depigmented area in the skin. This study examined the effect of Phototherapy plus oral  Silybummarianum  on the treatment of skin lesions of Vitiligo. Materials and methods:  In this randomized controlled clinical trial, 34 patients with vitiligo who were referred to Dermatology Clinic of Shahid Faghihi Hospital, Shiraz, Iran, were randomly divided into two groups. The first group was treated with phototherapy plus Narrowband UVB plus oral silymarin and the other group was treated with phototherapy with placebo. The patients in both groups were evaluated with vitiligo area severity index (VASI) at the beginning and end of the study. SPSS software version 23 was used for statistical analyses. Results:  The mean of the VASI score showed a statistically significant decrease in both groups at the end of the study ( p  < .05), but the decrease in the VASI score in patients who received  Silybum marianum  was more in comparison with the other group. Conclusion:  This study showed that probably  Silybum marianum  is a good choice for patients with vitiligo; however, further studies are recommended to be conducted to confirm our result.",2020,"The mean of the VASI score showed a statistically significant decrease in both groups at the end of the study (p < .05), but the decrease in the VASI score in patients who received Silybum marianum was more in comparison with the other group.
","['patients with vitiligo', '34 patients with vitiligo who were referred to Dermatology Clinic of Shahid Faghihi Hospital, Shiraz, Iran', 'skin lesions of Vitiligo']","['phototherapy plus oral Silybum marianum product versus phototherapy alone', 'phototherapy plus Narrowband UVB plus oral silymarin', 'phototherapy with placebo', 'Phototherapy plus oral Silybummarianum']","['mean of the VASI score', 'vitiligo area severity index (VASI', 'VASI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C3812390', 'cui_str': 'Dermatology clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0331428', 'cui_str': 'Carduus marianus'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",34.0,0.0316455,"The mean of the VASI score showed a statistically significant decrease in both groups at the end of the study (p < .05), but the decrease in the VASI score in patients who received Silybum marianum was more in comparison with the other group.
","[{'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Jowkar', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Godarzi', 'Affiliation': 'Dermatology Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Parvizi', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1595506']
1364,30920880,"Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial.","PURPOSE


This trial aimed to assess the efficacy and safety of the paclitaxel plus fluorouracil regimen versus the cisplatin plus fluorouracil regimen in definitive concurrent chemoradiotherapy (dCRT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).
PATIENTS AND METHODS


Patients with locally advanced ESCC were enrolled and randomly assigned to either the paclitaxel plus fluorouracil group or the cisplatin plus fluorouracil group. The patients in the paclitaxel plus fluorouracil group were treated with paclitaxel and fluorouracil one cycle per week in dCRT for five cycles followed by paclitaxel and fluorouracil one cycle per month in consolidation chemotherapy for two cycles. The patients in the cisplatin/5-fluorouracil group were treated with cisplatin and fluorouracil one cycle per month in dCRT for two cycles followed by two cycles in consolidation chemotherapy. The radiotherapy dose was 61.2 Gy delivered in 34 fractions. The primary end point was 3-year overall survival (OS).
RESULTS


Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015. The median follow-up of the surviving patients was 48.7 months (interquartile range, 42.6-60.9). The 3-year OS was 55.4% in the paclitaxel plus fluorouracil group and 51.8% in the cisplatin plus fluorouracil group (hazard ratio, 0.905 [95% CI, 0.698 to 1.172];  P  = .448). The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973 [95% CI, 0.762 to 1.243];  P  = .828). Compared with the cisplatin plus fluorouracil group, the paclitaxel plus fluorouracil group had significantly lower incidences of acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue ( P  < .05), but higher incidences of acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis ( P  < .05).
CONCLUSION


The paclitaxel plus fluorouracil regimen did not significantly prolong the OS compared with the standard cisplatin plus fluorouracil regimen in dCRT in patients with locally advanced ESCC.",2019,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973","['Four hundred thirty-six patients with ESCC in six centers were recruited at a 1:1 ratio between April 2012 and July 2015', 'Locally Advanced Esophageal Squamous Cell Cancer', 'patients with locally advanced ESCC', 'patients with locally advanced esophageal squamous cell carcinoma (ESCC', 'Patients with locally advanced ESCC']","['paclitaxel plus fluorouracil', 'cisplatin/5-fluorouracil', 'chemoradiotherapy (dCRT', 'Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil', 'radiotherapy', 'standard cisplatin plus fluorouracil', 'cisplatin plus fluorouracil regimen', 'paclitaxel and fluorouracil', 'Chemoradiotherapy', 'cisplatin plus fluorouracil', 'cisplatin and fluorouracil']","['OS', '3-year OS', '3-year progression-free survival', '3-year overall survival (OS', 'efficacy and safety', 'acute grade 3 or higher anemia, thrombocytopenia, anorexia, nausea, vomiting, and fatigue', 'acute grade 3 or higher leukopenia, radiation dermatitis, and radiation pneumonitis']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0206063', 'cui_str': 'Pneumonia, Radiation'}]",436.0,0.0572158,"The 3-year progression-free survival was also not significantly different between the paclitaxel plus fluorouracil group and the cisplatin plus fluorouracil group (43.7%  v  45.5%, respectively; hazard ratio, 0.973","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': '2 Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Zhengfei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Weixin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jialiang', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': '3 Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chaoyang', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Huarong', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ""4 Zhenjiang First People's Hospital, Zhenjiang, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': '5 The First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': '6 Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': '7 Fujian Provincial Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Saiquan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Kuaile', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': '1 Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02122']
1365,30690869,Acceptability of locally-produced Ready-to-Use Supplementary Food (RUSF) for children under two years in Cambodia: A cluster randomised trial.,"In Cambodia, existing food products for treating or preventing undernutrition have met with limited success. Therefore, in 2014, alternative ready-to-use foods were developed. This trial aimed to assess the acceptability of the novel ready-to-use supplementary food (RUSF) as a snack or mixed with borbor (white rice porridge), compared with corn-soy blend plus plus (CSB++) and borbor fortified with micronutrient powder (MNP). The nonblinded, randomised 4 × 4 crossover trial recruited 95 children aged 9-23 months from communities in peri-urban Phnom Penh. Small quantities (100 g for porridges, 42 g for snack) of each food were offered for three consecutive days at testing sites (homes of health volunteers). Main outcomes were children's consumption, caregivers' assessment of children's preferences, and caregivers' ranking of the foods. Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003). The odds of children consuming over 50% were greatest for borbor fortified with MNP versus RUSF snack (unadjusted OR = 6.79, CI = 2.80-16.47, p < 0.001). However, the median energy children received when consuming the RUSF with borbor (57 kcals) or as a snack (48 kcals) was greater than with CSB++ (15 kcals) or borbor fortified with MNP (18 kcals; p < 0.001). Therefore, although children ate less RUSF, it provided approximately three times more kilocalories. Caregivers reported that their children had the highest preference for borbor fortified with MNP. Caregivers themselves ranked the novel RUSF snack highest. Thus, the innovative RUSF was considered sufficiently acceptable to proceed to an effectiveness trial.",2019,Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003).,"['95 children aged 9-23\xa0months from communities in peri-urban Phnom Penh', 'children under two years in Cambodia']","['corn-soy blend plus plus (CSB++) and borbor fortified with micronutrient powder (MNP', 'locally-produced Ready-to-Use Supplementary Food (RUSF', 'novel ready-to-use supplementary food (RUSF']","[""children's consumption, caregivers' assessment of children's preferences, and caregivers' ranking of the foods""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",95.0,0.150168,Median percentage consumed of the test food servings ranged from 21 to 50% (p = 0.003).,"[{'ForeName': 'Bindi', 'Initials': 'B', 'LastName': 'Borg', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mihrshahi', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Daream', 'Initials': 'D', 'LastName': 'Sok', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Chamnan', 'Initials': 'C', 'LastName': 'Chhoun', 'Affiliation': 'Department of Fisheries Post-Harvest Technologies and Quality Control, Fisheries Administration, Ministry of Agriculture, Forestry and Fisheries, Phnom Penh, Cambodia.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Laillou', 'Affiliation': 'Child Survival and Development Section, UNICEF, Phnom Penh, Cambodia.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Wieringa', 'Affiliation': 'UMR-204 Nutripass, Institut de Recherche pour le Développement, IRD/UM/SupAgro, Montpellier, France.'}]",Maternal & child nutrition,['10.1111/mcn.12780']
1366,31418022,"Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial.","BACKGROUND


Respiratory syncytial virus (RSV) is a common cause of respiratory tract illness and hospitalization in neonates and infants. RSV vaccination during pregnancy may protect offspring in their first months of life.
METHODS


This randomized, observer-blind, multicenter, phase 2 study evaluated the immunogenicity and safety of an RSV candidate vaccine in healthy nonpregnant women aged 18-45 years. Four hundred participants were randomized (1:1:1:1) to receive a single intramuscular dose of vaccine containing 30 µg, 60 µg, or 120 µg of RSV fusion protein engineered to preferentially maintain a prefusion conformation (RSV-PreF vaccine) or placebo.
RESULTS


Thirty days postvaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75-, 4.42- and 4.36-fold; RSV-B neutralizing antibody GMTs 2.36-, 2.54- and 2.76-fold; and palivizumab competing antibody (PCA) concentrations 11.69-, 14.38- and 14.24-fold compared with baseline levels in the 30 µg, 60 µg, and 120 µg RSV-PreF groups, respectively. Antibody titers and PCA concentrations at day 30 were significantly higher with the 120 µg compared to the 30 µg RSV-PreF vaccine. All RSV-PreF vaccine formulations and the placebo had similar reactogenicity profiles. No serious adverse events were considered to be related to the RSV-PreF vaccine.
CONCLUSIONS


The 3 formulations of the investigational RSV-PreF vaccine were well-tolerated and induced RSV-A and RSV-B neutralizing antibodies and PCAs in healthy, nonpregnant women.
CLINICAL TRIALS REGISTRATION


NCT02956837.",2019,"Thirty days post-vaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75, 4.42 and 4.36fold; RSV-B neutralizing antibody GMTs 2.36, 2.54 and 2.76fold; and palivizumab competing antibody (PCA) concentrations 11.69, 14.38 and 14.24fold compared to baseline levels in the 30µg, 60µg and 120µg RSV-PreF groups, respectively.","['Four hundred participants', 'neonates and infants', 'non-pregnant women', 'healthy non-pregnant 18-45-year-old women', 'healthy, non-pregnant women']","['placebo', 'respiratory syncytial virus candidate vaccine', 'vaccine containing 30µg, 60µg, or 120µg of RSV-F protein engineered to preferentially maintain a pre-fusion conformation (RSV-PreF vaccine) or placebo', 'RSV candidate vaccine', 'RSV vaccination']","['tolerated and induced RSV-A and RSV-B neutralizing antibodies and PCAs', 'reactogenicity profiles', 'Immunogenicity and safety', 'Antibody titers and PCA concentrations', 'immunogenicity and safety']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",400.0,0.370908,"Thirty days post-vaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75, 4.42 and 4.36fold; RSV-B neutralizing antibody GMTs 2.36, 2.54 and 2.76fold; and palivizumab competing antibody (PCA) concentrations 11.69, 14.38 and 14.24fold compared to baseline levels in the 30µg, 60µg and 120µg RSV-PreF groups, respectively.","[{'ForeName': 'Tino F', 'Initials': 'TF', 'LastName': 'Schwarz', 'Affiliation': 'Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Würzburg, Germany.'}, {'ForeName': 'Roderick A', 'Initials': 'RA', 'LastName': 'McPhee', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, Inserm, clinical investigation center 1417, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and University Hospital, Belgium.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Talli', 'Affiliation': 'Ravi-ja Uuringukeskus Innomedica OÜ, Tallinn, Estonia.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Picciolato', 'Affiliation': 'GSK, Rixensart.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Rongman', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Thi Lien-Anh', 'Initials': 'TL', 'LastName': 'Nguyen', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Dieussaert', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GlaxoSmithKline (GSK), Rockville, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz395']
1367,30924166,"Can furosemide prevent transfusion-associated circulatory overload? Results of a pilot, double-blind, randomized controlled trial.","BACKGROUND


Transfusion-associated circulatory overload (TACO) is a leading cause of transfusion-attributable morbidity. It is unclear whether diuretics are safe and effective in preventing this reaction.
MATERIALS AND METHODS


In a pilot controlled feasibility trial, inpatients 65 years or older ordered a single unit of red blood cells were randomized to pre-transfusion furosemide 20 mg or placebo intravenously. Primary outcome was the ability to enroll 80 patients within a 2-month time period. Secondary feasibility outcomes included proportion of RBC transfusions meeting eligibility criteria, proportion of eligible patients enrolled, and compliance to study protocol. Clinical outcomes included the incidence of TACO and associated complications.
RESULTS


Nine months of enrollment were required for 80 patients to complete the study, due primarily to fewer transfusions than expected meeting eligibility criteria and lower than anticipated consent rates. Protocol compliance was below target due to missing chart documentation of patient fluid balance, and transfusion infusion time. Blinding was maintained throughout the study and treatment arms were well-balanced. A single case of TACO occurred in each arm, for an overall incidence of 2.5%. No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed.
CONCLUSION


The study protocol was not feasible as designed, primarily due to challenges in patient enrollment. Modifications to trial design to improve feasibility in future studies have been identified.",2019,"No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed.
",['inpatients 65\u2009years or older ordered a single unit of red blood cells'],"['pre-transfusion furosemide 20\u2009mg or placebo', 'TACO', 'furosemide']","['incidence of TACO and associated complications', 'peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0986198', 'cui_str': 'Furosemide 20 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4553714', 'cui_str': 'Taco'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4553714', 'cui_str': 'Taco'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.361932,"No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Pendergrast', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Armali', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cserti-Gazdewich', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute of Clinical and Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Lieberman', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Nagina', 'Initials': 'N', 'LastName': 'Parmar', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Scales', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Skeate', 'Affiliation': 'Canadian Blood Services, Toronto, Ontario, Canada.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}]",Transfusion,['10.1111/trf.15270']
1368,30908879,Antegrade Hepatic Artery and Portal Vein Perfusion Versus Portal Vein Perfusion Alone in Living Donor Liver Transplantation: A Randomized Trial.,"Traditionally, deceased donor liver grafts receive dual perfusion (DP) through the portal vein and the hepatic artery (HA) either in situ or on the back table. HA perfusion is avoided in living donor liver grafts for fear of damage to the intima and consequent risk of hepatic artery thrombosis (HAT). However, biliary vasculature is predominantly derived from the HA. We hypothesized that antegrade perfusion of the HA in addition to the portal vein on the back table could reduce the incidence of postoperative biliary complications. Consecutive adult patients undergoing living donor liver transplantations were randomized after donor hepatectomy to receive graft perfusion of histidine-tryptophan-ketoglutarate solution either via both the HA and portal vein (DP group, n = 62) or only through the portal vein (standard perfusion [SP] group, n = 62). The primary endpoint was the occurrence of biliary complications (biliary leak/stricture). Secondary endpoints included HAT and patient survival. The incidence of biliary stricture was significantly lower in the DP group (6.5% versus 19.4%; odds ratio, 0.29; 95% confidence interval, 0.09-0.95; P = 0.04). There was no significant reduction in the incidence of HAT, bile leak, or hospital stay between the 2 groups. The 3-year mortality and graft survival rates were significantly higher among patients who received DP compared with SP (P = 0.004 and P = 0.003, respectively). On multivariate analysis, nonperfusion of the HA and preceding bile leak were found to be risk factors for the development of biliary stricture (P = 0.04 and P < 0.001, respectively). In conclusion, DP of living donor liver grafts through both the HA and portal vein on the back table may protect against the development of biliary stricture. This could translate to improved patient survival in the short term.",2019,"Three year patient and graft survival was significantly higher among patients who received dual perfusion compared to standard perfusion[P=0.004, P=0.003].","['live donor liver transplantation', 'Consecutive adult patients undergoing live donor liver transplants (LDLT']","['donor hepatectomy to receive graft perfusion of HTK (Histidine-tryptophan-ketoglutarate) solution either via both the hepatic artery and portal vein (dual perfusion group,n=62) or only through the portal vein (standard perfusion', 'Antegrade hepatic artery and portal vein perfusion versus portal vein perfusion alone']","['occurrence of biliary complications (biliary leak/stricture', 'graft survival', 'incidence of HAT, bile leak or hospital stay', 'patient survival', 'hepatic artery thrombosis and patient survival', 'biliary vasculature', 'incidence of biliary stricture']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}]","[{'cui': 'C0411259', 'cui_str': 'Removal of liver from donor (procedure)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery (body structure)'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444765', 'cui_str': 'Hat (physical object)'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392106', 'cui_str': 'Hepatic artery thrombosis (disorder)'}, {'cui': 'C0005839', 'cui_str': 'vasculature'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture (disorder)'}]",,0.0720787,"Three year patient and graft survival was significantly higher among patients who received dual perfusion compared to standard perfusion[P=0.004, P=0.003].","[{'ForeName': 'Johns', 'Initials': 'J', 'LastName': 'Shaji Mathew', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'K Y Santosh', 'Initials': 'KYS', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Krishnanunni', 'Initials': 'K', 'LastName': 'Nair', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Binoj Sivasankara Pillai', 'Initials': 'BSP', 'LastName': 'Thankamony Amma', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Krishnakumar', 'Affiliation': 'Department of Transplant Anaesthesia, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Unnikrishnan', 'Initials': 'U', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Ramachandran Narayana', 'Initials': 'RN', 'LastName': 'Menon', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Sunny', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Dhar', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Othiyil Vayoth', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Sudhindran', 'Initials': 'S', 'LastName': 'Surendran', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25455']
1369,30927032,Correction to: Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial.,"In the original version of the article, Philippe M. Glauser's, Philippe Brosi's, Benjamin Speich's, Samuel A. Käser's, Andres Heigl's, and Christoph A. Maurer's first and last names were interchanged. The names are correct as reflected here. The original article has been corrected.",2019,"In the original version of the article, Philippe M. Glauser's, Philippe Brosi's, Benjamin Speich's, Samuel A. Käser's, Andres Heigl's, and Christoph A. Maurer's first and last names were interchanged.",[],['Prophylactic Intraperitoneal Onlay Mesh'],[],[],"[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]",[],,0.0184303,"In the original version of the article, Philippe M. Glauser's, Philippe Brosi's, Benjamin Speich's, Samuel A. Käser's, Andres Heigl's, and Christoph A. Maurer's first and last names were interchanged.","[{'ForeName': 'Philippe M', 'Initials': 'PM', 'LastName': 'Glauser', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brosi', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Speich', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Käser', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Heigl', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Maurer', 'Affiliation': 'Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland. christoph.maurer@hin.ch.'}]",World journal of surgery,['10.1007/s00268-019-04979-z']
1370,28948436,"Mapping health-related quality of life scores from FACT-G, FAACT, and FACIT-F onto preference-based EQ-5D-5L utilities in non-small cell lung cancer cachexia.","BACKGROUND


Health-related quality of life (HRQoL) measurements from disease-specific tools cannot be directly used in economic evaluations. This study aimed to develop and validate mapping algorithms that predicted EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) utilities from Functional Assessment of Anorexia-Cachexia Therapy (FAACT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and their common component (Functional Assessment of Cancer Therapy-General-FACT-G) in patients with non-small cell lung cancer cachexia.
METHODS


Data were collected on five occasions over a 12-week period in two multicenter placebo-controlled trials. EQ-5D-5L utilities were calculated using both English and Dutch value sets. The study sample was divided into development and validation datasets according to patients' geographical residence. Generalized estimating equations were applied to five different sets of independent variables including overall, Trial Outcome Index (TOI), and individual subscales results. The best performing models were selected based on mean absolute error (MAE) and root-mean square error (RMSE).
RESULTS


EQ-5D-5L and FAACT/FACIT-F results were available for 96 patients. The developed algorithms showed a good predictive performance, with acceptable MAE/RMSE and small differences between mean observed and predicted EQ-5D-5L utilities. In FACT-G models, Physical Well-Being had the highest explanatory value, while Emotional Well-Being did not significantly affect the EQ-5D-5L score; Anorexia-Cachexia and Fatigue subscales were highly statistically significant in FAACT and FACIT-F models, respectively, as well as the TOI scores. The Eastern Cooperative Oncology Group status was included as covariate in all models.
CONCLUSION


The developed algorithms enable the estimation of EQ-5D-5L utilities from three cancer-specific instruments when preference-based HRQoL data are missing.",2019,"The developed algorithms showed a good predictive performance, with acceptable MAE/RMSE and small differences between mean observed and predicted EQ-5D-5L utilities.","['Chronic Illness Therapy-Fatigue', 'patients with non-small cell lung cancer cachexia', 'Data were collected on five occasions over a 12-week period in two multicenter', '96 patients']","['placebo', 'FACIT-F) and their common component (Functional Assessment of Cancer Therapy-General-FACT-G']","['EQ-5D-5L utilities', 'TOI scores', 'EQ-5D-5L score; Anorexia-Cachexia and Fatigue subscales', 'mean absolute error (MAE) and root-mean square error (RMSE']","[{'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}]",96.0,0.0316017,"The developed algorithms showed a good predictive performance, with acceptable MAE/RMSE and small differences between mean observed and predicted EQ-5D-5L utilities.","[{'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Meregaglia', 'Affiliation': 'CeRGAS (Research Centre on Health and Social Care Management), Bocconi University, Via Roentgen 1, 20136, Milan, Italy. michela.meregaglia@unibocconi.it.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Borsoi', 'Affiliation': 'CeRGAS (Research Centre on Health and Social Care Management), Bocconi University, Via Roentgen 1, 20136, Milan, Italy.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'Department of Health Services Research, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Tarricone', 'Affiliation': 'CeRGAS (Research Centre on Health and Social Care Management), Bocconi University, Via Roentgen 1, 20136, Milan, Italy.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-017-0930-6']
1371,30865795,A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.,"BACKGROUND


Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries.
METHODS


We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics.
RESULTS


We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events.
CONCLUSIONS


Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).",2019,"The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09).","['women and adolescents in low-resource countries', 'A total of 1705 patients', '3412 patients in Malawi, Pakistan, Tanzania, and Uganda', 'Miscarriage Surgery']","['Prophylactic Antibiotics', 'oral doxycycline and 400 mg of oral metronidazole or identical placebos', 'placebo', 'antibiotic prophylaxis', 'antibiotics', 'Antibiotic prophylaxis']","['pelvic infection', 'adverse events', 'Pelvic infection', 'risk of pelvic infection']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0030790', 'cui_str': 'Pelvic Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",3412.0,0.686341,"The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lissauer', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Middleton', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Jonathan R B', 'Initials': 'JRB', 'LastName': 'Bishop', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Merriel', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weeks', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Chisale', 'Initials': 'C', 'LastName': 'Mhango', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mataya', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Taulo', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Ngalawesa', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'Chirwa', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Colleta', 'Initials': 'C', 'LastName': 'Mphasa', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Tayamika', 'Initials': 'T', 'LastName': 'Tambala', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chiudzu', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mwalwanda', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mboma', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Rahat', 'Initials': 'R', 'LastName': 'Qureshi', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Humera', 'Initials': 'H', 'LastName': 'Ismail', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Mbaruku', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Chibwana', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Watts', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Beatus', 'Initials': 'B', 'LastName': 'Simon', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ditai', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Otim Tom', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'JaneFrances', 'Initials': 'J', 'LastName': 'Acam', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ekunait', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Unzia', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Iyaku', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Makiika', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bar-Zeev', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Desmond', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Sabaratnam', 'Initials': 'S', 'LastName': 'Arulkumaran', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Ahmet M', 'Initials': 'AM', 'LastName': 'Gulmezoglu', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': ""From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).""}]",The New England journal of medicine,['10.1056/NEJMoa1808817']
1372,30898325,"Establishing the feasibility, acceptability and preliminary efficacy of a multi-component behavioral intervention to reduce pain and substance use and improve physical performance in older persons living with HIV.","Older persons living with HIV (PLWH), often defined as age 50 years and older, are a rapidly growing population, with high rates of chronic pain, substance use, and decreased physical functioning. No interventions currently exist that address all three of these health outcomes simultaneously. An 8-week behavioral intervention combining cognitive-behavioral therapy and tai chi reinforced with text messaging (CBT/TC/TXT) was developed and pilot tested in a community-based AIDS service organization with substance using PLWH aged 50 years and older who experienced chronic pain. Fifty-five participants were enrolled in a three arm randomized controlled trial that compared the CBT/TC/TXT intervention (N = 18) to routine Support Group (SG) (N = 19) and Assessment Only (AO) (N = 18) to assess the intervention's feasibility, acceptability and preliminary efficacy to reduce pain and substance use and improve physical performance. Participants were assessed at baseline, treatment-end (week 8) and week 12. Feasibility and acceptability indicators showed moderate levels of participant enrollment (62% of those eligible), excellent 12-week assessment completion (84%) and high attendance at CBT and tai chi sessions (>60% attended at least 6 of 8 sessions). Efficacy indicators showed within-group improvements from baseline to week 12 in the CBT/TC/TXT group, including all four substance use outcomes, percent pain relief in the past 24 h, and in two physical performance measures. Observed between-group changes included greater reductions in days of heavy drinking in the past 30 days for both CBT/TC/TXT (19%) and SG (13%) compared to the AO group. Percent pain relief in the past 24 h improved in the CBT/TC/TXT group relative to SG, and the CBT/TC/TXT's physical performance score improved relative to both the SG and AO groups. Findings demonstrate that the CBT/TC/TXT intervention is feasible to implement, acceptable and has preliminary efficacy for reducing substance use and pain and improving physical performance among a vulnerable population of older PLWH.",2019,"Percent pain relief in the past 24 h improved in the CBT/TC/TXT group relative to SG, and the CBT/TC/TXT's physical performance score improved relative to both the SG and AO groups.","['Older persons living with HIV (PLWH), often defined as age 50\u202fyears and older', 'community-based AIDS service organization with substance using PLWH aged 50\u202fyears and older who experienced chronic pain', 'older persons living with HIV', 'Fifty-five participants']","['behavioral intervention combining cognitive-behavioral therapy and tai chi reinforced with text messaging (CBT/TC/TXT', 'CBT/TC/TXT intervention', 'CBT/TC/TXT intervention (N\u202f=\u202f18) to routine Support Group (SG', 'multi-component behavioral intervention']","['pain and substance use and improve physical performance', 'Percent pain relief', 'Efficacy indicators', 'days of heavy drinking', ""CBT/TC/TXT's physical performance score"", 'pain relief']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",55.0,0.0426691,"Percent pain relief in the past 24 h improved in the CBT/TC/TXT group relative to SG, and the CBT/TC/TXT's physical performance score improved relative to both the SG and AO groups.","[{'ForeName': 'Alison A', 'Initials': 'AA', 'LastName': 'Moore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States of America. Electronic address: alisonmoore@ucsd.edu.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Lake', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'Integrated Substance Abuse Programs, Department of Psychiatry and Biobehavioral Sciences and School of Nursing, University of California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Karlamangla', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Kuerbis', 'Affiliation': 'Silberman School of Social Work, Hunter College at City University of New York, New York, NY, United States of America.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Preciado', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Jenkins', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Blanca X', 'Initials': 'BX', 'LastName': 'Dominguez', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Jury', 'Initials': 'J', 'LastName': 'Candelario', 'Affiliation': 'APAIT, A Division of Special Services for Groups, Los Angeles, CA, United States of America.'}, {'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Liao', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lingqi', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Center for Health Services and Society, Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, United States of America; Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, UCLA, Los Angeles, United States of America.'}, {'ForeName': 'M Carrington', 'Initials': 'MC', 'LastName': 'Reid', 'Affiliation': 'Division of Geriatrics and Palliative Care, Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medical College, New York, NY, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.02.003']
1373,30827035,Adjuvant gonadotropin-releasing hormone analogues for the prevention of chemotherapy-induced premature ovarian failure in premenopausal women.,"BACKGROUND


This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has significantly improved prognosis for women with malignant and some non-malignant conditions. This treatment, however, is associated with ovarian toxicity. The use of gonadotropin-releasing hormone (GnRH) analogues, both agonists and antagonists, may have a protective effect on the ovaries. The primary mechanism of action of GnRH analogues is to suppress the gonadotropin levels to simulate pre-pubertal hormonal milieu and subsequently prevent primordial follicles from maturation and therefore decrease the number of follicles that are more vulnerable to chemotherapy.
OBJECTIVES


To assess the efficacy and safety of GnRH analogues given before or in parallel to chemotherapy to prevent chemotherapy-related ovarian damage in premenopausal women with malignant or non-malignant conditions.
SEARCH METHODS


The search was run for the original review in July 2011, and for the first update in July 2014. For this update we searched the following databases in November 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Chinese Biomedicine Database (CBM).
SELECTION CRITERIA


Randomised controlled trials (RCTs), in all languages, which examined the effect of GnRH analogues for chemotherapy-induced ovarian failure in premenopausal women, were eligible for inclusion in the review.
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted data and assessed trial quality using the Cochrane 'Risk of bias' tool. We analysed binary data using risk ratios (RRs) with 95% confidence intervals (CI) and for continuous data, we used the standardized mean difference (SMD) to combine trials. We applied the random-effects model in our analyses. We used the GRADE approach to produce a 'Summary of findings' table for our main outcomes of interest.
MAIN RESULTS


We included 12 RCTs involving 1369 women between the ages of 12 and 51.1 years. Participants were diagnosed with breast malignancy, ovarian malignancy, or Hodgkin's lymphoma, and most of them received alkylating, or platinum complexes, based chemotherapy. The included studies were funded by a university (n = 1), research centres (n = 4), and pharmaceutical companies (n = 1). Trials were at high or unclear risk of bias.Comparison 1: GnRH agonist plus chemotherapy versus chemotherapy aloneThe incidence of menstruation recovery or maintenance was 178 of 239 (74.5%) in the GnRH agonist group and 110 of 221 (50.0%) in the control group during a follow-up period no longer than 12 months (RR 1.60, 95% CI 1.14 to 2.24; 5 studies, 460 participants; I 2  = 79%; low-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P = 0.006). However, we observed no difference during a follow-up period longer than 12 months between these two groups (P = 0.24). In the GnRH agonist group, 326 of 447 participants had menstruation recovery or maintenance (72.9%) in comparison to the control group, in which 276 of 422 participants had menstruation recovery or maintenance (65.4%) during a follow-up period longer than 12 months (RR 1.08, 95% CI 0.95 to 1.22; 8 studies, 869 participants; I 2  = 56%; low-certainty evidence).The incidence of premature ovarian failure was 43 of 401 (10.7%) in the GnRH agonist group and 96 of 379 (25.3%) in the control group (RR 0.44, 95% CI 0.31 to 0.61; 4 studies, 780 participants; I 2  = 0%; moderate-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P < 0.00001).The incidence of pregnancy was 32 of 356 (9.0%) in the GnRH agonist group and 22 of 347 (6.3%) in the control group (RR 1.59, 95% CI 0.93 to 2.70; 7 studies, 703 participants; I 2  = 0%; low-certainty evidence), with no difference between groups (P = 0.09). However, we are cautious about this conclusion because there were insufficient data about whether the participants intended to become pregnant.The incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I 2  = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).The most common adverse effects of GnRH analogues included hot flushes, vaginal dryness, urogenital symptoms, and mood swings. The pooled analysis of safety data showed no difference in adverse effects between GnRH agonist group and control group.Comparison 2: GnRH agonist-antagonist cotreatment plus chemotherapy versus chemotherapy aloneOnly one RCT discussed GnRH agonist-antagonist cotreatment. The limited evidence showed the incidence of menstruation recovery or maintenance was 20 of 25 (80%) in both cotreatment group and control group during a 12-month follow-up period (RR 1.00, 95% CI 0.76 to 1.32; 50 participants; very low-certainty evidence), with no difference between groups (P = 1.00). In the cotreatment group, 13 of 25 participants had menstruation recovery or maintenance (52.0%) in comparison to the control group, in which 14 of 25 participants had menstruation recovery or maintenance (56.0%) during a follow-up period longer than 12 months (RR 0.93, 95% CI 0.56 to 1.55; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.78). The incidence of pregnancy was 1 of 25 (4.0%) in the cotreatment group and 0 of 25 (0%) in the control group (RR 3.00, 95% CI 0.13 to 70.30; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.49).
AUTHORS' CONCLUSIONS


GnRH agonist appears to be effective in protecting the ovaries during chemotherapy, in terms of maintenance and resumption of menstruation, treatment-related premature ovarian failure and ovulation. Evidence for protection of fertility was insufficient and needs further investigation. Evidence was also insufficient to assess the effect of GnRH agonist and GnRH antagonist cotreatment on ovarian protection against chemotherapy. The included studies differed in some important aspects of design, and most of these studies had no age-determined subgroup analysis. Large and well-designed RCTs with longer follow-up duration should be conducted to clarify the effects of GnRH analogues in preventing chemotherapy-induced ovarian failure, especially on different age groups or different chemotherapy regimens. Furthermore, studies should address the effects on pregnancy rates and anti-tumour therapy.",2019,"The incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I 2  = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).The","[""Participants were diagnosed with breast malignancy, ovarian malignancy, or Hodgkin's lymphoma, and most of them received alkylating, or platinum complexes, based chemotherapy"", 'women with malignant and some non-malignant conditions', '1369 women between the ages of 12 and 51.1 years', 'premenopausal women with malignant or non-malignant conditions', 'premenopausal women']","['GnRH agonist and GnRH antagonist cotreatment', 'GnRH agonist-antagonist cotreatment plus chemotherapy versus chemotherapy', 'gonadotropin-releasing hormone (GnRH', 'GnRH agonist plus chemotherapy versus chemotherapy', 'Adjuvant gonadotropin-releasing hormone analogues', 'GnRH agonist ']","['hot flushes, vaginal dryness, urogenital symptoms, and mood swings', 'incidence of pregnancy', 'adverse effects', 'premature ovarian failure', 'incidence of ovulation', 'efficacy and safety', 'incidence of menstruation recovery or maintenance', 'menstruation recovery or maintenance']","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues, endocrine therapy drugs'}]","[{'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085633', 'cui_str': 'Mood swings (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0085215', 'cui_str': 'Ovarian Failure, Premature'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",1369.0,0.363925,"The incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I 2  = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).The","[{'ForeName': 'Hengxi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, No. 17, Section Three, Ren Min Nan Lu Avenue, Chengdu, Sichuan, China, 610041.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Jinke', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008018.pub3']
1374,30907130,Effect of multimedia-based nursing visit on perioperative anxiety in esophageal squamous cell carcinoma patients undergoing video-assisted thoracoscopic surgery.,"Little is known about the multimedia-based preoperative nursing visit for squamous cell carcinoma (ESCC) patients undergoing video-assisted thoracoscopic surgery (VAST). The aim of this study was to evaluate the effects of preoperative multimedia-based nursing visit on perioperative anxiety in ESCC patients undergoing VAST. A total of 128 ESCC patients undergoing VAST were randomly divided into intervention group ( n  = 63) or control group ( n  = 65). The anxiety level was measured by state-trait anxiety inventory (STAI) and visual analog scale (VAS). The vital signs were also recorded. The data were collected at three different time points: before the intervention, 1 h before surgery and 24 h after surgery. There was no statistically significant difference in baseline STAI score, VAS scores and vital signs ( P  > 0.05). The intervention group reported significantly lower anxiety and improved vital signs in terms of systolic blood pressure, diastolic blood pressure and heart rate at 1 h before surgery and 24 h after surgery ( P  < 0.05). However, no significant difference in respiratory rate was observed between two groups at 1 h before surgery and 24 h after surgery ( P  > 0.05). Preoperative nursing visit with multimedia could reduce perioperative anxiety levels as well as help to stabilize vital sign for ESCC patients undergoing VAST.",2019,"The intervention group reported significantly lower anxiety and improved vital signs in terms of systolic blood pressure, diastolic blood pressure and heart rate at 1 h before surgery and 24 h after surgery (P < 0.05).","['128 ESCC patients undergoing VAST', 'squamous cell carcinoma (ESCC) patients undergoing', 'esophageal squamous cell carcinoma patients undergoing', 'ESCC patients undergoing VAST']","['preoperative multimedia-based nursing visit', 'video-assisted thoracoscopic surgery (VAST', 'video-assisted thoracoscopic surgery', 'multimedia-based nursing visit']","['perioperative anxiety', 'lower anxiety and improved vital signs', 'perioperative anxiety levels', 'respiratory rate', 'systolic blood pressure, diastolic blood pressure and heart rate', 'baseline STAI score, VAS scores and vital signs', 'anxiety level', 'state-trait anxiety inventory (STAI) and visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",128.0,0.0281521,"The intervention group reported significantly lower anxiety and improved vital signs in terms of systolic blood pressure, diastolic blood pressure and heart rate at 1 h before surgery and 24 h after surgery (P < 0.05).","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Nursing, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xiao', 'Affiliation': 'Department of Nursing, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}, {'ForeName': 'Minxin', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Nursing, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Breast, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University , Shanghai , China.'}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine , Shanghai , China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Nursing, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Department of Nursing, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, The Affiliated Tumor Hospital of Nantong University , Nantong , Jiangsu Province , China.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1595687']
1375,30792154,"Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Women with polycystic ovary syndrome (PCOS) have an increased risk of pregnancy complications. Epi-analysis of two previous randomised controlled trials that compared metformin with placebo during pregnancy in women with PCOS showed a significant reduction in late miscarriages and preterm births in the metformin group. The aim of this third randomised trial (PregMet2) was to test the hypothesis that metformin prevents late miscarriage and preterm birth in women with PCOS.
METHODS


PregMet2 was a randomised, placebo-controlled, double-blind, multicentre trial done at 14 hospitals in Norway, Sweden, and Iceland. Singleton pregnant women with PCOS aged 18-45 years were eligible for inclusion. After receiving information about the study at their first antenatal visit or from the internet, women signed up individually to participate in the study. Participants were randomly assigned (1:1) to receive metformin or placebo by computer-generated random numbers. Randomisation was in blocks of ten for each country and centre; the first block had a random size between one and ten to assure masking. Participants were assigned to receive oral metformin 500 mg twice daily or placebo during the first week of treatment, which increased to 1000 mg twice daily or placebo from week 2 until delivery. Placebo tablets and metformin tablets were identical and participants and study personnel were masked to treatment allocation. The primary outcome was the composite incidence of late miscarriage (between week 13 and week 22 and 6 days) and preterm birth (between week 23 and week 36 and 6 days), analysed in the intention-to-treat population. Secondary endpoints included the incidence of gestational diabetes, preeclampsia, pregnancy-induced hypertension, and admission of the neonate to the neonatal intensive care unit. We also did a post-hoc individual participant data analysis of pregnancy outcomes, pooling data from the two previous trials with the present study. The study was registered with ClinicalTrials.gov, number NCT01587378, and EudraCT, number 2011-002203-15.
FINDINGS


The study took place between Oct 19, 2012, and Sept 1, 2017. We randomly assigned 487 women to metformin (n=244) or placebo (n=243). In the intention-to-treat analysis, our composite primary outcome of late miscarriage and preterm birth occurred in 12 (5%) of 238 women in the metformin group and 23 (10%) of 240 women in the placebo group (odds ratio [OR] 0·50, 95% CI 0·22-1·08; p=0·08). We found no significant differences for our secondary endpoints, including incidence of gestational diabetes (60 [25%] of 238 women in the metformin group vs 57 [24%] of 240 women in the placebo group; OR 1·09, 95% CI 0·69-1·66; p=0·75). We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators. In the post-hoc pooled analysis of individual participant data from the present trial and two previous trials, 18 (5%) of 397 women had late miscarriage or preterm delivery in the metformin group compared with 40 (10%) of 399 women in the placebo group (OR 0·43, 95% CI 0·23-0·79; p=0·004).
INTERPRETATION


In pregnant women with PCOS, metformin treatment from the late first trimester until delivery might reduce the risk of late miscarriage and preterm birth, but does not prevent gestational diabetes.
FUNDING


Research Council of Norway, Novo Nordisk Foundation, St Olav's University Hospital, and Norwegian University of Science and Technology.",2019,"We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators.","['women with PCOS', 'Women with polycystic ovary syndrome (PCOS', '487 women to', 'pregnant women with polycystic ovary syndrome (PregMet2', 'pregnant women with PCOS', '14 hospitals in Norway, Sweden, and Iceland', 'Singleton pregnant women with PCOS aged 18-45 years were eligible for inclusion']","['placebo', 'metformin', 'metformin or placebo', 'metformin with placebo', 'oral metformin 500 mg twice daily or placebo', 'Placebo tablets and metformin tablets']","['late miscarriages and preterm births', 'composite incidence of late miscarriage', 'incidence of gestational diabetes, preeclampsia, pregnancy-induced hypertension, and admission of the neonate to the neonatal intensive care unit', 'incidence of gestational diabetes', 'preterm birth', 'risk of late miscarriage and preterm birth', 'late miscarriage or preterm delivery', 'serious adverse events', 'late miscarriage and preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C4324509', 'cui_str': 'Late miscarriage'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",487.0,0.700303,"We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators.","[{'ForeName': 'Tone S', 'Initials': 'TS', 'LastName': 'Løvvik', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecology and Obstetrics, St Olav's University Hospital, Trondheim, Norway. Electronic address: tone.s.lovvik@ntnu.no.""}, {'ForeName': 'Sven M', 'Initials': 'SM', 'LastName': 'Carlsen', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Endocrinology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Berglind', 'Initials': 'B', 'LastName': 'Steffensen', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bixo', 'Affiliation': 'Department of Clinical Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gómez-Real', 'Affiliation': 'Department of Obstetrics and Gynaecology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lønnebotn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kristin V', 'Initials': 'KV', 'LastName': 'Hestvold', 'Affiliation': ""Women's Clinic, Vestre Viken Hospital Trust, Drammen, Norway.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Zabielska', 'Affiliation': ""Women's Clinic, Vestfold Hospital Trust, Tønsberg, Norway.""}, {'ForeName': 'Angelica L', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Trouva', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Thorarinsdottir', 'Affiliation': ""Women's Clinic, Telemark Hospital Trust, Skien, Norway.""}, {'ForeName': 'Sissel', 'Initials': 'S', 'LastName': 'Hjelle', 'Affiliation': ""Women's Clinic, Ålesund Hospital, Ålesund, Norway.""}, {'ForeName': 'Ann Hilde', 'Initials': 'AH', 'LastName': 'Berg', 'Affiliation': ""Women's Clinic, Innlandet Hospital Trust, Lillehammer, Norway.""}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Andræ', 'Affiliation': ""Women's Clinic, Nordlands Hospital Trust, Bodø, Norway.""}, {'ForeName': 'Inger S', 'Initials': 'IS', 'LastName': 'Poromaa', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mohlin', 'Affiliation': 'Department of Clinical Sciences, Umeå University, Umeå, Sweden; Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Underdal', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecology and Obstetrics, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Vanky', 'Affiliation': ""Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Gynaecology and Obstetrics, St Olav's University Hospital, Trondheim, Norway.""}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30002-6']
1376,30246357,Intraoperative S-ketamine for the reduction of opioid consumption and pain one year after spine surgery: A randomized clinical trial of opioid-dependent patients.,"BACKGROUND


We aimed to explore the effect of intraoperative S-ketamine on analgesic consumption and pain one year after spine surgery in chronic opioid-dependent patients undergoing spinal fusion surgery.
METHODS


Single-centre, randomized, blinded trial of 147 patients.
INTERVENTION


Perioperative S-ketamine bolus 0.5 mg/kg followed by S-ketamine 0.25 mg kg -1   hr -1  infusion or placebo.
MAIN OUTCOMES


Analgesic use, pain (visual analogue scale 0-100 mm [VAS]) and labour market attachment one year after surgery assessed by written questionnaires.
RESULTS


Response rate was 67%. One year after surgery, the daily use of oral morphine equivalents was lower in the ketamine group versus the placebo group: 0 (0-20) mg versus 20 (0-62) mg, (p = 0.02), and fewer patients had a daily use of any analgesics in the ketamine group versus placebo group, 42% (95% CI 23-61) versus 74% (95% CI 58-87), (p = 0.04). Mobilization pain was lower in the ketamine group compared to the placebo group: Median difference 17 mm (95% CI -30 to -3), (p = 0.02). Pain at rest was lower in the ketamine group compared to the placebo group with median difference: 13 mm (95% CI -23 to -3), (p = 0.01). Further, labour market attachment was better in the ketamine group, (p = 0.02).
CONCLUSION


Intraoperative ketamine may reduce analgesic use, pain, and improve labour market attachment one year after spine surgery in a chronic opioid-dependent population.
SIGNIFICANCE


This randomized clinical trial shows that intraoperative ketamine may reduce opioid use and pain and improve labour market attachment one year after spine surgery in an opioid-dependent population.",2019,This randomized clinical trial shows that intraoperative ketamine may reduce opioid use and pain and improve labour market attachment one year after spine surgery in an opioid-dependent population.,"['patients', 'after spine surgery', 'one year after spine surgery in an opioid-dependent population', 'after spine surgery in chronic opioid-dependent patients undergoing spinal fusion surgery', '147 patients']","['ketamine', 'intraoperative ketamine', 'placebo', 'bolus 0.5\xa0mg/kg followed by S-ketamine 0.25\xa0mg\xa0kg -1  \xa0hr -1  infusion or placebo', 'Intraoperative ketamine', 'Intraoperative S-ketamine', 'intraoperative S-ketamine']","['Pain at rest', 'Analgesic use, pain (visual analogue scale 0-100\xa0mm [VAS]) and labour market attachment one year after surgery assessed by written questionnaires', 'Mobilization pain', 'analgesic consumption and pain one year', 'labour market attachment', 'opioid use and pain and improve labour market attachment', 'opioid consumption and pain one year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0919636', 'cui_str': 'Operative spinal fusion'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",147.0,0.680192,This randomized clinical trial shows that intraoperative ketamine may reduce opioid use and pain and improve labour market attachment one year after spine surgery in an opioid-dependent population.,"[{'ForeName': 'Rikke Vibeke', 'Initials': 'RV', 'LastName': 'Nielsen', 'Affiliation': 'Department of Neuroanesthesiology, Rigshospitalet - Glostrup, Copenhagen University Hospital, Glostrup, Denmark.'}, {'ForeName': 'Jonna Storm', 'Initials': 'JS', 'LastName': 'Fomsgaard', 'Affiliation': 'Department of Neuroanesthesiology, Rigshospitalet - Glostrup, Copenhagen University Hospital, Glostrup, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jørgen Berg', 'Initials': 'JB', 'LastName': 'Dahl', 'Affiliation': 'Department of Anesthesiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Anesthesiology, Zealand University Hospital Koege, Koege, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1317']
1377,30896330,A Behavioral Confirmation and Reduction of the Natural versus Synthetic Drug Bias.,"Research reveals a biased preference for natural v. synthetic drugs; however, this research is based on self-report and has not examined ways to reduce the bias. We examined these issues in 5 studies involving 1125 participants. In a pilot study ( N  = 110), participants rated the term  natural  to be more positive than the term  synthetic , which reveals a default natural-is-better belief. In studies 1 ( N  = 109) and 2 ( N  = 100), after a supposed personality study, participants were offered a thank you ""gift"" of a natural or synthetic pain reliever. Approximately 86% (study 1) and 93% (study 2) of participants chose the natural v. synthetic pain reliever, which provides a behavioral choice confirmation of the natural drug bias. In studies 3 ( N  = 350) and 4 ( N  = 356), participants were randomly assigned to a control or experimental condition and were asked to consider a scenario in which they had a medical issue requiring a natural v. synthetic drug. The experimental condition included a stronger (study 3) or weaker (study 4) rational appeal about the natural drug bias and a statement suggesting that natural and synthetic drugs can be good or bad depending on the context. In both studies, the natural bias was reduced in the experimental condition, and perceived safety and effectiveness mediated this effect. Overall, these data indicate a bias for natural over synthetic drugs in preferences and behavioral choices, which might be reduced with a rational appeal.",2019,The experimental condition included a stronger (study 3) or weaker (study 4) rational appeal about the natural drug bias and a statement suggesting that natural and synthetic drugs can be good or bad depending on the context.,['1125 participants'],['control or experimental condition and were asked to consider a scenario in which they had a medical issue requiring a natural v. synthetic drug'],[],[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0259849', 'cui_str': 'Synthetic Drugs'}]",[],1125.0,0.036387,The experimental condition included a stronger (study 3) or weaker (study 4) rational appeal about the natural drug bias and a statement suggesting that natural and synthetic drugs can be good or bad depending on the context.,"[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, Gettysburg College, Gettysburg, PA, USA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Dillard', 'Affiliation': 'Department of Psychology, Grand Valley State University, Allendale, MI, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Osorio', 'Affiliation': 'Department of Psychology, Gettysburg College, Gettysburg, PA, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Lappas', 'Affiliation': 'Department of Biology, Lebanon Valley College, Annville, PA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19838527']
1378,31887280,Comparison of Perioperative Parameters in Femtosecond Laser-Assisted Cataract Surgery Using 3 Nuclear Fragmentation Patterns.,"PURPOSE


The purpose of this study was to compare the perioperative parameters of quadrant, sextant, and grid lens fragmentation patterns in femtosecond laser-assisted cataract surgery (FLACS).
DESIGN


Prospective randomized clinical trial.
METHODS


Setting: Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
STUDY POPULATION


A total of 894 eyes in 661 patients with cataracts were enrolled. Intervention or observation procedures: the nuclear density was graded according to the Emery-Little classification. Patients received lens fragmentation using a quadrant, sextant, or grid pattern after random allocation. Evaluations included intraoperative parameters, complications, and postoperative outcomes.
MAIN OUTCOME MEASUREMENTS


effective phacoemulsification time (EPT), intraoperative complications, visual acuity and intraocular pressure at one day postoperatively, as well as endothelial cell density, endothelial cell loss, and central corneal thickness at 1 week postoperatively.
RESULTS


In grade 1 nuclei, the mean EPT in the grid group was the shortest compared to those in the quadrant (P = 0.011) and sextant (P = 0.001) groups. In grade 2 nuclei, all 3 patterns showed no significant differences in the mean EPT (P > 0.05). In grade 3 nuclei, the sextant group revealed shorter mean EPT than the grid (P = 0.017) and quadrant (P > 0.05) groups. In grades 4 and 5 nuclei, the quadrant pattern had the shortest mean EPT among all 3 patterns (P < 0.05). The grid pattern is associated with higher intraocular pressure in hard nuclei (grades 4 and 5) than the other 2 patterns (P < 0.05).
CONCLUSIONS


The grid and quadrant patterns allow for shorter EPT in soft (grade 1) and hard (grades 4 and 5) nuclei, respectively. All 3 patterns can be selected for treating grade 2 nuclei. The sextant pattern may be the best option when treating grade 3 nuclei. The grid pattern should be avoided in hard nuclei combined with glaucoma or glaucoma suspect.",2020,"In grade 2 nuclei, all three patterns showed no significant difference in the mean EPT (p > 0.05).","['A total of 894 eyes in 661 patients with cataracts were enrolled', 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China']","['femtosecond laser-assisted cataract surgery (FLACS', 'Femtosecond Laser-assisted Cataract Surgery']","['mean EPT', 'nuclear density', 'endothelial cell density (ECD), endothelial cell loss (ECL) and central corneal thickness (CCT', 'intraoperative parameters, complications, and postoperative outcomes', 'Effective phacoemulsification time (EPT), intraoperative complications, visual acuity and intraocular pressure (IOP', 'shorter mean EPT']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",661.0,0.031457,"In grade 2 nuclei, all three patterns showed no significant difference in the mean EPT (p > 0.05).","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Lyu', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Zeren', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Plastic Surgery, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Ni', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Eye Center of the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China. Electronic address: xlren@zju.edu.cn.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.017']
1379,31710269,A mobile app to promote alcohol and drug SBIRT skill translation among multi-disciplinary health care trainees: Results of a randomized controlled trial.,"Background : Adherence to clinical practice guidelines for alcohol and drug screening, brief intervention, and referral to treatment (SBIRT) is often inadequate. Mobile apps developed as clinical translation tools could improve the delivery of high fidelity SBIRT.  Methods : This study tested the effectiveness of an SBIRT mobile app conceptually aligned with the Theory of Planned Behavior (TPB) to support SBIRT delivery by health care trainees (nursing, social work, internal medicine, psychiatry, and psychology) working in clinical settings ( N  = 101). Bivariate analyses examined the rate of SBIRT delivery between trainees assigned to the experimental (app) and control (no app) study conditions; as well as the relationship between TPB-based constructs, intention to deliver SBIRT, and screening rates.  Results : No significant differences were identified between the study conditions in SBIRT delivery. Significant correlations were found between intent to screen and TPB variables including attitudes/behavioral beliefs concerning substance use treatment ( r  = .49,  p  = .01); confidence in clinical skills ( r  = .36,  p  = .01); subjective norms ( r  = .54,  p  = .01) and perceived behavioral control over appointment time constraints ( r  = .42,  p  = .01). Also significant were correlations between percent of patients screened and confidence ( r  = .24,  p  = .05); subjective norms ( r  = .22,  p  = .05) and perceived behavioral control ( r  = .28,  p  = .01).  Conclusions : The negative results of the study condition comparisons indicate the need for further investigation of strategies to optimize mobile app utilization, engagement, and effectiveness as a clinical translation tool. Findings of significant correlations between substance use screening rates and both norms and confidence support the potential value of the TPB model in explaining behavior of health care learners in SBIRT delivery.",2019,"Bivariate analyses examined the rate of SBIRT delivery between trainees assigned to the experimental (app) and control (no app) study conditions; as well as the relationship between TPB-based constructs, intention to deliver SBIRT, and screening rates.  ",['multi-disciplinary health care trainees'],"[' ', 'SBIRT mobile app conceptually aligned with the Theory of Planned Behavior (TPB']","['rate of SBIRT delivery', 'screen and TPB variables including attitudes/behavioral beliefs concerning substance use treatment', 'behavioral control']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0150359', 'cui_str': 'Substance use treatments and procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0380138,"Bivariate analyses examined the rate of SBIRT delivery between trainees assigned to the experimental (app) and control (no app) study conditions; as well as the relationship between TPB-based constructs, intention to deliver SBIRT, and screening rates.  ","[{'ForeName': 'Alexa C', 'Initials': 'AC', 'LastName': 'Curtis', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Varada', 'Initials': 'V', 'LastName': 'Sarovar', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wamsley', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Khanh', 'Initials': 'K', 'LastName': 'Ly', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Satterfield', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, California, USA.'}]",Substance abuse,['10.1080/08897077.2019.1686723']
1380,31706460,Implementation and Evaluation of the Abriendo Caminos Program: A Randomized Control Trial Intervention for Hispanic Children and Families.,"OBJECTIVE


To describe the methodology of a family-focused, culturally tailored program, Abriendo Caminos, for the prevention of excess weight gain in children.
DESIGN


Randomized control trial with outcome assessment at pretest, posttest, and 6 months after intervention or abbreviated-attention control group.
SETTING


Community setting across 5 sites (Illinois, California, Iowa, Texas, and Puerto Rico).
PARTICIPANTS


Mexican American and Puerto Rican families (parent and 1 child aged 6-18 years). A sample size of 100 families (50 intervention and 50 control) per site (n = 500) will provide adequate power to detect intervention effects.
INTERVENTION


Families will participate in 6 weekly, 2-hour group workshops on nutrition education through combined presentations and activities, family wellness, and physical activity.
MAIN OUTCOME MEASURES


The primary outcome is prevention of excess weight gain in children; secondary outcomes include changes in child diet, specifically fruit, vegetable, and sugar-sweetened beverage consumption, and changes in parents' diets and improvement of family routines. Measures will be collected at baseline, postintervention, and 6 months after.
ANALYSIS


Modeling to assess changes within and between experimental groups will be checked using standard methods including assessment of model fit, influence diagnostics, adjusted R 2 , and multicollinearity. Significance of effects will be examined using Type III tests.",2019,"A sample size of 100 families (50 intervention and 50 control) per site (n = 500) will provide adequate power to detect intervention effects.
","['Mexican American and Puerto Rican families (parent and 1 child aged 6-18 years', 'Hispanic Children and Families', 'Community setting across 5 sites (Illinois, California, Iowa, Texas, and Puerto Rico', 'children', '100 families (50 intervention and 50 control) per site (n\u202f=\u202f500']","['abbreviated-attention control group', 'Abriendo Caminos Program']","[""prevention of excess weight gain in children; secondary outcomes include changes in child diet, specifically fruit, vegetable, and sugar-sweetened beverage consumption, and changes in parents' diets and improvement of family routines""]","[{'cui': 'C0025884', 'cui_str': 'Chicanas'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]",100.0,0.100795,"A sample size of 100 families (50 intervention and 50 control) per site (n = 500) will provide adequate power to detect intervention effects.
","[{'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; University of Illinois Extension, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL. Electronic address: teranmd@illinois.edu.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Nickols-Richardson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; University of Illinois Extension, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Salma M A', 'Initials': 'SMA', 'LastName': 'Musaad', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Villegas', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hammons', 'Affiliation': 'Child and Family Science, California State University, Fresno, CA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wiley', 'Affiliation': 'Department of Human Development and Family Studies, Auburn University, Auburn, AL; Child and Family Science, California State University, Fresno, CA.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Fiese', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois at Urbana-Champaign, Urbana-Champaign, IL.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.08.011']
1381,30854721,"Comments on the paper by Nielsen et al. entitled ""Intraoperative S-ketamine for the reduction of opioid consumption and pain one year after spine surgery: A randomized clinical trial of opioid-dependent patients"".",,2019,,"['dependent patients', 'after spine surgery']","['entitled ""Intraoperative S-ketamine', 'opioid']",['opioid consumption and pain one year'],"[{'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",,0.0997881,,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'An', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Anaesthesiology, Changzheng Hospital, Shanghai, China.'}]","European journal of pain (London, England)",['10.1002/ejp.1394']
1382,30896743,Dietary Calcium Intake and Bone Loss Over 6 Years in Osteopenic Postmenopausal Women.,"CONTEXT


Calcium intakes are commonly lower than the recommended levels, and increasing calcium intake is often recommended for bone health.
OBJECTIVE


To determine the relationship between dietary calcium intake and rate of bone loss in older postmenopausal women.
PARTICIPANTS


Analysis of observational data collected from a randomized controlled trial. Participants were osteopenic (hip T-scores between -1.0 and -2.5) women, aged >65 years, not receiving therapy for osteoporosis nor taking calcium supplements. Women from the total cohort (n = 1994) contributed data to the analysis of calcium intake and bone mineral density (BMD) at baseline, and women from the placebo group (n = 698) contributed data to the analysis of calcium intake and change in BMD. BMD and bone mineral content (BMC) of the spine, total hip, femoral neck, and total body were measured three times over 6 years.
RESULTS


Mean calcium intake was 886 mg/day. Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status, and past hormone replacement use. There was no relationship between bone loss and quintile of calcium intake at any site, with or without adjustment for covariables. Total body bone balance (i.e., change in BMC) was unrelated to an individuals' calcium intake (P = 0.99).
CONCLUSIONS


Postmenopausal bone loss is unrelated to dietary calcium intake. This suggests that strategies to increase calcium intake are unlikely to impact the prevalence of and morbidity from postmenopausal osteoporosis.",2019,"Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status and past hormone replacement use.","['women aged >65 years not receiving therapy for osteoporosis, nor taking calcium supplements', 'osteopenic postmenopausal women', 'older postmenopausal women', 'Participants were osteopenic (hip T-scores between -1.0 and -2.5']",['placebo'],"['bone loss', 'BMD and bone mineral content (BMC) of the spine, total hip, femoral neck and total body', 'Baseline BMDs', 'Dietary calcium intake and bone loss', 'calcium intake and bone mineral density (BMD', 'calcium intake and change in BMD', 'Total body bone balance', 'bone loss and quintile of calcium intake']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0006726', 'cui_str': 'Calcium, Dietary'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.119109,"Baseline BMDs were not related to quintile of calcium intake at any site, before or after adjustment for baseline age, height, weight, physical activity, alcohol intake, smoking status and past hormone replacement use.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Bristow', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00111']
1383,30902674,Effects of Elastic Resistance Training on Functional Performance and Myokines in Older Women-A Randomized Controlled Trial.,"OBJECTIVES


To investigate the short- and long-term effects of elastic resistance training (ERT) on physical performance, inflammatory markers, and myokines in older women living in a nursing home.
DESIGN


A randomized controlled trial, with 12 weeks of ERT intervention.
SETTING AND PARTICIPANTS


Nursing home. Twenty female nursing home residents (mean age = 84 ± 8 years) were randomized into 2 groups: the training group (n = 11), and the control group (n = 9).
MEASURES


Muscle mass was estimated with bioelectrical impedance, and the functional test Short Physical Performance Battery (SPPB) was performed, whereas handgrip strength and plasma concentration of myokines and inflammatory markers were measured before and after the intervention period. Additional blood samples were also taken after the fourth ERT session. A mixed model (group × time) analysis of variance was applied to determine the effect on primary and secondary outcomes.
RESULTS


After 1 exercise session, the training group showed a significant increase in brain-derived neurotrophic factor (BDNF) (P = .04) and a decrease in interleukin (IL)-8 (P = .01) plasma concentration. After 12 weeks of intervention, the results showed a significant group × time effects for the SPPB total score (P < .01), as well as gait speed (P = .04), chair rise (P < .01), and BDNF concentration (P = .02). However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).
CONCLUSIONS/IMPLICATIONS


The present study emphasizes the clinical impact of moderate-intensity ERT on mobility and functional performance in older women. The results indicate that an increase in exercise-induced peripheral BDNF may have a protective role in the preservation of muscular function in older women. Incorporating ERT into nursing homes could be a feasible preventive strategy to counteract functional deterioration.",2019,"However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).
","['Twenty female nursing home residents (mean age\xa0=\xa084 ± 8\xa0years', 'Nursing home', 'Older Women', 'older women', 'older women living in a nursing home']","['ERT intervention', 'Elastic Resistance Training', 'elastic resistance training (ERT']","['SPPB total score', 'mobility and functional performance', 'handgrip strength and plasma concentration of myokines and inflammatory markers', 'BDNF concentration', 'Functional Performance and Myokines', 'physical performance, inflammatory markers, and myokines', 'gait speed', 'grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein', 'functional test Short Physical Performance Battery (SPPB', 'brain-derived neurotrophic factor (BDNF', 'interleukin (IL)-8', 'chair rise']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C3853978'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C2607857'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0254610', 'cui_str': 'IL15'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",20.0,0.0611107,"However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).
","[{'ForeName': 'Felicita', 'Initials': 'F', 'LastName': 'Urzi', 'Affiliation': 'University of Primorska, Faculty of Mathematics, Natural Sciences and Information Technologies, Koper, Slovenia. Electronic address: felicita.urzi@upr.si.'}, {'ForeName': 'Uros', 'Initials': 'U', 'LastName': 'Marusic', 'Affiliation': 'Science and Research Centre Koper, Institute for Kinesiology Research, Koper, Slovenia.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Ličen', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Izola, Slovenia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Buzan', 'Affiliation': 'University of Primorska, Faculty of Mathematics, Natural Sciences and Information Technologies, Koper, Slovenia. Electronic address: elena.buzan@famnit.upr.si.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.151']
1384,31706286,"A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children.","BACKGROUND


Nocturnal enuresis (NE), or 'bedwetting', is a form of night-time urinary incontinence occurring in younger children. A diagnosis of NE can be socially disruptive and psychologically stressful for a child. The most common strategies used by parents to manage NE are waking the child during the night to use the bathroom and limiting the child's water intake before going to bed. Behavioural or educational therapies for NE such as urotherapy or bladder retraining are widely accepted and considered as a mainstream treatment option for non-neurogenic lower urinary tract dysfunction in children. Pharmacotherapy also plays an ancillary role. However, there is no gold standard therapy or intervention to effectively manage NE.
METHODS


This study aims to determine the efficacy of a herbal combination in the treatment of NE in children. The target population for this study is 80 children aged between 6 and 14 years old (males and females) who have primary nocturnal enuresis ≥3 per week (wet nights). The active group will receive one or two capsules per day containing 420 mg of a proprietary blend of Urox® (Seipel Group, Brisbane, Australia) containing Cratevox™ (Crataeva nurvala L; Capparidaceae; Varuna) stem bark extract standardised for 1.5% lupeol: non-standardised Equisetum arvense L. (Equisetaceae; Horsetail) stem extract; and, non-standardised Lindera aggregata Sims. The primary outcome for this study is the frequency of nocturia. Secondary outcomes include safety, quality of life, and daytime incontinence. Each participation will be involved in the trial for 32 weeks including contact with the research team every 2 weeks for the first 8 weeks and then every 8 weeks until trial completion.
DISCUSSION


This study examines a novel treatment for an under-researched health condition affecting many children. Despite the availability of several therapies for NE, there is insufficient evidence to support the use of any one intervention and as such this randomised placebo-controlled phase II trial will be an important contribution to understanding potential new treatments for this condition.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registration Number: 12618000288224.
PROTOCOL


23 February 2018, version 1.1.",2019,"Each participation will be involved in the trial for 32 weeks including contact with the research team every 2 weeks for the first 8 weeks and then every 8 weeks until trial completion.
","['Australian and New Zealand', '80 children aged between 6 and 14\u2009years old (males and females) who have primary nocturnal enuresis ≥3 per week (wet nights', 'children', 'under-researched health condition affecting many children', '23 February 2018, version 1.1', 'younger children', 'nocturnal enuresis in children']","['placebo', 'herbal combination', 'bedtime buddy®', 'Urox® (Seipel Group, Brisbane, Australia) containing Cratevox™ (Crataeva nurvala L; Capparidaceae; Varuna) stem bark extract standardised for 1.5% lupeol: non-standardised Equisetum arvense L. (Equisetaceae; Horsetail) stem extract']","['frequency of nocturia', 'safety, quality of life, and daytime incontinence']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2228139', 'cui_str': 'Primary nocturnal enuresis'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0270327', 'cui_str': 'Nighttime Urinary Incontinence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1135845', 'cui_str': 'Crateva'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0065254', 'cui_str': 'lup-20(29)-en-3beta-ol'}, {'cui': 'C0331746', 'cui_str': 'Equisetum arvense (organism)'}, {'cui': 'C0949569', 'cui_str': 'Equisetaceae'}, {'cui': 'C0331747', 'cui_str': 'Equisetum palustre (organism)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}]",,0.136764,"Each participation will be involved in the trial for 32 weeks including contact with the research team every 2 weeks for the first 8 weeks and then every 8 weeks until trial completion.
","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Schloss', 'Affiliation': 'Office of Research, Endeavour College of Natural Health, Brisbane, Australia.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Ryan', 'Affiliation': 'Office of Research, Endeavour College of Natural Health, Brisbane, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Reid', 'Affiliation': 'Office of Research, Endeavour College of Natural Health, Brisbane, Australia.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Steel', 'Affiliation': 'Office of Research, Endeavour College of Natural Health, Brisbane, Australia. amie.steel@uts.edu.au.'}]",BMC pediatrics,['10.1186/s12887-019-1797-8']
1385,30565397,Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: Final five-year results of the patient-level pooled analysis from the TARGET I and TARGET II trials.,"OBJECTIVES


The study reports the final 5-year safety and effectiveness outcomes of the novel abluminal groove-filled biodegradable polymer-coated FIREHAWK sirolimus-eluting stent in a large patient cohort.
BACKGROUND


The TARGET clinical program was conducted to evaluate the performance of the FIREHAWK stent, and this objective performance criterion study pooled long-term safety and efficacy data from three TARGET trials for greater statistical power to analyze low-frequency events.
METHODS


Patient-level pooled data from 1,007 individuals in the TARGET I randomized controlled trial (n = 227), TARGET I long lesion cohort (n = 50), and TARGET II registry (n = 730) were prospectively collected and analyzed. The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven indicated target lesion revascularization (ID-TLR) at 5 years. All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years.
RESULTS


Among 947 patients (94.0%) who completed the 5-year clinical follow-up, the 5-year TLF event rate was 8.1%; the events included 18 cardiac deaths, 36 TV-MIs, and 33 ID-TLRs. Only four (0.4%) very late probable or definite stent thrombosis events were observed beyond 1 year after stent implantation. In the subgroup analysis, lesion length ≥ 30 mm was associated with higher long-term TLF incidence, while the use of a predilation-sizing-postdilation technique showed no significant effect on long-term outcomes.
CONCLUSIONS


Five-year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events.",2019,"All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years.
","['All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years', 'de novo coronary lesions', '947 patients (94.0%) who completed the 5-year clinical follow-up, the', 'Patient-level pooled data from 1,007 individuals in the TARGET']","['novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent', 'TARGET', 'novel abluminal groove-filled biodegradable polymer-coated FIREHAWK sirolimus-eluting stent']","['stent thrombosis events', 'thrombotic events', '5-year TLF event rate', 'target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven indicated target lesion revascularization (ID-TLR', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.097485,"All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years.
","[{'ForeName': 'Chongjian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Ruiyan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Daqing Oil Field General Hospital, Daqing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Affiliated Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'General Hospital of Shenyang Military Region, Shenyang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28051']
1386,31375361,Effects of Culturally Tailored Nutrition Education on Dietary Quality of Hispanic Mothers: A Randomized Control Trial.,"OBJECTIVE


To assess whether participation in a culturally tailored nutrition education program increases diet quality of Hispanic mothers.
DESIGN


A randomized controlled trial.
SETTING


Community centers and universities.
PARTICIPANTS


Sixty-five mothers (35 in experimental group, 30 in control group) completed pre- and postworkshop surveys. Eligibility criteria included being of Mexican or Puerto Rican descent and having a child between the ages of 6 and 18 years who could participate in the workshops with the parent.
INTERVENTION


Families in the experimental group participated in a 6-week workshop series that included weekly nutrition education classes.
MAIN OUTCOME MEASURE


Diet quality was assessed by the Rate Your Plate questionnaire.
ANALYSIS


Repeated measures ANOVA was used to compare differences between the experimental and control groups. A Wilcoxon signed rank test was conducted to test for significant shifts in categorization pre- and postprogram.
RESULTS


There was a significant change in diet quality categorization after participating in the workshops (P < .001, effect size 0.39). No changes were found in the control group.
CONCLUSIONS AND IMPLICATIONS


Abriendo Caminos was effective at increasing the diet quality of Hispanic mothers who participated the most in the program. More research is needed in this at-risk population to determine the relationships among nutrition knowledge, diet quality, and achievement of healthy weight.",2019,"There was a significant change in diet quality categorization after participating in the workshops (P < .001, effect size 0.39).","['Hispanic mothers who participated the most in the program', 'Hispanic mothers', 'Community centers and universities', 'Eligibility criteria included being of Mexican or Puerto Rican descent and having a child between the ages of 6 and 18 years who could participate in the workshops with the parent', 'Hispanic Mothers', 'Sixty-five mothers (35 in experimental group, 30 in control group) completed pre- and postworkshop surveys']","['Culturally Tailored Nutrition Education', 'culturally tailored nutrition education program']","['diet quality', 'Diet quality', 'Rate Your Plate questionnaire', 'diet quality categorization']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",65.0,0.0442626,"There was a significant change in diet quality categorization after participating in the workshops (P < .001, effect size 0.39).","[{'ForeName': 'Amber J', 'Initials': 'AJ', 'LastName': 'Hammons', 'Affiliation': 'Department of Child and Family Science, California State University, Fresno, CA. Electronic address: ahammons@csufresno.edu.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL; Department of Human Development and Family Studies, University of Illinois, Urbana-Champaign, IL; University of Illinois Extension, University of Illinois, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Barragan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Villegas', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wiley', 'Affiliation': 'Department of Human Development and Family Studies, Auburn University, Auburn, AL.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Fiese', 'Affiliation': 'Department of Human Development and Family Studies, University of Illinois, Urbana-Champaign, IL; Family Resiliency Center, University of Illinois, Urbana-Champaign, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.017']
1387,31369841,Post-exercise hypotension and skeletal muscle oxygenation is regulated by nitrate-reducing activity of oral bacteria.,"Post-exercise hypotension (PEH) is a common physiological phenomenon leading to lower blood pressure after acute exercise, but it is not fully understood how this intriguing response occurs. This study investigated whether the nitrate-reducing activity of oral bacteria is a key mechanism to trigger PEH. Following a randomized, double blind and crossover design, twenty-three healthy individuals (15 males/8 females) completed two treadmill trials at moderate intensity. After exercise, participants rinsed their mouth with antibacterial mouthwash to inhibit the activity of oral bacteria or a placebo mouthwash. Blood pressure was measured before, 1h and 2 h after exercise. The microvascular response to a reactive hyperaemia test, as well as blood and salivary samples were taken before and 2 h after exercise to analyse nitrate and nitrite concentrations and the oral microbiome. As expected, systolic blood pressure (SBP) was lower (1 h: -5.2 ± 1.0 mmHg; P < 0.001); 2 h: -3.8 ± 1.1 mmHg, P = 0.005) after exercise compared to baseline in the placebo condition. This was accompanied by an increase of circulatory nitrite 2 h after exercise (2h: 100 ± 13 nM) compared to baseline (59 ± 9 nM; P = 0.013). Additionally, an increase in the peak of the tissue oxygenation index (TOI) during the reactive hyperaemia response was observed after exercise (86.1 ± 0.6%) compared to baseline levels (84.8 ± 0.5%; P = 0.010) in the placebo condition. On the other hand, the SBP-lowering effect of exercise was attenuated by 61% at 1 h in the recovery period, and it was fully attenuated 2 h after exercise with antibacterial mouthwash. This was associated with a lack of changes in circulatory nitrite (P > 0.05), and impaired microvascular response (peak TOI baseline: 85.1 ± 3.1%; peak TOI post-exercise: 84.6 ± 3.2%; P > 0.05). Diversity of oral bacteria did not change after exercise in any treatment. These findings show that nitrite synthesis by oral commensal bacteria is a key mechanism to induce the vascular response to exercise over the first period of recovery thereby promoting lower blood pressure and greater muscle oxygenation.",2019,"This was associated with a lack of changes in circulatory nitrite (P > 0.05), and impaired microvascular response (peak TOI baseline: 85.1 ± 3.1%; peak TOI post-exercise: 84.6 ± 3.2%; P > 0.05).",['twenty-three healthy individuals (15 males/8 females'],"['placebo mouthwash', 'Post-exercise hypotension (PEH']","['Blood pressure', 'circulatory nitrite', 'peak of the tissue oxygenation index (TOI) during the reactive hyperaemia response', 'microvascular response', 'systolic blood pressure (SBP']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C2936233', 'cui_str': 'Postexercise Hypotension'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",23.0,0.169928,"This was associated with a lack of changes in circulatory nitrite (P > 0.05), and impaired microvascular response (peak TOI baseline: 85.1 ± 3.1%; peak TOI post-exercise: 84.6 ± 3.2%; P > 0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cutler', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kiernan', 'Affiliation': 'Peninsula Medical School, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Willis', 'Affiliation': 'Centre for Genomic Regulation (CRG), The Barcelona Institute of Science & Technology, Barcelona, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gallardo-Alfaro', 'Affiliation': 'Research Group on Community Nutrition and Oxidative Stress, University of Balearic Islands & CIBEROBN (CB12/03/30038), Palma de Mallorca, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Casas-Agustench', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gabaldon', 'Affiliation': 'Centre for Genomic Regulation (CRG), The Barcelona Institute of Science & Technology, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; Institució Catalana de Recerca I Estudis Avançats (ICREA), Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bescos', 'Affiliation': 'Institute of Health & Community, University of Plymouth, Plymouth, UK. Electronic address: Raul.Bescos@plymouth.ac.uk.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2019.07.035']
1388,31127478,Association of Body Mass Index and Risk of Stroke After Acute Minor Stroke or TIA: a Post Hoc Analysis of a Randomized Controlled Trial.,"The ""obesity paradox"" was reported in patients with stroke. We aimed to evaluate the pattern and magnitude of association between body mass index (BMI) and prognosis of stroke in patients with minor ischemic stroke or transient ischemic attack (TIA). A total of 5163 patients with available BMI data from the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial were included. Patients were classified into three groups according to their BMI values: normal weight (< 23.9 kg/m 2 ), overweight (24-27.9 kg/m 2 ), and obese (≥ 28.0 kg/m 2 ). The efficacy outcomes included a new stroke (ischemic or hemorrhagic), poor functional outcome defined as modified Rankin scale ≥ 2 points and death from any cause within 90 days. The interaction effects were determined using multivariable Cox or logistic regression models. After 90 days of follow up, there were 513 new strokes. Overweight (BMI 24-27.9 kg/m 2 ) patients had a higher risk of recurrent strokes than those with normal weight (10.8% vs 8.8%; HR = 1.24, 95% CI 1.02-1.50) after adjusting for the baseline covariates, but no significant association was observed for those who were obese (P = 0.37). No significant association was found between being overweight or obese and poor functional outcome or death. For patients with a minor ischemic stroke or TIA, being overweight was associated with an increased risk of recurrent stroke compared to being of normal weight in our study.Trial registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00979589.",2019,No significant association was found between being overweight or obese and poor functional outcome or death.,"['5163 patients with available BMI data from the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial were included', 'Overweight', 'Patients were classified into three groups according to their BMI values: normal weight (<\u200923.9\xa0kg/m 2 ), overweight (24-27.9\xa0kg/m 2 ), and obese (≥\u200928.0\xa0kg/m 2 ', 'After Acute Minor Stroke or TIA', 'patients with stroke', 'patients with minor ischemic stroke or transient ischemic attack (TIA']",[],"['Body Mass Index and Risk of Stroke', 'risk of recurrent stroke', 'new stroke (ischemic or hemorrhagic), poor functional outcome defined as modified Rankin scale ≥\u20092 points and death from any cause within 90\xa0days', 'overweight or obese and poor functional outcome or death', 'higher risk of recurrent strokes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",5163.0,0.0808888,No significant association was found between being overweight or obese and poor functional outcome or death.,"[{'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology and Institute of Neurology, First Affiliated Hospital, Fujian Medical University, Fujian, China. doctorlinyi78@gmail.com.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. wangyongjun@ncrcnd.org.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurotoxicity research,['10.1007/s12640-019-00056-4']
1389,27377563,"Relationships Between Mental Health, Skill Sets, and Violence Perpetration Among Adolescent Girls.","This study examines relationships between emotional health, stress management skills, fight-avoidance skills, and two forms of violence perpetration among adolescent girls at high risk for violence involvement. Participants ( n = 253) were 13- to 17-year-old girls enrolled in a randomized controlled trial. The current study was completed with baseline data collected prior to the start of the intervention. Analyses examined self-report outcome measures of physical violence perpetration in the past 6 months (five-item scale, α = .79) and relational aggression perpetration in the past 30 days (six-item scale, α = .77). Independent variables included baseline measures of self-esteem (four-item scale, α = .89), emotional distress (six-item scale, α = .89), stress management skills (eight-item scale, α = .86), and fight avoidance skills (five-item scale, α = .70). Multivariate regression models predicted each form of violence perpetration controlling for age, race/ethnicity, violence victimization, and clustering of participants within clinics. Initial bivariate results showed that stress management skills and fight avoidance skills were inversely and significantly related to perpetration of both relational and physical violence. Emotional distress was related to significantly higher levels of both violence outcomes. In contrast, self-esteem was not significantly related to either violence outcome. Multivariate analyses revealed that stress management skills and fight avoidance skills were significantly protective against perpetration of both relational aggression and physical violence. In conclusion, findings suggest that clinicians providing services to adolescent girls involved in high risk behaviors assess and foster girls' development of stress management and fight avoidance skills to help reduce their risk of involvement in relational violence and physical fighting.",2019,Multivariate analyses revealed that stress management skills and fight avoidance skills were significantly protective against perpetration of both relational aggression and physical violence.,"['Adolescent Girls', 'adolescent girls at high risk for violence involvement', 'Participants ( n = 253) were 13- to 17-year-old girls enrolled']",[],"['relational aggression perpetration', 'physical violence perpetration', 'stress management skills and fight avoidance skills', 'self-esteem', 'relational aggression and physical violence', 'Emotional distress', 'self-esteem (four-item scale, α = .89), emotional distress (six-item scale, α = .89), stress management skills (eight-item scale, α = .86), and fight avoidance skills', 'perpetration of both relational and physical violence', 'Relationships Between Mental Health, Skill Sets, and Violence Perpetration']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0444864', 'cui_str': 'AM 13 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0222045'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0042693', 'cui_str': 'Violence'}]",253.0,0.0186214,Multivariate analyses revealed that stress management skills and fight avoidance skills were significantly protective against perpetration of both relational aggression and physical violence.,"[{'ForeName': 'Calae D', 'Initials': 'CD', 'LastName': 'Philippe', 'Affiliation': '1 University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Gloppen', 'Affiliation': '1 University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Renee E', 'Initials': 'RE', 'LastName': 'Sieving', 'Affiliation': '1 University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Iris W', 'Initials': 'IW', 'LastName': 'Borowsky', 'Affiliation': '1 University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Pettingell', 'Affiliation': '1 University of Minnesota, Minneapolis, USA.'}]",Journal of interpersonal violence,['10.1177/0886260516657909']
1390,30460403,Correction to: Purse-string approximation vs. primary closure with a drain for stoma reversal surgery: results of a randomized clinical trial.,"In the original publication, surname of first author is misspelt as ""Amamo"". It should be ""Amano"" as given in this Correction.",2019,"In the original publication, surname of first author is misspelt as ""Amamo"".",[],['Purse-string approximation vs. primary closure with a drain for stoma reversal surgery'],[],[],"[{'cui': 'C3540771', 'cui_str': 'String'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],,0.0236194,"In the original publication, surname of first author is misspelt as ""Amamo"".","[{'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Kumamoto', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan. kumamotk@saitama-med.ac.jp.'}, {'ForeName': 'Norimichi', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hatano', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Noriyasu', 'Initials': 'N', 'LastName': 'Chika', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tajima', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ohsawa', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}, {'ForeName': 'Erito', 'Initials': 'E', 'LastName': 'Mochiki', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}]",Surgery today,['10.1007/s00595-018-1735-7']
1391,27352792,Make a Move: A Comprehensive Effect Evaluation of a Sexual Harassment Prevention Program in Dutch Residential Youth Care.,"Sexual harassment-unwanted sexual comments, advances, or behaviors-and sexual violence are still prevalent worldwide, leading to a variety of physical, cognitive, and emotional problems among those being harassed. In particular, youth in care are at risk of becoming perpetrators (and victims) of sexual harassment. However, in general, there are very few interventions targeting this at-risk group, and no such programs exist in the Netherlands. To this end, a group intervention program-Make a Move-targeting determinants of sexual harassment was developed. This program was implemented and evaluated among boys ( N = 177) in Dutch residential youth care (20 institutions). A pre-test, post-test, and 6-month follow-up design including an intervention and a waiting list control group with randomized assignment of institutions (cluster randomized trial) was used to measure the effects of the intervention on determinants of sexual harassment. Multilevel (mixed) regression analysis with Bonferroni correction for multiple testing (α = .005) showed no significant effects of Make a Move on determinants of sexual harassment ( ps > .03, Cohen's ds < .44). Results are discussed in light of a three-way explanatory model focusing on intervention content, evaluation, and implementation as potential explanations for not finding any measurable intervention effects.",2019,"Multilevel (mixed) regression analysis with Bonferroni correction for multiple testing (α = .005) showed no significant effects of Make a Move on determinants of sexual harassment ( ps > .03, Cohen's ds < .44).","['boys ( N = 177) in Dutch residential youth care (20 institutions', 'Dutch Residential Youth Care']",['Sexual Harassment Prevention Program'],['sexual harassment'],"[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0162790', 'cui_str': 'Sexual Harrassment'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0162790', 'cui_str': 'Sexual Harrassment'}]",177.0,0.0189225,"Multilevel (mixed) regression analysis with Bonferroni correction for multiple testing (α = .005) showed no significant effects of Make a Move on determinants of sexual harassment ( ps > .03, Cohen's ds < .44).","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'van Lieshout', 'Affiliation': '1 Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Fraukje E F', 'Initials': 'FEF', 'LastName': 'Mevissen', 'Affiliation': '1 Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Breukelen', 'Affiliation': '1 Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Jonker', 'Affiliation': '2 Rutgers, Utrecht, The Netherlands.'}, {'ForeName': 'Robert A C', 'Initials': 'RAC', 'LastName': 'Ruiter', 'Affiliation': '1 Maastricht University, Maastricht, The Netherlands.'}]",Journal of interpersonal violence,['10.1177/0886260516654932']
1392,27381981,Boozy Nights and Violent Fights: Perceptions of Environmental Cues to Violence and Crime in Licensed Venues.,"This article examines perceptions of environmental cues to crime, violence, and injuries in barroom settings, and how they differ between bar fight participants and non-participants. Bouncer friendliness, patron sex composition, and room temperature were chosen as experimental variables based on three criteria: (a) emerged as a theme in bar user focus groups, (b) unclear effects in the literature, and (c) policy relevant and easy to modify. These experimental variables were manipulated in written vignettes set in a bar. A three-part online questionnaire recorded 681 male university students' responses to questions on demographics, the experiment, drinking and clubbing habits, and the Snell Masculinity Scale. A 2 × 2 × 2 randomized independent groups factorial design with covariates was embedded in the questionnaire, measuring the effects of the experimental variables on bar users' perceived fear of victimization, likelihood and frequency of crime, venue preference, and perceived severity of injuries after accounting for prior bar fight participation and masculinity. Participants generally rated perceived fear of victimization, likelihood and frequency of crime, and severity of injuries to be highest when the bouncer was unfriendly, the temperature was hot, and patrons were majority male. Only main effects were significant ( p < .01). Masculinity scale responses were not related to participant perceptions. While fight participants (9.8% of the sample) and non-participants had similar perceptions of the risk associated with certain environmental cues, fight participants were significantly (a) less fearful of victimization in settings they perceived as dangerous and (b) more willing to drink in any hypothetical venue.",2019,"While fight participants (9.8% of the sample) and non-participants had similar perceptions of the risk associated with certain environmental cues, fight participants were significantly (a) less fearful of victimization in settings they perceived as dangerous and (b) more willing to drink in any hypothetical venue.",['681 male university students'],[],"['Masculinity scale responses', 'fear of victimization, likelihood and frequency of crime, and severity of injuries', 'fear of victimization, likelihood and frequency of crime, venue preference, and perceived severity of injuries', 'Bouncer friendliness, patron sex composition, and room temperature']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",[],"[{'cui': 'C0042757', 'cui_str': 'Masculinity'}, {'cui': 'C0222045'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",681.0,0.016884,"While fight participants (9.8% of the sample) and non-participants had similar perceptions of the risk associated with certain environmental cues, fight participants were significantly (a) less fearful of victimization in settings they perceived as dangerous and (b) more willing to drink in any hypothetical venue.","[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'de Andrade', 'Affiliation': '1 Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Homel', 'Affiliation': '1 Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Mazerolle', 'Affiliation': '2 The University of Queensland, St Lucia, Australia.'}]",Journal of interpersonal violence,['10.1177/0886260516657910']
1393,30822414,"A Double-Blind, Randomized Trial Shows the Role of Zonal Priming and Direct Topical Application of Epigallocatechin-3-Gallate in the Modulation of Cutaneous Scarring in Human Skin.","BACKGROUND


Epigallocatechin-3-gallate (EGCG), a polyphenol, influences cutaneous wound healing because of its antiangiogenic, anti-inflammatory, and antioxidant properties. We previously showed the role of EGCG in scarring in ex vivo human scar models. Here, we evaluate direct application of topical EGCG compared with zonal priming, a unique concept in the immediate treatment of the zone of injury at the time of wounding before scar formation.
TRIAL DESIGN


Double-blind randomized controlled trial.
METHODS


We assessed EGCG application compared with placebo over 1-6 weeks in scars created in 62 human volunteers using quantitative noninvasive devices, immunohistochemical analysis, mRNA sequencing, and quantitative real-time reverse transcriptase-PCR of tissue biopsy samples.
RESULTS


EGCG reduced mast cells at weeks 1-3, as evidenced by gene and protein analyses (P ≤ 0.01). M2 macrophages were increased with EGCG compared with placebo. EGCG application by zonal priming significantly down-regulated VEGFA and CD31 at week 1 and at 1-2 weeks after direct application (P ≤ 0.01). Direct EGCG application also reduced scar thickness at weeks 1-3 (P = 0.001) and increased scar elasticity at week 4 (P = 0.01). Increased hydration was evident both noninvasively and by increased hyaluronic acid levels (P < 0.01) at week 3.
CONCLUSIONS


We show the beneficial role of both zonal priming and direct EGCG application in scar therapy with positive effects on scar thickness, erythema, hydration, and elasticity. Trial register: International standard randomized controlled trial, registration number ISRCTN 18643079; July 16, 2018.",2019,"Increased hydration was evident both noninvasively and by increased hyaluronic acid levels (P < 0.01) at week 3.
","['Cutaneous Scarring in\xa0Human\xa0Skin', '62 human volunteers']","['Direct EGCG', 'placebo', 'Epigallocatechin-3-gallate (EGCG', 'topical EGCG', 'Epigallocatechin-3-Gallate', 'zonal priming and direct EGCG application', 'EGCG']","['Increased hydration', 'EGCG application by zonal priming significantly down-regulated VEGFA and CD31', 'M2 macrophages', 'scar elasticity', 'scar thickness, erythema, hydration, and elasticity', 'hyaluronic acid levels', 'mast cells', 'scar thickness']","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0013764'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024880', 'cui_str': 'Basophils, Tissue'}]",62.0,0.258746,"Increased hydration was evident both noninvasively and by increased hyaluronic acid levels (P < 0.01) at week 3.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ud-Din', 'Affiliation': 'Plastic and Reconstructive Surgery Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Foden', 'Affiliation': 'Medical Statistics, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Mazhari', 'Affiliation': 'Adult Histopathology, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al-Habba', 'Affiliation': 'Adult Histopathology, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Baguneid', 'Affiliation': 'Vascular Surgery, Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bulfone-Paus', 'Affiliation': 'Faculty of Biology, Medicine and Health, Centre for Dermatology Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'McGeorge', 'Affiliation': 'Grosvenor Nuffield Hospital, Chester, UK.'}, {'ForeName': 'Ardeshir', 'Initials': 'A', 'LastName': 'Bayat', 'Affiliation': 'Plastic and Reconstructive Surgery Research, University of Manchester, Manchester, UK. Electronic address: ardeshir.bayat@manchester.ac.uk.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.01.030']
1394,30882914,Pharmacokinetics of Ursodeoxycholic Acid in Elderly Volunteers Compared With Younger Adults in a Korean Population.,"Ursodeoxycholic acid (UDCA) is a secondary bile acid component used for treating primary biliary cirrhosis. This study evaluated and compared the pharmacokinetic (PK) profiles of UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA) in healthy elderly subjects and younger adults. In this randomized, open-label, 2-treatment, 1-sequence, and parallel study, subjects received 400 or 800 mg UDCA on day 1, followed by 200 mg UDCA twice daily for 2 weeks. Blood samples were obtained up to 24 hours after the first UDCA dose. Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels from baseline were assessed to determine the safety and pharmacological effects of UDCA. This study examined the outcomes of 16 elderly subjects and 16 younger adults. Dose-normalized peak concentration of and systemic exposure to UDCA were 2 to 4 times higher, and the corresponding values of G-UDCA and T-UDCA were 1.7 times higher in the elderly subjects than in the younger adults. The subjects in both groups showed multiple peak profiles of UDCA and its conjugates. The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA. This study is the first to confirm that the PK measurements of UDCA were higher in elderly subjects than in younger adults, which may improve the clinical outcomes of elderly subjects.",2019,The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA.,"['elderly subjects', '16 elderly subjects and 16 younger adults', 'elderly subjects than in younger adults', 'Elderly Volunteers Compared With Younger Adults in a Korean Population', 'healthy elderly subjects and younger adults']","['Ursodeoxycholic acid (UDCA', 'UDCA and its conjugates glyco-UDCA (G-UDCA) and tauro-UDCA (T-UDCA', 'UDCA', 'Ursodeoxycholic Acid']","['Blood samples', 'Changes in miRNA-122, γ-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase (substance)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",16.0,0.0143199,The miRNA-122 levels and hepatic enzyme test results were within the normal range in the elderly subjects after multiple administration of UDCA.,"[{'ForeName': 'Soyoung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seonghae', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Clinical Trials Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Chun', 'Initials': 'SC', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seo Hyun', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joo-Youn', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Yong', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': 'Clinical Trials Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]",Journal of clinical pharmacology,['10.1002/jcph.1409']
1395,29659382,Tenofovir Versus Entecavir for the Treatment of Acute-on-Chronic Liver Failure due to Reactivation of Chronic Hepatitis B With Genotypes B and C.,"BACKGROUND AND AIMS


Acute-on-chronic liver failure (ACLF) can be triggered by reactivation of chronic hepatitis B (CHB). Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are now the most potent antiviral agents for CHB. This study aimed to compare the short-term safety and efficacy of TDF with ETV in the treatment of ACLF due to reactivation of CHB [hepatitis B virus (HBV)-ACLF].
PATIENTS AND METHODS


In total, 67 consecutive patients with HBV-ACLF were divided into TDF group (n=32) receiving daily TDF (300 mg/d) and ETV group (n=35) receiving daily ETV (0.5 mg/d). They were prospectively followed-up and the primary endpoint was overall survival at 3 months.
RESULTS


At 2 weeks, the TDF group had significantly higher HBV-DNA reduction (P=0.003), lower HBV-DNA level (P=0.001), higher rate of HBV-DNA undetectbility (P=0.007), lower Child-Turcotte-Pugh (CTP; P=0.003), and model for end-stage liver disease (P=0.002) scores than the ETV group. At 3 months, HBV-DNA was undetectable in all survived patients; CTP (P=0.970) and model for end-stage liver disease (P=0.192) scores were comparable between the 2 groups, but markedly lower than at baseline (P<0.01); the TDF group had significantly higher cumulative survival rate than the ETV group (P=0.025). The white blood cell count (hazard ratio, 2.726; 95% confidence interval, 2.691-7.897; P=0.000), and HBV-DNA reduction (hazard ratio, 0.266; 95% confidence interval, 0.033-0.629; P=0.013) at 2 weeks were independent predictors for mortality. Both drugs were well tolerated.
CONCLUSIONS


The short-term efficacy of TDF was superior to ETV for the treatment of HBV-ACLF. The white blood cell count and HBV-DNA reduction at 2 weeks were independent predictors for mortality at 3 months.",2019,"At 2 weeks, the TDF group had significantly higher HBV-DNA reduction (P=0.003), lower HBV-DNA level (P=0.001), higher rate of HBV-DNA undetectbility (P=0.007), lower Child-Turcotte-Pugh",['67 consecutive patients with HBV-ACLF'],"['TDF', 'Tenofovir disoproxil fumarate (TDF) and entecavir (ETV', 'ETV group (n=35) receiving daily ETV', 'daily TDF', 'TDF with ETV', 'Tenofovir Versus Entecavir']","['HBV-DNA reduction', 'tolerated', 'lower Child-Turcotte-Pugh', 'white blood cell count and HBV-DNA reduction', 'white blood cell count', 'HBV-DNA', 'cumulative survival rate', 'rate of HBV-DNA undetectbility', 'lower HBV-DNA level', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0010456', 'cui_str': 'Cumulative Survival Rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",67.0,0.0513871,"At 2 weeks, the TDF group had significantly higher HBV-DNA reduction (P=0.003), lower HBV-DNA level (P=0.001), higher rate of HBV-DNA undetectbility (P=0.007), lower Child-Turcotte-Pugh","[{'ForeName': 'Yue-Meng', 'Initials': 'YM', 'LastName': 'Wan', 'Affiliation': 'Gastroenterology Department II or Hepatology Center, The 2nd Affiliated Hospital of Kunming Medical University.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Gastroenterology Department II or Hepatology Center, The 2nd Affiliated Hospital of Kunming Medical University.'}, {'ForeName': 'Zhi-Yuan', 'Initials': 'ZY', 'LastName': 'Xu', 'Affiliation': 'Gastroenterology Department II or Hepatology Center, The 2nd Affiliated Hospital of Kunming Medical University.'}, {'ForeName': 'Hua-Mei', 'Initials': 'HM', 'LastName': 'Wu', 'Affiliation': 'Gastroenterology Department II or Hepatology Center, The 2nd Affiliated Hospital of Kunming Medical University.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Gastroenterology Department II or Hepatology Center, The 2nd Affiliated Hospital of Kunming Medical University.'}, {'ForeName': 'Xi-Nan', 'Initials': 'XN', 'LastName': 'Wu', 'Affiliation': 'Public Health Institute of Kunming Medical University, Kunming City, Yunnan Province, China.'}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Gastroenterology Department II or Hepatology Center, The 2nd Affiliated Hospital of Kunming Medical University.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001038']
1396,30852167,Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention.,"OBJECTIVES


Advance care planning (ACP) is important to ensure that nursing home (NH) residents receive care concordant with their goals. Video interventions have been developed to improve the process of ACP. Yet, little is known about which NH characteristics are associated with implementation of ACP video interventions in clinical practice. Our objective was to examine NH-level characteristics associated with the implementation of an ACP video intervention as part of the Pragmatic trial of Video Education in Nursing Homes (PROVEN) trial.
DESIGN


Cross-sectional study of NHs in PROVEN.
SETTING AND PARTICIPANTS


119 NHs randomized to receive the ACP video intervention.
MEASUREMENTS


The outcomes were the proportion of short- (<100 days) and long-stay (≥100 days) NH residents who were (1) offered to watch a video and (2) shown a video, aggregated to the NH-level, and measured using electronic forms of video offers. The association between outcomes and NH facility characteristics (eg, staffing, resident acuity) and participation in other aspects of the PROVEN trial (eg, monthly check-in calls) were estimated using multivariate linear regression models. NH characteristics were measured using data from Online Survey Certification and Reporting data, Long-term Care: Facts on Care in the US and NH Compare.
RESULTS


Offer rates were 69% [standard deviation (SD): 28] for short-stay and 56% (SD: 20) for long-stay residents. Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents. After adjusting for NH characteristics, compared to 1-star NHs, higher star-rated NHs had higher offer rates. Champions' participation in check-in calls was positively associated with both outcomes for long-stay residents.
CONCLUSIONS/IMPLICATIONS


Lower-quality NHs seem unable to integrate a novel ACP video education program into routine care processes. Ongoing support for and engagement with NH staff to champion the intervention throughout implementation is important for the success of a pragmatic trial within NHs.",2019,Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents.,['Nursing Homes (PROVEN) trial'],"['ACP video intervention', 'Video interventions', 'Advance care planning (ACP']",['proportion of short- (<100\xa0days) and long-stay'],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",119.0,0.0703926,Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents.,"[{'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI. Electronic address: lacey_loomer@brown.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Belanger', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Hebrew Senior Life, Institute for Aging Research, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hebrew Senior Life, Institute for Aging Research, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI; Center for Gerontology and Healthcare Research, School of Public Health, Brown University, Providence, RI; Center of Innovation in HSR&D, Providence Veterans Administration Medical Center, Providence, RI.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.133']
1397,30793422,Comparing the effectiveness of integrating ergonomics and motor control to conventional treatment for pain and functional recovery of work-related neck-shoulder pain: A randomized trial.,"BACKGROUND


Work-related neck and shoulder pain (WRNSP) is highly prevalent among patients who seek physiotherapy treatment. Clinicians may tend to focus on teaching home exercises and provide general advice about workplace improvement. The present study investigates the short- and long-term impact of an intervention approach that emphasizes on integrating the motor control re-education with ergonomic advice.
METHODS


Participants diagnosed with WRNSP (n = 101) were randomly assigned into two groups in this randomized controlled trial. The Ergo-motor Group (EM, n = 51) received an integrated intervention with ergonomic advice/modifications and motor control training individualized for each participant based on their specific work demands. Control Group (CO, n = 50) received treatment for pain relief and general exercises of their necks at a designated physiotherapy clinic. Neck pain intensity and functional outcome measures were assessed before, immediately and 1-year after the 12-week intervention programmes. Global Rating of Change Score was used to evaluate the perceived recovery at 1-year follow-up.
RESULTS


Both groups reported significant reductions in pain and functional disability scores at post-intervention (EM, n = 44; CO, n = 42) and 1-year follow-up (EM, n = 40; CO, n = 38); however, no significant between-group differences were found (p > 0.05). Significantly higher rating in global recovery score was reported in EM group at 1-year follow-up (p < 0.05).
CONCLUSIONS


Intervention integrating ergonomic advice/modification with motor control exercise was found to be equally effective as pain relief and general exercise for pain and functional recovery. However, at 1-year follow-up, such integrated approach resulted in significantly better global recovery perceived by people with WRNSP.
SIGNIFICANCE


Integrating ergonomic intervention and motor control training achieved similar reduction in pain and functional outcomes compared to conventional physiotherapy at post-intervention and at 1-year follow-up, for patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability. The Ergo-motor Group reported significantly better perceived overall recovery at 1-year follow-up.",2019,"Integrating ergonomic intervention and motor control training achieved similar reduction in pain and functional outcomes compared to conventional physiotherapy at post-intervention and at 1-year follow-up, for patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability.","['patients who seek physiotherapy treatment', 'patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability', 'pain and functional recovery of work-related neck-shoulder pain', 'Participants diagnosed with WRNSP (n\xa0=\xa0101']","['motor control exercise', 'integrated intervention with ergonomic advice/modifications and motor control training individualized', 'conventional physiotherapy', 'Integrating ergonomic intervention and motor control training', 'Control Group (CO, n\xa0=\xa050) received treatment for pain relief and general exercises of their necks at a designated physiotherapy clinic', 'integrating ergonomics and motor control to conventional treatment']","['pain and functional disability scores', 'pain and functional outcomes', 'pain relief and general exercise for pain and functional recovery', 'Global Rating of Change Score', 'global recovery', 'Neck pain intensity and functional outcome measures', 'global recovery score', 'overall recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0556554', 'cui_str': 'Ergonomic education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",101.0,0.137233,"Integrating ergonomic intervention and motor control training achieved similar reduction in pain and functional outcomes compared to conventional physiotherapy at post-intervention and at 1-year follow-up, for patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability.","[{'ForeName': 'Sharon M H', 'Initials': 'SMH', 'LastName': 'Tsang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Billy C L', 'Initials': 'BCL', 'LastName': 'So', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Rufina W L', 'Initials': 'RWL', 'LastName': 'Lau', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Grace P Y', 'Initials': 'GPY', 'LastName': 'Szeto', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]","European journal of pain (London, England)",['10.1002/ejp.1381']
1398,30833170,"Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.","BACKGROUND


Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes. Few clinical trials have reported on the concomitant use of GLP-1 receptor agonists with sodium-glucose cotransporter-2 (SGLT-2) inhibitors. We aimed to investigate the efficacy and safety of semaglutide when added to SGLT-2 inhibitor therapy in patients with inadequately controlled type 2 diabetes.
METHODS


The SUSTAIN 9 double-blind, parallel-group trial was done at 61 centres in six countries (Austria, Canada, Japan, Norway, Russia, and the USA). Adults with type 2 diabetes and HbA 1c  7·0-10·0% (53-86 mmol/mol), despite at least 90 days of treatment with an SGLT-2 inhibitor, were randomly assigned (1:1) to receive subcutaneous semaglutide 1·0 mg or volume-matched placebo once weekly for 30 weeks, after a dose-escalation schedule of 4 weeks of 0·25 mg semaglutide or placebo and 4 weeks of 0·5 mg semaglutide or placebo. Existing antidiabetic medications, including SGLT-2 inhibitor treatment, were continued for the duration of the trial. Rescue medication, defined as intensification of background antidiabetic treatment or the initiation of new glucose-lowering medications, could be given to patients meeting specific criteria at the discretion of the investigator. The primary outcome was change in HbA 1c  from baseline at week 30, assessed in the full analysis set (all patients randomly allocated to treatment) using on-treatment data collected before rescue medication was started. The confirmatory secondary outcome was change in bodyweight from baseline to week 30. Safety was also assessed in the safety analysis set (all patients who received at least one dose of treatment). The trial was registered with ClinicalTrials.gov (NCT03086330).
FINDINGS


Between March 15, and Dec 4, 2017, 302 patients were enrolled and randomly assigned to receive semaglutide 1·0 mg or placebo (full analysis set), of whom 301 received at least one dose of treatment (safety analysis set). One patient was assigned to semaglutide but was not treated (reason unknown). 294 (97·4%) patients completed the trial and 267 (88·4%) completed treatment. Baseline characteristics were generally comparable between groups. In addition to randomised medication and SGLT-2 inhibitor, 216 (71·5%) patients were taking metformin and 39 (12·9%) were taking sulphonylurea. Patients given semaglutide had greater reductions in HbA 1c  (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001). 356 adverse events were reported by 104 (69·3%) patients in the semaglutide group, and 247 adverse events were reported by 91 (60·3%) patients in the placebo group. Gastrointestinal adverse events were most common and were reported in 56 (37·3%) patients in the semaglutide group and 20 (13·2%) in the placebo group. Serious adverse events occurred in seven (4·7%) patients in the semaglutide group and six (4·0%) in the placebo group. Severe or blood glucose-confirmed hypoglycaemic events were reported in four patients on semaglutide (2·7%). 16 patients stopped treatment early because of an adverse event, 13 of whom were in the semaglutide group. There were no deaths during the trial.
INTERPRETATION


Adding semaglutide to SGLT-2 inhibitor therapy significantly improves glycaemic control and reduces bodyweight in patients with inadequately controlled type 2 diabetes, and is generally well tolerated.
FUNDING


Novo Nordisk.",2019,Patients given semaglutide had greater reductions in HbA 1c  (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001).,"['patients with inadequately controlled type 2 diabetes', '16 patients stopped treatment early because of an adverse event, 13 of whom were in the semaglutide group', 'Adults with type 2 diabetes and HbA 1c  7·0', '294', 'Between March 15, and Dec 4, 2017, 302 patients']","['placebo', 'SGLT-2 inhibitor', 'metformin', 'SGLT-2 inhibitor therapy', 'subcutaneous semaglutide 1·0 mg or volume-matched placebo', 'semaglutide 1·0 mg or placebo', 'semaglutide or placebo and 4 weeks of 0·5 mg semaglutide or placebo', 'sulphonylurea']","['Gastrointestinal adverse events', 'change in bodyweight', 'Severe or blood glucose-confirmed hypoglycaemic events', 'adverse events', 'change in HbA 1c', '356 adverse events', 'efficacy and safety', 'glycaemic control and reduces bodyweight', 'Serious adverse events', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",302.0,0.598547,Patients given semaglutide had greater reductions in HbA 1c  (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001).,"[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Mount Sinai Hospital, Toronto, ON, Canada. Electronic address: zinman@lunenfeld.ca.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Bhosekar', 'Affiliation': 'Novo Nordisk, Bengaluru, India.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Albany Medical Center Division of Community Endocrinology, Albany, NY, USA.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ludvik', 'Affiliation': '1st Medical Department and Karl Landsteiner Institute for Obesity and Metabolic Disorders, Rudolfstiftung Hospital, Vienna, Austria.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Thielke', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thrasher', 'Affiliation': 'Medical Investigations, Inc, Little Rock, AR, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Woo', 'Affiliation': 'University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, San Diego, CA, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30066-X']
1399,29521723,Large Balloon Dilatation Versus Mechanical Lithotripsy After Endoscopic Sphincterotomy in the Management of Large Common Bile Duct Stones in Cirrhotic Patients: A Randomized Study.,"BACKGROUND AND STUDY AIM


Removal of large common bile duct (CBD) stones is one of the challenges faced during endoscopic retrograde cholangiopancreatography, and it seems more difficult in cirrhotic patients because of suspected higher rates of adverse events, especially bleeding diathesis. This study aimed at comparing the success rate and complications between mechanical lithotripsy (ML) and large balloon dilation (LBD) after endoscopic sphincterotomy in patients with liver cirrhosis.
PATIENTS AND METHODS


Ninety-eight cirrhotic patients with calcular obstructive jaundice were included and randomly divided into 2 groups: group A comprising 49 patients treated by LBD and group B comprising 49 patients treated by ML. All patients underwent sphincterotomy initially. All patients were subjected to thorough history taking and complete clinical examination. Pancreatic enzyme concentrations were measured 4 hours before and 24 hours after the procedure, and complete blood cell count and liver function tests were performed before and the morning after the procedure. Before and during endoscopic retrograde cholangiopancreatography, stone size and number were verified.
RESULTS


The success rate for CBD clearance was 98% and 93.8% for LBD and ML, respectively. The rate of adverse events in this study was 10.2% (10/98), and bleeding was the commonest reported complication (5/10). Group B developed more (16.3%) adverse events than group A (4.1%), and the difference was statistically significant (P=0.04).
CONCLUSION


Endoscopic sphincterotomy followed by LBD is a safe and effective treatment for large CBD stones in cirrhotic patients in comparison with sphincterotomy followed by ML.",2019,"Group B developed more (16.3%) adverse events than group A (4.1%), and the difference was statistically significant (P=0.04).
","['Cirrhotic Patients', 'patients with liver cirrhosis', 'Ninety-eight cirrhotic patients with calcular obstructive jaundice', 'cirrhotic patients']","['Endoscopic sphincterotomy followed by LBD', 'mechanical lithotripsy (ML) and large balloon dilation (LBD', 'Endoscopic Sphincterotomy', 'LBD and group B comprising 49 patients treated by ML', 'Large Balloon Dilatation Versus Mechanical Lithotripsy', 'endoscopic sphincterotomy']","['Pancreatic enzyme concentrations', 'bleeding', 'adverse events', 'complete blood cell count and liver function tests', 'rate of adverse events', 'success rate for CBD clearance']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}]","[{'cui': 'C0085263', 'cui_str': 'Endoscopic Biliary Sphincterotomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0920330', 'cui_str': 'Product containing pancreatic enzyme (product)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0023901', 'cui_str': 'Liver Function Tests'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",98.0,0.0417099,"Group B developed more (16.3%) adverse events than group A (4.1%), and the difference was statistically significant (P=0.04).
","[{'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Radwan', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Emara', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Ibrahim', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Mahmoud E', 'Initials': 'ME', 'LastName': 'Moursy', 'Affiliation': 'Gastroenterology Department, Al-Ahrar Teaching Hospital, Zagazig.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001000']
1400,30830883,Effects of a Short-term Mindfulness-Based Intervention on Comfort of Stroke Survivors Undergoing Inpatient Rehabilitation.,"PURPOSE


The aim of the study was to evaluate the effectiveness of a modified short-term mindfulness-based intervention on improving the mindfulness, comfort, and ambulation ability of stroke survivors undergoing inpatient rehabilitation in Wuhan, China.
DESIGN


A two-group, nonrandomized, nonconcurrent design was used.
METHOD


Participants undergoing inpatient rehabilitation were nonrandomly divided into control group (n = 25) and intervention group (n = 25) to avoid possible ethical discrimination as well as interaction among participants. The control group received routine care; the intervention group received a 2-week mindfulness-based intervention, which included weekly 1.5-hour group practice, individual daily practice, and routine care. Data were collected using questionnaires and assessments of ambulation before and after 2 weeks of observation.
FINDINGS


Improvement on the Mindful Attention Awareness Scale score, the overall score of the Shortened General Comfort Questionnaire, and the scores of the physical, psychospiritual, and sociocultural subscales in the intervention group was greater than those in the control group (p < .05). No significant difference (p > .05) was observed between the two groups when comparing scores of the environmental subscale of Shortened General Comfort Questionnaire, Berg Balance Scale, 10-Meter Walk Test, and Functional Ambulation Classification scale.
CONCLUSIONS AND CLINICAL RELEVANCE


A 2-week mindfulness-based intervention can significantly improve stroke survivors' mindfulness and comfort but does not significantly affect ambulation ability.",2019,A 2-week mindfulness-based intervention can significantly improve stroke survivors' mindfulness and comfort but does not significantly affect ambulation ability.,"['stroke survivors undergoing inpatient rehabilitation in Wuhan, China', 'Participants undergoing inpatient rehabilitation', 'Stroke Survivors Undergoing Inpatient Rehabilitation']","['routine care; the intervention group received a 2-week mindfulness-based intervention, which included weekly 1.5-hour group practice, individual daily practice, and routine care', 'modified short-term mindfulness-based intervention', 'Short-term Mindfulness-Based Intervention']","['environmental subscale of Shortened General Comfort Questionnaire, Berg Balance Scale, 10-Meter Walk Test, and Functional Ambulation Classification scale', ""stroke survivors' mindfulness and comfort"", 'Mindful Attention Awareness Scale score, the overall score of the Shortened General Comfort Questionnaire, and the scores of the physical, psychospiritual, and sociocultural subscales']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0222045'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",25.0,0.0136758,A 2-week mindfulness-based intervention can significantly improve stroke survivors' mindfulness and comfort but does not significantly affect ambulation ability.,"[{'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'HOPE School of Nursing, Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Weijing', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'HOPE School of Nursing, Wuhan University, Wuhan, Hubei, China.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/rnj.0000000000000098']
1401,32079999,The Influence of a Positive Empathetic Interaction on Conditioned Pain Modulation and Manipulation-induced Analgesia in People With Lateral Epicondylalgia.,"OBJECTIVE


Conditioned pain modulation (CPM) and manipulation-induced analgesia (MIA) are 2 forms of endogenous analgesia. Many forms of analgesia can be influenced by the nature of the patient-clinician interaction. The aim of this study was to evaluate the influence of an empathetic and supportive interaction on CPM and MIA in people with lateral epicondylalgia (LE).
MATERIAL AND METHODS


In a double-blind, randomized, controlled trial, 68 participants with LE were assigned to 2 groups: the empathetic and neutral interaction groups. The interactions were carried out by a trained, professional role-play actor, playing the part of a research assistant. The research assistant actor spent 15 minutes before CPM and MIA assessment interacting with the participants in an empathetic or neutral manner. Immediately after the interaction, a blinded assessor measured pressure pain threshold at the symptomatic elbow and ipsilateral wrist during CPM and MIA testing. Linear mixed models were used to evaluate differences in CPM and MIA responses between the interaction groups.
RESULTS


There was a significant difference in Consultation and Relational Empathy scores between the groups (P<0.001), indicating that the intervention group experienced a more empathic interaction. Both groups showed a significant increase in pressure pain threshold measures, indicative of a CPM and MIA analgesic response (P<0.001), however, the analgesic responses were greater in the group that had experienced a supportive, empathetic interaction (post CPM, wrist: P<0.001; elbow: P=0.001) (post MIA wrist: P<0.001; elbow: P=0.001).
DISCUSSION


A single session of empathetic interaction positively influenced both CPM and MIA responses in people with LE.",2020,"Both groups showed a significant increase in PPT measures, indicative of a CPM and MIA analgesic response (P<0.001), however the analgesic responses were greater in the group that had experienced a supportive, empathetic interaction (post CPM, wrist: P<0.001; elbow: P=0.001), (post MIA wrist: P=<0.001; elbow: P=0.001).
","['People with Lateral Epicondylalgia', 'people with LE', 'people with Lateral Epicondylalgia (LE', '68 participants with LE']","['Positive Empathetic Interaction', 'Conditioned pain modulation (CPM) and manipulation induced analgesia (MIA']","['pressure pain threshold (PPT', 'analgesic responses', 'empathic interaction', 'PPT measures, indicative of a CPM and MIA analgesic response', 'CARE scores', 'CPM and MIA responses']","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",68.0,0.101625,"Both groups showed a significant increase in PPT measures, indicative of a CPM and MIA analgesic response (P<0.001), however the analgesic responses were greater in the group that had experienced a supportive, empathetic interaction (post CPM, wrist: P<0.001; elbow: P=0.001), (post MIA wrist: P=<0.001; elbow: P=0.001).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Muhsen', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Moss', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gibson', 'Affiliation': 'School of Physiotherapy, University of Notre Dame Australia, Fremantle, WA, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Walker', 'Affiliation': 'Chiropractic program, College of Science, Health, Engineering and Education, Murdoch University.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schug', 'Affiliation': 'Discipline of Anaesthesiology, University of Western Australia, Perth.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000822']
1402,30707478,Contralateral segmental transcutaneous electrical nerve stimulation inhibits nociceptive flexion reflex in healthy participants.,"BACKGROUND


Transcutaneous electrical nerve stimulation (TENS) is a non-invasive treatment to relieve pain. Contralateral TENS (i.e. TENS administered to the contralateral side of a painful body part) is beneficial when TENS cannot be directly applied to pain site, such as in cases of trauma. Although TENS produces segmental analgesia in an ipsilateral limb, it has been unclear whether TENS produces higher analgesic effects in the contralateral segmental area. The aim of the present study was to investigate the analgesic effects of TENS in contralateral segmental or extra-segmental areas on physiological and subjective pain outcomes, using a nociceptive flexion reflex (NFR) method.
METHODS


We randomly allocated 60 healthy participants to three groups: contralateral segmental TENS (CS-TENS); contralateral extra-segmental TENS (CE-TENS); and contralateral placebo TENS (CP-TENS). CS-TENS was applied to right superficial sural nerve and CE-TENS was applied to the right superficial femoral nerve, each for 30 minutes. The magnitude of the NFR elicited by electrical stimulation of the left sural nerve was measured at baseline and at three subsequent 10-minute intervals. Subjective pain intensity was measured simultaneously with a visual analogue scale (VAS).
RESULTS


At 30 min, the NFR magnitude of CS-TENS group was significantly lower than that of the CP-TENS group (p = 0.021). There were no significant differences in VAS scores among the groups at any time point.
CONCLUSIONS


Our findings suggest that CS-TENS inhibited NFR. Although there was no significant between-group difference in subjective pain intensity, factors such as a placebo effect probably impacted it.
SIGNIFICANCE


Our findings provide support for the contralateral approach at stimulation sites when TENS cannot be directly administered to a pain site (e.g. due to disease or trauma).",2019,"At 30 min, the NFR magnitude of CS-TENS group was significantly lower than that of the CP-TENS group (p = 0.021).","['60 healthy participants to three groups', 'healthy participants']","['Contralateral TENS (i.e. TENS', 'CP-TENS', 'contralateral segmental TENS (CS-TENS); contralateral extra-segmental TENS (CE-TENS); and contralateral placebo TENS (CP-TENS', 'TENS', 'Contralateral segmental transcutaneous electrical nerve stimulation inhibits nociceptive flexion reflex', 'Transcutaneous electrical nerve stimulation (TENS', 'nociceptive flexion reflex (NFR) method']","['NFR magnitude', 'Subjective pain intensity', 'subjective pain intensity', 'VAS scores', 'visual analogue scale (VAS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1264664', 'cui_str': 'Number fraction'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.0290577,"At 30 min, the NFR magnitude of CS-TENS group was significantly lower than that of the CP-TENS group (p = 0.021).","[{'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Rehabilitation, Gakkentoshi Hospital, Kyoto, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Shomoto', 'Affiliation': 'Graduate School of Health Science, Kio University, Nara, Japan.'}]","European journal of pain (London, England)",['10.1002/ejp.1373']
1403,30872083,A Systematic Approach for Prescribing Posthospitalization Home-Based Physical Activity for Mobility in Older Adults: The PATH Study.,"BACKGROUND


Older patients experience increased loss of mobility after hospitalization, largely because of physical disabilities and inactivity. There are, however, no current recommendations for prescribing physical activity (PA) at hospital discharge.
OBJECTIVES


Develop a decisional tree for the systematic prescription of an individualized, adapted, nonsupervised home-based PA program for older adults after hospital discharge; investigate its feasibility, acceptability, and safety; and estimate its efficacy at improving physical function and mobility.
DESIGN


Pragmatic prospective single-arm pilot study.
SETTING AND PARTICIPANTS


Geriatric assessment unit (GAU).
PARTICIPANTS


Age ≥65 years, Mini-Mental State Examination score ≥18, hospitalization >7 days, discharge to home, no PA contraindications, understand French or English.
METHODS


Development of a decisional tree for prescription of home-based exercise programs (Preventing loss of Autonomy by Treatment Post-Hospitalization: PATH tool) through meetings with a group of experts. The PATH tool was implemented in a short-term geriatric hospital. Feasibility, acceptability, and safety outcomes were measured and potential efficacy estimated after a 12-week period.
RESULTS


The decisional tree has 3 main components (cognitive, cardio strength, and balance) and comprises 27 different mobility profiles and PA programs. Fifty-six of the first 100 successively admitted GAU patients were found eligible, of whom 29 agreed to participate and 17 completed the protocol. Most were satisfied (14/17) and enjoyed (13/17) the program, and most health professionals found it relevant to patients (7/8) without extra burden (6/8) to patient care. Adherence to the PA program was 5 sessions/wk, and a medium to large effect size on walking speed (P < .01, d = 1.04), chair stand performance (P = .04, d = 0.75), and PA level (P = .07, d = 0.56) was observed after a 12-week period.
CONCLUSIONS AND IMPLICATIONS


This study suggests that implementing the PATH tool might be feasible across GAUs, as well as safe and acceptable for patients and health care professionals. If this intervention proves beneficial after conducting a randomized controlled trial, this hospital-initiated care transition strategy should be implemented in short-term geriatric hospitals to prevent long-term mobility disability.",2019,"Develop a decisional tree for the systematic prescription of an individualized, adapted, nonsupervised home-based PA program for older adults after hospital discharge; investigate its feasibility, acceptability, and safety; and estimate its efficacy at improving physical function and mobility.
","['Older patients', 'Age ≥65\xa0years, Mini-Mental State Examination score ≥18, hospitalization >7\xa0days, discharge to home, no PA contraindications, understand French or English', 'older adults after hospital discharge', 'Older Adults', 'Geriatric assessment unit (GAU', 'Fifty-six of the first 100 successively admitted GAU patients were found eligible, of whom 29 agreed to participate and 17 completed the protocol']",['decisional tree for prescription of home-based exercise programs'],"['Feasibility, acceptability, and safety outcomes', 'feasibility, acceptability, and safety', 'PA level', 'chair stand performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184713', 'cui_str': 'Patient discharge, to home, routine (procedure)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0040811', 'cui_str': 'Trees'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",100.0,0.0309619,"Develop a decisional tree for the systematic prescription of an individualized, adapted, nonsupervised home-based PA program for older adults after hospital discharge; investigate its feasibility, acceptability, and safety; and estimate its efficacy at improving physical function and mobility.
","[{'ForeName': 'Livia P', 'Initials': 'LP', 'LastName': 'Carvalho', 'Affiliation': ""Centre de Recherche, Institut Universitaire de Gériatrie de Montréal (IUGM), CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada; Département des Sciences de l'Activité Physique, Faculté des Sciences, Université du Québec à Montréal, Montreal, Canada.""}, {'ForeName': 'Marie-Jeanne', 'Initials': 'MJ', 'LastName': 'Kergoat', 'Affiliation': ""Centre de Recherche, Institut Universitaire de Gériatrie de Montréal (IUGM), CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada; Faculté de Médecine, Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Bolduc', 'Affiliation': ""Centre de Recherche, Institut Universitaire de Gériatrie de Montréal (IUGM), CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Mylène', 'Initials': 'M', 'LastName': 'Aubertin-Leheudre', 'Affiliation': ""Centre de Recherche, Institut Universitaire de Gériatrie de Montréal (IUGM), CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada; Département des Sciences de l'Activité Physique, Faculté des Sciences, Université du Québec à Montréal, Montreal, Canada. Electronic address: aubertin-leheudre.mylene@uqam.ca.""}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.143']
1404,30835880,"Effects of blood storage age on immune, coagulation, and nitric oxide parameters in transfused patients undergoing cardiac surgery.","BACKGROUND


Retrospective studies suggested that storage age of RBCs is associated with inflammation and thromboembolism. The Red Cell Storage Duration Study (RECESS) trial randomized subjects undergoing complex cardiac surgery to receive RBCs stored for shorter versus longer periods, and no difference was seen in the primary outcome of change in multiple organ dysfunction score.
STUDY DESIGN AND METHODS


In the current study, 90 subjects from the RECESS trial were studied intensively using a range of hemostasis, immunologic, and nitric oxide parameters. Samples were collected before transfusion and on Days 2, 6, 28, and 180 after transfusion.
RESULTS


Of 71 parameters tested, only 4 showed a significant difference after transfusion between study arms: CD8+ T-cell interferon-γ secretion and the concentration of extracellular vesicles bearing the B-cell marker CD19 were higher, and plasma endothelial growth factor levels were lower in recipients of fresh versus aged RBCs. Plasma interleukin-6 was higher at Day 2 and lower at Days 6 and 28 in recipients of fresh versus aged RBCs. Multiple parameters showed significant modulation after surgery and transfusion. Most analytes that changed after surgery did not differ based on transfusion status. Several extracellular vesicle markers, including two associated with platelets (CD41a and CD62P), decreased in transfused patients more than in those who underwent surgery without transfusion.
CONCLUSIONS


Transfusion of fresh versus aged RBCs does not result in substantial changes in hemostasis, immune, or nitric oxide parameters. It is possible that transfusion modulates the level of platelet-derived extracellular vesicles, which will require study of patients randomly assigned to receipt of transfusion to define.",2019,Plasma interleukin-6 was higher at Day 2 and lower at Days 6 and 28 in recipients of fresh versus aged RBCs.,"['90 subjects from the RECESS trial', 'transfused patients undergoing cardiac surgery']",[],"['immune, coagulation, and nitric oxide parameters', 'CD8+ T-cell interferon-γ secretion and the concentration of extracellular vesicles bearing the B-cell marker CD19', 'plasma endothelial growth factor levels', 'multiple organ dysfunction score', 'Plasma interleukin-6', 'hemostasis, immune, or nitric oxide parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],"[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0443980', 'cui_str': 'B-cell marker (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079280', 'cui_str': 'ECDGF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1960439', 'cui_str': 'MODS Scores'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",90.0,0.19215,Plasma interleukin-6 was higher at Day 2 and lower at Days 6 and 28 in recipients of fresh versus aged RBCs.,"[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine in St. Louis, Saint Louis, Missouri.'}, {'ForeName': 'Roman M', 'Initials': 'RM', 'LastName': 'Sniecinski', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'Inglis', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Ranganathan', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Heitman', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Fania', 'Initials': 'F', 'LastName': 'Szlam', 'Affiliation': 'Department of Anesthesiology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Danesh', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Mars', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Keating', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}, {'ForeName': 'Jerrold H', 'Initials': 'JH', 'LastName': 'Levy', 'Affiliation': 'Department of Anesthesiology and Critical Care, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Assmann', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Steiner', 'Affiliation': 'Department of Hematology and Pediatrics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Doctor', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine in St. Louis, Saint Louis, Missouri.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Norris', 'Affiliation': 'Vitalant Research Institute, San Francisco, California.'}]",Transfusion,['10.1111/trf.15228']
1405,29787954,DUPLICATE: The effectiveness of a cognitive training program in people with mild cognitive impairment: A study in urban community.,"OBJECTIVE


To assess the effectiveness of a cognitive training program on global cognition among people with mild cognitive impairment.
METHODS


In this experimental study, using purposive sampling, 60 participants age 50 years and over who complained of subjective memory impairment were screened in their communities by public health volunteers with the Abbreviated Mental Test. Those with dementia were excluded as well as those with depression, which were screened out by the Thai Geriatric Depression Scale (TGDS-15). Mild cognitive impairment was diagnosed and confirmed by the Montreal Cognitive Assessment (MoCA) and joint agreement between a psychiatrist and a neurologist. The participants were alternately assigned to receive a cognitive training program (intervention group) while the other half received their normal usual therapy (control group). The program involved training of 4 aspects of cognition through 6 sessions; 2 sessions per month for 3 months. The MoCA and TGDS-15 scales were given at baseline and again at week 13, and at months 6 and 9. Independent t-tests were used to compare changes in global cognition among the two groups.
RESULTS


MoCA scores at 9 months were significantly higher than at baseline in both groups. However, the mean difference in intervention group was significantly higher than control group. TGDS-15 scores at 6 months was significantly lower than at baseline among the intervention group but not the control group.
CONCLUSION


This cognitive training program helped to improve global cognition and reduce depressive symptoms.",2018,"TGDS-15 scores at 6 months was significantly lower than at baseline among the intervention group but not the control group.
","['people with mild cognitive impairment', 'urban community', '60 participants age 50 years and over who complained of subjective memory impairment were screened in their communities by public health volunteers with the Abbreviated Mental Test']","['cognitive training program (intervention group) while the other half received their normal usual therapy (control group', 'cognitive training program']","['TGDS-15 scores', 'global cognition', 'Thai Geriatric Depression Scale (TGDS-15', 'MoCA scores', 'global cognition and reduce depressive symptoms', 'Montreal Cognitive Assessment (MoCA) and joint agreement', 'Mild cognitive impairment', 'MoCA and TGDS-15 scales']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450977', 'cui_str': ""Hodkinson's test""}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3496286'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0222045'}]",60.0,0.0197505,"TGDS-15 scores at 6 months was significantly lower than at baseline among the intervention group but not the control group.
","[{'ForeName': 'Chalermpong', 'Initials': 'C', 'LastName': 'Sukontapol', 'Affiliation': 'Vachira Phuket Hospital, Muang District, Phuket, 83000, Thailand. Electronic address: chalermpongs@hotmail.com.'}, {'ForeName': 'Sasithorn', 'Initials': 'S', 'LastName': 'Kemsen', 'Affiliation': 'Songkhlarajanakarindra Psychiatric Hospital, Muang District, Songkhla, 90000, Thailand. Electronic address: sasit3124@hotmail.co.th.'}, {'ForeName': 'Sirintorn', 'Initials': 'S', 'LastName': 'Chansirikarn', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Ratchathewi, Bangkok10400, Thailand. Electronic address: sirintorn.cha@mahidol.ac.th.'}, {'ForeName': 'Daochompu', 'Initials': 'D', 'LastName': 'Nakawiro', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Ratchathewi, Bangkok, 10400, Thailand. Electronic address: daochompu.nak@mahidol.ac.th.'}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Kuha', 'Affiliation': 'Institute of Geriatrics Medicine, Department of Medical Service, Ministry of Public Health, Muang District, Nonthaburi11000, Thailand. Electronic address: orawan.k@dms.mail.go.th.'}, {'ForeName': 'Unchulee', 'Initials': 'U', 'LastName': 'Taemeeyapradit', 'Affiliation': 'Songkhlarajanakarindra Psychiatric Hospital, Muang District, Songkhla, 90000, Thailand. Electronic address: unchulee44@gmail.com.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2018.05.019']
1406,30849931,Acute Effects of Interrupting Prolonged Sitting With Intermittent Physical Activity on Blood Pressure in Preadolescent Children.,"PURPOSE


To compare the acute effects of intermittent physical activity (PA) across 4 different intensities on blood pressure.
METHODS


Thirty children (12 males and 18 females; aged 7-11 y; 33% overweight/obese; 53% nonwhite) completed 4 experimental conditions in random order: 8 hours sitting interrupted with 20, 2-minute low-, moderate-, high-intensity PA breaks, or sedentary screen-time breaks. PA intensity corresponded with 25%, 50%, and 75% of heart rate reserve. Blood pressure was measured during each condition in the morning (0800 h), noon (1200 h), and afternoon (1600 h).
RESULTS


There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05). There was a significant effect of time with SBP decreasing throughout the day for all conditions (average morning SBP: 106 [1] mm Hg, average noon SBP: 101 [2] mm Hg, average afternoon SBP: 103 [1] mm Hg; P = .01). There were no significant effects of condition or time on diastolic blood pressure (all Ps > .05).
CONCLUSION


While sedentary behavior is known to be associated with hypertension in both adults and children, a single bout of prolonged sitting may be insufficient to produce hypertensive effects in otherwise healthy children. Future research should examine the appropriate dose of intermittent PA to accrue hypotensive responses in preadolescent children.",2019,There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05).,"['preadolescent children', 'aged 7-11\xa0y; 33% overweight/obese; 53% nonwhite) completed 4 experimental conditions in random order: 8', 'Thirty children (12 males and 18 females', 'Preadolescent Children']","['intermittent physical activity (PA', 'hours sitting interrupted with 20, 2-minute low-, moderate-, high-intensity PA breaks, or sedentary screen-time breaks', 'Prolonged Sitting With Intermittent Physical Activity']","['PA intensity', 'time with SBP', 'Blood Pressure', 'condition or time on diastolic blood pressure', 'systolic blood pressure', 'Blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",30.0,0.0442614,There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05).,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Weston', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nagy', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Tiwaloluwa A', 'Initials': 'TA', 'LastName': 'Ajibewa', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Hasson', 'Affiliation': 'University of Michigan.'}]",Pediatric exercise science,['10.1123/pes.2018-0224']
1407,30815933,"A pilot evaluation of an advocacy programme on knowledge, empowerment, family-school partnership and parent well-being.","BACKGROUND


Internationally, it has been recognised that parents need to advocate for their children with disabilities to receive services. However, many parents find advocacy difficult because of systemic and logistical barriers. As such, parents of children with disabilities may seek a special education advocate to help them understand their child's rights and secure services. Yet little research has been conducted about programmes to develop special education advocates.
METHODS


In this study, we conducted a comparison study to determine the association of an advocacy programme (i.e. the Volunteer Advocacy Project) on a primary outcome (i.e. special education knowledge) and other outcomes (i.e. family-school partnership, empowerment and parent well-being). Specifically, in 2017, 34 participants, all mothers of children with disabilities, were recruited from disability organisations in the USA. Seventeen mothers participated in the intervention group (i.e. the advocacy training), while 17 mothers participated in the wait list control group. The Volunteer Advocacy Project is a 36 hr advocacy training for individuals to gain instrumental and affective knowledge to advocate for their own children with disabilities and for other families. All participants completed a pre-survey and post-survey; only intervention group participants completed a 6-month follow-up survey.
RESULTS


Compared with 17 wait list control group participants, the 17 intervention group participants demonstrated improvements in special education knowledge, P = 0.002, η 2   = 0.32, and self-mastery, P = 0.04, η 2   = 0.15, and decreases in the quality of family-school partnerships, P = 0.002, η 2   = 0.32. At the follow-up survey, intervention group participants demonstrated increases in empowerment, P = 0.04, η 2   = 0.29, and special education knowledge, P = 0.02, η 2   = 0.38.
CONCLUSIONS


Implications for research including the need for a randomised controlled trial are discussed; also, practitioners need to evaluate advocacy training programmes regarding their effectiveness.",2019,"At the follow-up survey, intervention group participants demonstrated increases in empowerment, P = 0.04, η 2   = 0.29, and special education knowledge, P = 0.02, η 2   = 0.38.
","['Seventeen mothers participated in the intervention group (i.e. the advocacy training), while 17 mothers participated in the wait list control group', 'parents of children with disabilities', '34 participants, all mothers of children with disabilities, were recruited from disability organisations in the USA']","['advocacy programme (i.e. the Volunteer Advocacy Project', 'advocacy training', 'advocacy programme']","['quality of family-school partnerships', 'special education knowledge']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0259916', 'cui_str': 'Children with Disabilities'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}]","[{'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",17.0,0.0401774,"At the follow-up survey, intervention group participants demonstrated increases in empowerment, P = 0.04, η 2   = 0.29, and special education knowledge, P = 0.02, η 2   = 0.38.
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Burke', 'Affiliation': 'Department of Special Education, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Lee', 'Affiliation': 'Department of Special Education, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rios', 'Affiliation': 'Department of Special Education, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12613']
1408,30727006,Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial.,,2018,,['recurrent benign esophageal strictures'],['Dilation or biodegradable stent placement'],[],"[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0341130', 'cui_str': 'Benign esophageal stricture (disorder)'}]","[{'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}]",[],,0.20251,,"[{'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Walter', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Maarten W', 'Initials': 'MW', 'LastName': 'van den Berg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meike M', 'Initials': 'MM', 'LastName': 'Hirdes', 'Affiliation': 'Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Vleggaar', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Pierre H', 'Initials': 'PH', 'LastName': 'Deprez', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium.'}, {'ForeName': 'Bartolomé L', 'Initials': 'BL', 'LastName': 'Viedma', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'Laurence B', 'Initials': 'LB', 'LastName': 'Lovat', 'Affiliation': 'Division of Surgery and Interventional Science, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Bas L', 'Initials': 'BL', 'LastName': 'Weusten', 'Affiliation': 'Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Raf', 'Initials': 'R', 'LastName': 'Bisschops', 'Affiliation': 'Department of Gastroenterology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Haidry', 'Affiliation': 'Department of Gastroenterology, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Sanborn', 'Affiliation': 'Cook Research Incorporated, West Lafayette, Indiana, United States.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Leary"", 'Affiliation': 'Cook Research Incorporated, West Lafayette, Indiana, United States.'}, {'ForeName': 'Jeanin E', 'Initials': 'JE', 'LastName': 'van Hooft', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Siersema', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",Endoscopy,['10.1055/a-0843-5973']
1409,30872081,Signs and Symptoms of Low-Intake Dehydration Do Not Work in Older Care Home Residents-DRIE Diagnostic Accuracy Study.,"OBJECTIVES


To assess the diagnostic accuracy of commonly used signs and symptoms of low-intake dehydration in older care home residents.
DESIGN


Prospective diagnostic accuracy study.
SETTING


56 care homes offering residential, nursing, and/or dementia care to older adults in Norfolk and Suffolk, United Kingdom.
PARTICIPANTS


188 consecutively recruited care home residents aged ≥65 years, without cardiac or renal failure and not receiving palliative care. Overall, 66% were female, the mean age was 85.7 years (standard deviation 7.8), and the median Mini-Mental State Examination MMSE score was 23 (interquartile range 18-26).
INDEX TESTS


Over 2 hours, participants underwent double-blind assessment of 49 signs and symptoms of dehydration and measurement of serum osmolality from a venous blood sample. Signs and symptoms included skin turgor; mouth, skin, and axillary dryness; capillary refill; sunken eyes; blood pressure on resting and after standing; body temperature; pulse rate; and self-reported feelings of thirst and well-being.
REFERENCE STANDARD


Serum osmolality, with current dehydration defined as >300 mOsm/kg, and impending dehydration ≥295 mOsm/kg.
OUTCOME MEASURES


For dichotomous tests, we aimed for sensitivity and specificity >70%, and for continuous tests, an area under the curve in receiver operating characteristic plots of >0.7.
RESULTS


Although 20% of residents had current low-intake dehydration and a further 28% impending dehydration, none of the commonly used clinical signs and symptoms usefully discriminated between participants with or without low-intake dehydration at either cut-off.
CONCLUSIONS/IMPLICATIONS


This study consolidates evidence that commonly used signs and symptoms of dehydration lack even basic levels of diagnostic accuracy in older adults, implying that many who are dehydrated are not being identified, thus compromising their health and well-being. We suggest that these tests be withdrawn from practice and replaced with a 2-stage screening process that includes serum osmolarity, calculated from sodium, potassium, urea, and glucose levels (assessed routinely using the Khajuria and Krahn equation), followed by serum osmolality measurement for those identified as high risk (calculated serum osmolarity >295 mmol/L).",2019,"Although 20% of residents had current low-intake dehydration and a further 28% impending dehydration, none of the commonly used clinical signs and symptoms usefully discriminated between participants with or without low-intake dehydration at either cut-off.
","['56 care homes offering residential, nursing', 'older adults in Norfolk and Suffolk, United Kingdom', 'older adults', 'STANDARD\n\n\nSerum osmolality, with current dehydration defined as >300 mOsm/kg, and impending dehydration ≥295 mOsm/kg', '188 consecutively recruited care home residents aged ≥65\xa0years, without cardiac or renal failure and not receiving palliative care', 'older care home residents']",[],"['serum osmolarity, calculated from sodium, potassium, urea, and glucose levels', 'sensitivity and specificity >70%, and for continuous tests, an area under the curve in receiver operating characteristic plots of >0.7', 'median Mini-Mental State Examination MMSE score', 'Signs and symptoms included skin turgor; mouth, skin, and axillary dryness; capillary refill; sunken eyes; blood pressure on resting and after standing; body temperature; pulse rate; and self-reported feelings of thirst and well-being']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0454866', 'cui_str': 'Norfolk (geographic location)'}, {'cui': 'C0454876', 'cui_str': 'Suffolk (geographic location)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum (procedure)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332190', 'cui_str': 'Impending (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0277937', 'cui_str': 'Skin turgor (observable entity)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0425716', 'cui_str': 'Capillary refill time'}, {'cui': 'C0423224', 'cui_str': 'Sunken eyes (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}]",188.0,0.0527188,"Although 20% of residents had current low-intake dehydration and a further 28% impending dehydration, none of the commonly used clinical signs and symptoms usefully discriminated between participants with or without low-intake dehydration at either cut-off.
","[{'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Bunn', 'Affiliation': 'School of Health Sciences, Norwich Research Park, University of East Anglia, Norwich, Norfolk, England, United Kingdom. Electronic address: d.bunn@uea.ac.uk.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Hooper', 'Affiliation': 'Norwich Medical School, Norwich Research Park, University of East Anglia, Norwich, Norfolk, England, United Kingdom.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.122']
1410,30874378,Effect of suvorexant on nighttime blood pressure in hypertensive patients with insomnia: The SUPER-1 study.,"Orexins are neuropeptides that play a role in maintaining wakefulness and contribute to central regulation of cardiovascular function. This first multicenter, randomized, double-blind study investigated the effects of suvorexant, a reversible dual orexin receptor antagonist, on nighttime blood pressure (BP) in patients with insomnia and hypertension. After a 4-week run-in period, adult outpatients (n = 82) with treated hypertension (clinic SBP <160 mm Hg) and insomnia were treated with suvorexant 20 mg/d or placebo before bedtime for 2 weeks. Twenty-four-hour ambulatory BP monitoring was performed at baseline and the end of treatment, and home BP measurements (morning and evening) were taken daily. Nighttime systolic BP (SBP), the primary endpoint, decreased slightly from baseline to week 2 in both the suvorexant and placebo groups (-4.4 vs -1.8 mm Hg; P = 0.494). Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring) also decreased slightly and similarly from baseline in both groups. In this study, suvorexant had no overall effect on BP in patients with insomnia and treated hypertension.",2019,"Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring) also decreased slightly and similarly from baseline in both groups.","['adult outpatients (n\xa0=\xa082) with treated hypertension (clinic SBP <160\xa0mm\xa0Hg) and', 'hypertensive patients with insomnia', 'patients with insomnia and treated hypertension', 'patients with insomnia and hypertension']","['suvorexant 20\xa0mg/d or placebo', 'placebo', 'suvorexant', 'suvorexant, a reversible dual orexin receptor antagonist']","['Nighttime systolic BP (SBP', 'Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring', 'nighttime blood pressure (BP', 'BP', 'nighttime blood pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0989369,"Clinic, 24-hour, daytime and morning SBP (ambulatory blood pressure monitoring) also decreased slightly and similarly from baseline in both groups.","[{'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Yamasaki', 'Affiliation': 'Yamasaki Family Clinic, Hyogo, Japan.'}, {'ForeName': 'Kazuro', 'Initials': 'K', 'LastName': 'Yagi', 'Affiliation': 'Yagi Hospital, Tokyo, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Tsukamoto', 'Affiliation': 'Tsukamoto Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Yamazaki', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Yukie', 'Initials': 'Y', 'LastName': 'Okawara', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Tomitani', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kanegae', 'Affiliation': 'Jichi Medical University School of Medicine, Tochigi, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13505']
1411,30809591,Intrathecal Immunoglobulin for treatment of adult patients with tetanus: A randomized controlled 2x2 factorial trial.,"Despite long-standing availability of an effective vaccine, tetanus remains a significant problem in many countries. Outcome depends on access to mechanical ventilation and intensive care facilities and in settings where these are limited, mortality remains high. Administration of tetanus antitoxin by the intramuscular route is recommended treatment for tetanus, but as the tetanus toxin acts within the central nervous system, it has been suggested that intrathecal administration of antitoxin may be beneficial. Previous studies have indicated benefit, but with the exception of one small trial no blinded studies have been performed. The objective of this study is to establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus. Secondary objectives: to determine whether the addition of intrathecal tetanus antitoxin reduces autonomic nervous system dysfunction and length of hospital/ intensive care unit stay; whether the addition of intrathecal tetanus antitoxin in the treatment of tetanus is safe and cost-effective; to provide data to inform recommendation of human rather than equine antitoxin. This study will enroll adult patients (≥16 years old) with tetanus admitted to the Hospital for Tropical Diseases, Ho Chi Minh City. The study is a 2x2 factorial blinded randomized controlled trial. Eligible patients will be randomized in a 1:1:1:1 manner to the four treatment arms (intrathecal treatment and human intramuscular treatment, intrathecal treatment and equine intramuscular treatment, sham procedure and human intramuscular treatment, sham procedure and equine intramuscular treatment). Primary outcome measure will be requirement for mechanical ventilation. Secondary outcome measures: duration of hospital/ intensive care unit stay, duration of mechanical ventilation, in-hospital and 240-day mortality and disability, new antibiotic prescription, incidence of ventilator associated pneumonia and autonomic nervous system dysfunction, total dose of benzodiazepines and pipecuronium, and incidence of adverse events.  Trial registration:  ClinicalTrials.gov NCT02999815  Registration date:  21 December 2016.",2018,"This study will enroll adult patients (≥16 years old) with tetanus admitted to the Hospital for Tropical Diseases, Ho Chi Minh City.","['adult patients with tetanus', 'enroll adult patients (≥16 years old) with tetanus admitted to the Hospital for Tropical Diseases, Ho Chi Minh City', 'patients with tetanus', 'hospital/ intensive care unit', 'Eligible patients']","['tetanus antitoxin', 'intrathecal tetanus antitoxin', 'intrathecal treatment and human intramuscular treatment, intrathecal treatment and equine intramuscular treatment, sham procedure and human intramuscular treatment, sham procedure and equine intramuscular treatment', 'Intrathecal Immunoglobulin']","['duration of hospital/ intensive care unit stay, duration of mechanical ventilation, in-hospital and 240-day mortality and disability, new antibiotic prescription, incidence of ventilator associated pneumonia and autonomic nervous system dysfunction, total dose of benzodiazepines and pipecuronium, and incidence of adverse events', 'requirement for mechanical ventilation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0039614', 'cui_str': 'Clostridium tetani Infection'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0039615', 'cui_str': 'Tetanus Antitoxin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0071102', 'cui_str': 'Pipecuronium'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.2239,"This study will enroll adult patients (≥16 years old) with tetanus admitted to the Hospital for Tropical Diseases, Ho Chi Minh City.","[{'ForeName': 'Huỳnh Thị', 'Initials': 'HT', 'LastName': 'Loan', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Lam Minh', 'Initials': 'LM', 'LastName': 'Yen', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Kestelyn', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Van', 'Initials': 'NV', 'LastName': 'Hao', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Tan', 'Initials': 'TT', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thi Phuong', 'Initials': 'NTP', 'LastName': 'Dung', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'Turner', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Geskus', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wolbers', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Le Van', 'Initials': 'LV', 'LastName': 'Tan', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'H Rogier', 'Initials': 'HR', 'LastName': 'Van Doorn', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, OX3 7FZ, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Wyncoll', 'Affiliation': ""Guys and St Thomas' Hospitals NHS Foundation Trust, London, SE1 7EH, UK.""}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Van', 'Initials': 'NV', 'LastName': 'Vinh Chau', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'C Louise', 'Initials': 'CL', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}]",Wellcome open research,['10.12688/wellcomeopenres.14587.2']
1412,30811082,The effect of acute exercise on the performance of verbal fluency in adolescents and young adults with Down syndrome: a pilot study.,"BACKGROUND


The high prevalence of cognitive dysfunction is well documented in individuals with Down syndrome. However, only a few studies have focused on the effect of exercise on cognitive performance in this population. In particular, verbal fluency has been shown to be relevant to the early onset of Alzheimer's disease in individuals with Down syndrome. Thus, this study was aimed at investigating the relationship between acute exercise and verbal fluency in this population.
METHODS


It was a pre-post design. Twenty-eight participants (aged 14-31) were assigned to high-intensity exercise (i.e. 70-85% of predicted maximum heart rate) (N = 8), moderate-intensity exercise (i.e. 50-69% of predicted maximum heart rate) (N = 10) or attentional control (N = 10) groups. Two exercise groups walked on a treadmill using an incremental walking protocol, and the attentional control group watched a video for 20 min. Measures of verbal fluency (i.e. semantic fluency and phonetic fluency) were tested pre-intervention and post-intervention.
RESULTS


The result showed a quadric trend between semantic fluency and intensity of exercise. The improvement in cognitive performance on semantic fluency test was observed in the moderate-intensity exercise. However, neither a linear trend nor a quadric trend was seen in phonetic fluency.
CONCLUSIONS


The result showed an inverted-U relationship between exercise intensity and semantic fluency. A larger sample size, testing time and more reliable psychophysiological measures (e.g. VO 2  max and neuroimaging technology), should be considered to explore the underlying mechanisms in this population.",2019,The improvement in cognitive performance on semantic fluency test was observed in the moderate-intensity exercise.,"['adolescents and young adults with Down syndrome', 'individuals with Down syndrome', 'Twenty-eight participants (aged 14-31']","['Two exercise groups walked on a treadmill using an incremental walking protocol, and the attentional control group watched a video for 20\xa0min', 'attentional control', 'acute exercise', 'high-intensity exercise']","['verbal fluency', 'cognitive performance on semantic fluency test', 'phonetic fluency', 'verbal fluency (i.e. semantic fluency and phonetic fluency', 'semantic fluency and intensity of exercise', 'cognitive performance', 'moderate-intensity exercise']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",28.0,0.0825524,The improvement in cognitive performance on semantic fluency test was observed in the moderate-intensity exercise.,"[{'ForeName': 'C-C J J', 'Initials': 'CJJ', 'LastName': 'Chen', 'Affiliation': 'Department of Kinesiology, Mississippi State University, Mississippi State, MS, USA.'}, {'ForeName': 'S D R', 'Initials': 'SDR', 'LastName': 'Ringenbach', 'Affiliation': 'School of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12603']
1413,30810500,Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity.,"Both aging and obesity are associated with increased levels of pro-inflammatory metabolites, while weight reduction is associated with improvements in inflammatory status. However, few studies have explored the response of key inflammatory markers to the combined settings of weight reduction in an aging population. There are also few studies that have investigated the potential impact of diet composition on inflammatory marker responses. In the MEASUR-UP trial, we evaluated changes in baseline levels of inflammatory markers with post-study levels for a traditional weight loss control group versus a group with generous, balanced protein intake. In this 6-month randomized controlled trial (RCT), older (≥60 years) adults with obesity (BMI ≥30 kg/m 2 ) and Short Physical Performance Battery (SPPB) score of 4-10 were randomly assigned to either a traditional weight loss regimen, (Control, n = 14) or one with higher protein intake (≥30 g) at each meal (Protein, n = 25). All participants were prescribed a hypo-caloric diet and attended weekly support and education groups and weigh-ins. Protein participants consumed ≥30 g of high-quality protein/meal, including lean and extra lean beef provided to them for two of the three meals per day. Protein intakes were 0.8 and 1.2 g/kg/day for Control and Protein, respectively. Adiponectin, leptin, C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), IL-6, IL-8, serum amyloid A (SAA), vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1), and glycated serum protein (GSP) levels were measured at 0 and 6-month time points. At the 6-month endpoint, there was significant weight loss and decrease in BMI in both the Control (-4.8 ± 8.2 kg; -2.3 ± 2.4 kg/m 2 ; p = 0.05) and Protein (-8.7 ± 7.4 kg; -2.9 ± 2.3 kg/m 2 ; p < 0.0001) groups. SPPB scores improved in both arms, with a superior functional response in Protein (p < 0.05). Body fat (%) at baseline was positively correlated with leptin, hs-CRP, VCAM-1, ICAM-1, and GSP. Several markers of inflammation responded to the Protein group: leptin (p < 0.001), hs-CRP (p < 0.01), and ICAM-1 (p < 0.01) were decreased and adiponectin increased (p < 0.01). There were no significant changes in any inflammatory markers in the Control arm. In the between group comparison, only adiponectin trended towards a group difference (more improvement in Protein; p < 0.07). Our findings in the MEASUR-UP trial show that a weight loss diet with enhanced protein intake is comparable to an adequate protein diet in terms of weight loss success and that it can lead to improvements in inflammatory status, specifically for adiponectin, leptin, hs-CRP, and ICAM-1. These findings are important given current recommendations for higher protein intakes in older adults and justify the additional study of the inflammatory impact of an enhanced protein diet. (ClinicalTrials.gov identifier: NCT01715753).",2019,"Several markers of inflammation responded to the Protein group: leptin (p < 0.001), hs-CRP (p < 0.01), and ICAM-1 (p < 0.01) were decreased and adiponectin increased (p < 0.01).","['older (≥60 years) adults with obesity (BMI ≥30\u2009kg/m 2 ) and Short Physical Performance Battery (SPPB) score of 4-10', 'Older Adults with Obesity', 'older adults']","['traditional weight loss regimen, (Control, n\u2009=\u200914) or one with higher protein intake', 'hypo-caloric diet and attended weekly support and education groups and weigh-ins', 'Weight Reduction and Enhanced Protein Intake']","['BMI', 'weight loss', 'Adiponectin, leptin, C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), IL-6, IL-8, serum amyloid A (SAA), vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1), and glycated serum protein', 'Body fat', 'Protein intakes', 'GSP) levels', 'adiponectin', 'SPPB scores', 'inflammatory markers', 'ICAM-1', 'leptin, hs-CRP, VCAM-1, ICAM-1, and GSP']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0002723', 'cui_str': 'Amyloid Protein SAA'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C3666909', 'cui_str': 'Glycate'}, {'cui': 'C0036825', 'cui_str': 'Serum Proteins'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0230093,"Several markers of inflammation responded to the Protein group: leptin (p < 0.001), hs-CRP (p < 0.01), and ICAM-1 (p < 0.01) were decreased and adiponectin increased (p < 0.01).","[{'ForeName': 'Kathryn N', 'Initials': 'KN', 'LastName': 'Porter Starr', 'Affiliation': 'a Center for the Study of Aging , Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Orenduff', 'Affiliation': 'a Center for the Study of Aging , Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'Shelley R', 'Initials': 'SR', 'LastName': 'McDonald', 'Affiliation': 'a Center for the Study of Aging , Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'd Department of Biostatistics and Bioinformatics , Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'a Center for the Study of Aging , Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'a Center for the Study of Aging , Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'Connie W', 'Initials': 'CW', 'LastName': 'Bales', 'Affiliation': 'a Center for the Study of Aging , Duke University Medical Center , Durham , NC , USA.'}]",Journal of nutrition in gerontology and geriatrics,['10.1080/21551197.2018.1564200']
1414,30811909,A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms.,"BACKGROUND


Systematic pelvic and paraaortic lymphadenectomy has been widely used in the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical trials has been limited.
METHODS


We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before participation in the trial. The primary end point was overall survival.
RESULTS


A total of 647 patients underwent randomization from December 2008 through January 2012, were assigned to undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included in the analysis. Among patients who underwent lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenectomy group (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval [CI], 0.83 to 1.34; P = 0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P = 0.29). Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P = 0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P = 0.049]).
CONCLUSIONS


Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectomy and was associated with a higher incidence of postoperative complications. (Funded by Deutsche Forschungsgemeinschaft and the Austrian Science Fund; LION ClinicalTrials.gov number, NCT00712218.).",2019,"Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P = 0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P = 0.049]).
","['647 patients underwent randomization from December 2008 through January 2012', 'patients with advanced ovarian cancer', 'We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy', 'Patients with Advanced Ovarian Neoplasms', 'patients who underwent lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes']","['paraaortic lymphadenectomy', 'lymphadenectomy (323 patients) or not undergo lymphadenectomy', 'Lymphadenectomy']","['postoperative complications', 'incidence of repeat laparotomy', 'median progression-free survival', 'overall or progression-free survival', 'median overall survival', 'mortality', 'Serious postoperative complications', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0919267', 'cui_str': 'Ovary Neoplasms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}]","[{'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",647.0,0.286579,"Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P = 0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P = 0.049]).
","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Lampe', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Aletti', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mustea', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Ingo B', 'Initials': 'IB', 'LastName': 'Runnebaum', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Burges', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kimmig', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Greggi', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'von Leffern', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wagner', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': ""From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A. du Bois), Department of Gynecology, Charité-Universitätsmedizin Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials, Philipps University Marburg (A.R., C.S.-B.), and the Department of Gynecology and Obstetrics, University Hospital Giessen and Marburg (U.W.), Marburg, the Department of Gynecology and Obstetrics, Kaiserswerther Diakonie (B.L.), and the Department of Obstetrics and Gynecology, Heinrich-Heine-University Düsseldorf (W.M.), Düsseldorf, the Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald (A.M.), the Department of Gynecology, University Medical Center Hamburg-Eppendorf (S.M.), and the Department of Gynecology and Obstetrics, Albertinen Krankenhaus (I.L.), Hamburg, University Women's Hospital, Department of Gynecology and Reproductive Medicine and Center for Gynecologic Oncology, Jena University Hospital, Jena (I.B.R.), the Department of Obstetrics and Gynecology, University Munich rechts der Isar (B.S.), and the Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-Universität München (A. Burges), Munich, West German Cancer Center, Department of Gynecology and Obstetrics, University of Duisburg-Essen, Duisburg (R.K.), the Department of Gynecology and Obstetrics, University Hospital Kiel, Kiel (F.H.), University Medical Center Freiburg, Freiburg (A.H.), University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns) - all in Germany; the Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori (D.L., F.R.), and the Department of Gynecologic Oncology, European Institute of Oncology, University of Milan (G.A.), Milan, the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome (G.S.), Gynecologic Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli, IRCCS Fondazione G. Pascale, Naples (S.G.), and the Cancer Reference Center, Centro di Riferimento Oncologico, Aviano (G.G.) - all in Italy; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria (C.M.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and the Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic (D.C.).""}]",The New England journal of medicine,['10.1056/NEJMoa1808424']
1415,30804274,Tacrolimus as the first-line agent in adult-onset minimal change disease: A randomized controlled study.,"Steroids have been the cornerstone of first-line therapy in adult-onset minimal change disease (MCD). The period of exposure to high dose steroids may be longer in adult MCD patients and would result in higher rates of steroid-related side effects. Although tacrolimus (TAC) is known to be effective in steroid-dependent/resistant MCD as well as in nephrotic syndrome due to other causes, there are minimal data available for assessing the effectiveness of TAC as the first-line agent in adult MCD. This is a prospective, open-label, randomized controlled study conducted from April 2014 to March 2016. Patients were randomized into two groups A and B which received TAC for 12 months and oral steroids for six months, respectively. Primary outcomes were remission rates, drug resistance was measured at 6, 12,and 18 months in each group and secondary outcomes were relapse rates, sustained remission rates, dependency, and adverse effects were measured at 18 months in both groups. At six months, total response (TR, i.e., complete and partial remission) was achieved in 80% in the TAC group and 78.26% in the steroid group (P = 1.000). At 12 months, TR was 60% in the TAC group and 43.48% in the steroid group (P = 0.386). At 18 months, TR rate was 44% in the TAC group and 43.48% in the steroid group (P = 1.000). About 32% in the TAC group and 39.13% in steroid group had relapsed by 18 months. Serious adverse effects were similar in the two groups, but overall adverse effects were more in the steroid group. TAC as a primary agent is not inferior to steroids in inducing remission. TAC may be considered as an alternative agent to steroid in high-risk groups such as elderly patients, uncontrolled diabetes and young females as a primary agent in the management of adult MCD.",2019,"At 12 months, TR was 60% in the TAC group and 43.48% in the steroid group (P = 0.386).","['from April 2014 to March 2016', 'elderly patients, uncontrolled diabetes and young females', 'adult MCD patients', 'adult-onset minimal change disease']","['tacrolimus (TAC', 'TAC', 'Tacrolimus']","['total response (TR, i.e., complete and partial remission', 'remission rates, drug resistance', 'relapse rates, sustained remission rates, dependency, and adverse effects', 'TR rate', 'overall adverse effects', 'Serious adverse effects']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1636149', 'cui_str': 'Mcd'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance (disorder)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0373541,"At 12 months, TR was 60% in the TAC group and 43.48% in the steroid group (P = 0.386).","[{'ForeName': 'Malagouda R', 'Initials': 'MR', 'LastName': 'Patil', 'Affiliation': 'Department of Nephrology, Karnataka Institute of Medical Sciences, Hubli, Karnataka, India.'}, {'ForeName': 'Smita Subhash', 'Initials': 'SS', 'LastName': 'Divyaveer', 'Affiliation': 'Department of Nephrology, Institute of Postgraduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Raychaudhary', 'Affiliation': 'Department of Nephrology, Institute of Postgraduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Mayuri', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Chetan', 'Initials': 'C', 'LastName': 'Mahajan', 'Affiliation': 'Department of Nephrology, Institute of Postgraduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'Sarkar', 'Affiliation': 'Department of Nephrology, Institute of Postgraduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Nephrology, Institute of Postgraduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India.'}]","Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia",[]
1416,30793412,Complete withdrawal is the most feasible treatment for medication-overuse headache: A randomized controlled open-label trial.,"BACKGROUND


Complete stop of acute medication and/or migraine medication for treatment of medication-overuse headache (MOH) has previously been reported more effective in reducing headache days and migraine days per month compared with restricted intake of acute medication. However, it is unknown whether complete stop or restricted intake is the most feasible treatment for patients.
OBJECTIVES


To investigate whether feasibility of withdrawal in MOH is different between complete stop of acute medication and restricted intake, and whether reductions in headache-related medication dependence, anxiety and depression differ between the treatments.
METHODS


Medication-overuse headache patients were included in a prospective, open-label, outpatient study and randomized to two months of withdrawal with either no analgesics or acute migraine medication (programme A) or acute medication restricted to 2 days/week (programme B). After 6 and 12 months, patients graded feasibility of withdrawal. Dependence was measured by Severity of Dependence Scale (SDS), while anxiety and depression were measured by Hospital Anxiety and Depression Scale (HADS).
RESULTS


We included 72 MOH patients with primary migraine and/or tension-type headache. Forty-nine completed withdrawal and the SDS questionnaire at 12-month follow-up, and the feasibility of withdrawal was significantly higher in programme A compared to programme B (p < 0.001). At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048).
CONCLUSIONS


Withdrawal with complete stop of acute medication was more feasible and most effective in reducing headache-related anxiety compared with restricted intake.
SIGNIFICANCE


A complete stop of all analgesics is the most effective treatment for MOH regarding reduction in headache days but has often been regarded as too challenging for patients. However, in this study, complete stop appears to be more feasible compared with restricted intake of analgesics seen from the patients' perspective.",2019,"At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048).
","['72 MOH patients with primary migraine and/or tension-type headache', 'Medication-overuse headache patients', 'patients']",['withdrawal with either no analgesics or acute migraine medication (programme A) or acute medication restricted to 2\xa0days/week (programme B'],"['anxiety score', 'headache-related anxiety', 'SDS questionnaire', 'Hospital Anxiety and Depression Scale (HADS', 'feasibility of withdrawal', 'Severity of Dependence Scale (SDS), while anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0033893', 'cui_str': 'Tension-Type Headache'}, {'cui': 'C0522254', 'cui_str': 'Analgesic Overuse Headache'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",72.0,0.0379628,"At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048).
","[{'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1383']
1417,30791125,Absence of Drug-Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial.,"Intravaginal rings (IVRs) are an established option for continuous administration of drugs in women. The combination of anastrozole (ATZ) and levonorgestrel (LNG) in an IVR with an intended 4-week wearing period has been considered for long-term treatment of endometriosis-associated pelvic pain. A randomized, parallel-group, multicenter phase 2b study to assess the efficacy and safety of different dose combinations in women with symptomatic endometriosis has recently been performed. This paper will focus on the investigation of pharmacokinetic (PK) effects of ATZ on LNG using data collected from this study. Two hundred sixteen patients were randomized to the treatment group with IVRs releasing LNG 40 μg/day alone or in combination with ATZ 300 μg/day, 600 μg/day, or 1050 μg/day for 12 weeks. PK blood samples were taken before dosing and before IVR replacement or removal (days 28, 56, and 84). The primary PK parameter was the plasma concentration in apparent steady state of ATZ and LNG at the end of each IVR wearing period. Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 μg/L at 300, 600, and 1050 μg/day nominal release, respectively). All point estimates for LNG concentration in apparent steady state ratios between the mono and combination IVR groups were close to 1, and the 90% confidence interval limits were in the 0.80 to 1.25 range (1.01 [0.85-1.19], 1.03 [0.88-1.20], 0.94 [0.80-1.10]). In conclusion, our data indicate there is no evidence of drug-drug interaction of ATZ on LNG.",2019,"Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 μg/L at 300, 600, and 1050 μg/day nominal release, respectively).","['Two hundred sixteen patients', 'women with symptomatic endometriosis', 'women']","['ATZ', 'Anastrozole', 'anastrozole (ATZ) and levonorgestrel (LNG', 'IVRs releasing LNG 40 μg/day alone or in combination with ATZ', 'Intravaginal rings (IVRs']","['ATZ concentrations', 'confidence interval limits', 'plasma concentration', 'efficacy and safety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",216.0,0.129062,"Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 μg/L at 300, 600, and 1050 μg/day nominal release, respectively).","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Nave', 'Affiliation': 'Clinical Sciences, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Mellinger', 'Affiliation': 'Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Clinical Sciences, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Höchel', 'Affiliation': 'Clinical Sciences, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmitz', 'Affiliation': 'Development, Bayer AG, Berlin, Germany.'}]",Journal of clinical pharmacology,['10.1002/jcph.1396']
1418,30721572,Randomized trial comparing effects of weight loss by liraglutide with lifestyle modification in non-alcoholic fatty liver disease.,"BACKGROUND & AIMS


We compared the effects of weight loss induced with the glucagon-like peptide-1 agonist liraglutide, with that of lifestyle modification, followed by weight maintenance after discontinuing intervention, in obese adults with non-alcoholic fatty liver disease (NAFLD).
METHODS


Thirty obese (mean age 40.7 ± 9.1 years, BMI 33.2 ± 3.6 kg/m 2  , 90% male) adults with NAFLD defined as liver fat fraction (LFF) > 5% on magnetic resonance imaging without other causes of hepatic steatosis were randomized to a supervised programme of energy restriction plus moderate-intensity exercise to induce ≥ 5% weight loss (DE group, n = 15), or liraglutide 3 mg daily (LI group, n = 15) for 26 weeks, followed by 26 weeks with only advice to prevent weight regain.
RESULTS


Diet and exercise and LI groups had significant (P < 0.01) and similar reductions in weight (-3.5 ± 3.3 vs -3.0 ± 2.2 kg), LFF (-8.1 ± 13.2 vs -7.0 ± 7.1%), serum alanine aminotransferase (-39 ± 35 vs -26 ± 33 U/L) and caspase-cleaved cytokeratin-18 (cCK-18) (-206 ± 252 vs -130 ± 158 U/L) at 26 weeks. At 52 weeks, the LI group significantly (P < 0.05) regained weight (1.8 ± 2.1 kg), LFF (4.0 ± 5.3%) and cCK-18 (72 ± 126 U/L), whereas these were unchanged in the DE group.
CONCLUSIONS


Liraglutide was effective for decreasing weight, hepatic steatosis and hepatocellular apoptosis in obese adults with NAFLD, but benefits were not sustained after discontinuation, in contrast with lifestyle modification. Continuing the exercise learned in the structured programme contributed to the maintenance of liver fat reduction.",2019,"At 52 weeks, the LI group significantly (P < 0.05) regained weight (1.8 ± 2.1 kg), LFF (4.0 ± 5.3%) and cCK-18 (72 ± 126 U/L), whereas these were unchanged in the DE group.
","['Thirty obese (mean age 40.7\xa0±', 'without other causes of hepatic steatosis', 'non-alcoholic fatty liver disease', 'obese adults with non-alcoholic fatty liver disease (NAFLD', 'obese adults with NAFLD']","['supervised programme of energy restriction plus moderate-intensity exercise to induce ≥ 5% weight loss (DE group, n\xa0=\xa015), or liraglutide 3\xa0mg daily (LI', 'glucagon-like peptide-1 agonist liraglutide', 'magnetic resonance imaging', 'Liraglutide', 'liraglutide']","['weight, hepatic steatosis and hepatocellular apoptosis', 'serum alanine aminotransferase', 'liver fat fraction (LFF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",,0.129569,"At 52 weeks, the LI group significantly (P < 0.05) regained weight (1.8 ± 2.1 kg), LFF (4.0 ± 5.3%) and cCK-18 (72 ± 126 U/L), whereas these were unchanged in the DE group.
","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Khoo', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, Singapore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Hsiang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Ranu', 'Initials': 'R', 'LastName': 'Taneja', 'Affiliation': 'Department of Diagnostic Radiology, Changi General Hospital, Singapore.'}, {'ForeName': 'Seok-Hwee', 'Initials': 'SH', 'LastName': 'Koo', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Gaik-Hong', 'Initials': 'GH', 'LastName': 'Soon', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Kam', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Ngai-Moh', 'Initials': 'NM', 'LastName': 'Law', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Tiing-Leong', 'Initials': 'TL', 'LastName': 'Ang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14065']
1419,31311779,RE: Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomised trial.,,2019,,['oesophagogastric variceal bleeding'],['haemostatic powder added to standard management'],[],"[{'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],,0.080814,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Johnston', 'Affiliation': 'Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Ryan Malcolm', 'Initials': 'RM', 'LastName': 'Buchanan', 'Affiliation': 'Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, UK ryan.buchanan@nhs.net.'}]",Gut,['10.1136/gutjnl-2019-319272']
1420,31685481,Antimicrobial central venous catheters do not reduce infections in pre-term babies.,"The studyGilbert R, Brown M, Rainford N et al. Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial.  Lancet Child Adolesc Health  2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections.",2019,"Lancet Child Adolesc Health  2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections.",[],"['Antimicrobial-impregnated central venous catheters', 'Antimicrobial central venous catheters']",[],[],"[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}]",[],,0.0614744,"Lancet Child Adolesc Health  2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections.","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Cook', 'Affiliation': 'Bazian, Economist Intelligence Unit healthcare, London, UK rob.cook@bazian.com.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Fortescue-Webb', 'Affiliation': 'Wessex Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Bazian, Economist Intelligence Unit healthcare, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.l4993']
1421,31672143,A clinical trial of enteral Levetiracetam for acute seizures in pediatric cerebral malaria.,"BACKGROUND


Acute seizures are common in pediatric cerebral malaria (CM), but usual care with phenobarbital risks respiratory suppression. We undertook studies of enteral levetiracetam (eLVT) to evaluate pharmacokinetics (PK), safety and efficacy including an open-label, randomized controlled trial (RCT) comparing eLVT to phenobarbital.
METHODS


Children 24-83 months old with CM were enrolled in an eLVT dose-finding study starting with standard dose (40 mg/kg load, then 30 mg/kg Q12 hours) titrated upward until seizure freedom was attained in 75% of subjects. The RCT that followed randomized children to eLVT vs. phenobarbital for acute seizures and compared the groups on minutes with seizures based upon continuous electroencephalogram. Due to safety concerns, midway through the study children allocated to phenobarbital received the drug only if they continued to have seizures (either clinically or electrographically) after benzodiazepine treatment. Secondary outcomes were treatment failure requiring cross over, coma duration and neurologic sequelae at discharge. PK and safety assessments were also undertaken.
RESULTS


Among 30 comatose CM children, eLVT was rapidly absorbed and well-tolerated. eLVT clearance was lower in patients with higher admission serum creatinine (SCr), but overall PK parameters were similar to prior pediatric PK studies. Within 4 h of the first dose, 90% reached therapeutic levels (> 20 μg/mL) and all were above 6 μg/mL. 7/7 children achieved seizure freedom on the initial eLVT dose. Comparing 23 eLVT to 21 phenobarbital patients among whom 15/21 received phenobarbital, no differences were seen for minutes with seizure, seizure freedom, coma duration, neurologic sequelae or death, but eLVT was safer (p = 0.019). Phenobarbital was discontinued in 3/15 due to respiratory side effects.
CONCLUSION


Enteral LVT offers an affordable option for seizure control in pediatric CM and is safer than phenobarbital.
TRIAL REGISTRATION


NCT01660672 . NCT01982812 .",2019,"eLVT clearance was lower in patients with higher admission serum creatinine (SCr), but overall PK parameters were similar to prior pediatric PK studies.","['Children 24-83\u2009months old with CM were enrolled in an', '30 comatose CM children', 'acute seizures in pediatric cerebral malaria']","['Phenobarbital', 'benzodiazepine', 'Enteral LVT', 'eLVT vs. phenobarbital', 'eLVT', 'enteral levetiracetam (eLVT', 'enteral Levetiracetam']","['therapeutic levels', 'eLVT clearance', 'minutes with seizure, seizure freedom, coma duration, neurologic sequelae or death', 'treatment failure requiring cross over, coma duration and neurologic sequelae at discharge', 'pharmacokinetics (PK), safety and efficacy', 'seizure freedom']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}]","[{'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162643'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.178529,"eLVT clearance was lower in patients with higher admission serum creatinine (SCr), but overall PK parameters were similar to prior pediatric PK studies.","[{'ForeName': 'Gretchen L', 'Initials': 'GL', 'LastName': 'Birbeck', 'Affiliation': 'Department of Neurology, University of Rochester, 265 Crittenden Blvd, Rochester, NY, 14642, USA. gretchen_birbeck@urmc.rochester.edu.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Herman', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California San Diego, Center for Research in Paediatric and Developmental Pharmacology, La Jolla, CA, USA.'}, {'ForeName': 'Fraction K', 'Initials': 'FK', 'LastName': 'Dzinjalamala', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Samah G', 'Initials': 'SG', 'LastName': 'Abdel Baki', 'Affiliation': 'Bio-Signal Group Co., Acton, MA, USA.'}, {'ForeName': 'Macpherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Neema M', 'Initials': 'NM', 'LastName': 'Toto', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Postels', 'Affiliation': ""Department of Neurology, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Gardiner', 'Affiliation': 'Department of Epidemiology & Biostatistics, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Taylor', 'Affiliation': 'Blantyre Malaria Project, Blantyre, Malawi.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Seydel', 'Affiliation': 'Blantyre Malaria Project, Blantyre, Malawi.'}]",BMC pediatrics,['10.1186/s12887-019-1766-2']
1422,31684903,Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial.,"BACKGROUND


Previous studies showed that parents of very preterm infants expressed feelings of incompetence and experienced high levels of stress upon the discharge of their infants. We conducted a systematic review of seven studies and observed potential benefits for parental outcomes when using discharge interventions that adopted guided participation (GP). More evidence is needed on the effective doses of discharge interventions underpinned by the principles of GP.
AIM


To investigate the feasibility and preliminarily estimate the effects on parental competence and stress outcomes of a newly developed, nurse-led, GP discharge program for mothers of very preterm infants.
METHODS


A two-arm randomized controlled trial was conducted in a neonatal intensive care unit (NICU). Mothers of infants with gestational ages of ≤32 weeks who had no congenital malformations and did not need to undergo major surgeries were recruited. All mothers were the primary caregivers to their infants. The intervention group received a nurse-led GP discharge intervention (three structured 30- to 60-min GP sessions and one follow-up phone call). The control group received usual care. The parental outcomes were measured using the Parenting Sense of Competence Scale (C-PSOC) and Perceived Stress Scale (C-PSS) at baseline (T0), on the day of discharge (T1), after the follow-up phone call (within 72 h after discharge) (T2), and 1 month after discharge (T3). The outcomes were analyzed using generalized estimating equations based on intention-to-treat principles.
RESULTS


Thirty infant-mother dyads were recruited. Greater improvements in the C-PSOC score were observed in the intervention group than in the control group at T1 and T2, although these differences were statistically insignificant. The intervention group exhibited greater improvements than the control group in the C-PSS scores at T1, T2, and T3, although these differences were also not statistically significant.
CONCLUSIONS


The findings suggest that a GP discharge intervention could improve parenting competence and stress among mothers with very preterm infants. The absence of adverse events suggests that the GP discharge intervention could be feasibly implemented in NICU settings. This feasibility study was not powered to determine the effectiveness of the intervention but is anticipated to lay the foundation for a future full-scale study.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03668912. Date of registration: 13 September 2018 (retrospectively registered).",2019,"Greater improvements in the C-PSOC score were observed in the intervention group than in the control group at T1 and T2, although these differences were statistically insignificant.","['mothers with very preterm infants', 'mothers of very preterm infants', 'Thirty infant-mother dyads', 'neonatal intensive care unit (NICU', 'Mothers of infants with gestational ages of ≤32\u2009weeks who had no congenital malformations and did not need to undergo major surgeries were recruited', 'All mothers were the primary caregivers to their infants', 'very preterm infants in a neonatal intensive care unit']","['GP discharge intervention', 'nurse-led GP discharge intervention (three structured 30- to 60-min GP sessions and one follow-up phone call', 'GP discharge program', 'guided participation discharge program', 'usual care']","['Parenting Sense of Competence Scale (C-PSOC) and Perceived Stress Scale (C-PSS) at baseline (T0), on the day of discharge (T1', 'C-PSOC score', 'parenting competence and stress', 'C-PSS scores']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",30.0,0.157492,"Greater improvements in the C-PSOC score were observed in the intervention group than in the control group at T1 and T2, although these differences were statistically insignificant.","[{'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'J P C', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR. janitachau@cuhk.edu.hk.'}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'S H S', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR.'}]",BMC pediatrics,['10.1186/s12887-019-1794-y']
1423,30777631,Cost Benefit of High-Dose vs Standard-Dose Influenza Vaccine in a Long-Term Care Population During an A/H1N1-Predominant Influenza Season.,"OBJECTIVES


Influenza is a leading cause of avoidable admissions for nursing home (NH) residents. We previously evaluated the effectiveness of a high-dose trivalent influenza vaccine (HD) compared to a standard-dose influenza vaccine (SD) through a cluster-randomized trial of NH residents. Fewer residents from facilities randomized to HD were hospitalized. In this article, we extend our analyses to consider direct medical care costs relative to vaccine costs for HD ($31.82/dose) as compared to SD ($12.04/dose).
DESIGN


Post hoc, cost-benefit analysis.
SETTING AND PARTICIPANTS


From the participating NH facilities (n = 817), we identified Medicare fee-for-service enrollees who were long-stay residents (>100 days) at the start of the 2013-2014 influenza season (November 1-May 31). The intervention was residence in a facility randomized to HD or SD influenza vaccine.
METHODS


We summed expenditures from long-stay NH residents' Medicare Part A, B, and D fee-for-service claims and compared person-level expenditures between residents of facilities offering HD vs SD. Expenditures were adjusted for clustering of residents within NHs, person-time, and prespecified covariates using 2-part, generalized linear models with bootstrapped standard errors. We examined the incremental cost-benefit of HD vs SD vaccines from a payer perspective.
RESULTS


There were 18,605 and 18,658 Medicare fee-for-service long-stay residents in facilities offering HD and SD, respectively. Person- and facility-adjusted total expenditures differed by $546 (P = .006). The $20 incremental cost of HD to SD offset adjusted expenditures for a net benefit of $526 per NH resident and a financial return on investment of 546/20 = 27:1.
CONCLUSIONS/IMPLICATIONS


The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose. These cost offsets applied to Medicare beneficiaries residing in NHs could result in important savings to the Medicare program.",2019,The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose.,"['817', 'There were 18,605 and 18,658 Medicare fee-for-service long-stay residents in facilities offering HD and SD, respectively', 'service enrollees who were long-stay residents (>100\xa0days) at the start of the 2013-2014 influenza season (November 1-May 31', 'nursing home (NH) residents', 'NH residents', 'From the participating NH facilities (n\xa0']","['standard-dose influenza vaccine (SD', 'HD vs SD vaccines', 'high-dose trivalent influenza vaccine (HD', 'High-Dose vs Standard-Dose Influenza Vaccine', 'HD influenza vaccine', 'HD or SD influenza vaccine']","['total health care expenditures', 'Person- and facility-adjusted total expenditures']","[{'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0242816', 'cui_str': 'Fees for Service'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4505396', 'cui_str': 'High-Dose Trivalent Influenza Vaccine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",,0.0473105,The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose.,"[{'ForeName': 'Theresa I', 'Initials': 'TI', 'LastName': 'Shireman', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI. Electronic address: Theresa_Shireman@brown.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ogarek', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gozalo', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI; Providence Veterans Administration Hospital, Providence, RI.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI; Providence Veterans Administration Hospital, Providence, RI.'}, {'ForeName': 'H Edward', 'Initials': 'HE', 'LastName': 'Davidson', 'Affiliation': 'Insight Therapeutics, LLC, Norfolk, VA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Insight Therapeutics, LLC, Norfolk, VA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Toronto, Ottawa, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gravenstein', 'Affiliation': 'Brown School of Public Health, Health Service Policy & Practice, Providence, RI; Center for Gerontology & Healthcare Research, Providence, RI; Providence Veterans Administration Hospital, Providence, RI; Warren Alpert Medical School of Brown University, Providence, RI.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.12.003']
1424,31246522,"Clofarabine Can Replace Anthracyclines and Etoposide in Remission Induction Therapy for Childhood Acute Myeloid Leukemia: The AML08 Multicenter, Randomized Phase III Trial.","PURPOSE


To identify effective and less toxic therapy for children with acute myeloid leukemia, we introduced clofarabine into the first course of remission induction to reduce exposure to daunorubicin and etoposide.
PATIENTS AND METHODS


From 2008 through 2017, 285 patients were enrolled at eight centers; 262 were randomly assigned to receive clofarabine and cytarabine (Clo+AraC, n = 129) or high-dose cytarabine, daunorubicin, and etoposide (HD-ADE, n = 133) as induction I. Induction II consisted of low-dose ADE given alone or combined with sorafenib or vorinostat. Consolidation therapy comprised two or three additional courses of chemotherapy or hematopoietic cell transplantation. Genetic abnormalities and the level of minimal residual disease (MRD) at day 22 of initial remission induction determined final risk classification. The primary end point was MRD at day 22.
RESULTS


Complete remission was induced after two courses of therapy in 263 (92.3%) of the 285 patients; induction failures included four early deaths and 15 cases of resistant leukemia. Day 22 MRD was positive in 57 of 121 randomly assigned evaluable patients (47%) who received Clo+AraC and 42 of 121 patients (35%) who received HD-ADE (odds ratio, 1.86; 95% CI, 1.03 to 3.41;  P  = .04). Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
CONCLUSION


Our findings suggest that the use of clofarabine with cytarabine during remission induction might reduce the need for anthracycline and etoposide in pediatric patients with acute myeloid leukemia and may reduce rates of cardiomyopathy and treatment-related cancer.",2019,"Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
","['Childhood Acute Myeloid Leukemia', 'children with acute myeloid leukemia', 'pediatric patients with acute myeloid leukemia', 'From 2008 through 2017', '285 patients were enrolled at eight centers; 262']","['daunorubicin and etoposide', 'chemotherapy or hematopoietic cell transplantation', 'Clofarabine', 'toxic therapy', 'Clo+AraC', 'clofarabine and cytarabine (Clo+AraC, n = 129) or high-dose cytarabine, daunorubicin, and etoposide (HD-ADE, n = 133) as induction I. Induction II consisted of low-dose ADE given alone or combined with sorafenib or vorinostat', 'Anthracyclines and Etoposide', 'clofarabine with cytarabine', 'clofarabine']","['overall survival rate', 'Genetic abnormalities and the level of minimal residual disease (MRD', '3-year event-free survival rate']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0092777', 'cui_str': 'clofarabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",285.0,0.106142,"Despite this result, the 3-year event-free survival rate (52.9% [44.6% to 62.8%] for Clo+AraC  v  52.4% [44.0% to 62.4%] for HD-ADE,  P  = .94) and overall survival rate (74.8% [67.1% to 83.3%] for Clo+AraC  v  64.6% [56.2% to 74.2%] for HD-ADE,  P  = .1) did not differ significantly across the two arms.
","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Norman J', 'Initials': 'NJ', 'LastName': 'Lacayo', 'Affiliation': ""2Lucile Packard Children's Hospital and Stanford Cancer Center, Palo Alto, CA.""}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Inaba', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Heym', 'Affiliation': ""3Cook Children's Medical Center, Fort Worth, TX.""}, {'ForeName': 'Raul C', 'Initials': 'RC', 'LastName': 'Ribeiro', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Taub', 'Affiliation': ""4Children's Hospital of Michigan, Detroit, MI.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McNeer', 'Affiliation': '5University of Chicago, Chicago, IL.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Degar', 'Affiliation': '6Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': ""7Rady Children's Hospital, San Diego, CA.""}, {'ForeName': 'Allen Eng-Juh', 'Initials': 'AE', 'LastName': 'Yeoh', 'Affiliation': '8National University Health System, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Coustan-Smith', 'Affiliation': '8National University Health System, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Triplett', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Susana C', 'Initials': 'SC', 'LastName': 'Raimondi', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""1St Jude Children's Research Hospital and the University of Tennessee Health Science Center, College of Medicine, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00327']
1425,30770244,Comparison of intravenous lidocaine/ketorolac combination to either analgesic alone for suspected renal colic pain in the ED.,"STUDY OBJECTIVE


To compare analgesic efficacy and safety of intravenous lidocaine and ketorolac combination to each analgesic alone for ED patients with suspected renal colic.
METHODS


We conducted a randomized, double-blind trial comparing analgesic efficacy of a combination of intravenous lidocaine (1.5 mg/kg) and ketorolac (30 mg), to ketorolac (30 mg), and to lidocaine (1.5 mg/kg) in patients aged 18-64 presenting to the ED with suspected renal colic. Primary outcome included difference in pain scores between the groups at 30 min. Secondary outcomes included a comparative reduction in pain scores in each group from baseline to 30 and 60 min as well as rates of adverse events and need for rescue analgesia at 30 and 60 min.
RESULTS


We enrolled 150 subjects (50 per group). The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89 (95% CI: -4.39 to -1.39); between Ketorolac and Lidocaine/Ketorolac group was -0.92 (95% CI: -2.44 to 0.61); and between Ketorolac and Lidocaine was -1.98 (95% CI: -3.69 to -0.27). A comparative percentage of subjects in each group required rescue analgesia at 30 and 60 min. No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. Commonly reported adverse effects were dizziness, nausea, and headache.
CONCLUSION


The administration of intravenous lidocaine/ketorolac combination to ED patients with suspected renal colic results in better analgesia in comparison to lidocaine alone but provides no analgesic advantages over ketorolac alone. Clinicaltrials.gov Registration: NCT02902770.",2020,The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89,"['ED patients with suspected renal colic', 'We enrolled 150 subjects (50 per group', 'patients aged 18-64 presenting to the ED with suspected renal colic']","['Ketorolac', 'Lidocaine', 'lidocaine', 'lidocaine and ketorolac combination', 'ketorolac', 'analgesic alone', 'lidocaine/ketorolac', 'Lidocaine/Ketorolac', 'intravenous lidocaine']","['comparative reduction in pain scores', 'mean pain scores', 'rescue analgesia', 'rates of adverse events and need for rescue analgesia at 30 and 60\u202fmin', 'suspected renal colic pain', 'analgesic efficacy and safety', 'pain scores', 'vital signs', 'dizziness, nausea, and headache', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518766'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",150.0,0.368904,The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89,"[{'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Motov', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Catsim', 'Initials': 'C', 'LastName': 'Fassassi', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Drapkin', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA. Electronic address: jdrapkin@maimonidesmed.org.'}, {'ForeName': 'Mahlaqa', 'Initials': 'M', 'LastName': 'Butt', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Hossain', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Likourezos', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Monfort', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brady', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Nechama', 'Initials': 'N', 'LastName': 'Rothberger', 'Affiliation': 'Department of Pharmacy, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Stefan S', 'Initials': 'SS', 'LastName': 'Mann', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flom', 'Affiliation': 'Peter Flom Consulting, New York, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Gulati', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.01.048']
1426,30768793,The process of change in psychotherapy with a pregnant patient following perinatal losses: An analysis of a case study.,"AIM


Despite research suggesting increased anxiety and depressive symptoms after a perinatal loss and during future pregnancies, little knowledge exists to guide clinicians treating pregnant women after perinatal loss. This case study explores processes that facilitated therapeutic change for a pregnant patient with major depressive disorder (MDD) and posttraumatic stress disorder after perinatal losses.
METHOD


The study integrated quantitative and narrative analyses in a single case derived from the pilot phase of a randomized controlled trial on supportive-expressive therapy for MDD.
RESULTS


The quantitative and narrative analyses suggest that an improvement in maladaptive interpersonal patterns toward the therapist, in the form of attachment avoidance, made it possible to form a strong alliance, which in turn led to a successful outcome.
CONCLUSIONS


The findings highlight the importance of improving maladaptive interpersonal patterns as a prerequisite to enable patients after pregnancy losses to develop and maintain a corrective therapeutic experience.",2019,"The quantitative and narrative analyses suggest that an improvement in maladaptive interpersonal patterns toward the therapist, in the form of attachment avoidance, made it possible to form a strong alliance, which in turn led to a successful outcome.
",['pregnant patient with major depressive disorder (MDD) and posttraumatic stress disorder after perinatal losses'],['supportive-expressive therapy'],"['anxiety and depressive symptoms', 'maladaptive interpersonal patterns']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0417216,"The quantitative and narrative analyses suggest that an improvement in maladaptive interpersonal patterns toward the therapist, in the form of attachment avoidance, made it possible to form a strong alliance, which in turn led to a successful outcome.
","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Cohen', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Leibovich', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Rayna', 'Initials': 'R', 'LastName': 'Markin', 'Affiliation': 'The Department of Education and Counseling, Villanova University, Villanova, Pennsylvania.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'The Department of Psychology, University of Haifa, Haifa, Israel.'}]",Journal of clinical psychology,['10.1002/jclp.22763']
1427,31702699,"Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial.","BACKGROUND


Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor, which is a period of significant physical activity, can decrease the instrumental vaginal delivery rate.
METHODS


In a multicenter, prospective, randomized, controlled trial, healthy adult pregnant women presenting with spontaneous labor were assigned to a ""Carbohydrate"" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a ""Fasting"" group (water only). The primary outcome was the instrumental vaginal delivery rate. Secondary outcomes included duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay. Statistical analysis was performed on an intention-to-treat basis. The primary outcome was tested with the ""Fasting"" group as the reference group. The P values for secondary outcomes were adjusted for multiple comparisons. The differences between groups are reported with 99% confidence interval (CI).
RESULTS


A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group). There was no difference in the rate of instrumental delivery between the Carbohydrate (21.0%) and the Fasting (22.4%) groups (difference, -1.4%; 99% CI, -4.9 to 2.2). No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).
CONCLUSIONS


Carbohydrate intake during labor did not modify the rate of instrumental vaginal delivery.",2020,"No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).
","['A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group', 'healthy adult pregnant women presenting with spontaneous labor']","['Carbohydrate"" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a ""Fasting"" group (water only', 'Oral Carbohydrate Intake', 'physical exercise']","['degree of self-reported fatigue', 'duration of labor', 'rate of cesarean delivery', 'instrumental vaginal delivery rate', 'self-reported hunger', 'rate of instrumental delivery', 'rate of instrumental vaginal delivery', 'muscle performance and decreases fatigue', 'rate of vomiting', 'length of hospitalization', 'Rate of Instrumental Vaginal Delivery', 'overall feeling', 'duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0452455', 'cui_str': 'Grape juice (substance)'}, {'cui': 'C0585323', 'cui_str': 'Every three hours (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",3984.0,0.23552,"No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).
","[{'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Simonet', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Caen Normandie, Caen, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Gakuba', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Caen Normandie, Caen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Desmeulles', 'Affiliation': 'Department of Anaesthesia, Centre Hospitalier (CH) du Cotentin, Cherbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Corouge', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU Jeanne de Flandre de Lille, Lille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Beucher', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'Department of Biostatistics, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and University of Caen Normandy, Caen, France.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Ducloy-Bouthors', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU Jeanne de Flandre de Lille, Lille, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dreyfus', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ""Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and Equipe d'Accueil (EA4650) University of Caen Normandy, Caen, France.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004515']
1428,30786792,A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder versus unfortified human milk on the growth of preterm very low birth weight infants.,,2019,,['preterm very low birth weight infants'],['fortification of human milk with an infant formula powder versus unfortified human milk'],[],"[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]",[],,0.0900118,,"[{'ForeName': 'Viraraghavan Vadakkencherry', 'Initials': 'VV', 'LastName': 'Ramaswamy', 'Affiliation': 'a Department of Neonatology , Nori Multi-Speciality Hospital , Vijayawada , India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1580260']
1429,30444856,The impact of hypothermia on outcomes in massively transfused patients.,"BACKGROUND


Hypothermia is associated with poor outcomes after injury. The relationship between hypothermia during contemporary large volume resuscitation and blood product consumption is unknown. We evaluated this association, and the predictive value of hypothermia on mortality.
METHODS


Patients predicted to receive massive transfusion at 12 level 1 trauma centers were randomized in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial and were grouped into those who were hypothermic (<36°C) or normothermic (36-38.5°C) within the first 6 hours of emergency department arrival. The impact of hypothermia or normothermia on the volume of blood product required during the first 24 hours was determined via negative binomial regression, adjusting for treatment arm, injury severity score, mechanism, demographics, pre-emergency department fluid volume, blood administered before becoming hypothermic, pulse and systolic blood pressure on arrival, and the time exposed to hypothermic or normothermic temperatures.
RESULTS


Of 680 patients, 590 had a temperature measured during the first 6 hours in hospital, and 399 experienced hypothermia. The mean number of red blood cell (RBC) units given to all patients in the first 24 hours of admission was 8.8 (95% confidence interval [CI], 7.9-9.6). In multivariable analysis, every 1°C decrease in temperature below 36.0°C was associated with a 10% increase (incidence rate ratio, 0.90; 95% CI, 0.89-0.92; p < 0.00) in consumption of RBCs during the first 24 hours of admission. There was no association between RBC administration and a temperature above 36°C. Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI, 1.7-4.5; p < 0.00) for 24-hour mortality and 1.8 (95% CI, 1.3-2.4; p < 0.00) for 30-day mortality.
CONCLUSION


Hypothermia is associated with increase in blood product consumption and mortality. These findings support the maintenance of normothermia in trauma patients and suggest that further investigation on the impact of cooling or rewarming during massive transfusion is warranted.
LEVEL OF EVIDENCE


Prognostic, level III.",2019,"Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI, 1.7-4.5; p < 0.00) for 24-hour mortality and 1.8 (95% CI, 1.3-2.4; p < 0.00) for 30-day mortality.
","['Patients predicted to receive massive transfusion at 12 level 1 trauma centers', 'trauma patients', 'massively transfused patients', '680 patients']",['hypothermia or normothermia'],"['30-day mortality', 'mean number of red blood cell (RBC) units', 'consumption of RBCs', 'injury severity score, mechanism, demographics, pre-emergency department fluid volume, blood administered before becoming hypothermic, pulse and systolic blood pressure on arrival, and the time exposed to hypothermic or normothermic temperatures', '24-hour mortality', 'blood product consumption and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0445103', 'cui_str': 'Normothermia (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}]",680.0,0.0743858,"Hypothermia on arrival was an independent predictor of mortality, with an adjusted odds ratio of 2.7 (95% CI, 1.7-4.5; p < 0.00) for 24-hour mortality and 1.8 (95% CI, 1.3-2.4; p < 0.00) for 30-day mortality.
","[{'ForeName': 'Erica Louise Walsh', 'Initials': 'ELW', 'LastName': 'Lester', 'Affiliation': ""From the Division of General Surgery (E.L.W.L.), Department of Surgery, University of Alberta, Edmonton, Alberta, Canada; Center for Translational Injury Research (E.E.F., J.H.), Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma (K.B.), Critical Care and Acute Care Surgery, School of Medicine, Oregon Health and Science University, Portland, Oregon; Division of Trauma and Critical Care (E.M.B.), Department of Surgery, School of Medicine, University of Washington, Seattle, Washington; Department of Surgery (M.C.), University of Colorado, Denver, Colorado; Center for Translational Injury Research (B.A.C.), Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma and Surgical Critical Care (T.C.T.C.F.), Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee; Division of Trauma (J.D.K.), Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama, Birmingham, Alabama; Division of Trauma (T.O.), Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, Tucson, Arizona; Trauma and Acute Care Service (S.B.R.), St. Michael's Hospital, Toronto, Ontario, Canada; R Adams Crowley Shock Trauma Center (T.S.), University of Maryland, Baltimore, Maryland; Division of Trauma (M.A.S.), Critical Care and Acute Care Surgery, Department of Surgery, Oregon Health and Science University, Portland, Oregon; and Division of Trauma and Critical Care (K.I.), LAC+USC Medical Center, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Brasel', 'Affiliation': ''}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Cotton', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Fabian', 'Affiliation': ''}, {'ForeName': 'Jeffery D', 'Initials': 'JD', 'LastName': 'Kerby', 'Affiliation': ''}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': 'OʼKeefe', 'Affiliation': ''}, {'ForeName': 'Sandro B', 'Initials': 'SB', 'LastName': 'Rizoli', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Scalea', 'Affiliation': ''}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Inaba', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002144']
1430,31693803,Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents.,"BACKGROUND


Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.
METHODS


We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction. The primary end point was overall vaccine efficacy in preventing virologically confirmed dengue caused by any dengue virus serotype.
RESULTS


Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 person-years] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the per-protocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). Efficacy trends varied according to serotype. The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively).
CONCLUSIONS


TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic. (Funded by Takeda Vaccines; TIDES ClinicalTrials.gov number, NCT02747927.).",2019,Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction.,"['Healthy children and adolescents 4 to 16 years of age', 'regions of Asia and Latin America in which the disease is endemic', '20,071 participants who were given at least one dose of', 'Participants presenting with febrile illness', 'Healthy Children and Adolescents']","['vaccine or placebo', 'tetravalent dengue vaccine candidate (TAK-003', 'placebo', 'TAK-003', 'Tetravalent Dengue Vaccine']","['vaccine efficacy', 'incidence of serious adverse events', 'efficacy against dengue leading to hospitalization', 'overall vaccine efficacy']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0743841', 'cui_str': 'Febrile syndrome'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",53.0,0.752459,Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction.,"[{'ForeName': 'Shibadas', 'Initials': 'S', 'LastName': 'Biswal', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Reynales', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Saez-Llorens', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Charissa', 'Initials': 'C', 'LastName': 'Borja-Tabora', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Pope', 'Initials': 'P', 'LastName': 'Kosalaraksa', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Chukiat', 'Initials': 'C', 'LastName': 'Sirivichayakul', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Veerachai', 'Initials': 'V', 'LastName': 'Watanaveeradej', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Rivera', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Espinoza', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'LakKumar', 'Initials': 'L', 'LastName': 'Fernando', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Dietze', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Kleber', 'Initials': 'K', 'LastName': 'Luz', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Rivaldo', 'Initials': 'R', 'LastName': 'Venâncio da Cunha', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Jimeno', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Brose', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rauscher', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'LeFevre', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Bizjajeva', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Bravo', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'From Takeda Vaccines, Singapore (S. Biswal); Centro de Atención e Investigación Médica, Bogota (H.R.), and Centro de Estudios en Infectología Pediatrica, Centro Médico Imbanaco and Department of Pediatrics, Universidad del Valle, Cali (P.L., E.L.-M.) - both in Colombia; the Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at Secretaria Nacional de Ciencia y Tecnologia (SENACYT), Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (X.S.-L., J.J.); the Research Institute for Tropical Medicine, Muntinlupa (C.B.-T.), and the University of the Philippines Manila, Ermita (L.B.) - both in the Philippines; Srinagarind Hospital, Khon Kaen University, Khon Kaen (P.K.), and the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University (C.S.), and Phramongkutklao Hospital (V.W.), Bangkok - all in Thailand; Hospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic (L.R.); National Autonomous University of Nicaragua, Leon (F.E.); Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka (L.K.F.); Universidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória (R.D.), Instituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal (K.L.), and Universidade Federal de Mato Grosso do Sul, Campo Grande (R.V.C.) - all in Brazil; Takeda Pharmaceuticals International, Zurich, Switzerland (A.B., M.B., M.R., I.L., S. Bizjajeva); and Takeda Vaccines, Boston (D.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1903869']
1431,30199311,"Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With  RAS  Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial.","PURPOSE


Cetuximab in combination with chemotherapy is a standard-of-care first-line treatment regimen for patients with  RAS  wild-type (wt) metastatic colorectal cancer (mCRC); however, the efficacy of cetuximab plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX) has never before been proven in a controlled and randomized phase III trial. To our knowledge, the TAILOR trial ( ClinicalTrials.gov identifier: NCT01228734) is the first randomized, multicenter, phase III study of the addition of cetuximab to first-line FOLFOX prospectively choosing a  RAS  wt population and thus providing confirmative data for the efficacy and safety of cetuximab plus FOLFOX versus FOLFOX alone.
PATIENTS AND METHODS


TAILOR is an open-label, randomized (1:1), multicenter, phase III trial in patients from China comparing FOLFOX-4 with or without cetuximab in  RAS  wt ( KRAS / NRAS , exons 2 to 4) mCRC. The primary end point of TAILOR was progression-free survival time; secondary end points included overall survival time, overall response rate, and safety and tolerability.
RESULTS


In the modified intent-to-treat population of 393 patients with  RAS  wt mCRC, adding cetuximab to FOLFOX-4 significantly improved the primary end point of progression-free survival time compared with FOLFOX-4 alone (hazard ratio, 0.69; 95% CI, 0.54 to 0.89;  P  = .004; median, 9.2  v  7.4 months, respectively), as well as the secondary end points of overall survival time (current assessment after 300 events: hazard ratio, 0.76; 95% CI, 0.61 to 0.96;  P  = .02; median, 20.7  v  17.8 months, respectively) and overall response rate (odds ratio, 2.41; 95% CI, 1.61 to 3.61;  P  < .001; 61.1%  v  39.5%, respectively). Treatment was well tolerated, and there were no new or unexpected safety findings.
CONCLUSION


The TAILOR study met all of its objectives and relevant clinical end points, confirming cetuximab in combination with FOLFOX as an effective standard-of-care first-line treatment regimen for patients with  RAS  wt mCRC.",2018,"Treatment was well tolerated, and there were no new or unexpected safety findings.
","['patients with  RAS  wt mCRC', 'patients with  RAS  wild-type (wt) metastatic colorectal cancer (mCRC', 'Wild-Type Metastatic Colorectal Cancer', 'patients from China comparing FOLFOX-4 with or without cetuximab in  RAS  wt ( KRAS / NRAS , exons 2 to 4) mCRC', 'Patients With']","['cetuximab plus FOLFOX versus FOLFOX', 'chemotherapy', 'cetuximab', 'First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4', 'cetuximab plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX', 'cetuximab in combination with FOLFOX']","['overall survival time, overall response rate, and safety and tolerability', 'overall survival time', 'progression-free survival time', 'Efficacy and Tolerability', 'TAILOR was progression-free survival time', 'overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0015295', 'cui_str': 'Exons'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",393.0,0.0520598,"Treatment was well tolerated, and there were no new or unexpected safety findings.
","[{'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Li-Zhu', 'Initials': 'LZ', 'LastName': 'Lin', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Xuenong', 'Initials': 'X', 'LastName': 'Ouyang', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Kaichun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Guanghai', 'Initials': 'G', 'LastName': 'Dai', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Houjie', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Junyuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Jiongjie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'S Peter', 'Initials': 'SP', 'LastName': 'Eggleton', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2018.78.3183']
1432,31694611,"Study protocol for a parallel-group, double-blinded, randomized, controlled, noninferiority trial: the effect and safety of hybrid electroconvulsive therapy (Hybrid-ECT) compared with routine electroconvulsive therapy in patients with depression.","BACKGROUND


Electroconvulsive therapy (ECT) is the most rapid and effective treatment for patients with depression, ECT can achieve remarkable antidepressant effects in the initial 3-4 sessions, but significant side effects limit its use. However, recent low-charge electrotherapy (LCE) studies have demonstrated antidepressant or antipsychotic effects with significantly fewer side effects. The aim of this study is to propose a novel two-step charge set strategy for ECT treatment, referred to as Hybrid-ECT, to decrease side effects by using a low charge while preserving treatment efficacy.
METHODS/DESIGN


A randomized, double-blinded, standard-controlled, parallel-group design will be carried out. We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)). We will evaluate participants across a wide variety of domains including clinical symptoms, cognitive, psychological and functional metrics. We will also perform magnetic resonance imaging (MRI) and event-related potential (ERPs) assessments during treatment to explore brain function differences between ECT and LCE.
DISCUSSION


This research proposes a simple but completely novel ECT strategy that aims to rapidly relieve depressive symptoms and minimize side effects. The mechanism of ECT and LCE will be further discussed.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, Number: ChiCTR1900022905 (Registration date: April 30, 2019).",2019,"We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)).","['Chinese Clinical Trial Registry, Number', 'patients with depression', '112 inpatients diagnosed with depression (unipolar or bipolar']","['routine electroconvulsive therapy', 'conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions', 'Electroconvulsive therapy (ECT', 'hybrid electroconvulsive therapy (Hybrid-ECT']",[],"[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]",[],112.0,0.471667,"We plan to enroll 112 inpatients diagnosed with depression (unipolar or bipolar) and randomly assign them to conventional ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately 2.8 joules per session)).","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Shu-Xian', 'Initials': 'SX', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ying-Jia', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Li-Chang', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Deng', 'Affiliation': ""Laboratory of Brain Stimulation and Biological Psychiatry, Brain Function and Psychosomatic Medicine Institute, Second People's Hospital of Huizhou, Huizhou, Guangdong, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'CAS Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Ying-Li', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Min-Zhi', 'Initials': 'MZ', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Key Laboratory of Intelligent Information Processing, Advanced Computer Research Center, Institute of Computing Technology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Xie', 'Affiliation': 'Department of Psychiatry, Shenzhen Kangning Hospital, Shenzhen, Guangdong, China. xxh.med@gmail.com.'}]",BMC psychiatry,['10.1186/s12888-019-2320-3']
1433,29415163,Genetic Variation of a DRD2 Co-expression Network is Associated with Changes in Prefrontal Function After D2 Receptors Stimulation.,"Dopamine D2 receptors (D2Rs) contribute to the inverted U-shaped relationship between dopamine signaling and prefrontal function. Genetic networks from post-mortem human brain revealed 84 partner genes co-expressed with DRD2. Moreover, eight functional single nucleotide polymorphisms combined into a polygenic co-expression index (PCI) predicted co-expression of this DRD2 network and were associated with prefrontal function in humans. Here, we investigated the non-linear association of the PCI with behavioral and Working Memory (WM) related brain response to pharmacological D2Rs stimulation. Fifty healthy volunteers took part in a double-blind, placebo-controlled, functional MRI (fMRI) study with bromocriptine and performed the N-Back task. The PCI by drug interaction was significant on both WM behavioral scores (P = 0.046) and related prefrontal activity (all corrected P < 0.05) using a polynomial PCI model. Non-linear responses under placebo were reversed by bromocriptine administration. fMRI results on placebo were replicated in an independent sample of 50 participants who did not receive drug administration (P = 0.034). These results match earlier evidence in non-human primates and confirm the physiological relevance of this DRD2 co-expression network. Results show that in healthy subjects, different alleles evaluated as an ensemble are associated with non-linear prefrontal responses. Therefore, brain response to a dopaminergic drug may depend on a complex system of allelic patterns associated with DRD2 co-expression.",2019,The PCI by drug interaction was significant on both WM behavioral scores (P = 0.046) and related prefrontal activity (all corrected P < 0.05) using a polynomial PCI model. Non-linear responses under placebo were reversed by bromocriptine administration.,"['Fifty healthy volunteers', 'healthy subjects']","['placebo', 'bromocriptine']","['fMRI results', 'Prefrontal Function', 'related prefrontal activity', 'WM behavioral scores']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.0559317,The PCI by drug interaction was significant on both WM behavioral scores (P = 0.046) and related prefrontal activity (all corrected P < 0.05) using a polynomial PCI model. Non-linear responses under placebo were reversed by bromocriptine administration.,"[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Selvaggi', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Pergola', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gelao', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Di Carlo', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': 'Nettis', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Amico', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Fazio', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rampino', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sambataro', 'Affiliation': 'Department of Experimental and Clinical Medical Science, University of Udine, Udine, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Blasi', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bertolino', 'Affiliation': 'Group of Psychiatric Neuroscience, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhy022']
1434,31694478,How specific is cognitive change? A randomized controlled trial comparing brief cognitive and mindfulness interventions for depression.,"Objective : There is a debate in psychotherapy research as to whether different kinds of psychotherapy work through specific mechanisms of change. Particularly, it is questioned whether cognitive change is specific to cognitive therapy. This study aimed to answer this question by comparing a brief cognitive intervention with an active comparison intervention (i.e., brief mindfulness-based intervention) and by following strict methodological guidelines.  Method:  72 currently depressed outpatients were randomized to either cognitive intervention ( n  = 39) or mindfulness-based intervention ( n  = 33). Automatic thoughts ( negative self-statements ,  well-being , and  self-confidence ), dysfunctional attitudes ( performance evaluation  and  approval by others ) and depressive symptoms were assessed before and six times during treatment. Within-person and between-person mediation effects were analyzed using multilevel structural equation modeling.  Results : There was no difference in cognitive change between the interventions. Negative self-statements and performance evaluations were significant mediators of the within-person effect of time on depressive symptoms, while the three other cognitive variables did not change. Conversely, change in depressive symptoms also mediated within-person cognitive change.  Conclusion : Cognitive change seems to be a general rather than a specific mechanism of change. However, the mutual impact of cognitive and depressive change does not support a unidirectional causal model.",2020,There was no difference in cognitive change between the interventions.,[],"['cognitive intervention with an active comparison intervention (i.e., brief mindfulness-based intervention', 'cognitive intervention ( n \u2009=\u200939) or mindfulness-based intervention', 'cognitive and mindfulness interventions']","['depressive symptoms', 'Automatic thoughts ( negative self-statements ,  well-being , and  self-confidence ), dysfunctional attitudes ( performance evaluation  and  approval by others ) and depressive symptoms', 'cognitive change']",[],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",72.0,0.0416822,There was no difference in cognitive change between the interventions.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hofheinz', 'Affiliation': 'Institute of Psychology, University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Reder', 'Affiliation': 'Institute of Psychology, University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, German.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1685138']
1435,31693994,A Controlled Evaluation of a CBPR Intervention's Effects on Physical Activity and the Related Psychosocial Constructs Among Minority Children in an Underserved Community.,"BACKGROUND


Effective physical activity interventions are needed for children because health behaviors track into adulthood, and risk factors for diseases begin early in life. No study has determined whether an intervention designed using a Community-Based Participatory Research approach can improve moderate to vigorous physical activity (MVPA) and the related psychosocial constructs in underserved children. This study determined whether improvements in MVPA and related psychosocial constructs (self-efficacy, knowledge, beliefs, attitudes, and skills) occurred following a Community-Based Participatory Research intervention in underserved, rural children. It was then determined if these constructs were mediators of MVPA.
METHODS


Two fifth-grade classes at a school (n = 19 and n = 20) were randomly assigned to an intervention or comparison group. The intervention group participated in a 4-week intervention designed to improve MVPA (wGT3X-BT accelerometer; ActiGraph, Pensacola, FL) and the related psychosocial constructs (written survey). Groups were assessed prior to and immediately following the intervention.
RESULTS


There were no differences at baseline between groups. MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05). Knowledge and skills were mediating variables of MVPA.
CONCLUSIONS


Priority should be placed on research that determines the sustained impact of similar Community-Based Participatory Research interventions.",2020,"MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05).","['Minority Children in an Underserved Community', 'underserved, rural children', 'underserved children', 'Two fifth-grade classes at a school (n = 19 and n = 20']","['4-week intervention designed to improve MVPA (wGT3X-BT accelerometer; ActiGraph, Pensacola, FL) and the related psychosocial constructs (written survey', 'Community-Based Participatory Research intervention', ""CBPR Intervention's""]","['knowledge, and skill scores', 'MVPA', 'MVPA and related psychosocial constructs (self-efficacy, knowledge, beliefs, attitudes, and skills', 'Physical Activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0256111,"MVPA (30.0 [4.4] min), knowledge, and skill scores were significantly higher in the intervention group compared with the comparison group at follow-up (P < .05).","[{'ForeName': 'Kara C', 'Initials': 'KC', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Shanda', 'Initials': 'S', 'LastName': 'McGraw', 'Affiliation': ''}, {'ForeName': 'Teirdre', 'Initials': 'T', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Higginbotham', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0135']
1436,31899888,"The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women.","BACKGROUND


The benefits of weight loss programs on mood, cognitive, and motor behavior are largely limited to those of calorie restriction or exercise alone. Our aim was to investigate the effect of combined calorie restriction and aerobic exercise intervention on mood, brain activity, and cognitive and motor behavior in overweight and obese women.
METHODS


Participants aged 36-56 years were randomized to either a control or an experimental group (aerobic exercise + 12.5% energy intake reduction) for a 6-month period. Changes in brain-derived neurotrophic factor levels, mood, prefrontal cortex activity, cognitive and motor performance were assessed.
RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05). Brain-derived neurotrophic factor level and learning of a speed-accuracy task remained unchanged. Although prefrontal cortex activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P < .05). An improvement in reaction time during the speed-accuracy task was observed (P < .05).
CONCLUSION


Combined calorie restriction and aerobic exercise intervention improved the psychosocial state, had little impact on cognition, and no effect on brain activity and learning of the speed-accuracy task.",2020,"RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05).","['Overweight and Obese Women', 'overweight and obese women', 'Participants aged 36-56 years']","['control or an experimental group (aerobic exercise + 12.5% energy intake reduction', 'Combined calorie restriction and aerobic exercise intervention', 'Combined Aerobic Exercise and Calorie Restriction', 'combined calorie restriction and aerobic exercise intervention']","['reaction time of visual scanning and associative learning', 'Changes in brain-derived neurotrophic factor levels, mood, prefrontal cortex activity, cognitive and motor performance', 'reaction time', 'Mood, Cognition, and Motor Behavior', 'Confusion and depression', 'tension', 'brain activity and learning of the speed-accuracy task', 'mood, brain activity, and cognitive and motor behavior', 'prefrontal cortex activity and executive functions']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0600082', 'cui_str': '% energy intake (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0337271,"RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': ''}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': ''}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Vizbaraitė', 'Affiliation': ''}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': ''}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0373']
1437,30741797,Oral Gonadotropin-Releasing Hormone Antagonist Relugolix Compared With Leuprorelin Injections for Uterine Leiomyomas: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the noninferiority of relugolix compared with leuprorelin acetate in reducing heavy menstrual bleeding associated with uterine leiomyomas.
METHODS


In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks. The primary endpoint was the proportion of patients with a total pictorial blood loss assessment chart score of less than 10 for weeks 6-12. Secondary endpoints included myoma and uterine volumes, and hemoglobin levels. A sample size of 144 patients per group (n=288) was estimated to provide at least 90% power to demonstrate noninferiority (prespecified noninferiority margin -15%; one-sided 0.025 level of significance).
RESULTS


From March 2016 to September 2017, 281 patients were randomized (relugolix, n=139, leuprorelin n=142). Demographic and baseline characteristics were well balanced; mean pictorial blood loss assessment chart score was 254.3 in the relugolix group and 263.7 in the leuprorelin group. The proportion of patients with total pictorial blood loss assessment chart score of less than 10 for weeks 6-12 was 82.2% in the relugolix group and 83.1% in the leuprorelin group, demonstrating noninferiority of relugolix compared with leuprorelin (relugolix-leuprorelin difference -0.9%; 95% CI: -10.10 to 8.35; prespecified noninferiority margin -15%; P=.001). Reductions in myoma and uterine volumes and increases in hemoglobin levels were comparable in the two groups. Relugolix was associated with an earlier effect on menstrual bleeding than leuprorelin (pictorial blood loss assessment chart score of less than 10, 64.2% vs 31.7% [relugolix-leuprorelin difference 32.5%; 95% CI: 20.95-44.13%] for weeks 2-6 and pictorial blood loss assessment chart score of 0, 52.6% vs 21.8% [30.7%; 95% CI: 19.45-42.00%] for weeks 2-6) and faster recovery of menses after treatment discontinuation (relugolix median [Q1, Q3], 37 days [32.0, 46.0]; leuprorelin median, 65 days [54.0, 77.0]). Adverse events and bone mineral density loss were similar between relugolix and leuprorelin treatment groups.
CONCLUSION


In women with uterine leiomyomas, once-daily treatment with relugolix, an oral gonadotropin-releasing hormone antagonist, demonstrated noninferiority to monthly leuprorelin for improvement of heavy menstrual bleeding at 6-12 weeks of treatment, had a more rapid effect on menstrual bleeding, and was generally well tolerated.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02655237; JAPIC Clinical Trial Information, JapicCTI-163128.
FUNDING SOURCE


Takeda Pharmaceutical Company Limited and an affiliate of NovaQuest Capital Management LLC.",2019,"Relugolix was associated with an earlier effect on menstrual bleeding than leuprorelin (pictorial blood loss assessment chart score of less than 10, 64.2% vs 31.7% [relugolix-leuprorelin difference 32.5%; 95% CI: 20.95-44.13%] for weeks 2-6 and pictorial blood loss assessment chart score of 0, 52.6% vs 21.8% [30.7%; 95% CI: 19.45-42.00%] for weeks 2-6) and faster recovery of menses after treatment discontinuation (relugolix median [Q1, Q3], 37 days [32.0, 46.0]; leuprorelin median, 65 days [54.0, 77.0]).","['From March 2016 to September 2017, 281 patients were randomized (relugolix, n=139, leuprorelin n=142', 'Uterine Leiomyomas', 'premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120']","['Leuprorelin Injections', 'Oral Gonadotropin-Releasing Hormone Antagonist Relugolix', 'leuprorelin acetate', 'relugolix (40 mg, oral, once daily) or leuprorelin acetate']","['hemoglobin levels', 'Reductions in myoma and uterine volumes', 'tolerated', 'menstrual bleeding than leuprorelin (pictorial blood loss assessment chart score', 'pictorial blood loss assessment chart score', 'Adverse events and bone mineral density loss', 'proportion of patients with a total pictorial blood loss assessment chart score', 'menstrual bleeding', 'proportion of patients with total pictorial blood loss assessment chart score', 'heavy menstrual bleeding', 'myoma and uterine volumes, and hemoglobin levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide Acetate'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}]",281.0,0.574734,"Relugolix was associated with an earlier effect on menstrual bleeding than leuprorelin (pictorial blood loss assessment chart score of less than 10, 64.2% vs 31.7% [relugolix-leuprorelin difference 32.5%; 95% CI: 20.95-44.13%] for weeks 2-6 and pictorial blood loss assessment chart score of 0, 52.6% vs 21.8% [30.7%; 95% CI: 19.45-42.00%] for weeks 2-6) and faster recovery of menses after treatment discontinuation (relugolix median [Q1, Q3], 37 days [32.0, 46.0]; leuprorelin median, 65 days [54.0, 77.0]).","[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan; and Takeda Pharmaceutical Company Limited, and Kindai University, Osaka, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Enya', 'Affiliation': ''}, {'ForeName': 'Kentarou', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': ''}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tanimoto', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hoshiai', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003141']
1438,30725491,An in vitro pilot study of apheresis platelets collected on Trima Accel system and stored in T-PAS+ solution at refrigeration temperature (1-6°C).,"BACKGROUND


Using platelet additive solution (PAS) to dilute fibrinogen during long-term cold storage of platelets (PLTs) decreases PLT activation and increases functional PLT shelf life. We performed a randomized, paired study to assess the in vitro quality of PLTs stored in the cold in T-PAS+ for up to 18 days evaluated against PLTs stored under currently allowable conditions (5-day room temperature-stored PLTs [RTP] and 3-day cold-stored PLTs [CSP]).
STUDY DESIGN AND METHODS


PLTs were collected from healthy volunteers (n = 10) and diluted to 65% T-PAS+/35% plasma before cold storage. Double-dose apheresis PLTs (in 100% plasma) were collected from the same donors and split into two bags (one bag RTP, one bag CSP). All bags were sampled on the day of collection (Day 0). CSP and RTP bags were sampled on Days 3 and 5, respectively. T-PAS+ samples were assessed on Days 3, 5, 14, 16, and 18 of storage for metabolism, hemostatic function, and activation.
RESULTS


After 18 days of storage in T-PAS+, pH was 6.71 ± 0.04, PLT count was comparable to Day 3 CSP, PLT function (aggregation and clot strength) was comparable to Day 5 RTP, and PLT activation was significantly increased.
CONCLUSION


Refrigerated PLTs stored in T-PAS+ for 18 days met FDA pH standards. Functional metrics suggest activity of T-PAS+-stored PLTs and the potential to contribute to hemostasis throughout 18 days of storage. Extending the shelf life of PLTs would increase access to hemostatic resuscitation for bleeding patients in military and civilian settings.",2019,Extending the shelf life of PLTs would increase access to hemostatic resuscitation for bleeding patients in military and civilian settings.,['PLTs were collected from healthy volunteers (n\u2009=\u200910) and diluted to 65% T-PAS+/35% plasma before cold storage'],['platelet additive solution (PAS'],"['PLT function (aggregation and clot strength', 'PLT activation', 'PLT count']","[{'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0939728,Extending the shelf life of PLTs would increase access to hemostatic resuscitation for bleeding patients in military and civilian settings.,"[{'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Reddoch-Cardenas', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Sharma', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Christi L', 'Initials': 'CL', 'LastName': 'Salgado', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Robbie K', 'Initials': 'RK', 'LastName': 'Montgomery', 'Affiliation': 'Texas A&M Health Science Center, Bryan, Texas.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Cantu', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Neslihan', 'Initials': 'N', 'LastName': 'Cingoz', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Darlington', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Heather F', 'Initials': 'HF', 'LastName': 'Pidcoke', 'Affiliation': 'Cellphire, Rockville, Maryland.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Kamucheka', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Cap', 'Affiliation': 'Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.'}]",Transfusion,['10.1111/trf.15150']
1439,31690281,Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness: results of a cluster randomized controlled trial (LION).,"BACKGROUND


Unhealthy lifestyle behaviours contribute to alarming cardiometabolic risk in patients with serious mental illness (SMI). Evidence-based practical lifestyle tools supporting patients and staff in improving patient lifestyle are lacking.
METHODS


This multi-site randomized controlled pragmatic trial determined the effectiveness of a twelve-month multimodal lifestyle approach, including a web-based tool to improve patients' cardiometabolic health, versus care-as-usual. Using the web tool, nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals, which were discussed during fortnightly regular care visits. Twenty-seven community-care and sheltered-living teams were randomized into intervention (N = 17) or control (N = 10) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1 ± 10.8 years) with increased waist circumference (WC), BMI or fasting glucose. The primary outcomes concerned differences in WC after six and twelve months intervention, while BMI and metabolic syndrome Z-score were secondary outcome measures.
RESULTS


General multilevel linear mixed models adjusted for antipsychotic medication showed that differences in WC change between intervention and control were - 0.15 cm (95%CI: - 2.49; 2.19) after six and - 1.03 cm (95%CI: - 3.42; 1.35) after twelve months intervention; however, the differences were not statistically significant. No intervention effects were found for secondary outcome measures. The intervention increased patients' readiness to change dietary behaviour.
CONCLUSION


A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health. Web-tool use was lower than expected and nurses need more lifestyle coaching knowledge and skills. The type of intervention and delivery mode need optimization to realize effective lifestyle care for SMI patients.
TRIAL REGISTRATION


Dutch Trial Registry, www.trialregister.nl , NTR3765, 21 December 2012.",2019,A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health.,"[""patients' cardiometabolic health, versus care-as-usual"", 'patients with serious mental illness (SMI', 'patients with serious mental illness', 'SMI patients', 'Twenty-seven community-care and sheltered-living teams were randomized into intervention (N\u2009=\u200917) or control (N\u2009=\u200910) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1\u2009±\u200910.8\u2009years) with increased']","['Multimodal lifestyle intervention', 'nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals']","['cardiometabolic health', 'WC change', 'BMI and metabolic syndrome Z-score', 'patient cardiometabolic health', 'waist circumference (WC), BMI or fasting glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",27.0,0.0841069,A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Looijmans', 'Affiliation': 'Department of Health Psychology, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700, RB, Groningen, The Netherlands. A.Looijmans@umcg.nl.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'Jörg', 'Affiliation': 'Rob Giel Research Centre, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bruggeman', 'Affiliation': 'Rob Giel Research Centre, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schoevers', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Corpeleijn', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2310-5']
1440,31608454,Transfusion-related immunomodulation: gamma irradiation alters the effects of leukoreduction on alloimmunization.,"BACKGROUND


Adverse events following blood transfusion include allosensitization and generalized immunosuppression, collectively referred to as transfusion-related immune modulation. We evaluated the immunological effects of red blood cell (RBC) and platelet transfusions on alloantibody responses and on immunoregulatory cells in nonimmunosuppressed patients undergoing cardiovascular surgery.
STUDY DESIGN AND METHODS


Patients were randomized to receive standard unmodified (STD), leukoreduced (LR), or leukoreduced and γ-irradiated (LRγ) RBCs. Patients received only apheresis platelets that were in-process LR and were γ-irradiated for the third arm. Nontransfused patients served as controls for the effects of surgery itself on immunologic changes. Antibodies to HLA were assessed with use of solid-phase assays. The effects of transfusion on adaptive and innate immunity were evaluated by assessing T regulatory cells (Tregs) and invariant natural killer T (iNKT) cells.
RESULTS


LR of blood products reduced the development of human leukocyte antigen (HLA) alloantibodies, but only in patients without preexisting HLA antibodies. However, if LR blood products were γ-irradiated, HLA antibody production was not reduced. Compared to nontransfused patients, recipients of STD or LR transfusions showed a significant increase in CD4+CD25 hi  T cells expressing FoxP3 or CTLA4 and also of iNKT cells producing interleukin-4. In contrast, recipients of LRγ blood products showed markedly lower increases in all three cellular assays.
CONCLUSION


LR decreased HLA alloantibody production in naïve recipients, but did not reduce the immunosuppressive effects of transfusion. LRγ reduced immunosuppression and was not associated with decreased HLA alloantibody production.",2019,"RESULTS


LR of blood products reduced the development of human leukocyte antigen (HLA) alloantibodies, but only in patients without preexisting HLA antibodies.","['Patients', 'nonimmunosuppressed patients undergoing cardiovascular surgery']","['red blood cell (RBC) and platelet transfusions', 'standard unmodified (STD), leukoreduced (LR), or leukoreduced and γ-irradiated (LRγ) RBCs']","['immunosuppressive effects of transfusion', 'T regulatory cells (Tregs) and invariant natural killer T (iNKT) cells', 'CD4+CD25 hi  T cells expressing FoxP3 or CTLA4 and also of iNKT cells producing interleukin-4', 'HLA antibody production', 'HLA alloantibody production', 'human leukocyte antigen (HLA) alloantibodies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C2350467', 'cui_str': 'iNKT Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0022144', 'cui_str': 'Alloantibodies'}, {'cui': 'C0033268'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}]",,0.0469828,"RESULTS


LR of blood products reduced the development of human leukocyte antigen (HLA) alloantibodies, but only in patients without preexisting HLA antibodies.","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Nelson', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Aldea', 'Affiliation': 'Department of Surgery, Division of Cardiothoracic Surgery, University of Washington, Seattle, Washington.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Warner', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Latchman', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Gunasekera', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Ayala', 'Initials': 'A', 'LastName': 'Tamir', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Gernsheimer', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Bolgiano', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Sherrill J', 'Initials': 'SJ', 'LastName': 'Slichter', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}]",Transfusion,['10.1111/trf.15555']
1441,31691521,Differentiated HIV care in South Africa: the effect of fast-track treatment initiation counselling on ART initiation and viral suppression as partial results of an impact evaluation on the impact of a package of services to improve HIV treatment adherence.,"INTRODUCTION


In response to suboptimal adherence and retention, South Africa's National Department of Health developed and implemented National Adherence Guidelines for Chronic Diseases. We evaluated the effect of a package of adherence interventions beginning in January 2016 and report on the impact of Fast-Track Treatment Initiation Counselling (FTIC) on ART initiation, adherence and retention.
METHODS


We conducted a cluster-randomized mixed-methods evaluation in 4 provinces at 12 intervention sites which implemented FTIC and 12 control facilities providing standard of care. Follow-up was by passive surveillance using clinical records. We included data on subjects eligible for FTIC between 08 Jan 2016 and 07 December 2016. We adjusted for pre-intervention differences using difference-in-differences (DiD) analyses controlling for site-level clustering.
RESULTS


We enrolled 362 intervention and 368 control arm patients. Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%). After adjusting for baseline ART initiation differences and covariates using DiD we found a 6% increase in ART initiation associated with FTIC (RD 6.3%; 95% CI: -0.6% to 13.3%). We found a small decrease in viral suppression within 18 months (RD -2.8%; 95% CI: -9.8% to 4.2%) with no difference after adjustment (RD: -1.9%; 95% CI: -9.1% to 5.4%) or when considering only those with a viral load recorded (84% intervention vs. 86% control). We found reduced crude 6-month retention in intervention sites (RD -7.2%; 95% CI: -14.0% to -0.4%). However, differences attenuated by 12 months (RD: -3.6%; 95% CI: -11.1% to 3.9%). Qualitative data showed FTIC counselling was perceived as beneficial by patients and providers.
CONCLUSIONS


We saw a short-term ART-initiation benefit to FTIC (particularly in districts where initiation prior to intervention was lower), with no reductions but also no improvement in longer-term retention and viral suppression. This may be due to lack of fidelity to implementation and delivery of those components that support retention and adherence. FTIC must continue to be implemented alongside other interventions to achieve the 90-90-90 cascade and fidelity to post-initiation counselling sessions must be monitored to determine impact on longer-term outcomes. Understanding the cost-benefit and role of FTIC may then be warranted.",2019,Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%).,"['4 provinces at 12 intervention sites which implemented FTIC and 12 control facilities providing standard of care', 'Differentiated HIV care in South Africa', 'We enrolled 362 intervention and 368 control arm patients', 'subjects eligible for FTIC between 08 Jan 2016 and 07 December 2016']",['Fast-Track Treatment Initiation Counselling (FTIC'],"['viral suppression', 'ART initiation', 'longer-term retention and viral suppression', 'ART initiation, adherence and retention']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.208107,Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%).,"[{'ForeName': 'Sophie Js', 'Initials': 'SJ', 'LastName': 'Pascoe', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Huber', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mokgadi', 'Initials': 'M', 'LastName': 'Phokojoe', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Marelize', 'Initials': 'M', 'LastName': 'Gorgens', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Yogan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fraser-Hurt', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25409']
1442,30673120,Pregabalin for neuropathic pain in adults.,"BACKGROUND


This review updates part of an earlier Cochrane Review titled ""Pregabalin for acute and chronic pain in adults"", and considers only neuropathic pain (pain from damage to nervous tissue). Antiepileptic drugs have long been used in pain management. Pregabalin is an antiepileptic drug used in management of chronic pain conditions.
OBJECTIVES


To assess the analgesic efficacy and adverse effects of pregabalin for chronic neuropathic pain in adults.
SEARCH METHODS


We searched CENTRAL, MEDLINE, and Embase for randomised controlled trials from January 2009 to April 2018, online clinical trials registries, and reference lists.
SELECTION CRITERIA


We included randomised, double-blind trials of two weeks' duration or longer, comparing pregabalin (any route of administration) with placebo or another active treatment for neuropathic pain, with participant-reported pain assessment.
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted data and assessed trial quality and biases. Primary outcomes were: at least 30% pain intensity reduction over baseline; much or very much improved on the Patient Global Impression of Change (PGIC) Scale (moderate benefit); at least 50% pain intensity reduction; or very much improved on PGIC (substantial benefit). We calculated risk ratio (RR) and number needed to treat for an additional beneficial (NNTB) or harmful outcome (NNTH). We assessed the quality of the evidence using GRADE.
MAIN RESULTS


We included 45 studies lasting 2 to 16 weeks, with 11,906 participants - 68% from 31 new studies. Oral pregabalin doses of 150 mg, 300 mg, and 600 mg daily were compared with placebo. Postherpetic neuralgia, painful diabetic neuropathy, and mixed neuropathic pain predominated (85% of participants). High risk of bias was due mainly to small study size (nine studies), but many studies had unclear risk of bias, mainly due to incomplete outcome data, size, and allocation concealment.Postherpetic neuralgia: More participants had at least 30% pain intensity reduction with pregabalin 300 mg than with placebo (50% vs 25%; RR 2.1 (95% confidence interval (CI) 1.6 to 2.6); NNTB 3.9 (3.0 to 5.6); 3 studies, 589 participants, moderate-quality evidence), and more had at least 50% pain intensity reduction (32% vs 13%; RR 2.5 (95% CI 1.9 to 3.4); NNTB 5.3 (3.9 to 8.1); 4 studies, 713 participants, moderate-quality evidence). More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (62% vs 24%; RR 2.5 (95% CI 2.0 to 3.2); NNTB 2.7 (2.2 to 3.7); 3 studies, 537 participants, moderate-quality evidence), and more had at least 50% pain intensity reduction (41% vs 15%; RR 2.7 (95% CI 2.0 to 3.5); NNTB 3.9 (3.1 to 5.5); 4 studies, 732 participants, moderate-quality evidence). Somnolence and dizziness were more common with pregabalin than with placebo (moderate-quality evidence): somnolence 300 mg 16% versus 5.5%, 600 mg 25% versus 5.8%; dizziness 300 mg 29% versus 8.1%, 600 mg 35% versus 8.8%.Painful diabetic neuropathy: More participants had at least 30% pain intensity reduction with pregabalin 300 mg than with placebo (47% vs 42%; RR 1.1 (95% CI 1.01 to 1.2); NNTB 22 (12 to 200); 8 studies, 2320 participants, moderate-quality evidence), more had at least 50% pain intensity reduction (31% vs 24%; RR 1.3 (95% CI 1.2 to 1.5); NNTB 22 (12 to 200); 11 studies, 2931 participants, moderate-quality evidence), and more had PGIC much or very much improved (51% vs 30%; RR 1.8 (95% CI 1.5 to 2.0); NNTB 4.9 (3.8 to 6.9); 5 studies, 1050 participants, moderate-quality evidence). More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (63% vs 52%; RR 1.2 (95% CI 1.04 to 1.4); NNTB 9.6 (5.5 to 41); 2 studies, 611 participants, low-quality evidence), and more had at least 50% pain intensity reduction (41% vs 28%; RR 1.4 (95% CI 1.2 to 1.7); NNTB 7.8 (5.4 to 14); 5 studies, 1015 participants, low-quality evidence). Somnolence and dizziness were more common with pregabalin than with placebo (moderate-quality evidence): somnolence 300 mg 11% versus 3.1%, 600 mg 15% versus 4.5%; dizziness 300 mg 13% versus 3.8%, 600 mg 22% versus 4.4%.Mixed or unclassified post-traumatic neuropathic pain: More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (48% vs 36%; RR 1.2 (1.1 to 1.4); NNTB 8.2 (5.7 to 15); 4 studies, 1367 participants, low-quality evidence), and more had at least 50% pain intensity reduction (34% vs 20%; RR 1.5 (1.2 to 1.9); NNTB 7.2 (5.4 to 11); 4 studies, 1367 participants, moderate-quality evidence). Somnolence (12% vs 3.9%) and dizziness (23% vs 6.2%) were more common with pregabalin.Central neuropathic pain: More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (44% vs 28%; RR 1.6 (1.3 to 2.0); NNTB 5.9 (4.1 to 11); 3 studies, 562 participants, low-quality evidence) and at least 50% pain intensity reduction (26% vs 15%; RR 1.7 (1.2 to 2.3); NNTB 9.8 (6.0 to 28); 3 studies, 562 participants, low-quality evidence). Somnolence (32% vs 11%) and dizziness (23% vs 8.6%) were more common with pregabalin.Other neuropathic pain conditions: Studies show no evidence of benefit for 600 mg pregabalin in HIV neuropathy (2 studies, 674 participants, moderate-quality evidence) and limited evidence of benefit in neuropathic back pain or sciatica, neuropathic cancer pain, or polyneuropathy.Serious adverse events, all conditions: Serious adverse events were no more common with placebo than with pregabalin 300 mg (3.1% vs 2.6%; RR 1.2 (95% CI 0.8 to 1.7); 17 studies, 4112 participants, high-quality evidence) or pregabalin 600 mg (3.4% vs 3.4%; RR 1.1 (95% CI 0.8 to 1.5); 16 studies, 3995 participants, high-quality evidence).
AUTHORS' CONCLUSIONS


Evidence shows efficacy of pregabalin in postherpetic neuralgia, painful diabetic neuralgia, and mixed or unclassified post-traumatic neuropathic pain, and absence of efficacy in HIV neuropathy; evidence of efficacy in central neuropathic pain is inadequate. Some people will derive substantial benefit with pregabalin; more will have moderate benefit, but many will have no benefit or will discontinue treatment. There were no substantial changes since the 2009 review.",2019,"Serious adverse events, all conditions: Serious adverse events were no more common with placebo than with pregabalin 300 mg (3.1% vs 2.6%; RR 1.2 (95% CI 0.8 to 1.7); 17 studies, 4112 participants, high-quality evidence) or pregabalin 600 mg (3.4% vs 3.4%; RR 1.1 (95% CI 0.8 to 1.5); 16 studies, 3995 participants, high-quality evidence).
","['neuropathic pain in adults', '45 studies lasting 2 to 16 weeks, with 11,906 participants - 68% from 31 new studies', 'chronic neuropathic pain in adults', '674 participants, moderate-quality evidence', 'Central neuropathic pain']","['Pregabalin', 'Oral pregabalin', 'pregabalin', 'placebo']","['moderate-quality evidence', 'Patient Global Impression of Change (PGIC) Scale', '8.8%.Painful diabetic neuropathy', 'calculated risk ratio (RR) and number needed to treat for an additional beneficial (NNTB) or harmful outcome (NNTH', 'Serious adverse events, all conditions: Serious adverse events', 'traumatic neuropathic pain', 'neuropathic back pain or sciatica, neuropathic cancer pain, or polyneuropathy', 'Postherpetic neuralgia', 'Postherpetic neuralgia, painful diabetic neuropathy, and mixed neuropathic pain', 'Somnolence and dizziness', 'Somnolence', 'analgesic efficacy and adverse effects', 'pain intensity reduction', 'dizziness', 'somnolence']","[{'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia (disorder)'}, {'cui': 'C0751074', 'cui_str': 'Diabetic Neuralgia'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",11906.0,0.623031,"Serious adverse events, all conditions: Serious adverse events were no more common with placebo than with pregabalin 300 mg (3.1% vs 2.6%; RR 1.2 (95% CI 0.8 to 1.7); 17 studies, 4112 participants, high-quality evidence) or pregabalin 600 mg (3.4% vs 3.4%; RR 1.1 (95% CI 0.8 to 1.5); 16 studies, 3995 participants, high-quality evidence).
","[{'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Derry', 'Affiliation': 'Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LE.'}, {'ForeName': 'Rae Frances', 'Initials': 'RF', 'LastName': 'Bell', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Straube', 'Affiliation': ''}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Wiffen', 'Affiliation': ''}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Aldington', 'Affiliation': ''}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Moore', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007076.pub3']
1443,31302205,A randomized trial provided new evidence on the accuracy and efficiency of traditional vs. electronically annotated abstraction approaches in systematic reviews.,"OBJECTIVES


Data Abstraction Assistant (DAA) is a software for linking items abstracted into a data collection form for a systematic review to their locations in a study report. We conducted a randomized cross-over trial that compared DAA-facilitated single-data abstraction plus verification (""DAA verification""), single data abstraction plus verification (""regular verification""), and independent dual data abstraction plus adjudication (""independent abstraction"").
STUDY DESIGN AND SETTING


This study is an online randomized cross-over trial with 26 pairs of data abstractors. Each pair abstracted data from six articles, two per approach. Outcomes were the proportion of errors and time taken.
RESULTS


Overall proportion of errors was 17% for DAA verification, 16% for regular verification, and 15% for independent abstraction. DAA verification was associated with higher odds of errors when compared with regular verification (adjusted odds ratio [OR] = 1.08; 95% confidence interval [CI]: 0.99-1.17) or independent abstraction (adjusted OR = 1.12; 95% CI: 1.03-1.22). For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
CONCLUSION


Independent abstraction may only be necessary for complex data items. DAA provides an audit trail that is crucial for reproducible research.",2019,"For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
",['26 pairs of data abstractors'],"['DAA-facilitated single-data abstraction plus verification (""DAA verification']",['proportion of errors and time taken'],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",,0.133149,"For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction.
","[{'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E6140, Baltimore, MD 21205, USA. Electronic address: tli19@jhu.edu.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Saldanha', 'Affiliation': 'Center for Evidence Synthesis in Health, Department of Health Services, Policy, and Practice, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA; Department of Epidemiology (Secondary), Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jap', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Bryant T', 'Initials': 'BT', 'LastName': 'Smith', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Canner', 'Affiliation': 'Department of Surgery, Center for Outcomes Research, Johns Hopkins School of Medicine, 720 Rutland Avenue, Turner 74, Baltimore, MD 21205, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Hutfless', 'Affiliation': 'Department of Surgery, Johns Hopkins School of Medicine, 600 N Wolfe St, Blalock 406, Baltimore, MD 21205, USA.'}, {'ForeName': 'Vernal', 'Initials': 'V', 'LastName': 'Branch', 'Affiliation': '119 Landings Drive, Suite 403, Mooresville, NC 28117, USA.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Carini', 'Affiliation': 'Department of Medicine, School of Medicine, University of California San Francisco, 3333 California Street, San Francisco, CA 94143, USA.'}, {'ForeName': 'Wiley', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Internal Medicine, Kaiser Permanente Northwest, 500 NE Multnomah Street, Suite 100, KPB-2, Portland, OR 97232, USA.'}, {'ForeName': 'Berry', 'Initials': 'B', 'LastName': 'de Bruijn', 'Affiliation': 'Internal Medicine, National Research Council Canada, Digital Technologies Research Centre, 1200 Montreal Road, Ottawa, Ontario K1A 0R6, Canada.'}, {'ForeName': 'Byron C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Internal Medicine, College of Computer and Information Science, Northeastern University, 440 Huntington Avenue, 476 West Village H, Boston, MA 02115, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Walsh', 'Affiliation': 'Internal Medicine, California Breast Cancer Organizations, 900 Kent Drive, Davis, CA 95616, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Whamond', 'Affiliation': 'Internal Medicine, Cochrane Consumer Network, 1421 Woodstock Road, Fredericton, New Brunswick E3C 1P2, Canada.'}, {'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Murad', 'Affiliation': 'Internal Medicine, Evidence-based Practice Center, Mayo Clinic, 200 1st Street, Rochester, MN 55905, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Sim', 'Affiliation': 'Department of Medicine, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Berlin', 'Affiliation': 'Internal Medicine, Epidemiology, Johnson & Johnson, 1125 Trenton-Harbourton Road, K3-Zone 1, Titusville, NJ 08560, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lau', 'Affiliation': 'Department of Health Services, Policy, and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health, 121 South Main Street, Box G-S121-8, Providence, RI 02912, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Dickersin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E6152, Baltimore, MD 21205, USA.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Schmid', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, 121 South Main Street, Box G-S121-7, Providence, RI 02912, USA.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.07.005']
1444,30690595,Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome.,"OBJECTIVE


To compare the effectiveness of lung lavage with surfactant vs. bolus surfactant treatment in meconium aspiration syndrome (MAS).
PATIENTS AND METHODS


This randomized controlled trial included newborns ventilated with MAS. In lavage group (n = 17) 30 ml/kg of diluted porcine surfactant was instilled into the lung. In bolus group (n = 16) porcine surfactant (100 mg/kg) was administered as bolus. Respiratory outcomes and mortality were compared between groups.
RESULTS


Duration of respiratory support was found to be similar between lavage and bolus groups (3 vs. 3.5 days, p = 0.36). Death or requirement for extracorporeal membrane oxygenation (ECMO) was 12% vs. 6%; respectively (RR: 2, 95% CI 0.16-24.48; p = 1.0). Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement did not differ among the groups.
CONCLUSION


Lung lavage did not show any advantage over bolus therapy on duration of respiratory support. The incidence of pneumothorax and surfactant re-administration decreased nonsignificantly in lavage group.
CLINICAL TRIAL REGISTRATION


We registered the trial to ClinicalTrials.gov (http://clinicaltrials.gov) under identifier NCT02041546.
REGISTRY NAME


Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome.",2019,"Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement did not differ among the groups.
","['Meconium Aspiration Syndrome', 'newborns ventilated with MAS', 'meconium aspiration syndrome (MAS']","['lung lavage with surfactant vs. bolus surfactant treatment', 'Lung Lavage with Dilute Surfactant vs. Bolus Surfactant', 'Dilute Poractant Alfa', 'porcine surfactant', 'diluted porcine surfactant']","['Death or requirement for extracorporeal membrane oxygenation (ECMO', 'duration of respiratory support', 'Duration of respiratory support', 'Respiratory outcomes and mortality', 'Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement', 'incidence of pneumothorax and surfactant re-administration']","[{'cui': 'C0025048', 'cui_str': 'Meconium Aspiration Syndrome'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0771648', 'cui_str': 'Poractant alfa'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0019541', 'cui_str': 'High-Frequency Ventilation'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",,0.174174,"Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement did not differ among the groups.
","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Arayici', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Sari', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Kadioglu Simsek', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Erbu', 'Initials': 'E', 'LastName': 'Yarci', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Alyamac Dizdar', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Uras', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Fuat Emre', 'Initials': 'FE', 'LastName': 'Canpolat', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Serife Suna', 'Initials': 'SS', 'LastName': 'Oguz', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy081']
1445,29905758,Short-stay unit hospitalisation vs. standard care outcomes in older internal medicine patients-a randomised clinical trial.,"Background


the effect of hospitalisation in emergency department-based short-stay units (SSUs) has not been studied in older patients. We compared SSU hospitalisation with standard care at an Internal Medicine Department (IMD) in acutely admitted older internal medicine patients.
Methods


pragmatic randomised clinical trial. We randomly assigned patients aged 75 years or older, acutely admitted for an internal medicine disease and assessed to be suitable for SSU hospitalisation to SSU hospitalisation or IMD hospitalisation. SSU hospitalisation was provided by a pragmatic 'fast-track' principle. The primary outcome was 90-day mortality. Secondary outcomes included adverse events, change in Lawton Instrumental Activities of Daily Living (IADL) score within 90 days from admission, in-hospital length of stay and unplanned readmissions within 30 days after discharge.
Results


between January 2015 and October 2016, 430 participants were randomised (median age 84 years in both groups). Ninety-day mortality was 22(11%) in the SSU group and 32(15%) in the IMD group (odds ratio (OR) 0.66; 95% confidence interval (CI) 0.37-1.18; P = 0.16). When comparing the SSU group to the IMD group, 16(8%) vs. 45(21%) experienced at least one adverse event (OR 0.31; 95% CI 0.17-0.56; P < 0.001); 6(3%) vs. 35(20%) experienced a reduction in IADL score within 90 days from admission (P < 0.001); median in-hospital length of stay was 73 h [interquartile range, IQR 36-147] vs. 100 h [IQR 47-169], (P < 0.001), and 26(13%) vs. 58(29%) were readmitted (OR 0.37; 95% CI 0.22-0.61; P < 0.001).
Conclusions


mortality at 90 days after admission was not significantly lower in the SSU group, but SSU hospitalisation was associated with a lower risk of adverse events, less functional decline, fewer readmissions and shorter hospital stay.
Trial registration


NCT02395718.",2018,Ninety-day mortality was 22(11%) in the SSU group and 32(15%) in the IMD group (odds ratio (OR) 0.66; 95% confidence interval (CI) 0.37-1.18; P = 0.16).,"['acutely admitted older internal medicine patients', 'patients aged 75 years or older, acutely admitted for an internal medicine disease and assessed to be suitable for SSU hospitalisation to SSU hospitalisation or IMD hospitalisation', 'older internal medicine patients', 'Results\n\n\nbetween January 2015 and October 2016, 430 participants were randomised (median age 84 years in both groups', 'older patients']","['SSU', 'SSU hospitalisation with standard care at an Internal Medicine Department (IMD']","['90-day mortality', 'adverse events, change in Lawton Instrumental Activities of Daily Living (IADL) score within 90 days from admission, in-hospital length of stay and unplanned readmissions within 30 days after discharge', 'IADL score', 'SSU hospitalisation', 'adverse event', 'functional decline, fewer readmissions and shorter hospital stay']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",430.0,0.341987,Ninety-day mortality was 22(11%) in the SSU group and 32(15%) in the IMD group (odds ratio (OR) 0.66; 95% confidence interval (CI) 0.37-1.18; P = 0.16).,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Strøm', 'Affiliation': 'Department of Emergency Medicine, Holbaek Hospital, University of Copenhagen, Holbaek, Denmark.'}, {'ForeName': 'Lars Simon', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Löwe', 'Affiliation': 'Department of Emergency Medicine, North Denmark Regional Hospital, Hjoerring, Denmark.'}, {'ForeName': 'Anne Kathrine', 'Initials': 'AK', 'LastName': 'Lorentzen', 'Affiliation': 'Department of Emergency Medicine, Holbaek Hospital, University of Copenhagen, Holbaek, Denmark.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Lohse', 'Affiliation': 'Department of Anaesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kim Hvid Benn', 'Initials': 'KHB', 'LastName': 'Madsen', 'Affiliation': 'Department of Emergency Medicine, Holbaek Hospital, University of Copenhagen, Holbaek, Denmark.'}, {'ForeName': 'Søren Wistisen', 'Initials': 'SW', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Emergency Medicine, Holbaek Hospital, University of Copenhagen, Holbaek, Denmark.'}, {'ForeName': 'Thomas Andersen', 'Initials': 'TA', 'LastName': 'Schmidt', 'Affiliation': 'Department of Emergency Medicine, Holbaek Hospital, University of Copenhagen, Holbaek, Denmark.'}]",Age and ageing,['10.1093/ageing/afy090']
1446,30686607,"Introduction of Physician-Nurse Bedside Rounding and Ward Task List to Improve Quality of Care in Gynaecology: Prospective, Single-Blinded, Pre- and Post-Intervention Study.","OBJECTIVE


This study sought to determine whether physician-nurse bedside rounds and ward task list improve quality of care as measured by patient satisfaction, earlier discharge, and reduced trainee interruptions.
METHODS


This prospective, single-blind, pre- and post-intervention study included patients admitted to the gynaecology ward at St. Michael's Hospital in Toronto, Ontario, involving a 6-week baseline, 6-week intervention, and 2-week second baseline phase. During the intervention phase, a chief resident and charge nurse rounded at the bedside simultaneously daily. Nurses recorded non-urgent issues on a ward task list. Patients completed a subset of the National Research Corporation Picker satisfaction questionnaire, discharge times were noted, and residents recorded pages (Canadian Task Force Classification II-2).
RESULTS


There were 89, 104, and 30 admissions during baseline care, intervention, and second baseline phases, respectively. Mean discharge time in the intervention phase was significantly earlier than baseline (11:18 am ± 1 hour 59 minutes vs. 12:37 pm ± 2 hours 37 minutes, P < 0.001), with early discharges doubling (69% vs. 36%, P < 0.001). Discharge times returned to baseline after the intervention (12:36 pm ± 2 hours 39 minutes). Intervention phase patients appreciated bedside care plans (86 of 94 patients, 92%), with improved National Research Corporation Picker responses, which diminished post-intervention. Paging interruptions were lower during the intervention phase compared with the baseline phase (1.0 ± 1.1 vs. 3.4 ± 2.1, P < 0.001), with non-urgent pages decreasing most (0.5 ± 0.8 vs. 3.0 ± 2.0, P < 0.001).
CONCLUSION


Combining physician-nurse bedside rounds and ward task list reduces trainee interruptions, positively affects patient satisfaction, and promotes early discharge. Following these initiatives, discharge time, patient satisfaction, and resident paging interruptions returned to baseline.",2019,"Paging interruptions were lower during the intervention phase compared with the baseline phase (1.0±1.1 vs. 3.4±2.1, P<0.001), with non-urgent pages decreasing most (0.5±0.8 vs. 3.0±2.0, P<0.001).
","[""patients admitted to the gynaecology ward at St. Michael's Hospital in Toronto, Ontario, involving a 6-week baseline, 6-week intervention, and 2-week second baseline phase""]",[],"['bedside care plans', 'National Research Corporation Picker satisfaction questionnaire, discharge times', 'Discharge times', 'Mean discharge time', 'discharge time, patient satisfaction, and resident paging interruptions', 'Paging interruptions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",[],"[{'cui': 'C2961279', 'cui_str': 'Bedside-Care'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0035168'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",,0.0451009,"Paging interruptions were lower during the intervention phase compared with the baseline phase (1.0±1.1 vs. 3.4±2.1, P<0.001), with non-urgent pages decreasing most (0.5±0.8 vs. 3.0±2.0, P<0.001).
","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Shirreff', 'Affiliation': 'Department of Obstetrics and Gynaecology, Mount Sinai Hospital, Toronto, ON. Electronic address: lindsay.shirreff@sinaihealthsystem.ca.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Husslein', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Guylaine G', 'Initials': 'GG', 'LastName': 'Lefebvre', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON.'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Shore', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, St. Michael's Hospital, Toronto, ON.""}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.11.004']
1447,30702758,Internet-based treatment of depressive symptoms in a Kurdish population: A randomized controlled trial.,"OBJECTIVE


Kurdish immigrants in Sweden have a doubled risk of mental health problems, and refugee and immigrant populations underutilize mental health services. The present study investigated the efficacy of culturally adapted guided internet-based cognitive behavior therapy (ICBT) for depressive symptoms in a Kurdish population.
METHOD


We included 50 individuals who were randomized to either an 8-week treatment or a wait-list. The Beck Depression Inventory-II was the primary outcome measure, and measures of anxiety and insomnia were secondary outcomes.
RESULTS


Depressive symptoms were significantly reduced (intention-to-treat analysis) in the treatment group, with a between-group effect size at posttreatment of Cohen's d = 1.27. Moderate to large between-group effects were also observed on all secondary outcome measures. Treatment effects were sustained at 11-month follow-up.
CONCLUSION


The results provide preliminary support for culturally adapted ICBT as a complement to other treatment formats for treating symptoms of depression in a Kurdish population.",2019,"Depressive symptoms were significantly reduced (intention-to-treat analysis) in the treatment group, with a between-group effect size at posttreatment of Cohen's d = 1.27.","['depressive symptoms in a Kurdish population', 'Kurdish immigrants in Sweden have a doubled risk of mental health problems, and refugee and immigrant populations underutilize mental health services', '50 individuals']",['culturally adapted guided internet-based cognitive behavior therapy (ICBT'],"['anxiety and insomnia', 'Depressive symptoms']","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",50.0,0.19114,"Depressive symptoms were significantly reduced (intention-to-treat analysis) in the treatment group, with a between-group effect size at posttreatment of Cohen's d = 1.27.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Nygren', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brohede', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kocher', 'Initials': 'K', 'LastName': 'Koshnaw', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Shevan Sherzad', 'Initials': 'SS', 'LastName': 'Osman', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Journal of clinical psychology,['10.1002/jclp.22753']
1448,31550617,Effects of transcranial direct current stimulation over the posterior parietal cortex on episodic memory reconsolidation.,"Consolidated memories may return to labile/unstable states after their reactivation, thus requiring a restabilization process that is known as reconsolidation. During this time-limited reconsolidation window, reactivated existing memories can be strengthened, weakened or updated with new information. Previous studies have shown that non-invasive stimulation of the lateral prefrontal cortex after memory reactivation strengthened existing verbal episodic memories through reconsolidation, an effect documented by enhanced delayed memory recall (24 h post-reactivation). However, it remains unknown whether the left posterior parietal cortex (PPC), a region involved during reactivation of existing episodic memories, contributes to reconsolidation. To address this question, in this double-blind experiment healthy participants (n = 27) received transcranial direct current stimulation (tDCS) with the anode over the left PPC after reactivation of previously learned verbal episodic memories. Memory recall was tested 24 h later. To rule out unspecific effects of memory reactivation or tDCS alone, we included two control groups: one that receives tDCS with the anode over the left PPC without reactivation (n = 27) and another one that receives tDCS with the anode over a control site (primary visual cortex) after reactivation (n = 27). We hypothesized that tDCS with the anode over the left PPC after memory reactivation would enhance delayed recall through reconsolidation relative to the two control groups. No significant between groups differences in the mean number of words recalled on day 3 occurred, suggesting no beneficial effect of tDCS over the left PPC. Alternative explanations were discussed, including efficacy of tDCS, different stimulation parameters, electrode montage, and stimulation site within the PPC.",2019,"No significant between groups differences in the mean number of words recalled on day 3 occurred, suggesting no beneficial effect of tDCS over the left PPC.",['healthy participants (n\xa0=\xa027) received'],"['tDCS alone', 'transcranial direct current stimulation (tDCS) with the anode over the left PPC after reactivation of previously learned verbal episodic memories', 'transcranial direct current stimulation', 'tDCS with the anode over the left PPC without reactivation (n\xa0=\xa027) and another one that receives tDCS with the anode over a control site (primary visual cortex']","['Memory recall', 'mean number of words recalled']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0038446', 'cui_str': 'Striate Cortex'}]","[{'cui': 'C0679063', 'cui_str': 'Memory recall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0406003,"No significant between groups differences in the mean number of words recalled on day 3 occurred, suggesting no beneficial effect of tDCS over the left PPC.","[{'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Crossman', 'Affiliation': 'Department of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Bartl', 'Affiliation': 'Department of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Soerum', 'Affiliation': 'Department of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sandrini', 'Affiliation': 'Department of Psychology, University of Roehampton, London, UK. Electronic address: marco.sandrini@roehampton.ac.uk.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2019.08.009']
1449,29570547,Impact of Music Therapy on Hospitalized Patients Post-Elective Orthopaedic Surgery: A Randomized Controlled Trial.,,2018,,['Hospitalized Patients Post-Elective Orthopaedic Surgery'],['Music Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}]",[],,0.326334,,[],Orthopedic nursing,['10.1097/NOR.0000000000000440']
1450,29131730,Psychological Benefits of Yoga for Female Inmates.,"Female inmates involved in the Yoga Prison Project at two correctional facilities in South Carolina served as subjects. Inmates were selected from those who applied to participate in a ten-week trauma-focused yoga program. To create control and experimental groups, inmates who requested to participate were randomly assigned to be in the class (Treatment Group, n = 33) or a waitlist (Control Group, n = 17). Inmates on the waitlist subsequently joined the next class, so all who applied and were eligible participated in a yoga class. Measures of stress, depression, self control, anxiety, self awareness and rumination were used and data was collected from both groups before the initial yoga class began and again at the end, ten weeks later. To assess the changes from pre-intervention to post-intervention, mixed design ANOVA tests were conducted. Inmates in the yoga group reported significant decreases in depression and stress and improved self-awareness. No significant changes were found on measures of anxiety, rumination and self-control in the yoga groups. Although not statistically significant, anxiety scores did decrease and self-control scores improved for the yoga group, while inmates in the control group reported a worsening or no change on these two measures. No changes were found in rumination levels. The results suggest that Yoga is a relatively inexpensive intervention that could benefit both inmates and prison staff by reducing some negative behaviors and possibly mental health problems.",2017,"No significant changes were found on measures of anxiety, rumination and self-control in the yoga groups.","['Inmates were selected from those who applied to participate in a ten-week trauma-focused yoga program', 'inmates who requested to participate', 'Female Inmates', 'Female inmates involved in the Yoga Prison Project at two correctional facilities in South Carolina served as subjects']",[],"['stress, depression, self control, anxiety, self awareness and rumination', 'anxiety scores', 'anxiety, rumination and self-control', 'rumination levels', 'self-control scores', 'depression and stress and improved self-awareness']","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0442681', 'cui_str': 'Penal institution (environment)'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self (observable entity)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0100622,"No significant changes were found on measures of anxiety, rumination and self-control in the yoga groups.","[{'ForeName': 'Yoika', 'Initials': 'Y', 'LastName': 'Danielly', 'Affiliation': 'University of San Francisco.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Silverthorne', 'Affiliation': 'University of San Francisco.'}]",International journal of yoga therapy,['10.17761/1531-2054-27.1.9']
1451,30681754,Long-term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open-label extensions.,"BACKGROUND AND PURPOSE


The aim was to evaluate the efficacy of the catechol-O-methyltransferase inhibitor opicapone (25 and 50 mg) as adjunct therapy to levodopa in a pooled population of Parkinson's disease patients who participated in the pivotal double-blind trials of opicapone and their 1-year open-label extensions.
METHODS


Data (placebo, opicapone 25 mg and opicapone 50 mg) from the BIPARK-1 and BIPARK-2 double-blind and open-label studies were combined. The studies had similar designs, eligibility criteria and assessment methods. The primary efficacy variable in both double-blind studies was the change from baseline in absolute OFF time based on patient diaries.
RESULTS


Double-blind treatment with opicapone (25 and 50 mg) significantly reduced absolute daily OFF time from a baseline of 6.1-6.6 h. The mean (and 95% confidence interval) treatment effect versus placebo was -35.1 (-62.1, -8.2) min (P = 0.0106) for the 25 mg dose and -58.1 (-84.5, -31.7) min (P < 0.0001) for the 50 mg dose. Reductions in OFF time were mirrored by significant increases in ON time without troublesome dyskinesia (P < 0.05 and P < 0.0001 for the 25 and 50 mg doses, respectively). No significant differences were observed for ON time with troublesome dyskinesia. Patient diary results from the open-label phase indicated a maintenance of effect for patients previously treated with opicapone 50 mg. The group previously treated with the 25 mg dose benefitted with further optimization of therapy during the open-label phase, whilst switching from placebo to opicapone led to significant reductions in OFF time and increased ON time.
CONCLUSIONS


Over at least 1 year of open-label therapy, opicapone consistently reduced OFF time and increased ON time without increasing the frequency of troublesome dyskinesia.",2019,"RESULTS


Double-blind treatment with opicapone (25 and 50 mg) significantly reduced absolute daily OFF time from a baseline of 6.1-6.6 h.","[""fluctuating Parkinson's disease patients"", ""pooled population of Parkinson's disease patients who participated in the pivotal double-blind trials of opicapone and their 1-year open-label extensions""]","['placebo', 'levodopa', 'catechol-O-methyltransferase inhibitor opicapone', 'placebo, opicapone 25 mg and opicapone', 'opicapone']","['OFF time', 'OFF time and increased ON time', 'ON time without troublesome dyskinesia', 'absolute OFF time', 'frequency of troublesome dyskinesia', 'absolute daily OFF time', 'ON time with troublesome dyskinesia']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2933912', 'cui_str': '2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4521910', 'cui_str': 'Catechol-O-methyltransferase inhibitor'}, {'cui': 'C2933912', 'cui_str': '2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.328549,"RESULTS


Double-blind treatment with opicapone (25 and 50 mg) significantly reduced absolute daily OFF time from a baseline of 6.1-6.6 h.","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon, Lisbon, Torres Vedras, Portugal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lees', 'Affiliation': 'Reta Lila Weston Institute, University College London, London, UK.'}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Rocha', 'Affiliation': 'Department of Research and Development, BIAL - Portela & Ca SA, S. Mamede do Coronado, Portugal.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Rascol', 'Affiliation': 'Clinical Investigation Centre CIC1436, Departments of Clinical Pharmacology and Neurosciences, NS-Park/FCRIN Network, University Hospital of Toulouse, INSERM, University Toulouse 3, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Soares-da-Silva', 'Affiliation': 'Department of Research and Development, BIAL - Portela & Ca SA, S. Mamede do Coronado, Portugal.'}]",European journal of neurology,['10.1111/ene.13914']
1452,30679095,"Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial.","BACKGROUND


Oral insulin 338 (I338) is a long-acting, basal insulin analogue formulated in a tablet with the absorption-enhancer sodium caprate. We investigated the efficacy and safety of I338 versus subcutaneous insulin glargine (IGlar) in patients with type 2 diabetes.
METHODS


This was a phase 2, 8-week, randomised, double-blind, double-dummy, active-controlled, parallel trial completed at two research institutes in Germany. Insulin-naive adult patients with type 2 diabetes, inadequately controlled on metformin monotherapy or combined with other oral antidiabetic drugs (HbA 1c  7·0-10·0%; BMI 25·0-40·0 kg/m 2 ), were randomly assigned (1:1) to receive once-daily I338 plus subcutaneous placebo (I338 group) or once-daily IGlar plus oral placebo (IGlar group). Randomisation occurred by interactive web response system stratified by baseline treatment with oral antidiabetic drugs. Patients and investigators were masked to treatment assignment. Weekly insulin dose titration aimed to achieve a self-measured fasting plasma glucose (FPG) concentration of 4·4-7·0 mmol/L. The recommended daily starting doses were 2700 nmol I338 or 10 U IGlar, and maximum allowed doses throughout the trial were 16 200 nmol I338 or 60 U IGlar. The primary endpoint was treatment difference in FPG concentration at 8 weeks for all randomly assigned patients receiving at least one dose of trial product (ie, the full analysis set). The trial has been completed and is registered at ClinicalTrials.gov, number NCT02470039.
FINDINGS


Between June 1, 2015, and Oct 19, 2015, 82 patients were screened for eligibility and 50 patients were randomly assigned to the I338 group (n=25) or the IGlar group (n=25). Mean FPG concentration at baseline was 9·7 (SD 2·8) in the I338 group and 9·1 (1·7) in the IGlar group. Least square mean FPG concentration at 8 weeks was 7·1 mmol/L (95% CI 6·4-7·8) in the I338 group and 6·8 mmol/L (6·5-7·1) in the IGlar group, with no significant treatment difference (0·3 mmol/L [-0·5 to 1·1]; p=0·46). I338 and IGlar were well tolerated by patients. Adverse events were reported in 15 (60%) patients in the I338 group and 17 (68%) patients in the IGlar group. The most common adverse events were diarrhoea (three [12%] patients in each group) and nasopharyngitis (five [20%] in the I338 group and two [8%] in the IGlar group). Most adverse events were graded mild (47 of 68 events), and no severe adverse events were reported. One patient in the IGlar group had a treatment-emergent serious adverse event (urogenital haemorrhage of moderate intensity, assessed by the investigator as unlikely to be related to treatment; the patient recovered). Incidence of hypoglycaemia was low in both groups (n=7 events in the I338 group; n=11 in the IGlar group), with no severe episodes.
INTERPRETATION


I338 can safely improve glycaemic control in insulin-naive patients with type 2 diabetes with no evidence of a difference compared with insulin glargine, a widely used subcutaneously administered basal insulin. Further development of this particular oral insulin project was discontinued because I338 doses were high and, therefore, production of the required quantities of I338 for wide public use was deemed not commercially viable. Improvement of technologies involved in the product's development is the focus of ongoing research.
FUNDING


Novo Nordisk.",2019,The most common adverse events were diarrhoea (three [12%] patients in each group) and nasopharyngitis (five [20%] in the I338 group and two [8%] in the IGlar group).,"['type 2 diabetes', 'Insulin-naive adult patients with type 2 diabetes', 'HbA 1c  7·0-10·0%; BMI 25·0-40·0 kg/m 2 ', 'patients with type 2 diabetes', 'Between June 1, 2015, and Oct 19, 2015, 82 patients were screened for eligibility and 50 patients were randomly assigned to the I338 group (n=25) or the IGlar group (n=25']","['oral basal insulin versus subcutaneous insulin glargine', 'metformin monotherapy or combined with other oral antidiabetic drugs', 'receive once-daily I338 plus subcutaneous placebo (I338 group) or once-daily IGlar plus oral placebo (IGlar group', 'subcutaneous insulin glargine (IGlar', 'insulin glargine']","['Adverse events', 'treatment-emergent serious adverse event (urogenital haemorrhage of moderate intensity', 'nasopharyngitis', 'glycaemic control', 'fasting plasma glucose (FPG) concentration', 'Mean FPG concentration', 'diarrhoea', 'severe adverse events', 'Least square mean FPG concentration', 'Efficacy and safety', 'Incidence of hypoglycaemia', 'efficacy and safety', 'FPG concentration']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0919591', 'cui_str': 'Urogenital bleeding'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",82.0,0.341686,The most common adverse events were diarrhoea (three [12%] patients in each group) and nasopharyngitis (five [20%] in the I338 group and two [8%] in the IGlar group).,"[{'ForeName': 'Inge B', 'Initials': 'IB', 'LastName': 'Halberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark. Electronic address: ibh@novonordisk.com.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lyby', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Wassermann', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil Mainz GmbH & Co KG, Mainz, Germany.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(18)30372-3']
1453,29669668,Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations.,"BACKGROUND


GSP301 is a fixed-dose combination (FDC) of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate developed as a single nasal spray (NS).
OBJECTIVE


To assess the relative bioavailability of mometasone administered as GSP301 FDC versus two mometasone monotherapy NS formulations.
METHODS


In this single-dose, open-label, crossover study, healthy adults (age range, 18-65 years) were randomized equally to one of six treatment sequences for three 72-hour treatment periods with GSP301 (olopatadine 665 μg-mometasone 50 μg), the mometasone furoate monotherapy component of GSP301 (MF-sponsor, 50 μg), and U.S. Food and Drug Administration-approved mometasone (MF, 50 μg); all the treatments were administered as two sprays per nostril. To evaluate the relative bioavailability of mometasone, pharmacokinetic (PK) estimates, the maximum plasma concentration (Cmax), the area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞) were compared by analysis of variance. Safety and tolerability were also assessed.
RESULTS


A total of 30 healthy subjects were randomized. Most subjects were white men who were not obese, mean age of ∼43 years. The geometric mean ratios for natural log transformed Cmax, AUC0-t, and AUC0-∞ of mometasone in GSP301 to MF-sponsor were 113.83, 118.36, and 118.50, respectively. For GSP301 and MF, geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ were 141.84, 109.92, and 115.14, respectively. The percentages of subjects who reported treatment-emergent adverse events (TEAE) were 10.0%, 13.3%, and 10.3% for GSP301, MF-sponsor, and MF treatments, respectively. All TEAEs were mild, and none resulted in discontinuation.
CONCLUSION


Mometasone bioavailability with GSP301 was comparable with MF-sponsor and MF monotherapies. A slightly higher Cmax was observed with GSP301 than with MF, but AUC was comparable. The addition of olopatadine to mometasone in GSP301 did not considerably affect the PK of mometasone. GSP301 was well tolerated, with only mild adverse events reported.",2018,"For GSP301 and MF, geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ were 141.84, 109.92, and 115.14, respectively.","['Most subjects were white men who were not obese, mean age of ∼43 years', 'healthy adults (age range, 18-65 years', '30 healthy subjects']","['mometasone', 'intranasal mometasone', 'corticosteroid mometasone furoate', 'GSP301 (olopatadine 665 μg-mometasone 50 μg), the mometasone furoate monotherapy component of GSP301 (MF-sponsor, 50 μg), and U.S. Food and Drug Administration-approved mometasone', 'antihistamine olopatadine hydrochloride', 'olopatadine', 'GSP301', 'GSP301 FDC versus two mometasone monotherapy NS formulations']","['relative bioavailability of mometasone, pharmacokinetic (PK) estimates, the maximum plasma concentration (Cmax), the area under the plasma concentration time curve (AUC) from time 0 to the last time point with measurable concentration (AUC0-t), and AUC from time 0 to time infinity (AUC0-∞', 'For GSP301 and MF, geometric mean ratios for Cmax, AUC0-t, and AUC0-∞', 'treatment-emergent adverse events (TEAE', 'relative bioavailability', 'Cmax', 'Mometasone bioavailability', 'geometric mean ratios for natural log transformed Cmax, AUC0-t, and AUC0-∞ of mometasone', 'Safety and tolerability']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0771892', 'cui_str': 'Olopatadine hydrochloride'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0918427,"For GSP301 and MF, geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ were 141.84, 109.92, and 115.14, respectively.","[{'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'From the Inflamax Research Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Salapatek', 'Affiliation': 'From the Inflamax Research Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Ravi S', 'Initials': 'RS', 'LastName': 'Talluri', 'Affiliation': 'Glenmark Pharmaceuticals Ltd., Navi Mumbai, India.'}, {'ForeName': 'Sudeesh K', 'Initials': 'SK', 'LastName': 'Tantry', 'Affiliation': 'Glenmark Pharmaceuticals Inc, Mahwah, New Jersey.'}]",Allergy and asthma proceedings,['10.2500/aap.2018.39.4134']
1454,29641281,"A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients.","The aim of this study was to test the clinical efficacy of TissueGene-C (TG-C), a cell and gene therapeutic for osteoarthritis consisting of non-transformed and transduced chondrocytes (3:1) retrovirally transduced to overexpress transforming growth factor-β1. A total of 163 Kellgren-Lawrence grade 3 patients with knee osteoarthritis were randomly assigned to receive intra-articular TG-C or placebo. Primary efficacy measures included criteria for subjective assessment by International Knee Documentation Committee (IKDC) and pain severity by Visual Analog Scale (VAS) for 52 weeks. Secondary efficacy measures included IKDC and VAS at 26 and 39 weeks; pain, stiffness, and physical function by the Western Ontario and McMaster Universities Arthritis Index (WOMAC); and pain, symptoms, daily activities, function in sports and recreation, and quality of life by the Knee Injury and Osteoarthritis Outcome Score (KOOS), X-ray, magnetic resonance imaging, and soluble urine and blood biomarkers. TG-C was associated with statistically significant improvement over placebo in the total IKDC score and individual categories, and in the VAS score at 26, 39, and 52 weeks. WOMAC and KOOS scores also improved with TG-C over placebo. Patients treated with TG-C showed trends directed toward thicker cartilage and slower growing rates of subchondral bone surface area in the medial tibia, lateral tibia, lateral patella, and lateral patella femoral regions, although these were not statistically significant (p > 0.05). Serum C-terminal telopeptide of type I collagen (CTX-I) and urine CTX-II levels were lower over 1 year in TG-C than placebo-treated patients, with CTX-I level reaching statistical significance. These tendencies supported TG-C as holding great potential as a disease-modifying osteoarthritis drug. The most frequent adverse events in the TG-C group were peripheral edema (9%), arthralgia (8%), joint swelling (6%), and injection site pain (5%). TG-C was associated with statistically significant improvements in function and pain in patients with knee osteoarthritis. The unexpected adverse events were not observed.",2018,"TG-C was associated with statistically significant improvement over placebo in the total IKDC score and individual categories, and in the VAS score at 26, 39, and 52 weeks.","['Knee Osteoarthritis Patients', 'patients with knee osteoarthritis', 'osteoarthritis consisting of non-transformed and transduced chondrocytes (3:1) retrovirally transduced to overexpress transforming growth factor-β1', '163 Kellgren-Lawrence grade 3 patients with knee osteoarthritis']","['Cell and Gene Therapy', 'placebo', 'TissueGene-C (TG-C', 'CTX', 'intra-articular TG-C or placebo']","['peripheral edema', 'criteria for subjective assessment by International Knee Documentation Committee (IKDC) and pain severity by Visual Analog Scale (VAS', 'Serum C-terminal telopeptide of type', 'adverse events', 'arthralgia', 'I collagen (CTX-I) and urine CTX-II levels', 'joint swelling', 'function and pain', 'IKDC and VAS at 26 and 39 weeks; pain, stiffness, and physical function by the Western Ontario and McMaster Universities Arthritis Index (WOMAC); and pain, symptoms, daily activities, function in sports and recreation, and quality of life by the Knee Injury and Osteoarthritis Outcome Score (KOOS), X-ray, magnetic resonance imaging, and soluble urine and blood biomarkers', 'total IKDC score and individual categories, and in the VAS score', 'WOMAC and KOOS scores', 'Efficacy and Safety', 'thicker cartilage and slower growing rates of subchondral bone surface area', 'injection site pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0225369', 'cui_str': 'Chondrocyte'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}]","[{'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0034380'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}]",163.0,0.0547638,"TG-C was associated with statistically significant improvement over placebo in the total IKDC score and individual categories, and in the VAS score at 26, 39, and 52 weeks.","[{'ForeName': 'Myung-Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': '1 Inha University Hospital , Incheon, South Korea .'}, {'ForeName': 'Chul-Won', 'Initials': 'CW', 'LastName': 'Ha', 'Affiliation': '2 Samsung Medical Center, Sung Kyun Kwan University School of Medicine , Seoul, South Korea .'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': '3 The Catholic University of Korea College of Medicine , Seoul, South Korea .'}, {'ForeName': 'Sung-Do', 'Initials': 'SD', 'LastName': 'Cho', 'Affiliation': '4 Ulsan University Hospital, University of Ulsan College of Medicine , Ulsan, South Korea .'}, {'ForeName': 'Eui-Sung', 'Initials': 'ES', 'LastName': 'Choi', 'Affiliation': '5 Chungbuk National University Hospital , Cheongju, South Korea .'}, {'ForeName': 'Jeong-Ku', 'Initials': 'JK', 'LastName': 'Ha', 'Affiliation': '6 Seoul Paik Hospital, Inje University , Seoul, South Korea .'}, {'ForeName': 'Ju-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': '7 Jeonbuk National University Medical School , Jeonju, South Korea .'}, {'ForeName': 'Jae-Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': '8 Ewha Womans University Mokdong Hospital , Seoul, South Korea .'}, {'ForeName': 'Seong-Il', 'Initials': 'SI', 'LastName': 'Bin', 'Affiliation': '9 Asan Medical Center, University of Ulsan College of Medicine , Ulsan, South Korea .'}, {'ForeName': 'Choong-Hyeok', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': '10 College of Medicine, Hanyang University , Seoul, South Korea .'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kyung', 'Affiliation': '11 Kyungpook National University , Daegu, South Korea .'}, {'ForeName': 'Myung-Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': '12 Seoul National University Hospital , Seoul, South Korea .'}]",Human gene therapy. Clinical development,['10.1089/humc.2017.249']
1455,30676487,"Efficacy and safety of single dose oral delafloxacin compared with intramuscular ceftriaxone for uncomplicated gonorrhea treatment: an open-label, non-inferiority, Phase 3, multicenter, randomized study.","BACKGROUND


We evaluated single oral dose delafloxacin versus single intramuscular (IM) ceftriaxone in participants with uncomplicated urogenital gonorrhea (primary objective). Secondary objectives included the efficacy, safety, and tolerability of delafloxacin versus ceftriaxone for uncomplicated urogenital, rectal, and/or pharyngeal gonorrhea.
METHODS


In this open-label, multicenter study, 460 participants at 25 study centers were randomized (2:1) to receive a single 900mg oral dose of delafloxacin or 250mg IM ceftriaxone. N. gonorrhoeae culture, nucleic acid amplification test (NAAT) and clinical responses were evaluated. The primary efficacy endpoint was the urogenital microbiological cure in the urogenital microbiological intention-to-treat (UMITT) population; non-inferiority (NI) was assessed using a 10% NI margin.
RESULTS


In the UMITT population, urogenital cure rates for delafloxacin were 85.1% (194/228) vs 91.0% (91/100) for ceftriaxone [95% CI -13.18% to 1.36%]. As the lower bound of the CI exceeded the pre-specified -10% NI margin, delafloxacin did not demonstrate non-inferiority to ceftriaxone. Treatment failures were more often associated with N. gonorrhoeae with higher delafloxacin minimum inhibitory concentration (MIC) values. In microbiologically evaluable participants, failure occurred in 1 of 177 (0.6%) urogenital infections caused by isolates with delafloxacin MICs <0.008 μg/mL, and 31 of 48 (64.6%) infections caused by isolates with delafloxacin MICs >0.008 μg/mL. Gastrointestinal adverse events (AEs) were common with 900mg of delafloxacin, and typically included mild to moderate diarrhea, flatulence, nausea, and vomiting. The most common AE was diarrhea in both treatment groups.
CONCLUSIONS


A single 900mg dose of delafloxacin is not a reliable treatment for uncomplicated urogenital gonorrhea. Treatment failures were common in infections caused by N. gonorrhoeae with delafloxacin MICs >0.008 μg/mL. Additional testing with alternative dosing regimens could be considered.ClinicalTrials.gov Identifier: NCT02015637.",2019,A single 900mg dose of delafloxacin is not a reliable treatment for uncomplicated urogenital gonorrhea.,"['uncomplicated gonorrhea treatment', 'participants with uncomplicated urogenital gonorrhea (primary objective', '460 participants at 25 study centers', 'uncomplicated urogenital gonorrhea']","['intramuscular ceftriaxone', 'single 900mg oral dose of delafloxacin or 250mg IM ceftriaxone', 'delafloxacin versus single intramuscular (IM) ceftriaxone', 'delafloxacin', 'delafloxacin versus ceftriaxone', 'ceftriaxone']","['delafloxacin minimum inhibitory concentration (MIC) values', 'failure', 'efficacy, safety, and tolerability', 'urogenital microbiological cure in the urogenital microbiological intention-to-treat (UMITT) population; non-inferiority (NI', 'diarrhea', 'urogenital cure rates for delafloxacin', 'uncomplicated urogenital, rectal, and/or pharyngeal gonorrhea', 'Efficacy and safety', 'moderate diarrhea, flatulence, nausea, and vomiting']","[{'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2828290', 'cui_str': 'delafloxacin'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C2828290', 'cui_str': 'delafloxacin'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",460.0,0.153867,A single 900mg dose of delafloxacin is not a reliable treatment for uncomplicated urogenital gonorrhea.,"[{'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Hook', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Golden', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Taylor', 'Affiliation': 'Louisiana State University Health Sciences Center, New Orleans.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Henry', 'Affiliation': 'Firma Clinical Research.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Tseng', 'Affiliation': 'Firma Clinical Research.'}, {'ForeName': 'Jerri', 'Initials': 'J', 'LastName': 'Swerdlow', 'Affiliation': 'Melinta Therapeutics, Lincolnshire.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nenninger', 'Affiliation': 'Melinta Therapeutics, Lincolnshire.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cammarata', 'Affiliation': 'Melinta Therapeutics, Lincolnshire.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000971']
1456,30376537,Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial.,"BACKGROUND


Rib fractures occur in up to 40% of trauma patients and are associated with increased mortality. Opiate-based pain regimens remain the cornerstone of rib fracture management; however, concerns around opioids have fostered interest in alternative analgesics. Ketamine is currently being used in lieu of opioids, but little evidence exists supporting its use within the trauma population.
METHODS


A prospective, randomized, double-blind placebo-controlled trial of adult patients with three or more rib fractures admitted to a Level I trauma center was conducted. Exclusion criteria included age older than 64 years, Glasgow Coma Scale score less than 13, and chronic opiate use. The experimental arm received low-dose ketamine (LDK) at 2.5 μg·kg·min while the placebo cohort received an equivalent rate of 0.9% normal saline. All infusions were continued for 48 hours. The primary outcome was reduction in numeric pain score (NPS) during the first 24 hours. Secondary outcomes studied included oral morphine equivalent (OME) utilization, length of stay, epidural rates, pulmonary complications, and adverse events.
RESULTS


Forty-five (49%) of 91 patients were randomized to the experimental arm. Both groups were similar in makeup. Overall, 74.7% were male, had a median age of 49 years, and an Injury Severity Score (ISS) of 14. Low-dose ketamine was not associated with a significant reduction in 24-hour NPS or OME totals. Subgroup analysis of 45 severely injured patients (ISS, >15) demonstrated that LDK was associated with a significant reduction in OME utilization during the first 24 hours (35.7 vs. 68, p = 0.03), 24 hours to 48 hours (64.2 vs. 96, p = 0.03), and overall (152.1 vs. 198, p = 0.048). No difference in other secondary outcomes or adverse events was noted.
CONCLUSION


Low-dose ketamine failed to decrease NPS or OME within the overall cohort, but a decrease in OME was observed among patients with an ISS greater than 15. Confirmatory studies are necessary to determine if LDK is a useful adjunct among severely injured patients.
LEVEL OF EVIDENCE


Therapeutic study, level II.",2019,"Subgroup analysis of 45 severely injured patients (ISS, >15) demonstrated that LDK was associated with a significant reduction in OME utilization during the first 24 hours (35.7 vs. 68, p = 0.03), 24 hours to 48 hours (64.2 vs. 96, p = 0.03), and overall (152.1 vs. 198, p = 0.048).","['adult patients with three or more rib fractures admitted to a Level I trauma center was conducted', 'adult patients with multiple rib fractures', 'Forty-five (49%) of 91 patients', 'Exclusion criteria included age older than 64 years, Glasgow Coma Scale score less than 13, and chronic opiate use', 'severely injured patients']","['Ketamine', 'ketamine', 'placebo', 'low-dose ketamine (LDK']","['numeric pain score (NPS', 'OME utilization', '24-hour NPS or OME totals', 'OME', 'adverse events', 'mortality', 'oral morphine equivalent (OME) utilization, length of stay, epidural rates, pulmonary complications, and adverse events', 'NPS or OME']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",45.0,0.398711,"Subgroup analysis of 45 severely injured patients (ISS, >15) demonstrated that LDK was associated with a significant reduction in OME utilization during the first 24 hours (35.7 vs. 68, p = 0.03), 24 hours to 48 hours (64.2 vs. 96, p = 0.03), and overall (152.1 vs. 198, p = 0.048).","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Carver', 'Affiliation': 'From the Division of Trauma and Acute Care Surgery, Department of Surgery (T.W.C.), Division of Trauma and Acute Care Surgery, Department of Surgery (N.W.K.), Division of Critical Care Pharmacy, Department of Pharmacy (J.J.), Division of Trauma and Acute Care Surgery, Department of Surgery (W.J.P.), Division of Regional Anesthesia and Acute Pain Management, Department of Anesthesia (K.M.D.), Division of Trauma and Acute Care Surgery, Department of Surgery (L.B.S.), Division of Biostatistics (A.S., Z.Y.), and Division of General Surgery, Department of Surgery (J.S.P.), Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Kugler', 'Affiliation': ''}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Peppard', 'Affiliation': ''}, {'ForeName': 'Karin Madsen', 'Initials': 'KM', 'LastName': 'Drescher', 'Affiliation': ''}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Somberg', 'Affiliation': ''}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': ''}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Jasmeet S', 'Initials': 'JS', 'LastName': 'Paul', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002103']
1457,31033610,Comparison of the Effect of 5 Different Treatment Options for Managing Patellar Tendinopathy: A Secondary Analysis.,"OBJECTIVE


Currently, no treatments exist for patellar tendinopathy (PT) that guarantee quick and full recovery. Our objective was to assess which treatment option provides the best chance of clinical improvement and to assess the influence of patient and injury characteristics on the clinical effect of these treatments.
DESIGN


A secondary analysis was performed on the combined databases of 3 previously performed double-blind randomized controlled trials.
PATIENTS


In total, 138 patients with PT were included in the analysis.
INTERVENTIONS


Participants were divided into 5 groups, based on the treatment they received: Extracorporeal shockwave therapy (ESWT) (n = 31), ESWT plus eccentric training (n = 43), eccentric training (n = 17), topical glyceryl trinitrate patch plus eccentric training (n = 16), and placebo treatment (n = 31).
MAIN OUTCOME MEASURES


Clinical improvement (increase of ≥13 points on the Victorian Institute of Sport Assessment-Patella score) after 3 months of treatment.
RESULTS


Fifty-two patients (37.7%) improved clinically after 3 months of treatment. Odds ratios (ORs) for clinical improvement were significantly higher in the eccentric training group (OR 6.68, P = 0.009) and the ESWT plus eccentric training group (OR 5.42, P = 0.015) compared with the other groups. We found evidence that a high training volume, a longer duration of symptoms, and older age negatively influence a treatment's clinical outcome (trend toward significance).
CONCLUSIONS


Our study confirmed the importance of exercise, and eccentric training in particular, in the management of PT. The role of ESWT remains uncertain. Further research focusing on the identified prognostic factors is needed to be able to design patient-specific treatment protocols for the management of PT.",2019,"Odds ratios (ORs) for clinical improvement were significantly higher in the eccentric training group (OR 6.68, P = 0.009) and the ESWT plus eccentric training group (OR 5.42, P = 0.015) compared with the other groups.","['Managing Patellar Tendinopathy', '138 patients with PT were included in the analysis']","['Extracorporeal shockwave therapy (ESWT', 'topical glyceryl trinitrate patch plus eccentric training', 'placebo treatment', 'eccentric training', 'ESWT plus eccentric training']","['Odds ratios (ORs) for clinical improvement', 'Victorian Institute of Sport Assessment-Patella score']","[{'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",138.0,0.0545842,"Odds ratios (ORs) for clinical improvement were significantly higher in the eccentric training group (OR 6.68, P = 0.009) and the ESWT plus eccentric training group (OR 5.42, P = 0.015) compared with the other groups.","[{'ForeName': 'Dafne', 'Initials': 'D', 'LastName': 'van Rijn', 'Affiliation': 'Center for Sports Medicine, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'van den Akker-Scheek', 'Affiliation': 'Center for Sports Medicine, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Steunebrink', 'Affiliation': 'Department of Sports Medicine, Martini ziekenhuis Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ron L', 'Initials': 'RL', 'LastName': 'Diercks', 'Affiliation': 'Center for Sports Medicine, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Zwerver', 'Affiliation': 'Center for Sports Medicine, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van der Worp', 'Affiliation': 'Center for Sports Medicine, University Medical Center Groningen, Groningen, the Netherlands.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000520']
1458,30888736,Safety and efficacy of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: One-year results from a prospective patient-level pooled analysis of NeoVas trials.,"OBJECTIVES


This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial.
BACKGROUND


Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated.
METHODS


Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.
RESULTS


The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded.
CONCLUSIONS


This pooled, patient-level analysis indicates that the NeoVas BRS has promising 1-year efficacy and safety profiles.",2019,BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents.,"['de novo coronary artery disease', 'Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n\u2009=\u2009278) and NeoVas registry (n\u2009=\u2009825', 'patients with coronary lesions']","['novel sirolimus-eluting bioresorbable scaffold', 'NeoVas sirolimus-eluting bioresorbable scaffold (BRS']","['stent thromboses (ST', '12-month rate of TLF', '12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization', 'Safety and efficacy']","[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1103.0,0.103106,BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Department of Cardiology, Centre for Coronary Heart Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Wuhan Asia Heart Hospital, Affiliated to Wuhan University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Huiliang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Chinese Armed Police Force General Hospital, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, Gansu, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, 2nd Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, Liaoning, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28067']
1459,30675741,Effects of the neuromuscular bandage as rehabilitative treatment of patients with drooling and intellectual disability: an interventional study.,"BACKGROUND


The aim of this work was to assess the effect of neurological bandages (Kinesio Taping) for managing saliva flow in patients with drooling and intellectual disability.
METHODS


Quasi-experimental study included 30 patients (20 male and 10 female participants) mean age of 15 years with intellectual disability and drooling [Public Special Education Centre in Cartagena (Murcia, Spain)]. Treatment consisted of the application of a strip of neuromuscular bandage applied in the suprahyoid area for a 3-month period. Efficacy was assessed by means of three clinical scales: the Sialorrhea clinical scale, the drooling rating scale and the drooling impact scale. These evaluations were performed at baseline, after 1 and 3 months of intervention.
RESULTS


Clinical improvements were obtained, showing statistically significant reductions in drooling after 1 month (P < 0.001) and 3 months (P < 0.001).
CONCLUSIONS


The application of neuromuscular bandages in the suprahyoid muscle area can be a useful option for managing drooling in patients with intellectual disability.",2019,"RESULTS


Clinical improvements were obtained, showing statistically significant reductions in drooling after 1 month (P < 0.001) and 3 months (P < 0.001).
","['Quasi-experimental study included 30 patients (20 male and 10 female participants) mean age of 15\xa0years with intellectual disability and drooling [Public Special Education Centre in Cartagena (Murcia, Spain', 'patients with intellectual disability', 'patients with drooling and intellectual disability']","['neurological bandages (Kinesio Taping', 'neuromuscular bandage']","['Efficacy', 'drooling', 'Sialorrhea clinical scale, the drooling rating scale and the drooling impact scale']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0013132', 'cui_str': 'Drooling'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}]","[{'cui': 'C0013132', 'cui_str': 'Drooling'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",30.0,0.0278441,"RESULTS


Clinical improvements were obtained, showing statistically significant reductions in drooling after 1 month (P < 0.001) and 3 months (P < 0.001).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lorca Larrosa', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Murcia, Murcia, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ruiz Roca', 'Affiliation': 'Faculty of Medicine and Dentistry, Hospital Morales Meseguer Clinica Odontologica, Murcia, Spain.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Ruiz Roca', 'Affiliation': 'Head of studies at Public Special Education Center (C.P.E.E. Primitiva López), Cartagena, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'López-Jornet', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Murcia, Murcia, Spain.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12593']
1460,30668851,'Health Promoting School' Model in Prevention of Vector-Borne Diseases in Odisha: A Pilot Intervention.,"We tested 'Health-Promoting School model' for vector-borne diseases (VBDs) through behavioural changes among students in India for better control of the diseases in the community. A total of 1098 students from eight co-ed schools (four controls and four interventions) of Odisha participated in the study. Intervention was 12 h of class room teaching and activities on mosquito dynamics, source identification, prevention and management of VBDs. Control schools were provided with the leaflets and posters covering the objectives. Impact was assessed through change in knowledge and practice through pre- and post-test. Total mean transformed score in pre-intervention survey in both the groups was nearly 33, which increased to 38.6 and 53.9 in control and intervention group, respectively. In intervention group the mean days of absenteeism due to VBDs was reduced nearly by four times. The model can be used as effective health-promoting measures for vector control.",2019,We tested 'Health-Promoting School model' for vector-borne diseases (VBDs) through behavioural changes among students in India for better control of the diseases in the community.,"['Odisha', '1098 students from eight co-ed schools (four controls and four interventions) of Odisha participated in the study', 'students in India for better control of the diseases in the community']","[""Health-Promoting School model' for vector-borne diseases (VBDs""]","['Total mean transformed score', 'mean days of absenteeism due to VBDs']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]",1098.0,0.0145111,We tested 'Health-Promoting School model' for vector-borne diseases (VBDs) through behavioural changes among students in India for better control of the diseases in the community.,"[{'ForeName': 'Subhashisa', 'Initials': 'S', 'LastName': 'Swain', 'Affiliation': 'Public Health Foundation of India, Indian Institute of Public Health-Bhubaneswar (IIPH-B), Bhubaneswar, India.'}, {'ForeName': 'Sandipana', 'Initials': 'S', 'LastName': 'Pati', 'Affiliation': 'Department of Health & Family Welfare, Disease Surveillance Unit, Office of Additional District Medical Officer (Public Health) Bhubaneswar, Government of Odisha, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Sanghamitra', 'Initials': 'S', 'LastName': 'Pati', 'Affiliation': 'Regional Medical Research Centre, Indian Council of Medical Research, Bhubaneswar, Odisha, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy077']
1461,30951042,Reproducibility of the measurement of central corneal thickness in healthy subjects obtained with the optical low coherence reflectometry pachymeter and comparison with the ultrasonic pachymetry.,"Background


Corneal pachymetry is widely used for refractive surgery and follow up in keratoconus, accurate measurement is essential for a safe surgery.
Objective


To assess intraobserver reliability of central corneal thickness (CCT) measurements using optical low-coherence reflectometry (OLCR) technology and its agreement with ultrasonic pachymeter (US).
Method


Randomized and prospective comparative evaluation of diagnostic technology. One randomly healthy eye of subjects was scanned three times with both devices. Intraobserver within-subject standard deviation (Sw), coefficient of variation (CVw) and intraclass correlation coefficient (ICC) were obtained for reliability analysis; for study agreement, data were analyzed using the paired-sample t test and the Bland-Altman LoA method. The mean of three scans of each equipment was used to assess the LoA.
Results


The study enrolled 30 eyes of 30 subjects with average age of 28.70 ± 8.06 years. For repeatability, the Sw were 3.41 and 5.96 µ, the intraobserver CVw was 2 and 4% and ICC 0.991 and 0.988, for OLCR and US respectively. The mean CCT difference between OLCR and US was 8.90 ± 9.03 µ (95% confidence interval: 5.52-2.27 µ), and the LoA was 35.40 µ.
Conclusions


OLCR technology provided reliable intraobserver CCT measurements. Both pachymetry measurements may be used interchangeably with minimum calibration adjustment.",2019,"The mean CCT difference between OLCR and US was 8.90 ± 9.03 µ (95% confidence interval: 5.52-2.27 µ), and the LoA was 35.40 µ.
Conclusions


","['healthy subjects obtained with the optical low coherence reflectometry pachymeter and comparison with the ultrasonic pachymetry', 'study enrolled 30 eyes of 30 subjects with average age of 28.70 ± 8.06 years']",['central corneal thickness (CCT) measurements using optical low-coherence reflectometry (OLCR) technology'],"['Intraobserver within-subject standard deviation (Sw), coefficient of variation (CVw) and intraclass correlation coefficient (ICC', 'intraobserver CVw', 'central corneal thickness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}]",30.0,0.0350375,"The mean CCT difference between OLCR and US was 8.90 ± 9.03 µ (95% confidence interval: 5.52-2.27 µ), and the LoA was 35.40 µ.
Conclusions


","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Garza-Leon', 'Affiliation': 'Fundación Destellos de Luz. Monterrey, N.L., Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Plancarte-Lozano', 'Affiliation': 'Fundación Destellos de Luz. Monterrey, N.L., Mexico.'}, {'ForeName': 'Agustín Del', 'Initials': 'AD', 'LastName': 'Valle-Penella', 'Affiliation': 'Fundación Destellos de Luz. Monterrey, N.L., Mexico.'}, {'ForeName': 'María de Lourdes', 'Initials': 'ML', 'LastName': 'Guzmán-Martínez', 'Affiliation': 'Fundación Destellos de Luz. Monterrey, N.L., Mexico.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Villarreal-González', 'Affiliation': 'Fundación Destellos de Luz. Monterrey, N.L., Mexico.'}]",Cirugia y cirujanos,['10.24875/CIRUE.M18000007']
1462,30423130,"Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial.","BACKGROUND


Low-frequency vibrations have been proposed as a means of accelerating tooth movement and reducing orthodontic treatment times.
OBJECTIVE


To determine any differences in the accuracy of dental movement in patients treated with a low-frequency vibration aligner protocol and/or by reducing the aligner replacement interval with respect to a conventional protocol.
DESIGN


This trial was designed as a single-centre, randomized controlled clinical trial.
METHODS


Participants: Patients (aged 27.1 ± 9.0 years) who required orthodontic treatment with aligners. Randomization: Patients were randomly allocated to three arms as determined by a computer-randomization scheme. Group A were assigned a conventional protocol (aligners replaced every 14 days); group B also used a low-frequency vibration device for 20 minutes per day; group C followed the same vibration protocol but replaced their aligners every 7 days. Blinding: The operator who performed the set-up and the one who analysed the data were blinded to the group of the patients. Outcome: Pre- and post-treatment digital models were analysed using VAM software to identify the accuracy/imprecision of dental movements. One-way analysis of variance (P < 0.05) and the Bonferroni post hoc test were used to identify any statistically significant differences between the three arms in terms of the accuracy of tooth movement versus the prescription.
RESULTS


Numbers analysed: A total of 45 patients (15 for group) were analysed (i.e. 2286 dental movements). Outcome: No statistically significant differences emerged between groups A and C in the upper arch, or among groups A, B, and C in the lower. Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001). Harms: No adverse events or side-effects were registered.
CONCLUSIONS


Considering all tooth and movement types of the 45 participants, the mean total imprecision was 2.1 ± 0.9 degrees, with respect to a mean prescription of 5.7 ± 2.2 degrees. There was no difference in accuracy between replacing the aligners accompanied by low-frequency vibration every 7 days and replacing them every 14 days without vibration. Moreover, low-frequency vibration seemed to improve the accuracy of a conventional protocol in terms of upper incisor rotation.
TRIAL REGISTRATION


The German Clinical Trials Register (DRK00015613).",2019,"Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001).","['45 patients (15 for group) were analysed (i.e. 2286 dental movements', 'patients treated with a low-frequency vibration aligner protocol and/or by reducing the aligner replacement interval with respect to a conventional protocol', 'Methods\n\n\nParticipants: Patients (aged 27.1 ± 9.0 years) who required orthodontic treatment with aligners']","['Accelerating aligner treatment using low-frequency vibration', 'conventional protocol (aligners replaced every 14 days); group B also used a low-frequency vibration device for 20 minutes per day; group C followed the same vibration protocol']","['mesiodistal tipping', 'accuracy', 'upper incisor rotation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3873181', 'cui_str': 'Every fourteen days'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",45.0,0.115544,"Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001).","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lombardo', 'Affiliation': 'Postgraduate School of Orthodontics, University of Ferrara, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Arreghini', 'Affiliation': 'Postgraduate School of Orthodontics, University of Ferrara, Italy.'}, {'ForeName': 'Luis T', 'Initials': 'LT', 'LastName': 'Huanca Ghislanzoni', 'Affiliation': 'Department of Biomedical Sciences and Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Siciliani', 'Affiliation': 'Postgraduate School of Orthodontics, University of Ferrara, Italy.'}]",European journal of orthodontics,['10.1093/ejo/cjy076']
1463,30394153,"The effect of maternal obesity on fetal biometry, body composition, and growth velocity.","Introduction:  The aim of this secondary analysis was to investigate the relationship between maternal body mass index (BMI) and fetal biometry, body composition, and velocity measurements at 28 and 36 weeks gestation. Materials and methods:  The current analysis involves 911 overweight or obese women who were randomized to the Standard Care group of the LIMIT randomized trial. Results:  The fetus of women with Class 3 obesity (BMI ≥ 40.0) showed the greatest increase in all biometry  z -scores, abdominal area (AA), and abdominal fat mass (AFM) compared with women classified as overweight (BMI 25.0-29.9). In women with Class 3 obesity, AA velocity was increased by 0.035 cm 2  (0.004, 0.066,  p  = .029) and the  z -score velocity was increased by 0.238 (0.022, 0.453,  p  = .03). Estimated fetal weight (EFW) velocity for women with Class 3 obesity was higher than that of overweight women by 2.028 g per day (0.861, 3.196,  p <.001) and the  z -score velocity was also higher by 0.441 per day (0.196, 0.687,  p  < .001). Conclusions:  Maternal obesity is associated with an increase in fetal abdominal circumference, AFM and area along with EFW velocity over time. Women with Class 3 obesity (BMI ≥ 40.0) may represent a higher risk group for perpetuating the intergenerational transmission of obesity to their offspring.",2020,"The fetus of women with Class 3 obesity (BMI ≥ 40.0) showed the greatest increase in all biometry z-scores, abdominal area (AA) and abdominal fat mass (AFM) compared with women classified as overweight (BMI 25.0-29.9).",['911 overweight or obese women who were randomised to the Standard Care group of the LIMIT randomised trial'],[],"['maternal body mass index (BMI) and fetal biometry, body composition and velocity measurements', 'abdominal area (AA) velocity', 'z-score velocity', 'fetal biometry, body composition and growth velocity', 'biometry z-scores, abdominal area (AA) and abdominal fat mass (AFM', 'Estimated fetal weight (EFW) velocity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0436191', 'cui_str': 'Velocity measurement (procedure)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1529904', 'cui_str': '(11C)AFM'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}]",911.0,0.1856,"The fetus of women with Class 3 obesity (BMI ≥ 40.0) showed the greatest increase in all biometry z-scores, abdominal area (AA) and abdominal fat mass (AFM) compared with women classified as overweight (BMI 25.0-29.9).","[{'ForeName': 'Cecelia M', 'Initials': 'CM', 'LastName': ""O'Brien"", 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Robinson Research Institute, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Robinson Research Institute, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deussen', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Robinson Research Institute, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Grivell', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Robinson Research Institute, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Robinson Research Institute, University of Adelaide, Adelaide, Australia.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1543658']
1464,30465635,Exercise training in thermo-mineral spring water has beneficial effects on hemodynamic and health-related factors in young-older hypertensive women: A randomized control trial.,"The aim of the study was to evaluate the effects of an 8-week aerobic training in mineral geothermal water on hemodynamic variables, VO 2max , and body composition in sedentary hypertensive women. Twenty postmenopausal women (58.55 ± 3.28 years) were divided into an exercise group (2 days/week, 30-40 minutes, 60%-75% of HR max ) and control group. Compared to the control group, a significant reduction in systolic blood pressure, heart rate, rate pressure product, body fat percent, and a significant improvement in VO 2max  values was found. Aerobic training in thermo-mineral spring water is a safe and effective training modality in the young-older hypertensive population.",2020,"Compared to the control group, a significant reduction in systolic blood pressure, heart rate, rate pressure product, body fat percent, and a significant improvement in VO 2max  values was found.","['young-older hypertensive women', 'young-older hypertensive population', 'Twenty postmenopausal women (58.55\xa0±\xa03.28\xa0years', 'sedentary hypertensive women']","['Aerobic training', 'aerobic training', 'Exercise training']","['hemodynamic variables, VO 2max , and body composition', 'systolic blood pressure, heart rate, rate pressure product, body fat percent, and a significant improvement in VO 2max  values']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0167943,"Compared to the control group, a significant reduction in systolic blood pressure, heart rate, rate pressure product, body fat percent, and a significant improvement in VO 2max  values was found.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Arazi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Asadi', 'Affiliation': 'Department of Sport Sciences, Islamic Azad University, Rasht Branch, Rasht, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Taati', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Guilan, Rasht, Iran.'}]",Journal of women & aging,['10.1080/08952841.2018.1547003']
1465,30472778,High-frequency repetitive transcranial magnetic stimulation and intermittent theta-burst stimulation for spasticity management in secondary progressive multiple sclerosis.,"BACKGROUND AND PURPOSE


The spasticity phenomenon is a significant factor in the development of disability. Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment method for this disorder. Our aim was to compare the effects of two protocols of rTMS - the high-frequency (HF) rTMS (20 Hz) and the intermittent theta-burst stimulation (iTBS) - on the level of spasticity and concomitant symptoms in patients with secondary progressive multiple sclerosis with an analysis of the duration of the effects up to 12 weeks after the stimulation course.
METHODS


Thirty-four patients with secondary progressive multiple sclerosis and lower spastic paraparesis were randomized into three groups: (i) HF-rTMS (20 Hz); (ii) iTBS; (iii) sham stimulation. Spasticity and spasticity-associated symptoms were assessed by the Modified Ashworth Scale, the Subjective Evaluating Spasticity Scale (SESS), the numerical analog scale, the Modified Fatigue Impact Scale and the pain level scale.
RESULTS


The Modified Ashworth Scale was significantly reduced after the stimulation course in the HF-rTMS and iTBS groups. The SESS was reduced post-intervention and at the two follow-ups in the iTBS group, whilst HF-rTMS produced an SESS reduction only at the 2-week follow-up, with no effects in the sham group. Conversely, reduction in pain and fatigue was found in the HF-rTMS group.
CONCLUSIONS


The results show that HF-rTMS and iTBS significantly reduce spasticity measured by the Modified Ashworth Scale, in contrast to sham stimulation. Some evidence was found in favor of a longer-lasting effect of iTBS on the SESS and of a reduction in pain and fatigue after HF-rTMS.",2019,"The results show that HF-rTMS and iTBS significantly reduce spasticity measured by the Modified Ashworth Scale, in contrast to sham stimulation.","['patients with secondary progressive multiple sclerosis with an analysis of the duration of the effects up to 12\xa0weeks after the stimulation course', 'secondary progressive multiple sclerosis', 'Thirty-four patients with secondary progressive multiple sclerosis and lower spastic paraparesis']","['High-frequency repetitive transcranial magnetic stimulation and intermittent theta-burst stimulation', 'rTMS - the high-frequency (HF) rTMS', 'HF-rTMS (20\xa0Hz); (ii) iTBS; (iii) sham stimulation', 'Repetitive transcranial magnetic stimulation (rTMS', 'HF-rTMS and iTBS', 'intermittent theta-burst stimulation (iTBS) ']","['pain and fatigue', 'Modified Ashworth Scale', 'Spasticity and spasticity-associated symptoms', 'SESS reduction', 'spasticity', 'Modified Ashworth Scale, the Subjective Evaluating Spasticity Scale (SESS), the numerical analog scale, the Modified Fatigue Impact Scale and the pain level scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0037771', 'cui_str': 'Spastic Lower Extremity Weakness'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale (assessment scale)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",34.0,0.0234381,"The results show that HF-rTMS and iTBS significantly reduce spasticity measured by the Modified Ashworth Scale, in contrast to sham stimulation.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Korzhova', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bakulin', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sinitsyn', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poydasheva', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Suponeva', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zakharova', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piradov', 'Affiliation': 'Research Center of Neurology (RCN), Moscow, Russia.'}]",European journal of neurology,['10.1111/ene.13877']
1466,30521044,Effects of Zinc Combined with Probiotics on Antibiotic-associated Diarrhea Secondary to Childhood Pneumonia.,"AIM


The aim of this study was to evaluate the impact of zinc combined with probiotics (Bifico) on antibiotic-associated diarrhea (AAD) secondary to pneumonia.
METHODS


A total of 50 patients with AAD secondary to pneumonia were randomly divided into a probiotics group (Bifico) and a combined group (zinc combined with Bifico) and 25 pneumonia patients without AAD as the control group. Serum levels of zinc, diamine oxidase (DAO) activity, D-lactate and intestinal flora [Bifidobacterium, Escherichia coli and Bifidobacterium/E. coli (B/E) ratio] were detected before and after intervention.
RESULTS


The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia. Notably, the combined treatment increased the population of Bifidobacterium, while the number of E. coli was reduced, the B/E value was improved and DAO activity and D-lactate levels were markedly reduced.
CONCLUSION


Patients with AAD secondary to pneumonia benefit from zinc supplementation of probiotic treatment.",2019,The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia.,"['25 pneumonia patients without AAD as the control group', '50 patients with AAD secondary to pneumonia', 'Antibiotic-associated Diarrhea Secondary to Childhood Pneumonia']","['probiotics group (Bifico) and a combined group (zinc combined with Bifico', 'zinc combined with probiotics (Bifico', 'Zinc Combined with Probiotics']","['Serum levels of zinc, diamine oxidase (DAO) activity, D-lactate and intestinal flora [Bifidobacterium, Escherichia coli and Bifidobacterium/E. coli (B/E) ratio', 'number of E. coli', 'population of Bifidobacterium', 'DAO activity and D-lactate levels', 'overall efficiency']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0019587', 'cui_str': 'Histaminase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0522080', 'cui_str': 'D-lactate (substance)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",50.0,0.0297627,The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xiang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Xiu-Qi', 'Initials': 'XQ', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Mu-Yan', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'The Medical Science Experiment Center, Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Mei-Xiong', 'Initials': 'MX', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yun', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Qing-Wen', 'Initials': 'QW', 'LastName': 'Shan', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy069']
1467,29110707,Correction to: Effects of a multi-level intervention on the pattern of physical activity among in-school adolescents in Oyo state Nigeria: a cluster randomised trial.,"CORRECTION


After publication of the article [1], it has been brought to our attention that there is an error in figure 1. The number of excluded secondary schools should read ""50"" and not ""72"". The rest of the data in the figure is accurate.",2017,The rest of the data in the figure is accurate.,['school adolescents in Oyo state Nigeria'],['multi-level intervention'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",[],,0.0405181,The rest of the data in the figure is accurate.,"[{'ForeName': 'Mojisola Morenike', 'Initials': 'MM', 'LastName': 'Oluwasanu', 'Affiliation': 'African Regional Health Education Centre, Department of Health Promotion and Education, Faculty of Public Health, College of Medicine, University of Ibadan, Ibadan, Nigeria. ope3m@yahoo.com.'}, {'ForeName': 'Oladimeji', 'Initials': 'O', 'LastName': 'Oladepo', 'Affiliation': 'African Regional Health Education Centre, Department of Health Promotion and Education, Faculty of Public Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}]",BMC public health,['10.1186/s12889-017-4885-4']
1468,30417697,A Prospective Evaluation of the Effect of Supervised Hand Therapy After Carpal Tunnel Surgery.,"Background:  The objective of this investigation is to examine the effect of postoperative therapy after routine carpal tunnel release. Our hypothesis was that supervised hand therapy does not improve outcomes after routine carpal tunnel release.  Methods : Patients with carpal tunnel syndrome were randomly assigned to one of 3 groups based on the last digit of their medical record numbers to one of 3 groups: standard 6-week postoperative rehabilitation (standard therapy), expedited one-session postoperative rehabilitation group (expedited therapy), and no postoperative rehabilitation group (no therapy). The primary outcome measures were Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and return to work. The outcome questionnaire was completed preoperatively, at the 2-week follow-up visit, and monthly to 6 months after surgery.  Results:  All 3 treatment groups had similar mean QuickDASH scores preoperatively. At 1- to 6-month follow-up, all 3 groups had similar QuickDASH scores at each visit, and all showed a significant decline from baseline (preoperative) QuickDASH score. Overall, QuickDASH score decreased significantly from a preoperative visit mean of 42.7 to a final postoperative (visit 8) mean of 6.69. There was no significant difference in the mean QuickDASH score among all 3 groups at 6-month follow-up. There was no significance in the time of return to work among the 3 groups (standard therapy, 21.8 days; expedited therapy, 20.9 days; no therapy, 16.6 days).  Conclusions : This investigation adds evidence that supervised hand therapy does not improve the outcomes of routine carpal tunnel surgery as measured by QuickDASH and return to work.",2020,There was no significant difference in the mean QuickDASH score among all 3 groups at 6-month follow-up.,['Patients with carpal tunnel syndrome'],"['standard 6-week postoperative rehabilitation (standard therapy), expedited one-session postoperative rehabilitation group (expedited therapy), and no postoperative rehabilitation group (no therapy', 'Supervised Hand Therapy']","['mean QuickDASH scores', 'mean QuickDASH score', 'QuickDASH scores', 'Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and return to work', 'time of return to work', 'Overall, QuickDASH score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0291675,There was no significant difference in the mean QuickDASH score among all 3 groups at 6-month follow-up.,"[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Gil', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Barrett', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kleiner', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Akelman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Arnold-Peter C', 'Initials': 'AC', 'LastName': 'Weiss', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718812155']
1469,30424914,Immediate Effects of the Semi-Occluded Ventilation Mask on Subjects Diagnosed With Functional Dysphonia and Subjects With Normal Voices.,"PURPOSE


The present study was designed to assess the immediate effects of the semi-occluded ventilation mask (SOVM) in subjects with functional dysphonia and subjects with normal voice.
METHODS


Sixty-four participants were included in this study (48 women and 16 men). Thirty-one of them were diagnosed with functional dysphonia and 33 with normal voice. All subjects were randomly assigned to one of two conditions: an experimental condition using the SOVM (n = 33) and a control condition with participants not using the SOVM (n = 31). Thus, within both conditions, participants could be either dysphonic or normal-voiced. This produced a total of four different groups: (1) subjects with normal voice with SOVM (n = 17), (2) subjects with normal voice without SOVM (n = 16), (3) dysphonic subjects with SOVM (n = 16), and (4) dysphonic subjects without SOVM (n = 15). All participants underwent aerodynamic, electroglottographic (EGG), and acoustic assessments, and were also asked to assess their own voice, before and after voice exercises.
RESULTS


Significant differences were found for aerodynamic, EGG, and acoustic variables when comparing SOVM conditions (dysphonic and normal) against control. Cepstral peak prominence and EGG contact quotient showed an increase among dysphonic participants with SOVM. L1-L0 showed an increase for all participants in SOVM condition (dysphonic and normal). Self-perceived resonant voice quality showed an increase for both groups in SOVM condition. Glottal airflow showed a decrease for the dysphonic participants in SOVM condition. Phonation threshold pressure and subglottic pressure showed a decrease for both groups in SOVM condition.
CONCLUSION


The present study suggests that immediate positive effect could be produced by connected speech phonatory tasks using the SOVM in both dysphonic subjects and subjects with normal voice, the change being greater among the former. SOVM seems to promote an easy voice production and a more efficient phonation.",2020,Cepstral peak prominence and EGG contact quotient showed an increase among dysphonic participants with SOVM. L1-L0,"['Sixty-four participants were included in this study (48 women and 16 men', 'Thirty-one of them were diagnosed with functional dysphonia and 33 with normal voice', 'four different groups: (1) subjects with normal voice with SOVM (n\u202f=\u202f17), (2) subjects with normal voice without SOVM (n\u202f=\u202f16), (3) dysphonic subjects with SOVM (n\u202f=\u202f16), and (4) dysphonic subjects without SOVM (n\u202f=\u202f15', 'Subjects Diagnosed With Functional Dysphonia and Subjects With Normal Voices', 'dysphonic participants with SOVM. L1-L0', 'subjects with functional dysphonia and subjects with normal voice']","['control condition with participants not using the SOVM', 'semi-occluded ventilation mask (SOVM', 'aerodynamic, electroglottographic (EGG', 'Semi-Occluded Ventilation Mask']","['Cepstral peak prominence and EGG contact quotient', 'Glottal airflow', 'Self-perceived resonant voice quality', 'Phonation threshold pressure and subglottic pressure', 'SOVM condition (dysphonic and normal', 'aerodynamic, EGG, and acoustic variables']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0234759', 'cui_str': 'Normal voice (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0577554', 'cui_str': 'Resonant (qualifier value)'}, {'cui': 'C0042943', 'cui_str': 'Voice Quality'}, {'cui': 'C0031577', 'cui_str': 'Phonation'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",64.0,0.0316294,Cepstral peak prominence and EGG contact quotient showed an increase among dysphonic participants with SOVM. L1-L0,"[{'ForeName': 'Kharina', 'Initials': 'K', 'LastName': 'Frisancho', 'Affiliation': 'Department of EDUCATION, Universidad Nacional de San Agustin, Arequipa, Perú.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Salfate', 'Affiliation': 'Hospital Salvador, Department of otolaryngology, Santiago, Chile.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Lizana', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Universidad de los Andes, CHILE; Department of Otolaryngology, Voice Center, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Santiago, Chile.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de Chile, Santiago, Chile.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.10.004']
1470,30381319,Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial.,"BACKGROUND


Sexual dysfunction is common in patients with either ischaemic heart disease (IHD) or implantable cardioverter defibrillator (ICD) and has a negative impact on quality of life. Non-pharmacological treatment options are lacking. The purpose of this trial was to assess the effect of sexual rehabilitation versus usual care for males with erectile dysfunction and either IHD and/or ICD.
METHODS


Participants with erectile dysfunction and IHD and/or ICD were randomised to 12 weeks of sexual rehabilitation consisting of physical exercise training, pelvic floor exercise and psychoeducation, or usual care.
PRIMARY OUTCOME


sexual function by the International Index of Erectile Function (IIEF). Secondary outcome: sexual function by the Psychosocial Adjustment to Illness Scale. Exploratory outcomes: exercise capacity, pelvic floor strength/endurance, self-reported health and mental health.
RESULTS


154 participants were included, mean age 61.6 years (SD 6.1). Sexual rehabilitation compared with usual care improved sexual function with a mean difference IIEF score of 6.7 (95% CI 3.1 to 10.4, p<0.0003) at 4 months between groups (unadjusted IIEF mean scores 36.4 vs 31.3) and a mean difference of 6.7, 95% CI 3.2 to 10.1 (p<0.0002) at 6 months between groups (unadjusted mean scores IIEF 37.1 vs 32.2). No effects were seen on the secondary outcome. Sexual rehabilitation improved exercise capacity on cycle ergometer measured by Watt max with a mean difference of 10.3, 95% CI 3.6 to 16.9 (p<0.003) and pelvic floor strength (p<0.01). No differences were seen on self-reported health and mental health.
CONCLUSION


Sexual rehabilitation compared with usual care improves sexual function and exercise capacity.
TRIAL REGISTRATION


NCT01796353; Results.",2019,"Sexual rehabilitation improved exercise capacity on cycle ergometer measured by Watt max with a mean difference of 10.3, 95% CI 3.6 to 16.9 (p<0.003) and pelvic floor strength (p<0.01).","['patients with either ischaemic heart disease (IHD) or', 'cardiac patients with erectile dysfunction', 'Participants with erectile dysfunction and IHD and/or ICD', 'males with erectile dysfunction and either IHD and/or ICD', '154 participants were included, mean age 61.6 years (SD 6.1']","['sexual rehabilitation consisting of physical exercise training, pelvic floor exercise and psychoeducation, or usual care', 'Sexual rehabilitation', 'implantable cardioverter defibrillator (ICD', 'sexual rehabilitation versus usual care']","['Exploratory outcomes: exercise capacity, pelvic floor strength/endurance, self-reported health and mental health', 'self-reported health and mental health', 'sexual function with a mean difference IIEF score', 'sexual function and exercise capacity', 'sexual function by the Psychosocial Adjustment to Illness Scale', 'sexual function by the International Index of Erectile Function (IIEF', 'exercise capacity on cycle ergometer', 'pelvic floor strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0262718', 'cui_str': 'Pelvic muscle exercises'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0222045'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}]",154.0,0.102077,"Sexual rehabilitation improved exercise capacity on cycle ergometer measured by Watt max with a mean difference of 10.3, 95% CI 3.6 to 16.9 (p<0.003) and pelvic floor strength (p<0.01).","[{'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Palm', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ann-Dorthe Olsen', 'Initials': 'AO', 'LastName': 'Zwisler', 'Affiliation': 'The National Knowledge Centre for Rehabilitation and Palliative Care, Nyborg, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lau Casper', 'Initials': 'LC', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Øster Farimagsgade, Denmark.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Giraldi', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karina Gregersen', 'Initials': 'KG', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lindschou', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Steinke', 'Affiliation': 'School of Nursing, Wichita State University, Wichita, Kansas, USA.'}, {'ForeName': 'Selina Kikkenborg', 'Initials': 'SK', 'LastName': 'Berg', 'Affiliation': 'Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-313778']
1471,30457892,Randomized Controlled Pilot Study of Dietary Supplementation with Turmeric or Herbal Combination Tablets on Skin Barrier Function in Healthy Subjects.,"To compare the effects of turmeric tablets and turmeric-containing herbal combination tablets versus placebo on skin barrier function and sebum production by measuring facial sebum and transepidermal water loss (TEWL) in healthy subjects. This study was a prospective, double-blinded, rater-blinded, randomized pilot study. Thirty-three generally healthy participants were recruited from the UC Davis Department of Dermatology clinic and the surrounding community from 2016 to 2017, 30 participants were enrolled, and 28 participants completed the study. Thirty individuals were recruited and randomized to the placebo, turmeric, or herbal combination tablet groups. The participants were instructed to take the intervention tablets by mouth twice daily for 4 weeks. Facial sebum production and TEWL were assessed at baseline and 4 weeks. Twenty-eight participants completed the study and there were no adverse events. There were no significant changes in sebum excretion rate in any group after 4 weeks compared with baseline. In the herbal combination tablet group, there was a significant decrease in TEWL ( P  = .003). No significant changes in TEWL were detected in the turmeric or placebo groups. Turmeric-containing herbal combination tablets significantly decreased TEWL after 4 weeks of twice-daily supplementation. There were no adverse events in any of the three intervention arms. Overall, our findings spark future interest in determining how oral supplementation with herbal formulations may improve skin barrier function and skin appearance, and potentially offer alternative or complementary treatment options.",2018,"In the herbal combination tablet group, there was a significant decrease in TEWL (P = .003).","['Healthy Subjects', 'Thirty-three generally healthy participants were recruited from the UC Davis Department of Dermatology clinic and the surrounding community from 2016 to 2017, 30 participants were enrolled, and 28 participants completed the study', 'Thirty individuals', 'healthy subjects']","['Dietary Supplementation with Turmeric or Herbal Combination Tablets', 'placebo, turmeric, or herbal combination tablet groups', 'turmeric tablets and turmeric-containing herbal combination tablets versus placebo']","['Facial sebum production and TEWL', 'TEWL', 'skin barrier function and sebum production by measuring facial sebum and transepidermal water loss (TEWL', 'adverse events', 'sebum excretion rate', 'Skin Barrier Function', 'skin barrier function and skin appearance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C3812390', 'cui_str': 'Dermatology clinic (environment)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0033268'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",33.0,0.241833,"In the herbal combination tablet group, there was a significant decrease in TEWL (P = .003).","[{'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Vaughn', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Ashley K', 'Initials': 'AK', 'LastName': 'Clark', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Notay', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}]",Journal of medicinal food,['10.1089/jmf.2018.0015']
1472,30507214,Anger-reduction treatment reduces negative affect reactivity to daily stressors.,"OBJECTIVE


Negative affect (NA) reactivity to daily stressors may confer health risks over and above stress exposure, especially in chronically angry adults. This randomized controlled trial tests the hypothesis that a 12-week cognitive-behavioral therapy (CBT) anger-reduction treatment would decrease NA reactivity to daily stressors assessed via ambulatory diary for those in treatment, but not on a wait-list for treatment.
METHOD


Healthy adults (N = 158, aged 20-45 years, 53.20% women) scoring high on Spielberger's (1988) Trait Anger, a scale from the State-Trait Anger Expression Inventory, were randomly assigned to a CBT treatment or wait-list control group, and completed 24 hr of prerandomization and postintervention ecological momentary assessment (EMA) of NA intensity and stress events every 20 ± 5 min. A longitudinal model using a generalized estimating equation examined whether stressor exposure and NA reactions to momentary stressors changed from pre- to posttreatment in the CBT group.
RESULTS


There was a significant 3-way interaction (t28 = 2.29, p = .03) between stressor, treatment group, and EMA day, indicating that NA reactivity decreased for the treatment group 1.60 points more than for the wait-list group (a 379.38% greater change in NA reactivity). NA during stressors was 1.18 points lower (a 28.42% decrease) for the treatment group at EMA Day 2 (p = .04), whereas wait-list NA during stressors nonsignificantly increased.
CONCLUSION


CBT to decrease chronic anger is associated with lower NA reactivity to daily stressors in this sample and could be a promising treatment to mitigate the health impact of stress in this clinical population. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"There was a significant 3-way interaction (t28 = 2.29, p = .03) between stressor, treatment group, and EMA day, indicating that NA reactivity decreased for the treatment group 1.60 points more than for the wait-list group (a 379.38% greater change in NA reactivity).","['chronically angry adults', ""Healthy adults (N = 158, aged 20-45 years, 53.20% women) scoring high on Spielberger's (1988""]","['cognitive-behavioral therapy (CBT) anger-reduction treatment', 'CBT treatment or wait-list control group, and completed 24 hr of prerandomization and postintervention ecological momentary assessment (EMA', 'CBT']","['NA reactivity', 'NA reactivity to daily stressors assessed via ambulatory diary']","[{'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",,0.0368619,"There was a significant 3-way interaction (t28 = 2.29, p = .03) between stressor, treatment group, and EMA day, indicating that NA reactivity decreased for the treatment group 1.60 points more than for the wait-list group (a 379.38% greater change in NA reactivity).","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McIntyre', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Mogle', 'Affiliation': 'College of Nursing, Pennsylvania State University.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Scodes', 'Affiliation': 'Division of Biostatistics, New York State Psychiatric Institute.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University Medical Center.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Shapiro', 'Affiliation': 'Department of Psychiatry, Division of Consultation-Liaison Psychiatry, Columbia University Medical Center.'}, {'ForeName': 'Ethan E', 'Initials': 'EE', 'LastName': 'Gorenstein', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center.'}, {'ForeName': 'Felice A', 'Initials': 'FA', 'LastName': 'Tager', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Monk', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Almeida', 'Affiliation': 'Department of Human Development and Family Studies, Pennsylvania State University.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Sloan', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000359']
1473,30381901,High protein diet promotes body weight loss among Brazilian postpartum women.,"There is evidence in the general population that adhering to a high protein and low carbohydrate diet may help in losing weight. However, there is little evidence among postpartum women. The aim of this study is to evaluate the effect of a high protein diet on weight loss among postpartum women. A parallel-randomized controlled trial with 94 postpartum women was conducted in a maternity ward in Mesquita county (recruitment from February 2009 to December 2010) and in a polyclinic in Rio de Janeiro city (recruitment from December 2010 to December 2011). Women were randomized to the intervention group (IG) or control group (CG), and both groups received an isocaloric diet (1,800 kcal). Additionally, the IG received approximately 25 g of protein obtained from 125 g per week of sardine to increase daily dietary protein content and was advised to restrict carbohydrate intake. The CG received nutritional counselling to follow the national nutrition guidelines (15% protein, 60% carbohydrates, and 25% lipids). A linear mixed-effects model was used to test the effect of high protein intake and macronutrient intake on weight loss during the postpartum period. Body weight decreased in the IG compared with the CG (ß = -0.325; p = 0.049) among overweight and obese postpartum women. The percentage of energy intake from lipid (ß = -0.023; p = 0.050) was negatively associated with body weight, and carbohydrate intake (ß = 0.020; p = 0.026) was positively associated with body weight over time among all women. Protein intake and lower carbohydrate intake may be used as a dietary strategy to improve body weight loss during the postpartum period.",2019,"The percentage of energy intake from lipid (ß = -0.023; p = 0.050) was negatively associated with body weight, and carbohydrate intake (","['Brazilian postpartum women', 'postpartum women', '94 postpartum women was conducted in a maternity ward in Mesquita county (recruitment from February 2009 to December 2010) and in a polyclinic in Rio de Janeiro city (recruitment from December 2010 to December 2011']","['intervention group (IG) or control group (CG', 'High protein diet', 'high protein diet', 'isocaloric diet', 'CG (ß', 'high protein intake and macronutrient intake']","['body weight, and carbohydrate intake ', 'weight loss', 'percentage of energy intake from lipid', 'Body weight', 'body weight loss', 'body weight']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0445581', 'cui_str': 'Rio (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",94.0,0.0281551,"The percentage of energy intake from lipid (ß = -0.023; p = 0.050) was negatively associated with body weight, and carbohydrate intake (","[{'ForeName': 'Maria Beatriz Trindade', 'Initials': 'MBT', 'LastName': 'de Castro', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josue de Castro (INJC), Federal University of Rio de Janeiro, Graduate Program of Nutrition/INJC, Rio de Janeiro, Brazil.'}, {'ForeName': 'Diana Barbosa', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marina Campos', 'Initials': 'MC', 'LastName': 'Araujo', 'Affiliation': 'Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation/Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Ilana Nogueira', 'Initials': 'IN', 'LastName': 'Bezerra', 'Affiliation': 'Mater in Nutrition and Health Course, Ceará State University, Fortaleza, Brazil.'}, {'ForeName': 'Amanda Rodrigues Amorim', 'Initials': 'ARA', 'LastName': 'Adegboye', 'Affiliation': 'Department of Psychology, Social Work and Counselling, Faculty of Education and Health, University of Greenwich, London, UK.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Kac', 'Affiliation': 'Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josue de Castro (INJC), Federal University of Rio de Janeiro, Graduate Program of Nutrition/INJC, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",Maternal & child nutrition,['10.1111/mcn.12746']
1474,30612946,Letrozole versus testosterone for promotion of endogenous puberty in boys with constitutional delay of growth and puberty: a randomised controlled phase 3 trial.,"BACKGROUND


The treatment of constitutional delay of growth and puberty (CDGP) is an underinvestigated area in adolescent medicine. We tested the hypothesis that peroral aromatase inhibition with letrozole is more efficacious than intramuscular injection of low-dose testosterone in inducing puberty in boys with CDGP.
METHODS


We did a randomised, controlled, open-label trial at four paediatric centres in Finland. Boys aged at least 14 years with CDGP who wanted medical intervention and exhibited the first signs of puberty were randomly assigned in blocks of ten to receive either six intramuscular injections of low-dose testosterone (about 1 mg/kg bodyweight) every 4 weeks for 6 months or peroral letrozole 2·5 mg once daily for 6 months. All boys were followed up for 6 months after the end of treatment. The primary outcomes were changes in testicular volume and hormonal markers of puberty at 6 months after treatment initiation, which were assessed in all participants who received the assigned treatment. All patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01797718.
FINDINGS


Between Aug 1, 2013, and Jan 30, 2017, 30 boys were randomly assigned to receive testosterone (n=15) or letrozole (n=15). One boy in the testosterone group was excluded from the primary analyses because of a protocol deviation. During treatment, boys in the letrozole group had higher serum concentrations of luteinising hormone, follicle-stimulating hormone, testosterone, and inhibin B than did boys in the testosterone group. Testicular growth from baseline to 6 months was greater in the letrozole group than in the testosterone group (7·2 mL [95% CI 5·2-9·3] vs 2·2 mL [1·4-2·9]; between-group difference per month 0·9 mL [95% CI 0·6-1·2], p<0·0001). Most adverse events were mild. One boy in the testosterone group had aggressive behaviour for 1 week after each injection, and one boy in the letrozole group had increased irritability at 6 months.
INTERPRETATION


Letrozole might be a feasible alternative treatment to low-dose testosterone for boys with CDGP who opt for medical intervention. However, the risks and benefits of manipulating the reproductive axis during early puberty should be weighed carefully.
FUNDING


Helsinki University Hospital, Academy of Finland, and Finnish Foundation for Pediatric Research.",2019,"During treatment, boys in the letrozole group had higher serum concentrations of luteinising hormone, follicle-stimulating hormone, testosterone, and inhibin B than did boys in the testosterone group.","['boys with constitutional delay of growth and puberty', 'four paediatric centres in Finland', 'boys with CDGP who opt for medical intervention', 'Between Aug 1, 2013, and Jan 30, 2017, 30 boys', 'Boys aged at least 14 years with CDGP who wanted medical intervention and exhibited the first signs of puberty', 'boys with CDGP']","['Letrozole', 'testosterone', 'six intramuscular injections of low-dose testosterone', 'Letrozole versus testosterone', 'mL', 'peroral letrozole', 'letrozole']","['Testicular growth', 'irritability', 'aggressive behaviour', 'changes in testicular volume and hormonal markers of puberty', 'serum concentrations of luteinising hormone, follicle-stimulating hormone, testosterone, and inhibin B']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0342538', 'cui_str': 'Constitutional delay of growth and puberty (disorder)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0449990', 'cui_str': 'First sign (attribute)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0558238', 'cui_str': 'Testicular growth, function (observable entity)'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429619', 'cui_str': 'Testicular volume (observable entity)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0971174', 'cui_str': 'inhibin B'}]",30.0,0.291837,"During treatment, boys in the letrozole group had higher serum concentrations of luteinising hormone, follicle-stimulating hormone, testosterone, and inhibin B than did boys in the testosterone group.","[{'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Varimo', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Huopio', 'Affiliation': 'Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kariola', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Tenhola', 'Affiliation': 'Kymenlaakso Central Hospital, Kotka, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Voutilainen', 'Affiliation': 'Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Toppari', 'Affiliation': 'Department of Pediatrics, Turku University Hospital, and Institute of Biomedicine, Research Centre for Integrative Physiology and Pharmacology, University of Turku, Turku, Finland.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Toiviainen-Salo', 'Affiliation': 'Medical Imaging Center, Department of Pediatric Radiology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Esa', 'Initials': 'E', 'LastName': 'Hämäläinen', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Department of Clinical Chemistry, University of Helsinki, Helsinki, Finland.""}, {'ForeName': 'Mari-Anne', 'Initials': 'MA', 'LastName': 'Pulkkinen', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Lääperi', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Tarkkanen', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Department of Physiology, Medicum Unit, and Translational Stem Cell Biology and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.""}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Vaaralahti', 'Affiliation': 'Department of Physiology, Medicum Unit, and Translational Stem Cell Biology and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Päivi J', 'Initials': 'PJ', 'LastName': 'Miettinen', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hero', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Raivio', 'Affiliation': ""Pediatric Research Center, Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Department of Physiology, Medicum Unit, and Translational Stem Cell Biology and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland. Electronic address: taneli.raivio@helsinki.fi.""}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(18)30377-8']
1475,28655016,Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.,"Importance


Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited.
Objective


To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI.
Design, Setting, and Participants


Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015.
Interventions


Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints.
Main Outcomes and Measures


The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes).
Results


Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild.
Conclusions and Relevance


Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention.
Trial Registration


clinicaltrials.gov Identifier: NCT01784172.",2017,"At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001).","['women with stress urinary incontinence (SUI', 'women with SUI', '504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study', 'Women', 'women with stress urinary incontinence', '12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015', 'With Stress Urinary Incontinence']","['electroacupuncture', 'sham electroacupuncture', 'Electroacupuncture', 'electroacupuncture involving the lumbosacral region (n\u2009=\u2009252) or sham electroacupuncture (n\u2009=\u2009252) with no skin penetration on sham acupoints', 'electroacupuncture vs sham electroacupuncture']","['mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes', 'mean 72-hour incontinence episodes', 'Mean 72-hour incontinence episodes', 'mean urine leakage', 'urine leakage', 'amount of urine leakage', 'Mean urine leakage', 'incidence of treatment-related adverse events', 'Urinary Leakage']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0024094', 'cui_str': 'Lumbosacral Region'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0042037'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",504.0,0.451398,"At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001).","[{'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Huanfang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China3Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Yuelai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': ""Shaanxi Province Hospital of Traditional Chinese Medicine, Xi'an, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'The First Hospital of Hunan University of Chinese Medicine, Changsha, China.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Daemen College Physical Therapy Wound Care Clinic, Daemen College, Amherst, New York.'}, {'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Ai', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Pang', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zongshi', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Shiyan', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Hongjiao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Baoyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}]",JAMA,['10.1001/jama.2017.7220']
1476,31679018,"Effects of sleep on a high-heat capacity mattress on sleep stages, EEG power spectra, cardiac interbeat intervals and body temperatures in healthy middle-aged men‡.","STUDY OBJECTIVES


This study deals with the question whether a slow (non-disturbing) reduction of core body temperature (CBT) during sleep increases sleep stage N3 and EEG slow wave energy (SWE) and leads to a slowing of heart rate in humans.
PARTICIPANTS


Thirty-two healthy male subjects with a mean ± SD age 46 ± 4 years and body mass index 25.2 ± 1.8 kg/m2.
METHODS


A high-heat capacity mattress (HM) was used to lower body temperatures in sleep and was compared to a conventional low-heat capacity mattress (LM) in a double-blinded fashion. Polysomnography was performed accompanied by measurements of skin-, core body- and mattress surface-temperatures, and heart rate. EEG power spectral analyses were carried out using Fast Fourier Transform. Interbeat intervals were derived from the electrocardiogram.
RESULTS


The HM led to a larger decline in CBT, mediated through higher heat conduction from the core via the proximal back skin onto the mattress together with reduced heart rate. These effects occurred together with a significant increase in sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297 Hz) accumulated in NREM sleep. In the 2nd half of the night sSWE increase was significantly correlated with body temperature changes, for example with CBT decline in the same phase.
CONCLUSIONS


A HM subtly decreases CBT, leading to an increased amount of sleep stage N3 and of sSWE, as well as a slowing of heart rate.",2020,"These effects occurred together with a significant increase in sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297Hz) accumulated in NREM sleep.",[],"['conventional low-heat capacity mattress', 'slow (non-disturbing) reduction of core body temperature (CBT']","['CBT decline', 'sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297Hz) accumulated in NREM sleep', 'heart rate']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0270784,"These effects occurred together with a significant increase in sleep stage N3 and standardized slow wave energy (sSWE, 0.791-4.297Hz) accumulated in NREM sleep.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Herberger', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kräuchi', 'Affiliation': 'Psychiatric University Clinics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glos', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lederer', 'Affiliation': 'Advanced Sleep Research GmbH, Berlin, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Assmus', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hein', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Penzel', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Interdisciplinary Center of Sleep Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",Sleep,['10.1093/sleep/zsz271']
1477,31678098,Dose-Finding Study of Lorexys for Hypoactive Sexual Desire Disorder in Premenopausal Women.,"INTRODUCTION


Prior medication treatment for hypoactive sexual desire disorder (HSDD) in women has left about half the subjects without benefit. Lorexys (LOR), a proprietary combination of the stimulating/excitatory dopamine-norepinephrine reuptake inhibitor bupropion (BUP) and the sedating/inhibitory serotonergic agonist-antagonist trazodone (TRZ), was developed as a multifunctional solution for this problem.
AIM


Test efficacy, safety, and tolerability of LOR in a range of doses in a combined phase IB/IIA study in premenopausal outpatients with HSDD.
METHODS


Otherwise healthy premenopausal women from 25-50 years of age with HSDD were tested in an open-label, active-control, one-way crossover study, with three 4-week treatments of extended-release TRZ and/or sustained-release BUP. Evaluations were made before and after each treatment. A washout of at least a week followed each treatment. The order of treatments was a standard dose of BUP; a subtherapeutic dose of BUP and TRZ (LOR-low); and a threshold-therapeutic dose of BUP and TRZ (LOR-mod). A midpoint interim analysis was planned to consider adapting doses for efficacy or safety.
MAIN OUTCOME MEASURE


The primary efficacy measure was the Female Sexual Function Index, Desire domain; the main secondary efficacy measures included the Female Sexual Distress Scale-Revised 13th item, on bother about low desire, and a Patient's Global Impression of Change. The main outcome comparison was the proportions of responders. Safety measures were elicited adverse events, Epworth Sleepiness Scale, Columbia Suicide Severity Rating Scale 6-item SCREEN version, vital signs, electrocardiograms, and standard laboratory tests.
RESULTS


Interim analysis did not require altering doses. Most evaluable subjects responded to LOR-mod (at the standard thresholds for response based on minimum clinically relevant difference from baseline, 79% on Female Sexual Function Index, Desire domain, 87% on Female Sexual Distress Scale-Revised Item 13, and 79% on Patient's Global Impression of Change; each P < .05 vs BUP). As expected, close to half responded to BUP (38%, 45%, and 52%, respectively). Response to LOR-low was intermediate (not significant vs BUP). Sensitivity analyses to compensate for carryover effects supported the efficacy of LOR-mod. Elicited adverse events showed the expected profile of TRZ, but led to no sedative-type dropouts or worsening on the Epworth Sleepiness Scale.
CLINICAL IMPLICATIONS


The open-label 1-way crossover design of this phase IB/IIA study limits conclusions, but the consistency of responder analyses showing superiority of LOR-mod dose over control, and the lack of central depressant dropouts, favor further development in double-blind placebo-control trials.
STRENGTH & LIMITATIONS


Strengths include large margins of efficacy over control agent, rapid onset of action, and rigorous safety assessment. Limitations are open-label, cross-over design/lack of placebo control and 1-month duration of exposure.
CONCLUSION


Moderate-dose LOR was generally well-tolerated and was significantly more effective than BUP (active control). The results seem highly favorable compared to previously tested agents. Pyke RE, Clayton AH. Dose-Finding Study of Lorexys for Hypoactive Sexual Desire Disorder in Premenopausal Women. J Sex Med 2019;16:1885-1894.",2019,"Elicited adverse events showed the expected profile of TRZ, but led to no sedative-type dropouts or worsening on the Epworth Sleepiness Scale.
","['premenopausal outpatients with HSDD', 'Premenopausal Women', 'Otherwise healthy premenopausal women from 25-50 years of age with HSDD']","['TRZ', 'Lorexys', 'BUP and TRZ (LOR-mod', 'BUP and TRZ (LOR-low', 'norepinephrine reuptake inhibitor bupropion (BUP) and the sedating/inhibitory serotonergic agonist-antagonist trazodone (TRZ']","['elicited adverse events, Epworth Sleepiness Scale, Columbia Suicide Severity Rating Scale 6-item SCREEN version, vital signs, electrocardiograms, and standard laboratory tests', 'Female Sexual Function Index, Desire domain', 'Female Sexual Distress Scale', 'Epworth Sleepiness Scale', ""Female Sexual Distress Scale-Revised 13th item, on bother about low desire, and a Patient's Global Impression of Change"", 'efficacy, safety, and tolerability of LOR']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0162757', 'cui_str': '5-Hydroxytryptamine Agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0352528,"Elicited adverse events showed the expected profile of TRZ, but led to no sedative-type dropouts or worsening on the Epworth Sleepiness Scale.
","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Pyke', 'Affiliation': 'President, Pykonsult, LLC, 23 Eastview Drive, New Fairfield, CT, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia, 2955 Ivy Road, Suite 210, Charlottesville, VA, USA. Electronic address: AHC8V@virginia.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.09.005']
1478,31654837,Decreased cardiovascular mortality in the ITALUNG lung cancer screening trial: Analysis of underlying factors.,"OBJECTIVES


In the ITALUNG lung cancer screening trial after 9.3 years of follow-up we observed an unexpected significant decrease of cardiovascular (CV) mortality in subjects invited for low-dose CT (LDCT) screening as compared to controls undergoing usual care. Herein we extended the mortality follow-up and analyzed the potential factors underlying such a decrease.
MATERIALS AND METHODS


The following factors were assessed in screenes and controls: burden of CV disease at baseline, changes in smoking habits, use of CV drugs and frequency of planned vascular procedures after randomisation. Moreover, in the screenes we evaluated inclusion of presence of coronary artery calcification (CAC) in the LDCT report form that was transmitted to the participant and his/her General Practitioner.
RESULTS


The 2-years extension of follow-up confirmed a significant decrease of CV mortality in the subjects of the active group compared to control subjects (15.6 vs 34.0 per 10,000; p = 0.001) that was not observed in the drops-out of the active group. None of the explaining factors we considered significantly differed between active and control group. However, the subjects of the active group with reported CAC experienced a not significantly lower CV mortality and showed a significantly higher use of CV drugs and frequency of planned vascular procedures than the control group.
CONCLUSIONS


LDCT screening for lung cancer offers the opportunity for detection of CAC that is an important CV risk factor. Although the underlying mechanisms are not clear, our results suggest that the inclusion of information about CAC presence in the LDCT report may represent a candidate factor to explain the decreased CV mortality observed in screened subjects of the ITALUNG trial, possibly resulting in intervention for patient care to prevent CV deaths. Further studies investigating whether prospective reporting and rating of CAC have independent impact on such interventions and CV mortality are worthy.",2019,"The 2-years extension of follow-up confirmed a significant decrease of CV mortality in the subjects of the active group compared to control subjects (15.6 vs 34.0 per 10,000; p = 0.001) that was not observed in the drops-out of the active group.",[],"['LDCT screening', 'CT (LDCT) screening']","['screenes and controls: burden of CV disease at baseline, changes in smoking habits, use of CV drugs and frequency of planned vascular procedures', 'cardiovascular (CV) mortality', 'CV mortality', 'cardiovascular mortality', 'CV drugs and frequency of planned vascular procedures', 'coronary artery calcification (CAC']",[],"[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}]",,0.0527915,"The 2-years extension of follow-up confirmed a significant decrease of CV mortality in the subjects of the active group compared to control subjects (15.6 vs 34.0 per 10,000; p = 0.001) that was not observed in the drops-out of the active group.","[{'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'Clinical Epidemiology Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy. Electronic address: d.puliti@ispro.toscana.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mascalchi', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, Italy. Electronic address: m.mascalchi@dfc.unifi.it.'}, {'ForeName': 'Francesca Maria', 'Initials': 'FM', 'LastName': 'Carozzi', 'Affiliation': 'Regional Prevention Laboratory Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy. Electronic address: f.carozzi@ispro.toscana.it.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carrozzi', 'Affiliation': 'Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy; Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Italy. Electronic address: laura.carrozzi@unipi.it.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falaschi', 'Affiliation': 'Radiology Department, University Hospital of Pisa, Italy. Electronic address: f.falaschi@ao-pisa.toscana.it.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Clinical Epidemiology Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy. Electronic address: paci.eugenio@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lopes Pegna', 'Affiliation': 'Pneumonology Department, Careggi Hospital, Florence, Italy. Electronic address: a.lopespegna@gmail.com.'}, {'ForeName': 'Ferruccio', 'Initials': 'F', 'LastName': 'Aquilini', 'Affiliation': 'Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy. Electronic address: f.aquilini@ao-pisa.toscana.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Barchielli', 'Affiliation': 'Clinical Epidemiology Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy. Electronic address: abarchielli@virgilio.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Bartolucci', 'Affiliation': 'Radiology Department, Careggi Hospital, Florence, Italy. Electronic address: mauriziobartolucci1@gmail.com.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Grazzini', 'Affiliation': 'Pneumonology Department, Hospital of Pistoia, Italy. Electronic address: mgrazzini@yahoo.com.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Picozzi', 'Affiliation': 'Radiodiagnostic Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy. Electronic address: g.picozzi@ispro.toscana.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pistelli', 'Affiliation': 'Cardiothoracic and Vascular Department, University Hospital of Pisa, Italy. Electronic address: f.pistelli@ao-pisa.toscana.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rosselli', 'Affiliation': 'Tuscan Regional Health Agency, Florence, Italy. Electronic address: ale.rosselli1@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'Clinical Epidemiology Unit, ISPRO - Oncological Network, Prevention and Research Institute, Florence, Italy. Electronic address: m.zappa@ispro.toscana.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.10.006']
1479,31468607,The effect of aquatic exercises on the physical and functional fitness of adults with Down syndrome: A non-randomised controlled trial.,"BACKGROUND


The importance of exercise for individuals with Down syndrome (DS) has been well documented. The use of aquatic exercises may be an attractive alternative to land-based exercises for individuals with musculoskeletal conditions such as low muscle tone and excess adiposity as found in adults with DS. As a result, the purpose of the current study was to study the effect of an aquatic training intervention on the functional fitness for adults with DS.
METHODS


Participants were recruited from two intellectually disabled care centres in the Western Cape of South Africa. Twenty-three adults with DS (13 men and 10 women) (31.4 ± 7.4 years) were allocated to an aquatic training group or a control group. The exercise group performed 35 min of aquatic training, three times a week for 6 weeks, with an increase duration of 45 min after 3 weeks. Outcome measures assessed were aerobic capacity, muscular strength, functional ability and balance.
RESULTS


The aerobic capacity and functional ability of the participants in the aquatic group improved significantly than in the control group with strong to medium effect sizes. Two out of the three strength parameters also improved significantly than in the control group.
CONCLUSIONS


The functional fitness of adults with DS improved with an aquatic intervention but was insufficient to improve balance and upper body strength. The improvement of various parameters associated with functional fitness is important in this population who age prematurely, suffer from the early onset of age-related conditions, are vulnerable to falls and susceptible to chronic conditions.",2019,The aerobic capacity and functional ability of the participants in the aquatic group improved significantly than in the control group with strong to medium effect sizes.,"['Twenty-three adults with DS (13 men and 10 women) (31.4\xa0±\xa07.4\xa0years', 'adults with DS', 'adults with Down syndrome', 'individuals with Down syndrome (DS', 'Participants were recruited from two intellectually disabled care centres in the Western Cape of South Africa']","['exercise group performed 35\xa0min of aquatic training', 'aquatic exercises', 'aquatic training intervention', 'aquatic intervention', 'aquatic training group or a control group']","['balance and upper body strength', 'aerobic capacity, muscular strength, functional ability and balance', 'aerobic capacity and functional ability', 'functional fitness']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",23.0,0.0313231,The aerobic capacity and functional ability of the participants in the aquatic group improved significantly than in the control group with strong to medium effect sizes.,"[{'ForeName': 'Pieter-Henk', 'Initials': 'PH', 'LastName': 'Boer', 'Affiliation': 'Department of Human Movement Science, Faculty of Education, Cape Peninsula University of Technology, Wellington, South Africa.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'de Beer', 'Affiliation': 'Department of Human Movement Science, Faculty of Education, Cape Peninsula University of Technology, Wellington, South Africa.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12687']
1480,29943364,Aspirin for Primary Prevention of Cardiovascular Disease and Renal Disease Progression in Chronic Kidney Disease Patients: a Multicenter Randomized Clinical Trial (AASER Study).,"BACKGROUND


Patients with chronic kidney disease (CKD) are at high risk for developing cardiovascular events. However, limited evidence is available regarding the use of aspirin in CKD patients to decrease cardiovascular risk and to slow renal disease progression.
STUDY DESIGN


Prospective, multicenter, open-label randomized controlled trial.
SETTING AND PARTICIPANTS


One hundred eleven patients with estimated glomerular filtration rate (eGFR) 15-60 ml/min/1.73 m 2  without previous cardiovascular events.
INTERVENTION


Aspirin treatment (100 mg/day) (n = 50) or usual therapy (n = 61). Mean follow-up time was 64.8 ± 16.4 months.
OUTCOMES


The primary endpoint was composed of cardiovascular death, acute coronary syndrome (nonfatal MI, coronary revascularization, or unstable angina pectoris), cerebrovascular disease, heart failure, or nonfatal peripheral arterial disease. Secondary endpoints were fatal and nonfatal coronary events, renal events (defined as doubling of serum creatinine, ≥ 50% decrease in eGFR, or renal replacement therapy), and bleeding episodes.
RESULTS


During follow-up, 17 and 5 participants suffered from a primary endpoint in the control and aspirin groups, respectively. Aspirin did not significantly reduce primary composite endpoint (HR, 0.396 (0.146-1.076), p = 0.069. Eight patients suffered from a fatal or nonfatal coronary event in the control group compared to no patients in the aspirin group. Aspirin significantly reduced the risk of coronary events (log-rank, 5.997; p = 0.014). Seventeen patients in the control group reached the renal outcome in comparison with 3 patients in the aspirin group. Aspirin treatment decreased renal disease progression in a model adjusted for age, baseline kidney function, and diabetes mellitus (HR, 0.272; 95% CI, 0.077-0.955; p = 0.043) but did not when adjusted for albuminuria. No differences were found in minor bleeding episodes between groups and no major bleeding was registered.
LIMITATIONS


Small sample size and open-label trial.
CONCLUSIONS


Long-term treatment with low-dose aspirin did not reduce the composite primary endpoint; however, there were reductions in secondary endpoints with fewer coronary events and renal outcomes. ClinicalTrials.gov Identifier: NCT01709994.",2018,"Aspirin significantly reduced the risk of coronary events (log-rank, 5.997; p = 0.014).","['Patients with chronic kidney disease (CKD', 'Chronic Kidney Disease Patients', 'One hundred eleven patients with estimated glomerular filtration rate (eGFR) 15-60\xa0ml']","['usual therapy', 'Aspirin', 'aspirin']","['minor bleeding episodes', 'cardiovascular death, acute coronary syndrome (nonfatal MI, coronary revascularization, or unstable angina pectoris), cerebrovascular disease, heart failure, or nonfatal peripheral arterial disease', 'fatal and nonfatal coronary events, renal events (defined as doubling of serum creatinine, ≥\u200950% decrease in eGFR, or renal replacement therapy), and bleeding episodes', 'renal outcome', 'risk of coronary events', 'coronary events and renal outcomes', 'renal disease progression', 'cardiovascular risk', 'fatal or nonfatal coronary event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3811844'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",111.0,0.0693144,"Aspirin significantly reduced the risk of coronary events (log-rank, 5.997; p = 0.014).","[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Goicoechea', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain. marian.goicoechea@gmail.com.'}, {'ForeName': 'Soledad García', 'Initials': 'SG', 'LastName': 'de Vinuesa', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Quiroga', 'Affiliation': 'Nephrology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Verde', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Bernis', 'Affiliation': 'Nephrology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Morales', 'Affiliation': 'Spanish Kidney Research Network (REDINREN), FEDER FUND, Madrid, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Fernández-Juárez', 'Affiliation': 'Spanish Kidney Research Network (REDINREN), FEDER FUND, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'de Sequera', 'Affiliation': 'Nephrology Department, Hospital Universitario Infanta Leonor, Madrid, Spain.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Verdalles', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Delgado', 'Affiliation': 'Nephrology Department, Clinica Ruber, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Nephrology Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Nephrology Department, Hospital Universitario Severo Ochoa, Madrid, Spain.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Abad', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Spanish Kidney Research Network (REDINREN), FEDER FUND, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Luño', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-018-6802-1']
1481,30649257,Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults.,"OBJECTIVE


The aim of this study was to investigate the effects of piezocision (surgical protocol with sutures) in orthodontic treatment using CAD/CAM (computer-aided design and computer-aided manufacturing) customized orthodontic appliances.
DESIGN


The study is designed as a parallel group, randomized controlled trial (RCT).
SETTING


University Hospital.
ETHICAL APPROVAL


The study was approved by the ethic committee of the University Hospital Liege, Belgium.
SUBJECTS AND METHODS


This RCT was conducted on 24 adult patients requiring orthodontic treatment to release mild overcrowding. Patients were all treated with a customized appliance and randomly assigned by means of sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment. A blinded orthodontist validated appliance removal or further adjustments based on the model study.
OUTCOME MEASURES


The overall treatment time and the time between archwire changes were recorded. Moreover, clinical and radiological features such as tooth resorption, gingival recessions, and the presence of scars were evaluated.
RESULTS


A total of 24 patients (12 control and 12 test) completed the study. The overall treatment time was significantly shorter in the test group than the control group. Likewise, the time difference between all arch changes was significantly lower when piezocision was performed, except for the first arch at the mandible and the last arches at both maxillae. During the fine-tuning phase, no significant difference was found between the two groups. All periodontal and radiographic parameters remained stable from the start to the end of treatment in both the groups. However, minor scars were found in 66 per cent cases.
LIMITATIONS


This trial was a single-centre trial.
CONCLUSIONS


Piezocision seems to be an effective method to accelerate orthodontic treatment in cases of mild overcrowding. However, the effect was only observed during the alignment phase and a greater efficiency was found in the maxilla. The technique may be contraindicated in patients with a high smile line since the risk of slight scarring exists.
REGISTRATION


ClinicalTrails.gov (Identifier: NCT03406130).",2019,The overall treatment time was significantly shorter in the test group than the control group.,"['24 adult patients requiring orthodontic treatment to release mild overcrowding', '24 patients (12 control and 12 test) completed the study', 'adults']","['Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances', 'piezocision (surgical protocol with sutures', 'sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment', 'CAD/CAM']","['overall treatment time', 'overall treatment time and the time between archwire changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029331', 'cui_str': 'Orthodontic Appliances'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",24.0,0.0393089,The overall treatment time was significantly shorter in the test group than the control group.,"[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Charavet', 'Affiliation': 'Department of Orthodontics and DentoFacial Orthopedics, University Hospital of Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Nastasia', 'Initials': 'N', 'LastName': 'Jackers', 'Affiliation': 'Department of Orthodontics and DentoFacial Orthopedics, University Hospital of Liège, Belgium.'}, {'ForeName': 'Adelin', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': 'Department of Biostatistics and Medico-Economic Information, University Hospital of Liège, Belgium.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Dental Biomaterials Research Unit, Faculty of Medicine, University of Liège, Belgium.'}]",European journal of orthodontics,['10.1093/ejo/cjy082']
1482,30649318,"Corrigendum: Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial.",,2019,,[],[],[],[],[],[],,0.20971,,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lombardo', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Arreghini', 'Affiliation': ''}, {'ForeName': 'Luis T Huanca', 'Initials': 'LTH', 'LastName': 'Ghislanzoni', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Siciliani', 'Affiliation': ''}]",European journal of orthodontics,['10.1093/ejo/cjy084']
1483,30635497,Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery.,"BACKGROUND


This randomized trial compared ultrasound-guided interscalene block (ISB) and costoclavicular brachial plexus block (CCB) for arthroscopic shoulder surgery. We hypothesized that CCB would provide equivalent analgesia to ISB 30 min after surgery without the risk of hemidiaphragmatic paralysis.
METHODS


All 44 patients received an ultrasound-guided block of the intermediate cervical plexus. Subsequently, they were randomized to ISB or CCB. The local anesthetic agent (20 mL of levobupivacaine 0.5% and epinephrine 5 µg/mL) and pharmacological block adjunct (4 mg of intravenous dexamethasone) were identical for all study participants. After the block performance, a blinded investigator assessed ISBs and CCBs every 5 min until 30 min using a composite scale that encompassed the sensory function of the supraclavicular nerves, the sensorimotor function of the axillary nerve and the motor function of the suprascapular nerve. A complete block was defined as one displaying a minimal score of six points (out of a maximum of eight points) at 30 min. Onset time was defined as the time required to reach the six-point minimal composite score. The blinded investigator also assessed the presence of hemidiaphragmatic paralysis at 30 min with ultrasonography.Subsequently, all patients underwent general anesthesia. Postoperatively, a blinded investigator recorded pain scores at rest at 0.5, 1, 2, 3, 6, 12, and 24 hours. Patient satisfaction at 24 hours, consumption of intraoperative and postoperative narcotics, and opioid-related side effects (eg, nausea/vomiting, pruritus) were also tabulated.
RESULTS


Both groups displayed equivalent postoperative pain scores at 0.5, 1, 2, 3, 6, 12, and 24 hours. ISB resulted in a higher incidence of hemidiaphragmatic paralysis (100% vs 0%; P < 0.001) as well as a shorter onset time (14.0 (5.0) vs 21.6 (6.4) minutes; p<0.001). However, no intergroup differences were found in terms of proportion of patients with minimal composite scores of 6 points at 30 min, intraoperative/postoperative opioid consumption, side effects, and patient satisfaction at 24 hours.
CONCLUSION


Compared to ISB, CCB results in equivalent postoperative analgesia while circumventing the risk of hemidiaphragmatic paralysis. Further confirmatory trials are required. Future studies should also investigate if CCB can provide surgical anesthesia for arthroscopic shoulder surgery.
CLINICAL TRIALS REGISTRATION


NCT03411343.",2019,ISB resulted in a higher incidence of hemidiaphragmatic paralysis (100% vs 0%; P < 0.001) as well as a shorter onset time (14.0 (5.0) vs 21.6 (6.4) minutes; p<0.001).,['arthroscopic shoulder surgery'],"['ISB', 'ISB, CCB', 'interscalene and costoclavicular blocks', 'ultrasound-guided interscalene block (ISB) and costoclavicular brachial plexus block (CCB', 'ultrasound-guided block of the intermediate cervical plexus', 'pharmacological block adjunct (4 mg of intravenous dexamethasone', 'CCB', 'levobupivacaine 0.5% and epinephrine']","['Patient satisfaction at 24 hours, consumption of intraoperative and postoperative narcotics, and opioid-related side effects (eg, nausea/vomiting, pruritus', 'hemidiaphragmatic paralysis', 'intraoperative/postoperative opioid consumption, side effects, and patient satisfaction', 'pain scores', 'equivalent postoperative pain scores', 'shorter onset time']","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0589495', 'cui_str': 'Interscalene approach (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0007854', 'cui_str': 'Cervical Plexus'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.242384,ISB resulted in a higher incidence of hemidiaphragmatic paralysis (100% vs 0%; P < 0.001) as well as a shorter onset time (14.0 (5.0) vs 21.6 (6.4) minutes; p<0.001).,"[{'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile julian.aliste@uchile.cl.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Maccioni', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Infante', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Clínico Universidad de Chile, University of Chile, Santiago, Chile.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'De Q', 'Initials': 'DQ', 'LastName': 'Tran', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Quebec, Canada.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2018-100055']
1484,30616300,Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis.,"BACKGROUND


Cystic fibrosis (CF) is the commonest inherited life-shortening illness in white populations, caused by a mutation in the gene that codes for the cystic fibrosis transmembrane regulator protein (CFTR), which functions as a salt transporter. This mutation mainly affects the airways where excess salt absorption dehydrates the airway lining leading to impaired mucociliary clearance. Consequently, thick, sticky mucus accumulates making the airway prone to chronic infection and progressive inflammation; respiratory failure often ensues. Other complications include malnutrition, diabetes and subfertility.Increased understanding of the condition has allowed pharmaceutical companies to design mutation-specific therapies targeting the underlying molecular defect. CFTR potentiators target mutation classes III and IV and aim to normalise airway surface liquid and mucociliary clearance, which in turn impacts on the chronic infection and inflammation. This is an update of a previously published review.
OBJECTIVES


To evaluate the effects of CFTR potentiators on clinically important outcomes in children and adults with CF.
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles, reviews and online clinical trial registries. Last search: 21 November 2018.
SELECTION CRITERIA


Randomised controlled trials (RCTs) of parallel design comparing CFTR potentiators to placebo in people with CF. A separate review examines trials combining CFTR potentiators with other mutation-specific therapies.
DATA COLLECTION AND ANALYSIS


The authors independently extracted data, assessed the risk of bias in included trials and used GRADE to assess evidence quality. Trial authors were contacted for additional data.
MAIN RESULTS


We included five RCTs (447 participants with different mutations) lasting from 28 days to 48 weeks, all assessing the CFTR potentiator ivacaftor. The quality of the evidence was moderate to low, mainly due to risk of bias (incomplete outcome data and selective reporting) and imprecision of results, particularly where few individuals experienced adverse events. Trial design was generally well-documented. All trials were industry-sponsored and supported by other non-pharmaceutical funding bodies.F508del (class II) (140 participants)One 16-week trial reported no deaths, or changes in quality of life (QoL) or lung function (either relative or absolute change in forced expiratory volume in one second (FEV1) (moderate-quality evidence). Pulmonary exacerbations and cough were the most reported adverse events in ivacaftor and placebo groups, but there was no difference between groups (low-quality evidence); there was also no difference between groups in participants interrupting or discontinuing treatment (low-quality evidence). Number of days until the first exacerbation was not reported, but there was no difference between groups in how many participants developed pulmonary exacerbations. There was also no difference in weight. Sweat chloride concentration decreased, mean difference (MD) -2.90 mmol/L (95% confidence interval (CI) -5.60 to -0.20).G551D (class III) (238 participants)The 28-day phase 2 trial (19 participants) and two 48-week phase 3 trials (adult trial (167 adults), paediatric trial (52 children)) reported no deaths. QoL scores (respiratory domain) were higher with ivacaftor in the adult trial at 24 weeks, MD 8.10 (95% CI 4.77 to 11.43) and 48 weeks, MD 8.60 (95% CI 5.27 to 11.93 (moderate-quality evidence). The adult trial reported a higher relative change in FEV1 with ivacaftor at 24 weeks, MD 16.90% (95% CI 13.60 to 20.20) and 48 weeks, MD 16.80% (95% CI 13.50 to 20.10); the paediatric trial reported this at 24 weeks, MD 17.4% (P < 0.0001)) (moderate-quality evidence). These trials demonstrated absolute improvements in FEV1 (% predicted) at 24 weeks, MD 10.80% (95% CI 8.91 to 12.69) and 48 weeks, MD 10.44% (95% CI 8.56 to 12.32). The phase 3 trials reported increased cough, odds ratio (OR) 0.57 (95% CI 0.33 to 1.00) and episodes of decreased pulmonary function, OR 0.29 (95% CI 0.10 to 0.82) in the placebo group; ivacaftor led to increased dizziness in adults, OR 10.55 (95% CI 1.32 to 84.47). There was no difference between groups in participants interrupting or discontinuing treatment (low-quality evidence). Fewer participants taking ivacaftor developed serious pulmonary exacerbations; adults taking ivacaftor developed fewer exacerbations (serious or not), OR 0.54 (95% CI 0.29 to 1.01). A higher proportion of participants were exacerbation-free at 24 weeks with ivacaftor (moderate-quality evidence). Ivacaftor led to a greater absolute change from baseline in FEV1 (% predicted) at 24 weeks, MD 10.80% (95% CI 8.91 to 12.69) and 48 weeks, MD 10.44% (95% CI 8.56 to 12.32); weight also increased at 24 weeks, MD 2.37 kg (95% CI 1.68 to 3.06) and 48 weeks, MD 2.75 kg (95% CI 1.74 to 3.75). Sweat chloride concentration decreased at 24 weeks, MD -48.98 mmol/L (95% CI -52.07 to -45.89) and 48 weeks, MD -49.03 mmol/L (95% CI -52.11 to -45.94).R117H (class IV) (69 participants)One 24-week trial reported no deaths. QoL scores (respiratory domain) were higher with ivacaftor at 24 weeks, MD 8.40 (95% CI 2.17 to 14.63), but no relative changes in lung function were reported (moderate-quality evidence). Pulmonary exacerbations and cough were the most reported adverse events in both groups, but there was no difference between groups; there was no difference between groups in participants interrupting or discontinuing treatment (low-quality evidence). Number of days until the first exacerbation was not reported, but there was no difference between groups in how many participants developed pulmonary exacerbations. No changes in absolute change in FEV1 or weight were reported. Sweat chloride concentration decreased, MD -24.00 mmol/L (CI 95% -24.69 to -23.31).
AUTHORS' CONCLUSIONS


There is no evidence supporting the use of ivacaftor in people with the F508del mutation. Both G551D phase 3 trials demonstrated a clinically relevant impact of ivacaftor on outcomes at 24 and 48 weeks in adults and children (over six years of age) with CF. The R117H trial demonstrated an improvement in the respiratory QoL score, but no improvement in respiratory function.As new mutation-specific therapies emerge, it is important that trials examine outcomes relevant to people with CF and their families and that adverse events are reported robustly and consistently. Post-market surveillance is essential and ongoing health economic evaluations are required.",2019,"Sweat chloride concentration decreased at 24 weeks, MD -48.98 mmol/L","['children and adults with CF', '447 participants with different mutations) lasting from 28 days to 48 weeks, all assessing the CFTR potentiator ivacaftor', 'people with the F508del mutation', 'adults and children (over six years of age) with CF', 'people with CF']","['F508del (class II', 'Ivacaftor', 'CFTR potentiators', 'placebo']","['lung function', 'Pulmonary exacerbations and cough', 'QoL scores (respiratory domain', 'pulmonary exacerbations', 'deaths, or changes in quality of life (QoL) or lung function (either relative or absolute change in forced expiratory volume in one second (FEV1) (moderate-quality evidence', 'adverse events', 'FEV1', 'respiratory QoL score', 'cough, odds ratio (OR) 0.57', 'Sweat chloride concentration decreased, mean difference (MD', 'respiratory function', 'serious pulmonary exacerbations', 'absolute change in FEV1 or weight', 'Sweat chloride concentration', 'episodes of decreased pulmonary function', 'dizziness', 'weight']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4521703', 'cui_str': 'Cystic fibrosis transmembrane conductance regulator potentiator (disposition)'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C4521703', 'cui_str': 'Cystic fibrosis transmembrane conductance regulator potentiator (disposition)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",52.0,0.526914,"Sweat chloride concentration decreased at 24 weeks, MD -48.98 mmol/L","[{'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Skilton', 'Affiliation': 'c/o Cochrane Cystic Fibrosis and Genetic Disorders Review Group, University of Liverpool, Institute in the Park, Eaton Road, Liverpool, UK, L12 2AP.'}, {'ForeName': 'Ashma', 'Initials': 'A', 'LastName': 'Krishan', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Sinha', 'Affiliation': ''}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Southern', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009841.pub3']
1485,31484660,Efficacy of Difluoromethylornithine and Aspirin for Treatment of Adenomas and Aberrant Crypt Foci in Patients with Prior Advanced Colorectal Neoplasms.,"Difluoromethylornithine (DFMO), an inhibitor of polyamine synthesis, was shown to act synergistically with a NSAID for chemoprevention of colorectal neoplasia. We determined the efficacy and safety of DFMO plus aspirin for prevention of colorectal adenomas and regression of rectal aberrant crypt foci (ACF) in patients with prior advanced adenomas or cancer. A double-blinded, placebo-controlled trial was performed in 104 subjects (age 46-83) randomized (1:1) to receive daily DFMO (500 mg orally) plus aspirin (325 mg) or matched placebos for one year. All polyps were removed at baseline. Adenoma number (primary endpoint) and rectal ACF (index cluster and total) were evaluated at a one year colonoscopy. ACF were identified by chromoendoscopy. Toxicity was monitored, including audiometry. Eighty-seven subjects were evaluable for adenomas or ACF modulation ( n  = 62). At one year of treatment, adenomas were detected in 16 (38.1%) subjects in the DFMO plus aspirin arm ( n  = 42) versus 18 (40.9%) in the placebo arm ( n  = 44;  P  = 0.790); advanced adenomas were similar ( n  = 3/arm). DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared with placebo ( P  = 0.036). Total rectal ACF burden was also reduced in the treatment versus the placebo arm relative to baseline (74% vs. 45%,  P  = 0.020). No increase in adverse events, including ototoxicity, was observed in the treatment versus placebo arms. While adenoma recurrence was not significantly reduced by one year of DFMO plus aspirin, the drug combination significantly reduced rectal ACF number consistent with a chemopreventive effect.",2019,DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared to placebo (p= 0.036).,"['Patients with Prior Advanced Colorectal Neoplasms', '104 subjects (age 46- 83', 'patients with prior advanced adenomas or cancer', 'Eighty-seven subjects were evaluable for adenomas or ACF modulation (n=62']","['daily DFMO', 'Difluoromethylornithine and Aspirin', 'DFMO plus aspirin', 'placebo', 'Difluoromethylornithine (DFMO', 'aspirin']","['Adenoma number (primary endpoint) and rectal ACF (index cluster and total', 'median number of rectal ACF', 'adenoma recurrence', 'Total rectal ACF burden', 'Toxicity', 'rectal aberrant crypt foci (ACF', 'adverse events, including ototoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0009404', 'cui_str': 'Colorectal Tumors'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002260', 'cui_str': 'Eflornithine'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}]",87.0,0.482134,DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared to placebo (p= 0.036).,"[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota. sinicrope.frank@mayo.edu.'}, {'ForeName': 'Pruthvi R', 'Initials': 'PR', 'LastName': 'Velamala', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Louis M Wong Kee', 'Initials': 'LMWK', 'LastName': 'Song', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Viggiano', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Bruining', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gostout', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kraichely', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Navtej S', 'Initials': 'NS', 'LastName': 'Buttar', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Schroeder', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kisiel', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Larson', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Seth R', 'Initials': 'SR', 'LastName': 'Sweetser', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Sedlack', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Sinicrope', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': ""Della'Zanna"", 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Joni S', 'Initials': 'JS', 'LastName': 'Noaeill', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Foster', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0167']
1486,30649556,Serum C-Reactive Protein Levels in Healthy Neonates in Different Gestational and Postnatal Ages.,"There is paucity of normative data on serum C-reactive protein (CRP) in neonates. In Part I of study, we compared CRP in healthy neonates (from 28°/7 weeks to 416/7 weeks of gestation) between various gestational and postnatal age groups in first week. We planned recruitment of 50 participants each in 'term', 'late preterm' and 'moderate-to-very preterm' groups, equally divided in '24-95 h' and '96-168 h' postnatal age sub-groups. In Part II of study, we assayed CRP weekly in moderate-to-very preterm neonates until day 28 to evaluate its trend. Among 154 subjects, term neonates had higher CRP, with highest values among term infants aged 24-95 h. Barring postnatal age, maternal/perinatal factors did not affect CRP levels. CRP did not change significantly over 28 days in moderate-to-very preterm neonates. In conclusion, serum CRP in healthy neonates is highest among term infants aged 24-95 h and does not vary significantly in the first month of life among moderate-to-very preterm infants.",2019,"In conclusion, serum CRP in healthy neonates is highest among term infants aged 24-95 h and does not vary significantly in first 1 month of life among moderate-to-very preterm infants.","['Healthy Neonates in Different Gestational and Postnatal Ages', 'healthy neonates (from 28°/7\u2009weeks to 416/7\u2009weeks of gestation) between various gestational and postnatal age groups in first week', ""50 participants each in 'term', 'late preterm' and 'moderate-to-very preterm' groups, equally divided in '24-95\u2009h' and '96-168\u2009h' postnatal age sub-groups"", '154 subjects, term neonates had higher CRP, with highest values among term infants aged 24-95\u2009h', 'healthy neonates']",['CRP'],"['CRP levels', 'serum CRP', 'serum C-reactive protein (CRP', 'CRP', 'Serum C-Reactive Protein Levels']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}]",50.0,0.0681683,"In conclusion, serum CRP in healthy neonates is highest among term infants aged 24-95 h and does not vary significantly in first 1 month of life among moderate-to-very preterm infants.","[{'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Palanisamy', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India.'}, {'ForeName': 'Sourabh', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India.'}, {'ForeName': 'Savita Verma', 'Initials': 'SV', 'LastName': 'Attri', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India.'}, {'ForeName': 'Venkataseshan', 'Initials': 'V', 'LastName': 'Sundaram', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy079']
1487,30110521,Endovascular coiling versus neurosurgical clipping for people with aneurysmal subarachnoid haemorrhage.,"BACKGROUND


Around 30% of people who are admitted to hospital with aneurysmal subarachnoid haemorrhage (SAH) will rebleed in the initial month after the haemorrhage if the aneurysm is not treated. The two most commonly used methods to occlude the aneurysm for prevention of rebleeding are microsurgical clipping of the neck of the aneurysm and occlusion of the lumen of the aneurysm by means of endovascular coiling. This is an update of a systematic review that was previously published in 2005.
OBJECTIVES


To compare the effects of endovascular coiling versus neurosurgical clipping in people with aneurysmal SAH on poor outcome, rebleeding, neurological deficit, and treatment complications.
SEARCH METHODS


We searched the Cochrane Stroke Group Trials Register (March 2018). In addition, we searched CENTRAL (2018, Issue 2), MEDLINE (1966 to March 2018), Embase (1980 to March 2018), US National Institutes of Health Ongoing Trials Register (March 2018), and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (last searched March 2018). We also contacted trialists.
SELECTION CRITERIA


We included randomised trials comparing endovascular coiling with neurosurgical clipping in people with SAH from a ruptured aneurysm.
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted data, and assessed trial quality and risk of bias using the GRADE approach. We contacted trialists to obtain missing information. We defined poor outcome as death or dependence in daily activities (modified Rankin scale 3 to 6 or Glasgow Outcome Scale (GOS) 1 to 3). In the special worst-case scenario analysis, we assumed all participants in the group with better outcome with missing follow-up information had a poor outcome and those in the other group with missing data a good outcome.
MAIN RESULTS


We included four randomised trials involving 2458 participants (range per trial: 20 to 2143 participants). Evidence is mostly based on the largest trial. Most participants were in good clinical condition and had an aneurysm on the anterior circulation. None of the included trials was at low risk of bias in all domains. One trial was at unclear risk in one domain, two trials at unclear risk in three domains, and one trial at high risk in one domain.After one year of follow-up, 24% of participants randomised to endovascular treatment and 32% of participants randomised to the surgical treatment group had poor functional outcome. The risk ratio (RR) of poor outcome (death or dependency) for endovascular coiling versus neurosurgical clipping was 0.77 (95% confidence interval (CI) 0.67 to 0.87; 4 trials, 2429 participants, moderate-quality evidence), and the absolute risk reduction was 7% (95% CI 4% to 11%). In the worst-case scenario analysis for poor outcome, the RR for endovascular coiling versus neurosurgical clipping was 0.80 (95% CI 0.71 to 0.91), and the absolute risk reduction was 6% (95% CI 2% to 10%). The RR of death at 12 months was 0.80 (95% CI 0.63 to 1.02; 4 trials, 2429 participants, moderate-quality evidence). In a subgroup analysis of participants with an anterior circulation aneurysm, the RR of poor outcome was 0.78 (95% CI 0.68 to 0.90; 2 trials, 2157 participants, moderate-quality evidence), and the absolute risk decrease was 7% (95% CI 3% to 10%). In subgroup analysis of those with a posterior circulation aneurysm, the RR was 0.41 (95% CI 0.19 to 0.92; 2 trials, 69 participants, low-quality evidence), and the absolute decrease in risk was 27% (95% CI 6% to 48%). At five years, 28% of participants randomised to endovascular treatment and 32% of participants randomised to surgical treatment had poor functional outcome. The RR of poor outcome for endovascular coiling versus neurosurgical clipping was 0.87 (95% CI 0.75 to 1.01, 1 trial, 1724 participants, low-quality evidence). At 10 years, 35% participants allocated to endovascular and 43% participants allocated to surgical treatment had poor functional outcome. At 10 years RR of poor outcome for endovascular coiling versus neurosurgical clipping was 0.81 (95% CI 0.70 to 0.92; 1 trial, 1316 participants, low-quality evidence). The RR of delayed cerebral ischaemia at two to three months for endovascular coiling versus neurosurgical clipping was 0.84 (95% CI 0.74 to 0.96; 4 trials, 2450 participants, moderate-quality evidence). The RR of rebleeding for endovascular coiling versus neurosurgical clipping was 1.83 (95% CI 1.04 to 3.23; 4 trials, 2458 participants, high-quality evidence) at one year, and 2.69 (95% CI 1.50 to 4.81; 1 trial, 1323 participants, low-quality evidence) at 10 years. The RR of complications from intervention for endovascular coiling versus neurosurgical clipping was 1.05 (95% CI 0.44 to 2.53; 2 trials, 129 participants, low-quality evidence).
AUTHORS' CONCLUSIONS


The evidence in this systematic review comes mainly from one large trial, and long-term follow-up is available only for a subgroup of participants within that trial. For people in good clinical condition with ruptured aneurysms of either the anterior or posterior circulation the data from randomised trials show that, if the aneurysm is considered suitable for both neurosurgical clipping and endovascular coiling, coiling is associated with a better outcome. There is no reliable trial evidence that can be used directly to guide treatment in people with a poor clinical condition.",2018,"The RR of delayed cerebral ischaemia at two to three months for endovascular coiling versus neurosurgical clipping was 0.84 (95% CI 0.74 to 0.96; 4 trials, 2450 participants, moderate-quality evidence).","['people with aneurysmal SAH', 'people who are admitted to hospital with aneurysmal subarachnoid haemorrhage (SAH', 'people with aneurysmal subarachnoid haemorrhage', '2458 participants (range per trial: 20 to 2143 participants', 'people with a poor clinical condition', 'people with SAH from a ruptured aneurysm', '1966 to March 2018), Embase (1980 to March 2018), US National Institutes of Health']","['endovascular coiling versus neurosurgical clipping', 'endovascular coiling with neurosurgical clipping', 'Endovascular coiling versus neurosurgical clipping']","['moderate-quality evidence', 'risk ratio (RR) of poor outcome (death or dependency) for endovascular coiling versus neurosurgical clipping', 'RR of rebleeding', 'RR of death', 'RR of delayed cerebral ischaemia', 'death or dependence in daily activities (modified Rankin scale 3 to 6 or Glasgow Outcome Scale (GOS', 'absolute risk decrease', 'poor functional outcome', 'absolute risk reduction']","[{'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0162869', 'cui_str': 'Aneurysm, Ruptured'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0185010', 'cui_str': 'Clipping'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0185010', 'cui_str': 'Clipping'}, {'cui': 'C0917798', 'cui_str': 'Cerebral Ischemia'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",2458.0,0.310058,"The RR of delayed cerebral ischaemia at two to three months for endovascular coiling versus neurosurgical clipping was 0.84 (95% CI 0.74 to 0.96; 4 trials, 2450 participants, moderate-quality evidence).","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital, Puijonlaaksontie 2, Kuopio, Kuopio, Finland, 70029.'}, {'ForeName': 'Mervyn DI', 'Initials': 'MD', 'LastName': 'Vergouwen', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'van der Schaaf', 'Affiliation': ''}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': ''}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wermer', 'Affiliation': ''}, {'ForeName': 'Mike J', 'Initials': 'MJ', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Gabriel Je', 'Initials': 'GJ', 'LastName': 'Rinkel', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003085.pub3']
1488,30638856,"Efficacy and safety of burosumab in children aged 1-4 years with X-linked hypophosphataemia: a multicentre, open-label, phase 2 trial.","BACKGROUND


Children with X-linked hypophosphataemia have high concentrations of circulating phosphatonin fibroblast growth factor 23 (FGF23), which causes renal phosphate wasting and hypophosphataemia, rickets, skeletal deformities, and growth impairment. Burosumab, a human monoclonal antibody against FGF23, improves phosphate homoeostasis and rickets in children aged 5-12 years with X-linked hypophosphataemia. We aimed to assess the safety and efficacy of burosumab in younger children with X-linked hypophosphataemia.
METHODS


In this open-label, phase 2 trial at three hospitals in the USA, children (aged 1-4 years) with X-linked hypophosphataemia received burosumab (0·8 mg/kg) via subcutaneous injection every 2 weeks for 64 weeks. The dose was increased to 1·2 mg/kg if two consecutive pre-dose serum phosphorus concentrations were below 1·03 mmol/L (3·2 mg/dL), serum phosphorus had increased by less than 0·16 mmol/L (<0·5 mg/dL) from baseline, and a dose of burosumab had not been missed. Participants could continue to receive burosumab for up to an additional 96 weeks during the extension period. Key inclusion criteria were age 1-4 years at the time of informed consent; fasting serum phosphorus concentration of less than 0·97 mmol/L (3·0 mg/dL); serum creatinine 8·8-35·4 μmol/L (0·1-0·4 mg/dL); radiographic evidence of rickets (at least five participants were required to have a Thacher Rickets Severity Score of ≥1·5 at the knee); and a confirmed PHEX mutation or a variant of unknown significance in the patient or direct relative also affected with X-linked hypophosphataemia. Conventional therapy was stopped upon enrolment. The coprimary endpoints were safety and change from baseline to week 40 in fasting serum phosphorus concentrations. Changes in rickets severity from baseline to weeks 40 and 64 (assessed radiographically using Thacher Rickets Severity Score and an adaptation of the Radiographic Global Impression of Change), and recumbent length or standing height, were key secondary outcomes. This trial is registered with ClinicalTrials.gov, number NCT02750618, and is ongoing.
FINDINGS


Between May 16, 2016, and June 10, 2016, we enrolled 13 children with X-linked hypophosphataemia. All 13 children completed 64 weeks of treatment and were included in the efficacy and safety analysis; none exceeded 70 weeks of treatment at the time of analysis. Serum phosphorus least squares mean increase from baseline to week 40 of treatment was 0·31 mmol/L (SE 0·04; 95% CI 0·24-0·39; 0·96 mg/dL [SE 0·12]; p<0·0001). All patients had at least one adverse event. 14 treatment-related adverse events, mostly injection site reactions, occurred in five children. One serious adverse event considered unrelated to treatment (tooth abscess) occurred in a child with a history of tooth abscess. All other adverse events were mild to moderate, except a severe food allergy considered unrelated to treatment. No instances of nephrocalcinosis or noteworthy changes in the results of a standard safety chemistry panel emerged. Total Thacher Rickets Severity Score decreased by a least squares mean of -1·7 (SE 0·1; p<0·0001) from baseline to week 40 and by -2·0 (SE 0·1; p<0·0001) by week 64. The Radiographic Global Impression of Change score also indicated significant improvement, with a least squares mean score of +2·3 (SE 0·1) at week 40 and +2·2 (0·1) at week 64 (both p<0·0001). Mean length or standing height Z score was maintained from baseline to week 64.
INTERPRETATION


Burosumab had a favourable safety profile, increased serum phosphorus, and improved rickets and prevented early declines in growth in children aged 1-4 years with X-linked hypophosphataemia. These findings could substantially alter the treatment of young children with X-linked hypophosphataemia.
FUNDING


Ultragenyx Pharmaceutical and Kyowa Kirin International.",2019,Total Thacher Rickets Severity Score decreased by a least squares mean of -1·7 (SE 0·1; p<0·0001) from baseline to week 40 and by -2·0 (SE 0·1; p<0·0001) by week 64.,"['Key inclusion criteria were age 1-4 years at the time of informed consent; fasting serum phosphorus concentration of less than 0·97 mmol/L (3·0 mg/dL); serum creatinine 8·8-35·4 μmol/L (0·1-0·4 mg/dL); radiographic evidence of rickets (at least five participants were required to have a Thacher Rickets Severity Score of ≥1·5 at the knee); and a confirmed PHEX mutation or a variant of unknown significance in the patient or direct relative also affected with X-linked hypophosphataemia', 'children aged 5-12 years with X-linked hypophosphataemia', 'children aged 1-4 years with X-linked hypophosphataemia', 'young children with X-linked hypophosphataemia', 'Between May 16, 2016, and June 10, 2016, we enrolled 13 children with X-linked hypophosphataemia', 'younger children with X-linked hypophosphataemia', 'three hospitals in the USA, children (aged 1-4 years) with X-linked hypophosphataemia received']","['Conventional therapy', 'burosumab (0·8 mg/kg) via subcutaneous injection']","['safety and efficacy', 'rickets severity', 'Total Thacher Rickets Severity Score', 'serum phosphorus', 'adverse events, mostly injection site reactions', 'safety and change from baseline to week 40 in fasting serum phosphorus concentrations', 'Mean length or standing height Z score', 'Radiographic Global Impression of Change score', 'Efficacy and safety', 'phosphate homoeostasis and rickets', 'Thacher Rickets Severity Score and an adaptation of the Radiographic Global Impression of Change), and recumbent length or standing height', 'serum phosphorus concentrations', 'Serum phosphorus least squares mean increase']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C3540852', 'cui_str': 'Hypophosphatemia, X-Linked'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4301607', 'cui_str': 'burosumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0424645', 'cui_str': 'Standing height (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",13.0,0.0772633,Total Thacher Rickets Severity Score decreased by a least squares mean of -1·7 (SE 0·1; p<0·0001) from baseline to week 40 and by -2·0 (SE 0·1; p<0·0001) by week 64.,"[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Whyte', 'Affiliation': 'Shriners Hospital for Children, St Louis, MO, USA. Electronic address: mwhyte@shrinenet.org.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Carpenter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Gottesman', 'Affiliation': 'Shriners Hospital for Children, St Louis, MO, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Skrinar', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'San Martin', 'Affiliation': 'Ultragenyx Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(18)30338-3']
1489,31829170,Benefits of ultra-fast-track anesthesia for children with congenital heart disease undergoing cardiac surgery.,"BACKGROUND


To compare the outcomes of ultra-fast-track anesthesia (UFTA) and conventional anesthesia in cardiac surgery for children with congenital heart disease (CHD) and low birth weight.
METHODS


One hundred and ninety-four CHD children, aged 6 months to 2 years, weighting 5 to 10 kg, were selected for this study. The 94 boys and 100 girls with the American Society of Anesthesiologists (ASA) physical status III and IV were randomly divided into two groups each consisting of 97 patients, and were subjected to ultra-fast-track and conventional anesthesia for cardiac surgery. For children in UFTA group, sevoflurane was stopped when cardiopulmonary bypass (CPB) started and cis-atracurium was stopped at the beginning of rewarming, and remifentanil (0.3 μg/kg/mim) was then infused. Propofol and remifentanil were discontinued at skin closure. 10 min after surgery, extubation was performed in operating room. For children in conventional anesthesia group, anesthesia was given routinely and they were directly sent to ICU with a tracheal tube. Extubation time, ICU stay and hospital stay after operation were recorded. Sedation-agitation scores (SAS) were assessed and adverse reactions as well as other anesthesia -related events were recorded.
RESULTS


The extubation time, ICU stay and hospital stay were significantly shorter in UFTA group (P < 0.05) and SAS at extubation was lower in UFTA group than in conventional anesthesia group, but similar in other time points. For both groups, no airway obstruction and other serious complications occurred, and incidence of other anesthesia -related events were low.
CONCLUSIONS


UFTA shortens extubation time, ICU stay and hospital stay for children with CHD and does not increase SAS and incidence of adverse reactions.",2019,"The extubation time, ICU stay and hospital stay were significantly shorter in UFTA group (P < 0.05) and SAS at extubation was lower in UFTA group than in conventional anesthesia group, but similar in other time points.","['94 boys and 100 girls with the American Society of Anesthesiologists (ASA) physical status III and IV', 'One hundred and ninety-four CHD children, aged 6\u2009months to 2\u2009years, weighting 5 to 10\u2009kg', 'children with congenital heart disease (CHD) and low birth weight', 'children with CHD', 'children with congenital heart disease undergoing cardiac surgery']","['ultra-fast-track and conventional anesthesia for cardiac surgery', 'ultra-fast-track anesthesia (UFTA) and conventional anesthesia', 'remifentanil', 'sevoflurane', 'ultra-fast-track anesthesia', 'Propofol and remifentanil']","['Sedation-agitation scores (SAS', 'extubation time, ICU stay and hospital stay', 'Extubation time, ICU stay and hospital stay after operation', 'SAS and incidence of adverse reactions', 'SAS at extubation', 'no airway obstruction and other serious complications']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",194.0,0.0318834,"The extubation time, ICU stay and hospital stay were significantly shorter in UFTA group (P < 0.05) and SAS at extubation was lower in UFTA group than in conventional anesthesia group, but similar in other time points.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China.'}, {'ForeName': 'Yanpei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China. yanpei508@163.com.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China Emergency General Hospital, 29 Liufangnanli Rd, Beijing, 100028, China. lina13120@163.com.'}]",BMC pediatrics,['10.1186/s12887-019-1832-9']
1490,30982716,Quality of Life and Pain Medication Use in Persons With Advanced Dementia Living in Long-Term Care Facilities.,"OBJECTIVES


In residents with dementia living in a long-term care facility (LTCF), un(der)treated pain may trigger behavioral disturbances, mood syndromes, and deterioration of physical functioning and self-maintenance. Because these factors can have considerable impact on the quality of life (QoL), this study aimed to (1) compare characteristics of persons with advanced dementia living in LTCFs with and without pain medication; (2) compare QoL in these persons with and without pain, stratified by type of pain medication use; and (3) explore associations between the use of paracetamol and QoL in persons with advanced dementia living in LTCFs.
DESIGN AND SETTING


This study analyzed baseline data from the Communication, Systematic Assessment and Treatment of Pain, Medication Review, Occupational Therapy, and Safety Study; a multicenter, cluster-randomized effectiveness-implementation clinical hybrid trial in 67 Norwegian LTCF clusters.
PARTICIPANTS


In total, 407 LTCF residents (rural and urban areas) aged ≥65 years, with Functional Assessment Staging scores of 5-7 (ie, moderate to advanced dementia).
MAIN OUTCOME MEASURE


QoL as assessed by the 6 QUALIDEM (validated questionnaire to measure QoL in persons with dementia living in LTCF) domains applicable to persons with moderate to severe dementia. The association between QoL and paracetamol was estimated using linear mixed-effect models, adjusting for confounding variables.
RESULTS


62.0% used pain medication (paracetamol, opioids, or both). QoL was lower in residents using pain medication, compared with those without pain medication [mean QUALIDEM score 68.8 (standard deviation 17.4 vs) 75.5 (standard deviation 14.6), respectively, P < .001). Multilevel analysis showed that paracetamol use was not associated with QoL.
CONCLUSIONS AND IMPLICATIONS


Persons with advanced dementia living in LTCF using pain medication have a lower QoL compared with those not using pain medication. These results are of key importance for the clinician because they stress the need for regular medication review and pain management. When measured cross-sectionally, use of paracetamol is not associated with increased QoL.",2019,"QoL was lower in residents using pain medication, compared with those without pain medication [mean QUALIDEM score 68.8 (standard deviation 17.4 vs) 75.5 (standard deviation 14.6), respectively, P < .001).","['Persons With Advanced Dementia Living in Long-Term Care Facilities', 'persons with advanced dementia living in LTCFs with and without pain medication', 'persons with advanced dementia living in LTCFs', '407 LTCF residents (rural and urban areas) aged ≥65\xa0years, with Functional Assessment Staging scores of 5-7 (ie, moderate to advanced dementia', '67 Norwegian LTCF clusters', 'residents with dementia living in a long-term care facility (LTCF', 'Persons with advanced dementia living in LTCF using pain medication']","['paracetamol and QoL', 'paracetamol']","['QoL', 'pain medication (paracetamol, opioids, or both', 'Quality of Life and Pain Medication Use', 'quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0034380'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",407.0,0.0409399,"QoL was lower in residents using pain medication, compared with those without pain medication [mean QUALIDEM score 68.8 (standard deviation 17.4 vs) 75.5 (standard deviation 14.6), respectively, P < .001).","[{'ForeName': 'Paulien H', 'Initials': 'PH', 'LastName': 'van Dam', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, the Netherlands. Electronic address: P.H.van_Dam@lumc.nl.'}, {'ForeName': 'Monique A A', 'Initials': 'MAA', 'LastName': 'Caljouw', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Dagrun D', 'Initials': 'DD', 'LastName': 'Slettebø', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, the Netherlands; Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bettina S', 'Initials': 'BS', 'LastName': 'Husebo', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Bergen, Norway; Municipality of Bergen, Bergen, Norway.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.02.019']
1491,30523758,Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2.,"PURPOSE


Gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA) significantly improved survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and a Karnofsky performance status (PS) of 70% or greater. Because of the low number of patients with reduced PS, the efficacy of this regimen in fragile patients remains unclear. This study aimed to evaluate the efficacy and tolerability of different GA dosing regimens in patients with a poor PS.
PATIENTS AND METHODS


In the phase I part of this study, patients were randomly assigned to one of the following four parallel GA treatment arms (six patients per arm): a biweekly schedule of NAB-paclitaxel (150 mg/m 2  [arm A] or 125 mg/m 2  [arm C]) plus gemcitabine 1,000 mg/m 2  or a standard schedule of 3 weeks on and 1 week off of NAB-paclitaxel (100 mg/m 2  [arm B] or 125 mg/m 2  [arm D]) plus gemcitabine 1,000 mg/m 2 . The two regimens with the better tolerability profile on the basis of predefined criteria were evaluated in the phase II part of the study, the primary end point of which was 6-month actuarial survival.
RESULTS


Arms B and D were selected for the phase II part of the study. A total of 221 patients (111 patients in arm B and 110 patients in arm D) were enrolled. Baseline characteristics including median age (71 and 68 years in arms B and D, respectively), sex (51% and 55% men in arms B and D, respectively), and metastatic disease (88% and 84% in arms B and D, respectively) were comparable between arms. The most frequent grade 3 or 4 toxicities in arms B and D were anemia (12% and 7%, respectively), neutropenia (32% and 30%, respectively), thrombocytopenia (7% and 11%, respectively), asthenia (14% and 16%, respectively), and neurotoxicity (11% and 16%, respectively). In arms B and D, there were no significant differences in response rate (24% and 28%, respectively), median progression-free survival (5.7 and 6.7 months, respectively), and 6-month overall survival (63% and 69%, respectively).
CONCLUSION


NAB-paclitaxel administered at either 100 and 125 mg/m 2  in combination with gemcitabine on days 1, 8, and 15 every 28 days is well tolerated and results in acceptable safety and efficacy in patients with metastatic pancreatic ductal adenocarcinoma and a poor PS.",2019,"In arms B and D, there were no significant differences in response rate (24% and 28%, respectively), median progression-free survival (5.7 and 6.7 months, respectively), and 6-month overall survival (63% and 69%, respectively).
","['221 patients (111 patients in arm B and 110 patients in arm D) were enrolled', 'patients with metastatic pancreatic ductal adenocarcinoma and a poor PS', 'patients with a poor PS', 'patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and a Karnofsky performance status (PS) of 70% or greater', 'Patients With Pancreatic Cancer and an ECOG Performance Status of 2']","['gemcitabine', 'Nanoparticle Albumin-Bound Paclitaxel', 'Gemcitabine', 'Gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA', 'NAB-paclitaxel', 'gemcitabine alone']","['survival', '6-month actuarial survival', 'metastatic disease', '6-month overall survival', 'median progression-free survival', 'efficacy and tolerability', 'acceptable safety and efficacy', 'neutropenia', 'neurotoxicity', 'toxicities', 'anemia', 'asthenia', 'response rate', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",221.0,0.0317709,"In arms B and D, there were no significant differences in response rate (24% and 28%, respectively), median progression-free survival (5.7 and 6.7 months, respectively), and 6-month overall survival (63% and 69%, respectively).
","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""1 Vall d'Hebrón University Hospital and Vall d'Hebrón Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pazo-Cid', 'Affiliation': '2 Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén-Ponce', 'Affiliation': '3 Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': '4 Hospital Clínico de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Vera', 'Affiliation': '5 Hospital de Navarra, Pamplona, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Reboredo', 'Affiliation': '6 Hospital Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Muñoz Martin', 'Affiliation': '7 Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': '8 Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Díaz Beveridge', 'Affiliation': '9 Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'La Casta', 'Affiliation': '10 Hospital Universitario Donostia, Donostia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Martín Valadés', 'Affiliation': '11 Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Joaquina', 'Initials': 'J', 'LastName': 'Martínez-Galán', 'Affiliation': '12 Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Immaculada', 'Initials': 'I', 'LastName': 'Ales', 'Affiliation': '13 Hospital Universitario Carlos Haya, Málaga, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': '14 Hospital Clínico Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Perea', 'Affiliation': '15 Centro Nacional de Investigaciones Oncológicas and Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hidalgo', 'Affiliation': '15 Centro Nacional de Investigaciones Oncológicas and Centro Integral Oncológico Clara Campal, Madrid, Spain.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00089']
1492,30429580,Correction: A pilot randomised blinded placebo-controlled trial of paracetamol for later treatment of a patent ductus arteriosus.,In the published version of this paper the author Yan Chen was missed out of the author list. This has now been corrected in the HTML and PDF versions of the paper.,2019,This has now been corrected in the HTML and PDF versions of the paper.,['later treatment of a patent ductus arteriosus'],"['Correction', 'placebo', 'paracetamol']",[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",[],,0.0521726,This has now been corrected in the HTML and PDF versions of the paper.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kluckow', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia. martin.kluckow@sydney.edu.au.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Carlisle', 'Affiliation': 'The Canberra Hospital, Canberra, ACT, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Broom', 'Affiliation': 'The Canberra Hospital, Canberra, ACT, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Woods', 'Affiliation': 'Royal Prince Alfred Women and Babies Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Jeffery', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Desai', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Evans', 'Affiliation': 'Royal Prince Alfred Women and Babies Hospital and University of Sydney, Sydney, NSW, Australia.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-018-0265-x']
1493,30624767,Comparison of Cognitive Impairments After Intensive Care Unit Sedation Using Dexmedetomidine and Propofol Among Older Patients.,"Despite the high prevalence of cognitive impairment among older adults, little is known about the association of the selection of dexmedetomidine and propofol on cognitive functions of patients after a critical illness. Patients aged ≥70 years who received intensive care unit (ICU) care from Cangzhou Central Hospital between 2013 and 2016 were enrolled and randomized into a dexmedetomidine group and a propofol group with matched demographic and clinical characteristics. At discharge from the ICU and 4 weeks later, the cognitive status of patients was assessed and compared using the Montreal Cognitive Assessment system. There were 164 patients included in the dexmedetomidine group and 159 patients in the propofol group. No significant difference was observed between the 2 groups in terms of age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications. Further, patients from the 2 groups at ICU discharge did not demonstrate significant difference on the Montreal Cognitive Assessment component scores, which showed significant differences between the 2 groups 4 weeks later (P < .05). Moreover, dexmedetomidine and propofol showed different levels of impacts on the cognitive function of patients discharged from the postanesthesia care unit, neurological ICU, and medical ICU. This study demonstrated that patients discharged from the ICU who received propofol for sedation showed less impairment on the cognitive functions when compared with patients who received dexmedetomidine during ICU care 4 weeks after discharge. Despite some limitations, this study provides insights to the decision-making process in the selection of appropriate sedation strategy, especially for the elderly patients.",2019,"No significant difference was observed between the 2 groups in terms of age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications.","['Older Patients', 'older adults', 'Patients aged ≥70 years who received intensive care unit (ICU) care from Cangzhou Central Hospital between 2013 and 2016', '164 patients included in the dexmedetomidine group and 159 patients in the propofol group', 'elderly patients']","['dexmedetomidine', 'dexmedetomidine and propofol', 'propofol', 'Dexmedetomidine and Propofol']","['cognitive functions', 'cognitive function', 'age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications', 'Cognitive Impairments', 'Montreal Cognitive Assessment component scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3496286'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.015223,"No significant difference was observed between the 2 groups in terms of age, female sex, body weight, educational level, ICU and hospital stay, comorbidities, and medications.","[{'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Cangzhou Central Hospital, Hebei, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Cangzhou Prison, Hebei, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Internal Medicine, Cangzhou Central Hospital, Hebei, China.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Internal Medicine, Cangzhou People's Hospital, China.""}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Internal Medicine, Cangzhou Central Hospital, Hebei, China.'}]",Journal of clinical pharmacology,['10.1002/jcph.1372']
1494,30633369,Characterization of the Effect of Renal Impairment on Upadacitinib Pharmacokinetics.,"Upadacitinib is a novel selective Janus kinase 1 inhibitor developed for treatment of rheumatoid arthritis and other autoimmune diseases. The objective of this study was to assess the pharmacokinetics and safety of a single upadacitinib dose in subjects with normal renal function and in subjects with renal impairment. A total of 24 subjects between the ages of 18 and 75 years were assigned to 1 of 4 renal function groups based on estimated glomerular filtration rate (normal, mild, moderate, severe; N = 6/group). A single 15-mg dose of upadacitinib extended-release formulation was administered under fasting conditions. Serial plasma and urine samples were assayed to evaluate the effect of renal impairment on upadacitinib exposure through regression analysis and analysis of covariance. The primary analysis was the regression analysis of upadacitinib exposures versus estimated glomerular filtration rate. The point estimates for upadacitinib plasma exposure ratios (90% confidence interval [CI]) in subjects with mild, moderate, and severe renal impairment were 1.18 (90%CI, 1.06-1.32), 1.33 (90%CI, 1.11-1.59), and 1.44 (90%CI, 1.14-1.82) for area under the plasma concentration-time curve and 1.06 (90%CI, 0.92-1.23), 1.11 (90%CI, 0.88-1.40), and 1.14 (90%CI, 0.84-1.56) for maximum observed plasma concentration, respectively, relative to subjects with normal renal function based on the regression analysis. The analysis of covariance categorical analysis provided consistent results. Upadacitinib was well tolerated by all subjects, and no safety issues were identified in subjects with renal impairment. Renal impairment has a limited effect on upadacitinib pharmacokinetics. This is in agreement with the known limited role of urinary excretion in upadacitinib elimination. Based on the limited impact on exposure, no dose adjustment is necessary for upadacitinib in subjects with impaired renal function.",2019,Upadacitinib is a novel selective Janus kinase 1 inhibitor developed for treatment of rheumatoid arthritis and other autoimmune diseases.,"['subjects with normal renal function and in subjects with renal impairment', 'subjects with impaired renal function', '24 subjects between the ages of 18 and 75 years', 'subjects with renal impairment']",[],"['upadacitinib plasma exposure ratios', 'severe renal impairment', 'pharmacokinetics and safety', 'glomerular filtration rate', 'plasma concentration-time curve']","[{'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",24.0,0.0874002,Upadacitinib is a novel selective Janus kinase 1 inhibitor developed for treatment of rheumatoid arthritis and other autoimmune diseases.,"[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Trueman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Department of Statistics, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Immunology Development, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Marbury', 'Affiliation': 'Orlando Clinical Research Center, Orlando, FL, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1375']
1495,30082845,Correction: Different enteral nutrition formulas have no effect on glucose homeostasis but on diet-induced thermogenesis in critically ill medical patients: a randomized controlled trial.,"After publication, the author noticed that Table 2 was incorrectly formatted for the final PDF despite being correct in earlier proofs. The table was correct in the HTML version of the article. The EJCN apologizes for the inadvertent error in the formatting of Table 2. The corrected version is uploaded and should be read in conjunction with the original paper. Any inconvenience to the author and readership is regretted.",2019,Any inconvenience to the author and readership is regretted.,['critically ill medical patients'],['Correction'],['glucose homeostasis'],"[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]",,0.0312782,Any inconvenience to the author and readership is regretted.,"[{'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Wewalka', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria. marlene.wewalka@meduniwien.ac.at.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Drolz', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Seeland', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Schneeweiss', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Schmid', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Internal Medicine, LKH Kirchdorf, Hausmanningerstrasse 8, 4560, Kirchdorf, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zauner', 'Affiliation': 'Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Intensive Care Unit, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0269-9']
1496,30617276,"Correction: Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).",Supplementary Figure 1 and Supplementary Tables 1-4 have been re-uploaded so as to reflect the versions supplied during proofs stage. The publisher apologizes for the error in versioning. The HTML version of the paper has been updated.,2019,The publisher apologizes for the error in versioning.,['treatment-resistant depression (TRD'],"['ketamine', 'placebo']",[],"[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.237743,The publisher apologizes for the error in versioning.,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0311-2']
1497,30629148,"First-in-human, Randomized, Double-blind Clinical Trial of Differentially Adjuvanted PAMVAC, A Vaccine Candidate to Prevent Pregnancy-associated Malaria.","BACKGROUND


Malaria in pregnancy has major impacts on mother and child health. To complement existing interventions, such as intermittent preventive treatment and use of impregnated bed nets, we developed a malaria vaccine candidate with the aim of reducing sequestration of asexual ""blood-stage"" parasites in the placenta, the major virulence mechanism.
METHODS


The vaccine candidate PAMVAC is based on a recombinant fragment of VAR2CSA, the Plasmodium falciparum protein responsible for binding to the placenta via chondroitin sulfate A (CSA). Healthy, adult malaria-naive volunteers were immunized with 3 intramuscular injections of 20 μg (n = 9) or 50 μg (n = 27) PAMVAC, adjuvanted with Alhydrogel or glucopyranosyl lipid adjuvant in stable emulsion (GLA-SE) or in a liposomal formulation with QS21 (GLA-LSQ). Allocation was random and double blind. The vaccine was given every 4 weeks. Volunteers were observed for 6 months following last immunization.
RESULTS


All PAMVAC formulations were safe and well tolerated. A total of 262 adverse events (AEs) occurred, 94 (10 grade 2 and 2 grade 3) at least possibly related to the vaccine. No serious AEs occurred. Distribution and severity of AEs were similar in all arms. PAMVAC was immunogenic in all participants. PAMVAC-specific antibody levels were highest with PAMVAC-GLA-SE. The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.
CONCLUSIONS


PAMVAC formulated with Alhydrogel or GLA-based adjuvants was safe, well tolerated, and induced functionally active antibodies. Next, PAMVAC will be assessed in women before first pregnancies in an endemic area.
CLINICAL TRIALS REGISTRATION


EudraCT 2015-001827-21; ClinicalTrials.gov NCT02647489.",2019,"The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.
","['women before first pregnancies in an endemic area', 'Healthy, adult malaria-naive volunteers were immunized with three intramuscular injections of 20 μg (n=9) or 50 μg (n=27']","['PAMVAC, adjuvanted either with Alhydrogel, or with Glucopyranosyl Lipid Adjuvant in stable emulsion (GLA-SE', 'liposomal formulation with QS21 (GLA-LSQ', 'PAMVAC']","['safe and well tolerated', 'Distribution and severity of AE', 'PAMVAC-specific antibody levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}]","[{'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0211668', 'cui_str': 'QS-21'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1277793', 'cui_str': 'Specific antibody measurement'}]",,0.28677,"The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Mihály', 'Initials': 'M', 'LastName': 'Sulyok', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Egger-Adam', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Resende', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'de Jongh', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Mette H', 'Initials': 'MH', 'LastName': 'Jensen', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Helle Holm', 'Initials': 'HH', 'LastName': 'Smedegaard', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Sisse B', 'Initials': 'SB', 'LastName': 'Ditlev', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Soegaard', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Poulsen', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Dyring', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Carlos Lamsfus', 'Initials': 'CL', 'LastName': 'Calle', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Knoblich', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Deloron', 'Affiliation': 'Mère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.'}, {'ForeName': 'Nicaise', 'Initials': 'N', 'LastName': 'Ndam', 'Affiliation': 'Mère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique and Institut de Recherche Clinique du Bénin, Cotonou.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Houard', 'Affiliation': 'European Vaccine Initiative, Heidelberg, Germany.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': 'Howard', 'Affiliation': 'Infectious Disease Research Institute, Seattle, Washington.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Reed', 'Affiliation': 'Infectious Disease Research Institute, Seattle, Washington.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Leroy', 'Affiliation': 'European Vaccine Initiative, Heidelberg, Germany.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': 'Mère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.'}, {'ForeName': 'Thor G', 'Initials': 'TG', 'LastName': 'Theander', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salanti', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Nielsen', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1140']
1498,30562305,Changes in Unilateral Upper Limb Muscular Strength and Electromyographic Activity After a 16-Week Strength Training Intervention in Survivors of Breast Cancer.,"Hagstrom, AD, Shorter, KA, and Marshall, PWM. Changes in unilateral upper limb muscular strength and Electroymographic activity after a 16-week strength training intervention in survivors of breast cancer. J Strength Cond Res 33(1): 225-233, 2019-Upper limb strength deficits are frequently observed following breast cancer (BC) and its treatments. It is currently unknown whether these unilateral deficits can be corrected by a standard bilateral strength training intervention. Twenty-three survivors of BC were included in this analysis. Fourteen performed a 16-week resistance training (RT) intervention, 9 were assigned to a usual care waitlist control group. Electromyographic analysis of the pectoralis major and triceps brachii were monitored during 3 maximal isometric contractions and a fatiguing endurance task. Muscular strength was significantly different between limbs at the start of the intervention (p = 0.02). Electromyographic amplitude and median frequency did not differ between limbs at the start of the intervention. Muscular strength was significantly different between limbs in the RT group at the end of the intervention (p = 0.01). Electromyographic amplitude did not differ between limbs or groups at the end of the intervention. Bilateral strength training did not correct the unilateral strength deficit observed in this group of survivors of breast cancer. Periods of unilateral strength training should be implemented into periodized RT programs in this cohort.",2019,Muscular strength was significantly different between limbs in the RT group at the end of the intervention (p = 0.01).,"['Twenty-three survivors of BC', 'survivors of breast cancer', 'Survivors of Breast Cancer']","['Bilateral strength training', '16-week resistance training (RT) intervention', 'strength training intervention', 'unilateral strength training', '16-Week Strength Training Intervention', 'usual care waitlist control group']","['Unilateral Upper Limb Muscular Strength and Electromyographic Activity', 'Muscular strength', 'unilateral strength deficit', 'Electromyographic amplitude and median frequency', 'unilateral upper limb muscular strength and Electroymographic activity', 'Electromyographic amplitude', 'Hagstrom, AD, Shorter, KA, and Marshall, PWM']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032350', 'cui_str': 'Pokeweed Lectins'}]",,0.0107563,Muscular strength was significantly different between limbs in the RT group at the end of the intervention (p = 0.01).,"[{'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Hagstrom', 'Affiliation': 'School of Science and Technology, Department of Sport and Exercise Science University of New England, Armidale, Australia.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Shorter', 'Affiliation': 'School of Science and Technology, Department of Sport and Exercise Science University of New England, Armidale, Australia.'}, {'ForeName': 'Paul W M', 'Initials': 'PWM', 'LastName': 'Marshall', 'Affiliation': 'School of Science and Health, Department of Sport and Exercise Science Western Sydney University, Campbelltown, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000001890']
1499,30604663,"Participation in structured programming may prevent unhealthy weight gain during the summer in school-aged children from low-income neighbourhoods: feasibility, fidelity and preliminary efficacy findings from the Camp NERF study.","OBJECTIVE


Evaluate the feasibility, fidelity and preliminary efficacy of Camp NERF to prevent unhealthy weight gain and promote healthy behaviours in children during the summer.
DESIGN


Camp NERF was an 8-week, multicomponent, theory-based programme coupled with the US Department of Agriculture's Summer Food Service Program. Twelve eligible elementary-school sites were randomized to one of three treatment groups: (i) Active Control (non-nutrition, -physical activity (PA), -mental health); (ii) Standard Care (nutrition and PA); or (iii) Enhanced Care (nutrition and PA, plus cognitive behavioural techniques) programming. Efficacy was determined by assessing mean change by group in child outcomes using hierarchical linear regression models.
SETTING


Low-income, urban neighbourhoods in Columbus, OH, USA.ParticipantsEconomically disadvantaged, racial minority children of elementary school age (kindergarten-5th grade).
RESULTS


Eighty-seven child-caregiver dyads consented; eighty-one completed pre- and post-intervention assessments resulting in a 93·10 % retention rate. Delivery of the intended lesson occurred 79-90 % of the time. Of the children, 56·98 % (n 49) were female; 89·53 % (n 77) were Black. Overall mean change in BMI Z-score from baseline to post-intervention was -0·03 (se 0·05); change in BMI Z-score did not differ significantly between treatment group. Change in nutrition, PA, mental health or psychosocial outcomes did not differ between groups.
CONCLUSIONS


Results from the current study demonstrate feasibility and fidelity, yet no intervention effect of Camp NERF. Instead, findings suggest that participation in structured programming of any type (health behaviour-related or not) may prevent unhealthy summer weight gain. Additional studies are needed to confirm findings. Results have implications for child nutrition policy addressing the issue of summer health.",2019,"Change in nutrition, PA, mental health or psychosocial outcomes did not differ between groups.
","['Of the children, 56·98 % (n 49) were female; 89·53 % (n 77) were Black', 'Eighty-seven child-caregiver dyads consented; eighty-one completed pre- and post-intervention assessments resulting in a 93·10 % retention rate', 'Twelve eligible elementary-school sites', 'Low-income, urban neighbourhoods in Columbus', 'children during the summer', 'racial minority children of elementary school age (kindergarten-5th grade', 'school-aged children from low-income neighbourhoods']","['Camp NERF', '0·03 (se 0·05', 'Active Control (non-nutrition, -physical activity (PA), -mental health); (ii) Standard Care (nutrition and PA); or (iii) Enhanced Care (nutrition and PA, plus cognitive behavioural techniques) programming']","['Efficacy', 'unhealthy weight gain', 'Change in nutrition, PA, mental health or psychosocial outcomes', 'BMI Z-score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",49.0,0.0590309,"Change in nutrition, PA, mental health or psychosocial outcomes did not differ between groups.
","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hopkins', 'Affiliation': '1Department of Human Sciences,The Ohio State University,313 Campbell Hall,1787 Neil Avenue,Columbus,OH 43210,USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Holloman', 'Affiliation': '3Department of Statistics,The Ohio State University,Columbus,OH,USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Melnyk', 'Affiliation': '4College of Nursing,The Ohio State University,Columbus,OH,USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fristad', 'Affiliation': '5Department of Psychiatry and Behavioral Health,The Ohio State University,Columbus,OH,USA.'}, {'ForeName': 'Jacqueline D', 'Initials': 'JD', 'LastName': 'Goodway', 'Affiliation': '1Department of Human Sciences,The Ohio State University,313 Campbell Hall,1787 Neil Avenue,Columbus,OH 43210,USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Kennel', 'Affiliation': '1Department of Human Sciences,The Ohio State University,313 Campbell Hall,1787 Neil Avenue,Columbus,OH 43210,USA.'}, {'ForeName': 'Ihuoma', 'Initials': 'I', 'LastName': 'Eneli', 'Affiliation': ""6Nationwide Children's Hospital Center for Healthy Weight and Nutrition,Columbus,OH,USA.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gunther', 'Affiliation': '1Department of Human Sciences,The Ohio State University,313 Campbell Hall,1787 Neil Avenue,Columbus,OH 43210,USA.'}]",Public health nutrition,['10.1017/S1368980018003403']
1500,26002823,Antibiotics for acute laryngitis in adults.,"BACKGROUND


This is an update of the original review published in 2005. Acute laryngitis is a common illness worldwide. Diagnosis is often made by case history alone and treatment often targets symptoms.
OBJECTIVES


To assess the effectiveness and safety of different antibiotic therapies in adults with acute laryngitis. A secondary objective was to report the rates of adverse events associated with these treatments.
SEARCH METHODS


We searched CENTRAL (2014, Issue 11), MEDLINE (January 1966 to November week 3, 2014), EMBASE (1974 to December 2014), LILACS (1982 to December 2014) and BIOSIS (1980 to December 2014).
SELECTION CRITERIA


Randomised controlled trials (RCTs) comparing any antibiotic therapy with placebo for acute laryngitis. The main outcome was objective voice scores.
DATA COLLECTION AND ANALYSIS


Two review authors independently extracted and synthesised data.
MAIN RESULTS


We included three RCTs (351 participants) that had moderate to high risk of bias. The quality of the evidence was very low for all outcomes. We downgraded the studies because of limitations in study design or execution (risk of bias), imprecision and inconsistency of results. We included a new trial presented only as a conference abstract in this update.In one study of acute laryngitis in adults, 100 participants were randomised to receive penicillin V (800 mg twice daily for five days) or an identical placebo. A recording of each patient reading a standardised text was made at the first visit, during re-examination after one and two weeks, and at follow-up after two to six months. No significant differences were found between the groups. The trial also measured symptoms reported by participants and found no significant differences.One study investigated erythromycin for acute laryngitis in 106 adults. The mean objective voice scores measured at the first visit, at re-examination after one and two weeks, and at follow-up after two to six months did not significantly differ between the groups. At one week there were significant beneficial differences in the severity of reported vocal symptoms (slight, moderate and severe) as judged by participants (P value = 0.042). However, the rates of participants having improved voice disturbance (subjective symptoms) at one and two weeks were not significantly different among groups. Comparing erythromycin and placebo groups on the rate of persistence of cough at two weeks, the risk ratio (RR) was 0.38 (95% confidence interval (CI) 0.15 to 0.97, P value = 0.04) and the number needed to treat for an additional beneficial outcome (NNTB) was 5.87 (95% CI 3.09 to 65.55). We calculated a RR of 0.64 (95% CI 0.46 to 0.90, P value = 0.034) and a NNTB of 3.76 (95% CI 2.27 to 13.52; P value = 0.01) for the subjective voice scores at one week.A third trial from Russia included 145 patients with acute laryngitis symptoms. Participants were randomised to three treatment groups: Group 1: seven-day course of fusafungine (six times a day by inhalation); Group 2: seven-day course of fusafungine (six times a day by inhalation) plus clarithromycin (250 mg twice daily for seven days); Group 3: no treatment. Clinical cure rates were measured at days 5 ± 1, 8 ± 1 and 28 ± 2. The authors reported significant differences in the rates of clinical cure at day 5 ± 1 favouring fusafungine (one trial; 93 participants; RR 1.50, 95% CI 1.02 to 2.20; P value = 0.04) and fusafungine plus clarithromycin (one trial 97 participants; RR 1.47, 95% CI 1.00 to 2.16; P value = 0.05) when compared to no treatment. However, no significant differences were found at days 8 ± 1 and 28 ± 2. Also, no significant differences were found when comparing fusafungine to fusafungine plus clarithromycin at days 5 ± 1, 8 ± 1 and 28 ± 2.
AUTHORS' CONCLUSIONS


Antibiotics do not appear to be effective in treating acute laryngitis when assessing objective outcomes. They appear to be beneficial for some subjective outcomes. Erythromycin could reduce voice disturbance at one week and cough at two weeks when measured subjectively. Fusafungine could increase the cure rate at day five. The included RCTs had important methodological problems and these modest benefits from antibiotics may not outweigh their cost, adverse effects or negative consequences for antibiotic resistance patterns.",2015,"However, the rates of participants having improved voice disturbance (subjective symptoms) at one and two weeks were not significantly different among groups.","['January 1966 to November week 3, 2014), EMBASE (1974 to December 2014), LILACS (1982 to December 2014) and BIOSIS (1980 to December 2014', 'adults with acute laryngitis', 'acute laryngitis in adults', 'acute laryngitis in adults, 100 participants', '106 adults', '145 patients with acute laryngitis symptoms', '351 participants) that had moderate to high risk of bias']","['fusafungine (six times a day by inhalation); Group 2: seven-day course of fusafungine (six times a day by inhalation) plus clarithromycin', 'penicillin V', 'antibiotic therapies', 'placebo', 'clarithromycin', 'Fusafungine', 'Erythromycin', 'erythromycin', 'erythromycin and placebo', 'RCTs']","['Clinical cure rates', 'severity of reported vocal symptoms (slight, moderate and severe', 'voice disturbance', 'subjective voice scores', 'cure rate', 'mean objective voice scores', 'rates of adverse events', 'rate of persistence of cough', 'objective voice scores', 'rates of clinical cure', 'effectiveness and safety', 'voice disturbance (subjective symptoms', 'number needed to treat for an additional beneficial outcome (NNTB', 'risk ratio (RR']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0456588', 'cui_str': '1974 (qualifier value)'}, {'cui': 'C0456590', 'cui_str': '1982 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001327', 'cui_str': 'Acute laryngitis (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0060879', 'cui_str': 'fusafungin'}, {'cui': 'C0585293', 'cui_str': 'Six times daily (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0030840', 'cui_str': 'phenoxymethylpenicillin'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1527340', 'cui_str': 'Voice Disturbance'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",145.0,0.372394,"However, the rates of participants having improved voice disturbance (subjective symptoms) at one and two weeks were not significantly different among groups.","[{'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Reveiz', 'Affiliation': 'Free time independent Cochrane reviewer, Potomac, MD, USA.'}, {'ForeName': 'Andrés Felipe', 'Initials': 'AF', 'LastName': 'Cardona', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004783.pub5']
1501,30601990,Dental arch effects after early and later timed cervical headgear treatment-a randomized controlled trial.,"BACKGROUND


Cervical headgear (CH) is a commonly used orthodontic appliance and its dentoalveolar changes are known. However, the effects related to gender and timing have gained less attention.
OBJECTIVES


To examine dimensions of dental arches among children with Class II occlusion without posterior mandibular rotation according to timing of Kloehn-type CH treatment.
TRIAL DESIGN


Prospective, randomized, parallel-group controlled trial.
METHODS


Sixty-seven seven-year-old children with a Class II occlusion were included in the study. The children were randomized into two equal-size groups in 1:1 ratio by sealed-envelope randomization. The early group (EG, n = 33) was treated between T0 and T1 (26 months), right after eruption of the first maxillary molars. The late group (LG, n = 34) was treated between T1 and T2 (24 months). The children were treated with CH until normal Class I occlusion on first molars was achieved. Impressions for dental casts were taken from all participants at T0, T1, and T2. Blinding was applicable for outcome assessors. Changes in dental cast measurements were compared between the groups and genders using t-test, Mann-Whitney U-test, and repeated measures analysis of variance.
RESULTS


Of the children, 56 completed the study. The maxillary arch length and the transversal changes between the upper canines and upper first molars were significantly increased in EG at T0-T1 (P < 0.001). At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males. No harms were encountered.
CONCLUSIONS


The male gender benefits most from early timing of the CH treatment, showing larger dimensions at the end of the follow-up. The results clearly indicated a wider and longer upper dental arch and spontaneous expansion of the lower dental arch after treatment.
CLINICAL REGISTRATION


NCT02010346.",2019,"At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males.","['children', 'children with Class II occlusion without posterior mandibular rotation according to timing of Kloehn-type CH treatment', 'Methods\n\n\nSixty-seven seven-year-old children with a Class II occlusion were included in the study']","['\n\n\nCervical headgear (CH', 'T0-T1', 'CH']","['wider and longer upper dental arch and spontaneous expansion', 'mandibular arch length', 'dental cast measurements', 'maxillary arch length and the transversal changes', 'transversal dimension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0231063', 'cui_str': 'First branchial arch structure'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",,0.0535027,"At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Julku', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hannula', 'Affiliation': 'Department of Oral Development and Orthodontics, Research Unit of Oral Health Sciences, University of Oulu, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pirilä-Parkkinen', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Tolvanen', 'Affiliation': 'Department of Community Dentistry, Institute of Dentistry, University of Turku, Finland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}]",European journal of orthodontics,['10.1093/ejo/cjy083']
1502,30590412,Switching From a Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen: A Randomized Clinical Trial to Determine the Effect on Peripheral Blood and Ileum Biopsies From Antiretroviral Therapy-suppressed Human Immunodeficiency Virus-infected Individuals.,"BACKGROUND


Optimization of combination antiretroviral therapy (cART) can impact the human immunodeficiency virus (HIV) reservoir. We evaluated the effect on the HIV reservoir in peripheral blood and ileum biopsies in patients switching from boosted protease inhibitor (PI/r)-based therapy to dolutegravir (DTG)-based therapy.
METHODS


Impact of Integrase-inhibitor DOlutegravir On the viral Reservoir (INDOOR) is a phase 4 open-label clinical trial that randomly included 42 HIV type 1-infected individuals on effective cART: 20 who switched from PI/r-based to DTG-based cART (switch group), and 22 who remained in PI/r-based regimens (control group). We analyzed blood and ileum biopsies to quantify episomal, total, and integrated HIV DNA, cell-associated HIV RNA, residual plasma viremia, T-cell subsets, cell activation, and inflammation markers.
RESULTS


There were no related adverse events or treatment discontinuations due to drug intolerance. The HIV reservoir was consistently larger in ileal than in peripheral CD4+ T cells in both groups (P < .01). Residual viremia in plasma decreased in the switch group (P = .03). However, we did not observe significant longitudinal changes in low-level viral replication, total and integrated HIV reservoir, HIV transcription, T-cell maturation subsets, immunoactivation markers, inflammatory soluble proteins, or cellular markers of latently infected cells.
CONCLUSIONS


The INDOOR study is the first evaluation of changes in HIV reservoir size in ileum biopsies and in peripheral blood in individuals switched from PI/r- to DTG-based cART. Although this switch was safe and well tolerated, it had no impact on a large array of immunological and inflammatory markers or on HIV reservoir markers in peripheral or in ileal CD4+ T cells.
CLINICAL TRIALS REGISTRATION


EudraCT 2014-004331-39.",2019,Residual viremia in plasma decreased in the switch group (p=0.03).,"['42 HIV-1-infected individuals on effective cART: 20 who switched from boosted PI-based to DTG-based cART (switch group), and 22 who remained in boosted PI-based regimens (control group', 'ART-suppressed HIV-infected individuals']","['EudraCT', 'protease inhibitor (PI)-based therapy to dolutegravir (DTG)-based therapy', 'combination antiretroviral therapy (cART']","['safe and well tolerated', 'Residual viremia in plasma', 'adverse events', 'low-level viral replication, total and integrated HIV reservoir, HIV transcription, T-cell maturation subsets, immunoactivation markers, inflammatory soluble proteins, or cellular markers of latently infected cells', 'blood and ileum biopsies to quantify episomal, total, and integrated HIV-DNA, cell-associated HIV-RNA, residual plasma viremia, T-cell subsets, cell activation, and inflammation markers']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442537', 'cui_str': 'Reservoir (environment)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005768'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure (body structure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C2362651', 'cui_str': 'T cell subsets'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",42.0,0.027668,Residual viremia in plasma decreased in the switch group (p=0.03).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Morón-López', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Rutsaert', 'Affiliation': 'Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Urrea', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Puertas', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Torrella', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Clercq', 'Affiliation': 'Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium.'}, {'ForeName': 'Bibiana Planas', 'Initials': 'BP', 'LastName': 'Ribas', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gálvez', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Salgado', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium.'}, {'ForeName': 'Julià', 'Initials': 'J', 'LastName': 'Blanco', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martinez-Picado', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1095']
1503,30581026,Optimal Position for Transnasal Flexible Laryngoscopy.,"OBJECTIVE


Transnasal flexible laryngoscopy (TFL) is a simple, safe, and cost-effective procedure. TFL is routinely performed to awake patients in a sitting position but there is no a definite data about ideal head and neck position to be applied. The aim of this study is to determine which position is most appropriate to obtain the best laryngeal view during the TFL.
METHODS


The TFL videos of 132 randomized patients were evaluated by three blind observers experienced with laryngology. Three basic head positions; simple head extension (SHE), sniffing position (SP), and neutral position (NP) were performed during the TFL-Interobserver agreements for the grading system scores were assessed by using the kappa (k) statistic.
RESULTS


For the SHE and SP, the numbers of patients constituting grade 1 were 127 (96.2%) and 126 (95.5%), respectively, while grade 2a were 5 (3.8%) and 6 (4.5%), respectively. In NP, the number of patients constituting grade 1 was 5 (3.8%), while grade 2a was 83 (62.9%), grade 2b was 37 (28%), and grade 3 was 7 (5.3%). The k score of the SHE was 0.826 (P < 0.001) between the ratings of observer 1 and observer 2, 0.905 (P < 0.001) between observer 1 and observer 3, and 0.919 (P < 0.001) between observer 2 and observer 3. These values denote nearly perfect agreement. A complete agreement was seen in 130 of the 132 (98.48%) videos.
CONCLUSION


SHE and SP both provide a better glottic view than the NP and demonstrate the same success.",2020,"The k score of the SHE was 0.826 (P < 0.001) between the ratings of observer 1 and observer 2, 0.905 (P < 0.001) between observer 1 and observer 3, and 0.919 (P < 0.001) between observer 2 and observer 3.",[],"['Transnasal flexible laryngoscopy (TFL', 'TFL']","['head extension (SHE), sniffing position (SP), and neutral position (NP', 'k score of the SHE']",[],"[{'cui': 'C0521131', 'cui_str': 'Transnasal approach (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1301705', 'cui_str': 'Sniffing position'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",132.0,0.0563219,"The k score of the SHE was 0.826 (P < 0.001) between the ratings of observer 1 and observer 2, 0.905 (P < 0.001) between observer 1 and observer 3, and 0.919 (P < 0.001) between observer 2 and observer 3.","[{'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Tasli', 'Affiliation': 'Birecik State Hospital, Department of Otolaryngology, Head and Neck Surgery, Sanliurfa, Turkey. Electronic address: hamditasli@gmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Birkent', 'Affiliation': 'Centrium Hospital, Department of Otolaryngology, Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Karakoc', 'Affiliation': 'Gulhane Medical School, Department of Otolaryngology, Head and Neck Surgery, Ankara, Turkey.'}, {'ForeName': 'Mert Cemal', 'Initials': 'MC', 'LastName': 'Gokgoz', 'Affiliation': 'Siirt State Hospital, Department of Otolaryngology, Head and Neck Surgery, Siirt, Turkey.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.11.006']
1504,25358904,Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology.,"BACKGROUND


Human chorionic gonadotropin (HCG) is routinely used for final oocyte maturation triggering in in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) cycles, but the use of HCG for this purpose may have drawbacks. Gonadotropin-releasing hormone (GnRH) agonists present an alternative to HCG in controlled ovarian hyperstimulation (COH) treatment regimens in which the cycle has been down-regulated with a GnRH antagonist. This is an update of a review first published in 2010.
OBJECTIVES


To evaluate the effectiveness and safety of GnRH agonists in comparison with HCG for triggering final oocyte maturation in IVF and ICSI for women undergoing COH in a GnRH antagonist protocol.
SEARCH METHODS


We searched databases including the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of Controlled Trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and trial registers for published and unpublished articles (in any language) on randomised controlled trials (RCTs) of gonadotropin-releasing hormone agonists versus HCG for oocyte triggering in GnRH antagonist IVF/ICSI treatment cycles. The search is current to 8 September 2014.
SELECTION CRITERIA


RCTs that compared the clinical outcomes of GnRH agonist triggers versus HCG for final oocyte maturation triggering in women undergoing GnRH antagonist IVF/ICSI treatment cycles were included.
DATA COLLECTION AND ANALYSIS


Two or more review authors independently selected studies, extracted data and assessed study risk of bias. Treatment effects were summarised using a fixed-effect model, and subgroup analyses were conducted to explore potential sources of heterogeneity. Treatment effects were expressed as mean differences (MDs) for continuous outcomes and as odds ratios (ORs) for dichotomous outcomes, together with 95% confidence intervals (CIs). Primary outcomes were live birth and rate of ovarian hyperstimulation syndrome (OHSS) per women randomised. Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods were used to assess the quality of the evidence for each comparison.
MAIN RESULTS


We included 17 RCTs (n = 1847), of which 13 studies assessed fresh autologous cycles and four studies assessed donor-recipient cycles. In fresh autologous cycles, GnRH agonists were associated with a lower live birth rate than was seen with HCG (OR 0.47, 95% CI 0.31 to 0.70; five RCTs, 532 women, I(2) = 56%, moderate-quality evidence). This suggests that for a woman with a 31% chance of achieving live birth with the use of HCG, the chance of a live birth with the use of an GnRH agonist would be between 12% and 24%.In women undergoing fresh autologous cycles, GnRH agonists were associated with a lower incidence of mild, moderate or severe OHSS than was HCG (OR 0.15, 95% CI 0.05 to 0.47; eight RCTs, 989 women, I² = 42%, moderate-quality evidence). This suggests that for a woman with a 5% risk of mild, moderate or severe OHSS with the use of HCG, the risk of OHSS with the use of a GnRH agonist would be between nil and 2%.In women undergoing fresh autologous cycles, GnRH agonists were associated with a lower ongoing pregnancy rate than was seen with HCG (OR 0.70, 95% CI 0.54 to 0.91; 11 studies, 1198 women, I(2) = 59%, low-quality evidence) and a higher early miscarriage rate (OR 1.74, 95% CI 1.10 to 2.75; 11 RCTs, 1198 women, I² = 1%, moderate-quality evidence). However, the effect was dependent on the type of luteal phase support provided (with or without luteinising hormone (LH) activity); the higher rate of pregnancies in the HCG group applied only to the group that received luteal phase support without LH activity (OR 0.36, 95% CI 0.21 to 0.62; I(2) = 73%, five RCTs, 370 women). No evidence was found of a difference between groups in risk of multiple pregnancy (OR 3.00, 95% CI 0.30 to 30.47; two RCTs, 62 women, I(2) = 0%, low-quality evidence).In women with donor-recipient cycles, no evidence suggested a difference between groups in live birth rate (OR 0.92, 95% CI 0.53 to 1.61; one RCT, 212 women) or ongoing pregnancy rate (OR 0.88, 95% CI 0.58 to 1.32; three RCTs, 372 women, I² = 0%). We found evidence of a lower incidence of OHSS in the GnRH agonist group than in the HCG group (OR 0.05, 95% CI 0.01 to 0.28; three RCTs, 374 women, I² = 0%).The main limitation in the quality of the evidence was risk of bias associated with poor reporting of methods in the included studies.
AUTHORS' CONCLUSIONS


Final oocyte maturation triggering with GnRH agonist instead of HCG in fresh autologous GnRH antagonist IVF/ICSI treatment cycles prevents OHSS to the detriment of the live birth rate. In donor-recipient cycles, use of GnRH agonists instead of HCG resulted in a lower incidence of OHSS, with no evidence of a difference in live birth rate.Evidence suggests that GnRH agonist as a final oocyte maturation trigger in fresh autologous cycles is associated with a lower live birth rate, a lower ongoing pregnancy rate (pregnancy beyond 12 weeks) and a higher rate of early miscarriage (less than 12 weeks). GnRH agonist as an oocyte maturation trigger could be useful for women who choose to avoid fresh transfers (for whatever reason), women who donate oocytes to recipients or women who wish to freeze their eggs for later use in the context of fertility preservation.",2014,"No evidence was found of a difference between groups in risk of multiple pregnancy (OR 3.00, 95% CI 0.30 to 30.47; two RCTs, 62 women, I(2) = 0%, low-quality evidence).In women with donor-recipient cycles, no evidence suggested a difference between groups in live birth rate (OR 0.92, 95% CI 0.53 to 1.61; one RCT, 212 women) or ongoing pregnancy rate (OR 0.88, 95% CI 0.58 to 1.32; three RCTs, 372 women, I² = 0%).","['Menstrual Disorders and Subfertility Group (MDSG', 'women undergoing GnRH antagonist IVF/ICSI treatment cycles were included', 'women undergoing COH in a GnRH antagonist protocol']","['Gonadotropin-releasing hormone agonist versus HCG', 'HCG', 'GnRH agonist', 'GnRH agonist triggers versus HCG', 'Gonadotropin-releasing hormone (GnRH) agonists', 'gonadotropin-releasing hormone agonists versus HCG', 'Human chorionic gonadotropin (HCG']","['OHSS', 'live birth and rate of ovarian hyperstimulation syndrome (OHSS', 'rate of early miscarriage', 'live birth rate', 'incidence of mild, moderate or severe OHSS', 'early miscarriage rate', 'Grades of Recommendation, Assessment, Development and Evaluation (GRADE', 'ongoing pregnancy rate', 'risk of multiple pregnancy']","[{'cui': 'C0025345', 'cui_str': 'Menstruation Disorders'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C4324508', 'cui_str': 'Early miscarriage'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}]",,0.443049,"No evidence was found of a difference between groups in risk of multiple pregnancy (OR 3.00, 95% CI 0.30 to 30.47; two RCTs, 62 women, I(2) = 0%, low-quality evidence).In women with donor-recipient cycles, no evidence suggested a difference between groups in live birth rate (OR 0.92, 95% CI 0.53 to 1.61; one RCT, 212 women) or ongoing pregnancy rate (OR 0.88, 95% CI 0.58 to 1.32; three RCTs, 372 women, I² = 0%).","[{'ForeName': 'Mohamed A F M', 'Initials': 'MA', 'LastName': 'Youssef', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Fulco', 'Initials': 'F', 'LastName': 'Van der Veen', 'Affiliation': ''}, {'ForeName': 'Hesham G', 'Initials': 'HG', 'LastName': 'Al-Inany', 'Affiliation': ''}, {'ForeName': 'Monique H', 'Initials': 'MH', 'LastName': 'Mochtar', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Griesinger', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nagi Mohesen', 'Affiliation': ''}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Aboulfoutouh', 'Affiliation': ''}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD008046.pub4']
1505,27922724,Antenatal breastfeeding education for increasing breastfeeding duration.,"BACKGROUND


Breast milk is well recognised as the best food source for infants. The impact of antenatal breastfeeding (BF) education on the duration of BF has not been evaluated.
OBJECTIVES


To assess the effectiveness of antenatal breastfeeding (BF) education for increasing BF initiation and duration.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register on 1 March 2016, CENTRAL (The Cochrane Library, 2016, Issue 3), MEDLINE (1966 to 1 March 2016) and Scopus (January 1985 to 1 March 2016). We contacted experts and searched reference lists of retrieved articles.
SELECTION CRITERIA


All identified published, unpublished and ongoing randomised controlled trials (RCTs) assessing the effect of formal antenatal BF education or comparing two different methods of formal antenatal BF education, on the duration of BF. We included RCTs that only included antenatal interventions and excluded those that combined antenatal and intrapartum or postpartum BF education components. Cluster-randomised trials were included in this review. Quasi-randomised trials were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS


We assessed all potential studies identified as a result of the search strategy. Two review authors extracted data from each included study using the agreed form and assessed risk of bias. We resolved discrepancies through discussion. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS


This review update includes 24 studies (10,056 women). Twenty studies (9789 women) contribute data to analyses. Most studies took place in high-income countries such as the USA, UK, Canada and Australia. In the first five comparisons, we display the included trials according to type of intervention without pooling data. For the 'Summary of findings' we pooled data for a summary effect.Five included studies were cluster-randomised trials: all of these adjusted data and reported adjustments as odds ratios (OR). We have analysed the data using the generic inverse variance method and presented results as odds ratios, because we were unable to derive a cluster-adjusted risk ratio from the published cluster-trial. We acknowledge that the use of odds ratio prevents the pooling of these cluster trials in our main analyses. One method of BF education with standard (routine) careThere were no group differences for duration of any BF in days or weeks. There was no evidence that interventions improved the proportion of women with any BF or exclusive BF at three or six months. Single trials of different interventions were unable to show that education improved initiation of BF, apart from one small trial at high risk of attrition bias. Many trial results marginally favoured the intervention but had wide confidence intervals crossing the line of no effect. BF complications such as mastitis and other BF problems were similar in treatment arms in single trials reporting these outcomes. Multiple methods of BF education versus standard careFor all trials included in this comparison we have presented the cluster-adjusted odds ratios as reported in trial publications. One three-arm study found the intervention of BF booklet plus video plus Lactation Consultant versus standard care improved the proportion of women exclusively BF at three months (OR 2.60, 95% CI 1.25 to 5.40; women = 159) and marginally at six months (OR 2.40, 95% CI 1.00 to 5.76; women = 175). For the same trial, an intervention arm without a lactation consultant but with the BF booklet and video did not have the same effect on proportion of women exclusively BF at three months (OR 1.80, 95% CI 0.80 to 4.05; women = 159) or six months (OR 0.90, 95% CI 0.30 to 2.70; women = 184). One study compared monthly BF sessions and weekly cell phone message versus standard care and reported improvements in the proportion of women exclusively BF at both three and six months (three months OR 1.80, 95% CI 1.10 to 2.95; women = 390; six months OR 2.40, 95% CI 1.40 to 4.11; women = 390). One study found monthly BF sessions and weekly cell phone messages improved initiation of BF over standard care (OR 2.61, 95% CI 1.61 to 4.24; women = 380). BF education session versus standard care, pooled analyses for 'Summary of findings' (SoF)This comparison does not include cluster-randomised trials reporting adjusted odds ratios. We did not downgrade any evidence for trials' lack of blinding; no trial had adequate blinding of staff and participants. The SoF table presents risk ratios for all outcomes analysed. For proportion of women exclusively BF there is no evidence that antenatal BF education improved BF at three months (RR 1.06, 95% CI 0.90 to 1.25; women = 822; studies = 3; moderate quality evidence) or at six months (RR 1.07, 95% CI 0.87 to 1.30; women = 2161; studies = 4; moderate quality evidence). For proportion of women with any BF there were no group differences in BF at three (average RR 0.98, 95% CI 0.82 to 1.18; women = 654; studies = 2; I² = 60%; low-quality evidence) or six months (average RR 1.05, 95% CI 0.90 to 1.23; women = 1636; studies = 4; I² = 61%; high-quality evidence). There was no evidence that antenatal BF education could improve initiation of BF (average RR 1.01, 95% CI 0.94 to 1.09; women = 3505; studies = 8; I² = 69%; high-quality evidence). Where we downgraded evidence this was due to small sample size or wide confidence intervals crossing the line of no effect, or both.There was insufficient data for subgroup analysis of mother's occupation or education.
AUTHORS' CONCLUSIONS


There was no conclusive evidence supporting any antenatal BF education for improving initiation of BF, proportion of women giving any BF or exclusively BF at three or six months or the duration of BF. There is an urgent need to conduct a high-quality, randomised controlled study to evaluate the effectiveness and adverse effects of antenatal BF education, especially in low- and middle-income countries. Evidence in this review is primarily relevant to high-income settings.",2016,We did not downgrade any evidence for trials' lack of blinding; no trial had adequate blinding of staff and participants.,"['infants', '1966 to 1 March 2016) and Scopus (January 1985 to 1 March 2016', '24 studies (10,056 women']","['BF education session', 'Antenatal breastfeeding education', 'antenatal breastfeeding (BF) education']","['BF initiation and duration', 'antenatal BF education improved BF', 'BF', 'initiation of BF', 'proportion of women with any BF or exclusive BF', 'initiation of BF over standard care', 'proportion of women exclusively BF', 'BF complications such as mastitis and other BF problems']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",10056.0,0.201183,We did not downgrade any evidence for trials' lack of blinding; no trial had adequate blinding of staff and participants.,"[{'ForeName': 'Pisake', 'Initials': 'P', 'LastName': 'Lumbiganon', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, 123 Mitraparb Road, Amphur Muang, Khon Kaen, Thailand, 40002.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Martis', 'Affiliation': 'Liggins Institute, The University of Auckland, Park Road, Grafton, Auckland, New Zealand, 1142.'}, {'ForeName': 'Malinee', 'Initials': 'M', 'LastName': 'Laopaiboon', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, 123 Mitraparb Road, Amphur Muang, Khon Kaen, Thailand, 40002.'}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Festin', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Ho', 'Affiliation': 'Department of Paediatrics, Penang Medical College, 4 Sepoy Lines, Penang, Malaysia, 10450.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hakimi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Universitas Gadjah Mada, Jl. Farmako, Sekip, Yogyakarta, Daerah Istimewa Yogyakarta, Indonesia, 55281.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006425.pub4']
1506,29127772,Interventions for treating collagenous colitis.,"BACKGROUND


Collagenous colitis is a cause of chronic diarrhea. This updated review was performed to identify therapies for collagenous colitis that have been assessed in randomized controlled trials (RCTs).
OBJECTIVES


The primary objective was to assess the benefits and harms of treatments for collagenous colitis.
SEARCH METHODS


We searched CENTRAL, the Cochrane IBD Group Specialized Register, MEDLINE and EMBASE from inception to 7 November 2016.
SELECTION CRITERIA


We included RCTs comparing a therapy with placebo or active comparator for the treatment of active or quiescent collagenous colitis.
DATA COLLECTION AND ANALYSIS


Data were independently extracted by two authors. The primary outcome was clinical response or maintenance of response as defined by the included studies. Secondary outcome measures included histological response, quality of life and the occurrence of adverse events. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The Cochrane risk of bias tool was used to assess bias. The overall quality of the evidence was assessed using the GRADE criteria.
MAIN RESULTS


Twelve RCTs (476 participants) were included. These studies assessed bismuth subsalicylate, Boswellia serrata extract, mesalamine, cholestyramine, probiotics, prednisolone and budesonide therapy. Four studies were low risk of bias. One study assessing mesalamine and cholestyramine was judged to be high risk of bias due to no blinding. The other studies had an unclear risk of bias for random sequence generation (five studies) allocation concealment (six studies), blinding (one study), incomplete outcome data (one study) and selective outcome reporting (one study). Clinical response occurred in 100% (4/4) of patients who received bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks) compared to 0% (0/5) of patients who received placebo (1 study; 9 participants; RR 10.80, 95% CI 0.75 to 155.93; GRADE = very low). Clinical response occurred in 44% (7/16) of patients who received Boswellia serrata extract (three 400 mg/day capsules for 8 weeks) compared to 27% (4/15) of patients who received placebo (1 study; 31 participants; RR 1.64, 95% CI 0.60 to 4.49; GRADE = low). Clinical response occurred in 80% (24/30) of budesonide patients compared to 44% (11/25) of mesalamine patients (1 study; 55 participants; RR 1.82, 95% CI 1.13 to 2.93; GRADE = low). Histological response was observed in 87% (26/30) of budesonide patients compared to 44% (11/25) of mesalamine patients (1 study, 55 participants; RR 1.97, 95% CI 1.24 to 3.13; GRADE = low). There was no difference between the two treatments with respect to adverse events (RR 0.69, 95% CI 0.43 to 1.10; GRADE = low), withdrawals due to adverse events (RR 0.09, 95% CI 0.01 to 1.65; GRADE = low) and serious adverse events (RR 0.12, 95% CI 0.01 to 2.21; GRADE = low). Clinical response occurred in 44% (11/25) of mesalamine patients (3 g/day) compared to 59% (22/37) of placebo patients (1 study; 62 participants; RR 0.74, 95% CI 0.44 to 1.24; GRADE = low). Histological response was observed in 44% (11/25) and 51% (19/37) of patients receiving mesalamine and placebo, respectively (1 study; 62 participants; RR 0.86, 95% CI 0.50 to 1.47; GRADE = low). There was no difference between the two treatments with respect to adverse events (RR 1.26, 95% CI 0.84 to 1.88; GRADE = low), withdrawals due to adverse events (RR 5.92, 95% CI 0.70 to 49.90; GRADE = low) and serious adverse events (RR 4.44, 95% CI 0.49 to 40.29; GRADE = low). Clinical response occurred in 63% (5/8) of prednisolone (50 mg/day for 2 weeks) patients compared to 0% (0/3) of placebo patients (1 study, 11 participants; RR 4.89, 95% CI 0.35 to 68.83; GRADE = very low). Clinical response occurred in 29% (6/21) of patients who received probiotics (2 capsules containing 0.5 x 10 10  CFU each of L. acidophilus LA-5 and B. animalis subsp. lactis strain BB-12 twice daily for 12 weeks) compared to 13% (1/8) of placebo patients (1 study, 29 participants, RR 2.29, 95% CI 0.32 to 16.13; GRADE = very low). Clinical response occurred in 73% (8/11) of patients who received mesalamine (800 mg three times daily) compared to 100% (12/12) of patients who received mesalamine + cholestyramine (4 g daily) (1 study, 23 participants; RR 0.74, 95% CI 0.50 to 1.08; GRADE = very low). Clinical response occurred in 81% (38/47) of patients who received budesonide (9 mg daily in a tapering schedule for 6 to 8 weeks) compared to 17% (8/47) of placebo patients (3 studies; 94 participants; RR 4.56, 95% CI 2.43 to 8.55; GRADE = low). Histological response was higher in budesonide participants (72%, 34/47) compared to placebo (17%, 8/47) (RR 4.15, 95% CI 2.25 to 7.66; GRADE = low). Clinical response was maintained in 68% (57/84) of budesonide patients compared to 20% (18/88) of placebo patients (3 studies, 172 participants, RR 3.30 95% CI 2.13 to 5.09; GRADE = low). Histological response was maintained in 48% (19/40) of budesonide patients compared to 15% (6/40) of placebo patients (2 studies; 80 participants; RR 3.17, 95% CI 1.44 to 6.95; GRADE = very low). No difference was found between budesonide and placebo for adverse events (5 studies; 290 participants; RR 1.18, o95% CI 0.92 to 1.51; GRADE = low), withdrawals due to adverse events (5 studies, 290 participants; RR 0.97, 95% CI 0.43 to 2.17; GRADE = very low) or serious adverse events (4 studies, 175 participants; RR 1.11, 95% CI 0.15 to 8.01; GRADE = very low). Adverse effects reported in the budesonide studies include nausea, vomiting, neck pain, abdominal pain, excessive sweating and headache. Adverse effects reported in the mesalamine studies included nausea and skin rash. Adverse effects in the prednisolone study included abdominal pain, headache, sleep disturbance, mood change and weight gain.
AUTHORS' CONCLUSIONS


Low quality evidence suggests that budesonide may be effective for inducing and maintaining clinical and histological response in patients with collagenous colitis. We are uncertain about the benefits and harms of therapy with bismuth subsalicylate, Boswellia serrata extract, mesalamine with or without cholestramine, prednisolone and probiotics. These agents and other therapies require further study.",2017,"Histological response was higher in budesonide participants (72%, 34/47) compared to placebo (17%, 8/47) (RR 4.15, 95% CI 2.25 to 7.66; GRADE = low).","['patients with collagenous colitis', 'Twelve RCTs (476 participants) were included']","['placebo', 'prednisolone', 'mesalamine + cholestyramine', 'mesalamine and cholestyramine', 'budesonide', 'probiotics', 'bismuth subsalicylate, Boswellia serrata extract, mesalamine with or without cholestramine, prednisolone and probiotics', 'Boswellia serrata extract', 'bismuth subsalicylate', 'mesalamine', 'bismuth subsalicylate, Boswellia serrata extract, mesalamine, cholestyramine, probiotics, prednisolone and budesonide therapy']","['clinical response or maintenance of response', 'histological response, quality of life and the occurrence of adverse events', 'Histological response', 'Risk ratios (RR) and 95% confidence intervals (CI', 'adverse events', 'abdominal pain, headache, sleep disturbance, mood change and weight gain', 'nausea and skin rash', 'benefits and harms of treatments for collagenous colitis', 'nausea, vomiting, neck pain, abdominal pain, excessive sweating and headache', 'serious adverse events', 'Adverse effects', 'Clinical response', 'withdrawals due to adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238067', 'cui_str': 'Colitis, Collagenous'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C0008402', 'cui_str': 'colestyramine'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0053792', 'cui_str': 'bismuth subsalicylate'}, {'cui': 'C2608032', 'cui_str': 'Boswellia serrata'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0085633', 'cui_str': 'Mood swings (finding)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238067', 'cui_str': 'Colitis, Collagenous'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0700590', 'cui_str': 'Diaphoresis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]",55.0,0.575381,"Histological response was higher in budesonide participants (72%, 34/47) compared to placebo (17%, 8/47) (RR 4.15, 95% CI 2.25 to 7.66; GRADE = low).","[{'ForeName': 'Tahir S', 'Initials': 'TS', 'LastName': 'Kafil', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Petrease H', 'Initials': 'PH', 'LastName': 'Patton', 'Affiliation': ''}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': ''}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Chande', 'Affiliation': ''}, {'ForeName': 'John Wd', 'Initials': 'JW', 'LastName': 'McDonald', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003575.pub6']
1507,6779335,Drug preference and mood in humans: d-amphetamine.,"A total of 31 normal human volunteers participated in a nine-session experiment. During the first four sessions, they received alternately 5 mg d-amphetamine or placebo. During the next five sessions, they were given a choice between amphetamine and placebo. Subjective effects were assessed using the Profile of Mood States (POMS) before the drug was taken and 1, 3, and 6 h later. Subjects chose amphetamine a mean of 4.03 times. Compared with placebo, amphetamine produced changes in mood on the POMS including increased Vigor, Elation, Friendliness, Arousal and Positive Mood and decreased Confusion. These differences were greatest 3 hr after ingestion. Mood changes produced by d-amphetamine were comparable in all subjects regardless of the actual number of times each chose the drug. These data suggest that that subjective effects do not predict drug choice. The results are discussed in terms of developing methods for predicting the abuse potential of psychotropic drugs.",1980,"Compared with placebo, amphetamine produced changes in mood on the POMS including increased Vigor, Elation, Friendliness, Arousal and Positive Mood and decreased Confusion.","['31 normal human volunteers participated in a nine-session experiment', 'humans']","['amphetamine and placebo', 'placebo, amphetamine', 'amphetamine or placebo', 'amphetamine']","['Vigor, Elation, Friendliness, Arousal and Positive Mood and decreased Confusion', 'Subjective effects', 'Profile of Mood States (POMS']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0233492', 'cui_str': 'Elation (finding)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}]",31.0,0.0641971,"Compared with placebo, amphetamine produced changes in mood on the POMS including increased Vigor, Elation, Friendliness, Arousal and Positive Mood and decreased Confusion.","[{'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Johanson', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Uhlenhuth', 'Affiliation': ''}]",Psychopharmacology,[]
1508,30590573,Pain relief after orthodontic archwire installation-a comparison between intervention with paracetamol and chewing gum: a randomized controlled trial.,"BACKGROUND


Pain and discomfort are main concerns at the commencement of orthodontic treatment. It may have negative impact on compliance or even discourage patients from being treated. Orthodontic pain can be alleviated by paracetamol or use of chewing gum. However, studies comparing their effectiveness are scarce.
OBJECTIVES


To compare the effectiveness of paracetamol versus chewing gum for pain alleviation and to investigate the frequency of bracket loss during the first day of fixed orthodontic treatment.
TRAIL DESIGN


Prospective randomized multicentre clinical trial.
METHODS


Sixty patients (28 boys and 32 girls), between 12 and 18 years of age were randomly allocated either to take paracetamol (31 patients) or to use chewing gum (29 patients). After one arch bonding and insertion of the initial archwire, the patients rated the sensation of pain on a visual analogue scale with the jaw at rest and when biting after 6 hours (T1), at bedtime (T2), and the next morning (T3). Paracetamol (1000 mg) was taken 1 hour and chewing gum was used 10 minutes prior to pain rating at T2 and T3. A simple method of randomization was used in this study, and blinding of subjects and the operators to the type of intervention was not possible because of the nature of the treatments.
RESULTS


There was no detectable difference in pain sensation between the groups at T1. At T2 and T3 the chewing gum group displayed higher mean values than the paracetamol group but when adjusting for age, gender, and mode of pain registration, there was no significant difference between the groups. There was no bracket loss in the chewing gum group, whereas two patients in the paracetamol group lost two brackets.
CONCLUSIONS


The effect of chewing gum and paracetamol for initial orthodontic pain relief seems equivalent. Short term use of chewing gum is not a risk factor for bracket loss.
TRIAL REGISTRATION


This study was not registered.",2019,"At T2 and T3 the chewing gum group displayed higher mean values than the paracetamol group but when adjusting for age, gender, and mode of pain registration, there was no significant difference between the groups.","['Methods\n\n\nSixty patients (28 boys and 32 girls), between 12 and 18 years of age']","['paracetamol (31 patients) or to use chewing gum', 'paracetamol and chewing gum', 'Paracetamol', 'paracetamol', 'chewing gum and paracetamol', 'chewing gum']","['frequency of bracket loss', 'Pain relief', 'bracket loss', 'Orthodontic pain', 'sensation of pain on a visual analogue scale', 'pain sensation', 'mean values']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4321298', 'cui_str': 'Chewing gum'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0433819,"At T2 and T3 the chewing gum group displayed higher mean values than the paracetamol group but when adjusting for age, gender, and mode of pain registration, there was no significant difference between the groups.","[{'ForeName': 'Abdulrahman K', 'Initials': 'AK', 'LastName': 'Alshammari', 'Affiliation': 'Department of Orthodontics, College of Dentistry, University of Hail, Saudi Arabia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huggare', 'Affiliation': 'Division of Orthodontics, Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjy081']
1509,31672793,Varying Association of Extended Hours Dialysis with Quality of Life.,"BACKGROUND AND OBJECTIVES


Little is known about the effect of changes in dialysis hours on patient-reported outcome measures. We report the effect of doubling dialysis hours on a range of patient-reported outcome measures in a randomized trial, overall and separately for important subgroups.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


The A Clinical Trial of IntensiVE Dialysis trial randomized 200 participants to extended or standard weekly hours hemodialysis for 12 months. Patient-reported outcome measures included two health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score). Outcomes were assessed as the mean difference from baseline using linear mixed effects models adjusted for time point and baseline score, with interaction terms added for subgroup analyses. Prespecified subgroups were dialysis location (home- versus institution-based), dialysis vintage (≤6 months versus >6 months), region (China versus Australia, New Zealand, Canada), and baseline score (lowest, middle, highest tertile). Multiplicity-adjusted  P  values (Holm-Bonferroni) were calculated for the main analyses.
RESULTS


Extended dialysis hours was associated with improvement in Short Form-6 Dimension (mean difference, 0.027; 95% confidence interval [95% CI], 0.00 to 0.05;  P =0.03) which was not significant after adjustment for multiple comparisons ( P adjusted  =0.05). There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09;  P =0.2;  P adjusted  =0.2) or in quality-adjusted life years. There were small positive differences in generic and disease-specific quality of life: Physical Component Summary (mean difference, 2.3; 95% CI, 0.6 to 4.1;  P =0.01;  P adjusted  =0.04), Mental Component Summary (mean difference, 2.5; 95% CI, 0.5 to 4.6;  P =0.02;  P adjusted  =0.05) and Kidney Disease Component Score (mean difference, 3.5; 95% CI, 1.5 to 5.5;  P =0.001;  P adjusted  =0.005). The results did not differ among predefined subgroups or by baseline score.
CONCLUSIONS


The effect of extended hours hemodialysis on patient-reported outcome measures reached statistical significance in some but not all measures. Within each measure the effect was consistent across predefined subgroups. The clinical importance of these differences is unclear.",2019,"There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09;  P =0.2;  P adjusted  =0.2) or in quality-adjusted life years.",['200 participants to extended or standard weekly hours hemodialysis for 12 months'],[],"['generic and disease-specific quality of life: Physical Component Summary', 'Kidney Disease Component Score', 'health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score', 'Mental Component Summary', 'EuroQOL-5 Dimensions-3 Level health utility', 'Short Form-6 Dimension']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",200.0,0.449499,"There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09;  P =0.2;  P adjusted  =0.2) or in quality-adjusted life years.","[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'van den Broek-Best', 'Affiliation': 'Department of Medicine, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Sydney School of Public Health University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Renal Department, Sunshine Coast University Hospital, Birtinya, Australia.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'Renal Services, North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jinsheng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, Fourth Hospital Affiliated to Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, Australia; and.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; mjardine@georgeinstitute.org.au.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06800619']
1510,31664940,Association of platelet function with depression and its treatment with sertraline in patients with chronic kidney disease: analysis of a randomized trial.,"BACKGROUND


Major Depressive Disorder (MDD) can lead to adverse cardiovascular outcomes in patients with chronic kidney disease (CKD). Although one of the proposed mechanisms is heightened platelet activation, effects of MDD and its treatment with a selective serotonin reuptake inhibitor (SSRI) on platelet function in patients with CKD remain unclear.
METHODS


In a pre-specified analysis, changes from baseline to 12 weeks in whole blood platelet aggregation (WBPA) and plasma levels of E-selectin and P-selectin on treatment with sertraline vs. placebo were investigated in 175 patients with CKD (estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73m 2 ) and MDD (MDD+/CKD+) in a randomized, double-blind trial. Correlations between severity of depressive symptoms and platelet function were also analyzed. In order to investigate whether differences in platelet function were due to presence of CKD or MDD, we compared a subgroup of 49 MDD+/CKD+ patients with eGFR < 30 ml/min/1.73m 2  to 43 non-depressed CKD controls (28 CKD with eGFR < 30 ml/min/1.73m 2  [MDD-/CKD+] and 15 individuals with eGFR ≥90 ml/min/1.73m 2  [MDD-/CKD-].
RESULTS


In MDD+/CKD+ individuals, there were no significant correlations between severity of depressive symptoms and platelet function, and no significant changes in platelet function after 12 weeks of treatment with sertraline vs. placebo. There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03). WBPA to ADP was lower in the MDD-/CKD- group (8.0 Ω [5.0 Ω, 11.0 Ω]) as compared to the MDD-/CKD+ group (12.5 Ω [8.0 Ω, 14.5 Ω]), P = 0.01, and the MDD+/CKD+ group (11.0 Ω [8.0 Ω, 15.0 Ω]), P < 0.01.
CONCLUSIONS


Heightened ADP-induced platelet aggregability was observed in CKD patients compared to controls with normal kidney function, regardless of presence of comorbid MDD, and treatment with sertraline did not affect platelet function. These findings suggest that increased platelet activation may not be a major contributory underlying mechanism by which depression may lead to worse cardiovascular outcomes in patients with CKD. Future studies should include positive MDD controls without CKD to confirm our findings.
TRIAL REGISTRATION


ClinicalTrials.gov identifier numbers: CAST Study: NCT00946998 (Recruitment Status: Completed. First Posted: July 27, 2009. Results First Posted: January 30, 2018). WiCKDonASA Study: NCT01768637 (Recruitment Status: Completed. First Posted: January 15, 2013. Results First Posted: April 19, 2019).",2019,There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03).,"['patients with chronic kidney disease (CKD', '15 individuals with eGFR ≥90', 'patients with chronic kidney disease', '175 patients with CKD', 'patients with CKD remain unclear', 'patients with CKD']","['WiCKDonASA', 'MDD-/CKD', 'serotonin reuptake inhibitor (SSRI', 'MDD+/CKD', 'sertraline', 'sertraline vs. placebo', 'MDD (MDD+/CKD']","['blood platelet aggregation (WBPA) and plasma levels of E-selectin', 'severity of depressive symptoms and platelet function', 'platelet aggregability', 'depressive symptoms and platelet function', 'WBPA to ADP', 'platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0162758', 'cui_str': '5-HT Uptake Inhibitors'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]",175.0,0.0493685,There were no significant differences in platelet function among MDD+/CKD+ patients and controls without MDD except in WBPA to 10 μM ADP (P = 0.03).,"[{'ForeName': 'Nishank', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Internal Medicine, University of Arkansas for Medical Sciences, 5323 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wan', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Department of Internal Medicine, University of Arkansas for Medical Sciences, 5323 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Anuoluwapo', 'Initials': 'A', 'LastName': 'Adelodun', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Ware', 'Affiliation': 'Department of Physiology and Biophysics, University of Arkansas for Medical Sciences, Little Rock, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Sarode', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA.'}, {'ForeName': 'S Susan', 'Initials': 'SS', 'LastName': 'Hedayati', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, MC 8516, Dallas, TX, 75390, USA. susan.hedayati@utsouthwestern.edu.'}]",BMC nephrology,['10.1186/s12882-019-1576-7']
1511,31505665,"Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults.","BACKGROUND


This double-blind study assessed immunogenicity, lot consistency, and safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP).
METHODS


Healthy adults (N = 1197) were randomized 2:2:2:2:1 to receive 1 of 3 consistency lots of rVSVΔG-ZEBOV-GP (2 × 107 plaque-forming units [pfu]), high-dose 1 × 108 pfu, or placebo. Antibody responses pre-/postvaccination (28 days, 6 months; in a subset [n = 566], months 12, 18, and 24) were measured. post hoc analysis of risk factors associated with arthritis following vaccination was performed.
RESULTS


ZEBOV-GP enzyme-linked immunosorbent assay (ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days (>58-fold) and persisted through 24 months. The 3 manufacturing lots demonstrated equivalent immunogenicity at 28 days. Neutralizing antibody GMTs increased by 28 days in all rVSVΔG-ZEBOV-GP groups, peaking at 18 months with no decrease through 24 months. At 28 days, ≥94% of vaccine recipients seroresponded (ZEBOV-GP ELISA, ≥2-fold increase, titer ≥200 EU/mL), with responses persisting at 24 months in ≥91%. Female sex and a history of arthritis were identified as potential risk factors for the development of arthritis postvaccination.
CONCLUSIONS


Immune responses to rVSVΔG-ZEBOV-GP persisted to 24 months. Immunogenicity and safety results support continued rVSVΔG-ZEBOV-GP development.
CLINICAL TRIALS REGISTRATION


NCT02503202.",2019,(ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days,"['Healthy Adults', 'Healthy adults (N = 1197']","['rVSVΔG-ZEBOV-GP (2 × 107 plaque-forming units [pfu]), high-dose 1 × 108 pfu, or placebo', 'rVSVΔG-ZEBOV-GP Vaccine', 'recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP', 'Placebo']","['equivalent immunogenicity', 'Neutralizing antibody GMTs', 'Immunogenicity and safety', 'ZEBOV-GP enzyme-linked immunosorbent assay', 'ELISA) geometric mean titers (GMTs) increased postvaccination']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1623048', 'cui_str': 'Vesicular stomatitis virus (organism)'}, {'cui': 'C0949896', 'cui_str': 'Zaire Ebola Virus'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}]","[{'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",1197.0,0.27196,(ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days,"[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Halperin', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Onorato', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Grant-Klein', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Nichols', 'Affiliation': 'NewLink Genetics, Inc., BioProtection Systems, Ames, Iowa.'}, {'ForeName': 'Beth-Ann', 'Initials': 'BA', 'LastName': 'Coller', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Frans A', 'Initials': 'FA', 'LastName': 'Helmond', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiz241']
1512,29607497,Low dose naltrexone for induction of remission in Crohn's disease.,"BACKGROUND


Crohn's disease is a transmural, relapsing inflammatory condition afflicting the digestive tract. Opioid signalling, long known to affect secretion and motility in the gut, has been implicated in the inflammatory cascade of Crohn's disease. Low dose naltrexone, an opioid antagonist, has garnered interest as a potential therapy.
OBJECTIVES


The primary objective was to evaluate the efficacy and safety of low dose naltrexone for induction of remission in Crohn's disease.
SEARCH METHODS


A systematic search of MEDLINE, Embase, PubMed, CENTRAL, and the Cochrane IBD Group Specialized Register was performed from inception to 15 January 2018 to identify relevant studies. Abstracts from major gastroenterology conferences including Digestive Disease Week and United European Gastroenterology Week and reference lists from retrieved articles were also screened.
SELECTION CRITERIA


Randomized controlled trials of low dose naltrexone (LDN) for treatment of active Crohn's disease were included.
DATA COLLECTION AND ANALYSIS


Data were analyzed on an intention-to-treat basis using Review Manager (RevMan 5.3.5). The primary outcome was induction of clinical remission defined by a Crohn's disease activity index (CDAI) of < 150 or a pediatric Crohn's disease activity index (PCDAI) of < 10. Secondary outcomes included clinical response (70- or 100-point decrease in CDAI from baseline), endoscopic remission or response, quality of life, and adverse events as defined by the included studies. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The methodological quality of included studies was evaluated using the Cochrane risk of bias tool. The overall quality of the evidence supporting the primary outcome and selected secondary outcomes was assessed using the GRADE criteria.
MAIN RESULTS


Two studies were identified (46 participants). One study assessed the efficacy and safety of 12 weeks of LDN (4.5 mg/day) treatment compared to placebo in adult patients (N = 34). The other study assessed eight weeks of LDN (0.1 mg/kg, maximum 4.5 mg/day) treatment compared to placebo in pediatric patients (N = 12). The primary purpose of the pediatric study was to assess safety and tolerability. Both studies were rated as having a low risk of bias. The study in adult patients reported that 30% (5/18) of LDN treated patients achieved clinical remission at 12 weeks compared to 18% (3/16) of placebo patients, a difference that was not statistically significant (RR 1.48, 95% CI 0.42 to 5.24). The study in children reported that 25% of LDN treated patients achieved clinical remission (PCDAI < 10) compared to none of the patients in the placebo group, although it was unclear if this result was for the randomized placebo-controlled trial or for the open label extension study. In the adult study 70-point clinical response rates were significantly higher in those treated with LDN than placebo. Eighty-three per cent (15/18) of LDN patients had a 70-point clinical response at week 12 compared to 38% (6/16) of placebo patients (RR 2.22, 95% CI 1.14 to 4.32). The effect of LDN on the proportion of adult patients who achieved a 100-point clinical response was uncertain. Sixty-one per cent (11/18) of LDN patients achieved a 100-point clinical response compared to 31% (5/16) of placebo patients (RR 1.96, 95% CI 0.87 to 4.42). The proportion of patients who achieved endoscopic response (CDEIS decline > 5 from baseline) was significantly higher in the LDN group compared to placebo. Seventy-two per cent (13/18) of LDN patients achieved an endoscopic response compared to 25% (4/16) of placebo patients (RR 2.89; 95% CI 1.18 to 7.08). However, there was no statistically significant difference in the proportion of patients who achieved endoscopic remission. Endoscopic remission (CDEIS < 3) was achieved in 22% (4/18) of the LDN group compared to 0% (0/16) of the placebo group (RR 8.05; 95% CI 0.47 to 138.87). Pooled data from both studies show no statistically significant differences in withdrawals due to adverse events or specific adverse events including sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue. No serious adverse events were reported in either study. GRADE analyses rated the overall quality of the evidence for the primary and secondary outcomes (i.e. clinical remission, clinical response, endoscopic response, and adverse events) as low due to serious imprecision (sparse data).
AUTHORS' CONCLUSIONS


Currently, there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of LDN used to treat patients with active Crohn's disease. Data from one small study suggests that LDN may provide a benefit in terms of clinical and endoscopic response in adult patients with active Crohn's disease. Data from two small studies suggest that LDN does not increase the rate of specific adverse events relative to placebo. However, these results need to be interpreted with caution as they are based on very small numbers of patients and the overall quality of the evidence was rated as low due to serious imprecision. Further randomized controlled trials are required to assess the efficacy and safety of LDN therapy in active Crohn's disease in both adults and children.",2018,"Pooled data from both studies show no statistically significant differences in withdrawals due to adverse events or specific adverse events including sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue.","[""active Crohn's disease in both adults and children"", ""active Crohn's disease were included"", 'adult patients (N = 34', ""Crohn's disease"", ""adult patients with active Crohn's disease"", ""patients with active Crohn's disease"", 'pediatric patients (N = 12', 'adult patients who achieved a 100-point clinical response was uncertain']","['LDN', 'placebo', 'naltrexone', 'LDN therapy', 'naltrexone (LDN']","['clinical response rates', 'endoscopic response (CDEIS decline', 'clinical remission, clinical response, endoscopic response, and adverse events', 'safety and tolerability', '70-point clinical response', 'Risk ratios (RR) and 95% confidence intervals (CI', '100-point clinical response', 'sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue', 'clinical remission', 'endoscopic response', 'rate of specific adverse events', 'endoscopic remission', 'clinical response (70- or 100-point decrease in CDAI from baseline), endoscopic remission or response, quality of life, and adverse events', ""induction of clinical remission defined by a Crohn's disease activity index (CDAI) of < 150 or a pediatric Crohn's disease activity index (PCDAI) of < 10"", 'serious adverse events', 'efficacy and safety', 'Endoscopic remission']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index (assessment scale)""}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C2931133', 'cui_str': ""Pediatric Crohn's disease""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.598783,"Pooled data from both studies show no statistically significant differences in withdrawals due to adverse events or specific adverse events including sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue.","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, 100 Dundas Street, Suite 200, London, ON, Canada, N6A 5B6.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Segal', 'Affiliation': ''}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': ''}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Chande', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010410.pub3']
1513,27764898,Prophylactic abdominal drainage for pancreatic surgery.,"BACKGROUND


The use of surgical drains has been considered mandatory after pancreatic surgery. The role of prophylactic abdominal drainage to reduce postoperative complications after pancreatic surgery is controversial.
OBJECTIVES


To assess the benefits and harms of routine abdominal drainage after pancreatic surgery, compare the effects of different types of surgical drains, and evaluate the optimal time for drain removal.
SEARCH METHODS


For the initial version of this review, we searched the Cochrane Library (2015, Issue 3), MEDLINE (1946 to 9 April 2015), Embase (1980 to 9 April 2015), Science Citation Index Expanded (1900 to 9 April 2015), and Chinese Biomedical Literature Database (CBM) (1978 to 9 April 2015). For this updated review, we searched the Cochrane Library, MEDLINE, Embase, Science Citation Index Expanded, and CBM from 2015 to 28 August 2016.
SELECTION CRITERIA


We included all randomized controlled trials that compared abdominal drainage versus no drainage in people undergoing pancreatic surgery. We also included randomized controlled trials that compared different types of drains and different schedules for drain removal in people undergoing pancreatic surgery.
DATA COLLECTION AND ANALYSIS


We identified five trials (of 985 participants) which met our inclusion criteria. Two review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CI). For all analyses, we employed the random-effects model.
MAIN RESULTS


Drain use versus no drain useWe included three trials involving 711 participants who were randomized to the drainage group (N = 358) and the no drainage group (N = 353) after pancreatic surgery. There was inadequate evidence to establish the effect of drains on mortality at 30 days (2.2% with drains versus 3.4% no drains; RR 0.78, 95% CI 0.31 to 1.99; three studies; low-quality evidence), mortality at 90 days (2.9% versus 11.6%; RR 0.24, 95% CI 0.05 to 1.10; one study; low-quality evidence), intra-abdominal infection (7.3% versus 8.5%; RR 0.89, 95% CI 0.36 to 2.20; three studies; very low-quality evidence), wound infection (12.3% versus 13.3%; RR 0.92, 95% CI 0.63 to 1.36; three studies; low-quality evidence), morbidity (64.8% versus 62.0%; RR 1.04, 95% CI 0.93 to 1.16; three studies; moderate-quality evidence), length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies; moderate-quality evidence), or additional open procedures for postoperative complications (11.5% versus 9.1%; RR 1.18, 95% CI 0.55 to 2.52; three studies). There was one drain-related complication in the drainage group (0.6%). Type of drainWe included one trial involving 160 participants who were randomized to the active drain group (N = 82) and the passive drain group (N = 78) after pancreatic surgery. There was no evidence of differences between the two groups in mortality at 30 days (1.2% with active drain versus 0% with passive drain), intra-abdominal infection (0% versus 2.6%), wound infection (6.1% versus 9.0%; RR 0.68, 95% CI 0.23 to 2.05), morbidity (22.0% versus 32.1%; RR 0.68, 95% CI 0.41 to 1.15), or additional open procedures for postoperative complications (1.2% versus 7.7%; RR 0.16, 95% CI 0.02 to 1.29). The active drain group was associated with shorter length of hospital stay (MD -1.90 days, 95% CI -3.67 to -0.13; 14.1% decrease of an 'average' length of hospital stay) than in the passive drain group. The quality of evidence was low, or very low. Early versus late drain removalWe included one trial involving 114 participants with a low risk of postoperative pancreatic fistula who were randomized to the early drain removal group (N = 57) and the late drain removal group (N = 57) after pancreatic surgery. There was no evidence of differences between the two groups in mortality at 30 days (0% for both groups) or additional open procedures for postoperative complications (0% with early drain removal versus 1.8% with late drain removal; RR 0.33, 95% CI 0.01 to 8.01). The early drain removal group was associated with lower rates of postoperative complications (38.5% versus 61.4%; RR 0.63, 95% CI 0.43 to 0.93), shorter length of hospital stay (MD -2.10 days, 95% CI -4.17 to -0.03; 21.5% decrease of an 'average' length of hospital stay), and hospital costs (17.0% decrease of 'average' hospital costs) than in the late drain removal group. The quality of evidence for each of the outcomes was low.
AUTHORS' CONCLUSIONS


It is unclear whether routine abdominal drainage has any effect on the reduction of mortality and postoperative complications after pancreatic surgery. In case of drain insertion, low-quality evidence suggests that active drainage may reduce hospital stay after pancreatic surgery, and early removal may be superior to late removal for people with low risk of postoperative pancreatic fistula.",2016,"The active drain group was associated with shorter length of hospital stay (MD -1.90 days, 95% CI -3.67 to -0.13; 14.1% decrease of an 'average' length of hospital stay) than in the passive drain group.","['160 participants who were randomized to the active drain group (N = 82) and the passive drain group (N = 78) after pancreatic surgery', '711 participants who were randomized to the drainage group (N = 358) and the no drainage group (N = 353) after pancreatic surgery', '114 participants with a low risk of postoperative pancreatic fistula who were randomized to the early drain removal group (N = 57) and the late drain removal group (N = 57) after pancreatic surgery', 'pancreatic surgery', '985 participants) which met our inclusion criteria', '1946 to 9 April 2015), Embase (1980 to 9 April 2015), Science Citation Index Expanded (1900 to 9 April 2015), and Chinese Biomedical Literature Database (CBM) (1978 to 9 April 2015', 'people undergoing pancreatic surgery']","['Prophylactic abdominal drainage', 'abdominal drainage versus no drainage', 'prophylactic abdominal drainage']","['moderate-quality evidence), length of hospital stay', 'postoperative complications', 'drain-related complication', 'shorter length of hospital stay', 'hospital stay', 'intra-abdominal infection', ""average' length of hospital stay"", ""average' length of hospital stay), and hospital costs"", 'mortality', 'morbidity', 'wound infection', 'risk ratio (RR']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0456589', 'cui_str': '1978 (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",114.0,0.269392,"The active drain group was associated with shorter length of hospital stay (MD -1.90 days, 95% CI -3.67 to -0.13; 14.1% decrease of an 'average' length of hospital stay) than in the passive drain group.","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Immunology, College of Basic Medicine, Chongqing Medical University, No.1 Yixue Road, Chongqing, Chongqing, China, 450000.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Nansheng', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Sirong', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1514,23440811,Intravenous immunoglobulin as adjuvant therapy for Wegener's granulomatosis.,"BACKGROUND


Wegener's granulomatosis (WG) is a necrotizing small-vessel vasculitis that can affect any organ in the body but mainly affects the upper and lower respiratory tract, the kidneys, joints, skin and eyes. The current mainstay of remission induction therapy is systemic corticosteroids in combination with oral daily cyclophosphamide (CYC) which induces remission in 75% to 100% of cases. Although standard therapy is effective in inducing partial or complete remission, 50% of complete remissions are followed by at least one relapse. This is an update of a review first published in 2009.
OBJECTIVES


To determine if intravenous immunoglobulin (IVIg) adjuvant therapy provides a therapeutic advantage over and above treatment with systemic corticosteroids in combination with immunosuppressants for the treatment of WG.
SEARCH METHODS


For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched November 2012) and CENTRAL (2012, Issue 11). Trial databases were searched by the TSC for details of ongoing and unpublished studies. No date or language restrictions were applied.
SELECTION CRITERIA


Randomized controlled trials (RCTs), or quasi RCTs, or randomized cross-over trials. Participants had to be adults with a confirmed diagnosis of WG.
DATA COLLECTION AND ANALYSIS


Two authors independently extracted data and assessed trial quality. Relative risk was used to analyze dichotomous variables, and mean difference (MD) was used to analyze continuous variables.
MAIN RESULTS


We included one RCT with 34 participants who were randomly assigned to receive IVIg or placebo once daily in addition to azathioprine and prednisolone for remission maintenance. There were no significant differences between adjuvant IVIg and adjuvant placebo in mortality, serious adverse events, time to relapse, open-label rescue therapy, and infection rates. The fall in disease activity score, derived from patient-reported symptoms, was slightly greater in the IVIg group than in the placebo group at one month (MD 2.30; 95% Confidence interval (CI) 1.12 to 3.48, P < 0.01) and three months (MD 1.80; 95% CI 0.35 to 3.25, P = 0.01). There was a significant increase in total adverse events in the IVIg group (relative risk (RR) 3.50; 95% CI 1.44 to 8.48, P < 0.01).
AUTHORS' CONCLUSIONS


There is insufficient evidence from one RCT that IVIg adjuvant therapy provides a therapeutic advantage compared with the combination of steroids and immunosuppressants for patients with WG. Given the high cost of IVIg (one dose at 2 g/kg for a 70 kg patient = $8,400), it should be limited to treat WG in the context of a well conducted RCT powered to detect patient-relevant outcomes.",2013,"There were no significant differences between adjuvant IVIg and adjuvant placebo in mortality, serious adverse events, time to relapse, open-label rescue therapy, and infection rates.","[""Wegener's granulomatosis"", 'patients with WG', 'Participants had to be adults with a confirmed diagnosis of WG']","['Intravenous immunoglobulin', 'azathioprine and prednisolone', 'IVIg or placebo', 'placebo', 'intravenous immunoglobulin (IVIg) adjuvant therapy', 'cyclophosphamide (CYC']","['total adverse events', 'fall in disease activity score', 'mortality, serious adverse events, time to relapse, open-label rescue therapy, and infection rates']","[{'cui': 'C3495801', 'cui_str': 'Wegener Granulomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1.0,0.449267,"There were no significant differences between adjuvant IVIg and adjuvant placebo in mortality, serious adverse events, time to relapse, open-label rescue therapy, and infection rates.","[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Fortin', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, Canada. patricia@ti.ubc.ca.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Tejani', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bassett', 'Affiliation': ''}, {'ForeName': 'Vijaya M', 'Initials': 'VM', 'LastName': 'Musini', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007057.pub3']
1515,30601950,"Noninferiority of Simplified Dolutegravir Monotherapy Compared to Continued Combination Antiretroviral Therapy That Was Initiated During Primary Human Immunodeficiency Virus Infection: A Randomized, Controlled, Multisite, Open-label, Noninferiority Trial.","BACKGROUND


Patients who start combination antiretroviral therapy (cART) during primary human immunodeficiency virus type 1 (HIV-1) infection show a smaller HIV-1 latent reservoir, less immune activation, and less viral diversity compared to patients who start cART during chronic infection. We conducted a pilot study to determine whether these properties would allow sustained virological suppression after simplification of cART to dolutegravir monotherapy.
METHODS


EARLY-SIMPLIFIED is a randomized, open-label, noninferiority trial. Patients who started cART <180 days after a documented primary HIV-1 infection and had an HIV-1 RNA <50 copies/mL plasma for at least 48 weeks were randomized (2:1) to monotherapy with dolutegravir 50 mg once daily or to continuation of cART. The primary efficacy endpoint was the proportion of patients with <50 HIV-1 RNA copies/mL on or before week 48; noninferiority margin 10%.
RESULTS


Of the 101 patients randomized, 68 were assigned to simplification to dolutegravir monotherapy and 33 to continuation of cART. At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group vs 32/32 (100%) in the cART group (difference, 0.00%; 95% confidence interval, -100%, 4.76%). This showed noninferiority of the dolutegravir monotherapy at the prespecified level.
CONCLUSION


In this pilot study consisting of patients who initiated cART during primary HIV-1 infection and had <50 HIV-1 RNA copies/mL for at least 48 weeks, monotherapy with once-daily dolutegravir was noninferior to cART. Our results suggest that future simplification studies should use a stratification according to time of HIV infection and start of first cART.
CLINICAL TRIALS REGISTRATION


NCT02551523.",2019,"At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group versus 32/32 (100%) in the cART group (difference 0.00%, 95%-CI","['patients who initiated cART <180 days after the estimated day of a documented primary HIV-1 infection and had <50 HIV-1 RNA copies/mL for at least 48 weeks', '101 patients randomized']","['dolutegravir monotherapy', '95%-CI', 'started cART', 'simplified dolutegravir monotherapy', 'monotherapy with once-daily dolutegravir was non-inferior to cART', 'start combination antiretroviral therapy (cART', 'monotherapy with dolutegravir 50 mg once-daily or to continuation of cART']","['virological response', 'proportion of patients with <50 HIV-1 RNA copies/mL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",101.0,0.327696,"At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group versus 32/32 (100%) in the cART group (difference 0.00%, 95%-CI","[{'ForeName': 'Dominique L', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Teja', 'Initials': 'T', 'LastName': 'Turk', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tschumi', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grube', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hampel', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Depmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Schreiber', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Silvio D', 'Initials': 'SD', 'LastName': 'Brugger', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Greiner', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Steffens', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'De Torrenté-Bayard', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Courlet', 'Affiliation': 'Service of Clinical Pharmacology, University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Neumann', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Kuster', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Flepp', 'Affiliation': 'Center of Infectious Diseases Zurich, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Bertisch', 'Affiliation': 'Checkpoint Zurich, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Decosterd', 'Affiliation': 'Service of Clinical Pharmacology, University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Böni', 'Affiliation': 'Institute of Medical Virology, University of Zurich, Switzerland.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Metzner', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Kouyos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Huldrych F', 'Initials': 'HF', 'LastName': 'Günthard', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1131']
1516,30601976,Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial.,"BACKGROUND


We investigated whether dolutegravir (DTG) monotherapy could be used to maintain virological suppression in people living with human immunodeficiency virus (HIV) on a successful dolutegravir-based triple therapy.
METHODS


MONCAY (MONotherapy of TiviCAY) was a 48-week, multicentric, randomized, open-label, 12% noninferiority margin trial. Patients with CD4 nadir >100/μL, plasma HIV-1 RNA <50 copies/mL for ≥12 months, and stable regimen with DTG/abacavir (ABC)/lamivudine (3TC) were 1:1 randomized to continue their regimen or to DTG monotherapy. The primary endpoint was the proportion of patients with HIV RNA <50 copies/mL at week 24 in intention-to-treat snapshot analysis. Virologic failure (VF) was defined as 2 consecutive HIV RNA >50 copies/mL within 2 weeks apart.
RESULTS


Seventy-eight patients were assigned to DTG monotherapy and 80 to continue DTG/ABC/3TC. By week 24, 2 patients in the DTG group experienced VF without resistance to the integrase strand transfer inhibitor (INSTI) class; 1 patient discontinued DTG/ABC/3TC due to an adverse event. The success rate at week 24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm (difference, 2.7%; 95% confidence interval [CI], -5.0 to 10.8). During subsequent follow-up, 5 additional VFs occurred in the DTG arm (2 of which harbored emerging resistance mutation to INSTI). The cumulative incidence of VF at week 48 was 9.7% (95% CI, 2.8 to 16.6) in the DTG arm compared with 0% in the DTG/ABC/3TC arm (P = .005 by the log-rank test). The Data Safety Monitoring Board recommended to reintensify the DTG arm with standardized triple therapy.
CONCLUSIONS


Because the risk of VF with resistance increases over time, we recommend avoiding DTG monotherapy as a maintenance strategy among people living with chronic HIV infection.
CLINICAL TRIALS REGISTRATION


NCT02596334 and EudraCT 2015-002853-36.",2019,"The success rate at W24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm; difference 2.7%, 95% CI: -5.0 to 10.8.","['Seventy-eight patients', 'Patients with CD4 nadir>100/μL, plasma HIV-1 RNA', 'people living with HIV on a successful dolutegravir-based triple-therapy', 'virologically suppressed people living with chronic HIV infection', 'people living with chronic HIV infection']","['dolutegravir/abacavir/lamivudine (DTG/ABC/3TC', 'dolutegravir monotherapy', 'Dolutegravir monotherapy versus dolutegravir/abacavir/lamivudine']","['proportion of patients with HIV RNA', 'Virologic failure (VF', 'cumulative incidence of VF', 'success rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0853112', 'cui_str': 'Chronic infection with HIV'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",78.0,0.147554,"The success rate at W24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm; difference 2.7%, 95% CI: -5.0 to 10.8.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Hocqueloux', 'Affiliation': ""Service des Maladies Infectieuses et Tropicales, CHR d'Orléans-La Source, Tours.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Prazuck', 'Affiliation': ""Service des Maladies Infectieuses et Tropicales, CHR d'Orléans-La Source, Tours.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Service des Maladies Infectieuses, CHU Bretonneau, Tours.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sunder', 'Affiliation': 'Service des Maladies Infectieuses et Tropicales, CHG de Niort.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Esnault', 'Affiliation': 'Service des Maladies Infectieuses, CHD de Vendée, La Roche-sur-Yon.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rey', 'Affiliation': ""Le Trait d'Union, Hôpitaux Universitaires de Strasbourg.""}, {'ForeName': 'Gwenaël', 'Initials': 'G', 'LastName': 'Le Moal', 'Affiliation': 'Service des Maladies Infectieuses, CHU La Milétrie, Poitiers.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Roncato-Saberan', 'Affiliation': 'Service des Maladies Infectieuses, Groupe Hospitalier de La Rochelle-Ré-Aunis, Nancy.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'Service des Maladies Infectieuses, CHRU-Brabois, Nancy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Billaud', 'Affiliation': 'Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Valéry', 'Affiliation': ""Département d'Informatique Médicale, CHR d'Orléans-La Source, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Avettand-Fènoël', 'Affiliation': 'Laboratoire de Microbiologie clinique, CHU Necker and Université Paris Descartes, Sorbonne Paris Cité.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': ""Unité de Biostatistique et de Recherche Clinique, CHU de Caen; EA2656 Groupe de Recherche sur l'Adaptation Microbienne (GRAM 2.0), Université Caen Normandie, Caen, France.""}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Allavena', 'Affiliation': 'Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1132']
1517,30565793,Donepezil for gait and falls in mild cognitive impairment: a randomized controlled trial.,"BACKGROUND AND PURPOSE


Cognitive enhancers are commonly prescribed to people with Alzheimer's disease and related dementias to improve cognition and function. However, their effectiveness for individuals in the pre-stages of dementia, particularly in functional motor outcomes, remains unknown. We aimed to determine the efficacy of donepezil, a cognitive enhancer that improves cholinergic neurotransmission, on gait performance in mild cognitive impairment (MCI).
METHODS


This was a double-blind, placebo-controlled trial including 60 older adults with MCI, randomized to receive donepezil (10 mg/daily, maximal dose) or placebo. Primary outcome was gait speed (cm/s) under single and three dual-task conditions (counting backwards by 1 or 7 and naming animals) measured using an electronic walkway. Dual-task gait cost (DTC), a valid measure of motor-cognitive interaction, was calculated as the percentage change between single (S) and dual-task (D) gait speeds: [(S - D)/S] × 100. Secondary outcomes included attention, executive function, balance and falls.
RESULTS


After 6 months, the donepezil group experienced an improvement in dual-task gait speed (range 4-11 cm/s), although this was not statistically significant. The donepezil group showed a significant reduction in DTC (improvement) by counting backwards by 1 and 7 compared with placebo (10.25% vs. 1.75%, P = 0.048; 21.38% vs. 14.64%, P = 0.037, intention-to-treat analysis). Per-protocol analyses showed that all three DTCs improved in the donepezil group, along with a non-significant reduction of rate of falls.
CONCLUSIONS


Donepezil treatment improved dual-task gait speed and DTC in elderly patients with MCI. Our results support the concept of reducing falls in MCI by targeting the motor-cognitive interface.",2019,"The donepezil group showed a significant reduction in DTC (improvement) by counting backwards by 1 and 7 compared with placebo (10.25% vs. 1.75%, P = 0.048; 21.38% vs. 14.64%, P = 0.037, intention-to-treat analysis).","['60 older adults with MCI', 'elderly patients with MCI', 'mild cognitive impairment (MCI', 'mild cognitive impairment']","['donepezil', 'Donepezil', 'placebo']","['dual-task gait speed and DTC', 'gait speed (cm/s) under single and three dual-task conditions (counting backwards by 1 or 7 and naming animals) measured using an electronic walkway', 'rate of falls', 'Dual-task gait cost (DTC', 'dual-task gait speed', 'DTC', 'percentage change between single (S) and dual-task (D) gait speeds: [(S - D)/S', 'attention, executive function, balance and falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0439392', 'cui_str': 'cm/s'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",60.0,0.467072,"The donepezil group showed a significant reduction in DTC (improvement) by counting backwards by 1 and 7 compared with placebo (10.25% vs. 1.75%, P = 0.048; 21.38% vs. 14.64%, P = 0.037, intention-to-treat analysis).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montero-Odasso', 'Affiliation': 'Gait and Brain Lab, Parkwood Institute and Lawson Health Research Institute, University of Western Ontario, London, ON.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Speechley', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chertkow', 'Affiliation': 'Jewish General Hospital Memory Clinic, McGill University, Montreal, QC.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sarquis-Adamson', 'Affiliation': 'Gait and Brain Lab, Parkwood Institute and Lawson Health Research Institute, University of Western Ontario, London, ON.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borrie', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vanderhaeghe', 'Affiliation': ""Pharmacy Services, St Joseph's Health Care, London, ON.""}, {'ForeName': 'G Y', 'Initials': 'GY', 'LastName': 'Zou', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fraser', 'Affiliation': 'Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, QC.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': 'Department of Medicine, Université de Montréal and Montreal Heart Institute, Montreal, QC.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Muir-Hunter', 'Affiliation': 'Gait and Brain Lab, Parkwood Institute and Lawson Health Research Institute, University of Western Ontario, London, ON.'}]",European journal of neurology,['10.1111/ene.13872']
1518,27885650,Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.,"BACKGROUND


Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of Crohn's disease.
OBJECTIVES


The objectives of this review were to assess the efficacy and safety of anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
SEARCH METHODS


We searched the following databases from inception to 12 September 2016: PubMed, MEDLINE, EMBASE, and the Cochrane Library (CENTRAL). References and conference abstracts were searched to identify additional studies.
SELECTION CRITERIA


Randomized controlled trials (RCTs) trials in which monoclonal antibodies against IL-12/23p40 were compared to placebo or another active comparator in patients with active Crohn's disease were included.  DATA COLLECTION AND ANALYSIS: Two authors independently screened  studies for inclusion and extracted data. Methodological quality was assessed using the Cochrane risk of bias tool. The primary outcome was failure to induce clinical remission, defined as a Crohn's disease activity index (CDAI) of < 150 points. Secondary outcomes included failure to induce clinical improvement, adverse events, serious adverse events, and withdrawals due to adverse events. Clinical improvement was defined as decreases of > 70 or > 100 points in the CDAI from baseline. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for each outcome. Data were analyzed on an intention-to-treat basis. The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria.
MAIN RESULTS


Six RCTs (n = 2324 patients) met the inclusion criteria. A low risk of bias was assigned to all studies. The two briakinumab trials were not pooled due to differences in doses and time points for analysis. In both studies there was no statistically significant difference in remission rates. One study (n = 79) compared doses of 1 mg/kg and 3 mg/kg to placebo. In the briakinumab group 70% (44/63) of patients failed to enter clinical remission at 6 or 9 weeks compared to 81% (13/16) of placebo patients (RR 0.86, 95% CI 0.65 to 1.14). Subgroup analysis revealed no significant differences by dose. The other briakinumab study (n = 230) compared intravenous doses of 200 mg, 400 mg and 700 mg with placebo. Eighty-four per cent (154/184) of briakinumab patients failed to enter clinical remission at six weeks compared to 91% (42/46) of placebo patients (RR 0.92, 95% CI 0.83 to 1.03). Subgroup analysis revealed no significant differences by dose. GRADE analyses of the briakinumab studies rated the overall quality of the evidence for the outcome clinical remission as low. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication. The ustekinumab studies were pooled despite differences in intravenous doses (i.e. 1mg/kg, 3 mg/kg, 4.5 mg/kg, and 6 mg/kg), however the subcutaneous dose group was not included in the analysis, as it was unclear if subcutaneous was equivalent to intravenous dosing. There was a statistically significant difference in remission rates. At week six, 84% (764/914) of ustekinumab patients failed to enter remission compared to 90% (367/406) of placebo patients (RR 0.92, 95% CI 0.88 to 0.96; 3 studies; high-quality evidence). Subgroup analysis showed a statistically significant difference for the 6.0 mg/kg dose group (moderate-quality evidence). There were statistically significant differences in clinical improvement between ustekinumab and placebo-treated patients. In the ustekinumab group, 55% (502/914) of patients failed to improve clinically (i.e. 70-point decline in CDAI score), compared to 71% (287/406) of placebo patients (RR 0.78, 95% CI 0.71 to 0.85; 3 studies). Subgroup analysis revealed significant differences compared to placebo for the 1 mg/kg, 4.5 mg/kg and 6 mg/kg dosage subgroups. Similarly for a 100-point decline in CDAI, 64% (588/914) of patients in the ustekinumab group failed to improve clinically compared to 78% (318/406) of placebo patients (RR 0.82, 95% CI 0.77 to 0.88; 3 studies; high-quality evidence). Subgroup analysis showed a significant difference compared to placebo for the 4.5 mg/kg and 6.0 mg/kg (high-quality evidence) dose groups. There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events. Sixty-two per cent (860/1386) of ustekinumab patients developed at least one adverse event compared to 64% (407/637) of placebo patients (RR 0.97, 95% CI 0.90 to 1.04; 4 studies; high-quality evidence). Five per cent (75/1386) of ustekinumab patients had a serious adverse event compared to 6% (41/637) of placebo patients (RR 0.83, 95% CI 0.58 to 1.20; 4 studies; moderate-quality evidence). The most common adverse events in briakinumab patients were injection site reactions and infections. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious adverse events.
AUTHORS' CONCLUSIONS


High quality evidence suggests that ustekinumab is effective for induction of clinical remission and clinical improvement in patients with moderate to severe Crohn's disease. Moderate to high quality evidence suggests that the optimal dosage of ustekinumab is 6 mg/kg. Briakinumab and ustekinumab appear to be safe. Moderate quality evidence suggests no increased risk of serious adverse events. Future studies are required to determine the long-term efficacy and safety of ustekinumab in patients with moderate to severe Crohn's disease.",2016,"There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events.","[""patients with active Crohn's disease were included"", ""Crohn's disease"", 'Six RCTs (n = 2324 patients) met the inclusion criteria', ""patients with moderate to severe Crohn's disease""]","['placebo', 'ustekinumab', 'Anti-IL-12/23p40 antibodies', 'anti-IL-12/23p40 antibodies', 'Briakinumab and ustekinumab']","[""Worsening of Crohn's disease and serious infections"", 'CDAI score', 'serious adverse event', 'clinical improvement', ""failure to induce clinical remission, defined as a Crohn's disease activity index (CDAI"", 'risk of serious adverse events', 'failure to induce clinical improvement, adverse events, serious adverse events, and withdrawals due to adverse events', 'clinical remission', 'Methodological quality', 'enter remission', 'efficacy and safety', 'adverse event', 'remission rates', 'incidence of adverse events, serious adverse events or withdrawal due to adverse events', 'risk ratio (RR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2744325', 'cui_str': 'briakinumab'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index (assessment scale)""}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",2324.0,0.709342,"There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events.","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Cochrane IBD Group, Robarts Clinical Trials, 100 Dundas Street, Suite 200, London, ON, Canada, N6A 5B6.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Timmer', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1519,17054213,Early intervention for psychosis.,"BACKGROUND


Proponents of early intervention have argued that outcome might be improved if more therapeutic efforts were focused on the early stages of schizophrenia or on people with prodromal symptoms. Early intervention in schizophrenia has two elements that are distinct from standard care: early detection and phase-specific treatment. Both elements may be offered as supplements to standard care, or may be provided through a specialised early intervention team. Early intervention is now well established as a therapeutic approach in America, Europe and Australasia, but it is unclear how far early detection, phase-specific treatments, and the use of early intervention teams are underpinned by evidence of effectiveness.
OBJECTIVES


To evaluate the effects of: (a) early detection; (b) phase-specific treatments; and (c) specialised early intervention teams in the treatment of people with prodromal symptoms or first episode psychosis.
SEARCH STRATEGY


We searched CINAHL (1982-2002), The Cochrane Controlled Trials Register (November 2001), The Cochrane Schizophrenia Group Register (July 2003), EMBASE (1980-2002), MEDLINE (1966-2002), PsycINFO (1967-2002), reference lists and contacted the European First Episode Network (2003). For the 2006 update we searched the Cochrane Schizophrenia Group's register.
SELECTION CRITERIA


We included all randomised controlled trials designed to prevent progression to psychosis in people showing prodromal symptoms, or to improve outcome for people with first episode psychosis. Eligible interventions, alone and in combination, included early detection, phase-specific treatments, and care from specialised early intervention teams. We accepted cluster-randomised trials but excluded non-randomised trials.
DATA COLLECTION AND ANALYSIS


We reliably selected studies, quality rated them and extracted data. For dichotomous data, we estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we calculated the number needed to treat/harm statistic (NNT/H) and used intention-to-treat analysis (ITT).
MAIN RESULTS


We included seven studies with a total of 941 participants. Six studies were small with numbers of participants ranging between 56 and 83, and one study randomised 547 people. None of the studies had similar interventions and therefore they were analysed separately. One small Australian trial (n=59) was concerned with a phase-specific intervention (low dose risperidone and cognitive behavioural therapy) for people with prodromal symptoms. This group were significantly less likely to develop psychosis at a six month follow up than people who only received care from a specialised team which did not involve phase-specific treatment (n=59, RR 0.27 CI 0.1 to 0.9, NNT 4 CI 2 to 20). This effect was not significant at 12 month follow up (n=59, 1 RCT, RR 0.54 CI 0.2 to 1.3). A UK-based study (EDIE) randomised 60 people with prodromal symptoms, to cognitive behavioural therapy (CBT) or a monitoring group. Only two outcomes were reported: leaving the study early and transition to psychosis, both sets of data were non-significant. A Chinese trial used a phase-specific intervention (family therapy) plus out patient care trial for people in their first episode of psychosis and found reduced admission rates care compared with those who received only outpatient care (n=83, RR 0.28 CI 0.1 to 0.6, NNT 3 CI 2 to 6). The applicability of this finding was, however, questionable. One Dutch study (n=76) comparing phase-specific intervention (family therapy) plus specialised team with specialised team for people in their first episode of schizophrenia found no difference between intervention and control groups at 12 months for the outcome of relapse (n=76, RR 1.05 CI 0.4 to 3.0). The large Scandinavian study (n=547) allocated people with first episode schizophrenia to integrated treatment (assertive community treatment plus family therapy, social skills training and a modified medication regime) or standard care. Global state outcome GAF significantly favoured integrated treatment (n=419, WMD -3.71 CI -6.7 to -0.7) by one year, but by two years data were non-significant. Rates of attrition were significantly lower (n=547, RR 0.59 CI 0.4 to 0.8, NNT 9 CI 6 to 18) for integrated treatment by one and two year follow-up. PRIME (USA) was the only double blind study and allocated people with prodromal symptoms to olanzapine or placebo. No significant differences were found between olanzapine and placebo in preventing conversion to psychosis by about 12 months (n=60, RR 0.58 CI 0.3 to 1.2). Clinical Global Impression change scores 'severity of illness' were equivocal by 12 months. Scale of Prodromal Symptoms (SOPS) scores were also equivocal and the PANSS, total, positive and negative outcomes were non-significant. There were no significant differences between the olanzapine and placebo group on adverse effects rating scales - SAS, BAS and AIMS scores; Weight gain was significantly higher in the olanzapine group (n=59, WMD 7.63 CI 4.0 to 11.2) by 12 months. Finally one more Australian study included people in their first episode of psychosis who were acutely suicidal and allocated people to phase-specific cognitively orientated therapy or standard care. Outcome data for leaving the study early and suicide were equivocal.
AUTHORS' CONCLUSIONS


We identified insufficient trials to draw any definitive conclusions. The substantial international interest in early intervention offers an opportunity to make major positive changes in psychiatric practice, but making the most of this opportunity requires a concerted international programme of research to address key unanswered questions.",2006,"Global state outcome GAF significantly favoured integrated treatment (n=419, WMD -3.71 CI -6.7 to -0.7) by one year, but by two years data were non-significant.","['people with prodromal symptoms or first episode psychosis', 'people with first episode psychosis', 'seven studies with a total of 941 participants', 'The large Scandinavian study (n=547) allocated people with first episode schizophrenia to', 'Six studies were small with numbers of participants ranging between 56 and 83, and one study randomised 547 people', 'people with prodromal symptoms', 'Finally one more Australian study included people in their first episode of psychosis who were acutely suicidal and allocated people to phase-specific cognitively orientated therapy or standard care', '60 people with prodromal symptoms, to cognitive behavioural therapy (CBT) or a monitoring group']","['placebo', 'integrated treatment (assertive community treatment plus family therapy, social skills training and a modified medication regime) or standard care', 'olanzapine or placebo', 'phase-specific intervention (family therapy) plus specialised team with specialised team', 'olanzapine', 'specific intervention (low dose risperidone and cognitive behavioural therapy']","['adverse effects rating scales - SAS, BAS and AIMS scores; Weight gain', 'Rates of attrition', 'Scale of Prodromal Symptoms (SOPS) scores', 'Global state outcome GAF', 'conversion to psychosis']","[{'cui': 'C3494358', 'cui_str': 'Prodromal Syndromes'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0424013', 'cui_str': 'Orientated (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}, {'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C3494358', 'cui_str': 'Prodromal Syndromes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]",941.0,0.122507,"Global state outcome GAF significantly favoured integrated treatment (n=419, WMD -3.71 CI -6.7 to -0.7) by one year, but by two years data were non-significant.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'The Lantern Centre, Vicarage Lane, Of Watling Street Road, Fulwood, Preston, Lancashire, UK. max.marshall@manchester.ac.uk'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rathbone', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1520,17636718,WITHDRAWN: Eletriptan for acute migraine.,"BACKGROUND


Eletriptan (Relpax) is a new triptan soon to be made available by prescription for the treatment of acute migraine. Currently five triptans are available by prescription and more are under development. In light of the many drugs for treating acute migraine, there is a need for evidence-based assessments to help determine the relative efficacy and harm of these treatments.
OBJECTIVES


To determine the efficacy of eletriptan for treating a single migraine attack using the outcomes of headache response and pain-free response at 0.5, 1, 2 and 4 hours, and sustained relief over 24 hours. To express efficacy in terms of number-needed-to-treat (NNT). To determine the adverse effects of a single dose of eletriptan and express this in terms of number-needed-to-harm (NNH). To allow for the comparison of the efficacy of eletriptan with other migraine treatments evaluated systematically in the same way.
SEARCH STRATEGY


Data from all Phase III randomised placebo-controlled trials were made available by the manufacturer, Pfizer Inc. To date, these trials comprise the only data on eletriptan relevant to this review in a published or unpublished form; thus, searches of electronic databases for further trials of eletriptan were not conducted. Date of last search: January 2000.
SELECTION CRITERIA


Trials of eletriptan for acute migraine; randomised allocation to treatment groups, including a placebo group; double-blind design; International Headache Society diagnostic criteria for migraine with or without aura; single migraine attack; single-dose treatment at standard doses; adult population; baseline pain of moderate or severe intensity using a 4-point standardised rating scale (0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain); and dichotomous or percentage data for at least one of the main efficacy outcomes.
DATA COLLECTION AND ANALYSIS


Trials were scored for quality and data extracted by two independent reviewers. Dichotomous or percentage data were extracted and pooled to calculate the relative benefit (RB) or relative risk (RR) and NNTs or NNHs for a number of outcomes for eletriptan 20 mg, 40 mg and 80 mg. The main outcomes considered were headache response at 1 and 2 hours, pain-free response at 2 hours, sustained relief over 24 hours and adverse effects. Minor outcomes considered were headache response at 0.5 and 4 hours, and pain-free response at 0.5, 1 and 4 hours.
MAIN RESULTS


Six trials met the inclusion criteria. Significant benefit of eletriptan over placebo was shown for eletriptan 20 mg, 40 mg and 80 mg for the primary efficacy outcomes of headache response and pain-free response at 2 hours. For headache response at 2 hours, the NNTs (with 95% confidence intervals) were 4.4 (3.4 to 6.2), 2.9 (2.6 to 3.3) and 2.6 (2.4 to 3.0) for eletriptan 20 mg, 40 mg and 80 mg, respectively. For pain-free response at 2 hours, the NNTs were 9.9 (6.9 to 18), 4.0 (3.6 to 4.5) and 3.7 (3.4 to 4.2), for eletriptan 20 mg, 40 and 80 mg, respectively. There was no significant difference in the incidence of major adverse effects between any dose of eletriptan and placebo. The incidence of minor adverse effects was significantly higher for all eletriptan doses than for placebo, with NNHs of 11 (95% confidence interval, 6.2 to 39), 7.0 (5.2 to 11) and 3.7 (3.1 to 4.5) for eletriptan 20 mg, 40 mg and 80 mg, respectively.
AUTHORS' CONCLUSIONS


Eletriptan 20 mg, 40 mg and 80 mg are effective for the treatment of an acute migraine attack. Effectiveness is dose-related, with statistically significant differences between doses for pain-free response and 24-hour outcomes. Eletriptan compares well with other triptans available for outcomes measured up to 2 hours and provides meaningful relief for 24 hours. Taken as a single dose, eletriptan was well tolerated and caused no major harm. The incidence of minor harm was dose-dependent, with 80 mg giving significantly more adverse effects than 40 mg.",2007,Eletriptan compares well with other triptans available for outcomes measured up to 2 hours and provides meaningful relief for 24 hours.,"['acute migraine', 'group; double-blind design; International Headache Society diagnostic criteria for migraine with or without aura; single migraine attack; single-dose treatment at standard doses; adult population; baseline pain of moderate or severe intensity using a 4-point standardised rating scale (0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain']","['eletriptan', 'Eletriptan', 'Eletriptan (Relpax', 'placebo']","['headache response and pain-free response', 'incidence of minor adverse effects', 'adverse effects', 'headache response at 1 and 2 hours, pain-free response at 2 hours, sustained relief over 24 hours and adverse effects', 'pain-free response', 'headache response', 'incidence of major adverse effects', 'relative benefit (RB) or relative risk (RR) and NNTs or NNHs']","[{'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0222045'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]","[{'cui': 'C0759933', 'cui_str': 'eletriptan'}, {'cui': 'C1171655', 'cui_str': 'Relpax'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.274373,Eletriptan compares well with other triptans available for outcomes measured up to 2 hours and provides meaningful relief for 24 hours.,"[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Smith', 'Affiliation': 'Oxford Brookes University, School of Health and Social Care, Jack Straws Lane, Marston, Oxford, UK, OX3 0FL. lesleysmith@brookes.ac.uk'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Oldman', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'McQuay', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Moore', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1521,15495017,Galantamine for Alzheimer's disease.,"BACKGROUND


Galantamine is a specific, competitive, and reversible acetylcholinesterase inhibitor.
OBJECTIVES


To assess the clinical effects of galantamine in patients with probable or possible Alzheimer's disease (AD), and potential moderators of effect.
SEARCH STRATEGY


The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group, last updated on 25 August 2005 using the terms galanthamin*, galantamin* and Reminyl. Published reviews were inspected for further sources. Additional information was collected from unpublished clinical research reports for galantamine obtained from Janssen.
SELECTION CRITERIA


Trials selected were randomised, double-blind, parallel-group comparisons of galantamine with placebo for a treatment duration of greater than 4 weeks in subjects with AD.
DATA COLLECTION AND ANALYSIS


Data were extracted independently by the reviewers and pooled where appropriate and possible. Outcomes of interest include the clinical global impression of change (CIBIC-plus or CGIC), Alzheimer's Disease Assessment Scale-cognitive sub scale (ADAS-cog), Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL), Disability Assessment for Dementia scale (DAD) and Neuropsychiatric Inventory (NPI). Potential moderating variables of treatment effect assessed included trial duration, dose, and diagnosis of possible vs. probable Alzheimer's disease.
MAIN RESULTS


Seven trials with a total 3777 subjects were included in the analysis. Treatment with galantamine led to a significantly greater proportion of subjects with improved or unchanged global rating scale rating (k=7), at all dosing levels except for 8mg/d . Confidence intervals for the ORs overlapped across the dose range of 16mg to 36mg per day, with point estimates of 1.6-2.1 when analysed with the intention-to-treat sample. Treatment with galantamine also led to significantly greater reduction in ADAS-cog score at all dosing levels (k=7), with greater effect over 6 months compared to 3 months. Confidence intervals again overlapped. Point estimate of effect was lower for 8mg/d but similar for 16mg to 36mg per day. For example, treatment effect for 24mg/d over 6 months was 3.1point reduction in ADAS-cog (95%CI 2.6-3.7, k=4, ITT).ADCS-ADL, DAD and NPI were reported only in a small proportion of trials: all showed significant treatment effect in some individual trials at least. Confidence interval of treatment effect for the one trial recruiting patients with possible AD overlapped with the other six recruiting patients with probable AD. Galantamine's adverse effects appeared similar to those of other cholinesterase inhibitors and to be dose related.
REVIEWERS' CONCLUSIONS


Subjects in these trials were similar to those seen in earlier anti dementia AD trials, consisting primarily of mildly to moderately impaired outpatients. Galantamine's effect on more severely impaired subjects has not yet been assessed.Nevertheless, this review shows consistent positive effects for galantamine for trials of 3 to 6 months duration. Although there was not a statistically significant dose-response effect, doses above 8mg/d were, for the most part, consistently statistically significant. Galantamine's safety profile is similar to that of other cholinesterase inhibitors with respect to cholinergically mediated gastrointestinal symptoms. It appears that doses of 16 mg/d were best tolerated in the single trial where medication was titrated over a 4 week period, and because this dose showed statistically indistinguishable efficacy with higher doses, it is probably most preferable initially. Longer term use of galantamine has not been assessed in a controlled fashion.",2004,"Treatment with galantamine also led to significantly greater reduction in ADAS-cog score at all dosing levels (k=7), with greater effect over 6 months compared to 3 months.","['subjects with AD', ""patients with probable or possible Alzheimer's disease (AD"", ""Alzheimer's disease"", 'Seven trials with a total 3777 subjects were included in the analysis']","['galantamine with placebo', 'galantamine', 'Galantamine']","['proportion of subjects with improved or unchanged global rating scale rating', 'ADAS-cog', 'ADAS-cog score', ""clinical global impression of change (CIBIC-plus or CGIC), Alzheimer's Disease Assessment Scale-cognitive sub scale (ADAS-cog), Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL), Disability Assessment for Dementia scale (DAD) and Neuropsychiatric Inventory ""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",3777.0,0.37238,"Treatment with galantamine also led to significantly greater reduction in ADAS-cog score at all dosing levels (k=7), with greater effect over 6 months compared to 3 months.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loy', 'Affiliation': 'Department of Public Health and Community Medicine, University of Sydney, Edward Ford Building, Sydney, NSW, Australia, 2006.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1522,12917950,Memantine for dementia.,"BACKGROUND


Alzheimer's disease, vascular and mixed dementia are the three commonest forms of dementia affecting older people. There is evidence that the excitatory activity of L-glutamate plays a role in the pathogenesis of Alzheimer's disease and in the damage from an ischaemic stroke. A low affinity antagonist to N-Methyl-D-aspartate (NMDA) type receptors, such as memantine, may prevent excitatory amino acid neurotoxicity without interfering with the physiological actions of glutamate required for memory and learning.
OBJECTIVES


To determine the clinical efficacy and safety of memantine for people with Alzheimer's disease, or vascular or mixed dementia.
SEARCH STRATEGY


Trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 15 April 2003 using the terms: memantin*, D-145, DMAA, DRG-0267. All major health care databases and trial databases within the scope of the group are searched regularly to keep this Register up to date.
SELECTION CRITERIA


Double-blind, parallel group, placebo-controlled, randomized and unconfounded trials in which memantine was administered to people with dementia.
DATA COLLECTION AND ANALYSIS


Data were extracted, pooled where possible, and weighted mean differences, standardized mean differences or odds ratios were estimated. Intention-to-treat (ITT) and observed cases (OC) analyses are reported, where data were available.
MAIN RESULTS


Effect of memantine in patients with moderate to severe Alzheimer's disease: analysis of the change from baseline at 28 weeks gave statistically significant results in favour of memantine for 20 mg/day on cognition (MD: 6.1. 95% CI 2.99 to 9.21, P=0.0001) activities of daily living (MD 2.10, 95% CI 0.46 to 3.74, p=0.01) and in the global clinical impression of change measured by the CIBIC-Plus at 28 weeks (MD -0.30, 95% CI -0.58 to -0.02, p=0.04), in all cases the analysis was the ITT-LOCF population (Reisberg 2000). There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of memantine for the number who suffer agitation. Effect of memantine in patients with mild to moderate vascular dementia: analysis of the change from baseline at 28 weeks gave statistically significant results in favour of memantine ( 20 mg/day ) for cognition (MD -2.19, 95% CI -3.16 to -1.21, P<0.0001) but there was no benefit for the clinical impression of change, or for global measures of dementia (MMM300, and MMM500). There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of memantine for the number who suffer agitation. Effect of memantine in patients with Alzheimer's disease and vascular dementia at 12 weeks: there was no statistically significant difference between memantine (10 mg/day) and placebo in activities of daily living. There was a benefit in favour of memantine (10 mg/day) compared with placebo at 12 weeks, for the numbers improved in terms of clinical impression of change (60/82 compared with 38/84 - OR 3.30, 95% CI 1.72 to 6.33, P=0.0003) (Winblad 1999). Effect of memantine in patients with vascular dementia, Alzheimer's disease and dementia of non-specified type at 6 weeks: there were beneficial effects on cognition (Ditzler 1991), activities of daily living (Ditzler 1991, Pantev 1993), behaviour (Pantev 1993) and global scales (Gortelmeyer 1992; Pantev 1993; Ditzler 1991) and in global impression of change (Gortelmeyer 1992; Ditzler 1991). There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of placebo for the number who suffer restlessness.
REVIEWER'S CONCLUSIONS


There is a beneficial effect of memantine (20 mg/day) for patients with moderate to severe Alzheimer disease on cognition and functional decline but not in the clinical impression of change. Patifor patients with moderate to severe Alzheimer disease on cognition and functional decline but not in the clinical impression of change. Patients with mild to moderate vascular dementia receiving memantine 20 mg/day had less cognitive deterioration at 28 weeks but again this effect was not clinically discernible. There is a possible beneficial effect on cognition, function and global scales for memantine at 6 weeks in mixed populations. The drug is well tolerated and the incidence of adverse effects is low. More studies are needed.",2003,"There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of memantine for the number who suffer agitation.","[""patients with moderate to severe Alzheimer's disease"", 'patients with moderate to severe Alzheimer disease', 'patients with mild to moderate vascular dementia', ""patients with Alzheimer's disease and vascular dementia at 12 weeks"", ""patients with vascular dementia, Alzheimer's disease and dementia of non-specified type at 6 weeks"", ""people with Alzheimer's disease, or vascular or mixed dementia"", 'Patients with mild to moderate vascular dementia receiving', 'people with dementia', 'Patifor patients with moderate to severe Alzheimer disease on']","['Memantine', 'memantine', 'placebo']","['cognitive deterioration', 'cognition and functional decline', 'clinical impression of change', 'cognition, function and global scales', 'activities of daily living', 'number of drop-outs and total number of adverse effects', 'Intention-to-treat (ITT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011269', 'cui_str': 'Dementia, Vascular'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3532942', 'cui_str': 'Dementia with mixed etiology'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",,0.469189,"There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of memantine for the number who suffer agitation.","[{'ForeName': 'Sastre A', 'Initials': 'SA', 'LastName': 'Areosa', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sherriff', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1523,29923184,Donepezil for dementia due to Alzheimer's disease.,"BACKGROUND


Alzheimer's disease is the most common cause of dementia in older people. One approach to symptomatic treatment of Alzheimer's disease is to enhance cholinergic neurotransmission in the brain by blocking the action of the enzyme responsible for the breakdown of the neurotransmitter acetylcholine. This can be done by a group of drugs known as cholinesterase inhibitors. Donepezil is a cholinesterase inhibitor.This review is an updated version of a review first published in 1998.
OBJECTIVES


To assess the clinical efficacy and safety of donepezil in people with mild, moderate or severe dementia due to Alzheimer's disease; to compare the efficacy and safety of different doses of donepezil; and to assess the effect of donepezil on healthcare resource use and costs.
SEARCH METHODS


We searched Cochrane Dementia and Cognitive Improvement's Specialized Register, MEDLINE, Embase, PsycINFO and a number of other sources on 20 May 2017 to ensure that the search was as comprehensive and up-to-date as possible. In addition, we contacted members of the Donepezil Study Group and Eisai Inc.
SELECTION CRITERIA


We included all double-blind, randomised controlled trials in which treatment with donepezil was administered to people with mild, moderate or severe dementia due to Alzheimer's disease for 12 weeks or more and its effects compared with those of placebo in a parallel group of patients, or where two different doses of donepezil were compared.
DATA COLLECTION AND ANALYSIS


One reviewer (JSB) extracted data on cognitive function, activities of daily living, behavioural symptoms, global clinical state, quality of life, adverse events, deaths and healthcare resource costs. Where appropriate and possible, we estimated pooled treatment effects. We used GRADE methods to assess the quality of the evidence for each outcome.
MAIN RESULTS


Thirty studies involving 8257 participants met the inclusion criteria of the review, of which 28 studies reported results in sufficient detail for the meta-analyses. Most studies were of six months' duration or less. Only one small trial lasted 52 weeks. The studies tested mainly donepezil capsules at a dose of 5 mg/day or 10 mg/day. Two studies tested a slow-release oral formulation that delivered 23 mg/day. Participants in 21 studies had mild to moderate disease, in five studies moderate to severe, and in four severe disease. Seventeen studies were industry funded or sponsored, four studies were funded independently of industry and for nine studies there was no information on source of funding.Our main analysis compared the safety and efficacy of donepezil 10 mg/day with placebo at 24 to 26 weeks of treatment. Thirteen studies contributed data from 3396 participants to this analysis. Eleven of these studies were multicentre studies. Seven studies recruited patients with mild to moderate Alzheimer's disease, two with moderate to severe, and four with severe Alzheimer's disease, with a mean age of about 75 years. Almost all evidence was of moderate quality, downgraded due to study limitations.After 26 weeks of treatment, donepezil compared with placebo was associated with better outcomes for cognitive function measured with the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog, range 0 to 70) (mean difference (MD) -2.67, 95% confidence interval (CI) -3.31 to -2.02, 1130 participants, 5 studies), the Mini-Mental State Examination (MMSE) score (MD 1.05, 95% CI 0.73 to 1.37, 1757 participants, 7 studies) and the Severe Impairment Battery (SIB, range 0 to 100) (MD 5.92, 95% CI 4.53 to 7.31, 1348 participants, 5 studies). Donepezil was also associated with better function measured with the Alzheimer's Disease Cooperative Study activities of daily living score for severe Alzheimer's disease (ADCS-ADL-sev) (MD 1.03, 95% CI 0.21 to 1.85, 733 participants, 3 studies). A higher proportion of participants treated with donepezil experienced improvement on the clinician-rated global impression of change scale (odds ratio (OR) 1.92, 95% CI 1.54 to 2.39, 1674 participants, 6 studies). There was no difference between donepezil and placebo for behavioural symptoms measured by the Neuropsychiatric Inventory (NPI) (MD -1.62, 95% CI -3.43 to 0.19, 1035 participants, 4 studies) or by the Behavioural Pathology in Alzheimer's Disease (BEHAVE-AD) scale (MD 0.4, 95% CI -1.28 to 2.08, 194 participants, 1 study). There was also no difference between donepezil and placebo for Quality of Life (QoL) (MD -2.79, 95% CI -8.15 to 2.56, 815 participants, 2 studies).Participants receiving donepezil were more likely to withdraw from the studies before the end of treatment (24% versus 20%, OR 1.25, 95% CI 1.05 to 1.50, 2846 participants, 12 studies) or to experience an adverse event during the studies (72% vs 65%, OR 1.59, 95% 1.31 to 1.95, 2500 participants, 10 studies).There was no evidence of a difference between donepezil and placebo for patient total healthcare resource utilisation.Three studies compared donepezil 10 mg/day to donepezil 5 mg/day over 26 weeks. The 5 mg dose was associated with slightly worse cognitive function on the ADAS-Cog, but not on the MMSE or SIB, with slightly better QoL and with fewer adverse events and withdrawals from treatment. Two studies compared donepezil 10 mg/day to donepezil 23 mg/day. There were no differences on efficacy outcomes, but fewer participants on 10 mg/day experienced adverse events or withdrew from treatment.
AUTHORS' CONCLUSIONS


There is moderate-quality evidence that people with mild, moderate or severe dementia due to Alzheimer's disease treated for periods of 12 or 24 weeks with donepezil experience small benefits in cognitive function, activities of daily living and clinician-rated global clinical state. There is some evidence that use of donepezil is neither more nor less expensive compared with placebo when assessing total healthcare resource costs. Benefits on 23 mg/day were no greater than on 10 mg/day, and benefits on the 10 mg/day dose were marginally larger than on the 5 mg/day dose, but the rates of withdrawal and of adverse events before end of treatment were higher the higher the dose.",2018,"There was no difference between donepezil and placebo for behavioural symptoms measured by the Neuropsychiatric Inventory (NPI) (MD -1.62, 95% CI -3.43 to 0.19, 1035 participants, 4 studies) or by the Behavioural Pathology in Alzheimer's Disease (BEHAVE-AD) scale (MD 0.4, 95% CI -1.28 to 2.08, 194 participants, 1 study).","[""people with mild, moderate or severe dementia due to Alzheimer's disease for 12 weeks or more and its effects compared with those of"", 'MD 1.05, 95% CI 0.73 to 1.37, 1757 participants, 7 studies) and the Severe Impairment Battery (SIB, range 0 to 100) (MD 5.92, 95% CI 4.53 to 7.31, 1348 participants, 5 studies', '3396 participants to this analysis', 'Seventeen studies were industry funded or sponsored, four studies were funded independently of industry and for nine studies there was no information on source of funding', ""dementia due to Alzheimer's disease"", ""people with mild, moderate or severe dementia due to Alzheimer's disease"", ""people with mild, moderate or severe dementia due to Alzheimer's disease treated for periods of 12 or 24 weeks with"", 'Thirty studies involving 8257 participants met the inclusion criteria', ""Seven studies recruited patients with mild to moderate Alzheimer's disease, two with moderate to severe, and four with severe Alzheimer's disease, with a mean age of about 75 years""]","['donepezil and placebo', 'donepezil', 'Donepezil', 'placebo']","['cognitive function', 'safety and efficacy', ""Alzheimer's Disease Assessment Scale-Cognitive"", 'cognitive function, activities of daily living and clinician-rated global clinical state', 'clinician-rated global impression of change scale', 'efficacy outcomes', 'clinical efficacy and safety', 'healthcare resource use and costs', 'adverse events', 'rates of withdrawal and of adverse events', 'Quality of Life (QoL', 'cognitive function, activities of daily living, behavioural symptoms, global clinical state, quality of life, adverse events, deaths and healthcare resource costs', 'behavioural symptoms', 'Mini-Mental State Examination (MMSE) score']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0376244', 'cui_str': 'funding'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]",8257.0,0.612948,"There was no difference between donepezil and placebo for behavioural symptoms measured by the Neuropsychiatric Inventory (NPI) (MD -1.62, 95% CI -3.43 to 0.19, 1035 participants, 4 studies) or by the Behavioural Pathology in Alzheimer's Disease (BEHAVE-AD) scale (MD 0.4, 95% CI -1.28 to 2.08, 194 participants, 1 study).","[{'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Birks', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, UK, OX3 7LD.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Harvey', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001190.pub3']
1524,30308538,Twenty-four hour versus extended antibiotic administration after surgery in complicated appendicitis: A randomized controlled trial.,"BACKGROUND


Recent investigations noted noninferiority in short-course antimicrobial treatments following source control in abdominal infections. We set out to investigate noninferiority of a short and fixed (24 hours) antibiotic administration compared to extended treatment after source control in complicated appendicitis in a prospective single-center open-label randomized controlled trial.
METHODS


After Institutional Review Board (IRB) approval, all consecutive adult patients (age, ≥ 18 years) with complicated appendicitis including gangrenous appendicitis, perforated appendicitis, and appendicitis with periappendicular abscess between May 2016 and February 2018 were randomly allocated to antibacterial therapy limited to 24 hours (short) vs. >24 hours (extended) administration after appendectomy. Primary outcomes included composite postoperative complications and Comprehensive Complication Index (CCI). Secondary outcome was hospital length of stay (HLOS). Follow-up analysis at 1 month was conducted per intention and per protocol.
RESULTS


A total of 80 patients were enrolled with 39 and 41 cases allocated to the short and the extended therapy group, respectively. Demographic profile and disease severity was similar between the study groups. Overall rate of complications was 17.9% and 29.3% in the short and extended group, respectively (p = 0.23). Mean CCI did not differ between the study groups (p = 0.29). Hospital length of stay was significantly reduced in the short therapy group (61 ± 34 hours vs. 81 ± 40 hours, p = 0.005).
CONCLUSION


In the current prospective randomized investigation, the short (24 hours) antibiotic administration following appendectomy did not result in a worse primary outcome in complicated appendicitis. The short interval administration resulted in a significant reduction in HLOS with a major cost-saving and antibacterial stewardship perspective.
LEVEL OF EVIDENCE


Therapeutic Level IV.",2019,"Hospital length of stay was significantly reduced in the short therapy group (61 ± 34 hours vs. 81 ± 40 hours, p = 0.005).
","['after surgery in complicated appendicitis', '80 patients were enrolled with 39 and 41 cases allocated to the short and the extended therapy group, respectively', 'consecutive adult patients (age, ≥ 18 years) with complicated appendicitis including gangrenous appendicitis, perforated appendicitis, and appendicitis with periappendicular abscess between May 2016 and February 2018']","['antibacterial therapy limited to 24 hours (short) vs. >24 hours (extended) administration after appendectomy', 'extended antibiotic administration']","['hospital length of stay (HLOS', 'Mean CCI', 'Overall rate of complications', 'HLOS', 'composite postoperative complications and Comprehensive Complication Index (CCI', 'Demographic profile and disease severity', 'Hospital length of stay']","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1168273', 'cui_str': 'Gangrenous appendicitis'}, {'cui': 'C0854119', 'cui_str': 'Perforated Appendicitis'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}]","[{'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",80.0,0.198396,"Hospital length of stay was significantly reduced in the short therapy group (61 ± 34 hours vs. 81 ± 40 hours, p = 0.005).
","[{'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Saar', 'Affiliation': 'From the Division of Acute Care Surgery, Department of Surgery (S.S., M.R., E.H.N., E.L., K.G.I., J.L., P.T.), North Estonia Medical Centre, Tallinn; School of Medicine, University of Tartu (S.S., V.M., A.L., U.L., P.T.), Tartu, Estonia; and Division of Trauma, Hand and Reconstructive Surgery (T.L.), Goethe University Hospital, Frankfurt/Main, Germany.'}, {'ForeName': 'Vladislav', 'Initials': 'V', 'LastName': 'Mihnovitš', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lustenberger', 'Affiliation': ''}, {'ForeName': 'Mariliis', 'Initials': 'M', 'LastName': 'Rauk', 'Affiliation': ''}, {'ForeName': 'Erast-Henri', 'Initials': 'EH', 'LastName': 'Noor', 'Affiliation': ''}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Lipping', 'Affiliation': ''}, {'ForeName': 'Karl-Gunnar', 'Initials': 'KG', 'LastName': 'Isand', 'Affiliation': ''}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Lepp', 'Affiliation': ''}, {'ForeName': 'Andrus', 'Initials': 'A', 'LastName': 'Lomp', 'Affiliation': ''}, {'ForeName': 'Urmas', 'Initials': 'U', 'LastName': 'Lepner', 'Affiliation': ''}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Talving', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002086']
1525,30536592,Evaluation of oral tranexamic acid in the treatment of melasma.,"BACKGROUND


Melasma is an acquired, chronic, recurrent hypermelanosis that occurs exclusively in areas exposed to the sun. Its treatment can be very challenging. Tranexamic acid (TA) is an inhibitor of plasmin, and it is a synthetic derivative of the amino acid lysine that reversibly blocks binding sites on the plasminogen molecule, inhibiting the plasminogen activator from converting plasminogen to plasmin.
AIMS


This study evaluated the efficacy of oral TA in the treatment of melasma in patients from a philanthropic dermatological clinic.
PATIENTS/METHODS


This was a monocentric, randomized, double-blind, controlled clinical trial. Patients with facial melasma were randomly divided into the following two groups: A (TA 250 mg orally twice daily) or B (oral placebo twice daily). Evaluations were performed before and after 12 weeks of treatment with photographs, colorimetry, MELASQoL, and MASI. All patients were instructed to use tinted sunscreen (SPF 50).
RESULTS


Of the 47 patients selected, 37 completed the study, with 20 in group A and 17 in group B; the patients consisted of one male and 36 females, and the mean age was 43.97 years old. Based on the four methods of evaluation, the melasma in 50% of patients in group A improved versus only 5.9% of patients in group B (P < 0.005). There was an improvement according to all evaluation methods in the treatment group. No patient had severe side effects.
CONCLUSIONS


We conclude that tranexamic acid was effective in 50% of patients according to four methods of evaluation when compared to the placebo.",2018,"Based on the four methods of evaluation, the melasma in 50% of patients in group A improved versus only 5.9% of patients in group B (P ","['Patients with facial melasma', 'melasma', ' 37 completed the study, with 20 in group A and 17 in group B; the patients consisted of one male and 36 females, and the mean age was 43.97\xa0years old', 'melasma in patients from a philanthropic dermatological clinic', '47 patients selected']","['A (TA 250\xa0mg orally twice daily) or B (oral placebo', 'placebo', 'tranexamic acid', 'oral tranexamic acid', 'tinted sunscreen (SPF 50', 'Tranexamic acid (TA', 'oral TA']",['severe side effects'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",1.0,0.0991747,"Based on the four methods of evaluation, the melasma in 50% of patients in group A improved versus only 5.9% of patients in group B (P ","[{'ForeName': 'Mariana Morais Tavares', 'Initials': 'MMT', 'LastName': 'Colferai', 'Affiliation': 'Universidade de Mogi das Cruzes, Dermatology, Mogi das Cruzes, Brazil.'}, {'ForeName': 'Gabriela Momente', 'Initials': 'GM', 'LastName': 'Miquelin', 'Affiliation': 'Universidade de Mogi das Cruzes, Dermatology, Mogi das Cruzes, Brazil.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Steiner', 'Affiliation': 'Universidade de Mogi das Cruzes, Dermatology, Mogi das Cruzes, Brazil.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12830']
1526,30563446,"Correction to: Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial.","Following publication of the original article [1], the authors notified us o that the Table 1 citation within the legend was not presented as initially requested.",2018,"Following publication of the original article [1], the authors notified us o that the Table 1 citation within the legend was not presented as initially requested.",['migraine'],['non-invasive vagus nerve stimulation (nVNS'],[],"[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]",[],,0.303402,"Following publication of the original article [1], the authors notified us o that the Table 1 citation within the legend was not presented as initially requested.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Martelletti', 'Affiliation': 'Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Barbanti', 'Affiliation': 'Headache and Pain Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Grazzi', 'Affiliation': 'Neuroalgology Unit, Carlo Besta Neurological Institute and Foundation, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Pierangeli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.'}, {'ForeName': 'Innocenzo', 'Initials': 'I', 'LastName': 'Rainero', 'Affiliation': 'Department of Neuroscience, University of Turin, Turin, Italy.'}, {'ForeName': 'Pierangelo', 'Initials': 'P', 'LastName': 'Geppetti', 'Affiliation': 'Headache Centre, University Hospital of Careggi, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ambrosini', 'Affiliation': 'IRCCS Neuromed, Pozzilli, IS, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Sarchielli', 'Affiliation': 'Neurologic Clinic, Santa Maria della Misericordia Hospital, Perugia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'Headache Science Centre, IRCCS C. Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc., Basking Ridge, NJ, USA. eric.liebler@electrocore.com.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'de Tommaso', 'Affiliation': 'Neurophysiology and Pain Unit, University of Bari Aldo Moro, Bari, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of headache and pain,['10.1186/s10194-018-0949-9']
1527,31661438,Repair of small abdominal wall hernias. The comparison of open in-lay and on-lay techniques.,"BACKGROUND


Our aim was to report the results of open in-lay placement of a composite mesh for repair of small abdominal wall hernias compared to a control group of on-lay polypropylene mesh placement.
MATERIALS AND METHODS


The patients were divided into two groups in which group-1 (n=27) included patients who underwent a repair with composite mesh, Ventralex Patch, which was fixed in-lay to the abdominal wall and group-2 (n=34) included patients with a repair with simple polypropylene mesh fixed on-lay to the abdominal wall. Due to the limited dimensions of the Ventralex Patch, in order to match the defects in both groups no randomization was done prior to the operation and patients were divided into groups consequently. All the patients were explored under general or spinal anesthesia. No further subcutaneous dissection was performed in order not to increase the seroma during onlay mesh placement.
RESULTS


The demographic data between study groups were similar. The postoperative complication rate was significantly low in group 1 (0%), compared to group 2 (23.5%) which included seroma (n=3) and wound infection (n=5), however, the mean operative time was significantly high in group l (61 minutes) compared to group 2 (39 minutes). There were no recurrences occurred in both group.
CONCLUSION


Although, the patch itself has tendency to make a dome formation when placed intra-abdominally, a composite polypropylene and ePTFE hernia patch has better outcomes if placed precisely with minimal extra-peritoneal and extensive intra-peritoneal dissection. We assume that inadequate liberation of omental attachments around the defect enhances the prior reported failures of the product.
KEY WORDS


Composite mesh, Hernia, Ventralex patch.",2019,"The postoperative complication rate was significantly low in group 1 (0%), compared to group 2 (23.5%) which included seroma (n=3) and wound infection (n=5), however, the mean operative time was significantly high in group l (61 minutes) compared to group 2 (39 minutes).",['Repair of small abdominal wall hernias'],"['repair with composite mesh, Ventralex Patch, which was fixed in-lay to the abdominal wall and group-2 (n=34) included patients with a repair with simple polypropylene mesh fixed on-lay to the abdominal wall', 'Composite mesh, Hernia, Ventralex patch']","['recurrences', 'seroma', 'postoperative complication rate', 'included seroma (n=3) and wound infection', 'mean operative time']","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh (physical object)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",,0.019833,"The postoperative complication rate was significantly low in group 1 (0%), compared to group 2 (23.5%) which included seroma (n=3) and wound infection (n=5), however, the mean operative time was significantly high in group l (61 minutes) compared to group 2 (39 minutes).","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kalayci', 'Affiliation': ''}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Agcaoglu', 'Affiliation': ''}]",Annali italiani di chirurgia,[]
1528,30554466,A double-blind randomized controlled trial to assess efficacy of bromocriptine in cirrhotic patients with hepatic parkinsonism.,"BACKGROUND


Parkinsonism like features can be seen in cirrhotics, possibly related to alterations in brain dopamine metabolism, transport and receptor integrity at basal ganglia. Hepatic parkinsonism is often not suspected and only ammonia-reducing therapies are given to such patients. We investigated the efficacy and safety of bromocriptine, a dopaminergic agent, in patients with hepatic parkinsonism.
PATIENTS AND METHODS


Cirrhotics were screened for the presence of extrapyramidal symptoms and were diagnosed as hepatic parkinsonism if any two of tremor, bradykinesia and/or rigidity were present, supported by MRI brain showing T1 hyperintensities in basal ganglia and substantia nigra. Patients were randomized to receive placebo (Gr A, n = 22) or bromocriptine (Gr B, n = 24) for 12 weeks. Complete, partial and non-response were defined as 30%, 10%-30% and <10% reduction,respectively, in Unified Parkinson's Disease Rating Scale motor score.
RESULTS


Of 1016 cirrhotics, 50 (4.9%) had hepatic parkinsonism. Patients in two treatment groups were comparable for MELD score, arterial NH3 and frequency of portosystemic shunts. Bromocriptine therapy for 12 weeks resulted in improvement in rigidity, tremors, bradykinesia and gait compared to placebo with complete and partial response in seven vs none (29.1%, 0%, P < 0.01) and 12 vs one (50%, 4.5%, P < 0.01) patients. Prolonged and more severe motor symptoms were associated with non-response to bromocriptine therapy. There were no major side effects in either treatment group.
CONCLUSIONS


Hepatic parkinsonism is seen in ~5% cirrhotics. Bromocriptine is a safe and effective therapy for these patients and is more effective in mild to moderate hepatic parkinsonism.",2019,"Patients in two treatment groups were comparable for MELD score, arterial NH3 and frequency of portosystemic shunts.","['patients with hepatic parkinsonism', 'Cirrhotics were screened for the presence of extrapyramidal symptoms and were diagnosed as hepatic parkinsonism if any two of tremor, bradykinesia and/or rigidity were present, supported by MRI brain showing T1 hyperintensities in basal ganglia and substantia nigra', 'Of 1016 cirrhotics, 50 (4.9%) had hepatic parkinsonism', 'cirrhotic patients with hepatic parkinsonism']","['placebo', 'Bromocriptine', 'bromocriptine']","['Complete, partial and non-response', ""Unified Parkinson's Disease Rating Scale motor score"", 'rigidity, tremors, bradykinesia and gait', 'major side effects', 'MELD score, arterial NH3 and frequency of portosystemic shunts', 'severe motor symptoms', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0412675', 'cui_str': 'Magnetic resonance imaging of brain and brain stem (procedure)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0038590', 'cui_str': 'Substantia Nigra'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032720', 'cui_str': 'Portosystemic Shunt'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.124854,"Patients in two treatment groups were comparable for MELD score, arterial NH3 and frequency of portosystemic shunts.","[{'ForeName': 'Amrish', 'Initials': 'A', 'LastName': 'Sahney', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Barjesh Chander', 'Initials': 'BC', 'LastName': 'Sharma', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Lovkesh', 'Initials': 'L', 'LastName': 'Anand', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder Mohan', 'Initials': 'RM', 'LastName': 'Dhamija', 'Affiliation': 'Department of Neurology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14024']
1529,30484730,Cancer!? I Don't Have Time for That: Impact of a Psychosocial Intervention for Young Adults with Cancer.,"PURPOSE


Young adult oncology has gained momentum in recognizing the unique medical and psychosocial needs of the population of adolescents and young adults with cancer (AYAC). However, many of their psychosocial needs remain unmet and we are yet to identify how clinical or research programs can be tailored to meet these needs. The aim of the study was to evaluate the impact of a cognitive-behavioral intervention adapted to meet the psychosocial needs and issues of AYAC and delivered either through Skype or face-to-face sessions against a control condition.
METHODS


A total of 113 AYAC aged between 18 and 39 years were randomly assigned to a brief three-session intervention or control/care-as-usual group. They were then assessed at three time points of baseline (time 1), post (time 2), and 3-month postintervention (time 3) using self-report questionnaires targeting overall outcomes of mood/emotional well-being and health-related quality of life (HRQOL) and specific outcomes of illness-related self-efficacy and family/social and sexual relationship well-being.
RESULTS


Significant between-group differences were obtained from time 1 to time 2 on outcomes of social/family and sexual relationship well-being, whereas groups did not differ from time 2 to time 3. Within-group results from time 1 to time 2 showed significant improvements in sexual esteem for both groups, whereas only AYAC of the intervention group significantly improved on outcomes of anxiety, overall mood/emotional well-being and HRQOL. In addition, improvements in self-efficacy were obtained only for the intervention group from time 2 to time 3.
CONCLUSION


When compared with a control/care-as-usual condition, the intervention had a positive impact on psychological and relationship well-being. Results suggested that the intervention was beneficial and clinically relevant to the population of AYAC.",2019,"RESULTS


Significant between-group differences were obtained from time 1 to time 2 on outcomes of social/family and sexual relationship well-being, whereas groups did not differ from time 2 to time 3.","['A total of 113 AYAC aged between 18 and 39 years', 'adolescents and young adults with cancer (AYAC', 'Young Adults with Cancer']","['brief three-session intervention or control/care-as-usual group', 'Psychosocial Intervention', 'cognitive-behavioral intervention']","['self-report questionnaires targeting overall outcomes of mood/emotional well-being and health-related quality of life (HRQOL) and specific outcomes of illness-related self-efficacy and family/social and sexual relationship well-being', 'social/family and sexual relationship well-being', 'outcomes of anxiety, overall mood/emotional well-being and HRQOL', 'sexual esteem', 'self-efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",113.0,0.0397066,"RESULTS


Significant between-group differences were obtained from time 1 to time 2 on outcomes of social/family and sexual relationship well-being, whereas groups did not differ from time 2 to time 3.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Aubin', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Rosberger', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Hafez', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Noory', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Perez', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Lehmann', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Batist', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'Jewish General Hospital , Montreal, Canada .'}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2017.0101']
1530,18333864,Effects of CYP3A4 inducers with and without CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers.,"AIMS


To assess the potential of known CYP3A4 inducers, with and without CYP3A4 inhibitors, to alter the pharmacokinetic profile of maraviroc.
METHODS


Two separate, open, randomized, placebo-controlled studies were conducted in healthy subjects. Study 1 was a 28-day parallel-group study with three treatment groups of 12 subjects each. On days 1-7, all subjects received maraviroc 100 mg b.i.d.; on days 8-21, subjects received maraviroc 100 mg b.i.d. plus either rifampicin 600 mg q.d., efavirenz (EFV) 600 mg q.d., or placebo q.d. as assigned; on days 22-28, the maraviroc dose was increased to 200 mg b.i.d. for patients receiving either rifampicin or EFV. Study 2 was a 21-day, two-way crossover study with three cohorts (12 subjects per cohort). On days 1-21, subjects received maraviroc 300 mg b.i.d. and boosted lopinavir (LPV/r, lopinavir 400 mg + ritonavir 100 mg) or placebo b.i.d. in cohort 1, maraviroc 100 mg b.i.d. and boosted saquinavir (SQV/r, saquinavir 1000 mg + ritonavir 100 mg) or placebo b.i.d. in cohort 2, and maraviroc 100 mg b.i.d. and 1000 mg saquinavir + LPV/r (400 mg/100 mg) or placebo b.i.d. in cohort 3. On days 8-21, subjects in all three cohorts also received EFV 600 mg or placebo q.d.
RESULTS


Maraviroc (100 mg b.i.d.) exposure (AUC(12) and C(max)) was reduced in the presence of rifampicin and EFV by approximately 70% and 50%, respectively. Maraviroc AUC(12) and C(max) approached preinduction values when the maraviroc dose was increased to 200 mg b.i.d. for both the rifampicin-treated and EFV-treated groups. Co-administration of LPV/r with maraviroc (300 mg b.i.d.) resulted in geometric mean ratios (GMRs) of 395% and 197% for maraviroc AUC(12) and C(max), respectively, compared with placebo; addition of EFV resulted in GMRs of 253% and 125% for AUC(12) and C(max), respectively. Co-administration of SQV/r with maraviroc (100 mg b.i.d.) resulted in GMRs of 977% and 478% for maraviroc AUC(12) and C(max), respectively, compared with placebo; addition of EFV resulted in GMRs of 500% and 226% for AUC(12) and C(max), respectively. No pharmacokinetic data are reported for cohort 3 because all subjects were discontinued during period 1 due to poor toleration of the drug regimen. There were no serious adverse events reported in either study, and most adverse events were mild or moderate in severity and resolved without intervention.
CONCLUSION


As expected with a CYP3A4 substrate, maraviroc exposure (C(max) and AUC(12)) was significantly reduced by the known CYP3A4 inducers, rifampicin and EFV, by approximately 70% and 50%, respectively. Upward adjustment of the maraviroc dose during co-administration with rifampicin or EFV appears to compensate for this reduction. Protease inhibitors (PIs) significantly increased maraviroc exposure; however, the addition of EFV to the maraviroc + PI regimens reduced the magnitude of PI-mediated increase in maraviroc exposure (by approximately 50%), but the net effect was still CYP3A4 inhibition.",2008,"exposure (AUC(12) and C(max)) was reduced in the presence of rifampicin and EFV by approximately 70% and 50%, respectively.","['healthy volunteers', 'Study 1 was a 28-day parallel-group study with three treatment groups of 12 subjects each', 'healthy subjects', 'three cohorts (12 subjects per cohort']","['Co', 'SQV/r with maraviroc', 'maraviroc 100 mg b.i.d. plus either rifampicin 600 mg q.d., efavirenz (EFV) 600 mg q.d., or placebo', 'CYP3A4 inducers with and without CYP3A4 inhibitors', 'placebo', 'rifampicin or EFV', 'maraviroc 300 mg b.i.d. and boosted lopinavir (LPV/r, lopinavir 400 mg + ritonavir 100 mg) or placebo', 'boosted saquinavir (SQV/r, saquinavir 1000 mg + ritonavir', 'rifampicin', 'saquinavir + LPV', 'EFV 600 mg or placebo q.d', 'Maraviroc', 'LPV/r with maraviroc']","['geometric mean ratios (GMRs', 'CYP3A4 substrate, maraviroc exposure (C(max) and AUC(12', 'exposure (AUC(12) and C(max', 'serious adverse events', 'maraviroc exposure']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1593581', 'cui_str': 'efavirenz 600 MG [Sustiva]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3850041', 'cui_str': 'CYP3A4 Inducers'}, {'cui': 'C3850053', 'cui_str': 'CYP3A4 Inhibitors'}, {'cui': 'C1965208', 'cui_str': 'maraviroc 300 MG'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1597570', 'cui_str': 'Ritonavir 100 MG [Norvir]'}, {'cui': 'C0286738', 'cui_str': 'Saquinavir'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3714798', 'cui_str': 'CYP3A4'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143003,"exposure (AUC(12) and C(max)) was reduced in the presence of rifampicin and EFV by approximately 70% and 50%, respectively.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Abel', 'Affiliation': 'Pfizer Global R&D, Sandwich, UK.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'Lyndsey A', 'Initials': 'LA', 'LastName': 'Whitlock', 'Affiliation': ''}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Ridgway', 'Affiliation': ''}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Muirhead', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/j.1365-2125.2008.03134.x']
1531,30535188,"A Randomized, Double-blinded, Placebo-controlled Trial of Sitagliptin for Reducing Inflammation and Immune Activation in Treated and Suppressed Human Immunodeficiency Virus Infection.","BACKGROUND


Dipeptidyl peptidase-4 (DPP-4) inhibitors have pleotropic anti-inflammatory and immune regulatory effects in addition to glucoregulation. We evaluated inflammation and immune markers in suppressed human immunodeficiency virus (HIV) infection during treatment with the DPP-4 inhibitor sitagliptin.
METHODS


Virologically suppressed adults with HIV without diabetes on stable antiretroviral therapy (ART) with ≥100/μL CD4 cells were randomized to 16 weeks of sitagliptin 100 mg/day vs placebo in a multicenter trial. The primary endpoint was the change in plasma soluble CD14 (sCD14) from baseline to week 15-16.
RESULTS


Ninety participants were randomized, and 42 from each arm were included in per-protocol analyses. Participants were 45% non-Hispanic white, 38% non-Hispanic black, and 15% Hispanic, with a median age of 51 years; 83% were male; and the median CD4 count was 602 cells/μL. At week 15-16, there was no difference in sCD14 change between the 2 arms (P = .69). Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10 (95% confidence interval, -57% to -35%) at week 15 (P < .001). There were no significant between-arm differences in other soluble biomarkers, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation. Sitagliptin was well tolerated.
CONCLUSIONS


Sixteen weeks of sitagliptin had no effect on sCD14 levels in virologically suppressed participants with HIV. CXCL10, a chemokine involved in atherogenesis that predicts non-AIDS events during ART, declined markedly with sitagliptin. This suggests that DPP-4 inhibition has the potential to reduce cardiovascular morbidity in treated HIV infection.
CLINICAL TRIALS REGISTRATION


NCT01426438.",2019,"Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10","['Evaluable participants were 45% non-Hispanic white, 38% non-Hispanic black, 15% Hispanic, median age of 51 years, 83% male, with median CD4 count 602 cells/mm 3', 'Treated and Suppressed HIV Infection', 'adults with HIV without diabetes mellitus on stable ART with ≥100/mm 3 CD4 cells', 'Ninety participants were randomized, and 42 from each arm were included in per-protocol analyses']","['placebo', 'sitagliptin 100 mg/d vs. placebo', 'Sitagliptin', 'Placebo', 'CXCL10', '\n\n\nDipeptidyl peptidase-4 (DPP-4) inhibitors']","['cardiovascular morbidity', 'tolerated', 'CXCL10', 'sCD14 change', 'change in plasma soluble CD14 (sCD14', 'soluble CD163, soluble CD26, interleukin-6, C-reactive protein, soluble tumour necrosis factor receptors I and II, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation', 'Additional soluble biomarkers, and lymphocyte and monocyte activation', 'sCD14 levels', 'Inflammation and Immune Activation']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C3653297', 'cui_str': 'Dipeptidyl peptidase 4 (DPP-4) inhibitors'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}]",90.0,0.579292,"Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Lake', 'Affiliation': 'University of Texas Health Science Center, Houston.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kinslow', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Coombs', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Floris-Moore', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Yarasheski', 'Affiliation': 'Washington University, St. Louis, Missouri.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1051']
1532,30529025,Transcutaneous Electrical Nerve Stimulation Combined With Voice Therapy in Women With Muscle Tension Dysphonia.,"OBJECTIVES


The purpose of the present study was to investigate the effect of Voice Therapy (VT) with and without Transcutaneous Electrical Nerve Stimulation (TENS) in women with Muscle Tension Dysphonia (MTD).
METHODS


A total of 20 women with MTD participated in the study. Participants underwent evaluation of auditory-perceptual assessment, acoustic voice analysis, Vocal Tract Discomfort (VTD), and musculoskeletal pain before and after the treatment. The participants were divided into two groups: (1) TENS + VT group (10 participants) and (2) VT group (10 participants). Both groups received 10 sessions of treatment, twice a week, each lasting 50 minutes. The statistical analysis was performed using Wilcoxon signed ranked and Mann-Whitney U tests (P < 0.05).
RESULTS


After VT, significant improvements were observed in all auditory-perceptual parameters and all VTD items except for the tickling frequency and severity. The VT caused significant reduction in the frequency of pain in anterior neck, posterior neck, and the larynx. Also, VT resulted in a significant reduction in pain intensity only in the larynx. After VT + TENS, significant improvements were observed in all auditory-perceptual parameters, shimmer, and all VTD items. Moreover, the VT + TENS led to a significant decrease in the frequency and intensity of pain in anterior neck, posterior neck, the larynx, masseters, shoulders, and upper back. The findings of between-group comparison after treatment showed significantly more reduction in the frequency (dry and pain items) and severity (tight and pain items) of the VTD in VT + TENS group compared with VT group. Regarding the musculoskeletal pain, significantly more reduction in the frequency and intensity of pain in anterior neck and the larynx was observed in VT + TENS group compared with VT group.
CONCLUSIONS


The VT and VT + TENS could lead to positive outcomes in auditory perceptual assessment, acoustic voice analysis, the VTD, and assessment of musculoskeletal pain. In some items of frequency and severity of VTD scale and assessment of musculoskeletal pain, VT + TENS also produced better results compared with VT. As a result, TENS was recommended as a complementary therapy for patients with MTD, especially when these patients had more complaints about VTD and musculoskeletal pain.",2020,"After VT + TENS, significant improvements were observed in all auditory-perceptual parameters, shimmer, and all VTD items.","['women with Muscle Tension Dysphonia (MTD', 'Women With Muscle Tension Dysphonia', '20 women with MTD participated in the study']","['Voice Therapy (VT) with and without Transcutaneous Electrical Nerve Stimulation (TENS', 'Transcutaneous Electrical Nerve Stimulation Combined With Voice Therapy', 'TENS', 'TENS\u202f+\u202fVT']","['frequency (dry and pain items) and severity (tight and pain items', 'auditory-perceptual assessment, acoustic voice analysis, Vocal Tract Discomfort (VTD), and musculoskeletal pain', 'auditory-perceptual parameters', 'frequency and intensity of pain in anterior neck, posterior neck, the larynx, masseters, shoulders, and upper back', 'auditory perceptual assessment, acoustic voice analysis, the VTD, and assessment of musculoskeletal pain', 'frequency of pain in anterior neck, posterior neck, and the larynx', 'auditory-perceptual parameters, shimmer, and all VTD items', 'frequency and intensity of pain in anterior neck and the larynx', 'pain intensity', 'frequency and severity of VTD scale', 'complaints about VTD and musculoskeletal pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0427195', 'cui_str': 'Muscle tension (finding)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0230101', 'cui_str': 'Upper back structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]",20.0,0.0303922,"After VT + TENS, significant improvements were observed in all auditory-perceptual parameters, shimmer, and all VTD items.","[{'ForeName': 'Banafshe', 'Initials': 'B', 'LastName': 'Mansuri', 'Affiliation': 'Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Torabinejhad', 'Affiliation': 'Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address: torabinezhad.f@iums.ac.ir.'}, {'ForeName': 'Ali Ashraf', 'Initials': 'AA', 'LastName': 'Jamshidi', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Dabirmoghaddam', 'Affiliation': 'Otolaryngology Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Behnoosh', 'Initials': 'B', 'LastName': 'Vasaghi-Gharamaleki', 'Affiliation': 'Department of Basic Sciences in Rehabilitation, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghelichi', 'Affiliation': 'Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.11.003']
1533,28224749,Re: Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial.,,2017,,['women with a cyst or abscess of the Bartholin gland (WoMan-trial'],['Re: Word catheter and marsupialisation'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0004768', 'cui_str': 'Bartholin Glands'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0185032', 'cui_str': 'Marsupialization - action (qualifier value)'}]",[],,0.324057,,"[{'ForeName': 'Kamana', 'Initials': 'K', 'LastName': 'Subba', 'Affiliation': 'Department of Obstetrics and Gynaecology, George Eliot Hospital NHS Trust, Nuneaton, UK.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Matts', 'Affiliation': 'Department of Obstetrics and Gynaecology, George Eliot Hospital NHS Trust, Nuneaton, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.14497']
1534,31116229,"ERRATA: The effectiveness of current informative material in improving awareness and opinion of undergraduate students towards organ donation: a comparative, randomized survey study.",[This corrects the article doi: 10.6061/clinics/2019/e743].,2019,[This corrects the article doi: 10.6061/clinics/2019/e743].,['undergraduate students towards organ donation'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0282366', 'cui_str': 'Organ Donation'}]",[],[],,0.0145252,[This corrects the article doi: 10.6061/clinics/2019/e743].,[],"Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2019/e743err']
1535,30537080,Dressings and topical agents for preventing pressure ulcers.,"BACKGROUND


Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013.
OBJECTIVES


To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting.
SEARCH METHODS


In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification.
SELECTION CRITERIA


We included randomised controlled trials that enrolled people at risk of pressure ulcers.
DATA COLLECTION AND ANALYSIS


Two review authors independently selected trials, assessed risk of bias and extracted data.
MAIN RESULTS


The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.Topical agentsThere were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (Dermalex TM  9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the Dermalex TM  group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).DressingsSix trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang' huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision).
AUTHORS' CONCLUSIONS


Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.",2018,"Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias).","['people of any age, without existing pressure ulcers', 'Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents', 'enrolled people at risk of pressure ulcers']","['placebo', 'fatty acid to olive oil', 'dressings and topical agents', 'fatty acid versus olive oil', 'Silicone dressings', 'Dimethyl sulfoxide (DMSO) cream', 'fatty acid']","[""pressure ulcer preventive dressing' (PPD"", 'pressure ulcers', 'pressure ulcer incidence', 'risk of pressure ulcer incidence']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0563204', 'cui_str': 'Pressure sore risk'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1271483', 'cui_str': 'Silicone dressing'}, {'cui': 'C0012403', 'cui_str': 'Dimethyl Sulfoxide'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",3629.0,0.343673,"Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias).","[{'ForeName': 'Zena Eh', 'Initials': 'ZE', 'LastName': 'Moore', 'Affiliation': ""School of Nursing & Midwifery, Royal College of Surgeons in Ireland, 123 St. Stephen's Green, Dublin, Ireland, D2.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009362.pub3']
1536,29498050,WBC alloimmunization: effects on the laboratory and clinical endpoints of therapeutic granulocyte transfusions.,"BACKGROUND


Although the subject of many previous studies, the importance of white blood cell (WBC) alloimmunization in granulocyte transfusion therapy has not been settled. In this study, we report the results of the effects of WBC antibodies in the RING (Resolving Infection in Neutropenia with Granulocytes) study, a randomized controlled trial comparing the efficacy of daily granulocyte transfusion therapy plus antimicrobials versus antimicrobials alone; the primary outcome results have been published previously.
STUDY DESIGN AND METHODS


One hundred fourteen subjects were enrolled in the study. Serum samples for WBC antibody determination were obtained from each subject at baseline and at 2 and 6 weeks. One hundred subjects had at least one antibody test result. Samples were tested for human leukocyte antigen (HLA) Class I and Class II antibodies as well as for granulocyte-specific antibodies using granulocyte agglutination and immunofluorescence techniques. All testing was performed at a central laboratory.
RESULTS


Baseline WBC alloimmunization was modest, depending somewhat on the assay. Seroconversion during the study was slightly higher in the granulocyte transfusion arm, but the differences were not statistically significant. There was no demonstrable effect of the presence of alloimmunization on the primary outcome (survival and microbial response at 42 days), the occurrence of transfusion reactions (either overall or pulmonary), or posttransfusion neutrophil increments.
CONCLUSION


The presence or development of WBC antibodies had no demonstrable effect on any clinical aspect of granulocyte transfusion therapy. It appears that, at least in the patient population studied, there is no evidence suggesting need for concern about recipient WBC alloimmunization when prescribing granulocyte transfusions.",2018,"Seroconversion during the study was slightly higher in the granulocyte transfusion arm, but the differences were not statistically significant.","['Neutropenia with Granulocytes', 'One hundred fourteen subjects were enrolled in the study', 'One hundred subjects had at least one antibody test result']",['daily granulocyte transfusion therapy plus antimicrobials versus antimicrobials alone'],"['Baseline WBC alloimmunization', 'Seroconversion', 'Serum samples for WBC antibody determination', 'occurrence of transfusion reactions (either overall or pulmonary), or posttransfusion neutrophil increments']","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies (procedure)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0274435', 'cui_str': 'Blood Transfusion-Associated Adverse Reactions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}]",114.0,0.047354,"Seroconversion during the study was slightly higher in the granulocyte transfusion arm, but the differences were not statistically significant.","[{'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Price', 'Affiliation': 'Department of Medicine, University of Washington.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Strauss', 'Affiliation': 'Department of Pathology, University of Iowa Hospital, Iowa City, Iowa.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ness', 'Affiliation': 'Department of Pathology, Division of Transfusion Medicine, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Taye H', 'Initials': 'TH', 'LastName': 'Hamza', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Harrison', 'Affiliation': 'Corrona LLC, Waltham, Massachusetts.'}, {'ForeName': 'Susan F', 'Initials': 'SF', 'LastName': 'Assmann', 'Affiliation': 'New England Research Institutes, Watertown, Massachusetts.'}]",Transfusion,['10.1111/trf.14551']
1537,30535100,Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial.,"BACKGROUND


Gram-negative bacteremia is a major cause of morbidity and mortality in hospitalized patients. Data to guide the duration of antibiotic therapy are limited.
METHODS


This was a randomized, multicenter, open-label, noninferiority trial. Inpatients with gram-negative bacteremia, who were afebrile and hemodynamically stable for at least 48 hours, were randomized to receive 7 days (intervention) or 14 days (control) of covering antibiotic therapy. Patients with uncontrolled focus of infection were excluded. The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative, or distant complications; and readmission or extended hospitalization (>14 days). The noninferiority margin was set at 10%.
RESULTS


We included 604 patients (306 intervention, 298 control) between January 2013 and August 2017 in 3 centers in Israel and Italy. The source of the infection was urinary in 411 of 604 patients (68%); causative pathogens were mainly Enterobacteriaceae (543/604 [90%]). A 7-day difference in the median duration of covering antibiotics was achieved. The primary outcome occurred in 140 of 306 patients (45.8%) in the 7-day group vs 144 of 298 (48.3%) in the 14-day group (risk difference, -2.6% [95% confidence interval, -10.5% to 5.3%]). No significant differences were observed in all other outcomes and adverse events, except for a shorter time to return to baseline functional status in the short-course therapy arm.
CONCLUSIONS


In patients hospitalized with gram-negative bacteremia achieving clinical stability before day 7, an antibiotic course of 7 days was noninferior to 14 days. Reducing antibiotic treatment for uncomplicated gram-negative bacteremia to 7 days is an important antibiotic stewardship intervention.
CLINICAL TRIALS REGISTRATION


NCT01737320.",2019,"The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization (>14 days).","['604 patients (306 intervention, 298 control) between January 2013 and August 2017 in three centers in Israel and Italy', 'hospitalized patients', 'Patients with uncontrolled focus of infection were excluded', 'Inpatients with Gram-negative bacteremia, afebrile and hemodynamically stable for at least 48 hours']","['antibiotic therapy', 'Antibiotic Therapy']","['composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization', 'shorter time to return to baseline functional status', 'median duration of covering antibiotics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}]","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3249881', 'cui_str': 'Infection - suppurative (disorder)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",604.0,0.222348,"The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization (>14 days).","[{'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Yahav', 'Affiliation': 'Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Franceschini', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Fidi', 'Initials': 'F', 'LastName': 'Koppel', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Turjeman', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Babich', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Bitterman', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Neuberger', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Ghanem-Zoubi', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Eliakim-Raz', 'Affiliation': 'Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Pertzov', 'Affiliation': 'Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Stern', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Dickstein', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Maroun', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Zayyad', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Bishara', 'Affiliation': 'Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Alon', 'Affiliation': 'Department of Medicine B, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Edel', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine F, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Venturelli', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mussini', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Leibovici', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Mical', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1054']
1538,30522389,Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.,"Objectives:  With the emerging trends, more cluster randomized trials will be conducted in older adults, where facilities are randomized rather than individuals. Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available. We document ICCs for measures commonly used in community-dwelling older adults and discuss implications.  Method:  Secondary analysis of a range of baseline measures from the  On the Move  cluster randomized trial, whose ICCs were computed using a linear mixed model.  Results:  Self-reported disability measures related to facility characteristics and sense of community had the greatest ICCs (>0.10), while mobility performance measures had 0.05 to 0.10, and cognitive measure 0.11.  Discussion:  The ICCs for measures commonly used in older adults are of a sufficient magnitude to have a substantial impact on planned sample size of a study and credibility of results, and should be taken into consideration in study planning and data analysis.",2020,"Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available.","['community-dwelling older adults', 'Community-Dwelling Older Adults', 'older adults']",[],['mobility performance measures'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0469596,"Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available.","[{'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wert', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'VanSwearingen', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'University of Pittsburgh, PA, USA.'}]",Journal of aging and health,['10.1177/0898264318816216']
1539,30335720,A Low-Carbohydrate Ketogenic Diet Reduces Body Mass Without Compromising Performance in Powerlifting and Olympic Weightlifting Athletes.,"Greene, DA, Varley, BJ, Hartwig, TB, Chapman, P, and Rigney, M. A low-carbohydrate ketogenic diet reduces body mass without compromising performance in powerlifting and Olympic weightlifting athletes. J Strength Cond Res 32(12): 3382-3391, 2018-Weight class athletes use weight-making strategies to compete in specific weight categories with an optimum power-to-weight ratio. There is evidence that low carbohydrate diets might offer specific advantages for weight reduction without the negative impact on strength and power previously hypothesized to accompany carbohydrate restriction. Therefore, the purpose of this study was to determine whether a low-carbohydrate ketogenic diet (LCKD) could be used as a weight reduction strategy for athletes competing in the weight class sports of powerlifting and Olympic weightlifting. Fourteen intermediate to elite competitive lifting athletes (age 34 ± 10.5, n = 5 female) consumed an ad libitum usual diet (UD) (>250 g daily intake of carbohydrates) and an ad libitum LCKD (≤50 g or ≤10% daily intake of carbohydrates) in random order, each for 3 months in a crossover design. Lifting performance, body composition, resting metabolic rate, blood glucose, and blood electrolytes were measured at baseline, 3 months, and 6 months. The LCKD phase resulted in significantly lower body mass (-3.26 kg, p = 0.038) and lean mass (-2.26 kg, p = 0.016) compared with the UD phase. Lean mass losses were not reflected in lifting performances that were not different between dietary phases. No other differences in primary or secondary outcome measures were found between dietary phases. Weight class athletes consuming an ad libitum LCKD decreased body mass and achieved lifting performances that were comparable with their UD. Coaches and athletes should consider using an LCKD to achieve targeted weight reduction goals for weight class sports.",2018,"The LCKD phase resulted in significantly lower body mass (-3.26 kg, p = 0.038) and lean mass (-2.26 kg, p = 0.016) compared with the UD phase.","['Powerlifting and Olympic Weightlifting Athletes', 'athletes competing in the weight class sports of powerlifting and Olympic weightlifting', 'Fourteen intermediate to elite competitive lifting athletes (age 34 ± 10.5, n = 5 female', '3382-3391, 2018-Weight class athletes use weight-making strategies to compete in specific weight categories with an optimum power-to-weight ratio', 'J Strength Cond Res 32(12']","['ad libitum usual diet (UD) (>250 g daily intake of carbohydrates) and an ad libitum LCKD (≤50 g or ≤10% daily intake of carbohydrates', 'low-carbohydrate ketogenic diet (LCKD', 'Low-Carbohydrate Ketogenic Diet']","['Lean mass losses', 'lean mass', 'body mass and achieved lifting performances', 'Lifting performance, body composition, resting metabolic rate, blood glucose, and blood electrolytes', 'body mass']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0206244', 'cui_str': 'Lifting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0449816', 'cui_str': 'Specific weight (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}]",,0.0249123,"The LCKD phase resulted in significantly lower body mass (-3.26 kg, p = 0.038) and lean mass (-2.26 kg, p = 0.016) compared with the UD phase.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Greene', 'Affiliation': 'School of Exercise Science, Australian Catholic University, Strathfield, New South Wales, Australia.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Varley', 'Affiliation': ''}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hartwig', 'Affiliation': ''}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rigney', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002904']
1540,30461578,"Does Tracheal Lidocaine Instillation Reduce Intracranial Pressure Changes After Tracheal Suctioning in Severe Head Trauma? A Prospective, Randomized Crossover Study.","OBJECTIVES


Tracheal suctioning is a routine procedure in mechanically ventilated children, however, in severe head-injured patients it can result in potential deleterious increase in intracranial pressure. We aimed to assess the effect of tracheal lidocaine administration on intracranial pressure during tracheal suctioning.
DESIGN


Prospective randomized controlled crossover study.
SETTING


PICU of a tertiary hospital.
PATIENTS


Eleven patients with severe head trauma (Glasgow Coma Scale score 4-8) INTERVENTIONS:: Lidocaine (1.5 mg/kg) or saline solution was endotracheally instilled before a standardized tracheal suctioning maneuver. Each patient received both treatments in a crossover design. Cerebral hemodynamic and systemic and ventilatory effects were assessed at four time points: in baseline (T0), within 2 minutes (T1), 5 minutes (T2), and 15 minutes after tracheal instillation (T3). The 2-minute time interval around tracheal suctioning was used to assess each treatment efficacy MEASUREMENTS AND MAIN RESULTS:: The time course of intracranial pressure was different throughout the study in both treatment groups, with a significant increase of intracranial pressure from 14.82 ± 3.48 to 23.27 ± 9.06 with lidocaine (p = 0.003) and from 14.73 ± 2.41 to 30.45 ± 13.14 with saline (p = 0.02). The mean variation in intracranial pressure immediately after tracheal suctioning was smaller with lidocaine instillation than saline (8.45 vs 15.72 mm Hg; p = 0.006). Patients treated with lidocaine returned to baseline intracranial pressure value at 5 minutes after tracheal suctioning whereas those receiving saline solution returned to baseline intracranial pressure value at 15 minutes. Although patients treated with lidocaine had no significant hemodynamic changes, patients receiving saline solution experienced a higher mean value of mean arterial pressure (99.36 vs 81.73 mm Hg; p = 0.004) at T1.
CONCLUSIONS


This preliminary study showed that tracheal lidocaine instillation can attenuate increase in intracranial pressure induced by tracheal suctioning and favor a faster return to the intracranial pressure baseline levels without significant hemodynamic and ventilatory changes.",2019,"The time course of intracranial pressure was different throughout the study in both treatment groups, with a significant increase of intracranial pressure from 14.82 ± 3.48 to 23.27 ± 9.06 with lidocaine (p = 0.003) and from 14.73 ± 2.41 to 30.45 ± 13.14 with saline (p = 0.02).","['mechanically ventilated children', 'Eleven patients with severe head trauma (Glasgow Coma Scale score 4-8', 'PICU of a tertiary hospital']","['Lidocaine', 'Tracheal suctioning', 'lidocaine', 'tracheal lidocaine instillation', 'saline solution', 'Tracheal Lidocaine Instillation', 'tracheal lidocaine']","['intracranial pressure', 'time course of intracranial pressure', 'mean variation in intracranial pressure', 'baseline intracranial pressure value', 'Cerebral hemodynamic and systemic and ventilatory effects', 'hemodynamic changes', 'mean arterial pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",11.0,0.0744729,"The time course of intracranial pressure was different throughout the study in both treatment groups, with a significant increase of intracranial pressure from 14.82 ± 3.48 to 23.27 ± 9.06 with lidocaine (p = 0.003) and from 14.73 ± 2.41 to 30.45 ± 13.14 with saline (p = 0.02).","[{'ForeName': 'Paulo Sérgio Lucas', 'Initials': 'PSL', 'LastName': 'da Silva', 'Affiliation': 'Pediatric Intensive Care Unit, Department of Pediatrics, Hospital do Servidor Público Municipal, São Paulo, Brazil.'}, {'ForeName': 'Vania Euzébio', 'Initials': 'VE', 'LastName': 'de Aguiar', 'Affiliation': 'Pediatric Intensive Care Unit, Department of Pediatrics, Hospital do Servidor Público Municipal, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Cunio Machado', 'Initials': 'MCM', 'LastName': 'Fonseca', 'Affiliation': 'Health Technology Assessment Unit, Federal University of São Paulo (UNIFESP), São Paulo, Brazil.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001817']
1541,30352291,Motivational interviewing to support LDL-C therapeutic goals and lipid-lowering therapy compliance in patients with acute coronary syndromes (IDEAL-LDL) study: rationale and design.,"BACKGROUND


Achieving low-density lipoprotein cholesterol (LDL-C) target levels after an acute coronary syndrome (ACS) is of paramount importance, and is often burdened by undertreatment and medication or lifestyle non-adherence issues.
OBJECTIVE


We examined the effect of a patient-centered, physician-led motivational intervention following ACS on relevant secondary prevention aspects.
METHODS-DESIGN


The IDEAL-LDL is a single-center, randomized controlled clinical trial, conducted among patients hospitalized due to an ACS. Following discharge, all patients undergo a baseline assessment of lipid profile. Patients in the intervention group receive an in-person educational session and an informative leaflet, and also undergo two phone-based, motivational interviewing sessions at 1 and 6 months. These interventions emphasize on LDL-C goals, adherence to lipid-lowering medication, and healthy dietary-lifestyle habits, and are not provided to patients in the control group, who receive usual care. At 12 months after each patient's discharge, an in-person interview and lipid profile reassessment are performed. The primary outcomes are the assessment of LDL-C goal achievement (<70 mg/dL or >50% reduction from baseline levels) from baseline to 1 year and changes in medication adherence. Secondary outcomes relate to the incidence of the composite outcome of cardiovascular death, nonfatal myocardial infarction/stroke, need for myocardial revascularization, and recurrent hospitalization during the follow-up period.
DISCUSSION


This paper describes the protocol, design, and rationale for key methodology for an ongoing clinical trial featuring a simple and feasible intervention. Similar adherence efficacy trials have not led to sufficient improvements, and there remains a gap regarding how adherence interventions should be implemented into clinical care.",2019,"Secondary outcomes relate to the incidence of the composite outcome of cardiovascular death, nonfatal myocardial infarction/stroke, need for myocardial revascularization, and recurrent hospitalization during the follow-up period.
","['acute coronary syndrome (ACS', 'patients with acute coronary syndromes (IDEAL-LDL', 'patients hospitalized due to an ACS']","['Motivational interviewing to support LDL-C therapeutic goals and lipid-lowering therapy compliance', 'person educational session and an informative leaflet, and also undergo two phone-based, motivational interviewing sessions', 'patient-centered, physician-led motivational intervention following ACS']","['medication adherence', 'incidence of the composite outcome of cardiovascular death, nonfatal myocardial infarction/stroke, need for myocardial revascularization, and recurrent hospitalization during the follow-up period', 'assessment of LDL-C goal achievement']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0027056', 'cui_str': 'Myocardial Revascularization'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",,0.0622949,"Secondary outcomes relate to the incidence of the composite outcome of cardiovascular death, nonfatal myocardial infarction/stroke, need for myocardial revascularization, and recurrent hospitalization during the follow-up period.
","[{'ForeName': 'Aristi', 'Initials': 'A', 'LastName': 'Boulmpou', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kartas', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Farmakis', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Zafeiropoulos', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Nevras', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Papadimitriou', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Tampaki', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Vlachou', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Leonidas', 'Initials': 'L', 'LastName': 'Lillis', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Koutsakis', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Karvounis', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakoulas', 'Affiliation': 'Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki, St. Kiriakidi 1, 54636, Thessaloniki, Greece. Electronic address: ggiannakoulas@auth.gr.'}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2018.10.002']
1542,30346530,"An evaluation of the implementation of a parent-led, games-based physical activity intervention: the Active Play at Home quasi-randomized trial.","Trial Registration


NCT02058342. Registered 6 February 2014 retrospectively registered.",2019,"Trial Registration


NCT02058342.",[],['games-based physical activity intervention'],[],[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.218576,"Trial Registration


NCT02058342.","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Rubin', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA, USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Honea', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Castner', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA, USA.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'McGarrah', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Rose', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dumont-Driscoll', 'Affiliation': 'Department of Pediatrics, University of Florida, Gainesville, FL, USA.'}]",Health education research,['10.1093/her/cyy035']
1543,30338514,Interventions for reducing inflammation in familial Mediterranean fever.,"BACKGROUND


Familial Mediterranean fever, a hereditary auto-inflammatory disease, mainly affects ethnic groups living in the Mediterranean region. Early studies reported colchicine as a potential drug for preventing attacks of familial Mediterranean fever. For those people who are colchicine-resistant or intolerant, drugs such as rilonacept, anakinra, canakinumab, etanercept, infliximab, thalidomide and interferon-alpha might be beneficial. This is an updated version of the review.
OBJECTIVES


To evaluate the efficacy and safety of interventions for reducing inflammation in people with familial Mediterranean fever.
SEARCH METHODS


We used detailed search strategies to search the following databases: CENTRAL; MEDLINE; Embase; Chinese Biomedical Literature Database (CBM); China National Knowledge Infrastructure Database (CNKI); Wan Fang; and VIP. In addition, we also searched the clinical trials registries including ClinicalTrials.gov, the International Standard Randomized Controlled Trial Number Register, the WHO International Clinical Trials Registry Platform and the Chinese Clinical Trial Registry, as well as references listed in relevant reports.Date of last search: 21 August 2018.
SELECTION CRITERIA


Randomized controlled studies (RCTs) of people diagnosed with familial Mediterranean fever, comparing active interventions (including colchicine, anakinra, rilonacept, canakinumab, etanercept, infliximab, thalidomide, interferon-alpha, ImmunoGuard™ (a herbal dietary supplement) and non-steroidal anti-inflammatory drugs) with placebo or no treatment, or comparing active drugs to each other.
DATA COLLECTION AND ANALYSIS


The authors independently selected studies, extracted data and assessed risk of bias. We pooled data to present the risk ratio or mean difference with their 95% confidence intervals. We assessed overall evidence quality according to the GRADE approach.
MAIN RESULTS


We included nine RCTs with a total of 249 participants (aged three to 53 years); five were of cross-over and four of parallel design. Six studies used oral colchicine, one used oral ImmunoGuard™ and the remaining two used rilonacept or anakinra as a subcutaneous injection. The duration of each study arm ranged from one to eight months.The three studies of ImmunoGuard™, rilonacept and anakinra were generally well-designed, except for an unclear risk of detection bias in one of these. However, some inadequacy existed in the four older studies on colchicine, which had an unclear risk of selection bias, detection bias and reporting bias, and also a high risk of attrition bias and other potential bias. Neither of the two studies comparing a single to a divided dose of colchicine were adequately blinded, furthermore one study had an unclear risk of selection bias and reporting bias, a high risk of attrition bias and other potential bias.We aimed to report on the number of participants experiencing an attack, the timing of attacks, the prevention of amyloid A amyloidosis, any adverse drug reactions and the response of a number of biochemical markers from the acute phase of an attack, but data were not available for all outcomes across all comparisons.One study (15 participants) reported a significant reduction in the number of people experiencing attacks at three months with 0.6 mg colchicine three times daily (14% versus 100%), risk ratio 0.21 (95% confidence interval 0.05 to 0.95) (low-quality evidence). A further study (22 participants) of 0.5 mg colchicine twice daily showed no significant reduction in the number of participants experiencing attacks at two months (low-quality evidence). A study of rilonacept in individuals who were colchicine-resistant or intolerant (14 participants) also showed no reduction at three months (moderate-quality evidence). Likewise, a study of anakinra given to colchicine-resistant people (25 participants) showed no reduction in the number of participants experiencing an attack at four months (moderate-quality evidence).Three studies reported no significant differences in duration of attacks: one comparing colchicine to placebo (15 participants) (very low-quality evidence); one comparing single-dose colchicine to divided-dose colchicine (90 participants) (moderate-quality evidence); and one comparing rilonacept to placebo (14 participants) (low-quality evidence). Three studies reported no significant differences in the number of days between attacks: two comparing colchicine to placebo (24 participants in total) (very low-quality evidence); and one comparing rilonacept to placebo (14 participants) (low-quality evidence).No study reported on the prevention of amyloid A amyloidosis.One study of colchicine reported loose stools and frequent bowel movements (very low-quality evidence) and a second reported diarrhoea (very low-quality evidence). The rilonacept study reported no significant differences in gastrointestinal symptoms, hypertension, headache, respiratory tract infections, injection site reactions and herpes, compared to placebo (low-quality evidence). The ImmunoGuard study observed no side effects (moderate-quality evidence). The anakinra study reported no significant differences between intervention and placebo, including injection site reaction, headache, presyncope, dyspnea and itching (moderate-quality evidence). When comparing single and divided doses of colchicine, one study reported no difference in adverse events (including anorexia, nausea, diarrhoea, abdominal pain, vomiting and elevated liver enzymes) between groups (moderate-quality evidence) and the second study reported no adverse effects were detected.The rilonacept study reported no significant reduction in acute phase response indicators after three months (low-quality evidence). In the ImmunoGuard™ study, these indicators were not reduced after one month of treatment (moderate-quality evidence). The anakinra study, reported that C-reactive protein was significantly reduced after four months (moderate-quality evidence). One of the single dose versus divided dose colchicine studies reported no significant reduction in acute phase response indicators after eight months (low-quality evidence), while the second study reported no significant reduction in serum amyloid A concentration after six months (moderate-quality evidence).
AUTHORS' CONCLUSIONS


There were limited RCTs assessing interventions for people with familial Mediterranean fever. Based on the evidence, three times daily colchicine appears to reduce the number of people experiencing attacks, colchicine single dose and divided dose might not be different for children with familial Mediterranean fever and anakinra might reduce C-reactive protein in colchicine-resistant participants; however, only a few RCTs contributed data for analysis. Further RCTs examining active interventions, not only colchicine, are necessary before a comprehensive conclusion regarding the efficacy and safety of interventions for reducing inflammation in familial Mediterranean fever can be drawn.",2018,"The anakinra study reported no significant differences between intervention and placebo, including injection site reaction, headache, presyncope, dyspnea and itching (moderate-quality evidence).","['familial Mediterranean fever', 'people with familial Mediterranean fever', 'nine RCTs with a total of 249 participants (aged three to 53 years); five were of cross-over and four of parallel design', 'resistant people (25 participants', 'individuals who were colchicine-resistant or intolerant (14 participants', 'people diagnosed with familial Mediterranean fever, comparing active interventions (including']","['placebo', 'colchicine, anakinra, rilonacept, canakinumab, etanercept, infliximab, thalidomide, interferon-alpha, ImmunoGuard™ (a herbal dietary supplement', 'colchicine', 'rilonacept to placebo', 'colchicine to placebo']","['number of participants experiencing attacks', 'gastrointestinal symptoms, hypertension, headache, respiratory tract infections, injection site reactions and herpes', 'adverse events (including anorexia, nausea, diarrhoea, abdominal pain, vomiting and elevated liver enzymes', 'acute phase response indicators', 'adverse effects', 'C-reactive protein', 'duration of attacks', 'number of people experiencing attacks', 'number of days between attacks', 'injection site reaction, headache, presyncope, dyspnea and itching (moderate-quality evidence', 'efficacy and safety', 'loose stools and frequent bowel movements', 'serum amyloid A concentration']","[{'cui': 'C0031069', 'cui_str': 'Polyserositis, Recurrent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C2343589', 'cui_str': 'rilonacept'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C1310982', 'cui_str': 'ImmunoGuard'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0019340', 'cui_str': 'Herpes NOS'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0001349', 'cui_str': 'Response, Acute-Phase'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0700200', 'cui_str': 'Presyncope'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C0239978', 'cui_str': 'Increased frequency of defecation (finding)'}, {'cui': 'C0002723', 'cui_str': 'Amyloid Protein SAA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",249.0,0.389526,"The anakinra study reported no significant differences between intervention and placebo, including injection site reaction, headache, presyncope, dyspnea and itching (moderate-quality evidence).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, West China Hospital, Sichuan University, No.37,Guoxue Lane, Chengdu, Sichuan, China, 610041.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Youping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010893.pub3']
1544,30337119,Effects of the Lung Volume on the Electroglottographic Waveform in Trained Female Singers.,"OBJECTIVES


To determine if in singing there is an effect of lung volume on the electroglottographic waveform, and if so, how it varies over the voice range.
STUDY DESIGN


Eight trained female singers sang the tune ""Frère Jacques"" in 18 conditions: three phonetic contexts, three dynamic levels, and high or low lung volume. Conditions were randomized and replicated.
METHODS


The audio and EGG signals were recorded in synchrony with signals tracking respiration and vertical larynx position. The first 10 Fourier descriptors of every EGG cycle were computed. These spectral data were clustered statistically, and the clusters were mapped by color into a voice range profile display, thus visualizing the EGG waveform changes under the influence of f o  and SPL. The rank correlations and effect sizes of the relationships between relative lung volume and several adduction-related EGG wave shape metrics were similarly rendered on a color scale, in voice range profile-style 'voice maps.'
RESULTS


In most subjects, EGG waveforms varied considerably over the voice range. Within subjects, reproducibility was high, not only across the replications, but also across the phonetic contexts. The EGG waveforms were quite individual, as was the nature of the EGG shape variation across the range. EGG metrics were significantly correlated to changes in lung volume, in parts of the range of the song, and in most subjects. However, the effect sizes of the relative lung volume were generally much smaller than the effects of f o  and SPL, and the relationships always varied, even changing polarity from one part of the range to another.
CONCLUSIONS


Most subjects exhibited small, reproducible effects of the relative lung volume on the EGG waveform. Some hypothesized influences of tracheal pull were seen, mostly at the lowest SPLs. The effects were however highly variable, both across the moderately wide f o -SPL range and across subjects. Different singers may be applying different techniques and compensatory behaviors with changing lung volume. The outcomes emphasize the importance of making observations over a substantial part of the voice range, and not only of phonations sustained at a few fundamental frequencies and sound levels.",2020,"EGG metrics were significantly correlated to changes in lung volume, in parts of the range of the song, and in most subjects.","['Trained Female Singers', 'Eight trained female singers sang the tune ""Frère Jacques"" in 18 conditions: three phonetic contexts, three dynamic levels, and high or low lung volume']",[],['Electroglottographic Waveform'],"[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0335076', 'cui_str': 'Singer'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}]",[],"[{'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}]",,0.0289933,"EGG metrics were significantly correlated to changes in lung volume, in parts of the range of the song, and in most subjects.","[{'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Ternström', 'Affiliation': 'Department of Speech, Music and Hearing, School of Electrical Engineering and Computer Science, KTH Royal Institute of Technology, Stockholm, Sweden. Electronic address: stern@kth.se.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""D'Amario"", 'Affiliation': 'Department of Speech, Music and Hearing, School of Electrical Engineering and Computer Science, KTH Royal Institute of Technology, Stockholm, Sweden; Audio Lab, Department of Electronic Engineering, University of York, Heslington, United Kingdom.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Selamtzis', 'Affiliation': 'Department of Speech, Music and Hearing, School of Electrical Engineering and Computer Science, KTH Royal Institute of Technology, Stockholm, Sweden.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.09.006']
1545,30461319,"A Prospective, Randomized Trial Comparing Open and Endoscopic Carpal Tunnel Release Within the Same Patient.","Background:  Surgical management of carpal tunnel syndrome includes performing an endoscopic (ECTR) or open (OCTR) carpal tunnel release. Several studies have shown less postoperative pain and improvement in grip and pinch strength with the endoscopic technique. The goal of this study was to prospectively examine outcomes, patient satisfaction, and complications after both ECTR and OCTR in the opposite hands of the same patient.  Methods:  This was a prospective study in which patients with bilateral carpal tunnel syndrome underwent surgical release with both techniques, with initial operative approach randomized in the more symptomatic hand. Demographic data and functional outcomes were recorded, including the pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength testing, grip strength, carpal tunnel syndrome functional status score, carpal tunnel syndrome symptom severity score, and overall satisfaction.  Results:  Thirty patients completed the study; there were no significant differences in any measure at any of the postoperative time points. Symptom severity and functional status scores were not significantly different between groups at any evaluation. Subjectively, 24 of 30 patients did state they preferred the ECTR, mostly citing less pain as their primary reason, although pain scores were not significantly different. Differences in overall satisfaction were also not significant.  Conclusions:  Both techniques are well tolerated with no differences in outcomes. With the added cost and equipment associated with ECTR, and no added benefit, the usefulness of ECTR is questionable.",2020,Symptom severity and functional status scores were not significantly different between groups at any evaluation.,"['patients with bilateral carpal tunnel syndrome underwent surgical release with both techniques, with initial operative approach randomized in the more symptomatic hand']","['Endoscopic Carpal Tunnel Release', 'endoscopic (ECTR) or open (OCTR) carpal tunnel release']","['postoperative pain', 'grip and pinch strength', 'overall satisfaction', 'postoperative time points', 'Symptom severity and functional status scores', 'pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength testing, grip strength, carpal tunnel syndrome functional status score, carpal tunnel syndrome symptom severity score, and overall satisfaction', 'pain scores', 'Demographic data and functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3864035', 'cui_str': 'Bilateral carpal tunnel syndrome (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0458125', 'cui_str': 'Endoscopic carpal tunnel release (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0196576', 'cui_str': 'Carpal tunnel decompression'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",30.0,0.0282083,Symptom severity and functional status scores were not significantly different between groups at any evaluation.,"[{'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Michelotti', 'Affiliation': 'University of Wisconsin-Madison, USA.'}, {'ForeName': 'Kavita T', 'Initials': 'KT', 'LastName': 'Vakharia', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Romanowsky', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, USA.'}, {'ForeName': 'Randy M', 'Initials': 'RM', 'LastName': 'Hauck', 'Affiliation': 'Pennsylvania State University College of Medicine, Hershey, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718812129']
1546,31654838,Patient-reported outcomes from the randomized phase III ALEX study of alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer.,"OBJECTIVES


Alectinib demonstrated superior efficacy and a safety profile that compared favorably with crizotinib in treatment-naïve ALK+ non-small-cell lung cancer (NSCLC) in the phase III ALEX study. We present patient-reported outcomes (PROs) from ALEX to assess disease burden, treatment-related symptom tolerability, and health-related quality of life (HRQoL) with alectinib versus crizotinib.
MATERIALS AND METHODS


Patients were randomized to receive alectinib 600 mg or crizotinib 250 mg twice daily until disease progression, death, or withdrawal. Pre-specified PRO endpoints were: mean change from baseline in symptoms, HRQoL, and functioning; and time to deterioration (TTD) in cough, dyspnea, chest pain, arm/shoulder pain, fatigue, and a composite of three symptoms (cough, dyspnea, chest pain). PRO data were collected using EORTC QLQ-C30 and LC13 questionnaires. Raw scores were standardized to a 0-100-point range, with a ≥10-point score change defined as clinically meaningful. TTD was defined as the time from randomization until confirmed clinically meaningful deterioration (i.e., a ≥10-point score change from baseline).
RESULTS


Baseline completion rates and characteristics were balanced in the PRO-evaluable population (alectinib n = 100, 66%; crizotinib n = 97, 64%). On average, alectinib-treated patients reported clinically meaningful improvements in lung cancer symptoms for longer than crizotinib-treated patients. Between-treatment differences in lung cancer symptoms tended to favor alectinib from 11.1 months (45 weeks) onwards, around the time of median PFS with crizotinib (11.1 months). TTD in lung cancer symptoms was similar between treatment arms, despite longer duration of symptom improvement with alectinib; composite symptom endpoint (hazard ratio 1.10 [95% confidence interval: 0.72-1.68]). Duration of clinically meaningful improvement in HRQoL was longer with alectinib versus crizotinib (Week 88 vs. Week 68, respectively). Better patient-reported tolerability was observed with alectinib versus crizotinib on common treatment-related symptoms.
CONCLUSION


PRO data support the superior efficacy and tolerability of alectinib relative to crizotinib demonstrated in the ALEX study.",2019,"On average, alectinib-treated patients reported clinically meaningful improvements in lung cancer symptoms for longer than crizotinib-treated patients.","['patients with ALK-positive non-small-cell lung cancer', 'Patients']","['crizotinib', 'alectinib versus crizotinib', 'alectinib 600\u2009mg or crizotinib 250\u2009mg twice daily until disease progression, death, or withdrawal']","['HRQoL', 'tolerability', 'PRO data', 'symptom tolerability, and health-related quality of life (HRQoL', 'TTD in lung cancer symptoms', 'lung cancer symptoms', 'Raw scores', 'symptoms, HRQoL, and functioning; and time to deterioration (TTD) in cough, dyspnea, chest pain, arm/shoulder pain, fatigue, and a composite of three symptoms (cough, dyspnea, chest pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3204579', 'cui_str': 'crizotinib 250 MG [Xalkori]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",,0.111851,"On average, alectinib-treated patients reported clinically meaningful improvements in lung cancer symptoms for longer than crizotinib-treated patients.","[{'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, 69008 Lyon, France. Electronic address: maurice.perol@lyon.unicancer.fr.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Department of Oncology, Royal North Shore Hospital, St Leonards 2065, New South Wales, Australia. Electronic address: nick.pavlakis@sydney.edu.au.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Levchenko', 'Affiliation': 'Petrov Scientific Research Oncology Institute, St. Petersburg 197758, Russia. Electronic address: maurice.perol@lyon.unicancer.fr.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Platania', 'Affiliation': 'Fondazione IRCCS, 20133 Milan, Italy. Electronic address: marco.platania@istitutotumori.mi.it.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Portuguese Oncology Institute of Porto (IPO Porto), 4200-072 Porto, Portugal. Electronic address: julio.oliveira@ipoporto.min-saude.pt.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, 10126 Turin, Italy. Electronic address: silvia.novello@unito.it.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Chiari', 'Affiliation': 'Hospital of Perugia, Santa Maria della Misericordia, 06129 Perugia, Italy. Electronic address: ritachiari@libero.it.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moran', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology-Badalona, Hospital Universitari Germans Trias i Pujol, Universitat Autonoma de Barcelona (UAB), Badalona Applied Research Group in Oncology (B-ARGO), 08916 Badalona, Barcelona, Spain. Electronic address: mmoran@iconcologia.net.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Mitry', 'Affiliation': 'F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland. Electronic address: e.mitry@me.com.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Nüesch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland. Electronic address: eveline.nueesch.en1@roche.com.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland. Electronic address: ting.liu.tl3@roche.com.'}, {'ForeName': 'Bogdana', 'Initials': 'B', 'LastName': 'Balas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland. Electronic address: bogdana_ioana.balas@roche.com.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Konopa', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, 80-001 Gdansk, Poland. Electronic address: konopa@gumed.edu.pl.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, 1011 Lausanne, Switzerland. Electronic address: Solange.Peters@chuv.ch.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.10.002']
1547,30371937,Antibiotics for exacerbations of chronic obstructive pulmonary disease.,"BACKGROUND


Many patients with an exacerbation of chronic obstructive pulmonary disease (COPD) are treated with antibiotics. However, the value of antibiotics remains uncertain, as systematic reviews and clinical trials have shown conflicting results.
OBJECTIVES


To assess effects of antibiotics on treatment failure as observed between seven days and one month after treatment initiation (primary outcome) for management of acute COPD exacerbations, as well as their effects on other patient-important outcomes (mortality, adverse events, length of hospital stay, time to next exacerbation).
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, MEDLINE, Embase, and other electronically available databases up to 26 September 2018.
SELECTION CRITERIA


We sought to find randomised controlled trials (RCTs) including people with acute COPD exacerbations comparing antibiotic therapy and placebo and providing follow-up of at least seven days.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened references and extracted data from trial reports. We kept the three groups of outpatients, inpatients, and patients admitted to the intensive care unit (ICU) separate for benefit outcomes and mortality because we considered them to be clinically too different to be summarised as a single group. We considered outpatients to have a mild to moderate exacerbation, inpatients to have a severe exacerbation, and ICU patients to have a very severe exacerbation. When authors of primary studies did not report outcomes or study details, we contacted them to request missing data. We calculated pooled risk ratios (RRs) for treatment failure, Peto odds ratios (ORs) for rare events (mortality and adverse events), and mean differences (MDs) for continuous outcomes using random-effects models. We used GRADE to assess the quality of the evidence. The primary outcome was treatment failure as observed between seven days and one month after treatment initiation.
MAIN RESULTS


We included 19 trials with 2663 participants (11 with outpatients, seven with inpatients, and one with ICU patients).For outpatients (with mild to moderate exacerbations), evidence of low quality suggests that currently available antibiotics statistically significantly reduced the risk for treatment failure between seven days and one month after treatment initiation (RR 0.72, 95% confidence interval (CI) 0.56 to 0.94; I² = 31%; in absolute terms, reduction in treatment failures from 295 to 212 per 1000 treated participants, 95% CI 165 to 277). Studies providing older antibiotics not in use anymore yielded an RR of 0.69 (95% CI 0.53 to 0.90; I² = 31%). Evidence of low quality from one trial in outpatients suggested no effects of antibiotics on mortality (Peto OR 1.27, 95% CI 0.49 to 3.30). One trial reported no effects of antibiotics on re-exacerbations between two and six weeks after treatment initiation. Only one trial (N = 35) reported health-related quality of life but did not show a statistically significant difference between treatment and control groups.Evidence of moderate quality does not show that currently used antibiotics statistically significantly reduced the risk of treatment failure among inpatients with severe exacerbations (i.e. for inpatients excluding ICU patients) (RR 0.65, 95% CI 0.38 to 1.12; I² = 50%), but trial results remain uncertain. In turn, the effect was statistically significant when trials included older antibiotics no longer in clinical use (RR 0.76, 95% CI 0.58 to 1.00; I² = 39%). Evidence of moderate quality from two trials including inpatients shows no beneficial effects of antibiotics on mortality (Peto OR 2.48, 95% CI 0.94 to 6.55). Length of hospital stay (in days) was similar in antibiotic and placebo groups.The only trial with 93 patients admitted to the ICU showed a large and statistically significant effect on treatment failure (RR 0.19, 95% CI 0.08 to 0.45; moderate-quality evidence; in absolute terms, reduction in treatment failures from 565 to 107 per 1000 treated participants, 95% CI 45 to 254). Results of this trial show a statistically significant effect on mortality (Peto OR 0.21, 95% CI 0.06 to 0.72; moderate-quality evidence) and on length of hospital stay (MD -9.60 days, 95% CI -12.84 to -6.36; low-quality evidence).Evidence of moderate quality gathered from trials conducted in all settings shows no statistically significant effect on overall incidence of adverse events (Peto OR 1.20, 95% CI 0.89 to 1.63; moderate-quality evidence) nor on diarrhoea (Peto OR 1.68, 95% CI 0.92 to 3.07; moderate-quality evidence).
AUTHORS' CONCLUSIONS


Researchers have found that antibiotics have some effect on inpatients and outpatients, but these effects are small, and they are inconsistent for some outcomes (treatment failure) and absent for other outcomes (mortality, length of hospital stay). Analyses show a strong beneficial effect of antibiotics among ICU patients. Few data are available on the effects of antibiotics on health-related quality of life or on other patient-reported symptoms, and data show no statistically significant increase in the risk of adverse events with antibiotics compared to placebo. These inconsistent effects call for research into clinical signs and biomarkers that can help identify patients who would benefit from antibiotics, while sparing antibiotics for patients who are unlikely to experience benefit and for whom downsides of antibiotics (side effects, costs, and multi-resistance) should be avoided.",2018,Only one trial (N = 35) reported health-related quality of life but did not show a statistically significant difference between treatment and control groups.,"['people with acute COPD exacerbations comparing', 'patients with an exacerbation of chronic obstructive pulmonary disease (COPD', '2663 participants (11 with outpatients, seven with inpatients, and one with ICU patients).For outpatients (with mild to moderate exacerbations', 'chronic obstructive pulmonary disease', 'outpatients, inpatients, and patients admitted to the intensive care unit (ICU) separate for benefit outcomes and mortality because we considered them to be clinically too different to be summarised as a single group']","['antibiotic therapy and placebo', 'antibiotics', 'Antibiotics', 'placebo']","['risk of adverse events', 'acute COPD exacerbations', 'length of hospital stay', 're-exacerbations', 'diarrhoea', 'pooled risk ratios (RRs) for treatment failure, Peto odds ratios (ORs) for rare events (mortality and adverse events), and mean differences (MDs', 'treatment failure', 'overall incidence of adverse events', 'risk of treatment failure', 'mortality', 'patient-important outcomes (mortality, adverse events, length of hospital stay, time to next exacerbation', 'health-related quality of life', 'Length of hospital stay']","[{'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0162643'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",93.0,0.43494,Only one trial (N = 35) reported health-related quality of life but did not show a statistically significant difference between treatment and control groups.,"[{'ForeName': 'Daniela J', 'Initials': 'DJ', 'LastName': 'Vollenweider', 'Affiliation': 'General Internal Medicine, mediX Zurich, Mattenhof 2, Zurich, ZH, Switzerland, 8051.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Frei', 'Affiliation': ''}, {'ForeName': 'Claudia A', 'Initials': 'CA', 'LastName': 'Steurer-Stey', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Garcia-Aymerich', 'Affiliation': ''}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010257.pub2']
1548,30321319,Comparing retainers constructed on conventional stone models and on 3D printed models: a randomized crossover clinical study.,"OBJECTIVES


The aim of this study was to compare vacuum-formed thermoplastic retainers (VFRs) constructed on stone models (VFR-CV) and those constructed on three-dimensional (3D) printed models (VFR-3D) based on patients' perspective and post-treatment stability.
STUDY DESIGN


The research was designed as a crossover, randomized control trial.
MATERIALS AND METHODS


Subjects comprised patients receiving fixed appliances at a teaching institution and indicated for VFRs. Post-treatment stone models were scanned with a structured-light scanner. A fused deposition modelling machine was used to construct acrylonitrile-butadiene-styrene (ABS)-based replicas from the 3D scanned images. VFRs were fabricated on the original stone and printed models. Analysis comprised independent t-tests and repeated measures analysis of variance.
RANDOMIZATION


Subjects were allocated to two groups using Latin squares methods and simple randomization. A week after debond, subjects received either VFR-CV first (group A) or VFR-3D first (group B) for 3 months, then the interventions were crossed over for another 3 months.
BLINDING


In this single-blinded study, subjects were assigned a blinding code for data entry; data were analysed by a third party.
OUTCOME MEASURES


The primary outcome measured was oral health-related quality of life (OHRQoL) based on Oral Health Impact Profile-14 (OHIP-14). Secondary outcome was post-treatment stability measured using Little's Irregularity Index (LII).
RESULTS


A total of 30 subjects (15 in each group) were recruited but 3 dropped out. Analysis included 13 subjects from group A and 14 subjects from group B. Group A showed an increase in LII (P < 0.05) after wearing VFR-CV and VFR-3D, whereas group B had no significant increase in LII after wearing both VFRs. Both groups reported significant improvement in OHRQoL after the first intervention but no significant differences after the second intervention. LII changes and OHIP-14 scores at T2 and T3 between groups, and overall between the retainers were not significantly different. No harm was reported during the study.
CONCLUSION


VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
REGISTRATION


NCT02866617 (ClinicalTrials.gov).",2019,"Conclusion


VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
",['30 subjects (15 in each group) were recruited but 3 dropped out'],"['vacuum-formed thermoplastic retainers (VFRs', 'VFR-CV first (group A) or VFR-3D first']","[""post-treatment stability measured using Little's Irregularity Index (LII"", 'LII changes and OHIP-14 scores', 'oral health-related quality of life (OHRQoL) based on Oral Health Impact Profile-14 (OHIP-14', 'OHRQoL', 'LII']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",30.0,0.104057,"Conclusion


VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
","[{'ForeName': 'Norhidayah', 'Initials': 'N', 'LastName': 'Mohd Tahir', 'Affiliation': 'Department of Paediatric Dentistry and Orthodontics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Nurazreena', 'Initials': 'WN', 'LastName': 'Wan Hassan', 'Affiliation': 'Department of Paediatric Dentistry and Orthodontics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Roslan', 'Initials': 'R', 'LastName': 'Saub', 'Affiliation': 'Department of Community Oral Health and Clinical Prevention, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}]",European journal of orthodontics,['10.1093/ejo/cjy063']
1549,31653801,Unilateral Elbow Flexion and Leg Press Training Induce Cross-Education But Not Global Training Gains in Children.,"PURPOSE


Whereas cross-education has been extensively investigated with adults, there are far fewer youth investigations. Two studies suggested that children had greater global responses to unilateral knee extensor fatigue and training, respectively, than adults. The objective of this study was to compare global training responses and cross-education effects after unilateral elbow flexion (EFlex) and leg press (LP) training.
METHODS


Forty-three prepubertal youths (aged 10-13 y) were randomly allocated into dominant LP (n = 15), EFlex (n = 15) training groups, or a control (n = 13). Experimental groups trained 3 times per week for 8 weeks and were tested pretraining and posttraining for ipsilateral and contralateral 1-repetition maximum LP; knee extensor, knee flexors, elbow flexors; and handgrip maximum voluntary isometric contractions (MVIC), and countermovement jump.
RESULTS


In comparison to no significant changes with the control group, dominant elbow flexors training demonstrated significant ( P < .001) improvements only with ipsilateral and contralateral upper body testing (EFlex MVIC [15.9-21.5%], EFlex 1-repetition maximum [22.9-50.8%], handgrip MVIC [5.5-13.8%]). Dominant LP training similarly exhibited only significant ( P < .001) improvements for ipsilateral and contralateral lower body testing (LP 1-repetition maximum [59.6-81.8%], knee extensor MVIC [12.4-18.3%], knee flexor MVIC [7.9-22.3%], and countermovement jump [11.1-18.1%]).
CONCLUSIONS


The ipsilateral and contralateral training adaptations in youth were specific to upper or lower body training, respectively.",2020,"In comparison to no significant changes with the control group, dominant elbow flexors training demonstrated significant ( P < .001) improvements only with ipsilateral and contralateral upper body testing","['Forty-three prepubertal youths (aged 10-13\xa0y', 'Children']","['EFlex', 'tested pretraining and posttraining for ipsilateral and contralateral 1-repetition maximum LP; knee extensor, knee flexors, elbow flexors; and handgrip maximum voluntary isometric contractions (MVIC), and countermovement jump', 'Dominant LP training', 'Unilateral Elbow Flexion and Leg Press Training Induce Cross-Education', 'unilateral elbow flexion (EFlex) and leg press (LP) training', 'LP']","['global responses', 'ipsilateral and contralateral lower body testing (LP 1-repetition maximum', 'knee extensor MVIC', 'ipsilateral and contralateral upper body testing', 'knee flexor MVIC']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",,0.0154133,"In comparison to no significant changes with the control group, dominant elbow flexors training demonstrated significant ( P < .001) improvements only with ipsilateral and contralateral upper body testing","[{'ForeName': 'Aymen', 'Initials': 'A', 'LastName': 'Ben Othman', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Chaouachi', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Makhlouf', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Farthing', 'Affiliation': 'University of Saskatchewan.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'University of Potsdam.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': 'Memorial University of Newfoundland.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Chaouachi', 'Affiliation': 'National Center of Medicine and Science in Sports (CNMSS).'}]",Pediatric exercise science,['10.1123/pes.2019-0079']
1550,30296875,Improved Medication Management With Introduction of a Perioperative and Prescribing Pharmacist Service.,"BACKGROUND


The medication lists in pre-admission clinic (PAC) questionnaires completed by patients prior to surgery are often inaccurate, potentially leading to medication errors during hospitalization. Studies have shown pharmacists are more accurate when obtaining a medication history and transcribing prescription orders, thereby reducing errors.
OBJECTIVE


To evaluate the impact of a PeRiopErative and Prescribing (PREP) pharmacist on postoperative medication management.
METHODS


A randomized prospective interventional study enrolled elective surgery patients at high risk for medication misadventure to receive PREP pharmacy service or usual care (control group). A best possible medication history (BPMH) was obtained by the PREP pharmacist and was available to surgical staff on admission. The PREP pharmacist also prepared discharge prescriptions for their patients. The primary outcomes for the study were accuracy of BPMH and discharge prescriptions compared to usual care. The study was powered to 80% with 2-tailed significance α of .05.
RESULTS


The medication history in the PREP pharmacist group had fewer errors than the control group: 9% (5/53) versus 96% (49/51;  P  < .001). Discharge prescriptions prepared by the PREP pharmacist had fewer errors than control group: 25% versus 78% ( P  < .001). Significantly, more PREP pharmacist patients received a discharge summary with a complete medication list: 75% versus 33% ( P  = .001). Inpatient prescribing was more accurate in the PREP pharmacist patients: 0.64 versus 1.31 errors per patient ( P  = .047).
CONCLUSION


Inclusion of the PREP pharmacist role in the elective surgery multidisciplinary team improved the accuracy of medication histories, inpatient prescribing, and discharge prescriptions for patients at high risk of medication misadventure.",2020,Discharge prescriptions prepared by the PREP pharmacist had fewer errors than control group: 25% versus 78% ( P < .001).,"['patients at high risk of medication misadventure', 'enrolled elective surgery patients at high risk for medication misadventure to receive PREP pharmacy service or usual care (control group']",['PeRiopErative and Prescribing (PREP) pharmacist'],['accuracy of BPMH and discharge prescriptions'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0031321', 'cui_str': 'Services, Pharmacy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",,0.0474237,Discharge prescriptions prepared by the PREP pharmacist had fewer errors than control group: 25% versus 78% ( P < .001).,"[{'ForeName': 'Anny D', 'Initials': 'AD', 'LastName': 'Nguyen', 'Affiliation': 'Pharmacy Department, Frankston Hospital, Peninsula Health, Frankston, Victoria, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Lam', 'Affiliation': 'Pharmacy Department, Frankston Hospital, Peninsula Health, Frankston, Victoria, Australia.'}, {'ForeName': 'Iouri', 'Initials': 'I', 'LastName': 'Banakh', 'Affiliation': 'Pharmacy Department, Frankston Hospital, Peninsula Health, Frankston, Victoria, Australia.'}, {'ForeName': 'Skip', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': 'Pharmacy Department, Frankston Hospital, Peninsula Health, Frankston, Victoria, Australia.'}, {'ForeName': 'Tyron', 'Initials': 'T', 'LastName': 'Crofts', 'Affiliation': 'Department of Anaesthesia, Frankston Hospital, Peninsula Health, Frankston, Victoria, Australia.'}]",Journal of pharmacy practice,['10.1177/0897190018804961']
1551,30343617,Measuring the Impact of Medication-Related Interventions on 30-Day Readmission Rates in a Skilled Nursing Facility.,"BACKGROUND


There is a lack of published literature that measures the impact of transitional care pharmacist (TCP) medication-related interventions within the skilled nursing facility (SNF) setting.
OBJECTIVES


To evaluate the impact of TCP medication-related interventions on 30-day hospital readmissions among SNF patients compared to current standard of care.
METHODS


This was a retrospective pilot study. All patients included in the study were discharged from an inpatient facility to a SNF. The control group received transitional services from a care team with no pharmacist. The intervention group received transitional services from a care team plus a pharmacist.
RESULTS


The 30-day readmission rates in the intervention group were 14 (12%)/116 compared to the control group, 19 (16%)/116; however, the difference was not statistically significant ( P  = .35). The median time to readmission was statistically significantly longer in the intervention group, 17.5 days, compared to the control group, 10 days ( P  = .02). One hundred seventy-four medication-related interventions were performed in the intervention group during the study period.
CONCLUSION


This study demonstrates that TCP interventions in an SNF are associated with a significant delay in readmission. A continuation of the pilot program may show a role in reducing all-cause 30-day readmission and ED visit rates.",2020,"The 30-day readmission rates in the intervention group were 14 (12%)/116 compared to the control group, 19 (16%)/116; however, the difference was not statistically significant ( P = .35).","['SNF patients', 'One hundred seventy-four medication-related interventions were performed in the intervention group during the study period', 'All patients included in the study were discharged from an inpatient facility to a SNF']","['transitional services from a care team with no pharmacist', 'transitional services from a care team plus a pharmacist', 'TCP medication-related interventions', 'TCP interventions']","['30-day readmission rates', '30-day hospital readmissions', 'median time to readmission', '30-Day Readmission Rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0044091', 'cui_str': 'tenocyclidine-TCP'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0252722,"The 30-day readmission rates in the intervention group were 14 (12%)/116 compared to the control group, 19 (16%)/116; however, the difference was not statistically significant ( P = .35).","[{'ForeName': 'Priya B', 'Initials': 'PB', 'LastName': 'Amin', 'Affiliation': 'Coastal Medical, Providence, RI, USA.'}, {'ForeName': 'Chad D', 'Initials': 'CD', 'LastName': 'Bradford', 'Affiliation': 'Scripps Mercy Hospital Chula Vista, Chula Vista, CA, USA.'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Rizos', 'Affiliation': 'System Clinical Pharmacy Services, Sharp Healthcare, San Diego, CA, USA.'}, {'ForeName': 'Bijal M', 'Initials': 'BM', 'LastName': 'Shah', 'Affiliation': 'Touro University College of Pharmacy, Vallejo, CA, USA.'}]",Journal of pharmacy practice,['10.1177/0897190018803229']
1552,30256229,Effects of an Empowerment Program on Resilience and Posttraumatic Growth Levels of Cancer Survivors: A Randomized Controlled Feasibility Trial.,"BACKGROUND


Psychosocial empowerment of cancer survivors can help improve their psychological resilience and enhance their posttraumatic growth. However, there is a lack of research exploring the effects of such empowerment programs on resilience and posttraumatic growth of cancer survivors.
OBJECTIVE


The aim of this study was to assess the feasibility of a randomized controlled trial on the effectiveness of an integrated empowerment program on cancer survivors.
METHODS


We conducted a randomized controlled trial with 89 adult cancer survivors (>25 years old) from 2 oncology hospitals. Using a table of random numbers, they were assigned randomly to the experimental group (n = 45), which participated in 10 sessions of a structured empowerment program, and the control group (n = 44), which received only routine care and no further intervention. Data were collected from patients using the Posttraumatic Growth Inventory and the Resilience Scale for Adults.
RESULTS


Posttraumatic growth and resilience levels significantly improved in the intervention group compared with the control group both at the end of and a month after the program.
CONCLUSION


This study's empowerment program is effective in improving posttraumatic growth and resilience levels of cancer survivors who are prone to trauma.
IMPLICATIONS FOR PRACTICE


By enhancing resilience and posttraumatic growth of cancer survivors, the empowerment program may help restore life, and thus its application can contribute to the psychosocial well-being of cancer survivors. Nurses with training and experience can integrate this kind of program into clinical settings.",2019,"RESULTS


Posttraumatic growth and resilience levels significantly improved in the intervention group compared with the control group both at the end of and a month after the program.
","['cancer survivors', 'cancer survivors who are prone to trauma', 'Cancer Survivors', '89 adult cancer survivors (>25 years old) from 2 oncology hospitals']","['integrated empowerment program', 'Empowerment Program', 'structured empowerment program, and the control group (n = 44), which received only routine care and no further intervention']","['Posttraumatic growth and resilience levels', 'Resilience and Posttraumatic Growth Levels']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",89.0,0.0614757,"RESULTS


Posttraumatic growth and resilience levels significantly improved in the intervention group compared with the control group both at the end of and a month after the program.
","[{'ForeName': 'Yeter Sinem', 'Initials': 'YS', 'LastName': 'Üzar-Özçetin', 'Affiliation': 'Author Affiliation: Faculty of Nursing, Psychiatric Nursing Department, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Hiçdurmaz', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000644']
1553,31001633,Persistence of Antibodies to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: 1-Year Follow-up With Memory Probe Vaccination.,"BACKGROUND


We previously reported the tolerability and immunogenicity 1 month after intramuscular administration of 2 bivalent virus-like particle (VLP)-based candidate norovirus vaccine formulations in adults. We now describe the persistence of immunity and responses to a memory probe vaccination 1 year later.
METHODS


A total of 454 healthy men and women aged 18-49 years in 3 equal groups received placebo (saline) or 15/50 or 50/50 vaccine formulations (ie, 15 or 50 µg of GI.1 genotype VLPs, respectively, and 50 µg of GII.4c VLPs) with MPL and Al(OH)3. Immunogenicity and safety were assessed up to day 365, when 351 participants received a memory probe vaccination of 15 µg each of GI.1 and GII.4c VLPs with Al(OH)3.
RESULTS


No safety signals were detected up to 1 year after the first vaccination. Pan-immunoglobulin, immunoglobulin A, and histo-blood group antigen-blocking (HBGA) antibody levels among vaccinees waned but remained higher than levels before vaccination and levels in placebo recipients on days 180 and 365. Memory probe vaccination increased all antibody titers. Levels of HBGA antibodies to GI.1 but not GII.4c were higher after the first vaccination in candidate vaccine groups, compared with those in the placebo group.
CONCLUSION


Levels of antibodies to both candidate norovirus VLP formulations persisted above baseline levels for at least 1 year after primary vaccination. HBGA-blocking responses to the memory probe for GI.1 but not GII.4c displayed characteristics of immune memory.
CLINICAL TRIALS REGISTRATION


NCT02142504.",2019,"HBGA antibodies to GI.1, but not GII.4c, were higher in candidate vaccine groups than the placebo group receiving their first NoV vaccination.
","['351 participants received a', 'Healthy 18-49 year-olds (N=454) in three equal groups received', 'healthy adults', 'adults']","['memory probe vaccination of 15µg each of GI.1 and GII.4c VLPs with Al(OH)3', 'Virus-Like Particle norovirus vaccine candidate formulations', 'placebo (saline) or 15/50 or 50/50 vaccine formulations', 'placebo']","['antibody titers', 'Immunogenicity and safety']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0077287', 'cui_str': 'tris(acetylacetonate) aluminum(III)'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles (morphologic abnormality)'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.21131,"HBGA antibodies to GI.1, but not GII.4c, were higher in candidate vaccine groups than the placebo group receiving their first NoV vaccination.
","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Baehner', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lloyd', 'Affiliation': 'Takeda Vaccines, Deerfield, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sherwood', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Mendelman', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiz170']
1554,30189765,Reduced Versus Conventional Dose Insulin for Hyperkalemia Treatment.,"BACKGROUND


Using a reduced dose of 5 units of regular insulin has been proposed as a strategy to mitigate the risk of hypoglycemia when treating hyperkalemia. The comparative efficacy and safety of this strategy to conventional 10 units is not well established.
OBJECTIVE


To compare the effectiveness of reduced and conventional dosed insulin for hyperkalemia treatment.
METHODS


Electronic medication administration reports of conventional or reduced doses of insulin given for hyperkalemia treatment were reviewed from July 2013 to September 2015. The primary outcome was reduction in serum potassium.
RESULTS


Ninety-two administrations of reduced dose insulin and 309 administrations of conventional dose insulin were included. No significant difference was found in potassium reduction between the groups (-0.096 mmol/L,  P  value = .2210). Post hoc subgroup analysis of patients with serum potassium > 6 mmol/L revealed a lower reduction in potassium in the reduced dose group compared to the conventional dose group (difference: -0.238 mmol/L,  P  value = .018).
CONCLUSIONS


Conventional dose insulin may be more effective than reduced dose regular insulin at baseline serum potassium levels >6 mmol/L in the treatment of hyperkalemia. Frequent monitoring of serum potassium and glucose after administration of insulin is necessary to confirm adequate response and avoidance of hypoglycemia.",2020,"No significant difference was found in potassium reduction between the groups (-0.096 mmol/L, P value = .2210).",['hyperkalemia treatment were reviewed from July 2013 to September 2015'],[],"['potassium reduction', 'reduction in potassium', 'reduction in serum potassium']","[{'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",[],"[{'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}]",,0.110508,"No significant difference was found in potassium reduction between the groups (-0.096 mmol/L, P value = .2210).","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Marshall B. Ketchum University, Fullerton, California, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Pintens', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Takamoto', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baumgartner', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Chelsea L', 'Initials': 'CL', 'LastName': 'Tasaka', 'Affiliation': 'University of California San Francisco Medical Center, San Francisco, California, USA.'}]",Journal of pharmacy practice,['10.1177/0897190018799220']
1555,30195416,Combination of Adaptive Statistical Iterative Reconstruction-V and Lower Tube Voltage During Craniocervical Computed Tomographic Angiography Yields Better Image Quality with a Reduced Radiation Dose.,"RATIONALE AND OBJECTIVES


To evaluate image quality and radiation exposure when using the adaptive statistical iterative reconstruction-V (ASIR-V) algorithm for reconstructing craniocervical computed tomographic angiography images acquired at 100 kVp.
MATERIALS AND METHODS


We randomly divided 121 patients into three groups: group A (conventional protocol), 120 kVp with filtered back projection; group B, 120 kVp with 50% ASIR-V; and group C, 100 kVp with 50% ASIR-V. All patients underwent scans in a 256-slice computed tomography (CT) scanner. Radiation dose (volume CT dose index), dose-length product, and effective dose, objective parameters such as arterial attenuation value, signal-to-noise ratio, contrast-to-noise ratio, and noise obtained at head, neck, and shoulder levels were compared among the groups. Subjective image quality was independently assessed by two radiologists, and interobserver reliability was assessed using kappa analysis.
RESULTS


The radiation dose in group C was the lowest (p < 0.01) with a 40% reduction in volume CT dose index, dose-length product, and effective dose values compared to group A, and group C showed higher arterial attenuation than either group A or B (p < 0.01). Additionally, signal-to-noise ratio and contrast-to-noise ratio were higher and noise was lower in groups B and C than group A. Group C had better subjective image quality than groups A and B (p < 0.05), and the interobserver reliability between the two radiologists was high (k = 0.783).
CONCLUSION


Compared to the conventional protocol, using 50% ASIR-V and the 100 kVp protocol during craniocervical computed tomographic angiography yields better objective and subjective image quality at lower radiation doses.",2019,"The radiation dose in group C was the lowest (p < 0.01) with a 40% reduction in volume CT dose index, dose-length product, and effective dose values compared to group A, and group C showed higher arterial attenuation than either group A or B (p < 0.01).",['We randomly divided 121 patients into three groups'],"['256-slice computed tomography (CT) scanner', 'group A (conventional protocol), 120 kVp with filtered back projection; group B, 120 kVp with 50% ASIR-V; and group C, 100 kVp with 50% ASIR-V', 'Adaptive Statistical Iterative Reconstruction-V and Lower Tube Voltage', 'adaptive statistical iterative reconstruction-V (ASIR-V) algorithm']","['higher arterial attenuation', 'subjective image quality', 'signal-to-noise ratio and contrast-to-noise ratio', 'interobserver reliability', 'Subjective image quality', 'volume CT dose index, dose-length product, and effective dose values', 'Radiation dose (volume CT dose index), dose-length product, and effective dose, objective parameters such as arterial attenuation value, signal-to-noise ratio, contrast-to-noise ratio, and noise obtained at head, neck, and shoulder levels']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0033363', 'cui_str': 'Projection'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0002045'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",121.0,0.0165378,"The radiation dose in group C was the lowest (p < 0.01) with a 40% reduction in volume CT dose index, dose-length product, and effective dose values compared to group A, and group C showed higher arterial attenuation than either group A or B (p < 0.01).","[{'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, 386 Ta-Chung First Rd., Kaohsiung 81362, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Academic radiology,['10.1016/j.acra.2018.07.019']
1556,30239857,Comparison of Early Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure in Preterm Infants with Respiratory Distress Syndrome.,"AIMS


To compare the effect of early nasal intermittent positive pressure ventilation (nIPPV) and nasal continuous positive airway pressure (nCPAP) in terms of the need for endotracheal ventilation in the treatment of respiratory distress syndrome (RDS) in preterm infants born between 24 and 32 gestational weeks.
METHODS


This is a randomized, controlled, prospective, single-centered study. Forty-two infants were randomized to nIPPV and 42 comparable infants to nCPAP (birth weight 1356 ± 295 and 1359 ± 246 g and gestational age 29.2 ± 1.7 and 29.4 ± 1.5 weeks, respectively).
RESULTS


The need for endotracheal intubation and invasive mechanical ventilation was significantly lower in the nIPPV group than the nCPAP group (11.9% and 40.5%, respectively, p < 0.05). There were no differences in the duration of total nasal respiratory support, duration of invasive mechanical ventilation, bronchopulmonary dysplasia or other early morbidities.
CONCLUSION


nIPPV compared with nCPAP reduced the need for endotracheal intubation and invasive mechanical ventilation in premature infants with RDS.",2019,"The need for endotracheal intubation and invasive mechanical ventilation was significantly lower in the nIPPV group than the nCPAP group (11.9% and 40.5%, respectively, p < 0.05).","['Preterm Infants with Respiratory Distress Syndrome', 'premature infants with RDS', 'Forty-two infants were randomized to nIPPV and 42 comparable infants to nCPAP (birth weight 1356\u2009±\u2009295 and 1359\u2009±', '246\xa0g and gestational age 29.2\u2009±\u20091.7 and 29.4\u2009±\u20091.5\u2009weeks, respectively', 'preterm infants born between 24 and 32 gestational weeks']","['Early Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure', 'nCPAP', 'early nasal intermittent positive pressure ventilation (nIPPV) and nasal continuous positive airway pressure (nCPAP']","['respiratory distress syndrome (RDS', 'need for endotracheal intubation and invasive mechanical ventilation', 'endotracheal intubation and invasive mechanical ventilation', 'duration of total nasal respiratory support, duration of invasive mechanical ventilation, bronchopulmonary dysplasia or other early morbidities']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'IPPV'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}]","[{'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",42.0,0.11106,"The need for endotracheal intubation and invasive mechanical ventilation was significantly lower in the nIPPV group than the nCPAP group (11.9% and 40.5%, respectively, p < 0.05).","[{'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Dursun', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Uslu', 'Affiliation': 'Assistance Professor, Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bulbul', 'Affiliation': 'Assistance Professor, Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Muhittin', 'Initials': 'M', 'LastName': 'Celik', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Zubarioglu', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Evrim Kiray', 'Initials': 'EK', 'LastName': 'Bas', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy058']
1557,30260472,Nebulised hypertonic saline for cystic fibrosis.,"BACKGROUND


Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review.
OBJECTIVES


To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance.
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases.Date of most recent searches: 08 August 2018.
SELECTION CRITERIA


Randomised and quasi-randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity).
DATA COLLECTION AND ANALYSIS


Two authors independently reviewed all identified trials and data, and assessed trial quality. The quality of the evidence was assessed using GRADE.
MAIN RESULTS


A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions.Hypertonic saline 3% to 7% versus placeboAt four weeks, we found very low-quality evidence from three placebo-controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice-daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV 1 ) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI -2.72 to 7.34) (low-quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great. One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low-quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low-quality evidence). Four trials (n = 80) found very low-quality evidence that sputum clearance was better with hypertonic saline.A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short-term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post-discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low-quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low-quality evidence).Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three-week trial (14 participants) to determine the effects of hypertonic saline on FEV 1  % predicted, mean difference (MD) 1.60% (95% CI -7.96 to 11.16) (very low-quality evidence). In the second trial, rhDNase led to a greater increase in FEV 1  % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low-quality evidence). One cross-over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low-quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross-over trial of 47 people (low-quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported.One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium-2-mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium-2-mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low-quality evidence).One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low-quality evidence).
AUTHORS' CONCLUSIONS


Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low-quality evidence from three trials), but this was not sustained at 48 weeks (low-quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults.Evidence from one small cross-over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV 1  was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes.Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria.",2018,"Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium-2-mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low-quality evidence).One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low-quality evidence).
","['adults with an acute exacerbation of lung disease (n = 132', 'adults and children over the age of 12 years with CF', 'children under six years of age', 'people with CF (any age or disease severity', 'lung disease in adults', 'people with CF', '13 participants using', 'A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification', 'cystic fibrosis (CF', 'cystic fibrosis']","['sodium-2-mercaptoethane sulphonate', 'placebo', 'Nebulised hypertonic saline', 'placebo or other mucolytic therapy', 'hypertonic saline to mannitol', 'hypertonic saline', 'hypertonic saline to amiloride', 'Hypertonic saline', 'nebulised hypertonic saline']","['lung function', 'FEV', 'sputum clearance', 'courses of antibiotics or adverse events', 'frequency of pulmonary exacerbations', 'rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting', 'efficacy and tolerability', 'Increased cough', 'Cough and wheeze', 'lung clearance index', 'quality of life', 'exacerbations requiring antibiotics per person', 'deaths', 'short-term lung function', 'mucociliary clearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0026698', 'cui_str': 'Mucolytics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0454505', 'cui_str': 'Sputum induction technique (regime/therapy)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0232292', 'cui_str': 'Tight chest (finding)'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary Transport'}]",243.0,0.634761,"Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium-2-mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low-quality evidence).One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low-quality evidence).
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wark', 'Affiliation': 'Centre for Healthy Lungs, Hunter Medical Research Institute, University of Newcastle, 1 Kookaburra Close, New Lambton, New South Wales, Australia, 2305.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001506.pub4']
1558,31652404,"Impact of 24-h high and low fermentable oligo-, di-, monosaccharide, and polyol diets on markers of exercise-induced gastrointestinal syndrome in response to exertional heat stress.","The study aimed to determine the effects of 24-h high (HFOD) and low (LFOD) fermentable oligo-, di-, monosaccharide, and polyol (FODMAP) diets before exertional heat stress on gastrointestinal integrity, function, and symptoms. Eighteen endurance runners consumed a HFOD and a LFOD (double-blind crossover design) before completing 2 h of running at 60% maximal oxygen uptake in 35 °C ambient temperature. Blood samples were collected before and after exercise to determine plasma cortisol and intestinal fatty acid binding protein (I-FABP) concentrations, and bacterial endotoxin and cytokine profiles. Breath hydrogen (H 2 ) and gastrointestinal symptoms (GIS) were determined pre-exercise, every 15 min during, and in recovery. No differences were observed for plasma cortisol concentration between diets. Plasma I-FABP concentration was lower on HFOD compared with LFOD ( p  = 0.033). A trend for lower lipopolysaccharide binding protein ( p  = 0.088), but not plasma soluble CD14 ( p  = 0.478) and cytokine profile ( p  > 0.05), responses on HFOD was observed. A greater area under the curve breath H 2  concentration ( p  = 0.031) was observed throughout HFOD (mean and 95% confidence interval: HFOD 2525 (1452-3597) ppm·4 h -1 ) compared with LFOD (1505 (1031-1978) ppm·4 h -1 ). HFOD resulted in greater severity of GIS compared with LFOD (pre-exercise,  p  = 0.017; during,  p  = 0.035; and total,  p  = 0.014). A 24-h HFOD before exertional heat stress ameliorates disturbances to epithelial integrity but exacerbates carbohydrate malabsorption and GIS severity in comparison with a LFOD.  Novelty  Twenty-four-hour high FODMAP diet ameliorated disturbances to gastrointestinal integrity. Twenty-four-hour high FODMAP diet results in greater carbohydrate malabsorption compared with low FODMAP diet. Incidence of GIS during exertional heat stress were pronounced on both low and high FODMAP diets, but greater GIS severity was observed with high FODMAP diet.",2019,"HFOD resulted in greater severity of GIS, compared to LFOD (pre-exercise p=0.017, during p=0.035, and total p=0.014).",['Eighteen endurance runners'],"['24-hour high and low fermentable oligo- di- mono- saccharide polyol diets', '24-h high (HFOD) and low (LFOD) fermentable oligo- di- mono- saccharide and polyol diets', 'FODMAP diet', 'HFOD']","['plasma cortisol and I-FABP concentrations, and bacterial endotoxin and cytokine profiles', 'GIS severity', 'plasma sCD14', 'AUC breath H2 concentration', 'Breath hydrogen (H2) and gastrointestinal symptoms (GIS', 'disturbances to gastrointestinal integrity', 'carbohydrate malabsorption', 'HFOD and LFOD', 'cytokine profile', 'severity of GIS', 'gastrointestinal integrity, function, and symptoms', 'HFOD', 'Plasma I-FABP concentration', 'plasma cortisol concentration']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}]","[{'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption Syndrome'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",18.0,0.0319401,"HFOD resulted in greater severity of GIS, compared to LFOD (pre-exercise p=0.017, during p=0.035, and total p=0.014).","[{'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Gaskell', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology - The Alfred Hospital, Monash University, Melbourne, Victoria 3004, Australia.'}, {'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria 3168, Australia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0187']
1559,30208343,Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TĀCcare trial).,"Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavioral mediators is lacking evidence. It is imperative to improve patient-centered dialysis care and to address call from Kidney Disease Improving Global Outcomes (KDIGO) guidelines for integration of symptom assessment and management in routine HD-care. Technology-Assisted stepped Collaborative Care (TĀCcare) is a multi-center randomized controlled trial (RCT) of 150 diverse HD patients from Pennsylvania and New Mexico, designed to compare the effectiveness of a 12-week stepped collaborative care intervention (cognitive behavioral therapy, CBT) with an attention control arm of technology-delivered health education. Collaborative care provides an integrated multi-disciplinary structured management plan. Furthermore, a stepped approach to pharmacotherapy and/or CBT allows for individualization of treatment according to patients' clinical status, preferences and treatment response. To simplify the delivery of CBT and to minimize patient and provider burden, we will use live video-conferencing with patients in dialysis units. We will examine the effect of these interventions on patient symptoms, HRQOL, treatment adherence and inflammatory biomarkers. This RCT tests a readily implementable intervention that can be integrated in routine HD-care and will generate novel and meaningful insights on strategies to alleviate common symptoms and improve HRQOL in HD.",2018,"Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly.","['150 diverse HD patients from Pennsylvania and New Mexico', 'hemodialysis patients (TĀCcare trial']","['Technology-Assisted stepped Collaborative Care (TĀCcare', 'stepped collaborative care intervention (cognitive behavioral therapy, CBT) with an attention control arm of technology-delivered health education', 'technology assisted stepped collaborative care intervention']","['hospitalization and mortality', 'patient symptoms, HRQOL, treatment adherence and inflammatory biomarkers']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018701'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",150.0,0.0453827,"Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly.","[{'ForeName': 'Maria-Eleni', 'Initials': 'ME', 'LastName': 'Roumelioti', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico School of Medicine Albuquerque, NM, United States.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Steel', 'Affiliation': 'Department of Surgery, Psychiatry and Psychology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Yabes', 'Affiliation': 'Center for Research on Heath Care, Division of General Internal Medicine, Department of Medicine and Biostatistics, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Vowles', 'Affiliation': 'Department of Psychology, University of New Mexico & Division of Physical Medicine and Rehabilitation, University of New Mexico Health Sciences Center, Albuquerque, NM, United States.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Vodovotz', 'Affiliation': 'Department of Immunology and Surgery, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Beach', 'Affiliation': 'Department of Psychology, University Center for Social and Urban Research, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rollman', 'Affiliation': 'Department of Medicine, Psychiatry, Biomedical Informatics, and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Weisbord', 'Affiliation': 'Renal and Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Unruh', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico School of Medicine Albuquerque, NM, United States.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Jhamb', 'Affiliation': 'Renal and Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States. Electronic address: jhambm@upmc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.002']
1560,30168896,Quality of life improvements in patients with cervical dystonia following treatment with a liquid formulation of abobotulinumtoxinA (Dysport ®  ).,"BACKGROUND AND PURPOSE


In patients with cervical dystonia, abobotulinumtoxinA solution for injection (ASI) has been shown to be similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores. In this secondary analysis, quality of life data as evaluated with the Cervical Dystonia Impact Profile (CDIP-58) are presented.
METHODS


This was a double-blind, randomized, active and placebo-controlled study followed by an open-label extension (NCT01261611). In the double-blind phase, patients were randomized (3:3:1) to one cycle of ASI 500 U (n = 156), abobotulinumtoxinA 500 U (n = 159) or placebo (n = 54). Following the double-blind phase, all patients received open-label ASI for up to four cycles.
RESULTS


The CDIP-58 total scores were significantly improved at week 4 of the double-blind phase in both the ASI 500 U and abobotulinumtoxinA 500 U groups versus placebo [least squares mean change from baseline of -9.5 (-11.51, -7.45) and -11.2 (-13.2, -9.26) vs. -0.9 (-4.04, 2.14), respectively; both P < 0.0001 vs. placebo]. All CDIP-58 domains contributed to this improvement and benefits were maintained across open-label treatment. Positive correlations were observed between CDIP-58 total score and all three TWSTRS domains (R = 0.42-0.62) and for all CDIP-58 subscales with the TWSTRS total score and domains (R = 0.23-0.60).
CONCLUSIONS


Repeat ASI injections are similarly effective to abobotulinumtoxinA in improving patient-reported outcomes of health-related quality of life. Positive correlations were found between TWSTRS total and domain scores and CDIP-58 total and domain scores.",2019,"The CDIP-58 total scores were significantly improved at week 4 of the double-blind phase in both the ASI 500 U and abobotulinumtoxinA 500 U groups versus placebo [least squares mean change from baseline of -9.5 (-11.51, -7.45) and -11.2 (-13.2, -9.26) vs. -0.9 (-4.04, 2.14), respectively; both P < 0.0001 vs. placebo].","['patients with cervical dystonia following treatment with a liquid formulation of abobotulinumtoxinA (Dysport ®  ', 'patients with cervical dystonia']","['abobotulinumtoxinA 500\xa0U (n\xa0=\xa0159) or placebo', 'abobotulinumtoxinA solution for injection (ASI', 'placebo', 'open-label ASI']","['CDIP-58 total scores', 'CDIP-58 total score', 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores', 'Quality of life improvements', 'TWSTRS total and domain scores and CDIP-58 total and domain scores', 'Cervical Dystonia Impact Profile (CDIP-58', 'quality of life data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C0591427', 'cui_str': 'Dysport'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991511', 'cui_str': 'Injectable Solution'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.32023,"The CDIP-58 total scores were significantly improved at week 4 of the double-blind phase in both the ASI 500 U and abobotulinumtoxinA 500 U groups versus placebo [least squares mean change from baseline of -9.5 (-11.51, -7.45) and -11.2 (-13.2, -9.26) vs. -0.9 (-4.04, 2.14), respectively; both P < 0.0001 vs. placebo].","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simonetta-Moreau', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse Pôle Neurosciences Purpan, ToNIC, Université de Toulouse, Inserm, UPS, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Volteau', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}]",European journal of neurology,['10.1111/ene.13800']
1561,30113526,Diabetic patients with essential hypertension treated with amlodipine: blood pressure and arterial stiffness effects of canagliflozin or perindopril.,"INTRODUCTION


Hypertension control reduces cardiovascular and renal risks in type 2 diabetes. Sodium-glucose cotransporter-2 inhibitors prevent renal glucose reabsorption and decrease glucose plasma levels, blood pressure (BP) and weight reduction. Treatment of hypertension and sodium-glucose cotransporter-2 are able to improve arterial stiffness.
AIMS


To evaluate, in patients with type 2 diabetes and hypertension, the effects of 6 months treatment with canagliflozin, or perindopril, an angiotensin converting enzyme inhibitor, on central BP and carotid-femoral pulse wave velocity (cfPWV).
METHODS


Thirty type 2 diabetic patients with hypertension taking amlodipine, 10 mg daily, and metformin, 750-2000 mg daily, were randomized and a third medication was added: canagliflozin, 300 mg daily (n = 15, nine women, mean age: 63 ± 8 years), or perindopril, 10 mg daily (n = 15, five women, mean age 59 ± 4 years), for 6 months. Ambulatory BP monitoring was assessed at baseline and after 3 and 6 months of treatment, whereas cfPWV was measured before and after 6 months of treatment. Plasma fasting glucose, glycated hemoglobin, creatinine, plasma and urinary sodium and potassium were also measured.
RESULTS


Both treatments significantly reduced BP and cfPWV. Only canagliflozin maintained the PWV action after adjusting for BP values and reduced glycemia, glycated hemoglobin and 24 h urinary sodium. Other security laboratory parameters, including gluthamic oxaloacetic transaminase, gluthamic piruvic transaminase; and bilirubin failed to show any change.
CONCLUSION


Canagliflozin reduced BP and improve arterial stiffness, independently of the BP effect. These two conditions could explain the cardiovascular protection observed with canagliflozin compared with perindopril.",2019,"Only canagliflozin maintained the PWV action after adjusting for BP values and reduced glycemia, glycated hemoglobin and 24 h urinary sodium.","['type 2 diabetes', 'patients with type 2 diabetes and hypertension', ' 750-2000\u200amg daily', 'Diabetic patients with essential hypertension treated with', 'Thirty type 2 diabetic patients with hypertension taking']","['Sodium-glucose cotransporter-2 inhibitors', 'perindopril', 'canagliflozin or perindopril', 'canagliflozin', 'amlodipine, 10\u200amg daily, and metformin', 'canagliflozin, or perindopril, an angiotensin converting enzyme inhibitor', 'amlodipine']","['cardiovascular protection', 'BP and cfPWV', 'cardiovascular and renal risks', 'gluthamic oxaloacetic transaminase, gluthamic piruvic transaminase; and bilirubin', 'cfPWV', 'PWV action', 'BP values and reduced glycemia, glycated hemoglobin and 24\u200ah urinary sodium', 'central BP and carotid-femoral pulse wave velocity (cfPWV', 'Plasma fasting glucose, glycated hemoglobin, creatinine, plasma and urinary sodium and potassium', 'BP and improve arterial stiffness', 'Ambulatory BP monitoring', 'renal glucose reabsorption and decrease glucose plasma levels, blood pressure (BP) and weight reduction']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0316485,"Only canagliflozin maintained the PWV action after adjusting for BP values and reduced glycemia, glycated hemoglobin and 24 h urinary sodium.","[{'ForeName': 'Agustin J', 'Initials': 'AJ', 'LastName': 'Ramirez', 'Affiliation': 'Foundation for Study of Hypertension and Cardiovascular Risk.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Sanchez', 'Affiliation': 'Foundation for Study of Hypertension and Cardiovascular Risk.'}, {'ForeName': 'Ramiro A', 'Initials': 'RA', 'LastName': 'Sanchez', 'Affiliation': 'Foundation for Study of Hypertension and Cardiovascular Risk.'}]",Journal of hypertension,['10.1097/HJH.0000000000001907']
1562,30146902,Conventional vs 3-Dimensional Printed Cast Wear Comfort.,"Background:  The objective of this study was to determine the functionality of 3-dimensional (3D) printed orthoses for upper extremity immobilization compared with conventional immobilization.  Methods:  Twelve healthy volunteers were fitted with a 3D custom printed short arm cast and a short arm fiberglass cast in separate sessions. The Jebsen Hand Function Test (JHFT) was used to test function and dexterity in each cast. All volunteers completed a modified version of the Patient-Rated Wrist Evaluation (PRWE). Skin complications were recorded.  Results:  There were no significant differences during the JHFT between casts, although one-third of the participants in the 3D cast could perform the tasks in a normal time, which they could not in the fiberglass cast. The average PRWE function score was lower in the 3D cast group than in the fiberglass group (45.5 vs. 80.8). Minor skin irritation was noted in 42% of patients in the fiberglass cast group compared with only 1 patient (8%) in the 3D cast group. One patient in the fiberglass group required a cast change due to inappropriate fit.  Conclusions:  Both casting techniques demonstrate similar objective function based on the JHFT. Patient satisfaction, comfort, and perceived function are superior in the 3D printed casts.",2020,"Patient satisfaction, comfort, and perceived function are superior in the 3D printed casts.",['Twelve healthy volunteers'],"['Conventional vs 3-Dimensional Printed Cast Wear Comfort', 'JHFT', 'conventional immobilization']","['Minor skin irritation', 'average PRWE function score', 'Skin complications', 'Patient satisfaction, comfort, and perceived function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",12.0,0.0726821,"Patient satisfaction, comfort, and perceived function are superior in the 3D printed casts.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Graham', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Kaela', 'Initials': 'K', 'LastName': 'Frizzell', 'Affiliation': 'Philadelphia College of Osteopathic Medicine, PA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Watkins', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Beredjiklian', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rivlin', 'Affiliation': 'Rothman Institute and Jefferson Medical College, Philadelphia, PA, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718795291']
1563,30109474,"A Randomized, Placebo-Controlled, Blinded, Crossover, Pilot Study of the Effects of Dextromethorphan/Quinidine for the Treatment of Neurobehavioral Symptoms in Adults with Autism.","Prior studies have demonstrated successful irritability treatment using dopaminergic antagonists in autistic patients. The purpose of this pilot study was to assess the effect of dextromethorphan/quinidine (DM/Q) in autistic adults (18-60 years of age). This was a randomized, blinded, crossover, study of 14 patients randomized to DM/Q or a placebo for 8 weeks, washed out for 4 weeks, then crossed over to the opposite treatment. There were no serious adverse events. Subjects were significantly lower on the Aberrant Behavioral Checklist for Irritability (ABC-IR) (F 1,10  = 7.42; p = 0.021). Improvements in aggression and Clinical Global Impression were also seen. The findings suggest that DM/Q is well-tolerated and associated with improvements in irritability and aggression in adults with autism.",2020,"Subjects were significantly lower on the Aberrant Behavioral Checklist for Irritability (ABC-IR) (F 1,10  = ","['14 patients randomized to', 'Adults with Autism', 'adults with autism', 'autistic patients', 'autistic adults (18-60\xa0years of age']","['Placebo', 'DM/Q or a placebo', 'Dextromethorphan/Quinidine', 'dextromethorphan/quinidine (DM/Q']","['Neurobehavioral Symptoms', 'irritability and aggression', 'aggression and Clinical Global Impression', 'serious adverse events', 'Aberrant Behavioral Checklist for Irritability (ABC-IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2946981', 'cui_str': 'Dextromethorphan / Quinidine'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",14.0,0.190192,"Subjects were significantly lower on the Aberrant Behavioral Checklist for Irritability (ABC-IR) (F 1,10  = ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chez', 'Affiliation': 'Sutter Neuroscience Institute, Sacramento, CA, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kile', 'Affiliation': 'Sutter Neuroscience Institute, Sacramento, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Sutter Neuroscience Institute, Sacramento, CA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Parise', 'Affiliation': 'Sutter Institute for Medical Research, 2801 Capitol Ave Suite 400, Sacramento, CA, 95816, USA. parisec@sutterhealth.org.'}, {'ForeName': 'Bobbie', 'Initials': 'B', 'LastName': 'Benabides', 'Affiliation': 'Sutter Institute for Medical Research, 2801 Capitol Ave Suite 400, Sacramento, CA, 95816, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hankins', 'Affiliation': 'Sutter Institute for Medical Research, 2801 Capitol Ave Suite 400, Sacramento, CA, 95816, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3703-x']
1564,31648204,Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease.,"BACKGROUND


Parkinson's disease (PD) results in a global decrease in information processing, ultimately resulting in dysfunction executing motor-cognitive tasks. Motor-cognitive impairments contribute to postural instability, often leading to falls and decreased physical activity. The aim of this study was to determine the effects of a multimodal training (MMT) versus single-modal (SMT) training on motor symptoms, fall frequency, and physical activity in patients with PD classified as fallers.
METHODS


Individuals with PD were randomized into SMT (n = 11) or MMT (n = 10) and completed training 3 times per week for 8 weeks. The SMT completed gait and cognitive training separately, whereas MMT completed gait and cognitive training simultaneously during each 45-minute session. Physical activity, 30-day fall frequency, and PD motor symptoms were assessed at baseline, posttreatment, and during a 4-week follow-up.
RESULTS


Both groups exhibited significant (P < .05) improvements in clinical ratings of motor function, as symptoms improved by 8% and 15% for SMT and MMT, respectively. Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]). The MMT resulted in a significant 60% reduction in falls.
CONCLUSIONS


Although SMT and MMT approaches are both effective in improving physical activity and motor symptoms of PD, only MMT reduced fall frequency after the intervention.",2019,Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]).,"[""Individuals With Parkinson's Disease"", 'patients with PD classified as fallers', 'Individuals with PD']","['multimodal training (MMT) versus single-modal (SMT) training', 'MMT', 'Multimodal Training', 'SMT']","['clinical ratings of motor function', 'falls', 'physical activity and motor symptoms of PD', 'motor symptoms, fall frequency, and physical activity', 'Physical activity', 'Physical activity, 30-day fall frequency, and PD motor symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0165732,Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]).,"[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Penko', 'Affiliation': ''}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Barkley', 'Affiliation': ''}, {'ForeName': 'Anson B', 'Initials': 'AB', 'LastName': 'Rosenfeldt', 'Affiliation': ''}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0595']
1565,30145269,Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial.,"Adults with intellectual and developmental disabilities (IDD) represent an underserved segment of the US population with a high prevalence of obesity and limited options for weight management. Previous research has demonstrated clinically meaningful weight loss of 7% of total body weight in in adults with IDD using an enhanced Stop Light Diet (eSLD) in combination with monthly at-home face-to-face (FTF) behavioral sessions, and a recommendation for increased physical activity. However, the time and cost associated with FTF delivery (travel + sessions) limits the potential for scaling and implementation and suggests the need for the evaluation of less costly and burdensome strategies for intervention delivery. Therefore, we will conduct a 24-mo. randomized trial to compare a weight management intervention (6 mos. weight loss, 12 mos. maintenance, 6 mos. no-contact follow-up) delivered to 120 overweight/obese adults with IDD in their home, either remotely (RD) using video conferencing on a tablet computer, or during FTF visits. Our primary aim is whether RD is non-inferior to FTF for weight loss (0-6 mos.). Secondarily, we will compare the RD and FTF groups on mean weight loss, the proportion of participants who achieve clinically meaningful weight loss, and changes in quality of life across 24 months. We will also conduct cost analysis, cost-effectiveness, and contingent valuation analyses to compare the RD and FTF groups.",2018,"no-contact follow-up) delivered to 120 overweight/obese adults with IDD in their home, either remotely (RD) using video conferencing on a tablet computer, or during FTF visits.","['adults with intellectual and developmental disabilities', '120 overweight/obese adults with IDD in their home, either remotely (RD) using', 'Adults with intellectual and developmental disabilities (IDD']","['video conferencing', 'weight management', 'weight management intervention']","['quality of life', 'weight loss', 'mean weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0034380'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.022165,"no-contact follow-up) delivered to 120 overweight/obese adults with IDD in their home, either remotely (RD) using video conferencing on a tablet computer, or during FTF visits.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: lptomey@ku.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: mmayo@kumc.edu.'}, {'ForeName': 'J Leon', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': 'Department of Health, Sport, and Exercise Sciences, University of Kansas, Lawrence, KS 66045, USA. Electronic address: jlg@ku.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lee', 'Affiliation': 'Department of Health Policy and Management, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jhonas@ku.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Sherman', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: joesherman@ku.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.08.010']
1566,30132010,Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury.,"OBJECTIVE


To determine whether transcranial direct current stimulation augments the analgesic effect of breathing-controlled electrical stimulation in patients with spinal cord injury who have chronic neuropathic pain.
DESIGN


Sham-controlled, single-blinded, single-centre, cross-over study of 12 participants with incomplete spinal cord injury. The treatment protocol included a 20-min transcranial direct current stimulation (sham or active), followed by a 20-min breathing-controlled electrical stimulation to the median nerve on the dominant side. The treatment session with sham or control transcranial direct current stimulation was given on different days in a randomized order. Visual analogue scale was used to assess neuropathic pain at baseline, 10 min after transcranial direct current stimulation, and 10 min after breathing-controlled electrical stimulation.
RESULTS


Participants were blinded to the status of transcranial direct current stimulation. Out of the 12 participants, 10 completed sessions of both sham and active transcranial direct current stimulation, while the other 2 completed only active transcranial direct current stimulation and breathing-controlled electrical stimulation treatment. Out of the 12 participants, 7 showed analgesic effects after active transcranial direct current stimulation, while sham transcranial direct current stimulation produced some analgesic effects in 4 out of 10 participants. At the group level, there was no difference between active and sham transcranial direct current stimulation treatment. All except one participant responded positively to breathing-controlled electrical stimulation in all sessions. Visual analogue scale score for pain decreased significantly after breathing-controlled electrical stimulation combined with either active transcranial direct current stimulation or sham transcranial direct current stimulation treatment.
CONCLUSION


The immediate analgesic effect of breathing-controlled electrical stimulation was confirmed. However, this effect was not augmented after one session of transcranial direct current stimulation treatment.",2018,"Visual analogue scale score for pain decreased significantly after breathing-controlled electrical stimulation combined with either active transcranial direct current stimulation or sham transcranial direct current stimulation treatment.
","['neuropathic pain after spinal cord injury', 'patients with spinal cord injury who have chronic neuropathic pain', '12 participants with incomplete spinal cord injury']","['breathing-controlled electrical stimulation', 'Combined transcranial direct current stimulation and breathing-controlled electrical stimulation', 'sham or control transcranial direct current stimulation', 'transcranial direct current stimulation', '20-min transcranial direct current stimulation (sham or active), followed by a 20-min breathing-controlled electrical stimulation to the median nerve on the dominant side', 'active transcranial direct current stimulation or sham transcranial direct current stimulation treatment', 'sham and active transcranial direct current stimulation, while the other 2 completed only active transcranial direct current stimulation and breathing-controlled electrical stimulation treatment']","['Visual analogue scale', 'breathing-controlled electrical stimulation', 'analgesic effects', 'neuropathic pain', 'Visual analogue scale score for pain']","[{'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0454508', 'cui_str': 'Breathing control (regime/therapy)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0445480', 'cui_str': 'Dominant side (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",12.0,0.217233,"Visual analogue scale score for pain decreased significantly after breathing-controlled electrical stimulation combined with either active transcranial direct current stimulation or sham transcranial direct current stimulation treatment.
","[{'ForeName': 'Shengai', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'PMR, UTHealth, , 77025 Houston, USA.'}, {'ForeName': 'Argyrios', 'Initials': 'A', 'LastName': 'Stampas', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Frontera', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2379']
1567,30082268,Comparison of everolimus-eluting bioresorbable vascular scaffolds and metallic stents: three-year clinical outcomes from the ABSORB China randomised trial.,"AIMS


Absorb bioresorbable vascular scaffolds (BVS) and XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) had comparable angiographic and clinical outcomes up to one year in patients enrolled in the ABSORB China randomised trial. Whether these favourable results with BVS continue beyond one year up to three years is unknown. In this study we sought to analyse the outcomes from the trial up to three-year follow-up.
METHODS AND RESULTS


ABSORB China was a prospective, open-label, multicentre trial in which 480 patients with one or two native coronary artery lesions were randomised 1:1 to BVS (N=241) vs. CoCr-EES (N=239). Clinical endpoints included target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction or ischaemia-driven target lesion revascularisation), its components, and definite/probable stent/scaffold thrombosis (ST). There were no significant differences in clinical outcomes in patients treated with BVS and CoCr-EES up to three years, including TLF (5.5% vs. 4.7%, p=0.68) and definite/probable ST (0.9% vs. 0.0%, p=0.50). STs in the BVS arm consisted of one probable subacute event at 15 days and one definite very late event at 622 days. Among 32 BVS patients with a reference vessel diameter between 2.25 and 3.75 mm by quantitative coronary angiography and in whom post-dilatation was performed at >16 atm with a balloon:scaffold diameter >1:1 and balloon ≤scaffold diameter 0.5 mm, no TLF or ST events occurred within three years.
CONCLUSIONS


In the ABSORB China trial, BVS and CoCr-EES had similar results up to three-year follow-up, the time at which the scaffold has completely resorbed. BVS outcomes may be further optimised by appropriate lesion selection and implantation technique.",2018,"There were no significant differences in clinical outcomes in patients treated with BVS and CoCr-EES up to three years, including TLF (5.5% vs. 4.7%, p=0.68) and definite/probable ST (0.9% vs. 0.0%, p=0.50).","['480 patients with one or two native coronary artery lesions', '32 BVS patients with a reference vessel diameter between 2.25 and 3.75 mm by']","['CoCr-EES', 'everolimus-eluting bioresorbable vascular scaffolds and metallic stents', 'quantitative coronary angiography', 'BVS', 'AIMS\n\n\nAbsorb bioresorbable vascular scaffolds (BVS) and XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES']","['clinical outcomes', 'target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction or ischaemia-driven target lesion revascularisation), its components, and definite/probable stent/scaffold thrombosis (ST', 'TLF', 'TLF or ST events']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4068875', 'cui_str': '2.25 (qualifier value)'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",480.0,0.069241,"There were no significant differences in clinical outcomes in patients treated with BVS and CoCr-EES up to three years, including TLF (5.5% vs. 4.7%, p=0.68) and definite/probable ST (0.9% vs. 0.0%, p=0.50).","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': ''}, {'ForeName': 'Lefeng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Jifu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hai-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': ''}, {'ForeName': 'Shih-Wa', 'Initials': 'SW', 'LastName': 'Ying', 'Affiliation': ''}, {'ForeName': 'Wai-Fung', 'Initials': 'WF', 'LastName': 'Cheong', 'Affiliation': ''}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': ''}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-17-00796']
1568,30132724,Yoga Education Program for Improving Memory in Older Adults: A Multicity 5-Year Follow-Up Study.,"This article reports a multicity study on the effect of a yoga education program (YEP) in improving memory and cognitive functions of a nonclinical sample of community-dwelling older adults. Specifically, the intervening personal resources that bolster or hinder YEP effectiveness were examined. Of the original cohort of 918 older adults randomized into intervention and waitlist control groups, 792 remained with the study 5 years later. Results indicated that weekly YEP lessons and self-practice improved participants' scores on the Mini-Mental State Examination (MMSE) and Rivermead Behavioral Memory Test-Third Edition (RBMT-3). Participants from Asian cities, women, Hindus and Buddhists, middle class, highly educated, retired, ever single or widowed, living alone or with children and kin, were more responsive to the YEP. Regular attendance and self-practice were strong moderators of YEP effectiveness, with self-practice having the strongest predictor effect. Some cultural variations and improvisations would lend the YEP a wider application.",2020,"Regular attendance and self-practice were strong moderators of YEP effectiveness, with self-practice having the strongest predictor effect.","['community-dwelling older adults', 'Participants from Asian cities, women, Hindus and Buddhists, middle class, highly educated, retired, ever single or widowed, living alone or with children and kin, were more responsive to the YEP', '918 older adults', 'Older Adults']","['yoga education program (YEP', 'Yoga Education Program']","['Mini-Mental State Examination (MMSE) and Rivermead Behavioral Memory Test-Third Edition (RBMT-3', 'memory and cognitive functions']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587175', 'cui_str': 'Buddhist, follower of religion (person)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0857756', 'cui_str': 'Highly educated'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439044', 'cui_str': 'Lives alone (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C4273837', 'cui_str': 'RBMT-3 - Rivermead Behavioral Memory Test-Third Edition'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",918.0,0.0126049,"Regular attendance and self-practice were strong moderators of YEP effectiveness, with self-practice having the strongest predictor effect.","[{'ForeName': 'Samta P', 'Initials': 'SP', 'LastName': 'Pandya', 'Affiliation': 'Tata Institute of Social Sciences, Mumbai, India.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464818794153']
1569,31586771,A phase 1b study of necitumumab in combination with abemaciclib in patients with stage IV non-small cell lung cancer.,"OBJECTIVES


Necitumumab, an anti-EGFR antibody, and abemaciclib, a CDK4/6 inhibitor, have shown activity in patients with non-small cell lung cancer (NSCLC) and have non-overlapping toxicities. A 2-part, single-arm, multicenter, phase 1b trial was conducted to test the safety and efficacy of necitumumab plus abemaciclib in patients with advanced NSCLC who had received ≤2 lines of chemotherapy, including a platinum-based one.
MATERIALS AND METHODS


Part A was a dose-escalation phase for abemaciclib (100, 150, 200 mg, Q12 H) in combination with necitumumab 800 mg D1D8 Q3W to determine the recommended dose for the expansion cohort, Part B. The primary endpoint was progression-free survival (PFS) rate at 3 months.
RESULTS


Sixty-six patients entered the study: 71% male, 41% squamous histology, 15% never-smokers. In Part A (n = 15), the maximum tolerated dose of abemaciclib was 150 mg Q12H in combination with necitumumab 800 mg. In 57 patients treated at this dose level, the 3-month PFS rate was 32.3% (95% CI: 20.4-44.8); median PFS was 2.14 months (1.41-2.76). The overall response rate (ORR) was 5.3% (1.1-14.6). The median OS was 6.93 months (4.96-12.85). In the exploratory subgroup analysis of EGFR expression-negative patients (n = 10), both the 3-month PFS and ORR were 0.0%. The most common grade 3 treatment-emergent adverse events were fatigue (14%), dyspnea (9%), diarrhea (7%), vomiting (7%), and hypokalemia (7%).
CONCLUSIONS


Abemaciclib 150 mg Q12H with necitumumab 800 mg did not produce an additive effect over single-agent activity in patients with Stage IV NSCLC. The safety profile was consistent with the individual study drugs.",2019,The overall response rate (ORR) was 5.3% (1.1-14.6).,"['patients with non-small cell lung cancer (NSCLC', 'Sixty-six patients entered the study: 71% male, 41% squamous histology, 15% never-smokers', 'patients with stage IV non-small cell lung cancer', 'patients with advanced NSCLC who had received ≤2 lines of chemotherapy, including a platinum-based one', 'patients with Stage IV NSCLC']","['necitumumab in combination with abemaciclib', 'necitumumab 800\u202fmg D1D8 Q3W', 'necitumumab plus abemaciclib']","['hypokalemia', 'median PFS', '3-month PFS rate', 'dyspnea', 'median OS', 'vomiting', 'overall response rate (ORR', 'progression-free survival (PFS) rate', 'diarrhea', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C2352806', 'cui_str': 'necitumumab'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",66.0,0.07763,The overall response rate (ORR) was 5.3% (1.1-14.6).,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Gustave Roussy Cancer Center, Villejuif, France and Paris-Sud University, Orsay, France. Electronic address: benjamin.besse@gustaveroussy.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Aix Marseille University, CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Centre Essais Précoces en Cancérologie de Marseille CLIP², Marseille, France.'}, {'ForeName': 'Ingel', 'Initials': 'I', 'LastName': 'Demedts', 'Affiliation': 'AZ Delta, Wilgenstraat 2, Department of Pulmonary Diseases, Roeselare, 8800, Belgium.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Fuentes Pradera', 'Affiliation': 'Hospital Universitario Nuestra Señora de Valme, Autovia Sevilla-Cadiz, s/n ONCOLOGY, Sevilla, 46014, Spain.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': 'CHU de Brest - Hôpital Morvan, 5 Avenue Foch, Brest, 29200, France.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Gazzah', 'Affiliation': 'Gustave Roussy Cancer Center, Villejuif, France and Paris-Sud University, Orsay, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Soldatenkova', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Jong Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'University Hospital KU Leuven, Leuven, Belgium.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.09.002']
1570,31677296,A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention.,"AIM


To examine the effect of a family-oriented multidisciplinary intervention programme to curtail weight increase in young children with obesity.
METHODS


Children who weighed more than one kilogram above the 97th percentile for height at the preschool assessment in Oppland County, Norway, were identified. Parents residing in one part of the county were invited to participate in a group-based three-year intervention programme while the rest had no interventions. Body mass index (BMI) and family characteristics at entry and measurements at birth were explanatory variables, and change in BMI standard deviation score (SDS) the outcome measure. For the intervention group, outcome was also related to skinfold thicknesses, waist-to-height ratio and physical ability.
RESULTS


The programme was completed by 31 families in the intervention and 33 in the control group. At entry, the respective median (interquartile) age was 5.83 (0.36) and 5.74 (0.66) years, and the BMI SDS 2.35 (1.06) and 1.95 (0.49), P = .012. The median decrease in BMI SDS was 0.19 in both groups. The decline increased with increasing BMI SDS at entry, but irrespective of group. Social or behavioural factor or other anthropometric measures were not associated with outcome.
CONCLUSION


The intervention programme had no effect on BMI SDS.",2020,"For the intervention group, outcome was also related to skinfold thicknesses, waist-to-height ratio and physical ability.
","['young children with obesity', 'Children who weighed more than one kilogram above the 97 th  percentile for height at the pre-school assessment in Oppland County, Norway, were identified']",['family-oriented multidisciplinary intervention program'],"['skinfold thicknesses, waist-to-height ratio and physical ability', 'Social or behavioural factor or other anthropometric measures', 'Body mass index (BMI) and family characteristics at entry and measurements at birth were explanatory variables, and change in BMI standard deviation score (SDS', 'BMI SDS']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015579', 'cui_str': 'Family Characteristics'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",97.0,0.0279488,"For the intervention group, outcome was also related to skinfold thicknesses, waist-to-height ratio and physical ability.
","[{'ForeName': 'Hilde Mjell', 'Initials': 'HM', 'LastName': 'Donkor', 'Affiliation': 'Department of Paediatrics, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Jacob Holter', 'Initials': 'JH', 'LastName': 'Grundt', 'Affiliation': 'Department of Paediatrics, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Petur Benedikt', 'Initials': 'PB', 'LastName': 'Júlíusson', 'Affiliation': 'Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Geir Egil', 'Initials': 'GE', 'LastName': 'Eide', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hurum', 'Affiliation': 'Department of Paediatrics, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bjerknes', 'Affiliation': 'Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Markestad', 'Affiliation': 'Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15080']
1571,31640921,Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study.,"BACKGROUND


We aimed to clinically evaluate the effect of platelet-rich plasma (PRP) therapy in patients with acute lateral ankle sprain treated with rigid immobilization.
METHODS


Patients with first-time grade II lateral ankle sprain clinically diagnosed were evaluated (n=21). A rigid immobilization was placed in all patients for ten days; previously, an application of PRP over the anterior talofibular ligament was performed in patients from the experimental group. The Visual Analogue Scale, the American Orthopedic Foot and Ankle Score, and the Foot and Ankle Disability Index were applied at 3, 5, 8 and 24 weeks of follow-up period.
RESULTS


The experimental group presented the highest reduction in pain and better functional scores than the control group at 8 weeks. At the end of follow-up period the results of both groups were similar.
CONCLUSIONS


A similar evolution was observed in patients treated with rigid immobilization with or without PRP after 24 weeks.
TRIAL REGISTRATION


Clinical Trials.gov with ID NCT02609308.",2019,The experimental group presented the highest reduction in pain and better functional scores than the control group at 8 weeks.,"['Patients with first-time grade II lateral ankle sprain clinically diagnosed were evaluated (n=21', 'patients with acute lateral ankle sprain treated with rigid immobilization']","['platelet-rich plasma (PRP) therapy', 'lateral ankle sprain with platelet-rich plasma']","['pain and better functional scores', 'Visual Analogue Scale, the American Orthopedic Foot and Ankle Score, and the Foot and Ankle Disability Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0435123,The experimental group presented the highest reduction in pain and better functional scores than the control group at 8 weeks.,"[{'ForeName': 'Juancarlos', 'Initials': 'J', 'LastName': 'Blanco-Rivera', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Elizondo-Rodríguez', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Simental-Mendía', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Vilchez-Cavazos', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Peña-Martínez', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Acosta-Olivo', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital ""Dr. José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico. Electronic address: dr.carlosacosta@gmail.com.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2019.09.004']
1572,30068022,Natalizumab for induction of remission in Crohn's disease.,"BACKGROUND


This systematic review update summarizes the current evidence on the use of natalizumab for induction of remission in Crohn's disease (CD).
OBJECTIVES


To determine the efficacy and safety of natalizumab for induction of remission in CD.
SEARCH METHODS


We searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Trials Register, and clinicaltrials.gov from inception to 10 May 2018.
SELECTION CRITERIA


We included randomized controlled trials (RCTs) comparing natalizumab to a placebo or control therapy for induction of remission in CD.
DATA COLLECTION AND ANALYSIS


Two authors independently screened studies, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was failure to enter clinical remission. Secondary outcomes included clinical response, mean change in Crohn's Disease Activity Index (CDAI), adverse events (AEs), withdrawal due to AEs and serious AEs. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (95% CI). For continuous outcomes we calculated the mean difference (MD) and 95% CI. Data were pooled for meta-analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). We used GRADE to assess the overall quality of the evidence.
MAIN RESULTS


A total of five RCTs (1771 participants) were included. Four studies (1692 participants) compared one, two or three infusions of natalizumab (300 mg or 3 mg/kg or 6mg/kg) to placebo. One study (79 participants) compared three infusions of natalizumab (300 mg) and infliximab (5 mg/kg) to infliximab and placebo. Four studies were rated as low risk of bias. One study was rated as unclear risk of bias for selective reporting.One, two and three infusions of natalizumab were superior to placebo for induction of remission and clinical response. Infusions were administered at weeks zero, four and eight. After one infusion, 76% (849/1117) of natalizumab participants failed to enter remission at 4 weeks compared to 83% (411/494) of placebo participants (RR 0.91, 95% CI 0.86 to 0.96, 3 studies, GRADE high quality). At 4 weeks, the RR for clinical response was 0.78 (95% CI 0.66 to 0.92, 3 studies, 1611 participants, GRADE moderate quality). After two infusions, after 8 weeks, 66% (693/1049) of natalizumab participants failed to enter remission compared to 77% (382/494) of placebo participants (RR 0.85, 95% CI 0.76 to 0.95; 3 studies, GRADE moderate quality). At 8 weeks, the RR for clinical response was 0.73 (95% CI 0.58 to 0.91, 3 studies, 1543 participants, GRADE low quality). After three infusions, at 12 weeks, 61% (596/983) of natalizumab participants failed to enter remission compared to 73% (313/431) of placebo participants (RR 0.85, 95% CI 0.78 to 0.92, 2 studies, GRADE high quality). At 12 weeks, the RR for clinical response was 0.76 (95% CI 0.67 to 0.86, 2 studies, 1414 participants, GRADE high quality). One study (507 participants) reported on change in CADI from baseline. Natalizumab participants had a larger drop in mean CDAI scores than placebo participants at 4, 8 and 12 weeks.The rates of AEs, withdrawals due to AEs and serious AEs were similar across groups at 4, 8 and 12 weeks. After one infusion, 74% (50/68) of natalizumab participants experienced an AE compared to 81% (51/63) of placebo participants (RR 0.91, 95% CI 0.75 to 1.09, GRADE moderate quality). Withdrawal due to an AE occurred in 1% (1/68) of natalizumab participants and 3% of placebo participants (RR 0.46, 95% CI 0.04 to 4.98, GRADE low quality). SAEs occurred in 10% (7/68) of natalizumab participants compared to 11% (7/63) of placebo participants (RR 0.93, 95% CI 0.34 to 2.49, GRADE low quality). After two infusions, 86% (57/66) of natalizumab participants experienced an AE compared to 81% (51/63) of placebo participants (RR 1.07, 95% CI 0.92 to 1.24, GRADE moderate quality). Withdrawal due to an AE occurred in 3% (2/66) natalizumab participants compared to 3% (2/63) placebo participants (RR 0.95, 95% CI 0.14 to 6.57, GRADE low quality). SAEs occurred in 9% (6/66) of natalizumab participants and 11% (7/63) of placebo participants (RR 0.82, 95% CI 0.29 to 2.30, GRADE low quality). After three infusions, 86% (848/984) of natalizumab participants experienced an AE compared to 83% (359/431) placebo participants (RR 1.03, 95% CI 0.98 to 1.08, GRADE high quality). Withdrawals due to AEs occurred in 8% (82/984) of natalizumab participants compared to 10% (45/431) of placebo participants (RR 0.86, 95% CI 0.59 to 1.26, GRADE moderate quality). SAEs occurred in 7% (65/983) of natalizumab participants and 8% (36/431) of placebo participants (RR 0.76. 95% CI 0.37 to 1.56, GRADE low quality). Adverse events included headache, nausea, nasopharyngitis, abdominal pain, fatigue, vomiting, and exacerbation of CD.The study comparing combination therapy with natalizumab and infliximab to infliximab and placebo demonstrated similar remission rates at 10 weeks. Sixty-four per cent (33/52) of participants assigned to natalizumab and infliximab failed to achieve remission compared to 70% (19/27) assigned to placebo and infliximab (RR 0.90, 95% CI 0.65 to 1.24, GRADE moderate quality). The rates of AEs (moderate quality evidence), withdrawals due to AEs (low quality evidence) and serious AEs (low quality evidence) were similar across groups at 10 weeks. Adverse events included headache, exacerbation of CD, nausea, and nasopharyngitis.Natalizumab is associated with the development of progressive multifocal leukoencephalopathy (PML) resulting in some patient deaths. There are currently no tests which can reliably predict those at risk of developing PML.
AUTHORS' CONCLUSIONS


High quality data suggest that natalizumab is effective for induction of clinical remission and response in some patients with moderately to severely active CD. However, none of the included studies had the power to detect rare but serious adverse events such as PML. Due to the association with PML, and the availability of alternative agents that are not associated with PML, natalizumab is not likely to be used in patients who fail currently available medical therapy. The use of natalizumab in select patients (e.g. patients allergic to different biologics) needs to be carefully considered against the potential risk of developing PML. Futher studies of natalizumab are not likely to be done.",2018,"The rates of AEs, withdrawals due to AEs and serious AEs were similar across groups at 4, 8 and 12 weeks.","[""Crohn's disease"", 'patients with moderately to severely active CD', ""Crohn's disease (CD"", 'A total of five RCTs (1771 participants) were included', 'patients who fail currently available medical therapy']","['Natalizumab', 'placebo', 'placebo or control therapy', 'infliximab and placebo', 'placebo and infliximab', 'natalizumab', 'infliximab', 'natalizumab and infliximab']","['mean CDAI scores', 'remission rates', 'rates of AEs, withdrawals due to AEs and serious AEs', 'Withdrawals due to AEs', 'achieve remission', 'RR for clinical response', ""clinical response, mean change in Crohn's Disease Activity Index (CDAI), adverse events (AEs), withdrawal due to AEs and serious AEs"", 'efficacy and safety', 'SAEs', 'rates of AEs (moderate quality evidence), withdrawals due to AEs (low quality evidence) and serious AEs (low quality evidence', 'failure to enter clinical remission', 'headache, nausea, nasopharyngitis, abdominal pain, fatigue, vomiting, and exacerbation', 'headache, exacerbation of CD, nausea, and nasopharyngitis', 'risk ratio (RR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index (assessment scale)""}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",79.0,0.703769,"The rates of AEs, withdrawals due to AEs and serious AEs were similar across groups at 4, 8 and 12 weeks.","[{'ForeName': 'Seana Ml', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'John Wd', 'Initials': 'JW', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006097.pub3']
1573,29847967,Intranasal Dexmedetomidine in Termination of First Trimester Pregnancy of Suction Evacuation.,"OBJECTIVE


Deep sedation without intubation for termination of first trimester pregnancy of suction evacuation entails use of sedatives such as propofol or a combination of propofol and sulfentanil, with unwanted complications. Dexmedetomidine is an α2-adrenorecepter agonist which provides sedation, anxiolysis and analgesia, without any of the complications associated with the popular sedatives.
METHODS


A total number of 90 patients were randomized to three groups: (1) group P, treated with intranasal saline, intravenous saline and propofol; (2) group DP, treated with intranasal dexmedetomidine, intravenous saline and propofol; and (3) group SP, treated with intranasal saline, intravenous sulfentanil and propofol. The primary outcome was the consumption of propofol, and the secondary outcomes were numeric rating scale (NRS) anxiety score, NRS pain score of uterine cramping, amount of blood loss, use of oxytocin and NRS satisfaction scores of obstetric and gynecological (ob/gyn) physicians and patients.
RESULTS


The consumption of propofol, NRS pain score of uterine cramping after surgery, NRS anxiety score, and amount of blood loss in group DP were significantly lower than those in group P and group SP. Ob/gyn physicians' satisfaction score in group DP was significantly higher compared with group SP and group P.
CONCLUSIONS


Sedation with intranasal dexmedetomidine (1 μg/kg) provided effective analgesia and anxiolysis, reduced consumption of propofol and lower blood loss in termination of first trimester pregnancy of suction evacuation. Compared with propofol or the combination of propofol and sulfentanil, intranasal dexmedetomidine was associated with higher satisfaction score of ob/gyn physicians. No unforeseen perioperative respiratory and cardiovascular adverse events occurred.",2018,No unforeseen perioperative respiratory and cardiovascular adverse events occurred.,['A total number of 90 patients'],"['Dexmedetomidine', 'propofol and sulfentanil', 'propofol and sulfentanil, intranasal dexmedetomidine', 'intranasal saline, intravenous sulfentanil and propofol', 'propofol', 'Intranasal Dexmedetomidine', 'intranasal dexmedetomidine', 'intranasal saline, intravenous saline and propofol; (2) group DP, treated with intranasal dexmedetomidine, intravenous saline and propofol']","['consumption of propofol, NRS pain score of uterine cramping after surgery, NRS anxiety score, and amount of blood loss', 'effective analgesia and anxiolysis, reduced consumption of propofol and lower blood loss', 'unforeseen perioperative respiratory and cardiovascular adverse events', 'consumption of propofol, and the secondary outcomes were numeric rating scale (NRS) anxiety score, NRS pain score of uterine cramping, amount of blood loss, use of oxytocin and NRS satisfaction scores of obstetric and gynecological (ob/gyn) physicians and patients']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1961138', 'cui_str': 'Anxiolysis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0222045'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",90.0,0.0574248,No unforeseen perioperative respiratory and cardiovascular adverse events occurred.,"[{'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Hang', 'Affiliation': 'Department of Dermatology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Qingdao Women and Children's Hospital, Qingdao, Shandong, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Dalian Medical University, Dalian, Liaoning, China.'}]",Asian journal of anesthesiology,['10.6859/aja.201803_56(1).0001']
1574,30045133,A Cognitive-Behavioral Intervention for the Symptom Clusters of Chinese Patients With Gastrointestinal Tract Cancer Undergoing Chemotherapy: A Pilot Study.,"BACKGROUND


Patients with gastrointestinal tract (GIT) cancer undergoing chemotherapy often experience several symptoms that constitute symptom clusters and can cause patients to suffer. Effective interventions are lacking for this kind of patients.
OBJECTIVE


The aims of this study were to test the feasibility and acceptability of a cognitive-behavioral (CB) intervention developed for Chinese patients with GIT cancer undergoing chemotherapy and to estimate the efficacy of the intervention for symptom clusters.
METHODS


In this pilot, quasi-randomized controlled trial, 40 patients were assigned to the CB intervention or control group. The CB intervention, considering characteristics of patients and Chinese culture, contained 4 sections including cognitive reframing, cancer-diet education, relaxation, and exercise techniques. Symptom clusters, illness perception, anxiety, and depression were measured.
RESULTS


Thirty-nine patients (97.5%) completed the study program and expressed willingness to follow the intervention. Compared with the control group, all outcomes were improved (all P < .05) in the CB group after the intervention, except for the gastrointestinal symptom cluster (t = 0.25, P = .802). In the CB group, the scores of all outcomes (all P < .05) decreased except for depression (t = 1.76, P = .095).
CONCLUSION


The CB intervention is partially feasible and acceptable. It may also help to improve part of the symptom clusters of Chinese patients with GIT cancer undergoing chemotherapy. However, some modifications are needed in future studies to better test effectiveness.
IMPLICATIONS FOR PRACTICE


Symptom management remains a major problem in clinical nursing. Such a CB intervention can be beneficial to the clinical management of symptom clusters.",2019,"In the CB group, the scores of all outcomes (all P < .05) decreased except for depression (t = 1.76, P = .095).
","['Chinese patients with GIT cancer undergoing', 'Patients with gastrointestinal tract (GIT) cancer undergoing', '40 patients', 'Chinese Patients With Gastrointestinal Tract Cancer Undergoing Chemotherapy', 'Chinese patients with GIT cancer undergoing chemotherapy']","['Cognitive-Behavioral Intervention', 'chemotherapy', 'CB intervention or control group', 'CB intervention', 'cognitive-behavioral (CB) intervention']","['Symptom clusters, illness perception, anxiety, and depression']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",40.0,0.0299695,"In the CB group, the scores of all outcomes (all P < .05) decreased except for depression (t = 1.76, P = .095).
","[{'ForeName': 'Xinqiong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Author Affiliations: School of Nursing, Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jingfang', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000625']
1575,29982371,Changes in facial expressions following functional orthopaedic treatment for Class II division 1 malocclusion: a prospective controlled study.,"OBJECTIVE


The aim of this study was to quantify changes in facial expressions in children with Class II division 1 malocclusion treated with functional appliances.
MATERIALS AND METHODS


A prospective controlled study was carried out evaluating 20 children with Class II division 1 malocclusion (ages 9-13) treated with a functional appliance for 12 months (treatment group). Age- and gender-matched children without immediate orthodontic treatment need were followed up without treatment for 12 months (control group). A frame-mode video sequence was taken of each subject at the beginning and end of the 12-month study period, during which 5 distinct facial expressions (posed smile, spontaneous smile, aggressive smile, lip pucker, and maximal mouth opening) were recorded. Frames at which each facial expression was at its peak were analysed. Changes in horizontal and vertical facial anthropometric distances brought about by performing each facial expression were measured. Intragroup differences following treatment were assessed using paired t-tests, whereas intergroup differences were assessed using unpaired t-tests.
RESULTS


All treated children showed an improvement in dentoalveolar relationships. Initial facial expressions differed between groups, with the treatment group showing less marked changes during lip pucker and more marked changes during maximal mouth opening. In contrast, no statistically significant differences were found between groups for the final facial expressions.
CONCLUSIONS


This study suggests that functional appliance use in growing children with Class II division 1 malocclusion tends to normalize soft-tissue movements during facial expressions.",2019,Age- and gender-matched children without immediate orthodontic treatment need were followed up without treatment for 12 months (control group).,"['20 children with Class II division 1 malocclusion (ages 9-13) treated with a functional appliance for 12 months (treatment group', 'children with Class II division 1 malocclusion', 'children with Class II division 1 malocclusion treated with functional appliances', 'Class II division 1 malocclusion']",['functional orthopaedic treatment'],"['dentoalveolar relationships', 'Changes in horizontal and vertical facial anthropometric distances', 'final facial expressions', 'facial expressions', 'Initial facial expressions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0243112'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",20.0,0.0354243,Age- and gender-matched children without immediate orthodontic treatment need were followed up without treatment for 12 months (control group).,"[{'ForeName': 'Ourania', 'Initials': 'O', 'LastName': 'Stergiopulos', 'Affiliation': 'Division of Orthodontics, University Clinic of Dental Medicine, University of Geneva.'}, {'ForeName': 'Odyssia', 'Initials': 'O', 'LastName': 'Houstis', 'Affiliation': 'Private Practice, Zurich, Switzerland.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Kiliaridis', 'Affiliation': 'Division of Orthodontics, University Clinic of Dental Medicine, University of Geneva.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Antonarakis', 'Affiliation': 'Division of Orthodontics, University Clinic of Dental Medicine, University of Geneva.'}]",European journal of orthodontics,['10.1093/ejo/cjy047']
1576,31642130,"Effects of a novel bites, steps and eating rate-focused weight loss randomised controlled trial intervention on body weight and eating behaviours.","BACKGROUND


Eating rate (ER), comprising the amount of food consumed per unit of time, is associated with obesity and energy intake (EI).
METHODS


The present study tested whether adding a self-monitoring wearable device to a multifaceted 8-week weight loss intervention increased weight loss. In addition, the device's effect on secondary change outcomes in EI, ER and estimated energy expenditure was explored. Tertiary outcomes included examining eating behaviours measured by the Weight-Related Eating Questionnaire (WREQ). Seventy-two adults who were overweight or obese [mean (SD) age, 37.7 (15.3) years; body mass index, 31.3 (3.2) kg m -2  ] were randomised into two groups: intervention workbook plus device (WD) or intervention workbook only (WO). Three 24-h dietary recalls were obtained before weeks 0 and 8. Participants were weighed, consumed a test meal and completed 7-day Physical Activity Recall and WREQ at weeks 0 and 8.
RESULTS


There was no significant difference between WD and WO groups with respect to weight change [-0.46 (1.11) vs. 0.26 (0.82) kg, respectively], ER, EI, energy expenditure or WREQ scores, although there were significant changes over time, and within-group changes on all of these variables. At week 8, participants were dichotomised into weight loss or weight stable/gainers groups. A significant time by group change was seen in susceptibility to external cues scores, with significant time effects for susceptibility and restraint.
CONCLUSIONS


An intervention focused on reducing ER, energy density and increasing steps was effective for weight loss, although the wearable device provided no additional benefit. Participants with higher susceptibility to external eating may be more responsive to this intervention.",2020,"A significant time by group change was seen in susceptibility to external cues scores, with significant time effects for susceptibility and restraint.
","['15.3)\xa0years; body mass index, 31.3\xa0(3.2)\xa0kg m -2  ', 'Participants with higher susceptibility to external eating', 'Seventy-two adults who were overweight or obese [mean (SD) age, 37.7\xa0']",['intervention workbook plus device (WD) or intervention workbook only (WO'],"['body weight and eating behaviours', 'weight change', 'susceptibility to external cues scores', 'EI, ER and estimated energy expenditure', 'ER, EI, energy expenditure or WREQ scores', 'weight loss', 'eating behaviours measured by the Weight-Related Eating Questionnaire (WREQ']","[{'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",72.0,0.0550441,"A significant time by group change was seen in susceptibility to external cues scores, with significant time effects for susceptibility and restraint.
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Beatty', 'Affiliation': 'Department of Nutrition and Food Sciences, The University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Greene', 'Affiliation': 'Department of Nutrition and Food Sciences, The University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Blissmer', 'Affiliation': 'Department of Kinesiology, The University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Delmonico', 'Affiliation': 'Department of Kinesiology, The University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Melanson', 'Affiliation': 'Department of Nutrition and Food Sciences, The University of Rhode Island, Kingston, RI, USA.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12704']
1577,32061356,A comparison of the use of a suprapatellar Chinese Aircraft-shaped Sleeve System versus suprapatellar intramedullary nailing for tibial shaft fractures: Outcomes over a one-year follow-up.,"INTRODUCTION


This study aimed to investigate the effectiveness and safety of the Chinese Aircraft-shaped Sleeve (CASS) system on the clinical outcomes of tibial intermedullary nailing using a suprapatellar approach for the treatment of tibial fractures in a cohort of adult Chinese patients over a minimum one-year follow-up.
METHODS


After institutional review board approval, skeletally mature patients with Orthopaedic Trauma Association (OTA) type 42 tibial shaft fractures were randomized into either a SP approach using CASS group or a conventional SP approach group after informed consent was obtained. The operations were performed by a single senior orthopaedic surgeon according to group assignments. A group of 33 patients were treated using the CASS system and the other group of 34 patients were treated using a conventional SP approach. Both groups fully complied with research requirements and completed 12 months of follow-up. Magnetic resonance images (MRI) were obtained for the evaluation of the patellofemoral joint (PFJ) and residual debris preoperatively, as well as one week and 12 months postoperatively. Radiographs were used to assess alignment and union, visual analog scores (VAS) were used to assess anterior knee pain, and range of motion (ROM) and the Lysholm knee scoring scales were used for evaluating the operated knee at the 12-month follow-up.
RESULTS


Differences in cartilage lesion changes observed by MRI between the two groups were statistically significant (P = 0.030 at 1 week postoperatively; P = 0.025 at 12 months postoperatively). No significant differences were evident with respect to debris residue, malalignments, nonunion, VAS, ROM and Lysholm knee scoring scale with the exception of stair climbing (P = 0.02).
CONCLUSION


Based on the data of this one-year clinical follow-up study, the SP approach using the CASS system offers the potential to benefit patients suffering from tibial shaft fractures, who will be treated with intramedullary nailing especially for smaller patients.",2020,"No significant differences were evident with respect to debris residue, malalignments, nonunion, VAS, ROM and Lysholm knee scoring scale with the exception of stair climbing (P = 0.02).
","['A group of 33 patients were treated using the CASS system and the other group of 34 patients', 'tibial fractures in a cohort of adult Chinese patients over a minimum one-year follow-up', 'skeletally mature patients with Orthopaedic Trauma Association (OTA) type 42 tibial shaft fractures', 'tibial shaft fractures', 'patients suffering from tibial shaft fractures']","['tibial intermedullary nailing', 'Magnetic resonance images (MRI', 'conventional SP approach', 'Chinese Aircraft-shaped Sleeve (CASS) system', 'intramedullary nailing', 'SP approach using CASS group or a conventional SP approach', 'suprapatellar Chinese Aircraft-shaped Sleeve System versus suprapatellar intramedullary nailing']","['cartilage lesion changes', 'alignment and union, visual analog scores (VAS', 'effectiveness and safety', 'anterior knee pain, and range of motion (ROM) and the Lysholm knee scoring scales', 'debris residue, malalignments, nonunion, VAS, ROM and Lysholm knee scoring scale']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0643514', 'cui_str': 'CASS'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C3645563', 'cui_str': 'Association type reference set (foundation metadata concept)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001881', 'cui_str': 'Aircraft'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0643514', 'cui_str': 'CASS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scale'}, {'cui': 'C0222045'}, {'cui': 'C0440266', 'cui_str': 'Debris (substance)'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}]",33.0,0.0214631,"No significant differences were evident with respect to debris residue, malalignments, nonunion, VAS, ROM and Lysholm knee scoring scale with the exception of stair climbing (P = 0.02).
","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou, Jiangsu 215004, China; Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Gao', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Hong-Zhen', 'Initials': 'HZ', 'LastName': 'Wang', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Rong-Xun', 'Initials': 'RX', 'LastName': 'Qian', 'Affiliation': 'Department of Joint Surgery, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Hui-Qiang', 'Initials': 'HQ', 'LastName': 'Shan', 'Affiliation': 'Department of Orthopaedics, Affiliated Kunshan Hospital of Jiangsu University, Suzhou, Jiangsu 215300, China.'}, {'ForeName': 'Qi-Rong', 'Initials': 'QR', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, the Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou, Jiangsu 215004, China. Electronic address: dongqirong@suda.edu.cn.'}]",Injury,['10.1016/j.injury.2020.01.026']
1578,29912763,Factors Associated With Adenoma Detection in Propofol-sedated Patients.,"GOALS


To assess the factors associated with adenoma detection in propofol-sedated patients.
BACKGROUNDS


Low adenoma detection rate (ADR) are linked to increased risk of interval cancer and related deaths. Compared with air insufflation (AI) colonoscopy, the method of water exchange (WE) significantly decreased insertion pain and increased ADR in unsedated patients. Deep sedation with propofol has been increasingly used in colonoscopy. One report suggested that WE significantly increased ADR in propofol-sedated patients, but the factors associated with adenoma detection were not analyzed.
STUDY


Post hoc multiple logistic regression analyses were performed based on pooled data from 2 randomized controlled trials to assess the factors associated with adenoma detection in propofol-sedated patients.
RESULTS


Propofol-sedated patients (n=510) were randomized to AI and WE. The baseline characteristics were comparable. Multiple logistic regression analyses show that age, withdrawal time, indications (screening vs. diagnostic), and WE were significantly and independently associated with higher ADR. WE had fewer patients with inadequate Boston Bowel Preparation Scale score of <6. Despite a significantly shorter inspection time, WE had significantly higher overall ADR than AI, especially in those with adequate Boston Bowel Preparation Scale of ≥6. Right colon ADR (17.5% vs. 10.5%), flat ADR (32.3% vs. 19.4%), combined advanced and sessile serrated ADR (13.1% vs. 7.4%) of WE were significantly higher than those of AI.
CONCLUSIONS


WE enhanced quality of colonoscopy in propofol-sedated patients by significantly improving colon cleanliness and overall ADR. Colonoscopists with patients under propofol sedation might consider evaluating WE method for performance improvement.",2019,"Compared with air insufflation (AI) colonoscopy, the method of water exchange (WE) significantly decreased insertion pain and increased ADR in unsedated patients.","['sedated patients', 'unsedated patients', 'sedated Patients', 'sedated patients (n=510']","['air insufflation (AI) colonoscopy', 'Propofol', 'propofol']","['quality of colonoscopy', 'flat ADR', 'ADR', 'insertion pain and increased ADR', 'Right colon ADR', 'inadequate Boston Bowel Preparation Scale score', 'colon cleanliness and overall ADR']","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",510.0,0.0273162,"Compared with air insufflation (AI) colonoscopy, the method of water exchange (WE) significantly decreased insertion pain and increased ADR in unsedated patients.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills and David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Departments of Medical Research.'}, {'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Medicine, Division of Gastroenterology, Dalin Tzu Chi Hospital, Dalin, Chiayi.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tseng', 'Affiliation': 'Medicine, Division of Gastroenterology, Dalin Tzu Chi Hospital, Dalin, Chiayi.'}, {'ForeName': 'Chi-Tan', 'Initials': 'CT', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Tzu Chi University.'}, {'ForeName': 'Linhui', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yanglin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills and David Geffen School of Medicine at UCLA, Los Angeles, CA.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001080']
1579,30010086,Nicotine replacement therapy sampling via primary care: Methods from a pragmatic cluster randomized clinical trial.,"BACKGROUND


Primary care is the most important point of healthcare contact for smokers. Brief physician advice to quit, based on the 5As/AAR model, offers some efficacy but is inconsistently administered and has limited population impact. Nicotine replacement therapy (NRT) sampling, defined as provision of a brief NRT starter kit, when added to the 5As/AAR, is well-suited to primary care because it is simple, brief, and can be provided to all smokers. This article describes the design and methods of an ongoing comparative effectiveness trial testing standard care vs. standard care + NRT sampling within primary care.
METHODS


Smokers were recruited directly from primary care practices between July 2014 and December 2017 within an established network of South Carolina clinics. Interventions were delivered randomly by clinic personnel, and phone-based follow-ups were centrally coordinated by research staff to track outcomes through six months post-intervention. Primary study aims are to examine the impact of NRT sampling on smoking, inclusive of cessation, quit attempts, and uptake of evidence-based treatment.
RESULTS


Twenty-two clinics were recruited. Across clinics, patient census ranged from 985 to 10,957 and number of providers ranged from 1 to 63. Average patient age across clinics was 52.9 years and smoking prevalence across ranged from 10.6% to 28.5%.
CONCLUSION


Improving the effectiveness and reach of brief interventions within primary care could have a considerable impact on population quit rates. We consider the advantages and disadvantages of key methodological decisions relevant to the design of future primary care-based cessation trials.",2018,"Across clinics, patient census ranged from 985 to 10,957 and number of providers ranged from 1 to 63.","['Twenty-two clinics were recruited', 'Smokers were recruited directly from primary care practices between July 2014 and December 2017 within an established network of South Carolina clinics']","['Nicotine replacement therapy (NRT', 'NRT sampling', 'standard care vs. standard care\u202f+\u202fNRT sampling', 'Nicotine replacement therapy sampling']",[],"[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],22.0,0.0629565,"Across clinics, patient census ranged from 985 to 10,957 and number of providers ranged from 1 to 63.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC, USA; Hollings Cancer Center, MUSC, Charleston, SC, USA. Electronic address: dahne@musc.edu.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Department of Public Health Sciences, MUSC, Charleston, SC, USA; Hollings Cancer Center, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Boatright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC, USA; Hollings Cancer Center, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Garrett-Mayer', 'Affiliation': 'Department of Public Health Sciences, MUSC, Charleston, SC, USA; Hollings Cancer Center, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Douglas O', 'Initials': 'DO', 'LastName': 'Fleming', 'Affiliation': 'Care Coordination Institute, Greenville, SC, USA; Spatial Sciences Institute, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Care Coordination Institute, Greenville, SC, USA; School of Medicine, University of South Carolina Greenville, Greenville, SC, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'Care Coordination Institute, Greenville, SC, USA; School of Medicine, University of South Carolina Greenville, Greenville, SC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC), Charleston, SC, USA; Department of Public Health Sciences, MUSC, Charleston, SC, USA; Hollings Cancer Center, MUSC, Charleston, SC, USA. Electronic address: carpenter@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.008']
1580,31606521,"Perioperative course and quality of life in a prospective randomized multicenter phase III trial, comparing standard lobectomy versus anatomical segmentectomy in patients with non-small cell lung cancer up to 2 cm, stage IA (7th edition of TNM staging system).","OBJECTIVES


For early stage non-small cell lung cancer (NSCLC) retrospective data of functionally compromised patients undergoing segmentectomy showed equal outcomes for perioperative complications and quality of life (QoL) compared with lobectomy patients. However no prospectively randomized data comparing patients eligible for both procedures are available.
MATERIALS AND METHODS


We conducted a prospective, randomized, multicenter phase III trial and investigated perioperative complications and QoL in patients with NSCLC stage IA (7th edition) undergoing segmentectomy versus lobectomy. The EORTC Questionnaire Core-30 (QLQ C-30) supplemented by thirteen-item lung cancer-specific module (LC13) was assessed before surgery, at discharge, 6 weeks, 3, 6 and 12 months post-surgery.
RESULTS


108 patients with verified or suspected NSCLC up to 2 cm diameter were enrolled, whereby 54 were assigned to lobectomy and 54 to segmentectomy. Due to nodal disease, tumor size and surgical reasons estimated during the operation, eight patients of the segmentectomy group received a lobectomy. In hospital and 90 days mortality was 0% in both groups. Perioperative complications were observed in 6 (11.3%) patients after segmentectomy and in 8 patients (14.8%) after lobectomy (p = 0.563), while the 90-day morbidity were 17% and 25.9% (9 and 14 patients), respectively (p = 0.452). Twelve months after surgery, there was a significant deterioration to the baselines of physical (p < 0.001) and cognitive functioning (p = 0.025), dyspnea (p < 0.001) and fatigue (p = 0.003) in the lobectomy group. Dyspnea showed a faster recovery in the segmentectomy compared to lobectomy group with statistical significance (p = 0.016 after 12 months).
CONCLUSION


In patients with early-stage NSCLC, segmentectomy is associated with a statistically not significant lower perioperative morbidity and appears to provide a superior recovery in QoL compared with lobectomy patients.",2019,"Twelve months after surgery, there was a significant deterioration to the baselines of physical (p < 0.001) and cognitive functioning (p = 0.025), dyspnea (p < 0.001) and fatigue (p = 0.003) in the lobectomy group.","['patients with non-small cell lung cancer up to 2\u202fcm, stage IA (7th edition of TNM staging system', 'patients with NSCLC stage IA (7th edition) undergoing', 'For early stage non-small cell lung cancer', '108 patients with verified or suspected NSCLC up to 2\u202fcm diameter were enrolled, whereby 54 were assigned to lobectomy and 54 to segmentectomy']","['segmentectomy versus lobectomy', 'standard lobectomy versus anatomical segmentectomy', 'lobectomy']","['perioperative complications and quality of life (QoL', 'dyspnea', 'Perioperative course and quality of life', 'cognitive functioning', '90-day morbidity', 'perioperative morbidity', 'Perioperative complications', 'Dyspnea', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0457150', 'cui_str': 'Stage Ia'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1515169', 'cui_str': 'TNM Staging System'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}]","[{'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]","[{'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0034380'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",108.0,0.09841,"Twelve months after surgery, there was a significant deterioration to the baselines of physical (p < 0.001) and cognitive functioning (p = 0.025), dyspnea (p < 0.001) and fatigue (p = 0.003) in the lobectomy group.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Stamatis', 'Affiliation': 'Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany. Electronic address: georgios.stamatis@uk-essen.de.'}, {'ForeName': 'Gunda', 'Initials': 'G', 'LastName': 'Leschber', 'Affiliation': 'Departement of Thoracic Surgery, Evangelische Lungenklinik ELK Chest Hospital, Berlin, Germany.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Schwarz', 'Affiliation': 'Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Diana Lütke', 'Initials': 'DL', 'LastName': 'Brintrup', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ose', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Weinreich', 'Affiliation': 'Pneumology, Ruhrlandklinik, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Bernward', 'Initials': 'B', 'LastName': 'Passlick', 'Affiliation': 'Departement of Thoracic Surgery, University Freiburg, Germany.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Hecker', 'Affiliation': 'Departement of Thoracic Surgery, Evangelisches Krankenhaus Herne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kugler', 'Affiliation': 'Departement of Thoracic Surgery, LungenClinic Grosshansdorf, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Dienemann', 'Affiliation': 'Departement of Thoracic Surgery, Heidelberg University, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krbek', 'Affiliation': 'Departement of Thoracic Surgery, Krankenhaus Bethanien Moers, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Eggeling', 'Affiliation': 'Departement of Thoracic Surgery, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Hatz', 'Affiliation': 'Departement of Thoracic Surgery, Asklepios Fachkliniken München-Gauting, Germany.'}, {'ForeName': 'Michael Rolf', 'Initials': 'MR', 'LastName': 'Müller', 'Affiliation': 'Departement of Thoracic Surgery, Otto Wagner Spital Wien, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Weder', 'Affiliation': 'Departement of Thoracic Surgery, UniversitätsSpital Zürich, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University of Duisburg-Essen, Essen, Germany.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.09.021']
1581,31630683,"Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial.","BACKGROUND


The microorganism present in breast milk, added to other factors, determine the colonization of infants. The objective of the present study is to evaluate the safety, tolerance and effects of the consumption of a milk formula during the first year of life that is supplemented with L. fermentum CECT5716 or Bifidobacterium breve CECT7263, two strains originally isolated from breast milk.
METHODS


A randomized, double blind, controlled, parallel group study including healthy, formula-fed infants was conducted. Two hundred and thirty-six 1-month-old infants were selected and randomly divided into three study groups according to a randomization list. Infants in the control group received a standard powdered infant formula until 12 months of age. Infants in the probiotic groups received the same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263. Main outcome was weigh-gain of infants as safety marker.
RESULTS


One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group). The growth of infants in the three groups was consistent with standards. No significant differences were observed in the main outcome, weight-gain (Control group: 5.77 Kg ± 0.95, Lf group: 5.77 Kg ± 1.31, Bb group: 5.58 Kg ± 1.10; p = 0.527). The three milk formulae were well tolerated, and no adverse effects were related to the consumption of any of the formula. Infants receiving B. breve CECT7263 had a 1.7 times lower risk of crying than the control group (OR = 0.569, CI 95% 0.568-0.571; p = 0.001). On the other hand, the incidence of diarrhoea in infants receiving the formula supplemented with L. fermentum CECT5716 was a 44% lower than in infants receiving the control formula (p = 0.014). The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).
CONCLUSIONS


The addition of L. fermentum CECT5716 Lc40 or B. breve CECT7263, two probiotic strains naturally found in breast milk, to infant formulae is safe and induces beneficial effects on the health of infants.
TRIAL REGISTRATION


The trial was retrospectively registered in the US Library of Medicine ( www.clinicaltrial.gov ) with the number NCT03204630 . Registered 11 August 2016.",2019,"The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).
","['Two hundred and thirty-six 1-month-old infants', 'healthy, formula-fed infants', 'One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group']","['Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263', 'same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263']","['incidence of diarrhoea', 'weight-gain', 'risk of crying', 'duration of diarrhoea', 'weigh-gain of infants as safety marker']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0317603', 'cui_str': 'Lactobacillus fermentum'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",189.0,0.135768,"The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maldonado', 'Affiliation': 'Pediatric Unit, University Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gil-Campos', 'Affiliation': 'Unit of Metabolism and Pediatric Research (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Cordoba, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Maldonado-Lobón', 'Affiliation': 'Biosearch Life, Research Department, Granada, Spain.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Benavides', 'Affiliation': 'Pediatric Clinic Roquetas, Roquetas de Mar, Almería, Spain.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Flores-Rojas', 'Affiliation': 'Unit of Metabolism and Pediatric Research (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Cordoba, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jaldo', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jiménez Del Barco', 'Affiliation': 'Clinic ""Cristo de la Salud"" Albolote, Granada, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bolívar', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Valero', 'Affiliation': 'Biosearch Life, Research Department, Granada, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Prados', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Peñalver', 'Affiliation': 'Andalusian Health Service, Andalusia, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Olivares', 'Affiliation': 'Biosearch Life, Research Department, Granada, Spain. molivares@biosearchlife.com.'}]",BMC pediatrics,['10.1186/s12887-019-1753-7']
1582,29871544,Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.,"Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.",2020,"Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time.","['persons with dementia (PWDs', '10 nursing homes over a 14-week period', 'Persons With Dementia']","['M&M program', 'Individualized Music Listening Program', 'Music & Memory (M&M']","['agitation, behavioral symptoms, and use of psychotropic medications']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",,0.0490489,"Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time.","[{'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Kwak', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'University of Montana, Missoula, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': ""O'Connell Valuch"", 'Affiliation': 'University of Wisconsin-Milwaukee, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464818778991']
1583,29851031,Vaccines for preventing typhoid fever.,"BACKGROUND


Typhoid fever and paratyphoid fever continue to be important causes of illness and death, particularly among children and adolescents in south-central and southeast Asia. Two typhoid vaccines are widely available, Ty21a (oral) and Vi polysaccharide (parenteral). Newer typhoid conjugate vaccines are at varying stages of development and use. The World Health Organization has recently recommended a Vi tetanus toxoid (Vi-TT) conjugate vaccine, Typbar-TCV, as the preferred vaccine for all ages.
OBJECTIVES


To assess the effects of vaccines for preventing typhoid fever.
SEARCH METHODS


In February 2018, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, and mRCT. We also searched the reference lists of all included trials.
SELECTION CRITERIA


Randomized and quasi-randomized controlled trials (RCTs) comparing typhoid fever vaccines with other typhoid fever vaccines or with an inactive agent (placebo or vaccine for a different disease) in adults and children. Human challenge studies were not eligible.
DATA COLLECTION AND ANALYSIS


Two review authors independently applied inclusion criteria and extracted data, and assessed the certainty of the evidence using the GRADE approach. We computed vaccine efficacy per year of follow-up and cumulative three-year efficacy, stratifying for vaccine type and dose. The outcome addressed was typhoid fever, defined as isolation of Salmonella enterica serovar Typhi in blood. We calculated risk ratios (RRs) and efficacy (1 - RR as a percentage) with 95% confidence intervals (CIs).
MAIN RESULTS


In total, 18 RCTs contributed to the quantitative analysis in this review: 13 evaluated efficacy (Ty21a: 5 trials; Vi polysaccharide: 6 trials; Vi-rEPA: 1 trial; Vi-TT: 1 trial), and 9 reported on adverse events. All trials but one took place in typhoid-endemic countries. There was no information on vaccination in adults aged over 55 years of age, pregnant women, or travellers. Only one trial included data on children under two years of age.Ty21a vaccine (oral vaccine, three doses)A three-dose schedule of Ty21a vaccine probably prevents around half of typhoid cases during the first three years after vaccination (cumulative efficacy 2.5 to 3 years: 50%, 95% CI 35% to 61%, 4 trials, 235,239 participants, moderate-certainty evidence). These data include patients aged 3 to 44 years.Compared with placebo, this vaccine probably does not cause more vomiting, diarrhoea, nausea or abdominal pain (2 trials, 2066 participants; moderate-certainty evidence), headache, or rash (1 trial, 1190 participants; moderate-certainty evidence); however, fever (2 trials, 2066 participants; moderate-certainty evidence) is probably more common following vaccination.Vi polysaccharide vaccine (injection, one dose)A single dose of Vi polysaccharide vaccine prevents around two-thirds of typhoid cases in the first year after vaccination (year 1: 69%, 95% CI 63% to 74%; 3 trials, 99,979 participants; high-certainty evidence). In year 2, trial results were more variable, with the vaccine probably preventing between 45% and 69% of typhoid cases (year 2: 59%, 95% CI 45% to 69%; 4 trials, 194,969 participants; moderate-certainty evidence). These data included participants aged 2 to 55 years of age.The three-year cumulative efficacy of the vaccine may be around 55% (95% CI 30% to 70%; 11,384 participants, 1 trial; low-certainty evidence). These data came from a single trial conducted in South Africa in the 1980s in participants aged 5 to 15 years.Compared with placebo, this vaccine probably did not increase the incidence of fever (3 trials, 132,261 participants; moderate-certainty evidence) or erythema (3 trials, 132,261 participants; low-certainty evidence); however, swelling (3 trials, 1767 participants; moderate-certainty evidence) and pain at the injection site (1 trial, 667 participants; moderate-certainty evidence) were more common in the vaccine group.Vi-rEPA vaccine (two doses)Administration of two doses of the Vi-rEPA vaccine probably prevents between 50% and 96% of typhoid cases during the first two years after vaccination (year 1: 94%, 95% CI 75% to 99%; year 2: 87%, 95% CI 56% to 96%, 1 trial, 12,008 participants; moderate-certainty evidence). These data came from a single trial with children two to five years of age conducted in Vietnam.Compared with placebo, both the first and the second dose of this vaccine increased the risk of fever (1 trial, 12,008 and 11,091 participants, low-certainty evidence) and the second dose increase the incidence of swelling at the injection site (one trial, 11,091 participants, moderate-certainty evidence).Vi-TT vaccine (two doses)We are uncertain of the efficacy of administration of two doses of Vi-TT (PedaTyph) in typhoid cases in children during the first year after vaccination (year 1: 94%, 95% CI -1% to 100%, 1 trial, 1625 participants; very low-certainty evidence). These data come from a single cluster-randomized trial in children aged six months to 12 years and conducted in India. For single dose Vi-TT (Typbar-TCV), we found no efficacy trials evaluating the vaccine with natural exposure.There were no reported serious adverse effects in RCTs of any of the vaccines studied.
AUTHORS' CONCLUSIONS


The licensed Ty21a and Vi polysaccharide vaccines are efficacious in adults and children older than two years in endemic countries. The Vi-rEPA vaccine is just as efficacious, although data is only available for children. The new Vi-TT vaccine (PedaTyph) requires further evaluation to determine if it provides protection against typhoid fever. At the time of writing, there were only efficacy data from a human challenge setting in adults on the Vi-TT vaccine (Tybar), which clearly justify the ongoing field trials to evaluate vaccine efficacy.",2018,"Compared with placebo, this vaccine probably did not increase the incidence of fever (3 trials, 132,261 participants; moderate-certainty evidence) or erythema (3 trials, 132,261 participants; low-certainty evidence); however, swelling (3 trials, 1767 participants; moderate-certainty evidence) and pain at the injection site (1 trial, 667 participants; moderate-certainty evidence) were more common in the vaccine group.","['adults and children', 'South Africa in the 1980s in participants aged 5 to 15 years', 'adults aged over 55 years of age, pregnant women, or travellers', 'adults and children older than two years in endemic countries', 'children under two years of age', 'patients aged 3 to 44 years', 'children and adolescents in south-central and southeast Asia', 'participants aged 2 to 55 years of age', 'children two to five years of age conducted in Vietnam', 'children aged six months to 12 years and conducted in India']","['vaccines', 'TT vaccine (PedaTyph', 'Vi polysaccharide vaccine (injection, one dose)A single dose of Vi polysaccharide vaccine', 'placebo', 'polysaccharide vaccines', 'Vi-TT (PedaTyph', 'Ty21a (oral) and Vi polysaccharide (parenteral', 'vaccine', 'inactive agent (placebo or vaccine', 'Ty21a vaccine (oral vaccine', 'Vi-rEPA vaccine']","['calculated risk ratios (RRs) and efficacy', 'risk of fever', 'adverse events', 'headache, or rash', 'incidence of fever', 'vomiting, diarrhoea, nausea or abdominal pain', 'typhoid fever', 'incidence of swelling', 'typhoid fever, defined as isolation of Salmonella enterica serovar Typhi in blood']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003983', 'cui_str': 'Southeast Asia'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2713386', 'cui_str': 'Pedatyph'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0036125', 'cui_str': 'Salmonella typhosa'}, {'cui': 'C0005768'}]",1190.0,0.775767,"Compared with placebo, this vaccine probably did not increase the incidence of fever (3 trials, 132,261 participants; moderate-certainty evidence) or erythema (3 trials, 132,261 participants; low-certainty evidence); however, swelling (3 trials, 1767 participants; moderate-certainty evidence) and pain at the injection site (1 trial, 667 participants; moderate-certainty evidence) were more common in the vaccine group.","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Milligan', 'Affiliation': 'Cochrane Infectious Diseases Group, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK, L3 5QA.'}, {'ForeName': 'Mical', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Neuberger', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD001261.pub4']
1584,30226448,Breaking up sitting time after stroke (BUST-stroke).,"OBJECTIVES


People with stroke sit for long periods each day, which may compromise blood glucose control and increase risk of recurrent stroke. Studies in other populations have found regular activity breaks have a significant immediate (within-day) positive effect on glucose metabolism. We examined the effects of breaking up uninterrupted sitting with frequent, short bouts of light-intensity physical activity in people with stroke on post-prandial plasma glucose and insulin.
METHODS


Randomized within-participant crossover trial. We included people between 3 months and 10 years post-stroke, ambulant with minimal assistance and not taking diabetic medication other than metformin. The three experimental conditions (completed in random order) were: sitting for 8 h uninterrupted, sitting with 3 min bouts of light-intensity exercise while standing every 30 min, or sitting with 3 min of walking every 30 min. Meals were standardized and bloods were collected half- to one-hourly via an intravenous cannula.
RESULTS


A total of 19 participants (9 female, mean [SD] age 68.2 [10.2]) completed the trial. The majority ( n = 12, 63%) had mild stroke symptoms (National Institutes of Stroke Scale score 0-13). There was no significant effect of experimental condition on glucose (mean [SD] positive incremental area [+iAUC] mmol·L·h-1 under the curve during sitting 42.3 [29.5], standing 47.4 [23.1], walking 44.6 [26.5], p = 0.563) or insulin (mean + iAUC pmol·L·h-1 sitting 14,161 [7,560], standing 14,043 [8,312], walking 14,008 [8,269], p = 0.987).
CONCLUSION


Frequent, short bouts of light-intensity physical activity did not have a significant effect on post-prandial plasma glucose and insulin in this sample of people with stroke. Further studies are needed to identify strategies that improve inactivity-related glucose metabolism after stroke.",2018,"There was no significant effect of experimental condition on glucose (mean [SD] positive incremental area [+iAUC] mmol·L·h-1 under the curve during sitting 42.3 [29.5], standing 47.4 [23.1], walking 44.6 [26.5], p = 0.563) or insulin (mean + iAUC pmol·L·h-1 sitting 14,161 [7,560], standing 14,043 [8,312], walking 14,008 [8,269], p = 0.987).
","['people between 3 months and 10 years post-stroke, ambulant with minimal assistance and not taking diabetic medication other than', '19 participants (9 female, mean [SD] age 68.2 [10.2]) completed the trial', 'people with stroke on post-prandial plasma glucose and insulin']","['sitting for 8 h uninterrupted, sitting with 3 min bouts of light-intensity exercise while standing every 30 min, or sitting with 3 min of walking every 30 min', 'breaking up uninterrupted sitting with frequent, short bouts of light-intensity physical activity', 'metformin']","['mild stroke symptoms', 'experimental condition on glucose (mean [SD] positive incremental area [+iAUC] mmol·L·h-1', 'glucose metabolism']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",19.0,0.129218,"There was no significant effect of experimental condition on glucose (mean [SD] positive incremental area [+iAUC] mmol·L·h-1 under the curve during sitting 42.3 [29.5], standing 47.4 [23.1], walking 44.6 [26.5], p = 0.563) or insulin (mean + iAUC pmol·L·h-1 sitting 14,161 [7,560], standing 14,043 [8,312], walking 14,008 [8,269], p = 0.987).
","[{'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': '1 School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Janssen', 'Affiliation': '1 School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Crowfoot', 'Affiliation': '1 School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': '4 School of Biomedical Sciences and Pharmacy, and Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Ashlee', 'Initials': 'A', 'LastName': 'Dunn', 'Affiliation': '4 School of Biomedical Sciences and Pharmacy, and Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mackie', 'Affiliation': '1 School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': '5 Clinical Research Design, Information Technology and Statistical Support (CReDITSS), Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Lin K', 'Initials': 'LK', 'LastName': 'Ong', 'Affiliation': '2 Centre for Research Excellence in Stroke Recovery and Rehabilitation, Florey Institute of Neuroscience, Melboure, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': '5 Clinical Research Design, Information Technology and Statistical Support (CReDITSS), Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Patterson', 'Affiliation': '7 School of Health Sciences, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Spratt', 'Affiliation': '2 Centre for Research Excellence in Stroke Recovery and Rehabilitation, Florey Institute of Neuroscience, Melboure, Australia.'}, {'ForeName': 'F Rohan', 'Initials': 'FR', 'LastName': 'Walker', 'Affiliation': '2 Centre for Research Excellence in Stroke Recovery and Rehabilitation, Florey Institute of Neuroscience, Melboure, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bernhardt', 'Affiliation': '2 Centre for Research Excellence in Stroke Recovery and Rehabilitation, Florey Institute of Neuroscience, Melboure, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': '9 Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493018801222']
1585,29928755,Prophylactic abdominal drainage for pancreatic surgery.,"BACKGROUND


The use of surgical drains has been considered mandatory after pancreatic surgery. The role of prophylactic abdominal drainage to reduce postoperative complications after pancreatic surgery is controversial.
OBJECTIVES


To assess the benefits and harms of routine abdominal drainage after pancreatic surgery, compare the effects of different types of surgical drains, and evaluate the optimal time for drain removal.
SEARCH METHODS


For the last version of this review, we searched CENTRAL (2016, Issue 8), and MEDLINE, Embase, Science Citation Index Expanded, and Chinese Biomedical Literature Database (CBM) to 28 August 2016). For this updated review, we searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, and CBM from 2016 to 15 November 2017.
SELECTION CRITERIA


We included all randomized controlled trials that compared abdominal drainage versus no drainage in people undergoing pancreatic surgery. We also included randomized controlled studies that compared different types of drains and different schedules for drain removal in people undergoing pancreatic surgery.
DATA COLLECTION AND ANALYSIS


We identified six studies (1384 participants). Two review authors independently identified the studies for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CI). For all analyses, we used the random-effects model.
MAIN RESULTS


Drain use versus no drain useWe included four studies with 1110 participants, who were randomized to the drainage group (N = 560) and the no drainage group (N = 550) after pancreatic surgery. There was little or no difference in mortality at 30 days between groups (1.5% with drains versus 2.3% with no drains; RR 0.78, 95% CI 0.31 to 1.99; four studies, 1055 participants; moderate-quality evidence). Drain use probably slightly reduced mortality at 90 days (0.8% versus 4.2%; RR 0.23, 95% CI 0.06 to 0.90; two studies, 478 participants; moderate-quality evidence). We were uncertain whether drain use reduced intra-abdominal infection (7.9% versus 8.2%; RR 0.97, 95% CI 0.52 to 1.80; four studies, 1055 participants; very low-quality evidence), or additional radiological interventions for postoperative complications (10.9% versus 12.1%; RR 0.87, 95% CI 0.79 to 2.23; three studies, 660 participants; very low-quality evidence). Drain use may lead to similar amount of wound infection (9.8% versus 9.9%; RR 0.98 , 95% CI 0.68 to 1.41; four studies, 1055 participants; low-quality evidence), and additional open procedures for postoperative complications (9.4% versus 7.1%; RR 1.33, 95% CI 0.79 to 2.23; four studies, 1055 participants; low-quality evidence) when compared with no drain use. There was little or no difference in morbidity (61.7% versus 59.7%; RR 1.03, 95% CI 0.94 to 1.13; four studies, 1055 participants; moderate-quality evidence), or length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies, 711 participants; moderate-quality evidence) between groups. There was one drain-related complication in the drainage group (0.2%). Health-related quality of life was measured with the pancreas-specific quality-of-life questionnaire (FACT-PA; a scale of 0 to 144 with higher values indicating a better quality of life). Drain use may lead to similar quality of life scores, measured at 30 days after pancreatic surgery, when compared with no drain use (105 points versus 104 points; one study, 399 participants; low-quality evidence). Hospital costs and pain were not reported in any of the studies.Type of drainWe included one trial involving 160 participants, who were randomized to the active drain group (N = 82) and the passive drain group (N = 78) after pancreatic surgery. An active drain may lead to similar mortality at 30 days (1.2% with active drain versus 0% with passive drain; low-quality evidence), and morbidity (22.0% versus 32.1%; RR 0.68, 95% CI 0.41 to 1.15; low-quality evidence) when compared with a passive drain. We were uncertain whether an active drain decreased intra-abdominal infection (0% versus 2.6%; very low-quality evidence), wound infection (6.1% versus 9.0%; RR 0.68, 95% CI 0.23 to 2.05; very low-quality evidence), or the number of additional open procedures for postoperative complications (1.2% versus 7.7%; RR 0.16, 95% CI 0.02 to 1.29; very low-quality evidence). Active drain may reduce length of hospital stay slightly (MD -1.90 days, 95% CI -3.67 to -0.13; one study; low-quality evidence; 14.1% decrease of an 'average' length of hospital stay). Additional radiological interventions, pain, and quality of life were not reported in the study.Early versus late drain removalWe included one trial involving 114 participants with a low risk of postoperative pancreatic fistula, who were randomized to the early drain removal group (N = 57) and the late drain removal group (N = 57) after pancreatic surgery. There was no mortality in either group. Early drain removal may slightly reduce morbidity (38.6% with early drain removal versus 61.4% with late drain removal; RR 0.63, 95% CI 0.43 to 0.93; low-quality evidence), length of hospital stay (MD -2.10 days, 95% CI -4.17 to -0.03; low-quality evidence; 21.5% decrease of an 'average' length of hospital stay), and hospital costs (MD -EUR 2069.00, 95% CI -3872.26 to -265.74; low-quality evidence; 17.0% decrease of 'average' hospital costs). We were uncertain whether early drain removal reduced additional open procedures for postoperative complications (0% versus 1.8%; RR 0.33, 95% CI 0.01 to 8.01; one study; very low-quality evidence). Intra-abdominal infection, wound infection, additional radiological interventions, pain, and quality of life were not reported in the study.
AUTHORS' CONCLUSIONS


It was unclear whether routine abdominal drainage had any effect on the reduction of mortality at 30 days, or postoperative complications after pancreatic surgery. Moderate-quality evidence suggested that routine abdominal drainage probably slightly reduced mortality at 90 days. Low-quality evidence suggested that use of an active drain compared to the use of a passive drain may slightly reduce the length of hospital stay after pancreatic surgery, and early removal may be superior to late removal for people with low risk of postoperative pancreatic fistula.",2018,"There was little or no difference in morbidity (61.7% versus 59.7%; RR 1.03, 95% CI 0.94 to 1.13; four studies, 1055 participants; moderate-quality evidence), or length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies, 711 participants; moderate-quality evidence) between groups.","['160 participants', '2016 to 15 November 2017', '114 participants with a low risk of postoperative pancreatic fistula, who were randomized to the early drain removal group (N = 57) and the late drain removal group (N = 57) after pancreatic surgery', 'pancreatic surgery', 'Drain use versus no drain useWe included four studies with 1110 participants', 'people undergoing pancreatic surgery']","['Prophylactic abdominal drainage', 'abdominal drainage versus no drainage', 'active drain', 'prophylactic abdominal drainage', 'passive drain group (N = 78) after pancreatic surgery']","['Intra-abdominal infection, wound infection, additional radiological interventions, pain, and quality of life', 'postoperative complications', 'pain, and quality of life', 'drain-related complication', 'length of hospital stay', 'intra-abdominal infection', ""average' length of hospital stay), and hospital costs"", 'moderate-quality evidence), or length of hospital stay', 'Health-related quality of life', 'quality of life', 'Hospital costs and pain', 'mortality', 'morbidity', 'wound infection', 'risk ratio (RR']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1112209', 'cui_str': 'Intra-Abdominal Infections'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",114.0,0.317971,"There was little or no difference in morbidity (61.7% versus 59.7%; RR 1.03, 95% CI 0.94 to 1.13; four studies, 1055 participants; moderate-quality evidence), or length of hospital stay (MD -0.66 days, 95% CI -1.60 to 0.29; three studies, 711 participants; moderate-quality evidence) between groups.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatopancreatobiliary Surgery, The People's Hospital of Jianyang City, No. 180, Hospital Road, Jianyang, Sichuan, China, 641499.""}, {'ForeName': 'Sirong', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Nansheng', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Zuojin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010583.pub4']
1586,31615480,"HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol.","BACKGROUND


Hydroxyurea (HU) is recommended as standard practice for youth with sickle cell disease (SCD). Yet, despite its efficacy, HU adherence in adolescents and young adults is often poor. Poor medication adherence increases disease burden, healthcare cost and widens health disparities. Adolescence is a critical time to improve adherence through improved chronic disease self-management. This study aims to test the efficacy of an intervention delivered to youth/parent dyads by community health workers (CHWs), augmented by tailored text messages on HU adherence (primary outcome). Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
METHODS


Hydroxyurea Adherence for Personal Best in Sickle Cell Disease, ""HABIT,"" is a 12 month multi-center randomized controlled trial. One hundred four youth, 10 to 18 years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads, will be randomized 1:1 to either the HABIT intervention or to usual clinical care plus education handouts. All subjects will complete clinic visits at months 0, 2, 4, 6 (efficacy component), 9 and 12 (sustainability component) for assessment of HbF biomarker, other hematologic parameters, and to complete questionnaires. In addition, dyads assigned to the HABIT intervention will work with CHWs to identify a daily habit (e.g., brushing teeth) on which to build a HU adherence habit. Tailored daily text message reminders to support the habit will be developed by the dyad in collaboration with the CHWs and sent to parent and youth. At the 6 month visit, the intervention will end and the sustainability portion of the trial will begin. All data analyses will be based on intention to treat with all randomized subjects included in the analyses.
DISCUSSION


Prior retrospective studies demonstrate that a majority of adolescents are poorly adherent to HU. If efficacious, the HABIT intervention has the potential to improve the lives of youth with SCD.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03462511 . Registered March 6, 2018, last updated July 26, 2019.",2019,"Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
","['One hundred four youth, 10 to 18\u2009years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads', 'adolescents and young adults', 'youth with sickle cell disease (SCD', 'youth with sickle cell disease']","['Hydroxyurea (HU', 'HABIT intervention or to usual clinical care plus education handouts', 'HABIT intervention', 'intervention delivered to youth/parent dyads by community health workers (CHWs', 'hydroxyurea adherence']","['HABIT efficacy', 'disease burden, healthcare cost and widens health disparities', 'intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",104.0,0.0982274,"Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.
","[{'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Smaldone', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA. ams130@columbia.edu.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Manwani', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Aygun', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': 'Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Findley', 'Affiliation': 'Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Massei', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Green', 'Affiliation': 'Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}]",BMC pediatrics,['10.1186/s12887-019-1746-6']
1587,31619187,"A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis.","BACKGROUND


Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor currently being investigated as a treatment for anemia of chronic kidney disease (CKD) in both dialysis and nondialysis patients. In clinical studies to date, daprodustat has been administered orally as a once-daily regimen. This randomized, double-blind, placebo-controlled study characterized the initial dose-hemoglobin response as well as the efficacy and safety of three times weekly (TIW) daprodustat in hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule.
METHODS


103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5 g/dL and previously receiving a stable dose of rhEPO or its analogs were randomized 1:1:1:1:1 to receive daprodustat 10, 15, 25, or 30 mg or placebo TIW over 29 days.
RESULTS


Mean baseline hemoglobin was 10.6 g/dL for the placebo group and each daprodustat cohort. Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29. Using a Bayesian approach, the estimated dose conversion ratio between once-daily and TIW daprodustat was ~ 2.0 across the evaluated dose range using an E max  model. Daprodustat was generally well tolerated, with an adverse event (AE) profile consistent with the hemodialysis population.
CONCLUSIONS


These data help inform the appropriate dose conversion ratio to be applied to daily doses to obtain equivalent daprodustat TIW doses and suggest TIW treatment with daprodustat can treat anemia of CKD safely, supporting future long-term studies for this indication using a TIW dosing regimen.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02689206 ; date registered: 02/11/2016.",2019,Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29.,"['patients with anemia on hemodialysis', 'hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule', '103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5\u2009g/dL and previously receiving a stable dose of rhEPO or its analogs']","['placebo', 'placebo TIW']","['efficacy and safety', 'mean hemoglobin', 'Mean baseline hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",103.0,0.127547,Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29.,"[{'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Bailey', 'Affiliation': 'R&D, Clinical Sciences, GlaxoSmithKline, 1250 S. Collegeville Road, Mail Code UP 4200, Collegeville, PA, 19426, USA. christine.k.bailey@gsk.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caltabiano', 'Affiliation': 'R&D, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Cobitz', 'Affiliation': 'R&D, Clinical Sciences, GlaxoSmithKline, 1250 S. Collegeville Road, Mail Code UP 4200, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'R&D, Clinical Statistics, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Mahar', 'Affiliation': 'R&D, Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Vickas V', 'Initials': 'VV', 'LastName': 'Patel', 'Affiliation': 'R&D, Discovery Medicine, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.'}]",BMC nephrology,['10.1186/s12882-019-1547-z']
1588,29570173,Gastric Emptying of Elemental Liquid Diets Versus Semisolid Diets in Bedridden Gastrostomy-fed Patients.,"BACKGROUND


Aspiration is a common problem in bedridden gastrostomy-fed patients. We compared gastric emptying of an elemental liquid diet and a commercial semisolid diet in bedridden gastrostomy-fed patients.
METHODS


Study 1: from January 2013 to December 2016, consecutive bedridden patients receiving percutaneous endoscopic gastrostomy (PEG) semisolid feeding hospitalized due to aspiration pneumonia were switched to elemental liquid diet feedings. The frequency of defecation, tube feed contents aspirated from the trachea, and aspiration pneumonia during hospitalization were retrospectively reviewed. Study 2 was a randomized, crossover trial comparing C sodium acetate gastric emptying of a commercial elemental liquid or a commercial semisolid diet in bedridden PEG patients and controls.
RESULTS


Study 1: 18 patients were enrolled. Elemental liquid diet was aspirated from the trachea in 1 (5.6%) (once in 24 observations); neither aspiration pneumonia nor diarrhea developed during elemental liquid diet feeding over 2 weeks observation. Study 2: 8 PEG patients and 8 healthy subjects were separately randomized to assess gastric emptying of the commercial elemental and semisolid diets. The elemental liquid diet was associated with a significant decrease of the 10%, 30%, or 50% emptying (excretion) time (P<0.05) and an increased the area under the curve (% dose/h) compared with the commercial semisolid diet (P<0.05). In healthy subjects there was no significant difference in gastric empting between the 2 diets.
CONCLUSIONS


Elemental liquid diets emptied more rapidly from the stomach than semisolid diets in bedridden PEG patients. They may prevent or reduce aspiration pneumonia compared with semisolid diets.",2019,"The elemental liquid diet was associated with a significant decrease of the 10%, 30%, or 50% emptying (excretion) time (P<0.05) and an increased the area under the curve (% dose/h) compared with the commercial semisolid diet (P<0.05).","['bedridden PEG patients and controls', 'healthy subjects', 'bedridden PEG patients', 'Bedridden Gastrostomy-fed Patients', 'feeding hospitalized due to aspiration pneumonia', 'Study 2: 8 PEG patients and 8 healthy subjects', 'Study 1: 18 patients were enrolled', 'Study 1: from January 2013 to December 2016, consecutive bedridden patients receiving', 'bedridden gastrostomy-fed patients']","['Elemental Liquid Diets Versus Semisolid Diets', 'C sodium acetate gastric emptying of a commercial elemental liquid or a commercial semisolid diet', 'percutaneous endoscopic gastrostomy (PEG) semisolid', 'elemental liquid diet and a commercial semisolid diet']","['gastric empting', 'aspiration pneumonia nor diarrhea', 'gastric emptying', 'emptying (excretion) time']","[{'cui': 'C0741453', 'cui_str': 'Bedridden'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4321409', 'cui_str': 'Person, Non-Mobile'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0301569', 'cui_str': 'Soft food diet'}, {'cui': 'C0142785', 'cui_str': 'Sodium Acetate'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0219152,"The elemental liquid diet was associated with a significant decrease of the 10%, 30%, or 50% emptying (excretion) time (P<0.05) and an increased the area under the curve (% dose/h) compared with the commercial semisolid diet (P<0.05).","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Horiuchi', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Ryosei', 'Initials': 'R', 'LastName': 'Sakai', 'Affiliation': 'Institute for Innovation, Ajinomoto Co. Inc., Kawasaki, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Tamaki', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kajiyama', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Morikawa', 'Affiliation': 'Department of Surgery, Showa Inan General Hospital, Komagane.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001028']
1589,31538590,Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial.,"STUDY OBJECTIVES


This secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children's caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect.
METHODS


Omega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted.
RESULTS


Eighty-one percent (n tx  = 156; n placebo  = 150) of children had 180-day trial outcome data; 68% (n tx  = 134; n placebo  = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo.
CONCLUSIONS


Although there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01576783.
CITATION


Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197-1208.",2019,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","['Male children', 'toddlers born preterm', 'Toddlers Born Preterm', ""Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation"", ""children's caregiver-reported sleep"", 'Eighty-one percent (n tx  = 156; n']","['DHA+AA supplementation', 'docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation', 'Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep', 'placebo', 'DHA + 200 mg AA supplementation or placebo', 'Docosahexaenoic acid and arachidonic acid supplementation']","['total sleep change', ""sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire"", 'child sex, birth weight, and caregiver depressive symptomatology']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.812072,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Pelak', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7902']
1590,31538598,Eye-Blink Parameters Detect On-Road Track-Driving Impairment Following Severe Sleep Deprivation.,"STUDY OBJECTIVES


Drowsiness leads to 20% of fatal road crashes, while inability to assess drowsiness has hampered drowsiness interventions. This study examined the accuracy of eye-blink parameters for detecting drowsiness related driving impairment in real time.
METHODS


Twelve participants undertook two sessions of 2-hour track-driving in an instrumented vehicle following a normal night's sleep or 32 to 34 hours of extended wake in a randomized crossover design. Eye-blink parameters and lane excursion events were monitored continuously.
RESULTS


Sleep deprivation increased the rates of out-of-lane driving events and early drive terminations. Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score) were also increased following sleep deprivation. A time-on-task (drive duration) effect was evident for out-of-lane events rate and most eye-blink parameters after sleep deprivation. The JDS demonstrated the strongest association with the odds of out-of-lane events in the same minute, whereas measures of blink duration and prolonged eye closure were stronger indicators of risk for out-of-lane events over longer periods of 5 minutes and 15 minutes, respectively. Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
CONCLUSIONS


Eyelid closure parameters are useful tools for monitoring and predicting drowsiness-related driving impairment (out-of-lane events) that could be utilized for monitoring drowsiness and assessing the efficacy of drowsiness interventions.
CLINICAL TRIAL REGISTRATION


This study is registered with the Australian New Zealand Clinical Trial Registry (ANCTR), http://www.anzctr.org.au/TrialSearch.aspx ACTRN12612000102875.
CITATION


Shekari Soleimanloo S, Wilkinson VE, Cori JM,Westlake J, Stevens B, Downey LA, Shiferaw BA, Rajaratnam SMW, Howard ME. Eye-blink parameters detect on-road track-driving impairment following severe sleep deprivation. J Clin Sleep Med. 2019;15(9):1271-1284.",2019,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
",['severe sleep deprivation'],"[""2-hour track-driving in an instrumented vehicle following a normal night's sleep""]","['rates of out-of-lane driving events and early drive terminations', 'blink duration and prolonged eye closure', 'A time-on-task (drive duration) effect', 'Eye-blink parameters and lane excursion events', 'Eye-Blink Parameters Detect', ""Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}]","[{'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1269837', 'cui_str': 'Surgical closure of eye structure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1293738', 'cui_str': 'Eyelid closure'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",12.0,0.019793,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
","[{'ForeName': 'Shamsi', 'Initials': 'S', 'LastName': 'Shekari Soleimanloo', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Wilkinson', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cori', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Westlake', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stevens', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Brook A', 'Initials': 'BA', 'LastName': 'Shiferaw', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences, Monash University, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7918']
1591,31267293,Effectiveness of a School Based Smokeless Tobacco Intervention: A Cluster Randomized Trial.,"To assess the effectiveness of intervention in improving knowledge, attitude and perception regarding smokeless tobacco (SLT) use and its harmful effects and intention to quit SLT among school going adolescents. A school-based cluster randomized control trial was carried out in 18 secondary schools targeting male and female students from grades 6 to 10 in Karachi. Primary outcome was knowledge about hazards of smokeless tobacco (SLT) and secondary outcomes were attitude and Perception about hazards of SLT, and intention to quit SLT. We enrolled 738 participants in intervention group and 589 in the control group. Mean score of knowledge significantly improved in intervention as compared to control group (P value < 0.01). Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group. Generalized estimating equations were used to assess the association of factors with knowledge regarding harmful effects of SLT use. Significant predictors of increase in knowledge score were found in children: who had seen any anti SLT messages on social media in the past 30 days, who were getting information regarding harmful effects of SLT use in school or textbooks and who had friends using SLT. A school-based intervention was effective in increasing knowledge regarding the harmful effects of SLT use and intention to quit SLT use among school adolescents. Introduction of such educational programmes on a regular basis in schools or as part of school curriculum can have an impact on reducing prevalence of SLT use.Trial Registration NCT03418506. https://register.clinicaltrials.gov/NCT03418506 .",2019,Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group.,"['school going adolescents', '738 participants in intervention group and 589 in the control group', '18 secondary schools targeting male and female students from grades 6 to 10 in Karachi']",['School Based Smokeless Tobacco Intervention'],"['knowledge about hazards of smokeless tobacco (SLT) and secondary outcomes were attitude and Perception about hazards of SLT, and intention to quit SLT', 'Mean score of knowledge', 'knowledge score', 'Intention to quit']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",738.0,0.0593552,Intention to quit was found to be proportionately higher (33%) in the intervention group as compared to control group.,"[{'ForeName': 'Shafquat', 'Initials': 'S', 'LastName': 'Rozi', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan. shafquat.rozi@aku.edu.'}, {'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Zahid', 'Affiliation': 'Department of Surgery, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.'}, {'ForeName': 'Talat', 'Initials': 'T', 'LastName': 'Roome', 'Affiliation': 'Department of Pathology, Dow University of Health Sciences, University Road, Karachi, 75270, Pakistan.'}, {'ForeName': 'Maryam Pyar Ali', 'Initials': 'MPA', 'LastName': 'Lakhdir', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.'}, {'ForeName': 'Sobiya', 'Initials': 'S', 'LastName': 'Sawani', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Razzak', 'Affiliation': 'Department of Pathology, Dow University of Health Sciences, University Road, Karachi, 75270, Pakistan.'}, {'ForeName': 'Zahid Ahmad', 'Initials': 'ZA', 'LastName': 'Butt', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, V6T 1Z4, Canada.'}]",Journal of community health,['10.1007/s10900-019-00689-8']
1592,29685711,"Letter to the Editor on ""Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial"".",,2018,,['After Total Knee Arthroplasty'],['Liposomal Bupivacaine'],['Pain Scores and Reduces Opioid Use'],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.115436,,"[{'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Shafer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, California.'}]",The Journal of arthroplasty,['10.1016/j.arth.2018.03.032']
1593,31077026,Improvement in Food Intolerance Resulting from Roux-En-Y Gastric Bypass after Speech Therapy Intervention in Chewing.,"INTRODUCTION


Food intolerance is expected during the postoperative period following gastric bypass and may be associated with inadequate chewing.
OBJECTIVE


To evaluate chewing before and after speech therapy intervention in subjects undergoing Roux-en-Y gastric bypass who present with food intolerance.
MATERIALS AND METHODS


This was a randomized controlled trial, approved by the Brazilian Ethics and Research Committee under n. 438,600. The study population was allocated into two groups: the study group (SG), who received speech therapy intervention, and the control group (CG), who did not receive any intervention, in six visits at 7, 15, 30, 60, and 90 days (v7, v15, v30, v60, and v90) after the initial visit (v0). During v0 and v90, a chewing evaluation was performed according to the MBGR protocol adapted. The significance level adopted was 5%.
RESULTS


A total of 30 females (88%) and 4 males (12%) were analyzed. The SG had 18 subjects, and the CG had 16, with mean ages of 50.17 ± 12.28 years and 45.69 ± 9.78 years, respectively. The postoperative time ranged from 4 to19 months. In the SG, a marked improvement in the number of episodes of food intolerance was observed (p < 0.001), an improvement in the intake of cereals and meats (p = 0.004 and p < 0.001, respectively), and an improvement in chewing capacity and swallowing (p = 0.002 and p = 0.011, respectively).
CONCLUSION


Speech therapy intervention in chewing led to a marked improvement of food acceptance and food intolerance resulting from Roux-en-Y gastric bypass.",2019,"In the SG, a marked improvement in the number of episodes of food intolerance was observed (p < 0.001), an improvement in the intake of cereals and meats (p = 0.004 and p < 0.001, respectively), and an improvement in chewing capacity and swallowing (p = 0.002 and p = 0.011, respectively).
","['A total of 30 females (88%) and 4 males (12%) were analyzed', 'subjects undergoing Roux-en-Y gastric bypass who present with food intolerance', '18 subjects, and the CG had 16, with mean ages of 50.17\u2009±\u200912.28\xa0years and 45.69\u2009±']","['Speech therapy intervention', 'speech therapy intervention, and the control group (CG), who did not receive any intervention', 'speech therapy intervention']","['intake of cereals and meats', 'food acceptance and food intolerance', 'postoperative time', 'chewing capacity and swallowing', 'Food Intolerance', 'number of episodes of food intolerance']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0149696', 'cui_str': 'Food, Sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0149696', 'cui_str': 'Food, Sensitivity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",,0.0193409,"In the SG, a marked improvement in the number of episodes of food intolerance was observed (p < 0.001), an improvement in the intake of cereals and meats (p = 0.004 and p < 0.001, respectively), and an improvement in chewing capacity and swallowing (p = 0.002 and p = 0.011, respectively).
","[{'ForeName': 'Débora Cardoso', 'Initials': 'DC', 'LastName': 'Rossi', 'Affiliation': 'Institute of Education and Research Santa Casa de Misericórdia de Belo Horizonte, Domingos Vieira, 590, Belo Horizonte, MG, CEP 30150240, Brazil. deborarossi@terra.com.br.'}, {'ForeName': 'Aleida Nazareth', 'Initials': 'AN', 'LastName': 'Soares', 'Affiliation': 'IEP Santa Casa BH, Belo Horizonte, Brazil.'}, {'ForeName': 'Kennedy Rossi Santos', 'Initials': 'KRS', 'LastName': 'Silva', 'Affiliation': 'Federal University of Minas Gerais (UFMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Ana Teresa B O', 'Initials': 'ATBO', 'LastName': 'Britto', 'Affiliation': 'Pontifical Catholic University of Minas Gerais (PUCMG), Belo Horizonte, Brazil.'}, {'ForeName': 'Adriana Aparecida', 'Initials': 'AA', 'LastName': 'Bosco', 'Affiliation': 'IEP Santa Casa BH, Belo Horizonte, Brazil.'}]",Obesity surgery,['10.1007/s11695-019-03931-3']
1594,31852811,"Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204).","BACKGROUND


The addition of bevacizumab to chemotherapy improved outcomes for patients with metastatic colon cancer. E5204 was designed to test whether the addition of bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery, could improve overall survival (OS) in patients with stage II/III adenocarcinoma of the rectum.
SUBJECTS, MATERIALS, AND METHODS


Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled. Patients were randomized to mFOLFOX6 (Arm A) or mFOLFOX6 with bevacizumab (Arm B) administered every 2 weeks for 12 cycles.
RESULTS


E5204 registered only 355 patients (17% of planned accrual goal) as it was terminated prematurely owing to poor accrual. At a median follow-up of 72 months, there was no difference in 5-year overall survival (88.3% vs. 83.7%) or 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%, p = .029).The most common grade 3-4 treatment-related AEs were neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue.
CONCLUSION


At 17% of its planned accrual, E5204 did not meet its primary endpoint. The addition of bevacizumab to FOLFOX6 in the adjuvant setting did not significantly improve OS in patients with stage II/III rectal cancer.
IMPLICATIONS FOR PRACTICE


At 17% of its planned accrual, E5204 was terminated early owing to poor accrual. At a median follow-up of 72 months, there was no significant difference in 5-year overall survival (88.3% vs. 83.7%) or in 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. Despite significant advances in the treatment of rectal cancer, especially in improving local control rates, the risk of distant metastases and the need to further improve quality of life remain a challenge. Strategies combining novel agents with chemoradiation to improve both distant and local control are needed.",2020,"The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%,  ","['patients with stage II/III rectal cancer', 'patients with stage II/III adenocarcinoma of the rectum', 'patients with metastatic colon cancer', 'Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled', 'Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation']","['bevacizumab', 'mFOLFOX6', 'Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab', 'bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery', 'mFOLFOX6 with bevacizumab']","['rate of treatment-related grade ≥\u20093 adverse events (AEs', 'OS', '5-year disease-free survival', 'overall survival (OS', 'neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0278484', 'cui_str': 'Colon cancer Dukes D'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",355.0,0.170331,"The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%,  ","[{'ForeName': 'A Bapsi', 'Initials': 'AB', 'LastName': 'Chakravarthy', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Meropol', 'Affiliation': 'Flatiron Health, New York, New York, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'Abbott-Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston Salem, North Carolina, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Diasio', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Giantonio', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Catalano', 'Affiliation': 'Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Haller', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Rashid A', 'Initials': 'RA', 'LastName': 'Awan', 'Affiliation': 'University of Pittsburgh Cancer Institute (UPCI), Johnstown, Pennsylvania, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Mulcahy', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Santala', 'Affiliation': 'Montana Cancer Consortium, Billings, Montana, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cripps', 'Affiliation': 'Ottawa Health Research Institute-General Division, Ottawa, Ontario, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weis', 'Affiliation': 'Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'Southeast Cancer Control Consortium, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Cynthia G', 'Initials': 'CG', 'LastName': 'Leichman', 'Affiliation': 'Laura and Issac Perlmutter Cancer Center at NYU Langone, New York, New York, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrelli', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, Delaware, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brierley', 'Affiliation': 'University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Tepper', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0437']
1595,31483544,Use of Guanfacine for Cannabis Use Disorder and Related Symptomology.,"BACKGROUND AND OBJECTIVES


No medication has Food and Drug Administration approval for cannabis use disorder (CUD), and most medication development focuses on the withdrawal syndrome. We evaluated the effects of short-term treatment using the α-2A-adrenergic receptor agonist, guanfacine, on withdrawal symptoms in volunteers with CUD and a history of early onset of cannabis use.
METHODS


Non-treatment-seeking healthy volunteers (n = 7) who met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria for CUD participated in a two-phase, within-subjects study. Volunteers received placebo or guanfacine (3 mg/day) for the first 8-day inpatient study and the alternative medication for the second 8-day inpatient study. On day 1 of both treatment periods, participants received 30 mg of synthetic Δ 9  -tetrahydrocannabinol for standardization of abstinence onset. On days 2 to 7, participants received study medication. Cannabis withdrawal symptoms, sleep, craving, and physiology were assessed on all inpatient days.
RESULTS


Compared with placebo, guanfacine did not show significant effects on withdrawal, craving, or sleep, although there were trends for guanfacine to increase positive mood symptoms and decrease craving-associated compulsivity.
DISCUSSION AND CONCLUSIONS


Compared with former studies, we could not prove significant improvement in sleep or decrease of negative symptoms, but we found trends for increased positive mood symptoms. Our data did not show significant effects of guanfacine on withdrawal symptoms or craving. Due to early and longer cannabis use, our subjects indicate a great severity of illness increasing the likelihood of treatment resistance.
SCIENTIFIC SIGNIFICANCE


On the basis of trends demonstrated here and other lines of evidence, further investigation is warranted regarding the utility of guanfacine as a potential treatment for CUD. (Am J Addict 2019;00:1-10).",2019,"Compared with placebo, guanfacine did not show significant effects on withdrawal, craving, or sleep, although there were trends for guanfacine to increase positive mood symptoms and decrease craving-associated compulsivity.
","['Non-treatment-seeking healthy volunteers (n\u2009=\u20097) who met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria for CUD participated in a two-phase, within-subjects study', 'volunteers with CUD and a history of early onset of cannabis use']","['placebo or guanfacine', 'placebo, guanfacine', '30\u2009mg of synthetic Δ 9  -tetrahydrocannabinol', 'guanfacine', 'Guanfacine', 'α-2A-adrenergic receptor agonist, guanfacine']","['positive mood symptoms', 'Cannabis withdrawal symptoms, sleep, craving, and physiology', 'positive mood symptoms and decrease craving-associated compulsivity', 'withdrawal symptoms or craving', 'withdrawal, craving, or sleep', 'negative symptoms']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C4521957', 'cui_str': 'Adrenergic receptor agonist (disposition)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal (disorder)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.0396674,"Compared with placebo, guanfacine did not show significant effects on withdrawal, craving, or sleep, although there were trends for guanfacine to increase positive mood symptoms and decrease craving-associated compulsivity.
","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Holst', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Mathai', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Marguerite M', 'Initials': 'MM', 'LastName': 'Patel', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rodgman', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Mariyah Z', 'Initials': 'MZ', 'LastName': 'Hussain', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'De La Garza', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Verrico', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Michael E. DeBakey VA Medical Center & Baylor College of Medicine, Houston, Texas.'}]",The American journal on addictions,['10.1111/ajad.12959']
1596,31271934,Bone geometry and trabecular bone score in transgender people before and after short- and long-term hormonal treatment.,"BACKGROUND


Gender-affirming hormonal treatment (HT) in adult transgender people influences bone mineral density (BMD). Besides BMD, bone geometry and trabecular bone score are associated with fracture risk. However, it is not known whether bone geometry and TBS changes during HT.
PURPOSE


To investigate the bone geometry and TBS in adult transgender people at different time points, up to 25 years, of HT.
METHODS


A total of 535 trans women and 473 trans men were included, who were divided into three groups at time of their DXA: 20-29 years, 30-39 years, and 40-59 years. Subsequently, each group was divided into different HT durations: baseline, or after 5, 15, or 25 years of HT. Hip structure analysis was performed to measure subperiosteal width, endocortical diameter, average cortical thickness, and section modulus. TBS was calculated based on lumbar spine DXA images.
RESULTS


In trans women in all age groups and in young trans men, no differences were observed in periosteal width, endocortical diameter, average cortical thickness, and section modulus for different durations of HT. In trans men aged 40-59 years, subperiosteal width, endocortical diameter, and section modulus were slightly higher in the groups who were using HT compared to the (peri- or postmenopausal) baseline group. In younger trans women, TBS tended to be higher in those using HT compared to the baseline groups, and in older trans women TBS was higher in those using HT for 25 years versus baseline (+0.04, 95%CI +0.00; +0.08). In younger trans men, TBS tended to be lower in those who used HT compared to the baseline groups, and in older trans men TBS was lower in those using 5 years HT versus baseline (-0.05, 95%CI -0.08; -0.01).
CONCLUSION


No differences in cortical bone geometry parameters were found during different HT-durations. TBS increased in trans women and decreased in trans men, indicating that estrogens have positive effects on TBS. These data may be helpful in determining what sex reference values for calculating T-scores and Z-scores in adult transgender people should be used.",2019,"In trans women in all age groups and in young trans men, no differences were observed in periosteal width, endocortical diameter, average cortical thickness, and section modulus for different durations of HT.","['In trans men aged 40-59\u202fyears, subperiosteal width, endocortical diameter, and section modulus were slightly higher in the groups who were using HT compared to the (peri- or postmenopausal) baseline group', '535 trans women and 473 trans men were included, who were divided into three groups at time of their DXA: 20-29\u202fyears, 30-39\u202fyears, and 40-59\u202fyears']",['Gender-affirming hormonal treatment (HT'],"['older trans women TBS', 'subperiosteal width, endocortical diameter, average cortical thickness, and section modulus', 'periosteal width, endocortical diameter, average cortical thickness, and section modulus for different durations of HT', 'Bone geometry and trabecular bone score', 'cortical bone geometry parameters', 'TBS', 'bone mineral density (BMD', 'BMD, bone geometry and trabecular bone score']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0442033', 'cui_str': 'Periosteal (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",535.0,0.0497678,"In trans women in all age groups and in young trans men, no differences were observed in periosteal width, endocortical diameter, average cortical thickness, and section modulus for different durations of HT.","[{'ForeName': 'Chantal M', 'Initials': 'CM', 'LastName': 'Wiepjes', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Center of Expertise on Gender Dysphoria, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska C', 'Initials': 'MC', 'LastName': 'Vlot', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Christel J M', 'Initials': 'CJM', 'LastName': 'de Blok', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Center of Expertise on Gender Dysphoria, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'Nota', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Center of Expertise on Gender Dysphoria, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Renate T', 'Initials': 'RT', 'LastName': 'de Jongh', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'den Heijer', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands; Center of Expertise on Gender Dysphoria, Amsterdam UMC, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Electronic address: m.denheijer@amsterdamumc.nl.'}]",Bone,['10.1016/j.bone.2019.06.029']
1597,31402384,Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is the leading cause of infant lower respiratory tract disease and hospitalization worldwide.
METHODS


Safety and immunogenicity of RSV fusion (F) protein nanoparticle vaccine or placebo were evaluated in 50 healthy third-trimester pregnant women. Assessments included vaccine tolerability and safety in women and infants, and RSV-specific antibody measures in women before and after vaccination, at delivery and post partum.
RESULTS


The vaccine was well tolerated; no meaningful differences in pregnancy or infant outcomes were observed between study groups. RSV-specific antibody levels increased significantly among vaccine recipients, including responses competitive with well-described monoclonal antibodies specific for multiple RSV neutralizing epitopes. No significant antibody increase was seen among placebo recipients, although a shallow upward trend across the RSV season was noted. Transplacental antibody transfer was 90%-120% across assays for infants of vaccinated women. Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days. Half-lives of RSV-specific antibodies in infants approximated 40 days. There was no evidence of severe RSV disease in infants of vaccinated mothers.
CONCLUSIONS


Data from this phase 2 study support a maternal immunization strategy to protect infants from RSV disease.
CLINICAL TRIALS REGISTRATION


NCT02247726.",2019,Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days.,"['Healthy Third-Trimester Pregnant Women and Their Infants', '50 healthy third-trimester pregnant women', 'infants of vaccinated women', 'women and infants, and RSV-specific antibody measures in women before and after vaccination, at delivery and postpartum']","['RSV fusion (F) protein nanoparticle vaccine or placebo', 'Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine']","['vaccine tolerability and safety', 'RSV season', 'Transplacental antibody transfer', 'RSV-specific antibody levels', 'severe RSV disease', 'placental antibody transfer rates', 'Safety and Immunogenicity']","[{'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein product'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1277793', 'cui_str': 'Specific antibody measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",50.0,0.298342,Women with an interval of ≥30 days between vaccination and delivery demonstrated higher placental antibody transfer rates than women with an interval <30 days.,"[{'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Muňoz', 'Affiliation': 'Baylor College of Medicine, Houston Texas.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Somia P', 'Initials': 'SP', 'LastName': 'Hickman', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Sapeckshita', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Piedra', 'Affiliation': 'Baylor College of Medicine, Houston Texas.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Glenn', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'August', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fries', 'Affiliation': 'Novavax, Inc., Gaithersburg, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz390']
1598,31596213,Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA.
METHODS


In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective.
RESULTS


In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
CONCLUSIONS


CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01588275.",2019,"However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
","['patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h', 'moderate obstructive sleep apnea (OSA', 'Moderate Obstructive Sleep Apnea']","['MAD or CPAP', 'Mandibular Advancement Device Versus Continuous Positive Airway Pressure', 'MAD therapy with CPAP therapy', 'mandibular advancement device (MAD', 'CPAP', 'continuous positive airway pressure (CPAP) therapy']","['Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR', 'Societal costs', 'AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire', 'costs per QALY', 'AHI reduction', 'AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",85.0,0.0515504,"However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained).
","[{'ForeName': 'Grietje E', 'Initials': 'GE', 'LastName': 'de Vries', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Aarnoud', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Johannes Q P J', 'Initials': 'JQPJ', 'LastName': 'Claessen', 'Affiliation': 'Department of Ear Nose and Throat surgery, Martini Hospital Groningen, The Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pulmonary Diseases, Martini Hospital Groningen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Maten', 'Affiliation': 'Department of Pulmonary Diseases, Medical Center Leeuwarden, The Netherlands.'}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Clinical Neurophysiology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Stegenga', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, The Netherlands.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7980']
1599,31538599,Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep?,"STUDY OBJECTIVES


The safety profile of the dual orexin receptor antagonists (DORAs) are currently unknown with regard to nocturnal responsivity among people with insomnia. We compared the auditory awakening thresholds (AATs) of the DORA suvorexant (10 and 20 mg) versus placebo in 12 individuals with DSM-5 insomnia.
METHODS


The study used a double-blind, placebo-controlled, three-way crossover design. Participants were randomly assigned to a treatment sequence that included placebo, suvorexant 10 mg, and suvorexant 20 mg. At the time of maximum drug concentration, auditory tones were played during stable stage N2 sleep. Tones increased by 5-decibel (db) increments until the participant awakened. The db at awakening was recorded as the AAT and compared between conditions. The proportion of awakenings higher than 85 db was also compared between conditions. Finally, sensitivity analyses were also conducted using surrounding thresholds (80 db and 90 db).
RESULTS


The mean AAT did not differ significantly between either dose of suvorexant compared to placebo. Moreover, the proportions of individuals who remained asleep at the AAT 85 db cutoff did not differ across conditions. In addition, wake after sleep onset decreased and total sleep time increased in the suvorexant 20 mg condition compared to placebo.
CONCLUSIONS


Suvorexant (10 and 20 mg) preserved the ability to respond to nocturnal stimuli, whereas the 20-mg dose improved the sleep of people with insomnia. This suggests that DORAs such as suvorexant can effectively treat insomnia while allowing patients to awaken to nocturnal stimuli in the environment.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs; Identifier NCT03312517; URL: https://clinicaltrials.gov/ct2/show/NCT03312517.
CITATION


Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, SinghM, Tonnu CV, Fellman-Couture C. Can the orexin antagonist suvorexant preserve the ability to awaken to auditory stimuli while improving sleep? J Clin Sleep Med. 2019;15(9):1285-1291.",2019,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"['people with insomnia', '12 individuals with DSM-5 insomnia', 'Non-elderly Insomniacs']","['auditory awakening thresholds (AATs) of the DORA suvorexant', 'Belsomra 10 mg and 20 mg to Placebo', 'placebo, suvorexant 10 mg, and suvorexant 20 mg', 'placebo', 'dual orexin receptor antagonists (DORAs']","['total sleep time', 'mean AAT', 'sleep of people with insomnia', 'proportion of awakenings higher', 'Ability to Awaken to Auditory Stimuli']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C3854974', 'cui_str': 'Belsomra'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3854969', 'cui_str': 'suvorexant 10 MG'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}]",,0.0638037,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Kieulinh Michelle', 'Initials': 'KM', 'LastName': 'Tran', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christine V', 'Initials': 'CV', 'LastName': 'Tonnu', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7920']
1600,31538602,CPAP and Health-Related Quality of Life in Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial.,"STUDY OBJECTIVES


To determine the effect of continuous positive airway pressure (CPAP) treatment on health-related quality of life (HRQoL) in adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA).
METHODS


This was a secondary outcome analysis of the RICCADSA trial, conducted in Sweden between 2005 and 2013. Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI] ≥ 15 events/h; Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires at baseline and after 12 months were included. Patients were randomized to CPAP (n = 102) or no CPAP (n = 104). The primary outcome was the between-group difference in absolute change in the SF-36 components. Within-group changes as well as variables associated with absolute change in the domains in the entire population were also tested.
RESULTS


Mean SF-36 scores were similar at baseline, ranging from 44.9 ± 9.6 to 92.2 ± 15.8 in various domains, and between-group changes from baseline were not statistically significant at 1 year. There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group. The change in Physical Component Summary (PCS) was determined by female sex (beta coefficient -0.19, 95% confidence interval [CI] -7.25 to -0.98, P = .010), baseline AHI (beta coefficient -0.19, 95% CI -0.21 to -0.03, P = .009), CPAP use (h/night) (beta coefficient -0.16, 95% CI -0.93 to -0.06, P = .028), and acute myocardial infarction at baseline (beta coefficient 0.18, 95% CI 0.59 to 5.19, P = .014). Determinants of the change in MCS from baseline were change in the ESS score (beta coefficient -0.14, 95% CI -0.87 to -0.01, P = .054) and change in the Zung Self-rated Depression Scale scores (beta coefficient -0.33, 95% CI -0.58 to -0.24, P < .001).
CONCLUSIONS


Assignment to CPAP treatment compared to no CPAP had no significant effect on HRQoL as measured by the SF-36 in adults with CAD and nonsleepy OSA. Although several components of the SF-36 scores were improved within the CPAP group, CPAP use was associated with a decrease in PCS. The improvement in MCS was determined by the improvement in daytime sleepiness and depressive mood.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT00519597.
CITATION


Wallström S, Balcan B, Thunström E, Wolf A, Peker Y. CPAP and health-related quality of life in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. J Clin Sleep Med. 2019;15(9):1311-1320.",2019,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","['Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI', 'adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial', 'Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial', 'adults with CAD and nonsleepy OSA', 'adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA']","['no CPAP', 'continuous positive airway pressure (CPAP', 'CPAP']","['CPAP and Health-Related Quality of Life', 'beta coefficient', 'MCS', 'baseline AHI (beta coefficient', 'HRQoL', 'ESS score', 'Zung Self-rated Depression Scale scores', 'Mean SF-36 scores', 'SF-36 scores', 'health-related quality of life (HRQoL', 'CPAP use (h/night) ', ' Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires', 'Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS', 'PCS', 'change in Physical Component Summary (PCS', 'Bodily pain and General health scores', 'acute myocardial infarction', 'daytime sleepiness and depressive mood', 'absolute change in the SF-36 components']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4273947', 'cui_str': 'Zung self rating depression scale score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",,0.224914,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallström', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Balcan', 'Affiliation': 'Department of Pulmonary Medicine, Marmara University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunström', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Peker', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7926']
1601,29610951,Correction to: Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality.,"The second to last sentence in the Results section of the Abstract should be corrected to, ""At 180-days follow-up, there was a significant improvement in total VAS scores.""",2018,"The second to last sentence in the Results section of the Abstract should be corrected to, ""At 180-days follow-up, there was a significant improvement in total VAS scores.""",[],['Disposable Negative-Pressure Wound Therapy with Standard Care'],['total VAS scores'],[],"[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.014181,"The second to last sentence in the Results section of the Abstract should be corrected to, ""At 180-days follow-up, there was a significant improvement in total VAS scores.""","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Tanaydin', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands. volkan.tanaydin@mumc.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beugels', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Andriessen', 'Affiliation': 'Andriessen Consultants, Malden, The Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Sawor', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'R R W J', 'Initials': 'RRWJ', 'LastName': 'van der Hulst', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Aesthetic plastic surgery,['10.1007/s00266-018-1123-0']
1602,29522152,Methodological and Efficacy Issues in a Randomized Clinical Trial Investigating Vitreous Floater Treatment-Reply.,,2018,,[],[],[],[],[],[],,0.0450255,,"[{'ForeName': 'Chirag P', 'Initials': 'CP', 'LastName': 'Shah', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2018.0218']
1603,31635952,"Effectiveness of a chronic cough management algorithm at the transitional stage from acute to chronic cough in children: a multicenter, nested, single-blind, randomised controlled trial.","BACKGROUND


Chronic (lasting at least 4 weeks) cough in children is an important cause of morbidity. An algorithmic approach to the management of coughs in children evaluated in observational studies and a randomised controlled trial (RCT) enrolled children referred with median cough duration of 16 weeks to specialist centres. We investigated whether applying an evidence-based cough management algorithm in non-specialist settings earlier, once cough persisted for more than 4 weeks, improved cough resolution compared with usual care.
METHODS


We undertook a multicentre, single-blind RCT nested within a prospective cohort study of children (<15 years) in Australia presenting to three primary care or three hospital emergency departments with an acute respiratory illness with cough. Children were excluded if they had a known diagnosis of an underlying chronic medical condition (excluding asthma) or had an immunosuppressive illness or were taking immunomodulating drugs for more than 2 weeks in the preceding 30 days, or had severe symptoms requiring inpatient hospitalisation. Children were followed up for 8 weeks; those with a persistent cough at day 28 were randomly assigned to the cough management algorithm or to usual care. Randomisation was stratified by reason for presentation, study site, and cough duration (4 weeks to <6 weeks vs ≥6 weeks) using computer-generated permuted blocks (block size of four) with a 1:1 allocation. The primary outcome was the proportion of children with cough resolution at day 56 (defined as resolved if the child did not cough for at least 3 days and nights since day 28 or a more than 75% reduction in their average day and night cough score). Absolute risk differences (RD absolute ) were calculated by modified intention-to-treat analysis (ITT). This trial is registered with the Australia New Zealand Clinical Trials Registry, ACTRN12615000132549.
FINDINGS


Between July 7, 2015, and Oct 31, 2018, 1018 children were screened, 509 were enrolled in the cohort study, and of 115 children in the ITT analysis, 57 were randomly assigned to the intervention group and 58 to the control group. Children had a median age of 1·6 years (IQR 1·0-4·5); 45 (39%) of 115 were Indigenous, and 59 (51%) were boys. By day 56, 33 (58%) of 57 children in the intervention group achieved cough resolution compared with 23 (40%) 58 in the control group; cough resolution was unknown in 12 (21%) of 57 children receiving the intervention and in 13 (22%) of 58 receiving the control. The RD absolute  assuming children with an unknown cough outcome were still coughing at day 56 was 18·3% (95% CI 0·3-36·2); the number needed-to-treat for benefit was five (95% CI 3-364); the adjusted odds ratio was 1·5 (95% CI 1·3-1·6), favouring the intervention group.
INTERPRETATION


This study suggests an evidence-based cough management algorithm improves cough resolution in community-based children in the early phases of chronic cough. However, larger studies to confirm these findings in primary care are required.
FUNDING


National Health and Medical Research Council.",2019,five (95% CI 3-364); the adjusted odds ratio was 1·5,"['community-based children in the early phases of chronic cough', 'Between July 7, 2015, and Oct 31, 2018, 1018 children were screened, 509 were enrolled in the cohort study, and of 115 children in the ITT analysis, 57 were randomly assigned to the intervention group and 58 to the control group', 'transitional stage from acute to chronic cough in children', 'Children were excluded if they had a known diagnosis of an underlying chronic medical condition (excluding asthma) or had an immunosuppressive illness or were taking immunomodulating drugs for more than 2 weeks in the preceding 30 days, or had severe symptoms requiring inpatient hospitalisation', 'children (<15 years) in Australia presenting to three primary care or three hospital emergency departments with an acute respiratory illness with cough', 'children referred with median cough duration of 16 weeks to specialist centres', 'Children were followed up for 8 weeks; those with a persistent cough at day 28', 'Children had a median age of 1·6 years (IQR 1·0-4·5); 45 (39%) of 115 were Indigenous, and 59 (51%) were boys']","['cough management algorithm or to usual care', 'chronic cough management algorithm']","['still coughing', 'cough resolution', 'Absolute risk differences (RD absolute ', 'night cough score', 'proportion of children with cough resolution']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0562483', 'cui_str': 'Persistent cough (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0002045'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",1018.0,0.221586,five (95% CI 3-364); the adjusted odds ratio was 1·5,"[{'ForeName': 'Kerry-Ann F', 'Initials': 'KF', 'LastName': ""O'Grady"", 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia. Electronic address: kerryann.ogrady@qut.edu.au.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Grimwood', 'Affiliation': 'School of Medicine, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia; Departments of Infectious Diseases and Paediatrics, Gold Coast Health, Gold Coast, QLD, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Central Clinical School, University of Sydney, Sydney, NSW, Australia; Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Sheree', 'Initials': 'S', 'LastName': 'Rablin', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Lovie-Toon', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kaus', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Buntain', 'Affiliation': ""Wesley Medical Centre, Auchenflower, QLD, Australia; Department of Respiratory Medicine, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Adsett', 'Affiliation': '78 Margaret Street, Toowoomba, QLD, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'The Toowoomba Hospital, Toowoomba, QLD, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'Caboolture Hospital, Caboolture, QLD, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Caboolture Community Medical Centre, Caboolture, QLD, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Toombs', 'Affiliation': 'UQ Rural Clinical School, University of Queensland, Toowoomba, QLD, Australia.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ""Institute of Health and Biomedical Innovation, Centre for Children's Health Research, Queensland University of Technology, South Brisbane, QLD, Australia; Menzies School of Health Research, Charles Darwin University, Darwin Northern Territory, Australia; Department of Respiratory Medicine, QLD Children's Hospital, South Brisbane, QLD, Australia.""}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30327-X']
1604,31629703,Comparing remnant lipoprotein cholesterol measurement methods to evaluate efficacy of ezetimibe/statin vs statin therapy.,"BACKGROUND


Elevated remnant lipoprotein cholesterol (RLP-C) levels increase cardiovascular disease risk. However, RLP-C measurement methods are not standardized, leading to variations across studies.
OBJECTIVE


To evaluate the effect of ezetimibe (Eze) + statins vs statin monotherapy on RLP-C using immunoseparation (IM), vertical auto profile (VAP) ultracentrifugation, and calculated RLP-C measurement methods.
METHODS


This post hoc analysis evaluated data pooled from 3 first-line (all-statin [simvastatin 10/20/40/80 mg] vs Eze + statin [Eze 10 mg + simvastatin]) and 2 second-line (statin [atorvastatin uptitrated to 40/80 mg] vs statin + Eze [atorvastatin 20/40 mg + Eze 10 mg]) studies. Similarity of RLP-C methods was evaluated using Pearson correlation coefficients and Bland-Altman plots. RLP-C changes and percent changes from baseline were measured by all 3 methods in first-line and VAP and calculated methods in second-line studies.
RESULTS


Correlations between methods were generally moderate to strong for RLP-C levels, changes, and percent changes across treatment groups (r = 0.29-0.79) but with little evidence of agreement by Bland-Altman plots. Baseline RLP-C levels for Eze + statin vs all-statin groups were lower by IM (14.0 vs 14.0) compared with VAP (36.9 vs 35.9) and calculated (32.8 vs 33.3) methods. RLP-C changes (mg/dL) and percent changes from baseline were significantly greater (P < .01) with Eze + statins vs statins by VAP, calculated, and IM methods (between-treatment differences: -5.0 and -12.0, -2.0 and -5.4, and -1.5 and -12.1, respectively) in first-line, and VAP and calculated methods (between-treatment differences: -5.0 and -19.9 and -2.0 and -7.3) in second-line studies.
CONCLUSION


Although the 3 methods showed little agreement, each supported Eze + statins for achieving greater RLP-C reductions vs statin monotherapy; variability of results reinforces urgent need to standardize RLP-C measurements.",2019,RLP-C changes (mg/dL) and percent changes from baseline were significantly greater (P ,[],"['Eze 10\xa0mg\xa0+\xa0simvastatin]) and 2 second-line (statin [atorvastatin uptitrated to 40/80\xa0mg] vs statin\xa0+\xa0Eze [atorvastatin 20/40\xa0mg\xa0', 'ezetimibe (Eze)\xa0+ statins vs statin monotherapy', 'ezetimibe/statin vs statin therapy', 'statin [simvastatin 10/20/40/80\xa0mg] vs Eze\xa0+\xa0statin']","['Baseline RLP-C levels', 'RLP-C changes', 'RLP-C using immunoseparation (IM), vertical auto profile (VAP) ultracentrifugation, and calculated RLP-C measurement methods', 'RLP-C levels']",[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0041609', 'cui_str': 'Ultracentrifugation'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1299991', 'cui_str': 'Measurement method'}]",,0.0939386,RLP-C changes (mg/dL) and percent changes from baseline were significantly greater (P ,"[{'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'CGH Medical Center, Sterling, IL, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: Peter.Toth@cghmc.com.'}, {'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.'}, {'ForeName': 'W Virgil', 'Initials': 'WV', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, University of Milan, Multimedica IRCCS, Milan, Italy.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Davidson', 'Affiliation': 'The University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farnier', 'Affiliation': 'Lipid Clinic, Point Médical, and Departement of Cardiology, CHU Dijon-Bourgogne, Dijon, France.'}, {'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Tomassini', 'Affiliation': 'Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': 'Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Polis', 'Affiliation': 'Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tershakovec', 'Affiliation': 'Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2019.09.001']
1605,30007333,A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 2-quality of treatment.,"OBJECTIVE


To compare the quality of orthodontic treatment between 0.018-inch and 0.022-inch slot bracket systems.
SUBJECTS AND METHODS


Eligible participants aged 12 years or over were allocated to the 0.018-inch or 0.022-inch slot MBT appliance (3M-Unitek, Monrovia, California, USA) using block randomization in groups of 10. Outcome measures included: 1. ABO cast-radiograph evaluation (CR-EVAL), 2. peer assessment rating (PAR) scores, 3. incisor inclination, and 4. patient perception using the Index of Orthodontic Treatment Need aesthetic component (IOTN AC) and three validated questionnaires before, during and after treatment. Parametric tests [independent samples t-test and two-way analysis of variance (ANOVA)] and non-parametric tests (chi-square with Fisher's exact tests and Mann-Whitney U-test) assessed differences between groups (P < 0.05).
RESULTS


Of the 187 participants randomized (1:1 ratio), 34 withdrew or were excluded (protocol deviations or poor cooperation). There were 77 patients in the 0.018-inch slot group and 76 patients in the 0.022-inch slot group (overall mean age: 19.1 years). Baseline characteristics were similar between groups (P > 0.05). The mean total ABO CR-EVAL scores were 34.7 and 34.5; mean percentage PAR score reduction 74.1 per cent and 77.1 per cent; mean change for maxillary incisor inclination 2.9 degrees and 1.6 degrees and for mandibular incisor inclination 2.7 degrees and 1.4 degrees for the 0.018-inch and 0.022-inch groups, respectively. Improvement in patient perception of aesthetics after treatment was statistically significant for both groups (P < 0.05). However, there were no statistically significant differences between the two treatment groups for ABO CR-EVAL, percentage PAR score reduction, incisor inclination, and patient perception of treatment (P > 0.05). No adverse events were observed during treatment.
LIMITATIONS


It was impossible to blind clinicians or patients to allocation and oral hygiene and periodontal outcomes were not assessed.
CONCLUSIONS


There were no statistically or clinically significant differences in the quality of occlusal outcomes, incisor inclination and patient perception of treatment between 0.018-inch and 0.022-inch slot bracket systems.
REGISTRATION


The trial was registered with ClinicalTrials.gov on 5 March 2014, registration number: NCT02080338.
PROTOCOL


The protocol was published at DOI: 10.1186/1745-6215-15-389.",2019,"There were no statistically or clinically significant differences in the quality of occlusal outcomes, incisor inclination and patient perception of treatment between 0.018-inch and 0.022-inch slot bracket systems.
","['Eligible participants aged 12 years or over were allocated to the 0.018-inch or 0.022-inch', '77 patients in the 0.018-inch slot group and 76 patients in the 0.022-inch slot group (overall mean age: 19.1 years', '187 participants randomized (1:1 ratio']","['slot MBT appliance (3M-Unitek, Monrovia, California, USA']","[' 1. ABO cast-radiograph evaluation (CR-EVAL), 2. peer assessment rating (PAR) scores, 3. incisor inclination, and 4', 'adverse events', 'ABO CR-EVAL, percentage PAR score reduction, incisor inclination, and patient perception of treatment', 'mean total ABO CR-EVAL scores', 'PAR score reduction', 'patient perception of aesthetics', 'quality of occlusal outcomes, incisor inclination and patient perception of treatment']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450304', 'cui_str': '0.018""'}, {'cui': 'C0450305', 'cui_str': '0.022""'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0243112'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}]",187.0,0.191767,"There were no statistically or clinically significant differences in the quality of occlusal outcomes, incisor inclination and patient perception of treatment between 0.018-inch and 0.022-inch slot bracket systems.
","[{'ForeName': 'Yassir A', 'Initials': 'YA', 'LastName': 'Yassir', 'Affiliation': 'Orthodontic Department, School of Dentistry, University of Dundee, UK.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'El-Angbawi', 'Affiliation': 'Orthodontic Department, College of Dentistry, University of Baghdad, Iraq.'}, {'ForeName': 'Grant T', 'Initials': 'GT', 'LastName': 'McIntyre', 'Affiliation': 'Orthodontic Department, College of Dentistry, University of Baghdad, Iraq.'}, {'ForeName': 'Gavin F', 'Initials': 'GF', 'LastName': 'Revie', 'Affiliation': 'Orthodontic Department, College of Dentistry, University of Baghdad, Iraq.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bearn', 'Affiliation': 'Orthodontic Department, College of Dentistry, University of Baghdad, Iraq.'}]",European journal of orthodontics,['10.1093/ejo/cjy038']
1606,31630690,Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO 2 -C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy.,"BACKGROUND


Most extremely low gestational age neonates (ELGANS, postmenstrual age at birth (PMA) < 28 completed weeks) require supplemental oxygen and experience frequent intermittent hypoxemic and hyperoxemic episodes. Hypoxemic episodes and exposure to inadequately high concentrations of oxygen are associated with an increased risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death beyond 36 weeks PMA. Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C) reduces time outside the hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload. Effects on clinically important outcomes in ELGANs such as ROP, BPD, NEC, NDI and mortality have not yet been studied.
METHODS


An outcome-assessor-blinded, randomized controlled, parallel-group trial was designed and powered to study the effect of FiO 2 -C (in addition to routine manual control (RMC) of FiO 2 ), compared to RMC only, on death and severe complications related to hypoxemia and/or hyperoxemia. 2340 ELGANS with a GA of 23 + 0/7 to 27 + 6/7 weeks will be recruited in approximately 75 European tertiary care neonatal centers. Study participants are randomly assigned to RMC (control-group) or FiO 2 -C in addition to RMC (intervention-group). Central randomization is stratified for center, gender and PMA at birth (< 26 weeks and ≥ 26 weeks). FiO 2 -C is provided by commercially available and CE-marked ventilators with an FiO 2 -C algorithm intended for use in newborn infants. The primary outcome variable (composite of death, severe ROP, BPD or NEC) is assessed at 36 weeks PMA (or, in case of ROP, until complete vascularization of the retina, respectively). The co-primary outcome variable (composite outcome of death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment) is assessed at 24 months corrected age.
DISCUSSION


Short-term studies on FiO 2 -C showed improved time ELGANs spent within their assigned SpO 2  target range, but effects of FiO 2 -C on clinical outcomes are yet unknown and will be addressed in the FiO 2 -C trial. This will ensure an appropriate assessment of safety and efficacy before FiO 2 -C may be implemented as standard therapy.
TRIAL REGISTRATION


The study is registered at www.ClinicalTrials.gov: NCT03168516 , May 30, 2017.",2019,"Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C) reduces time outside the hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload.","['low gestational age neonates ', 'newborn infants', '2340']","['Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C', 'closed-loop automatic control of the inspiratory fraction of oxygen (FiO 2 -C', 'RMC (control-group) or FiO 2 -C in addition to RMC (intervention-group']","['death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment', 'risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death', 'composite of death, severe ROP, BPD or NEC', ""hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload"", 'ROP, BPD, NEC, NDI and mortality']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",28.0,0.307759,"Closed-loop automated control of the inspiratory fraction of oxygen (FiO 2 -C) reduces time outside the hemoglobin oxygen saturation (SpO 2 ) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload.","[{'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Maiwald', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.""}, {'ForeName': 'Hendrik J', 'Initials': 'HJ', 'LastName': 'Niemarkt', 'Affiliation': 'Máxima Medical Centre Veldhoven, Veldhoven, The Netherlands.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Urschitz', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hummler', 'Affiliation': ""Children's Hospital University of Ulm, Ulm, Germany.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'UniversitätsSpital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': ""Center for Pediatric Clinical Studies (CPCS), University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.""}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany. Axel.Franz@med.uni-tuebingen.de.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-019-1735-9']
1607,31626000,"Continuity With Patients, Preceptors, and Peers Improves Primary Care Training: A Randomized Medical Education Trial.","PURPOSE


Infusing continuity of care into medical student clerkships may accelerate professional development, preserve patient-centered attitudes, and improve primary care training. However, prospective, randomized studies of longitudinal curricula are lacking.
METHOD


All entering Northwestern University Feinberg School of Medicine students in 2015 and 2016 were randomized to the Education Centered Medical Home (ECMH), a 4-year, team-based primary care clerkship; or a mentored individual preceptorship (IP) for 2 years followed by a traditional 4-week primary care clerkship. Students were surveyed 4 times (baseline, M1, M2, and M3 year [through 2018]); surveys included the Maslach Burnout Inventory (MBI); the Communication, Curriculum, and Culture (C3) survey assessing the hidden curriculum; and the Attitudes Toward Health Care Teams (ATHCT) scale. The authors analyzed results using an intent-to-treat approach.
RESULTS


Three hundred twenty-nine students were randomized; 316 (96%) participated in surveys. Seventy percent of all respondents would recommend the ECMH to incoming first-year students. ECMH students reported a more positive learning environment (overall quality, 4.4 ECMH vs 4.0 IP, P < .001), greater team-centered attitudes (ATHCT scale, 3.2 vs 3.0, P = .007), less exposure to negative aspects of the hidden curriculum (C3 scale, 4.6 vs 4.3, P < .001), and comparable medical knowledge acquisition. ECMH students established more continuity relationships with patients (2.2 vs 0.3, P < .001) and reported significantly higher professional efficacy (MBI-PE, 4.1 vs 3.9, P = .02).
CONCLUSIONS


In this randomized medical education trial, the ECMH provided superior primary care training across multiple outcomes compared with a traditional clerkship-based model, including improved professional efficacy.",2020,"ECMH students established more continuity relationships with patients (2.2 vs. 0.3, P < .001) and reported significantly higher professional efficacy (MBI-PE, 4.1 vs. 3.9, P = .02).
","['All entering Northwestern University Feinberg School of Medicine students in 2015 and 2016', '329 students were randomized; 316 (96%) participated in surveys']","['ECMH', 'Education Centered Medical Home (ECMH), a 4-year, team-based primary care clerkship; or a mentored Individual Preceptorship (IP) for two years followed by a traditional 4-week primary care clerkship']","['continuity relationships', 'professional efficacy', 'Maslach Burnout Inventory (MBI); the Communication, Curriculum, and Culture (C3) survey assessing the hidden curriculum; and the Attitudes Toward Health Care Teams (ATHCT) scale', 'greater team-centered attitudes (ATHCT scale', 'positive learning environment']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0456391', 'cui_str': 'Continuities (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}, {'cui': 'C0222045'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",2016.0,0.0384584,"ECMH students established more continuity relationships with patients (2.2 vs. 0.3, P < .001) and reported significantly higher professional efficacy (MBI-PE, 4.1 vs. 3.9, P = .02).
","[{'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Henschen', 'Affiliation': 'B.L. Henschen is assistant professor, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: http://orcid.org/0000-0003-0994-9725. D.T. Liss is research assistant professor, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: https://orcid.org/0000-0001-5505-2922. B.P. Golden is instructor, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: https://orcid.org/0000-0003-0576-3894. K.A. Cameron is research professor, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: http://orcid.org/0000-0002-3535-6459. J.A. Bierman is associate professor, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: http://orcid.org/0000-0001-7534-8499. E.R. Ryan was associate professor, Department of Family and Community Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, at the time of this work. She is currently associate dean and campus director, Northwest Campus, and professor, Clinical Family Medicine, Indiana University School of Medicine-Northwest Campus, Gary, Indiana; ORCID: http://orcid.org/0000-0001-8680-3741. L.A. Gard is research project coordinator, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois. E.G. Neilson is professor and Lewis Landsberg Dean, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: http://orcid.org/0000-0003-3723-8859. D.B. Wayne is Dr. John Sherman Professor of Medicine and Medical Education, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: http://orcid.org/0000-0001-6468-0744. D.B. Evans is assistant professor, Division of General Internal Medicine and Geriatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ORCID: https://orcid.org/0000-0003-0760-3034.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Liss', 'Affiliation': ''}, {'ForeName': 'Blair P', 'Initials': 'BP', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': ''}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Bierman', 'Affiliation': ''}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Gard', 'Affiliation': ''}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Neilson', 'Affiliation': ''}, {'ForeName': 'Diane B', 'Initials': 'DB', 'LastName': 'Wayne', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Evans', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003045']
1608,29371384,RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis.,"We evaluated the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and predefined sputum bacteria.Patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in 14- or 28-day on/off treatment cycles for 48 weeks. Primary end-points were time to first exacerbation and frequency of exacerbations. Enrolling countries and α level split (0.049 and 0.001 for 14- and 28-day cycles, respectively) differed from RESPIRE 1.Patients were randomised to ciprofloxacin DPI (14 days on/off (n=176) or 28 days on/off (n=171)) or placebo (14 days on/off (n=88) or 28 days on/off (n=86)). The exacerbation rate was low across treatment arms (mean±sd 0.6±0.9). Active treatment showed trends to prolonged time to first exacerbation (ciprofloxacin DPI 14 days on/off: hazard ratio 0.87, 95.1% CI 0.62-1.21; p=0.3965; ciprofloxacin DPI 28 days on/off: hazard ratio 0.71, 99.9% CI 0.39-1.27; p=0.0511) and reduced frequency of exacerbations (ciprofloxacin DPI 14 days on/off: incidence rate ratio 0.83, 95.1% CI 0.59-1.17; p=0.2862; ciprofloxacin DPI 28 days on/off: incidence rate ratio 0.55, 99.9% CI 0.30-1.02; p=0.0014), although neither achieved statistical significance. Ciprofloxacin DPI was well tolerated.Trends towards clinical benefit were seen with ciprofloxacin DPI, but primary end-points were not met.",2018,"Active treatment showed trends to prolonged time to first exacerbation (ciprofloxacin DPI 14 days on/off: hazard ratio 0.87, 95.1% CI 0.62-1.21; p=0.3965; ciprofloxacin DPI 28 days on/off: hazard ratio 0.71, 99.9% CI 0.39-1.27; p=0.0511) and reduced frequency of exacerbations (ciprofloxacin DPI 14 days on/off: incidence rate ratio 0.83, 95.1% CI 0.59-1.17; p=0.2862; ciprofloxacin DPI 28 days on/off: incidence rate ratio 0.55, 99.9% CI 0.30-1.02; p=0.0014), although neither achieved statistical significance.","['patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and predefined sputum bacteria', 'non-cystic fibrosis bronchiectasis']","['ciprofloxacin dry powder for inhalation (DPI', 'placebo', 'Ciprofloxacin DPI', 'ciprofloxacin DPI', 'ciprofloxacin dry powder', 'ciprofloxacin DPI 32.5\u2005mg or placebo']","['tolerated', 'exacerbation rate', 'frequency of exacerbations', 'time to first exacerbation and frequency of exacerbations', 'efficacy and safety', 'prolonged time to first exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0991575', 'cui_str': 'Inhalant Powder'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",,0.232621,"Active treatment showed trends to prolonged time to first exacerbation (ciprofloxacin DPI 14 days on/off: hazard ratio 0.87, 95.1% CI 0.62-1.21; p=0.3965; ciprofloxacin DPI 28 days on/off: hazard ratio 0.71, 99.9% CI 0.39-1.27; p=0.0511) and reduced frequency of exacerbations (ciprofloxacin DPI 14 days on/off: incidence rate ratio 0.83, 95.1% CI 0.59-1.17; p=0.2862; ciprofloxacin DPI 28 days on/off: incidence rate ratio 0.55, 99.9% CI 0.30-1.02; p=0.0014), although neither achieved statistical significance.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Aksamit', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA aksamit.timothy@mayo.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Soyza', 'Affiliation': 'Newcastle University and Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tiemo-Joerg', 'Initials': 'TJ', 'LastName': 'Bandel', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Criollo', 'Affiliation': 'Bayer Inc., Mississauga, ON, Canada.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Elborn', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Operschall', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Polverino', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Institut de Recerca Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Roth', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Royal Brompton Hospital and Imperial College London, London, UK.'}]",The European respiratory journal,['10.1183/13993003.02053-2017']
1609,29310197,Re: Effect of Electroacupuncture on Urinary Leakage among Women with Stress Urinary Incontinence: A Randomized Clinical Trial.,,2018,,['Women with Stress Urinary Incontinence'],['Electroacupuncture'],['Urinary Leakage'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}]",,0.0858161,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1016/j.juro.2017.09.111']
1610,29310198,Re: Effect of Electroacupuncture on Urinary Leakage among Women with Stress Urinary Incontinence: A Randomized Clinical Trial.,,2018,,['Women with Stress Urinary Incontinence'],['Electroacupuncture'],['Urinary Leakage'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}]",,0.0858161,,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Penson', 'Affiliation': ''}]",The Journal of urology,['10.1016/j.juro.2017.09.112']
1611,31637821,Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa.,"INTRODUCTION


The universal test-and-treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa.
METHODS


The TasP cluster-randomized trial (2012 to 2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 × 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level.
RESULTS


8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited.
CONCLUSIONS


PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART-initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90-90-90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context-specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register).",2019,"During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001).",['rural South Africa'],"['six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2\xa0×\xa011 clusters opened sequentially', 'universal ART']","['PVS', 'Contextual changes', 'cumulative HIV incidence', 'residency status, HIV status, and HIV care status']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",90.0,0.117108,"During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001).","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Centre Population et Développement, Institut de Recherche pour le Développement, Université Paris Descartes, Inserm, Paris, France.'}, {'ForeName': 'Mamadou H', 'Initials': 'MH', 'LastName': 'Diallo', 'Affiliation': 'Centre Population et Développement, Institut de Recherche pour le Développement, Université Paris Descartes, Inserm, Paris, France.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Plazy', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dabis', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25402']
1612,31512028,Pharmacokinetics and safety of neratinib during co-administration with loperamide in healthy subjects.,"PURPOSE


To evaluate the effects of multiple doses of loperamide on the pharmacokinetics and safety of a single oral dose of neratinib.
METHODS


This was an open-label, two-period, fixed-sequence study. Twenty healthy adult subjects received an oral dose of neratinib 240 mg daily on Days 1-4 of Period 1 followed by a 7-day washout. In Period 2, oral neratinib 240 mg was administered with loperamide 4 mg followed by two further doses of loperamide 2 mg 8 and 16 h later on Days 1-4. Pharmacokinetic sampling was performed for 72 h following each neratinib dose. Safety was monitored throughout the study.
RESULTS


A median t max  of ~ 6 h was observed for neratinib during both periods. Apparent clearance and volume of distribution were similar for Periods 1 and 2: mean CL ss /F 308.2 and 322.1 L/h; mean V zτ /F 7995 and 10,318 L, respectively. The half-life of neratinib increased in the presence of loperamide from 18.0 to 22.2 h. Mean exposure was within the same range without and with loperamide administration: C max  61.2 ng/mL and 49.5 ng/mL; AUC last  1086 ng h/mL and 1153 ng h/mL, and AUC tau  779 ng h/mL and 745 ng h/mL, respectively. Treatment-emergent adverse events were mainly mild in intensity, with the most frequent events being diarrhea (45%) and constipation (35%).
CONCLUSIONS


Neratinib administered alone and concomitantly with multiple oral doses of loperamide is generally safe and well tolerated. Loperamide has minimal effects on neratinib pharmacokinetic parameters.",2019,Mean exposure was within the same range without and with loperamide administration: C max  61.2 ,"['Twenty healthy adult subjects', 'healthy subjects', '7995 and 10,318']","['F', 'neratinib during co-administration with loperamide', 'loperamide', 'oral neratinib 240\xa0mg was administered with loperamide', 'oral dose of neratinib 240\xa0mg daily on Days 1-4 of Period 1 followed by a 7-day washout', 'AUC tau  779\xa0ng']","['constipation', 'median t max  of ', 'Safety', 'Apparent clearance and volume of distribution', 'L/h; mean V zτ', 'safe and well tolerated']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C2346686', 'cui_str': 'L/h'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",20.0,0.0756842,Mean exposure was within the same range without and with loperamide administration: C max  61.2 ,"[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Keyvanjah', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA. kkeyvanjah@pumabiotechnology.com.'}, {'ForeName': 'Blaire', 'Initials': 'B', 'LastName': 'Cooke', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Di Primeo', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sterling', 'Affiliation': 'Celerion, Lincoln, NE, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Olek', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Rubets', 'Affiliation': 'Certara, Montreal, QC, Canada.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Puma Biotechnology, Inc, 10880 Wilshire Blvd, Suite 2150, Los Angeles, CA, 90024, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03951-x']
1613,29408837,Reply: The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial.,,2018,,['Major Abdominal Surgery'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],[],,0.152682,,"[{'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Froessler', 'Affiliation': 'Lyell McEwin Hospital, Elizabeth Vale South Australia, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Palm', 'Affiliation': ''}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Nicolette A', 'Initials': 'NA', 'LastName': 'Hodyl', 'Affiliation': ''}, {'ForeName': 'Rajvinder', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Murphy', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000002056']
1614,31558086,A pulse-based diet and the Therapeutic Lifestyle Changes diet in combination with health counseling and exercise improve health-related quality of life in women with polycystic ovary syndrome: secondary analysis of a randomized controlled trial.,"Objective:  A favorable dietary composition to increase health-related quality of life (HRQoL) in PCOS remains unclear. We compared changes in HRQoL of women with PCOS who participated in a low-glycemic-index pulse-based (lentils, beans, split peas, and chickpeas) or the Therapeutic Lifestyle Changes (TLC) diet intervention. Methods:  Thirty women in the pulse-based and 31 in the TLC groups (18-35 years) completed a 16-week intervention without energy-restriction. Groups participated in health counseling (monthly) and aerobic exercise (5 days/week; 45 minutes/day). Results:  Fifty-five (90.2%) women completed a PCOS-specific HRQoL survey. Greatest mean increases in time-effects occurred in the domains of healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns, respectively ( p  ≤ 0.02), without group-by-time interactions ( p  ≥ 0.13). Decreased weight ( r  = -0.35) and homeostatic model assessment of insulin resistance ( r  = -0.18) correlated with increased scores of PCOS knowledge; adherence to intervention correlated with increased scores of active living ( r  = 0.39) and healthy eating ( r  = 0.53;  p  ≤ 0.03). Conclusions:  Both interventions improved HRQoL scores in women with PCOS without prescribed energy-restriction. Our observations add novel insights into current evidence and elucidate the need for future psychological research to target lifestyle modifications for improving HRQoL and unique psychological complications of PCOS in this high-risk population (CinicalTrials.gov identifier:NCT01288638).",2020,"Greatest mean increases in time-effects occurred in the domains of healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns, respectively ( p  ≤ 0.02), without group-by-time interactions ( p  ≥ 0.13).","['women with polycystic ovary syndrome', 'women with PCOS who participated in a low-glycemic-index pulse-based (lentils, beans, split peas, and chickpeas) or the Therapeutic Lifestyle Changes (TLC) diet intervention', 'women with PCOS without prescribed energy-restriction', 'Thirty women in the pulse-based and 31 in the TLC groups (18-35 years) completed a']","['pulse-based diet and the Therapeutic Lifestyle Changes diet in combination with health counseling and exercise', '16-week intervention without energy-restriction', 'health counseling (monthly) and aerobic exercise']","['Decreased weight', 'healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns', 'health-related quality of life (HRQoL', 'health-related quality of life', 'scores of active living', 'scores of PCOS knowledge; adherence', 'healthy eating', 'time-effects', 'HRQoL scores', 'homeostatic model assessment of insulin resistance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0950052', 'cui_str': 'Chickpea'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",30.0,0.103133,"Greatest mean increases in time-effects occurred in the domains of healthy eating, PCOS knowledge, active living, healthcare satisfaction, feelings and experiences about intervention, and health concerns, respectively ( p  ≤ 0.02), without group-by-time interactions ( p  ≥ 0.13).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kazemi', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'McBreairty', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'Division of Nutrition and Dietetics, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Pierson', 'Affiliation': 'Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Julianne J', 'Initials': 'JJ', 'LastName': 'Gordon', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Shani B', 'Initials': 'SB', 'LastName': 'Serrao', 'Affiliation': 'Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Chizen', 'Affiliation': 'Obstetrics and Gynecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2019.1666820']
1615,31628524,Metformin plus first-line chemotherapy versus chemotherapy alone in the treatment of epithelial ovarian cancer: a prospective open-label pilot trial.,"PURPOSE


To evaluate the efficacy of metformin plus first-line chemotherapy versus chemotherapy alone in the treatment of epithelial ovarian cancer.
METHODS


Epithelial ovarian cancer patients without diabetes mellitus were allocated to non-metformin group (paclitaxel plus carboplatin) or metformin group (paclitaxel plus carboplatin plus metformin). The primary endpoint was progression-free survival (PFS) and disease-free survival (DFS).
RESULTS


A total of 20 patients were assigned to metformin group and 24 patients to non-metformin group. The baseline information in two groups had no significant difference. The PFS and DFS of patients with metformin intake versus without metformin intake was 23 versus 21 months (p = 0.68) and 29 versus 26 months (p = 0.61), respectively. The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively. Metformin effectively inhibited the increase of IGF-1 and maintained the IGFBP-1.
CONCLUSIONS


Within the limitations of the small sample size, there was no evidence of meaningful effect on PFS by metformin even though evidence of modulation of IGF-1 signaling axis was apparent.",2019,"The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively.","['Epithelial ovarian cancer patients without diabetes mellitus', 'epithelial ovarian cancer', 'group and 24 patients to non-metformin group', '20 patients']","['Metformin', 'metformin group (paclitaxel plus carboplatin) or metformin group (paclitaxel plus carboplatin plus metformin', 'metformin', 'metformin plus first-line chemotherapy versus chemotherapy alone', 'Metformin plus first-line chemotherapy versus chemotherapy alone']","['IGF-1', 'progression-free survival (PFS) and disease-free survival (DFS']","[{'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.0241352,"The PFS and DFS of patients with normal weight versus obese/overweight were 23 versus 17 months (p = 0.14) and 27 versus 23 months (p = 0.50), respectively.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, 419 Fangxie Road, Shanghai, 200011, People's Republic of China. hongsun57@hotmail.com.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03963-7']
1616,31482224,Population pharmacokinetics and exposure-overall survival analysis of the transforming growth factor-β inhibitor galunisertib in patients with pancreatic cancer.,"PURPOSE


To evaluate the exposure-overall survival (OS) relationship in patients with advanced pancreatic cancer treated with galunisertib plus gemcitabine (GG) or gemcitabine plus placebo (GP).
METHODS


Galunisertib 300 mg/day was given orally as intermittent dosing and gemcitabine as per label. Galunisertib exposure metrics for each patient in the GG arm (n = 99) of a phase 2 study of pancreatic cancer were calculated. Parametric survival models were used to identify influential baseline and response covariates on OS.
RESULTS


The population pharmacokinetics dataset included data from 297 patients/healthy subjects (age: 22-84 years, weight: 39-126 kg) across multiple studies, including this pancreatic cancer study. Galunisertib was rapidly absorbed with peak concentrations attained within 0.5-2 h and had an elimination half-life of 8 h. Between-subject variance on apparent clearance was estimated to be 47%. Age was the only characteristic to have a statistically significant effect on apparent clearance. A parametric Weibull survival model with treatment effect (dose) estimated a hazard ratio of 0.796, after adjusting for patient baseline factors that were significantly associated with OS. There was also a flat daily exposure-OS relationship within the observed exposure range, once all significant baseline covariates were included. Response covariates, such as reduction in CA19-9, time on treatment, and cumulative exposure over treatment cycles were also identified as significant factors for OS for patients with pancreatic cancer.
CONCLUSIONS


This analysis suggests that 300 mg/day galunisertib administered as 150 mg twice daily for 14 days on/14 days off treatment is an appropriate dosing regimen for patients with pancreatic cancer.",2019,Age was the only characteristic to have a statistically significant effect on apparent clearance.,"['297 patients/healthy subjects (age: 22-84\xa0years, weight: 39-126\xa0kg) across multiple studies, including this pancreatic cancer study', 'patients with advanced pancreatic cancer treated with', 'patients with pancreatic cancer']","['transforming growth factor-β inhibitor galunisertib', 'galunisertib plus gemcitabine (GG) or gemcitabine plus placebo (GP', 'gemcitabine']","['flat daily exposure-OS relationship', 'apparent clearance', 'CA19-9, time on treatment, and cumulative exposure', 'exposure-overall survival (OS) relationship']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3896943'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",297.0,0.0698035,Age was the only characteristic to have a statistically significant effect on apparent clearance.,"[{'ForeName': 'Ivelina', 'Initials': 'I', 'LastName': 'Gueorguieva', 'Affiliation': 'Global PK/PD, Eli Lilly and Company, Sunninghill Road, Erl Wood Manor, ROB building, Windlesham, Surrey, GU20 6PH, UK. gueorguieva_ivelina@lilly.com.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Melisi', 'Affiliation': 'Digestive Molecular Clinical Oncology, University of Verona, Verona, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Merz', 'Affiliation': 'Digestive Molecular Clinical Oncology, University of Verona, Verona, Italy.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Waterhouse', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Miles', 'Affiliation': 'Global PK/PD, Eli Lilly and Company, Sunninghill Road, Erl Wood Manor, ROB building, Windlesham, Surrey, GU20 6PH, UK.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Lahn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cleverly', 'Affiliation': 'Global PK/PD, Eli Lilly and Company, Sunninghill Road, Erl Wood Manor, ROB building, Windlesham, Surrey, GU20 6PH, UK.'}, {'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Benhadji', 'Affiliation': 'Eli Lilly and Company, Bridgewater, NJ, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03931-1']
1617,31368191,"Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial.","Recent studies demonstrated the utility of perineural injection with platelet-rich plasma (PRP) and 5% dextrose (D5W) as novel strategies for treatment of carpal tunnel syndrome (CTS). The present study comprised a prospective, randomized, single-blind, head-to head comparative trial to compare the 6-month outcome of perineural injection with PRP or D5W in patients with moderate CTS. Fifty-two patients with unilateral moderate CTS were enrolled and randomized into two groups: The PRP group received a single 3-cc perineural injection of PRP under ultrasound guidance, and dextrose group received a single 3-cc perineural injection of D5W under ultrasound guidance. The Boston Carpal Tunnel Syndrome Questionnaire score was used as the primary outcome. Secondary outcomes included cross-sectional area (CSA) of the median nerve and electrophysiological assessments. Evaluations were performed at baseline and at 1, 3, and 6 months postinjection. All patients (26 patients per group) completed the study. Compared with the dextrose group, the PRP group demonstrated significant reductions in Boston Carpal Tunnel Syndrome Questionnaire function at 3 months (p = .044), distal motor latency at 6 months (p = .028), and CSA at 3 and 6 months (p = .010 and.018, respectively). A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months postinjection for patients with moderate CTS.",2019,A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months postinjection for patients with moderate CTS.,"['All patients (26 patients per group) completed the study', 'patients with moderate CTS', 'carpal tunnel syndrome (CTS', 'Fifty-two patients with unilateral moderate CTS', 'moderate carpal tunnel syndrome']","['PRP', 'single 3-cc perineural injection of PRP under ultrasound guidance, and dextrose group received a single 3-cc perineural injection of D5W under ultrasound guidance', 'dextrose', 'perineural injection with platelet-rich plasma (PRP) and 5% dextrose (D5W', 'perineural platelet-rich plasma and dextrose injections', 'perineural injection with PRP or D5W']","['distal motor latency', 'Boston Carpal Tunnel Syndrome Questionnaire score', 'cross-sectional area (CSA) of the median nerve and electrophysiological assessments', 'Boston Carpal Tunnel Syndrome Questionnaire function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}]",52.0,0.025784,A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months postinjection for patients with moderate CTS.,"[{'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Ying', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Chou', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Ming-Jen', 'Initials': 'MJ', 'LastName': 'Ke', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}, {'ForeName': 'Yung-Tsan', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, Taiwan, Republic of China.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.2950']
1618,32052249,Conducting a Pilot Randomized Controlled Trial on a Medical Inpatient Unit Utilizing Cognitive Remediation Therapy for Adolescents with Restrictive Eating Disorders: Protocol Updates and Reflections on Feasibility.,"We conducted a pilot randomized control trial (RCT) to simultaneously examine the feasibility of effectively implementing Cognitive Remediation Therapy (CRT) for adolescents with anorexia nervosa (AN) during medical hospitalization at a single-site hospital center. Employment of this protocol occurred on a general medical unit with diverse medical admitting diagnoses, not an eating disorder floor of a hospital and not part of a structured inpatient anorexia nervosa treatment program. This was the first time an RCT for a psychosocial intervention was implemented on this unit with patients with eating disorders. Here, we describe the process of piloting the study, including modifications that needed to be made to the original protocol. We also describe the feedback from major stakeholders regarding the process of conducting the pilot study. We summarize lessons learned and steps to take for smooth integration of an RCT of a therapeutic intervention on medical unit.Trial registration: ClinicalTrials.gov Identifier NCT02883413.",2020,We conducted a pilot randomized control trial (RCT) to simultaneously examine the feasibility of effectively implementing Cognitive Remediation Therapy (CRT) for adolescents with anorexia nervosa (AN) during medical hospitalization at a single-site hospital center.,"['Medical Inpatient Unit', 'adolescents with anorexia nervosa (AN) during medical hospitalization at a single-site hospital center', 'Adolescents with Restrictive Eating Disorders', 'patients with eating disorders']","['Utilizing Cognitive Remediation Therapy', 'effectively implementing Cognitive Remediation Therapy (CRT']",[],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",[],,0.0348861,We conducted a pilot randomized control trial (RCT) to simultaneously examine the feasibility of effectively implementing Cognitive Remediation Therapy (CRT) for adolescents with anorexia nervosa (AN) during medical hospitalization at a single-site hospital center.,"[{'ForeName': 'C Alix', 'Initials': 'CA', 'LastName': 'Timko', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA. timkoc@email.chop.edu.""}, {'ForeName': 'Kathleen Kara', 'Initials': 'KK', 'LastName': 'Fitzpatrick', 'Affiliation': ""Department of Psychiatry and Behavioral Sciences, Stanford Children's Hospital, Stanford, CA, USA.""}, {'ForeName': 'Tiffanie', 'Initials': 'T', 'LastName': 'Goulazian', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA.""}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Kirby', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parks', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA.""}, {'ForeName': 'Leela', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA.""}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Scharko', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA.""}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Peebles', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of clinical psychology in medical settings,['10.1007/s10880-020-09704-w']
1619,31610718,"Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2.","BACKGROUND


Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin.
METHODS


We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery.
RESULTS


Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients ( P <0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213;  P =0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963;  P =0.717).
CONCLUSIONS


Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.",2019,"In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963;  P =0.717).
","['anticoagulated patients undergoing elective or semi-urgent device surgery', 'patients undergoing pacemaker or defibrillator surgery', 'patients treated with direct oral anticoagulant versus continued warfarin', '408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery', '1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2']","['Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents']","['CSH', 'Risk of Device Pocket Hematoma']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]",1343.0,0.194536,"In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963;  P =0.717).
","[{'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Essebag', 'Affiliation': 'McGill University, McGill University Health Centre and Hôpital Sacré-Coeur de Montréal, QC, Canada (V.E.).'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'McMaster University, Hamilton Health Sciences, Population Health Research Institute, Hamilton, ON, Canada (J.S.H., J.E.,).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Joza', 'Affiliation': 'McGill University, McGill University Health Centre, Montreal, QC, Canada (J.J.).'}, {'ForeName': 'Pablo B', 'Initials': 'PB', 'LastName': 'Nery', 'Affiliation': 'Department of Medicine, University of Ottawa, University of Ottawa Heart Institute, ON, Canada (P.B.N., G.A.W., D.H.B.).'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Kalfon', 'Affiliation': 'Galilee Medical Centre, Naharyia, Israel (E.K.).'}, {'ForeName': 'Tiago L L', 'Initials': 'TLL', 'LastName': 'Leiria', 'Affiliation': 'Instituto de Cardiologia, Fundacao Universidade de Cardiologia, Porte Alegre, RS, Brazil (T.L.L.L).'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, ON, Canada (A.V.).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ayala-Paredes', 'Affiliation': 'Université de Sherbrooke, Hopital Fleurimont (F.A.-P.).'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coutu', 'Affiliation': ""Centre Hospitalier de L'Université de Montreal, Hopital Hotel-Dieu, QC, Canada (B.C.).""}, {'ForeName': 'Glen L', 'Initials': 'GL', 'LastName': 'Sumner', 'Affiliation': 'University of Calgary, Libin Cardiovascular Institute, Foothills Medical Centre, AB, Canada (G.L.S., K.K.).'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, QC, Canada (G.B., M.S.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Philippon', 'Affiliation': 'Laval University, Quebec Heart Institute, Quebec City, Canada (F.P.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eikelboom', 'Affiliation': 'McMaster University, Hamilton Health Sciences, Population Health Research Institute, Hamilton, ON, Canada (J.S.H., J.E.,).'}, {'ForeName': 'Roopinder K', 'Initials': 'RK', 'LastName': 'Sandhu', 'Affiliation': 'University of Alberta, Edmonton, Canada (R.K.S.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Dalhousie University, QEII Health Sciences Centre, Halifax, NS, Canada (J.S.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Leather', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, Canada (R.L.).'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Yung', 'Affiliation': 'Scarborough Health Network, University of Toronto, Clinical Adjunct, ON, Canada (D.Y.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Thibault', 'Affiliation': 'Montreal Heart Institute, Université de Montreal, QC, Canada (B.T.).'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Simpson', 'Affiliation': ""Heart Rhythm Service, Queen's University, Kingston ON, Canada (C.S.S.).""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmad', 'Affiliation': ""University of Toronto, St Michael's Hospital, ON, Canada (K.A.).""}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Toal', 'Affiliation': 'Saint John Regional Hospital, NB, Canada (S.T.).'}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Sturmer', 'Affiliation': 'Hôpital du Sacré-Coeur de Montréal, QC, Canada (G.B., M.S.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kavanagh', 'Affiliation': 'University of Calgary, Libin Cardiovascular Institute, Foothills Medical Centre, AB, Canada (G.L.S., K.K.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Crystal', 'Affiliation': 'Arrhythmia Services, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, ON, Canada (E.C.).'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa, University of Ottawa Heart Institute, ON, Canada (P.B.N., G.A.W., D.H.B.).'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krahn', 'Affiliation': 'University of British Columbia, Vancouver, Canada (A.D.K.).'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Birnie', 'Affiliation': 'Department of Medicine, University of Ottawa, University of Ottawa Heart Institute, ON, Canada (P.B.N., G.A.W., D.H.B.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007545']
1620,31614348,Comparison of Functional Outcomes between Functional Jejunal Interposition and Conventional Roux-en-Y Esophagojejunostomy after Total Gastrectomy for Gastric Cancer.,"BACKGROUND


The reconstruction of digestive tract after total gastrectomy is associated with various postoperative complications. We aimed to investigate the differences in functional outcomes of 2 reconstruction techniques following total gastrectomy: functional jejunal interposition (FJI) versus Roux-en-Y esophagojejunostomy.
METHODS


Sixty patients were enrolled and divided into FJI and Roux-en-Y groups. Nutritional parameters and incidences of reconstruction-related symptoms were evaluated. Oral glucose tolerance test and endoscopy examination were carried out.
RESULTS


The postoperative prognostic nutritional index scores and postoperative/preoperative body weight, meal intake, serum albumin level ratio were significantly higher in the FJI group than in the Roux-en-Y group. At 3, 6, and 12 months postoperatively, the elevations of plasma glucose level after glucose intake were more significant in the FJI group than in the Roux-en-Y group. The incidence of postoperative stasis symptoms in the Roux-en-Y group was significantly higher than in the FJI group, but no obvious difference was observed regarding dumping and reflux symptoms. The incidence rates of severe esophageal mucosa injury and severe anastomotic stricture were also similar between the 2 groups.
CONCLUSION


FJI reconstruction might accelerate the recovery of nutritional status and reduce the occurrence of stasis symptoms postoperatively as compared with Roux-en-Y esophagojejunostomy, which may have an advantage over FJI in stabilizing body glycometabolism after surgery. These 2 types of reconstruction may have a similar anti-reflux function to prevent severe reflux esophagitis and anastomotic stenosis.",2020,"The postoperative prognostic nutritional index scores and postoperative/preoperative body weight, meal intake, serum albumin level ratio were significantly higher in the FJI group than in the Roux-en-Y group.","['Sixty patients were enrolled and divided into FJI and Roux-en-Y groups', 'after Total Gastrectomy for Gastric Cancer']","['total gastrectomy: functional jejunal interposition (FJI) versus Roux-en-Y esophagojejunostomy', 'FJI reconstruction', 'Functional Jejunal Interposition and Conventional Roux-en-Y Esophagojejunostomy']","['postoperative prognostic nutritional index scores and postoperative/preoperative body weight, meal intake, serum albumin level ratio', 'elevations of plasma glucose level after glucose intake', 'incidence rates of severe esophageal mucosa injury and severe anastomotic stricture', 'incidence of postoperative stasis symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy (procedure)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C0161899', 'cui_str': 'Total gastrectomy (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0399643', 'cui_str': 'Jejunal interposition (procedure)'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0192362', 'cui_str': 'Esophagojejunostomy (procedure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0033326', 'cui_str': 'Prognostic Nutritional Index (PNI)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0556133', 'cui_str': 'Glucose intake (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0227176', 'cui_str': 'Esophagus Mucosa'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0333138', 'cui_str': 'Stasis (morphologic abnormality)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0125289,"The postoperative prognostic nutritional index scores and postoperative/preoperative body weight, meal intake, serum albumin level ratio were significantly higher in the FJI group than in the Roux-en-Y group.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yun', 'Affiliation': 'Department of General Surgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Zhiwei', 'Affiliation': 'Department of General Surgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China, surgery34@163.com.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Junsheng', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Xiaobin', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Cancan', 'Affiliation': 'Department of General Surgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jieshou', 'Affiliation': 'Department of General Surgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, China.'}]",Digestive surgery,['10.1159/000501677']
1621,31523039,"Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial.","BACKGROUND


Antenatal corticosteroids given to women before preterm birth improve infant survival and health. However, whether dexamethasone or betamethasone have better maternal, neonatal, and childhood health outcomes remains unclear. We therefore aimed to assess whether administration of antenatal dexamethasone to women at risk of preterm birth reduced the risk of death or neurosensory disability in their children at age 2 years compared with betamethasone. We also aimed to assess whether dexamethasone reduced neonatal morbidity, had benefits for the mother, or affected childhood body size, blood pressure, behaviour, or general health compared with betamethasone.
METHODS


In this multicentre, double-blind, randomised controlled trial, we recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies. Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids. We randomly assigned women (1:1) to receive two intramuscular injections of either 12 mg dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose), 24 h apart. The randomisation schedule used balanced, variable blocks that were stratified by hospital, gestational age, and number of fetuses (singleton or twins). We masked all participants, staff, and assessors to treatment groups. Analyses were by intention to treat. The primary outcome was death or neurosensory disability at age 2 years (corrected for prematurity). This study is registered with ANZCTR, ACTRN12608000631303.
FINDINGS


Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50%) women were assigned to receive dexamethasone and 667 (50%) women were assigned to receive betamethasone. 27 (4%) fetuses, infants, or children in the dexamethasone group and 28 (4%) fetuses, infants, or children in the betamethasone group died before age 2 years. The primary outcome of death or neurosensory disability at age 2 years was determined for 603 (79%) of 763 fetuses whose mothers received dexamethasone and 591 (79%) of 746 fetuses whose mothers received betamethasone. We found a similar incidence of death or neurosensory disability in the dexamethasone (198 [33%] of 603 infants) and betamethasone groups (192 [32%] of 591 infants; adjusted relative risk [adjRR] 0·97, 95% CI 0·83 to 1·13; p=0·66). 18 (3%) of 679 women in the dexamethasone group and 28 of 667 (4%) women in the betamethasone group reported side-effects. Discomfort at the injection site, the most frequent side-effect, was less likely in the dexamethasone group than in the betamethasone group (six [1%] women vs 17 [3%] women; p=0·02).
INTERPRETATION


The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment. Our findings indicate that either antenatal corticosteroid can be given to women before preterm birth to improve infant and child health.
FUNDING


National Health and Medical Research Council (Australia).",2019,The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment.,"['recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies', 'Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids', 'Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50', 'and 667 (50%) women']","['antenatal corticosteroid', 'dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose', 'betamethasone', 'Maternal intramuscular dexamethasone', 'dexamethasone', 'antenatal dexamethasone']","['death or neurosensory disability', 'side-effects', 'incidence of survival without neurosensory disability', 'Discomfort', 'death or neurosensory disability at age 2 years (corrected for prematurity', 'risk of death or neurosensory disability', 'neonatal morbidity']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0108964', 'cui_str': 'Celestone Chronodose'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",679.0,0.56823,The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment.,"[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand; School of Medicine, The University of Adelaide, Adelaide, SA, Australia. Electronic address: c.crowther@auckland.ac.nz.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Chad C', 'Initials': 'CC', 'LastName': 'Andersen', 'Affiliation': ""Department of Perinatal Medicine, Women's and Children's Hospital, Adelaide, SA, Australia.""}, {'ForeName': 'Philippa F', 'Initials': 'PF', 'LastName': 'Middleton', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Osteoporosis and Bone Biology, Garvan Institute of Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Department of Obstetrics and Gynaecology, The Royal Women's Hospital and Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Robinson', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(19)30292-5']
1622,31606903,Clinical Effects of a Pectin-Containing Oligomeric Formula in Tube Feeding Patients: A Multicenter Randomized Clinical Trial.,"BACKGROUND


A pectin-containing oligomeric formula (POF) is a unique type of enteral formula that transforms from a liquid to a gel after reacting with gastric acid. Reports on its clinical effects have been limited. The present study was conducted to examine and verify the clinical effects of POF.
METHODS


The study subjects were 201 stable patients receiving intragastric tube feeding. They were randomized into 2 groups to receive either POF or a standard polymeric formula (SPF) as a control. The duration of observation was 1 week. Analyses were conducted for the incidence of predefined composite events, including diarrhea, defecation treatments, and other enteral nutrition (EN) management-related events.
RESULTS


Composite events occurred in 15 of 98 patients in the POF group and 30 of 100 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.011). In particular, diarrhea occurred in 2 patients in the POF group and 13 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.003).
CONCLUSIONS


The results of this study suggest that POF is less likely to cause EN-related events, especially diarrhea, than SPF is.",2020,"RESULTS


Composite events occurred in 15 of 98 patients in the POF group and 30 of 100 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.011).","['201 stable patients receiving intragastric tube feeding', 'Tube Feeding Patients']","['pectin-containing oligomeric formula (POF', 'POF', 'POF or a standard polymeric formula (SPF', 'Pectin-Containing Oligomeric Formula']","['diarrhea, defecation treatments, and other enteral nutrition (EN) management-related events', 'Composite events', 'diarrhea', 'duration of observation']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442113', 'cui_str': 'Intragastric (qualifier value)'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}]","[{'cui': 'C0070203', 'cui_str': 'pectin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",201.0,0.0304863,"RESULTS


Composite events occurred in 15 of 98 patients in the POF group and 30 of 100 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.011).","[{'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Maruyama', 'Affiliation': 'Clinical Study Committee, Japanese Society of Parenteral and Enteral Nutrition, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Goshi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Joetsu General Hospital, Niigata, Japan.'}, {'ForeName': 'Yasushige', 'Initials': 'Y', 'LastName': 'Kashima', 'Affiliation': 'Department of Surgery, Tochigi Medical Center, Tochigi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Mizuhara', 'Affiliation': 'Department of Cardiovascular Surgery, Higashiwashinomiya Hospital, Saitama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Higashiguchi', 'Affiliation': 'Clinical Study Committee, Japanese Society of Parenteral and Enteral Nutrition, Tokyo, Japan.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10392']
1623,31594635,"Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women.","OBJECTIVE


To investigate the efficacy and safety of the oral gonadotropin-releasing hormone receptor antagonist, relugolix, in patients experiencing uterine fibroid-associated pain.
DESIGN


Phase 3, multicenter, randomized, double-blind, placebo-controlled study.
SETTING


Medical centers.
PATIENT(S)


Premenopausal Japanese women (N = 65) experiencing moderate-to-severe uterine fibroid-associated pain with a maximum Numerical Rating Scale (NRS) score of ≥4 were randomized and completed the study.
INTERVENTION(S)


Once-daily 40 mg relugolix (n = 33) or placebo (n = 32) for 12 weeks.
MAIN OUTCOME MEASURE(S)


Primary end point: proportion of patients with a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug. Secondary end points: proportion of patients with no pain (NRS = 0) and percentage of days without pain during the 28-day period before the final dose of study drug; adverse events.
RESULT(S)


More patients receiving relugolix versus placebo achieved a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug (57.6% vs. 3.1%). Similarly, more patients receiving relugolix versus placebo achieved a maximum NRS score of 0 (48.5% vs. 3.1%) and experienced more days without pain (96.4% vs. 71.4%). More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups. Most TEAEs were mild to moderate in intensity. TEAEs (≥10%) included hot flush, metrorrhagia, hyperhidrosis, and menorrhagia, consistent with relugolix's mechanism of action, and viral upper respiratory tract infection.
CONCLUSION(S)


Relugolix improved uterine fibroid-associated pain and was well tolerated.
CLINICAL TRIAL REGISTRATION NUMBERS


NCT02655224.
JAPIC CLINICAL TRIAL INFORMATION


JapicCTI-163127.",2019,"More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups.","['pain symptoms associated with uterine fibroids', 'patients experiencing uterine fibroid-associated pain', 'Japanese women', 'Centers', 'Premenopausal Japanese women (N = 65) experiencing moderate-to-severe uterine fibroid-associated pain with a maximum Numerical Rating Scale (NRS) score of ≥4 were randomized and completed the study']","['gonadotropin-releasing hormone antagonist', 'placebo', 'oral gonadotropin-releasing hormone receptor antagonist, relugolix']","['tolerated', 'hot flush, metrorrhagia, hyperhidrosis, and menorrhagia', 'uterine fibroid-associated pain', 'rate of treatment discontinuation', 'efficacy and safety', 'maximum NRS score', 'proportion of patients with a maximum NRS score', 'proportion of patients with no pain (NRS = 0) and percentage of days without pain', 'treatment-emergent adverse events']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521858', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0025874', 'cui_str': 'Dysfunctional Uterine Bleeding'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.621112,"More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups.","[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Enya', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Osaka, Japan. Electronic address: kazuaki.enya@takeda.com.'}, {'ForeName': 'Kentarou', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hoshiai', 'Affiliation': 'Kindai University, Osaka, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.07.013']
1624,30247010,e-Consent: approaching surgical consent with mobile technology,"Background


Patient recall of information about procedures, including risks and benefits and potential outcomes, is often insufficient. We sought to determine whether a multimedia educational tool enhances the informed consent discussion for elective neurosurgical procedures by increasing patient knowledge of the procedure.
Methods


Adult patients from a single neurosurgical site eligible for 4 neurosurgical procedures (lumbar spine or cervical spine decompression for degenerative disease, craniotomy for brain tumour or trigeminal neuralgia treatment) were offered enrolment. Patients were randomly assigned to either the control arm (standard consent discussion) or the intervention arm (review of an e-book containing information tailored to their disease/injury plus standard consent discussion). Participants completed a 14-item questionnaire before and after the consent discussion.
Results


Questionnaires were completed by 38 participants, 18 in the control group and 20 in the intervention group. The mean age was 62.2 (standard deviation [SD] 13.6) years and did not differ significantly between the 2 groups. The mean
baseline questionnaire scores were similar for the control and intervention groups (20.4 [SD 7.3] v. 20.6 [SD 6.7]). However, the mean scores on the follow-up questionnaire were significantly different between the 2 groups (20.2 [SD 4.0] v. 23.2 [SD 4.9],  p  = 0.02). There was no change in the scores on the 2 questionnaires in the control group, whereas, in the intervention group, the mean score was significantly higher after the intervention ( p  = 0.03).
Conclusion


The use of an electronic booklet appears to improve patients’ knowledge of their surgical procedure. The use of multimedia booklets in clinical practice could help standardize and optimize the consent process, ensuring that patients
receive the relevant information to make a truly informed decision.",2018,"We sought to determine whether a multimedia educational tool enhances the informed consent discussion for elective neurosurgical procedures by increasing patient knowledge of the procedure.
","['Adult patients from a single neurosurgical site eligible for 4 neurosurgical procedures (lumbar spine or cervical spine decompression for degenerative disease, craniotomy for brain tumour or trigeminal neuralgia treatment']","['electronic booklet', 'multimedia educational tool', 'control arm (standard consent discussion) or the intervention arm (review of an e-book containing information tailored to their disease/injury plus standard consent discussion', 'mobile technology']","['mean\nbaseline questionnaire scores', 'mean score', 'patients’ knowledge of their surgical procedure', 'mean scores on the follow-up questionnaire']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4041236', 'cui_str': 'Neurosurgical site (morphologic abnormality)'}, {'cui': 'C0524850', 'cui_str': 'Surgical Procedures, Neurologic'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}, {'cui': 'C0040997', 'cui_str': 'Fothergill Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0368037,"We sought to determine whether a multimedia educational tool enhances the informed consent discussion for elective neurosurgical procedures by increasing patient knowledge of the procedure.
","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Bethune', 'Affiliation': 'From the Division of Neurosurgery, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont. (Bethune, Costa, Davila-Foyo); and the Institute of Medical Sciences, University of Toronto, Toronto, Ont. (Valli).'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Davila-Foyo', 'Affiliation': 'From the Division of Neurosurgery, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont. (Bethune, Costa, Davila-Foyo); and the Institute of Medical Sciences, University of Toronto, Toronto, Ont. (Valli).'}, {'ForeName': 'Mikaeel', 'Initials': 'M', 'LastName': 'Valli', 'Affiliation': 'From the Division of Neurosurgery, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont. (Bethune, Costa, Davila-Foyo); and the Institute of Medical Sciences, University of Toronto, Toronto, Ont. (Valli).'}, {'ForeName': 'Leodante', 'Initials': 'L', 'LastName': 'da Costa', 'Affiliation': 'From the Division of Neurosurgery, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont. (Bethune, Costa, Davila-Foyo); and the Institute of Medical Sciences, University of Toronto, Toronto, Ont. (Valli).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.016017']
1625,31597476,Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation.,"BACKGROUND


Postoperative atrial fibrillation (POAF) occurs in up to 40% of patients undergoing cardiac surgery. Invasive stimulation of the vagal nerve previously demonstrated a reduced risk of POAF. Therefore, we examined the antiarrhythmic and anti-inflammatory effects of noninvasive low-level transcutaneous electrical stimulation (LLTS) of the greater auricular nerve in a pilot trial including patients undergoing cardiac surgery.
METHODS


Patients were randomized into a sham (n=20) or a treatment group (n=20) for LLTS. After cardiac surgery, electrodes were applied in the triangular fossa of the ear. Stimulation (amplitude 1 mA, frequency 1 Hz for 40 minutes, followed by a 20 minutes break) was performed for up to 2 weeks after cardiac surgery. Heart rhythm was recorded continuously using an ECG during the observation period. CRP (C-reactive protein) and IL (interleukin)-6 plasma concentrations were measured immediately after surgery as well as on day 2 and 7 postsurgery.
RESULTS


Patients receiving LLTS had a significantly reduced occurrence of POAF (4 of 20) when compared with controls (11 of 20,  P =0.022) during a similar mean Holter recording period. The median duration of POAF was comparable between the treatment and the control group (878 [249; 1660] minutes versus 489 [148; 1775] minutes;  P =0.661). No effect of LLTS on CRP or IL-6 levels was detectable.
CONCLUSIONS


LLTS of the greater auricular nerve may be a potential therapy for POAF. We demonstrated the feasibility to conduct a randomized trial of neurostimulation as an outlay for a multisite clinical trial.",2019,"RESULTS


Patients receiving LLTS had a significantly reduced occurrence of POAF (4 of 20) when compared with controls (11 of 20,  P =0.022) during a similar mean Holter recording period.","['Patients', 'patients undergoing cardiac surgery']","['LLTS', 'noninvasive low-level transcutaneous electrical stimulation (LLTS']","['risk of POAF', 'CRP (C-reactive protein) and IL ', 'interleukin)-6 plasma concentrations', 'Heart rhythm', 'Postoperative Atrial Fibrillation', 'occurrence of POAF', 'CRP or IL-6 levels', 'median duration of POAF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0999518,"RESULTS


Patients receiving LLTS had a significantly reduced occurrence of POAF (4 of 20) when compared with controls (11 of 20,  P =0.022) during a similar mean Holter recording period.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Andreas', 'Affiliation': 'Department of Cardiac Surgery (M.A., P.A., A.M., F.-M.K., A.K., G.L.), Medical University of Vienna, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Arzl', 'Affiliation': 'Department of Cardiac Surgery (M.A., P.A., A.M., F.-M.K., A.K., G.L.), Medical University of Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mitterbauer', 'Affiliation': 'Department of Cardiac Surgery (M.A., P.A., A.M., F.-M.K., A.K., G.L.), Medical University of Vienna, Austria.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Ballarini', 'Affiliation': 'Center for Medical Statistics, Informatics, and Intelligence Systems (CeMSIIS) (N.M.B.), Medical University of Vienna, Austria.'}, {'ForeName': 'Frieda-Maria', 'Initials': 'FM', 'LastName': 'Kainz', 'Affiliation': 'Department of Cardiac Surgery (M.A., P.A., A.M., F.-M.K., A.K., G.L.), Medical University of Vienna, Austria.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Kocher', 'Affiliation': 'Department of Cardiac Surgery (M.A., P.A., A.M., F.-M.K., A.K., G.L.), Medical University of Vienna, Austria.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Laufer', 'Affiliation': 'Department of Cardiac Surgery (M.A., P.A., A.M., F.-M.K., A.K., G.L.), Medical University of Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': 'Section for Medical Statistics, and Department of Clinical Pharmacology (M.W.), Medical University of Vienna, Austria.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007711']
1626,30801373,Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis.,"BACKGROUND


The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.
METHODS


Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.
RESULTS


Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.
CONCLUSIONS


On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2019,Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001).,"['Two hundred and twenty-three patients were enrolled in the observational cohort', 'Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers', 'Adult Symptomatic Lumbar Scoliosis', 'adult lumbar scoliosis', 'Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group']",['Operative Versus Nonoperative Treatment'],"['SRS-22 subscore and ODI outcomes', 'SRS-22 subscore', 'Nonadherence', 'SRS-22 subscore and ODI', 'ODI']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score (observable entity)'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0035168'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],223.0,0.151034,Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001).,"[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kelly', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Lurie', 'Affiliation': 'Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Yanik', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Shaffrey', 'Affiliation': 'Department of Neurological Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Christine R', 'Initials': 'CR', 'LastName': 'Baldus', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Oheneba', 'Initials': 'O', 'LastName': 'Boachie-Adjei', 'Affiliation': 'FOCOS Orthopedic Hospital, Accra, Ghana.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Buchowski', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Leah Y', 'Initials': 'LY', 'LastName': 'Carreon', 'Affiliation': 'Norton Leatherman Spine Center, Louisville, Kentucky.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Crawford', 'Affiliation': 'Norton Leatherman Spine Center, Louisville, Kentucky.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Mercy Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Errico', 'Affiliation': 'NYU Hospital for Joint Diseases, New York, NY.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Glassman', 'Affiliation': 'Norton Leatherman Spine Center, Louisville, Kentucky.'}, {'ForeName': 'Munish C', 'Initials': 'MC', 'LastName': 'Gupta', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Lenke', 'Affiliation': 'Department of Orthopedic Surgery, Columbia University, New York, NY.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lewis', 'Affiliation': 'UHN-Orthopedics, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Koski', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Evanston, Illinois.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Parent', 'Affiliation': 'Sainte-Justine University Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwab', 'Affiliation': 'Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Smith', 'Affiliation': 'Department of Neurological Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Lukas P', 'Initials': 'LP', 'LastName': 'Zebala', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Bridwell', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.18.00483']
1627,31085731,"Author response: DBS of the PSA and the VIM in essential tremor: A randomized, double-blind, crossover trial.",,2019,,[],[],[],[],[],[],,0.518331,,"[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Till A', 'Initials': 'TA', 'LastName': 'Dembek', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Steffen', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Allert', 'Affiliation': '(Bonn, Germany).'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wirths', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Voges', 'Affiliation': '(Magdeburg, Germany).'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': '(Cologne, Germany).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': '(Cologne and Marburg, Germany).'}]",Neurology,['10.1212/WNL.0000000000007521']
1628,31540611,Sleep reductions associated with illicit opioid use and clinic-hour changes during opioid agonist treatment for opioid dependence: Measurement by electronic diary and actigraphy.,"Sleep problems are commonly reported during opioid agonist treatment (OAT) for opioid use disorders. Inpatient studies have found both sleep disturbances and improved sleep during OAT. Illicit opioids can also disrupt sleep, but it is unclear how they affect sleep in outpatients receiving OAT. Therefore, we used electronic diary entries and actigraphy to measure sleep duration and timing in opioid-dependent participants (n = 37) treated with methadone (n = 15) or buprenorphine (n = 22). For 16 weeks, participants were assigned to attend our clinic under different operating hours in a crossover design: Early hours (07:00-09:00) vs. Late hours (12:00-13:00) for 4 weeks each in randomized order, followed for all participants by our Standard clinic hours (07:00-11:30) for 8 weeks. Throughout, participants made daily electronic diary self-reports of their sleep upon waking; they also wore a wrist actigraph for 6 nights in each of the three clinic-hour conditions. Drug use was assessed by thrice-weekly urinalysis. In linear mixed models controlling for other sleep-relevant factors, sleep duration and timing differed by drug use and by clinic hours. Compared to when non-using, participants slept less, went to bed later, and woke later when using illicit opioids and/or both illicit opioids and cocaine. Participants slept less and woke earlier when assigned to the Early hours. These findings highlight the role OAT clinic schedules can play in structuring the sleep/wake cycles of OAT patients and clarify some of the circumstances under which OAT patients experience sleep disruption in daily life.",2019,"Compared to when non-using, participants slept less, went to bed later, and woke later when using illicit opioids and/or both illicit opioids and cocaine.","['outpatients receiving OAT', 'opioid-dependent participants (n\u202f=\u202f37) treated with']","['methadone', 'buprenorphine', 'opioid agonist treatment (OAT', 'cocaine']",[],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",[],,0.027314,"Compared to when non-using, participants slept less, went to bed later, and woke later when using illicit opioids and/or both illicit opioids and cocaine.","[{'ForeName': 'Jeremiah W', 'Initials': 'JW', 'LastName': 'Bertz', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA. Electronic address: jeremiah.bertz@nih.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Epstein', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reamer', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kowalczyk', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Karran A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Kennedy', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Jobes', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ward', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Plitnick', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Rea', 'Affiliation': 'Rensselaer Polytechnic Institute, Lighting Research Center, Troy, NY, USA.'}, {'ForeName': 'Kenzie L', 'Initials': 'KL', 'LastName': 'Preston', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.011']
1629,31370981,Smokers with opioid use disorder may have worse drug use outcomes after varenicline than nicotine replacement.,"INTRODUCTION


Smokers with opioid use disorder (OUD) have little success with smoking cessation, possibly due to interactions between nicotine and opioid receptor systems. Smokers with OUD versus non-opioid substance use disorders (NOUD) have not been compared for response to smoking treatment. Data to make this comparison came from our previous study of 12 weeks (plus dose run-up) of varenicline (VAR) versus 12 weeks of nicotine patch (NRT), in a double-placebo design.
METHODS


The current study reports secondary analyses comparing smokers with OUD (n = 47) and NOUD (n = 90) on pretreatment smoking, alcohol and drug use, intolerance of physical discomfort, smoking medication adherence, and 3- and 6-month smoking and substance use outcomes (by VAR versus NRT).
RESULTS


Smokers with OUD did not differ on pretreatment alcohol or smoking measures while reporting significantly more drug use days. Smokers with OUD versus NOUD had significantly fewer days adherent to VAR or placebo capsules but not to patches, and were more tolerant of physical discomfort. While smoking and heavy drinking days at follow-ups did not differ by diagnosis, smokers with OUD had significantly more drug use days in months 4-6 when assigned to VAR (16.4 days) than to NRT (8.1 days).
CONCLUSIONS


NRT might be a better choice than VAR for smokers with OUD due to lower adherence and more drug use days with VAR. However, this novel comparison of smoking pharmacotherapy response in smokers with OUD versus NOUD needs to be confirmed with larger numbers of participants.",2019,"Smokers with OUD versus NOUD had significantly fewer days adherent to VAR or placebo capsules but not to patches, and were more tolerant of physical discomfort.","['Smokers with opioid use disorder (OUD', 'smokers with OUD (n\u202f=\u202f47) and NOUD (n\u202f=\u202f90) on pretreatment smoking, alcohol and drug use, intolerance of physical discomfort, smoking medication adherence, and 3- and 6-month smoking and substance use outcomes (by VAR versus NRT', 'Smokers with opioid use disorder', 'Smokers with OUD versus non-opioid substance use disorders (NOUD']","['nicotine patch (NRT', 'varenicline (VAR', 'varenicline']",['tolerant of physical discomfort'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",,0.0187383,"Smokers with OUD versus NOUD had significantly fewer days adherent to VAR or placebo capsules but not to patches, and were more tolerant of physical discomfort.","[{'ForeName': 'Rosemarie A', 'Initials': 'RA', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, USA. Electronic address: Damaris_Rohsenow@Brown.edu.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI 02912, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.06.005']
1630,31878319,"Effect of Exergame Training and Detraining on Lower-Body Strength, Agility, and Cardiorespiratory Fitness in Women with Fibromyalgia: Single-Blinded Randomized Controlled Trial.","The aim of this study was to analyze the effects of a 24 week exergame intervention and 24 weeks of detraining on lower-limb strength, agility, and cardiorespiratory fitness in women with fibromyalgia (FM). It was performed as a single-blinded randomized controlled trial of 55 women with FM. University facilities were used. The 24 week exergame intervention was focused on mobility, postural control, upper- and lower-limb coordination, aerobic fitness, and strength. Participants performed 120 min of exergaming per week, which was divided into two sessions. Twenty-four weeks after the end of the intervention, participants were re-evaluated. A chair-stand test, 10 step stair test, and six-minute walk test were conducted to assess lower-body strength, agility, and cardiorespiratory fitness, respectively. The exergame intervention significantly improved lower-limb strength and cardiorespiratory fitness. However, no significant effects on agility were observed. After the detraining period, lower-limb strength and agility returned to their baseline level, but improvements in cardiorespiratory fitness were sustained over time. Exergaming was therefore shown to be beneficial for physical fitness in people with FM. However, exergames had to be played regularly to maintain the benefits. This long-term intervention (24 weeks) may have changed the lifestyle of women with FM, which could explain why cardiorespiratory fitness improvements remained after the detraining period. Future research should focus on lifestyle changes after long-term interventions.",2019,"The 24 week exergame intervention was focused on mobility, postural control, upper- and lower-limb coordination, aerobic fitness, and strength.","['Women with Fibromyalgia', 'women with fibromyalgia (FM', 'people with FM', '55 women with FM']",['Exergame Training and Detraining'],"['lower-limb strength and agility', 'agility', 'lower-limb strength, agility, and cardiorespiratory fitness', 'lower-body strength, agility, and cardiorespiratory fitness', 'lower-limb strength and cardiorespiratory fitness', 'mobility, postural control, upper- and lower-limb coordination, aerobic fitness, and strength', 'Lower-Body Strength, Agility, and Cardiorespiratory Fitness', 'cardiorespiratory fitness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",55.0,0.0429045,"The 24 week exergame intervention was focused on mobility, postural control, upper- and lower-limb coordination, aerobic fitness, and strength.","[{'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Avda: Universidad S/N, 10003 Cáceres, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Borrega-Mouquinho', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Avda: Universidad S/N, 10003 Cáceres, Spain.'}, {'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Fuentes-García', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Avda: Universidad S/N, 10003 Cáceres, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Avda: Universidad S/N, 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17010161']
1631,28823947,"Safety, pharmacokinetics and dose-response characteristics of GSK2269557, an inhaled PI3Kδ inhibitor under development for the treatment of COPD.","BACKGROUND


While current therapies reduce symptoms in chronic obstructive pulmonary disease (COPD) patients, substantial unmet need remains and novel treatments are highly desired. Phosphoinositide 3-kinase δ (PI3Kδ) is a lipid kinase specifically expressed in leucocytes and involved in their recruitment and activation. This study evaluated the safety, pharmacokinetics (PK) and dose-response characteristics of inhaled GSK2269557, a PI3Kδ inhibitor, in moderate-to-severe COPD patients with stable disease.
METHODS


In this randomised, double-blind, placebo controlled, parallel group study, patients received once daily inhaled treatment with GSK2269557 1000 μg or placebo for 14 days (Part A, primary aim safety, N = 28 patients). In part B of the study (primary aim pharmacodynamic dose-response, N = 36 patients), GSK2269557 100, 200, 500, 700, 1000, 2000 μg or placebo was given for 14 days. In both Part A and B, GSK2269557 was added to the usual maintenance therapy. Safety, PK assessments and induced sputum collection for cytokine analysis were conducted at baseline and after 7 and 14 days of treatment. Adverse events (AEs) were monitored throughout.
RESULTS


In Part A, mean age was 61.7 years (SD 6.7), 29% were females, and mean FEV 1 % predicted was 59.7% (SD 11.4) 2 . In Part B, mean age was 63.3 years (SD 6.3), 44% were females, and mean FEV 1 % predicted was 56.5% (SD 11.5) 2 . GSK2269557 was well tolerated in both parts of the study; the most commonly reported AEs were cough and headache, with cough being reported with a greater incidence in the GSK2269557 groups vs. placebo (Part A: 19% vs. 14% and Part B: range of 0-80% for different doses vs. 0% on placebo). No drug-related serious AEs or clinically significant changes in any other safety parameters were reported. GSK2269557 was rapidly absorbed into plasma following all doses with a maximum peak at approximately 2 h. Following repeat administration, accumulation in plasma was approximately 2-3 fold from Day 1 to Day 7. At Day 14, relative to placebo, sputum interleukin (IL)-8 and IL-6 levels were reduced on average by 32% and 29% respectively after inhalation of GSK2269557 1000 μg in Part A. In Part B, although inhibition of both IL-8 and IL-6 levels was observed, the levels were variable and there was insufficient evidence to support a monotonic dose-response.
CONCLUSIONS


In this study, inhaled GSK2269557 had an acceptable safety profile for progression into larger studies in COPD patients. Moreover, inhalation of GSK2269557 resulted in suppression of sputum IL-8 and IL-6 levels, consistent with the known anti-inflammatory activity of a PI3Kδ inhibitor. Inhibition of inflammatory cytokines in the airway compartment may contribute to the potential therapeutic benefit of a PI3Kδ inhibitor in chronically inflamed COPD patients.",2017,"At Day 14, relative to placebo, sputum interleukin (IL)-8 and IL-6 levels were reduced on average by 32% and 29% respectively after inhalation of GSK2269557 1000 μg in Part A.","['COPD patients', 'chronically inflamed COPD patients', 'moderate-to-severe COPD patients with stable disease', 'chronic obstructive pulmonary disease (COPD) patients']","['placebo', 'PI3Kδ inhibitor', 'GSK2269557', 'inhaled GSK2269557, a PI3Kδ inhibitor', 'GSK2269557 1000\xa0μg or placebo', 'Phosphoinositide 3-kinase δ (PI3Kδ']","['Safety, PK assessments and induced sputum collection for cytokine analysis', 'tolerated', 'sputum interleukin (IL)-8 and IL-6 levels', 'suppression of sputum IL-8 and IL-6 levels', 'inhibition of both IL-8 and IL-6 levels', 'safety, pharmacokinetics (PK', 'accumulation in plasma', 'cough and headache', 'Adverse events (AEs']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4078792', 'cui_str': 'GSK2269557'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0044602', 'cui_str': 'Phosphoinositide 3 Kinase'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1272358', 'cui_str': 'Collection of induced sputum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.345953,"At Day 14, relative to placebo, sputum interleukin (IL)-8 and IL-6 levels were reduced on average by 32% and 29% respectively after inhalation of GSK2269557 1000 μg in Part A.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Hamblin', 'Affiliation': 'Refractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Begg', 'Affiliation': 'Refractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dunsire', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sriskantharajah', 'Affiliation': 'Refractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montembault', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, UK.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Leemereise', 'Affiliation': 'GlaxoSmithKline, Zeist, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Galinanes-Garcia', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Centre North, German Centre for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Kirsten', 'Affiliation': 'Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Centre North, German Centre for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fuhr', 'Affiliation': 'PAREXEL International GmbH, EPCU Berlin, Germany.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Hessel', 'Affiliation': 'Refractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK. Electronic address: edith.m.hessel@gsk.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2017.08.008']
1632,31299040,Development of transfusion guidelines for injured children using a Modified Delphi Consensus Process.,"BACKGROUND


There is wide variability of transfusion practices for children with hemorrhagic injuries across trauma centers. We are planning a multicenter, randomized clinical trial evaluating tranexamic acid in children with hemorrhage. Standardization of transfusion practices across sites is important to minimize confounding. Therefore, we sought to generate consensus-based transfusion guidelines for the trial.
METHODS


We used a modified Delphi process utilizing a multi-site, multi-disciplinary panel of experts to develop our transfusion guidelines. A survey of 23 clinical categories on various aspects of transfusion practices was developed and distributed via SurveyMonkey®. Statements were graded on a 5-point Likert scale (""Strongly agree"" to ""This intervention may be harmful""). Statements were accepted if ≥ 80% of the panelists rated the statement as ""Strongly agree"" or ""Agree"". After each round, the responses were calculated and the results included on subsequent rounds.
RESULTS


35 panelists from four pediatric trauma centers participated in the study, including 11 (31%) pediatric EM physicians, 8 (23%) pediatric trauma surgeons, 5 (14%) transfusionists, 5 (14%) pediatric anesthesiologists, and 6 (17%) pediatric critical care physicians (range of 8 to 10 from each clinical site). Four survey iterations were performed. In total 176 statements were rated and 39 were accepted by criteria across all 23 categories. An rational algorithm for transfusion in trauma was then developed.
CONCLUSIONS


We successfully developed transfusion guidelines for various aspects of the management of children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation. We anticipate implementation of these guidelines will help minimize heterogeneity of transfusion practices across clinical sites for the upcoming clinical trial evaluating tranexamic acid in children with hemorrhage.",2019,We successfully developed transfusion guidelines for various aspects of the management of children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation.,"['injured children', 'children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation', 'children with hemorrhage', 'children with hemorrhagic injuries across trauma centers', '35 panelists from four pediatric trauma centers participated in the study, including 11 (31%) pediatric EM physicians, 8 (23%) pediatric trauma surgeons, 5 (14%) transfusionists, 5 (14%) pediatric anesthesiologists, and 6 (17%) pediatric critical care physicians (range of 8 to 10 from each clinical site']",['tranexamic acid'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0586908', 'cui_str': 'Trauma surgeon (occupation)'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],176.0,0.155164,We successfully developed transfusion guidelines for various aspects of the management of children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation.,"[{'ForeName': 'A Francois', 'Initials': 'AF', 'LastName': 'Trappey', 'Affiliation': ""From the David Grant Air Force Medical Center (A.F.T.), Travis Air Force Base, Fairfield, California; Division of Trauma and Acute Care Surgery (A.F.T.), General Surgery Residency Program (K.M.T.), Department of Surgery, Emergency Medicine and Pediatrics (N.K.), UC Davis Health System, Division of Pediatric General and Thoracic Surgery (J.T.S.), Division of Public Health Sciences (M.A.N.), University of California at Davis, Davis, California; Division of Pediatric Emergency Medicine (H.A.H.), Primary Children's Hospital, University of Utah Health, Salt Lake City, Utah; Department of Emergency Medicine (S.R.M.), Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania; Emergency Medicine (R.M.S.), Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio; Department of Emergency Medicine, Trauma, Acute Care Surgery and Surgical Critical Care (J.M.G.), and Division of Emergency Medicine (D.K.N.), University of California at Davis, Davis, California.""}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': ''}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Stephenson', 'Affiliation': ''}, {'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Nuno', 'Affiliation': ''}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Hewes', 'Affiliation': ''}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Meyers', 'Affiliation': ''}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Galante', 'Affiliation': ''}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Nishijima', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002432']
1633,31152605,Population Pharmacokinetic Modeling and Exposure-Response Assessment for the Antibody-Drug Conjugate Brentuximab Vedotin in Hodgkin's Lymphoma in the Phase III ECHELON-1 Study.,"The efficacy of the CD30-directed antibody-drug conjugate (ADC) brentuximab vedotin was established in combination with chemotherapy as frontline treatment for advanced classical Hodgkin's lymphoma in the randomized phase III ECHELON-1 study. Population pharmacokinetic (PK) and exposure-response models were developed to quantify sources of PK variability and relationships between exposure and safety/efficacy end points in ECHELON-1. The influence of patient-specific factors on the PK of the ADC and the microtubule-disrupting payload monomethyl auristatin E (MMAE) was investigated; none of the significant covariates had a clinically relevant impact. Exposure-response analyses evaluated relationships between time-averaged area under the curve (AUC; ADC, MMAE) and efficacy end points (ADC) or safety parameters (ADC, MMAE). Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges. Exposure-safety analyses supported the recommended brentuximab vedotin starting dose (1.2 mg/kg every 2 weeks), and effective management of peripheral neuropathy and neutropenia with dose modification/reduction and febrile neutropenia with granulocyte colony-stimulating factor primary prophylaxis.",2019,Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges.,"[""advanced classical Hodgkin's lymphoma""]","['chemotherapy', 'granulocyte colony-stimulating factor primary prophylaxis', 'CD30-directed antibody-drug conjugate (ADC) brentuximab vedotin']","['time-averaged area under the curve (AUC; ADC, MMAE) and efficacy end points (ADC) or safety parameters (ADC, MMAE']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0192173,Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges.,"[{'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Suri', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Mould', 'Affiliation': 'Projections Research, Inc., Phoenixville, Pennsylvania, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Collins', 'Affiliation': 'Oxford Cancer and Haematology Centre, Oxford University Hospital, Oxford, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Endres', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington, USA.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Gomez-Navarro', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1530']
1634,31368908,"Comparison of Effectiveness of Etoricoxib and Diclofenac on Pain and Perioperative Sequelae After Surgical Avulsion of Mandibular Third Molars: A Randomized, Controlled, Clinical Trial.","OBJECTIVE


The objective of this analysis was to compare the efficacy of etoricoxib and diclofenac in the management of perioperative sequelae following impacted mandibular third molar surgery.
MATERIALS AND METHODS


Ninety-seven patients who needed surgical avulsion of an impacted mandibular third molar were chosen for the study. All patients were randomly allocated to receive one of the following treatments, twice a day for 5 days after surgery: placebo (n=33), diclofenac (n=32), or etoricoxib (n=32). The primary outcome evaluated was postoperative pain, recorded by each patient and evaluated using the Visual Analogue Scale score. The secondary outcomes chosen were, compared with preoperative ones, changes in postoperative swelling and maximum mouth opening.
RESULTS


Compared with placebo, treatment with etoricoxib and diclofenac demonstrated an enhancement in the primary outcome. Furthermore, when compared with the other groups, patients who had undergone etoricoxib presented a significant median reduction in postoperative pain at 2 hours (P<0.001), 12 hours (P=0.025), and at 48 hours (P=0.018) after surgery. Moreover, the linear regression analysis showed that diclofenac and etoricoxib determined a significant influence on Visual Analogue Scale at 2, 6, 12, 24, 48 hours and at 10 days after surgery. There were no differences in swelling and maximum mouth opening values between groups.
DISCUSSION


This study demonstrated that both treatments were effective. However, treatment with etoricoxib showed a greater reduction in the incidence and severity of postoperative pain following third molar surgery compared with diclofenac and placebo.",2019,"There were no differences in swelling and maximum mouth opening values between groups.
","['Ninety-seven patients who needed surgical avulsion of an impacted mandibular third molar were chosen for the study', 'impacted mandibular third molar surgery']","['Etoricoxib and Diclofenac', 'diclofenac', 'placebo', 'etoricoxib', 'etoricoxib and diclofenac']","['postoperative pain', 'visual analogue scale (VAS) score', 'incidence and severity of postoperative pain', 'Pain and Perioperative Sequelae', 'VAS', 'swelling and maximum mouth opening values', 'postoperative swelling and maximum mouth opening']","[{'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0185044', 'cui_str': 'Avulsion - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",97.0,0.462934,"There were no differences in swelling and maximum mouth opening values between groups.
","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Isola', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, School of Dentistry, University of Catania, Catania.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Matarese', 'Affiliation': 'Department of Biomedical and Odontostomatological Sciences and Morphological and Functional Images, School of Dentistry.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Unit of Statistical and Mathematical Sciences, Department of Economics, University of Messina, Messina.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Dalessandri', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Dental School, University of Brescia, Brescia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Migliorati', 'Affiliation': 'Department of Odontostomatology, School of Dentistry, University of Genova, Genova, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Pedullà', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, School of Dentistry, University of Catania, Catania.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rapisarda', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, School of Dentistry, University of Catania, Catania.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000748']
1635,31898118,Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial.,"BACKGROUND


Short-term health care costs following completion of health risk assessments and coaching programs in the VA have not been assessed.
OBJECTIVE


To compare VA health care expenditures among veterans who participated in a behavioral intervention trial that randomized patients to complete a HRA followed by health coaching (HRA + coaching) or to complete the HRA without coaching (HRA-alone).
DESIGN


Four-hundred seventeen veterans at three Veterans Affairs (VA) Medical Centers or Clinics were randomized to HRA + coaching or HRA-alone. Veterans randomized to HRA-alone (n = 209) were encouraged to discuss HRA results with their primary care team, while veterans randomized to HRA + coaching (n = 208) received two brief telephone-delivered health coaching calls.
PARTICIPANTS


We included 411 veterans with available cost data.
MAIN MEASURES


Total VA health expenditures 6 months following trial enrollment were estimated using a generalized linear model with a gamma distribution and log link function. In exploratory analysis, model-based recursive partitioning was used to determine whether the intervention effect on short-term costs differed among any patient subgroups.
KEY RESULTS


Most participants were male (85%); mean age was 56, and mean body mass index was 34. From the generalized linear model, 6-month estimated mean total VA expenditures were similar ($8665 for HRA + coaching vs $9900 for HRA-alone, p = 0.25). In exploratory subgroup analysis, among unemployed veterans with good sleep and fair or poor perceived health, mean observed expenditures in the HRA + coaching group were higher than in the HRA-alone group ($12,814 vs $7971). Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612).
CONCLUSIONS


Compared to completing and receiving HRA results, working with health coaches to set actionable health behavior change goals following HRA completion did not reduce short-term health expenditures.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT01828567.",2020,"Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612).
","['veterans who participated in a behavioral intervention trial that randomized patients to complete a', 'Medical Centers or Clinics', 'Four-hundred seventeen veterans at three Veterans Affairs (VA', '411 veterans with available cost data', 'n = 209', 'Most participants were male (85%); mean age was 56, and mean body mass index was 34']","['HRA-alone', 'HRA + coaching', 'HRA followed by health coaching (HRA + coaching) or to complete the HRA without coaching (HRA-alone', 'telephone-delivered health coaching calls', 'HRA + coaching or HRA-alone']",['mean total VA expenditures'],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",411.0,0.0415601,"Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612).
","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sloan', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Stechuchak', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Damschroder', 'Affiliation': 'Ann Arbor VA HSR&D/Center for Clinical Management Research, P.O. Box 130170, Ann Arbor, MI, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), , Durham Veterans Affairs Health Care System, Durham, NC, USA. matthew.maciejewski@va.gov.'}]",Journal of general internal medicine,['10.1007/s11606-019-05455-z']
1636,31577867,Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies.,"OBJECTIVE


To analyze the effect of adjunctive brexpiprazole on metabolic parameters and body weight in adults with major depressive disorder (MDD) based on pooled data from 4 short-term studies and 1 long-term extension study.
METHODS


The short-term studies (June 2011 to November 2016) were randomized, double-blind, placebo-controlled studies in outpatients with MDD (DSM-IV-TR criteria) and inadequate response to 1-3 prior antidepressant treatments (ADTs) plus 1 prospective ADT. Patients were randomized to adjunctive brexpiprazole (fixed or flexible doses in the range of 1-3 mg/d; n = 1,032) or placebo (n = 819) for 6 weeks. The long-term study (October 2011 to May 2017) was a 52-week (amended to 26 weeks), open-label, uncontrolled study of adjunctive brexpiprazole 0.5-3 mg/d (flexible dose; n = 2,938). Mean changes from baseline and categorical shifts in fasting metabolic parameters (cholesterol, triglycerides, and glucose) and body weight were analyzed.
RESULTS


Mean changes from baseline in metabolic parameters were small after 6 weeks (all < 2 mg/dL) and 52 weeks (all < 4 mg/dL, except triglycerides, 15.83 mg/dL) of treatment. In most cases, the incidence of unfavorable shifts in metabolic parameters was lower than the incidence of favorable shifts. Mean body weight increase at last visit in the short-term studies was 1.5 kg with ADT + brexpiprazole and 0.3 kg with ADT + placebo. During long-term treatment, mean body weight increased by 3.8 kg over 58 weeks.
CONCLUSIONS


Adjunctive brexpiprazole was associated with small changes in metabolic parameters and moderate weight gain during short- and long-term treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT01360866.",2019,"Mean changes from baseline in metabolic parameters were small after 6 weeks (all < 2 mg/dL) and 52 weeks (all < 4 mg/dL, except triglycerides, 15.83 mg/dL) of treatment.","['Patients With Major Depressive Disorder Treated With', 'outpatients with MDD (DSM-IV-TR criteria) and inadequate response to 1-3 prior antidepressant treatments (ADTs) plus 1 prospective ADT', 'adults with major depressive disorder (MDD']","['ADT + brexpiprazole', 'ADT + placebo', 'placebo', 'adjunctive brexpiprazole', 'Adjunctive Brexpiprazole']","['metabolic parameters and moderate weight gain', 'fasting metabolic parameters (cholesterol, triglycerides, and glucose) and body weight', 'mean body weight', 'metabolic parameters and body weight', 'Mean body weight increase', 'Metabolic Parameters and Body Weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0464562,"Mean changes from baseline in metabolic parameters were small after 6 weeks (all < 2 mg/dL) and 52 weeks (all < 4 mg/dL, except triglycerides, 15.83 mg/dL) of treatment.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Thriving Mind South Florida, 7205 Corporate Center Dr, Ste 200, Miami, FL 33126. jnewcomer@thrivingmind.org.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eriksson', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA.'}, {'ForeName': 'Stine R', 'Initials': 'SR', 'LastName': 'Meehan', 'Affiliation': 'H. Lundbeck A/S, Valby, Copenhagen, Denmark.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12680']
1637,31575375,"Effects of 1 year of exercise training versus combined exercise training and weight loss on body composition, low-grade inflammation and lipids in overweight patients with coronary artery disease: a randomized trial.","BACKGROUND


Dyslipidaemia and low-grade inflammation are central in atherogenesis and linked to overweight and physical inactivity. Lifestyle changes are important in secondary prevention of coronary artery disease (CAD). We compared the effects of combined weight loss and interval training with interval training alone on physical fitness, body composition, dyslipidaemia and low-grade inflammation in overweight, sedentary participants with CAD.
METHODS


Seventy CAD patients, BMI 28-40 kg/m 2  and age 45-75 years were randomised to (1) 12 weeks' aerobic interval training (AIT) at 90% of peak heart rate three times/week followed by 40 weeks' AIT twice weekly or (2) a low energy diet (LED) (800-1000 kcal/day) for 8-10 weeks followed by 40 weeks' weight maintenance including AIT twice weekly and a high-protein/low-glycaemic load diet. Effects of the intervention were evaluated by physical fitness, body weight and composition. Dyslipidaemia was described using both biochemical analysis of lipid concentrations and lipoprotein particle subclass distribution determined by density profiling. Low-grade inflammation was determined by C-reactive protein, soluble urokinase-type plasminogen activator receptor and tumour necrosis factor α. Effects on continuous outcomes were tested by mixed-models analysis.
RESULTS


Twenty-six (74%) AIT and 29 (83%) LED + AIT participants completed the study. At baseline subject included 43 (78%) men; subjects averages were: age 63 years (6.2), body weight 95.9 kg (12.2) and VO 2 peak 20.7 mL O 2 /kg/min (4.9). Forty-six (84%) had pre-diabetes (i.e. impaired fasting glucose and/or impaired glucose tolerance). LED + AIT reduced body weight by 7.2 kg (- 8.4; - 6.1) and waist circumference by 6.6 cm (- 7.7; - 5.5) compared to 1.7 kg (- 0.7; - 2.6) and 3.3 cm (- 5.1; - 1.5) after AIT (within-group p < 0.001, between-group p < 0.001 and p = 0.018, respectively). Treatments caused similar changes in VO 2 peak and lowering of total cholesterol, triglycerides, non-HDL cholesterol and low-grade inflammation. A shift toward larger HDL particles was seen following LED + AIT while AIT elicited no change.
CONCLUSIONS


Both interventions were feasible. Both groups obtained improvements in VO 2 peak, serum-lipids and inflammation with superior weight loss and greater central fat loss following LED + AIT. Combined LED induced weight loss and exercise can be recommended to CAD patients. Trial registration NCT01724567, November 12, 2012, retrospectively registered (enrolment ended in April 2013).",2019,"Both groups obtained improvements in VO 2 peak, serum-lipids and inflammation with superior weight loss and greater central fat loss following LED + AIT.","['overweight, sedentary participants with CAD', 'Twenty-six (74', 'November 12, 2012, retrospectively registered (enrolment ended in April 2013', 'overweight patients with coronary artery disease', 'Forty-six (84%) had pre-diabetes (i.e. impaired fasting glucose', 'At baseline subject included 43 (78%) men; subjects averages were: age 63\xa0years (6.2), body weight 95.9\xa0kg (12.2) and VO 2 peak 20.7\xa0mL', 'Seventy CAD patients, BMI 28-40\xa0kg/m 2  and age 45-75\xa0years']","[""aerobic interval training (AIT) at 90% of peak heart rate three times/week followed by 40\xa0weeks' AIT twice weekly or (2) a low energy diet (LED"", 'weight maintenance including AIT twice weekly and a high-protein/low-glycaemic load diet', 'LED\u2009', 'exercise training versus combined exercise training and weight loss', 'combined weight loss and interval training with interval training alone']","['and/or impaired glucose tolerance', 'Dyslipidaemia', 'Low-grade inflammation', 'weight loss', 'waist circumference', 'VO 2 peak and lowering of total cholesterol, triglycerides, non-HDL cholesterol and low-grade inflammation', 'LED\u2009+\u2009AIT reduced body weight', 'physical fitness, body composition, dyslipidaemia and low-grade inflammation', 'body composition, low-grade inflammation and lipids', 'VO 2 peak, serum-lipids and inflammation with superior weight loss and greater central fat loss', 'physical fitness, body weight and composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456698', 'cui_str': 'times/week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C3654008', 'cui_str': 'Low-energy diets'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",70.0,0.111963,"Both groups obtained improvements in VO 2 peak, serum-lipids and inflammation with superior weight loss and greater central fat loss following LED + AIT.","[{'ForeName': 'Lene Rørholm', 'Initials': 'LR', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, University of Copenhagen, Building 67, 1st, Bispebjerg Bakke 23, 2400, Copenhagen, NW, Denmark. lrpedersen@gmail.com.'}, {'ForeName': 'Rasmus Huan', 'Initials': 'RH', 'LastName': 'Olsen', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, University of Copenhagen, Building 67, 1st, Bispebjerg Bakke 23, 2400, Copenhagen, NW, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Anholm', 'Affiliation': 'Department of Internal Medicine, Glostrup University Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Eugen-Olsen', 'Affiliation': 'Clinical Research Centre, Hvidovre University Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Department of Medical Biochemistry, Genetics and Molecular Biochemistry, Hvidovre University Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Simonsen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Bispebjerg University Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rosemary L', 'Initials': 'RL', 'LastName': 'Walzem', 'Affiliation': 'Faculty of Nutrition, Texas A & M University, College Station, TX, USA.'}, {'ForeName': 'Steen Bendix', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department of Internal Medicine, Amager and Hvidovre University Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, University of Copenhagen, Building 67, 1st, Bispebjerg Bakke 23, 2400, Copenhagen, NW, Denmark.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0934-x']
1638,29788075,Effects of Immunonutrition in Advanced Human Immunodeficiency Virus Disease: A Randomized Placebo-controlled Clinical Trial (Promaltia Study).,"Background


While nutritional interventions with prebiotics and probiotics seem to exert immunological effects, their clinical implications in human immunodeficiency virus (HIV)-infected subjects initiating antiretroviral therapy (ART) at advanced HIV disease remain unclear.
Methods


This was a pilot multicenter randomized, placebo-controlled, double-blind study in which 78 HIV-infected, ART-naive subjects with <350 CD4 T cells/μL or AIDS were randomized to either daily PMT25341 (a mixture of synbiotics, omega-3/6 fatty acids and amino acids) or placebo for 48 weeks, each in combination with first-line ART. Primary endpoints were changes in CD4 T-cell counts and CD4/CD8 ratio from baseline to week 48 and safety. Secondary endpoints were changes in markers of T-cell activation, bacterial translocation, inflammation, and α and β microbiota diversity.
Results


Fifty-nine participants completed the follow-up with a mean CD4+ T-cell count of 221 ± 108 cells/μL and mean CD4/CD8 ratio of 0.26 ± 0.19. PMT25341 was well tolerated, without grade 3-4 adverse effects attributable to the intervention. While most of the assessed biomarkers improved during the follow-up in both arms, PMT25341-treated subjects did not experience any significant change, compared to placebo-treated subjects, in mean CD4+ T-cell count change (278 vs 250 cells/μL, P = .474) or CD4/CD8 ratio change (0.30 vs 0.32, P = .854). Similarly, we did not detect differences between treatment arms in secondary endpoints.
Conclusions


In HIV-infected patients initiating ART at advanced disease, the clear immunological benefits of ART were not enhanced by this nutritional intervention targeting the gut-associated lymphoid tissue and microbiota.
Clinical Trials Registration


NCT00870363.",2019,"While most of the assessed biomarkers improved during the follow-up in both arms, PMT25341-treated subjects did not experience any significant change, compared to placebo-treated subjects, in mean CD4+ T-cell count change (278 vs 250 cells/μL, P = .474) or CD4/CD8 ratio change (0.30 vs 0.32, P = .854).","['Advanced Human Immunodeficiency Virus Disease', '78 HIV-infected, ART-naive subjects with <350 CD4 T cells/μL or AIDS', 'human immunodeficiency virus (HIV)-infected subjects initiating antiretroviral therapy (ART) at advanced HIV disease remain unclear']","['Immunonutrition', 'placebo', 'daily PMT25341 (a mixture of synbiotics, omega-3/6 fatty acids and amino acids) or placebo', 'Placebo', 'PMT25341']","['changes in markers of T-cell activation, bacterial translocation, inflammation, and α and β microbiota diversity', 'tolerated', 'mean CD4+ T-cell count change', 'CD4/CD8 ratio change', 'changes in CD4 T-cell counts and CD4/CD8 ratio']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0282583', 'cui_str': 'Bacterial Translocation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",59.0,0.487627,"While most of the assessed biomarkers improved during the follow-up in both arms, PMT25341-treated subjects did not experience any significant change, compared to placebo-treated subjects, in mean CD4+ T-cell count change (278 vs 250 cells/μL, P = .474) or CD4/CD8 ratio change (0.30 vs 0.32, P = .854).","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Serrano-Villar', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'de Lagarde', 'Affiliation': 'HIV Unit, Hospital Universitario Doce de Octubre, Madrid.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vázquez-Castellanos', 'Affiliation': 'Area of Genomics and Health, FISABIO-Salud Pública, Valencia.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Vallejo', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid.'}, {'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Bernadino', 'Affiliation': 'HIV Unit, Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz (IdiPAZ), Madrid.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Madrid', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Matarranz', 'Affiliation': 'HIV Unit, Hospital Universitario Doce de Octubre, Madrid.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Díaz-Santiago', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gutiérrez', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Cabello', 'Affiliation': 'Infectious Diseases Division, Hospital Universitario Fundación Jiménez Díaz, Madrid.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Villar-García', 'Affiliation': 'Infectious Diseases Department, Hospital del Mar, Instituto Hospital del Mar de Investigaciones Médicas (IMIM), Barcelona.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Blanco', 'Affiliation': 'Department of Infectious Diseases, Hospital San Pedro - Centro de Investigación Biomédica de la Rioja (CIBIR), Logroño.'}, {'ForeName': 'Otilia', 'Initials': 'O', 'LastName': 'Bisbal', 'Affiliation': 'HIV Unit, Hospital Universitario Doce de Octubre, Madrid.'}, {'ForeName': 'Talía', 'Initials': 'T', 'LastName': 'Sainz', 'Affiliation': 'Pediatric Tropical and Infectious Diseases Department, Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz (IdiPAZ), Valencia.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Moya', 'Affiliation': 'Area of Genomics and Health, FISABIO-Salud Pública, Valencia.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'HIV Unit, Hospital Universitario Doce de Octubre, Madrid.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Gosalbes', 'Affiliation': 'Area of Genomics and Health, FISABIO-Salud Pública, Valencia.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Estrada', 'Affiliation': 'HIV Unit, Hospital Clínico San Carlos, Madrid, Spain.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy414']
1639,30877216,Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale.,"OBJECTIVE


We evaluated the effect of sarilumab on patient-perceived impact of rheumatoid arthritis (RA) using the 7-domain RA Impact of Disease (RAID) scale.
METHODS


Two phase III, randomized, controlled trials of sarilumab in patients with active, longstanding RA were analyzed: (1) sarilumab 150 mg and 200 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARD) versus placebo + csDMARD [TARGET (NCT01709578)]; and (2) sarilumab 200 mg versus adalimumab (ADA) 40 mg monotherapy [MONARCH (NCT02332590)]. Least-squares mean (LSM) differences in RAID total score (range 0-10) and 7 key RA symptoms, including pain and fatigue (baseline to Weeks 12 and 24), were compared. ""Responders"" by RAID total score were defined by improvements from baseline ≥ minimal clinically important difference (MCID), and ≥ patient-acceptable symptom-state (PASS) at endpoint.
RESULTS


Sarilumab 150 mg and 200 mg + csDMARD were nominally superior (p < 0.05) versus placebo + csDMARD and 200 mg sarilumab versus ADA 40 mg in LSM differences for RAID total score at weeks 12 (-0.93 and -1.13; -0.49, respectively) and 24 (-0.75 and -1.01; -0.78), and all effects of RA (except functional impairment in MONARCH Week 12). Effects were greater in physical domains (e.g., pain) than mental domains (e.g., emotional well-being). More patients receiving sarilumab versus placebo or ADA reported improvements ≥ MCID and PASS in total RAID scores at both assessments.
CONCLUSION


Based on the RAID, sarilumab + csDMARD or as monotherapy reduced the effect of RA on patients' lives to a greater extent than placebo + csDMARD or ADA monotherapy. (ClinicalTrials.gov: NCT01709578 and NCT02332590).",2019,"More patients receiving sarilumab versus placebo or adalimumab reported improvements ≥MCID and PASS in total RAID scores at both assessments.
","['patients with active, long-standing RA']","['sarilumab 150 mg and 200 mg twice-weekly plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARDs) versus placebo+csDMARDs [TARGET (NCT01709578)]; sarilumab 200 mg versus adalimumab 40 mg monotherapy', 'Sarilumab', 'adalimumab', 'placebo+csDMARDs', 'placebo or adalimumab']","['physical domains (e.g., pain', '≥Patient Acceptable Symptom State (PASS', '≥MCID and PASS in total RAID scores', 'Least squares mean (LSM) differences in RAID total score (range 0-10), and 7 key RA symptoms, including pain and fatigue', '7-domain RA Impact of Disease (RAID) scale', 'RAID total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0222045'}]",,0.132715,"More patients receiving sarilumab versus placebo or adalimumab reported improvements ≥MCID and PASS in total RAID scores at both assessments.
","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Proudfoot', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Chieh-I', 'Initials': 'CI', 'LastName': 'Chen', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guillonneau', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mangan', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Reaney', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA. matthew.reaney@iqvia.com.""}]",The Journal of rheumatology,['10.3899/jrheum.180904']
1640,30017814,"Design and rationale of the ""Sedation strategy and cognitive outcome after critical illness in early childhood"" study.","There is increasing concern that sedatives commonly used during critical illness may be neurotoxic during the period of early brain development. The Sedation strategy and cognitive outcome after critical illness in early childhood (RESTORE-cognition) study is a prospective cohort study designed to examine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We assess multiple domains of neurocognitive function 2.5-5 years post-hospital discharge, at a single time point and depending on participant and clinician availability, in up to 500 subjects who had normal baseline cognitive function, were aged 2 weeks to 8 years at pediatric intensive care unit admission, and were enrolled in a cluster randomized controlled trial of a sedation protocol (the RESTORE trial; U01 HL086622 and HL086649). In addition, to provide comparable data on an unexposed group with similar baseline biological characteristics and environment, we are studying matched, healthy siblings of RESTORE patients. Our goal is to increase understanding of the relationships between sedative exposure, critical illness, and long-term neurocognitive outcomes in infants and young children by studying these subjects 2.5 to 5 years after their index hospitalization. This paper highlights the design challenges in conducting comprehensive neurocognitive assessment procedures across a broad age span at multiple testing centers across the United States. Our approach, which includes building interprofessional teams and novel cohort retention strategies, may be of help in future longitudinal trials.",2018,There is increasing concern that sedatives commonly used during critical illness may be neurotoxic during the period of early brain development.,"['500 subjects who had normal baseline cognitive function, were aged 2\u202fweeks to 8\u202fyears at pediatric intensive care unit admission', 'healthy siblings of RESTORE patients', 'infants and young children by studying these subjects 2.5 to 5\u202fyears after their index hospitalization']",['sedation protocol'],[],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",[],500.0,0.0755644,There is increasing concern that sedatives commonly used during critical illness may be neurotoxic during the period of early brain development.,"[{'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': ""From the School of Nursing, University of Pennsylvania, Philadelphia, United States; Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States; The Children's Hospital, Philadelphia Research Institute, Philadelphia, United States. Electronic address: curley@nursing.upenn.edu.""}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Watson', 'Affiliation': ""Department of Pediatrics, University of Washington, Seattle, United States; Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, United States.""}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cassidy', 'Affiliation': 'From the School of Nursing, University of Pennsylvania, Philadelphia, United States.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Delinger', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, United States.""}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, United States.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Asaro', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, United States.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, United States; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, United States; Department of Pediatrics, Harvard Medical School, Boston, United States.""}, {'ForeName': 'Sue R', 'Initials': 'SR', 'LastName': 'Beers', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.004']
1641,31313296,Concomitant Intake of Coca-Cola to Manage the Drug-Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers.,"We aimed to evaluate the effect of the acid beverage Coca-Cola on the pharmacokinetics of velpatasvir (VEL) when given with omeprazole. This was an open-label, randomized, crossover trial in 11 healthy adults. A single dose of sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg was administered alone (reference) or with omeprazole 40 mg once daily with water (intervention I); in the intervention II arm, omeprazole 40 mg was combined with 250 mL of Coca-Cola. Geometric mean ratios (GMRs) were calculated for VEL area under the concentration-time curve from zero to infinity (AUC 0-inf  ) and maximum plasma concentration (C max  ). VEL exposure was reduced by 26.7% when SOF/VEL was coadministered with omeprazole vs. reference: GMRs (90% confidence interval (CI)) were 73.3% (55.6-96.8) and 69.1% (52.3-91.2) for AUC 0-inf  and C max  , respectively. Intake of SOF/VEL with Coca-Cola compensated for the interaction with omeprazole and resulted in a higher VEL exposure. GMRs (90% CI) were 161.6% (122.4-213.3) for AUC 0-inf  and 143.9% (109.0-190.0) for C max  . Therefore, Coca-Cola can be used to overcome the drug-drug interaction between VEL and omeprazole.",2019,GMRs (90% CI) were 161.6% (122.4-213.3) for AUC 0-inf  and 143.9% (109.0-190.0) for C max  .,"['11 healthy adults', 'Healthy Volunteers']","['Omeprazole', 'sofosbuvir/velpatasvir (SOF/VEL) 400/100', 'omeprazole 40\xa0mg once daily with water (intervention', 'omeprazole 40\xa0mg was combined with 250\xa0mL of Coca-Cola', 'acid beverage Coca-Cola', 'omeprazole']","['Geometric mean ratios (GMRs', 'GMRs', 'VEL exposure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4271578', 'cui_str': 'sofosbuvir / velpatasvir'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1602244', 'cui_str': 'Omeprazole 40 MG [Prilosec]'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0009169', 'cui_str': 'Erythroxylon'}, {'cui': 'C0684195', 'cui_str': 'Cola'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",11.0,0.0435659,GMRs (90% CI) were 161.6% (122.4-213.3) for AUC 0-inf  and 143.9% (109.0-190.0) for C max  .,"[{'ForeName': 'Minou', 'Initials': 'M', 'LastName': 'van Seyen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Evertine J', 'Initials': 'EJ', 'LastName': 'Abbink', 'Affiliation': 'Radboudumc Technology Center Clinical Studies, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost P H', 'Initials': 'JPH', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1569']
1642,30824635,Safety and Efficacy of Intravenous Golimumab in Adults with Ankylosing Spondylitis: Results through 1 Year of the GO-ALIVE Study.,"OBJECTIVE


Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year.
METHODS


A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL) index. Efficacy and safety were monitored through Week 52 and Week 60, respectively.
RESULTS


The primary endpoint (ASAS20) and all controlled endpoints at Week 16 were achieved. At Week 52, 69.5% and 65.0% of patients in the GOL group and placebo crossover group, respectively, achieved an ASAS20; 56.2% and 51.5% achieved an ASAS40; 56.2% and 55.3% achieved a BASDAI50; 24.8% and 24.3% achieved ASAS partial remission; and 25.7% and 26.2% met ASDAS inactive disease criteria (all last observation carried forward). Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6; ASQoL: -5.5 and -5.4). Through Week 60, 55.4% of all GOL-treated patients had ≥ 1 adverse events (AE); 3.4% had ≥ 1 serious AE.
CONCLUSION


Efficacy was maintained through 1 year with IV GOL 2 mg/kg among patients with active AS. AE were consistent with the known safety profile of GOL.",2019,Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6;,"['patients with active ankylosing spondylitis (AS) through 1 year', '208 patients', 'Adults with Ankylosing Spondylitis']","['intravenous (IV) golimumab (GOL', 'Intravenous Golimumab', 'placebo', 'GOL']","['Efficacy', 'BASFI and ASQoL scores', 'AS Quality of Life (ASQoL) index', 'Safety and Efficacy', 'Health-related quality of life', 'Efficacy and safety', 'Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI', 'ASAS partial remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0150141'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",208.0,0.213888,Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6;,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Reveille', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Caldron', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dudek', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland. ehsia@its.jnj.com.'}]",The Journal of rheumatology,['10.3899/jrheum.180718']
1643,31501059,Dyadic and Solitary Sexual Desire in Patients With Fibromyalgia: A Controlled Study.,"INTRODUCTION


Although fibromyalgia symptoms negatively affect patients' sexual life, sexual desire in women diagnosed with fibromyalgia has been understudied.
AIM


To describe and compare sexual desire in women diagnosed with fibromyalgia and healthy control women, and to investigate the influence of fibromyalgia and its pharmacologic treatment on sexual desire among women diagnosed with fibromyalgia.
METHODS


164 women diagnosed with fibromyalgia participated in the study. Participants' sexual desire, fibromyalgia symptoms, symptom interference in daily life activities, and perceived quality of life were measured. Further sociodemographic and health-related data were also recorded. 87 healthy women were selected as a control group, and their sexual desire was compared with those of women diagnosed with fibromyalgia.
MAIN OUTCOME MEASURES


Main outcome measures included the Sexual Desire Inventory and the Fibromyalgia Impact Questionnaire.
RESULTS


When compared with healthy control subjects, women diagnosed with fibromyalgia exhibited a significantly lower mean score on total desire (47.92 ± 17.48 vs 26.33 ± 21.95; P < .001), solitary desire (10.52 ± 5.96 vs 5.74 ± 7.01; P < .001), and dyadic desire (37.40 ± 13.98 vs 20.59 ± 16.94; P < .001). Women diagnosed with fibromyalgia who were taking antidepressants scored significantly lower on dyadic desire (P < .001), solitary desire (P < .001), and total desire (P < .001) than those who were not. Furthermore, a negative correlation between desire (dyadic and solitary) and Revised Fibromyalgia Impact Questionnaire (total and all subscales) was found. Linear regression showed that taking antidepressants, age, and the total Fibromyalgia Impact Questionnaire score explained 16% of the variance of total desire.
CLINICAL IMPLICATIONS


Knowing how fibromyalgia symptoms and their pharmacologic treatment affect women's sexual desire may have implications for designing care strategies according to individual needs.
STRENGTHS & LIMITATIONS


To the best of our knowledge, this is the first study that focuses on studying the impact of fibromyalgia on dyadic and solitary sexual desire. Limitations are related to having used an online questionnaire for data collection, having recruited the participants through a convenience sampling technique and not being able to isolate whether certain results are related to fibromyalgia symptoms or are side effects of the pharmacologic treatment used for symptom control.
CONCLUSION


Fibromyalgia impact seems to negatively influence dyadic and solitary sexual desire in women. In addition, other factors such as age or taking antidepressant drugs may result in lower sexual desire in these patients. López-Rodríguez MM, Pérez Fernández A, Hernández-Padilla JM, et al. Dyadic and Solitary Sexual Desire in Patients With Fibromyalgia: A Controlled Study. J Sex Med 2019;16:1518-1528.",2019,"Participants' sexual desire, fibromyalgia symptoms, symptom interference in daily life activities, and perceived quality of life were measured.","['Patients', '164 women diagnosed with fibromyalgia participated in the study', 'Patients With Fibromyalgia', 'women diagnosed with fibromyalgia and healthy control women', 'women diagnosed with fibromyalgia', '87 healthy women']",[],"['sexual desire, fibromyalgia symptoms, symptom interference in daily life activities, and perceived quality of life', 'Dyadic and Solitary Sexual Desire', 'sexual desire', 'desire (dyadic and solitary) and Revised Fibromyalgia Impact Questionnaire (total and all subscales', 'total Fibromyalgia Impact Questionnaire score', 'dyadic desire', 'Sexual Desire Inventory and the Fibromyalgia Impact Questionnaire', 'total desire', 'mean score on total desire', 'solitary desire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",164.0,0.136206,"Participants' sexual desire, fibromyalgia symptoms, symptom interference in daily life activities, and perceived quality of life were measured.","[{'ForeName': 'María Mar', 'Initials': 'MM', 'LastName': 'López-Rodríguez', 'Affiliation': 'Departamento de Enfermería, Fisioterapia y Medicina, Universidad de Almería, Almería, Spain.'}, {'ForeName': 'Aida Pérez', 'Initials': 'AP', 'LastName': 'Fernández', 'Affiliation': 'Facultad de Psicología, Universidad de Almería, Almería, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Hernández-Padilla', 'Affiliation': 'Departamento de Enfermería, Fisioterapia y Medicina, Universidad de Almería, Almería, Spain; Adult, Child and Midwifery Department, Middlesex University, London, United Kingdom. Electronic address: j.hernandez-padilla@ual.es.'}, {'ForeName': 'Cayetano', 'Initials': 'C', 'LastName': 'Fernández-Sola', 'Affiliation': 'Departamento de Enfermería, Fisioterapia y Medicina, Universidad de Almería, Almería, Spain; Associate Researcher, Faculty of Health Sciences, Universidad Autónoma de Chile, Temuco, Chile.'}, {'ForeName': 'Isabel María', 'Initials': 'IM', 'LastName': 'Fernández-Medina', 'Affiliation': 'Departamento de Enfermería, Fisioterapia y Medicina, Universidad de Almería, Almería, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Granero-Molina', 'Affiliation': 'Departamento de Enfermería, Fisioterapia y Medicina, Universidad de Almería, Almería, Spain; Associate Researcher, Faculty of Health Sciences, Universidad Autónoma de Chile, Temuco, Chile.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.07.026']
1644,31558274,Crestal bone-level changes and patient satisfaction with mandibular overdentures retained by one or two implants with immediate loading protocols: A randomized controlled clinical study.,"STATEMENT OF PROBLEM


Single-implant-retained overdentures are an alternative treatment option for an edentulous mandible. However, evaluation of their clinical performance with an immediate loading protocol is lacking.
PURPOSE


The purpose of this prospective randomized controlled clinical study was to evaluate crest bone-level changes and patient satisfaction with mandibular overdentures retained by 1 or 2 titanium-zirconium (Ti-Zr) implants with immediate loading protocols after 1 year.
MATERIAL AND METHODS


Thirty-six Ti-Zr implants were placed in 24 participants (single central implant in 12 participants and 2 interforaminal implants in 11 participants) by a single operator. LOCATOR attachments were used to retain the mandibular overdentures with an immediate loading protocol, and observations were made at 1 month and 1 year. Changes to the crestal bone level were evaluated with digital periapical radiographs. A 100-mm visual analog scale (VAS) was used to evaluate patient satisfaction. The Mann-Whitney U test was used to analyze the data.
RESULTS


At 1 month, the mean crestal bone loss was 0.23 mm in the 2-implant group (n=22) and 0.39 mm (P=.181) in the single-implant group (n=11). At 1 year, the bone loss was 0.67 mm in the 2-implant group and 0.88 mm (P=.248) in the single-implant group. The mean VAS score for patient satisfaction level increased from 38.3% to 49.7% for single-implant participants and from 40.5% to 54.8% for 2-implant participants 1 month after implant placement (P=.250) and from 38.3% to 54.5% for single-implant participants and from 40.5% to 58.9% for 2-implant participants after 1 year (P=.341).
CONCLUSIONS


Single-implant-retained mandibular overdentures with an immediate loading protocol may represent a viable treatment option considering crestal bone-level changes and patient satisfaction compared with 2-implant-retained mandibular overdentures after 1 year of follow-up.",2020,"The mean VAS score for patient satisfaction level increased from 38.3% to 49.7% for single-implant participants and from 40.5% to 54.8% for 2-implant participants 1 month after implant placement (P=.250) and from 38.3% to 54.5% for single-implant participants and from 40.5% to 58.9% for 2-implant participants after 1 year (P=.341).
",['Thirty-six Ti-Zr implants were placed in 24 participants (single central implant in 12 participants and 2 interforaminal implants in 11 participants) by a single operator'],['mandibular overdentures retained by 1 or 2 titanium-zirconium (Ti-Zr) implants with immediate loading protocols'],"['mean crestal bone loss', 'Crestal bone-level changes and patient satisfaction', 'bone loss', 'crest bone-level changes and patient satisfaction', 'crestal bone level', 'mean VAS score for patient satisfaction level', '100-mm visual analog scale (VAS']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0011459', 'cui_str': 'Overdenture'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0043506', 'cui_str': 'Zirconium'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2948667', 'cui_str': 'Crest'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",36.0,0.105496,"The mean VAS score for patient satisfaction level increased from 38.3% to 49.7% for single-implant participants and from 40.5% to 54.8% for 2-implant participants 1 month after implant placement (P=.250) and from 38.3% to 54.5% for single-implant participants and from 40.5% to 58.9% for 2-implant participants after 1 year (P=.341).
","[{'ForeName': 'Pravinkumar G', 'Initials': 'PG', 'LastName': 'Patil', 'Affiliation': 'Senior Lecturer, Division of Clinical Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia. Electronic address: pravinandsmita@yahoo.co.in.'}, {'ForeName': 'Liang Lin', 'Initials': 'LL', 'LastName': 'Seow', 'Affiliation': 'Professor, Division of Clinical Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2019.07.015']
1645,28902064,"Hypertension in the Faith Community: A Four-Week, Nurse Led, Diet/Exercise Intervention.",,2017,,['Hypertension in the Faith Community'],[],[],"[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],[],,0.012474,,[],Journal of Christian nursing : a quarterly publication of Nurses Christian Fellowship,['10.1097/CNJ.0000000000000436']
1646,31405764,"Effects of Preoperative Atorvastatin Treatment On Erectile Function After Radical Prostatectomy: Results From a Subgroup of ESTO1, a Randomized, Double-Blind, Placebo-Controlled Study.","INTRODUCTION


Erectile dysfunction is common after radical prostatectomy because of damage to the cavernous nerves. Thus, it is important to identify new ways to avoid this problem. For example, statins have shown positive effects on erectile function and may have anti-inflammatory effects that improve recovery after surgery.
AIM


The aim of this exploratory analysis of a subgroup from ESTO1, a randomized, double-blind, placebo-controlled study, was to evaluate the preoperative use of atorvastatin on erectile function after radical prostatectomy.
METHOD


Patients were randomized to either 80 mg atorvastatin or placebo daily before undergoing radical prostatectomy from study inclusion to the day of surgery. Altogether 118 men with prostate cancer and scheduled for radical prostatectomy were asked to fill out the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire before surgery and at 3, 6, 9, and 12 months after surgery.
MAIN OUTCOME MEASUREMENTS


The study was exploratory, with the main outcome being the overall difference between IIEF-5 scores in the 2 groups at 12 months. Several hypotheses generating sub-analyses were conducted.
RESULTS


Overall, 85% filled out the IIEF-5 questionnaire before their operation and 85%, 81%, 78%, and 78% completed it at 3, 6, 9, and 12 months follow-up, respectively. 52% of men had information available at all time points. There were no statistically significant differences between the groups at baseline in either erectile function, comorbidities, or tumor characteristics. The median duration of use of atorvastatin and placebo before surgery was 27 and 25 days, respectively. Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm. Furthermore, atorvastatin treatment compared with placebo improved IIEF-5 scores at 12 months after surgery when the cavernous nerves were at least partially intact bilaterally (P < .04, n = 65); however, after full bilateral or unilateral nerve-sparing, the difference was not statistically significant.
CLINICAL IMPLICATION


Short-term statin treatment did not improve recovery of erectile function after prostatectomy; however, further studies are needed before final conclusions.
STRENGTHS & LIMITATIONS


This was a randomized placebo-controlled study. Original ESTO1 study was designed to detect a difference in prostate cancer biomarkers.
CONCLUSION


Short-term atorvastatin treatment before radical prostatectomy had no statistically significant effect on the recovery of erectile functions in a non-selected cohort of patients undergoing radical prostatectomy. Further studies will be needed to clarify the role of long-term atorvastatin use before and after prostatectomy. Siltari A, Riikonen J, Fode M, et al. Effects of Preoperative Atorvastatin Treatment On Erectile Function After Radical Prostatectomy: Results From a Subgroup of ESTO1, a Randomized, Double-Blind, Placebo-Controlled Study. J Sex Med 2019;16:1597-1605.",2019,"Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm.","['Altogether 118 men with prostate cancer and scheduled for', 'Patients', 'patients undergoing radical prostatectomy']","['atorvastatin', 'Preoperative Atorvastatin', 'Preoperative atorvastatin', 'Radical Prostatectomy', 'atorvastatin and placebo', 'placebo', 'Preoperative Atorvastatin Treatment', 'atorvastatin or placebo', 'Short-term atorvastatin', 'radical prostatectomy', 'Placebo']","['erectile function, comorbidities, or tumor characteristics', 'Erectile Function', 'erectile function', 'recovery of erectile functions', 'IIEF-5 scores', 'IIEF-5 questionnaire']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",118.0,0.186472,"Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Siltari', 'Affiliation': 'Tampere University, Faculty of Medicine and Life Sciences, Tampere, Finland. Electronic address: aino.siltari@helsinki.fi.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riikonen', 'Affiliation': 'Tampere University Hospital, Department of Urology, Tampere, Finland.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Fode', 'Affiliation': 'Herlev and Gentofte Hospital, Department of Urology, Herlev, Denmark.'}, {'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Tampere University, Faculty of Medicine and Life Sciences, Tampere, Finland; Tampere University Hospital, Department of Urology, Tampere, Finland; Seinäjoki Central Hospital, Department of Surgery, Seinäjoki, Finland.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.07.001']
1647,27556393,"Effects of 10,000 steps a day on physical and mental health in overweight participants in a community setting: a preliminary study.","BACKGROUND


Being overweight is associated not only with physical health problems, but also with risk of mental health problems. Increased physical activity (PA) has been recommended for the prevention of cardiovascular disease; however, little is known about the effect of walking on physical and mental health outcomes.
OBJECTIVE


The purpose of the study was to explore the effectiveness of a pedometer-based PA intervention on physical and mental health states.
METHOD


Thirty-five overweight participants with body mass index (BMI) ≥25 kg•m-2 were selected and assigned to a 12-week pedometer-based walking program (10,000 steps•d-1). The profile of mood states, BMI, waist circumference (WC), body fat percentage (%BF), and lean body mass (LBM) were measured before and after the 12-week intervention. The number of step counts was recorded 5 days a week in a diary booklet.
RESULTS


The 30 participants who accumulated 10,000 steps•d-1 had significantly lower anxiety, depression, anger, fatigue, confusion, and total mood distress scores compared with measurements taken prior to the intervention. Further, the participants had higher vigor scores compared to baseline. Regarding physical health, the participants who accrued 10,000 steps a day had significantly lower body weight, WC, BMI, and %BP. After adjustment for gender, height, and daily steps at follow-up, changes in WC were negatively associated with depression, fatigue, confusion, and total mood distress.
CONCLUSIONS


An increase in PA by accumulating at least 10,000 steps•d-1 over a 12-week period improves physical and mood states in sedentary, overweight individuals.",2016,"The 30 participants who accumulated 10,000 steps•d-1 had significantly lower anxiety, depression, anger, fatigue, confusion, and total mood distress scores compared with measurements taken prior to the intervention.","['Thirty-five overweight participants with body mass index (BMI) ≥25 kg•m-2', 'overweight participants in a community setting']","['pedometer-based walking program', 'pedometer-based PA intervention']","['anxiety, depression, anger, fatigue, confusion, and total mood distress scores', 'depression, fatigue, confusion, and total mood distress', 'vigor scores', 'physical and mood states', 'number of step counts', 'body weight, WC, BMI, and %BP', 'Increased physical activity (PA', 'profile of mood states, BMI, waist circumference (WC), body fat percentage (%BF), and lean body mass (LBM', 'physical and mental health']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",35.0,0.0292749,"The 30 participants who accumulated 10,000 steps•d-1 had significantly lower anxiety, depression, anger, fatigue, confusion, and total mood distress scores compared with measurements taken prior to the intervention.","[{'ForeName': 'Kornanong', 'Initials': 'K', 'LastName': 'Yuenyongchaiwat', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health Sciences, Thammasat University, Pathumthani, Thailand.'}]",Brazilian journal of physical therapy,['10.1590/bjpt-rbf.2014.0160']
1648,31618678,"Antibiotic treatment for 6 days versus 12 days in patients with severe cellulitis: a multicentre randomized, double-blind, placebo-controlled, non-inferiority trial.","OBJECTIVES


To investigate whether antibiotic treatment of 6 days' duration is non-inferior to treatment for 12 days in patients hospitalized for cellulitis.
METHODS


This multicentre, randomized, double-blind, placebo-controlled, non-inferiority trial enrolled adult patients hospitalized for severe cellulitis who were treated with intravenous flucloxacillin. At day 6 participants with symptom improvement who were afebrile were randomized between an additional 6 days of oral flucloxacillin or placebo in a 1:1 ratio, stratified for diabetes and hospital. The primary outcome was cure by day 14, without relapse by day 28. Secondary outcomes included a modified cure assessment and relapse rate by day 90.
RESULTS


Between August 2014 and June 2017, 151 of 248 included participants were randomized. The intention-to-treat population consisted of 76 and 73 participants allocated to 12 and 6 days of antibiotic therapy, respectively (mean age 62 years, 67% males, 24% diabetics); 38/76 (50.0%) and 36/73 (49.3%) were cured in the 12- and 6-day groups respectively (ARR 0.7 percentage points, 95%CI: -15.0 to 16.3). Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95%CI: -8.0 to 20.8). After initial cure without relapse, day 90 relapse rates were higher in the 6-day group (6% versus 24%, p < 0.05).
CONCLUSIONS


Given the wide confidence intervals, we can neither confirm nor refute our hypothesis that 6 days of therapy is non-inferior to 12 days of therapy. However, a 6-day course resulted in significantly more frequent relapses by day 90. These findings require confirmation in future studies.",2020,"Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95% CI: -8.0 to 20.8).","['patients with severe cellulitis', 'At day 6 participants with symptom improvement who were afebrile', 'patients hospitalised for cellulitis', '73 participants allocated to 12 and 6\xa0days antibiotic therapy, respectively (mean age 62\xa0years, 67% males, 24% diabetics', 'Between August 2014 and June 2017, 151 of 248 included participants were randomised', 'non-inferiority trial enrolled adult patients hospitalised for severe cellulitis who were treated with']","['placebo', 'intravenous flucloxacillin', 'Antibiotic treatment', 'oral flucloxacillin or placebo']","['frequent relapses', 'modified cure assessment and relapse rate by day 90', 'relapse rates', 'Cure rates', 'cure by day 14, without relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.750223,"Cure rates were 56/76 (73.7%) and 49/73 (67.1%) with the modified cure assessment (ARR 6.6, 95% CI: -8.0 to 20.8).","[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Cranendonk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medicine, Division of Infectious Diseases, Amsterdam, the Netherlands; Amsterdam UMC, University of Amsterdam, Centre for Experimental and Molecular Medicine, Amsterdam Infection & Immunity Institute, Amsterdam, the Netherlands. Electronic address: d.r.cranendonk@amc.uva.nl.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Opmeer', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Clinical Research Unit, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Internal Medicine, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Branger', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brinkman', 'Affiliation': 'Department of Internal Medicine, OLVG-Oost, Amsterdam, the Netherlands.'}, {'ForeName': 'A I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Internal Medicine, University Medical Centre, University of Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'F N', 'Initials': 'FN', 'LastName': 'Lauw', 'Affiliation': 'Department of Internal Medicine, MC Slotervaart, Amsterdam, the Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Oosterheert', 'Affiliation': 'Department of Internal Medicine, University Medical Centre, University of Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Pijlman', 'Affiliation': 'Department of Internal Medicine, St Antonius Ziekenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'S U C', 'Initials': 'SUC', 'LastName': 'Sankatsing', 'Affiliation': 'Department of Internal Medicine, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Soetekouw', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Haarlem, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veenstra', 'Affiliation': 'Department of Internal Medicine, OLVG-West, Amsterdam, the Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Internal Medicine, Tergooiziekenhuizen, Hilversum, the Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Prins', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medicine, Division of Infectious Diseases, Amsterdam, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Wiersinga', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medicine, Division of Infectious Diseases, Amsterdam, the Netherlands; Amsterdam UMC, University of Amsterdam, Centre for Experimental and Molecular Medicine, Amsterdam Infection & Immunity Institute, Amsterdam, the Netherlands.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.09.019']
1649,31848443,Quality of life and psychological outcomes of body-weight supported locomotor training in spinal cord injured persons with long-standing incomplete lesions.,"STUDY DESIGN


Health-related quality of life (HRQOL) data from two parallel independent single-blinded controlled randomized studies of manual (Study 1) and robotic (Study 2) locomotor training were combined (ClinicalTrials.gov #NCT00854555).
OBJECTIVE


To assess effects of body-weight supported locomotor training (BWSLT) programs on HRQOL in persons with long-standing motor incomplete spinal cord injury and poor walking function.
SETTINGS


Two inpatient rehabilitation facilities and one outpatient clinic in Norway.
METHODS


Data were merged into intervention (locomotor training 60 days) or control group (""usual care""). Participants completed questionnaires before randomization and 2-4 weeks after the study period, including demographic characteristics, HRQOL (36-Item Short-Form Health Status Survey, SF-36), physical activity (The International Physical Activity Questionnaire Short Form, IPAQ-SF), exercise barrier self-efficacy (EBSE), and motivation for training (Behavioral Regulation in Exercise Questionnaire, BREQ). Physical outcomes i.e., Lower extremity motor score (LEMS) was assessed. The main outcome was change in HRQOL. Secondary outcomes included changes in IPAQ-SF, EBSE, BREQ, and physical outcomes.
RESULTS


We recruited 37 of 60 predetermined participants. They were autonomously motivated with high baseline physical activity. BWSLT with manual or robot assistance did not improve HRQOL, though LEMS increased in the BWSLT group compared with control group.
CONCLUSIONS


The study was underpowered due to recruitment problems. The training programs seem to benefit LEMS, but not other physical outcomes, and had minimal effects on HRQOL, EBSE, and motivation. Autonomous motivation and high physical activity prior to the study possibly limited the attainable outcome benefits, in addition to limitations due to poor baseline physical function.",2020,"BWSLT with manual or robot assistance did not improve HRQOL, though LEMS increased in the BWSLT group compared with control group.
","['spinal cord injured persons with long-standing incomplete lesions', 'Two inpatient rehabilitation facilities and one outpatient clinic in Norway', 'persons with long-standing motor incomplete spinal cord injury and poor walking function', 'We recruited 37 of 60 predetermined participants']","['intervention (locomotor training 60 days) or control group (""usual care', 'manual (Study 1) and robotic (Study 2) locomotor training', 'body-weight supported locomotor training', 'body-weight supported locomotor training (BWSLT) programs']","['Physical outcomes i.e., Lower extremity motor score (LEMS', 'Quality of life and psychological outcomes', 'demographic characteristics, HRQOL (36-Item Short-Form Health Status Survey, SF-36), physical activity (The International Physical Activity Questionnaire Short Form, IPAQ-SF), exercise barrier self-efficacy (EBSE), and motivation for training (Behavioral Regulation in Exercise Questionnaire, BREQ', 'changes in IPAQ-SF, EBSE, BREQ, and physical outcomes', 'HRQOL, EBSE, and motivation', 'HRQOL', 'change in HRQOL', 'LEMS']","[{'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",60.0,0.0940601,"BWSLT with manual or robot assistance did not improve HRQOL, though LEMS increased in the BWSLT group compared with control group.
","[{'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Piira', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, Tromsø, Norway. anu.piira@kurbadet.no.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Lannem', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Gjesdal', 'Affiliation': 'Department of Cardiology, Oslo university hospital Ullevål and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Knutsen', 'Affiliation': 'North Norway Rehabilitation Center, Tromsø, Norway.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, University of Tromsø, The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Glott', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Hjeltnes', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}, {'ForeName': 'Synnøve F', 'Initials': 'SF', 'LastName': 'Knutsen', 'Affiliation': 'North Norway Rehabilitation Center, Tromsø, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sørensen', 'Affiliation': 'Department of Coaching and Psychology, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Spinal cord,['10.1038/s41393-019-0401-2']
1650,31422065,Introducing Goals of Patient Care in Residential Aged Care Facilities to Decrease Hospitalization: A Cluster Randomized Controlled Trial.,"OBJECTIVES


The ""Goals of Patient Care"" (GOPC) process uses shared decision making to incorporate residents' prior advance care planning (ACP) or preferences into medical treatment orders, guiding health care decisions at a time of clinical deterioration should they be unable to voice their opinions. The objective was to determine whether GOPC medical treatment orders were more effective than ACP alone in preventing emergency department (ED) visits (no hospitalization), ED visits (with hospitalization), and deaths outside the residential aged care facility (RACF).
DESIGN


The study was a prospective cluster randomized controlled trial, with the intervention being the completion of GOPC process by a geriatrician, following a shared decision-making process, incorporating ACP documents or residents' preferences.
SETTING AND PARTICIPANTS


The study took place in 6 RACFs in Northern Metropolitan Melbourne, Australia. Eligible participants included all permanent residents in participating RACFs for whom written informed consent could be obtained.
MEASURES


The primary outcome was the effect on ED visits and hospitalizations at 6 months. Secondary outcomes included a difference in hospitalization rates at 3 and 12 months, total hospital bed-days, and in-RACF and in-hospital mortality rates.
RESULTS


More than 75% of residents participated, 181 randomized to Intervention and 145 to Control. The intervention did not result in a statistically significant change at 6 months; however, at 12 months, it reached statistical significance with 40% reduction in ED visits and hospitalizations compared with Control, with an incident rate ratio 0.63 [95% confidence interval (CI) 0.41-0.99, P = .044]. Mortality rates show increased likelihood of dying in the RACF, with statistical significance at 6 months at a relative risk ratio of 2.19 (95% CI 1.16-4.14, P = .016).
CONCLUSIONS AND IMPLICATIONS


In the RACF population, GOPC medical treatment orders were more effective than ACP alone for decreasing hospitalization and likelihood of dying outside the RACF. GOPC should be considered by both RACF staff and health services to decrease hospitalization and in-hospital mortality.",2019,"In the RACF population, GOPC medical treatment orders were more effective than ACP alone for decreasing hospitalization and likelihood of dying outside the RACF.","['Residential Aged Care Facilities to Decrease Hospitalization', '6 RACFs in Northern Metropolitan Melbourne, Australia', 'Eligible participants included all permanent residents in participating RACFs for whom written informed consent could be obtained']",['ACP'],"['emergency department (ED) visits (no hospitalization), ED visits (with hospitalization), and deaths outside the residential aged care facility (RACF', 'effect on ED visits and hospitalizations at 6\xa0months', 'ED visits and hospitalizations', 'hospitalization rates at 3 and 12\xa0months, total hospital bed-days, and in-RACF and in-hospital mortality rates', 'Mortality rates']","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0336603', 'cui_str': 'Hospital bed'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",181.0,0.0989409,"In the RACF population, GOPC medical treatment orders were more effective than ACP alone for decreasing hospitalization and likelihood of dying outside the RACF.","[{'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Martin', 'Affiliation': 'University of Melbourne, Melbourne, Victoria, Australia. Electronic address: Ruth.Martin2@easternhealth.org.au.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Hayes', 'Affiliation': 'Northern Health, Epping, Victoria, Australia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Hutchinson', 'Affiliation': 'Northern Health, Epping, Victoria, Australia; Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tacey', 'Affiliation': 'Northern Health, Epping, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': 'Northern Health, Epping, Victoria, Australia.'}, {'ForeName': 'Wen Kwang', 'Initials': 'WK', 'LastName': 'Lim', 'Affiliation': 'University of Melbourne, Melbourne, Victoria, Australia; Melbourne Health, Melbourne, Victoria, Australia.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.06.017']
1651,27530654,Stress Management and Health Promotion in a Sample of Women With Intimate Partner Violence: A Randomized Controlled Trial.,"The aim of the present study was to investigate the effectiveness of a stress management program regarding mitigating psychological repercussions in women who experience intimate partner violence (IPV). This randomized controlled trial took place from January 2015 to June 2015, in Attica, Greece. A total of 60 women were randomly assigned into an intervention and control group, with the intervention group ( n = 30) receiving stress management and a lifestyle program. Self-reported measures were used to assess stress, depression and anxiety levels, daily routine, severity of abuse, self-esteem, health locus of control, and self-efficacy. Statistical analysis showed a significant improvement in measures of stress, depression, anxiety, self-esteem, and self-efficacy in the intervention group. Daily routine and physical exercise also improved. Based on these findings, we strongly encourage health professionals to advise women experiencing current and past IPV to adopt stress management techniques to their daily program, as a further means of empowerment.",2019,"Statistical analysis showed a significant improvement in measures of stress, depression, anxiety, self-esteem, and self-efficacy in the intervention group.","['A total of 60 women', 'January 2015 to June 2015, in Attica, Greece', 'Women With Intimate Partner Violence', 'women who experience intimate partner violence (IPV']","['stress management program', 'Stress Management and Health Promotion', 'intervention group ( n = 30) receiving stress management and a lifestyle program']","['stress, depression and anxiety levels, daily routine, severity of abuse, self-esteem, health locus of control, and self-efficacy', 'measures of stress, depression, anxiety, self-esteem, and self-efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.0411965,"Statistical analysis showed a significant improvement in measures of stress, depression, anxiety, self-esteem, and self-efficacy in the intervention group.","[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Kokka', 'Affiliation': '1 Postgraduate Course Science of Stress and Health Promotion, School of Medicine, University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mikelatou', 'Affiliation': '1 Postgraduate Course Science of Stress and Health Promotion, School of Medicine, University of Athens, Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Fouka', 'Affiliation': '2 Technological Educational Institute of Athens, Athens, Greece.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Varvogli', 'Affiliation': '1 Postgraduate Course Science of Stress and Health Promotion, School of Medicine, University of Athens, Athens, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': '1 Postgraduate Course Science of Stress and Health Promotion, School of Medicine, University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Darviri', 'Affiliation': '1 Postgraduate Course Science of Stress and Health Promotion, School of Medicine, University of Athens, Athens, Greece.'}]",Journal of interpersonal violence,['10.1177/0886260516658759']
1652,30395320,"Letter: Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion.",,2019,,"['Letter', 'Symptomatic Adjacent Level Disease Requiring Surgery']",[],[],"[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],[],,0.066981,,"[{'ForeName': 'Guangzhou', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics West China Hospital Sichuan University Chengdu, Sichuan Province, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Orthopedics West China Hospital Sichuan University Chengdu, Sichuan Province, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics West China Hospital Sichuan University Chengdu, Sichuan Province, China.'}]",Neurosurgery,['10.1093/neuros/nyy502']
1653,29303812,Response: The OSLO-COMET Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection for Colorectal Metastases.,,2018,,[],['Laparoscopic Versus Open Liver Resection'],['Response'],[],"[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]",[],,0.074641,,"[{'ForeName': 'Åsmund Avdem', 'Initials': 'ÅA', 'LastName': 'Fretland', 'Affiliation': 'Oslo University Hospital, The Intervention Center, Oslo, Norway Oslo University Hospital, Department of Hepato-Pancreato-Biliary Surgery, Oslo, Norway University of Oslo, Institute of Clinical Medicine, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Edwin', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000002646']
1654,31383238,"Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.","STUDY OBJECTIVES


Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in postmenopausal women with insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious.
METHODS


Single-site, randomized control trial. One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia were randomized to 3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at pretreatment, posttreatment, and 6-month follow-up.
RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later. The CBTI group reported better quality of life as indicated by substantial improvements in emotional wellbeing and resiliency to physical and emotional problems, whereas the SRT and SHE groups only showed improvements in resiliency to physical problems. Pain complaints decreased as sleep improved but were not associated with specific treatment conditions. Similarly, insomnia remitters reported fewer daytime and nighttime hot flashes, although reductions were not associated with any specific treatment.
CONCLUSIONS


CBTI and SRT are efficacious options for postmenopausal women with chronic insomnia. Both interventions improve daytime function, quality of life, and work performance, although CBTI produces superior results including the added benefit of improved emotional health.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295; URL: https://clinicaltrials.gov/ct2/show/record/NCT01933295.",2019,"RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later.","['postmenopausal women with chronic insomnia', 'One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia', 'postmenopausal women with insomnia', 'Postmenopausal Women With Insomnia']","['3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI', 'Cognitive Behavioral Therapy', 'CBTI and SRT', 'sleep restriction therapy (SRT)-a single component of CBTI', 'CBTI', 'cognitive behavioral therapy']","['daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life', 'Pain complaints', 'daytime and nighttime hot flashes', 'daytime function, quality of life, and work performance', 'Improving Daytime Functioning, Work Performance, and Quality of Life', 'emotional wellbeing and resiliency to physical and emotional problems', 'quality of life', 'fatigue, energy, sleepiness, and work function', 'Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1286385', 'cui_str': 'Performance at Work'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",150.0,0.064667,"RESULTS


CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Roehrs', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7882']
1655,31556975,"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY).","OBJECTIVE


Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD).
METHODS


This was a multicenter, randomized, double-blind, placebo-controlled study in patients with DSM-5-defined MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Using a 2-stage sequential parallel-comparison design, patients were initially randomized in a 3:1 ratio to placebo or pimavanserin added to ongoing SSRI or SNRI therapy; at 5 weeks, placebo nonresponders were re-randomized to placebo or pimavanserin for an additional 5 weeks. Key endpoints were change from baseline to the end of each stage in 17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score.
RESULTS


Between December 2016 and October 2018, 207 patients were randomized. For the prespecified pooled Sequential Parallel Comparison Design analyses of Stages 1 and 2, the least squares (LS) mean (SE) difference for the HDRS-17 total score was -1.7 (0.85) (P = .039) and for the SDS score was -0.8 (0.29) (P = .004). At week 5 of Stage 1, LS mean (SE) difference for pimavanserin versus placebo was significant for changes on the HDRS-17 (-4.0 [1.09], P = .0003) and SDS (-1.2 [0.40], P = .0036) with effect sizes of 0.626 and 0.498, respectively. Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week. The most common adverse events with pimavanserin were dry mouth, nausea, and headache.
CONCLUSIONS


Pimavanserin demonstrated robust efficacy in patients with MDD and an inadequate response to an SSRI or SNRI. Tolerability was consistent with previous experience.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03018340.",2019,Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week.,"['Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY', 'patients with major depressive disorder (MDD', 'patients with DSM-5-defined MDD and an inadequate response to a', 'patients with MDD', 'Between December 2016 and October 2018, 207 patients were randomized']","['Placebo', 'placebo or pimavanserin added to ongoing SSRI or SNRI therapy', 'pimavanserin', 'placebo or pimavanserin', 'pimavanserin from placebo', 'Pimavanserin', 'placebo', 'Adjunctive Pimavanserin', 'selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI']","['Tolerability', 'SDS score', 'efficacy and safety', 'dry mouth, nausea, and headache', 'HDRS-17 total score', '17-item Hamilton Depression Rating Scale (HDRS-17) total score and Sheehan Disability Scale (SDS) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1579361', 'cui_str': 'SNRIs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}]",207.0,0.52314,Early and sustained separation of pimavanserin from placebo (P < .05) occurred at 1 week.,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, 55 Fruit St, Bulfinch 351, Boston, MA 02114. mfava@mgh.harvard.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12928']
1656,27437712,Prolonged use of Kinesiotaping does not enhance functional performance and joint proprioception in healthy young males: Randomized controlled trial.,"OBJECTIVES


The aim of this study was to investigate the effects of continuous (48-hour) use of Kinesiotaping (KT) on functional and proprioceptive performance in healthy, physically active men.
METHOD


Twenty-six healthy, physically active men (21.8±2.2 years old) were randomly allocated into two groups: 1) Kinesiotaping group (KG, tape applied with 40% tension for rectus femoris activation); 2) Control (CG, tape applied over rectus femoris without additional tension). Subjects attended the laboratory on five separate occasions: 1) familiarization; 2) baseline measurement without tape (BL); 3) immediately post-tape application (T0); 4) 24h (T24); and 5) 48h (T48) post-tape application. The outcomes were distance in the single (SHT) and triple hop tests (THT), vertical jump height (VJH), vertical jump power (VJP), and rate of force development (RFD). A mixed-model ANOVA was applied to verify differences between and within groups.
RESULTS


No significant (p >0.05) differences were found in the SHT and THT between groups and moments. Likewise, the main effects for VJH, VJP, and RFD were not significant (p >0.05).
CONCLUSION


The present study demonstrated no significant immediate or prolonged (48h) effects of KT on functional and proprioceptive performance.",2016,The present study demonstrated no significant immediate or prolonged (48h) effects of KT on functional and proprioceptive performance.,"['healthy young males', 'Twenty-six healthy, physically active men (21.8±2.2 years old', 'healthy, physically active men']","['Kinesiotaping', 'continuous (48-hour) use of Kinesiotaping (KT', 'Kinesiotaping group (KG, tape applied with 40% tension for rectus femoris activation); 2) Control (CG, tape applied over rectus femoris without additional tension', 'KT']","['functional performance and joint proprioception', 'distance in the single (SHT) and triple hop tests (THT), vertical jump height (VJH), vertical jump power (VJP), and rate of force development (RFD', 'VJH, VJP, and RFD', 'functional and proprioceptive performance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3853978'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0348385,The present study demonstrated no significant immediate or prolonged (48h) effects of KT on functional and proprioceptive performance.,"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Magalhães', 'Affiliation': 'Faculdade de Educação Física, Universidade de Brasília (UnB), Brasilia, DF, Brazil.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'Faculdade de Educação Física, Universidade de Brasília (UnB), Brasilia, DF, Brazil.'}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Freitas', 'Affiliation': 'Curso de Fisioterapia, Laboratório de Análise do Desempenho Funcional Humano, UnB, Campus UnB Ceilândia, Brasília, DF, Brazil.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Carmo', 'Affiliation': 'Faculdade de Educação Física, Universidade de Brasília (UnB), Brasilia, DF, Brazil.'}, {'ForeName': 'João P C', 'Initials': 'JP', 'LastName': 'Matheus', 'Affiliation': 'Curso de Fisioterapia, Laboratório de Análise do Desempenho Funcional Humano, UnB, Campus UnB Ceilândia, Brasília, DF, Brazil.'}, {'ForeName': 'Rodrigo L', 'Initials': 'RL', 'LastName': 'Carregaro', 'Affiliation': 'Faculdade de Educação Física, Universidade de Brasília (UnB), Brasilia, DF, Brazil.'}]",Brazilian journal of physical therapy,['10.1590/bjpt-rbf.2014.0151']
1657,27437714,"Delayed effect of Kinesio Taping on neuromuscular performance, balance, and lower limb function in healthy individuals: a randomized controlled trial.","BACKGROUND


Kinesio Taping (KT) is an elastic bandage that aims to improve neuromuscular performance, although there is no consensus as to its benefits.
OBJECTIVE


To analyze the immediate and delayed effects of KT on the neuromuscular performance of the femoral quadriceps, on balance, and lower limb function in healthy subjects.
METHOD


This is a randomized controlled trial. Thirty-six women with a mean age of 22.2±3.6 years and BMI of 22.5±2.3 Kg/m2 were divided into three groups: control, with ten minutes of rest (control, n=12), application of Kinesio Taping without tension (placebo, n=12) and with tension (KT, n=12) on the quadriceps. The primary outcome was isokinetic performance, while secondary outcomes were the single-hop test, one-footed static balance, and electromyographic activity. The evaluations were carried out in five stages: 1) before application of KT, 2) immediately after the application of KT, 3) after 24h, 4) after 48h, and 5) after 72h. Mixed ANOVA was used to determine differences between groups.
RESULTS


There was no change in one-footed static balance, electromyographic activity of the VL in the lower limb function, nor in isokinetic performance between groups.
CONCLUSION


KT promotes neither immediate nor delayed changes in neuromuscular performance of the femoral quadriceps in healthy women.",2016,"There was no change in one-footed static balance, electromyographic activity of the VL in the lower limb function, nor in isokinetic performance between groups.
","['healthy women', 'healthy subjects', 'healthy individuals', 'Thirty-six women with a mean age of 22.2±3.6 years and BMI of 22.5±2.3 Kg/m2']","['Kinesio Taping (KT', 'KT', 'Kinesio Taping', 'Kinesio Taping without tension (placebo, n=12) and with tension (KT, n=12) on the quadriceps']","['one-footed static balance, electromyographic activity', 'single-hop test, one-footed static balance, and electromyographic activity', 'neuromuscular performance, balance, and lower limb function', 'isokinetic performance', 'neuromuscular performance']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}]",36.0,0.0721111,"There was no change in one-footed static balance, electromyographic activity of the VL in the lower limb function, nor in isokinetic performance between groups.
","[{'ForeName': 'Caio A A', 'Initials': 'CA', 'LastName': 'Lins', 'Affiliation': 'Laboratório de Análise da Performance Neuromuscular (LAPERN), Departamento de Fisioterapia, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Borges', 'Affiliation': 'Laboratório de Análise da Performance Neuromuscular (LAPERN), Departamento de Fisioterapia, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}, {'ForeName': 'Liane B', 'Initials': 'LB', 'LastName': 'Macedo', 'Affiliation': 'Laboratório de Análise da Performance Neuromuscular (LAPERN), Departamento de Fisioterapia, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}, {'ForeName': 'Karinna S A', 'Initials': 'KS', 'LastName': 'Costa', 'Affiliation': 'Laboratório de Análise da Performance Neuromuscular (LAPERN), Departamento de Fisioterapia, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}, {'ForeName': 'Jamilson S', 'Initials': 'JS', 'LastName': 'Brasileiro', 'Affiliation': 'Laboratório de Análise da Performance Neuromuscular (LAPERN), Departamento de Fisioterapia, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.'}]",Brazilian journal of physical therapy,['10.1590/bjpt-rbf.2014.0161']
1658,27437716,The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of abdominopelvic training by virtual reality compared to pelvic floor muscle training (PFMT) using a gym ball (a previously tested and efficient protocol) on postmenopausal women's pelvic floor muscle (PFM) strength.
METHOD


A randomized controlled trial was conducted with 60 postmenopausal women, randomly allocated into two groups: Abdominopelvic training by virtual reality - APT_VR (n=30) and PFMT using a gym ball - PFMT_GB (n=30). Both types of training were supervised by the same physical therapist, during 10 sessions each, for 30 minutes. The participants' PFM strength was evaluated by digital palpation and vaginal dynamometry, considering three different parameters: maximum strength, average strength and endurance. An intention-to-treat approach was used to analyze the participants according to original groups.
RESULTS


No significant between-group differences were observed in most analyzed parameters. The outcome endurance was higher in the APT_VR group (p=0.003; effect size=0.89; mean difference=1.37; 95% CI=0.46 to 2.28).
CONCLUSION


Both protocols have improved the overall PFM strength, suggesting that both are equally beneficial and can be used in clinical practice. Muscle endurance was higher in patients who trained using virtual reality.",2016,"The outcome endurance was higher in the APT_VR group (p=0.003; effect size=0.89; mean difference=1.37; 95% CI=0.46 to 2.28).
","['postmenopausal women', ""postmenopausal women's pelvic floor muscle (PFM) strength"", '60 postmenopausal women']","['abdominopelvic training by virtual reality compared to pelvic floor muscle training (PFMT', 'training by virtual reality or gym ball', 'Abdominopelvic training by virtual reality - APT_VR (n=30) and PFMT using a gym ball - PFMT_GB']","['Muscle endurance', 'PFM strength', 'outcome endurance', 'overall PFM strength']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",60.0,0.0536524,"The outcome endurance was higher in the APT_VR group (p=0.003; effect size=0.89; mean difference=1.37; 95% CI=0.46 to 2.28).
","[{'ForeName': 'Natalia M', 'Initials': 'NM', 'LastName': 'Martinho', 'Affiliation': 'Curso de Fisioterapia, Escola de Enfermagem, Universidade Federal de Alfenas (UNIFAL-MG), Alfenas, MG, Brazil.'}, {'ForeName': 'Valéria R', 'Initials': 'VR', 'LastName': 'Silva', 'Affiliation': 'Curso de Fisioterapia, Escola de Enfermagem, Universidade Federal de Alfenas (UNIFAL-MG), Alfenas, MG, Brazil.'}, {'ForeName': 'Joseane', 'Initials': 'J', 'LastName': 'Marques', 'Affiliation': 'Curso de Fisioterapia, Escola de Enfermagem, Universidade Federal de Alfenas (UNIFAL-MG), Alfenas, MG, Brazil.'}, {'ForeName': 'Leonardo C', 'Initials': 'LC', 'LastName': 'Carvalho', 'Affiliation': 'Curso de Fisioterapia, Escola de Enfermagem, Universidade Federal de Alfenas (UNIFAL-MG), Alfenas, MG, Brazil.'}, {'ForeName': 'Denise H', 'Initials': 'DH', 'LastName': 'Iunes', 'Affiliation': 'Curso de Fisioterapia, Escola de Enfermagem, Universidade Federal de Alfenas (UNIFAL-MG), Alfenas, MG, Brazil.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Botelho', 'Affiliation': 'Curso de Fisioterapia, Escola de Enfermagem, Universidade Federal de Alfenas (UNIFAL-MG), Alfenas, MG, Brazil.'}]",Brazilian journal of physical therapy,['10.1590/bjpt-rbf.2014.0148']
1659,28697509,Akute Otitis Media: wie lange Antibiotika einsetzen?,,2017,,[],[],[],[],[],[],,0.0173869,,[],Laryngo- rhino- otologie,['10.1055/s-0043-105201']
1660,31557492,Endocrine effects of the novel ghrelin receptor inverse agonist PF-5190457: Results from a placebo-controlled human laboratory alcohol co-administration study in heavy drinkers.,"Both animal and human work suggests that the ghrelin system may be involved in the mechanisms that regulate the development and maintenance of alcohol use disorder. Previously, in a Phase 1b study, we tested pharmacological blockade of the growth hormone secretagogue receptor 1a (GHS-R1a, also known as the ghrelin receptor), in heavy drinking individuals with PF-5190457, an orally bioavailable, potent and selective GHS-R1a inverse agonist. We report here the effects of PF-5190457 on endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose during PF-5190457 dosing, as compared to placebo, in absence of alcohol as well as during an alcohol challenge when PF-5190457 was on steady-state. Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge. The safety-related relevance of these findings to further develop PF-5190547 in alcohol use disorder is discussed. CLINICALTRIALS.GOV: NCT02039349. This article is part of the special issue on 'Neuropeptides'.",2020,"Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge.",['controlled human laboratory alcohol co-administration study in heavy drinkers'],"['placebo', 'PF-5190457', 'novel ghrelin receptor inverse agonist']","['endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose', 'Blood hormone levels']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic Polypeptide Hormone'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine (substance)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.018613,"Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Saravanakumar', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jillian T', 'Initials': 'JT', 'LastName': 'Battista', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.107788']
1661,31445354,A phase II study of nab-paclitaxel and carboplatin chemotherapy plus necitumumab in the first-line treatment of patients with stage IV squamous non-small cell lung cancer.,"OBJECTIVES


Necitumumab is a second-generation, recombinant, human IgG1-type monoclonal antibody directed against EGFR approved for adult patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin. This study assessed the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) and carboplatin in combination with necitumumab as first-line therapy in patients with stage IV squamous NSCLC.
MATERIALS AND METHODS


The treatment regimen comprised triplet induction with necitumumab (800 mg) with nab-paclitaxel (100 mg/m 2 ) and carboplatin (AUC 6 mg*min/mL) for 4 cycles, followed by doublet maintenance with necitumumab and nab-paclitaxel with a 3-weekly schedule until progressive disease or unacceptable toxicity. The primary endpoint of the study was objective response rate (ORR).
RESULTS


Fifty-four patients were enrolled. Median age was 65 years (range, 47-80 years). The majority of the patients were male (n = 42 [77.8%]) with an ECOG PS of 1 (n = 42 [77.8%]). The ORR was 51% (n = 26/54), and the disease control rate was 78.4% (n = 40/54). Median overall survival (OS) was 15.5 months (95% confidence interval [CI]: 10.18-not calculable), and the OS rate at 12 months was 50.4% (95% CI: 29.0-68.4). Median progression-free survival was 5.6 months (95% CI: 4.24-7.69)]. The most frequently reported treatment-emergent adverse events were anemia (57.4%), fatigue (55.6%), neutrophil count decreased (55.6%), hypomagnesemia (44.4%), and rash (38.9%).
CONCLUSION


Necitumumab/nab-paclitaxel/carboplatin first-line therapy produced favorable efficacy outcomes with manageable toxicity in patients with stage IV squamous NSCLC. The safety profile was fairly comparable with previous necitumumab combination studies in lung cancer.",2019,Median progression-free survival was 5.6 months (95% CI: 4.24-7.69)].,"['patients with stage IV squamous non-small cell lung cancer', 'Fifty-four patients were enrolled', 'adult patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with', 'patients with stage IV squamous NSCLC', 'Median age was 65 years (range, 47-80 years']","['albumin-bound paclitaxel (nab-paclitaxel) and carboplatin', 'nab-paclitaxel and carboplatin chemotherapy plus necitumumab', 'carboplatin (AUC 6 mg*min/mL) for 4 cycles, followed by doublet maintenance with necitumumab and nab-paclitaxel', 'Necitumumab/nab-paclitaxel/carboplatin first-line therapy', 'gemcitabine and cisplatin', 'triplet induction with necitumumab (800\u202fmg) with nab-paclitaxel']","['fatigue', 'objective response rate (ORR', 'rash', 'ORR', 'Median overall survival (OS', 'OS rate', 'efficacy and safety', 'Median progression-free survival', 'disease control rate', 'hypomagnesemia', 'neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2352806', 'cui_str': 'necitumumab'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",54.0,0.101372,Median progression-free survival was 5.6 months (95% CI: 4.24-7.69)].,"[{'ForeName': 'Liza C', 'Initials': 'LC', 'LastName': 'Villaruz', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, USA. Electronic address: villaruzl@upmc.edu.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario de Malaga, Malaga, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': 'National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Mavroudis', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Greece.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jong Seok', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, USA.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.08.009']
1662,26647745,Interval training based on ventilatory anaerobic threshold increases cardiac vagal modulation and decreases high-sensitivity c-reative protein: randomized clinical trial in coronary artery disease.,"BACKGROUND


Autonomic dysfunction and inflammatory activity are involved in the development and progression of coronary artery disease (CAD), and exercise training has been shown to confer a cardiovascular benefit.
OBJECTIVE


To evaluate the effects that interval training (IT) based on ventilatory anaerobic threshold (VAT) has on heart rate variability (HRV) and high-sensitivity C-reactive protein (hs-CRP) levels, as well as the relationship between both levels, in patients with CAD and/or cardiovascular risk factors (RF).
METHOD


Forty-two men (aged 57.88±6.20 years) were divided into two training groups, CAD-T (n= 12) and RF-T (n= 10), and two control groups, CAD-C (n= 10) and RF-C (n=10). Heart rate and RR intervals in the supine position, cardiopulmonary exercise tests, and hs-CRP levels were measured before and after IT. HRV was analyzed by spectral and symbolic analysis. The CAD-T and RF-T underwent a 16-week IT program of three weekly sessions at training intensities based on the VAT.
RESULTS


In the RF-T, cardiac sympathetic modulation index and hs-CRP decreased (p<0.02), while cardiac parasympathetic modulation index increased (p<0.02). In the CAD-T, cardiac parasympathetic modulation index increased, while hs-CRP, systolic, and diastolic blood pressures decreased (p<0.02). Both control groups showed increase in hs-CRP parameters (p<0.02). There was a strong and significant association between parasympathetic and sympathetic modulations with hs-CRP.
CONCLUSION


The IT program based on the VAT promoted a decrease in hs-CRP associated with improvement in cardiac autonomic modulation.",2015,"In the RF-T, cardiac sympathetic modulation index and hs-CRP decreased (p<0.02), while cardiac parasympathetic modulation index increased (p<0.02).","['patients with CAD and/or cardiovascular risk factors (RF', 'Forty-two men (aged 57.88±6.20 years', 'coronary artery disease']","['interval training (IT) based on ventilatory anaerobic threshold (VAT', 'Interval training based on ventilatory anaerobic threshold']","['cardiac parasympathetic modulation index', 'HRV', 'heart rate variability (HRV) and high-sensitivity C-reactive protein (hs-CRP) levels', 'cardiac vagal modulation', 'hs-CRP parameters', 'cardiac autonomic modulation', 'RF-T, cardiac sympathetic modulation index and hs-CRP', 'Heart rate and RR intervals in the supine position, cardiopulmonary exercise tests, and hs-CRP levels', 'parasympathetic and sympathetic modulations', 'CAD-T, cardiac parasympathetic modulation index increased, while hs-CRP, systolic, and diastolic blood pressures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",42.0,0.0241357,"In the RF-T, cardiac sympathetic modulation index and hs-CRP decreased (p<0.02), while cardiac parasympathetic modulation index increased (p<0.02).","[{'ForeName': 'Nayara Y', 'Initials': 'NY', 'LastName': 'Tamburus', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de São Carlos, São Carlos, SP, Brazil.'}, {'ForeName': 'Roberta F L', 'Initials': 'RF', 'LastName': 'Paula', 'Affiliation': 'Faculdade de Ciências da Saúde, Universidade Metodista de Piracicaba, Piracicaba, SP, Brazil.'}, {'ForeName': 'Vandeni C', 'Initials': 'VC', 'LastName': 'Kunz', 'Affiliation': 'Centro Universitário Adventista, Engenheiro Coelho, SP, Brazil.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'César', 'Affiliation': 'Faculdade de Ciências da Saúde, UNIMEP, Piracicaba, SP, Brazil.'}, {'ForeName': 'Marlene A', 'Initials': 'MA', 'LastName': 'Moreno', 'Affiliation': 'Faculdade de Ciências da Saúde, Universidade Metodista de Piracicaba, Piracicaba, SP, Brazil.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'da Silva', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal de São Carlos, São Carlos, SP, Brazil.'}]",Brazilian journal of physical therapy,['10.1590/bjpt-rbf.2014.0124']
1663,30782652,"Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial.",,2019,,[],[],[],[],[],[],,0.0995001,,[],BMJ (Clinical research ed.),['10.1136/bmj.l457']
1664,31551155,Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial.,"OBJECTIVE


To evaluate the benefit of next-generation sequencing (NGS)-based preimplantation genetic testing for aneuploidy (PGT-A) for embryo selection in frozen-thawed embryo transfer.
DESIGN


Randomized controlled trial.
SETTING


Not applicable.
PATIENT(S)


Women aged 25-40 years undergoing IVF with at least two blastocysts that could be biopsied.
INTERVENTION(S)


Randomization for single frozen-thawed embryo transfer with embryo selection based on PGT-A euploid status versus morphology.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer.
RESULT(S)


A total of 661 women (average age 33.7 ± 3.6 years) were randomized to PGT-A (n = 330) or morphology alone (n = 331). The OPR was equivalent between the two arms, with no significant difference per embryo transfer (50% [137/274] vs. 46% [143/313]) or per intention to treat (ITT) at randomization (41.8% [138/330] vs. 43.5% [144/331]). Post hoc analysis of women aged 35-40 years showed a significant increase in OPR per embryo transfer (51% [62/122] vs. 37% [54/145]) but not per ITT.
CONCLUSION(S)


PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT. There was a significant increase in OPR per embryo transfer with the use of PGT-A in the subgroup of women aged 35-40 years who had two or more embryos that could be biopsied, but this was not significant when analyzed by ITT.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02268786.",2019,"CONCLUSION(S)


PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT.","['Women aged 25-40\xa0years undergoing IVF with at least two blastocysts that could be biopsied', 'good-prognosis patients', '661 women (average age 33.7 ± 3.6\xa0years']","['morphology alone', 'next-generation sequencing (NGS)-based preimplantation genetic testing', 'Randomization for single frozen-thawed embryo transfer with embryo selection based on PGT-A euploid status versus morphology']","['OPR', 'Ongoing pregnancy rate (OPR', 'embryo transfer', 'overall pregnancy outcomes', 'OPR per embryo transfer']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}]",661.0,0.230078,"CONCLUSION(S)


PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Munné', 'Affiliation': 'Cooper Genomics, Livingston, New Jersey; Department of Obstetrics, Gynecology, and Reproductive Science, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': 'Highland Park IVF Center, Fertility Centers of Illinois, Highland Park, Illinois.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Frattarelli', 'Affiliation': 'Fertility Institute of Hawaii, Honolulu, Hawaii.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Child', 'Affiliation': 'Oxford Fertility, Oxford, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Nakhuda', 'Affiliation': 'Olive Fertility Center, Vancouver, British Columbia, Canada.'}, {'ForeName': 'F Nicholas', 'Initials': 'FN', 'LastName': 'Shamma', 'Affiliation': 'IVF Michigan, Bloomfield Hills, Michigan.'}, {'ForeName': 'Kaylen', 'Initials': 'K', 'LastName': 'Silverberg', 'Affiliation': 'Texas Fertility Center, Austin, Texas; Ovation Fertility, Los Angeles, California.'}, {'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Kalista', 'Affiliation': 'Illumina, Foster City, California.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Handyside', 'Affiliation': 'School of Biosciences, University of Kent, Canterbury, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Katz-Jaffe', 'Affiliation': 'Colorado Center for Reproductive Medicine, Lone Tree, Colorado.'}, {'ForeName': 'Dagan', 'Initials': 'D', 'LastName': 'Wells', 'Affiliation': 'Reprogenetics, Oxford, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Gordon', 'Affiliation': 'Cooper Genomics, London, United Kingdom.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Stock-Myer', 'Affiliation': 'Melbourne IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Willman', 'Affiliation': 'Reproductive Science Center, San Ramon, California. Electronic address: susan@susanwillman.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.07.1346']
1665,31540607,Effects of access barriers and medication acceptability on buprenorphine-naloxone treatment utilization over 2 years: Results from a multisite randomized trial of adults with opioid use disorder.,"BACKGROUND


Nationwide efforts seek to address the opioid epidemic by increasing access to medications for opioid use disorder (OUD), particularly with buprenorphine. A poorly understood challenge is that among individuals with OUD who do receive buprenorphine, many do not adhere to the pharmacotherapy long enough to achieve sustained benefits. We aimed to identify factors associated with buprenorphine treatment utilization over time.
METHODS


We used random-intercept modeling to identify factors associated with buprenorphine treatment utilization over 2 years after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of buprenorphine compared to methadone. Key predictors were participants' reports of buprenorphine treatment accessibility and acceptability (assessed at first follow-up) and their interaction effects, controlling for baseline randomization status, sociodemographics, and other covariates.
RESULTS


Approximately 9.3-11.2% of participants utilized buprenorphine treatment over the 2 years of follow-up. Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors. In contrast, individuals who perceived buprenorphine to be unacceptable were least likely to use buprenorphine, regardless the level of perceived access to the medication. Buprenorphine treatment utilization was also negatively associated with Hispanic ethnicity, West coast context, and cumulative months receiving methadone treatment and incarceration during follow-up.
CONCLUSIONS


To engage more individuals with OUD in long-term treatment with buprenorphine, interventions should target buprenorphine treatment acceptability, in addition to increasing buprenorphine access, and tailor efforts to meet the needs of vulnerable populations.
TRIAL REGISTRATION


The START Follow-up Study on ClinicalTrials.gov (NCT01592461).",2019,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","['over 2\u202fyears after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of', 'individuals with OUD', 'adults with opioid use disorder', '2\u202fyears']","['methadone', 'buprenorphine-naloxone', 'buprenorphine', 'Buprenorphine', 'buprenorphine treatment utilization']",['Interaction effects'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042153', 'cui_str': 'use'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",789.0,0.0456768,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Evans', 'Affiliation': 'Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts Amherst, 312 Arnold House, 715 North Pleasant St. Amherst, MA 01003, USA. Electronic address: eaevans@umass.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: cyoo5@ucla.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhuang@ucla.edu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA 98108, USA. Electronic address: Andrew.Saxon@va.gov.'}, {'ForeName': 'Yih-Ing', 'Initials': 'YI', 'LastName': 'Hser', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhser@ucla.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.002']
1666,30638574,Multimorbidity and patient-centred care in the 3D trial.,,2019,,[],[],[],[],[],[],,0.0555078,,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marengoni', 'Affiliation': 'Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy. Electronic address: alessandra.marengoni@ki.se.'}, {'ForeName': 'Davide L', 'Initials': 'DL', 'LastName': 'Vetrano', 'Affiliation': 'Aging Research Center, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Calderón-Larrañaga', 'Affiliation': 'Aging Research Center, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Graziano', 'Initials': 'G', 'LastName': 'Onder', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica Sacro Cuore, Rome, Italy.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)32528-5']
1667,31551193,Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study.,"INTRODUCTION


Patients with testosterone deficiency (TD) can be treated with exogenous testosterone (T) to achieve and maintain physiologic T levels and prevent negative clinical symptoms; with many testosterone replacement therapies currently available, this registration safety study was conducted to further characterize the clinical profile of chronically administered, concentration-guided subcutaneous testosterone enanthate (TE) dosing.
AIM


The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD.
METHODS


In this phase III, 26-week study, 133 men 18-75 years of age with symptomatic TD self-administered SCTE-AI 75 mg once weekly for 6 weeks from July 2015 to June 2016. Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12.1-22.5 nmol/L). PK data were collected from a subgroup of patients receiving 75 mg SCTE-AI through week 12. Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed.
MAIN OUTCOME MEASURES


The main outcomes were the documentation of the reproducibility of trough concentration-guided exposure to SCTE, 6-month safety profile, and PK data for the 75 mg dose SCTE.
RESULTS


In total, 34 patients (25.6%) experienced adverse drug reactions; the most frequently reported were increased hematocrit (≥52%) in 10 patients (7.5%), injection-site hemorrhage in 6 patients (4.5%), injection-site bruising in 4 patients (3.0%), and increased prostate-specific antigen in 4 patients (3.0%). By week 26, mean systolic and diastolic blood pressure (BP) measured in the clinic increased by 3.4 mmHg (125.6-129.0 mmHg) and 1.8 mmHg (78.2-80.0 mmHg), respectively, from baseline. At week 12, ABPM showed 24-hour mean systolic and diastolic BP increases of 3.7 mmHg and 1.3 mmHg, respectively. All measured lipid fractions were below baseline levels at week 26. T, TE, dihydrotestosterone, and estradiol increased from weeks 1-12. T trough levels ranged from 300-650 ng/dL (10.4-22.5 nmol/L) in 82.4% and 83.2% of patients at weeks 12 and 26, respectively. Of the 965 assessed injections, mild pain was reported by 1 patient.
CLINICAL IMPLICATIONS


Dosing with SCTE is well-tolerated overall, yet associated with a numerically small mean systolic BP increase.
STRENGTHS & IMPLICATIONS


This study used a standardized ABPM protocol, confirming a numerically small systolic BP increase may be associated with reintroducing therapeutic T exposure in hypogonadal men. It is unknown at this time whether this applies with all routes of T supplementation.
CONCLUSION


SCTE-AI has a favorable safety profile and is well-tolerated, with a stable PK profile. Gittelman M, Jaffe JS, Kaminetsky JC. Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study. J Sex Med 2019;16:1741-1748. Clinicaltrials.gov Identifier: NCT02504541.",2019,"In total, 34 patients (25.6%) experienced adverse drug reactions; the most frequently reported were increased hematocrit (≥52%) in 10 patients (7.5%), injection-site hemorrhage in 6 patients (4.5%), injection-site bruising in 4 patients (3.0%), and increased prostate-specific antigen in 4 patients (3.0%).","['Patients with testosterone deficiency (TD', 'hypogonadal men', 'adult men with TD', '133 men 18-75 years of age with symptomatic TD self-administered SCTE-AI 75 mg once weekly for 6 weeks from July 2015 to June 2016']","['subcutaneous TE auto-injector (SCTE-AI', 'exogenous testosterone (T', 'New Subcutaneous Testosterone Enanthate Auto-Injector', 'SCTE']","['T trough levels', 'injection-site bruising', 'injection-site hemorrhage', 'mean systolic and diastolic blood pressure (BP', 'hematocrit', 'lipid fractions', 'prostate-specific antigen', 'T, TE, dihydrotestosterone, and estradiol', 'ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK', '24-hour mean systolic and diastolic BP', 'adverse drug reactions', 'documentation of the reproducibility of trough concentration-guided exposure to SCTE, 6-month safety profile, and PK data', 'mild pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C2984091', 'cui_str': 'Auto-Injector'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0076189', 'cui_str': 'testosterone enanthate'}]","[{'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0521508', 'cui_str': 'Injection site bruising (disorder)'}, {'cui': 'C0151698', 'cui_str': 'Injection site hemorrhage (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0038148', 'cui_str': 'Dihydrotestosterone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}]",133.0,0.10996,"In total, 34 patients (25.6%) experienced adverse drug reactions; the most frequently reported were increased hematocrit (≥52%) in 10 patients (7.5%), injection-site hemorrhage in 6 patients (4.5%), injection-site bruising in 4 patients (3.0%), and increased prostate-specific antigen in 4 patients (3.0%).","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gittelman', 'Affiliation': 'Uromedix, Aventura, FL, USA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Jaffe', 'Affiliation': 'Antares Pharma, Inc., Ewing, NJ, USA. Electronic address: jjaffe@antarespharma.com.'}, {'ForeName': 'Jed C', 'Initials': 'JC', 'LastName': 'Kaminetsky', 'Affiliation': 'Manhattan Medical Research, New York, NY, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.08.013']
1668,30655452,Sertraline or placebo in chronic breathlessness? Lessons from placebo research.,,2019,,[],"['Sertraline or placebo', 'placebo']",[],[],"[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.21493,,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'IMPACCT, University of Technology Sydney, Ultimo, Australia.'}]",The European respiratory journal,['10.1183/13993003.02316-2018']
1669,31136545,Low-Load vs. High-Load Resistance Training to Failure on One Repetition Maximum Strength and Body Composition in Untrained Women.,"Dinyer, TK, Byrd, MT, Garver, MJ, Rickard, AJ, Miller, WM, Burns, S, Clasey, JL, and Bergstrom, HC. Low-load vs. high-load resistance training to failure on one repetition maximum strength and body composition in untrained women. J Strength Cond Res 33(7): 1737-1744, 2019-This study examined the effects of resistance training (RT) to failure at low and high loads on one repetition maximum (1RM) strength and body composition (bone- and fat-free mass [BFFM] and percent body fat [%BF]) in untrained women. Twenty-three untrained women (age: 21.2 ± 2.2 years; height: 167.1 ± 5.7 cm; body mass: 62.3 ± 16.2 kg) completed a 12-week RT to failure intervention at a low (30% 1RM) (n = 11) or high (80% 1RM) (n = 12) load. On weeks 1, 5, and 12, subjects completed 1RM testing for 4 different exercises (leg extension [LE], seated military press [SMP], leg curl [LC], and lat pull down [LPD]) and a dual-energy x-ray absorptiometry scan to assess body composition. During weeks 2-4 and 6-7, the subjects completed 2 sets to failure for each exercise. During weeks 8-11, the subjects completed 3 sets to failure for each exercise. The 1RM strength increased from week 1 to week 5 (LE: 18 ± 16%; SMP: 9 ± 11%; LC: 12 ± 22%; LPD: 13 ± 9%), week 1 to week 12 (LE: 32 ± 24%; SMP: 17 ± 14%; LC: 23 ± 26%; LPD: 25 ± 13%), and week 5 to week 12 (LE: 11 ± 9%; SMP: 7 ± 9%; LC: 10 ± 7%; LPD: 11 ± 11%) in each exercise, with no significant differences between groups. There were no significant changes in BFFM (p = 0.241) or %BF (p = 0.740) for either group. Resistance training to failure at 30% 1RM and 80% 1RM resulted in similar increases in 1RM strength, but no change in BFFM or %BF. Untrained women can increase 1RM strength during RT at low and high loads, if repetitions are taken to failure.",2019,"Untrained women can increase 1RM strength during RT at low and high loads, if repetitions are taken to failure.","['Untrained Women', 'J Strength Cond Res 33(7', 'untrained women', 'Untrained women', 'n = 11) or high (80% 1RM', 'Twenty-three untrained women (age: 21.2 ± 2.2 years; height: 167.1 ± 5.7 cm; body mass: 62.3 ± 16.2 kg) completed a 12-week RT to failure intervention at a low (30% 1RM']","['resistance training (RT', '1RM testing for 4 different exercises (leg extension [LE], seated military press [SMP], leg curl [LC], and lat pull down [LPD]) and a dual-energy x-ray absorptiometry scan']","['BFFM', 'repetition maximum (1RM) strength and body composition (bone- and fat-free mass [BFFM] and percent body fat [%BF', 'Dinyer, TK, Byrd, MT, Garver, MJ, Rickard, AJ, Miller, WM, Burns, S, Clasey, JL, and Bergstrom, HC', '1RM strength']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0023979', 'cui_str': 'LATS'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}]",23.0,0.0150658,"Untrained women can increase 1RM strength during RT at low and high loads, if repetitions are taken to failure.","[{'ForeName': 'Taylor K', 'Initials': 'TK', 'LastName': 'Dinyer', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'M Travis', 'Initials': 'MT', 'LastName': 'Byrd', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Garver', 'Affiliation': 'School of Nutrition, Kinesiology, and Psychological Science, University of Central Missouri, Warrensburg, Missouri.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Rickard', 'Affiliation': 'School of Nutrition, Kinesiology, and Psychological Science, University of Central Missouri, Warrensburg, Missouri.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Miller', 'Affiliation': 'Department of Health, Science, and Recreation Management, University of Mississippi, Oxford, Mississippi.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Burns', 'Affiliation': 'School of Nutrition, Kinesiology, and Psychological Science, University of Central Missouri, Warrensburg, Missouri.'}, {'ForeName': 'Jody L', 'Initials': 'JL', 'LastName': 'Clasey', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Haley C', 'Initials': 'HC', 'LastName': 'Bergstrom', 'Affiliation': 'Department of Kinesiology and Health Promotion, University of Kentucky, Lexington, Kentucky.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003194']
1670,31843072,Therapeutic endometrial scratching and implantation after in vitro fertilization: a multicenter randomized controlled trial.,"OBJECTIVE


To study whether endometrial scratching in the luteal phase before ovarian stimulation increases clinical pregnancy rates in women with one or more previous implantation failures.
DESIGN


A nonblinded multicenter randomized clinical trial.
SETTING


Fertility clinics.
PATIENT(S)


Three hundred four eligible patients scheduled for IVF/intracytoplasmic sperm injection were randomized. The intervention group (n = 151) underwent endometrial scratching in the luteal phase before controlled ovarian stimulation, while no intervention was performed in the control group (n = 153).
INTERVENTION(S)


Endometrial scratching with a Pipelle de Cornier catheter in the luteal phase before ovarian stimulation.
MAIN OUTCOME MEASURE(S)


Clinical pregnancy rate and prenatal and birth data.
RESULT(S)


There was no overall significant improvement in clinical pregnancy rates between the control and intervention groups (38.5% vs. 44.4%; relative risk = 1.15; confidence interval [0.86-1.55]). However, subgroup analyses revealed that women with three or more previous implantation failures had a significant increase in clinical pregnancy rate (31.1% vs. 53.6%; relative risk = 1.72; confidence interval [1.05-2.83]) after scratching. No difference was seen as regards prenatal and birth data between the two groups.
CONCLUSION(S)


Endometrial scratching in the luteal phase before ovarian stimulation significantly enhances the clinical pregnancy rate in women with three or more prior implantation failures. This result seems to corroborate previous reports, which found that particularly women with repeated implantation failure seem to gain a positive effect from endometrial scratching. Importantly, there were no significant differences in prenatal data and birth data between the groups.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01963819.",2019,Endometrial scratching in the luteal phase before ovarian stimulation significantly enhances the clinical pregnancy rate in women with three or more prior implantation failures.,"['Three hundred four eligible patients scheduled for IVF/intracytoplasmic sperm injection', 'women with one or more previous implantation failures', 'Fertility clinics', 'vitro fertilization']","['Therapeutic endometrial scratching and implantation', 'Endometrial scratching with a Pipelle de Cornier catheter', 'endometrial scratching in the luteal phase before controlled ovarian stimulation, while no intervention']","['clinical pregnancy rates', 'clinical pregnancy rate', 'regards prenatal and birth data', 'Clinical pregnancy rate and prenatal and birth data', 'prenatal data and birth data']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441192', 'cui_str': 'Pipelle (physical object)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",304.0,0.380607,Endometrial scratching in the luteal phase before ovarian stimulation significantly enhances the clinical pregnancy rate in women with three or more prior implantation failures.,"[{'ForeName': 'Mia Steengaard', 'Initials': 'MS', 'LastName': 'Olesen', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark. Electronic address: miasolesen@gmail.com.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Hauge', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Ohrt', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark.'}, {'ForeName': 'Tine Nørregaard', 'Initials': 'TN', 'LastName': 'Olesen', 'Affiliation': 'Fertility Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Roskær', 'Affiliation': 'Fertility Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Bæk', 'Affiliation': 'Fertility Clinic, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Helle Olesen', 'Initials': 'HO', 'LastName': 'Elbæk', 'Affiliation': 'Fertility Clinic, Skive Regional Hospital, Skive.'}, {'ForeName': 'Bugge', 'Initials': 'B', 'LastName': 'Nøhr', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynecology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Nyegaard', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael Toft', 'Initials': 'MT', 'LastName': 'Overgaard', 'Affiliation': 'Department of Chemistry and Bioscience, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'Fertility Clinic, Skive Regional Hospital, Skive.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Agerholm', 'Affiliation': 'Fertility Clinic, Horsens Regional Hospital, Horsens, Denmark.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.08.010']
1671,30866662,"Response by Buist et al to Letter Regarding Article, ""Randomized Controlled Trial of Surgical Versus Catheter Ablation for Paroxysmal and Early Persistent Atrial Fibrillation"".",,2019,,[],['Surgical Versus Catheter Ablation'],[],[],"[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}]",[],,0.0492773,,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Buist', 'Affiliation': 'Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Adiyaman', 'Affiliation': 'Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007259']
1672,30638575,Multimorbidity and patient-centred care in the 3D trial.,,2019,,[],[],[],[],[],[],,0.0555078,,"[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Lewis-Barned', 'Affiliation': 'Diabetes and Endocrinology Service, North Shields, NE29 8NH, UK. Electronic address: nick.lewis-barned@nhct.nhs.uk.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Coulter', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'Diabetes and Endocrinology Service, North Shields, NE29 8NH, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Year of Care Partnerships, Northumbria Healthcare NHS Foundation Trust, North Shields, NE29 8NH, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)32529-7']
1673,30663592,The MANAGE trial.,,2019,,[],[],[],[],[],[],,0.0943843,,"[{'ForeName': 'Wilton A', 'Initials': 'WA', 'LastName': 'van Klei', 'Affiliation': 'Department of Anesthesiology, University Medical Center Utrecht, 3508 GA Utrecht, Netherlands. Electronic address: w.a.vanklei@umcutrecht.nl.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Dieleman', 'Affiliation': 'Department of Anesthesiology, University Medical Center Utrecht, 3508 GA Utrecht, Netherlands.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Beattie', 'Affiliation': 'University Health Network Toronto, Department of Anesthesia and Pain Management, Toronto, ON, Canada.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)32417-6']
1674,28347430,The IMPACT trial.,,2017,,[],[],[],[],[],[],,0.114892,,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Neurological Diseases Center, The Affiliated Hospital of Chengdu University, Chengdu 610081, China.'}, {'ForeName': 'Shiping', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'The Neurological Diseases Center, The Affiliated Hospital of Chengdu University, Chengdu 610081, China. Electronic address: csp2001@aliyun.com.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(17)30087-1']
1675,31842232,Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial.,"Background


Substitutive hospital-level care in a patient's home may reduce cost, health care use, and readmissions while improving patient experience, although evidence from randomized controlled trials in the United States is lacking.
Objective


To compare outcomes of home hospital versus usual hospital care for patients requiring admission.
Design


Randomized controlled trial. (ClinicalTrials.gov: NCT03203759).
Setting


Academic medical center and community hospital.
Patients


91 adults (43 home and 48 control) admitted via the emergency department with selected acute conditions.
Intervention


Acute care at home, including nurse and physician home visits, intravenous medications, remote monitoring, video communication, and point-of-care testing.
Measurements


The primary outcome was the total direct cost of the acute care episode (sum of costs for nonphysician labor, supplies, medications, and diagnostic tests). Secondary outcomes included health care use and physical activity during the acute care episode and at 30 days.
Results


The adjusted mean cost of the acute care episode was 38% (95% CI, 24% to 49%) lower for home patients than control patients. Compared with usual care patients, home patients had fewer laboratory orders (median per admission, 3 vs. 15), imaging studies (median, 14% vs. 44%), and consultations (median, 2% vs. 31%). Home patients spent a smaller proportion of the day sedentary (median, 12% vs. 23%) or lying down (median, 18% vs. 55%) and were readmitted less frequently within 30 days (7% vs. 23%).
Limitation


The study involved 2 sites, a small number of home physicians, and a small sample of highly selected patients (with a 63% refusal rate among potentially eligible patients); these factors may limit generalizability.
Conclusion


Substitutive home hospitalization reduced cost, health care use, and readmissions while increasing physical activity compared with usual hospital care.
Primary Funding Source


Partners HealthCare Center for Population Health and internal departmental funds.",2020,"Home patients spent a smaller proportion of the day sedentary (median, 12% vs. 23%) or lying down (median, 18% vs. 55%) and were readmitted less frequently within 30 days (7% vs. 23%).
","['Acutely Ill Adults', '2 sites, a small number of home physicians, and a small sample of highly selected patients (with a 63% refusal rate among potentially eligible patients', 'Patients\n\n\n91 adults (43 home and 48 control) admitted via the emergency department with selected acute conditions', 'patients requiring admission']",['home hospital versus usual hospital care'],"['health care use and physical activity during the acute care episode and at 30 days', 'laboratory orders', 'cost, health care use, and readmissions while increasing physical activity', 'adjusted mean cost of the acute care episode', 'total direct cost of the acute care episode (sum of costs for nonphysician labor, supplies, medications, and diagnostic tests', 'smaller proportion of the day sedentary']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085554', 'cui_str': 'Patient Care Episodes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4302923', 'cui_str': 'Laboratory order (record artifact)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0086143'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]",91.0,0.165426,"Home patients spent a smaller proportion of the day sedentary (median, 12% vs. 23%) or lying down (median, 18% vs. 55%) and were readmitted less frequently within 30 days (7% vs. 23%).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Levine', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ouchi', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Blanchfield', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'Saenz', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Burke', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.B., M.P.).""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Paz', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.B., M.P.).""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Diamond', 'Affiliation': 'Partners HealthCare at Home, Waltham, Massachusetts (K.D.).'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Pu', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, and Partners HealthCare System Center for Population Health, Boston, Massachusetts (C.T.P.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Schnipper', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}]",Annals of internal medicine,['10.7326/M19-0600']
1676,25692606,Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants.,"BACKGROUND


Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer adverse effects.
OBJECTIVES


To determine the effectiveness and safety of ibuprofen compared with indomethacin, other cyclo-oxygenase inhibitor, placebo or no intervention for closing a patent ductus arteriosus in preterm, low birth weight, or preterm and low birth weight infants.
SEARCH METHODS


We searched The Cochrane Library, MEDLINE, EMBASE, Clincialtrials.gov, Controlled-trials.com, and www.abstracts2view.com/pas in May 2014.
SELECTION CRITERIA


Randomised or quasi-randomised controlled trials of ibuprofen for the treatment of a PDA in newborn infants.
DATA COLLECTION AND ANALYSIS


Data collection and analysis conformed to the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS


We included 33 studies enrolling 2190 infants.Two studies compared intravenous (iv) ibuprofen versus placebo (270 infants). In one study (134 infants) ibuprofen reduced the incidence of failure to close a PDA (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.51 to 0.99; risk difference (RD) -0.18, 95% CI -0.35 to -0.01; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 3 to 100). In one study (136 infants), ibuprofen reduced the composite outcome of infant mortality, infants who dropped out, or infants who required rescue treatment (RR 0.58, 95% CI 0.38 to 0.89; RD -0.22, 95% CI -0.38 to -0.06; NNTB 5, 95% CI 3 to 17). One study (64 infants) compared oral ibuprofen with placebo and noted a significant reduction in failure to close a PDA (RR 0.26, 95% CI 0.11 to 0.62; RD -0.44, 95% CI -0.65 to -0.23; NNTB 2, 95% CI 2 to 4).Twenty-one studies (1102 infants) reported failure rates for PDA closure with ibuprofen (oral or iv) compared with indomethacin (oral or iv). There was no significant difference between the groups (typical RR 1.00, 95% CI 0.84 to 1.20; I(2) = 0%; typical RD 0.00, 95% CI -0.05 to 0.05; I(2) = 0%). The risk of developing necrotising enterocolitis (NEC) was reduced for ibuprofen (16 studies, 948 infants; typical RR 0.64, 95% CI 0.45 to 0.93; typical RD -0.05, 95% CI -0.08 to -0.01; NNTB 20, 95% CI 13 to 100; I(2) = 0% for both RR and RD). The duration of ventilatory support was reduced with ibuprofen (oral or iv) compared with iv or oral indomethacin (six studies, 471 infants; mean difference (MD) -2.4 days, 95% CI -3.7 to -1.0; I(2) = 19%).Eight studies (272 infants) reported on failure rates for PDA closure in a subgroup of the above studies comparing oral ibuprofen with indomethacin (oral or iv). There was no significant difference between the groups (typical RR 0.96, 95% CI 0.73 to 1.27; typical RD -0.01, 95% CI -0.12 to 0.09). The risk of NEC was reduced with oral ibuprofen compared with indomethacin (oral or iv) (seven studies, 249 infants; typical RR 0.41, 95% CI 0.23 to 0.73; typical RD -0.13, 95% CI -0.22 to -0.05; NNTB 8, 95% CI 5 to 20; I(2) = 0% for both RR and RD). There was a decreased risk of failure to close a PDA with oral ibuprofen compared with iv ibuprofen (four studies, 304 infants; typical RR 0.41, 95% CI 0.27 to 0.64; typical RD -0.21, 95% CI -0.31 to -0.12; NNTB 5, 95% CI 3 to 8). Transient renal insufficiency was less common in infants who received ibuprofen compared with indomethacin. High dose versus standard dose of iv ibuprofen, early versus expectant administration of iv ibuprofen, echocardiographically guided iv ibuprofen treatment vs. standard iv ibuprofen treatment and continuous infusion of ibuprofen vs. intermittent boluses of ibuprofen and long-term follow-up were studied in too few trials to draw any conclusions.
AUTHORS' CONCLUSIONS


Ibuprofen is as effective as indomethacin in closing a PDA and currently appears to be the drug of choice. Ibuprofen reduces the risk of NEC and transient renal insufficiency. Oro-gastric administration of ibuprofen appears as effective as iv administration. To make further recommendations, studies are needed to assess the effectiveness of high-dose versus standard-dose ibuprofen, early versus expectant administration of ibuprofen, echocardiographically guided versus standard iv ibuprofen, and continuous infusion versus intermittent boluses of ibuprofen. Studies are lacking evaluating the effect of ibuprofen on longer-term outcomes in infants with PDA.",2015,"The duration of ventilatory support was reduced with ibuprofen (oral or iv) compared with iv or oral indomethacin (six studies, 471 infants; mean difference (MD) -2.4 days, 95% CI -3.7 to -1.0; I(2) =","['270 infants', 'patent ductus arteriosus in preterm, low birth weight, or preterm and low birth weight infants', '33 studies enrolling 2190 infants', 'In one study (134 infants', 'infants with PDA', 'newborn infants', 'patent ductus arteriosus in preterm or low birth weight (or both) infants']","['ibuprofen, echocardiographically guided iv ibuprofen treatment vs. standard iv ibuprofen', 'indomethacin, other cyclo-oxygenase inhibitor, placebo or no intervention', 'intravenous (iv) ibuprofen', 'placebo', 'ibuprofen with indomethacin', 'ibuprofen vs. intermittent boluses of ibuprofen', 'ibuprofen, echocardiographically guided versus standard iv ibuprofen', 'Indomethacin', 'ibuprofen', 'ibuprofen (oral or iv) compared with iv or oral indomethacin', 'oral ibuprofen with placebo', 'indomethacin', 'Ibuprofen']","['incidence of failure to close a PDA (risk ratio', 'failure to close a PDA', 'risk of developing necrotising enterocolitis (NEC', 'failure rates for PDA closure', 'typical RD', 'risk of NEC', 'risk of NEC and transient renal insufficiency', 'composite outcome of infant mortality', 'duration of ventilatory support', 'failure rates', 'Transient renal insufficiency', 'risk of failure']","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0085387', 'cui_str': 'Prostaglandin Endoperoxide Synthase Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0021278', 'cui_str': 'Infant Mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",,0.235181,"The duration of ventilatory support was reduced with ibuprofen (oral or iv) compared with iv or oral indomethacin (six studies, 471 infants; mean difference (MD) -2.4 days, 95% CI -3.7 to -1.0; I(2) =","[{'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Ohlsson', 'Affiliation': 'Departments of Paediatrics, Obstetrics and Gynaecology and Institute of Health Policy, Management and Evaluation, University of Toronto, 600 University Avenue, Toronto, ON, Canada, M5G 1X5. aohlsson@mtsinai.on.ca.'}, {'ForeName': 'Rajneesh', 'Initials': 'R', 'LastName': 'Walia', 'Affiliation': ''}, {'ForeName': 'Sachin S', 'Initials': 'SS', 'LastName': 'Shah', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003481.pub6']
1677,25663723,Sex-Linked Mating Strategies Diverge with a Manipulation of Genital Salience.,"Trivers (1972) proposed that evolutionary factors should favor divergent mating strategies for males versus females. Such differences may be less pronounced among human beings than other animals and social norms and sex roles are also pertinent influences. The present experiment ( N  = 133 college undergraduates, 74 female) sought to bypass some of these other influences. Participants were randomly assigned to a condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow). They then reported on their interest in short-term (e.g., a one-night stand) and long-term (e.g., a potential marital partner) mating opportunities. A theory-consistent three-way interaction occurred such that the genital salience manipulation primed a shorter-term reproductive strategy among men and a longer-term reproductive strategy among women. The results provide unique support for evolution-linked ideas about sex differences in the form of a role for bodily attention.",2015,Participants were randomly assigned to a condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow).,"['133 college undergraduates, 74 female']",['condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow'],[],"[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0446509', 'cui_str': 'Genital region (body structure)'}, {'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C0336721', 'cui_str': 'Arrow, device (physical object)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}]",[],,0.0166517,Participants were randomly assigned to a condition designed to increase attention to the genital region (a downward pointing arrow) or not (an upward pointing arrow).,"[{'ForeName': 'Adam K', 'Initials': 'AK', 'LastName': 'Fetterman', 'Affiliation': 'Knowledge Media Research Center.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Kruger', 'Affiliation': 'North Dakota State University.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Robinson', 'Affiliation': 'North Dakota State University.'}]",Motivation and emotion,[]
1678,25353321,Interventions for deliberately altering blood pressure in acute stroke.,"BACKGROUND


It is unclear whether blood pressure should be altered actively during the acute phase of stroke. This is an update of a Cochrane review first published in 1997, and previously updated in 2001 and 2008.
OBJECTIVES


To assess the clinical effectiveness of altering blood pressure in people with acute stroke, and the effect of different vasoactive drugs on blood pressure in acute stroke.
SEARCH METHODS


We searched the Cochrane Stroke Group Trials Register (last searched in February 2014), the Cochrane Database of Systematic reviews (CDSR) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 2), MEDLINE (Ovid) (1966 to May 2014), EMBASE (Ovid) (1974 to May 2014), Science Citation Index (ISI, Web of Science, 1981 to May 2014) and the Stroke Trials Registry (searched May 2014).
SELECTION CRITERIA


Randomised controlled trials of interventions that aimed to alter blood pressure compared with control in participants within one week of acute ischaemic or haemorrhagic stroke.
DATA COLLECTION AND ANALYSIS


Two review authors independently applied the inclusion criteria, assessed trial quality and extracted data. The review authors cross-checked data and resolved discrepancies by discussion to reach consensus. We obtained published and unpublished data where available.
MAIN RESULTS


We included 26 trials involving 17,011 participants (8497 participants were assigned active therapy and 8514 participants received placebo/control). Not all trials contributed to each outcome. Most data came from trials that had a wide time window for recruitment; four trials gave treatment within six hours and one trial within eight hours. The trials tested alpha-2 adrenergic agonists (A2AA), angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor antagonists (ARA), calcium channel blockers (CCBs), nitric oxide (NO) donors, thiazide-like diuretics, and target-driven blood pressure lowering. One trial tested phenylephrine.At 24 hours after randomisation oral ACEIs reduced systolic blood pressure (SBP, mean difference (MD) -8 mmHg, 95% confidence interval (CI) -17 to 1) and diastolic blood pressure (DBP, MD -3 mmHg, 95% CI -9 to 2), sublingual ACEIs reduced SBP (MD -12.00 mm Hg, 95% CI -26 to 2) and DBP (MD -2, 95%CI -10 to 6), oral ARA reduced SBP (MD -1 mm Hg, 95% CI -3 to 2) and DBP (MD -1 mm Hg, 95% CI -3 to 1), oral beta blockers reduced SBP (MD -14 mm Hg; 95% CI -27 to -1) and DBP (MD -1 mm Hg, 95% CI -9 to 7), intravenous (iv) beta blockers reduced SBP (MD -5 mm Hg, 95% CI -18 to 8) and DBP (-5 mm Hg, 95% CI -13 to 3), oral CCBs reduced SBP (MD -13 mmHg, 95% CI -43 to 17) and DBP (MD -6 mmHg, 95% CI -14 to 2), iv CCBs reduced SBP (MD -32 mmHg, 95% CI -65 to 1) and DBP (MD -13, 95% CI -31 to 6), NO donors reduced SBP (MD -12 mmHg, 95% CI -19 to -5) and DBP (MD -3, 95% CI -4 to -2) while phenylephrine, non-significantly increased SBP (MD 21 mmHg, 95% CI -13 to 55) and DBP (MD 1 mmHg, 95% CI -15 to 16).Blood pressure lowering did not reduce death or dependency either by drug class (OR 0.98, 95% CI 0.92 to 1.05), stroke type (OR 0.98, 95% CI 0.92 to 1.05) or time to treatment (OR 0.98, 95% CI 0.92 to 1.05). Treatment within six hours of stroke appeared effective in reducing death or dependency (OR 0.86, 95% CI 0.76 to 0.99) but not death (OR 0.70, 95% CI 0.38 to 1.26) at the end of the trial. Although death or dependency did not differ between people who continued pre-stroke antihypertensive treatment versus those who stopped it temporarily (worse outcome with continuing treatment, OR 1.06, 95% CI 0.91 to 1.24), disability scores at the end of the trial were worse in participants randomised to continue treatment (Barthel Index, MD -3.2, 95% CI -5.8, -0.6).
AUTHORS' CONCLUSIONS


There is insufficient evidence that lowering blood pressure during the acute phase of stroke improves functional outcome. It is reasonable to withhold blood pressure-lowering drugs until patients are medically and neurologically stable, and have suitable oral or enteral access, after which drugs can than be reintroduced. In people with acute stroke, CCBs, ACEI, ARA, beta blockers and NO donors each lower blood pressure while phenylephrine probably increases blood pressure. Further trials are needed to identify which people are most likely to benefit from early treatment, in particular whether treatment started very early is beneficial.",2014,"Treatment within six hours of stroke appeared effective in reducing death or dependency (OR 0.86, 95% CI 0.76 to 0.99) but not death (OR 0.70, 95% CI 0.38 to 1.26) at the end of the trial.","['people with acute stroke', 'participants within one week of acute ischaemic or haemorrhagic stroke', '17,011 participants (8497 participants were assigned active therapy and 8514 participants received', 'acute stroke']","['vasoactive drugs', 'phenylephrine', 'alpha-2 adrenergic agonists (A2AA), angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor antagonists (ARA), calcium channel blockers (CCBs), nitric oxide (NO) donors, thiazide-like diuretics', 'placebo/control']","['systolic blood pressure (SBP, mean difference (MD) -8', 'oral CCBs reduced SBP', 'SBP', 'stroke type', 'disability scores', 'death', 'diastolic blood pressure', 'death or dependency', 'DBP (MD -2, 95%CI -10 to 6), oral ARA reduced SBP', 'blood pressure']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0001648', 'cui_str': 'Adrenomimetics'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0600437', 'cui_str': 'Nitric Oxide Donors'}, {'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",17011.0,0.353868,"Treatment within six hours of stroke appeared effective in reducing death or dependency (OR 0.86, 95% CI 0.76 to 0.99) but not death (OR 0.70, 95% CI 0.38 to 1.26) at the end of the trial.","[{'ForeName': 'Philip M W', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK, NG5 1PB.'}, {'ForeName': 'Kailash', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD000039.pub3']
1679,30590537,Human Direct Skin Feeding Versus Membrane Feeding to Assess the Mosquitocidal Efficacy of High-Dose Ivermectin (IVERMAL Trial).,"BACKGROUND


Ivermectin is being considered for mass drug administration for malaria, due to its ability to kill mosquitoes feeding on recently treated individuals. In a recent trial, 3-day courses of 300 and 600 mcg/kg/day were shown to kill Anopheles mosquitoes for at least 28 days post-treatment when fed patients' venous blood using membrane feeding assays. Direct skin feeding on humans may lead to higher mosquito mortality, as ivermectin capillary concentrations are higher. We compared mosquito mortality following direct skin and membrane feeding.
METHODS


We conducted a mosquito feeding study, nested within a randomized, double-blind, placebo-controlled trial of 141 adults with uncomplicated malaria in Kenya, comparing 3 days of ivermectin 300 mcg/kg/day, ivermectin 600 mcg/kg/day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. On post-treatment day 7, direct skin and membrane feeding assays were conducted using laboratory-reared Anopheles gambiae sensu stricto. Mosquito survival was assessed daily for 28 days post-feeding.
RESULTS


Between July 20, 2015, and May 7, 2016, 69 of 141 patients participated in both direct skin and membrane feeding (placebo, n = 23; 300 mcg/kg/day, n = 24; 600 mcg/kg/day, n = 22). The 14-day post-feeding mortality for mosquitoes fed 7 days post-treatment on blood from pooled patients in both ivermectin arms was similar with direct skin feeding (mosquitoes observed, n = 2941) versus membrane feeding (mosquitoes observed, n = 7380): cumulative mortality (risk ratio 0.99, 95% confidence interval [CI] 0.95-1.03, P = .69) and survival time (hazard ratio 0.96, 95% CI 0.91-1.02, P = .19). Results were consistent by sex, by body mass index, and across the range of ivermectin capillary concentrations studied (0.72-73.9 ng/mL).
CONCLUSIONS


Direct skin feeding and membrane feeding on day 7 resulted in similar mosquitocidal effects of ivermectin across a wide range of drug concentrations, suggesting that the mosquitocidal effects seen with membrane feeding accurately reflect those of natural biting. Membrane feeding, which is more patient friendly and ethically acceptable, can likely reliably be used to assess ivermectin's mosquitocidal efficacy.
CLINICAL TRIALS REGISTRATION


NCT02511353.",2019,Direct-skin-feeding on humans may lead to higher mosquito-mortality as ivermectin capillary-concentrations are higher.,"['69 of 141 patients participated in both direct-skin- and membrane-feeding (placebo n=23, 300mcg/kg/day', '141 adults with uncomplicated malaria in Kenya comparing 3-day', 'n=24, 600mcg/kg/day n=22']","['placebo', 'ivermectin', 'Ivermectin', 'ivermectin 0', 'direct-skin- and membrane-feeding', 'co-administered with dihydroartemisinin-piperaquine']","['survival-time', 'Mosquito survival', 'cumulative-mortality']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",141.0,0.245221,Direct-skin-feeding on humans may lead to higher mosquito-mortality as ivermectin capillary-concentrations are higher.,"[{'ForeName': 'Menno R', 'Initials': 'MR', 'LastName': 'Smit', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Eric O', 'Initials': 'EO', 'LastName': 'Ochomo', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu.'}, {'ForeName': 'Ghaith', 'Initials': 'G', 'LastName': 'Aljayyoussi', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Titus K', 'Initials': 'TK', 'LastName': 'Kwambai', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Bernard O', 'Initials': 'BO', 'LastName': ""Abong'o"", 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waterhouse', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Nabie M', 'Initials': 'NM', 'LastName': 'Bayoh', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Gimnig', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'Meghna R', 'Initials': 'MR', 'LastName': 'Desai', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Phillips-Howard', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1063']
1680,27091121,Fingolimod for relapsing-remitting multiple sclerosis.,"BACKGROUND


Fingolimod was approved in 2010 for the treatment of patients with the relapsing-remitting (RR) form of multiple sclerosis (MS). It was designed to reduce the frequency of exacerbations and to delay disability worsening. Issues on its safety and efficacy, mainly as compared to other disease modifying drugs (DMDs), have been raised.
OBJECTIVES


To assess the safety and benefit of fingolimod versus placebo, or other disease-modifying drugs (DMDs), in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS).
SEARCH METHODS


We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System (CNS) Group's Specialised Trials Register and US Food and Drug Administration reports (15 February 2016).
SELECTION CRITERIA


Randomised controlled trials (RCTs) assessing the beneficial and harmful effects of fingolimod versus placebo or other approved DMDs in people with RRMS.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures as expected by Cochrane.
MAIN RESULTS


Six RCTs met our selection criteria. The overall population included 5152 participants; 1621 controls and 3531 treated with fingolimod at different doses; 2061 with 0.5 mg, 1376 with 1.25 mg, and 94 with 5.0 mg daily. Among the controls, 923 participants were treated with placebo and 698 with others DMDs. The treatment duration was six months in three, 12 months in one, and 24 months in two trials. One study was at high risk of bias for blinding, three studies were at high risk of bias for incomplete outcome reporting, and four studies were at high risk of bias for other reasons (co-authors were affiliated with the pharmaceutical company). We retrieved 10 ongoing trials; four of them have been completed.Comparing fingolimod administered at the approved dose of 0.5 mg to placebo, we found that the drug at 24 months increased the probability of being relapse-free (risk ratio (RR) 1.44, 95% confidence interval (CI) (1.28 to 1.63); moderate quality of evidence), but it might lead to little or no difference in preventing disability progression (RR 1.07, 95% CI 1.02 to 1.11; primary clinical endpoints; low quality evidence). Benefit was observed for other measures of inflammatory disease activity including clinical (annualised relapse rate): rate ratio 0.50, 95% CI 0.40 to 0.62; moderate quality evidence; and magnetic resonance imaging (MRI) activity (gadolinium-enhancing lesions): RR of being free from (MRI) gadolinium-enhancing lesions: 1.36, 95% CI 1.27 to 1.45; low quality evidence.The mean change of MRI T2-weighted lesion load favoured fingolimod at 12 and 24 months.No significant increased risk of discontinuation due to adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. The risk of fingolimod discontinuation was significantly higher compared to placebo for the dose 1.25 mg at 24 months (RR 1.93, 95% CI 1.48 to 2.52).No significant increased risk of discontinuation due to serious adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months. A significant increased risk of discontinuation due to serious adverse events was found for fingolimod 5.0 mg (RR 2.77, 95% CI 1.04 to 7.38) compared to placebo at six months.Comparing fingolimod 0.5 mg to intramuscular interferon beta-1a, we found moderate quality evidence that the drug at one year slightly increased the number of participants free from relapse (RR 1.18, 95% CI 1.09 to 1.27) or from gadolinium-enhancing lesions (RR 1.12, 95% CI 1.05 to 1.19), and decreased the relapse rate (rate ratio 0.48, 95% CI 0.34 to 0.70). We did not detect any advantage for preventing disability progression (RR 1.02, 95% CI 0.99 to 1.06; low quality evidence). We did not detect any significant difference for MRI T2-weighted lesion load change.We found a greater likelihood of participants discontinuing fingolimod, as compared to other DMDs, due to adverse events in the short-term (six months) (RR 3.21, 95% CI 1.16 to 8.86), but there was no significant difference versus interferon beta-1a at 12 months (RR 1.51, 95% CI 0.81 to 2.80; moderate quality evidence). A higher incidence of adverse events was suggestive of the lower tolerability rate of fingolimod compared to interferon-beta 1a.Quality of life was improved in participants after switching from a different DMD to fingolimod at six months, but this effect was not found compared to placebo at 24 months.All studies were sponsored by Novartis Pharma.
AUTHORS' CONCLUSIONS


Treatment with fingolimod compared to placebo in RRMS patients is effective in reducing inflammatory disease activity, but it may lead to little or no difference in preventing disability worsening. The risk of withdrawals due to adverse events requires careful monitoring of patients over time. The evidence on the risk/benefit profile of fingolimod compared with intramuscular interferon beta-1a was uncertain, based on a low number of head-to-head RCTs with short follow-up duration. The ongoing trial results will possibly satisfy these issues.",2016,No significant increased risk of discontinuation due to adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months.,"['5152 participants; 1621 controls and 3531 treated with fingolimod at different doses; 2061 with 0.5 mg, 1376 with 1.25 mg, and 94 with 5.0 mg daily', 'people with relapsing-remitting multiple sclerosis (RRMS', 'patients with the relapsing-remitting (RR) form of multiple sclerosis (MS', 'people with RRMS', '923 participants were treated with']","['fingolimod versus placebo', 'Fingolimod', 'fingolimod versus placebo, or other disease-modifying drugs (DMDs', 'placebo']","['relapse rate', 'disability progression', 'Quality of life', 'moderate quality evidence', 'risk of discontinuation due to adverse events', 'safety and efficacy', 'risk of fingolimod discontinuation', 'disease activity', 'adverse events', 'tolerability rate of fingolimod', 'probability of being relapse-free (risk ratio', 'inflammatory disease activity', 'moderate quality evidence; and magnetic resonance imaging (MRI) activity (gadolinium-enhancing lesions): RR', 'inflammatory disease activity including clinical (annualised relapse rate): rate ratio', 'frequency of exacerbations and to delay disability worsening', 'risk of discontinuation due to serious adverse events']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",923.0,0.191233,No significant increased risk of discontinuation due to adverse events was observed for fingolimod 0.5 mg compared to placebo at six and 24 months.,"[{'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'La Mantia', 'Affiliation': 'Unit of Neurorehabilitation - Multiple Sclerosis Center, I.R.C.C.S. Santa Maria Nascente - Fondazione Don Gnocchi, Via Capecelatro, 66, Milano, Italy, 20148.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tramacere', 'Affiliation': ''}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Firwana', 'Affiliation': ''}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Pacchetti', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Palumbo', 'Affiliation': ''}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Filippini', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009371.pub2']
1681,31842106,Therapeutic Advantages of Frequent Physical Therapy Sessions for Patients With Lumbar Spinal Stenosis.,"STUDY DESIGN


A retrospective study of a randomized clinical trial and a prospective study of patients with lumbar spinal stenosis (LSS).
OBJECTIVE


The aim of this study was to identify the effects of the number of physical therapy (PT) sessions on clinical outcomes of patients with LSS.
SUMMARY OF BACKGROUND DATA


Supervised PT for patients with LSS has been reported to lead to better short-term outcomes in terms of disability and leg pain than unsupervised exercise. However, no studies have investigated the relationship between the number of PT sessions and the therapeutic effects in patients with LSS.
METHODS


All patients received exercise therapy for 6 weeks. Included were 43 patients receiving supervised PT twice a week (P2 group), 38 patients receiving supervised PT once a week (P1 group), and 43 patients receiving a home exercise program alone (HE group). Clinical outcomes were measured using the Zurich Claudication Questionnaire (ZCQ), a numerical rating scale (NRS) of back pain and leg pain, the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) at baseline and at 6 weeks.
RESULTS


At 6 weeks, the P2 group showed significant improvements in ZCQ physical function, back and leg pain on the NRS compared with the P1 group (P < 0.05). Compared with the HE group, the P2 group showed significant improvements in ZCQ symptom severity and physical function, back and leg pain on the NRS, and JOABPEQ gait disturbance (P < 0.05). There were no significant differences in mean changes after 6 weeks between the P1 and HE groups.
CONCLUSION


Six weeks of supervised PT twice a week resulted in significant short-term improvements in symptom severity, physical function, back and leg pain, and gait disturbance compared with once a week and/or home exercise alone. Patients with LSS should be treated with intensive and supervised exercise programs to obtain maximum benefit of exercise therapy.
LEVEL OF EVIDENCE


3.",2020,"Six weeks of supervised PT twice a week resulted in significant short-term improvements in symptom severity, physical function, back and leg pain, and gait disturbance compared with once a week and/or home exercise alone.","['patients with lumbar spinal stenosis (LSS', 'Patients with LSS', 'Patients with Lumbar Spinal Stenosis', '43 patients receiving supervised PT twice a week (P2 group), 38 patients receiving supervised PT once a week (P1 group), and 43 patients receiving a', 'patients with LSS']","['home exercise program alone (HE group', 'intensive and supervised exercise programs', 'exercise therapy', 'physical therapy (PT) sessions']","['ZCQ symptom severity and physical function, back and leg pain on the NRS, and JOABPEQ gait disturbance', 'ZCQ physical function, back and leg pain on the NRS', 'mean changes', 'Zurich Claudication Questionnaire (ZCQ), a numerical rating scale (NRS) of back pain and leg pain, the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ', 'symptom severity, physical function, back and leg pain, and gait disturbance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0575081', 'cui_str': 'Gait difficulty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",43.0,0.0337977,"Six weeks of supervised PT twice a week resulted in significant short-term improvements in symptom severity, physical function, back and leg pain, and gait disturbance compared with once a week and/or home exercise alone.","[{'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Minetama', 'Affiliation': 'Spine Care Center, Wakayama Medical University Kihoku Hospital, Wakayama, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Kawakami', 'Affiliation': ''}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Teraguchi', 'Affiliation': ''}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Kagotani', 'Affiliation': ''}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Mera', 'Affiliation': ''}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Sumiya', 'Affiliation': ''}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': ''}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Sachika', 'Initials': 'S', 'LastName': 'Matsuo', 'Affiliation': ''}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Sakon', 'Affiliation': ''}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nakatani', 'Affiliation': ''}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kitano', 'Affiliation': ''}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003363']
1682,31547949,Evaluation of the efficacy of different treatment modalities for painful temporomandibular disorders.,"The purpose of this study was to clinically evaluate the efficacies of three treatment methods and to compare their outcomes in patients with painful disc displacement. The study group comprised 45 patients with unilateral temporomandibular disorders who fell into Axis I group II (with limited mouth opening) of the Research Diagnostic Criteria for Temporomandibular Disorders. Magnetic resonance imaging was used for definitive diagnosis. The patients were divided randomly into three groups according to the treatment method: splint therapy, splint therapy with ultrasound-guided arthrocentesis, and splint therapy with low-level laser therapy. Patients were followed up after treatment for 6 months. The groups were compared in terms of pain and functional jaw movements (unassisted mouth opening without pain, maximum unassisted mouth opening, and contralateral movements). At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05). Group 2 had a quicker improvement in terms of mouth opening scores at the end of the first month, and unassisted mouth opening without pain was found to be more than 35 millimetres in all groups at the end of 6 months. All treatment modalities showed effective results on pain and functional jaw movements in the treatment of temporomandibular disorders.",2020,"At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05).","['patients with painful disc displacement', 'painful temporomandibular disorders', '45 patients with unilateral temporomandibular disorders who fell into Axis I group II (with limited mouth opening) of the Research Diagnostic Criteria for Temporomandibular Disorders']","['Magnetic resonance imaging', 'splint therapy, splint therapy with ultrasound-guided arthrocentesis, and splint therapy with low-level laser therapy']","['pain values', 'pain and functional jaw movements', 'pain and functional jaw movements (unassisted mouth opening without pain, maximum unassisted mouth opening, and contralateral movements', 'unassisted mouth opening without pain', 'functional jaw movements', 'mouth opening scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.0182591,"At the end of treatment, functional jaw movements were significantly increased while pain values were significantly decreased in all groups (P<0.05).","[{'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Abbasgholizadeh', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey. Electronic address: zeliha.sanivar@marmara.edu.tr.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Evren', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ozkan', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.08.010']
1683,31152865,Contacting authors by telephone increased response proportions compared with emailing: results of a randomized study.,"OBJECTIVE


The aim of the study was to compare response proportions and research costs of telephone calling vs. continued emailing nonresponding authors of studies included in a systematic review.
STUDY DESIGN AND SETTING


Key features of included studies were poorly reported in a systematic review of diabetes quality improvement interventions. We developed a survey to request additional information from contact authors. After three email contact attempts, only 76 of 279 authors (27%) had completed the survey. In this study, we randomly assigned nonresponding authors to contact by telephone calling vs. continued emailing to compare the effect of these strategies on response proportions and research costs.
RESULTS


We randomized 87 authors to telephone and 89 to email contact. Telephone contact increased survey completion (36.7% vs. 20.2%; adjusted risk difference of 15.6% [95% confidence interval: 2.90%, 28.4%]; adjusted odds ratio 2.26 [95% confidence interval: 1.10, 4.76]) but required more time to deliver (20 vs. 10 hours in total; 14 vs. 7 minutes per randomized author; 26 vs. 4 weeks), and cost more (total intervention cost of $504 Canadian dollars vs. $252 for the telephone and email arm, respectively).
CONCLUSION


Contacting nonresponding authors of included studies by telephone increased response compared with emailing but required more investigator time and had higher cost.",2019,"Telephone contact increased survey completion (36.7% vs. 20.2%; adjusted risk difference of 15.6% [95% CI: 2.90%, 28.4%]",[],[],['survey completion'],[],[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}]",87.0,0.308032,"Telephone contact increased survey completion (36.7% vs. 20.2%; adjusted risk difference of 15.6% [95% CI: 2.90%, 28.4%]","[{'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Danko', 'Affiliation': 'Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, RI, USA; Department of Health Services, Policy & Practice, School of Public Health, Brown University, Providence, RI, USA. Electronic address: kristin_danko@brown.edu.'}, {'ForeName': 'Issa J', 'Initials': 'IJ', 'LastName': 'Dahabreh', 'Affiliation': 'Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, RI, USA; Department of Health Services, Policy & Practice, School of Public Health, Brown University, Providence, RI, USA; Department of Epidemiology, School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Family Practice Health Centre, Women's College Research Institute, Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada; Department of Family and Community Medicine, Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moher', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.027']
1684,27025240,Circulating makorin ring finger protein 3 levels decline in boys before the clinical onset of puberty.,"OBJECTIVE


Makorin ring finger protein 3 (MKRN3) gene restrains the hypothalamic-pituitary-gonadal axis. In girls, peripheral levels of MKRN3 decline prior to the onset of puberty. We described longitudinal changes in serum MKRN3 levels in boys before and during puberty and assessed the effect of inhibition of estrogen biosynthesis on MKRN3 levels.
DESIGN


Longitudinal serum samples from a double-blind, randomized controlled study in 30 boys (age range: 9.1-14.2years) with idiopathic short stature who received placebo (Pl; n=14) or aromatase inhibitor letrozole (Lz; 2.5mg/day; n=16) for 2years.
METHODS


We analyzed the relationships between serum MKRN3 and clinical and biochemical markers of puberty by using summary measures.
RESULTS


Serum MKRN3 declined by 669±713 pg/mL per year (P<0.001). This change was biphasic, as the levels decreased during Tanner genital stage G1 (-2931±2750 pg/mL per year) and plateaued thereafter (-560±1510 pg/mL per year) (P<0.05). During G1, MKRN3 levels in Lz-treated subjects decreased slower than in Pl-treated boys (-782±3190 vs -2030±821 pg/mL per year, P<0.05). The decrease in serum MKRN3 levels in G1 was associated with increases in LH (r=-0.5, P<0.01), testosterone (r=-0.6, P<0.01), and inhibin B (r=-0.44, P<0.05) (n=26).
CONCLUSION


Peripheral MKRN3 levels in boys appear to serve as a readout of the diminishing central inhibition that controls the onset of puberty.",2016,"RESULTS


Serum MKRN3 declined by 669±713 pg/mL per year (P<0.001).","['30 boys (age range: 9.1-14.2years) with idiopathic short stature who received', 'Pl; n=14) or']","['aromatase inhibitor letrozole (Lz', 'placebo']","['Serum MKRN3', 'Peripheral MKRN3 levels', 'LH', 'serum MKRN3 levels']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}]","[{'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",30.0,0.251101,"RESULTS


Serum MKRN3 declined by 669±713 pg/mL per year (P<0.001).","[{'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Varimo', 'Affiliation': ""Children's HospitalUniversity of Helsinki and Helsinki UniversityFinland.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Dunkel', 'Affiliation': 'William Harvey Research InstituteBarts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Vaaralahti', 'Affiliation': 'Faculty of Medicine/ PhysiologyUniversity of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Päivi J', 'Initials': 'PJ', 'LastName': 'Miettinen', 'Affiliation': ""Children's HospitalUniversity of Helsinki and Helsinki UniversityFinland Research Programs UnitMolecular Neurology, and Biomedicum Stem Cell Center, University of Helsinki, Finland.""}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hero', 'Affiliation': ""Children's HospitalUniversity of Helsinki and Helsinki UniversityFinland.""}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Raivio', 'Affiliation': ""Children's HospitalUniversity of Helsinki and Helsinki UniversityFinland Faculty of Medicine/ PhysiologyUniversity of Helsinki, Helsinki, Finland taneli.raivio@helsinki.fi.""}]",European journal of endocrinology,['10.1530/EJE-15-1193']
1685,31004217,Correction to: Suspension syndrome: a potentially fatal vagally mediated circulatory collapse-an experimental randomized crossover trial.,The original version of this article unfortunately contained a mistake. Information was missing in the acknowledgements section. The correct information is given below.,2019,The original version of this article unfortunately contained a mistake.,[],['Correction to: Suspension syndrome'],[],[],"[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",[],,0.0253317,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rauch', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy. simon.rauch@eurac.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schenk', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Strapazzon', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dal Cappello', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Palma', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Erckert', 'Affiliation': 'Department of Cardiology, F. Tappeiner Hospital, 39012, Merano, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Oberhuber', 'Affiliation': 'Department of Internal Medicine I, Gastroenterology, Hepatology, Metabolism and Endocrinology, Medical University Innsbruck, 6020, Innsbruck, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bliemsrieder', 'Affiliation': 'Department of Anesthesiology, Garmisch-Partenkirchen Medical Center, 82467, Garmisch-Partenkirchen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brugger', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paal', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Brothers of St. John of God Hospital, Paracelsus Medical University, Kajetanerplatz 1, 5010, Salzburg, Austria.'}]",European journal of applied physiology,['10.1007/s00421-019-04141-6']
1686,31121871,"Reply to ""Comment on: Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder-A Randomized, Controlled 12-Month Trial, Nutrients 2018, 10, 369"".",We thank Vorland et al [...].,2019,We thank Vorland et al [...].,"['Nutrients 2018, 10, 369', 'Autism']",['Comprehensive Nutritional and Dietary Intervention'],[],"[{'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]",[],[],,0.0463945,We thank Vorland et al [...].,"[{'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Adams', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. jim.adams@asu.edu.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Audhya', 'Affiliation': 'Health Diagnostics, South Amboy, NJ 08879, USA. audhyatk@optonline.net.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Geis', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. autismstudynurseasu@gmail.com.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gehn', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. ecgehn@gmail.com.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Fimbres', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. Valeria.Fimbres@asu.edu.'}, {'ForeName': 'Elena L', 'Initials': 'EL', 'LastName': 'Pollard', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. epollard1025@gmail.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Southwest College of Naturopathic Medicine, Tempe, AZ 85282, USA. J.Mitchell@scnm.edu.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. julieaingram@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hellmers', 'Affiliation': 'Arizona Allergy Associates, Phoenix, AZ 85004, USA. rhellmers@aol.com.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Laake', 'Affiliation': 'Dana Laake Nutrition, Kensington, MD 20895, USA. danalaake@aol.com.'}, {'ForeName': 'Julie S', 'Initials': 'JS', 'LastName': 'Matthews', 'Affiliation': 'Nourishing Hope, San Francisco, CA 94117, USA. julie@NourishingHope.com.'}, {'ForeName': 'Kefeng', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'The Mitochondrial and Metabolic Disease Center, University of California, San Diego, CA 92093, USA. kli@ucsd.edu.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Naviaux', 'Affiliation': 'The Mitochondrial and Metabolic Disease Center, University of California, San Diego, CA 92093, USA. jnaviaux@ucsd.edu.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Naviaux', 'Affiliation': 'The Mitochondrial and Metabolic Disease Center, University of California, San Diego, CA 92093, USA. naviaux@ucsd.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Adams', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. thebeckyadams@gmail.com.'}, {'ForeName': 'Devon M', 'Initials': 'DM', 'LastName': 'Coleman', 'Affiliation': 'School for Engineering of Matter, Transport & Energy, Arizona State University, Tempe, AZ 85287, USA. devon.coleman@asu.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Quig', 'Affiliation': ""Doctor's Data, St. Charles, IL 60174, USA. dquig@DoctorsData.com.""}]",Nutrients,['10.3390/nu11051138']
1687,25462140,Neuroimaging effects of 1 Hz right temporoparietal rTMS on normal auditory processing: implications for clinical hallucination treatment paradigms.,"PURPOSE


Repetitive transcranial magnetic stimulation (rTMS) has attracted attention as a putative clinical neuromodulatory tool, including for ameliorating hallucinations, although existing clinical data are inconsistent. There is a notable paucity of research on its physiological effects on normal neuronal functioning.
METHODS


We neuroimaged 24 healthy adult volunteers undertaking a variable loading passive auditory task, randomized into 2 matched and double-masked groups: half received a 17-minute 1 Hz right temporoparietal rTMS paradigm and half sham rTMS.
RESULTS


One hertz rTMS led to attenuation of the underlying auditory cortex response to the stimulus and a contralateral increase in cortical activity. Subanalysis of the auditory tasks demonstrated that rTMS effects varied with stimulus frequency and differences between the active and sham conditions were lost at the highest frequency.
CONCLUSIONS


This work is, to the best of our knowledge, the first to neuroimage the effects of a ""hallucinatory rTMS protocol"" on basic auditory processing in healthy controls. Our data demonstrated that a so-called ""inhibitory paradigm"" can also produce distal neuronal activation and that effects can vary with neural loading. These results highlight the insufficient knowledge of the effects of rTMS on normal physiology, and this, combined with a lack of consensus on clinical trial parameters, may be contributing to the ambivalent data in therapeutic trials.",2014,"Subanalysis of the auditory tasks demonstrated that rTMS effects varied with stimulus frequency and differences between the active and sham conditions were lost at the highest frequency.
","['healthy controls', '24 healthy adult volunteers undertaking a']","['Hz right temporoparietal rTMS', 'variable loading passive auditory task, randomized into 2 matched and double-masked groups: half received a 17-minute 1 Hz right temporoparietal rTMS paradigm and half sham rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'rTMS']","['normal auditory processing', 'cortical activity']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",24.0,0.0521115,"Subanalysis of the auditory tasks demonstrated that rTMS effects varied with stimulus frequency and differences between the active and sham conditions were lost at the highest frequency.
","[{'ForeName': 'Derek K', 'Initials': 'DK', 'LastName': 'Tracy', 'Affiliation': ""*Green Parks House, Oxleas NHS Foundation Trust, Princess Royal University Hospital, Kent, United Kingdom; †Cognition, Schizophrenia and Imaging Laboratory, Department of Psychosis Studies, the Institute of Psychiatry, King's College, London, United Kingdom.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Sousa de Abreu', 'Affiliation': ''}, {'ForeName': 'Natasza', 'Initials': 'N', 'LastName': 'Nalesnik', 'Affiliation': ''}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lage', 'Affiliation': ''}, {'ForeName': 'Sukhwinder S', 'Initials': 'SS', 'LastName': 'Shergill', 'Affiliation': ''}]",Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society,['10.1097/WNP.0000000000000098']
1688,24823922,Vitamin D supplementation for cystic fibrosis.,"BACKGROUND


Cystic fibrosis (CF) is a genetic disorder with multiorgan effects. In a subgroup with pancreatic insufficiency malabsorption of the fat soluble vitamins (A, D, E, K) may occur. Vitamin D is involved in calcium homeostasis and bone mineralisation and may have extraskeletal effects. This review examines the evidence for vitamin D supplementation in cystic fibrosis.
OBJECTIVES


To assess the effects of vitamin D supplementation on the frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity in the cystic fibrosis population.
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search: 08 July 2013.
SELECTION CRITERIA


Randomised and quasi-randomised controlled studies of vitamin D supplementation compared to placebo in the cystic fibrosis population regardless of exocrine pancreatic function.
DATA COLLECTION AND ANALYSIS


Both authors independently assessed the risk of bias of each included study and extracted outcome data (from published study information) for assessment of bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events.
MAIN RESULTS


Six studies (239 participants) are included, although only three studies provided data from 69 adults and children with cystic fibrosis for analysis. One study compared a single high dose of vitamin D (250,000 IU) to placebo at the time of hospital admission with a respiratory exacerbation in 30 pancreatic insufficient adults with cystic fibrosis. The second study compared supplemental 800 international units (IU) vitamin D and placebo for 12 months in 30 osteopenic pancreatic insufficient adults; both groups continued 900 IU vitamin D daily. The third study compared supplemental 1 g calcium alone, 1600 IU vitamin D alone, 1600 IU vitamin D and 1 g calcium and placebo in a double-blind randomised cross-over study; only nine children who completed both vitamin D and placebo groups after six-months supplementation and a three-month washout period are included; pancreatic sufficiency or disease status of participants are not defined. The studies are not directly comparable due to differences in supplementation, outcome reporting and possibly participant characteristics (e.g. severity of lung disease, growth and nutrition, pancreatic sufficiency).The only outcome for which we could combine data from more than two studies was 25-hydroxyvitamin D levels; patients receiving vitamin D supplementation had significantly higher levels, mean difference 7.24 ng/ml (95% confidence interval 5.01 to 9.46). However, ironically one study reported 1,25(OH)2D with levels significantly favouring the placebo group, mean difference -30.30 pmol/ml (95% confidence interval -59.89 to -0.71). Bone mineral density was measured in two studies; both described no significant change between groups. There were no adverse events in any study.The remaining three studies are published as abstracts only and did not provide data for analysis. These abstracts include: a report of pre-intervention data in a study comparing daily calcitriol (0.25 or 0.5 micrograms) with placebo in pancreatic insufficient children and young adults; an interim report of a double-blind randomised control study comparing 5000 IU vitamin D daily for 12 weeks during winter in 67 adult cystic fibrosis patients; and a comparison of the effect of three months of vitamin D supplementation (dose not specified) with placebo on bone mineral density in 42 children with cystic fibrosis and low bone mineral density.Risk of bias was highly variable between all studies. Only one study had a low risk of bias for the five main criteria (random sequence generation, allocation, blinding, attrition and reporting). The rest of the studies had unclear or high risks of bias. Two studies had a low risk of bias for blinding and another two studies for attrition bias. In the studies published as abstracts, assessment of the risks of bias was uncertain in many aspects.
AUTHORS' CONCLUSIONS


In patients receiving vitamin D supplementation, 25-hydroxyvitamin D levels are significantly higher. However, there is no evidence of clinical benefit or harm in the limited number of small-sized published studies. Adherence to relevant cystic fibrosis guidelines on vitamin D supplementation should be considered until further evidence is available.",2014,There were no adverse events in any study.,"['cystic fibrosis population', 'groups after six-months supplementation and a three-month washout period are included; pancreatic sufficiency or disease status of participants are not defined', 'cystic fibrosis population regardless of exocrine pancreatic function', '30 osteopenic pancreatic insufficient adults', '69 adults and children with cystic fibrosis for analysis', '30 pancreatic insufficient adults with cystic fibrosis', '42 children with cystic fibrosis and low bone mineral density', 'pancreatic insufficient children and young adults', 'cystic fibrosis', '67 adult cystic fibrosis patients']","['placebo', 'calcitriol', 'vitamin D supplementation', 'vitamin D alone, 1600 IU vitamin D and 1 g calcium and placebo', 'supplemental 800 international units (IU) vitamin D and placebo', '5000 IU vitamin D', 'Vitamin D', 'vitamin D and placebo', 'vitamin D', 'Vitamin D supplementation']","['Bone mineral density', 'bone mineralization, growth and nutritional status, frequency of vitamin D deficiency, respiratory status, quality of life and adverse events', 'adverse events', 'frequency of vitamin D deficiency, respiratory outcomes and vitamin D toxicity', '25-hydroxyvitamin D levels']","[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242154', 'cui_str': 'Vitamin D toxicity'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",42.0,0.544612,There were no adverse events in any study.,"[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ferguson', 'Affiliation': 'Christchurch Hospital, Canterbury District Health Board, Private Bag 4710, Christchurch, New Zealand, 8140.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007298.pub4']
1689,31855848,Influence of Obesity and Impact of a Physical Activity Program on Postural Control and Functional and Physical Capacities in Institutionalized Older Adults: A Pilot Study.,"OBJECTIVE


To evaluate the role of obesity in the effects of physical activity (PA) on postural control and functional and physical capacities in the older adults and to assess the effectiveness of a PA program on these capacities.
METHODS


Six obese (age = 78.8 [3.7] y; body mass index > 30 kg/m2), 7 overweight (age = 80.9 [2.8] y; 25 < body mass index < 30 kg/m2), and 6 normal weight (age = 80.8 [5.7] y; body mass index < 25 kg/m2) older adults performed the time up and go test, the 6-minute walk test, and the Tinetti test. Static and dynamic (forward leaning) postural control tests were also assessed. All these tests were similarly assessed 4 months later, during which only the obese group and overweight group participated in a PA program.
RESULTS


Before PA, results of the time up and go test, 6-minute walk test, Tinetti test, quiet standing, and forward lean tests revealed that physical capacities and static and dynamic postural control were impaired in the obese group when compared to the normal weight group. After PA, results of quiet standing, physical and functional tests were improved for obese group.
CONCLUSIONS


Obesity is an additional constraint to age-related postural control and functional and physical capacities deteriorations. Nevertheless, a PA program is effective in improving balance and functional capacities in obese older adults.",2020,"After PA, results of quiet standing, physical and functional tests were improved for obese group.
","['Six obese (age', '25 < body mass index < 30\xa0kg/m2), and 6 normal weight (age = 80.8 [5.7', 'older adults', 'obese older adults', 'y', 'y; body mass index < 25\xa0kg/m2) older adults', '30\xa0kg/m2), 7 overweight (age = 80.9 [2.8', 'Institutionalized Older Adults']","['physical activity (PA', 'Physical Activity Program', 'PA program']","['body mass index ', 'Postural Control and Functional and Physical Capacities', 'postural control and functional and physical capacities', 'Static and dynamic (forward leaning) postural control tests', 'time up and go test, 6-minute walk test, Tinetti test, quiet standing, and forward lean tests revealed that physical capacities and static and dynamic postural control', 'quiet standing, physical and functional tests', 'balance and functional capacities']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",6.0,0.0156247,"After PA, results of quiet standing, physical and functional tests were improved for obese group.
","[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Maktouf', 'Affiliation': ''}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Durand', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Beaune', 'Affiliation': ''}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Boyas', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0376']
1690,31855850,Adults Want to Play Too: Feasibility of an Adult Physical Activity Program Designed to Maximize Enjoyment.,"BACKGROUND


Few adults in the United States obtain sufficient physical activity (PA) despite knowledge of the associated health benefits. The current feasibility study examined the feasibility of a novel modified sports intervention designed to promote enjoyment and sustained PA in sedentary adults.
METHODS


The US adults (N = 22, mean age 39.2 y, male/female percentage 54.5/45.5) in Central Pennsylvania participated in the PlayFit sports program for 60-minute sessions, 2 to 3 times per week, over the course of 10 weeks and 24 game sessions; completing 198 person sessions collectively. Primary outcomes were PA (accelerometry) and intervention satisfaction.
RESULTS


Percentage of time in moderate to vigorous activity ranged from 35.0% (volleyball) to 91.2% (ultimate frisbee). Percentage of time spent in vigorous activity ranged from 0.0% (volleyball) to 29.5% (team handball). Satisfaction, based on a 10-point scale with 10 being the most satisfied, ranged from 7.7 (kickball) to 8.7 (floor hockey and soccer). On average, all sports were rated highly, with the majority rated >8.5 and one rated <8.0. Percentage of time spent in the moderate to vigorous range was lower in men than in women (73.2% vs 80.0%, P = .01), but did not differ by age or body mass index.
CONCLUSIONS


PlayFit is a promising first step in exploring the potential of modified sports programs to enhance population PA levels.",2020,"Percentage of time spent in the moderate to vigorous range was lower in men than in women (73.2% vs 80.0%, P = .01), but did not differ by age or body mass index.
","['US adults (N = 22, mean age 39.2\xa0y, male/female percentage 54.5/45.5) in Central Pennsylvania participated in the', 'sedentary adults']","['Adult Physical Activity Program', 'PlayFit sports program', 'novel modified sports intervention']","['PA (accelerometry) and intervention satisfaction', 'Percentage of time spent']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0202905,"Percentage of time spent in the moderate to vigorous range was lower in men than in women (73.2% vs 80.0%, P = .01), but did not differ by age or body mass index.
","[{'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Upham', 'Affiliation': ''}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Auer', 'Affiliation': ''}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Sciamanna', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mowen', 'Affiliation': ''}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Silvis', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kraschnewski', 'Affiliation': ''}, {'ForeName': 'Liza S', 'Initials': 'LS', 'LastName': 'Rovniak', 'Affiliation': ''}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lehman', 'Affiliation': ''}, {'ForeName': 'Kalen', 'Initials': 'K', 'LastName': 'Kearcher', 'Affiliation': ''}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Vizzini', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Cesarone', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0306']
1691,30809674,"Comment on: Intravenous cyclophosphamide vs rituximab for the treatment of early diffuse scleroderma lung disease: open label, randomized, controlled trial.",,2019,,['early diffuse scleroderma lung disease'],['cyclophosphamide vs rituximab'],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1258104', 'cui_str': 'Diffuse Systemic Sclerosis'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.0625888,,"[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Oral', 'Affiliation': 'Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Bilgin', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ertuğrul Çağrı', 'Initials': 'EÇ', 'LastName': 'Bölek', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Gözde Kübra', 'Initials': 'GK', 'LastName': 'Yardımcı', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Kılıç', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez033']
1692,10922419,RESPONSE: re: randomized trial of high-dose chemotherapy and blood cell autografts for high-risk primary breast carcinoma,,2000,,['high-risk primary breast carcinoma'],['high-dose chemotherapy and blood cell autografts'],[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678222', 'cui_str': 'Breast Carcinoma'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0005773', 'cui_str': 'Blood Corpuscles'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]",[],,0.0479623,,"[{'ForeName': '', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': '', 'Initials': 'AU', 'LastName': 'Buzdar', 'Affiliation': ''}]",Journal of the National Cancer Institute,[]
1693,25365567,Competitive interaction leads to perceptual distancing between actors.,"People physically distance themselves from competitors and the disliked, and cooperate less with those who are further away. We examine whether social interaction can also impact the space people perceive between themselves and others by measuring the influence of competitive dynamics on visual perception. In 2 experiments, participants played a ball toss game until they reached a target score. In Experiment 1, a confederate stood across the room from the participant and either (a) played the same game competitively, (b) played the same game cooperatively, or (c) observed the participant without playing, while in Experiment 2, 2 participants played the same versions of the game with each other. After the game, participants provided an estimate of the distance between themselves and the other player. Participants in Experiment 1 who competed with the confederate consistently judged her to be more distant than participants who cooperated with the confederate or played alone. In Experiment 2, players who lost the competition perceived more distance between themselves and their opponents than did players who won, suggesting that the experience of losing a competition drives this perceptual distancing. These findings demonstrate the power of a socially distancing interaction to create perceptual distance between people.",2014,"In Experiment 2, players who lost the competition perceived more distance between themselves and their opponents than did players who won, suggesting that the experience of losing a competition drives this perceptual distancing.",['Participants in Experiment 1 who competed with the confederate consistently judged her to be more distant than participants who cooperated with the confederate or played alone'],[],[],"[{'cui': 'C0221191', 'cui_str': 'Judge (occupation)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],[],2.0,0.0174547,"In Experiment 2, players who lost the competition perceived more distance between themselves and their opponents than did players who won, suggesting that the experience of losing a competition drives this perceptual distancing.","[{'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Davoli', 'Affiliation': 'Department of Psychology, Central Michigan University.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Brockmole', 'Affiliation': 'Department of Psychology, University of Notre Dame.'}]",Journal of experimental psychology. Human perception and performance,['10.1037/a0038307']
1694,30233814,Correction:  Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial .,[This corrects the article DOI: 10.1136/rmdopen-2018-000723.].,2018,[This corrects the article DOI: 10.1136/rmdopen-2018-000723.].,['psoriatic arthritis'],['Secukinumab'],[],"[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}]",[],,0.0288597,[This corrects the article DOI: 10.1136/rmdopen-2018-000723.].,[],RMD open,['10.1136/rmdopen-2018-000723corr1']
1695,24401754,A Randomized controlled trial on safety and efficacy of single intramuscular versus staggered oral dose of 600 000IU Vitamin D in treatment of nutritional rickets.,"OBJECTIVE


Comparison of efficacy and safety of two different regimens of vitamin D-600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks-in treatment of nutritional rickets.
METHODS


Children with nutritional rickets (age: 0.5-5 years, n = 61) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection. Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up.
RESULTS


No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters. Serum 25 hydroxy vitamin D >100 ng/ml was found in two children in the oral group and one child in the intramuscular group. No child developed hypercalcemia or hypercalciuria after starting treatment.
CONCLUSION


Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets.",2014,No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters.,"['nutritional rickets', 'Children with nutritional rickets (age: 0.5-5 years, n = 61']","['600 000IU Vitamin D', 'vitamin D-600 000 IU', '60 000IU vitamin D']","['hypercalcemia or hypercalciuria', 'safety and efficacy', 'Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score', 'efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0020438', 'cui_str': 'Hypercalciuria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0428613', 'cui_str': 'Calcium/creatinine ratio measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",61.0,0.0732655,No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters.,"[{'ForeName': 'Krishanu', 'Initials': 'K', 'LastName': 'Mondal', 'Affiliation': ""Department of Paediatrics, Lady Hardinge Medical College, Kalawati Saran Children's Hospital, New Delhi, DL 110001, India.""}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': ""Department of Paediatrics, Lady Hardinge Medical College, Kalawati Saran Children's Hospital, New Delhi, DL 110001, India anjuseth.peds@gmail.com.""}, {'ForeName': 'Raman K', 'Initials': 'RK', 'LastName': 'Marwaha', 'Affiliation': 'Department of Endocrinology, Institute of Nuclear Medicine and Allied Sciences, New Delhi, DL 110001, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Dhanwal', 'Affiliation': 'Department of Medicine, Maulana Azad Medical College, New Delhi, DL 110001, India.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Aneja', 'Affiliation': ""Department of Paediatrics, Lady Hardinge Medical College, Kalawati Saran Children's Hospital, New Delhi, DL 110001, India.""}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Biochemistry, Lady Hardinge Medical College, New Delhi, DL 110001, India.'}, {'ForeName': 'Pitambar', 'Initials': 'P', 'LastName': 'Sonkar', 'Affiliation': ""Department of Radiology, Lady Hardinge Medical College, Kalawati Saran Children's Hospital, New Delhi, DL 110001, India.""}]",Journal of tropical pediatrics,['10.1093/tropej/fmt105']
1696,23188942,"Randomized double blind placebo control studies, the ""Gold Standard"" in intervention based studies.","Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the ""gold standard"" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; ""Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?"" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.",2012,RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect.,[],"['placebo', 'Valacyclovir']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}]",[],,0.460364,RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect.,"[{'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Department of Preventive and Social Medicine, Medical College and SSG Hospital, Baroda, Gujarat, India.'}]",Indian journal of sexually transmitted diseases and AIDS,['10.4103/0253-7184.102130']
1697,31148167,Cultural respect in general practice: a cluster randomised controlled trial.,,2019,,[],[],[],[],[],[],,0.206517,,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hickey', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, QLD.'}, {'ForeName': 'Roianne', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Griffith University, Gold Coast, QLD.'}]",The Medical journal of Australia,['10.5694/mja2.50215']
1698,32040244,Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial.,"OBJECTIVE


Enhanced cognitive behavior therapy (CBT-E) is a transdiagnostic treatment suitable for the full range of eating disorders (EDs). Although the effectiveness of CBT(-E) is clear, it is not being used as widely in clinical practice as guidelines recommend. The aim of the present study was to compare the effectiveness of CBT-E with treatment as usual (TAU), which was largely based on CBT principles.
METHOD


We conducted a randomized controlled trial on a total of 143 adult patients with an ED who received either CBT-E or TAU. The primary outcome was recovery from the ED. Secondary outcome measures were levels of ED psychopathology, anxiety, and depressive symptoms. Self-esteem, perfectionism, and interpersonal problems were repeatedly measured to examine possible moderating effects. We explored differences in duration and intensity between conditions.
RESULTS


After 80 weeks, there were no differences between conditions in decrease in ED psychopathology, or symptoms of anxiety and depression. However, in the first six weeks of treatment there was a larger decrease in ED psychopathology in the CBT-E condition. Moreover, when the internationally most widely used definition of recovery was applied, the recovery rate at 20 weeks of CBT-E was significantly higher (57.7%) than of TAU (36.0%). At 80 weeks, this difference was no longer significant (CBT-E 60.9%; TAU 43.6%). Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment.
DISCUSSION


With broader use of CBT-E, the efficiency, accessibility and effectivity (on self-esteem) of treatment for EDs could be improved.",2020,"Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment.
","['143 adult patients with an ED who received either', 'eating disorders']","['enhanced cognitive behavior therapy', 'CBT-E or TAU', 'CBT(-E', 'CBT-E', 'cognitive behavior therapy (CBT-E']","['recovery rate', 'Self-esteem, perfectionism, and interpersonal problems', 'levels of ED psychopathology, anxiety, and depressive symptoms', 'self-esteem', 'efficiency, accessibility and effectivity', 'recovery from the ED', 'ED psychopathology, or symptoms of anxiety and depression', 'ED psychopathology']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",143.0,0.132319,"Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment.
","[{'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'Center for Eating Disorders, PsyQ, Part of Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Deen', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van der Meer', 'Affiliation': 'Center for Eating Disorders, PsyQ, Part of Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Unna N', 'Initials': 'UN', 'LastName': 'Danner', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'van der Schuur', 'Affiliation': 'Center for Eating Disorders-PsyQ, Part of Lentis Psychiatric Institute, Groningen, The Netherlands.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Hoek', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}]",The International journal of eating disorders,['10.1002/eat.23239']
1699,30908593,Comment on Comparing Vitamin D Supplementation Versus Placebo for Urgency Urinary Incontinence: A Pilot Study.,,2019,,['Urgency Urinary Incontinence'],['Vitamin D Supplementation Versus Placebo'],[],"[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0652919,,"[{'ForeName': 'Gulistan', 'Initials': 'G', 'LastName': 'Bahat', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, Istanbul Medical School, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Altinkaynak', 'Affiliation': 'Department of Internal Medicine, Istanbul Medical School, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Tascioglu', 'Affiliation': 'Department of Internal Medicine, Istanbul Medical School, Istanbul University, Istanbul, Turkey.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15878']
1700,26148507,Luteal phase support for assisted reproduction cycles.,"BACKGROUND


Progesterone prepares the endometrium for pregnancy by stimulating proliferation in response to human chorionic gonadotropin(hCG) produced by the corpus luteum. This occurs in the luteal phase of the menstrual cycle. In assisted reproduction techniques(ART), progesterone and/or hCG levels are low, so the luteal phase is supported with progesterone, hCG or gonadotropin-releasing hormone (GnRH) agonists to improve implantation and pregnancy rates.
OBJECTIVES


To determine the relative effectiveness and safety of methods of luteal phase support provided to subfertile women undergoing assisted reproduction.
SEARCH METHODS


We searched databases including the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and trial registers. We conducted searches in November 2014, and further searches on 4 August 2015.
SELECTION CRITERIA


Randomised controlled trials (RCTs) of luteal phase support using progesterone, hCG or GnRH agonist supplementation in ART cycles.
DATA COLLECTION AND ANALYSIS


Three review authors independently selected trials, extracted data and assessed risk of bias. We calculated odds ratios (ORs) and 95%confidence intervals (CIs) for each comparison and combined data when appropriate using a fixed-effect model. Our primary out come was live birth or ongoing pregnancy. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS


Ninety-four women RCTs (26,198 women) were included. Most studies had unclear or high risk of bias in most domains. The main limitations in the evidence were poor reporting of study methods and imprecision due to small sample sizes.1. hCG vs placebo/no treatment (five RCTs, 746 women)There was no evidence of differences between groups in live birth or ongoing pregnancy (OR 1.67, 95% CI 0.90 to 3.12, three RCTs,527 women, I2 = 24%, very low-quality evidence, but I2 of 61% was found for the subgroup of ongoing pregnancy) with a random effects model. hCG increased the risk of ovarian hyperstimulation syndrome (OHSS) (1 RCT, OR 4.28, 95% CI 1.91 to 9.6, low quality evidence).2. Progesterone vs placebo/no treatment (eight RCTs, 875 women)Evidence suggests a higher rate of live birth or ongoing pregnancy in the progesterone group (OR 1.77, 95% CI 1.09 to 2.86, five RCTs, 642 women, I2 = 35%, very low-quality evidence). OHSS was not reported.3. Progesterone vs hCG regimens (16 RCTs, 2162 women)hCG regimens included comparisons of progesterone versus hCG and progesterone versus progesterone + hCG. No evidence showed differences between groups in live birth or ongoing pregnancy (OR 0.95, 95% CI 0.65 to 1.38, five RCTs, 833 women, I2 = 0%, low quality evidence) or in the risk of OHSS (four RCTs, 615 women, progesterone vs hCG OR 0.54, 95% CI 0.22 to 1.34; four RCTs,678 women; progesterone vs progesterone plus hCG, OR 0.34, 95% CI 0.09 to 1.26, low-quality evidence).4. Progesterone vs progesterone with oestrogen (16 RCTs, 2577 women)No evidence was found of differences between groups in live birth or ongoing pregnancy (OR 1.12, 95% CI 0.91 to 1.38, nine RCTs,1651 women, I2 = 0%, low-quality evidence) or OHSS (OR 0.56, 95% CI 0.2 to 1.63, two RCTs, 461 women, I2 = 0%, low-quality evidence).5. Progesterone vs progesterone + GnRH agonist (seven RCTs, 1708 women)Live birth or ongoing pregnancy rates were lower in the progesterone-only group and increased in women who received progester one and one or more GnRH agonist doses (OR 0.62, 95% CI 0.48 to 0.81, nine RCTs, 2861 women, I2 = 55%, random effects, low quality evidence). Statistical heterogeneity for this comparison was high because of unexplained variation in the effect size, but the direction of effect was consistent across studies. OHSS was reported in one study only (OR 1.00, 95% CI 0.33 to 3.01, 1 RCT, 300 women, very low quality evidence).6. Progesterone regimens (45 RCTs, 13,814 women)The included studies reported nine different comparisons between progesterone regimens. Findings for live birth or ongoing pregnancy were as follows: intramuscular (IM) versus oral: OR 0.71, 95% CI 0.14 to 3.66 (one RCT, 40 women, very low-quality evidence);IM versus vaginal/rectal: OR 1.24, 95% CI 1.03 to 1.5 (seven RCTs, 2309 women, I2 = 71%, very low-quality evidence); vaginal/rectal versus oral: OR 1.19, 95% CI 0.83 to 1.69 (four RCTs, 857 women, I2 = 32%, low-quality evidence); low-dose versus high-dose vaginal: OR 0.97, 95% CI 0.84 to 1.11 (five RCTs, 3720 women, I2 = 0%, moderate-quality evidence); short versus long protocol:OR 1.04, 95% CI 0.79 to 1.36 (five RCTs, 1205 women, I2 = 0%, low-quality evidence); micronised versus synthetic: OR 0.9, 95%CI 0.53 to 1.55 (two RCTs, 470 women, I2 = 0%, low-quality evidence); vaginal ring versus gel: OR 1.09, 95% CI 0.88 to 1.36 (oneRCT, 1271 women, low-quality evidence); subcutaneous versus vaginal gel: OR 0.92, 95% CI 0.74 to 1.14 (two RCTs, 1465 women,I2 = 0%, low-quality evidence); and vaginal versus rectal: OR 1.28, 95% CI 0.64 to 2.54 (one RCT, 147 women, very low-quality evidence). OHSS rates were reported for only two of these comparisons: IM versus oral, and low versus high-dose vaginal. No evidence showed a difference between groups.7. Progesterone and oestrogen regimens (two RCTs, 1195 women)The included studies compared two different oestrogen protocols. No evidence was found to suggest differences in live birth or ongoing pregnancy rates between a short and a long protocol (OR 1.08, 95% CI 0.81 to 1.43, one RCT, 910 women, low-quality evidence) or between a low dose and a high dose of oestrogen (OR 0.65, 95% CI 0.37 to 1.13, one RCT, 285 women, very low-quality evidence).Neither study reported OHSS.
AUTHORS' CONCLUSIONS


Both progesterone and hCG during the luteal phase are associated with higher rates of live birth or ongoing pregnancy than placebo.The addition of GnRHa to progesterone is associated with an improvement in pregnancy outcomes. OHSS rates are increased with hCG compared to placebo (only study only). The addition of oestrogen does not seem to improve outcomes. The route of progester one administration is not associated with an improvement in outcomes.",2015,"No evidence was found to suggest differences in live birth or ongoing pregnancy rates between a short and a long protocol (OR 1.08, 95% CI 0.81 to 1.43, one RCT, 910 women, low-quality evidence) or between a low dose and a high dose of oestrogen (OR 0.65, 95% CI 0.37 to 1.13, one RCT, 285 women, very low-quality evidence).Neither study reported OHSS.
","['subfertile women undergoing assisted reproduction', 'Cochrane Menstrual Disorders and Subfertility Group (MDSG', 'November 2014, and further searches on 4 August 2015', 'Ninety-four women RCTs (26,198 women) were included']","['placebo', 'Progesterone vs progesterone with oestrogen', 'progesterone and hCG', 'Progesterone vs hCG', 'progesterone, hCG or gonadotropin-releasing hormone (GnRH) agonists', 'Progesterone vs progesterone + GnRH agonist', 'Progesterone', 'hCG vs placebo', 'Progesterone and oestrogen regimens', 'hCG', 'progesterone versus hCG and progesterone versus progesterone + hCG', 'Progesterone vs placebo', 'progesterone, hCG or GnRH agonist supplementation']","['rates of live birth or ongoing pregnancy', 'live birth or ongoing pregnancy rates', 'rate of live birth or ongoing pregnancy', 'women)Live birth or ongoing pregnancy rates', 'OHSS rates', 'risk of ovarian hyperstimulation syndrome (OHSS', 'odds ratios (ORs) and 95%confidence intervals (CIs', 'live birth or ongoing pregnancy', 'OHSS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0025345', 'cui_str': 'Menstruation Disorders'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",3.0,0.500998,"No evidence was found to suggest differences in live birth or ongoing pregnancy rates between a short and a long protocol (OR 1.08, 95% CI 0.81 to 1.43, one RCT, 910 women, low-quality evidence) or between a low dose and a high dose of oestrogen (OR 0.65, 95% CI 0.37 to 1.13, one RCT, 285 women, very low-quality evidence).Neither study reported OHSS.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'van der Linden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, Nijmegen, Netherlands, 6500 HB.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': ''}, {'ForeName': 'Jan A M', 'Initials': 'JA', 'LastName': 'Kremer', 'Affiliation': ''}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Metwally', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009154.pub3']
1701,31128221,Estimated legacy effects from simulated post-trial data were less biased than from combined trial/post-trial data.,"OBJECTIVES


""Legacy effects"" describe the phenomena where treatment effects are apparent during the post-trial period that are not attributable to the direct effects observed within the trial. We investigate different approaches to analysis of trial and extended follow-up data for the evaluation of legacy effects.
STUDY DESIGN AND SETTING


We conducted a simulation to compare three approaches, which differed in terms of the time period and selection of trial participants included in the analysis.
RESULTS


The most common approach used for estimating legacy effects in the literature, which combines initial trial and post-trial follow-up data, gave the most biased estimates. Approaches using post-randomized controlled trial data had better performance in most scenarios. When the size of the legacy effect was set to differ according to whether or not drugs were taken after trial, the stratified approach using post-trial data but only from participants taking the drug after trial was less biased but often had lower power to detect a legacy effect.
CONCLUSION


When estimating legacy effects, approaches to analysis that are restricted to post-trial follow-up data are preferred. If data are available on participant drug use after trial, then both stratified and unstratified approaches to analysis of the post-trial data should be investigated.",2019,Approaches using post-RCT data had better performance in most scenarios.,[],[],[],[],[],[],,0.295722,Approaches using post-RCT data had better performance in most scenarios.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia. Electronic address: Lin.Zhu@uts.edu.au.'}, {'ForeName': 'Katy J L', 'Initials': 'KJL', 'LastName': 'Bell', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.010']
1702,31289879,"Comments on ""Photobiomodulation Improved the First Stages of Wound Healing Process After Abdominoplasty: An Experimental, Double-Blinded, Non-randomized Clinical Trial"".",,2019,,[],[],[],[],[],[],,0.47501,,"[{'ForeName': 'Dong-Xiao', 'Initials': 'DX', 'LastName': 'Zhu', 'Affiliation': 'Department of Ultrasound Diagnosis, The Affiliated Hospital of Jiangnan University, Wuxi, 214041, China.'}, {'ForeName': 'Feng-Lai', 'Initials': 'FL', 'LastName': 'Yuan', 'Affiliation': 'Department of Ultrasound Diagnosis, The Affiliated Hospital of Jiangnan University, Wuxi, 214041, China. bjjq88@163.com.'}, {'ForeName': 'Zi-Li', 'Initials': 'ZL', 'LastName': 'Sun', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing, 210023, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Yangzhou University, Yangzhou, 225000, Jiangsu, China.'}, {'ForeName': 'Si-Yu', 'Initials': 'SY', 'LastName': 'Liu', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing, 210023, Jiangsu, China.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01438-x']
1703,24626145,Daily Automated Telephone Assessment and Intervention Improved 1-Month Outcome in Paroled Offenders.,"This randomized trial evaluates whether automated telephony could be used to perform daily assessments in paroled offenders ( N  = 108) during their first 30 days after leaving prison. All subjects were called daily and answered assessment questions. Based on the content of their daily assessments, subjects in the intervention group received immediate feedback and a recommendation by automated telephony, and their probation officers also received a daily report by email. The outcome variables were analyzed using linear mixed models. The intervention group showed greater improvement than the control group in the summary scores ( M  = 9.6, 95% confidence interval [CI] = [0.5, 18.7],  p  = .038), in mental symptoms ( M  = 4.6, CI = [0.2, 9.0],  p  = .042), in alcohol drinking ( M  = 0.8, CI = [0.1, 1.4],  p  = .031), in drug use ( M  = 1.0, CI = [0.5, 1.6],  p  = .000), and in most stressful daily event ( M  = 1.9, CI = [1.1, 2.7],  p  = .000). In conclusion, automated telephony may be used to follow up and to give interventions, resulting in reduced stress and drug use, in paroled offenders.",2020,"The intervention group showed greater improvement than the control group in the summary scores (M = 9.6, 95% confidence interval [CI] = [0.5, 18.7], p = .038), in mental symptoms (M = 4.6, CI = [0.2, 9.0], p = .042), in alcohol drinking (M = 0.8, CI = [0.1, 1.4], p = .031), in drug use (M = 1.0, CI = [0.5, 1.6], p = .000), and in most stressful daily event (M = 1.9, CI = [1.1, 2.7], p = .000).",['paroled offenders (N = 108) during their first 30 days after leaving prison'],"['automated telephony', 'immediate feedback and a recommendation by automated telephony, and their probation officers also received a daily report by email', 'Daily Automated Telephone Assessment and Intervention']",['mental symptoms'],"[{'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0401946', 'cui_str': 'Probation officer (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0498334,"The intervention group showed greater improvement than the control group in the summary scores (M = 9.6, 95% confidence interval [CI] = [0.5, 18.7], p = .038), in mental symptoms (M = 4.6, CI = [0.2, 9.0], p = .042), in alcohol drinking (M = 0.8, CI = [0.1, 1.4], p = .031), in drug use (M = 1.0, CI = [0.5, 1.6], p = .000), and in most stressful daily event (M = 1.9, CI = [1.1, 2.7], p = .000).","[{'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Andersson', 'Affiliation': 'Malmö University, Sweden.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Vasiljevic', 'Affiliation': 'Malmö University, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Lund University, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Öjehagen', 'Affiliation': 'Lund University, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Berglund', 'Affiliation': 'Lund University, Sweden.'}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X14526800']
1704,27820726,β-Hydroxy β-Methylbutyrate (HMB) Supplementation Effects on Body Mass and Performance in Elite Male Rugby Union Players.,"McIntosh, ND, Love, TD, Haszard, J, Osborne, H, and Black, KE. β-hydroxy β-methylbutyrate (HMB) supplementation effects on body mass and performance in elite male rugby union players. J Strength Cond Res 32(1): 19-26, 2018-Preseason is characterized by high training volumes with short recovery periods β-hydroxy β-methylbutyrate (HMB) has been postulated to assist with recovery. β-hydroxy β-methylbutyrate has been shown to improve strength and body composition among untrained groups; the benefits of HMB among trained populations are unclear because of the methodologies employed. This randomized control trail determined the effects of 11 weeks HMB supplementation on body mass and performance measures in 27 elite rugby players. β-hydroxy β-methylbutyrate group (n = 13), mean ± SD age 20.3 ± 1.2 years, body mass 99.6 ± 9.1 kg; placebo group (n = 14), age 21.9 ± 2.8 years body mass 99.4 ± 13.9 kg for placebo. During the supplementation period, body mass increased with HMB 0.57 ± 2.60 kg but decreased with placebo 1.39 ± 2.02 kg (p = 0.029). There were no significant differences in any of the 4 strength variables (p > 0.05). However, on the yo-yo intermittent recovery test (YoYo IR-1), the placebo group improved 4.0 ± 2.8 levels but HMB decreased 2.0 ± 3.0 levels (p = 0.003). The results of this study suggest that HMB could be beneficial for gaining or maintaining body mass during periods of increased training load. However, it appears that HMB may be detrimental to intermittent running ability in this group although further research is required before firm conclusions can be made. Only 6 participants on HMB managed to complete both YoYo IR-1 tests because of injury, a larger sample size is required to fully investigate this potentially negative effect. Further, the mechanisms behind this decrement in performance cannot be fully explained and requires further biochemical and psychological investigation.",2018,"During the supplementation period, body mass increased with HMB 0.57 ± 2.60 kg but decreased with placebo 1.39 ± 2.02 kg (p = 0.029).","['elite male rugby union players', '27 elite rugby players', 'J Strength Cond Res 32(1', 'Elite Male Rugby Union Players', 'group (n = 13), mean ± SD age 20.3 ± 1.2 years, body mass 99.6 ± 9.1 kg; placebo group (n = 14), age 21.9 ±']","['HMB', 'placebo', 'HMB supplementation', 'β-Hydroxy β-Methylbutyrate (HMB) Supplementation', 'β-hydroxy β-methylbutyrate (HMB) supplementation', 'β-hydroxy β-methylbutyrate']","['body mass and performance measures', 'McIntosh, ND, Love, TD, Haszard, J, Osborne, H, and Black, KE', 'Body Mass and Performance', 'strength and body composition', 'body mass and performance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.181924,"During the supplementation period, body mass increased with HMB 0.57 ± 2.60 kg but decreased with placebo 1.39 ± 2.02 kg (p = 0.029).","[{'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'McIntosh', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Love', 'Affiliation': 'College of Engineering, Swansea University Swansea, United Kingdom.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Hamish R', 'Initials': 'HR', 'LastName': 'Osborne', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Black', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000001695']
1705,31387081,"The Acute Effects of a ""Reduced Sitting Preschool Day"" on Executive Function and Musculoskeletal Health in Preschoolers: A Randomized Cross-Over Study.","PURPOSE


To examine the acute effects of a reduced sitting day on executive function (EF) and musculoskeletal health in preschoolers.
METHODS


A sample of 29 children (54% boys; 4-5 y) participated in a randomized cross-over trial. Each child completed 2 protocols, which simulate a day at childcare in random order for 2.5 hours; a typical preschool day (50% sitting) and a reduced preschool day (25% sitting) where most sitting activities were replaced with standing activities. Sitting, standing, and stepping time were objectively assessed using an activPAL accelerometer. EF was evaluated using tablet-based EF assessments (inhibition, working memory, and task shifting). Musculoskeletal health was assessed using a handheld dynamometer and goniometer.
RESULTS


Compared with the typical preschool day, the reduced sitting day showed no significant differences for EF scores. Effect sizes for inhibition (d = 0.04), working memory (d = 0.02), and shifting (d = 0.11) were all small. For musculoskeletal health, no significant differences were reported after the reduced preschool day. The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
CONCLUSIONS


This study suggests that reducing sitting time is unlikely to result in acute changes in EF and musculoskeletal health among preschoolers.",2019,"The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
","['29 children (54% boys; 4-5\xa0y', 'preschoolers', 'Preschoolers']",['Reduced Sitting Preschool Day'],"['Musculoskeletal health', 'EF scores', 'working memory', 'Executive Function and Musculoskeletal Health', 'hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg', 'Sitting, standing, and stepping time', 'executive function (EF) and musculoskeletal health']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",29.0,0.149474,"The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
","[{'ForeName': 'Yvonne G', 'Initials': 'YG', 'LastName': 'Ellis', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Dylan P', 'Initials': 'DP', 'LastName': 'Cliff', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Howard', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'University of Wollongong.'}]",Pediatric exercise science,['10.1123/pes.2018-0239']
1706,22808589,"You can take the eyes out of the doll, but....","The perceived animacy of a face is well-predicted by the perceived animacy of the eyes presented in isolation. This is not true for other facial features (eg having a highly life-like nose does not appear to be crucial), suggesting that the eyes are a critical feature for perceiving life in a face. Here, we asked whether it was therefore possible to 'transplant' animacy into a face by transplanting the eyes into a face image. We conducted digital eye surgery on a series of morphed human/doll faces and found that while doll eyes make a morphed face look less alive, human eyes do not make you look more so. Thus, we cannot so easily transplant animacy into a face, but we can take it away.",2012,"Here, we asked whether it was therefore possible to 'transplant' animacy into a face by transplanting the eyes into a face image.",[],['digital eye surgery'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}]",[],,0.0184246,"Here, we asked whether it was therefore possible to 'transplant' animacy into a face by transplanting the eyes into a face image.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Balas', 'Affiliation': 'Department of Psychology, North Dakota State University, Fargo, ND 58105, USA. benjamin.balas@ndsu.edu'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horski', 'Affiliation': ''}]",Perception,[]
1707,31222789,Technology-assisted nursing for postpartum support: A randomized controlled trial.,"AIM


To determine if an electronic nursing intervention during the first 6 months postpartum was effective in improving mood and decreasing stress.
BACKGROUND


Unmet needs postpartum can have a negative impact on mood and parenting stress. Technology-assisted nursing care may provide needed support and reduce risk.
DESIGN


Randomized controlled trial (RCT) with three conditions.
METHODS


Enrollment began on 11 May 2017. Participants were randomized into one of three groups after completion of the baseline survey. Intervention I participants received standardized electronic messages four times/week for 6 months postpartum. Intervention II participants additionally received the option for nurse contact. Depression and parenting stress as measured using the Edinburgh Postnatal Depression Scale (EPDS) and Parenting Stress Index-Short form (PSI-SF) was obtained at 3 weeks, 3 months and 6 months postpartum and results compared with a usual care group. Patient satisfaction and nursing factors were measured.
RESULTS


Significantly higher satisfaction scores were found in both intervention groups as compared with control, but there were no significant changes in EPDS or PSI-SF.
CONCLUSION


The interventions were perceived as helpful and not burdensome. Better nurse-sensitive outcome measures are needed to adequately assess effectiveness.
IMPACT


Postpartum women report unmet needs for support and education. The interventions were perceived as being helpful but did not significantly reduce depressive symptoms or parenting stress. Nurses can use this research to inform development of innovative approaches to support postpartum women.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02843022.",2019,"Significantly higher satisfaction scores were found in both intervention groups as compare with control, but there were no significant changes in EPDS or PSI-SF.
CONCLUSION


The interventions were perceived as helpful and not burdensome.",['Enrollment began on 11 May 2017'],"['standardized electronic messages', 'Technology-assisted nursing care', 'Technology-Assisted Nursing for Postpartum Support', 'electronic nursing intervention']","['Depression and parenting stress', 'satisfaction scores', 'Edinburgh Postnatal Depression Scale (EPDS) and Parenting Stress Index-Short form (PSI-SF', 'depressive symptoms or parenting stress', 'Patient satisfaction and nursing factors']",[],"[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]",,0.1906,"Significantly higher satisfaction scores were found in both intervention groups as compare with control, but there were no significant changes in EPDS or PSI-SF.
CONCLUSION


The interventions were perceived as helpful and not burdensome.","[{'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'McCarter', 'Affiliation': 'Saint Anselm College, Manchester, New Hampshire.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Demidenko', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Tauna S', 'Initials': 'TS', 'LastName': 'Sisco', 'Affiliation': 'Department of Sociology and Social Work, Saint Anselm College, Manchester, New Hampshire.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': 'Emeritus-Active in Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}]",Journal of advanced nursing,['10.1111/jan.14114']
1708,31526352,Effect of Adding Proprioceptive Exercise to Balance Training in Older Adults with Diabetes: A Systematic Review.,"INTRODUCTION


Accidental fall is a serious problem in older adults. The incidence of accidental fall increases by any dysfunction in the proprioceptive system. The function of the proprioceptive system usually is much affected in people with Diabetes Mellitus (DM), particularly in older ages. However, proprioceptive exercise significantly improves the balance control in older adults, no systematic review demonstrated its effectiveness in improving the balance control in older adults with DM. Thus, this systematic review was conducted to examine the effectiveness of adding proprioceptive exercise to any balance training in older adults with DM.
METHODS


A systematic search was performed in five major databases. The inclusion criteria of this search included older adults with DM, peripheral neuropathy, randomized control trial, and proprioceptive dysfunction. The exclusion criterion of this search included any study where participants had a history of a disease that might affect the balance control such as ataxia, stroke, and Parkinsonism. The outcome of interest was the importance of including proprioceptive exercise in increasing the effectiveness of balance training in older adults with DM.
RESULTS


Nine RCTs met the inclusion criteria for this systematic review. Seven studies of these nine studies included randomization details. Only two studies included the blindness, and only one of them included double blindness. The description of the withdrawal of participants was shown in eight studies. All the included studies used a control group and accomplished the homogeny between subjects in the both groups.
CONCLUSION


This systematic review showed that proprioceptive exercise is a vital component that should be included in any balance training to gain short-term improvement in the balance control in older adults with DM.",2020,"The outcome of interest was the importance of including proprioceptive exercise in increasing the effectiveness of balance training in older adults with DM.
","['Older Adults with Diabetes', 'older adults', 'older adults with DM', 'people with diabetes mellitus (DM), particularly in older ages']","['proprioceptive exercise', 'balance training', 'Proprioceptive Exercise to Balance Training']",['balance control'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises (regime/therapy)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0286629,"The outcome of interest was the importance of including proprioceptive exercise in increasing the effectiveness of balance training in older adults with DM.
","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey.'}, {'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Department Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign, Champaign, IL, United States.'}]",Current diabetes reviews,['10.2174/1573399815666190712200147']
1709,31411726,Can Functional Brain Connectivity Predict Placebo Response in Chronic Pain?,,2019,,[],[],[],[],[],[],,0.114745,,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tétreault', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1581']
1710,31402538,CONTROL: A randomized phase 2 study of obeticholic acid and atorvastatin on lipoproteins in nonalcoholic steatohepatitis patients.,"BACKGROUND & AIMS


Nonalcoholic steatohepatitis (NASH) is a chronic and severe form of nonalcoholic fatty liver disease that can progress to cirrhosis and hepatocellular carcinoma and is a risk factor for cardiovascular disease. Although NASH has no approved treatments, obeticholic acid (OCA), a synthetic bile acid and farnesoid X receptor (FXR) agonist, was shown to improve histological features of NASH and fibrosis. Considering that FXR activation influences plasma lipoprotein concentrations, the Combination OCA aNd sTatins for monitoRing Of Lipids (CONTROL) study evaluated how statins can regulate lipoprotein metabolism with OCA treatment in patients with NASH.
METHODS


This randomized, double-blind, placebo-controlled, phase 2 study began with a 5-week screening/statin washout; 84 patients with NASH were randomly assigned (1:1:1:1) to receive placebo or 5 mg, 10 mg or 25 mg OCA once daily during the 16-week double-blind phase. Concurrent once daily atorvastatin (10 mg/days) was initiated at Week 4 with subsequent titration. Enrolled patients had biopsy-confirmed diagnosis of NASH with no evidence of hepatic decompensation. Plasma was collected to analyse lipoprotein parameters.
RESULTS


At Week 4, all OCA groups had an increase from baseline in mean low-density lipoprotein cholesterol (LDLc) and mean LDL particle concentration (LDLpc), mostly owing to large, less atherogenic LDLc particles. Atorvastatin 10 mg decreased LDLc and LDLpc levels below baseline in all OCA groups by Week 8; higher doses did not provide additional clinical benefits.
CONCLUSIONS


The CONTROL study showed that OCA-induced increases in LDLc in patients with NASH were mitigated with atorvastatin. The combination of OCA and atorvastatin was generally safe and well tolerated (NCT02633956).",2019,The combination of OCA and atorvastatin was generally safe and well-tolerated (NCT02633956).,"['nonalcoholic steatohepatitis patients', '84 patients with NASH', 'patients with NASH', 'Enrolled patients had biopsy-confirmed diagnosis of NASH with no evidence of hepatic decompensation']","['obeticholic acid and atorvastatin', 'atorvastatin', 'Atorvastatin', 'placebo', 'OCA and atorvastatin', 'Nonalcoholic steatohepatitis (NASH', 'NASH', 'OCA']","['LDLc and LDLpc levels', 'mean low-density lipoprotein cholesterol (LDLc) and mean LDL particle concentration (LDLpc), mostly owing to large, less atherogenic LDLc particles', 'LDLc', 'safe and well-tolerated']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",84.0,0.35248,The combination of OCA and atorvastatin was generally safe and well-tolerated (NCT02633956).,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Pockros', 'Affiliation': 'Division of Gastroenterology/Hepatology, Scripps Clinic, and the Scripps Translational Science Institute, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Division of Gastroenterology, Virginia Commonwealth University and Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Freilich', 'Affiliation': 'Kansas City Research Institute, Kansas City, MO, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Schiff', 'Affiliation': 'Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Institute for Liver Health, Chandler, AZ, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lawitz', 'Affiliation': 'Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Hellstern', 'Affiliation': 'Nature Coast Clinical Research, Inverness, FL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Owens-Grillo', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Van Biene', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14209']
1711,32034789,Antibacterial effectiveness of calcium hydroxide alone or in combination with Ibuprofen and Ciprofloxacin in teeth with asymptomatic apical periodontitis: a randomized controlled clinical study.,"AIM


To evaluate the antimicrobial effectiveness of Ca(OH) 2  paste combined with Ibuprofen or Ciprofloxacin in infected root canals of teeth with asymptomatic apical periodontitis.
METHODOLOGY


Forty-five patients were randomly divided into three groups using a web programme according to the medication selected: Ca(OH) 2  : 1 g Ca(OH) 2  powder with 1 mL propylene glycol, Ca(OH) 2   + Ibuprofen: 50 mg of Ibuprofen was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol, Ca(OH) 2   + Ciprofloxacin: 50 mg of Ciprofloxacin was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol. Root canal bacteriological samples were collected before root canal treatment (S1) and after chemo-mechanical procedures (S2). After root canal preparation, the intracanal medicaments were placed into the root canals to a level approximately 1 mm short of the working length using K-files and access cavities were filled temporarily. The participants were scheduled for a second visit 7 days later when the medication was removed mechanically, and after irrigation of the root canals, the final samples (S3) were collected. Samples were subjected to quantitative real-time polymerase chain reaction to evaluate the numbers of total bacteria, Enterococcus faecalis and Streptococcus species. For intragroup analysis, a Friedman test was used to compare reduction of counts of total bacteria, Streptococci and E. faecalis amongst the three samples (S1, S2 and S3). The chi-square test was used to compare the number of root canals positive for bacteria in S1, S2 and S3 amongst the groups.
RESULTS


Intragroup analysis revealed a significant reduction in the number of intracanal bacterial cells from S1 to S2 and from S2 to S3 in all medication groups (P < 0.01). Although there was no significant difference amongst the groups when comparing quantitative S1 or S2 data, there were significantly lower bacterial counts in the Ca(OH) 2   + Ciprofloxacin group (0.49 × 10 2  ) than the pure Ca(OH) 2  (1.25 × 10 2  ) and Ca(OH) 2   + Ibuprofen groups (0.76 × 10 2  ) at S3. The percentage reduction from S1 to S3 and from S2 to S3 was significantly greater in the Ca(OH)2 + Ciprofloxacin than the pure Ca(OH)2 and Ca(OH)2 + Ibuprofen groups (P < 0.05). In the Ca(OH) 2   + Ciprofloxacin group, there were significantly fewer positive cases (8/15) than the pure Ca(OH) 2  (13/15) and Ca(OH) 2   + Ibuprofen (13/15) groups (P < 0.05).
CONCLUSION


The addition of Ciprofloxacin to Ca(OH) 2  provided further antibacterial effectiveness when used as an intracanal medicament in vivo during root canal treatment.",2020,"RESULTS


Intragroup analysis revealed a significant reduction in the number of intracanal bacterial cells from S1 to S2 and from S2 to S3 in all medication groups (P < 0.01).","['Forty-five patients', 'teeth with asymptomatic apical periodontitis', 'infected root canals of teeth with asymptomatic apical periodontitis']","['Ciprofloxacin', 'Ca(OH)2 + Ciprofloxacin', 'ibuprofen was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol, Ca(OH) 2  + Ciprofloxacin', 'ciprofloxacin', 'ibuprofen and ciprofloxacin', 'ibuprofen or ciprofloxacin', 'Ibuprofen', 'web program according to the medication selected: Ca(OH) 2  : 1 g Ca(OH) 2  powder with 1 mL propylene glycol, Ca(OH) 2  + Ibuprofen', 'Ciprofloxacin was added into 950 mg Ca(OH) 2  powder and mixed with 1 mL propylene glycol', 'calcium hydroxide alone']","['counts of total bacteria, Streptococci and E. faecalis', 'Root canal bacteriological samples', 'bacterial counts', 'quantitative S1 or S2 data', 'number of intracanal bacterial cells', 'Antibacterial effectiveness']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0031030', 'cui_str': 'Periodontitis, Apical'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C2603574', 'cui_str': 'Ca(BD4)2'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C4046690', 'cui_str': 'propylene glycol, (S)-'}, {'cui': 'C0596235', 'cui_str': 'Ca 2+'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0205465', 'cui_str': 'Bacteriologic (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0004618', 'cui_str': 'Bacterial Count'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",45.0,0.0192476,"RESULTS


Intragroup analysis revealed a significant reduction in the number of intracanal bacterial cells from S1 to S2 and from S2 to S3 in all medication groups (P < 0.01).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karataş', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'M Ö', 'Initials': 'MÖ', 'LastName': 'Baltacı', 'Affiliation': 'Molecular Biology and Genetics, Microbiology, Faculty of Science, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Uluköylü', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adıgüzel', 'Affiliation': 'Molecular Biology and Genetics, Microbiology, Faculty of Science, Ataturk University, Erzurum, Turkey.'}]",International endodontic journal,['10.1111/iej.13277']
1712,31411650,Concerns About Potential Bias in a Randomized Clinical Trial of Integrated Prolonged Exposure Therapy vs Seeking Safety Integrated Coping Skills Therapy.,,2019,,[],[],[],[],[],[],,0.0271737,,"[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Najavits', 'Affiliation': 'Treatment Innovations, Newton Centre, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.2226']
1713,32066548,The Role of Mobile Phone Camera Recordings in the Diagnosis of Meniere's Disease and Pathophysiological Implications.,"OBJECTIVES


This study aimed to understand if videos of the patients' nystagmus recorded by themselves during the attacks can help in the diagnosis of Meniere's disease (MD).
MATERIALS AND METHODS


Sixty patients (age range 32-78 years) who had vestibular attacks and hearing complaints admitted to Çukurova University Hospital Otolaryngology Department and a private office between September 2013 and January 2017 were included in this randomized clinical trial study. Two groups with 30 patients each were formed. The first group was asked to send eye-videos recorded during the attack, while the patients in the second group were followed with conventional methods. Twenty-six patients in the first group were able to send satisfactory eye movement videos; four patients were excluded due to repeated recording faults. Twenty-seven patients in the second group could be followed; three patients were lost to follow-up. The number of attacks and time needed to diagnose both groups were compared.
RESULTS


The video group could be diagnosed in a shorter period compared to the control group. The diagnosis was made within two attacks (38 days) in the video group and within four attacks (92 days) in the control group.
CONCLUSION


This study shows that cell phone camera recordings of nystagmus of the patients are very helpful to diagnose MD. These recordings can also be used as an adjunct to understand the pathophysiology of the disease.",2020,"The diagnosis was made within two attacks (38 days) in the video group and within four attacks (92 days) in the control group.
","['Twenty-six patients in the first group were able to send satisfactory eye movement videos; four patients were excluded due to repeated recording faults', 'Sixty patients (age range 32-78 years) who had vestibular attacks and hearing complaints admitted to Çukurova University Hospital Otolaryngology Department and a private office between September 2013 and January 2017']",['Mobile Phone Camera Recordings'],['number of attacks and time needed to diagnose'],"[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",4.0,0.0271732,"The diagnosis was made within two attacks (38 days) in the video group and within four attacks (92 days) in the control group.
","[{'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Kıroğlu', 'Affiliation': 'Department of Otorhinolaryngology, Çukurova University School of Medicine, Adana, Turkey.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Dağkıran', 'Affiliation': 'Department of Otorhinolaryngology, Çukurova University School of Medicine, Adana, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2019.6605']
1714,23098653,Fatty acid composition of adipose tissue triglycerides after weight loss and weight maintenance: the DIOGENES study.,"Fatty acid composition of adipose tissue changes with weight loss. Palmitoleic acid as a possible marker of endogenous lipogenesis or its functions as a lipokine are under debate. Objective was to assess the predictive role of adipose triglycerides fatty acids in weight maintenance in participants of the DIOGENES dietary intervention study. After an 8-week low calorie diet (LCD) subjects with > 8 % weight loss were randomized to 5 ad libitum weight maintenance diets for 6 months: low protein (P)/low glycemic index (GI) (LP/LGI), low P/high GI (LP/HGI), high P/low GI (HP/LGI), high P/high GI (HP/HGI), and a control diet. Fatty acid composition in adipose tissue triglycerides was determined by gas chromatography in 195 subjects before the LCD (baseline), after LCD and weight maintenance. Weight change after the maintenance phase was positively correlated with baseline adipose palmitoleic (16:1n-7), myristoleic (14:1n-5) and trans-palmitoleic acid (16:1n-7t). Negative correlation was found with baseline oleic acid (18:1n-9). Lower baseline monounsaturated fatty acids (14:1n-5, 16:1n-7 and trans 16:1n-7) in adipose tissue triglycerides predict better weight maintenance. Lower oleic acid predicts lower weight decrease. These findings suggest a specific role of monounsaturated fatty acids in weight management and as weight change predictors.",2012,Negative correlation was found with baseline oleic acid (18:1n-9).,"['195 subjects before the LCD (baseline), after LCD and weight maintenance', 'participants of the DIOGENES dietary intervention study', 'subjects with > 8 % weight loss']","['adipose triglycerides fatty acids', 'low calorie diet (LCD', 'libitum weight maintenance diets for 6 months: low protein (P)/low glycemic index (GI) (LP/LGI), low P/high GI (LP/HGI), high P/low GI (HP/LGI), high P/high GI (HP/HGI), and a control diet']","['Weight change', 'Fatty acid composition in adipose tissue triglycerides', 'baseline adipose palmitoleic (16:1n-7), myristoleic (14:1n-5) and trans-palmitoleic acid']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0311129', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0069966', 'cui_str': 'C16:1n7'}]",195.0,0.0278061,Negative correlation was found with baseline oleic acid (18:1n-9).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kunešová', 'Affiliation': 'Obesity Management Centre, Institute of Endocrinology, Prague, Czech Republic. mkunesova@endo.cz'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hlavatý', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tvrzická', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Staňková', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kalousková', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Viguerie', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van Baak', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'A F H', 'Initials': 'AF', 'LastName': 'Pfeiffer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kafatos', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Langin', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zák', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': ''}, {'ForeName': 'W H M', 'Initials': 'WH', 'LastName': 'Saris', 'Affiliation': ''}]",Physiological research,[]
1715,23098660,Natural postmenopause is associated with an increase in combined cardiovascular risk factors.,"Cardiovascular disease, while rare in women of reproductive age, is the main cause of mortality in menopause. The purpose of our study was to determine the association of natural menopause with cardiovascular risk factors, including their clustering into metabolic syndrome (MS). A random 5 % representative population sample of women aged 45-54 years was examined. In 575 women, we were able to determine their natural reproductive aging status. Multiple regression analysis was used to calculate the association between age, menopausal status, and risk factors under study. After adjustment for age, there was an increase in the odds ratio of developing MS, as defined by NCEP (OR=2.0; 95 % CI [1.1; 3.7]), and an increase in plasma lipid ratios (total cholesterol/HDL-C, LDL-C/HDL-C, apolipoprotein-B/apolipoprotein-A1; p<0.05 for all) in postmenopausal women. Age, but not menopausal status, was associated with some single components of MS; only waist circumference significantly increased after menopause, independently of age. Clustering of risk factors in MS and lipid ratios (combined factors) was strongly associated with menopause whereas worsening of single components of MS was strongly associated with age. In conclusion, based on our results, the menopause may pose a risk to women through clustering of cardiovascular risk factors beyond simple aging.",2012,"Age, but not menopausal status, was associated with some single components of MS; only waist circumference significantly increased after menopause, independently of age.","['575 women', 'A random 5 % representative population sample of women aged 45-54 years']",[],"['plasma lipid ratios (total cholesterol/HDL-C, LDL-C/HDL-C, apolipoprotein-B/apolipoprotein-A1', 'odds ratio of developing MS', 'waist circumference']","[{'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0085201', 'cui_str': 'Apo AI'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",575.0,0.0259742,"Age, but not menopausal status, was associated with some single components of MS; only waist circumference significantly increased after menopause, independently of age.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lejsková', 'Affiliation': 'Institute for Postgraduate Medical Education, Prague, Czech Republic. magdalena.lejskova@ftn.cz'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Alušík', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Valenta', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Adámková', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Piťha', 'Affiliation': ''}]",Physiological research,[]
1716,31521161,Effect of play-based family-centered psychomotor/psychosocial stimulation on the development of severely acutely malnourished children under six in a low-income setting: a randomized controlled trial.,"BACKGROUND


The World Health Organization (WHO) recommends incorporating psychosocial stimulation into the management of severe acute malnutrition (SAM). However, there is little evidence about the effectiveness of these interventions for SAM children, particularly when serious food shortages and lack of a balanced diet prevail. The objective of this study was to examine whether family-based psychomotor/psychosocial stimulation in a low-income setting improves the development, linear growth, and nutritional outcomes in children with SAM.
METHOD


Children with SAM (N = 339) admitted for treatment to the Jimma University Specialized Hospital, Ethiopia, were randomized to a control (n = 170) or intervention (n = 169) group. Both groups received routine medical care and nutritional treatment at the hospital. The intervention group additionally received play-based psychomotor/psychosocial stimulation during their hospital stay, and at home for 6 months after being discharged from hospital. The fine motor (FM) and gross motor (GM) functions, language (LA) and personal-social (PS) skills of the children were assessed using adapted Denver II, the social-emotional (SE) behavior was assessed using adapted Ages and Stages Questionnaires: Social-Emotional, and the linear growth and nutritional status were determined through anthropometric assessments. All outcomes were assessed before the intervention, upon discharge from hospital, and 6 months after discharge (as end-line). The overtime changes of these outcomes measured in both groups were compared using Generalized Estimating Equations.
RESULTS


The intervention group improved significantly on GM during hospital follow-up by 0.88 points (p < 0.001, effect size = 0.26 SD), and on FM functions during the home follow-up by 1.09 points (p = 0.001, effect size = 0.22 SD). Both young and older children benefited similarly from the treatment. The intervention did not contribute significantly to linear growth and nutritional outcomes.
CONCLUSION


Psychomotor/psychosocial stimulation of SAM children enhances improvement in gross motor functions when combined with standard nutrient-rich diets, but it can enhance the fine motor functions even when such standard dietary care is not available.
TRIAL REGISTRATION


The trial was retrospectively registered on 30 January 2017 at the US National Institute of Health (ClinicalTrials.gov) # NCT03036176 .",2019,"The intervention group improved significantly on GM during hospital follow-up by 0.88 points (p < 0.001, effect size = 0.26 SD), and on FM functions during the home follow-up by 1.09 points (p = 0.001, effect size = 0.22 SD).","['children with SAM', '30 January 2017 at the US National Institute of Health (ClinicalTrials.gov) # NCT03036176 ', 'severe acute malnutrition (SAM', 'severely acutely malnourished children under six in a low-income setting', 'Children with SAM (N\u2009=\u2009339) admitted for treatment to the Jimma University Specialized Hospital, Ethiopia']","['routine medical care and nutritional treatment', 'play-based family-centered psychomotor/psychosocial stimulation', 'family-based psychomotor/psychosocial stimulation', 'play-based psychomotor/psychosocial stimulation']","['fine motor (FM) and gross motor (GM) functions, language (LA) and personal-social (PS) skills of the children were assessed using adapted Denver II, the social-emotional (SE) behavior', 'linear growth and nutritional outcomes', 'GM during hospital follow', 'FM functions', 'Social-Emotional, and the linear growth and nutritional status']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}]",,0.0356973,"The intervention group improved significantly on GM during hospital follow-up by 0.88 points (p < 0.001, effect size = 0.26 SD), and on FM functions during the home follow-up by 1.09 points (p = 0.001, effect size = 0.22 SD).","[{'ForeName': 'Teklu Gemechu', 'Initials': 'TG', 'LastName': 'Abessa', 'Affiliation': 'Department of Special Needs and Inclusive Education, College of Behavioral Sciences and Education, Jimma University, Jimma, Ethiopia. teklugem@yahoo.com.'}, {'ForeName': 'Berhanu Nigussie', 'Initials': 'BN', 'LastName': 'Worku', 'Affiliation': 'REVAL Rehabilitation Research Center, Biomedical Research Institute, Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Mekitie', 'Initials': 'M', 'LastName': 'Wondafrash', 'Affiliation': 'Department of Population and Family Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Tsinuel', 'Initials': 'T', 'LastName': 'Girma', 'Affiliation': 'Department of Pediatrics and Child Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Valy', 'Affiliation': 'Department of Healthcare, PXL University College, Hasselt, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lemmens', 'Affiliation': 'Department of Healthcare, PXL University College, Hasselt, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'I-Biostat, Hasselt University, Hasselt, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kolsteren', 'Affiliation': 'Department of Food Safety and Food Quality, University of Gent, Ghent, Belgium.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Granitzer', 'Affiliation': 'REVAL Rehabilitation Research Center, Biomedical Research Institute, Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University, Hasselt, Belgium.'}]",BMC pediatrics,['10.1186/s12887-019-1696-z']
1717,31409596,The Association of Fenofibrate with Kidney Tubular Injury in a Subgroup of Participants in the ACCORD Trial.,,2019,,[],['Fenofibrate'],[],[],"[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}]",[],,0.0455193,,"[{'ForeName': 'Kinsuk', 'Initials': 'K', 'LastName': 'Chauhan', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Girish N', 'Initials': 'GN', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Debnath', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Canada.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Coca', 'Affiliation': 'Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; steven.coca@mssm.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.00370119']
1718,31366591,Response to: 'Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study'.,,2020,,['chemotherapy-induced peripheral neuropathy'],['Acupuncture'],[],"[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.14622,,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kako', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan jkako-tky@umin.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Community Health Nursing, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Oosono', 'Affiliation': 'Community Health Nursing, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Noto', 'Affiliation': 'Department of Health Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2019-001976']
1719,31188172,Comparing Postoperative Analgesic Effect of Dexmedetomidine or Dexamethasone Added to Lidocaine Through Infraclavicular Block in Forearm Surgery.,"OBJECTIVE


The objective of this study was to compare the analgesic efficacy of dexamethasone versus dexmedetomidine added to lidocaine using infraclavicular block in patients undergoing forearm fracture surgery.
METHOD


Seventy-five patients aged 20 to 60 years were recruited for a prospective, double-blinded, randomized clinical trial. Ultrasound-guided infraclavicular brachial plexus block was performed in 3 groups by injecting 28 mL lidocaine plus 2 mL distilled water (Lido), 28 mL lidocaine plus 2 mL (8 mg) dexamethasone (Dexa), and 28 mL lidocaine plus 2 mL (1 µg/kg) dexmedetomidine (Dexm). Sensory and motor block onset time and the duration, hemodynamic variables, the time for the first analgesic request, and the total analgesic agents consumed within 6 hours after infraclavicular block were assessed.
RESULTS


Sensory block duration in the Dexm group was significantly greater than in the Lido (P=0.019) and Dexa (P=0.046) groups. The mean motor block duration in the Dexm group showed to be significantly longer than that in the Lido group (P=0.009). Pain intensity within 4 hours after block significantly increased in the Lido group compared with that in the Dexa and Dexm groups (P=0.001). Analgesic consumption during 6 hours after the procedure was higher in the Lido group when compared with the other 2 groups (P=0.001). The Dexm group showed the highest reduction in the mean arterial pressure (P=0.006) and heart rate (P=0.001) among the 3 groups.
CONCLUSIONS


There was no significant difference in postoperative pain intensity between the Dexa and Dexm groups, although DEXm demonstrated a longer sensory block duration in comparison with dexamethasone as a lidocaine adjuvant in infraclavicular block.",2019,"The dexamedetomidine group showed the highest reduction in the mean arterial pressure (P=0.006) and heart rate (P=0.001) between the three groups.
","['patients undergoing forearm fracture surgery', 'Forearm Surgery', 'Seventy-five patients 20-60 years old']","['Lidocaine', 'mL', 'lidocaine', 'mL lidocaine plus2▒mL distilled water (Lido), 28▒mL lidocaine plus2▒mL (8▒mg) dexamethasone (Dexa), and 28▒mL lidocaineplus2▒', 'Ultrasound-guided infraclavicular brachial plexus block', 'dexamedetomidine', 'dexmedetomidine', 'dexamethasone', 'Dexmedetomidine or Dexamethasone']","['analgesic efficacy', 'mean motor block duration', 'heart rate', 'Pain intensity', 'Analgesic consumption', 'postoperative pain intensity', 'Dexm).Sensory and motor block onset time and the duration, hemodynamic variables, the time for the first analgesic request, and the total analgesic agents', 'Sensory block duration', 'sensory block duration', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach (procedure)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",75.0,0.133958,"The dexamedetomidine group showed the highest reduction in the mean arterial pressure (P=0.006) and heart rate (P=0.001) between the three groups.
","[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Yaghoobi', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Shahamat', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': ''}, {'ForeName': 'Marzieh Beigom', 'Initials': 'MB', 'LastName': 'Khezri', 'Affiliation': ''}]",The Clinical journal of pain,['10.1097/AJP.0000000000000736']
1720,31426782,Correction to: Effectiveness of quality incentive payments in general practice (EQuIP-GP): a study protocol for a cluster-randomised trial of an outcomes-based funding model in Australian general practice to improve patient care.,"In the original publication of this article [1], the first name of the 3rd author is wrong.",2019,"In the original publication of this article [1], the first name of the 3rd author is wrong.",['general practice (EQuIP-GP'],['quality incentive payments'],[],"[{'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]",[],,0.053155,"In the original publication of this article [1], the first name of the 3rd author is wrong.","[{'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Peterson', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart and Launceston, Tasmania, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Department of General Practice, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Radford', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart and Launceston, Tasmania, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Robina, Queensland, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'Department of General Practice, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Australian Health Services Research Institute, University of Wollongong, Northfields Ave, Wollongong, NSW, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Mullan', 'Affiliation': 'School of Medicine, University of Wollongong and Illawarra Health and Medical Research Institute, Northfields Ave, Wollongong, NSW, Australia.'}, {'ForeName': 'Marijka J', 'Initials': 'MJ', 'LastName': 'Batterham', 'Affiliation': 'Statistical Consulting Centre, School of Mathematics and Applied Statistics, University of Wollongong; National Institute for Applied Statistics Research Australia, University of Wollongong; and Illawarra Health and Medical Research Institute, Northfields Ave, Wollongong, NSW, Australia.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'School of Medicine, University of Wollongong, Northfields Ave, Wollongong, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bonney', 'Affiliation': 'School of Medicine, University of Wollongong and Illawarra Health and Medical Research Institute, Northfields Ave, Wollongong, NSW, Australia. abonney@uow.edu.au.'}]",BMC health services research,['10.1186/s12913-019-4426-1']
1721,31557306,Pharmacogenomics and Placebo Response in a Randomized Clinical Trial in Asthma.,"Genetic variation may differentially modify drug and placebo treatment effects in randomized clinical trials. In asthma, although lung function and asthma control improvements are commonplace with placebo, pharmacogenomics of placebo vs. drug response remains unexamined. In a genomewide association study of subjective and objective outcomes with placebo treatment in Childhood Asthma Management Program of nedocromil/budesonide vs. placebo (N = 604), effect estimates for lead single nucleotide polymorphisms (SNPs) were compared across arms. The coughing/wheezing lead SNP, rs2392165 (β = 0.94; P = 1.10E-07) mapped to BBS9, a gene implicated in lung development that contains a lung function expression quantitative trait locus. The effect was attenuated with budesonide (P interaction   = 1.48E-07), but not nedocromil (P interaction   = 0.06). The lead forced vital capacity SNP, rs12930749 (β = -5.80; P = 1.47E-06), mapped to KIAA0556, a locus genomewide associated with respiratory diseases. The rs12930749 effect was attenuated with budesonide (P interaction   = 1.32E-02) and nedocromil (P interaction   = 1.09E-02). Pharmacogenomic analysis revealed differential effects with placebo and drug treatment that could potentially guide precision drug development in asthma.",2019,The rs12930749 effect was attenuated with budesonide (P interaction  =1.32E-02) and nedocromil (P interaction  =1.09E-02).,[],"['placebo', 'nedocromil', 'budesonide', 'nedocromil/budesonide versus placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068483', 'cui_str': 'Nedocromil'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]",[],,0.212646,The rs12930749 effect was attenuated with budesonide (P interaction  =1.32E-02) and nedocromil (P interaction  =1.09E-02).,"[{'ForeName': 'Rui-Sheng', 'Initials': 'RS', 'LastName': 'Wang', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Damien C', 'Initials': 'DC', 'LastName': 'Croteau-Chonka', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Edwin K', 'Initials': 'EK', 'LastName': 'Silverman', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Loscalzo', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1646']
1722,31519167,Effects of dietary intervention on vitamin B 12  status and cognitive level of 18-month-old toddlers in high-poverty areas: a cluster-randomized controlled trial.,"BACKGROUND


The local diet in high-poverty areas in China is mainly vegetarian, and children may be more vulnerable to vitamin B 12  deficiency.
OBJECTIVE


The aims of this study were to explore the vitamin B 12  status of toddlers living in high-poverty areas of China and to observe the effects of different complementary foods on the vitamin B 12  status and cognitive level of these toddlers.
METHODS


The study was nested within a cluster-randomized controlled trial implemented in 60 administrative villages (clusters) of Xichou County in which infants aged 6 months old were randomized to receive 50 g/d of pork (meat group), an equi-caloric fortified cereal supplement (fortified cereal group) or local cereal supplement (local cereal group) for one year. At 18 months, a subsample of the 180 toddlers (60 from each group) was randomly tested for serum vitamin B 12  and total homocysteine (tHcy) levels, and their neurodevelopment was evaluated.
RESULTS


The median serum concentrations of vitamin B 12  and tHcy were 360.0 pg/mL and 8.2 μmol/L, respectively, in children aged 18 months. Serum vitamin B 12  concentrations less than 300 pg/mL were found in 62 (34.4%) children, and concentrations less than 200 pg/mL were found in 30 (16.7%) children. The median vitamin B 12  concentration was significantly different among the three groups (P < 0.001). The highest vitamin B 12  level was demonstrated in the fortified cereal group (509.5 pg/mL), followed by the meat group (338.0 pg/mL) and the local cereal group (241.0 pg/mL). Vitamin B 12  concentration was positively correlated with the cognitive score (P < 0.001) and the fine motor score (P = 0.023) of the Bayley Scales of Infant Development, 3rd Edition (BSID III) screening test. Compared to the local cereal group, children in the meat group had higher cognitive scores (P < 0.05).
CONCLUSION


In poor rural areas of China, vitamin B 12  deficiency in toddlers was common due to low dietary vitamin B 12  intake. Fortified cereal and meat could help improve the vitamin B 12  status of children and might improve their cognitive levels.
TRIAL REGISTRATION


The larger trial in which this study was nested was registered at clinical trials.gov as NCT00726102 . It was registered on July 31, 2008.",2019,"Compared to the local cereal group, children in the meat group had higher cognitive scores (P < 0.05).
","['At 18\u2009months, a subsample of the 180 toddlers (60 from each group', 'vitamin B 12  status and cognitive level of 18-month-old toddlers in high-poverty areas', '60 administrative villages (clusters) of Xichou County in which infants aged 6\u2009months old', 'B 12  status of toddlers living in high-poverty areas of China']","['50\u2009g/d of pork (meat group), an equi-caloric fortified cereal supplement (fortified cereal group) or local cereal supplement (local cereal group', 'Fortified cereal and meat', 'vitamin', 'dietary intervention']","['fine motor score', 'median serum concentrations of vitamin B 12  and tHcy', 'serum vitamin B 12  and total homocysteine (tHcy) levels', 'cognitive score', 'higher cognitive scores', 'Bayley Scales of Infant Development, 3rd Edition (BSID III) screening test', 'median vitamin B 12  concentration', 'Serum vitamin B 12  concentrations less']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}]",60.0,0.1209,"Compared to the local cereal group, children in the meat group had higher cognitive scores (P < 0.05).
","[{'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': ""Department of Children and Adolescents Health Care, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute for Pediatric Research, MOE-Shanghai Key Laboratory of Children's Environmental Health, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Children and Adolescents Health Care, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute for Pediatric Research, MOE-Shanghai Key Laboratory of Children's Environmental Health, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Children and Adolescents Health Care, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute for Pediatric Research, MOE-Shanghai Key Laboratory of Children's Environmental Health, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Fengxiu', 'Initials': 'F', 'LastName': 'Ouyang', 'Affiliation': ""Ministry of Education and Shanghai Key Laboratory of Children's Environmental Health, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China.""}, {'ForeName': 'Jingqiu', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Shanghai Institute for Pediatric Research, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Key Laboratory of Pediatric Gastroenterology and Nutrition, No.1665, Kongjiang Road, Yangpu District, Shanghai, 200092, China. majingqiu@xinhuamed.com.cn.'}]",BMC pediatrics,['10.1186/s12887-019-1716-z']
1723,31486981,Correction to: Effects of relaxation on self-esteem of patients with cancer: a randomized clinical trial.,Cancellation of Open Access.,2020,Cancellation of Open Access.,['patients with cancer'],['relaxation'],['self-esteem'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",,0.0505823,Cancellation of Open Access.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Noruzi Zamenjani', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Golitaleb', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Zahedi', 'Affiliation': 'Faculty of Nursing and Midwifery, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jadidi', 'Affiliation': 'Chronic Diseases (Home Care) Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Nursing Care Research Center (NCRC), School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Masoud.Rezaei68@yahoo.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05068-6']
1724,31543242,Fibrosis Changes in the Placebo Arm of NASH Clinical Trials.,,2019,,[],['Placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.393786,,"[{'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Altayar', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Noureddin', 'Affiliation': 'Department of Internal Medicine, University of Nevada, Las Vegas, Nevada.'}, {'ForeName': 'Ma Ai', 'Initials': 'MA', 'LastName': 'Thanda Han', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Murad', 'Affiliation': 'Evidence-based Practice Center, Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Fatty Liver Program, Division of Digestive and Liver Diseases, Comprehensive Transplant Program, Cedars Sinai Medical Center, Los Angeles, California.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.05.016']
1725,31549391,Moving beyond an empiric trial to using combined physiology and anatomy to predict success of oral appliances in obstructive sleep apnoea.,,2019,,['obstructive sleep apnea'],[],[],"[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",[],[],,0.0195734,,"[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Rapoport', 'Affiliation': 'Icahn School of Medicine at Mt. Sinai, 5 East 98th St, Room 341, New York, NY, 10029.'}]",The Journal of physiology,['10.1113/JP278922']
1726,31444196,Correction:  paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial .,,2019,,['patients with acquired brain injury'],['paediatric goal management training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.139918,,[],BMJ open,['10.1136/bmjopen-2019-029273corr1']
1727,31637448,"[Local consolidative therapy vs. maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer: long-term results of a multi-institutional, phase II, randomized study].",,2019,,['patients with oligometastatic non-small-cell lung cancer'],['Local consolidative therapy vs. maintenance therapy or observation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],,0.0264062,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fabian', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, Hs.\xa050, 24105, Kiel, Deutschland. Alexander.Fabian@uksh.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Pyschny', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, Hs.\xa050, 24105, Kiel, Deutschland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, Hs.\xa050, 24105, Kiel, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-019-01528-4']
1728,29653861,Phase I Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis.,,2018,,['Neurotrophic Keratitis'],['Recombinant Human Nerve Growth Factor'],[],"[{'cui': 'C0339296', 'cui_str': 'Neurotrophic keratopathy'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}]",[],,0.0292157,,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bonini', 'Affiliation': 'Ophthalmology Department, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Lambiase', 'Affiliation': 'Sense Organs Department, Sapienza University, Rome, Italy. Electronic address: alessandro.lambiase@uniroma1.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rama', 'Affiliation': 'San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Filatori', 'Affiliation': 'Dompé Farmaceutici SpA, Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Allegretti', 'Affiliation': 'Dompé Farmaceutici SpA, Milan, Italy.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Chao', 'Affiliation': 'Dompé Farmaceutici SpA, Milan, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Mantelli', 'Affiliation': 'Dompé Farmaceutici SpA, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2018.03.004']
1729,31632771,Randomized phase II trial reporting overall survival advantage by adding local consolidative therapy to systemic therapy for oligometastatic non-small cell lung cancer: another step forward on the long road of evidence-based medicine for oligometastatic disease.,,2019,,['oligometastatic non-small cell lung cancer'],['local consolidative therapy'],[],"[{'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.165213,,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Windisch', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Guckenberger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}]",Journal of thoracic disease,['10.21037/jtd.2019.08.123']
1730,31229396,Building Blocks for Healthy Children: Evaluation of a Child Care Center-Based Obesity Prevention Pilot Among Low-Income Children.,"OBJECTIVE


To assess the impact of a multilevel nutrition intervention for low-income child care environments, staff, and center-enrolled children.
DESIGN


A cluster-randomized, controlled trial conducted among eligible centers. Staff and parent self-report surveys and objective field observations at baseline and follow-up were conducted.
SETTING


A total of 22 low-income child care centers (enrolling ≥ 25 2- to 5-year-old children).
PARTICIPANTS


Children aged 18-71 months; 408 children and 97 staff were randomized into intervention (208 children and 50 staff) and waitlist-control groups (200 children and 45 staff). Retention rates were high (87% for children and 93% for staff).
INTERVENTION(S)


A 6-session, 6-month director's child nutrition course with on-site technical support for center teachers.
MAIN OUTCOME MEASURE(S)


Center nutrition/physical activity environment; staff feeding styles, dietary patterns, and attitudes about food; child food preferences and dietary patterns.
ANALYSIS


Covariance regression analyses to assess the intervention effect, adjusting for clustering within centers.
RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). No significant intervention effects were found for child-level measures.
CONCLUSIONS AND IMPLICATIONS


Curriculum-driven training and implementation support improved nutritional policies and practices and staff-child interactions during meals. Future research could extend the intervention to families and the evaluation to children's dietary behaviors and weight changes.",2019,"RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). ","['Healthy Children', 'A total of 22 low-income child care centers', 'Children aged 18-71 months; 408 children and 97 staff were randomized into intervention (208 children and 50 staff) and waitlist-control groups (200 children and 45 staff', 'enrolling ≥ 25 2- to 5-year-old children', 'low-income child care environments, staff, and center-enrolled children', 'eligible centers', 'Low-Income Children']","['Child Care Center-Based Obesity Prevention Pilot', 'multilevel nutrition intervention']","['staff-level prompting/encouraging\xa0feeding styles', 'Retention rates', 'center nutrition training/education environment', 'nutrition total scores', 'child-level measures']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",408.0,0.0522384,"RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). ","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'Schuler', 'Affiliation': 'School of Social Work, College of Public Health, Temple University, Philadelphia, PA. Electronic address: brittany.schuler@temple.edu.'}, {'ForeName': 'Baylie', 'Initials': 'B', 'LastName': 'Fowler', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rubio', 'Affiliation': 'University of Minnesota Medical School, Twin Cities Campus, Twin Cities, MN.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kilby', 'Affiliation': 'Maryland State Department of Education, Baltimore, MD.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD; Distinguished Fellow, RTI International, Research Triangle Park, NC.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.04.017']
1731,31757693,Re: Randomized double-blind clinical trial evaluation of bone healing after third molar surgery with the use of leukocyte- and platelet-rich fibrin.,,2020,,[],['leukocyte- and platelet-rich fibrin'],[],[],"[{'cui': 'C4505052', 'cui_str': 'L-PRF'}]",[],,0.63846,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pimentel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil. Electronic address: pimentelthais@outlook.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ritto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Canellas', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Junger', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Medeiros', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.10.018']
1732,31522985,"Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study.","INTRODUCTION


Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of flibanserin with alcohol.
AIM


To evaluate the impact of the timing of alcohol consumption on flibanserin safety and tolerability.
METHODS


In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1-3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication.
OUTCOMES


The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence).
RESULTS


1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose-timing treatment, there were no statistically significant differences for flibanserin compared with placebo. Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0-5.0% after flibanserin dosing and 1.7-6.6% after placebo dosing.
CLINICAL IMPLICATIONS


Ethanol interaction with flibanserin was not observed in this study.
STRENGTHS & LIMITATIONS


This study provides information regarding the use of flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of flibanserin is not consistent with the drug's indicated bedtime dosing.
CONCLUSION


Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779-1786.",2019,Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing.,"['Healthy Premenopausal Women', 'premenopausal women', '64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years']","['alcohol consumption', 'flibanserin alone or ethanol', 'placebo', 'Flibanserin Administration Relative to Alcohol Intake', 'Flibanserin', 'ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol', 'once-daily flibanserin 100 mg or placebo']","['flibanserin safety and tolerability', 'primary endpoint event (syncope', 'incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence', 'percentage of participants experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention', 'orthostatic hypotension', 'incidence of hypotension, orthostatic hypotension, or syncope', 'Rates of hypotension']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4051422', 'cui_str': 'flibanserin 100 MG [Addyi]'}]","[{'cui': 'C0754280', 'cui_str': 'flibanserin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",64.0,0.448911,Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing.,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University School of Medicine and IntimMedicine Specialists, Washington, DC, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Sheryl A', 'Initials': 'SA', 'LastName': 'Kingsberg', 'Affiliation': ""University Hospitals Cleveland Medical Center, MacDonald Women's Hospital, Cleveland, OH, USA.""}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Parish', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Noel N', 'Initials': 'NN', 'LastName': 'Kim', 'Affiliation': 'Institute for Sexual Medicine, San Diego, CA, USA. Electronic address: nkim@ismlab.org.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Millheiser', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, CA, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.08.006']
1733,31380297,Probiotic Supplementation During Human Pregnancy Affects the Gut Microbiota and Immune Status.,"The consumption of probiotics and fermented foods has been very popular in recent decades. The primary aim of our study was to evaluate the effect of probiotics on the gut microbiota and the changes in inflammatory cytokines after an average of 6.7 weeks of probiotic administration among normal pregnant women. Thirty-two healthy pregnant women at 32 weeks of gestation were recruited and divided into two groups. The probiotic group ingested combined probiotics until after birth. The base characteristics of the probiotics and control groups showed no significant differences. The structure of the fecal microbiota at the genus level varied during the third trimester, and administration of probiotics had no influence on the composition of the fecal microbiota however, many highly abundant taxa and core microbiota at the genus level changed in the probiotic group when compared to the control group. The analysis of cytokines showed that IL-5, IL-6, TNF-α, and GM-CSF had equal levels between the baseline and control groups but were significantly increased after probiotic administration (baseline = control < probiotics). Additionally, levels of IL-1β, IL-2, IL-12, and IFN-γ significantly increased among the three groups (baseline < control < probiotics). This result demonstrated that probiotics helped to shift the anti-inflammatory state to a pro-inflammatory state. The correlation analysis outcome suggested that the relationship between the microbiota and the cytokines was not strain-dependent. The gut microbiota varied during the third trimester. The probiotics demonstrated immunomodulation effects that helped to switch over to a pro-inflammatory immune state in the third trimester, which was important for labor.",2019,"Additionally, levels of IL-1β, IL-2, IL-12, and IFN-γ significantly increased among the three groups (baseline < control < probiotics).","['normal pregnant women', 'Thirty-two healthy pregnant women at 32 weeks of gestation']","['probiotics', 'probiotic group ingested combined probiotics', 'Probiotic Supplementation']","['IL-5, IL-6, TNF-α, and GM-CSF had equal levels', 'levels of IL-1β, IL-2, IL-12, and IFN-γ', 'inflammatory cytokines', 'Gut Microbiota and Immune Status']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}]",32.0,0.0225971,"Additionally, levels of IL-1β, IL-2, IL-12, and IFN-γ significantly increased among the three groups (baseline < control < probiotics).","[{'ForeName': 'Yuyi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Kian Deng', 'Initials': 'KD', 'LastName': 'Tye', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Dongju', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Yimi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}, {'ForeName': 'Yingbing', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Clinical Medicine, International School of Jinan University, Guangzhou, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Jinan University, Guangzhou, China.'}]",Frontiers in cellular and infection microbiology,['10.3389/fcimb.2019.00254']
1734,31492152,Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial.,"BACKGROUND


Tacrolimus (TAC) is effective in treating membranous nephropathy (MN); however relapses are frequent after treatment cessation. We conducted a randomised controlled trial to examine whether the addition of mycophenolate mofetil (MMF) to TAC would reduce relapse rate.
METHODS


Forty patients with biopsy proven idiopathic MN and nephrotic syndrome were randomly assigned to receive either TAC monotherapy (n = 20) or TAC combined with MMF (n = 20) for 12 months. When patients had been in remission for 1 year on treatment the MMF was stopped and the TAC gradually withdrawn in both groups over 6 months. Patients also received supportive treatment with angiotensin blockade, statins, diuretics and anticoagulation as needed. Primary endpoint was relapse rate following treatment withdrawal. Secondary outcomes were remission rate, time to remission and change in renal function.
RESULTS


16/20 (80%) of patients in the TAC group achieved remission compared to 19/20 (95%) in the TAC/MMF group (p = 0.34). The median time to remission in the TAC group was 54 weeks compared to 40 weeks in the TAC/MMF group (p = 0.46). There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7). The addition of MMF to TAC did not adversely affect the safety of the treatment.
CONCLUSIONS


Addition of MMF to TAC does not alter the relapse rate of nephrotic syndrome in patients with MN.
TRIAL REGISTRATION


This trial is registered with EudraCTN2008-001009-41 . Trial registration date 2008-10-08.",2019,There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7).,"['idiopathic membranous glomerulonephritis', '2008-10-08', 'Forty patients with biopsy proven idiopathic MN and nephrotic syndrome', 'patients with MN']","['TAC', 'Mycophenolate mofetil and tacrolimus versus tacrolimus alone', 'MMF', 'angiotensin blockade, statins, diuretics and anticoagulation', 'Tacrolimus (TAC', 'TAC monotherapy', 'MMF to TAC', 'TAC combined with MMF', 'mycophenolate mofetil (MMF) to TAC']","['relapse rate of nephrotic syndrome', 'median time to remission', 'relapse rate', 'remission', 'remission rate, time to remission and change in renal function']","[{'cui': 'C0086445', 'cui_str': 'Idiopathic Membranous Glomerulonephritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",40.0,0.242055,There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7).,"[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Nikolopoulou', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK. lina.nikolopoulou13@imperial.ac.uk.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Condon', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Turner-Stokes', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'H Terence', 'Initials': 'HT', 'LastName': 'Cook', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Neill', 'Initials': 'N', 'LastName': 'Duncan', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Galliford', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Levy', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Lightstone', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Pusey', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Roufosse', 'Affiliation': 'Centre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cairns', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Griffith', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.'}]",BMC nephrology,['10.1186/s12882-019-1539-z']
1735,30428039,"Lipid metabolic networks, Mediterranean diet and cardiovascular disease in the PREDIMED trial.","Background


Perturbed lipid metabolic pathways may play important roles in the development of cardiovascular disease (CVD). However, existing epidemiological studies have focused more on discovering individual lipid metabolites for CVD risk prediction rather than assessing metabolic pathways.
Methods


This study included a subcohort of 787 participants and all 230 incident CVD cases from the PREDIMED trial. Applying a network-based analytical method, we identified lipid subnetworks and clusters from a global network of 200 lipid metabolites and linked these subnetworks/clusters to CVD risk.
Results


Lipid metabolites with more double bonds clustered within one subnetwork, whereas lipid metabolites with fewer double bonds clustered within other subnetworks. We identified 10 lipid clusters that were divergently associated with CVD risk. The hazard ratios [HRs, 95% confidence interval (CI)] of CVD per a 1-standard deviation (SD) increment in cluster score were 1.39 (1.17-1.66) for the hydroxylated phosphatidylcholine (HPC) cluster and 1.24 (1.11-1.37) for a cluster that included diglycerides and a monoglyceride with stearic acyl chain. Every 1-SD increase in the score of cluster that included highly unsaturated phospholipids and cholesterol esters was associated with an HR for CVD of 0.81 (95% CI, 0.67-0.98). Despite a suggestion that MedDiet modified the association between a subnetwork that included most lipids with a high degree of unsaturation and CVD, changes in lipid subnetworks/clusters during the first-year follow-up were not significantly different between intervention groups.
Conclusions


The degree of unsaturation was a major determinant of the architecture of lipid metabolic network. Lipid clusters that strongly predicted CVD risk, such as the HPC cluster, warrant further functional investigations.",2018,"Applying a network-based analytical method, we identified lipid subnetworks and clusters from a global network of 200 lipid metabolites and linked these subnetworks/clusters to CVD risk.
",['787 participants and all 230 incident CVD cases from the PREDIMED trial'],[],"['hazard ratios [HRs, 95% confidence interval (CI)] of CVD per a 1-standard deviation (SD) increment in cluster score', 'unsaturated phospholipids and cholesterol esters', 'Lipid metabolites', 'lipid metabolites']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",[],"[{'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0008387', 'cui_str': 'Cholesteryl Esters'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",787.0,0.126042,"Applying a network-based analytical method, we identified lipid subnetworks and clusters from a global network of 200 lipid metabolites and linked these subnetworks/clusters to CVD risk.
","[{'ForeName': 'Dong D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Razquin', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Yu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'Department of Preventive Medicine, University of Málaga, Málaga, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fito', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aros', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Broad Institute and MIT, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",International journal of epidemiology,['10.1093/ije/dyy198']
1736,31180819,Prospective Multicenter Study on the Prognostic and Predictive Impact of Tumor Budding in Stage II Colon Cancer: Results From the SACURA Trial.,"PURPOSE


The International Union Against Cancer highlighted tumor budding as a tumor-related prognostic factor. International assessment criteria for tumor budding were recently defined by the 2016 International Tumor Budding Consensus Conference (ITBCC2016). This study aimed to clarify the prognostic and predictive values of tumor budding in a randomized controlled trial evaluating the superiority of adjuvant chemotherapy with oral tegafur-uracil over surgery alone for stage II colon cancer (SACURA trial; ClinicalTrials.gov identifier: NCT00392899).
PATIENTS AND METHODS


Between 2006 and 2010, we enrolled 991 patients from 123 institutions with stage II colon cancer. Tumor budding was diagnosed by central review on the basis of the criteria adopted in the ITBCC2016. We prospectively recorded all clinical and pathologic data, including the budding grade, and performed prognostic analyses after 5 years of completing the patients' registration.
RESULTS


Of 991 tumors, 376, 331, and 284 were classified as BD1, BD2, and BD3, respectively; the 5-year relapse-free survival (RFS) rate was 90.9%, 85.1%, and 74.4%, respectively ( P  < .001), and ranged widely in T4 tumors (86.6% to 53.3%). The budding grade significantly correlated with recurrence in the liver, lungs, lymph nodes, and peritoneum ( P  < .001 to .01). Multivariable analysis revealed that budding and T stage exerted an independent impact on RFS, and on the basis of the Harrell concordance index, these two factors substantially contributed to the improvement of the Cox model for predicting RFS. Both the BD2 and BD3 groups demonstrated greater improvement in the 5-year recurrence rate in the adjuvant chemotherapy group than the surgery-alone group by approximately 5%, but the difference was statistically nonsignificant.
CONCLUSION


Tumor budding grade on the basis of the ITBCC2016 criteria should be routinely evaluated in pathologic practice and could improve the benefit of adjuvant chemotherapy for stage II colon cancer.",2019,"Both the BD2 and BD3 groups demonstrated greater improvement in the 5-year recurrence rate in the adjuvant chemotherapy group than the surgery-alone group by approximately 5%, but the difference was statistically nonsignificant.
","['991 patients from 123 institutions with stage II colon cancer', 'Stage II Colon Cancer', 'Between 2006 and 2010']",['adjuvant chemotherapy with oral tegafur-uracil over surgery alone'],"['5-year recurrence rate', 'BD1, BD2, and BD3', '5-year relapse-free survival (RFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0041917', 'cui_str': 'Uracil'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",991.0,0.175321,"Both the BD2 and BD3 groups demonstrated greater improvement in the 5-year recurrence rate in the adjuvant chemotherapy group than the surgery-alone group by approximately 5%, but the difference was statistically nonsignificant.
","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': '1National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Ishiguro', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nakatani', 'Affiliation': '3Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Hyogo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Matsuda', 'Affiliation': '4Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Nakamoto', 'Affiliation': '5Kobe City Medical Center West Hospital, Hyogo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kotake', 'Affiliation': '6Kouseiren Takaoka Hospital, Toyama, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Kurachi', 'Affiliation': '7Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Egawa', 'Affiliation': '8Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Yasumasa', 'Affiliation': '9Japan Community Health Care Organization Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': '10Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ikawa', 'Affiliation': '11Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Shinji', 'Affiliation': '12Nippon Medical School Chiba Hokusoh Hospital, Chiba, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': '13Kurume University, Fukuoka, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': '14Nagoya University, Aichi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': '15Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': '16Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': '2Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02059']
1737,31518717,Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.,"BACKGROUND & AIMS


Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial.
METHODS


Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year.
RESULTS


Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations.
CONCLUSIONS


In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.",2019,"Proportions of patients with dysphagia decreased from 15% to 7% (P<.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P<.001) from study entry to 1-year after MSA (Combined P<.001).","['Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n=152', 'patients with moderate to severe regurgitation despite once-daily PPI therapy', 'n=50) at 20 sites, from July 2015 through February 2017', 'Regurgitative gastroesophageal reflux disease (GERD']","['Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors', 'twice-daily PPIs', 'PPI therapy', 'MSA', 'proton-pump inhibitors (PPIs', 'laparoscopic MSA', 'magnetic sphincter augmentation (MSA', 'PPI therapy, MSA']","['peri-operative events, device explants, erosions, or migrations', 'control of regurgitation', 'Proportions of patients with dysphagia', 'GERD health-related quality of life improvement scores', 'bloating', 'regurgitation', 'foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use', 'Regurgitation, foregut scores, esophageal acid exposure, and adverse events', 'esophageal acid exposure time', 'severe regurgitation and excess reflux episodes', 'Relief of regurgitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",,0.0512771,"Proportions of patients with dysphagia decreased from 15% to 7% (P<.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P<.001) from study entry to 1-year after MSA (Combined P<.001).","[{'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Bell', 'Affiliation': 'Institute of Esophageal and Reflux Surgery, Englewood, Colorado. Electronic address: reg@iersurgery.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lipham', 'Affiliation': 'Department of Surgery, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Louie', 'Affiliation': 'Division of Thoracic Surgery, Swedish Medical Center, Seattle, Washington.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': ""Thoracic Surgery Department, St. Elizabeth's Healthcare, Edgewood, Kentucky.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luketich', 'Affiliation': 'Division of Thoracic Surgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Surgery, Adirondack Medical Center and Adirondack Surgical Group, Saranac Lake, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Richards', 'Affiliation': 'Department of Surgery, University of South Alabama, Mobile, Alabama.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Dunst', 'Affiliation': 'Department of Surgery, Oregon Clinic, Portland, Oregon.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lister', 'Affiliation': 'Arkansas Heartburn Treatment Center, Baptist Health Medical Center, Heber Springs, Arkansas.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McDowell-Jacobs', 'Affiliation': 'Department of Surgery, Knox Community Hospital, Mount Vernon, Ohio.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reardon', 'Affiliation': 'Department of Surgery, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'F Paul', 'Initials': 'FP', 'LastName': 'Buckley', 'Affiliation': 'Department of Surgery and Perioperative Care, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Shanu', 'Initials': 'S', 'LastName': 'Kothari', 'Affiliation': 'Department of Surgery, Prisma Health, Greenville, South Carolina.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Khaitan', 'Affiliation': 'Department of Surgery, Digestive Health Institute, University Hospitals, Cleveland Medical Center, Cleveland, Cleveland, Ohio.'}, {'ForeName': 'C Daniel', 'Initials': 'CD', 'LastName': 'Smith', 'Affiliation': 'Esophageal Institute of Atlanta, Atlanta, Georgia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Anne Arundel Health System and Johns Hopkins Medicine, Annapolis, Maryland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Albany Surgical PC, Albany, Georgia.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Surgery, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Abbas', 'Affiliation': 'Division of Thoracic Surgery, West Virginia University School of Medicine, Morgantown, West Virginia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Katz', 'Affiliation': 'Department of Gastroenterology, Weill Cornell Medicine, New York, New York.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.08.056']
1738,31517976,Effect of an Intervention Package and Teamwork Training to Prevent Healthcare Personnel Self-contamination During Personal Protective Equipment Doffing.,"BACKGROUND


More than 28 000 people were infected with Ebola virus during the 2014-2015 West African outbreak, resulting in more than 11 000 deaths. Better methods are needed to reduce the risk of self-contamination while doffing personal protective equipment (PPE) to prevent pathogen transmission.
METHODS


A set of interventions based on previously identified failure modes was designed to mitigate the risk of self- contamination during PPE doffing. These interventions were tested in a randomized controlled trial of 48 participants with no prior experience doffing enhanced PPE. Contamination was simulated using a fluorescent tracer slurry and fluorescent polystyrene latex spheres (PLSs). Self-contamination of scrubs and skin was measured using ultraviolet light visualization and swabbing followed by microscopy, respectively. Doffing sessions were videotaped and reviewed to score standardized teamwork behaviors.
RESULTS


Participants in the intervention group contaminated significantly fewer body sites than those in the control group (median [interquartile range], 6 [3-8] vs 11 [6-13], P = .002). The median contamination score was lower for the intervention group than the control group when measured by ultraviolet light visualization (23.15 vs 64.45, P = .004) and PLS swabbing (72.4 vs 144.8, P = .001). The mean teamwork score was greater in the intervention group (42.2 vs 27.5, P < .001).
CONCLUSIONS


An intervention package addressing the PPE doffing task, tools, environment, and teamwork skills significantly reduced the amount of self-contamination by study participants. These elements can be incorporated into PPE guidance and training to reduce the risk of pathogen transmission.",2019,"The mean teamwork score was greater in the intervention group (42.2 vs 27.5, P < .001).
","['48 participants with no prior experience doffing enhanced PPE', '28 000 people were infected with Ebola virus during the 2014-2015 West African outbreak, resulting in more than 11 000 deaths']",['Intervention Package and Teamwork Training'],"['Healthcare Personnel Self-contamination', 'ultraviolet light visualization', 'mean teamwork score', 'median contamination score', 'body sites']","[{'cui': 'C0070932', 'cui_str': 'PPED'}, {'cui': 'C0949892', 'cui_str': 'Ebola Virus'}, {'cui': 'C0238606', 'cui_str': 'West Africans (ethnic group)'}, {'cui': 'C0220888', 'cui_str': 'outbreaks'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet Light'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",48.0,0.0588798,"The mean teamwork score was greater in the intervention group (42.2 vs 27.5, P < .001).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Andonian', 'Affiliation': 'Department of Hospital Epidemiology and Infection Control, Johns Hopkins Hospital.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Kazi', 'Affiliation': 'Johns Hopkins Armstrong Institute for Patient Safety and Quality.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Therkorn', 'Affiliation': 'Department of Applied Biological Sciences, Johns Hopkins Applied Physics Laboratory.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Benishek', 'Affiliation': 'Johns Hopkins Armstrong Institute for Patient Safety and Quality.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Billman', 'Affiliation': 'Department of Hospital Epidemiology and Infection Control, Johns Hopkins Hospital.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Schiffhauer', 'Affiliation': 'Department of Hospital Epidemiology and Infection Control, Johns Hopkins Hospital.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Nowakowski', 'Affiliation': 'Department of Hospital Epidemiology and Infection Control, Johns Hopkins Hospital.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Osei', 'Affiliation': 'Johns Hopkins Armstrong Institute for Patient Safety and Quality.'}, {'ForeName': 'Ayse P', 'Initials': 'AP', 'LastName': 'Gurses', 'Affiliation': 'Johns Hopkins Armstrong Institute for Patient Safety and Quality.'}, {'ForeName': 'Yea-Jen', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, Johns Hopkins University School of Medicine.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Drewry', 'Affiliation': 'Department of Applied Biological Sciences, Johns Hopkins Applied Physics Laboratory.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Forsyth', 'Affiliation': 'Department of Applied Biological Sciences, Johns Hopkins Applied Physics Laboratory.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Vignesh', 'Affiliation': 'Johns Hopkins Armstrong Institute for Patient Safety and Quality.'}, {'ForeName': 'Ifeoluwa', 'Initials': 'I', 'LastName': 'Oresanwo', 'Affiliation': 'Johns Hopkins Armstrong Institute for Patient Safety and Quality.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Garibaldi', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Rainwater-Lovett', 'Affiliation': 'Department of Applied Biological Sciences, Johns Hopkins Applied Physics Laboratory.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Trexler', 'Affiliation': 'Department of Hospital Epidemiology and Infection Control, Johns Hopkins Hospital.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Maragakis', 'Affiliation': 'Department of Hospital Epidemiology and Infection Control, Johns Hopkins Hospital.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz618']
1739,16034864,Sertindole for schizophrenia.,"BACKGROUND


Sertindole is an atypical antipsychotic, which is thought to give a lower incidence of extrapyramidal side effects at clinically effective doses than typical antipsychotic drugs. In December 1998, Lundbeck Ltd., the manufacturers of sertindole, voluntarily suspended the availability of the drug due to concerns about cardiac arrhythmia and sudden cardiac death associated with its use. However, based on the advice of an appointed expert group, the Committee for Proprietary Medicinal Products (CPMP) lifted the suspension of sertindole in October 2001, a decision that was ratified by the European Commission on the 26th of June 2002. Lundbeck have committed to the CPMP to carry out two post-marketing surveillance (PMS) studies (which were initiated in July 2002) to provide additional epidemiological data under conditions of normal drug usage. Initial marketing of the product will be restricted and Lundbeck is currently in discussions with the US health authorities (FDA) to investigate whether, and if so when, it would be possible to launch Serdolect in the US market.
OBJECTIVES


To determine the effects of sertindole compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses.
SEARCH STRATEGY


Our Initial searches included electronic searches of Biological Abstracts (1980-1999), The Cochrane Library (Issue 1, 1999), The Cochrane Schizophrenia Group's Register (August 2000), EMBASE (1980-1999), LILACS (1982-1996), MEDLINE (1966-1999), PSYNDEX (1977-1995) and PsycLIT (1974-1999). In addition, we searched pharmaceutical databases on the Dialog Corporation Datastar and Dialog services. We searched references of all identified studies for further trials. We contacted the manufacturer of sertindole and authors of trials. We updated the literature search by searching the Cochrane Schizophrenia Group's Trials Register in April 2003.
SELECTION CRITERIA


All randomised controlled trials that compared sertindole to placebo or other antipsychotic (atypical or typical) drug treatments for patients with schizophrenia or related psychosis .
DATA COLLECTION AND ANALYSIS


We independently inspected citations and, where possible abstracts; ordered papers for re-inspection and quality assessment and independently extracted data. For homogeneous dichotomous data, we calculated the risk ratio (RR), 95% confidence interval (CI) and, where appropriate, the number needed to treat (NNT) or number needed to harm (NNH) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). We inspected all data for heterogeneity.
MAIN RESULTS


Currently the review includes three studies with a total of 1,104 participants. One was a medium term (eight weeks) placebo controlled study that examined three different doses of sertindole (8, 12 and 20mg/day). The remaining two studies compared the use of sertindole with haloperidol (10mg/day). One was a short term study (six weeks) that looked at four different doses of sertindole (8, 16, 20, 24mg/day) and the other was a long term study (one year) that evaluated the use of sertindole 24mg/day in participants attending outpatients. We excluded two large important studies because they did not report any usable data. (Both had greater than 50% loss to follow-up and data on 'leaving the study early' was inadequately reported). SERTINDOLE VERSUS PLACEBO: Sertindole at 20mg/day was found to be more effective than placebo in terms of BPRS total scores (1 study, n=78, MD 6.2, CI -11.8 to -0.6) and CGI total end point scores (1 study, n=78, MD -0.9, CI -1.6 to -0.2). A marginally statistically significantly greater number of participants that were treated with 20 mg of sertindole were reported to have been 'very much improved' as compared to those taking placebo (1 study, n=102, RR 7.6, CI 1.0 to 57.9, NNT 7.9, CI 4.3 to 41.1). There was no statistically significant difference between sertindole at 8 or 12 mg/day and placebo for these three outcome measures. There were no statistically significant differences between sertindole (8, 12 or 20 mg) and placebo for the incidence of extrapyramidal symptoms, extrapyramidal related events or use of medication to avoid extrapyramidal symptoms. There were no statistically significant differences found between sertindole and placebo for the movement disorders akathisia, cogwheel rigidity, hypertonia and tremor or somnolence. At eight weeks a statistically significant difference between placebo and all sertindole groups (8, 12 and 20 mg) for mean change from baseline in the QT and QTc intervals were observed (p values and SD were not reported). There was a statistically significant greater mean weight gain among participants taking sertindole (20 mg, mean weight gain of 3.3 kg) as compared to placebo (mean weight gain of 0.8 kg; p<0.05). SERTINDOLE VERSUS HALOPERIDOL: At one year, a greater number of participants who were treated with haloperidol as compared to sertindole (24mg/day) were leaving the study early due to any reason (1 study, n=282, RR 0.6, CI 0.4 to 1.0, NNH 8.8, CI 4.7 to 74.0) or non-compliance (1 study, n=282, RR 0.2, CI 0.0 to 0.7, NNH 12.8, CI 7.7 to 37.8). However, at six weeks, there was no statistically significant difference between sertindole (at 8, 16, 20, or 24mg) and haloperidol for this latter outcome. The incidence of EPS was higher among those treated with haloperidol than sertindole at 8, 16, 20 or 24mg/day (8mg: 1 study, n=245, RR 0.1, CI 0.0 to 0.7, NNH 11.4, CI 7.1 to 29.8; 16mg: 1 study, n=252, RR 0.3, CI 0.1 to 1.0, NNH 15.5, CI 8.0 to 217.9; and 20mg: 1 study, n=253, RR 0.2, CI 0.1 to 0.8, NNH 13.7, CI 7.7 to 68.3; 24mg: 2 studies, n=524, RR 0.6, CI 0.4 to 0.8, NNH 8.7, CI 5.4 to 23.0). More participants treated with haloperidol experienced akathisia, tremor and hypertonia than those treated with sertindole (Akathisia - 8mg: 1 study, n=245, RR 0.2, CI 0.1 to 0.5, NNH 6.0, CI 4.1 to 11.2; 16mg: 1 study, n=252, RR 0.1, CI 0.0 to 0.3, NNH 5.4, CI 3.9 9.0; 20mg: 1 study, n=253, RR 0.3, CI 0.2 to 0.7, NNH 7.3, CI 4.6 to 17.9; 24mg: 2 studies, n=524, RR 0.5, CI 0.3 to 0.7, NNH 8.6, CI 5.6 to 18.3. Tremor - 8mg: 1 study, n=245, RR 0.3, CI 0.1 to 0.7, NNH 8.5, CI 5.2 to 24.0; 16mg: 1 study, n=252, RR 0.2, CI 0.1 to 0.5, NNH 7.3, 4.8 to 15.6; 20mg: 1 study, n=253, RR 0.2, CI 0.1 to 0.6, NNH 7.8, CI 4.9 to 18.1; 24mg: 2 studies, n=524, RR 0.4, CI 0.2 to 0.6, NNH 8.2, CI 5.6 to 15.3. For Hypertonic - 24mg: 2 studies, n=524, RR 0.5, CI 0.3 to 0.8, NNH 12.4, CI 7.5 to 35.0; for sertindole 8, 16 and 20mg there was no statistically significant differences between the treatment groups). One study reported that at six weeks, there was a statistically significant greater increase from baseline to final value in mean QTc interval in the sertindole 16, 20 and 24mg groups (20, 26, and 24msec, respectively) than in the haloperidol group (0msec; p value was not reported), but no SD or any other measure of variance for the effect sizes were reported. For one long term study only one participant from the sertindole group (24mg) had a QT interval that exceeded 500msec (1 study, n=282, RR 3.0 CI 0.1 to 73.0), but 11participants treated with Sertindole had QTc intervals of at least 500msec, compared to none in the haloperidol treated group (1 study, n=282, RR 23.0, CI 1.4 to 386.6, NNH 12.8, CI 8.2 to 29.6). At six weeks, fewer participants treated with sertindole at 8mg or 24mg were affected by somnolence than those treated with haloperidol (sertindole 8mg: 1 study, n=245, RR 0.1, CI 0.0 to 0.7, NNH 11.4, CI 7.1 to 29.8; 24mg: 2 studies, n=524, RR 0.6, CI 0.4 to 1.0, NNH 14.8, CI 7.7 to 205.2). The incidence of rhinitis was found to be statistically significantly higher among those taking sertindole at 16 or 24mg as compared to haloperidol (16mg: 1 study, n=252, RR 10.8, CI 1.4 to 82.6, NNH 12.7, CI 7.7 to 36.7; 24mg: 2 studies, n= 524, RR 2.1, CI 1.4 to 3.1, NNH 8.7, CI 5.6 to 18.6). At one year, 33 participants treated with sertindole (24mg) had experienced the sexual adverse event of decreased ejaculatory volume, compared with six participants treated with haloperidol. However the number of included male participants was not reported and therefore the RR could not be calculated. At one year, more participants taking sertindole (24mg/day) had put on weight compared to those taking haloperidol (1 study, n=282, RR 6.3, CI 1.9 to 20.9, NNH 8.8, CI 5.7 to 19.1). At six weeks, all of the sertindole groups showed an increase in body weight from baseline to final evaluation ranging from 1.3kg to 1.9kg, all of which represented a statistically significantly different weight change than that recorded for the haloperidol treatment group (-0.1Kg). However, the actual weight gain for each sertindole dosage group was not reported and no SD or any other measure of variance was given.
AUTHORS' CONCLUSIONS


Sertindole at a dose of 20mg/day was found to be more antipsychotic than placebo. When used at 8, 12 or 20mg/day it appears to be as acceptable as placebo (in terms of various adverse events including movement disorders and somnolence), but seems to be associated with more cardiac problems (8, 12 or 20mg/day) and an increase in weight gain (20mg/day) than placebo. Sertindole at a dose of 24mg/day was better tolerated than haloperidol (in terms of participants leaving the study early). It was also found to be was associated with fewer movement disorders (at 8, 16, 20 or 24mg/day) and sedation (8 or 24mg/day) than haloperidol. However, it was shown to cause more cardiac anomalies (16, 20 or 24mg/day), weight gain (all doses combined), rhinitis (16 or 24mg/day), and problems with sexual functioning (24mg/day) than haloperidol. One short term study reported that sertindole 16mg/day was the most optimal dose.",2005,There was no statistically significant difference between sertindole at 8 or 12 mg/day and placebo for these three outcome measures.,"['participants attending outpatients', 'patients with schizophrenia or related psychosis ', '1,104 participants']","['Sertindole', 'LILACS', 'sertindole with haloperidol', 'placebo', 'antipsychotic (atypical or typical) drug treatments', 'haloperidol (sertindole', 'haloperidol', 'placebo, typical and other atypical antipsychotic drugs', 'sertindole', 'sertindole to placebo']","['mean weight gain', 'mean QTc interval', 'BPRS total scores', 'extrapyramidal symptoms, extrapyramidal related events or use of medication to avoid extrapyramidal symptoms', 'akathisia, tremor and hypertonia', 'weight', 'weight change', 'body weight', 'movement disorders akathisia, cogwheel rigidity, hypertonia and tremor or somnolence', 'fewer movement disorders', 'QT interval', 'CGI total end point scores', 'somnolence', 'actual weight gain', 'tolerated', 'cardiac anomalies', 'incidence of rhinitis', 'sexual adverse event of decreased ejaculatory volume', 'incidence of EPS', 'weight gain', 'QTc intervals']","[{'cui': 'C0730261', 'cui_str': 'Attends outpatients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0084528', 'cui_str': 'sertindole'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276996', 'cui_str': 'Atypical antipsychotic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0026826', 'cui_str': 'Hypermyotonia'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0151564', 'cui_str': 'Cogwheel Rigidity'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",1.0,0.0973388,There was no statistically significant difference between sertindole at 8 or 12 mg/day and placebo for these three outcome measures.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Department of General Practice, North Wales Clinical School, Cardiff University, Gwenfro Unit 5, Wrexham Technology Park, Wrexham, UK, LL13 7YP. lewisr17@Cardiff.ac.uk'}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Bagnall', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leitner', 'Affiliation': ''}]",The Cochrane database of systematic reviews,[]
1740,31914973,Correction to: Oral esketamine for treatment-resistant depression: rationale and design of a randomized controlled trial.,After publication of our article [1] we were notified that Figure 1 was wrongly presented.,2020,After publication of our article [1] we were notified that Figure 1 was wrongly presented.,[],['Oral esketamine'],[],[],"[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2825616'}]",[],,0.121425,After publication of our article [1] we were notified that Figure 1 was wrongly presented.,"[{'ForeName': 'Sanne Y', 'Initials': 'SY', 'LastName': 'Smith-Apeldoorn', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands. s.y.apeldoorn@umcg.nl.'}, {'ForeName': 'Jolien K E', 'Initials': 'JKE', 'LastName': 'Veraart', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Kamphuis', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}, {'ForeName': 'Antoinette D I', 'Initials': 'ADI', 'LastName': 'van Asselt', 'Affiliation': 'Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Aan Het Rot', 'Affiliation': 'Department of Psychology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schoevers', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, PO box 30.0001, 9700, RB, Groningen, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2398-7']
1741,31522894,Impact of a Pilot School-Based Nutrition Intervention on Fruit and Vegetable Waste at School Lunches.,"OBJECTIVE


To determine the preliminary impact of the Brighter Bites nutrition intervention on decreasing fruit and vegetable (F&V) waste at school lunches among fourth- and fifth-grade children.
METHOD


This was a nonrandomized pre-post-controlled study in Houston and Dallas, TX. Two schools received the Brighter Bites intervention (n = 76), and 1 comparison school (n = 39), during the 2017-2018 school year. Brighter Bites is a 16-week school-based nutrition intervention providing weekly distribution of fresh F&V plus nutrition education. Main outcome measures were direct observation and weights to measure the number of F&V dishes selected at school lunches, amount of F&V wasted (gm), and related nutrient waste (4 time points/child). Mixed-effects linear regression analysis was used to determine change in F&V selection and waste over time.
RESULTS


There was a significant decrease over time in proportion of F&V selected among those in the comparison school, but not the intervention schools (P < .001). Compared with children in the comparison group, those receiving Brighter Bites showed a significant decrease in the amount of F&V wasted at each meal (P < .001) and per item (P < .05) at the end of both 8 and 16 weeks of intervention. There were significant decreases in waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate (µg); and B 12  (µg) among those receiving Brighter Bites (P < .05).
CONCLUSIONS AND IMPLICATIONS


Although absolute food or nutrient changes were small even when significant, programs such as Brighter Bites may contribute to a healthy intake. Future studies are warranted that include a larger sample size with a stringent, cluster-randomized control trial design and consideration for other covariates.",2019,"There were significant decreases in waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate (µg); and B 12  (µg) among those receiving Brighter Bites (P < .05).
","['Fruit and Vegetable Waste at School Lunches', 'at school lunches among fourth- and fifth-grade children']","['Pilot School-Based Nutrition Intervention', 'Brighter Bites intervention', 'Brighter Bites nutrition intervention']","['fruit and vegetable (F&V) waste', 'waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate', 'amount of F&V', 'time in proportion of F&V', 'F&V selection and waste over time', 'direct observation and weights to measure the number of F&V dishes selected at school lunches, amount of F&V wasted (gm), and related nutrient waste (4 time points/child']","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0005658', 'cui_str': 'Bites'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0020498', 'cui_str': 'Vertebral Ankylosing Hyperostosis'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0211794,"There were significant decreases in waste of energy (kcal); dietary fiber (gm); vitamins B 1 , B 3 , and B 6  (mg); total folate (µg); and B 12  (µg) among those receiving Brighter Bites (P < .05).
","[{'ForeName': 'Shreela', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Epidemiology, Environmental Health, and Genetics, Michael and Susan Dell Center for Healthy Living, University of Texas School of Public Health, Houston, TX. Electronic address: Shreela.V.Sharma@uth.tmc.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas School of Public Health in Austin, Austin, TX.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Chow', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Ranjit', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas School of Public Health in Austin, Austin, TX.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Bounds', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hearne', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cramer', 'Affiliation': 'Houston Independent School District Food Service Support Facility, Houston, TX.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Oceguera', 'Affiliation': 'Houston Independent School District Food Service Support Facility, Houston, TX.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Farhat', 'Affiliation': 'Brighter Bites, Dallas, TX.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Markham', 'Affiliation': 'Department of Health Promotion Behavioral Sciences, University of Texas School of Public Health, Houston, TX.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.08.002']
1742,31981566,Change in Clinical Practice Associated With a Large Randomized Controlled Trial Comparing RBC Transfusion Strategies.,,2020,,[],[],[],[],[],[],,0.109654,,"[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Trentino', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia; Data and Digital Innovation, East Metropolitan Health Service, Perth, Australia. Electronic address: kevin.trentino@uwa.edu.au.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sanfilippo', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Leahy', 'Affiliation': 'Department of Haematology, PathWest Laboratory Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Farmer', 'Affiliation': 'Medical School and Division of Surgery, University of Western Australia, Perth, Australia; School of Health Sciences and Graduate Studies, Curtin University, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilfillan', 'Affiliation': 'Department of Cardiothoracic Surgery, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}]",Chest,['10.1016/j.chest.2020.01.004']
1743,31488098,Does the fortified milk with high iron dose improve the neurodevelopment of healthy infants? Randomized controlled trial.,"BACKGROUND


Since iron plays an important role in several physiological processes, its deficiency but also overload may harm the development of children. The aim was to assess the effect of iron-fortified milk on the iron biochemical status and the neurodevelopment of children at 12 months of age.
METHODS


Randomized controlled trial conducted in 133 Spanish children, allocated in two groups to receive formula milk fortified with 1.2 or 0.4 mg/100 mL of iron between 6 and 12 months of age. Psychomotor (PDI) and Mental (MDI) Development Index were assessed by the Bayley Scales before and after the intervention. Maternal obstetrical and psychosocial variables were recorded. The biochemical iron status of children was measured and data about breastfeeding, anthropometry and infections during the first year of life were registered.
RESULTS


Children fortified with 1.2 mg/100 mL of iron, compared with 0.4 mg/100 mL, showed higher serum ferritin (21.5 vs 19.1 μg/L) and lower percentage of both iron deficiency (1.1 to 5.9% vs 3.8 to 16.7%, respectively, from 6 to 12 months) and iron deficiency anemia (4.3 to 1.1% vs 0 to 4.2%, respectively, from 6 to 12 months) at the end of the intervention. No significant differences were found on neurodevelopment from 6 to 12 months between children who received high dose of Fe compared with those who received low dose.
CONCLUSION


Despite differences on the iron status were observed, there were no effects on neurodevelopment of well-nourished children in a developed country after iron supplementation with doses within dietary recommendations. Follow-up studies are needed to test for long-term neurodevelopmental improvement.
TRIAL REGISTRATION


Retrospectively registered in ClinicalTrials.gov with the ID: NCT02690675.",2019,"No significant differences were found on neurodevelopment from 6 to 12 months between children who received high dose of Fe compared with those who received low dose.
","['children at 12\u2009months of age', '133 Spanish children']","['formula milk fortified with 1.2 or 0.4\u2009mg/100', 'iron-fortified milk']","['iron deficiency anemia', 'serum ferritin', 'percentage of both iron deficiency', 'Psychomotor (PDI) and Mental (MDI) Development Index', 'Maternal obstetrical and psychosocial variables']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}]","[{'cui': 'C0452742', 'cui_str': 'Formula milk (substance)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1532525', 'cui_str': 'Fortified milk'}]","[{'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205484', 'cui_str': 'Obstetrical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.242689,"No significant differences were found on neurodevelopment from 6 to 12 months between children who received high dose of Fe compared with those who received low dose.
","[{'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Iglesias Vázquez', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Faculty of Medicine and Health Science, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Canals', 'Affiliation': 'CRAMC (Centre de Recerca en Avaluació I Mesura de la Conducta), Unit of Psychology, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Voltas', 'Affiliation': 'CRAMC (Centre de Recerca en Avaluació I Mesura de la Conducta), Unit of Psychology, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Jardí', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Faculty of Medicine and Health Science, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hernández', 'Affiliation': 'CRAMC (Centre de Recerca en Avaluació I Mesura de la Conducta), Unit of Psychology, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bedmar', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Faculty of Medicine and Health Science, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Escribano', 'Affiliation': 'Unit of Pediatrics, Faculty of Medicine and Health Science, Hospital Universitari Sant Joan de Reus, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Aranda', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Faculty of Medicine and Health Science, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Unit of Pediatrics, Faculty of Medicine and Health Science, Hospital Universitari Sant Joan de Reus, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Barroso', 'Affiliation': 'Unit of Pediatrics, Faculty of Medicine and Health Science, Hospital Universitari Sant Joan de Reus, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Ribot', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Faculty of Medicine and Health Science, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Arija', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Faculty of Medicine and Health Science, Universitat Rovira i Virgili, Reus, Spain. victoria.arija@urv.cat.'}]",BMC pediatrics,['10.1186/s12887-019-1679-0']
1744,30236776,Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.,"BACKGROUND


Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment.
METHODS


This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies.
DISCUSSION


The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination.
TRIAL REGISTRATION NUMBER


NCT03326713; clinicaltrials.gov.",2018,Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries.,"['hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors', 'Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries', 'hereditary breast and ovarian cancer (HBOC']","['targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC', 'guideline-based cancer genetic risk assessment']",['genetic counseling uptake'],"[{'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}]","[{'cui': 'C0017382', 'cui_str': 'Genetic Counseling'}]",,0.181131,Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries.,"[{'ForeName': 'Anita Y', 'Initials': 'AY', 'LastName': 'Kinney', 'Affiliation': 'Department of Epidemiology, School of Public Health, Rutgers University, New Brunswick, Jersey; Cancer Institute of New Jersey, Rutgers University, New Brunswick, Jersey. Electronic address: anita.kinney@rutgers.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Howell', 'Affiliation': 'Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ruckman', 'Affiliation': 'Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'McDougall', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, Mexico; Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Tawny W', 'Initials': 'TW', 'LastName': 'Boyce', 'Affiliation': 'Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Vicuña', 'Affiliation': 'Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico; Department of Psychology, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, Mexico; Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Dolores D', 'Initials': 'DD', 'LastName': 'Guest', 'Affiliation': 'Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Rycroft', 'Affiliation': 'Colorado Central Cancer Registry, Colorado Department of Public Health and Environment, Denver, CO, United States.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Valverde', 'Affiliation': 'Colorado School of Public Health, University of Colorado, Aurora, CO, United States.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Gallegos', 'Affiliation': 'Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Meisner', 'Affiliation': 'New Mexico Tumor Registry, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Wiggins', 'Affiliation': 'Department of Internal Medicine, University of New Mexico, Albuquerque, Mexico; Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico; New Mexico Tumor Registry, University of New Mexico, Albuquerque, Mexico.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Stroup', 'Affiliation': 'Department of Epidemiology, School of Public Health, Rutgers University, New Brunswick, Jersey; Cancer Institute of New Jersey, Rutgers University, New Brunswick, Jersey.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Paddock', 'Affiliation': 'Department of Epidemiology, School of Public Health, Rutgers University, New Brunswick, Jersey; Cancer Institute of New Jersey, Rutgers University, New Brunswick, Jersey.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Walters', 'Affiliation': 'Department of Health Behavior and Health Systems, University of North Texas Health Science Center, School of Public Health, Fort Worth, TX, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.005']
1745,30442772,Mirtazapine added to SSRIs or SNRIs for treatment resistant depression in primary care: phase III randomised placebo controlled trial (MIR).,,2018,,[],"['Mirtazapine added to SSRIs or SNRIs', 'placebo']",[],[],"[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.154601,,[],BMJ (Clinical research ed.),['10.1136/bmj.k4691']
1746,31713241,Is Placebo Response Responsible for Many Phase III Failures?,,2019,,[],[],[],[],[],[],,0.0358252,,"[{'ForeName': 'Teodora Pene', 'Initials': 'TP', 'LastName': 'Dumitrescu', 'Affiliation': 'Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Durham, North Carolina, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'McCune', 'Affiliation': 'Department of Population Sciences, Beckman Research Institute/City of Hope, Duarte, California, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Schmith', 'Affiliation': 'Nuventra Pharma Sciences, Cocoa Beach, Florida, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1632']
1747,31919898,"RE: Aliuskevicius M, Ostgaard SE, Hauge EM, et al. 2019. Influence of ibuprofen on bone healing after Colles' fracture: A randomized controlled clinical trial.",,2020,,"[""after Colles' fracture""]",['ibuprofen'],['bone healing'],"[{'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",,0.051282,,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Starlinger', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Balls-Berry', 'Affiliation': 'Department of Education, Mayo Clinic Rochester, Rochester, Minnesota.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Amadio', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Rochester, Rochester, Minnesota.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24582']
1748,31514168,"Effect of Drop Height on Vertical Jumping Performance in Pre-, Circa-, and Post-Pubertal Boys and Girls.","PURPOSE


To examine the effect of drop height on vertical jumping performance in children with respect to sex and maturity status.
METHODS


Thirty-seven pre-pubertal, 71 circa-pubertal, and 69 post-pubertal boys and girls performed, in a randomized order, 2 squat jumps, 2 countermovement jumps, and 2 drop jumps (DJ) from heights of 20, 30, 40, 50, 60, and 70 cm. The trial with the best jump height in each test was used for analysis.
RESULTS


No significant sex × maturity status × jump type interaction for jump height was observed. However, on average, the children jumped higher in the countermovement jump than in squat jump and DJs (+1.2 and +1.6 cm, P < .001, respectively), with no significant differences between DJs and squat jumps or between DJs when increasing drop heights. Regarding DJs, 59.3% of the participants jumped higher from drop heights of 20 to 40 cm.
CONCLUSIONS


Children, independent of sex and maturity status, performed best in the countermovement jump, and no performance gain was obtained by dropping from heights of 20 to 70 cm. During maturation, the use of drop heights between 20 and 40 cm may be considered in plyometric training, but the optimum height must be obtained individually.",2020,"However, on average, the children jumped higher in the countermovement jump than in squat jump and DJs (+1.2 and +1.6 cm, P < .001, respectively), with no significant differences between DJs and squat jumps or between DJs when increasing drop heights.","['69 post-pubertal boys and girls', 'Pre-, Circa-, and Post-Pubertal Boys and Girls', 'children with respect to sex and maturity status', 'Thirty-seven pre-pubertal, 71 circa-pubertal, and']",['Drop Height'],['performance gain'],"[{'cui': 'C1626404', 'cui_str': 'Post-pubertal'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}]","[{'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]",[],37.0,0.0389517,"However, on average, the children jumped higher in the countermovement jump than in squat jump and DJs (+1.2 and +1.6 cm, P < .001, respectively), with no significant differences between DJs and squat jumps or between DJs when increasing drop heights.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Birat', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebillaud', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bourdier', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Doré', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': 'Université Clermont Auvergne.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Edith Cowan University.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Patikas', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Ratel', 'Affiliation': 'Université Clermont Auvergne.'}]",Pediatric exercise science,['10.1123/pes.2019-0120']
1749,32129196,Comparison of the effect of linear and step-wise sodium and ultrafiltration profiling on dialysis adequacy in patients undergoing hemodialysis.,"Patients with chronic renal failure undergoing hemodialysis (HD) need to receive adequate dialysis. Dialysis inadequacy leads to an increase in the side effects and even frequent hospitalizations as well as increased therapeutic costs. Considering the fact that improving the adequacy of dialysis is one of the goals of nursing care in these patients, this study aimed to compare the effect of linear and step-wise sodium-ultrafiltration (UF) profiling on HD adequacy. This study is a clinical trial; a total of 32 patients from two dialysis centers in East Azerbaijan province were selected and randomly divided into two groups. Each patient underwent HD for three sessions by routine method, three sessions by linear sodium profile and UF, and three sessions by the step-wise sodium profile and UF. At the end of each HD method, Kt/V was calculated to determine the adequacy of dialysis. Data analysis was performed using Statistical Package for the Social Sciences software version 13 with generalized estimating equation statistical test. According to the results of this study, there was a statistically significant difference between the mean of adequacy of dialysis (Kt/V) in the three treatment methods (P <0.05), in which the mean score of dialysis adequacy in step-wise method was 0.14 more than the routine method, and in the linear method, it was 0.21 more than the routine method. The mean Kt/V scores were 1.24, 1.31, and 1.10 in the step-wise method, linear method, and routine method, respectively(P <0.05). The results of this study indicate that simultaneous application of sodium and UF profiles is effective in the hemodynamic stability of patients, which reduces uncomfortable complications during dialysis. Therefore, in order to improve dialysis adequacy and prevent the complications, usage of sodium and UF profiles is recommended.",2020,"The mean Kt/V scores were 1.24, 1.31, and 1.10 in the step-wise method, linear method, and routine method, respectively(P <0.05).","['Patients with chronic renal failure undergoing hemodialysis (HD', '32 patients from two dialysis centers in East Azerbaijan province', 'patients undergoing hemodialysis']","['adequate dialysis', 'linear and step-wise sodium and ultrafiltration profiling']","['mean Kt/V scores', 'side effects', 'mean of adequacy of dialysis (Kt/V', 'mean score of dialysis adequacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004486', 'cui_str': 'Azerbaijan SSR'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0429660', 'cui_str': 'Adequacy of dialysis (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",32.0,0.0160805,"The mean Kt/V scores were 1.24, 1.31, and 1.10 in the step-wise method, linear method, and routine method, respectively(P <0.05).","[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Hamidi', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Tabriz, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Roshangar', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Tabriz, Iran.'}, {'ForeName': 'Hamid Tayebi', 'Initials': 'HT', 'LastName': 'Khosroshahi', 'Affiliation': 'Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hassankhani', 'Initials': 'H', 'LastName': 'Hadi', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Tabriz, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Ghafourifard', 'Affiliation': 'Department of Medical Surgical Nursing, Faculty of Nursing and Midwifery, Tabriz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]","Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia",['10.4103/1319-2442.279960']
1750,31509796,Yoga Practices as an Alternative Training for Physical Fitness in Children With Visual Impairment.,"Physical activities provide fundamental benefits to children's health and well-being. They are vital for development and healthy life, but participation of children with visual impairment is limited. Herein, the authors report results of a 16-wk yoga program, evaluating its effects on physical fitness in children with visual impairment. Eighty-three children age 9-16 years (12.37 ± 2.19) participated in a 2-arm, single-blind wait-list-controlled study at a residential school in south India. Participants (yoga group 41, controls 42) were assessed on muscle strength, flexibility, endurance, coordination, and respiratory health. Significant improvements in physical fitness were observed after the yoga intervention (Group × Time interactions for right-hand grip strength, p < .001; sit-up, p < .001; sit and reach, p < .001; bilateral plate tapping, p < .001; and peak expiratory flow rate, p < .001). Left-hand grip strength showed main effects of time, although there were no Group × Time interactions. Results demonstrate yoga's ability to improve a wide range of physical variables in children with visual impairment.",2019,"Significant improvements in physical fitness were observed after the yoga intervention (Group × Time interactions for right-hand grip strength, p < .001; sit-up, p < .001; sit and reach, p < .001; bilateral plate tapping, p < .001; and peak expiratory flow rate, p < .001).","['children with visual impairment', 'Children With Visual Impairment', 'Eighty-three children age 9-16 years (12.37 ± 2.19) participated in a 2-arm, single-blind wait-list-controlled study at a residential school in south India']",[],"['muscle strength, flexibility, endurance, coordination, and respiratory health', 'physical fitness', 'peak expiratory flow rate', 'bilateral plate tapping']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}]",83.0,0.0374061,"Significant improvements in physical fitness were observed after the yoga intervention (Group × Time interactions for right-hand grip strength, p < .001; sit-up, p < .001; sit and reach, p < .001; bilateral plate tapping, p < .001; and peak expiratory flow rate, p < .001).","[{'ForeName': 'Soubhagyalaxmi', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'SVYASA.'}, {'ForeName': 'Balaram', 'Initials': 'B', 'LastName': 'Pradhan', 'Affiliation': 'SVYASA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hankey', 'Affiliation': 'SVYASA.'}]",Adapted physical activity quarterly : APAQ,['10.1123/apaq.2018-0167']
1751,31519550,Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial.,"BACKGROUND AND OBJECTIVES


The short-term effects of low-phosphate diets on fibroblast growth factor 23 (FGF23) level and the optimal amount of dietary phosphate restriction in patients undergoing hemodialysis remain unknown.
DESIGN SETTING, PARTICIPANTS, & MEASUREMENTS


This was a randomized, active-controlled trial with a crossover design that included 35 adults with ESKD undergoing thrice-weekly hemodialysis and with a serum phosphate level >5.5 mg/dl or between 3.5 and 5.5 mg/dl with regular phosphate binder use at a hemodialysis unit of tertiary teaching hospital in Taiwan. Subjects were randomized 1:1 to receive a very-low-phosphate diet, with a phosphate-to-protein ratio of 8 mg/g, or a low-phosphate diet, with a phosphate-to-protein ratio of 10 mg/g for 2 days, each with a 5-day washout during which subjects adhered to their usual diet. The primary outcome measure was mean difference in change-from-baseline intact FGF23 level between intervention groups. Secondary outcomes included difference in change-from-baseline serum phosphate, intact parathyroid hormone (PTH), and C-terminal FGF23 level between intervention groups.
RESULTS


There was no significant difference in the mean change-from-baseline in intact FGF23 levels between the two study diets. The very-low-phosphate diet significantly lowered serum phosphate (mean difference, 0.6 mg/dl; 95% confidence interval [95% CI], 0.2 to 1.0;  P =0.002). There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
CONCLUSIONS


Over the 2-day period, the FGF23-lowering effect of the very-low-phosphate diet is similar to that of the low-phosphate diet. The very-low-phosphate diet has an additional phosphate-lowering effect compared with the low-phosphate diet.",2019,"There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
","['Hemodialysis Patients', '35 adults with ESKD undergoing thrice-weekly hemodialysis and with a serum phosphate level >5.5 mg/dl or between 3.5 and 5.5 mg/dl with regular phosphate binder use at a hemodialysis unit of tertiary teaching hospital in Taiwan', 'patients undergoing hemodialysis remain unknown']","['Very-Low-Phosphate and Low-Phosphate Diets', 'low-phosphate diets', 'very-low-phosphate diet, with a phosphate-to-protein ratio of 8 mg/g, or a low-phosphate diet, with a phosphate-to-protein ratio']","['mean difference in change-from-baseline intact FGF23 level', 'intact FGF23 levels', 'serum phosphate', 'change-from-baseline serum phosphate, intact parathyroid hormone (PTH), and C-terminal FGF23 level', 'Fibroblast Growth Factor 23', 'change-from-baseline intact PTH and C-terminal FGF23 levels', 'fibroblast growth factor 23 (FGF23) level']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0452351', 'cui_str': 'Low phosphate diet (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",35.0,0.035397,"There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
","[{'ForeName': 'Wan-Chuan', 'Initials': 'WC', 'LastName': 'Tsai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, klchien@ntu.edu.tw mia23448@gmail.com.'}, {'ForeName': 'Hon-Yen', 'Initials': 'HY', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Yu-Sen', 'Initials': 'YS', 'LastName': 'Peng', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Shih-Ping', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Yen-Ling', 'Initials': 'YL', 'LastName': 'Chiu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Ju-Yeh', 'Initials': 'JY', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Hung-Yuan', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Mei-Fen', 'Initials': 'MF', 'LastName': 'Pai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Wan-Yu', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Kuan-Yu', 'Initials': 'KY', 'LastName': 'Hung', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Fang-Yeh', 'Initials': 'FY', 'LastName': 'Chu', 'Affiliation': 'Department of Clinical Pathology, and.'}, {'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Tsai', 'Affiliation': 'Dietary Department, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Kuo-Liong', 'Initials': 'KL', 'LastName': 'Chien', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei City, Taiwan; klchien@ntu.edu.tw mia23448@gmail.com.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.04250419']
1752,31515667,A prospective phase I multicentre randomized cross-over pharmacokinetic study to determine the effect of food on abiraterone pharmacokinetics.,"PURPOSE


Abiraterone acetate is used at a fixed oral dose of 1000 mg once daily (OD) taken fasted. By administering abiraterone acetate with food, a reduced dose can potentially be given while maintaining equivalent abiraterone exposure. Moreover, administering abiraterone acetate with a breakfast is considered more patient friendly. The aim of this study was to establish the bio-equivalent lower dose of abiraterone when taken with a continental breakfast (CB) compared to the standard intake of 1000 mg OD fasted.
METHODS


In this phase I, randomized cross-over, multi-center study, abiraterone pharmacokinetics (PK) were evaluated in patients with metastatic castration-resistant prostate cancer who were treated for 14 days with 1000 mg abiraterone acetate taken fasted, followed by 14 days of treatment with 500 mg taken with a CB.
RESULTS


14 patients were enrolled into the study, of whom 12 were eligible for PK analysis. The geometric mean ratio (GMR) (fed/fasted) was 0.88 (90% CI 0.73-1.07) for area-under-the-curve (AUC 0-24h ), 1.03 (90% CI 0.79-1.34) for C max  and 0.81 (90% CI 0.60-1.10) for C trough , respectively. High inter-patient variability (> 50%) was found for all PK parameters under both intake conditions. Patients seemed to be slightly more satisfied about the intake of 500 mg abiraterone acetate when taken with a CB compared to 1000 mg fasted.
CONCLUSION


In conclusion, a bioequivalent lower dose of abiraterone taken with food could not be established in our study. Although based on the absence of a exposure-toxicity relationship, the strict bioequivalence margins as defined by the FDA guidelines could be applied more flexible for abiraterone. Information on the effect of food on abiraterone pharmacokinetics as presented in our study can be used for patients with difficulties taken their medication fasted.",2019,The geometric mean ratio (GMR) (fed/fasted) was 0.88,"['patients with difficulties taken their medication fasted', '14 patients were enrolled into the study, of whom 12 were eligible for PK analysis', 'patients with metastatic castration-resistant prostate cancer who were treated for 14\xa0days with 1000\xa0mg']","['continental breakfast (CB', 'Abiraterone acetate', 'abiraterone acetate', 'abiraterone pharmacokinetics (PK', 'abiraterone']",['geometric mean ratio (GMR'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C1290952', 'cui_str': 'Taking medication (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0736296,The geometric mean ratio (GMR) (fed/fasted) was 0.88,"[{'ForeName': 'Floor J E', 'Initials': 'FJE', 'LastName': 'Lubberman', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Guillemette E', 'Initials': 'GE', 'LastName': 'Benoist', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Winald', 'Initials': 'W', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hamberg', 'Affiliation': 'Department of Medical Oncology, Franciscus Gasthuis and Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'van Oort', 'Affiliation': 'Department of Urology, Radboud Institute for Health Sciences, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Nielka P', 'Initials': 'NP', 'LastName': 'van Erp', 'Affiliation': 'Department of Pharmacy (864), Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. nielka.vanerp@radboudumc.nl.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-03952-w']
1753,31845141,Laparoscopic Versus Open Emergent Sigmoid Resection for Perforated Diverticulitis.,"BACKGROUND


Potential advantages of laparoscopic sigmoidectomy for perforated diverticulitis are still under consideration. This study is designed to determine if emergent laparoscopic sigmoidectomy for perforated diverticulitis is associated with outcomes comparable to the traditional open approach.
METHODS


The American College of Surgeons-National-Surgical-Quality-Improvement-Program (ACS-NSQIP) database was queried for laparoscopic and open emergent sigmoidectomy cases for perforated diverticulitis from 2012 through 2017. Using propensity score weights, 30-day outcomes between laparoscopic and open approaches were compared in two ways: one with converted cases as a separate group and another with converted cases combined with the laparoscopic-completed group (intention-to-treat).
RESULTS


A total of 3756 cases met inclusion criteria-282 laparoscopic-completed, 175 laparoscopic-converted-to-open, and 3299 open. The laparoscopic-completed approach had significantly better outcomes than open and laparoscopic-converted cases. When combining laparoscopic-completed and laparoscopic-converted cases (intention-to-treat), the laparoscopic approach still had significantly fewer complications per patient, less unplanned intubation (p = 0.01), and acute renal failure (p = 0.005) than the open group. Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group. Subgroup analysis comparing laparoscopic and open Hartmann's procedure and primary anastomosis with and without diverting stoma also showed favorable outcomes for the laparoscopic group.
CONCLUSIONS


Laparoscopic emergent sigmoid resection for perforated diverticulitis is associated with favorable outcomes compared to the open approach. Hartmann's procedure is still common and conversion rate is high. Training efforts that increase adoption of minimally invasive surgery and decrease conversion rates are justified. Randomized trials comparing laparoscopic and open approaches may allow further critical assessment of these findings.",2020,Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group.,"['The American College of Surgeons-National-Surgical-Quality-Improvement-Program (ACS-NSQIP) database was queried for laparoscopic and open emergent sigmoidectomy cases for perforated diverticulitis from 2012 through 2017', '3756 cases met inclusion criteria-282 laparoscopic-completed, 175 laparoscopic-converted-to-open, and 3299 open']","['Laparoscopic', 'Laparoscopic emergent sigmoid resection', 'laparoscopic-completed group (intention-to-treat', 'Laparoscopic Versus Open Emergent Sigmoid Resection', ""laparoscopic and open Hartmann's procedure and primary anastomosis with and without diverting stoma"", 'laparoscopic sigmoidectomy', 'laparoscopic']","['unplanned intubation', 'longer operating times and shorter hospital length of stay', 'acute renal failure']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy (procedure)'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}]",175.0,0.0810537,Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group.,"[{'ForeName': 'Yongjin F', 'Initials': 'YF', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, St Joseph Mercy Hospital, 4201 Varsity Dr suite a, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, St Joseph Mercy Hospital, 4201 Varsity Dr suite a, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Battaglia', 'Affiliation': 'Biostatistics and Epidemiology Methods Consulting, BEMC, LLC, Ann Arbor, MI, 48108, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Cleary', 'Affiliation': 'Department of Surgery, St Joseph Mercy Hospital, 4201 Varsity Dr suite a, Ann Arbor, MI, 48108, USA. Robert.Cleary@stjoeshealth.org.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04490-9']
1754,31760494,Evidence for and Against ACC/AHA 2017 Guideline for Target Systolic Blood Pressure of < 130 mmHg in Persons with Type 2 Diabetes.,"PURPOSE OF REVIEW


We summarize the evidence for and against a target systolic blood pressure (SBP) < 130 mmHg in individuals with type 2 diabetes mellitus (T2DM).
RECENT FINDINGS


The primary ACCORD trial pooled data from patients with more- and less-intense glycemic control and found no benefit to lowering SBP < 140 mmHg, findings consistent with multiple meta-analyses. However, a re-analysis of the ACCORD trial found that participants randomized to less-intense glycemic control (HbA1c 7.0-7.9%) benefited from targeting SBP < 120 vs. 140 mmHg. The SPRINT trial also found benefit for targeting SBP < 120 vs. 140 mmHg in participants at risk for cardiovascular events but excluded persons with T2DM. There is no consensus as to the optimal SBP target for patients with T2DM, though data suggest a benefit to targeting SBP < 130 mmHg in patients with less-intensive glucose control. Further research is also needed on BP control in the setting of newer anti-diabetic agents.",2019,The SPRINT trial also found benefit for targeting SBP < 120 vs. 140 mmHg in participants at risk for cardiovascular events but excluded persons with T2DM.,"['Persons with Type 2 Diabetes', 'individuals with type 2 diabetes mellitus (T2DM']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],[],,0.0252623,The SPRINT trial also found benefit for targeting SBP < 120 vs. 140 mmHg in participants at risk for cardiovascular events but excluded persons with T2DM.,"[{'ForeName': 'Jenny I', 'Initials': 'JI', 'LastName': 'Shen', 'Affiliation': 'Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1000 W. Carson St., Box 406, Torrance, CA, 90509, USA. jshen@labiomed.org.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Nicholas', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Providence St. Joseph Health, Los Angeles, CA, USA.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Norris', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]",Current cardiology reports,['10.1007/s11886-019-1251-4']
1755,32040960,"Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.","Background


Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT).
Objective


To determine the safety and efficacy of Triplex.
Design


First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933).
Setting


3 U.S. HCT centers.
Participants


102 CMV-seropositive HCT recipients at high risk for CMV reactivation.
Intervention


Intramuscular injections of Triplex or placebo were given on days 28 and 56 after HCT. Triplex is a recombinant attenuated poxvirus (modified vaccinia Ankara) expressing immunodominant CMV antigens.
Measurements


The primary outcomes were CMV events (CMV DNA level ≥1250 IU/mL, CMV viremia requiring antiviral treatment, or end-organ disease), nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD), all evaluated through 100 days after HCT, and grade 3 or 4 adverse events (AEs) within 2 weeks after vaccination that were probably or definitely attributable to injection.
Results


A total of 102 patients (51 per group) received the first vaccination, and 91 (89.2%) received both vaccinations (46 Triplex and 45 placebo). Reactivation of CMV occurred in 5 Triplex (9.8%) and 10 placebo (19.6%) recipients (hazard ratio, 0.46 [95% CI, 0.16 to 1.4]; P = 0.075). No Triplex recipient died of nonrelapse causes during the first 100 days or had serious AEs, and no grade 3 or 4 AEs related to vaccination were observed within 2 weeks after vaccination. Incidence of severe acute GVHD after injection was similar between groups (hazard ratio, 1.1 [CI, 0.53 to 2.4]; P = 0.23). Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
Limitation


The lower-than-expected incidence of CMV events in the placebo group reduced the power of the trial.
Conclusion


No vaccine-associated safety concerns were identified. Triplex elicited and amplified CMV-specific immune responses, and fewer Triplex-vaccinated patients had CMV viremia.
Primary Funding Source


National Cancer Institute and Helocyte.",2020,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","['≥1250', 'Participants\n\n\n102 CMV-seropositive HCT recipients at high risk for CMV reactivation', 'Transplant Recipients', '102 patients (51 per group) received the first vaccination, and 91 (89.2%) received']","['Poxvirus Vectored Cytomegalovirus Vaccine', 'placebo', 'Triplex or placebo', 'both vaccinations (46 Triplex and 45 placebo']","['Cytomegalovirus Viremia', 'CMV events (CMV DNA level', 'Incidence of severe acute GVHD', 'Levels of long-lasting, pp65-specific T cells with effector memory phenotype', 'nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD', 'CMV events', 'cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation', 'Triplex elicited and amplified CMV-specific immune responses', 'Reactivation of CMV']","[{'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviruses'}, {'cui': 'C0887903', 'cui_str': 'Cytomegalovirus Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",102.0,0.529622,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Aldoss', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Longmate', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Ariza-Heredia', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas (E.J.A.).'}, {'ForeName': 'Wasima N', 'Initials': 'WN', 'LastName': 'Rida', 'Affiliation': 'Biostatistics Consultant, Arlington, Virginia (W.N.R.).'}, {'ForeName': 'Chetan Raj', 'Initials': 'CR', 'LastName': 'Lingaraju', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Kaltcheva', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Dagis', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Hardwick', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicolas C', 'Initials': 'NC', 'LastName': 'Issa', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Farol', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Auayporn', 'Initials': 'A', 'LastName': 'Nademanee', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Monzr M', 'Initials': 'MM', 'LastName': 'Al Malki', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Don J', 'Initials': 'DJ', 'LastName': 'Diamond', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2511']
1756,31322672,Exercise Mitigates Bone Loss in Women With Severe Obesity After Roux-en-Y Gastric Bypass: A Randomized Controlled Trial.,"CONTEXT


Bone loss after bariatric surgery potentially could be mitigated by exercise.
OBJECTIVE


To investigate the role of exercise training (ET) in attenuating bariatric surgery-induced bone loss.
DESIGN


Randomized, controlled trial.
SETTING


Referral center for bariatric surgery.
PATIENTS


Seventy women with severe obesity, aged 25 to 55 years, who underwent Roux-en-Y gastric bypass (RYGB).
INTERVENTION


Supervised, 6-month, ET program after RYGB vs. standard of care (RYGB only).
OUTCOMES


Areal bone mineral density (aBMD) was the primary outcome. Bone microarchitecture, bone turnover, and biochemical markers were secondary outcomes.
RESULTS


Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P < 0.001); and increased bone turnover markers, including collagen type I C-telopeptide (CTX), procollagen type I N-propeptide (P1NP), sclerostin, and osteopontin (P < 0.05). Compared with RYGB only, exercise mitigated the percent loss of aBMD at femoral neck [estimated mean difference (EMD), -2.91%; P = 0.007;], total hip (EMD, -2.26%; P = 0.009), distal radius (EMD, -1.87%; P = 0.038), and cortical volumetric bone mineral density at distal radius (EMD, -2.09%; P = 0.024). Exercise also attenuated CTX (EMD, -0.20 ng/mL; P = 0.002), P1NP (EMD, -17.59 ng/mL; P = 0.024), and sclerostin levels (EMD, -610 pg/mL; P = 0.046) in comparison with RYGB. Exercise did not affect biochemical markers (e.g., 25(OH)D, calcium, intact PTH, phosphorus, and magnesium).
CONCLUSION


Exercise mitigated bariatric surgery-induced bone loss, possibly through mechanisms involving suppression in bone turnover and sclerostin. Exercise should be incorporated in postsurgery care to preserve bone mass.",2019,"RESULTS


Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P<.001).","['Seventy women with severe obesity aged 25-55 years', 'women with severe obesity after Roux-en-Y gastric bypass', 'Referral center for bariatric surgery (Clinical Hospital, Sao Paulo, Brazil']","['exercise training', 'exercise training program (RYGB+ET) vs. standard of care (RYGB']","['Exercise mitigates bone loss', 'Bone microarchitecture, bone turnover and biochemical markers', 'femoral neck, total hip, distal radius, and whole body aBMD', 'total hip', 'sclerostin levels', 'cortical volumetric bone mineral density', 'biochemical markers (e.g., 25(OH)D, calcium, iPTH, phosphorus, and magnesium', 'distal radius', 'percent loss of aBMD at femoral neck', 'Areal bone mineral density (aBMD', 'bone turnover markers, including CTX, P1NP, sclerostin, and osteopontin (P<.05']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}]",70.0,0.0887808,"RESULTS


Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P<.001).","[{'ForeName': 'Igor H', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Gastroenterology Department, Digestive Surgery Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Lima', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Gastroenterology Department, Digestive Surgery Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Metabolism Group, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00074']
1757,31507088,Integrated provision of topical pre-exposure prophylaxis in routine family planning services in South Africa: a non-inferiority randomized controlled trial.,"INTRODUCTION


Tenofovir-containing oral pre-exposure prophylaxis (PrEP) is recommended for those at substantial risk as part of combination HIV prevention. However, there are limited data, beyond clinical trial settings, to guide the introduction of PrEP in healthcare services with adequate levels of adherence. Since young women in Africa are at high risk of HIV and likely to utilize family planning (FP) services, the feasibility, acceptability and effectiveness of integrating topical PrEP provision into routine FP services was assessed.
METHODS


This two-arm, randomized controlled, non-inferiority, open-label extension trial was undertaken in urban and rural KwaZulu-Natal, South Africa. HIV-negative eligible women (n = 372) from the parent trial (Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004) were randomized to receive tenofovir gel either through intervention (FP clinics, n = 189) or control clinics (CAPRISA research clinics, n = 183). Non-inferiority was predefined as gel use in the intervention clinics would be no more than 20% lower than in the control clinics. Adherence, retention and HIV incidence rates were assessed.
RESULTS


Women were enrolled between November 2012 and October 2014, and followed up for 682.3 women-years (mean = 22 months). Baseline characteristics of women in intervention and control clinics were comparable and retention rates were 92.1% and 92.3% respectively. Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of -0.47 (CI: -1.16 to 0.21). Per-protocol estimates were on average 5.5 (CI: 5.0 to 6.1) and 5.8 (CI: 5.3 to 6.3) respectively, with a mean difference of -0.25 (CI: -0.98 to 0.48), meeting the non-inferiority criteria. Adherence, based on proportion of reported sex acts covered by two gel doses, was 79.9% (CI: 76.7 to 83.2) in intervention compared with 73.9% (CI: 70.7 to 77.1) in control clinics; mean difference:6.0% (CI: 1.5 to 10.6) (p = 0.009). HIV incidence rates were 3.5 (CI: 1.8 to 6.0) and 3.6 (CI: 1.9 to 6.3) per 100 women-years in intervention and control clinics respectively. Both these incidence rates were lower than the age-standardized rate of 6.2 per 100 women-years (n = 444) in the placebo arm of the parent trial (p = 0.019).
CONCLUSIONS


Provision of topical PrEP as part of an integrated FP service achieved higher adherence, and was as feasible, acceptable and effective in preventing HIV as provision through a research setting. This provides useful evidence for scale-up of oral PrEP in urban and rural high burden communities.",2019,"Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of -0.47 (CI: -1.16 to 0.21).","['HIV-negative eligible women (n\xa0=\xa0372) from the parent trial (Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004', 'routine family planning services in South Africa', 'urban and rural high burden communities', 'urban and rural KwaZulu-Natal, South Africa', 'Women were enrolled between November 2012 and October 2014, and followed up for 682.3 women-years (mean\xa0=\xa022\xa0months']","['placebo', 'Tenofovir-containing oral pre-exposure prophylaxis (PrEP', 'tenofovir gel either through intervention (FP clinics, n\xa0=\xa0189) or control clinics (CAPRISA research clinics', 'topical pre-exposure prophylaxis']","['retention rates', 'incidence rates', 'HIV incidence rates', 'Adherence, retention and HIV incidence rates']","[{'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.327364,"Women in intervention clinics and control clinics returned on average 5.2 (95% confidence interval (CI): 4.7 to 5.7) and 5.7 (CI: 5.2 to 6.2) used gel applicators per month respectively, with a mean difference of -0.47 (CI: -1.16 to 0.21).","[{'ForeName': 'Leila E', 'Initials': 'LE', 'LastName': 'Mansoor', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Yende-Zuma', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Baxter', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Mngadi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Tanuja N', 'Initials': 'TN', 'LastName': 'Gengiah', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Samsunder', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Arlington, VA, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'Eastern Virginia Medical School, CONRAD, Arlington, VA, USA.'}, {'ForeName': 'Quarraisha', 'Initials': 'Q', 'LastName': 'Abdool Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25381']
1758,30109552,"Correction to: Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study.",The author would like to correct the errors in the publication of the original article due to multiple small errors in scientific content of article due to author oversight. Errors do not change or invalidate conclusion of article.,2019,The author would like to correct the errors in the publication of the original article due to multiple small errors in scientific content of article due to author oversight.,[],"['robot-assisted radical prostatectomy', 'Ultrasound-guided transversus abdominis plane block (US-TAPb']",[],[],"[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0167914', 'cui_str': 'TAPB-H'}]",[],,0.0128344,The author would like to correct the errors in the publication of the original article due to multiple small errors in scientific content of article due to author oversight.,"[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Dal Moro', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology-Urology, University of Padova, Via Giustiniani 2, 35128, Padova, Italy. fabrizio.dalmoro@unipd.it.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aiello', 'Affiliation': 'Department of Anesthesiology, Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Pavarin', 'Affiliation': 'Department of Anesthesiology, Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Zattoni', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology-Urology, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.'}]",Journal of robotic surgery,['10.1007/s11701-018-0861-y']
1759,31509359,"Early Stabilization of Weight Changes Following Treatment With Olanzapine, Risperidone, and Aripiprazole: A 12-Month Naturalistic Study of First Episode Psychosis.","OBJECTIVE


The study objective was to examine whether and when antipsychotic-induced weight gain in first episode psychosis (FEP) stabilizes over a 12-month exposure to the same antipsychotic in a sample of previously untreated FEP patients.
METHODS


In this prospective naturalistic outcome study, 109 patients diagnosed with non-affective or affective psychosis (DSM-IV) were treated with the same antipsychotic medication (olanzapine n = 45, risperidone n = 39, or aripiprazole n = 25) throughout the first year of treatment. Body weight was measured and body mass index calculated at baseline and 1, 2, 3, 6, 9, and 12 months. Additional weight data over the second year were available, making extending the comparison for a second year possible.
RESULTS


Linear mixed model analysis showed a significant main effect of time (Type III test P < .001) after adjusting for baseline weight values. Post hoc pairwise comparisons showed that incremental weight changes subsequent to month 6 were insignificant, suggesting weight stabilization by month 9. No significant difference (P = .243) between groups or time × group interaction (P = .111) was observed. Similar findings were obtained with BMI. A follow-up analysis, of a subsample who continued treatment with the same antipsychotic for an additional 12 months (n = 57), confirmed weight stabilization in the second year. There was no significant main effect of time (P = .641), group (P = .539), or time × group interaction (P = .250).
CONCLUSIONS


Antipsychotic-induced weight gain occurs mostly in the first few months of treatment. Preventive interventions concurrent to second-generation antipsychotic treatment initiation in medication-naive FEP patients might be warranted.",2019,"There was no significant main effect of time (P = .641), group (P = .539), or time × group interaction (P = .250).
","['medication-naive FEP patients', '109 patients diagnosed with non-affective or affective psychosis (DSM-IV']","['antipsychotic-induced weight gain', 'Olanzapine, Risperidone, and Aripiprazole', 'antipsychotic medication (olanzapine n = 45, risperidone n = 39, or aripiprazole']","['Body weight', 'weight gain', 'Weight Changes', 'weight stabilization']","[{'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001723', 'cui_str': 'Psychoses, Affective'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",109.0,0.019861,"There was no significant main effect of time (P = .641), group (P = .539), or time × group interaction (P = .250).
","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Mustafa', 'Affiliation': 'Douglas Institute, Montréal, Quebec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Institute, Montréal, Quebec, Canada.'}, {'ForeName': 'Srividya', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'Douglas Institute, Montréal, Quebec, Canada.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Douglas Institute, Montréal, Quebec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lepage', 'Affiliation': 'Douglas Institute, Montréal, Quebec, Canada.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Malla', 'Affiliation': '6625, boulevard LaSalle, Montréal, QC, H4H 1R3, Canada. ashok.malla@mcgill.ca.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12717']
1760,31345677,Multiple vs Single Target Vegetable Exposure to Increase Young Children's Vegetable Intake.,"OBJECTIVE


To evaluate the effectiveness of repeated exposure to multiple vs single target vegetables in increasing young children's vegetable intake.
METHODS


A pilot randomized controlled trial (children aged 4-6 years, n = 32) was conducted, which exposed children at home 15 times over 5 weeks to either 1 (single target) or 3 (multiple target) vegetables. A comparison group did not change eating habits. Vegetable intake was measured by (1) a dinner meal consumed at research facilities, (2) 3-day weighed food records, and (3) usual vegetable intake (parent report). Measures were collected at baseline and either immediately after intervention (1), at 3-month follow-up (3) or both (2).
RESULTS


There were no differences between groups at baseline in vegetable intake. Usual vegetable intake increased in the multiple target group from .6 to 1.2 servings/d and did not change in other groups (P = .02). Food record data were not significant but underpowered. Vegetable intake from dinner meals was not significantly different between groups.
CONCLUSIONS AND IMPLICATIONS


Exposure to multiple vegetables simultaneously may be more effective than a single vegetable to increase young children's intake. Larger scale research is recommended to confirm the effectiveness of offering variety in exposure and to enhance the understanding of the mechanisms involved.",2019,Usual vegetable intake increased in the multiple target group from .6 to 1.2 servings/d and did not change in other groups (P = .02).,"[""young children's vegetable intake"", 'children aged 4-6 years, n\u202f=\u202f32']",['Multiple vs Single Target Vegetable Exposure'],"['change eating habits', 'vegetable intake', 'Vegetable intake', 'Usual vegetable intake']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1266864', 'cui_str': 'Eating habit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]",,0.0530548,Usual vegetable intake increased in the multiple target group from .6 to 1.2 servings/d and did not change in other groups (P = .02).,"[{'ForeName': 'Astrid A M', 'Initials': 'AAM', 'LastName': 'Poelman', 'Affiliation': 'CSIRO Agriculture & Food, Sensory, Flavour and Consumer Science, North Ryde, Australia; Wageningen University, Division of Human Nutrition,Wageningen, The Netherlands. Electronic address: astrid.poelman@csiro.au.'}, {'ForeName': 'Conor M', 'Initials': 'CM', 'LastName': 'Delahunty', 'Affiliation': 'CSIRO Agriculture & Food, Sensory, Flavour and Consumer Science, North Ryde, Australia.'}, {'ForeName': 'Maeva', 'Initials': 'M', 'LastName': 'Broch', 'Affiliation': 'CSIRO Agriculture & Food, Sensory, Flavour and Consumer Science, North Ryde, Australia.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Wageningen University, Division of Human Nutrition,Wageningen, The Netherlands.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.009']
1761,31421008,Changes in alpha-foetoprotein and Gc-globulin in relation to outcomes in non-acetaminophen acute liver failure.,"BACKGROUND


Changes in Gc-globulin (Gc) and in alpha-foetoprotein (AFP) have been shown to be related to outcome in patients with acute liver failure (ALF). Gc is a serum protein that complexes with intravascular actin released during cellular necrosis. AFP, also made by hepatocytes, is associated with hepatocellular growth and regeneration. Previously, low absolute levels or decreases over time in either AFP or Gc portended to be a poor outcome.
METHODS


In a retrospective analysis of the double-blind trial of intravenous N-acetylcysteine (NAC) for ALF not because of acetaminophen, sera on days 1 and 3 or days 2 and 4 following admission were available to measure AFP in 70 patients and Gc in 66 patients. Mann-Whitney U tests were performed on the admission values, the absolute change and the fractional change of AFP and Gc to compare TFS (transplant-free survival) and non-TFS (death or transplantation). Logistic regression and receiver operating characteristic (ROC) analyses were performed to evaluate the markers in comparison and in addition to King's College Criteria (KCC).
RESULTS


Transplant-free survival patients were characterized by increases in AFP, whereas non-TFS had significantly different (negative) absolute and fractional changes (P < .01). The addition of declining AFP levels to KCC improved the area under the curve in predicting non-TFS (AUC >70%). Gc globulin values did not differ between TFS and non-TFS in the 2-day intervals studied (P> .2).
CONCLUSION


In this comparison of two prognostic markers in patients with non-acetaminophen-induced ALF, rising AFP but not rising Gc levels was associated with TFS.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT00004467.",2019,"RESULTS


Transplant-free survival patients were characterized by increases in AFP, whereas non-TFS had significantly different (negative) absolute and fractional changes (P < .01).","['patients with acute liver failure (ALF', 'patients with non', 'non-acetaminophen acute liver failure', '70 patients and Gc in 66 patients']","['Gc-globulin (Gc) and in alpha-foetoprotein (AFP', 'acetaminophen', 'intravenous N-acetylcysteine (NAC']","['AFP', 'fractional change of AFP and Gc to compare TFS (transplant-free survival) and non-TFS (death or transplantation', 'Gc globulin values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162557', 'cui_str': 'Liver Failure, Fulminant'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0042872', 'cui_str': '25-HCC-Binding Protein'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0042872', 'cui_str': '25-HCC-Binding Protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",70.0,0.100023,"RESULTS


Transplant-free survival patients were characterized by increases in AFP, whereas non-TFS had significantly different (negative) absolute and fractional changes (P < .01).","[{'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Jody A', 'Initials': 'JA', 'LastName': 'Rule', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Lee', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14216']
1762,31387970,Financial Incentives to Promote Colorectal Cancer Screening: A Longitudinal Randomized Control Trial.,"BACKGROUND


Financial incentives may improve health behaviors. We tested the impact of offering financial incentives for mailed fecal immunochemical test (FIT) completion annually for 3 years.
METHODS


Patients, ages 50 to 64 years, not up-to-date with screening were randomized to receive either a mailed FIT outreach ( n  = 6,565), outreach plus $5 ( n  = 1,000), or $10 ( n  = 1,000) incentive for completion. Patients who completed the test were reinvited using the same incentive the following year, for 3 years. In year 4, patients who returned the kit in all preceding 3 years were reinvited without incentives. Primary outcome was FIT completion among patients offered any incentive versus outreach alone each year. Secondary outcomes were FIT completion for groups offered $5 versus outreach alone, $10 versus outreach alone, and $5 versus $10.
RESULTS


Year 1 FIT completion was 36.9% with incentives versus 36.2% outreach alone ( P  = 0.59) and was not statistically different for $10 (34.6%;  P  = 0.31) or $5 (39.2%;  P  = 0.070) versus outreach alone. Year 2 completion was 61.6% with incentives versus 60.8% outreach alone ( P  = 0.75) and not statistically different for $10 or $5 versus outreach alone. Year 3 completion was 79.4% with incentives versus 74.8% outreach alone ( P  = 0.080), and was higher for $10 (82.4%) versus outreach alone ( P  = 0.033), but not for $5 versus outreach alone. Completion was similar across conditions in year 4 (no incentives).
CONCLUSIONS


Offering small incentives did not increase FIT completion relative to standard outreach.
IMPACT


This was the first longitudinal study testing the impact of repeated financial incentives, and their withdrawal, on FIT completion.",2019,Year 2 completion was 61.6% with incentives vs. 60.8% outreach alone (P=0.75) and not statistically different for $10 or $5 vs. outreach alone.,"['In Year 4, patients who returned the kit in all preceding three years were re-invited without incentives', 'Colorectal Cancer Screening', 'Patients, aged 50-64 years, not up-to-date with screening']","['mailed FIT outreach (n=6,565), outreach plus $5 (n=1,000), or $10 (n=1,000) incentive for completion']",['FIT completion'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}]",,0.162109,Year 2 completion was 61.6% with incentives vs. 60.8% outreach alone (P=0.75) and not statistically different for $10 or $5 vs. outreach alone.,"[{'ForeName': 'Alicea', 'Initials': 'A', 'LastName': 'Lieberman', 'Affiliation': 'Rady School of Management, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Gneezy', 'Affiliation': 'Rady School of Management, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Berry', 'Affiliation': 'University of Texas Southwestern Medical Center, Moncrief Cancer Institute, Fort Worth, Texas.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Moncrief Cancer Institute, Fort Worth, Texas.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Family Medicine, John Peter Smith Health Network, Fort Worth, Texas.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'University of Texas Southwestern Medical Center, Harold C. Simmons Cancer Center, Dallas, Texas.'}, {'ForeName': 'Bijal A', 'Initials': 'BA', 'LastName': 'Balasubramanian', 'Affiliation': 'Department of Epidemiology, Genetics, & Environmental Science, UT Health School of Public Health, Dallas, Texas.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Argenbright', 'Affiliation': 'University of Texas Southwestern Medical Center, Moncrief Cancer Institute, Fort Worth, Texas.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'San Diego Veterans Affairs Healthcare System, San Diego, California. s1gupta@ucsd.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0039']
1763,31132978,Melatonin Improves Erythropoietin Hyporesponsiveness via Suppression of Inflammation.,"BACKGROUND


Inadequate response to Erythropoietin Stimulating Agents (ESA) despite using relatively larger doses regimen represents a potential risk factor of Cardiovascular (CV) related mortality in addition to health-care economic problems in anemic patients with Chronic Kidney Disease (CKD). Erythropoietin (EPO) hyporesponsiveness related to inflammation has been increased progressively. Melatonin is well known as a potent anti-inflammatory agent. Therefore, the current study was designed to evaluate whether melatonin could improve anemic patients response to EPO.
METHODS


This single controlled clinical study was carried out in 41 CKD patients with hemoglobin (Hb) levels less than 11g/dl divided randomly in a 1:1 ratio into 2 groups; treatment group who received 5mg melatonin plus their regular treatments and control group who received their regular treatments only. Hematological and iron status parameters include Hb level, serum iron (S. iron), Transferrin Saturation Ratio (TSAT) and serum ferritin (S. ferritin) in addition to inflammatory parameters that include tissue necrotic factor alfa (TNF-α), interleukin-1beta (IL-1β) and interleukin-6 (IL-6) determined before and after 12 weeks of treatment.
RESULTS


Melatonin remarkably increases the Hb level with a significant increase in S. iron and TSAT compared to baseline. The elevation of S. iron and TSAT was significantly higher in the melatonin group. Additionally, all inflammatory markers estimated were reduced significantly by melatonin compared to base line and control group.
CONCLUSION


The results of the current study showed that melatonin has an advantageous effect on improving EPO response in anemic patients with CKD.",2019,The elevation of S. iron and TSAT were significantly higher in melatonin group.,"['anemic patients with CKD', 'anemic patients with chronic kidney disease (CKD', '41 CKD patient with hemoglobin (Hb) level less than 11g/dl']","['melatonin', 'Melatonin', 'melatonin plus their regular treatments and control group who received their regular treatments only', 'erythropoietin stimulating agents (ESA']","['EPO response', 'elevation of S. iron and TSAT', 'S. iron and TSAT', 'Hematological and iron status parameters include Hb level, serum iron (S. iron), transferrin saturation ratio (TSAT) and serum ferritin (S. ferritin', 'tissue necrotic factor alfa (TNF-α), interleukin-1beta (IL-1β) and interleukin-6 (IL-6', 'Hb level']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3472649', 'cui_str': 'ESAS'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.0205443,The elevation of S. iron and TSAT were significantly higher in melatonin group.,"[{'ForeName': 'Evan Noori', 'Initials': 'EN', 'LastName': 'Hameed', 'Affiliation': 'Faculty of Pharmacy, University of Kufa, Najaf Governorate, Iraq.'}, {'ForeName': 'Haydar F', 'Initials': 'HF', 'LastName': 'Hadi Al Tukmagi', 'Affiliation': 'Mustafa College University, Pharmacy Department, Baghdad, Iraq.'}, {'ForeName': 'Hayder Ch Assad', 'Initials': 'HCA', 'LastName': 'Allami', 'Affiliation': 'Faculty of Pharmacy, University of Kufa, Najaf Governorate, Iraq.'}]",Reviews on recent clinical trials,['10.2174/1574887114666190528120357']
1764,31490251,Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration.,"BACKGROUND


Pectoral nerves (PECS II) block is a popular regional analgesia technique for breast surgery. PECS II block or local infiltration by surgeon may improve outcomes including quality of recovery (QoR).
METHODS


In this multicenter randomized clinical trial, 104 female patients undergoing breast surgery received: (1) PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group). Patients, anesthetists, surgeons, nursing staff, and research assistants were blinded to group allocation. Patients received standardized general anesthesia and multimodal analgesia. The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional) QoR-15 questionnaire measured 24 hours postoperatively. Secondary outcomes were pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible). Randomly assigned groups were compared on outcomes using the Wilcoxon rank-sum test, and the results were reported as median difference with 95% confidence interval.
RESULTS


One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn. Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery. Baseline QoR-15 global scores reported as median [quartiles] were 135 [129, 143] in the PECS group and 139 [127, 143] in the infiltration group. The 24-hour QoR-15 global score reported as median [quartiles] was 131 [116, 140] in the PECS group and 123 [117, 143] in the infiltration group (P = .60), with median difference (95% confidence interval) of -2 (-9 to 5). The median difference reported as infiltration minus PECS for QoR-15 domains was pain 0 (-2 to 1), physical comfort -1 (-3 to 2), physical independence 0 (-2 to 1), psychological support 0 (0-0), and emotions 0 (-1 to 2) (P > .28). The BPI pain subscale at 24 hours (0-40, lower score indicates less pain), reported as median [quartiles], was 7 [2, 13] in the PECS group and 10 [5, 17] in the infiltration group (P = .15). The BPI global score at 24 hours, reported as median [quartiles], was 20 [7, 36] in the PECS group and 23 [10, 43] in the infiltration group (P = .34) and at 3 months was 0 [0, 14] and 0 [0, 11] (P = .85).
CONCLUSIONS


After mostly minor surgery for breast cancer, PECS II block was not superior to local infiltration by the surgeon.",2020,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","['After Breast Surgery', '104 female patients undergoing breast surgery received: (1', 'One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn', 'Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery']","['Pectoral nerves (PECS II) block', 'PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group', 'standardized general anesthesia and multimodal analgesia', 'PECS', 'Pectoral Nerves Interfascial Plane (Pectoral Nerves II']","['QoR-15 questionnaire', 'global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional', 'BPI pain subscale', 'pain', 'quality of recovery (QoR', 'physical comfort -1 (-3 to 2), physical independence 0', 'pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible', 'Baseline QoR-15 global scores', 'Quality of Recovery', '24-hour QoR-15 global score', 'BPI global score']","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4273496', 'cui_str': 'Modified PECS block'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]",104.0,0.164772,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Barrington', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gloria J', 'Initials': 'GJ', 'LastName': 'Seah', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gotmaker', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': ""Pharmacy, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004371']
1765,31188437,"Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes.","CONTEXT


Patients with type 1 diabetes (T1D) have lower microbiota diversity and distinct gut microbial profiles that have been linked to changes in intestinal permeability. Prebiotics are nondigestible carbohydrates that alter gut microbiota and could potentially improve glycemic control and reduce intestinal permeability and thereby insulin sensitivity.
OBJECTIVE


To determine the effect of prebiotics on glycemic control, gut microbiota, and intestinal permeability in children with T1D.
DESIGN


A randomized, placebo-controlled trial in children 8 to 17 years of age with T1D using placebo or prebiotic oligofructose-enriched inulin for 12 weeks. Baseline, 3-month, and 6-month assessments included HbA1c, C-peptide, gut microbiota, intestinal permeability, frequency of diabetic ketoacidosis (DKA), and severe hypoglycemia.
RESULTS


Forty-three subjects were randomized and 38 completed the study. The groups were similar at baseline: prebiotic (N = 17), age 12.5 years (SD of 2.8), HbA1c 8.02% (SD of 0.82); placebo (N = 21), age 12.0 years (SD of 2.6), HbA1c 8.08% (SD of 0.91). No significant differences were found in the frequency of DKA or severe hypoglycemia. At 3-months, C-peptide was significantly higher (P = 0.029) in the group who received prebiotics, which was accompanied by a modest improvement in intestinal permeability (P = 0.076). There was a significant increase in the relative abundance of Bifidobacterium within the prebiotic group at 3 months that was no longer present after the 3-month washout. The placebo group had significantly higher relative abundance of Streptococcus, Roseburia inulinivorans, Terrisporobacter, and Faecalitalea compared with the prebiotic group at 3 months.
CONCLUSION


Prebiotics are a potentially novel, inexpensive, low-risk treatment addition for T1D that may improve glycemic control. Further larger-scale trials are needed.",2019,"The placebo group had significantly higher relative abundance of Streptococcus, Roseburia inulinovorans, Terrisporobacter and Faecalitalea compared to the prebiotic group at 3 months.
","['Patients with type 1 diabetes (T1D', 'children with type 1 diabetes', 'children 8-17 years with T1D using placebo or prebiotic oligofructose-enriched inulin for 12 weeks', '43 subjects were randomized and 38 completed the study', 'children with T1D']","['prebiotic', 'placebo']","['A1C, C-peptide, gut microbiota, IP, frequency of diabetic ketoacidosis (DKA), and severe hypoglycemia', 'frequency of DKA or severe hypoglycemia', 'relative abundance of Bifidobacterium', 'microbiota, intestinal permeability and glycemic control', 'relative abundance of Streptococcus, Roseburia inulinovorans, Terrisporobacter and Faecalitalea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C3986447', 'cui_str': 'Genus Faecalitalea (organism)'}]",43.0,0.236565,"The placebo group had significantly higher relative abundance of Streptococcus, Roseburia inulinovorans, Terrisporobacter and Faecalitalea compared to the prebiotic group at 3 months.
","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alissa C', 'Initials': 'AC', 'LastName': 'Nicolucci', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Virtanen', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Schick', 'Affiliation': 'International Microbiome Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Internal Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00481']
1766,32097140,Investigation of the effect of task-orientated rehabilitation program on motor skills of children with childhood cancer: a randomized-controlled trial.,"Problems have been reported in the execution and development of motor skills and its treatment as a cause of cancer in children. The purpose of this study was to examine the effect of the task-orientated rehabilitation program (ToRP) on motor skills of children with childhood cancer. Following the consort guideline, 93 children (49 males and 44 females) with pediatric cancer were randomized to either study (n = 52; 12.35 ± 3.43 years) or control (n = 41; 11.89 ± 3.56 years) groups. The study group received ToRP, and the control group received a home-based therapeutic strategies program for 20 sessions. Motor skill outcomes were assessed with Bruininks-Oseretsky Test of Motor Proficiency, Short Form (BOTMP-SF) by assessor who was blind to group allocation and interventions. The groups were homogenous in terms of demographic characteristics and motor skills. The study group showed a significant increase in both gross and fine motor skills (P values for all subtests: P < 0.001), whereas running speed, bilateral coordination, strength, response speed and visual motor control did not show significant improvement with the control group (P > 0.05). The ToRP appears to provide beneficial effects in improving motor skills at the early stages of rehabilitation for children with childhood cancer.",2020,The ToRP appears to provide beneficial effects in improving motor skills at the early stages of rehabilitation for children with childhood cancer.,"['93 children (49 males and 44 females) with pediatric cancer', 'children with childhood cancer']","['task-orientated rehabilitation program (ToRP', 'ToRP', 'task-orientated rehabilitation program', 'home-based therapeutic strategies program']","['running speed, bilateral coordination, strength, response speed and visual motor control', 'both gross and fine motor skills', 'Bruininks-Oseretsky Test of Motor Proficiency, Short Form (BOTMP-SF', 'motor skills', 'Motor skill outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0424013', 'cui_str': 'Orientated (finding)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0040477', 'cui_str': 'TORP'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",93.0,0.0414988,The ToRP appears to provide beneficial effects in improving motor skills at the early stages of rehabilitation for children with childhood cancer.,"[{'ForeName': 'Sedef', 'Initials': 'S', 'LastName': 'Şahin', 'Affiliation': 'Department of Occupational Therapy, Hacettepe University, Ankara.'}, {'ForeName': 'Burcu Semin', 'Initials': 'BS', 'LastName': 'Akel', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Istanbul Kultur University, Istanbul.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Huri', 'Affiliation': 'Department of Occupational Therapy.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Akyüz', 'Affiliation': 'Department of Pediatric Oncology, Hacettepe University, Ankara, Turkey.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000400']
1767,31292608,Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine.,"Migraine is one of the most disabling and prevalent of all disorders. To improve understanding of migraine mechanisms and to suggest a new therapeutic target, we investigated whether opening of ATP-sensitive potassium channels (KATP) would cause migraine attacks. In this randomized, double-blind, placebo-controlled, crossover study, 16 patients aged 18-49 years with one to five migraine attacks a month were randomly allocated to receive an infusion of 0.05 mg/min KATP channel opener levcromakalim and placebo on two different days (ClinicalTrials.gov number, NCT03228355). The primary endpoints were the difference in incidence of migraine attacks, headaches and the difference in area under the curve (AUC) for headache intensity scores (0-12 h) and for middle cerebral artery blood flow velocity (0-2 h) between levcromakalim and placebo. Between 24 May 2017 and 23 November 2017, 16 patients randomly received levcromakalim and placebo on two different days. Sixteen patients (100%) developed migraine attacks after levcromakalim compared with one patient (6%) after placebo (P = 0.0001); the difference of incidence is 94% [95% confidence interval (CI) 78-100%]. The incidence of headache over the 12 h observation period was higher but not significant after levcromakalim (n = 16) than after placebo (n = 7) (P = 0.016) (95% CI 16-71%). The AUC for headache intensity was significantly larger after levcromakalim compared to placebo (AUC0-12h, P < 0.0001). There was no change in mean middle cerebral artery blood flow velocity after levcromakalim compared to placebo (AUC0-2hP = 0.46). Opening of KATP channels caused migraine attacks in all patients. This suggests a crucial role of these channels in migraine pathophysiology and that KATP channel blockers could be potential targets for novel drugs for migraine.",2019,"The AUC for headache intensity was significantly larger after levcromakalim compared to placebo (AUC0-12h, P < 0.0001).","['16 patients aged 18-49 years with one to five migraine attacks a month', 'Between 24 May 2017 and 23 November 2017, 16 patients randomly received']","['KATP channel blockers', 'placebo', 'infusion of 0.05 mg/min KATP channel opener levcromakalim and placebo', 'levcromakalim and placebo']","['migraine attacks', 'mean middle cerebral artery blood flow velocity', 'incidence of headache', 'AUC for headache intensity', 'incidence of migraine attacks, headaches and the difference in area under the curve (AUC) for headache intensity scores (0-12 h) and for middle cerebral artery blood flow velocity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439420', 'cui_str': 'mg/min'}, {'cui': 'C0244960', 'cui_str': 'Levcromakalim'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.285709,"The AUC for headache intensity was significantly larger after levcromakalim compared to placebo (AUC0-12h, P < 0.0001).","[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Brain : a journal of neurology,['10.1093/brain/awz199']
1768,31767043,Variation in care for children undergoing the Fontan operation for hypoplastic left heart syndrome.,"BACKGROUND


The Single Ventricle Reconstruction Trial randomised neonates with hypoplastic left heart syndrome to a shunt strategy but otherwise retained standard of care. We aimed to describe centre-level practice variation at Fontan completion.
METHODS


Centre-level data are reported as median or median frequency across all centres and range of medians or frequencies across centres. Classification and regression tree analysis assessed the association of centre-level factors with length of stay and percentage of patients with prolonged pleural effusion (>7 days).
RESULTS


The median Fontan age (14 centres, 320 patients) was 3.1 years (range from 1.7 to 3.9), and the weight-for-age z-score was -0.56 (-1.35 + 0.44). Extra-cardiac Fontans were performed in 79% (4-100%) of patients at the 13 centres performing this procedure; lateral tunnels were performed in 32% (3-100%) at the 11 centres performing it. Deep hypothermic circulatory arrest (nine centres) ranged from 6 to 100%. Major complications occurred in 17% (7-33%). The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion. Centres with fewer patients (<6%) with prolonged pleural effusion and fewer (<41%) complications had a shorter length of stay (<10 days; sensitivity 1.0; specificity 0.71; area under the curve 0.96). Avoiding deep hypothermic circulatory arrest and higher weight-for-age z-score were associated with a lower percentage of patients with prolonged effusions (<9.5%; sensitivity 1.0; specificity = 0.86; area under the curve 0.98).
CONCLUSIONS


Fontan perioperative practices varied widely among study centres. Strategies to decrease the duration of pleural effusion and minimise complications may decrease the length of stay. Further research regarding deep hypothermic circulatory arrest is needed to understand its association with prolonged pleural effusion.",2019,The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion.,"['The median Fontan age (14 centres, 320 patients) was 3.1\xa0years (range from 1.7 to 3.9), and the weight-for-age z-score was -0.56 ', 'neonates with hypoplastic left heart syndrome', 'children undergoing the Fontan operation for hypoplastic left heart syndrome', 'patients with prolonged pleural effusion (>7\xa0days']",[],"['shorter length of stay', 'prolonged pleural effusion', 'length of stay', 'duration of pleural effusion', 'Major complications']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0152101', 'cui_str': 'Left Heart Hypoplasia Syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0190010', 'cui_str': 'Norwood Procedure, Stage III'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",320.0,0.0949982,The length of stay was 9.5 days (9-12); 15% (6-33%) had prolonged pleural effusion.,"[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Eckhauser', 'Affiliation': ""Divisions of Cardiothoracic Surgery and Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Van Rompay', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ram Kumar', 'Affiliation': ""Heart Institute, Children's Hospital of Los Angeles, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pizarro', 'Affiliation': 'Nemours Cardiac Center, Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ghanayem', 'Affiliation': ""Division of Pediatric Critical Care, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Burns', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Garick D', 'Initials': 'GD', 'LastName': 'Hill', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Mjaye', 'Initials': 'M', 'LastName': 'Mazwi', 'Affiliation': 'Department of Critical Care Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': 'Division of Pediatric Cardiology, Duke University, Durham, NC, USA.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': 'Division of Pediatric Cardiology, Columbia University College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Pediatric Cardiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zampi', 'Affiliation': ""Division of Pediatric Cardiology, University of Michigan, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.""}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': ""Division of Cardiovascular Surgery, Johns Hopkins University and All Children's Hospital, St. Petersburg, FL, USA.""}, {'ForeName': 'L LuAnn', 'Initials': 'LL', 'LastName': 'Minich', 'Affiliation': ""Divisions of Cardiothoracic Surgery and Pediatric Cardiology, University of Utah, Primary Children's Hospital, Salt Lake City, UT, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiology in the young,['10.1017/S1047951119002658']
1769,30395021,Significant Effect of Acupressure in Elevating Blood Stem Cell Factor During Chemotherapy in Patients With Gynecologic Cancer.,"BACKGROUND


Chemotherapy is used mainly to treat and control the progression of gynecological cancer. Bone marrow suppression, one of the adverse side effects of chemotherapy, may decrease immune function, increasing the risk of serious, fatal infections.
PURPOSE


The aims of this study were to evaluate the effectiveness of noninvasive acupressure in preventing and diminishing chemotherapy-induced myelosuppression in patients with gynecologic cancer and to determine whether this effect is associated with the regulation of the expressions of granulocyte-macrophage colony-stimulating factor and stem cell factor (SCF).
METHODS


In total, 28 women with gynecological cancer were randomly assigned either to the experimental group (n = 10) or to the control group (n = 18). The experimental group received acupressure of 5-minute duration to the Hegu (LI4), Quchi (LI11), Xuehai (SP10), Sanyinjiao (SP6), Taixi (K3), Zusanli (ST36), Taichong (LR3), and Baihui (GV20) points, respectively, three times per day for 6 weeks. The control group did not receive the acupressure intervention. The blood count, including white blood cells, platelets, and hemoglobin, and serum levels for SCF and granulocyte-macrophage colony-stimulating factor were assessed before (pretest) and 6 weeks after (posttest) the participants' first course of chemotherapy.
RESULTS


At posttest, blood hemoglobin had significantly decreased from (mean ± SD) 11.6 ± 2.2 to 10.8 ±1.6 mg/dl (p = .03) in the control group. However, no significant pretest-posttest difference in hemoglobin concentration (11.4 ± 1.0 vs. 10.9 ± 1.1 mg/dl) was detected in the experimental group. Levels of SCF increased significantly between pretest and posttest in both the control group (from 1196.10 ± 293.17 to 1325.05 ± 253.77 ng/ml; p = .01) and the acupressure group (from 1046.78 ± 469.52 to 1387.06 ± 310.00 ng/ml; p = .007). In addition, a borderline difference (p = .05) in mean pretest-posttest SCF increase was found between the acupressure group (340.28 ± 255.46 ng/ml) and the control group (128.94 ± 250.64 ng/ml). Finally, a significant time-dependent interactive effect was found between acupressure and the increased blood level of SCF at posttest (β = 211.34, p = .02).
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


The findings support that acupressure on specific acupoints increases blood SCF levels significantly, which may help protect chemotherapy patients from experiencing reduced hemoglobin levels and may relieve chemotherapy-induced myelosuppression in patients with gynecologic cancer. This noninvasive approach is suggested for practical implementation in patients undergoing a course of chemotherapy.",2018,Levels of SCF increased significantly between pretest and posttest in both the control group (from 1196.10 ± 293.17 to 1325.05 ± 253.77 ng/ml; p = .01) and the acupressure group (from 1046.78 ± 469.52 to 1387.06 ± 310.00 ng/ml; p = .007).,"['patients with gynecologic cancer', 'patients undergoing a course of chemotherapy', 'Patients With Gynecologic Cancer', '28 women with gynecological cancer']","['noninvasive acupressure', 'Acupressure', 'acupressure of 5-minute duration to the Hegu (LI4), Quchi (LI11), Xuehai', 'acupressure', 'acupressure intervention']","['blood SCF levels', 'hemoglobin levels', 'SP10), Sanyinjiao (SP6), Taixi (K3), Zusanli (ST36), Taichong (LR3), and Baihui (GV20) points', 'hemoglobin concentration', 'blood level of SCF', 'blood count, including white blood cells, platelets, and hemoglobin, and serum levels for SCF and granulocyte-macrophage colony-stimulating factor', 'Bone marrow suppression', 'Elevating Blood Stem Cell Factor', 'Levels of SCF', 'blood hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0005768'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0450552', 'cui_str': 'SP10 (body structure)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}]",28.0,0.0478355,Levels of SCF increased significantly between pretest and posttest in both the control group (from 1196.10 ± 293.17 to 1325.05 ± 253.77 ng/ml; p = .01) and the acupressure group (from 1046.78 ± 469.52 to 1387.06 ± 310.00 ng/ml; p = .007).,"[{'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Shih', 'Affiliation': 'MSN, RN, Doctoral Student, School of Nursing, College of Nursing, Taipei Medical University.'}, {'ForeName': 'Shun-Fa', 'Initials': 'SF', 'LastName': 'Yang', 'Affiliation': 'PhD, Professor, Institute of Biochemistry, Chung Shan Medical University.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Chien', 'Affiliation': 'PhD, Professor, Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Chang', 'Affiliation': 'MD, Director Physician, Department of Obstetrics and Gynecology, Taipei Medical University Hospital, and Clinical Associate Professor, Department of Medicine, College of Medicine, Taipei Medical University.'}, {'ForeName': 'Vincent H S', 'Initials': 'VHS', 'LastName': 'Chang', 'Affiliation': 'PhD, Associate Professor, The PhD program for Translational Medicine, College of Medical Science and Technology, Taipei Medical University.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': ''}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000257']
1770,31326304,"Daily Oral l-Arginine Plus Tadalafil in Diabetic Patients with Erectile Dysfunction: A Double-Blinded, Randomized, Controlled Clinical Trial.","INTRODUCTION


Erectile dysfunction is a common condition among diabetic men. Many treatments are now available with variable responses.
AIM


This study aimed to evaluate the effect of daily oral l-arginine plus tadalafil in diabetic patients with mild to moderate erectile dysfunction.
METHODS


A double-blinded, randomized, controlled clinical trial was conducted with 108 diabetic male patients. Each patient was assessed by medical and sexual histories, International Index of Erectile Function 5-item questionnaires, pharmaco-penile duplex ultrasonography, and serum testosterone level.
MAIN OUTCOME MEASURE


Improvement in International Index of Erectile Function 5-item, serum testosterone level and pharmaco-penile duplex ultrasonography.
RESULTS


Erectile functions were significantly improved in all patients after treatment as compared with baseline and placebo (P < .001). Patients who received both drugs showed significant improvement compared to those treated with single drugs, as assessed by International Index of Erectile Function scores and total testosterone (P < .001). Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone.
CONCLUSION


Daily use of l-arginine with tadalafil significantly increased the International Index of Erectile Function scores and total testosterone levels as compared to each drug alone in diabetic patients with erectile dysfunction. No differences were found based on pharmaco-penile duplex findings. El Taieb M, Hegazy E, Ibrahim A. Daily Orall-Arginine Plus Tadalafil in Diabetic Patients with Erectile Dysfunction: A Double-Blinded, Randomized, Controlled Clinical Trial. J Sex Med 2019; 19:1390-1397.",2019,"Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone.
","['diabetic patients with mild to moderate erectile dysfunction', 'diabetic men', 'diabetic patients with erectile dysfunction', 'Diabetic Patients with Erectile Dysfunction', '108 diabetic male patients']","['placebo', 'El Taieb M, Hegazy E, Ibrahim A. Daily Orall-Arginine Plus Tadalafil', 'l-arginine with tadalafil', 'daily oral l-arginine plus tadalafil', 'Daily Oral l-Arginine Plus Tadalafil']","['International Index of Erectile Function 5-item, serum testosterone level and pharmaco-penile duplex ultrasonography', 'medical and sexual histories, International Index of Erectile Function 5-item questionnaires, pharmaco-penile duplex ultrasonography, and serum testosterone level', 'International Index of Erectile Function scores and total testosterone', 'International Index of Erectile Function scores and total testosterone levels', 'Erectile functions']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",108.0,0.490958,"Pharmaco-penile ultrasound duplex results showed non-significant differences among patients treated with both drugs and those with each drug alone.
","[{'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'El Taieb', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Aswan University, Sahary City, Aswan, Egypt. Electronic address: moustafa.eltaib@aswu.edu.eg.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Hegazy', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, South Valley University, Qena, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Asuit University, Asyut, Egypt.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.06.009']
1771,29432408,A Randomized Trial Comparing Clinical Outcomes Between Zero-Profile and Traditional Multilevel Anterior Cervical Discectomy and Fusion Surgery for Cervical Myelopathy.,"STUDY DESIGN


Prospective randomized study from a single center OBJECTIVE.: The purpose of this study was to compare outcomes between a zero-profile (ZP) anterior cervical discectomy and fusion (ACDF) construct to a traditional ACDF with anterior cervical plate (ACP) in the treatment of multilevel cervical spondylotic myelopathy.
SUMMARY OF BACKGROUND DATA


Multilevel cervical spondylotic myelopathy can be treated by a variety of techniques, most commonly with corpectomy, ACDF, posterior cervical fusion, or a combination of the three. Examples in the literature of comparative effectiveness of different anterior approach types are few.
METHODS


A total of 104 patients with multilevel cervical spondylotic myelopathy were randomized in equal proportion between treated with ACDF and ZP or ACDF with ACP. Clinical efficacy of two groups was evaluated preoperatively and at all postoperative time points through 2 years postoperative by the Japanese Orthopedic Association score and the neck disability index. Radiographic changes from baseline, including disc height and cervical lordosis, were evaluated at the same postoperative time points. Complications were assessed perioperatively and through 2 years postoperatively.
RESULTS


The ZP and ACP ACDF groups demonstrated substantially equivalent Japanese Orthopaedic Association, neck disability index, disc height, and lordosis improvements from baseline, which were maintained through 2 years postoperatively. Complications occurred in 4% of ZP and 17% of ACP patients (P = 0.052), and zero (0%) ZP and four (8%) ACP patients reported hoarseness or dysphagia.
CONCLUSION


ZP used in multilevel ACDF may obtain favorable clinical outcomes and a lower postoperative complication.
LEVEL OF EVIDENCE


2.",2018,"Complications occurred in 4% of ZP and 17% of ACP patients (P = 0.052), and zero (0%) ZP and four (8%)",['104 patients with multilevel cervical spondylotic myelopathy'],"['ZP and ACP ACDF', 'ACDF and ZP or ACDF with ACP', 'zero-profile (ZP) anterior cervical discectomy and fusion (ACDF) construct to a traditional ACDF with anterior cervical plate (ACP', 'Zero-Profile and Traditional Multilevel Anterior Cervical Discectomy and Fusion Surgery', 'ACP']","['Japanese Orthopedic Association score and the neck disability index', 'Clinical efficacy', 'equivalent Japanese Orthopaedic Association, neck disability index, disc height, and lordosis improvements', 'hoarseness or dysphagia', 'Complications', 'disc height and cervical lordosis']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0037928', 'cui_str': 'Myelopathy'}]","[{'cui': 'C4552416', 'cui_str': 'Anterior cervical discectomy with fusion'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0024004', 'cui_str': 'Acquired lordosis (disorder)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]",104.0,0.0393045,"Complications occurred in 4% of ZP and 17% of ACP patients (P = 0.052), and zero (0%) ZP and four (8%)","[{'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Shenzhen Chinese Medicine Hospital, Guangdong, China.'}, {'ForeName': 'Hualong', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'The Fourth Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Lan', 'Affiliation': 'The Fourth Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Juyi', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'The Fourth Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Zhitao', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Shenzhen Chinese Medicine Hospital, Guangdong, China.'}, {'ForeName': 'Yeguang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Chinese Medicine Hospital, Guangdong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Chinese Medicine Hospital, Guangdong, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Shenzhen Chinese Medicine Hospital, Guangdong, China.'}, {'ForeName': 'Feiqiang', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'The Fourth Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Fuguang', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'The Fourth Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangdong, China.'}]",Spine,['10.1097/BRS.0000000000002323']
1772,31846024,Effects of Biopsychosocial Education on the Clinical Judgments of Medical Students and GP Trainees Regarding Future Risk of Disability in Chronic Lower Back Pain: A Randomized Control Trial.,"BACKGROUND


Chronic lower back pain (CLBP) is a major health care burden and often results in workplace absenteeism. It is a priority for appropriate management of CLBP to get individuals back to work as early as possible. Interventions informed by the flags approach, which integrates cognitive and behavioral approaches via identification of biopsychosocial barriers to recovery, have resulted in reduced pain-related work absences and increased return to work for individuals with CLBP. However, research indicates that physicians' adherence to biopsychosocial guidelines is low.
OBJECTIVE


The current study examined the effects of a flags approach-based educational intervention on clinical judgments of medical students and general practitioner (GP) trainees regarding the risk of future disability of CLBP patients.
DESIGN


Randomized controlled trial (trial registration number: ISRCTN53670726).
SETTING


University classroom.
SUBJECTS


Medical students and GP trainees.
METHODS


Using 40 fictional CLBP cases, differences in clinical judgment accuracy, weighting, and speed (experimental N = 32) were examined pre- and postintervention, as were flags approach knowledge, pain attitudes and beliefs, and empathy, in comparison with a no-intervention control group (control N = 31).
RESULTS


Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research.
CONCLUSIONS


Short flags approach-based educational video interventions on clinical judgment-making regarding the risk of future disability of CLBP patients may provide opportunities to gain biopsychosocial knowledge, overcome associated attitude barriers, and facilitate development of clinical judgment-making more aligned with psychological cues.",2020,"RESULTS


Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research.
","['medical students and general practitioner (GP) trainees regarding the risk of future disability of CLBP patients', 'University classroom', 'Medical students and GP trainees', 'Medical Students and GP Trainees Regarding Future Risk of Disability in Chronic Lower Back Pain', 'Chronic lower back pain (CLBP', 'CLBP patients']","['flags approach-based educational intervention', 'Biopsychosocial Education', 'educational intervention']","['flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues', 'flags approach knowledge, pain attitudes and beliefs, and empathy', 'clinical judgment accuracy, weighting, and speed (experimental N\u2009=\u200932']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0525744,"RESULTS


Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research.
","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Dwyer', 'Affiliation': 'Centre for Pain Research, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Pádraig', 'Initials': 'P', 'LastName': 'MacNeela', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Durand', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Main', 'Affiliation': 'Research Institute of Primary Care and Health Sciences, Keele University, Staffordshire, England.'}, {'ForeName': 'Phoebe E', 'Initials': 'PE', 'LastName': 'McKenna-Plumley', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamm', 'Affiliation': 'Department of Family & Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Conneely', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Slattery', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Darragh', 'Initials': 'D', 'LastName': 'Taheny', 'Affiliation': ''}, {'ForeName': 'Saoirse', 'Initials': 'S', 'LastName': 'NicGabhainn', 'Affiliation': 'Discipline of Health Promotion, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Murphy', 'Affiliation': 'Discipline of General Practice, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kropmans', 'Affiliation': 'Discipline of Medical Informatics and Education, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz284']
1773,31498251,The Effects of Simulation-Based Advanced Life Support Education for Nursing Students.,"Advanced life support education for nursing students is very important because nurses are first responders in emergency situations. The purpose of this study was to identify the effects of simulation-based advanced life support education on nursing students' knowledge, performance, self-efficacy, and teamwork. A nonequivalent control group posttest-only design was used. Fourth-year nursing students were randomly assigned to either simulation-based Korean Advanced Life Support (n = 30) or lecture-based education (n = 30) groups. Data were analyzed using descriptive statistics and the Mann-Whitney U test. The experimental group showed statistically significant higher scores in knowledge (P < .001), performance (P < .001), and self-efficacy (P = .049) when compared with the control group. However, there was no significant difference in teamwork scores between the two groups (P = .529). The 4.5-hour simulation-based Korean Advanced Life Support education was more effective than the 4.5-hour lecture-based education for nursing students in terms of knowledge, performance, and self-efficacy. Nurse educators should adopt simulation-based advanced life support education into the curriculum for the optimal competence of nursing students.",2020,"The experimental group showed statistically significant higher scores in knowledge (P < .001), performance (P < .001), and self-efficacy (P = .049) when compared with the control group.","['nursing students', 'Nursing Students', 'Fourth-year nursing students']","['simulation-based advanced life support education', 'simulation-based Korean Advanced Life Support (n = 30) or lecture-based education', 'Simulation-Based Advanced Life Support Education']","['self-efficacy', 'scores in knowledge', ""nursing students' knowledge, performance, self-efficacy, and teamwork"", 'teamwork scores']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]",,0.0260576,"The experimental group showed statistically significant higher scores in knowledge (P < .001), performance (P < .001), and self-efficacy (P = .049) when compared with the control group.","[{'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Author Affiliations: Graduate School, Chung-Ang University, Seoul, Republic of Korea (Mr Kim); University of Miami Miller School of Medicine, FL (Dr Issenberg); and Red Cross College of Nursing, Chung-Ang University, Seoul, Republic of Korea (Dr Roh).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Issenberg', 'Affiliation': ''}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Roh', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000560']
1774,31493626,"Efficacy and safety of a biosimilar recombinant human growth hormone (r-hGH Cristalia) compared with reference r-hGH in children with growth hormone deficiency (CERES study): A randomized, multicentric, investigator-blind, phase 3 trial.","OBJECTIVE


The CERES study was a randomized, multicenter, investigator-blind trial aimed to evaluate the efficacy and safety of a recombinant human growth hormone (r-hGH) developed by Cristalia, as a biosimilar product, with analytical, functional and pharmacokinetics similarities comparable to Genotropin™, in children with growth hormone deficiency (GHD).
DESIGN


A total of 135 naïve prepubertal children with GHD were recruited, of whom 97 were randomized in 14 Brazilian sites to received either r-hGH Cristalia (n = 49) or Genotropin™ (n = 48). Efficacy was evaluated considering the height standard deviation score (SDS) and growth velocity as auxological parameters, IGF-1 and IGFBP-3 were measured as pharmacodynamic parameters during 12 months treatment time. Safety was assessed by monitoring adverse events, immunogenicity, blood count with platelets, biochemical profile and hormonal levels particularly fasting glucose, insulin and HbA1C.
RESULTS


The auxological parameters and IGF-1 and IGFBP-3 levels were comparable between both groups of patients. At end of study or the 12th month treatment, the means growth velocity was 9.7 cm/year and 9.5 cm/year, for r-hGH Cristalia and Genotropin™, respectively. The ANCOVA mean difference between the groups was 0.16 cm/year to Cristalia group (CI 95% = -0.72 to 1.03 cm/year). There was no difference in adherence among the treatment groups. The safety profile was comparable between groups.
CONCLUSIONS


The clinical similarity between r-hGH and Genotropin™ was demonstrated within 12 month of treatment. On the basis of comparability of quality, safety, and efficacy to the reference product, r-hGH from Cristalia can be considered a cost-effective therapeutic option for patients with growth disorders.",2019,"The safety profile was comparable between groups.
","['135 naïve prepubertal children with GHD were recruited, of whom 97 were randomized in 14 Brazilian sites to received either', 'children with growth hormone deficiency (CERES study', 'patients with growth disorders', 'children with growth hormone deficiency (GHD']","['biosimilar recombinant human growth hormone (r-hGH Cristalia', 'recombinant human growth hormone (r-hGH', 'r-hGH Cristalia (n\u202f=\u202f49) or Genotropin']","['efficacy and safety', 'Efficacy', 'means growth velocity', 'height standard deviation score (SDS) and growth velocity as auxological parameters, IGF-1 and IGFBP-3', 'monitoring adverse events, immunogenicity, blood count with platelets, biochemical profile and hormonal levels particularly fasting glucose, insulin and HbA1C.\nRESULTS\n\n\nThe auxological parameters and IGF-1 and IGFBP-3 levels', 'safety profile', 'Efficacy and safety', 'quality, safety, and efficacy', 'adherence']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency (disorder)'}, {'cui': 'C0212600', 'cui_str': 'CERE'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0384570', 'cui_str': 'r-hGH-M'}, {'cui': 'C0699616', 'cui_str': 'Genotropin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",135.0,0.0373432,"The safety profile was comparable between groups.
","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Czepielewski', 'Affiliation': 'Serviço de Endocrinologia, Hospital de Clínicas de Porto Alegre, UFRGS, Porto Alegre, RS, Brazil. Electronic address: mczepielewski@hcpa.edu.br.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Garret', 'Affiliation': 'CEDOES, Vitória, ES, Brazil.'}, {'ForeName': 'S A C', 'Initials': 'SAC', 'LastName': 'Vencio', 'Affiliation': 'ICF - Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda, Aparecida de Goiânia, GO, Brazil.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rassi', 'Affiliation': 'Hospital Alberto Rassi - HGG, Goiânia, GO, Brazil.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Felicio', 'Affiliation': 'Hospital Universitário João de Barros Barreto, Universidade Federal do Pará, Belém, PA, Brazil.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Faria', 'Affiliation': 'Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA, São Luis, MA, Brazil.'}, {'ForeName': 'C C P', 'Initials': 'CCP', 'LastName': 'Senn', 'Affiliation': 'Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Bronstein', 'Affiliation': 'CPQUALI Pesquisa Clínica Ltda, São Paulo, SP, Brazil.'}, {'ForeName': 'M J A G', 'Initials': 'MJAG', 'LastName': 'Cerqueira', 'Affiliation': 'Instituto de Ensino e Pesquisa Clínica do Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'A C L', 'Initials': 'ACL', 'LastName': 'Neves', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, PE, Brazil.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Sgarbi', 'Affiliation': 'Unidade de Pesquisa Clínica de Marília Ltda (UpCliM), Marília, SP, Brazil.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Spinola-Castro', 'Affiliation': 'Universidade Federal de São Paulo - UNIFESP/EPM, São Paulo, SP, Brazil.'}, {'ForeName': 'M P R', 'Initials': 'MPR', 'LastName': 'Cunha', 'Affiliation': 'CAEP - Centro Avançado de Estudos e Pesquisas Ltda, Campinas, SP, Brazil.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bandeira', 'Affiliation': 'Centro de Pesquisas Médicas Básica e Clínica Ltda, Recife, PE, Brazil.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Toffoletto', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Afiune', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Baradelli', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Rodrigues', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scharf', 'Affiliation': 'Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2019.07.003']
1775,31305927,Appetite Control Is Improved by Acute Increases in Energy Turnover at Different Levels of Energy Balance.,"BACKGROUND


Weight control is hypothesized to be improved when physical activity and energy intake are both high [high energy turnover (ET)].
OBJECTIVE


The impact of three levels of ET on short-term appetite control is therefore investigated at fixed levels of energy balance.
DESIGN


In a randomized crossover trial, 16 healthy adults (25.1 ± 3.9 y of age; body mass index, 24.0 ± 3.2 kg/m2) spent three daylong protocols for four times in a metabolic chamber. Four conditions of energy balance (ad libitum energy intake, zero energy balance, -25% caloric restriction, and +25% overfeeding) were each performed at three levels of ET (PAL 1.3 low, 1.6 medium, and 1.8 high ET; by walking on a treadmill). Levels of appetite hormones ghrelin, GLP-1, and insulin (total area under the curve) were measured during 14 hours. Subjective appetite ratings were assessed by visual analog scales.
RESULTS


Compared with high ET, low ET led to decreased GLP-1 (at all energy balance conditions: P < 0.001) and increased ghrelin concentrations (caloric restriction and overfeeding: P < 0.001), which was consistent with higher feelings of hunger (zero energy balance: P < 0.001) and desire to eat (all energy balance conditions: P < 0.05) and a positive energy balance during ad libitum intake (+17.5%; P < 0.001).
CONCLUSION


Appetite is regulated more effectively at a high level of ET, whereas overeating and consequently weight gain are likely to occur at low levels of ET. In contrast to the prevailing concept of body weight control, the positive impact of physical activity is independent from burning up more calories and is explained by improved appetite sensations.",2019,"Compared to high ET, low ET led to decreased GLP-1 (at all energy balance conditions: p<0.001) and increased ghrelin concentrations (caloric restriction and overfeeding: p<0.001) which was consistent with higher feelings of hunger (zero energy balance: p<0.001) and desire to eat (all energy balance conditions: p<0.05) and a positive energy balance during ad libitum intake (+17.5%; p<0.001).
",['16 healthy adults (25.1 ±3.9 y; BMI 24.0 ±3.2 kg/m2) spent 4 x 3 daylong protocols in a metabolic chamber'],"['energy balance (ad libitum energy intake, zero energy balance, -25% caloric restriction and +25% overfeeding']","['GLP-1', 'Visual Analogue Scales', 'Subjective appetite ratings', 'Levels of appetite hormones ghrelin, GLP-1 and insulin (tAUC', 'appetite sensations', 'ghrelin concentrations (caloric restriction and overfeeding']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}]",16.0,0.0554693,"Compared to high ET, low ET led to decreased GLP-1 (at all energy balance conditions: p<0.001) and increased ghrelin concentrations (caloric restriction and overfeeding: p<0.001) which was consistent with higher feelings of hunger (zero energy balance: p<0.001) and desire to eat (all energy balance conditions: p<0.05) and a positive energy balance during ad libitum intake (+17.5%; p<0.001).
","[{'ForeName': 'Franziska A', 'Initials': 'FA', 'LastName': 'Hägele', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Büsing', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Alessa', 'Initials': 'A', 'LastName': 'Nas', 'Affiliation': 'Department of Applied Nutritional Science and Dietetics, Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Hasler', 'Affiliation': 'Applied Statistics, Faculty of Agricultural and Nutritional Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Manfred J', 'Initials': 'MJ', 'LastName': 'Müller', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': 'Institute of Psychological Sciences, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bosy-Westphal', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-01164']
1776,31488289,The Effect of Food on the Pharmacokinetics of Sildenafil after Single Administration of a Sublingual Testosterone and Oral Sildenafil Combination Tablet in Healthy Female Subjects.,"INTRODUCTION


Female sexual interest/arousal disorder (FSIAD) affects many women worldwide, but pharmacological treatment options are scarce. A new medicine being developed for FSIAD is an on-demand, dual-route, dual-release drug combination product containing 0.5 mg testosterone (T) and 50 mg sildenafil (S), referred to here as T+S.
AIM


The aim of this study was to compare the effect of a fed and a fasted state on the pharmacokinetics of sildenafil following administration of T+S.
METHODS


Eighteen healthy women were administered T+S under fed and fasted conditions during 2 separate overnight visits in this randomized, open-label, balanced, 2-period, 2-treatment, 2-sequence crossover study.
MAIN OUTCOME MEASURES


The pharmacokinetics of sildenafil and its active metabolite N-desmethyl sildenafil were determined over a 24-hour period. Total testosterone was assessed only at a limited number of time points for quality purposes, as sublingual uptake is not expected to be affected by food intake.
RESULTS


The observed geometric mean ratios (GMRs) and 90% confidence intervals of sildenafil were not all contained within the prespecified bounds (0.80, 1.25). The GMR (90% CI) for plasma AUC 0-last  was 1.2753 (0.9706-1.6755); for AUC 0-14h , it was 1.7521 (1.0819-2.8374); and for C max , it was 1.5591 (0.8634-2.8153). Only lower limits of the CIs fell within the bounds. For N-desmethyl sildenafil, the GMR (90% CI) for AUC 0-last  was 0.8437 (0.6738-1.0564); for AUC 0-10h , it was 1.0847 (0.7648-1.5383); and for C max , it was 1.0083 (0.6638-1.5318). Only the GMRs were contained within bounds. No differences were observed between plasma testosterone C max  and T max  under fed and fasted conditions, which is in line with expectations for a sublingual administration.
CLINICAL IMPLICATIONS


The T+S combination tablet ruptures too late when taken in a fasted state and should therefore not be taken on an empty stomach.
STRENGTHS & LIMITATIONS


This is a well-controlled study that provides important insights into the performance characteristics of the delayed-release coating of the combination tablet. The higher variability of the pharmacokinetic parameters in the fasted state was caused by severely delayed rupture in one-third of the women. A reason for this is proposed but the present data do not explain this phenomenon.
CONCLUSION


The pharmacokinetics of sildenafil from this modified-release tablet are more robust under fed conditions as compared to the artificial fasted condition where no food is consumed 10 hours prior to and 4 hours after dosing. The dosing situation under the tested fasting condition does not represent the expected common use of this product. Patients should, however, be instructed not to take the tablet on an empty stomach. Bloemers J, Gerritsen J, van Rooij K, et al. The Effect of Food on the Pharmacokinetics of Sildenafil After Single Administration of a Sublingual Testosterone and Oral Sildenafil Combination Tablet in Healthy Female Subjects. J Sex Med 2019; 19:1433-1443.",2019,"No differences were observed between plasma testosterone C max  and T max  under fed and fasted conditions, which is in line with expectations for a sublingual administration.
","['Healthy Female Subjects', 'Eighteen healthy women']","['testosterone (T) and 50 mg sildenafil (S', 'sildenafil', 'T+S', 'sildenafil and its active metabolite N-desmethyl sildenafil', 'Sildenafil', 'Sublingual Testosterone and Oral Sildenafil Combination Tablet']","['observed geometric mean ratios (GMRs) and 90% confidence intervals of sildenafil', 'Total testosterone', 'plasma testosterone C max  and T max  under fed and fasted conditions', 'plasma AUC 0-last']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1665319', 'cui_str': 'Desmethylsildenafil'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",18.0,0.1162,"No differences were observed between plasma testosterone C max  and T max  under fed and fasted conditions, which is in line with expectations for a sublingual administration.
","[{'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Bloemers', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands; Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, the Netherlands. Electronic address: j.bloemers@emotionalbrain.nl.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Gerritsen', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Rooij', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands; Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'de Leede', 'Affiliation': 'Exelion Bio-Pharmaceutical Consultancy BV, Waddinxveen, the Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van der Geest', 'Affiliation': '3D-PharmXchange BV, Tilburg, the Netherlands.'}, {'ForeName': 'Henderik W', 'Initials': 'HW', 'LastName': 'Frijlink', 'Affiliation': 'Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Hans P F', 'Initials': 'HPF', 'LastName': 'Koppeschaar', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Olivier', 'Affiliation': 'Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Tuiten', 'Affiliation': 'Emotional Brain BV, Almere, the Netherlands.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.06.015']
1777,31888670,Translational value of IDH1 and DNA methylation biomarkers in diagnosing lung cancers: a novel diagnostic panel of stage and histology-specificity.,"BACKGROUND


Lung cancer is the leading cause of cancer-related death worldwide, and the timely and serial assessment of low-dose computed tomography (LDCT) in high-risk populations remains a challenge. Furthermore, testing a single biomarker for the diagnosis of lung cancers is of relatively low effectiveness. Thus, a stronger diagnostic combination of blood biomarkers is needed to improve the diagnosis of non-small cell lung cancer (NSCLC).
METHODS


The blood levels of individual biomarkers [IDH1, DNA methylation of short stature homeobox 2 gene (SHOX2), and prostaglandin E receptor 4 gene (PTGER4)] were measured and statistically analyzed in samples from healthy controls and patients with lung cancer. In total, 221 candidates were enrolled and randomly assigned into two groups for the training and validation of a diagnostic panel. Additionally, a subgroup analysis was performed in the whole cohort.
RESULTS


A newly combined 3-marker diagnostic model for lung cancers was established and validated with area under the receiver operating characteristic (ROC) curve (AUC) values ranging from 0.835 to 0.905 in independent groups showing significantly stronger diagnostic value compared with a single tested biomarker. The sensitivity of the diagnostic model was as high as 86.1% and 80.0% in the training and validation sets, respectively. Although no apparent differences were found between the 3-marker and 2-marker models, the high clinical T-stage and histological type specificity of IDH1 and two other methylated DNA biomarkers were demonstrated in the subgroup analysis.
CONCLUSIONS


The combination of single biomarkers with high stage-specificity and histological type specificity (SHOX2 and PTGER4 DNA methylation and IDH1) showed better diagnostic performance in the detection of lung cancers compared with single marker assessment. A greater clinical utility of the panel may be developed by adding demographic/epidemiologic characteristics.",2019,"The sensitivity of the diagnostic model was as high as 86.1% and 80.0% in the training and validation sets, respectively.","['221 candidates', 'diagnosing lung cancers', 'healthy controls and patients with lung cancer']",[],"['receiver operating characteristic (ROC) curve (AUC) values', 'blood levels of individual biomarkers [IDH1, DNA methylation of short stature homeobox 2 gene (SHOX2), and prostaglandin E receptor 4 gene (PTGER4', 'sensitivity of the diagnostic model']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0013336', 'cui_str': 'Nanism'}, {'cui': 'C0242303', 'cui_str': 'Homeobox Sequence'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2936367', 'cui_str': 'Prostaglandin EP4 Receptors'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",221.0,0.0726371,"The sensitivity of the diagnostic model was as high as 86.1% and 80.0% in the training and validation sets, respectively.","[{'ForeName': 'Ruochuan', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jianbing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Chengming', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Sufei', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. sunnan@vip.126.com.'}, {'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. gaoshugeng@vip.sina.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. prof.jiehe@gmail.com.'}]",Journal of translational medicine,['10.1186/s12967-019-2117-7']
1778,31485931,Correction to: Trocar site closure with a novel anchor-based (neoClose ® ) system versus standard suture closure: a prospective randomized controlled trial.,"After careful review, the authors have noticed the following mistakes in the article entitled ""Trocar site closure with a novel anchor based (neoClose®) system versus standard suture closure: A prospective randomized controlled trial"": - Correct closure times are 19.9 seconds (SD 9.9) for the study group and 31.0 seconds (SD 20.1) for the control group (initial incorrect values were 20.2 seconds (SD 10.1) and 30 seconds (SD 19.1) respectively). The new correct P-value is <0.0001 (initial incorrect P-value was 0.0002). - Correct maximal needle depth values are 3.2 cm (SD 0.93) for the study group and 4.9 cm (SD 1.97) for the control group (initial incorrect values were 3.3 cm (SD 0.9) and 5.2 cm (SD 1.6) respectively). P-value remains unchanged at <0.0001. For these two outcomes, some values of control group patients were mistakenly included in the study group. These errors only marginally affected the mean and standard deviation values. Statistical significance of the results was not affected and the conclusions of the study remain unchanged.",2020,Statistical significance of the results was not affected and the conclusions of the study remain unchanged.,[],"['novel anchor based (neoClose®) system versus standard suture closure', 'Trocar site closure with a novel anchor-based (neoClose ® ) system versus standard suture closure']",[],[],"[{'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],,0.0818903,Statistical significance of the results was not affected and the conclusions of the study remain unchanged.,"[{'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Iranmanesh', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Angielyn R', 'Initials': 'AR', 'LastName': 'Rivera', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Kulvinder S', 'Initials': 'KS', 'LastName': 'Bajwa', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Alibhai', 'Affiliation': 'Surgical Group of North Texas, Grapevine, TX, USA.'}, {'ForeName': 'Brad E', 'Initials': 'BE', 'LastName': 'Snyder', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Felinski', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Sheilendra S', 'Initials': 'SS', 'LastName': 'Mehta', 'Affiliation': 'Texas Laparoscopic Consultants, Houston, TX, USA.'}, {'ForeName': 'Kavita D', 'Initials': 'KD', 'LastName': 'Chandwani', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Klein', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Walker', 'Affiliation': 'Health First Medical Group, Rockledge, FL, USA.'}, {'ForeName': 'Shinil K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA. shinil.k.shah@uth.tmc.edu.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Wilson', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.156, Houston, TX, 77030, USA.'}]",Surgical endoscopy,['10.1007/s00464-019-07111-3']
1779,31479435,Thermotherapy Combined With Therapeutic Exercise Improves Muscle Strength and Depression in Patients With Ischemic Stroke.,"PURPOSE


The study examined the effect of home-based thermotherapy combined with therapeutic exercise on muscle strength and depression in patients with ischemic stroke via a weekly evaluation over 4 weeks.
DESIGN/METHODS


A quasi-experimental, pre-/posttest research design without a control group was employed. A total of 22 patients participated. Self-reported daily logs were used to evaluate intervention adherence over the study period. The manual muscle testing and Aphasic Depression Rating Scale were administered at baseline and weekly for 4 weeks.
RESULTS


Muscle strength in both the upper and lower limbs significantly increased (p < .05), whereas the depression score significantly decreased (p < .05).
CONCLUSION


The intervention increased muscle strength and decreased depression during the first 3 months after stroke onset. The significant effects were found beginning during the third week of the intervention.
CLINICAL RELEVANCE


This intervention is inexpensive and can be easily applied by caregivers at home.",2019,"RESULTS


Muscle strength in both the upper and lower limbs significantly increased (p < .05), whereas the depression score significantly decreased (p < .05).
","['22 patients participated', 'Patients With Ischemic Stroke', 'patients with ischemic stroke via a weekly evaluation over 4 weeks']","['home-based thermotherapy combined with therapeutic exercise', 'Thermotherapy Combined With Therapeutic Exercise']","['Muscle strength', 'muscle strength and depression', 'Muscle Strength and Depression', 'manual muscle testing and Aphasic Depression Rating Scale', 'depression score', 'muscle strength and decreased depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020548', 'cui_str': 'Fever Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",,0.0118678,"RESULTS


Muscle strength in both the upper and lower limbs significantly increased (p < .05), whereas the depression score significantly decreased (p < .05).
","[{'ForeName': 'Yovita Dwi', 'Initials': 'YD', 'LastName': 'Setiyowati', 'Affiliation': 'Department of Nursing, Sint Carolus School of Health Sciences, Jakarta, Indonesia.'}, {'ForeName': 'Shan-Tair', 'Initials': 'ST', 'LastName': 'Wang', 'Affiliation': 'Institute of Gerontology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsing-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/rnj.0000000000000114']
1780,31482359,Impact of robotic assistance on mental workload and cognitive performance of surgical trainees performing a complex minimally invasive suturing task.,"BACKGROUND


Few studies have investigated the potential impact of robotic assistance on cognitive ergonomics during advanced minimally invasive surgery. The purpose of this study was to assess the impact of robotic assistance on mental workload and downstream cognitive performance in surgical trainees.
METHODS


Robot-naïve trainees from general surgery, urology and gynaecology, stratified by specialty and level of training, were randomised to either laparoscopic surgery (LS) or robotic-assisted laparoscopic surgery (RALS) and performed a time-limited, complex laparoscopic suturing task after watching a 5-min instructional video. The RALS group received an additional 5-min orientation to the robotic console. Subjective mental workload was measured using NASA Task Load Index. Concentration and executive cognitive function were assessed using Psychomotor Vigilance Task (PVT) and Wisconsin Card Sorting Test (WCST), respectively. A p value of 0.05 was considered significant.
RESULTS


Sixteen senior residents (SR; ≥ PGY3) and 14 junior residents (JR; PGY1-2) completed the study. There was no difference in mental workload between LS and RALS. Within JR there was no difference in task completion time comparing LS versus RALS; however, LS was associated with impaired concentration post-task versus pre-task (PVT reaction time 306 versus 324 ms, p = 0.03), which was not observed for RALS. In contrast, amongst SR, RALS took significantly longer than LS (10.3 vs. 14.5 min, p = 0.02) and was associated with significantly worse performance on WCST (p < 0.01).
CONCLUSIONS


Robotic assistance, in this setting, did not provide a technical performance advantage nor impact subjective mental workload with novice users regardless of level of surgery training. We observed a protective effect on cognitive performance offered by RALS to junior trainees with limited LS experience, yet a detrimental effect on senior trainees with greater LS ability and inadequate pre-study robotic training, suggesting that robotic consoles may be mentally taxing for robotic novices and consideration should be given to formal console training prior to initial clinical exposure.",2020,"CONCLUSIONS


Robotic assistance, in this setting, did not provide a technical performance advantage nor impact subjective mental workload with novice users regardless of level of surgery training.","['junior trainees with limited LS experience', 'Sixteen senior residents (SR; ≥\u2009PGY3) and 14 junior residents (JR; PGY1-2) completed the study', 'surgical trainees', 'Robot-naïve trainees from general surgery, urology and gynaecology, stratified by specialty and level of training', 'advanced minimally invasive surgery']","['laparoscopic surgery (LS) or robotic-assisted laparoscopic surgery (RALS) and performed a time-limited, complex laparoscopic suturing task after watching a 5-min instructional video', 'robotic assistance', 'surgical trainees performing a complex minimally invasive suturing task']","['Subjective mental workload', 'mental workload and cognitive performance', 'cognitive ergonomics', 'mental workload', 'Psychomotor Vigilance Task (PVT) and Wisconsin Card Sorting Test (WCST', 'task completion time', 'mental workload and downstream cognitive performance', 'Concentration and executive cognitive function', 'cognitive performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C4505392', 'cui_str': 'Cognitive Ergonomics'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions (observable entity)'}]",16.0,0.110122,"CONCLUSIONS


Robotic assistance, in this setting, did not provide a technical performance advantage nor impact subjective mental workload with novice users regardless of level of surgery training.","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lau', 'Affiliation': 'CSTAR (Canadian Surgical Technologies & Advanced Robotics), London Health Sciences Centre, London, Canada. elau9@uwo.ca.'}, {'ForeName': 'Nawar A', 'Initials': 'NA', 'LastName': 'Alkhamesi', 'Affiliation': 'CSTAR (Canadian Surgical Technologies & Advanced Robotics), London Health Sciences Centre, London, Canada.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Schlachta', 'Affiliation': 'CSTAR (Canadian Surgical Technologies & Advanced Robotics), London Health Sciences Centre, London, Canada.'}]",Surgical endoscopy,['10.1007/s00464-019-07038-9']
1781,31419597,Recovery of offline and online sentence processing in aphasia: Language and domain-general network neuroplasticity.,"This paper examined the effects of treatment on both offline and online sentence processing and associated neuroplasticity within sentence processing and dorsal attention networks in chronic stroke-induced agrammatic aphasia. Twenty-three neurotypical adults and 19 individuals with aphasia served as participants. Aphasic individuals were randomly assigned to receive a 12-week course of linguistically-based treatment of passive sentence production and comprehension (N = 14, treatment group) or to serve as control participants (N = 5, natural history group). Both aphasic groups performed two offline tasks at baseline and three months following (at post-testing) to assess production and comprehension of trained passive structures and untrained syntactically related and unrelated structures. The aphasic participants and a healthy age-matched group also performed an online eyetracking comprehension task and a picture-verification fMRI task, which were repeated at post-testing for the aphasic groups. Results showed that individuals in the treatment, but not in the natural history, group improved on production and comprehension of both trained structures and untrained syntactically related structures. Treatment also resulted in a shift toward more normal-like eye movements and a significant increase in neural activation from baseline to post-testing. Upregulation encompassed right hemisphere regions homologs of left hemisphere regions involved in both sentence processing and domain-general functions and was positively correlated with treatment gains, as measured by offline comprehension accuracy, and with changes in processing strategies during sentence comprehension, as measured by eyetracking. These findings provide compelling evidence in favor of the contribution of both networks within the right hemisphere to the restoration of normal-like sentence processing patterns in chronic aphasia.",2019,"Results showed that individuals in the treatment, but not in the natural history, group improved on production and comprehension of both trained structures and untrained syntactically related structures.","['Aphasic individuals', 'Twenty-three neurotypical adults and 19 individuals with aphasia served as participants', 'aphasia', 'chronic stroke-induced agrammatic aphasia']","['linguistically-based treatment of passive sentence production and comprehension (N\xa0=\xa014, treatment group) or to serve as control participants (N\xa0=\xa05, natural history group', 'online eyetracking comprehension task and a picture-verification fMRI task']","['normal-like eye movements', 'production and comprehension of both trained structures and untrained syntactically related structures', 'neural activation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033268'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0033268'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]",,0.0289431,"Results showed that individuals in the treatment, but not in the natural history, group improved on production and comprehension of both trained structures and untrained syntactically related structures.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA. Electronic address: elena.barbieri@northwestern.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mack', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Chiappetta', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Europa', 'Affiliation': 'Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Cynthia K', 'Initials': 'CK', 'LastName': 'Thompson', 'Affiliation': ""Center for the Neurobiology of Language Recovery, Northwestern University, Evanston, IL, USA; Cognitive Neurology and Alzheimer's Disease Center, Northwestern University, Chicago, IL, USA; Department of Neurology, Northwestern University, Chicago, IL, USA.""}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2019.06.015']
1782,31479717,"Cardiovascular benefits of tyrosol and its endogenous conversion into hydroxytyrosol in humans. A randomized, controlled trial.","INTRODUCTION


The simple phenol hydroxytyrosol (OHTyr) has been associated with the beneficial health effects of extra virgin olive oil. Pre-clinical studies have identified Tyr hydroxylation, mediated by cytochrome P450 isoforms CYP2A6 and CYP2D6, as an additional source of OHTyr.
AIM


We aimed to (i) confirm Tyr to OHTyr bioconversion in vivo in humans, (ii) assess the cardiovascular benefits of this bioconversion, and (iii) determine their interaction with a polygenic activity score (PAS) from CYP2A6 and CYP2D6 genotypes.
METHODS


Randomized, crossover, controlled study. Individuals at cardiovascular risk (n = 33) received: white wine (WW) (females 1, males 2 standard drinks/day), WW plus Tyr capsules (WW + Tyr) (25  mg Tyr capsule, one per WW drink), and water (control) ad libitum. Participants were classified by a PAS as low versus normal activity metabolizers.
RESULTS


OHTyr recovery following WW + Tyr was higher than after other interventions (P < 0.05). Low PAS individuals had lower OHTyr/Tyr ratios compared to individuals with normal PAS. WW + Tyr improved endothelial function, increased plasma HDL-cholesterol and antithrombin IIII, and decreased plasma homocysteine, endothelin 1, and CD40L, P65/RELA, and CFH gene expression in peripheral blood mononuclear cells (p < 0.05). Combining Tyr capsule(s) with WW abolished the increase in iNOS, eNOS, VEGFA, and CHF expressions promoted by WW (p < 0.05).
CONCLUSIONS


Tyr, and its partial biotransformation into OHTyr, promoted cardiovascular health-related benefits in humans after dietary doses of Tyr. The study design allowed the health effects of individual phenols to be singled out from the dietary matrix in which they are naturally found.",2019,Low PAS individuals had lower OHTyr/,"['humans', 'Individuals at cardiovascular risk (n\xa0=\xa033) received']","[' white wine (WW) (females 1, males 2 standard drinks/day), WW plus Tyr capsules (WW\xa0+\xa0Tyr) (25\xa0\xa0mg', 'WW\xa0', 'phenol hydroxytyrosol (OHTyr']","['iNOS, eNOS, VEGFA, and CHF expressions', 'polygenic activity score (PAS', 'endothelial function, increased plasma HDL-cholesterol and antithrombin IIII, and decreased plasma homocysteine, endothelin 1, and CD40L, P65/RELA, and CFH gene expression in peripheral blood mononuclear cells']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0349372', 'cui_str': 'White wine (substance)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0147288', 'cui_str': 'Tyr(TMA)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0299809', 'cui_str': 'p65(PAK)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",,0.053272,Low PAS individuals had lower OHTyr/,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Boronat', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Dr. Aiguader 88, 08003, Barcelona, Spain; Department of Experimental and Health Sciences, Universitat Pompeu Fabra (CEXS-UPF), Dr. Aiguader 80, 08003, Barcelona, Spain.""}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Mateus', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Dr. Aiguader 88, 08003, Barcelona, Spain.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Soldevila-Domenech', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Dr. Aiguader 88, 08003, Barcelona, Spain; Department of Experimental and Health Sciences, Universitat Pompeu Fabra (CEXS-UPF), Dr. Aiguader 80, 08003, Barcelona, Spain.""}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Guerra', 'Affiliation': 'Department of Experimental and Health Sciences, Universitat Pompeu Fabra (CEXS-UPF), Dr. Aiguader 80, 08003, Barcelona, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodríguez-Morató', 'Affiliation': 'Department of Experimental and Health Sciences, Universitat Pompeu Fabra (CEXS-UPF), Dr. Aiguader 80, 08003, Barcelona, Spain; CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN, CB06/03/028), Monforte de Lemos 3-5, 28029, Madrid, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Varon', 'Affiliation': ""Department of Pharmacy, Vall d'Hebron Barcelona Hospital Campus, Passeig de Vall d'Hebron 119-129, 08035, Barcelona, Spain.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, IMIM (Hospital del Mar Research Institute), Dr. Aiguader 88, 08003, Barcelona, Spain; CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN, CB06/03/028), Monforte de Lemos 3-5, 28029, Madrid, Spain.'}, {'ForeName': 'Francina', 'Initials': 'F', 'LastName': 'Barbosa', 'Affiliation': 'CAP Barceloneta, Parc Sanitari Rovira Virgili, Passeig Marítim, 25 08003, Barcelona, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Morales', 'Affiliation': 'Department of Biochemistry and Molecular Pharmacology, Instituto de Parasitología y Biomedicina López Neyra, CSIC, PTS Granada, Avda. del Conocimiento 17, 18016, Armilla, Granada, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gaedigk', 'Affiliation': ""Children's Mercy Kansas City, Division of Clinical Pharmacology, Toxicology and Therapeutic Innovation, and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Langohr', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Dr. Aiguader 88, 08003, Barcelona, Spain; Department of Statistics and Operations Research, Polytechnic University of Catalonia, Barcelona, Spain.""}, {'ForeName': 'Maria-Isabel', 'Initials': 'MI', 'LastName': 'Covas', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, IMIM (Hospital del Mar Research Institute), Dr. Aiguader 88, 08003, Barcelona, Spain; NUPROAS Handesbolag (NUPROAS HB), Nacka, Sweden.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Pérez-Mañá', 'Affiliation': 'School of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain; Hospital Universitari Germans Trias i Pujol (IGTP), Badalona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Cardiovascular Risk and Nutrition Research Group, IMIM (Hospital del Mar Research Institute), Dr. Aiguader 88, 08003, Barcelona, Spain; CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN, CB06/03/028), Monforte de Lemos 3-5, 28029, Madrid, Spain.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': ""Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Departments of Pharmacology & Toxicology, and Psychiatry, University of Toronto, 1 King's College Circle, Toronto, ON M5S 1A8, Canada.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Neurosciences Research Program, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Dr. Aiguader 88, 08003, Barcelona, Spain; Department of Experimental and Health Sciences, Universitat Pompeu Fabra (CEXS-UPF), Dr. Aiguader 80, 08003, Barcelona, Spain; CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN, CB06/03/028), Monforte de Lemos 3-5, 28029, Madrid, Spain. Electronic address: rtorre@imim.es.""}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2019.08.032']
1783,29610236,Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy.,,2018,,['adults with primary mitochondrial myopathy'],['elamipretide'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0162670', 'cui_str': 'Mitochondrial Myopathies'}]",[{'cui': 'C4279623'}],[],,0.0643836,,[],Neurology,['10.1212/WNL.0000000000005461']
1784,31266825,A Randomized Controlled Trial Testing Provision of Fecal and Blood Test Options on Participation for Colorectal Cancer Screening.,"Suboptimal participation is commonly observed in colorectal cancer screening programs utilizing fecal tests. This randomized controlled trial tested whether the offer of a blood test as either a ""rescue"" strategy for fecal test nonparticipants or an upfront choice, could improve participation. A total of 1,800 people (50-74 years) were randomized to control, rescue, or choice groups ( n  = 600/group). All were mailed a fecal immunochemical test (FIT, OC-Sensor, Eiken Chemical Company) and a survey assessing awareness of the screening tests. The rescue group was offered a blood test 12 weeks after FIT nonparticipation. The choice group was given the opportunity to choose to do a blood test (Colvera, Clinical Genomics) instead of FIT at baseline. Participation with any test after 24 weeks was not significantly different between groups (control, 37.8%; rescue, 36.9%; choice, 33.8%;  P  > 0.05). When the rescue strategy was offered after 12 weeks, an additional 6.5% participated with the blood test, which was greater than the blood test participation when offered as an upfront choice (1.5%;  P  < 0.001). Awareness of the tests was greater for FIT than for blood (96.2% vs. 23.1%;  P  < 0.0001). In a population familiar with FIT screening, provision of a blood test either as a rescue of FIT nonparticipants or as an upfront choice did not increase overall participation. This might reflect a lack of awareness of the blood test for screening compared with FIT.",2019,"Awareness of the tests was greater for FIT than for blood (96.2% vs 23.1%, p<0.0001).","['colorectal cancer screening', '1800 people (50-74y']",['fecal and blood test options'],"['fecal immunochemical test (FIT, OC-Sensor, Eiken Chemical Company']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0018941', 'cui_str': 'Blood Tests'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}]",,0.173561,"Awareness of the tests was greater for FIT than for blood (96.2% vs 23.1%, p<0.0001).","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Symonds', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia. Erin.Symonds@sa.gov.au.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Flight', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, School of Medicine, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Centre for Health Economics, Monash University, Caulfield East, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'College of Nursing and Health Sciences, Health and Social Care Economics Group, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Genomics Pty Ltd, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Robert J L', 'Initials': 'RJL', 'LastName': 'Fraser', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Carlene J', 'Initials': 'CJ', 'LastName': 'Wilson', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Graeme P', 'Initials': 'GP', 'LastName': 'Young', 'Affiliation': 'Flinders Centre for Innovation in Cancer, Bedford Park, South Australia, Australia.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0089']
1785,29578977,Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial: Correction.,,2018,,['After Membrane Rupture'],"['Foley Plus Oxytocin', 'Oxytocin']",[],"[{'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],,0.418757,,[],Obstetrics and gynecology,['10.1097/AOG.0000000000002541']
1786,31475502,A comparison of two interventions in the treatment of severe ankle sprains and lateral malleolar avulsion fractures.,"AIM


Stable ankle injuries are highly prevalent in the UK. Prevention of complications and reoccurrence is essential. The literature shows that plaster of Paris and AirLoc brace are clinically effective treatments for such injuries. However, there is no research measuring patients' satisfaction with these treatments. This study compared options in the treatment of severe ankle sprains and distal fibular avulsion fractures from patients' perspectives. The aim was to determine patients' preferred treatment between below knee plaster cast and AirLoc brace in the management of stable ankle injuries.
METHOD


A total of 39 patients who presented at an urban hospital with stable ankle injuries were recruited into a randomised controlled trial. Patient satisfaction levels were measured by questionnaire one week into treatment. The null hypothesis was 'there is no significant difference in satisfaction levels between the two devices'.
FINDINGS


There were statistically significant higher patient satisfaction levels in the AirLoc group compared to the plaster cast group. After analysis by the unrelated t -test, the null hypothesis was rejected. Comfort, daily activities, sleep, work and social life were the main contributing factors. Additionally, 67% of the AirLoc group compared to 46% of the plaster cast group were able to return to work. The number needed to treat for one additional AirLoc patient to return to work was 4.8 (five patients).
CONCLUSION


Patients' preferred treatment is the AirLoc brace. The inquiry method could be used to provide patient-centred care in other fields.",2019,There were statistically significant higher patient satisfaction levels in the AirLoc group compared to the plaster cast group.,"['severe ankle sprains and lateral malleolar avulsion fractures', ""severe ankle sprains and distal fibular avulsion fractures from patients' perspectives"", '39 patients who presented at an urban hospital with stable ankle injuries']",['knee plaster cast and AirLoc brace'],"['Comfort, daily activities, sleep, work and social life', 'patient satisfaction levels', 'satisfaction levels', 'Patient satisfaction levels']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332758', 'cui_str': 'Sprain Fracture'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0085111', 'cui_str': 'Ankle Injuries'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0032159', 'cui_str': 'Plaster Casts'}, {'cui': 'C0006086', 'cui_str': 'Braces'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0394989,There were statistically significant higher patient satisfaction levels in the AirLoc group compared to the plaster cast group.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, England.'}]",Emergency nurse : the journal of the RCN Accident and Emergency Nursing Association,['10.7748/en.2019.e1945']
1787,31133472,Visit-to-Visit Blood Pressure Variability and Progression of White Matter Hyperintensities Among Older People With Hypertension.,"OBJECTIVES


Visit-to-visit blood pressure (BP) variability is a risk factor for cardiovascular disease and cognitive decline. Our aim was to assess the association between visit-to-visit BP variability and progression of white matter hyperintensities (WMH).
DESIGN


Post-hoc analysis in the magnetic resonance imaging substudy of the randomized controlled trial prevention of dementia by intensive vascular care.
SETTING AND PARTICIPANTS


Community-dwelling people age 70-78 years with hypertension.
METHODS


Participants had 3 to 5 twice yearly BP measurements and 2 magnetic resonance imaging scans at 3 and 6 years follow-up. We used linear regression adjusted for age, sex, WMH at scan 1, (change in) total brain volume, and cardiovascular risk factors.
RESULTS


Among the 122 participants, there was a modest association between visit-to-visit systolic BP variability and WMH progression [beta = 0.03 mL/y per point increase in variability, 95% confidence interval (CI) 0.00-0.05, P = .058]. Additional adjustment for slope in systolic BP reduced the associated P value to .043. Visit-to-visit diastolic BP variability was not associated with WMH progression (beta = 0.01 mL/y, 95% CI -0.02 to 0.03, P = .68). Visit-to-visit pulse pressure variability was associated with WMH progression (beta 0.03 mL/y, 95% CI 0.01-0.05, P < .01).
CONCLUSIONS


Higher visit-to-visit systolic BP and pulse pressure variability is associated with more progression of WMH among people age 70-78 years with hypertension.
IMPLICATIONS


Interventions to reduce visit-to-visit BP variability may be most effective in people with low WMH burden.",2019,Visit-to-visit diastolic BP variability was not associated with WMH progression (beta = 0.01 ,"['people with low WMH burden', 'Community-dwelling people age 70-78\xa0years with hypertension', 'Participants had 3 to 5 twice yearly BP measurements and 2 magnetic resonance imaging scans at 3 and 6\xa0years follow-up', '122 participants', 'Older People With Hypertension', 'people age 70-78\xa0years with hypertension']",[],"['Higher visit-to-visit systolic BP and pulse pressure variability', 'systolic BP', 'WMH progression', 'Visit-to-visit diastolic BP variability', 'visit-to-visit systolic BP variability and WMH progression [beta\xa0']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",122.0,0.145461,Visit-to-visit diastolic BP variability was not associated with WMH progression (beta = 0.01 ,"[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'van Middelaar', 'Affiliation': 'Department of Neurology, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: t.vanmiddelaar@amc.uva.nl.'}, {'ForeName': 'Edo', 'Initials': 'E', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Moll van Charante', 'Affiliation': 'Department of General Practice, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'van Gool', 'Affiliation': 'Department of Neurology, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van Dalen', 'Affiliation': 'Department of Neurology, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.04.003']
1788,29876684,Correction to: Factors predicting chronic pain after open inguinal hernia repair: a regression analysis of randomized trial comparing three different meshes with three fixation methods (FinnMesh Study).,"In the original publication, co-authors affiliations were incorrect.",2018,"In the original publication, co-authors affiliations were incorrect.",['after open inguinal hernia repair'],[],['chronic pain'],"[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}]",[],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",,0.112686,"In the original publication, co-authors affiliations were incorrect.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matikainen', 'Affiliation': 'Department of Surgery, North Karelia Central Hospital, Tikkamäentie 16, 80210, Joensuu, Finland. markku.matikainen@siunsote.fi.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aro', 'Affiliation': 'Department of Surgery, North Karelia Central Hospital, Tikkamäentie 16, 80210, Joensuu, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vironen', 'Affiliation': 'Department of Surgery, Helsinki University Hospital, Turuntie 150, 02740, Espoo, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kössi', 'Affiliation': 'Department of Surgery, Paijat-Hame Central Hospital, Keskussairaalankatu 7, 15850, Lahti, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hulmi', 'Affiliation': 'Department of Surgery, North Karelia Central Hospital, Tikkamäentie 16, 80210, Joensuu, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Silvasti', 'Affiliation': 'Department of Surgery, North Karelia Central Hospital, Tikkamäentie 16, 80210, Joensuu, Finland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ilves', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Porrassalmenkatu 35, 50100, Mikkeli, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hertsi', 'Affiliation': 'Department of Surgery, Savonlinna Central Hospital, Keskussairaalantie 6, 57120, Savonlinna, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mustonen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Puijonlaaksontie 2, 70210, Kuopio, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Paajanen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Puijonlaaksontie 2, 70210, Kuopio, Finland.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-018-1788-y']
1789,30006024,The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial.,"INTRODUCTION


Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders.
OBJECTIVES


This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV.
METHODS


Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed.
DISCUSSION


This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.",2018,"This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.","['Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores', 'patients with severe alcohol use disorders', 'patients ever infected with HCV', 'patients with a history of comorbid HCV and alcohol use', 'patients with hepatitis C virus (HCV']","['enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention', 'enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling', 'integrated alcohol treatment', 'Hep ART intervention combined enhanced TAU', 'Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention', 'usual (TAU', 'HCV-alcohol treatment']","['alcohol consumption and economic outcomes', 'Timeline Followback (TLFB', 'alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0678274', 'cui_str': 'Abstinences, Alcohol'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0475427,"This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.","[{'ForeName': 'Rae Jean', 'Initials': 'RJ', 'LastName': 'Proeschold-Bell', 'Affiliation': 'Duke Global Health Institute, Duke University, Box 90392, Durham, NC 27708-0392, USA; Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: Rae.jean@duke.edu.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Evon', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States. Electronic address: Donna_evon@med.unc.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Makarushka', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: Christina.makarushka@duke.edu.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Wong', 'Affiliation': 'Division of Clinical Decision Making, Tufts Medical Center, 800 Washington St #302, Boston, MA 02111, USA. Electronic address: JWong@TuftsMedicalCenter.org.'}, {'ForeName': 'Santanu K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Department of Medicine, Duke University, 411 West Chapel Hill St, Suite 500, Durham, NC 27701, USA. Electronic address: santanu.datta@duke.edu.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Box 90392, Durham, NC 27708-0392, USA. Electronic address: jia.yao@duke.edu.'}, {'ForeName': 'Ashwin A', 'Initials': 'AA', 'LastName': 'Patkar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States; Department of Community and Family Medicine, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States. Electronic address: Ashwin.patkar@duke.edu.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2213 Elba Street, Suite 165, Durham, NC 27705, United States. Electronic address: paolo.mannelli@duke.edu.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Hodge', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA. Electronic address: Terra.hodge@duke.edu.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Naggie', 'Affiliation': 'Duke University School of Medicine, Infectious Diseases, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA; Durham VA Medical Center, Durham, NC 27705, USA. Electronic address: susanna.naggie@duke.edu.'}, {'ForeName': 'Julius M', 'Initials': 'JM', 'LastName': 'Wilder', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA. Electronic address: julius.wilder@duke.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fried', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, CB# 7584, Chapel Hill, NC 27599-7584, United States. Electronic address: mfried@med.unc.edu.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Box 2721, Durham, NC 27710, United States. Electronic address: donna.niedzwiecki@duke.edu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, DUMC 3913, Durham, NC 27710, USA; Duke Clinical Research Institute, 2400 Pratt Street, Rm. 0311, Terrace Level, Durham, NC 27705, USA. Electronic address: Andrew.muir@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.003']
1790,31463529,Patient navigation for overactive bladder improves access to care.,"INTRODUCTION AND HYPOTHESIS


Patients with overactive bladder (OAB) become discouraged with medication therapy because of the side effects, minimal subjective improvement and costs of therapy. With the implementation of a patient navigation pathway there is increased communication, subsequently leading to increased patient retention rates and utilization of third-line therapies.
METHODS


This was a quality improvement study carried out over a 17-month period comparing utilization of a navigation pathway versus patients without navigation. The data were obtained using an online database (PPS Analytics) to compare medication use, cystoscopy, urodynamic studies, use of third-line therapy, and return visits.
RESULTS


A total of 535 patients were included in the analysis and broken down into two respective groups. Group 1 were those placed on the navigation pathway and able to be reached via telephone (n = 431). Group 2 were those started on the navigation pathway who were not able to be reached via telephone, but were chart reviewed by a navigator (n = 104). Third-line therapy usage for groups 1 and 2 was 24% and 11% respectively. Return visits for additional OAB management for groups 1 and 2 were found to be 71% and 50% respectively.
CONCLUSION


Patient retention levels and utilization of third-line therapies are significantly improved when utilizing a navigation pathway. With 24% of the patients included in this study opting for third-line therapy, this represents a 600% increase in third-line therapies over national averages.",2020,"With the implementation of a patient navigation pathway there is increased communication, subsequently leading to increased patient retention rates and utilization of third-line therapies.
","['A total of 535 patients were included in the analysis and broken down into two respective groups', 'Patients with overactive bladder (OAB']",['navigation pathway versus patients without navigation'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443161', 'cui_str': 'Breaking down (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],535.0,0.0178035,"With the implementation of a patient navigation pathway there is increased communication, subsequently leading to increased patient retention rates and utilization of third-line therapies.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rohloff', 'Affiliation': 'Metro Health Hospital: University of Michigan Health Department of Urological Surgery, 5900 Byron Center Avenue, Wyoming, MI, 49519, USA. Matthew.Rohloff@metrogr.org.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Peifer', 'Affiliation': 'Metro Health Hospital: University of Michigan Health Department of Urological Surgery, 5900 Byron Center Avenue, Wyoming, MI, 49519, USA.'}, {'ForeName': 'Jannah H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Metro Health Hospital: University of Michigan Health Department of Urological Surgery, 5900 Byron Center Avenue, Wyoming, MI, 49519, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04085-7']
1791,31443716,"A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections.","BACKGROUND


Over many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. This study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent RTIs in children.
METHODS


This study was a randomized (3:3:1), placebo-controlled, double-blind, single-centre, phase IV trial carried out in Italy to assess the efficacy of OM-85 (Broncho-Vaxom ® ; Vifor Pharma; Meyrin 2/Geneva, Switzerland) in reducing the number of new RTI episodes in 288 children aged 1 to 6 years with a history of recurrent RTIs and to compare the efficacy of the standard 3-month regimen with that of administration of OM-85 for 6 months during a 6-month study period.
RESULTS


The number of RTIs and of children who experienced at least one RTI were significantly lower among patients receiving OM-85 for 3 months than among those given placebo (33% vs 65.1%, p < 0.0001). Differences were statistically significant for upper RTIs (i.e., common cold/viral pharyngitis and acute otitis media; p < 0.0001 and p = 0.006, respectively). Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively). No difference was seen between children who received OM-85 for 3 and those who received OM-85 for 6 months. The prevalence of atopy as well as the history of recurrent wheezing and age of the study child did not influence the results. Benefit was maximally evident among children with a history of frequent recurrences. OM-85 was well tolerated and safe, even in children who received an influenza vaccination.
CONCLUSIONS


The use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile. The greater effect observed in children prone to several respiratory episodes than in non-prone children seems to indicate that this lysate should be administered especially to children with a proven high susceptibility to RTIs.",2019,"Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively).","['children suffering from recurrent respiratory tract infections', '288 children aged 1 to 6\xa0years with a history of recurrent RTIs', 'children']","['placebo', 'OM-85', 'OM-85 (Broncho-Vaxom ® ']","['tolerated and safe', 'number of RTIs', 'efficacy and safety', 'risk of recurrent RTIs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0863094', 'cui_str': 'Recurrent respiratory tract infections'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0054145', 'cui_str': 'Broncho-Vaxom'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",288.0,0.104231,"Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively).","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy. susanna.esposito@unimi.it.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bianchini', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bosis', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Tagliabue', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Coro', 'Affiliation': ""Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Argentiero', 'Affiliation': 'Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Principi', 'Affiliation': 'Università degli Studi di Milano, Milan, Italy.'}]",Journal of translational medicine,['10.1186/s12967-019-2040-y']
1792,31722694,STructured lifestyle education for people WIth SchizophrEnia (STEPWISE): mixed methods process evaluation of a group-based lifestyle education programme to support weight loss in people with schizophrenia.,"BACKGROUND


STEPWISE is a theory-informed self-management education programme that was co-produced with service users, healthcare professionals and interventionists to support weight loss for people with schizophrenia. We report the process evaluation to inform understanding about the intervention and its effectiveness in a randomised controlled trial (RCT) that evaluated its efficacy.
METHODS


Following the UK Medical Research Council (MRC) Guidelines for developing and evaluating complex interventions, we explored implementation quality. We considered causal mechanisms, unanticipated consequences and contextual factors associated with variation in actual and intended outcomes, and integrated treatment fidelity, using the programme theory and a pipeline logic model. We followed a modified version of Linnan and Steckler's framework and single case design. Qualitative data from semi-structured telephone interviews with service-users (n = 24), healthcare professionals delivering the intervention (n = 20) and interventionists (n = 7) were triangulated with quantitative process and RCT outcome data and with observations by interventionists, to examine convergence within logic model components.
RESULTS


Training and course materials were available although lacked co-ordination in some trusts. Healthcare professionals gained knowledge and some contemplated changing their practice to reflect the (facilitative) 'style' of delivery. They were often responsible for administrative activities increasing the burden of delivery. Healthcare professionals recognised the need to address antipsychotic-induced weight gain and reported potential value from the intervention (subject to the RCT results). However, some doubted senior management commitment and sustainability post-trial. Service-users found the intervention highly acceptable, especially being in a group of people with similar experiences. Service-users perceived weight loss and lifestyle benefits; however, session attendance varied with 23% (n = 47) attending all group-sessions and 17% (n = 36) attending none. Service-users who lost weight wanted closer monitoring and many healthcare professionals wanted to monitor outcomes (e.g. weight) but it was outside the intervention design. No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention.
CONCLUSIONS


This process evaluation provides a greater understanding of why STEPWISE was unsuccessful in promoting weight loss during the clinical trial. Further research is required to evaluate whether different levels of contact and objective monitoring can support people with schizophrenia to lose weight.
TRIAL REGISTRATION


ISRCTN, ISRCTN19447796. Registered 20 March 2014.",2019,"No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention.
","['people with schizophrenia', 'people WIth SchizophrEnia (STEPWISE']","['mixed methods process evaluation of a group-based lifestyle education programme', 'healthcare professionals delivering the intervention']","['RCT outcomes', 'weight loss']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0741741,"No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gossage-Worrall', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. r.gossage-worrall@sheffield.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hind', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.'}, {'ForeName': 'Katharine D', 'Initials': 'KD', 'LastName': 'Barnard-Kelly', 'Affiliation': 'Faculty of Health & Social Science, Bournemouth University, Poole, Dorset, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Honorary Research Consultant, Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust and Honorary Reader in Early Psychosis, School of Health Sciences, Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Etherington', 'Affiliation': 'Patient Representative, Independent Service User Consultant, Manchester, UK.'}, {'ForeName': 'Lizzie', 'Initials': 'L', 'LastName': 'Swaby', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.'}, {'ForeName': 'Richard I G', 'Initials': 'RIG', 'LastName': 'Holt', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC psychiatry,['10.1186/s12888-019-2282-5']
1793,31947038,Using Virtual Reality to Examine the Neural and Physiological Responses to Height and Perturbations in Quiet Standing.,"We describe an experimental setup, which uses virtual reality to understand neural responses to height and perturbations in human postural control. This system could help clinicians develop better methods to alleviate symptoms from a significant fear of heights, especially in the elderly and those with movement disorders, such as Parkinson's disease. In our design, EEG and EKG systems monitor the participants' neural responses and heart activities respectively, while they try to maintain balance on a force plate in an induced virtual world, experiencing randomized height changes and perturbations. These responses are then analyzed to understand the participants' anxiety caused by height and postural challenges.",2019,"This system could help clinicians develop better methods to alleviate symptoms from a significant fear of heights, especially in the elderly and those with movement disorders, such as Parkinson's disease.",[],[],[],[],[],[],,0.0199412,"This system could help clinicians develop better methods to alleviate symptoms from a significant fear of heights, especially in the elderly and those with movement disorders, such as Parkinson's disease.","[{'ForeName': 'Rachneet', 'Initials': 'R', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Rongyi', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Ziegelman', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sowers', 'Affiliation': ''}, {'ForeName': 'Manuel E', 'Initials': 'ME', 'LastName': 'Hernandez', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,['10.1109/EMBC.2019.8857647']
1794,31503332,Safety and efficacy of trabectedin when administered in the inpatient versus outpatient setting: Clinical considerations for outpatient administration of trabectedin.,"BACKGROUND


The results of the randomized, phase 3 ET743-SAR-3007 trial demonstrated that trabectedin had a significantly longer progression-free survival (PFS) compared with dacarbazine in patients with advanced leiomyosarcoma/liposarcoma after the failure of prior chemotherapy. Patients randomized to trabectedin received a 24-hour intravenous infusion either in an inpatient or outpatient setting. Herein, the authors reported the safety, efficacy, and patient-reported outcomes based on first infusion site of care.
METHODS


Patients were randomized 2:1 to trabectedin (at a dose of 1.5 mg/m 2  ) or dacarbazine (1 g/m 2  over 20-120 minutes) with overall survival (OS) as the primary endpoint and PFS, time to disease progression, objective response rate, duration of response, safety, and patient-reported symptom scoring as secondary endpoints. The setting of the trabectedin infusion was based on institutional preference and categorized based on the setting of the first infusion.
RESULTS


Of the 378 patients who were treated with trabectedin, 100 (27%) and 277 (73%), respectively, first received trabectedin in the inpatient and outpatient setting. No differences were observed with regard to PFS or OS based on site of care. The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively. Grade 3/4 adverse events (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]) were reported in 87 inpatients (87%) compared with 219 outpatients (79%); grade 3/4 serious adverse events were reported in 43 inpatients (43%) and 92 outpatients (33%). Extravasation occurred in 0 inpatients and 5 outpatients (2%), whereas the incidence of catheter-related complications was similar between groups (16% vs 15%).
CONCLUSIONS


Although the majority of patients who were randomized to trabectedin received outpatient therapy, the outcomes of the current study suggested equivalent safety and efficacy in either setting.",2019,"The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively.","['Patients', 'patients with advanced leiomyosarcoma/liposarcoma after the failure of prior chemotherapy', '378 patients who were treated with trabectedin, 100 (27%) and 277 (73%), respectively, first received trabectedin in the inpatient and outpatient setting', 'inpatient versus outpatient setting']","['trabectedin', 'dacarbazine']","['longer progression-free survival (PFS', 'median PFS', 'safety, efficacy', 'median OS', 'Safety and efficacy', 'PFS, time to disease progression, objective response rate, duration of response, safety, and patient-reported symptom scoring', 'grade 3/4 serious adverse events', 'Extravasation', 'incidence of catheter-related complications', 'Grade 3/4 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023269', 'cui_str': 'LMS - Leiomyosarcoma'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma (disorder)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",219.0,0.0655235,"The median PFS was 4.1 months versus 4.2 months (hazard ratio, 0.90; P = .49) for inpatients versus outpatients, respectively, and the median OS was 14.3 months versus 13.7 months (hazard ratio, 0.89; P = .40), respectively.","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, Institute of Cancer Research, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Medical Oncology and Hematology, Monter Cancer Center, Northwell Health, New Hyde Park, New York.'}, {'ForeName': 'Shreyaskumar R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Clinical Oncology, Janssen Research & Development LLC, Raritan, New Jersey.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'McGowan', 'Affiliation': 'Medical Group Oncology, Janssen Scientific Affairs LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Shalaby', 'Affiliation': 'Medical Group Oncology, Janssen Scientific Affairs LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Knoblauch', 'Affiliation': 'Clinical Oncology, Janssen Research & Development LLC, Raritan, New Jersey.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32462']
1795,31443893,Mindfulness practice predicts interleukin-6 responses to a mindfulness-based alcohol relapse prevention intervention.,"Chronic alcohol misuse can result in chronically elevated interleukin (IL)-6, a pro-inflammatory cytokine, in the bloodstream. Given that Mindfulness-Based Relapse Prevention (MBRP) has been shown to reduce alcohol misuse, MBRP might also be effective in reducing IL-6 concentrations. Past research has found, however, that IL-6 does not respond consistently to mindfulness-based interventions. Building on prior studies, we examined whether between-person variability in engagement with mindfulness training (i.e., formal mindfulness practice time) is associated with between-person variability in changes in serum IL-6, using data from a randomized controlled trial evaluating MBRP for Alcohol Dependence (MBRP-A). Participants were 72 alcohol dependent adults (mean age = 43.4 years, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n = 46) or after a 26-week delay (n = 26). IL-6 concentrations did not significantly change from pre- to post-intervention for the full sample. Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27). The association between practice time and IL-6 changes remained significant when controlling for intervention timing (i.e., immediate or after the 26-week delay), demographic characteristics, and changes in mindful awareness, obsessive-compulsive drinking, and depressive symptoms. The association between practice time and IL-6 changes was not significant when omitting the minimum treatment dose requirement. Overall, results suggest that the level of engagement in mindfulness training may predict changes in the inflammatory pathophysiology in adults with alcohol dependence.",2019,"Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27).","['Participants were 72 alcohol dependent adults (mean age\u202f=\u202f43.4\u202fyears, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n\u202f=\u202f46) or after a 26-week delay (n\u202f=\u202f26', 'adults with alcohol dependence']","['Mindfulness-Based Relapse Prevention (MBRP', 'mindfulness training', 'IL-6']","['mindful awareness, obsessive-compulsive drinking, and depressive symptoms', 'reduced IL-6 levels', 'IL-6 concentrations', 'mindfulness practice time', 'practice time and IL-6 changes']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",72.0,0.0290657,"Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'McClintock', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States of America. Electronic address: asmcclintock@wisc.edu.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Department of Counseling Psychology, University of Wisconsin-Madison, United States of America.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Coe', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, United States of America.'}, {'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Zgierska', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.018']
1796,31464152,Indirect treatment comparison of valbenazine and deutetrabenazine efficacy and safety in tardive dyskinesia.,"Aim:  Utilize the Bucher indirect treatment comparison (ITC) method to compare valbenazine and deutetrabenazine efficacy using clinical trial data.  Methods:  Outcomes included mean change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response (≥50% improvement), clinical global impression of change response (score ≤2) and safety outcomes. Data were pooled by trial and dose; outcomes were analyzed at multiple time points.  Results:  ITC of AIMS score improvement significantly favored valbenazine 80 mg/day at 6 weeks versus deutetrabenazine 36 mg/day at 8 weeks, while valbenazine 40 mg/day was statistically similar to all doses of deutetrabenazine at all time points. No significant differences between drugs were found in AIMS and clinical global impression of change responses and safety outcomes.  Conclusion:  In this ITC of pooled trial data, valbenazine was generally favorable over deutetrabenazine, although dose titration and equivalency should be considered when interpreting results.",2019,No significant differences between drugs were found in AIMS and clinical global impression of change responses and safety outcomes.  ,['tardive dyskinesia'],"['valbenazine and deutetrabenazine', 'valbenazine', 'deutetrabenazine']","['Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response (≥50% improvement), clinical global impression of change response (score ≤2) and safety outcomes', 'AIMS and clinical global impression of change responses and safety outcomes']","[{'cui': 'C3714760', 'cui_str': 'TD - Tardive dyskinesia'}]","[{'cui': 'C4078701', 'cui_str': 'valbenazine'}, {'cui': 'C4277781', 'cui_str': 'deutetrabenazine'}]","[{'cui': 'C0450978', 'cui_str': 'Abnormal Involuntary Movement Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0529868,No significant differences between drugs were found in AIMS and clinical global impression of change responses and safety outcomes.  ,"[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Aggarwal', 'Affiliation': 'Novel Health Strategies, Columbia, MD 21044, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Serbin', 'Affiliation': 'Neurocrine Biosciences, Inc., San Diego, CA 92130, USA.'}, {'ForeName': 'Chuck', 'Initials': 'C', 'LastName': 'Yonan', 'Affiliation': 'Neurocrine Biosciences, Inc., San Diego, CA 92130, USA.'}]",Journal of comparative effectiveness research,['10.2217/cer-2019-0059']
1797,31454771,"Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes.","OBJECTIVE


To determine whether IV immunoglobulin (IVIg) is more effective than placebo at reducing disability in patients with diabetes and demyelinating polyneuropathy features.
METHODS


This is a double-blinded, single-center, randomized, controlled crossover trial of IVIg treatment vs placebo. The primary outcome measure was the mean change in Overall Neuropathy Limitation Scale (ONLS) scores during the IVIg phasecompared with the placebo phase. Secondary outcomes include changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects.
RESULTS


Twenty-five subjects were recruited between March 2015 and April 2017. The mean change in ONLS scores was -0.2 points during the IVIg phase and 0.0 points during the placebo phase ( p  = 0.23). Secondary outcomes did not show significant differences between IVIg and placebo.
CONCLUSIONS


IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo. Therefore, careful consideration of the primary diagnosis is required before immunomodulatory therapy.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for patients with diabetes and demyelinating polyneuropathy features, IVIg did not significantly reduce disability.",2019,"CONCLUSIONS


IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo.","['Twenty-five subjects were recruited between March 2015 and April 2017', 'patients with diabetes and demyelinating polyneuropathy features', 'patients with diabetes', 'demyelinating polyneuropathy and diabetes']","['placebo', 'IV immunoglobulin (IVIg']","['changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects', 'mean change in Overall Neuropathy Limitation Scale (ONLS) scores', 'mean change in ONLS scores', 'disability, improve strength, or quality of life']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",25.0,0.538441,"CONCLUSIONS


IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo.","[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Breiner', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. abreiner@toh.ca.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barnett Tapia', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Leif Erik', 'Initials': 'LE', 'LastName': 'Lovblom', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'Katzberg', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000586']
1798,31454777,Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).,"OBJECTIVE


To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).
METHODS


In this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS]).
RESULTS


The primary end point was not met. In patients who completed the 2-year follow-up (45 with cholecalciferol and 45 with placebo), all efficacy parameters favored cholecalciferol with an ARR reduction ( p  = 0.012), less new hypointense T1-weighted lesions ( p  = 0.025), a lower volume of hypointense T1-weighted lesions ( p  = 0.031), and a lower progression of EDSS ( p  = 0.026). The overall rate of adverse events was well balanced between groups.
CONCLUSIONS


Although the primary end point was not met, these data suggest a potential treatment effect of cholecalciferol in patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration. Together with the good safety profile, these data support the exploration of cholecalciferol treatment in such patients with RRMS.
CLINICALTRIALSGOV IDENTIFIER


NCT01198132.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with RRMS and low serum 25OHD, cholecalciferol did not significantly affect ARRs.",2019,"The overall rate of adverse events was well balanced between groups.
","['patients with relapsing-remitting MS (RRMS', 'patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration', 'relapsing-remitting MS', '75 nmol/L), a treatment with interferon beta-1a 44 μg ', '181 patients with RRMS']","['placebo', 'cholecalciferol', 'Cholecalciferol', 'high-dose oral cholecalciferol 100,000 IU or placebo']","['safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS', 'low serum 25-hydroxy vitamin D (25OHD) concentration', 'ARR reduction', 'annualized relapse rate (ARR', 'overall rate of adverse events', 'new hypointense T1-weighted lesions', 'lower volume of hypointense T1-weighted lesions', 'lower progression of EDSS', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",181.0,0.116533,"The overall rate of adverse events was well balanced between groups.
","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Camu', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France. w-camu@chu-montpellier.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lehert', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pierrot-Deseilligny', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hautecoeur', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Besserve', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Jean Deleglise', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Payet', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Thouvenot', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Souberbielle', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000597']
1799,32112593,Recruiting participants to an Internet-based eating disorder prevention trial: Impact of the recruitment strategy on symptom severity and program utilization.,"OBJECTIVE


Using data from a randomized controlled trial, we examined two different strategies to recruit participants for an indicated preventive intervention (StudentBodies-AN) for women at risk for anorexia nervosa and compared symptom severity and program utilization in participants recruited through each strategy.
METHOD


We recruited participants by announcing the study (a) in lectures at universities and handing out screening questionnaires (face-to-face recruitment) and (b) through different media channels, and the participants completed the screening questionnaire on our study website (media-based recruitment). We compared symptom severity and program utilization between the two groups.
RESULTS


A total of 4,646 women (face-to-face: 3,741, media-based: 905) were screened and 168 women (face-to-face: 114, media-based: 54) were randomized to the intervention. We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face. Also, participants recruited through media were more likely to log onto the program (χ 2  = 5.06; p = .029) and accessed more of the intervention.
DISCUSSION


Recruitment through media seems both more feasible and suitable to reach individuals in need of indicative prevention, and should be part of a multimodal recruitment package. Future studies should be explicitly designed to investigate the impact of recruitment modality on reach and effectiveness including cost-effectiveness analyses.",2020,"We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face.","['women at risk for anorexia nervosa and compared symptom severity and program utilization in participants recruited through each strategy', '4,646 women (face-to-face: 3,741, media-based: 905) were screened and 168 women (face-to-face: 114, media-based: 54', 'We recruited participants by announcing the study (a) in lectures at universities and handing out screening questionnaires (face-to-face recruitment) and (b) through different media channels, and the participants completed the screening questionnaire on our study website (media-based recruitment']",['preventive intervention (StudentBodies-AN'],"['symptom severity and program utilization', 'core behaviors and attitudes of disordered eating (EDE global score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4646.0,0.0490366,"We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face.","[{'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Vollert', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'von Bloh', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Eiterich', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Beintner', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Hütter', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Craig Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23250']
1800,31947040,The Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Balance Control in Children with Cerebral Palsy.,"Cerebral palsy (CP) is a neurological disorder which can result in balance and mobility impairments. Four children with spastic CP participated and randomly assigned to experimental and control groups. The experimental group received 1-Hz repetitive Transcranial Magnetic Stimulation (rTMS) four times a week for 3 weeks, and the control group received sham rTMS using the similar experimental protocol. Each rTMS session lasted for 20 minutes. Postural balance was quantified by analyzing the center of pressure (COP) signal of a force plate according to the Romberg test. The balance was also evaluated using the Berg Balance Scale (BBS). The evaluations were done before and after the treatment. COP signal features showed up to 70% improvement following rTMS treatment, whereas there was no notable improvements in the control group. Similarly the BBS assessment presented balance enhancement only in the experimental group. These results, particularly under closed eye foam condition may imply an improvement in proprioception system.Our findings suggested that rTMS has a potential to be used as a therapeutic method to improve postural balance in children with CP.",2019,"COP signal features showed up to 70% improvement following rTMS treatment, whereas there was no notable improvements in the control group.","['Children with Cerebral Palsy', 'Four children with spastic CP', 'children with CP']","['rTMS', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'control group received sham rTMS', '1-Hz repetitive Transcranial Magnetic Stimulation (rTMS']","['COP signal features', 'Berg Balance Scale (BBS', 'balance enhancement', 'postural balance', 'proprioception system', 'Postural balance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",,0.0100454,"COP signal features showed up to 70% improvement following rTMS treatment, whereas there was no notable improvements in the control group.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dadashi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nourian', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molavi', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Rafieenazari', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,['10.1109/EMBC.2019.8857361']
1801,30859515,High Prevalence of Undiagnosed Hyperglycemia in Low-Income Overweight and Obese Hispanic Women in Oregon.,"BACKGROUND


Overweight Hispanic women are at high risk for type 2 diabetes. A clinical diagnosis of hyperglycemia is often necessary to access interventions. We examined the prevalence of undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC).
METHODS


Among 196 overweight or obese Hispanic women (mean age 44 ± 10 years, mean weight 86.8 ± 16.5 kg, mean body mass index [BMI] 36.5 ± 6.4 kg/m 2 ) enrolled in a randomized clinical weight-loss trial, we compared A1C and fasting blood glucose (FBG) obtained at baseline with women's existing diabetes and prediabetes diagnoses in the medical record.
RESULTS


According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis. Among participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had at least one test in the prediabetes range (baseline A1C and FBG were in prediabetes range for 39 and 55 participants, respectively), and 13% (11/87) had at least one test in the diabetic range (baseline A1C and FBG values in diabetes range for 3 and 11 participants, respectively).
DISCUSSION


We found substantial prevalence of undiagnosed hyperglycemia among a sample of overweight and obese Hispanic women. It is possible that limited awareness of diabetes risk may be a barrier to patient compliance with screening recommendations.",2019,"According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis.","['undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC', 'participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had at least one test in the', 'Overweight Hispanic women', 'Low-Income Overweight and Obese Hispanic Women in Oregon', 'overweight and obese Hispanic women', '196 overweight or obese Hispanic women (mean age 44\u2009±\u200910\xa0years, mean weight 86.8\u2009±\u200916.5\xa0kg, mean body mass index', ""participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis""]",[],"['prediabetes range (baseline A1C and FBG', 'diabetic range (baseline A1C and FBG values', 'undiagnosed hyperglycemia', 'Undiagnosed Hyperglycemia', 'A1C and fasting blood glucose (FBG']","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],"[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",196.0,0.0531146,"According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis.","[{'ForeName': 'Nangel M', 'Initials': 'NM', 'LastName': 'Lindberg', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA. Nangel.M.Lindberg@kpchr.org.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Stevens', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gille', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Arias-Gastélum', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shuster', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Vaughn', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Meagan C', 'Initials': 'MC', 'LastName': 'Shaw', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Virginia Garcia Memorial Health Center, Cornelius, OR, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00578-9']
1802,31420350,Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial.,"BACKGROUND AND OBJECTIVES


Erythropoiesis-stimulating agents correct anemia of CKD but may increase cardiovascular risk. We compared cardiovascular outcomes and all-cause mortality associated with monthly methoxy polyethylene glycol-epoetin beta with those of the shorter-acting agents epoetin alfa/beta and darbepoetin alfa in patients with anemia of CKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We conducted a multicenter, open-label, noninferiority trial in which patients were randomized to receive methoxy polyethylene glycol-epoetin beta or reference erythropoiesis-stimulating agents, stratified by maintenance or correction treatment status and C-reactive protein level. The trial had a prespecified noninferiority margin of 1.20 for the hazard ratio (HR) for the primary end point (a composite of all-cause mortality, nonfatal myocardial infarction or stroke, adjudicated by an independent blinded committee). This trial is registered with ClinicalTrials.gov, number NCT00773513.
RESULTS


In total, 2818 patients underwent randomization, received methoxy polyethylene glycol-epoetin beta or a reference agent, and were followed for a median of 3.4 years (maximum, 8.4 years). In the modified intention-to-treat analysis, a primary end point event occurred in 640 (45.4%) patients in the methoxy polyethylene glycol-epoetin beta arm, and 644 (45.7%) in the reference arm (HR 1.03; 95% confidence interval [95% CI], 0.93 to 1.15,  P =0.004 for noninferiority). All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19). Results in patient subgroups on dialysis or treated in the correction or maintenance settings were comparable to the primary analysis.
CONCLUSIONS


In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality.",2019,"All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19).","['patients with anemia of CKD', '2818 patients underwent randomization, received', 'Anemia of CKD']","['methoxy polyethylene glycol-epoetin beta with those of the shorter-acting agents epoetin alfa/beta and darbepoetin alfa', 'methoxy polyethylene glycol-epoetin beta or reference erythropoiesis-stimulating agents, stratified by maintenance or correction treatment status and C-reactive protein level', 'methoxy polyethylene glycol-epoetin beta or a reference agent', 'Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents']","['hazard ratio (HR', 'All-cause mortality', 'mortality, nonfatal myocardial infarction or stroke', 'Cardiovascular Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1328071', 'cui_str': 'Methoxy polyethylene glycol-epoetin beta'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2818.0,0.313869,"All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Retired from Alessandro Manzoni Hospital, ASST Lecco, Lecco, Italy; f.locatelli@asst-lecco.it.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Hannedouche', 'Affiliation': 'School of Medicine, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Morgan', 'Affiliation': 'Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Oguey', 'Affiliation': 'Clinical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01380219']
1803,32048205,Ocrelizumab for Treating Patients with Primary Progressive Multiple Sclerosis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.,"Ocrelizumab is indicated for relapsing remitting and primary progressive multiple sclerosis (RRMS and PPMS, respectively). In an appraisal undertaken by the National Institute for Health and Care Excellence (NICE), the company Roche presented the evidence for ocrelizumab used in patients with PPMS, which came from one single randomised controlled trial (RCT) comparing ocrelizumab versus placebo. Based on results from this trial, the licensed indication was restricted to patients with early PPMS in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. Overall, the Evidence Review Group (ERG) found that the RCT had a low risk of bias. In the post-hoc defined magnetic resonance imaging (MRI) active subgroup, matching the label indication, the risk of confirmed disability progression sustained for 12 weeks (CDP-12) was significantly delayed in the ocrelizumab group compared to placebo. However, considering the same risk with progression sustained for 24 weeks (CDP-24), which was deemed the most clinically relevant, the benefit from ocrelizumab did not reach statistical significance. In the same MRI active subgroup, benefits from ocrelizumab on functional outcomes and on health-related quality of life were not clearly demonstrated. A de novo Markov model was used to estimate the cost-effectiveness of ocrelizumab versus best supportive care (BSC) for treating patients with PPMS. Health states were defined by the Expanded Disability Status Scale (EDSS), ranging from 0 to 9. Disability progression was based on the MSBase natural history cohort that exhibited disease progression in the absence of disease-modifying therapy. Treatment with ocrelizumab delayed disability progression, with evidence of its clinical effectiveness obtained from the RCT. The economic analysis was undertaken from the National Health Service and Personal Social Services perspective, and the outcomes were reported in terms of life years gained and quality-adjusted life years (QALYs), with the overall results reported in terms of an incremental cost-effectiveness ratio (ICER), expressed as cost per QALY gained over a 50-year time horizon. Both costs and effects were discounted at 3.5% per annum. The company undertook deterministic one-way sensitivity analyses and scenario analyses, including probabilistic sensitivity analysis (PSA). The ERG raised several concerns, which were discussed at the appraisal committee meetings, resulting in the committee's preferences being applied and a revised economic analysis from the company. Under an approved patient access scheme with appraisal committee preferences applied, analyses yielded an ICER of approximately £78,300 per QALY. Sensitivity analysis results indicated that the treatment effect on CDP-12 had the greatest impact. Results for the PSA showed that at a willingness-to-pay threshold of £30,000 per QALY gained, ocrelizumab versus BSC had a zero probability of being cost-effective. Following new analyses submitted by the company, with a revised confidential patient access scheme, NICE recommended ocrelizumab in the treatment of early PPMS in adults with imaging features characteristic of inflammatory activity.",2020,"In the same MRI active subgroup, benefits from ocrelizumab on functional outcomes and on health-related quality of life were not clearly demonstrated.","['patients with PPMS', 'Patients with Primary Progressive Multiple Sclerosis']","['Ocrelizumab', 'ocrelizumab versus placebo', 'placebo', 'ocrelizumab versus best supportive care (BSC', 'RCT']","['Disability progression', 'incremental cost-effectiveness ratio (ICER', 'health-related quality of life', 'Expanded Disability Status Scale (EDSS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751964', 'cui_str': 'Multiple Sclerosis, Primary Progressive'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}]",,0.0482329,"In the same MRI active subgroup, benefits from ocrelizumab on functional outcomes and on health-related quality of life were not clearly demonstrated.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Auguste', 'Affiliation': 'Warwick Evidence, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, UK. P.Auguste@warwick.ac.uk.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Colquitt', 'Affiliation': 'Effective Evidence, Coventry, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Connock', 'Affiliation': 'Warwick Evidence, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Loveman', 'Affiliation': 'Effective Evidence, Coventry, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Court', 'Affiliation': 'Warwick Evidence, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ciccarelli', 'Affiliation': 'University College London (UCL) Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Counsell', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Armoiry', 'Affiliation': 'Warwick Evidence, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, UK.'}]",PharmacoEconomics,['10.1007/s40273-020-00889-4']
1804,31443887,A pilot study assessing acceptability and feasibility of hatha yoga for chronic pain in people receiving opioid agonist therapy for opioid use disorder.,"The purpose of this project was to assess the feasibility and acceptability of a hatha yoga program designed to target chronic pain in people receiving opioid agonist therapy for opioid use disorder. We conducted a pilot randomized trial in which people with chronic pain who were receiving either methadone maintenance therapy (n = 20) or buprenorphine (n = 20) were randomly assigned to weekly hatha yoga or health education (HE) classes for 3 months. We demonstrated feasibility in many domains, including recruitment of participants (58% female, mean age 43), retention for follow-up assessments, and ability of teachers to provide interventions with high fidelity to the manuals. Fifty percent of participants in yoga (95% CI: 0.28-0.72) and 65% of participants in HE (95% CI: 0.44-0.87) attended at least 6 of 12 possible classes (p = 0.62). Sixty-one percent in the yoga group reported practicing yoga at home, with a mean number of times practicing per week of 2.67 (SD = 2.37). Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05). In conclusion, yoga can be delivered on-site at opioid agonist treatment programs with home practice taken up by the majority of participants. Future research may explore ways of increasing the yoga ""dosage"" received. This may involve testing strategies for increasing either class attendance or the amount of home practice or both.",2019,"Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05).","['n\u202f=\u202f20) or', 'participants (58% female, mean age 43), retention for follow-up assessments, and ability of teachers to provide interventions with high fidelity to the manuals', 'n\u202f=\u202f20', 'people receiving opioid agonist therapy for opioid use disorder', 'people with chronic pain who were receiving either']","['hatha yoga', 'methadone maintenance therapy', 'hatha yoga program', 'hatha yoga or health education (HE) classes for 3\u202fmonths', 'buprenorphine']","['anxiety and pain', 'feasibility and acceptability']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018701'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.09203,"Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05).","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Butler Hospital, United States of America; Brown University, United States of America. Electronic address: luebelacker@butler.org.'}, {'ForeName': 'Donnell', 'Initials': 'D', 'LastName': 'Van Noppen', 'Affiliation': 'Butler Hospital, United States of America.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Tremont', 'Affiliation': 'Brown University, United States of America; Rhode Island Hospital, United States of America.'}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Bailey', 'Affiliation': 'Brown University, United States of America; Stanley Street Treatment and Resources, United States of America.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Abrantes', 'Affiliation': 'Butler Hospital, United States of America; Brown University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Butler Hospital, United States of America; Brown University, United States of America; Boston University, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.015']
1805,31446994,"Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies.","OBJECTIVES


Most lung cancer diagnoses occur in elderly patients, who are underrepresented in clinical trials. We present a pooled analysis of safety and efficacy in elderly patients (≥75 years) who received pembrolizumab (a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors.
METHODS


The pooled analysis included patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors from the KEYNOTE-010 (NCT01905657), KEYNOTE-024 (NCT02142738), and KEYNOTE-042 (NCT02220894) studies. In KEYNOTE-010, patients were randomized to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and KEYNOTE-042, patients were randomized to first-line pembrolizumab 200 mg Q3W or platinum-based chemotherapy. Overall survival (OS) was estimated by the Kaplan-Meier method, and safety data were summarized in elderly patients (≥75 years).
RESULTS


The analysis included 264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS ≥ 50%. Pembrolizumab improved OS among elderly patients with PD-L1 TPS ≥ 1% (hazard ratio [HR], 0.76 [95% CI, 0.56-1.02]) and PD-L1 TPS ≥ 50% (HR, 0.40 [95% CI, 0.25-0.64]). Pembrolizumab as first-line therapy also improved OS among elderly patients with PD-L1 TPS ≥ 50% (from KEYNOTE-024 and KEYNOTE-042) compared with chemotherapy (HR, 0.41 [95% CI, 0.23‒0.73]). Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy. Immune-mediated AEs and infusion reactions were more common with pembrolizumab versus chemotherapy (overall, 24.8% vs 6.7%; grade 3‒4: 9.4% vs 0%; no grade 5 events).
CONCLUSIONS


In this pooled analysis of elderly patients with advanced NSCLC with PD-L1‒positive tumors, pembrolizumab improved OS versus chemotherapy, with a more favorable safety profile. Outcomes with pembrolizumab in patients ≥75 years were comparable to those in the overall populations in the individual studies.",2019,"Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy.","['a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors', 'elderly patients (≥75 years) who received', '264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS\u202f≥\u202f50', 'elderly patients with advanced NSCLC with PD-L1‒positive tumors', 'patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors', 'elderly patients (≥75 years', 'elderly patients', 'elderly patients with PD-L1-positive advanced non-small-cell lung cancer', 'patients ≥75 years']","['pembrolizumab versus chemotherapy', 'Pembrolizumab', 'pembrolizumab', 'pembrolizumab improved OS versus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab 200\u2009mg Q3W or platinum-based chemotherapy', 'pembrolizumab 2 or 10\u2009mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy']","['Safety and efficacy', 'Immune-mediated AEs and infusion reactions', 'Overall survival (OS', 'safety and efficacy']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",264.0,0.245098,"Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy.","[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Nosaki', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Minami-ku, Fukuoka-shi, Fukuoka 811-1395, Japan. Electronic address: knosaki@east.ncc.go.jp.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan. Electronic address: hideosaka@me.com.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan. Electronic address: yhosomi@cick.jp.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'The Netherlands Cancer Institute, Postbus 90203, 1006 BE Amsterdam, the Netherlands. Electronic address: p.baas@nki.nl.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, Av. Dr. Arnaldo, 251 - Cerqueira César, São Paulo, SP 01246-000, Brazil. Electronic address: gilberto.castro@usp.br.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangdong, 106 Zhongshan 2nd Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng 510080, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Baltimore, 21287 MD, USA. Electronic address: brahmju@jhmi.edu.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital, P. Vall d'Hebron, 119-129, 08035 and IOB Quiron, Barcelona, Spain. Electronic address: efelip@vhio.net.""}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: takeshi.sawada@merck.com.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Noguchi', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: kazuo.noguchi@merck.com.'}, {'ForeName': 'Shi Rong', 'Initials': 'SR', 'LastName': 'Han', 'Affiliation': 'MSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: shi.rong.han@merck.com.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: bilal.piperdi@merck.com.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Kush', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: debra_kush@merck.com.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Lopes', 'Affiliation': 'Sylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Ave, Miami, FL 33136, USA. Electronic address: glopes.md@gmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2019.07.004']
1806,31451521,"Effect of Intermittent Versus Continuous Low-Dose Aspirin on Nasal Epithelium Gene Expression in Current Smokers: A Randomized, Double-Blinded Trial.","A chemopreventive effect of aspirin (ASA) on lung cancer risk is supported by epidemiologic and preclinical studies. We conducted a randomized, double-blinded study in current heavy smokers to compare modulating effects of intermittent versus continuous low-dose ASA on nasal epithelium gene expression and arachidonic acid (ARA) metabolism. Fifty-four participants were randomized to intermittent (ASA 81 mg daily for one week/placebo for one week) or continuous (ASA 81 mg daily) for 12 weeks. Low-dose ASA suppressed urinary prostaglandin E2 metabolite (PGEM; change of -4.55 ± 11.52 from baseline 15.44 ± 13.79 ng/mg creatinine for arms combined,  P  = 0.02), a surrogate of COX-mediated ARA metabolism, but had minimal effects on nasal gene expression of nasal or bronchial gene-expression signatures associated with smoking, lung cancer, and chronic obstructive pulmonary disease. Suppression of urinary PGEM correlated with favorable changes in a smoking-associated gene signature ( P  < 0.01). Gene set enrichment analysis (GSEA) showed that ASA intervention led to 1,079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database. In conclusion, low-dose ASA had minimal effects on known carcinogenesis gene signatures in nasal epithelium of current smokers but results in wide-ranging genomic changes in the nasal epithelium, demonstrating utility of nasal brushings as a surrogate to measure gene-expression responses to chemoprevention. PGEM may serve as a marker for smoking-associated gene-expression changes and systemic inflammation. Future studies should focus on NSAIDs or agent combinations with broader inhibition of pro-inflammatory ARA metabolism to shift gene signatures in an anti-carcinogenic direction.",2019,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"['Fifty-four participants were randomized to intermittent ', 'current heavy smokers', 'current smokers']","['intermittent versus continuous low dose ASA', 'aspirin (ASA', 'placebo', 'intermittent versus continuous low dose aspirin', 'ASA intervention', 'ASA']","['nasal epithelium gene expression', 'lung cancer risk', 'Suppression of urinary PGEM', 'urinary prostaglandin E2 metabolite (PGEM', 'nasal epithelium gene expression and arachidonic acid (ARA) metabolism']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C3241966'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0599331', 'cui_str': 'Nasal Epithelium'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",54.0,0.22044,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"[{'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Garland', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona. lgarland@azcc.arizona.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guillen-Rodriguez', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Chiu-Hsieh', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Merenstein', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Lel', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Hanqiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Avrum E', 'Initials': 'AE', 'LastName': 'Spira', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Beane', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wojtowicz', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'H-H Sherry', 'Initials': 'HS', 'LastName': 'Chow', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0036']
1807,31453920,A Reliability and Comparative Analysis of the New Randomized King-Devick Test.,"OBJECTIVE


The King-Devick (K-D) test is a rapid visual screening tool that can assess underlying brain trauma such as concussion via impairments in saccadic rhythm. A new tablet version of the K-D test using randomized numbers is now available, but reliability for this new version and comparison to the traditional K-D test has not yet been reported. Known for learning effects in the test, the aim of this study was to determine test-retest reliability and to compare performance of the new ""randomized"" version to the ""traditional"" K-D test version. We hypothesized that the ""traditional"" K-D test would show a greater rate of improvement with repeat application, compared with the ""randomized"" K-D test.
METHODS


Using a cross-sectional, repeated measures design in a healthy university student cohort (n = 96; age 21.6 ± 2.8 years; 49 women, 47 men), participants were required to complete the K-D test twice with a one-week break between testing sessions. Participants were randomly assigned into a ""traditional"" group, where they completed a test-retest of the established K-D protocol, using the same numbers; or the ""randomized"" group, where they completed test-retest protocol using 2 different sets of numbers.
RESULTS


Reliability testing showed a strong intraclass correlation coefficient for both the ""traditional"" test group (control group; 0.95 [CI: 0.91-0.97]) and the ""randomized test group"" (0.97 [CI: 0.95-0.98]). However, contrary to our hypothesis, no differences were found between ""traditional"" and ""randomized"" groups for baseline (control: 42.5 seconds [CI: 40.2-44.9 s] vs randomized: 41.5 [38.7-44.4], P = 0.23) and repeated testing between groups (control: 40.0 seconds [37.9-42.1 s] vs randomized: 39.5 [36.9-42.0], P = 0.55), with both groups showing improved times with repeated testing (control: 2.1 seconds [CI: 1.1-3.2 seconds] and randomized: 1.9 seconds CI: [0.9-2.9 seconds], P < 0.001).
CONCLUSIONS


The ""randomized"" version of the K-D test, using different sets of numbers, demonstrates good reliability that is comparable to the traditional K-D testing protocol that uses the same number sets. However, similar to the ""traditional"" K-D test, learning effects were also observed in the ""randomized"" test, suggesting that learning effects are not because of content memorization, but rather familiarity of the test. As a result, although either test format is suitable for sideline concussion screening or return to play decisions, comparison of data should be made to the individual's baseline rather than to normative data sets.",2020,"RESULTS


Reliability testing showed a strong intraclass correlation coefficient for both the ""traditional"" test group (control group; 0.95 [CI: 0.91-0.97]) and the ""randomized test group"" (0.97 [CI: 0.95-0.98]).","['healthy university student cohort (n = 96; age 21.6 ± 2.8 years; 49 women, 47 men']",[],[],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],[],49.0,0.0905727,"RESULTS


Reliability testing showed a strong intraclass correlation coefficient for both the ""traditional"" test group (control group; 0.95 [CI: 0.91-0.97]) and the ""randomized test group"" (0.97 [CI: 0.95-0.98]).","[{'ForeName': 'Minh Q', 'Initials': 'MQ', 'LastName': 'Nguyen', 'Affiliation': 'School of Allied Health (MQN, AJP), Human Services and Sport, La Trobe University, Melbourne, Australia; and Sports Performance Research Institute New Zealand (SPRINZ) (DK), Faculty of Health and Environmental Science, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Pearce', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000829']
1808,31453915,Transcranial Magnetic Stimulation in Adults With Amblyopia.,"BACKGROUND


Through transcranial magnetic stimulation (TMS) it is possible to change cortical excitability of the visual cortex, and to influence binocular balance. The main goal of our study is to assess the effect of transcranial magnetic stimulation, specifically theta burst stimulation (TBS), in a group of amblyopic volunteers measuring several visual parameters: visual acuity, suppressive imbalance, and stereoacuity.
METHODS


Thirteen volunteers aged 19 to 24 years, randomly split in 2 groups, underwent 1 session of continuous TBS, stimulating the right occipital lobe. The first group with 8 volunteers was exposed to active stimulation with cTBS, and the other group with 5 volunteers was exposed to placebo stimulation.
RESULTS


Significant improvements in visual acuity, suppressive imbalance, and stereoacuity were found in the amblyopic eye after cTBS. The average value of amblyopia in visual acuity before stimulation was 0.32 ± 0.20 logMar and after cTBS was 0.19 ± 0.17 logMar. The mean value for the control group before placebo stimulation was 0.28 ± 0.17 and after placebo stimulation was 0.28 ± 0.16. The suppressive imbalance in the group of amblyope subjects stimulated before cTBS was 0.26 ± 0.18 and after was 0.12 ± 0.12; the suppressive imbalance of the control group before the placebo stimulation was 0.34 ± 0.37 and after was 0.32 ± 0.40.
CONCLUSIONS


Visual acuity, suppressive imbalance, and stereoacuity had significant enhancements compared with baseline after cTBS over the right occipital lobe in an ambliopic population.",2020,The mean value for the control group before placebo stimulation was 0.28 ± 0.17 and after placebo stimulation was 0.28 ± 0.16.,"['Adults With Amblyopia', 'Thirteen volunteers aged 19 to 24 years']","['placebo stimulation', 'Transcranial Magnetic Stimulation', 'transcranial magnetic stimulation, specifically theta burst stimulation (TBS', 'transcranial magnetic stimulation (TMS']","['average value of amblyopia in visual acuity', 'mean value', 'several visual parameters: visual acuity, suppressive imbalance, and stereoacuity', 'visual acuity, suppressive imbalance, and stereoacuity', 'suppressive imbalance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}]",13.0,0.100827,The mean value for the control group before placebo stimulation was 0.28 ± 0.17 and after placebo stimulation was 0.28 ± 0.16.,"[{'ForeName': 'Ana Rita', 'Initials': 'AR', 'LastName': 'Tuna', 'Affiliation': 'CICS-Health Sciences Research Centre (ART, NP, FMB, AF, AFN, MVP), Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal; Dr. Lopes Dias School of Health (NP), Polytechnic Institute of Castelo Branco, Castelo Branco, Portugal; Department of Physics (FMB, AFN), University of Beira Interior, Covilhã, Portugal; and CICS-Health Sciences Research Centre (MVP), Faculty of Health Sciences, University of Beira Interior; ULS Guarda, Guarda, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'Francisco Miguel', 'Initials': 'FM', 'LastName': 'Brardo', 'Affiliation': ''}, {'ForeName': 'Andresa', 'Initials': 'A', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Amélia Fernandes', 'Initials': 'AF', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Maria Vaz', 'Initials': 'MV', 'LastName': 'Pato', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000828']
1809,31290573,"A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759).","BACKGROUND


Cryopreservation extends platelet (PLT) shelf life from 5 to 7 days to 2 to 4 years. However, only 73 patients have been transfused cryopreserved PLTs in published randomized controlled trials (RCTs), making safety data insufficient for regulatory approval.
STUDY DESIGN AND METHODS


The Cryopreserved vs. Liquid Platelet (CLIP) study was a double-blind, pilot, multicenter RCT involving high-risk cardiothoracic surgical patients in four Australian hospitals. The objective was to test, as the primary outcome, the feasibility and safety of the protocol. Patients were allocated to study group by permuted block randomization, with patients and clinicians blinded by use of an opaque shroud placed over each study PLT unit. Up to 3 units of cryopreserved or liquid-stored PLTs were administered per patient. No other aspect of patient care was affected. Adverse events were actively sought.
RESULTS


A total of 121 patients were randomized, of whom 23 received cryopreserved PLTs and 18 received liquid-stored PLTs. There were no differences in blood loss (median, 715 mL vs. 805 mL at 24 hr; difference between groups 90 mL [95% CI, -343.8 to 163.8 mL], p = 0.41), but the Bleeding Academic Research Consortium criterion for significant postoperative hemorrhage in cardiac surgery composite bleeding endpoint occurred in nearly twice as many patients in the liquid-stored group (55.6% vs. 30.4%, p = 0.10). Red blood cell transfusion requirements were a median of 3 units in the cryopreserved group versus 4 units with liquid-stored PLTs (difference between groups, 1 unit [95% CI, -3.1 to 1.1 units]; p = 0.23). Patients in the cryopreserved group were more likely to be transfused fresh-frozen plasma (78.3% vs. 27.8%, p = 0.002) and received more study PLT units (median, 2 units vs. 1 unit; difference between groups, 1 unit [95% CI, -0.03 to 2.0 units]; p = 0.012). There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function. No patient had died at 28 days, and postoperative length of stay was similar in each group.
CONCLUSION


In this pilot RCT, compared to liquid-stored PLTs, cryopreserved PLTs were associated with no evidence of harm. A definitive study testing safety and hemostatic effectiveness is warranted.",2019,"There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function.","['73 patients', 'high-risk cardiothoracic surgical patients in four Australian hospitals', 'A total of 121 patients']","['cryopreserved platelets', 'Cryopreserved vs. Liquid Platelet (CLIP', 'cryopreserved PLTs and 18 received liquid-stored PLTs']","['perioperative surgical bleeding', 'blood loss', 'Red blood cell transfusion requirements', 'Adverse events', 'postoperative hemorrhage in cardiac surgery composite bleeding endpoint', 'postoperative length of stay', 'feasibility and safety', 'transfused fresh-frozen plasma', 'potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",121.0,0.428619,"There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Reade', 'Affiliation': 'Joint Health Command, Australian Defence Force, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Denese C', 'Initials': 'DC', 'LastName': 'Marks', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Deans', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Faulke', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gattas', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Holley', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Irving', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bronwyn L', 'Initials': 'BL', 'LastName': 'Pearse', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alistair G', 'Initials': 'AG', 'LastName': 'Royse', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15423']
1810,31440874,Exploration of Intervention Strategies to Reduce Public Stigma Associated with Gambling Disorder.,"Stigma associated with gambling disorder is complex, and is a key obstacle that prevents sufferers from seeking early help for their condition. However, little research has addressed how best to reduce gambling stigma. This study explored the effectiveness of video intervention styles, that have been used to reduce public stigma for conditions such as mental illness and substance use disorders. This was done to determine which would be most suitable, considering the unique characteristics of gambling disorder. An online survey of 164 people living in Australia was conducted which examined attitudes toward gamblers experiencing problems before and after an intervention. Participants were randomly allocated to one of three interventions (contact, education, advocacy) or a control video. The study found that each intervention was associated with changes to different components of stigma. Importantly, the education intervention increased labelling, but reduced stereotype endorsement and anger. Advocacy also reduced anger, attributions of character flaws, and anticipated discrimination and recoverability. While these interventions were generally effective at reducing stigma, the contact intervention was mixed, effectively intervening for some aspects of stigma, but increasing stigma on others. No single intervention reduced all aspects of stigma, suggesting that a complementary approach utilising specific elements of each intervention style could be used to deliver relevant information and effectively reduce stigma. Taken together, this suggests that research should be conducted into comprehensive, combined interventions, that include aspects of all three intervention styles, in an attempt to reduce more aspects of stigma simultaneously.",2020,"While these interventions were generally effective at reducing stigma, the contact intervention was mixed, effectively intervening for some aspects of stigma, but increasing stigma on others.",['164 people living in Australia was conducted which examined attitudes toward gamblers experiencing problems before and after an intervention'],"['video intervention styles', 'three interventions (contact, education, advocacy) or a control video']","['anger, attributions of character flaws, and anticipated discrimination and recoverability', 'stereotype endorsement and anger']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",164.0,0.0317752,"While these interventions were generally effective at reducing stigma, the contact intervention was mixed, effectively intervening for some aspects of stigma, but increasing stigma on others.","[{'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Brown', 'Affiliation': 'School of Health, Medical and Applied Sciences, CQUniversity, Rockhampton, QLD, 4701, Australia.'}, {'ForeName': 'Alex M T', 'Initials': 'AMT', 'LastName': 'Russell', 'Affiliation': 'Experimental Gambling Research Laboratory, School of Health, Medical and Applied Sciences, CQUniversity, Level 6, 400 Kent St, Sydney, NSW, 2000, Australia. a.m.russell@cqu.edu.au.'}]",Journal of gambling studies,['10.1007/s10899-019-09888-3']
1811,30358853,Using graphic warning labels to counter effects of social cues and brand imagery in cigarette advertising.,"Exposure to cigarette advertising can increase the likelihood of youth smoking initiation and may encourage people who already smoke to continue. Requiring prominent, graphic warning labels could reduce these effects. We test whether graphic versus text-only warning labels in cigarette advertisements influence cognitive and emotional factors associated with youth susceptibility to smoking and adult intentions to quit. We conducted two randomized, between-subjects experiments with middle-school youth (n = 474) and adult smokers (n = 451). Both studies employed a two (graphic or text-only warnings) by two (advertisements with social cues or brand imagery) factorial design with a fifth, offset control group (social cue advertisements with the current US Surgeon General's Warning). Graphic warnings outperformed text-only warnings in reducing visual attention to the advertisement, generating visual attention to the warning and arousing more negative affect. Graphic warnings also reduced the appeal of cigarette brands among youth relative to social cue advertisements with the Surgeon General's warnings. None of the warnings (graphic or textual) influenced health risk beliefs. Graphic warning labels on cigarette advertisements appear to have effects similar to those observed on cigarette packs in previous work, with an added benefit of reducing cigarette brand appeal among youth.",2019,"Graphic warnings outperformed text-only warnings in reducing visual attention to the advertisement, generating visual attention to the warning and arousing more negative affect.","['subjects experiments with middle-school youth (n = 474) and adult smokers (n = 451', 'cigarette advertising']","['graphic versus text-only warning labels', 'Graphic warning labels']","['visual attention', 'health risk beliefs', 'likelihood of youth smoking initiation']","[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",474.0,0.0114754,"Graphic warnings outperformed text-only warnings in reducing visual attention to the advertisement, generating visual attention to the warning and arousing more negative affect.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kemp', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jesch', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Scolere', 'Affiliation': 'Department of Design and Merchandising, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Greiner Safi', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Porticella', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Avery', 'Affiliation': 'Department of Policy Analysis and Management, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Dorf', 'Affiliation': 'Cornell Law School, Ithaca, NY, USA.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Mathios', 'Affiliation': 'Department of Policy Analysis and Management, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}]",Health education research,['10.1093/her/cyy039']
1812,31444535,Pelvic floor muscle training for female stress urinary incontinence: a randomised control trial comparing home and outpatient training.,"INTRODUCTION AND HYPOTHESIS


In the literature, it is suggested that supervised pelvic floor muscle training (PFMT) might be the first option treatment for female stress urinary incontinence (SUI). However, inadequate accessibility to health care and scarce individual resources may prevent adherence to the treatment. Our study is aimed at comparing the efficacy of performing PFMT in an outpatient clinic and at home in Brazilian incontinent women, and to verify if home PFMT may be an alternative to those not able to attend the outpatient sessions.
METHODS


A total of 69 women with predominant SUI were randomised into two groups: outpatient PFMT and home PFMT. The primary outcome was the cure of SUI defined as <2 g of leakage in a 20-min pad test. Secondary outcomes were: pelvic floor muscle function; urinary symptoms; quality of life; patient satisfaction; and adherence to home exercise sets. The assessments were conducted at baseline and after 3 months of treatment. Statistical analyses consisted of Student's t, Mann-Whitney U, Chi-squared, and Wilcoxon tests, with a 5% cut-off for significance.
RESULTS


A superior objective cure of SUI was observed in the outpatient clinic (62%) compared with the home (28%) PFMT groups (OR: 4.0 [95% CI: 1.4-11.0]; p = 0.011). Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week. The home adherence to the exercises was superior in the outpatient PFMT group only during the first-month training.
CONCLUSIONS


Outpatient PFMT was associated with a higher objective cure of SUI than home PFMT. However, subjective findings show equal benefit of home PFMT providing evidence that this may be an alternative treatment to our population.",2020,"Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week.","['Brazilian incontinent women', 'female stress urinary incontinence (SUI', 'female stress urinary incontinence', '69 women with predominant SUI']","['supervised pelvic floor muscle training (PFMT', 'PFMT', 'Pelvic floor muscle training', 'outpatient PFMT and home PFMT']","['SUI', 'satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage', 'cure of SUI defined as <2\xa0g of leakage in a 20-min pad test', 'pelvic floor muscle function; urinary symptoms; quality of life; patient satisfaction; and adherence to home exercise sets']","[{'cui': 'C0231238', 'cui_str': 'Incontinent (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",69.0,0.0554048,"Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week.","[{'ForeName': 'Fátima Faní', 'Initials': 'FF', 'LastName': 'Fitz', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil. fanifitz@yahoo.com.br.'}, {'ForeName': 'Márcia Maria', 'Initials': 'MM', 'LastName': 'Gimenez', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'de Azevedo Ferreira', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Mayanni Magda Perreira', 'Initials': 'MMP', 'LastName': 'Matias', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Maria Augusta Tezelli', 'Initials': 'MAT', 'LastName': 'Bortolini', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}, {'ForeName': 'Rodrigo Aquino', 'Initials': 'RA', 'LastName': 'Castro', 'Affiliation': 'Department of Gynaecology, Universidade Federal de São Paulo, Rua Napoleão de Barros, 608 - Vila Clementino, São Paulo, SP, CEP 04024-002, Brazil.'}]",International urogynecology journal,['10.1007/s00192-019-04081-x']
1813,31056697,"Infant Pneumococcal Carriage During Influenza, RSV, and hMPV Respiratory Illness Within a Maternal Influenza Immunization Trial.","In this post-hoc analysis of midnasal pneumococcal carriage in a community-based, randomized prenatal influenza vaccination trial in Nepal with weekly infant respiratory illness surveillance, 457 of 605 (75.5%) infants with influenza, respiratory syncytial virus (RSV), or human metapneumovirus (hMPV) illness had pneumococcus detected. Pneumococcal carriage did not impact rates of lower respiratory tract disease for these 3 viruses. Influenza-positive infants born to mothers given influenza vaccine had lower pneumococcal carriage rates compared to influenza-positive infants born to mothers receiving placebo (58.1% versus 71.6%, P = 0.03). Maternal influenza immunization may impact infant acquisition of pneumococcus during influenza infection. Clinical Trials Registration. NCT01034254.",2019,"Influenza-positive infants born to mothers given influenza vaccine had lower pneumococcal carriage rates compared to infants born to placebo mothers (58.1% versus 71.6%, p=0.03).","['Nepal with weekly infant respiratory illness surveillance, 457 of 605 (75.5%) infants with influenza, RSV or hMPV illness had pneumococcus detected', 'Influenza-positive infants born to mothers given']","['Maternal influenza immunization', 'influenza vaccine', 'placebo']","['pneumococcal carriage rates', 'RSV- or hMPV']","[{'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1258014', 'cui_str': 'Human Metapneumovirus'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1258014', 'cui_str': 'Human Metapneumovirus'}]",,0.199023,"Influenza-positive infants born to mothers given influenza vaccine had lower pneumococcal carriage rates compared to infants born to placebo mothers (58.1% versus 71.6%, p=0.03).","[{'ForeName': 'Alastair F', 'Initials': 'AF', 'LastName': 'Murray', 'Affiliation': 'School of Medicine and Health Sciences, George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital, Washington.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kuypers', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Global Health, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project - Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Leclerq', 'Affiliation': 'Nepal Nutrition Intervention Project - Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, Seattle.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz212']
1814,31022313,Group exposure and response prevention for college students with social anxiety: A randomized clinical trial.,"OBJECTIVE


Social anxiety increases college student drop-out risk and stifles employment opportunities. Group cognitive-behavioral therapy with exposure (CBT ERP) has the potential to alleviate campus resource strain but remains under-researched with college students. The present study investigated the efficacy of group CBT ERP in a randomized clinical trial on a college campus.
METHOD


Thirty-one postsecondary students were randomly assigned to an exposure-only group or an active control.
RESULTS


Linear mixed-effects models indicated significant Group × Time interactions for general social anxiety (t = -2.02, g = 0.62) and depression (t = -2.77, g = 0.55); nonsignificant main effects were found for group and time variables. On a measure of fear of negative evaluation, only the main effect of time was significant (t = 2.15, p = 0.032).
CONCLUSIONS


When compared to an active control group, CBT ERP is an efficacious and time-effective treatment for college students experiencing social anxiety.",2019,"On a measure of fear of negative evaluation, only the main effect of time was significant (t = 2.15, p = 0.032).
","['Thirty-one postsecondary students', 'college students experiencing social anxiety', 'college students with social anxiety', 'Social anxiety increases college student drop-out risk and stifles employment opportunities']","['exposure-only group or an active control', 'CBT ERP', 'Group cognitive-behavioral therapy with exposure (CBT ERP']","['general social anxiety', 'depression']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1456798', 'cui_str': 'Stifle'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",31.0,0.0283219,"On a measure of fear of negative evaluation, only the main effect of time was significant (t = 2.15, p = 0.032).
","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Zaboski', 'Affiliation': 'Department of Special Education, School Psychology, & Early Childhood Studies, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Joyce-Beaulieu', 'Affiliation': 'Department of Special Education, School Psychology, & Early Childhood Studies, University of Florida, Gainesville, Florida.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kranzler', 'Affiliation': 'Department of Special Education, School Psychology, & Early Childhood Studies, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, Division of Medical Psychology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Gayle', 'Affiliation': 'Independent Practice, Gainesville, Florida.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'MacInnes', 'Affiliation': 'Department of Human Development and Organization Studies, University of Florida, Gainesville, Florida.'}]",Journal of clinical psychology,['10.1002/jclp.22792']
1815,30839405,Nebulized salbutamol diminish the blood glucose fluctuation in the treatment of non-oliguric hyperkalemia of premature infants.,"BACKGROUND


Hyperkalemia is a risky and potentially life-threatening condition in pre-term infants. Glucose-insulin infusion has been considered a major therapeutic way for non-oligouric hyperkalemia but affects the stability of blood sugar level. We aimed to evaluate the effectiveness of salbutamol nebulization compared to glucose-insulin infusion for the treatment of non-oliguric hyperkalemia in premature infants.
METHODS


Forty premature infants (gestation age ≤36 weeks) with non-oliguric hyperkalemia (central serum potassium level greater than 6.0 mmol/L) within 72 h of birth were enrolled in this study. These infants were randomly assigned into two groups. One group received a regular insulin bolus with glucose infusion (Group A; n = 20), and the other received salbutamol (Ventolin) by nebulization (Group B; n = 20). Potassium level, blood sugar, heart rate, and blood pressure were recorded for each group before treatment and at 3, 12, 24, 48, and 72 h post-treatment.
RESULTS


The serum potassium levels were reduced after treatment in both groups. No significant changes in heart rate or blood pressure were observed in either group. The fluctuation in glucose levels was gentler in the salbutamol-treated group than in the glucose-insulin infusion group.
CONCLUSION


Salbutamol nebulization is not only as effective as glucose-insulin infusion for treating non-oliguric hyperkalemia in premature infants but can avoid potential side effects such as vigorous blood glucose fluctuations.",2019,"The fluctuation in glucose levels was gentler in the salbutamol-treated group than in the glucose-insulin infusion group.
","['Forty premature infants (gestation age ≤36 weeks) with non-oliguric hyperkalemia (central serum potassium level greater than 6.0 mmol/L) within 72 h of birth were enrolled in this study', 'non-oliguric hyperkalemia in premature infants', 'non-oliguric hyperkalemia of premature infants']","['salbutamol nebulization', 'Glucose-insulin infusion', 'glucose-insulin infusion', 'regular insulin bolus with glucose infusion', 'Nebulized salbutamol', 'salbutamol (Ventolin) by nebulization']","['serum potassium levels', 'blood glucose fluctuation', 'heart rate or blood pressure', 'Potassium level, blood sugar, heart rate, and blood pressure', 'fluctuation in glucose levels']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0021641', 'cui_str': 'Insulin, Regular'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0877314', 'cui_str': 'Blood glucose fluctuation'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",40.0,0.024294,"The fluctuation in glucose levels was gentler in the salbutamol-treated group than in the glucose-insulin infusion group.
","[{'ForeName': 'Hean-Pat', 'Initials': 'HP', 'LastName': 'Saw', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, ROC.'}, {'ForeName': 'Cheng-Di', 'Initials': 'CD', 'LastName': 'Chiu', 'Affiliation': 'School of Medicine, China Medical University, Taichung, Taiwan, ROC.'}, {'ForeName': 'You-Pen', 'Initials': 'YP', 'LastName': 'Chiu', 'Affiliation': 'School of Medicine, China Medical University, Taichung, Taiwan, ROC.'}, {'ForeName': 'Hui-Ru', 'Initials': 'HR', 'LastName': 'Ji', 'Affiliation': 'School of Medicine, China Medical University, Taichung, Taiwan, ROC.'}, {'ForeName': 'Jia-Yuh', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1016/j.jcma.2018.04.002']
1816,31215163,InDependent but not Alone: A Web-Based Intervention to Promote Physical and Mental Health among Military Spouses.,"BACKGROUND


Military spouses must cope with multiple threats to their physical and mental health, yet few interventions have been developed to promote health in this population.
METHODS


For this quasi-experimental study, military spouses (N = 231) received a standard educational intervention or an interactive, theory-based intervention; both were delivered online and lasted 10 weeks. The educational intervention directed participants to content on the existing website, Operation Live Well. The interactive intervention was based on Self-Determination Theory, delivered weekly content via podcasts, and encouraged participants to complete weekly challenges to improve physical activity, diet, and mental health. Linear mixed effects models were used to examine self-reported changes in stress, anxiety, depression, loneliness, self-esteem, physical activity, and diet from pre- to post-intervention.
RESULTS


Significant improvements were observed for all mental health outcomes, total physical activity, and sugar consumption. However, there were no significant group by time interaction effects.
CONCLUSIONS


Web-based interventions may promote positive changes in mental health and health behaviours among military spouses. In this study, an interactive theory-based intervention was no more effective than an information-based intervention. Future studies should aim to determine the minimum ""dose"" needed to elicit meaningful changes in this population.",2019,"RESULTS


Significant improvements were observed for all mental health outcomes, total physical activity, and sugar consumption.","['Military Spouses', 'military spouses (N\xa0=\xa0231', 'military spouses']","['interactive theory-based intervention', 'educational intervention directed participants to content on the existing website, Operation Live', 'standard educational intervention or an interactive, theory-based intervention; both were delivered online and lasted 10\xa0weeks']","['stress, anxiety, depression, loneliness, self-esteem, physical activity, and diet from pre- to post-intervention', 'time interaction effects', 'mental health outcomes, total physical activity, and sugar consumption', 'mental health and health behaviours']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.031536,"RESULTS


Significant improvements were observed for all mental health outcomes, total physical activity, and sugar consumption.","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mailey', 'Affiliation': 'Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Brandon C', 'Initials': 'BC', 'LastName': 'Irwin', 'Affiliation': 'Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Jillian M', 'Initials': 'JM', 'LastName': 'Joyce', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA.'}, {'ForeName': 'Wei-Wen', 'Initials': 'WW', 'LastName': 'Hsu', 'Affiliation': 'Kansas State University, Manhattan, KS, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12168']
1817,30659024,Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer.,"PURPOSE


In the phase III FLAURA study, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib significantly improved progression-free survival (PFS) versus standard-of-care (SoC) EGFR-TKI (gefitinib or erlotinib) in patients with previously untreated EGFR (exon 19 deletion or L858R) mutation-positive advanced non-small cell lung cancer (NSCLC). Interim overall survival (OS) data were encouraging, but not formally statistically significant at current maturity (25%). Here we report exploratory postprogression outcomes.
PATIENTS AND METHODS


Patients were randomized 1:1 to receive osimertinib (80 mg orally, once daily) or SoC EGFR-TKI (gefitinib 250 mg or erlotinib 150 mg, orally, once daily). Treatment beyond disease progression was allowed if the investigator judged ongoing clinical benefit. Patients receiving SoC EGFR-TKI could cross over to receive osimertinib after independently confirmed objective disease progression with documented postprogression T790M-positive mutation status.
RESULTS


At data cutoff (June 12, 2017), 138 of 279 (49%) and 213 of 277 (77%) patients discontinued osimertinib and SoC EGFR-TKI, respectively, of whom 82 (59%) and 129 (61%), respectively, started a subsequent treatment. Median time to discontinuation of any EGFR-TKI or death was 23.0 months [95% confidence interval (CI), 19.5-not calculable (NC)] in the osimertinib arm and 16.0 months (95% CI, 14.8-18.6) in the SoC EGFR-TKI arm. Median second PFS was not reached (95% CI, 23.7-NC) in the osimertinib arm and 20.0 months (95% CI, 18.2-NC) in the SoC EGFR-TKI arm [hazard ratio (HR), 0.58; 95% CI, 0.44-0.78;  P  = 0.0004].
CONCLUSIONS


All postprogression endpoints showed consistent improvement with osimertinib versus SoC EGFR-TKI, providing further confidence in the interim OS data.",2019,"Median second PFS was not reached (95% CI, 23.7-NC) in the osimertinib arm and 20.0 months (95% CI, 18.2-NC) in the SoC EGFR-TKI arm [hazard ratio (HR), 0.58; 95% CI, 0.44-0.78;  P  = 0.0004].
","['patients with previously untreated EGFR (exon 19 deletion or L858R) mutation-positive advanced non-small cell lung cancer (NSCLC', 'Patients', 'Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer']","['EGFR-TKI (gefitinib or erlotinib', 'Osimertinib versus Standard-of-Care EGFR-TKI', 'SoC EGFR-TKI (gefitinib 250 mg or erlotinib', 'osimertinib']","['Median second PFS', 'Median time to discontinuation of any EGFR-TKI or death', 'progression-free survival (PFS) versus standard-of-care (SoC', 'Interim overall survival (OS) data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.197317,"Median second PFS was not reached (95% CI, 23.7-NC) in the osimertinib arm and 20.0 months (95% CI, 18.2-NC) in the SoC EGFR-TKI arm [hazard ratio (HR), 0.58; 95% CI, 0.44-0.78;  P  = 0.0004].
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France. david.planchard@gustaveroussy.fr.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Boyer', 'Affiliation': ""Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Jong-Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Arunee', 'Initials': 'A', 'LastName': 'Dechaphunkul', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Parneet K', 'Initials': 'PK', 'LastName': 'Cheema', 'Affiliation': 'Faculty of Medicine and Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Todd', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'McKeown', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rukazenkov', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3325']
1818,31351121,Identifying compliant participants through data matching improved estimation of intervention efficacy: randomized trials with opt-in/opt-out strategies.,"OBJECTIVES


We propose a data-matching approach to estimate intervention efficacy for randomized controlled trials (RCTs) when there is noncompliance to the allocated treatment with induced selection bias.
STUDY DESIGN AND SETTING


We considered a large RCT to compare health care costs and hospital length of stay 12 months after randomization. Participants allocated to the intervention group were eligible to receive health-coaching and disease-management services. An opt-out approach was adopted for recruitment. Control-group participants received usual care but were allowed to opt-in to receive the intervention. Using ""nearest-neighbor""-matched data, we identified compliant participants in both arms to estimate intervention efficacy. Results were compared with intention-to-treat (ITT), instrumental-variable-adjusted ITT, per-protocol (PP), and as-treated (AT) analyses.
RESULTS


The ITT estimated an intervention effect of a 1.5% reduction in cost, but 56.7% of intervention-group participants did not receive health coaching. The PP and AT found an increase in cost of 9.4% and 17.1%, respectively. The matching method estimated a 12.3% reduction in cost. After adjustment for baseline covariates, the intervention group had lower same-day admission cost (13.6%; 95% CI: 7.3%-20.0%; P < 0.001) and shorter hospital stay (11.2%; 95% CI: 2.6%-19.9%; P = 0.021).
CONCLUSION


Opt-in/opt-out strategies in RCTs misled intervention comparisons and the matching approach improved estimation of intervention efficacy.",2019,"After adjustment for baseline covariates, the intervention group had lower same-day admission cost (13.6%; 95% CI: 7.3%-20.0%; P < 0.001) and shorter hospital stay (11.2%; 95% CI: 2.6%-19.9%; P = 0.021).
",[],"['Control-group participants received usual care but were allowed to opt-in to receive the intervention', 'health-coaching and disease-management services']","['shorter hospital stay', 'lower same-day admission cost']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.10387,"After adjustment for baseline covariates, the intervention group had lower same-day admission cost (13.6%; 95% CI: 7.3%-20.0%; P < 0.001) and shorter hospital stay (11.2%; 95% CI: 2.6%-19.9%; P = 0.021).
","[{'ForeName': 'Shu Kay', 'Initials': 'SK', 'LastName': 'Ng', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan Q4111, Australia. Electronic address: s.ng@griffith.edu.au.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan Q4111, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scuffham', 'Affiliation': 'School of Medicine and Menzies Health Institute Queensland, Griffith University, Nathan Q4111, Australia.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.07.013']
1819,30171489,Structured physiotherapy including a work place intervention for patients with neck and/or back pain in primary care: an economic evaluation.,"A cluster-randomized controlled trial, WorkUp, was conducted for working-aged patients at risk of sick leave or on short-term sick leave due to acute/subacute neck and/or back pain in Sweden. The purpose of WorkUp was to facilitate participants to stay at work or in case of sick leave, return-to-work. The aim of this study was to study whether the WorkUp trial was cost-effective. Patients in the intervention and reference group received structured evidence-based physiotherapy, while patients in the intervention group also received a work place dialogue with the employer as an add-on. The participants, 352 in total, were recruited from 20 physiotherapeutic units in primary healthcare in southern Sweden. The economic evaluation was performed both from a healthcare and a societal perspective with a 12-month time frame with extensive univariate sensitivity analyses. Results were presented as incremental cost-effectiveness ratios (ICER) with outcomes measured as quality-adjusted life-years (QALY) and proportion working for at least 4 weeks in a row without reported sick leave at 12-month follow-up. From the healthcare perspective, the ICER was €23,606 (2013 price year) per QALY gain. From the societal perspective the intervention was dominating, i.e.. less costly and more effective than reference care. Bootstrap analysis showed that the probability of the intervention to be cost-effective at €50,000 willingness-to-pay per QALY was 85% from the societal perspective. Structured evidence-based physiotherapeutic care together with workplace dialogue is a cost-effective alternative from both a societal and a healthcare perspective for acute/subacute neck and/or back pain patients.Trial registration ClinicalTrials.gov: NCT02609750.",2019,"From the healthcare perspective, the ICER was €23,606 (2013 price year) per QALY gain.","['participants, 352 in total, were recruited from 20 physiotherapeutic units in primary healthcare in southern Sweden', 'working-aged patients at risk of sick leave or on short-term sick leave due to acute/subacute neck and/or back pain in Sweden', 'participants to stay at work or in case of sick leave, return-to-work', 'acute/subacute neck and/or back pain patients', 'patients with neck and/or back pain in primary care']","['work place dialogue with the employer as an add-on', 'structured evidence-based physiotherapy', 'Structured physiotherapy including a work place intervention']",['incremental cost-effectiveness ratios (ICER) with outcomes measured as quality-adjusted life-years (QALY) and proportion working'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0043227', 'cui_str': 'Work'}]",,0.132874,"From the healthcare perspective, the ICER was €23,606 (2013 price year) per QALY gain.","[{'ForeName': 'Sanjib', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Health Economics Unit, Department of Clinical Science (Malmö), Lund University, Medicon Village, Scheelevägen 2, 22381, Lund, Sweden. sanjib.saha@med.lu.se.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Grahn', 'Affiliation': 'Department of Clinical Sciences Lund, Orthopedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Ulf-G', 'Initials': 'UG', 'LastName': 'Gerdtham', 'Affiliation': 'Health Economics Unit, Department of Clinical Science (Malmö), Lund University, Medicon Village, Scheelevägen 2, 22381, Lund, Sweden.'}, {'ForeName': 'Kjerstin', 'Initials': 'K', 'LastName': 'Stigmar', 'Affiliation': 'Department of Health Sciences, Physiotherapy, Lund University, Lund, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Holmberg', 'Affiliation': 'Department of Research and Development, Region Kronoberg, Växjo, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jarl', 'Affiliation': 'Health Economics Unit, Department of Clinical Science (Malmö), Lund University, Medicon Village, Scheelevägen 2, 22381, Lund, Sweden.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-018-1003-1']
1820,31337647,Uptake of Cervical Cancer Screening in Ethiopia by Self-Sampling HPV DNA Compared to Visual Inspection with Acetic Acid: A Cluster Randomized Trial.,"In Ethiopia, the standard method of cervical cancer screening is using Visual Inspection with Acetic Acid (VIA). Self-collection-based human papillomavirus (HPV) testing is assumed to improve the uptake of screening, especially for hard to reach populations. We investigated whether HPV DNA testing with the self-collection of cervical samples would be associated with increased uptake and adherence to procedures at the population level compared with VIA within defined rural population in Ethiopia. A total of 22 clusters (comprising 2,356 women ages 30-49 years) were randomized in two arms. Following the community mobilization, women of the clusters were invited to go either to the local health post for a self-collection-based HPV DNA testing (arm A) or Butajira Hospital for VIA screening (arm B). In the HPV arm, of the 1,213 sensitized women, 1,020 (84.1%) accessed the health post for self-sampling compared with the VIA arm, where 575 of 1,143 (50.5%) visited the hospital for VIA ( P  < 0.0001). Of those women who attended the VIA and HPV arms, 40% and 65.4% adhered to all procedures expected after screening, respectively. Out of women positive for high risk HPV, 122 (85%) attended VIA as a follow-up test. The trial demonstrated significantly higher levels of population-based uptake and adherence for self-collection HPV testing. Women were more receptive for VIA after their HPV testing result was positive. Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.",2019,Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.,"['A total of 22 clusters (comprising 2,356 women ages 30-49 years']","['Acetic Acid', 'Acetic Acid (VIA', 'Self-collection-based human papillomavirus (HPV) testing', 'local health post for a self-collection-based HPV DNA testing (arm A) or Butajira Hospital for VIA screening (arm B']","['levels of population-based uptake and adherence for self-collection HPV testing', 'health post for self-sampling']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",2356.0,0.197346,Self-collection HPV testing can be done at the local health facility and may significantly improve the uptake of cervical cancer screening in Ethiopia.,"[{'ForeName': 'Muluken', 'Initials': 'M', 'LastName': 'Gizaw', 'Affiliation': 'Addis Ababa University, School of Public Health, Department of Preventive Medicine, Ethiopia.'}, {'ForeName': 'Brhanu', 'Initials': 'B', 'LastName': 'Teka', 'Affiliation': 'Addis Ababa University, School of Medicine, Department of Microbiology, Immunology and Parasitology, Ethiopia.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Ruddies', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Tamrat', 'Initials': 'T', 'LastName': 'Abebe', 'Affiliation': 'Addis Ababa University, School of Medicine, Department of Microbiology, Immunology and Parasitology, Ethiopia.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Gynecology, Charité-Universitätmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Addis Ababa University, School of Public Health, Department of Preventive Medicine, Ethiopia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Ahmedin', 'Initials': 'A', 'LastName': 'Jemal', 'Affiliation': 'Department of Intramural Research, American Cancer Society, Atlanta, Georgia.'}, {'ForeName': 'Adamu', 'Initials': 'A', 'LastName': 'Addissie', 'Affiliation': 'Addis Ababa University, School of Public Health, Department of Preventive Medicine, Ethiopia.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institute of Medical Epidemiology, Biometrics and Informatics Martin-Luther-University, Halle-Wittenberg, Germany. eva.kantelhardt@uk-halle.de.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0156']
1821,31376781,Fostering adolescent curiosity through a question brainstorming intervention.,"INTRODUCTION


High adolescent curiosity is associated with several positive outcomes, yet questioning, a common behavioral manifestation of curiosity, declines once children enter formal schooling. The present quasi-experimental study empirically investigated whether directly teaching students to question helps to foster students' more enduring, dispositional tendency towards curiosity.
METHOD


The study explored the impact of a direct-instruction student-brainstorming intervention, the Question Formulation Technique (QFT), on adolescents' curiosity. The study's sample included adolescents (N = 3173) in four public high schools in the United States nested within 43 educators' English/Language Arts classrooms. Teachers (N = 43) were randomly assigned to two groups, one of which received professional development in the QFT in fall 2015 and the other in the winter of 2016. The study utilized student self-report questionnaires and teacher fidelity checks at three time points (fall, winter, and spring) to consider the impact of the QFT on participating adolescents' curiosity.
RESULTS


Multilevel modeling results indicated a positive treatment effect of the QFT on adolescents' curiosity, a positive adherence effect on adolescents' curiosity growth, and a positive dosage effect on adolescents' curiosity growth.
CONCLUSIONS


The study suggests that adolescent dispositional curiosity can be significantly increased by directly teaching students to question.",2019,"RESULTS


Multilevel modeling results indicated a positive treatment effect of the QFT on adolescents' curiosity, a positive adherence effect on adolescents' curiosity growth, and a positive dosage effect on adolescents' curiosity growth.
","['Teachers (N\u202f=\u202f43', ""adolescents' curiosity"", ""study's sample included adolescents (N\u202f=\u202f3173) in four public high schools in the United States nested within 43 educators' English/Language Arts classrooms""]","['direct-instruction student-brainstorming intervention, the Question Formulation Technique (QFT', 'professional development in the QFT', 'QFT']",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010472', 'cui_str': 'Curiosity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0023010', 'cui_str': 'Language Arts'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0243107', 'cui_str': 'development'}]",[],,0.029311,"RESULTS


Multilevel modeling results indicated a positive treatment effect of the QFT on adolescents' curiosity, a positive adherence effect on adolescents' curiosity growth, and a positive dosage effect on adolescents' curiosity growth.
","[{'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Harvard University, United States. Electronic address: shelby_clark@gse.harvard.edu.'}, {'ForeName': 'Allen G', 'Initials': 'AG', 'LastName': 'Harbaugh', 'Affiliation': 'Boston University, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Seider', 'Affiliation': 'Boston College, United States.'}]",Journal of adolescence,['10.1016/j.adolescence.2019.07.007']
1822,31438807,Extending the use of routine outcome monitoring: Predicting long-term outcomes in cognitive behavioral therapy for severe health anxiety.,"Objective:  Routine outcome monitoring (ROM) is a well-evidenced means of improving psychotherapy's effectiveness. However, it is unclear how meaningful ROM is for problems that span physical and mental health, such as severe health anxiety. Physical and mental health comorbidities are common amongst severe health anxiety sufferers and cognitive behavioral therapy (CBT) is a recommended treatment.  Method:  Seventy-nine participants received CBT for severe health anxiety in a clinical trial. The Outcome Rating Scale (ORS: a ROM assessment of wellbeing) was completed at each session. Multilevel modeling assessed whether last-session ORS predicted health anxiety and other outcomes over 12-month follow-up. Similar models were developed using health anxiety as a comparative outcome-predictor. Outcome-improvements of treatment-responders with sudden gains were compared to those of non-sudden-gainers.  Results:  Last-session ORS scores predicted all outcomes up to 12 months later, with a comparable predictive effect to health anxiety. Sudden-gainers on the ORS reported significantly greater improvement in depression, functioning, and wellbeing, but no difference in health anxiety or other measures.  Conclusion:  The ORS may be a feasible, overall estimate of health, functioning, and quality of life in psychotherapy for severe health anxiety. Sudden gains on the ORS may be clinically meaningful with respect to some long-term outcomes.",2020,"Sudden-gainers on the ORS reported significantly greater improvement in depression, functioning, and wellbeing, but no difference in health anxiety or other measures.  ","['Method:  Seventy-nine participants received', 'severe health anxiety']","['cognitive behavioral therapy (CBT', 'cognitive behavioral therapy', 'CBT']","['Outcome Rating Scale (ORS: a ROM assessment of wellbeing', 'severe health anxiety', 'depression, functioning, and wellbeing', 'health anxiety', 'Outcome-improvements of treatment-responders with sudden gains']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C4273786', 'cui_str': 'Outcome Rating Scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276802', 'cui_str': 'Sudden onset'}]",79.0,0.0496876,"Sudden-gainers on the ORS reported significantly greater improvement in depression, functioning, and wellbeing, but no difference in health anxiety or other measures.  ","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Malins', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Moghaddam', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morriss', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schröder', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1657250']
1823,30138718,Rationale and design of the Study To Understand Fall Reduction and Vitamin D in You (STURDY): A randomized clinical trial of Vitamin D supplement doses for the prevention of falls in older adults.,"Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ≥70 years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29 ng/mL and at elevated fall risk, will be randomized to one of four vitamin D3 (cholecalciferol) supplement doses: 200 (control), 1000, 2000, or 4000 IU/day and treated for up to 2 years. Stage 1 is designed to identify the best of the non-control doses for fall prevention. If a best dose is selected, Stage 2 will start seamlessly, with enrollees assigned to control or the best dose in Stage 1 continuing on that dose unchanged, enrollees assigned to the two non-control, non-best doses in Stage 1 switched to the best dose, and new enrollees randomly assigned 1:1 to control or the best dose. In Stage 2, we will compare the control dose group to the best dose group to potentially confirm the efficacy of that dose for fall prevention. The primary outcome measure in both stages is time to first fall or death, whichever comes first. Falls are ascertained from calendars, scheduled interviews, or interim self-reports. Secondary outcome measures include time to each component of the composite primary outcome and gait speed. Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score.
CLINICAL TRIAL REGISTRATION


NCT02166333.",2018,"Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score.
","['1200 community-dwelling persons, aged ≥70\u202fyears, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29\u202fng/mL and at elevated fall risk', 'older adults']","['vitamin D3 (cholecalciferol', 'Vitamin D supplement', 'vitamin D supplementation']","['Fall Reduction and Vitamin D in You (STURDY', 'Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score', 'time to each component of the composite primary outcome and gait speed', 'both stages is time to first fall or death, whichever comes first']","[{'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0960273', 'cui_str': 'CAME'}]",,0.113765,"Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score.
","[{'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Division of Cardiology, Johns Hopkins School of Medicine, Baltimore, MD, United States; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States. Electronic address: edonnell@jhmi.edu.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Schrack', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Johns Hopkins School of Nursing, Baltimore, MD, United States; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Walston', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Kalyani', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine at the University of Vermont, Burlington, VT, United States.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'Department of Pathology, University of Maryland Medical Center, Baltimore, MD, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Center on Aging and Health, Johns Hopkins University, Baltimore, MD, United States; Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, United States; Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2018.08.004']
1824,31425468,Ketamine infusion for pain control in elderly patients with multiple rib fractures: Results of a randomized controlled trial.,"BACKGROUND


Rib fractures are associated with increased mortality, particularly in the elderly. While opiate-based pain regimens remain the cornerstone of rib fracture management, issues related to opioids have driven research into alternative analgesics. Adjunctive ketamine use in lieu of opioids continues to increase but little evidence exists to support its efficacy or safety within the elderly trauma population.
METHODS


A prospective, randomized, double-blind placebo-controlled trial of elderly patients (age, ≥65 years) with three or more rib fractures admitted to a Level I trauma center was conducted. Exclusion criteria included Glasgow Coma Scale score less than 14, and chronic opiate use. Groups were randomized to either low-dose ketamine (LDK) at 2 μg·kg·min or an equivalent rate of 0.9% normal saline. The primary outcome was reduction in numeric pain scores (NPS). Secondary outcomes included oral morphine equivalent (OME) utilization, epidural rates, pulmonary complications, and adverse events.
RESULTS


Thirty (50.8%) of 59 were randomized to the experimental arm. Groups were similar in makeup. Low-dose ketamine failed to reduce 24-hour NPS or OME totals. Subgroup analysis of 24 patients with Injury Severity Score greater than 15 demonstrated that LDK was associated with a reduction in OME utilization the first 24-hours (25.6 mg vs. 42.6 mg, p = 0.04) but at no other time points. No difference in other secondary outcomes or adverse events was noted.
CONCLUSION


Low-dose ketamine failed to affect NPS or OME within the overall cohort, but a decrease in OME was observed in those with an Injury Severity Score greater than 15. Additional studies are necessary to confirm whether LDK benefits severely injured elderly patients.
LEVEL OF EVIDENCE


Therapeutic, level I.",2019,"Subgroup analysis of 24 patients with ISS >15 demonstrated that LDK was associated with a reduction in OME utilization the first 24-hours (25.6 vs. 42.6mg, p=0.04) but at no other time points.","['benefits severely injured elderly patients', 'elderly patients (age ≥65) with ≥3 rib fractures admitted to a Level 1 trauma center was conducted', 'Thirty of 59 (50.8', 'Elderly Patients with Multiple Rib Fractures']","['placebo', 'Ketamine', 'ketamine (LDK', 'ketamine', 'LDK']","['OME', 'adverse events', 'oral morphine equivalent (OME) utilization, epidural rates, pulmonary complications, and adverse events', 'numeric pain scores (NPS', 'OME utilization', '24-hour NPS or OME totals', 'NPS or OME']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.314311,"Subgroup analysis of 24 patients with ISS >15 demonstrated that LDK was associated with a reduction in OME utilization the first 24-hours (25.6 vs. 42.6mg, p=0.04) but at no other time points.","[{'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Kugler', 'Affiliation': 'From the Division of Trauma and Acute Care Surgery, Department of Surgery (N.W.K., T.W.C., W.J.P., K.B., L.B.S.), Medical College of Wisconsin, Milwaukee; Division of Critical Care Pharmacy, Department of Pharmacy, (J.J.), Froedtert Memorial Lutheran Hospital, Wauwatosa; Division of Regional Anesthesia and Acute Pain Management, Department of Anesthesia (K.M.D.), Division of Biostatistics (A.S., L.R.), Medical College of Wisconsin, Milwaukee, Wisconsin; Division of General Surgery, Department of Surgery, (J.S.P.), University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Carver', 'Affiliation': ''}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Peppard', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Karin Madsen', 'Initials': 'KM', 'LastName': 'Drescher', 'Affiliation': ''}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rein', 'Affiliation': ''}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Somberg', 'Affiliation': ''}, {'ForeName': 'Jasmeet S', 'Initials': 'JS', 'LastName': 'Paul', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002479']
1825,32013717,Usefulness of Abdominal Drain in Laparoscopic Roux-en-Y Gastric Bypass: A Randomized Controlled Trial.,"Background:  Laparoscopic Roux-en-Y gastric bypass (RYGB) is one of the most common procedures to treat morbid obesity. Abdominal drains are often placed during the operation to detect complications earlier. The aim of this study was to assess the benefit of routine drain placement during laparoscopic RYGB.  Materials and Methods:  A consecutive series of patients undergoing laparoscopic RYGB between 2017 and 2018 was analyzed. The sample was randomized before the procedure into two groups: with abdominal drain (G1) and without abdominal drain placement (G2). Patients with intraoperative complications were excluded from the randomization. Postoperative complications and pain (visual analogue scale) were compared between groups.  Results:  A total of 84 patients were included; 45 belonged to G1 and 39 to G2. Mean age (G1 44 years versus G2 48 years) and body mass index (G1 43 kg/m 2  versus G2 44 kg/m 2 ) were similar in both groups. There were no significant differences between groups in preoperative comorbidities. Mean operative time was 92 minutes in both groups. Mean pain score at postoperative day 0 was similar in both groups (G1 3.2 versus G2 3.5,  P  = .58), but was higher in G1 at postoperative day 1 (G1 3.1, G2 1.1,  P  = .02). Postoperative Clavien-Dindo I-II complications were similar in both groups (G1 9% versus G2 1%,  P  = .37). No major complications, reoperations, or 30-day mortality occurred in the entire cohort.  Conclusions:  Drain placement in laparoscopic RYGB was associated with greater postoperative pain and did not show benefits in early detection of postoperative complications. Routine placement of abdominal drain in laparoscopic RYGB might not be recommended.",2020,Conclusions:  Drain placement in laparoscopic RYGB was associated with greater postoperative pain and did not show benefits in early detection of postoperative complications.,"['Mean age (G1 44 years versus G2 48 years) and body mass index (G1 43\u2009kg/m 2  versus G2 44\u2009kg/m 2 ', 'Laparoscopic Roux-en-Y Gastric Bypass', 'patients undergoing laparoscopic RYGB between 2017 and 2018 was analyzed', 'A total of 84 patients were included; 45 belonged to G1 and 39 to G2', 'Patients with intraoperative complications']","['Abdominal Drain', 'abdominal drain (G1) and without abdominal drain placement (G2', 'Drain placement', 'routine drain placement', 'Laparoscopic Roux-en-Y gastric bypass (RYGB']","['Mean operative time', 'major complications, reoperations, or 30-day mortality', 'Postoperative Clavien-Dindo I-II complications', 'postoperative pain', 'Mean pain score', 'Postoperative complications and pain (visual analogue scale', 'preoperative comorbidities']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}]","[{'cui': 'C0441140', 'cui_str': 'Abdominal drain (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",84.0,0.280267,Conclusions:  Drain placement in laparoscopic RYGB was associated with greater postoperative pain and did not show benefits in early detection of postoperative complications.,"[{'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Peña', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Schlottmann', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Laxague', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Emmanuel Ezequiel', 'Initials': 'EE', 'LastName': 'Sadava', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Buxhoeveden', 'Affiliation': 'Department of General Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0783']
1826,29470334,Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial: Correction.,,2018,,[],[],['Maternal Pulse Pressure and the Risk of Postepidural Complications'],[],[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.236439,,[],Obstetrics and gynecology,['10.1097/AOG.0000000000002540']
1827,31995838,Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials.,"BACKGROUND


Baricitinib, an oral selective Janus kinase 1 and 2 inhibitor, effectively reduced atopic dermatitis (AD) severity in a phase II study with concomitant topical corticosteroids.
OBJECTIVES


To evaluate the efficacy and safety of baricitinib in patients with moderate-to-severe AD who had an inadequate response to topical therapies.
METHODS


In two independent, multicentre, double-blind, phase III monotherapy trials, BREEZE-AD1 and BREEZE-AD2, adults with moderate-to-severe AD were randomized 2 : 1 : 1 : 1 to once-daily placebo, baricitinib 1 mg, 2 mg, or 4 mg for 16 weeks.
RESULTS


At week 16, more patients achieved the primary end point of Validated Investigator's Global Assessment of AD (0, 1) on baricitinib 4 mg and 2 mg compared with placebo in BREEZE-AD1 [N = 624; baricitinib 4 mg 16·8% (P < 0·001), 2 mg 11·4% (P < 0·05), 1 mg 11·8% (P < 0·05), placebo 4·8%], and BREEZE-AD2 [N = 615; baricitinib 4 mg 13·8% (P = 0·001), 2 mg 10·6% (P < 0·05), 1 mg 8·8% (P = 0·085), placebo 4·5%]. Improvement in itch was achieved as early as week 1 for 4 mg and week 2 for 2 mg. Improvements in night-time awakenings, skin pain and quality-of-life measures were observed by week 1 for both 4 mg and 2 mg (P ≤ 0·05, all comparisons). The most common adverse events in patients treated with baricitinib were nasopharyngitis and headache. No cardiovascular events, venous thromboembolism, gastrointestinal perforation, significant haematological changes, or death were observed with any baricitinib dosage.
CONCLUSIONS


Baricitinib improved clinical signs and symptoms in patients with moderate-to-severe AD within 16 weeks of treatment and induced rapid reduction of itch. The safety profile remained consistent with prior findings from baricitinib clinical development in AD, with no new safety concerns.",2020,"Improvements in night-time awakenings, skin pain, and quality-of-life measures were observed by Week 1 for both 4-mg and 2-mg (P≤0.05, all comparisons).","['patients with moderate-to-severe AD', 'Patients with Moderate-to-Severe Atopic Dermatitis', 'adults with moderate-to-severe AD']","['placebo, baricitinib 1-mg, 2-mg or 4-mg for 16 weeks', 'baricitinib', 'Topical Corticosteroids']","['atopic dermatitis (AD) severity', 'efficacy and safety', 'night-time awakenings, skin pain, and quality-of-life measures', 'nasopharyngitis and headache', 'cardiovascular events, venous thromboembolism, gastrointestinal perforation, significant haematological changes, or death', 'clinical signs and symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}]",,0.136248,"Improvements in night-time awakenings, skin pain, and quality-of-life measures were observed by Week 1 for both 4-mg and 2-mg (P≤0.05, all comparisons).","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Galimberti', 'Affiliation': 'Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ""University of California, San Diego and Rady Children's Hospital, San Diego, CA, USA.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'King', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology George Washington University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University of Bonn, Bonn, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsunemi', 'Affiliation': 'Department of Dermatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Costanzo', 'Affiliation': 'Humanitas University and Dermatology Unit, Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Janes', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'DeLozier', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Brinker', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Nunes', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergology, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18898']
1828,32179935,Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial.,,2020,,[],['extracorporeal membrane oxygenation'],[],[],"[{'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}]",[],,0.144314,,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-05994-8']
1829,32199152,"Interplay between PCI access site, anticoagulant agent, and bleeding: Insights from the REGULATE-PCI randomized trial.",,2020,,[],[],[],[],[],[],,0.0367254,,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Marquis-Gravel', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Zelenkofske', 'Affiliation': 'Regado Biosciences, Basking Ridge, NJ, USA.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Mount Sinai School of Medicine, New York, NY, USA.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université Paris-Diderot, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke Medicine, Durham, NC, USA. Electronic address: thomas.povsic@duke.edu.'}]",American heart journal,['10.1016/j.ahj.2020.02.013']
1830,31820012,"Peer review: single-blind, double-blind, or all the way-blind?","A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding. Ideally, peer review is impartial. Among the many models of peer review, the single blind is currently the most adopted model in scientific journals. The double-blind model has been claimed to decrease bias, despite some difficulty in implementation.",2020,A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding.,[],[],[],[],[],[],,0.145548,A scholarly peer review is the process whereby referees scrutinize research work or a manuscript within their field of expertise and decide on its acceptability for publication in a journal or scientific proceeding.,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Bazi', 'Affiliation': 'American University of Beirut, Beirut, Lebanon. tb14@aub.edu.lb.'}]",International urogynecology journal,['10.1007/s00192-019-04187-2']
1831,27067285,DHEA supplementation and ICSI outcomes: was this really randomized trial?,,2016,,[],[],[],[],[],[],,0.179409,,"[{'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Haydardedeoglu', 'Affiliation': 'Department of Obstetrics and Gynecology, Adana, Turkey. Electronic address: bulenthaydar@yahoo.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2016.03.033']
1832,32176887,Studies Using Randomized Trial Data to Compare Nonrandomized Exposures.,,2020,,[],[],[],[],[],[],,0.0791849,,"[{'ForeName': 'Catharine B', 'Initials': 'CB', 'LastName': 'Stack', 'Affiliation': 'American College of Physicians, Philadelphia, Pennsylvania (C.B.S., A.R.M.).'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Meibohm', 'Affiliation': 'American College of Physicians, Philadelphia, Pennsylvania (C.B.S., A.R.M.).'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Liao', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington (J.M.L.).'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Guallar', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine, Baltimore, Maryland (E.G.).'}]",Annals of internal medicine,['10.7326/M20-0071']
1833,32234533,Reducing an entrée portion size does not affect the amount of dessert consumed.,"BACKGROUND


Increasing portion size has been shown to increase energy intake. However, little is known about the effect of reducing portion size on subsequent consumption and the consequent energy intake.
OBJECTIVE


The purpose of this study was to examine the effect of decreasing portion size of an entrée on the amount of dessert consumed as a following course.
METHODS


A total of 81 participants were instructed to consume a lunch entrée and dessert ad libitum. The participants were given the same entrée and dessert on the same day of the week for four consecutive weeks. However, the entrée was reduced to 90%, 85%, 80%, and 75% of the amount they consumed in the first week of the study. Participants were randomized into four groups and were served the reduced entrée according to a Latin square design. Dessert was consumed ad libitum. In addition, subjects' hunger and satiety levels were assessed before the entrée, after the entrée, and after dessert.
RESULTS


Reducing portion size had no effect on the amount of dessert consumed despite the finding that measures of hunger and satiety indicated that participants experienced increased hunger at 80% and 75% portion reductions.
CONCLUSIONS


Reduction in the portion size of an entrée by up to 25% did not increase the amount of dessert consumed, despite an increase in perceived hunger at lower portion sizes. Further investigation is needed to study how much further portion size could be reduced with a sustained decrease in energy intake without compensation, as well as to examine potential interventions for portion control that could reduce daily energy intake.",2020,"CONCLUSIONS


Reduction in the portion size of an entrée by up to 25% did not increase the amount of dessert consumed, despite an increase in perceived hunger at lower portion sizes.",['81 participants'],[],"['perceived hunger', 'hunger', 'hunger and satiety levels', 'hunger and satiety']",[],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",81.0,0.0367898,"CONCLUSIONS


Reduction in the portion size of an entrée by up to 25% did not increase the amount of dessert consumed, despite an increase in perceived hunger at lower portion sizes.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levitsky', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA; Department of Psychology, Cornell University, Ithaca, NY, USA. Electronic address: dal4@cornell.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Agaronnik', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Colten', 'Initials': 'C', 'LastName': 'Morace', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Barre', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'John Jeshurun', 'Initials': 'JJ', 'LastName': 'Michael', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104684']
1834,29492702,Correction to: Prognostic impact of baseline glucose levels in acute myocardial infarction complicated by cardiogenic shock-a substudy of the IABP-SHOCK II-trial.,The title of this article was rendered incorrectly; the correct title is as follows.,2018,The title of this article was rendered incorrectly; the correct title is as follows.,['acute myocardial infarction'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]",[],[],,0.0694035,The title of this article was rendered incorrectly; the correct title is as follows.,"[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Abdin', 'Affiliation': 'Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Centre Luebeck, Luebeck, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Pöss', 'Affiliation': 'Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Centre Luebeck, Luebeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Centre Luebeck, Luebeck, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Internal Medicine/Cardiology, University of Leipzig-Heart Centre Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Centre Luebeck, Luebeck, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha', 'Affiliation': 'Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), University Heart Centre Luebeck, Luebeck, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen and Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology, University of Leipzig-Heart Centre Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany. holger.thiele@medizin.uni-leipzig.de.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-018-1225-3']
1835,31409559,Exergaming as a Physical Exercise Strategy Reduces Frailty in People With Dementia: A Randomized Controlled Trial.,"OBJECTIVES


People with dementia are known to be physically frailer, more sedentary, and participate less in regular physical exercise compared to their healthy peers. Physical activity interventions have the potential to reduce the level of frailty in community-dwelling older adults. Exergaming combines physical exercise with cognitive stimulation in a virtual environment. It is an innovative and fun way of exercising, which may aid people with dementia to be more physically active. The primary aim of this study was to investigate the efficacy of a 12-week exergame training and equally long aerobic training, both compared to an active control group, on frailty in people with dementia.
DESIGN


A 3-armed randomized controlled trial compared exergame training, aerobic training, and an active control intervention.
PARTICIPANTS


115 people with dementia [mean (standard deviation [SD]) age = 79.2 (6.9) years; mean (SD) Mini-Mental State Examination score = 22.9 (3.4)].
METHODS


Participants were randomized and individually trained 3 times a week during 12 weeks. The Evaluative Frailty Index for Physical activity (EFIP) was used to assess the level of frailty at baseline and after the 12-week intervention period. Between-group differences were analyzed with analysis of covariance.
RESULTS


The exergame group showed a trend toward higher adherence compared to the aerobic group (87.3% vs 81.1%, P = .05). A significant reduction on the EFIP was found in the exergame group (EG) compared to the active control group (CG) [mean difference (95% confidence interval) between EG and CG: -0.034 [-0.062, -0.007], P = .012], with a small-to-moderate effect size (partial η 2  = 0.055).
CONCLUSIONS AND IMPLICATIONS


This is the first study to show that a 12-week exergame intervention reduces the level of frailty in people with dementia. This is an important and promising result, because frailty is a powerful predictor for adverse health outcomes, and its reduction may have positive effects on health status. Moreover, exergaming resulted in high adherence rates of physical exercise, which makes it an effective strategy to engage people with dementia in physical activity.",2019,A significant reduction on the EFIP was found in the exergame group (EG) compared to the active control group (CG) [mean difference (95% confidence interval) between EG and CG: -0.034,"['community-dwelling older adults', 'people with dementia', 'Participants', 'People with dementia', 'People With Dementia', '115 people with dementia [mean (standard deviation [SD]) age\xa0=\xa079.2 (6.9) years']","['exergame training and equally long aerobic training', 'regular physical exercise', 'Physical activity interventions', 'exergame training, aerobic training, and an active control intervention', 'exergame intervention', 'Physical Exercise Strategy', 'Exergaming combines physical exercise with cognitive stimulation']","['EFIP', 'Evaluative Frailty Index for Physical activity (EFIP', 'higher adherence', 'level of frailty', 'mean (SD) Mini-Mental State Examination score']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}]","[{'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]",115.0,0.101464,A significant reduction on the EFIP was found in the exergame group (EG) compared to the active control group (CG) [mean difference (95% confidence interval) between EG and CG: -0.034,"[{'ForeName': 'Esther G A', 'Initials': 'EGA', 'LastName': 'Karssemeijer', 'Affiliation': 'Department of Geriatric Medicine, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands; Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem J R', 'Initials': 'WJR', 'LastName': 'Bossers', 'Affiliation': 'BeweegStrateeg, Groningen, the Netherlands; Center for Human Movement Sciences, University Medical Center, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Justine A', 'Initials': 'JA', 'LastName': 'Aaronson', 'Affiliation': 'Department of Medical Psychology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Lianne M J', 'Initials': 'LMJ', 'LastName': 'Sanders', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands; Department of Medical Psychology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands; Center for Cognition, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatric Medicine, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands; Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: Marcel.OldeRikkert@Radboudumc.nl.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.06.026']
1836,29595841,Correction:  4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis .,[This corrects the article DOI: 10.1136/rmdopen-2017-000582.][This corrects the article DOI: 10.1136/rmdopen-2017-000582.].,2018,[This corrects the article DOI: 10.1136/rmdopen-2017-000582.][This corrects the article DOI: 10.1136/rmdopen-2017-000582.].,['psoriatic arthritis '],"['certolizumab pegol', 'placebo']",[],"[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0491418,[This corrects the article DOI: 10.1136/rmdopen-2017-000582.][This corrects the article DOI: 10.1136/rmdopen-2017-000582.].,[],RMD open,['10.1136/rmdopen-2017-000582corr1']
1837,32139128,"Letter to the editor concerning ""Vicenti G, Bizzoca D, Nappi VS, et al. The impact of lag screw in the healing time of distal tibia fractures treated with minimally invasive plate osteosynthesis: A randomized clinical trial injury. 2020"".",,2020,,[],"['minimally invasive plate osteosynthesis', 'lag screw']",[],[],"[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]",[],,0.0288424,,"[{'ForeName': 'Guojin', 'Initials': 'G', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China. Electronic address: zhouf@bjmu.edu.cn.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedic Surgery, Peking University Third Hospital, No 49, North Garden Rd, HaiDian District, Beijing 100191, China.'}]",Injury,['10.1016/j.injury.2020.02.123']
1838,30655568,"Rifaximin alters gut microbiota profile, but does not affect systemic inflammation - a randomized controlled trial in common variable immunodeficiency.","Common variable immunodeficiency (CVID) patients have reduced gut microbial diversity compared to healthy controls. The reduced diversity is associated with gut leakage, increased systemic inflammation and ten ""key"" bacteria that capture the gut dysbiosis (dysbiosis index) in CVID. Rifaximin is a broad-spectrum non-absorbable antibiotic known to reduce gut leakage (lipopolysaccharides, LPS) in liver disease. In this study, we explored as a 'proof of concept' that altering gut microbial composition could reduce systemic inflammation, using CVID as a disease model. Forty adult CVID patients were randomized, (1:1) to twice-daily oral rifaximin 550 mg versus no treatment for 2 weeks in an open-label, single-centre study. Primary endpoints were reduction in plasma/serum levels of soluble (s) CD14, sCD25, sCD163, neopterin, CRP, TNF, LPS and selected cytokines measured at 0, 2 and 8 weeks. Secondary endpoint was changes in intra-individual bacterial diversity in stool samples. Rifaximin-use did not significantly change any of the inflammation or gut leakage markers, but decreased gut microbial diversity compared with no treatment (p = 0.002). Importantly, the gut bacteria in the CVID dysbiosis index were not changed by rifaximin. The results suggest that modulating gut microbiota by rifaximin is not the chosen intervention to affect systemic inflammation, at least not in CVID.",2019,"Rifaximin-use did not significantly change any of the inflammation or gut leakage markers, but decreased gut microbial diversity compared with no treatment (p = 0.002).",['Forty adult CVID patients'],"['Rifaximin', 'rifaximin 550\u2009mg versus no treatment']","['CVID dysbiosis index', 'inflammation or gut leakage markers', 'changes in intra-individual bacterial diversity in stool samples', 'reduction in plasma/serum levels of soluble (s) CD14, sCD25, sCD163, neopterin, CRP, TNF, LPS and selected cytokines', 'gut microbial diversity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C2710456', 'cui_str': 'rifaximin 550 MG [XIFAXAN]'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0068527', 'cui_str': '2-Amino-6-(1,2,3-trihydroxypropyl)-4(3H)-pteridinone'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",40.0,0.0735508,"Rifaximin-use did not significantly change any of the inflammation or gut leakage markers, but decreased gut microbial diversity compared with no treatment (p = 0.002).","[{'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Jørgensen', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway. s.f.jorgensen@medisin.uio.no.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Macpherson', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bjørnetrø', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holm', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kummen', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rashidi', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Michelsen', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lekva', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Halvorsen', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trøseid', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Mollnes', 'Affiliation': 'Research Laboratory, Nordland Hospital, Bodø, and Faculty of Health Sciences, K.G. Jebsen TREC, University of Tromsø, Tromsø, Norway.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Berge', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yndestad', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Karlsen', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Hov', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fevang', 'Affiliation': 'Research Institute of Internal Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital, Rikshospitalet, Norway.'}]",Scientific reports,['10.1038/s41598-018-35367-7']
1839,32179181,Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear taken - A randomised controlled trial.,,2020,,['cervical cancer screening'],[],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],[],,0.0359161,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cornet', 'Affiliation': 'De Groet, General Practice Oetingen, Gooik, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'General Medicine, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arbyn', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100194']
1840,30922885,Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection.,"OBJECTIVE


The objective of this study was to compare two different rating scales within one Delphi study for defining consensus in core outcome set development and to explore the influence of consensus criteria on the outcome selection.
STUDY DESIGN AND SETTING


Randomized controlled parallel group trial with 1:1 allocation within the first Delphi round of the Core Outcome Set in the Incontinence-Associated Dermatitis project. Outcomes were rated on a three-point or nine-point Likert scale. Decisions about which outcomes to retain were determined by commonly used consensus criteria (i.e., [combinations of] proportions with restricted ranges, central tendency within a specific range, and decrease in variance).
RESULTS


Fifty-seven participants (group 1 = 28, group 2 = 29) rated 58 outcomes. The use of the nine-point scale resulted in almost twice as many outcomes being rated as ""critical"" compared with the three-point scale (24 vs. 13). Stricter criteria and combining criteria led to less outcomes being identified as ""critical"".
CONCLUSION


The format of rating scales in Delphi studies for core outcome set development and the definition of the consensus criteria influence outcome selection. The use of the nine-point scale might be recommended to inform the consensus process for a subsequent rating or face-to-face meeting. The three-point scale might be preferred when determining final consensus.",2019,"The use of the nine-point scale resulted in almost twice as many outcomes being rated as ""critical"" compared with the three-point scale (24 vs. 13).",['Fifty-seven participants (group 1\xa0'],[],[],"[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]",[],[],,0.0579712,"The use of the nine-point scale resulted in almost twice as many outcomes being rated as ""critical"" compared with the three-point scale (24 vs. 13).","[{'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'De Meyer', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kottner', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Beele', 'Affiliation': 'Department of Dermatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitt', 'Affiliation': 'Center for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus TU Dresden, Dresden, Germany.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Center for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van Hecke', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Nursing Department, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Verhaeghe', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Department Health Care, VIVES University College, Roeselare, Belgium.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Beeckman', 'Affiliation': 'Department of Public Health and Primary Care, Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; Faculty of Medicine & Health Sciences, School of Nursing and Midwifery, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland; School of Health Sciences, Örebro University, Örebro, Sweden. Electronic address: Dimitri.Beeckman@UGent.be.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.03.011']
1841,30395309,"In Reply: Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion.",,2019,,[],[],[],[],[],[],,0.0745614,,"[{'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Ghobrial', 'Affiliation': 'Department of Neurological Surgery and the Miami Project to Cure Paralysis University of Miami Miller School of Medicine/Jackson Memorial Hospital Miami, Florida.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Lavelle', 'Affiliation': 'Department of Orthopedic Surgery SUNY Upstate Medical University Syracuse, New York.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Florman', 'Affiliation': 'Maine Medical Center Neuroscience Institute Scarborough, Maine.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Department of Orthopedic Surgery Columbia University Medical Center New York, New York.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Levi', 'Affiliation': 'Department of Neurological Surgery and the Miami Project to Cure Paralysis University of Miami Miller School of Medicine/Jackson Memorial Hospital Miami, Florida.'}]",Neurosurgery,['10.1093/neuros/nyy503']
1842,30545427,Correction to: Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.,After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].,2018,After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].,['female entertainment workers in Cambodia'],['Mobile Link - a theory-based messaging intervention'],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.138426,After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2].,"[{'ForeName': 'Carinne', 'Initials': 'C', 'LastName': 'Brody', 'Affiliation': 'Public Health Program, College of Education and Health Sciences, Touro University California, Vallejo, CA, USA.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Tuot', 'Affiliation': 'KHANA Center for Population Health, Research, No. 33, Street 71, Phnom Penh, Cambodia.'}, {'ForeName': 'Pheak', 'Initials': 'P', 'LastName': 'Chhoun', 'Affiliation': 'KHANA Center for Population Health, Research, No. 33, Street 71, Phnom Penh, Cambodia.'}, {'ForeName': 'Dallas', 'Initials': 'D', 'LastName': 'Swendenman', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Kaplan', 'Affiliation': 'KHANA Center for Population Health, Research, No. 33, Street 71, Phnom Penh, Cambodia.'}, {'ForeName': 'Siyan', 'Initials': 'S', 'LastName': 'Yi', 'Affiliation': 'Public Health Program, College of Education and Health Sciences, Touro University California, Vallejo, CA, USA. siyan@doctor.com.'}]",Trials,['10.1186/s13063-018-3090-9']
1843,30771791,"Correction to: A randomised controlled trial of a mitochondrial therapeutic target for bipolar depression: mitochondrial agents, N-acetylcysteine, and placebo.",The original article [1] contained two minor errors.,2019,The original article [1] contained two minor errors.,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.161613,The original article [1] contained two minor errors.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia. mikebe@barwonhealth.org.au.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.'}, {'ForeName': 'Gin S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.'}, {'ForeName': 'Chee H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville, VIC, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Samuni', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tanious', 'Affiliation': 'CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'McAulay', 'Affiliation': 'CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, NSW, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dowling', 'Affiliation': 'Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': 'School of Psychology, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Waterdrinker', 'Affiliation': 'Melbourne Health, 300 Grattan St, Melbourne, VIC, Australia.'}, {'ForeName': 'Deidre', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, University of Melbourne, the Melbourne Clinic, 130 Church St Richmond, Melbourne, VIC, Australia.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, P.O. Box 291, Geelong, VIC, Australia.'}]",BMC medicine,['10.1186/s12916-019-1280-2']
1844,30988478,A values-alignment intervention protects adolescents from the effects of food marketing.,"Adolescents are exposed to extensive marketing for junk food, which drives overconsumption by creating positive emotional associations with junk food 1-6 . Here we counter this influence with an intervention that frames manipulative food marketing as incompatible with important adolescent values, including social justice and autonomy from adult control. In a preregistered, longitudinal, randomized, controlled field experiment, we show that this framing intervention reduces boys' and girls' implicit positive associations with junk food marketing and substantially improves boys' daily dietary choices in the school cafeteria. Both of these effects were sustained for at least three months. These findings suggest that reframing unhealthy dietary choices as incompatible with important values could be a low-cost, scalable solution to producing lasting, internalized change in adolescents' dietary attitudes and choices.",2019,Both of these effects were sustained for at least three months.,[],[],[],[],[],[],,0.0598307,Both of these effects were sustained for at least three months.,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA. christopher.bryan@chicagobooth.edu.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Cintia P', 'Initials': 'CP', 'LastName': 'Hinojosa', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0586-6']
1845,30563831,Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.,,2018,,[],[],['death and major trauma'],[],[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]",,0.25942,,[],BMJ (Clinical research ed.),['10.1136/bmj.k5343']
1846,27128653,Randomized Controlled Trial of Use of the Peanut Ball During Labor.,,2016,,[],['Peanut Ball During Labor'],[],[],"[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]",[],,0.158061,,[],MCN. The American journal of maternal child nursing,['10.1097/NMC.0000000000000240']
1847,31175689,Do We Have Clinical Equipoise (or Uncertainty) About How Much Protein to Provide to Critically Ill Patients?,"The current recommendation for protein dose in critically ill patients is 1.2-2.0 g/kg/d. Despite this recommendation, there is significant variation in the amount of protein prescribed and delivered worldwide. We contend clinical equipoise, or a state of genuine uncertainty about 2 (dosing) strategies, exists because guideline-based recommendations for protein dose in critically ill patients are rooted in a weak evidentiary base, leaving the clinician with no good basis for choosing a lower or higher protein dose. We outline evidence for and against high protein dose and introduce a pragmatic, registry-based, multicenter, randomized controlled trial, known as EFFORT, which aims to resolve the high vs low protein dose controversy.",2020,The current recommendation for protein dose in critically ill patients is 1.2-2.0 g/kg/d.,[],[],[],[],[],[],,0.107431,The current recommendation for protein dose in critically ill patients is 1.2-2.0 g/kg/d.,"[{'ForeName': 'Jayshil J', 'Initials': 'JJ', 'LastName': 'Patel', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Compher', 'Affiliation': 'Biobehavioral Health Sciences Department, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': 'Department of Critical Care Medicine, Kingston General Hospital, Kingston, Ontario, Canada.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10320']
1848,31094581,"Re: ""Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A Six-Week, Placebo-Controlled, Fixed-Dose Trial"" by Findling et al. (J Child Adolesc Psychopharmacol 2019;29:80-89).",,2019,,['Children with Attention-Deficit/Hyperactivity Disorder'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",[],[],,0.201362,,"[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Mosholder', 'Affiliation': 'Divisions of Epidemiology 1, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Divisions of Psychiatric Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Divisions of Psychiatric Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tiffany R', 'Initials': 'TR', 'LastName': 'Farchione', 'Affiliation': 'Divisions of Psychiatric Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0061']
1849,31403986,Understanding Complex Roles of Family for Latina Health: Evaluating Family Obligation Stress.,We developed a measure of family obligation stress and compared its relationship to health and unmet health care needs relative to social support among a sample of US-based Latinas. Data come from a randomized controlled trial within 4 clinics to increase mammography among Latinas (n = 539). The 1-factor measure had acceptable reliability and construct validity. Family obligation stress was associated with worse health and greater unmet health care needs. Family obligation stress varied by years in the United States and country of origin. Our measure of family obligation stress contributes new venues to family research among Latino populations.,2019,Family obligation stress was associated with worse health and greater unmet health care needs.,"['Latino populations', '4 clinics to increase mammography among Latinas (n = 539']",[],[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",[],[],539.0,0.0222332,Family obligation stress was associated with worse health and greater unmet health care needs.,"[{'ForeName': 'Yamilé', 'Initials': 'Y', 'LastName': 'Molina', 'Affiliation': 'Community Health Sciences Division, School of Public Health, University of Illinois at Chicago (Dr Molina); University of Illinois Cancer Center, Chicago (Dr Henderson); Departments of Health Services (Drs Ornelas and Patrick) and Epidemiology (Dr Beresford), School of Public Health, University of Washington, Seattle; Department of Radiology, School of Medicine, University of Washington, Seattle (Dr Scheel); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington (Ms Bishop); Health Education Program Coordinator, Sea Mar Community Health Centers, Seattle, Washington (Ms Doty); and Kaiser Permanente Research Center for Health Research, Portland, Oregon (Dr Coronado).'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Scheel', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Bishop', 'Affiliation': ''}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Doty', 'Affiliation': ''}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': ''}, {'ForeName': 'Shirley A A', 'Initials': 'SAA', 'LastName': 'Beresford', 'Affiliation': ''}, {'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000232']
1850,31124823,Efficacy of a Polyglycol Dimethacrylate-Based Adhesive in Sealing the Implant-Abutment Interface.,"PURPOSE


The purpose of this study was to assess the effectiveness of a polyglycol dimethacrylate-based adhesive in preventing bacterial leakage through implant-abutment interfaces (IAIs).
MATERIALS AND METHODS


After implant installation, the adhesive was applied in the experimental group (n = 10). None was applied in the control group (n = 10). Samples were collected from the inner walls of implants on days 0 and 90. The real-time polymerase chain reaction was used to detect bacterial DNA.
RESULTS


All samples from the control group, versus 30% from the experimental group, harbored bacterial DNA on day 90.
CONCLUSIONS


This polyglycol dimethacrylate-based adhesive may be used to seal the IAI. Further studies are warranted to verify its effectiveness over longer time periods.",2019,"All samples from the control group, versus 30% from the experimental group, harbored bacterial DNA on day 90.
",[],"['Polyglycol Dimethacrylate-Based Adhesive', 'polyglycol dimethacrylate-based adhesive']",[],[],"[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0440254', 'cui_str': 'Dimethacrylate (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]",[],,0.0187835,"All samples from the control group, versus 30% from the experimental group, harbored bacterial DNA on day 90.
","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bosquê Keedi', 'Affiliation': 'MSc Student, Department of Prosthodontics, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'André Duarte', 'Initials': 'AD', 'LastName': 'Azevedo Marques', 'Affiliation': 'MSc Student, Department of Prosthodontics, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Viviane Aparecida', 'Initials': 'VA', 'LastName': 'Arenas Rodrigues', 'Affiliation': 'PhD Student, Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Mario Julio', 'Initials': 'MJ', 'LastName': 'Avila-Campos', 'Affiliation': 'Head Professor, Department of Microbiology, Institute of Biomedical Sciences, University of Sao Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Tortamano', 'Affiliation': 'Head Professor, Department of Prosthodontics, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.'}]",Implant dentistry,['10.1097/ID.0000000000000882']
1851,31253858,T2DM treatment trial results.,,2019,,[],[],[],[],[],[],,0.0157058,,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Greenhill', 'Affiliation': 'Nature Reviews Endocrinology, . nrendo@nature.com.'}]",Nature reviews. Endocrinology,['10.1038/s41574-019-0234-2']
1852,31397904,Model-Informed Approach to Assess the Treatment Effect Conditional to the Level of Placebo Response.,"One of the most important reasons for failure of placebo-controlled randomized controlled clinical trials (RCTs) is the lack of appropriate methodologies for detecting treatment effect (TE; difference between placebo and active treatment response) in the presence of excessively low/high levels of placebo response. Although, the higher the level of placebo response in a trial, the lower the apparent detectable TE. TE is usually estimated in a conventional analysis of an RCT as an ""apparent"" TE value conditional to the level of placebo response in that RCT. A model-informed methodology is proposed to establish a relationship between level of placebo response and TE. This relationship is used to estimate the ""typical"" TE associated with a ""typical"" level of placebo response, irrespective of the level of placebo response observed. The approach can be valuable for providing a reliable estimate of TE, for conducting risk/benefit analysis, and for determining dosage recommendations.",2019,"The approach can be valuable for providing a reliable estimate of TE, for conducting risk/benefit analysis, and for determining dosage recommendations.",[],['placebo'],['level of placebo response'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",,0.291665,"The approach can be valuable for providing a reliable estimate of TE, for conducting risk/benefit analysis, and for determining dosage recommendations.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gomeni', 'Affiliation': 'Pharmacometrica, La Fouillade, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rabinowitz', 'Affiliation': 'Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Goyal', 'Affiliation': 'GlaxoSmithKline Research and Development, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Françoise Marie Madeleine', 'Initials': 'FMM', 'LastName': 'Bressolle-Gomeni', 'Affiliation': 'Pharmacometrica, La Fouillade, France.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1584']
1853,31017594,Correction: Substituent-controlled racemization of dissymmetric coordination capsules.,"Correction for 'Substituent-controlled racemization of dissymmetric coordination capsules' by Kentaro Harada et al., Org. Biomol. Chem., 2019, DOI: 10.1039/c9ob00388f.",2019,"Correction for 'Substituent-controlled racemization of dissymmetric coordination capsules' by Kentaro Harada et al., Org.","[' 2019, DOI']",['dissymmetric coordination capsules'],[],[],"[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",[],,0.0139486,"Correction for 'Substituent-controlled racemization of dissymmetric coordination capsules' by Kentaro Harada et al., Org.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Department of Chemistry, Graduate School of Science, Hiroshima University, 1-3-1, Kagamiyama, Higashi-Hiroshima, Hiroshima, 739-8526, Japan. haino@hiroshima-u.ac.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sekiya', 'Affiliation': ''}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Maehara', 'Affiliation': ''}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Haino', 'Affiliation': ''}]",Organic & biomolecular chemistry,['10.1039/c9ob90070e']
1854,31419294,"Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults.","Direct venous inoculation of 3.2 × 103 aseptic, purified, cryopreserved, vialed Plasmodium falciparum (Pf) strain NF54 sporozoites, PfSPZ Challenge (NF54), has been used for controlled human malaria infection (CHMI) in the United States, 4 European countries, and 6 African countries. In nonimmune adults, this results in 100% infection rates. We conducted a double-blind, randomized, dose-escalation study to assess the infectivity of the 7G8 clone of Pf (PfSPZ Challenge [7G8]). Results showed dose-dependent infectivity from 43% for 8 × 102 PfSPZ to 100% for 4.8 × 103 PfSPZ. PfSPZ Challenge (7G8) will allow for more complete assessment by CHMI of antimalarial vaccines and drugs.",2019,Results showed dose-dependent infectivity from 43% for 8x102 PfSPZ to 100% for 4.8x103 PfSPZ.,['malaria-naive adults'],"['7G8 clone of Pf (PfSPZ Challenge [7G8', 'PfSPZ Challenge (7G8']",[],"[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009013', 'cui_str': 'Clones'}]",[],,0.0885804,Results showed dose-dependent infectivity from 43% for 8x102 PfSPZ to 100% for 4.8x103 PfSPZ.,"[{'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Berry', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Travassos', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Strauss', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Adams', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Biraj', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Eappen', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Manoj', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Gunasekera', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Malaria Research Group, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Plowe', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jessie K', 'Initials': 'JK', 'LastName': 'Kennedy', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Potter', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Deye', 'Affiliation': 'Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'B K L', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Inc, Rockville, Maryland.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz410']
1855,31708457,"Letter to the Editor on ""Treatment of lateral ankle sprain with platelet-rich plasma: A randomized clinical study"".",,2019,,[],['platelet-rich plasma'],[],[],"[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]",[],,0.0230868,,"[{'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Dahmen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Liam D A', 'Initials': 'LDA', 'LastName': 'Paget', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Gustaaf', 'Initials': 'G', 'LastName': 'Reurink', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands; Aspetar, Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Academic Center for Evidence Based Sports medicine (ACES), The Netherlands; Amsterdam Collaboration for Health and Safety in Sports (ACHSS), International Olympic Committee (IOC) Research Center Amsterdam UMC, The Netherlands. Electronic address: g.m.kerkhoffs@amsterdamumc.nl.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2019.10.008']
1856,31443886,The impact of drug court participation on mortality: 15-year outcomes from a randomized controlled trial.,"AIM


To test the effects of drug court participation on long-term mortality risk.
METHODS


During 1997-98, 235 individuals charged with a non-violent offense were randomly assigned to Baltimore City Drug Treatment Court (BCDTC) or traditional adjudication. Heroin was the predominant substance of choice among the sample. Participant mortality was observed for 15 years following randomization.
RESULTS


Over 20% of participants died during the study, at an average age of 46.6 years, and 64.4% of deaths were substance-use related. Survival analyses estimated that neither mortality from any cause nor from substance use-related causes significantly differed between BCDTC and traditional adjudication.
CONCLUSIONS


Frequent and premature death among the sample indicates that this is a high-risk population in need of effective substance use treatment. Roughly half of drug treatment courts are now estimated to offer medication assisted treatment (MAT), which is currently the most effective treatment for opioid use disorders. In this study of BCDTC implemented over 15 years ago, only 7% of participants received MAT, which may explain the lack of program impact on mortality. Historical barriers to providing MAT in drug court settings include access, concerns about diversion, negative attitudes, blanket prohibitions, and stigma. Drug treatment courts should implement best practice standards for substance use treatment and overdose prevention, including increased access to MAT and naloxone, and training to reduce stigmatizing language and practice.",2019,"Survival analyses estimated that neither mortality from any cause nor from substance use-related causes significantly differed between BCDTC and traditional adjudication.
","['During 1997-98, 235 individuals charged with a non-violent offense']","['Baltimore City Drug Treatment Court (BCDTC) or traditional adjudication', 'Heroin']","['mortality', 'Participant mortality']","[{'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0242151', 'cui_str': 'Violent'}]","[{'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",235.0,0.0492535,"Survival analyses estimated that neither mortality from any cause nor from substance use-related causes significantly differed between BCDTC and traditional adjudication.
","[{'ForeName': 'Brook W', 'Initials': 'BW', 'LastName': 'Kearley', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood Street, Baltimore, MD 21201, USA. Electronic address: brook.kearley@ssw.umaryland.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cosgrove', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood Street, Baltimore, MD 21201, USA. Electronic address: jcosgrove@ssw.umaryland.edu.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood Street, Baltimore, MD 21201, USA. Electronic address: awimberly@ssw.umaryland.edu.'}, {'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Gottfredson', 'Affiliation': 'University of Maryland, Department of Criminology and Criminal Justice, 2220 Samuel J. LeFrak Hall, 7251 Preinkert Drive, College Park, MD 20742, USA. Electronic address: gott@umd.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.004']
1857,28760878,Correction to: Effect of Intensive Blood Pressure Lowering on Left Ventricular Hypertrophy in Patients With Hypertension: SPRINT (Systolic Blood Pressure Intervention Trial).,,2017,,['Patients'],['Intensive Blood Pressure Lowering'],['Left Ventricular Hypertrophy'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}]",,0.0366193,,[],Circulation,['10.1161/CIR.0000000000000528']
1858,31429793,Correction to: Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial.,"Following publication of the original article [1], the authors notified us of a few requested editions that were not implemented adequately during proofing. The publisher apologizes for the inconvenience caused to our authors and readers.",2019,The publisher apologizes for the inconvenience caused to our authors and readers.,[],['benznidazole or placebo'],[],[],"[{'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0945331,The publisher apologizes for the inconvenience caused to our authors and readers.,"[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Villar', 'Affiliation': 'Grupo de Cardiología Preventiva, Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Calle 157 No 19- 55, Campus el, Bosque, Bucaramanga, Colombia. jvillar@unab.edu.co.'}, {'ForeName': 'Víctor Mauricio', 'Initials': 'VM', 'LastName': 'Herrera', 'Affiliation': 'Grupo de Cardiología Preventiva, Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Calle 157 No 19- 55, Campus el, Bosque, Bucaramanga, Colombia.'}, {'ForeName': 'Juan Guillermo Pérez', 'Initials': 'JGP', 'LastName': 'Carreño', 'Affiliation': 'Departamento de Investigaciones, Fundación Cardioinfantil- Instituto de Cardiología, Bogotá, Colombia.'}, {'ForeName': 'Eliana Váquiro', 'Initials': 'EV', 'LastName': 'Herrera', 'Affiliation': 'Departamento de Investigaciones, Fundación Cardioinfantil- Instituto de Cardiología, Bogotá, Colombia.'}, {'ForeName': 'Yeny Zulay Castellanos', 'Initials': 'YZC', 'LastName': 'Domínguez', 'Affiliation': 'Grupo de Cardiología Preventiva, Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Calle 157 No 19- 55, Campus el, Bosque, Bucaramanga, Colombia.'}, {'ForeName': 'Skarlet Marcell', 'Initials': 'SM', 'LastName': 'Vásquez', 'Affiliation': 'Grupo de Cardiología Preventiva, Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Calle 157 No 19- 55, Campus el, Bosque, Bucaramanga, Colombia.'}, {'ForeName': 'Zulma Milena', 'Initials': 'ZM', 'LastName': 'Cucunubá', 'Affiliation': 'Grupo de Parasitología, Instituto Nacional de Salud, Bogotá, Colombia.'}, {'ForeName': 'Nilda Graciela', 'Initials': 'NG', 'LastName': 'Prado', 'Affiliation': 'Departamento de Clínica, Patología y Tratamiento, Instituto Nacional de Parasitología Mario Fatala Chabén, Buenos Aires, Argentina.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Hernández', 'Affiliation': 'Departamento de Clínica, Patología y Tratamiento, Instituto Nacional de Parasitología Mario Fatala Chabén, Buenos Aires, Argentina.'}]",Trials,['10.1186/s13063-019-3630-y']
1859,31399033,Correction to: Effect of liraglutide on cardiac function in patients with type 2 diabetes mellitus: randomized placebo-controlled trial.,"Following publication of the original article [1], the authors reported an error in Fig. 3. The bars in the upper right panel that represent heart rate in placebo treated patients is not correct.",2019,The bars in the upper right panel that represent heart rate in placebo treated patients is not correct.,['patients with type 2 diabetes mellitus'],"['liraglutide', 'placebo']","['cardiac function', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.279912,The bars in the upper right panel that represent heart rate in placebo treated patients is not correct.,"[{'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, LUMC postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. m.b.bizino@lumc.nl.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Jos J M', 'Initials': 'JJM', 'LastName': 'Westenberg', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, LUMC postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Elisabeth H M', 'Initials': 'EHM', 'LastName': 'Paiman', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, LUMC postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Jan W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department of Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hildebrandus J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, LUMC postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}]",Cardiovascular diabetology,['10.1186/s12933-019-0905-2']
1860,30919782,Comparison of Sertraline with Rifampin in the treatment of Cholestatic Pruritus: A Randomized Clinical Trial.,"BACKGROUND


Pruritus is one of the most common and disabling symptoms of liver disease such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Cholestyramine, rifampin, opioid antagonists, antihistaminic agents and SSRIs are used for the management of pruritus. Due to rifampin drug interactions as well as its serious side effects such as hepatotoxicity, clinicians are endeavoruing to find a safer and a more effective substitution.
OBJECTIVE


The purpose of this study was to compare the efficacy and safety of sertraline with rifampin in the management of cholestatic pruritus.
METHODS


In a single-blinded randomized clinical trial a total of 36 patients of PSC and PBC were divided into two equal groups, one group received 100 mg/day sertraline and the other group received rifampin 300 mg/day for 4 weeks. Visual analog scale was used to record pruritus severity at baseline and 4 weeks after drug intervention, also, ALT, AST, ALP and total bilirubin of all patients were measured at three different time points.
RESULTS


Over the follow-up period, pruritus had relieved in both groups, but there was no significant differences between sertraline and rifampin in pruritus management (pvalue=0.740), also there was no significant difference between the two intervention strategies (A versus B) in total bilirubin level (pvalue=0.106). Moreover, the ALT, AST and ALP levels were found to be significantly different between the two groups (Pvalue˂0.01).
CONCLUSION


There is no difference between sertraline and rifampin in pruritus improvement, but sertraline has less adverse effects on hepatobiliary enzyme levels, so it seems to be safer than rifampin.",2019,"Moreover, the ALT, AST and ALP levels was found to be significantly different between two groups (Pvalue˂0.01).
","['36 patients of PSC and PBC', 'Cholestatic pruritus']","['sertraline', 'Cholestyramine, rifampin, opioid antagonists, antihistaminic agents and SSRIs', 'rifampin', 'sertraline with rifampin', 'Sertraline with Rifampin']","['ALT, AST and ALP levels', 'Visual analog scale', 'efficacy and safety', 'total bilirubin level', 'ALT, AST, ALP and total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0008402', 'cui_str': 'colestyramine'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}]",,0.167132,"Moreover, the ALT, AST and ALP levels was found to be significantly different between two groups (Pvalue˂0.01).
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ataei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kord', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Larki', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yasrebifar', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mehrpooya', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Seyedtabib', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hasanzarrini', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Reviews on recent clinical trials,['10.2174/1574887114666190328130720']
1861,31758661,Making Better Dose Decisions: Using Exposure-Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment.,"Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor antagonist in clinical development with positive phase III outcomes for acute treatment of migraine. This paper describes the population exposure-response (E-R) modeling and simulations, which were used to inform the phase III dose-selection rationale, based on ~ 800 participants pooled across two phase IIb randomized dose-finding clinical trials. The E-R model describes the placebo and ubrogepant treatment effects based on migraine pain end points (2-hour pain relief and 2-hour pain freedom) at various dose levels. Sensitivity analyses were conducted to evaluate various assumptions of placebo response in light of the high placebo response observed in one phase II trial. A population pharmacokinetic model describing the effect of formulations was included in the E-R simulation framework to assess potential dose implications of a formulation switch from phase II to phase III. Model-based simulations predict that a dose of 25 mg or higher is likely to achieve significantly better efficacy than placebo with desirable efficacy levels. The understanding of E-R helped support the dose selection for the phase III clinical trials.",2020,"Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor antagonist in clinical development with positive Phase III outcomes for acute treatment of migraine.",[],"['placebo', 'Ubrogepant (MK-1602']",['migraine pain endpoints (2-hour pain relief and 2-hour pain freedom'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C4505937', 'cui_str': 'MK-1602'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",800.0,0.0400702,"Ubrogepant (MK-1602) is a novel, oral, calcitonin gene-related peptide receptor antagonist in clinical development with positive Phase III outcomes for acute treatment of migraine.","[{'ForeName': 'Chi-Chung', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Tiffini', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kowalski', 'Affiliation': 'Ann Arbor Pharmacometrics Group (A2PG), Ann Arbor, Michigan, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Ann Arbor Pharmacometrics Group (A2PG), Ann Arbor, Michigan, USA.'}, {'ForeName': 'Huub Jan', 'Initials': 'HJ', 'LastName': 'Kleijn', 'Affiliation': 'Certara Strategic Consulting, Oss, The Netherlands.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Jones', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Rolien', 'Initials': 'R', 'LastName': 'Bosch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'DeAngelis', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Xie', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Prajakti A', 'Initials': 'PA', 'LastName': 'Kothare', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.12730']
1862,31823403,A personalized computational model predicts cancer risk level of oral potentially malignant disorders and its web application for promotion of non-invasive screening.,"BACKGROUND


Despite their high accuracy to recognize oral potentially malignant disorders (OPMDs) with cancer risk, non-invasive oral assays are poor in discerning whether the risk is high or low. However, it is critical to identify the risk levels, since high-risk patients need active intervention, while low-risk ones simply need to be follow-up. This study aimed at developing a personalized computational model to predict cancer risk level of OPMDs and explore its potential web application in OPMDs screening.
METHODS


Each enrolled patient was subjected to the following procedure: personal information collection, non-invasive oral examination, oral tissue biopsy and histopathological analysis, treatment, and follow-up. Patients were randomly divided into a training set (N = 159) and a test set (N = 107). Random forest was used to establish classification models. A baseline model (model-B) and a personalized model (model-P) were created. The former used the non-invasive scores only, while the latter was incremented with appropriate personal features.
RESULTS


We compared the respective performance of cancer risk level prediction by model-B, model-P, and clinical experts. Our data suggested that all three have a similar level of specificity around 90%. In contrast, the sensitivity of model-P is beyond 80% and superior to the other two. The improvement of sensitivity by model-P reduced the misclassification of high-risk patients as low-risk ones. We deployed model-P in web.opmd-risk.com, which can be freely and conveniently accessed.
CONCLUSION


We have proposed a novel machine-learning model for precise and cost-effective OPMDs screening, which integrates clinical examinations, machine learning, and information technology.",2020,"In contrast, the sensitivity of model-P is beyond 80% and superior to the other two.",[],[],[],[],[],[],,0.0145534,"In contrast, the sensitivity of model-P is beyond 80% and superior to the other two.","[{'ForeName': 'Xiangjian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Changlei', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Oral Medicine, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Lanyan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Oral Pathology, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qinghong', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Oral and Maxillofacial surgery, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Oral Medicine, North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Xueke', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Fanglong', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qizhi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hu', 'Affiliation': 'Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Hefei National Laboratory for Physical Sciences at Microscale and School of Life Science, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China.'}]",Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology,['10.1111/jop.12983']
1863,31852502,The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change.,"BACKGROUND


Staff and service users have expressed concerns that service improvements in British mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation.
METHOD


A cluster randomised controlled trial called DOORWAYS was conducted on eight British, inner-city acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses' perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered.
RESULTS


Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group.
CONCLUSION


Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.
TRIAL REGISTRATION


ISRCTN, ISRCTN 06545047. Registered 29/04/2010, https://www.isrctn.com/search?q=06545047.",2019,"In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward.","['British mental health wards', 'eight British, inner-city acute mental health wards']",[],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}]",[],[],,0.135494,"In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Laker', 'Affiliation': 'Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University, Chelmsford Campus, Bishop Hall Lane, Chelmsford, Essex, CM1 1SQ, UK. caroline.laker@anglia.ac.uk.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cella', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, PO77, Room 2.11, London Henry Wellcome Building, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Agbediro', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Callard', 'Affiliation': 'Birkbeck, Department of Psychosocial Studies, University of London, Malet Street, Bloomsbury, London, WC1E 7HX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, King's College London, Institute of Psychiatry, Psychology & Neuroscience, PO77, Room 2.11, London Henry Wellcome Building, 16 De Crespigny Park, London, SE5 8AF, UK.""}]",BMC psychiatry,['10.1186/s12888-019-2370-6']
1864,31875256,Fluids affecting bladder urgency and lower urinary symptoms (FABULUS): methods and protocol for a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS


We present the design of a randomized controlled trial, Fluids Affecting Bladder Urgency and Lower Urinary Symptoms (FABULUS), with the purpose of testing the common clinical advice of treating overactive bladder by eliminating potentially irritating beverages (PIBs) that are caffeinated, artificially sweetened, citric, or alcoholic. The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations. Secondary outcomes include change in urgency symptoms and volume per void.
METHODS


We report the methods for FABULUS and discuss how challenges presented in the literature and from a prior proof-of-concept feasibility trial are addressed by strengthening study design, procedures, and instruments. We introduce the concept of standardized automated tutorials for assisting participants in compliance from study start to finish. The tutorials contain a detailed explanation of the study, including tips for complying with the extensive diary requirements, and parallel tutorials to intervention and control groups for consistency in format and time of instructional content. The intervention tutorial on eliminating PIBs places emphasis on maintaining steady fluid intake volume, as fluctuations have been a confounder in prior work.
RESULTS


Study results promise to inform about both the tutorial approach and specific PIB reduction for effectively treating overactive bladder.
CONCLUSIONS


OAB can have a negative impact on quality of life, and current medical treatments carry costs and side-effect risks. If simple lifestyle changes can improve or prevent these bladder symptoms, multiple medical and public health advances could result.",2020,The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations.,[],[],"['quality of life', 'change in urgency symptoms and volume per void']",[],[],"[{'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.102426,The primary hypothesis is that women taught to reduce PIBs will show less void frequency compared with a control group instructed in diet/exercise recommendations.,"[{'ForeName': 'Megan O', 'Initials': 'MO', 'LastName': 'Schimpf', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecology, University of Michigan, L4000 University Hospital South, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA. mschimpf@med.umich.edu.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecology, University of Michigan, L4000 University Hospital South, 1500 E. Medical Center Dr., Ann Arbor, MI, 48109, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04209-z']
1865,31984781,"To attend, or not to attend: Examining caregiver intentions and study compliance in a pediatric, randomized controlled trial.","BACKGROUND/AIMS


The  Intent to Attend  is a brief questionnaire recommended by the National Research Council to address dropout concerns and improve prediction of missing data in clinical trials, although implementation has been very limited. As a formative study in pediatric research, the relationship between caregiver intentions and study compliance was investigated in a 180-day trial of dietary supplementation of preterm toddlers. Treatment effect estimation in the context of missing data was also explored.
METHODS


Study compliance (i.e. study completion, supplement adherence, and diary completion) was tracked over three study visits. Baseline questionnaires asked caregivers about intentions concerning study completion via the  Intent to Attend , screened for mental health symptoms (depression, trait anxiety), and captured family demographics. Simple and multiple logistic regression models were built to examine associations between caregiver intent and compliance outcomes. The  Intent to Attend  was also employed as an auxiliary variable to account for missing data within mixed models estimating the treatment effect on the primary outcomes.
RESULTS


Of the 316 caregiver-child dyads included, 95% of caregivers with low intentions had a child complete the study, but only 87% of caregivers with high intentions had a child complete the study. Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20). No effect measure modification by caregiver mental health, child sex, or annual income was detected. Income was the only significant predictor of study non-completion; the lowest income group was almost four times more likely to be study non-completers compared with the highest income group, even after adjustment for child sex and caregiver mental health (adjusted odds ratio = 3.59, 95% confidence interval: 1.38, 9.31). When using  Intent to Attend  as an auxiliary variable, similar results were obtained when compared with the original treatment effect estimates on the primary outcomes.
CONCLUSION


Contrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver-child interactions during pediatric trial participation.",2020,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).",['preterm toddlers'],[],"['caregiver mental health, child sex, or annual income', 'child sex and caregiver mental health']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}]",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]",316.0,0.224541,"Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20).","[{'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Sullivan', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Wiese', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""The Research Institute, Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.""}]","Clinical trials (London, England)",['10.1177/1740774519893307']
1866,32134163,KEYNOTE-032: A Randomized Phase I Study of Pembrolizumab in Chinese Patients with Advanced Non-Small-Cell Lung Cancer.,"LESSONS LEARNED


Results of the KEYNOTE-032 study showed that the safety and pharmacokinetic profiles of pembrolizumab in Chinese patients were comparable with those observed in international studies, and antitumor activity was encouraging. These data support further evaluation of pembrolizumab to improve clinical outcomes in Chinese patients with advanced non-small cell lung cancer.
BACKGROUND


The KEYNOTE-032 study evaluated pembrolizumab pharmacokinetics and clinical outcomes in Chinese patients with locally advanced and/or metastatic non-small-cell lung cancer (NSCLC) and prior treatment failure and/or ineligibility for standard therapy.
METHODS


Patients were randomized 1:1:1 to pembrolizumab 2 mg/kg, 10 mg/kg, or 200 mg every 3 weeks (up to 35 cycles). Safety and pharmacokinetics were primary endpoints; antitumor activity was a secondary endpoint.
RESULTS


A total of 42 of 44 randomized patients received pembrolizumab treatment (2 mg/kg, n = 14; 10 mg/kg, n = 13; 200 mg, n = 15). Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions. Pembrolizumab single dose half-life following 2 mg/kg, 10 mg/kg, and 200 mg was 15.1, 15.8, and 12.3 days, respectively. Serum exposure at the doses studied (range, 2-10 mg/kg) was approximately linear; steady-state area under the curve 0-21 days  (95% confidence interval [CI]) was 730.9 (627.4-851.6), 2,819.2 (2,009.4-3,955.4), and 931.0 (724.4-1,196.6) μg•day/mL, respectively. After 7.9 (range, 0.7-13.1) months median follow-up overall, objective response rate was 14.3% (95% CI, 5.4%-28.5%); median progression-free survival was 2.1 (95% CI, 2.1-4.2) months, and median overall survival was not reached (95% CI, 6.6 months-not reached).
CONCLUSION


Pembrolizumab had manageable toxicity, linear serum exposure, and encouraging antitumor activity in Chinese patients with advanced NSCLC.",2020,"Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions.","['Chinese patients with advanced non-small cell lung cancer', 'Chinese patients with locally advanced and/or metastatic non-small-cell lung cancer (NSCLC) and prior treatment failure', 'Patients', 'Chinese patients with advanced NSCLC', 'Chinese patients', 'Chinese Patients with Advanced Non-Small-Cell Lung Cancer']","['pembrolizumab treatment', 'pembrolizumab', 'Pembrolizumab']","['adverse events (AEs', 'objective response rate', 'safety and pharmacokinetic profiles of pembrolizumab', 'antitumor activity', 'immune-mediated AEs and infusion reactions', 'median overall survival', 'Safety and pharmacokinetics', 'median progression-free survival', 'manageable toxicity, linear serum exposure', 'Serum exposure']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0162643'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",44.0,0.397296,"Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions.","[{'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shaodong', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': ""MSD China, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': ""MSD China, Shanghai, People's Republic of China.""}, {'ForeName': 'HaoJin', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""MSD China, Beijing, People's Republic of China.""}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2020-0067']
1867,30011255,"Lateral Epicondylitis ""Placebo"" Surgery Was Actually a Lateral Denervation Procedure: Response.",,2018,,[],"['Lateral Epicondylitis ""Placebo"" Surgery']",[],[],"[{'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],,0.1713,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kroslak', 'Affiliation': ''}, {'ForeName': 'George A C', 'Initials': 'GAC', 'LastName': 'Murrell', 'Affiliation': ''}]",The American journal of sports medicine,['10.1177/0363546518783971']
1868,31037732,The value of peer mentoring for the psychosocial wellbeing of junior doctors: a randomised controlled study.,,2019,,['junior doctors'],['peer mentoring'],[],"[{'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C4255266', 'cui_str': 'Mentoring'}]",[],,0.0231745,,"[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Chanchlani', 'Affiliation': ""Centre for Medical Officer Recruitment and Education (CMORE), Royal Brisbane and Women's Hospital, Brisbane, QLD.""}, {'ForeName': 'Jeremy Sl', 'Initials': 'JS', 'LastName': 'Ong', 'Affiliation': 'Royal Perth Hospital, Perth, WA.'}]",The Medical journal of Australia,['10.5694/mja2.50162']
1869,32084251,Racial/ethnic differences in circulating natriuretic peptide levels: The Diabetes Prevention Program.,"Natriuretic peptides are cardiac-derived hormones that enhance insulin sensitivity and reduce fat accumulation. Low natriuretic peptide levels are associated with increased risk of type 2 diabetes mellitus (DM2); a condition with variable prevalence across racial/ethnic groups. Few studies have examined whether circulating natriuretic peptide levels and their response to preventive interventions for DM2 differ by race/ethnicity. The Diabetes Prevention Program (DPP) is a clinical trial (July 31, 1996- July 31, 2001) that randomized participants to preventive interventions for DM2. Using stored serum samples, we examined N-terminus pro-B-type natriuretic peptide (NT-proBNP) levels in 3,220 individuals (56% white; 19% African-American; 15% Hispanic; 5% American-Indian; 5% Asian). The influence of race/ethnicity on NT-proBNP concentrations at baseline and after two years of treatment with placebo, lifestyle, or metformin was examined with multivariable-adjusted regression. At baseline, NT-proBNP differed significantly by race (P < .001), with the lowest values in African-American individuals. Hispanic individuals also had lower baseline NT-proBNP levels compared with whites (P< .001), while NT-proBNP levels were similar between white, American-Indian, and Asian individuals. At two years of follow-up, NT-proBNP levels decreased in African-Americans in each of the DPP study arms, whereas they were stable or increased in the other racial/ethnic groups. In the DPP, African-American individuals had lower circulating NT-proBNP levels compared with individuals in other racial/ethnic groups at baseline and after two years of preventive interventions. Further studies should examine the cardio-metabolic implications of lower natriuretic peptide levels in African-Americans. Trial Registration: ClinicalTrials.gov NCT00004992.",2020,"At two years of follow-up, NT-proBNP levels decreased in African-Americans in each of the DPP study arms, whereas they were stable or increased in the other racial/ethnic groups.","['African-Americans', '3,220 individuals (56% white; 19% African-American; 15% Hispanic; 5% American-Indian; 5% Asian']","['placebo, lifestyle, or metformin']","['baseline NT-proBNP levels', 'NT-proBNP concentrations', 'circulating NT-proBNP levels', 'NT-proBNP levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",,0.0351531,"At two years of follow-up, NT-proBNP levels decreased in African-Americans in each of the DPP study arms, whereas they were stable or increased in the other racial/ethnic groups.","[{'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Vanderbilt University School of Medicine, Nashville, TN, United States of America.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Diabetes Research Center (Diabetes Unit), Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Diabetes Prevention Program Data Coordinating Center, The Biostatistics Center, George Washington University, Rockville, MD, United States of America.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Biomarker Research Laboratory/TIMI Clinical Trial Laboratory, Department of Pathology, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Vanderbilt University School of Medicine, Nashville, TN, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0229280']
1870,32194254,Commentary on 'Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to eight weeks later: A randomized controlled trial' (Int J Surg 2020;76:37-44).,,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.137515,,"[{'ForeName': 'Meer M', 'Initials': 'MM', 'LastName': 'Chisthi', 'Affiliation': 'Department of General Surgery, Government Medical College, Trivandrum, Kerala, 695011, India. Electronic address: meerchisthi@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.015']
1871,32247085,"An Invited Commentary on ""comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to eight weeks later: A randomized controlled trial"" (Int J Surg 2020;76:37-44).",,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]",[],,0.137814,,"[{'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Chiarello', 'Affiliation': 'Department of Surgery, General Surgery Operative Unit, ""San Giovanni di Dio"" Hospital, Crotone, Italy. Electronic address: mikikr2001@gmail.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Brisinda', 'Affiliation': 'Department of Surgery, Catholic School of Medicine, ""Agostino Gemelli"" Hospital, Rome, Italy.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.062']
1872,31399943,Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay.,"INTRODUCTION


There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery.
METHOD


Prospective randomised study of patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm), where an IGB was inserted within the 6 months before surgery, and the control arm (C-arm).
RESULTS


The study included 66 patients: 65.6% women, 69.6% with bypass. Age: 43 years (SD 10.2) B-arm and 42.6 years (SD 9.2) in the C-arm. We found 34.4% therapeutic failures in IGB. The mean body weight loss, %EWL and BMI reduction before surgery was 16.2 kg (SD 9.84) B-arm versus 4.7 (SD 8.70) in the C-arm, 23.6% versus 4.7% (p < 0.001) and 6.04 versus 1 (p < 0.001), respectively. The hospital stay was 7 days (p 25-75 : 5-8) B-arm and 7 days (p 25-75 : 5-9) in the C-arm (p = 0.937). Post-surgical morbidity with IGB was 25% versus 29.5% in the C-arm, p = 0.689. The number needed to treat (NNT) to prevent of post-surgical morbidity was 23 patients. The B-arm presented 54.5% moderate-severe post-surgical adverse events (12.5%) versus 82.6% in the C-arm (23.5%), p = 0.111. The cost of placing a balloon was more than 4000 Euros each.
CONCLUSIONS


The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations. The balloon achieves a higher weight loss result when compared to a diet programme, its added cost must also be given due consideration.
TRAIL REGISTRY


This study has been registered on ClinicalTrials.gov with the Identifier: NCT01998243 (November 28, 2013).",2020,"The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations.","['Age', 'bariatric surgery (sleeve gastrectomy and gastric bypass', 'patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm', '66 patients: 65.6% women, 69.6% with bypass']","['preoperative intragastric balloon (IGB', 'IGB', 'Preoperative intragastric balloon']","['mean body weight loss, %EWL and BMI reduction', 'hospital stay', 'hospital stay or rate of re-operations', 'weight loss', 'moderate-severe post-surgical adverse events', 'cost of placing a balloon']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0442113', 'cui_str': 'Intragastric (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0063416', 'cui_str': 'immunoglobulin B'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]",66.0,0.0589934,"The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vicente Martin', 'Affiliation': 'Gastroenterology Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'Luis R', 'Initials': 'LR', 'LastName': 'Rabago Torre', 'Affiliation': 'Gastroenterology Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain. lrabagot@gmail.com.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Castillo Herrera', 'Affiliation': 'Gastroenterology Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Arias Rivero', 'Affiliation': 'Gastroenterology Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Perez Ferrer', 'Affiliation': 'Gastroenterology Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Collado Pacheco', 'Affiliation': 'Gastroenterology Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Martin Rios', 'Affiliation': 'Internal Medicine Department, Hospital Rey Juan Carlos, c/Gladiolo sn, 28933, Móstoles, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Barba Martin', 'Affiliation': 'Internal Medicine Department, Hospital Rey Juan Carlos, c/Gladiolo sn, 28933, Móstoles, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ramiro Martin', 'Affiliation': 'Surgical Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Vazquez-Echarri', 'Affiliation': 'Surgical Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Herrera Merino', 'Affiliation': 'Surgical Department, Hospital Severo Ochoa, Av. de Orellana, s/n, 28911, Leganés, Madrid, Spain.'}]",Surgical endoscopy,['10.1007/s00464-019-07061-w']
1873,32019814,"Vitamin B 12 , Folate, and Cognition in 6- to 9-Year-Olds: A Randomized Controlled Trial.","BACKGROUND AND OBJECTIVES


Vitamin B 12  and folate are important for normal brain development. Our objective for this study was to measure the effects of 6-month supplementation of vitamin B 12  and/or folic acid in early childhood on cognition when the children were 6 to 9 years old.
METHODS


The study is a follow-up of a factorial randomized, double-blind, placebo-controlled trial in 1000 North Indian children. Children 6 to 30 months of age were randomly assigned to receive a placebo or 1.8 µg of vitamin B 12 , 150 mg of folic acid, or both daily for 6 months. After 6 years, we re-enrolled 791 of these children for cognitive assessments. We compared the scores of the main outcomes (the Wechsler Intelligence Scale for Children, Fourth Edition [India], the Crichton Verbal Scale, and subtests of the NEPSY-II) between the study groups. We also measured the associations between markers of the B vitamins (plasma cobalamin, folate, and total homocysteine concentrations) in early childhood and the cognitive outcomes.
RESULTS


There were no differences between the intervention groups and the placebo group on the cognitive outcomes. Plasma cobalamin, folate, and total homocysteine concentrations in early childhood were associated with the cognitive outcomes at follow-up in the unadjusted models. These associations disappeared in models adjusted for relevant confounders.
CONCLUSIONS


Our findings, from both an observational and a randomized design suggest that vitamin B 12  and folate in children 6 to 36 months have limited public health relevance for long-term cognition.",2020,"Plasma cobalamin, folate, and total homocysteine concentrations in early childhood were associated with the cognitive outcomes at follow-up in the unadjusted models.","['early childhood on cognition when the children were 6 to 9 years old', 'After 6 years, we re-enrolled 791 of these children for cognitive assessments', 'Children 6 to 30 months of age', '1000 North Indian children']","['vitamin', 'vitamin B 12  and/or folic acid', 'placebo or 1.8 µg of vitamin B 12 , 150 mg of folic acid', 'placebo']","['B vitamins (plasma cobalamin, folate, and total homocysteine concentrations', 'Plasma cobalamin, folate, and total homocysteine concentrations', 'cognitive outcomes', 'Vitamin B 12 , Folate, and Cognition', 'Wechsler Intelligence Scale for Children, Fourth Edition [India], the Crichton Verbal Scale, and subtests of the NEPSY-II']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444858', 'cui_str': 'AM 6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086024', 'cui_str': 'Cobalamins'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0204457', 'cui_str': 'WISC-V'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}]",1000.0,0.381983,"Plasma cobalamin, folate, and total homocysteine concentrations in early childhood were associated with the cognitive outcomes at follow-up in the unadjusted models.","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India; sunita.taneja@sas.org.in.'}, {'ForeName': 'Ravi P', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Bergen, Norway; and.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}]",Pediatrics,['10.1542/peds.2019-2316']
1874,31402136,Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes Study.,"OBJECTIVES


To investigate the impact of a complex multifaceted intervention on the appropriateness of prescribing for Belgian nursing home (NH) residents.
DESIGN


A multicenter, nonblinded, cluster-randomized controlled trial, with randomization at the NH level, was set up [Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes (COME-ON) Study]. The complex intervention consisted of repeated interdisciplinary case conferences (ICCs) involving the general practitioner, pharmacist, and nurse, aimed at performing a medication review for each NH resident included. The ICCs were supported by a blended training program and local interdisciplinary meetings (discussion of the appropriate use of specific medication classes at the NH level). Control NHs delivered usual care. (isrctn.com: ISRCTN66138978).
SETTING AND PARTICIPANTS


Belgian NHs with at least 35 NH residents were eligible to participate. Eligible residents were those aged 65 years or over, not receiving palliative care, and being treated by a participating general practitioner.
MEASURES


The primary outcome measure related to appropriateness of prescribing at resident level and was considered successful when at least 1 potentially inappropriate medication (PIM) or potential prescribing omission (PPO) present at baseline had been solved at the end of study and when there were no new PIMs or PPOs at the end of study compared with baseline. Secondary outcomes included clinical outcomes, medication use, criterion-specific prevalence of PIMs and PPOs, and ICC outcomes.
RESULTS


In total, 54 NHs (24 intervention; 30 control) and 1804 NH residents (847 intervention; 957 control) participated. Using a 3-level mixed-effects model accounting for data clustering, a significant effect in favor of the intervention was observed (odds ratio 1.479 [95% confidence interval 1.062-2.059, P = .021]). There was no significant difference between groups for most clinical outcomes. The median number of medications did not change over time in either group.
CONCLUSIONS AND IMPLICATIONS


The complex multifaceted intervention tested in the COME-ON study successfully improved appropriateness of prescribing in NHs.",2019,There was no significant difference between groups for most clinical outcomes.,"['Eligible residents were those aged 65\xa0years or over, not receiving palliative care, and being treated by a participating general practitioner', 'In total, 54 NHs (24 intervention; 30 control) and 1804 NH residents (847 intervention; 957 control) participated', 'Belgian NHs with at least 35 NH residents were eligible to participate', 'Belgian nursing home (NH) residents']","['complex multifaceted intervention', 'repeated interdisciplinary case conferences (ICCs']","['appropriateness of prescribing at resident level and was considered successful when at least 1 potentially inappropriate medication (PIM) or potential prescribing omission (PPO', 'new PIMs or PPOs', 'median number of medications', 'clinical outcomes, medication use, criterion-specific prevalence of PIMs and PPOs, and ICC outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0556657', 'cui_str': 'Case conference (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0636794,There was no significant difference between groups for most clinical outcomes.,"[{'ForeName': 'Goedele', 'Initials': 'G', 'LastName': 'Strauven', 'Affiliation': 'KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Anrys', 'Affiliation': 'UC Louvain, Louvain Drug Research Institute, Clinical Pharmacy Research Group, Brussels, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Vandael', 'Affiliation': 'KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Henrard', 'Affiliation': 'UC Louvain, Louvain Drug Research Institute, Clinical Pharmacy Research Group, Brussels, Belgium; UC Louvain, Institute of Health and Society, Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Lepeleire', 'Affiliation': 'KU Leuven, Department Public Health and Primary Care, ACHG, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'UC Louvain, Louvain Drug Research Institute, Clinical Pharmacy Research Group, Brussels, Belgium; UC Louvain, CHU UCL Namur, Pharmacy Department, Yvoir, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Foulon', 'Affiliation': 'KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium. Electronic address: veerle.foulon@kuleuven.be.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.06.006']
1875,31404005,"Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial: The MIRO Trial.","BACKGROUND


Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer.
OBJECTIVES


The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial.
METHODS


We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18.
RESULTS


The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia.
CONCLUSIONS


Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.",2020,"At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303).","['Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus', '13 study centers between 2009 and 2012', 'Patients With Esophageal Cancer']","['Minimally Invasive Versus Open Esophagectomy', 'open esophagectomy (OE', 'Hybrid minimally invasive esophagectomy (HMIE', 'transthoracic OE or HMIE', 'HMIE and OE']","['pain', 'Postoperative complications', 'Health-related Quality of Life', 'social functioning', 'short- and long-term health-related quality of life (HRQOL', 'global HRQOL', 'role functioning, pain, and dysphagia', 'role functioning [-33.33 (HMIE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4517717', 'cui_str': 'Thirty-three point three three'}]",13.0,0.257365,"At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303).","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France.'}, {'ForeName': 'Sheraz', 'Initials': 'S', 'LastName': 'Markar', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, United Kingdom.'}, {'ForeName': 'Tienhan Sandrine', 'Initials': 'TS', 'LastName': 'Dabakuyo-Yonli', 'Affiliation': 'Epidemiology and Quality of Life Unit, INSERM 1231 Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Hepatobiliary and Digestive Surgery, CHU of Rennes, University of Rennes 1, Rennes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': 'Department of Digestive and Hepatobiliary Surgery, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Collet', 'Affiliation': 'Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux, France.'}, {'ForeName': 'Xavier Benoit', 'Initials': 'XB', 'LastName': ""D'Journo"", 'Affiliation': 'Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Perniceni', 'Affiliation': 'Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carrere', 'Affiliation': 'Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, CRCT UMR, Toulouse, France.'}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Mabrut', 'Affiliation': 'Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of Digestive and General Surgery, CHU Louis Mourier, AP-HP, Université Paris 7, Denis Diderot PRES Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Peschaud', 'Affiliation': 'Department of Surgery and Oncology, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Université de Versailles, Boulogne-Billancourt, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Digestive Surgery Department, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Methodology and Quality of Life Unit in Cancer, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003559']
1876,32066146,Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.,"Background


Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred.
Objective


To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo.
Design


Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333).
Setting


North America.
Participants


Adults with known cardiovascular disease and diabetes or metabolic syndrome.
Intervention


Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week.
Measurements


Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication.
Results


After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
Limitation


The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period.
Conclusion


Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased.
Primary Funding Source


National Institutes of Health.",2020,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","['6158 patients', 'patients without rheumatic disease who tolerated LD-MTX during an active run-in period', 'randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2', '2391 participants assigned to', 'Participants\n\n\nAdults with known cardiovascular disease and diabetes or metabolic syndrome']","['placebo', '\n\n\nLow-dose methotrexate (LD-MTX', 'LD-MTX', 'Low-Dose Methotrexate', 'LD-MTX versus placebo', 'folic acid']","['increased risk for skin cancer', 'Renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]",6158.0,0.678699,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Karlson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Barbhaiya', 'Affiliation': 'Hospital for Special Surgery, New York, New York (M.B.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Aruna D', 'Initials': 'AD', 'LastName': 'Pradhan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Deepak A', 'Initials': 'DA', 'LastName': 'Rao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Ritter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-3369']
1877,31405765,"Paroxetine, but not Vortioxetine, Impairs Sexual Functioning Compared With Placebo in Healthy Adults: A Randomized, Controlled Trial.","INTRODUCTION


Sexual dysfunction is prevalent among patients with depression, but assessment of treatment-emergent sexual dysfunction (TESD), a common side effect of antidepressants, can be confounded by the treatment of depressive symptoms in some patients.
AIM


To evaluate sexual functioning in healthy volunteers administered vortioxetine compared with paroxetine, an antidepressant known to cause sexual dysfunction, and placebo.
METHODS


This phase 4, multicenter, randomized, double-blind, placebo-controlled, 4-arm, fixed-dose, head-to-head study compared sexual functioning in healthy volunteers administered vortioxetine (10 and 20 mg once daily [QD]), paroxetine (20 mg QD), or placebo for 5 weeks. Approximately equal numbers of men and women ages 18-40 years with normal sexual functioning (self-reported Changes in Sexual Functioning Questionnaire Short-Form [CSFQ-14] score > 47 for men; > 41 for women) were enrolled. Two modified full analysis sets adjusting for treatment non-compliance were prespecified.
MAIN OUTCOME MEASURE


The primary endpoint was change in CSFQ-14 total score for vortioxetine (10 and 20 mg) vs paroxetine after 5 weeks. Additional endpoints included CSFQ-14 change scores vs placebo, CSFQ-14 subscales, and patient global impression.
RESULTS


Of the 361 subjects enrolled (mean age, 28.4 years), approximately 57% were white, 34% black/African American, and 4% Asian. Vortioxetine 10 mg was associated with significantly less TESD than paroxetine (mean difference, +2.74 points; P = .009). Although vortioxetine 20 mg was associated with numerically less TESD than paroxetine (mean difference, +1.05 points), this difference did not reach statistical significance. Non-compliance appeared to influence results, particularly the paroxetine and vortioxetine 20 mg arms. Paroxetine, but not vortioxetine, was associated with statistically significantly more TESD vs placebo. Vortioxetine also had better outcomes than paroxetine in the 3 phases and 5 dimensions of sexual functioning measured by CSFQ-14.
CLINICAL IMPLICATIONS


These data establish that vortioxetine is associated with less TESD than paroxetine in healthy individuals, suggesting that vortioxetine may be a drug of choice in managing depressive disorders when sexual functioning is a concern.
STRENGTHS & LIMITATIONS


Conducting the study in healthy adults mitigated the risk of an underlying condition (eg, depression) confounding the results. Assay sensitivity was demonstrated by statistically significant TESD with paroxetine vs placebo. The single comparator, paroxetine, and short study duration limit the generalizability of these results.
CONCLUSION


Vortioxetine is associated with less TESD than paroxetine in healthy adults across all phases and dimensions of the sexual response cycle. Vortioxetine was not significantly different from placebo on sexual functioning; however, the difference was significant between paroxetine and placebo, validating study results. Jacobsen P, Zhong W, Nomikos G, et al. Paroxetine, but not Vortioxetine, Impairs Sexual Functioning Compared With Placebo in Healthy Adults: A Randomized, Controlled Trial. J Sex Med 2019; 16:1638-1649.",2019,"Vortioxetine was not significantly different from placebo on sexual functioning; however, the difference was significant between paroxetine and placebo, validating study results.","['healthy volunteers administered', 'Healthy Adults', 'approximately 57% were white, 34% black/African American, and 4% Asian', 'healthy individuals', 'Approximately equal numbers of men and women ages 18-40 years with normal sexual functioning (self-reported Changes in Sexual Functioning Questionnaire Short-Form [CSFQ-14] score > 47 for men; > 41 for women) were enrolled', 'patients with depression', 'healthy adults', '361 subjects enrolled (mean age, 28.4 years']","['vortioxetine (10 and 20 mg once daily [QD]), paroxetine (20 mg QD), or placebo', 'paroxetine', 'paroxetine and vortioxetine', 'Paroxetine', 'placebo', 'vortioxetine', 'Placebo', 'Vortioxetine']","['CSFQ-14 change scores vs placebo, CSFQ-14 subscales, and patient global impression', 'CSFQ-14 total score', 'Assay sensitivity', 'TESD', 'sexual functioning']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",361.0,0.40004,"Vortioxetine was not significantly different from placebo on sexual functioning; however, the difference was significant between paroxetine and placebo, validating study results.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': 'Takeda Development Center Americas, Inc., Deerfield, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Takeda Development Center Americas, Inc., Deerfield, IL, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nomikos', 'Affiliation': 'Takeda Development Center Americas, Inc., Deerfield, IL, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA. Electronic address: ahc8v@virginia.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.06.018']
1878,31266826,Proteomic Analysis of Plasma Reveals Fat Mass Influences Cancer-Related Pathways in Healthy Humans Fed Controlled Diets Differing in Glycemic Load.,"Increased adiposity and diets high in glycemic load (GL) are associated with increased risk of many chronic diseases including cancer. Using plasma from 80 healthy individuals [40 men/40 women, 29 with DXA-derived low fat mass (FM) and 51 with high FM] in a randomized cross-over-controlled feeding trial and arrays populated with 3,504 antibodies, we measured plasma proteins collected at baseline and end of each of two 28-day controlled diets: a low GL diet high in whole grains, legumes, fruits, and vegetables (WG) and a high GL diet high in refined grains and added sugars (RG). Following univariate testing for proteins differing by diet, we evaluated pathway-level involvement. Among all 80 participants, 172 proteins were identified as differing between diets. Stratifying participants by high and low FM identified 221 and 266 proteins, respectively, as differing between diets (unadjusted  P  < 0.05). These candidate proteins were tested for overrepresentation in Reactome pathways, corresponding to 142 (of 291) pathways in the high-FM group and 72 (of 274) pathways in the low-FM group. We observed that the cancer-related pathways,  DNA Repair, DNA Replication , and  Cell Cycle , were overrepresented in the high-FM participants while pathways involved in post-translational protein modification were overrepresented in participants with either FM. Although high-GL diets are associated with increased risk of some cancers, our study further suggests that biology associated with consumption of GL diets is variable depending on an individual's adiposity and dietary recommendations related to cancer prevention be made with the additional consideration of an individual's FM.",2019,Stratifying participants by high and low FM identified 221 and 266 proteins respectively as differing between diets (unadjusted p<0.05).,"['healthy humans fed controlled diets differing in glycemic load', '80 healthy individuals [40 men/40 women, 29 with DXA-derived low-fat mass (FM) and 51 with high FM', 'Among all 80 participants, 172 proteins were identified as differing between diets']","['low GL diet high in whole grains, legumes, fruits, and vegetables (WG) and a high GL diet high in refined grains and added sugars (RG']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0453184', 'cui_str': 'Legumes'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]",[],172.0,0.0369332,Stratifying participants by high and low FM identified 221 and 266 proteins respectively as differing between diets (unadjusted p<0.05).,"[{'ForeName': 'Carly B', 'Initials': 'CB', 'LastName': 'Garrison', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Meredith A J', 'Initials': 'MAJ', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. jlampe@fredhutch.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0175']
1879,31383231,NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h.
METHODS


This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study.
RESULTS


A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes,  P  < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective.
CONCLUSIONS


Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.",2019,"The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001).","['Positional Obstructive Sleep Apnea', '117 participants were randomized (58 SPT first, 59 APAP first', '112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort', 'naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI', 'patients with exclusive positional obstructive sleep apnea (ePOSA']","['NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure', 'NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP', 'SPT']","['Polysomnography and objective adherence determination (device data', 'mean AHI difference (SPT-APAP', 'supine apnea-hypopnea index (sAHI) ≥', 'nonsupine AHI (nsAHI) and a nsAHI', 'average nightly adherence']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]",117.0,0.0276488,"The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h,  P  < .001).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Uhles', 'Affiliation': 'Clayton Sleep Institute, Maplewood, Missouri.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Abaluck', 'Affiliation': 'Paoli Hospital Sleep Center, Paoli, Pennsylvania.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Winslow', 'Affiliation': 'Norton Clinical Research Group, Louisville, Kentucky.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Schweitzer', 'Affiliation': ""St. Luke's Hospital, Chesterfield, Missouri.""}, {'ForeName': 'Raymond A', 'Initials': 'RA', 'LastName': 'Gaskins', 'Affiliation': 'Med One Sleep, Fayetteville, North Carolina.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Doekel', 'Affiliation': 'Sleep Disorders Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep and Wake Disorders, Chevy Chase, Maryland.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7868']
1880,31383235,Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.,"STUDY OBJECTIVES


Patients with obstructive sleep apnea (OSA) have been shown to have high levels of inflammatory markers. Anti-inflammatory treatment with montelukast and intranasal steroids have demonstrated efficacy for mild OSA in children; this has not been fully evaluated in adults. This study investigated the response of mild OSA in adults to anti-inflammatory medical therapy.
METHODS


Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG) were recruited to a prospective double-blind, randomized control trial. Patients were treated for 12 weeks with montelukast and fluticasone or placebo. All underwent a pretreatment and posttreatment PSG. Epworth Sleepiness Scale (ESS) score was obtained pretreatment and at 6 and 12 weeks posttreatment.
RESULTS


A total of 26 patients completed the study with 13 in each group. Mean age in the treatment and placebo groups were 58.3 ± 10.3 and 54.8 ± 14 years, respectively. There was no significant difference between groups reporting nasal congestion ( P  = .186), rhinitis ( P  = .666), or snoring ( P  = .177). There was no difference in the pretreatment ESS score ( P  = .077), body mass index ( P  = .173), or AHI ( P  = .535). The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05). Neither group showed significant change in AHI. In patients in the treatment group, the 6- and 12-week follow-up ESS scores were not significantly different from pretreatment scores ( P  = .37-.46).
CONCLUSIONS


Intranasal steroids and montelukast did not decrease AHI; however, total sleep time and percent of stage R sleep significantly increased. Self-reported improvement could be explained by observed changes in sleep parameters. Larger prospective studies could help elucidate the effects of medical therapy on adult patients with OSA.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults; Identifier: NCT01089647; URL: https://clinicaltrials.gov/ct2/show/record/NCT01089647.",2019,The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05).,"['Adults aged ≥ 21 years with an apnea-hypopnea index (AHI) ≤ 15 events/h on polysomnography (PSG', 'adults to anti-inflammatory medical therapy', 'Adult Patients', 'mild OSA in children', 'Patients with obstructive sleep apnea (OSA', '26 patients completed the study with 13 in each group', 'adult patients with OSA', 'Mild Obstructive Sleep Apnea in Adults']","['Title: Montelukast and Nasa ICS', 'montelukast and fluticasone or placebo', 'placebo', 'Medical Therapy', 'montelukast and intranasal steroids']","['nasal congestion', 'total sleep time and percent of stage R sleep', 'stage R sleep', 'Epworth Sleepiness Scale (ESS) score', 'total sleep time', 'body mass index', 'pretreatment ESS score', 'AHI', 'Mild Obstructive Sleep Apnea']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0242776', 'cui_str': 'NASA'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",,0.045252,The posttreatment PSG in the treatment group demonstrated a significant increase in total sleep time ( P  = .02) and percent of stage R sleep ( P  = .05).,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Smith', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sarber', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Charlene P', 'Initials': 'CP', 'LastName': 'Spiceland', 'Affiliation': 'College School of Business, Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Stacey L', 'Initials': 'SL', 'LastName': 'Ishman', 'Affiliation': ""Division of Pediatric Otolaryngology, Department of Otolaryngology-Head and Neck Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Augelli', 'Affiliation': 'Weill Medical College, Cornell University, New York, New York.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Romaker', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7876']
1881,30010085,Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.,"PURPOSE


We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions.
METHODS


The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. Advisory groups of current and former smokers, quitline service providers, clinicians, and patient advocates were formed for the project. The study used both retrospective and prospective recruitment strategies. Randomization of patients occurred within state-based quitlines, with aggressive tracking of participants. We collected data at baseline and 1-week, 3-month and 6-months after receiving the intervention. The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials. Exploratory outcomes included making an appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening.
RESULTS


We have enrolled and randomized 516 quitline patients and learned many lessons about executing the trial based on significant patient and stakeholder engagement.
CONCLUSIONS


Conducting patient-centered outcomes research requires new ways of thinking and continuously checking-in with patients/stakeholders. The engagement of quitline service providers and patient advisors has been key to successful recruitment and dissemination planning. PCORI- CER-1306-03385 ClinicalTrials.gov NCT ID: NCT02286713.",2018,"The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials.",[],"['appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening', 'video decision aid to standard educational materials', 'patient-centered decision aid', 'PCORI- CER-1306-03385 ClinicalTrials.gov NCT ID']",['knowledgeable about lung cancer screening'],[],"[{'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1446911', 'cui_str': 'Scheduling'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}]","[{'cui': 'C1998726', 'cui_str': 'Is informed (finding)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]",516.0,0.0699302,"The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Kamisha H', 'Initials': 'KH', 'LastName': 'Escoto', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Viola B', 'Initials': 'VB', 'LastName': 'Leal', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bailey', 'Affiliation': 'North American Quitline Consortium, Phoenix, AZ, United States.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Cantor', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Lianne E', 'Initials': 'LE', 'LastName': 'Jacobs', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Esparza', 'Affiliation': 'Houston Health Department, Houston, TX, United States.'}, {'ForeName': 'Myrna C', 'Initials': 'MC', 'LastName': 'Godoy', 'Affiliation': 'Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Housten', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Luckett', 'Affiliation': 'Information & Quality Healthcare, Ridgeland, MS, United States.'}, {'ForeName': 'Reginald F', 'Initials': 'RF', 'LastName': 'Munden', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Rabius', 'Affiliation': 'Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States. Electronic address: bvolk@mdanderson.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.007']
1882,32122152,Integration of Mixed Methods in Community-Based Participatory Research: Development of a Disease Prevention Intervention for Ultra-Orthodox Jewish Women.,"PURPOSE


To describe the development of the first disease prevention intervention with ultra-Orthodox Jewish (UOJ) women in Israel using mixed methods and community-based participatory research (CBPR).
DESIGN


This collaborative, 7-staged development process used an exploratory sequential mixed methods design integrated into a community-based participatory approach.
SETTING


The UOJ community in Israel, a high-risk, low socioeconomic, culturally insular minority that practices strict adherence to religious standards, maintains determined seclusion from mainstream culture and preserves traditional practices including extreme modesty and separation between the sexes.
PARTICIPANTS


Women from a targeted UOJ community in Israel with distinct geographic, religious, and cultural parameters. These included 5 key informant interviewees, 5 focus groups with 6 to 8 participants in each, a cluster randomized sample of 239 questionnaire respondents (an 87% response rate), and 11 steering committee participants.
METHOD


Qualitative data were analyzed through Interpretative Phenomenological Analysis by 2 researchers. Quantitative data were collected via questionnaire (designed based on qualitative findings) and analyzed utilizing descriptive statistics.
RESULTS


Barriers to health behavior engagement and intervention preferences were identified. The final intervention included walking programs, health newsletters, community leader trainings, teacher and student trainings, and health integration into schools.
CONCLUSION


Utilizing mixed methods in CBPR improved cultural tailoring, potentially serving as a model for intervention design in other difficult to access, low socioeconomic, and culturally insular populations.",2020,"To describe the development of the first disease prevention intervention with ultra-Orthodox Jewish (UOJ) women in Israel using mixed methods and community-based participatory research (CBPR).
","['239 questionnaire respondents (an 87% response rate), and 11 steering committee participants', 'Women from a targeted UOJ community in Israel with distinct geographic, religious, and cultural parameters', 'Ultra-Orthodox Jewish Women', 'The UOJ community in Israel, a high-risk, low socioeconomic, culturally insular minority that practices strict adherence to religious standards, maintains determined seclusion from mainstream culture and preserves traditional practices including extreme modesty and separation between the sexes']","['ultra-Orthodox Jewish (UOJ', 'walking programs, health newsletters, community leader trainings, teacher and student trainings, and health integration into schools']",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0204742', 'cui_str': 'Secluding patient (procedure)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],239.0,0.0465275,"To describe the development of the first disease prevention intervention with ultra-Orthodox Jewish (UOJ) women in Israel using mixed methods and community-based participatory research (CBPR).
","[{'ForeName': 'Elisheva', 'Initials': 'E', 'LastName': 'Leiter', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'Program of Medical Humanities, Hebrew University Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Milka', 'Initials': 'M', 'LastName': 'Donchin', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Keren L', 'Initials': 'KL', 'LastName': 'Greenberg', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Keidar', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Wetzler', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Siemiatycki', 'Affiliation': ""Bishvilaych, The Evelyne Barnett Women's Medical Center, Jerusalem, 9548311, Israel.""}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Calderon-Margalit', 'Affiliation': 'Hebrew University of Jerusalem, Braun School of Public Health and Community Medicine, Jerusalem, Israel.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Zwas', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Hadassah University Medical Center, Jerusalem, Israel.'}]",American journal of health promotion : AJHP,['10.1177/0890117120906965']
1883,32114088,Does the Narrative Voice Influence Parental Perceptions of Pediatrician Blogs?,"OBJECTIVE


To determine parental perceptions of pediatrician blog posts by narrative voice.
METHODS


Three blog posts each on 2 topics (vaccines and sleep) were written by an established physician blogger and varied by narrative voice (personal, third person objective and mixed). Topics were chosen to be applicable to all parents. Blog posts were evaluated by a communications expert, 2 research investigators, and 3 parents to confirm differences in narrative voice. We sampled parents of children 0 to 18 years old in 4 primary and subspecialty care clinics, and 1 inpatient medical unit. Participants were randomized to read 2 blog posts (1 per topic) that varied by narrative voice. Participants rated their perceptions of the accuracy, reliability, and appeal for each blog posts on a 5-point Likert Scale. The Kruskal-Wallis test was used to compare the distribution of parental rankings for accuracy, reliability, and appeal.
RESULTS


The average participant age (n = 258) was 39.8 (SD 9.7), 83% were female. Blog posts written in the third person objective voice were rated as more accurate and reliable than those in the personal or mixed voice. There was effect modification by topic, with parents rating the sleep blog posts as more accurate than the vaccine blog posts. There was no difference in the appeal of information by narrative voice or topic of blog post.
CONCLUSIONS


The narrative voice used to convey information on pediatrician blog posts can influence reader perception of accuracy and reliability. Physician bloggers can enhance parental trust of their content using study findings.",2020,Blog posts written in the 3 rd  person objective voice were rated as more accurate and reliable than those in the personal or mixed voice.,"['sampled parents of children 0-18 years old in 4 primary and subspecialty care clinics, and one inpatient medical unit', 'The average participant age (n=258) was 39.8 (SD 9.7), 83% were female']",[],['appeal of information by narrative voice or topic of blog post'],"[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.0198006,Blog posts written in the 3 rd  person objective voice were rated as more accurate and reliable than those in the personal or mixed voice.,"[{'ForeName': 'Mersine A', 'Initials': 'MA', 'LastName': 'Bryan', 'Affiliation': ""Department of Pediatrics (MA Bryan), University of Washington School of Medicine, Seattle Children's Research Institute, Seattle, Wash. Electronic address: mersine@uw.edu.""}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Evans', 'Affiliation': 'Department of Pediatrics (Y Evans), University of Washington School of Medicine, Seattle, Wash.'}, {'ForeName': 'Carlie', 'Initials': 'C', 'LastName': 'Morishita', 'Affiliation': 'University of Washington (C Morishita), Seattle, Wash.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Midamba', 'Affiliation': ""Seattle Children's Research Institute (N Midamba), Seattle, Wash.""}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Moreno', 'Affiliation': 'Department of Pediatrics (MA Moreno), University of Wisconsin School of Medicine, Madison, Wis.'}]",Academic pediatrics,['10.1016/j.acap.2020.02.025']
1884,30844989,Ischemic Preconditioning Improves Strength Endurance Performance.,"Carvalho, L and Barroso, R. Ischemic preconditioning improves strength endurance performance. J Strength Cond Res 33(12): 3332-3337, 2019-Ischemic preconditioning (IPC) has been used to improve performances in aerobic and anaerobic activities. However, a few studies aimed at observing the effects of IPC on resistance training. The purpose of this study is to examine the effects of IPC on the number of repetitions performed during high-load resistance training. We also aimed at investigating blood lactate concentration and muscle activation in an attempt to understand the physiological mechanisms that may be caused by IPC. Ten resistance-trained participants performed four 5-minute cycles of either IPC (250 mm Hg) or Placebo (10 mm Hg) before performing a single set to failure of knee extension exercise with 85% of 1 repetition maximum. We also assessed muscle activation during the set (EMGRMS), median power frequency (EMGMPF), and blood lactate concentration before, 3, 7, and 11 minutes after (peak value was identified and used to calculate delta to prevalues, Δlactate). Data are presented as mean, 90% confidence intervals (CIs), and were analyzed with paired t-test. The level of significance was set at p < 0.05. Participants performed on average 3.9 repetitions (90% CI = 2.4-5.4; p = 0.01), which is ∼20%, more in the IPC condition. There were no significant differences between IPC and Placebo for EMGMPF (5.0%; 90% CI = -5.2 to 15; p = 0.50), EMGRMS (4.5%; 90% CI = -8.8 to 17; p = 0.78), and Δlactate (44%; 90% CI = 11-144; p = 0.16). Our results demonstrate the effect of IPC just on the number of repetitions performed in high-load resistance exercise compared with the Placebo condition.",2019,"Participants performed on average 3.9 repetitions (90% CI = 2.4-5.4; p = 0.01), which is ∼20%, more in the IPC condition.",[],"['2018-Ischemic preconditioning (IPC', 'IPC', 'J Strength Cond Res XX(X', 'Placebo', 'Ischemic Preconditioning', 'Carvalho, L and Barroso, R. Ischemic preconditioning']","['muscle activation during the set (EMGRMS), median power frequency (EMGMPF), and blood lactate concentration', 'strength endurance performance', 'Strength Endurance Performance', 'EMGRMS']",[],"[{'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",,0.0972293,"Participants performed on average 3.9 repetitions (90% CI = 2.4-5.4; p = 0.01), which is ∼20%, more in the IPC condition.","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Carvalho', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, SP, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Barroso', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002846']
1885,30145267,A SMART design to determine the optimal treatment of chronic pain among military personnel.,"Chronic pain is a leading cause of disability among active duty service members in the U.S. armed forces. Standard rehabilitative care and complementary and integrative health therapies are used for chronic pain rehabilitation. However, the optimal sequence and duration of these therapies has yet to be determined. This article describes a sequential multiple assignment randomized trial (SMART) protocol being used to identify the optimal components and sequence of standard rehabilitative care and complementary and integrative health therapies for reducing pain impact and improving other patient outcomes. Active duty service members referred to Madigan Army Medical Center for treatment of chronic pain are being recruited to the Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies study. Study participants are randomized to either standard rehabilitative care (physical and occupational therapy and psychoeducation) or complementary and integrative health therapies (chiropractic, acupuncture, yoga and psychoeducation). Those participants who do not respond to the first 3 weeks of treatment are randomized to receive an additional 3 weeks of either (1) the alternative treatment or (2) the first-stage treatment plus the alternative treatment. This study will also determine factors associated with treatment response that can support clinical decision making, such as baseline fitness, pain catastrophizing, kinesiophobia, post-traumatic stress, pain self-efficacy, and biological indicators. The information gained from this research will be applicable to all integrative chronic pain rehabilitation programs throughout the U.S. Department of Defense and the U.S. Department of Veterans Affairs, and the broader rehabilitation community.",2018,Active duty service members referred to Madigan Army Medical Center for treatment of chronic pain are being recruited to the Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies study.,['chronic pain among military personnel'],"['standard rehabilitative care (physical and occupational therapy and psychoeducation) or complementary and integrative health therapies (chiropractic, acupuncture, yoga and psychoeducation', 'standard rehabilitative care and complementary and integrative health therapies', 'Standard rehabilitative care and complementary and integrative health therapies']",['Chronic pain'],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",,0.0344217,Active duty service members referred to Madigan Army Medical Center for treatment of chronic pain are being recruited to the Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies study.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Flynn', 'Affiliation': 'Madigan Army Medical Center, 9040 Jackson Ave, Tacoma, WA 98431, USA. Electronic address: diane.m.flynn4.civ@mail.mil.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Eaton', 'Affiliation': 'School of Nursing & Health Studies, University of Washington Bothell, Box 358531, Bothell, WA 98011, USA. Electronic address: lineaton@uw.edu.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Langford', 'Affiliation': 'School of Medicine, University of Washington Seattle, Box 356340, Seattle, WA 98195, USA. Electronic address: dalejwl@uw.edu.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ieronimakis', 'Affiliation': 'Madigan Army Medical Center, Department of Clinical Investigations, 9040 Jackson Ave, Tacoma, WA 98431, USA. Electronic address: nicholas.m.ieronimakis.civ@mail.mil.'}, {'ForeName': 'Honor', 'Initials': 'H', 'LastName': 'McQuinn', 'Affiliation': 'Madigan Army Medical Center, 9040 Jackson Ave, Tacoma, WA 98431, USA. Electronic address: honor.m.mcquinn.civ@mail.mil.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Burney', 'Affiliation': 'Madigan Army Medical Center, Department of Clinical Investigations, 9040 Jackson Ave, Tacoma, WA 98431, USA. Electronic address: richard.o.burney.mil@mail.mil.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Holmes', 'Affiliation': 'Madigan Army Medical Center, Department of Pain Management, 9040 Jackson Ave, Tacoma, WA 98431, USA. Electronic address: samuel.l.holmes12.mil@mail.mil.'}, {'ForeName': 'Ardith Z', 'Initials': 'AZ', 'LastName': 'Doorenbos', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, 845 S. Damen Ave, Chicago, IL 60612, USA. Electronic address: ardith@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.08.008']
1886,31489810,Preoperative respiratory muscle endurance training improves ventilatory capacity and prevents pulmonary postoperative complications after lung surgery.,"BACKGROUND


Resection surgery is the main treatment for non-small cell lung cancer (NSCLC). Postoperative complications and mortality are mostly linked to respiratory failure consecutive to respiratory muscle overload.
AIM


We aimed to evaluate the effect of preoperative respiratory muscle endurance training (RMET) on respiratory muscle capacity and postoperative complications in patients undergoing NSCLC resection.
DESIGN


Randomized controlled trial.
SETTING


French university hospital.
POPULATION


Patients eligible for NSCLC resection.
METHODS


The training group (T group) performed a 3-week preoperative RMET added to usual chest physical therapy while the control group (C group) had only the latter. The primary outcome was the change in respiratory muscle endurance. Secondary outcomes were postoperative complications and mortality. Assessments were performed similarly at baseline and after the intervention. We conducted multivariable analyses with analysis of covariance (ANCOVA) taking into account baseline values for isocapnic hyperpnoea endurance test, exercise capacity and pulmonary function tests. The number of pulmonary postoperative complication was analyzed by Fisher-exact test.
RESULTS


We included 26 patients with NSCLC (14 in the T group and 12 in the C group). Respiratory muscle endurance significantly increased in the T group after the RMET compared with C group (+229±199 vs. -5±371 sec, P=0.001). This increase was associated with a significantly lower number of pulmonary postoperative complications (2 vs. 10, P=0.037).
CONCLUSIONS


Preoperative RMET improved respiratory muscle endurance and decreased pulmonary postoperative complications after surgery for NSCLC. These positive results obtained after RMET may help improve the perioperative course for such patients. These results should be confirmed in larger randomized controlled trials, including higher number of patients especially with altered respiratory muscle function.
CLINICAL REHABILITATION IMPACT


Low-cost and easy to perform, RMET training could serve as complementary tool to usual chest physical therapy, before lung resection surgery.",2020,"Respiratory muscle endurance significantly increased in the T group after the RMET compared with C group (+229±199 vs. -5±371 sec, p=0.001).","['patients undergoing NSCLC resection', 'French university hospital', '26 patients with NSCLC', 'Patients eligible for NSCLC resection', 'after lung surgery']","['preoperative respiratory muscle endurance training (RMET', 'preoperative RMET added to usual chest physical therapy', 'Resection surgery', 'Preoperative respiratory muscle endurance training']","['number of pulmonary postoperative complication', 'respiratory muscle capacity and postoperative complications', 'change in respiratory muscle endurance', 'Respiratory muscle endurance', 'respiratory muscle endurance', 'postoperative complications and mortality', 'ventilatory capacity', 'pulmonary postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",26.0,0.0917245,"Respiratory muscle endurance significantly increased in the T group after the RMET compared with C group (+229±199 vs. -5±371 sec, p=0.001).","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Laurent', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France - hlaurent@chu-clermontferrand.fr.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Aubreton', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Galvaing', 'Affiliation': 'Department of Thoracic and Endocrinological Surgery, Center Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ""CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation (DRCI), Clermont-Ferrand, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Department of Pneumology, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Costes', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Filaire', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05781-2']
1887,32106080,The Effects of Ecologically Valid Intervention Strategies on the Locomotor Skills of Children With Visual Impairments.,"Children with visual impairments often exhibit difficulties with locomotor skills (e.g., the ability to move one's body from one place to another), warranting the need for ecologically valid interventions with conditions that attempt to match the real world in a variety of settings. Parents and physical education teachers are the ones choosing to provide movement opportunities for children with visual impairments and must be included in any ecologically valid intervention strategy. This was a descriptive-analytic study. To support the greatest diversity in settings, the authors recruited 94 participants (blind = 44 and low vision = 50; Mage = 13.01 years, SD = 3.26) from schools for the deaf and blind in the United States (teacher led, n = 17) or Latvia (teacher led, n = 57), through an online LISTSERV throughout the United States (parent led, n = 10), and a control subgroup (n = 10). At the pretest, no participant's motor development met age expectations. Children with visual impairments from multiple locations and cultures significantly improved compared with controls who did not. Results were most favorable when the physical educator was the interventionist. However, further research is needed to replicate these findings.",2020,Children with visual impairments from multiple locations and cultures significantly improved compared with controls who did not.,"['Children With Visual Impairments', 'Parents and physical education teachers', 'children with visual impairments', 'Children with visual impairments', '94 participants (blind = 44 and low vision = 50; Mage = 13.01 years, SD = 3.26) from schools for the deaf and blind in the United States (teacher led, n = 17) or Latvia (teacher led, n = 57), through an online LISTSERV throughout the United States (parent led, n = 10), and a control subgroup (n = 10']",['Ecologically Valid Intervention Strategies'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0042798', 'cui_str': 'Vision, Diminished'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023128', 'cui_str': 'Republic of Latvia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],[],94.0,0.0489682,Children with visual impairments from multiple locations and cultures significantly improved compared with controls who did not.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Brian', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bostick', 'Affiliation': 'Louisiana Tech University.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Starrett', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Aija', 'Initials': 'A', 'LastName': 'Klavina', 'Affiliation': 'Latvian Academy of Sports Education.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Taunton Miedema', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pennell', 'Affiliation': 'Pepperdine University.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Stribing', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Gilbert', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Lieberman', 'Affiliation': 'State University of New York, College at Brockport.'}]",Adapted physical activity quarterly : APAQ,['10.1123/apaq.2019-0019']
1888,31375087,"Study protocol: multicenter double-blind, randomized, placebo-controlled trial of rituximab for the treatment of childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial).","BACKGROUND


Eighty percent of children with idiopathic nephrotic syndrome respond well to steroid therapy, but up to 50% of patients with steroid-sensitive nephrotic syndrome exhibit frequently relapsing (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS. Recent studies suggested that rituximab could also be a first-line treatment for early-stage uncomplicated FRNS/SDNS, although further studies are required to confirm its efficacy and safety.
METHODS/DESIGN


We are conducting a multicenter, double-blind, randomized placebo controlled trial to investigate the efficacy and safety of rituximab for the treatment of childhood-onset early-stage uncomplicated FRNS/SDNS. Patients will be allocated to receive two 375 mg/m 2  doses (maximum dose: 500 mg) of either rituximab or placebo. Investigators are permitted to request the disclosure of a subject's allocation code if he or she exhibits treatment failure. Additionally, if placebo-treated subjects display early relapse (a sign of treatment failure), they have the option to receive rituximab in an unblinded phase. The primary endpoint is relapse-free survival during the observation period.
DISCUSSION


The results will provide important data on the use of rituximab for patients with uncomplicated FRNS/SDNS. In the future, rituximab treatment will enable most patients with uncomplicated FRNS/SDNS to discontinue or reduce steroid therapy without relapse, and it is possible that rituximab could represent an immunosuppressive therapy for these diseases.
TRIAL REGISTRATION


This trial was prospectively registered to the JMACCT Clinical Trials Registry on September 6, 2018 (Trial ID: JMA-IIA00380 ).",2019,Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS.,"['patients with complicated FRNS/SDNS', 'patients with steroid-sensitive nephrotic syndrome exhibit frequently relapsing (FRNS) or steroid-dependent nephrotic syndrome (SDNS', 'Eighty percent of children with idiopathic nephrotic syndrome', 'childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial', 'patients with uncomplicated FRNS/SDNS', 'childhood-onset early-stage uncomplicated FRNS/SDNS']","['placebo', 'rituximab', 'steroid therapy', 'rituximab or placebo']","['relapse-free survival', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0403396', 'cui_str': 'Steroid-sensitive nephrotic syndrome (disorder)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome (disorder)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3496337', 'cui_str': 'Nephrotic Syndrome, Type 2'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.457912,Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS.,"[{'ForeName': 'China', 'Initials': 'C', 'LastName': 'Nagano', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Sako', 'Affiliation': 'Division for Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kamei', 'Affiliation': 'Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishikura', 'Affiliation': 'Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hidefumi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Kandai', 'Initials': 'K', 'LastName': 'Nozu', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Iijima', 'Affiliation': 'Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan. iijima@med.kobe-u.ac.jp.'}]",BMC nephrology,['10.1186/s12882-019-1470-3']
1889,31087128,Correction to: Differences in prothrombotic response between the uninterrupted and interrupted apixaban therapies in patients undergoing cryoballoon ablation for paroxysmal atrial fibrillation: a randomized controlled study.,"In the original publication of the article, the table 2 was published incorrectly.",2019,"In the original publication of the article, the table 2 was published incorrectly.",['patients undergoing cryoballoon ablation for paroxysmal atrial fibrillation'],['uninterrupted and interrupted apixaban therapies'],['prothrombotic response'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0364454,"In the original publication of the article, the table 2 was published incorrectly.","[{'ForeName': 'Monami', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuya', 'Initials': 'Y', 'LastName': 'Inden', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan. inden@med.nagoya-u.ac.jp.'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Sairaku', 'Affiliation': 'Department of Cardiology, Onomichi General Hospital, Hiroshima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yanagisawa', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takenaka', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Mayuho', 'Initials': 'M', 'LastName': 'Maeda', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}]",Heart and vessels,['10.1007/s00380-019-01424-y']
1890,32109005,A well-tolerated new amino acid-based formula for cow's milk allergy.,"OBJECTIVES


Infants with cow's milk allergy (CMA) are in need of a substitute formula up to 2 years. The are three requisites for a substitute of milk in CMA: tolerability, nutritional adequacy, and cost-effectiveness. We evaluate here the tolerability of a new amino acid-based infant formula for the management of CMA.
METHODS


In a phase III/IV prospective, multicentre, open-label, international study, infants and children with immunoglobulin E-mediated CMA were exposed to a diagnostic double-blinded, placebo-controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo. If tolerant to it, the study formula was integrated into the patients' usual daily diet for 7 days. Efficacy on day 7 was assessed in terms of symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data.
RESULTS


Thirty children (17 M and 13 F; median age, 1.58; range, 0.08-12.83 years) completed the open challenge and were able to consume the study formula for at least 7 days. No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%. Sixteen patient under the age of two continued with the optional extension phase.
CONCLUSIONS


The study formula meets the American Academy of Pediatric criteria for hypoallergenicity and is well tolerated in short-term use. During optional phase, growth of the patients was not hindered by the study formula.",2020,"No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%.","['infants and children with immunoglobulin E-mediated CMA', 'Thirty children (17 M and 13 F; median age, 1.58; range, 0.08-12.83 years', 'Sixteen patient under the age of two continued with the optional extension phase', ""Infants with cow's milk allergy (CMA""]","['placebo-controlled food challenge with a new amino acid formula by Blemil Plus Elemental using Neocate as the placebo', 'new amino acid-based infant formula']","['symptoms associated with CMA, amount of formula consumed, nutritional and energy intake, and anthropometric data', 'signs or symptoms of allergic reactions']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517417', 'cui_str': 'Zero point zero eight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0266815', 'cui_str': ""Cow's milk protein sensitivity (disorder)""}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0379545', 'cui_str': 'Neocate'}, {'cui': 'C4074817', 'cui_str': 'Amino acid-based infant formula (finding)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}]",30.0,0.0326434,"No signs or symptoms of allergic reactions were recorded among children assuming either the test or the control formula, with a lower 95% one-sided confidence interval for the proportion of subjects who did not experience allergic reactions above 90%.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fierro', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Rocco L', 'Initials': 'RL', 'LastName': 'Valluzzi', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Banzato', 'Affiliation': 'Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Ma A', 'Initials': 'MA', 'LastName': 'Plaza', 'Affiliation': 'Hospital Sant Joan de Deu, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Bosque', 'Affiliation': 'Consorci Sanitari Parc Taulí, Sabadell, Spain.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Íbero', 'Affiliation': 'Hospital de Terrassa, Terrassa, Spain.'}, {'ForeName': 'Luis A Z', 'Initials': 'LAZ', 'LastName': 'Echeverría', 'Affiliation': 'Hospital Severo Ochoa, Laganès, Spain.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Mennini', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Dahdah', 'Affiliation': 'Pediatric Allergy Unit, Bambino Gesù Hospital, Roma, Italy.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'de Castellar', 'Affiliation': 'Laboratorios Ordesa, Sant Boi de Llobregat, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Tort', 'Affiliation': 'Laboratorios Ordesa, Sant Boi de Llobregat, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Jiménez', 'Affiliation': 'Laboratorios Ordesa, Sant Boi de Llobregat, Spain.'}]","Immunity, inflammation and disease",['10.1002/iid3.286']
1891,31370809,Changes in microparticle profiles by vitamin D receptor activation in chronic kidney disease - a randomized trial.,"BACKGROUND


Microparticles (MPs) are biomarkers and mediators of disease through their expression of surface receptors, reflecting activation or stress in their parent cells. Endothelial markers, ICAM-1 and VCAM-1, are implicated in atherosclerosis and associated with cardiovascular risk. Chronic kidney disease (CKD) patients have endothelial dysfunction and high levels of endothelial derived MPs. Vitamin D treatment has been reported to ameliorate endothelial function in CKD patients. We aimed to examine cell specific MP profiles and concentrations of MPs expressing the atherosclerotic markers ICAM-1 and VCAM-1 after treatment with paricalcitol in patients with CKD stage 3-4.
METHODS


Sub-study of the previously reported SOLID trial where 36 patients were randomly assigned to placebo, 1 or 2 μg paricalcitol, for 12 weeks. MPs were measured by flow cytometry after labelling with antibodies against endothelial (CD62E), platelet (CD62P, CD41, CD154) leukocyte (CD45) and vascular (CD54, CD106) markers.
RESULTS


Patients had a mean age of 65 years with a mean eGFR of 40 mL/min/1.73m 2 . Concentrations of ICAM-1 positive MPs were significantly reduced by treatment (repeated measures ANOVA p = 0.04). Repeated measures MANOVA of concentrations of endothelial, platelet and leukocyte MPs showed sustained levels in the 2 μg treatment group (p = 0.85) but a decline in the 1 μg (p = 0.04) and placebo groups (p = 0.005).
CONCLUSIONS


Treatment with paricalcitol reduces concentrations of ICAM-1 positive MPs. This is accompanied by sustained concentrations of all cell specific MPs in the 2 μg group, and decreasing concentrations in the other groups, possibly due to a more healthy and reactive endothelium with paricalcitol treatment.",2019,"Repeated measures MANOVA of concentrations of endothelial, platelet and leukocyte MPs showed sustained levels in the 2 μg treatment group (p = 0.85) but a decline in the 1 μg (p = 0.04) and placebo groups (p = 0.005).
","['36 patients', 'Patients had a mean age of 65\u2009years with a mean eGFR of 40\u2009mL/min/1.73m 2 ', 'patients with CKD stage 3-4', 'Chronic kidney disease (CKD) patients', 'CKD patients']","['paricalcitol', 'placebo, 1 or 2\u2009μg paricalcitol', 'placebo', 'vitamin D receptor activation', 'Vitamin D']","['Concentrations of ICAM-1 positive MPs', 'endothelial function', 'Endothelial markers, ICAM-1 and VCAM-1', 'ICAM-1 positive MPs', 'antibodies against endothelial (CD62E), platelet (CD62P, CD41, CD154) leukocyte (CD45) and vascular (CD54, CD106) markers', 'concentrations of endothelial, platelet and leukocyte MPs showed sustained levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0249582', 'cui_str': 'paricalcitol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0108082', 'cui_str': 'Cholecalciferol Receptors'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.124298,"Repeated measures MANOVA of concentrations of endothelial, platelet and leukocyte MPs showed sustained levels in the 2 μg treatment group (p = 0.85) but a decline in the 1 μg (p = 0.04) and placebo groups (p = 0.005).
","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lundwall', 'Affiliation': 'Department of Cardiology, Danderyd University Hospital, 182 88, Stockholm, Sweden. kristina.lundwall@sll.se.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Mörtberg', 'Affiliation': 'Department of Nephrology, Danderyd University Hospital, 182 88, Stockholm, Sweden.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Mobarrez', 'Affiliation': 'Department of Medicine, Danderyd University Hospital, 182 88, Stockholm, Sweden.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Jacobson', 'Affiliation': 'Department of Nephrology, Danderyd University Hospital, 182 88, Stockholm, Sweden.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Jörneskog', 'Affiliation': 'Department of Medicine, Danderyd University Hospital, 182 88, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Spaak', 'Affiliation': 'Department of Cardiology, Danderyd University Hospital, 182 88, Stockholm, Sweden.'}]",BMC nephrology,['10.1186/s12882-019-1445-4']
1892,31370830,"Baby's first bites: a randomized controlled trial to assess the effects of vegetable-exposure and sensitive feeding on vegetable acceptance, eating behavior and weight gain in infants and toddlers.","BACKGROUND


The start of complementary feeding in infancy plays an essential role in promoting healthy eating habits. Evidence shows that it is important what infants are offered during this first introduction of solid foods: e.g. starting exclusively with vegetables is more successful for vegetable acceptance than starting with fruits. How infants are introduced to solid foods also matters: if parents are sensitive and responsive to infant cues during feeding, this may promote self-regulation of energy intake and a healthy weight. However, the effectiveness of the what and the how of complementary feeding has never been experimentally tested in the same study. In the current project the what and how (and their combination) are tested in one study to determine their relative importance for fostering vegetable acceptance and self-regulation of energy intake in infants.
METHODS


A four-arm randomized controlled trial (Baby's First Bites (BFB)) was designed for 240 first-time Dutch mothers and their infants, 60 per arm. In this trial, we compare the effectiveness of (a) a vegetable-exposure intervention focusing on the what in complementary feeding; (b) a sensitive feeding intervention focusing on the how in complementary feeding, (c) a combined intervention focusing on the what and how in complementary feeding; (d) an attention-control group. All mothers participate in five sessions spread over the first year of eating solid foods (child age 4-16 months). Primary outcomes are vegetable consumption, vegetable liking and self-regulation of energy intake. Secondary outcomes are child eating behaviors, child anthropometrics and maternal feeding behavior. Outcomes are assessed before, during and directly after the interventions (child age 18 months), and when children are 24 and 36 months old.
DISCUSSION


The outcomes are expected to assess the impact of the interventions and provide new insights into the mechanisms underlying the development of vegetable acceptance, self-regulation and healthy eating patterns in infants and toddlers, as well as the prevention of overweight. The results may be used to improve current dietary advice given to parents of their young children on complementary feeding.
TRIAL REGISTRATION


The trial was retrospectively registered during inclusion of participants at the Netherlands National Trial Register (identifier NTR6572 ) and at ClinicalTrials.gov ( NCT03348176 ). Protocol issue date: 1 April 2018; version number 1.",2019,"A four-arm randomized controlled trial (Baby's First Bites (BFB)) was designed for 240 first-time Dutch mothers and their infants, 60 per arm.","['infants and toddlers', '240 first-time Dutch mothers and their infants, 60 per arm', 'healthy eating habits', ""Baby's first bites""]","['vegetable-exposure and sensitive feeding', 'vegetable-exposure intervention']","['vegetable consumption, vegetable liking and self-regulation of energy intake', 'child eating behaviors, child anthropometrics and maternal feeding behavior', 'vegetable acceptance, eating behavior and weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0005658', 'cui_str': 'Bites'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0382235,"A four-arm randomized controlled trial (Baby's First Bites (BFB)) was designed for 240 first-time Dutch mothers and their infants, 60 per arm.","[{'ForeName': 'S M C', 'Initials': 'SMC', 'LastName': 'van der Veek', 'Affiliation': 'Institute of Education and Child Studies (trial sponsor), Leiden University, P.O. Box 9555, 2300, RB, Leiden, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700, AA, Wageningen, The Netherlands.'}, {'ForeName': 'J H M', 'Initials': 'JHM', 'LastName': 'de Vries', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700, AA, Wageningen, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jager', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700, AA, Wageningen, The Netherlands. gerry.jager@wur.nl.'}, {'ForeName': 'C M J L', 'Initials': 'CMJL', 'LastName': 'Vereijken', 'Affiliation': 'Danone Nutricia Research, P.O. Box 80141, 3508, TC, Utrecht, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Weenen', 'Affiliation': 'Danone Nutricia Research, P.O. Box 80141, 3508, TC, Utrecht, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Winden', 'Affiliation': 'Nutricia Early Life Nutrition, P.O. Box 445, 2700, AK, Zoetermeer, The Netherlands.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'van Vliet', 'Affiliation': 'Institute of Education and Child Studies (trial sponsor), Leiden University, P.O. Box 9555, 2300, RB, Leiden, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Schultink', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700, AA, Wageningen, The Netherlands.'}, {'ForeName': 'V W T', 'Initials': 'VWT', 'LastName': 'de Wild', 'Affiliation': 'Institute of Education and Child Studies (trial sponsor), Leiden University, P.O. Box 9555, 2300, RB, Leiden, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Janssen', 'Affiliation': 'Institute of Education and Child Studies (trial sponsor), Leiden University, P.O. Box 9555, 2300, RB, Leiden, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mesman', 'Affiliation': 'Institute of Education and Child Studies (trial sponsor), Leiden University, P.O. Box 9555, 2300, RB, Leiden, The Netherlands.'}]",BMC pediatrics,['10.1186/s12887-019-1627-z']
1893,31241488,Individualization of Migraine Prevention: A Randomized Controlled Trial of Psychophysical-based Prediction of Duloxetine Efficacy.,"OBJECTIVE


Finding an effective preventive agent for the individual migraineur is often long and frustrating. An individual-specific, efficacy-predicting tool would be invaluable in directing, shortening, and improving this process. As the serotonin-norepinephrine reuptake inhibitor duloxetine is a pain modulator, we hypothesized that pronociceptivity will directly predict drug efficacy, so that the more pronociceptive the patient is, the more efficacious the drug. Therefore, we used psychophysical pain measures to predict duloxetine efficacy in migraine prevention.
METHODS


Fifty-five migraineurs participated: 27 received duloxetine and 28 nonactive placebo. Responses to painful stimuli, conditioned pain modulation, and temporal summation of pain were measured before treatment. Treatment outcome measures included changes in attack frequency, migraine days, pain levels, and a reported self-estimate of migraine improvement at weeks 4 and 5. To examine treatment effects, the outcome measures were compared with pretreatment levels. Treatment by the psychophysical-predictor effect on treatment outcome was examined in separate regression models.
RESULTS


Duloxetine was more efficacious than placebo in migraine prevention, as indicated by the patient's estimation of migraine improvement (duloxetine: 52.3±30.4%; placebo: 26.0±27.3%; P=0.001). Further, this measure, in the duloxetine group, was predicted by higher pretreatment pain ratings for tonic heat pain (P=0.012); greater pain sensitivity at baseline predicted greater percent of migraine improvement in duloxetine (r=0.47; P=0.013), but not in placebo (r=-0.36; P=0.060).
DISCUSSION


Our results suggest how personalized medicine can be applied to designing appropriate migraine prevention treatment. Psychophysical testing can reveal and characterize pronociceptive migraineurs, who seem to be more likely than non-pronociceptive ones to benefit from migraine prevention with serotonin-norepinephrine reuptake inhibitors.",2019,"RESULTS


Duloxetine was more efficacious than placebo in migraine prevention as indicated by the patient's estimation of migraine-improvement (duloxetine: 52.3±30.4%; placebo: 26.0±27.3%; P=0.001).",['Fifty-five migraineurs participated; 27 received'],"['placebo', 'Duloxetine', 'serotonin norepinephrine reuptake inhibitors (SNRI) duloxetine', 'duloxetine and 28 non-active placebo', 'duloxetine', 'Migraine Prevention']","['higher pre-treatment pain ratings for tonic heat pain', 'Responses to painful stimuli, conditioned pain modulation and temporal summation of pain', 'changes in attack-frequency, migraine-days, pain levels and a reported self-estimate of migraine-improvement', 'pain-sensitivity']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1291732', 'cui_str': 'Treatment pain'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",55.0,0.0831359,"RESULTS


Duloxetine was more efficacious than placebo in migraine prevention as indicated by the patient's estimation of migraine-improvement (duloxetine: 52.3±30.4%; placebo: 26.0±27.3%; P=0.001).","[{'ForeName': 'Lee B', 'Initials': 'LB', 'LastName': 'Kisler', 'Affiliation': 'Laboratory of Clinical Neurophysiology, Technion Faculty of Medicine.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Weissman-Fogel', 'Affiliation': 'Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Coghill', 'Affiliation': ""Department of Anesthesiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Department of Neurology, Rambam Health Care Campus.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yarnitsky', 'Affiliation': 'Laboratory of Clinical Neurophysiology, Technion Faculty of Medicine.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Granovsky', 'Affiliation': 'Laboratory of Clinical Neurophysiology, Technion Faculty of Medicine.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000739']
1894,31357259,Aerobic Training Performed at Ventilatory Threshold Improves Psychological Outcomes in Adolescents With Obesity.,"BACKGROUND


Physical activity may be as effective as some drugs for improving psychological outcomes; however, vigorous exercise may be needed for improving these outcomes in adolescents with obesity. The aim of this study is to examine the effects of low- and high-intensity training on self-esteem and symptoms of depression and anxiety in adolescents with obesity.
METHODS


A total of 62 pubertal adolescents with obesity (age 15 [1.5] y, body mass index 34.87 [4.22] kg/m2) were randomized into high-intensity group (HIG, n = 31) or low-intensity group (LIG, n = 31) for 24 weeks. All participants also received nutritional, psychological, and clinical counseling. Body composition and measures of depressive symptoms, anxiety, and self-esteem were assessed at baseline and after 24 weeks.
RESULTS


Depressive symptoms decreased significantly in both HIG (d = 1.16) and LIG (d = 0.45) (P ≤ .01). Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002). No changes were observed in state anxiety or self-esteem.
CONCLUSIONS


Results from the present study demonstrate that 24 weeks of multidisciplinary intervention improves depression and anxiety symptoms in adolescents with obesity; however, the magnitude of changes is higher in HIG compared with LIG.",2019,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","['adolescents with obesity', '62 pubertal adolescents with obesity (age 15 [1.5]\xa0y, body mass index 34.87 [4.22]\xa0kg/m2', 'Adolescents With Obesity']","['Aerobic Training Performed at Ventilatory Threshold', 'low- and high-intensity training', 'multidisciplinary intervention']","['Psychological Outcomes', 'self-esteem and symptoms of depression and anxiety', 'Trait anxiety', 'Depressive symptoms', 'depression and anxiety symptoms', 'Body composition and measures of depressive symptoms, anxiety, and self-esteem', 'state anxiety or self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",62.0,0.0340544,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","[{'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Fidelix', 'Affiliation': ''}, {'ForeName': 'Mara C', 'Initials': 'MC', 'LastName': 'Lofrano-Prado', 'Affiliation': ''}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': ''}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Wagner L', 'Initials': 'WL', 'LastName': 'do Prado', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0193']
1895,31378080,Mindfulness Training Supports Quality of Life and Advance Care Planning in Adults With Metastatic Cancer and Their Caregivers: Results of a Pilot Study.,"BACKGROUND


Emotional distress often causes patients with cancer and their family caregivers (FCGs) to avoid end-of-life discussions and advance care planning (ACP), which may undermine quality of life (QoL). Most ACP interventions fail to address emotional barriers that impede timely ACP.
AIM


We assessed feasibility, acceptability, and preliminary effects of a mindfulness-based intervention to facilitate ACP for adults with advanced-stage cancer and their FCGs.
DESIGN


A single-arm pilot was conducted to assess the impact of a 6-week group mindfulness intervention on ACP behaviors (patients only), QoL, family communication, avoidant coping, distress, and other outcomes from baseline (T1) to post-intervention (T2) and 1 month later (T3).
PARTICIPANTS


Eligible patients had advanced-stage solid malignancies, limited ACP engagement, and an FCG willing to participate. Thirteen dyads (N = 26 participants) enrolled at an academic cancer center in the United States.
RESULTS


Of eligible patients, 59.1% enrolled. Attendance (70.8% across 6 sessions) and retention (84.6% for patients; 92.3% for FCGs) through T3 were acceptable. Over 90% of completers reported high intervention satisfaction. From T1 to T3, patient engagement more than doubled in each of 3 ACP behaviors assessed. Patients reported large significant decreases in distress at T2 and T3. Family caregivers reported large significant improvements in QoL and family communication at T2 and T3. Both patients and FCGs reported notable reductions in sleep disturbance and avoidant coping at T3.
CONCLUSIONS


The mindfulness intervention was feasible and acceptable and supported improvements in ACP and associated outcomes for patients and FCGs. A randomized trial of mindfulness training for ACP is warranted. The study is registered at ClinicalTrials.gov with identifier NCT02367508 ( https://clinicaltrials.gov/ct2/show/NCT02367508 ).",2020,Attendance (70.8% across 6 sessions) and retention (84.6% for patients; 92.3% for FCGs) through T3 were acceptable.,"['Emotional distress often causes patients with cancer and their family caregivers (FCGs', 'adults with advanced-stage cancer and their FCGs', 'Thirteen dyads (N = 26 participants) enrolled at an academic cancer center in the United States', 'Adults With Metastatic Cancer and Their Caregivers', 'Eligible patients had advanced-stage solid malignancies, limited ACP engagement, and an FCG willing to participate']","['6-week group mindfulness intervention', 'Mindfulness Training', 'mindfulness-based intervention to facilitate ACP', 'mindfulness training']","['QoL and family communication', 'ACP behaviors', 'sleep disturbance and avoidant coping', 'Attendance', 'distress']","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",26.0,0.0959599,Attendance (70.8% across 6 sessions) and retention (84.6% for patients; 92.3% for FCGs) through T3 were acceptable.,"[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Beck-Coon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick V', 'Initials': 'PV', 'LastName': 'Stutz', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Tasneem L', 'Initials': 'TL', 'LastName': 'Talib', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Chinh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, USA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Cottingham', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Cleveland', 'Initials': 'C', 'LastName': 'Shields', 'Affiliation': 'Department of Human Development and Family Studies, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Madison E', 'Initials': 'ME', 'LastName': 'Stout', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Stump', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Alexia M', 'Initials': 'AM', 'LastName': 'Torke', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Helft', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909119862254']
1896,31383978,Effects of LC-PUFA supply via complementary food on infant development-a food based intervention (RCT) embedded in a total diet concept.,"BACKGROUND


With the introduction of complementary food, long-chain PUFA (LC-PUFA) supply usually decreases during the second 6 months of life. However, the need for LC-PUFA is still high for infant's rapid development. The aim of this randomized, controlled intervention trial was to examine the effects of an increased n-3 (LC-)PUFA supply using alternative complementary foods on infants' visual and cognitive development.
METHODS


Mother-child dyads of term infants were recruited in maternity hospitals and randomly assigned to one of three study groups, which all were fed according to the German dietary schedule for infant nutrition. Intervention group IG-R (n = 54) received jars of complementary food with rapeseed oil, IG-F (n = 48) jars with oily fish twice a week and the control group (CG, n = 58) the same jars as IG-R with corn oil instead of rapeseed oil during the intervention period (5th-10th month of age). The outcome measures were latencies of FVEP, Bayley's mental developmental index (MDI), and psychomotor developmental index (PDI).
RESULTS


At 10 months of age, there were no significant differences in latencies of FVEP, Bayley's MDI, or in PDI index between the intervention and control groups.
CONCLUSIONS


Fish and rapeseed oil used as (LC-)PUFA sources provided with complementary feeding embedded in a structured infant diet did not affect visual or cognitive development of term infants.",2020,"At 10 months of age, there were no significant differences in latencies of FVEP, Bayley's MDI, or in PDI index between the intervention and control groups.
","['Mother-child dyads of term infants were recruited in maternity hospitals', ""infants' visual and cognitive development""]","['Intervention group IG-R (n\u2009=\u200954) received jars of complementary food with rapeseed oil, IG-F (n\u2009=\u200948) jars with oily fish twice a week and the control group (CG, n\u2009=\u200958) the same jars as IG-R with corn oil instead of rapeseed oil', 'LC-PUFA', 'increased n-3 (LC-)PUFA supply using alternative complementary foods', 'German dietary schedule for infant nutrition', 'Fish and rapeseed oil']","[""latencies of FVEP, Bayley's MDI, or in PDI index"", ""latencies of FVEP, Bayley's mental developmental index (MDI), and psychomotor developmental index (PDI"", 'visual or cognitive development']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4318417', 'cui_str': 'Jar'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0072982', 'cui_str': 'rapeseed oil'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0021279', 'cui_str': 'Infant Nutrition Physiology'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}]","[{'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",,0.0405203,"At 10 months of age, there were no significant differences in latencies of FVEP, Bayley's MDI, or in PDI index between the intervention and control groups.
","[{'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Kalhoff', 'Affiliation': 'Pediatric Clinic Dortmund, Dortmund, Germany. hermann.kalhoff@klinikumdo.de.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Mesch', 'Affiliation': 'Research Department of Child Nutrition (FKE), Pediatric University Clinic, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Stimming', 'Affiliation': 'Research Department of Child Nutrition (FKE), Pediatric University Clinic, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Israel', 'Affiliation': 'Neurological Clinic, Lüdenscheid, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Spitzer', 'Affiliation': 'Klinikum Arnsberg, Arnsberg, Germany.'}, {'ForeName': 'Latifa', 'Initials': 'L', 'LastName': 'Beganovic', 'Affiliation': 'Pediatric Clinic Dortmund, Dortmund, Germany.'}, {'ForeName': 'Rocio Estella', 'Initials': 'RE', 'LastName': 'Perez', 'Affiliation': 'Pediatric Clinic Dortmund, Dortmund, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""LMU-Ludwig-Maximilians-Universität Munich, Dr. von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Warschburger', 'Affiliation': 'Department Psychology, Potsdam University, Potsdam, Germany.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Kersting', 'Affiliation': 'Research Department of Child Nutrition (FKE), Pediatric University Clinic, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Libuda', 'Affiliation': 'Research Department of Child Nutrition (FKE), Pediatric University Clinic, Ruhr University, Bochum, Germany.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0491-0']
1897,31375042,Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes.,"BACKGROUND


The I-HART CGM study has shown that real-time continuous glucose monitoring (rtCGM) has greater beneficial impact on hypoglycemia than intermittently scanned continuous glucose monitoring (iscCGM) in adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections). In this subanalysis, we present the impact of rtCGM and iscCGM on glycemic variability (GV).
METHODS


Forty participants were recruited to this parallel group study. Following two weeks of blinded rtCGM (DexcomG4), participants were randomized to rtCGM (Dexcom G5;  n  = 20) or iscCGM (Freestyle Libre;  n  = 20) for eight weeks. An open-extension phase enabled participants on rtCGM to continue for a further eight weeks and those on iscCGM to switch to rtCGM over this period. Glycemic variability measures at baseline, 8- and 16-week endpoints were compared between groups.
RESULTS


At the eight-week endpoint, between-group differences demonstrated significant reduction in several GV measures with rtCGM compared to iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR];  P  < .05). Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P  < .05). At 16 weeks, the iscCGM group switching to rtCGM showed significant improvement in GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR.
CONCLUSION


Our data suggest most, but not all, GV measures improve with rtCGM compared with iscCGM, particularly those measures associated with the risk of hypoglycemia. Selecting appropriate glucose monitoring technology to address GV in this high-risk cohort is important to minimize the risk of glucose extremes and severe hypoglycemia.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03028220.",2020,Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P  < .05).,"['adults with type 1 diabetes at high risk (Gold score ≥4 or recent severe hypoglycemia using insulin injections', 'Forty participants were recruited to this parallel group study', 'Adults With Highest Risk Type 1 Diabetes']","['rtCGM and iscCGM', 'scanned continuous glucose monitoring (iscCGM', 'Continuous Glucose Monitoring', 'rtCGM (Dexcom G5;  n  = 20) or iscCGM']","['glycemic variability (GV', 'iscCGM (GRADE%hypoglycemia, index of glycemic control [IGC], and average daily risk range [ADRR', 'risk of hypoglycemia', 'Glycemic Variability and Hypoglycemic Excursions', 'Glycemic variability measures', 'mean average glucose and glycemic variability percentage and GRADE%hyperglycemia', 'GRADE%hypoglycemia, personal glycemic status, IGC, and ADRR', 'several GV measures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0441633'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",40.0,0.0227794,Intermittently scanned continuous glucose monitoring reduced mean average glucose and glycemic variability percentage and GRADE%hyperglycemia compared with rtCGM ( P  < .05).,"[{'ForeName': 'Parizad', 'Initials': 'P', 'LastName': 'Avari', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Moscardo', 'Affiliation': 'Department of Engineering, Universitat Politecnica de Valencia, Spain.'}, {'ForeName': 'Narvada', 'Initials': 'N', 'LastName': 'Jugnee', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.'}]",Journal of diabetes science and technology,['10.1177/1932296819867688']
1898,30998806,Concerns Regarding Phase 1b Clinical Trial of Atezolizumab Plus nab-Paclitaxel for Metastatic Breast Cancer.,,2019,,['Metastatic Breast Cancer'],['Atezolizumab Plus nab-Paclitaxel'],[],"[{'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]",[],,0.0239702,,"[{'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.'}]",JAMA oncology,['10.1001/jamaoncol.2019.0314']
1899,31380699,"Acceptance-enhanced behavior therapy for trichotillomania: Randomized controlled trial rationale, method, and strategies for recruiting minority participants.","Trichotillomania (TTM) involves the chronic pulling out of hair to the point of hair loss or thinning, which continues despite repeated attempts to stop. Behavior therapy is a promising treatment for the condition, but studies have been limited by the lack of a credible control condition, small sample sizes, follow-up periods of short duration, and low participation by underrepresented populations. In the current article, the authors describe the theoretical rationale for an acceptance-enhanced form of behavior therapy for TTM in adults and describe the methodology used to test the efficacy of this intervention against a psychoeducation and supportive control condition. In addition, the authors discuss the importance of and difficulties encountered with enrolling minority participants into TTM research, as well as strategies used to enhance minority recruitment. Finally, the authors discuss the instruments, procedures, and related outcomes of the fidelity measures used in the randomized controlled trial.",2019,"In the current article, the authors describe the theoretical rationale for an acceptance-enhanced form of behavior therapy for TTM in adults and describe the methodology used to test the efficacy of this intervention against a psychoeducation and supportive control condition.","['trichotillomania', 'recruiting minority participants']","['Acceptance-enhanced behavior therapy', 'Trichotillomania (TTM', 'Behavior therapy']",[],"[{'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}]",[],,0.0628233,"In the current article, the authors describe the theoretical rationale for an acceptance-enhanced form of behavior therapy for TTM in adults and describe the methodology used to test the efficacy of this intervention against a psychoeducation and supportive control condition.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Neal-Barnett', 'Affiliation': 'Kent State University, Kent, Ohio.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Woods', 'Affiliation': 'Texas A&M University, College Station, Texas.'}, {'ForeName': 'Flint M', 'Initials': 'FM', 'LastName': 'Espil', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Martale', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Kent State University, Kent, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Alexander', 'Affiliation': 'Texas A&M University, College Station, Texas.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Walther', 'Affiliation': 'Brown University School of Medicine, Providence, Rhode Island.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Twohig', 'Affiliation': 'Utah State University, Logan, Utah.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Saunders', 'Affiliation': 'Marquette University.'}, {'ForeName': 'Shawn P', 'Initials': 'SP', 'LastName': 'Cahill', 'Affiliation': 'University of Wisconsin-Milwaukee.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Franklin', 'Affiliation': 'University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}]",Bulletin of the Menninger Clinic,['10.1521/bumc_2019_83_04']
1900,32080000,Effect on Opioids Requirement of Early Administration of Intranasal Ketamine for Acute Traumatic Pain.,"OBJECTIVES


To evaluate the efficacy and safety of early administration of low-dose intranasal ketamine on reducing the need for opioid and nonopioid analgesic agents in emergency department (ED) patients with acute moderate to severe acute limbs' trauma pain.
PATIENTS AND METHODS


This is a double-blind, randomized, prospective, controlled study conducted in the ED. The included patients were randomly assigned to intranasal pulverization of ketamine or placebo. Protocol treatment was given at the triage. The primary outcome is the need for opioids during ED stay. Secondary outcome included the requirement of nonopioid analgesic agents and the percentage of patients discharged from the ED with a visual analog scale (VAS) <30. A combined outcome score including the 3 outcome items was constructed.
RESULTS


The authors included 1102 patients, 550 patients in the placebo group, and 552 in the intranasal ketamine group. The groups were similar regarding demographics, clinical characteristics, and baseline VAS. The need for opioids was decreased in the intranasal ketamine group compared with the placebo group (17.2% vs. 26.5%; P<0.001). The need for nonopioid analgesics was significantly lower in the intranasal ketamine group compared with the placebo group (31.1% vs. 39.6%; P=0.003). The percentage of patients discharged with a VAS score <30 was significantly higher in the intranasal ketamine group (P<0.001). The mean combined outcome score was 0.97 in the placebo group and 0.67 in the intranasal ketamine group (P<0.001).
CONCLUSION


Intranasal ketamine administered early in the triage was associated with a decrease in opioids and nonopioid analgesics need in patients with acute limb trauma-related pain.",2020,Need for opioids was decreased in intranasal ketamine group compared to placebo (17.2% vs. 26.5%; P<0.001).,"['Acute Traumatic Pain', '1102 patients, 550 patients in placebo group, and 552 in intranasal ketamine group', ""emergency department (ED) patients with acute moderate to severe acute limbs' trauma pain"", 'patients with acute limb trauma related pain']","['ketamine or placebo', 'low-dose intranasal ketamine', 'Intranasal ketamine', 'Intranasal Ketamine', 'placebo', 'ketamine', 'intranasal ketamine']","['percentage of patients discharged with VAS score', 'requirement of non-opioid analgesic agents, and percentage of patients discharged from the ED with visual analog scale (VAS) <30', 'efficacy and safety', 'mean combined outcome score', 'need for opioids during ED stay']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242937', 'cui_str': 'Non-Opioid Analgesics'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",1102.0,0.350227,Need for opioids was decreased in intranasal ketamine group compared to placebo (17.2% vs. 26.5%; P<0.001).,"[{'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Bouida', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Khaoula', 'Initials': 'K', 'LastName': 'Bel Haj Ali', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Ben Soltane', 'Affiliation': 'Research Laboratory LR12SP18, University of Monastir.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Msolli', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Boubaker', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Sekma', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Kaouthar', 'Initials': 'K', 'LastName': 'Beltaief', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Grissa', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Methamem', 'Affiliation': 'Emergency Department, Farhat Hached University Hospital.'}, {'ForeName': 'Riadh', 'Initials': 'R', 'LastName': 'Boukef', 'Affiliation': 'Research Laboratory LR12SP18, University of Monastir.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Belguith', 'Affiliation': 'Epidemiology and Preventive Medicine Department, University Hospital of Monastir, Monastir.'}, {'ForeName': 'Semir', 'Initials': 'S', 'LastName': 'Nouira', 'Affiliation': 'Emergency Department, Fattouma Bourguiba University Hospital.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000821']
1901,31220560,Long-term efficacy of Chinese medicine Bushen Capsule on cognition and brain activity in patients with amnestic mild cognitive impairment.,"Mild cognitive impairment (MCI), regarded as the prodromal stage before the clinical phase of Alzheimer's disease (AD), has been considered for early intervention. Unfortunately, many trials in this stage with drugs with single-target turned out to be little or no effect. Multi-targeting in nature based on the theory of Traditional Chinese Medicine (TCM) offers another prospect for intervention. Together with advanced functional magnetic resonance imaging (fMRI) technique for more sensitive and objective evaluation, we investigated the long-term therapeutic effects of a TCM compound on cognition and task-related neuronal activity. Sixty amnestic MCI (aMCI) participants from randomly divided into drug (30 with Bushen capsules (BSC)) and placebo (30 with placebo capsules) groups for this 2-years trial. Neuropsychological and N-back task-fMRI data were acquired at baseline and two follow-ups to assess, via linear mixed effect models, the changes of cognitive ability and brain activation over treatments. The drug group, compared with placebo group, exhibited improvement or stabilization in memory measures over time. Analyses of fMRI revealed that the placebo group exhibited higher activation magnitude and spatial extents at left superior parietal lobule; importantly, the greater activation identified in placebo group was related to more decline in the digit span. BSC showed long-term ameliorative effects on cognitive performances in aMCI patients, which might result from the regulation of abnormal brain activities. Our study provided evidence for the potential of TCM in early prevention of AD, as well as the feasibility of neuroimaging biomarkers in clinical trials.",2019,"Analyses of fMRI revealed that the placebo group exhibited higher activation magnitude and spatial extents at left superior parietal lobule; importantly, the greater activation identified in placebo group was related to more decline in the digit span.","['aMCI patients', 'Sixty amnestic MCI (aMCI) participants', 'patients with amnestic mild cognitive impairment']","['placebo', 'advanced functional magnetic resonance imaging (fMRI) technique', 'Traditional Chinese Medicine (TCM', 'Chinese medicine Bushen Capsule', 'TCM']","['activation magnitude and spatial extents at left superior parietal lobule', 'stabilization in memory measures', 'Mild cognitive impairment (MCI', 'cognition and brain activity', 'cognitive ability and brain activation', 'cognitive performances', 'Neuropsychological and N-back task-fMRI data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0152303', 'cui_str': 'Structure of superior parietal lobule'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",,0.21489,"Analyses of fMRI revealed that the placebo group exhibited higher activation magnitude and spatial extents at left superior parietal lobule; importantly, the greater activation identified in placebo group was related to more decline in the digit span.","[{'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Traditional Chinese Medicine, Beijing 100700, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Caishui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Traditional Chinese Medicine, Beijing 100700, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Traditional Chinese Medicine, Beijing 100700, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Elaine Lai-Han', 'Initials': 'EL', 'LastName': 'Leung', 'Affiliation': 'State Key Laboratory of Quality Research in Chinese Medicine, Macau Institute for Applied Research in Medicine and Health, Macau University of Science and Technology, Macau.'}, {'ForeName': 'Qingqiong', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China.'}, {'ForeName': 'Xing-Xing', 'Initials': 'XX', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Quality Research in Chinese Medicine, Macau Institute for Applied Research in Medicine and Health, Macau University of Science and Technology, Macau. Electronic address: xxfan@must.edu.mo.'}, {'ForeName': 'Zhanjun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China; BABRI Centre, Beijing Normal University, Beijing 100875, PR China. Electronic address: zhang_rzs@bnu.edu.cn.'}]",Pharmacological research,['10.1016/j.phrs.2019.104319']
1902,32078145,"Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial.","OBJECTIVE


The aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis.
METHODS


A multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. The primary endpoint was to achieve at least a 20% improvement (ASAS20) in patients at 24 weeks according to the Assessment of Spondyloarthritis International Society criteria. The secondary endpoint included other efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters.
RESULTS


Following the random assignment of 648 patients into HS016 (n = 416) and adalimumab (n = 232) groups, no significant difference was found in the ASAS20 response rates at 24 weeks between the HS016 (364/416, 87.5%) and adalimumab (209/232, 90.1%) treatments and the difference between the response rates (- 2.59%; 90% confidence interval [CI] - 6.77 to 1.60) was within the predefined equivalence margin (± 15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05). Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases. Plasma concentrations of HS016 and adalimumab from weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (C max,ss ) was equivalent for HS016 (7356.6 ng/mL) and adalimumab (7600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the adalimumab group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody (NAb) tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the adalimumab group (p > 0.05).
CONCLUSION


HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period.
TRIAL REGISTRATION NUMBER


ChiCTR1900022520.",2020,"Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate.","['Chinese Patients with Active Ankylosing Spondylitis', 'active ankylosing spondylitis', 'Patients with active ankylosing spondylitis', '648 patients into HS016', '28 locations in China']","['Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016', 'adalimumab (HS016', 'HS016 or adalimumab', 'adalimumab', 'HS016', 'adalimumab (Humira']","['ASAS20 response rates', 'efficacy and safety', 'rates of treatment-emergent adverse events (TEAEs', 'efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters', 'Plasma concentrations of HS016 and adalimumab', 'positive neutralizing antibody (NAb) tests', 'achieve at least a 20% improvement (ASAS20', 'response rates']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1171255', 'cui_str': 'Humira'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",648.0,0.221968,"Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate.","[{'ForeName': 'Jinmei', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Mengtao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Rheumatology and Immunology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Dongbao', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology, Changhai Hospital, Shanghai, 200433, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, 610000, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230001, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Kunming Medical University, Kunming, 650032, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, 250001, China.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310009, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Rheumatology, Xiangya Hospital, Central South University, Changsha, 410008, China.'}, {'ForeName': 'Cibo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Beijing Hospital, Beijing, 100010, China.'}, {'ForeName': 'Xiumei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, 30001, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, 410007, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.'}, {'ForeName': 'Xiangyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology, Peking University Third Hospital, Beijing, 100089, China.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Tianwang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Guangdong Second Provincial General Hospital, Guangzhou, 510310, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang, 050000, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Zhuzhou Central Hospital, Zhuzhou, 412000, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, 200052, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, China-Japan Friendship Hospital, Beijing, 100020, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430022, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Jiangsu Province Hospital, Nanjing, 210000, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Rheumatology, Tianjian Medical University General Hospital, Tianjin, 300052, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, 030001, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. zengxfpumc@163.com.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00408-z']
1903,32067764,"Letter regarding ""Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of a hip fracture: Results of a randomized controlled trial"".",,2020,,['a hip fracture'],"['Letter regarding ""Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of']",[],"[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]",[],,0.0562403,,"[{'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Saka', 'Affiliation': 'Department of Orthopaedics, Teikyo University School of Medicine, 1-2-11, Kaga, Itabashi, Tokyo, Japan. Electronic address: natsumi613@gmail.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Banno', 'Affiliation': 'Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27, Showa-ku, Nagoya 466-0064, Japan; Department of Psychiatry, Nagoya University Graduate School of Medicine, Tsurumai-cho 65, Showa-ku, Nagoya 466-8560, Japan; Systematic Review Workshop Peer Support Group (SRWS-PSG), Japan. Electronic address: solvency@med.nagoya-u.ac.jp.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Systematic Review Workshop Peer Support Group (SRWS-PSG), Japan; Department of Nephrology and Dialysis, Kyoritsu Hospital, Chuo-cho 16-5, Kawanishi 666-0016, Japan; Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. Electronic address: yssh0108@yahoo.co.jp.'}]",Injury,['10.1016/j.injury.2020.02.025']
1904,31610549,Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial.,"Background


The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.
Objective


To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.
Design


3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).
Setting


6 university hospitals in Spain.
Participants


190 adults (aged 18 to 75 years) with thrombotic APS.
Intervention


Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).
Measurements


The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.
Results


After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.
Limitation


Anticoagulation intensity was not measured in the rivaroxaban group.
Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
Primary Funding Source


Bayer Hispania.",2019,"Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","['Setting\n\n\n6 university hospitals in Spain', 'Participants\n\n\n190 adults (aged 18 to 75 years) with thrombotic APS', 'Antiphospholipid Syndrome']","['Rivaroxaban Versus Vitamin K Antagonist', 'vitamin K antagonists (VKAs', 'rivaroxaban', 'Rivaroxaban']","['risk ratio (RR', 'Major bleeding', 'Limitation\n\n\nAnticoagulation intensity', 'proportion of patients with new thrombotic events; the primary safety outcome was major bleeding', 'recurrent thrombosis', 'time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding', 'Stroke']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid Antibody Syndrome'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",190.0,0.206485,"Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Ordi-Ros', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sáez-Comet', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Pérez-Conesa', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Riera-Mestre', 'Affiliation': 'Bellvitge University Hospital-IDIBELL, Barcelona, Spain (A.R.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castro-Salomó', 'Affiliation': 'Sant Joan de Reus University Hospital, Reus, Spain (A.C.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuquet-Pedragosa', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Ortiz-Santamaria', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Mauri-Plana', 'Affiliation': 'Mataró Hospital, Mataró, Spain (M.M.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solé', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Cortés-Hernández', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}]",Annals of internal medicine,['10.7326/M19-0291']
1905,31354946,The effects of auditory spatial training on informational masking release in elderly listeners: a study protocol for a randomized clinical trial.,"Background:  Regarding the strong auditory spatial plasticity capability of the central auditory system and the effect of short-term and long-term rehabilitation programs in elderly people, it seems that an auditory spatial training can help this population in informational masking release and better track speech in noisy environments. The main purposes of this study are developing an informational masking measurement test and an auditory spatial training program.  Protocol:  This study will be conducted in two parts. Part 1: develop and determine the validity of an informational masking measurement test by recruiting two groups of young (n=50) and old (n=50) participants with normal hearing who have no difficulty in understanding speech in noisy environments. Part 2 (clinical trial): two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training. Intervention: 15 sessions of auditory spatial training. The informational masking measurement test and Speech, Spatial and Qualities of Hearing Scale will be compared before intervention, immediately after intervention, and five weeks after intervention between the two groups.  Discussion:  Since auditory training programs do not deal with informational masking release, an auditory spatial training will be designed, aiming to improve hearing in noisy environments for elderly populations.  Trial registration:  Iranian Registry of Clinical Trials ( IRCT20190118042404N1) on 25  th  February 2019.",2019,"two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training.","['two groups of young (n=50) and old (n=50) participants with normal hearing who have no difficulty in understanding speech in noisy environments', '25  th  February 2019', 'two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments', 'elderly listeners', 'elderly people']","['short-term and long-term rehabilitation programs', 'auditory spatial training']","['informational masking measurement test and Speech, Spatial and Qualities of Hearing Scale', 'informational masking release']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0563025', 'cui_str': 'Noisy environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",,0.0363944,"two groups of 60-75-year-olds with normal hearing, who complain about difficulty in speech perception in noisy environments, will participate as control and intervention groups to examine the effect of auditory spatial training.","[{'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Jalaie', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",F1000Research,['10.12688/f1000research.18602.2']
1906,30148752,"Efficacy and Safety of Complete Mesocolic Excision in Patients With Colon Cancer: Three-year Results From a Prospective, Nonrandomized, Double-blind, Controlled Trial.","OBJECTIVE


The aim of the study was to evaluate the oncological outcomes of complete mesocolic excision (CME) in colon cancer patients.
SUMMARY BACKGROUND DATA


CME is considered a standard procedure for colon cancer patients. However, previous evidence regarding the effect of CME on prognosis has fundamental limitations that prevent it from being fully accepted.
METHODS


Patients who underwent radical resection for colon cancer were enrolled between November 2012 and March 2016. According to the principles of CME, patients were stratified into 2 groups based on intraoperative surgical fields and specimen photographs. The primary outcome was local recurrence-free survival (LRFS). The clinicopathological data and follow-up information were collected and recorded. The final follow-up date was April 2016. The trial was registered in ClinicalTrials.gov (identifier: NCT01724775).
RESULTS


There were 220 patients in the CME group and 110 patients in the noncomplete mesocolic excision (NCME) group. Baseline characteristics were well balanced. Compared with NCME, CME was associated with a greater number of total lymph nodes (24 vs 20, P = 0.002). Postoperative complications did not differ between the 2 groups. CME had a positive effect on LRFS compared with NCME (100.0% vs 90.2%, log-rank P < 0.001). Mesocolic dissection (100.0% vs 87.9%, log-rank P < 0.001) and nontumor deposits (97.2% vs 91.6%, log-rank P < 0.022) were also associated with improved LRFS.
CONCLUSIONS


Our findings demonstrate that, compared with NCME, CME improves 3-year LRFS without increasing surgical risks.",2020,"Mesocolic dissection (100.0% vs 87.9%, log-rank P < 0.001) and nontumor deposits (97.2% vs 91.6%, log-rank P < 0.022) were also associated with improved LRFS.
","['colon cancer patients', 'Patients who underwent radical resection for colon cancer were enrolled between November 2012 and March 2016', 'Patients With Colon Cancer', '220 patients in the CME group and 110 patients in the noncomplete mesocolic excision (NCME) group']","['complete mesocolic excision (CME', 'NCME', 'Complete Mesocolic Excision', 'NCME, CME', 'CME']","['LRFS', 'nontumor deposits', 'Postoperative complications', 'number of total lymph nodes', 'Efficacy and Safety', 'local recurrence-free survival (LRFS', 'Mesocolic dissection']","[{'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0641638', 'cui_str': 'NCME'}]","[{'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]",,0.266843,"Mesocolic dissection (100.0% vs 87.9%, log-rank P < 0.001) and nontumor deposits (97.2% vs 91.6%, log-rank P < 0.022) were also associated with improved LRFS.
","[{'ForeName': 'Zhidong', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yancheng', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Zhanlong', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Colorectal Cancer Diagnosis and Treatment Research, Beijing, China.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': ""Department of Pathology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Siyan', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': 'Department of Epidemiology, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Pathology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liang', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Mujun', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qiwei', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Youli', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yingjiang', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ""Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, China.""}]",Annals of surgery,['10.1097/SLA.0000000000003012']
1907,32071038,The effect of training GPs in motivational interviewing on incident cardiovascular disease and mortality in people with screen-detected diabetes. Results from the ADDITION-Denmark randomised trial.,"BACKGROUND


There is no long-term evidence on the effectiveness of training for motivational interviewing in diabetes treatment.
AIM


Within a trial of intensive treatment of people with screen-detected diabetes, which included training in motivational interviewing for GPs, the study examined the effect of the intervention on incident cardiovascular disease (CVD) and all-cause mortality.
DESIGN & SETTING


In the ADDITION-Denmark trial, 181 general practices were cluster randomised in a 2:1:1 ratio to: (i) to screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group). The study took place from 2001-2009.
METHOD


After around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.
RESULTS


Compared with the routine care group, the risk of CVD was similar in the intensive treatment group (hazard ratio [HR] 1.11, 95% confidence interval [CI] = 0.82 to 1.50) and the intensive treatment plus motivational interviewing group (HR 1.26, 95% CI = 0.96 to 1.64). The incidence of death was similar in all three treatment groups.
CONCLUSION


Training of GPs in intensive multifactorial treatment, with or without motivational interviewing, was not associated with a reduction in mortality or CVD among those with screen-detected diabetes.",2020,"After around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.
","['people with screen-detected diabetes', '181 general practices']","['screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group', 'training GPs in motivational interviewing']","['rates of first fatal and non-fatal CVD events and all-cause mortality', 'incidence of death', 'incident cardiovascular disease (CVD', 'mortality or CVD', 'risk of CVD']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",181.0,0.0678224,"After around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.
","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Charles', 'Affiliation': 'Senior Researcher, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark Mc@ph.au.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Bruun', 'Affiliation': 'Senior Biostatistician, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Simmons', 'Affiliation': 'Visiting Senior Researcher, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Else-Marie', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Post-doctoral Researcher, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Witte', 'Affiliation': 'Professor, Danish Diabetes Academy, Odense, Denmark.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Jorgensen', 'Affiliation': 'Professor, Clinical Epidemiology, Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Professor, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Helle Terkildsen', 'Initials': 'HT', 'LastName': 'Maindal', 'Affiliation': 'Professor, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Rubak', 'Affiliation': 'Clinical Associate Professor, Center for Pediatric Pulmonology and Allergology, Department of Child and Youth, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Annelli', 'Initials': 'A', 'LastName': 'Sandbaek', 'Affiliation': 'Head of Unit for Cross-sectoral Collaboration and Integrated Patient Care, Steno Diabetes Center Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Lauritzen', 'Affiliation': 'Professor, Department of Public Health, Research Group for General Practice, University of Aarhus, Aarhus, Denmark.'}]",BJGP open,['10.3399/bjgpopen20X101012']
1908,31370976,Effects of ascending buprenorphine doses on measures of experimental pain: A pilot study.,"BACKGROUND


Buprenorphine is widely used in the treatment of opioid use disorder and pain management. Little is known about the analgesic effects of high-dose sublingual buprenorphine, particularly in doses of >8 mg. The aim of this study was to examine the effect of ascending doses of buprenorphine upon acute pain measures in patients stabilized on buprenorphine as treatment for opioid dependence.
METHODS


The pilot study (n = 7) was a randomised, controlled, double-blind, double-dummy, within-subject crossover study examining cold-pressor threshold and tolerance testing under different buprenorphine dose conditions. Each participant attended three sessions to test the analgesic effect of buprenorphine in their usual dose (100%), 150% and 200% of their usual daily dose.
RESULTS


No significant effects of increased dose were seen on experimental pain measures. Expected physiological effects on pupil size and pulse were observed with increasing dose. No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition. No safety concerns with the 150 and 200% buprenorphine dose condition were observed.
DISCUSSION


This pilot study suggests that a ceiling effect on analgesia may be observed in people maintained on buprenorphine, though larger studies may confirm this finding. Clinical Trial Number: ACTRN12614001038684.",2019,"No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition.","['patients stabilized on', 'The pilot study (n\u202f=\u202f7']","['Buprenorphine', 'buprenorphine']","['experimental pain', 'subjective ratings of drug strength, or self-reported sedation', 'pupil size and pulse', 'experimental pain measures', ""lower ratings of 'bad effects' and intoxication"", 'acute pain measures', 'ratings drug liking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]",,0.138001,"No effect of buprenorphine condition was seen on subjective ratings of drug strength, or self-reported sedation, though lower ratings drug liking were seen with 150% and 200% conditions, and lower ratings of 'bad effects' and intoxication were reported with the 200% buprenorphine dose condition.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Monash Addiction Research Centre, Monash University, Melbourne, Australia; National Drug and Alcohol Research Centre, UNSW Sydney, Randwick, Australia; Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia. Electronic address: Suzanne.nielsen@monash.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demirkol', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia; University of Sydney, Division Addiction Medicine, Faculty of Medicine and Health, Sydney, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.002']
1909,31274608,The Preventive Effect of Parotid Gland Massage on Salivary Gland Dysfunction During High-Dose Radioactive Iodine Therapy for Differentiated Thyroid Cancer: A Randomized Clinical Trial.,"PURPOSE


To evaluate the preventive effect of parotid gland (PG) massage for PG damage during the I therapy, we prospectively investigated the serum amylase value and salivary gland scintigraphy (SGS) after I therapy.
MATERIALS AND METHODS


One hundred patients with thyroidectomized differentiated thyroid cancer who underwent high-dose I therapy were enrolled in the clinical trial and randomized into 2 groups (PG massage group and nonmassage group). The serum amylase value was obtained before and 24 hours after I therapy, and the SGSs were also taken just before and at 8 months after the I therapy. Change in serum amylase value and SGS was compared between PG massage and nonmassage groups.
RESULTS


The difference value of serum amylase was significantly lower in PG massage group than in nonmassage group (P = 0.0052). Worsening of PG function on SGS was observed in 43 (45.3%) of the 95 patients. The incidence rate of PG abnormality on F/U SGS was significantly lower in PG massage group than in nonmassage group (odds ratio, 0.3704; P = 0.0195). In the multiple regression analysis, PG massage significantly affected the abnormality on the 8-month F/U SGS (rpartial = -0.2741, P = 0.0090) after adjusting for clinical variables (age, sex, TNM stage, TSH preparation methods for the I therapy, and I dose).
CONCLUSIONS


PG gland massage significantly reduced the incidence rates of salivary gland dysfunction on the 8-month F/U SGS and the level of the serological marker of salivary gland destruction after I therapy. Therefore, PG gland massage could alleviate salivary gland damage related to I therapy.",2019,The difference value of serum amylase was significantly lower in PG massage group than in nonmassage group (P = 0.0052).,"['Differentiated Thyroid Cancer', 'One hundred patients with thyroidectomized differentiated thyroid cancer who underwent high-dose I therapy']","['PG massage', 'parotid gland (PG) massage', 'Radioactive Iodine Therapy', 'Parotid Gland Massage', 'PG gland massage']","['serum amylase value and salivary gland scintigraphy (SGS', 'serum amylase', 'Salivary Gland Dysfunction', 'Worsening of PG function on SGS', 'incidence rates of salivary gland dysfunction', 'incidence rate of PG abnormality on F/U SGS', 'serum amylase value and SGS', 'serum amylase value']","[{'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0030580', 'cui_str': 'Parotid Gland'}, {'cui': 'C0203610', 'cui_str': 'Teleradiotherapy with iodine-125 (procedure)'}]","[{'cui': 'C0428349', 'cui_str': 'Serum amylase (pancreatic) measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036098', 'cui_str': 'Salivary Glands'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",100.0,0.0353501,The difference value of serum amylase was significantly lower in PG massage group than in nonmassage group (P = 0.0052).,"[{'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Son', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Chang-Hee', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Ji-Hoon', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Do-Hoon', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Chae Moon', 'Initials': 'CM', 'LastName': 'Hong', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Ju Hye', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Shin Young', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Sang-Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Jaetae', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Byeong-Cheol', 'Initials': 'BC', 'LastName': 'Ahn', 'Affiliation': 'From the Department of Nuclear Medicine, School of Medicine, Kyungpook National University.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000002602']
1910,30998400,Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial,"BACKGROUND


Mobile health technologies are low cost, scalable interventions with the potential to promote patient engagement and behavior change. We aimed to test whether a culturally sensitive text messaging intervention supporting secondary prevention improves the control of risk factors in patients with coronary heart disease in China.
METHODS AND RESULTS


In this multicenter, single-blinded randomized controlled trial, 822 patients (mean age, 56.4 [SD, 9.5] years; 14.1% women) with coronary heart disease and without diabetes mellitus from 37 hospitals in China were enrolled between August 2016 and March 2017. In addition to usual care, the control group (n=411) received 2 thank you messages/month; the intervention group (n=411) received 6 text messages/week for 6 months delivered by an automated computerized system. The messages provided educational and motivational information related to disease-specific knowledge, risk factor control, physical activity, and medication adherence. The primary end point was change in systolic blood pressure from baseline to 6 months. Secondary end points included the proportion with systolic blood pressure <140 mm Hg, smoking status, and change in body mass index, LDL-C (low-density lipoprotein cholesterol), and physical activity (assessed using the International Physical Activity Questionnaire). The end points were assessed using analyses of covariance. Follow-up was 99.6%. At 6 months, systolic blood pressure was not significantly lower in the intervention group compared with the control group, with a mean change (SD) of 3.2 (14.3) mm Hg and 2.0 (15.0) mm Hg ( P>0.05) from baseline, respectively (mean net change, -1.3 mm Hg [95% CI, -3.3 to 0.8]; P=0.221). There were no significant differences in the change in LDL-C level, physical activity, body mass index, or smoking status between the 2 groups. Nearly all patients in the intervention group reported the text messages to be useful (96.1%), easy to understand (98.8%), appropriate in frequency (93.8%), and reported being willing to receive future text messages (94.8%).
CONCLUSIONS


Text messages supporting secondary prevention among patients with coronary heart disease did not lead to a greater reduction in blood pressure at 6 months. Mobile phone text messaging for secondary prevention was feasible and highly acceptable to patients.
CLINICAL TRIAL REGISTRATION


URL: https://clinicaltrials.gov . Unique identifier: NCT02888769.",2019,"There were no significant differences in the change in LDL-C level, physical activity, body mass index, or smoking status between the 2 groups.","['Patients With Coronary Heart Disease', 'patients with coronary heart disease in China', '822 patients (mean age, 56.4 [SD, 9.5] years; 14.1% women) with coronary heart disease and without diabetes mellitus from 37 hospitals in China were enrolled between August 2016 and March 2017', 'patients with coronary heart disease']","['Text Messaging', 'culturally sensitive text messaging intervention supporting secondary prevention', '2 thank you messages/month; the intervention group (n=411) received 6 text messages/week for 6 months delivered by an automated computerized system']","['blood pressure', 'Risk Factor Management', 'LDL-C level, physical activity, body mass index, or smoking status', 'proportion with systolic blood pressure <140 mm\u2009Hg, smoking status, and change in body mass index, LDL-C (low-density lipoprotein cholesterol), and physical activity (assessed using the International Physical Activity Questionnaire', 'text messages', 'systolic blood pressure', 'disease-specific knowledge, risk factor control, physical activity, and medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",822.0,0.177395,"There were no significant differences in the change in LDL-C level, physical activity, body mass index, or smoking status between the 2 groups.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Erica S', 'Initials': 'ES', 'LastName': 'Spatz', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT (E.S.S., Q.D., H.M.K.).'}, {'ForeName': 'Xueke', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Xiqian', 'Initials': 'X', 'LastName': 'Huo', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Qinglan', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT (E.S.S., Q.D., H.M.K.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Horak', 'Affiliation': 'Stanford University School of Medicine, CA (P.H.).'}, {'ForeName': 'Xuekun', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Wenchi', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney and The George Institute for Global Health, Australia (C.K.C.).'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (X.Z., X.B., X.H., X.W., W.G., X.Y., Y.S., X.W., H.Z., J. Liu, J. Li., X.L.).'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""Health Outcomes Research, Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, MO (J.A.S.).""}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Masoudi', 'Affiliation': 'Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT (E.S.S., Q.D., H.M.K.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005616']
1911,31001997,Clinical and Angiographic Predictors of Patient-Reported Angina 1 Year After Coronary Artery Bypass Graft Surgery.,"BACKGROUND


Studies of the relationship between patient self-reported angina symptoms using the Seattle Angina Questionnaire (SAQ) and angiographic findings after coronary artery bypass grafting surgery (CABG) are lacking. Nested within a randomized controlled trial, this prospective observational cohort comparison study aimed to assess which clinical characteristics and angiographic findings are associated with self-reported angina 1 year after CABG.
METHODS AND RESULTS


Patients from the ROOBY trial (Randomized On/Off Bypass) with protocol-specified 1-year post-CABG coronary angiography and SAQ assessments were included (n=1258). Patients reporting no angina (62.3%) within 4 weeks before the 1-year post-CABG study visit on the SAQ angina frequency domain were compared with patients reporting angina (37.7%). Multivariable modeling identified clinical variables and angiographic findings associated with angina. Sequential univariate and multivariable modeling found the following demographic and clinical factors were associated with angina after CABG: younger age, worse preoperative SAQ angina frequency score, smoking, diabetes mellitus, and pre-CABG depression. The only 1-year angiographic finding significantly associated with angina was incomplete revascularization of the left anterior descending (LAD) territory. Graft occlusions, incomplete revascularization of non-LAD territories, and ≥70% lesions in nonrevascularized native coronary arteries were not correlated with the presence or absence of angina. Further, only 30.6% of subjects reporting angina at 1 year had a residual major coronary artery stenosis of ≥70%.
CONCLUSIONS


Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression. The only angiographic finding associated with angina was a poorly revascularized LAD territory. These results may help guide physicians when counseling patients on expected improvements in angina symptoms and in making decisions regarding the need for coronary angiography after CABG. Whether intensive treatment of these comorbidities improves post-CABG angina symptoms requires further study.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov . Unique identifier: NCT00032630.",2019,"Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression.","['Patients from the ROOBY trial (Randomized On/Off Bypass) with protocol-specified 1-year post-CABG coronary angiography and SAQ assessments were included (n=1258', 'Patient-Reported Angina 1 Year']","['coronary artery bypass grafting surgery (CABG', 'Coronary Artery Bypass Graft Surgery']","['residual major coronary artery stenosis', 'Graft occlusions, incomplete revascularization of non-LAD territories', 'preoperative SAQ angina frequency score, smoking, diabetes mellitus, and pre-CABG depression', 'angina symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0404999,"Self-reported angina 1 year after CABG is associated with younger age, worse baseline SAQ angina frequency score, smoking, diabetes mellitus, and depression.","[{'ForeName': 'Brack', 'Initials': 'B', 'LastName': 'Hattler', 'Affiliation': 'Rocky Mountain Regional VA Medical Center, Aurora, CO (B.H., F.L.G.).'}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Carr', 'Affiliation': 'Northport Veterans Affairs Medical Center, Northport, NY (B.M.C., M.B., A.L.W.S.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Messenger', 'Affiliation': 'University of Colorado School of Medicine at the Anschutz Medical Campus, Aurora CO (B.H., J.M., E.K., F.L.G.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spertus', 'Affiliation': ""Saint Luke's Mid America Heart Institute/University of Missouri at Kansas City, Kansas City, MO (J.S.).""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Ebrahimi', 'Affiliation': 'Greater Los Angeles VA Medical Center, Los Angeles, CA (R.E.).'}, {'ForeName': 'Muath', 'Initials': 'M', 'LastName': 'Bishawi', 'Affiliation': 'Northport Veterans Affairs Medical Center, Northport, NY (B.M.C., M.B., A.L.W.S.).'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Quin', 'Affiliation': 'VA Boston Healthcare System, West Roxbury, MA (J.A.Q.).'}, {'ForeName': 'G Hossein', 'Initials': 'GH', 'LastName': 'Almassi', 'Affiliation': 'Zablocki Veterans Affairs Medical Center, Milwaukee, WI (G.H.A.).'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Collins', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Medical Center, Perry Point, MD (J.F.C.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kozora', 'Affiliation': 'University of Colorado School of Medicine at the Anschutz Medical Campus, Aurora CO (B.H., J.M., E.K., F.L.G.).'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Grover', 'Affiliation': 'Rocky Mountain Regional VA Medical Center, Aurora, CO (B.H., F.L.G.).'}, {'ForeName': 'A Laurie W', 'Initials': 'ALW', 'LastName': 'Shroyer', 'Affiliation': 'Northport Veterans Affairs Medical Center, Northport, NY (B.M.C., M.B., A.L.W.S.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.118.005119']
1912,31369089,Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.,"CONTEXT


Conventional hypoparathyroidism treatment with oral calcium and active vitamin D is aimed at correcting hypocalcemia but does not address other physiologic defects caused by PTH deficiency.
OBJECTIVE


To evaluate long-term safety and tolerability of recombinant human PTH (1-84) [rhPTH(1-84)].
DESIGN


Open-label extension study; 5-year interim analysis.
SETTING


12 US centers.
PATIENTS


Adults (N = 49) with chronic hypoparathyroidism.
INTERVENTION(S)


rhPTH(1-84) 25 or 50 µg/d initially, with 25-µg adjustments permitted to a 100 µg/d maximum.
MAIN OUTCOME MEASURE(S)


Safety parameters; composite efficacy outcome was the proportion of patients with ≥50% reduction in oral calcium (or ≤500 mg/d) and calcitriol (or ≤0.25 µg/d) doses, and albumin-corrected serum calcium normalized or maintained compared with baseline, not exceeding upper limit of normal.
RESULTS


Forty patients completed 60 months of treatment. Mean albumin-corrected serum calcium levels remained between 8.2 and 8.7 mg/dL. Between baseline and month 60, levels ± SD of urinary calcium, serum phosphorus, and calcium-phosphorus product decreased by 101.2 ± 236.24 mg/24 hours, 1.0 ± 0.78 mg/dL, and 8.5 ± 8.29 mg2/dL2, respectively. Serum creatinine level and estimated glomerular filtration rate were unchanged. Treatment-emergent adverse events (AEs) were reported in 48 patients (98.0%; hypocalcemia, 36.7%; muscle spasms, 32.7%; paresthesia, 30.6%; sinusitis, 30.6%; nausea, 30.6%) and serious AEs in 13 (26.5%). At month 60, 28 patients (70.0%) achieved the composite efficacy outcome. Bone turnover markers increased, peaked at ∼12 months, and then declined to values that remained above baseline.
CONCLUSION


Treatment with rhPTH(1-84) for 5 years demonstrated a safety profile consistent with previous studies and improved key biochemical parameters.",2019,Serum creatinine and estimated glomerular filtration rate were unchanged.,"['Forty patients completed 60 months of treatment', '12 US centers', 'Adults (N=49) with chronic hypoparathyroidism', 'Adults With Hypoparathyroidism']","['recombinant human PTH(1-84) (rhPTH[1-84', 'oral calcium', 'calcitriol', 'oral calcium and active vitamin D', 'Recombinant Human Parathyroid Hormone', 'rhPTH(1-84']","['Serum creatinine and estimated glomerular filtration rate', 'composite efficacy outcome', 'calcium-phosphorus product', 'serum phosphorus', 'urinary calcium', 'Mean albumin-corrected serum calcium', 'Safety and Efficacy', 'Bone turnover markers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0020063', 'cui_str': 'hPTH(1-84)'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",40.0,0.0483122,Serum creatinine and estimated glomerular filtration rate were unchanged.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mannstadt', 'Affiliation': 'Endocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Clarke', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bilezikian', 'Affiliation': 'Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, PC, Detroit, Michigan.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Denham', 'Affiliation': 'Clinical Trials of Texas, Inc., San Antonio, Texas.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Levine', 'Affiliation': ""Division of Endocrinology and Diabetes and Center for Bone Health, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Munro', 'Initials': 'M', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rothman', 'Affiliation': 'University Physicians Group - Research Division, Staten Island, New York.'}, {'ForeName': 'Dolores M', 'Initials': 'DM', 'LastName': 'Shoback', 'Affiliation': 'Endocrine Research Unit, Department of Medicine, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, California.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Endocrinology and Metabolism, Physicians East, Greenville, North Carolina.'}, {'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Osteoporosis and Bone Health Services, Mercy Health, Cincinnati, Ohio.'}, {'ForeName': 'Hak-Myung', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a member of the Takeda group of companies, Lexington, Massachusetts.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sherry', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a member of the Takeda group of companies, Cambridge, Massachusetts.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Vokes', 'Affiliation': 'Section of Endocrinology, University of Chicago Medicine, Chicago, Illinois.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-01010']
1913,31351659,"The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX).","INTRODUCTION


Cligosiban is an orally administered oxytocin receptor antagonist being developed to treat premature ejaculation (PE).
AIM


To determine the safety and efficacy of cligosiban capsules (dose range 400-800 mg) to improve intravaginal ejaculation latency time (IELT) and patient-reported outcomes in men with severe lifelong PE.
METHODS


Patients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if they rated their control of ejaculation as poor/very poor and their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts. Eligible patients were randomized to an 8-week treatment period with double-blind cligosiban or placebo (to be taken 1 to 6 hours prior to sexual activity). The starting dose was 400 mg (not more than 1 dose per day) which could be increased to 800 mg after 2 and/or 4 weeks of treatment. Assessments were conducted at 2, 4, and 8 weeks.
MAIN OUTCOME MEASURE


Efficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, and the Clinical Global Impression of Change.
RESULTS


The mean ratio of fold change from baseline in IELT to the last 4 weeks of treatment (cligosiban/placebo) was 1.9 compared to a baseline of 1.0 (P = .0079). The mean increase in IELT from baseline to the last 4 weeks of treatment was 61.0 seconds for cligosiban, which was significantly different from (and 3.6-fold greater than) the mean increase of 16.4 seconds for placebo (P = .0086). Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo. Cligosiban was generally well tolerated, with no serious or severe adverse events or other safety parameters.
CLINICAL IMPLICATIONS


This proof-of-concept study demonstrated the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE.
STRENGTHS AND LIMITATIONS


This was a Phase II, randomized, double-blind, placebo-controlled study that was adequately powered to detect a clinically meaningful difference in change in IELT between cligosiban and placebo. Larger studies will be needed to confirm these findings, determine the optimal dose of cligosiban and assess efficacy in men with acquired PE.
CONCLUSIONS


Cligosiban was well tolerated, and resulted in significant benefits in both objective and subjective measures of ejaculatory control in men with lifelong PE and therefore offers significant potential as an on-demand, orally administered agent for the treatment of PE. McMahon C, Althof S, Rosen R, et al. The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX). J Sex Med 2019; 16:1178-1187.",2019,Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo.,"['men with acquired PE', 'Eligible patients', 'men with lifelong PE', 'Men with Lifelong Premature Ejaculation', 'men with severe lifelong PE.\nMETHODS\n\n\nPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments']","['double-blind cligosiban or placebo', 'cligosiban capsules', 'Oxytocin Antagonist Cligosiban', 'placebo', 'Placebo']","['mean ratio of fold change', 'mean increase in IELT', 'ejaculation control and ejaculation-related personal distress scores', 'IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, and the Clinical Global Impression of Change', 'intravaginal ejaculation latency time (IELT', 'safety and efficacy']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.486538,Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McMahon', 'Affiliation': 'Australian Centre for Sexual Health, St. Leonards, New South Wales, Australia. Electronic address: chrisgmcmahon@gmail.com.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Giuliano', 'Affiliation': 'AP-HP, Neuro-Uro-Andrology, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, Garches, France; UMR1179 Inserm-Versailles Saint Quentin en Yvelines University, Versailles, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Miner', 'Affiliation': ""Departments of Family Medicine and Urology, Men's Health Center, Miriam Hospital, Brown University, Providence, RI, USA.""}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Osterloh', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Muirhead', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harty', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.016']
1914,31357256,Exercise Training Is Safe and Feasible in Patients Awaiting Liver Transplantation: A Pilot Randomized Controlled Trial.,,2019,,['Patients Awaiting Liver Transplantation'],['Exercise Training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",[],,0.07265,,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wallen', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Department of Anesthesia, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ingrid J', 'Initials': 'IJ', 'LastName': 'Hickman', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Toby G', 'Initials': 'TG', 'LastName': 'Pavey', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Aidan J', 'Initials': 'AJ', 'LastName': 'Woodward', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Graeme A', 'Initials': 'GA', 'LastName': 'Macdonald', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25616']
1915,31226412,Using health insurance reimbursement data to identify incident cancer cases.,"OBJECTIVES


The objective of this study was to establish an optimal population-level follow-up strategy for identifying incident cancers using health insurance reimbursement data in rural China.
STUDY DESIGN AND SETTING


We compared active follow-up and passive linkage with claims data for identification of incident cancer cases. Claims data were derived from the New Rural Cooperative Medical Scheme (NCMS). Follow-up data from subject enrollment to December 31, 2016, regarding 33,948 subjects in a large-scale randomized controlled trial were used in this study.
RESULTS


The overall sensitivity of passive linkage with NCMS claims data was significantly higher than that of active follow-up (95.6% vs. 54.9%, P < 0.001). Of 12 cases missed by the NCMS data set, seven were treated on an outpatient basis and there were therefore no records in the NCMS system, and five were diagnosed at primary (township-level) health facilities and excluded from the quality control process. Of the 123 cases missed by active follow-up, 54 were reported as negative, 69 were reported as positive but had inaccurate information regarding the site of cancer, or exceeded the 6-month limitation from the date of diagnosis.
CONCLUSION


Passive linkage with NCMS claims data is an efficient approach for identifying incident cancers in areas without cancer registries in rural China.",2019,Passive linkage with NCMS claims data is an efficient approach for identifying incident cancers in areas without cancer registries in rural China.,"['Follow-up data from subject enrollment to December 31, 2016 regarding 33,948 subjects in a large-scale randomized controlled trial', 'Of 12 cases missed by the NCMS dataset, seven were treated on an outpatient basis and there were therefore no records in the NCMS system, and five were diagnosed at primary (township-level) health facilities and excluded from the quality control process', 'incident cancers using health insurance reimbursement data in rural China']",[],['overall sensitivity of passive linkage with NCMS claims data'],"[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0034378'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0021684', 'cui_str': 'Third-Party Payments'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",33948.0,0.0733695,Passive linkage with NCMS claims data is an efficient approach for identifying incident cancers in areas without cancer registries in rural China.,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Mengfei', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Chuanhai', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Hua County People's Hospital, Wenming Road, Hua County, Henan Province, People's Republic of China.""}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': ""Anyang Cancer Hospital, #1 Hengbin North Road, Anyang City, Henan Province, People's Republic of China.""}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China.""}, {'ForeName': 'Zhonghu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China. Electronic address: zhonghuhe@foxmail.com.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ke', 'Affiliation': ""Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Road, Beijing, People's Republic of China. Electronic address: keyang@bjmu.edu.cn.""}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.06.009']
1916,29512468,Effects of Intensive Blood Pressure Control in Patients with Evident Cardiovascular Disease: An Investigation Using the SPRINT Study Data.,"BACKGROUND


Recent data advocate adoption of a more intensive treatment strategy for management of blood pressure (BP).
OBJECTIVE


We investigated whether the overall effects of the Systolic Blood Pressure Intervention Trial (SPRINT) are applicable to cardiovascular disease (CVD) patients.
METHODS


In a post hoc analysis we analyzed data from SPRINT that randomly assigned 9361 individuals to a systolic BP (SBP) target of <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). 1562 patients had clinically evident CVD (age=70.3±9.3 years, 24% females) at study entry and were followed for 3.1 years. Further, we assessed the effect of low (<150 mmHg) baseline SBP on outcome.
RESULTS


In CVD patients, there was no benefit from the intensive treatment regarding all endpoints, except for a marginally significant benefit on all-cause mortality (hazard ratio [HR]: 0.67; 95% confidence interval [CI], 0.45 to 1.00; p=0.0509). Further, while there was no increase in serious adverse events (SAE) in the intensive group, there was increased risk for study-related SAE, acute renal failure and electrolyte abnormalities. In patients with low baseline SBP there was a beneficial effect on allcause mortality (HR: 0.56; 95% CI: 0.33 to 0.96; p=0.033), but with greater stroke incidence (HR: 2.94; 95% CI: 1.04 to 8.29; p=0.042).
CONCLUSION


We confirm the beneficial effect of the intensive strategy in SPRINT study on all-cause mortality and the harmful effect on specific adverse outcomes in patients with CVD. However, in patients with low baseline SBP stroke may increase.",2019,"In CVD patients, there was no benefit from the intensive treatment regarding all endpoints, except for a marginally significant benefit on all-cause mortality (hazard ratio [HR]: 0.67; 95% confidence interval [CI], 0.45 to 1.00; p=0.0509).","['Patients with Evident Cardiovascular Disease', 'patients with CVD', '1562 patients had clinically evident CVD (age=70.3±9.3 years, 24% females) at study entry and were followed for 3.1 years', '9361 individuals to a systolic BP (SBP) target of <120 mmHg (intensive treatment) or <140 mmHg (standard treatment', 'cardiovascular disease (CVD) patients', 'patients with low baseline SBP stroke']","['Systolic Blood Pressure Intervention Trial (SPRINT', 'Intensive Blood Pressure Control']","['stroke incidence', 'serious adverse events (SAE', 'risk for study-related SAE, acute renal failure and electrolyte abnormalities', 'cause mortality', 'blood pressure (BP', 'allcause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",9361.0,0.3965,"In CVD patients, there was no benefit from the intensive treatment regarding all endpoints, except for a marginally significant benefit on all-cause mortality (hazard ratio [HR]: 0.67; 95% confidence interval [CI], 0.45 to 1.00; p=0.0509).","[{'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Vlachopoulos', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Terentes-Printzios', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Aznaouridis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Ioakeimidis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Xaplanteris', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Lazaros', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'Hypertension and Cardiometabolic Unit, First Department of Cardiology, Hippokration Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",Current vascular pharmacology,['10.2174/1570161116666180305160116']
1917,31351660,"The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX).","INTRODUCTION


Cligosiban is an orally administered, centrally penetrant oxytocin receptor antagonist being developed to treat premature ejaculation (PE).
AIM


To determine the efficacy of 3 dose levels of cligosiban caplets to prolong intravaginal ejaculation latency time (IELT) and improve patient-reported outcomes in men with lifelong PE.
METHODS


Patients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts and if they met other diagnostic criteria for lifelong PE. Eligible patients (target 220 evaluable) were randomized to double-blind cligosiban 400, 800, or 1200 mg or matching placebo caplets (to be taken 1 to 6 hours prior to sexual activity). Assessments were conducted at 2, 4, and 8 weeks.
MAIN OUTCOME MEASURE


Efficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, Patient's Global Impression of Severity, and the Clinical Global Impression of Change.
RESULTS


There were no clinically or statistically significant differences between cligosiban (at any dose level) and placebo for the primary endpoint (change in geometric IELT) or any of the secondary endpoints. Cligosiban was well tolerated with a side-effect profile similar to placebo.
CLINICAL IMPLICATIONS


This Phase IIb study failed to demonstrate the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE at doses up to 1200 mg.
STRENGTHS AND LIMITATIONS


This was a Phase IIb, randomized, double-blind, placebo-controlled study that was adequately powered but failed to detect a clinically meaningful or statistical difference in change in IELT between cligosiban at 3 dose levels and placebo. This is in contrast to a similarly designed proof-of-concept study where cligosiban was flexibly dosed at doses up to 800 mg and did demonstrate clinically meaningful and statistically significant changes in efficacy parameters. The reasons for this disparity are not known.
CONCLUSIONS


Cligosiban was well tolerated but failed to demonstrate efficacy for the treatment of men with lifelong PE at doses up to 1200 mg. Althof S, Osterloh IH, Muirhead GJ, et al. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med 2019; 16:1188-1198.",2019,The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation:,"['Patients were eligible for the study if their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts and if they met other diagnostic criteria for lifelong PE', 'men with lifelong PE.\nMETHODS\n\n\nPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments', 'Eligible patients (target 220 evaluable', 'Men with Lifelong Premature Ejaculation']","['Oxytocin Antagonist Cligosiban', 'placebo', 'Cligosiban', 'double-blind cligosiban 400, 800, or 1200 mg or matching placebo caplets', 'Placebo', 'cligosiban caplets']","['intravaginal ejaculation latency time (IELT', 'efficacy parameters', 'geometric IELT', ""IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, Patient's Global Impression of Severity, and the Clinical Global Impression of Change"", 'Intravaginal Ejaculatory Latency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C4720882', 'cui_str': 'PGI-S-Patient global impression of severity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.531489,The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation:,"[{'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Case Western Reserve University Medical School and Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA. Electronic address: stanley.althof@case.edu.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Osterloh', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Muirhead', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Therapy Research Services Ltd, Headcorn, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'PPD France, Ivry-sur-Seine, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.015']
1918,31765004,Medication Use Quality and Safety in Older Adults: 2018 Update.,"Improving the quality of medication use and medication safety is an important priority for prescribers who care for older adults. The objective of this article was to identify key articles from 2018 that address these issues. In addition, we selected four of these articles to annotate, critique, and discuss their broader implications for clinical practice. The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide). The second study, a nested case-control study using data from within the UK Clinical Practice Research Datalink, examined the association between anticholinergic exposure, overall and by anticholinergic medication class, and dementia risk in 40 770 older adults. The third study, a longitudinal cohort study of 1028 Swedish older adults, examined the association between antihypertensive medications and incident dementia. The last study was a randomized, double-blind, placebo-controlled trial that investigated the effect of daily low-dose aspirin (100 mg) for primary prevention on cardiovascular events and major hemorrhage in 19 144 community-dwelling older adults. Collectively, this current article provides insight into the pertinent topics of medication use quality and safety in older adults and helps raise awareness about optimal prescribing in older adults. J Am Geriatr Soc 67:2458-2462, 2019.",2019,"The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide).","['1028 Swedish older adults', 'prescribers who care for older adults', 'older adults', '19\u2009144 community-dwelling older adults', 'Older Adults', '40\u2009770 older adults']","['placebo', 'pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide', 'daily low-dose aspirin']","['cardiovascular events and major hemorrhage', 'quality of medication use and medication safety']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4517873', 'cui_str': '770'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1028.0,0.0307063,"The first study highlights a cluster-randomized trial that utilized a pharmacist-led education-based intervention delivered to both patients and physicians to deprescribe four types of inappropriate medications (sedative-hypnotics, first-generation antihistamines, selective nonsteroidal anti-inflammatory drugs, and glyburide).","[{'ForeName': 'Nagham J', 'Initials': 'NJ', 'LastName': 'Ailabouni', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Marcum', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Department of Medicine (Geriatrics), School of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Gray', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, Washington.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16243']
1919,32052372,Video Modeling and Video Feedback to Reduce Time to Perform Intravenous Cannulation in Medical Students: A Randomized-Controlled Mixed-Methods Study.,"PURPOSE


Combined video modeling (VM) and video feedback (VF) may be more beneficial than traditional feedback when teaching procedural skills. This study examined whether repeated VM and VF compared with VM alone reduced the time required for medical students to perform peripheral intravenous (IV) cannulation.
METHODS


Twenty-five novice medical students were randomly assigned to groups in a one-way blinded embedded mixed-methods study to perform IV cannulation. Participants received standardized instruction and performed IV cannulation on each other while being audio-video recorded. They were assigned to review a video of an expert performing IV cannulation (VM alone), or both the expert video and a video of their own most recent IV cannulation (VM+VF), before returning to perform another IV cannulation. This was repeated for a total of four IV cannulation encounters and three video reviews. A post-test interview was also conducted and analyzed qualitatively using thematic content analysis.
RESULTS


The median [interquartile range] time required to perform IV cannulation in the final encounter was significantly different between the VM+VF group vs VM alone group (126 [93-226] sec vs 345 [131-537] sec, respectively; median difference, 111 sec; 95% confidence interval, 8 to 391; P = 0.02). There was no significant difference in IV cannulation success between VM alone and VM+VF in the final encounter (75% vs 85% respectively; P = 0.65). For the VM+VF group, the time to perform IV cannulation was reduced after the final encounter compared with the baseline encounter (P = 0.002), which was not true of the VM alone group (P = 0.35).
CONCLUSION


Video modeling and feedback shortened time to IV skill completion, reduced complications, and improved satisfaction in novice medical students.",2020,There was no significant difference in IV cannulation success between VM alone and VM+VF in the final encounter (75% vs 85% respectively; P = 0.65).,"['Twenty-five novice medical students', 'Medical Students', 'novice medical students']","['VM and VF', 'VM+VF', 'Combined video modeling (VM) and video feedback (VF', 'expert performing IV cannulation (VM alone), or both the expert video and a video of their own most recent IV cannulation (VM+VF', 'Video Modeling and Video Feedback', 'standardized instruction and performed IV cannulation on each other while being audio-video recorded', 'VM alone']","['median [interquartile range] time required to perform IV cannulation', 'time to perform IV cannulation', 'feedback shortened time to IV skill completion, reduced complications, and improved satisfaction', 'IV cannulation success']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.085667,There was no significant difference in IV cannulation success between VM alone and VM+VF in the final encounter (75% vs 85% respectively; P = 0.65).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada. julie.l.yu@gmail.com.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Lo', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Madampage', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Jagmeet', 'Initials': 'J', 'LastName': 'Bajwa', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Olszynski', 'Affiliation': 'Department of Emergency Medicine, Royal University Hospital, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Lucy', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, Royal University Hospital, University of Saskatchewan, G525-103 Hospital Drive, Saskatoon, SK, S7N 0W8, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01570-2']
1920,31277966,Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.,"BACKGROUND


Responder analyses are used to determine whether changes that occur during a clinical trial are clinically meaningful; for subjective endpoints such as those based on patient-reported outcomes (PROs), responder analyses are particularly useful.
AIM


To identify the minimal clinically important difference (MCID) for selected scores on questionnaires assessing female sexual functioning and to use these differences to analyze the response in a large, controlled, phase 2b, dose-finding study of bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) and mixed HSDD/female sexual arousal disorder (FSAD).
METHODS


The responder analyses were performed for the change from baseline to end of study for a total of 7 endpoints. Each PRO endpoint was assessed using at least 1 of 4 types of responder analyses: a planned analysis anchored to MCIDs based on expert estimates (historical anchors); post hoc analyses based on self-reported global benefit; receiver operating characteristic (ROC) curves; and cumulative distribution function. The prespecified analysis groups were all female sexual dysfunction (FSD)-based diagnoses (all study participants), those with HSDD alone, and a combined group of those with FSAD alone plus those with mixed HSDD/FSAD. Post hoc analyses were also performed for subjects with mixed HSDD/FSAD with a primary diagnosis of HSDD.
OUTCOMES


MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events.
RESULTS


Outcomes matched those based on input from clinical experts. For all 7 endpoints, responder rates at the 1.75 mg dose in the overall modified intention-to-treat population achieved statistical significance compared with placebo (P ≤ .03).
CLINICAL IMPLICATIONS


These responder definitions were subsequently used in the bremelanotide phase 3 registration studies (RECONNECT) that evaluated the safety and efficacy of the bremelanotide 1.75 mg subcutaneous dose in premenopausal women with HSDD.
STRENGTHS & LIMITATIONS


MCIDs for this study were based on changes from a single-blind phase to account for changes due to the placebo effect. These analyses were restricted to a study population composed only of premenopausal women with a clinical diagnosis of HSDD and/or FSAD and were based on data from the same clinical trial.
CONCLUSION


Bremelanotide was safe and well tolerated and demonstrated significant improvement in efficacy vs placebo in the phase 2b trial. The multiple responder analyses offer a valuable approach for determining clinically important effects of bremelanotide for HSDD and FSAD. Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med 2019;16:1226-1235.",2019,"OUTCOMES


MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events.
","['premenopausal women with HSDD', 'premenopausal women with a clinical diagnosis of HSDD and/or FSAD and were based on data from the same clinical trial', 'subjects with mixed HSDD/FSAD with a primary diagnosis of HSDD', 'premenopausal women with hypoactive sexual desire disorder (HSDD) and mixed HSDD/female sexual arousal disorder (FSAD']","['bremelanotide', 'FSAD alone plus those with mixed HSDD/FSAD', 'placebo']","['Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events', 'safety and efficacy', 'safe and well tolerated', 'responder rates', 'efficacy', 'global benefit; receiver operating characteristic (ROC) curves; and cumulative distribution function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0020594', 'cui_str': 'Hypoactive Sexual Desire Disorder'}, {'cui': 'C0015786', 'cui_str': 'Female sexual arousal disorder (disorder)'}]","[{'cui': 'C1721339', 'cui_str': 'bremelanotide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.106031,"OUTCOMES


MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events.
","[{'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Case Western Reserve University School of Medicine, Department of Psychiatry, Cleveland, OH, USA. Electronic address: Stanley.Althof@case.edu.'}, {'ForeName': 'Leonard R', 'Initials': 'LR', 'LastName': 'Derogatis', 'Affiliation': 'Maryland Center for Sexual Health, Lutherville, MD, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Greenberg', 'Affiliation': 'S. Greenberg Statistical Consulting Inc, Berkeley, CA, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia, Department of Psychiatry, Charlottesville, VA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Palatin Technologies, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Johna', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Palatin Technologies, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Spana', 'Affiliation': 'Palatin Technologies, Inc, Cranbury, NJ, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.012']
1921,32043347,How to exercise to increase lipolysis and insulin sensitivity: Fasting or following a single high-protein breakfast.,"BACKGROUND


The purpose of this study was to investigate the lipolysis response and insulin sensitivity to high-intensity interval exercise (HIIE) upon fasting (HIIEFAST) and following the intake of a high-protein breakfast (HIIEHPFED).
METHODS


Overweight men participated in two sessions of HIIE after an overnight fast and post-HPFED with an interval of one week. Metabolic biomarkers were assessed before, immediately after, and 3h postexercise. To evaluate the metabolic effects of HIIE, two-way repeated-measures ANOVA was used.
RESULTS


Glycerol levels increased immediately after HIIEFAST and HIIEHPFED (P=0.0001) and decreased 3h after exercise in both states (P=0.001). There were no significant changes in free fatty acid (FFA) levels immediately after exercise, but a significant increase was observed 3h after exercise compared to the baseline and immediately after exercise in HIIEFAST and HIIEHPFED (P=0.0001). Insulin sensitivity was increased for 3h after HIIEHPFED compared to the baseline and immediately after exercise (P=0.04).
CONCLUSIONS


These findings suggest that fasting during exercise is not necessary for the greater stimulation of lipolysis and an increase in insulin sensitivity and that exercise following a high-protein breakfast can have a similar effect in overweight young men.",2020,"There were no significant changes in free fatty acid (FFA) levels immediately after exercise, but a significant increase was observed 3h after exercise compared to the baseline and immediately after exercise in HIIEFAST and HIIEHPFED (P = 0.0001).","['Overweight men participated in two sessions of HIIE after an overnight fast and post-HPFED with an interval of one week', 'overweight young men']",['high-intensity interval exercise (HIIE) upon fasting (HIIEFAST'],"['lipolysis response and insulin sensitivity', 'insulin sensitivity', 'Glycerol levels', 'Insulin sensitivity', 'Metabolic biomarkers', 'free fatty acid (FFA) levels', 'lipolysis and insulin sensitivity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}]",,0.0277678,"There were no significant changes in free fatty acid (FFA) levels immediately after exercise, but a significant increase was observed 3h after exercise compared to the baseline and immediately after exercise in HIIEFAST and HIIEHPFED (P = 0.0001).","[{'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Saghebjoo', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran - m_saghebjoo@birjand.ac.ir.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Kargar-Akbariyeh', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mohammadnia-Ahmadi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Saffari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Birjand, Iran.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10403-1']
1922,32043342,"Neuromuscular, hormonal and cardiovascular adaptations to eight-week HIIT and continuous aerobic training combined with neuromuscular electrical stimulation.","BACKGROUND


Whether high-or-low intensity exercise coupled with neuromuscular electrostimulation (NMES) affect IGF-1 and IGFBP-1 is unknown. The scope of this study was to test whether 8-week high-intensity interval training (HIIT) and continuous aerobic training (CA) combined with/without NMES performed at 65% and 120% of VO2max on a cycle ergometer induce different metabolic adaptations.
METHODS


A randomized controlled trial with a parallel groups study design was used. Thirty healthy untrained male participants (age: 21.33±1.24 years, height: 177.80±5.97 cm, weight: 73.74±7.90 kg, lean body mass: 64.29±5.11 kg, percent body fat: 12.43±5.34%) voluntarily participated in this study. Six participants were allocated to Control, six to HIIT, six to HIIT+NMES, six to CA, and six to CA+NMES.
RESULTS


Pre- to post-test IVO2max, blood lactate concentrations, O2 kinetics, peak torques at 60o/s and 180o/s were found statistically significant (P<0.05, P<0.001). IGF-1 pre 15 min in CA and IGF-1 post 30 min in HIIT group was found significantly higher compared to control group (16.93±8.40 vs. 6.05±4.25, P=0.024; 10.80±3.94 vs. 6.15±2.56, P=0.037), respectively. Additionally, IGFBP-1 were found significantly higher in CA+NMES group than HIIT group (0.95±0.67 vs. 1.23±0.56). Eight week post IGF-1/IGFBP-1 ratios were found higher in pre 15 min, post 30 min and post 24 h compared to baseline pre 15 min, post 30 min and post 24 h measurements in all groups (8.92±4.72 vs. 3.93±3.14; 9.41±3.72 vs. 3.99±1.76; 8.63±3.01 vs. 5.89±3.01, respectively). Also, IGFBP-1 post 30 min was significantly lower in HIIT+NMES while CA group showed significantly lower baseline and 24 h post IGFBP-1 compared to pre-test measurements (Z=-3.20, P=0.001; Z=-3.72, P=0.000; Z=-2.93, P=0.000).
CONCLUSIONS


HIIT and CA training induce different stimuli on IGF-1 and IGFBP-1 and NMES application combined with high-and-low intensity exercise is highly effective in improving athletic performance.",2020,"IGF-1/IGFBP-1 ratios were found higher in pre 15 min, post 30 min and post 24 h compared to baseline pre 15 min, post 30 min and post 24 h measurements in all groups (8.92±4.72 vs 3.93±3.14;","['Thirty healthy untrained male participants (age:21.33±1.24years, height:177.80±5.97cm, weight:73.74±7.90kg, lean body mass:64.29±5.11kg, percent body fat:12.43±5.34%) voluntarily participated in this study']","['8-week High-Intensity Interval Training (HIIT) and Continuous Aerobic Training (CA) combined with/without NMES', 'continuous aerobic training combined with neuromuscular electrical stimulation', 'high-or-low intensity exercise coupled with neuromuscular electrostimulation (NMES', 'HIIT and CA training']","['IGF-1/IGFBP-1 ratios', 'IGFBP-1', 'athletic performance', 'IVO2max, blood lactate concentrations, O2 kinetics, peak torques', 'IGFBP-1 post 30min']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123256', 'cui_str': 'IGFBP-1'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",6.0,0.0665087,"IGF-1/IGFBP-1 ratios were found higher in pre 15 min, post 30 min and post 24 h compared to baseline pre 15 min, post 30 min and post 24 h measurements in all groups (8.92±4.72 vs 3.93±3.14;","[{'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Umutlu', 'Affiliation': 'School of Physical Education and Sports, Final International University, Kyrenia, Cyprus - gokhan.umutlu@final.edu.tr.'}, {'ForeName': 'Nevzat', 'Initials': 'N', 'LastName': 'Demirci', 'Affiliation': 'School of Physical Education and Sports, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Ayhan T', 'Initials': 'AT', 'LastName': 'Erdoğan', 'Affiliation': 'School of Physical Education and Sports, Final International University, Kyrenia, Cyprus.'}, {'ForeName': 'Nasuh E', 'Initials': 'NE', 'LastName': 'Acar', 'Affiliation': 'School of Physical Education and Sports, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Şenay B', 'Initials': 'ŞB', 'LastName': 'Fidanci', 'Affiliation': 'School of Medicine, Department of Medical Chemistry, Mersin University, Mersin, Turkey.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10277-0']
1923,32043343,Acute effects of two different initial heart rates on testing the repeated sprint ability in elite women soccer players.,"BACKGROUND


Repeated sprint ability (RSA) in women's soccer is crucial to ensure high level of performance during the game. The aim of this study is to investigate the acute effects of two different initial heart rates intensities on fatigue when testing the RSA.
METHODS


Since there are many kinds of pre-match warming-ups, the heart rate reached at the end of two different warm-up protocols (~90 vs. ≈60% HRmax) as an indicator of internal load has been selected and the respective RSA performances were compared. RSA tests were performed by 19 elite women soccer players (age: 22.5±3.3 years, height 163.9±7.3 cm, body mass 54.3±6.4 kg, BMI 20.6±1.5 kg/m2) with two sets of ten shuttle-sprints (15+15 m) with a 1:3 exercise to rest ratio, in different days (randomized order) with different initial HR% (60% and 90% HRmax). In order to compare the different sprint performances a Fatigue Index (FI%) was computed; the blood lactate concentrations (BLa-) were measured before and after testing, to compare metabolic energy.
RESULTS


Significant differences among trials within each set (P<0.01) were found, as evidence of fatigue. Differences between sets were not found, (Factorial ANOVA 2x10; P>0.05). Although the BLa- after warm-up was higher between 90% vs. 60% HRmax (P<0.05), at the completion of RSA tests (after 3 minutes) the differences were considerably low and not significant (P>0.05).
CONCLUSIONS


This study shows that, contrary to male soccer, the initial heart rates, induced by different modes of warming-up, do not affect the overall performance while testing RSA in women's soccer players.",2020,"In order to compare the different sprint performances a Fatigue Index (FI%) was computed; the blood lactate concentrations (BLa-) were measured before and after testing, to compare metabolic energy.
","[""elite women's soccer players"", ""women's soccer"", ""women's soccer players"", '19 elite women soccer players (Age: 22.5±3.3 years, height 163.9±7.3 cm, body mass 54.3±6.4 kg, BMI 20.6±1.5 kg·m-2']",['Repeated Sprint Ability (RSA'],"['blood lactate concentrations (BLa', 'heart rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",19.0,0.0417237,"In order to compare the different sprint performances a Fatigue Index (FI%) was computed; the blood lactate concentrations (BLa-) were measured before and after testing, to compare metabolic energy.
","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ruscello', 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy - bruno.ruscello@uniroma2.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Esposito', 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Fusco', 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ceccarelli', 'Affiliation': 'AS Roma Women Football Club, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pomponi', 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Cristoforo', 'Initials': 'C', 'LastName': 'Filetti', 'Affiliation': 'U.S. Salernitana 1919 Football Club, Salerno, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pantanella', 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gabrielli', 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': ""D'ottavio"", 'Affiliation': 'Interdepartmental Center of Science and Culture of Sport, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10311-8']
1924,32043344,Effects of carbohydrate and protein co-ingestion during short-term moderate-intensity exercise on cognitive function.,"BACKGROUND


This study aimed to investigate the effects of isocaloric carbohydrate-electrolyte solution (CES) and carbohydrates-electrolyte-protein solution (CEPS) consumed during moderate-intensity exercise on cognitive function.
METHODS


Twenty-three healthy participants (age: 21.7±1.5 years, Body Mass Index: 21.8±2.0 kg/m2, and peak oxygen consumption (VO2peak): 42.4±6.9 mL/kg/min) were recruited in the study. Participants completed two main experiment trials using a cross-over study design. In each trial, they completed 30 minutes of 70% VO2peak cycling, and one of two solutions (CES or CEPS) was consumed. A battery of cognitive function tests (imPACT Package) was administrated at rest and immediately post-exercise.
RESULTS


Blood glucose concentrations decreased in both trials. Heart rate and blood lactate concentrations increased in both trials. However, no significant main effects of the exercise on all cognitive function variables (verbal and visual memory, visual-motor speed, reaction time, impulse control, and cognitive efficiency index) were observed (all P>0.05). Also, there was no difference in any of the cognitive function variables between the CES and CEPS trials (all P>0.05).
CONCLUSIONS


There was no difference in the cognitive performance when CES or CES-PRO solutions was consumed during 30 minutes moderate-intensity cycling.",2020,"However, no significant main effects of the exercise on all cognitive function variables (verbal and visual memory, visual-motor speed, reaction time, impulse control, and cognitive efficiency index) were observed (all P > 0.05).","['23 healthy participants (age: 21.7± 1.5 years, body mass index: 21.8± 2.0 kg/m2, and peak oxygen consumption (VO2peak']","['carbohydrate and protein co-ingestion', 'isocaloric Carbohydrate- electrolyte solution (CES) and Carbohydrates-electrolyte-protein solution (CEPS', 'two solutions (CES or CEPS', 'cognitive function tests (imPACT Package']","['Blood glucose concentrations', 'cognitive function variables (verbal and visual memory, visual-motor speed, reaction time, impulse control, and cognitive efficiency index', 'cognitive function', 'Heart rate and blood lactate concentrations', 'cognitive function variables', 'cognitive performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0542316', 'cui_str': 'Visual memory (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",23.0,0.122256,"However, no significant main effects of the exercise on all cognitive function variables (verbal and visual memory, visual-motor speed, reaction time, impulse control, and cognitive efficiency index) were observed (all P > 0.05).","[{'ForeName': 'Feng H', 'Initials': 'FH', 'LastName': 'Sun', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong, China - fhsun@eduhk.hk.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Cooper', 'Affiliation': 'Department of Sport Science, Sport Health and Performance Enhancement (SHAPE) Research Center, School of Science and Technology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Zhaohuan', 'Initials': 'Z', 'LastName': 'Gui', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Hong Kong, China.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10322-0']
1925,31246926,Lifesaving interventions in blackout conditions using night vision technology: Come to the dark side.,"BACKGROUND


During military combat operations and civilian night-time aeromedical transport, medical providers are frequently required to perform lifesaving interventions (LSIs) in low-light environments. Because definitive surgical care is often delayed until a white light environment is permissible, we sought to determine if night optical device (NOD) technology could enable surgical capabilities in blackout conditions.
METHODS


Using a crossover design, six surgeons performed 11 different procedures on six swine, three in normal light conditions (LC) and 3 in blackout conditions (BC) using two-chamber NODs after familiarization with the procedures in both conditions on manikins. Successful completion and procedural times were compared between groups.
RESULTS


Blackout conditions were confirmed with ambient light reading of 0.2 lux during BC versus 3962.9 lux for LC (p < 0.001). There were no significant differences in success rates for any procedure. There were no differences in operative times between BC and LC for extremity tourniquet placement, femoral artery cut-down and clamping, resuscitative thoracotomy, or percutaneous resuscitative endovascular balloon occlusion of the aorta placement. The following procedures took significantly longer in BC vs. LC: Focused Assessment with Sonography for Trauma examination (98 seconds vs. 62 seconds), peripheral IV placement (140 seconds vs. 35 seconds), intraosseous access (51 seconds vs. 26 seconds), jugular vein cut-down and access (237 seconds vs. 104 seconds), laparotomy and packing (71 seconds vs. 51 seconds), stapled splenectomy (137 seconds vs. 74 seconds), resuscitative endovascular balloon occlusion of the aorta placement via cutdown (1,008 seconds vs. 338 seconds), and cricothyroidotomy (177 seconds vs. 109 seconds) (all p < 0.05).
CONCLUSION


Lifesaving interventions can be safely and effectively performed in blackout conditions using NODs, although increased difficulty with select procedure types was identified. Focused training and technological improvements to currently available devices are needed.
LEVEL OF EVIDENCE


Basic science.",2019,"There were no differences in operative times between BC and LC for extremity tourniquet placement, femoral artery cut-down and clamping, resuscitative thoracotomy, or percutaneous resuscitative endovascular balloon occlusion of the aorta placement.","['six surgeons performed 11 different procedures on six swine, three in normal light conditions (LC) and 3 in blackout conditions (BC) using two-chamber NODs after familiarization with the procedures in both conditions on manikins']",['Lifesaving interventions'],"['resuscitative endovascular balloon occlusion', 'extremity tourniquet placement, femoral artery cut-down and clamping, resuscitative thoracotomy, or percutaneous resuscitative endovascular balloon occlusion of the aorta placement', 'ambient light reading', 'operative times', 'success rates', 'Successful completion and procedural times', 'jugular vein cut-down and access', 'peripheral IV placement', 'stapled splenectomy']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]",[],"[{'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022427', 'cui_str': 'Jugular Veins'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}]",,0.0439088,"There were no differences in operative times between BC and LC for extremity tourniquet placement, femoral artery cut-down and clamping, resuscitative thoracotomy, or percutaneous resuscitative endovascular balloon occlusion of the aorta placement.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Derickson', 'Affiliation': 'From the Madigan Army Medical Center (M.J.D., J.P.K., C.J.P., M.R.B., S.T.M., M.J.E., M.J.M., D.G.C.), Tacoma, Washington.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kuckelman', 'Affiliation': ''}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Morgan R', 'Initials': 'MR', 'LastName': 'Barron', 'Affiliation': ''}, {'ForeName': 'Shannon T', 'Initials': 'ST', 'LastName': 'Marko', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Eckert', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Cuadrado', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002190']
1926,31698336,Evaluation of Step-Counting Interventions Differing on Intensity Messages.,"BACKGROUND


Step-counting interventions with discrepant intensity emphases may elicit different effects.
METHODS


A total of 120 sedentary/low-active, postmenopausal women were randomly assigned to one of the following 3 groups: (1) 10,000 steps per day (with no emphasis on walking intensity/speed/cadence; basic intervention, 49 completers), (2) 10,000 steps per day and at least 30 minutes in moderate intensity (ie, at a cadence of at least 100 steps per minute; enhanced intervention, 47 completers), or (3) a control group (19 completers). NL-1000-determined steps and active minutes (a device-specific indicator of time at moderate+ intensity) were collected as process variables during the 12-week intervention. Outcome variables included systolic and diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow-mediated dilation, gait speed, and ActiGraph GT3X+-determined physical activity and sedentary behavior.
RESULTS


The ""basic group"" increased 5173 to 9602 steps per day and 9.2 to 30.2 active minutes per day. The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day. The only significant change over time for clinical variables was body mass index.
CONCLUSIONS


Interventions that use simple step-counters can achieve elevated volume and intensity of daily physical activity, regardless of emphasis on intensity. Despite this, few clinical outcomes were apparent in this sample of postmenopausal women with generally normal or controlled hypertension.",2020,"The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day.","['120 sedentary/low-active, postmenopausal women', 'postmenopausal women with generally normal or controlled hypertension']",[],"['systolic and diastolic blood pressure, anthropometric measurements, fasting blood glucose and insulin, flow-mediated dilation, gait speed, and ActiGraph GT3X+-determined physical activity and sedentary behavior', 'elevated volume and intensity of daily physical activity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",120.0,0.0543753,"The ""enhanced group"" similarly increased 5061 to 10,508 steps per day and 8.7 to 38.8 active minutes per day.","[{'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Schuna', 'Affiliation': ''}, {'ForeName': 'Damon L', 'Initials': 'DL', 'LastName': 'Swift', 'Affiliation': ''}, {'ForeName': 'Amber T', 'Initials': 'AT', 'LastName': 'Dragg', 'Affiliation': ''}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0439']
1927,28914720,"Effects of Corrective Exercise for Thoracic Hyperkyphosis on Posture, Balance, and Well-Being in Older Women: A Double-Blind, Group-Matched Design.","BACKGROUND AND PURPOSE


The purpose of this study was to identify the effects of a corrective exercise for thoracic hyperkyphosis on posture, balance, and well-being in Korean community-dwelling older women.
METHODS


Fifty women 65 years of age and older, recruited from 2 senior centers, participated in this study. Participants were assigned to either the experimental group (EG) or the control group (CG) on the basis of convenience of location, and 22 in each were analyzed. Participants in the EG underwent a thoracic corrective exercise program 1 hour each session, twice per week for 8 weeks (a total of 16 sessions), which consisted of specific exercises to enhance breathing, thoracic mobility and stability, and awareness of thoracic alignment. The CG received education on the same thoracic corrective exercise program and a booklet of the exercises. Outcome measures included the extent of postural abnormality (angle of thoracic kyphosis, kyphosis index calculated both in relaxed- and best posture using flexicurve, the ratio of the kyphosis index calculated best posture/relaxed posture, craniovertebral angle, and tragus-to-wall distance), balance (Short Physical Performance Battery and limit of stability), and well-being (Geriatric Depression Scale Short Form and the 36-Item Short Form Health Survey [SF-36]). All data were collected by 6 blinded assessors at baseline, at 8 weeks after the completion of intervention, and at 16 weeks for follow-up.
RESULTS AND DISCUSSION


For participants of the EG, means of all parameters showed significant improvements over time (P < .05), with improved values both in comparison of baseline to postintervention and baseline to follow-up. Means of CG parameters were significantly improved in only the angle of thoracic kyphosis and the tragus-to-wall distance (P < .05). Furthermore, in all parameters, percent change between baseline and postintervention data was significantly (P < .05) higher for the EG than that for the CG, except for the limit of stability and SF-36 which improved but not significantly. All parameters between baseline and follow-up data were significantly (P < .05) higher for the EG than those for the CG, except for the limit of stability.
CONCLUSIONS


The findings of this study suggest that a well-designed exercise program may be beneficial to improve spinal posture, balance, and well-being in older women with thoracic hyperkyphosis. We recommend the use of the therapeutic strategies utilized in this study to enhance thoracic posture, balance, and well-being of older women with thoracic hyperkyphosis. Future research is needed to apply this exercise protocol on a larger and more diverse population.",2019,"All parameters between baseline and follow-up data were significantly (P < .05) higher for the EG than those for the CG, except for the limit of stability.
","['older women with thoracic hyperkyphosis', 'Fifty women 65 years of age and older, recruited from 2 senior centers, participated in this study', 'Korean community-dwelling older women', 'Older Women']","['thoracic corrective exercise program', 'Corrective Exercise', 'corrective exercise', 'control group (CG']","['CG parameters', 'extent of postural abnormality (angle of thoracic kyphosis, kyphosis index calculated both in relaxed- and best posture using flexicurve, the ratio of the kyphosis index calculated best posture/relaxed posture, craniovertebral angle, and tragus-to-wall distance), balance (Short Physical Performance Battery and limit of stability), and well-being (Geriatric Depression Scale Short Form and the 36-Item Short Form Health Survey [SF-36', 'limit of stability and SF-36']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0022823'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",50.0,0.0494232,"All parameters between baseline and follow-up data were significantly (P < .05) higher for the EG than those for the CG, except for the limit of stability.
","[{'ForeName': 'Hyun-Jeong', 'Initials': 'HJ', 'LastName': 'Jang', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Lynne C', 'Initials': 'LC', 'LastName': 'Hughes', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, The University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Duck-Won', 'Initials': 'DW', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Cheongju University, Chungcheong Province, South Korea.'}, {'ForeName': 'Suhn-Yeop', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Daejeon, South Korea.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000146']
1928,32045316,Application of Nanocarbon in Breast Approach Endoscopic Thyroidectomy Thyroid Cancer Surgery.,"Objective:  This study aimed to investigate the application of nanocarbon in surgical endoscopy in patients with thyroid cancer for the clinical tracing of level VI sentinel lymph nodes (SLNs) and for parathyroid gland protection.  Materials and Methods:  Ninety-three patients with papillary thyroid carcinoma (PTC) who underwent an endoscopic thyroid cancer operation were included. We randomly divided these patients into a control group ( n  = 42) and a nanocarbon group ( n  = 51). For the nanocarbon group, after thyroid exposure, nanocarbon was injected into the thyroid gland, and the SLNs were resected and subjected to frozen sectioning and routine pathological examination. In addition, the postoperative calcium and parathyroid hormone (PTH) levels of both groups were analyzed to compare the features of the nanocarbon application.  Results:  The number of central lymph (level VI) nodes dissected and the number of metastatic lymph nodes identified were analyzed in both groups. The number of dissected lymph nodes from both unilateral and bilateral thyroid surgeries was significantly larger in the nanocarbon group than in the control group. At the same time, the number of identified metastasis lymph nodes dissected were higher in the nanocarbon group than in the control group. We assessed the postoperative calcium and PTH level to evaluate the parathyroid function. Our results show that the nanocarbon group had a better protective effect on parathyroid function than the control group.  Conclusions:  As a lymph node trace agent, nanocarbon could better evaluate and permit a more clear lymph dissection for patients with PTC. Nanocarbon contributes to a decrease in the incidence rate of parathyroid damage, which has great clinical value.",2020,The number of dissected lymph nodes from both unilateral and bilateral thyroid surgeries was significantly larger in the nanocarbon group than in the control group.,"['patients with thyroid cancer for the clinical tracing of level VI sentinel lymph nodes (SLNs) and for parathyroid gland protection', 'Ninety-three patients with papillary thyroid carcinoma (PTC) who underwent an endoscopic thyroid cancer operation were included', 'Breast Approach Endoscopic Thyroidectomy Thyroid Cancer Surgery', 'patients with PTC']","['nanocarbon', 'Nanocarbon']","['number of identified metastasis lymph nodes', 'postoperative calcium and PTH level', 'parathyroid function', 'number of dissected lymph nodes', 'postoperative calcium and parathyroid hormone (PTH) levels', 'number of central lymph']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0238463', 'cui_str': 'Thyroid Cancer, Papillary'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}]",93.0,0.0318611,The number of dissected lymph nodes from both unilateral and bilateral thyroid surgeries was significantly larger in the nanocarbon group than in the control group.,"[{'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Ma', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}, {'ForeName': 'Dong-Bao', 'Initials': 'DB', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}, {'ForeName': 'Wei-Feng', 'Initials': 'WF', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Linhai Hospital of Traditional Chinese Medicine, Taizhou, P.R. China.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0794']
1929,30892987,"Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With  BRAF  V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study.","PURPOSE


To determine the safety and preliminary efficacy of selective combination targeted therapy for  BRAF  V600E-mutant metastatic colorectal cancer (mCRC) in the safety lead-in phase of the open-label, randomized, three-arm, phase III BEACON Colorectal Cancer trial ( ClinicalTrials.gov identifier: NCT02928224; European Union Clinical Trials Register identifier: EudraCT2015-005805-35).
PATIENTS AND METHODS


Before initiation of the randomized portion of the BEACON Colorectal Cancer trial, 30 patients with  BRAF  V600E-mutant mCRC who had experienced treatment failure with one or two prior regimens were to be recruited to a safety lead-in of encorafenib 300 mg daily, binimetinib 45 mg twice daily, plus standard weekly cetuximab. The primary end point was safety, including the incidence of dose-limiting toxicities. Efficacy end points included overall response rate, progression-free survival, and overall survival.
RESULTS


Among the 30 treated patients, dose-limiting toxicities occurred in five patients and included serous retinopathy (n = 2), reversible decreased left ventricular ejection fraction (n = 1), and cetuximab-related infusion reactions (n = 2). The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%). In 29 patients with  BRAF  V600E-mutant tumors (one patient had a non- BRAF  V600E-mutant tumor and was not included in the efficacy analysis), the confirmed overall response rate was 48% (95% CI, 29.4% to 67.5%), median progression-free survival was 8.0 months (95% CI, 5.6 to 9.3 months), and median overall survival was 15.3 months (95% CI, 9.6 months to not reached), with median duration of follow-up of 18.2 months (range, 16.6 to 19.8 months).
CONCLUSION


In the safety lead-in, the safety and tolerability of the encorafenib, binimetinib, and cetuximab regimen is manageable and acceptable for initiation of the randomized portion of the study. The observed efficacy is promising compared with available therapies and, if confirmed in the randomized portion of the trial, could establish this regimen as a new standard of care for previously treated  BRAF  V600E-mutant mCRC.",2019,"The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%).","['30 patients with  BRAF  V600E-mutant mCRC who had experienced treatment failure with one or two prior regimens were to be recruited to a safety lead-in of', 'Patients With  BRAF', 'BRAF  V600E-mutant metastatic colorectal cancer (mCRC', 'V600E-Mutant Metastatic Colorectal Cancer']","['Binimetinib, Encorafenib, and Cetuximab Triplet Therapy', 'encorafenib, binimetinib, and cetuximab regimen', 'encorafenib 300 mg daily, binimetinib 45 mg twice daily, plus standard weekly cetuximab', 'selective combination targeted therapy']","['safety and tolerability', 'overall response rate, progression-free survival, and overall survival', 'dose-limiting toxicities', 'median progression-free survival', 'left ventricular ejection fraction', 'incidence of dose-limiting toxicities', 'anemia', 'median overall survival', 'Safety Lead', 'creatine phosphokinase', 'overall response rate', 'urinary tract infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162643'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",30.0,0.172122,"The most common grade 3 or 4 adverse events were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased AST (10%), and urinary tract infections (10%).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': '1 University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Huijberts', 'Affiliation': '2 Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': '3 West Cancer Center, Germantown, TN.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Yaeger', 'Affiliation': '4 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'Cuyle', 'Affiliation': '1 University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Elez', 'Affiliation': ""6 Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Fakih', 'Affiliation': '7 City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Montagut', 'Affiliation': ""8 Hospital del Mar-Institut Hospital del Mar d'Investigacions Mèdiques, Universitat Pompeu Fabra, Barcelona, Spain.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': '9 Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': '10 National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': '11 Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Desai', 'Affiliation': '12 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': '13 University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Gollerkeri', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Christy-Bittel', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Maharry', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sandor', 'Affiliation': '14 Array BioPharma Inc, Boulder, CO.'}, {'ForeName': 'Jan H M', 'Initials': 'JHM', 'LastName': 'Schellens', 'Affiliation': '15 Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kopetz', 'Affiliation': '16 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""6 Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02459']
1930,32040959,Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial.,"Background


Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of combined antiretroviral therapy (c-ART).
Objective


To assess the benefit of adding maraviroc, an antiretroviral drug with immunologic effects, to standard c-ART for patients with advanced disease at HIV diagnosis.
Design


Randomized controlled trial. (ClinicalTrials.gov: NCT01348308).
Setting


Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20).
Participants


416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE).
Intervention


C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.
Measurements


The primary end point was first occurrence of severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death). Prespecified secondary outcomes included primary outcome components, biological and pharmacokinetic measures, and adverse events graded 2 or higher.
Results


409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis. During 72 weeks of follow-up, incidence of severe morbidity was 11.1 per 100 person-years in the maraviroc group and 11.2 per 100 person-years in the placebo group (hazard ratio, 0.97 [95% CI, 0.57 to 1.67]). Incidence of adverse events graded 2 or higher was 36.1 versus 41.5 per 100 person-years (incidence rate ratio, 0.87 [CI, 0.65 to 1.15]).
Limitations


Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification.
Conclusion


Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
Primary Funding Source


INSERM-ANRS (French National Agency for Research on AIDS).",2020,"Conclusion


Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
","['Participants\n\n\n416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200', 'patients initiating therapy for advanced HIV infection', '409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis', 'Setting\n\n\nClinical sites in France (n\xa0= 25), Italy (n\xa0= 5), and Spain (n\xa0= 20', 'patients with advanced disease at HIV diagnosis', 'Advanced HIV Infection']","['Maraviroc Versus Placebo', 'placebo', 'placebo or maraviroc']","['Incidence of adverse events', 'biological and pharmacokinetic measures, and adverse events graded 2 or higher', 'incidence of severe morbidity', 'severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1619738', 'cui_str': 'Immune Restoration Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",416.0,0.753684,"Conclusion


Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': 'Vaccine Research Institute, Institut National de la Santé et de la Recherche médicale (INSERM), and Assistance Publique Hôpitaux de Paris (APHP), Hôpital H. Mondor, Créteil, France (Y.L., J.L.).'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelièvre', 'Affiliation': 'Vaccine Research Institute, Institut National de la Santé et de la Recherche médicale (INSERM), and Assistance Publique Hôpitaux de Paris (APHP), Hôpital H. Mondor, Créteil, France (Y.L., J.L.).'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Assoumou', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Aznar', 'Affiliation': 'Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica - Grupo de Estudio del SIDA, Madrid, Spain (E.A.).'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pulido', 'Affiliation': 'Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain (F.P.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tambussi', 'Affiliation': 'Istituto di ricovero e cura a carattere scientifico-Ospedale San Raffaele, Milano, Italy (G.T.).'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': ""Hospital universitario Vall d'Hebron, Barcelona, Spain (M.C.).""}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Meybeck', 'Affiliation': 'Service Universitaire des Maladies Infectieuses et du Voyageur, Centre Hospitalier de Tourcoing, Tourcoing, France (A.M.).'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'INSERM U944, Université de Paris, Hôpital Saint-Louis, APHP, Paris, France (J.M., C.D.).'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Delaugerre', 'Affiliation': 'INSERM U944, Université de Paris, Hôpital Saint-Louis, APHP, Paris, France (J.M., C.D.).'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Izopet', 'Affiliation': 'INSERM, U1043, Université Toulouse III Paul-Sabatier, Faculté de Médecine Toulouse-Purpan, Toulouse, France (J.I.).'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Peytavin', 'Affiliation': 'Université Paris Diderot, Sorbonne Paris Cité, Laboratoire de Pharmacologie-Toxicologie, Hôpital Bichat-Claude Bernard, APHP, Paris, France (G.P.).'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Cardon', 'Affiliation': ""ANRS, France Recherche Nord & Sud Sida-hiv Hépatites, Agence autonome de l'INSERM, Paris, France (F.C., A.D.).""}, {'ForeName': 'Alpha', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': ""ANRS, France Recherche Nord & Sud Sida-hiv Hépatites, Agence autonome de l'INSERM, Paris, France (F.C., A.D.).""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Lancar', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Béniguel', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Costagliola', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}]",Annals of internal medicine,['10.7326/M19-2133']
1931,32023535,Association of Decline in Physical Activity With Increased Negative Mood Following the Weight-Loss Phase in Women Enrolled in a Cognitive Behavioral Obesity Treatment.,"BACKGROUND


Physical activity (PA)-related mood improvement is important because it positively affects predictors of weight-management behaviors.
METHODS


Decline in PA, mood, and exercise self-efficacy after an initial 6 months of gains were assessed in 93 women in a behavioral obesity treatment.
RESULTS


Reduction in change in PA during months 6 to 24, but not actual PA, significantly predicted increased negative mood. For participants whose negative mood increased, their 7 days per week PA regimens were reduced by ∼2.5 days per week versus ∼1 day per week without an increase. Exercise self-efficacy significantly mediated the PA-mood change relationship.
CONCLUSIONS


Mood-related benefits of sustaining PA beyond initial treatment months were clarified.",2020,"For participants whose negative mood increased, their 7 days per week PA regimens were reduced by ∼2.5 days per week versus ∼1 day per week without an increase.","['93 women in a behavioral obesity treatment', 'Women']",['Cognitive Behavioral Obesity Treatment'],"['Exercise self-efficacy', 'Physical Activity', 'negative mood', 'PA, mood, and exercise self-efficacy', 'Negative Mood']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",93.0,0.0219379,"For participants whose negative mood increased, their 7 days per week PA regimens were reduced by ∼2.5 days per week versus ∼1 day per week without an increase.","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0436']
1932,31348053,Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial.,"BACKGROUND


Patients with lung cancer often experience reduced functional capacity and quality of life after surgery. The current study investigated the impact of a short-term, home-based, multimodal prehabilitation program on perioperative functional capacity in patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy for nonsmall cell lung cancer (NSCLC).
METHODS


A randomized controlled trial was conducted with 73 patients. Patients in the prehabilitation group (n = 37) received a 2-week multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance. Patients in the control group (n = 36) received the usual clinical care. The assessors were blinded to the patient allocation. The primary outcome was perioperative functional capacity measured as the 6-minute walk distance (6MWD), which was assessed at 1 day before and 30 days after surgery. A linear mixed-effects model was built to analyze the perioperative 6MWD. Other outcomes included lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality.
RESULTS


The median duration of prehabilitation was 15 days. The average 6MWD was 60.9 m higher perioperatively in the prehabilitation group compared to the control group (95% confidence interval [CI], 32.4-89.5; P < .001). There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
CONCLUSIONS


A 2-week, home-based, multimodal prehabilitation program could produce clinically relevant improvements in perioperative functional capacity in patients undergoing VATS lobectomy for lung cancer.",2019,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","['Patients in the prehabilitation group (n = 37', 'patients undergoing', '73 patients', 'Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer', 'patients undergoing VATS lobectomy for lung cancer', 'nonsmall cell lung cancer (NSCLC', 'Patients with lung cancer']","['short-term, home-based, multimodal prehabilitation program', 'usual clinical care', 'multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance', 'video-assisted thoracoscopic surgery (VATS) lobectomy']","['median duration of prehabilitation', 'Perioperative Functional Capability', 'lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity', 'perioperative functional capacity measured as the 6-minute walk distance (6MWD', 'functional capacity and quality of life', 'perioperative functional capacity', 'lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality', 'average 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4520228', 'cui_str': 'VATS (video-assisted thoracoscopic surgery) lobectomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.141417,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","[{'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'From the Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Central Research Laboratory, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'From the Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yushang', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Departments of Thoracic Surgery.'}, {'ForeName': 'Naixin', 'Initials': 'N', 'LastName': 'Liang', 'Affiliation': 'Departments of Thoracic Surgery.'}, {'ForeName': 'Shanqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Departments of Thoracic Surgery.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Enteral and Parenteral Nutrition, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'From the Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004342']
1933,32023537,Exploration of Habitual Walking Behavior and Home-Based Muscle Power Training in Individuals With Total Knee Arthroplasty.,"BACKGROUND


The purpose of this study was to investigate the effects of a home-based muscle power training program on muscle strength and power, functional performance, and physical activity behavior in individuals at least 6 months posttotal knee arthroplasty.
METHODS


Twelve men and women, mean age 63.9 (6.8) and 6 months to 2 years posttotal knee arthroplasty unilateral or bilateral), completed this study. Participants were randomly assigned to the home-based power training intervention or step-monitoring comparison group. Quadriceps muscle strength and power, 6-minute walk test, functional leg power, and habitual walking behavior (average daily steps, minutes per week of moderate to vigorous physical activity) were assessed before and after intervention and then compared between and within groups.
RESULTS


The authors found no significant differences between the groups on amount of change in any of the outcomes, but mixed results on differences within each of the groups on the outcome measures.
CONCLUSION


There were no differences between the groups for amount of change on the outcome measures the authors selected. Although within group differences varied slightly for each group, it was not enough to justify the more expensive home-based power training over the simpler step-monitoring intervention.",2020,There were no differences between the groups for amount of change on the outcome measures the authors selected.,"['Twelve men and women, mean age 63.9 (6.8) and 6 months to 2 years posttotal knee arthroplasty unilateral or bilateral', 'Individuals With Total Knee Arthroplasty', 'individuals at least 6 months posttotal knee arthroplasty']","['Habitual Walking Behavior and Home-Based Muscle Power Training', 'home-based muscle power training program', 'home-based power training intervention or step-monitoring comparison group']","['Quadriceps muscle strength and power, 6-minute walk test, functional leg power, and habitual walking behavior (average daily steps, minutes per week of moderate to vigorous physical activity', 'muscle strength and power, functional performance, and physical activity behavior']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3853978'}]",12.0,0.0165304,There were no differences between the groups for amount of change on the outcome measures the authors selected.,"[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Trudelle-Jackson', 'Affiliation': ''}, {'ForeName': 'Emerenciana', 'Initials': 'E', 'LastName': 'Hines', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Medley', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0233']
1934,31891298,Comparison of Patient Comfort During the First Stage of Conventional Versus Modified Two-Stage Inferior Alveolar Nerve Blocks in Pediatric Patients.,"Our aim was to compare the comfort of pediatric patients during the first stage of the conventional 2-stage inferior alveolar nerve block (IANB) versus the modified 2-stage IANB. This was a parallel group, single-blinded, randomized controlled trial. Pediatric patients meeting the inclusion criteria were randomly allocated to 1 of the 2 groups receiving IANB, group 1 (31 subjects) utilized a conventional 2-stage technique, and group 2 (33 subjects) utilized a modified 2-stage approach. Patient comfort was assessed indirectly by 2 observers using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during the first stage of the injections. FLACC score data between the 2 groups were analyzed using the chi-square test, and interobserver reliability was measured using kappa statistics. During the first stage of the injections, lower FLACC scores of 0 indicating a relaxed/comfortable patient experience were found in 57.6% of group 2 subjects compared with only 25.8% group 1 subjects, which was a statistically significant difference ( p -value .013). Interobserver reliability assessed using kappa coefficients (κ = 0.812) indicated excellent agreement. FLACC scores for the pediatric patients during the first stage of the modified 2-stage IANB technique were significantly lower than during the first stage of the conventional 2-stage IANB technique.",2019,FLACC scores for the pediatric patients during the first stage of the modified 2-stage IANB technique were significantly lower than during the first stage of the conventional 2-stage IANB technique.,"['Pediatric Patients', 'Pediatric patients meeting the inclusion criteria']","['conventional 2-stage inferior alveolar nerve block (IANB', 'Patient Comfort', 'IANB', 'conventional 2-stage technique, and group 2 (33 subjects) utilized a modified 2-stage approach']","['Face, Legs, Activity, Cry, Consolability (FLACC) scale', 'FLACC scores of 0 indicating a relaxed/comfortable patient experience', 'FLACC score data', 'FLACC scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",33.0,0.0400297,FLACC scores for the pediatric patients during the first stage of the modified 2-stage IANB technique were significantly lower than during the first stage of the conventional 2-stage IANB technique.,"[{'ForeName': 'Rose Maria', 'Initials': 'RM', 'LastName': 'Joseph', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Ashwin P', 'Initials': 'AP', 'LastName': 'Rao', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Srikant', 'Affiliation': 'Department of Oral Pathology & Microbiology, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Karuna', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}, {'ForeName': 'P Anupama', 'Initials': 'PA', 'LastName': 'Nayak', 'Affiliation': 'Department of Paedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}]",Anesthesia progress,['10.2344/anpr-66-03-03']
1935,32005206,Disabled People's Organisations increase access to services and improve well-being: evidence from a cluster randomized trial in North India.,"BACKGROUND


Disabled People's Organisations (DPOs) are the mainstay of disability responses worldwide. Yet there is no quantitative data assessing their effectiveness in low-and middle-income countries (LMICs). The aim of this study was to measure the effectiveness of DPOs as a low-cost intervention to improve well-being and access to services and facilities for people with disabilities.
METHODS


We undertook a cluster randomised intervention control trial across 39 distinct rural villages in Uttarakhand State, North India. A total of 527 participants were included from 39 villages: 302 people from 20 villages were assigned to the intervention arm and 225 from 19 villages were assigned to the control group. Over a 2-year period, people with disabilities were facilitated to form DPOs with regular home visits. Participants were also given financial support for public events and exposure visits to other DPOs. Seven domains were used to measure access and participation.
RESULTS


DPO formation had improved participation in community consultations (OR 2.57, 95% CI 1.4 to 4.72), social activities (OR 2.46, 95% CI 1.38 to 4.38), DPOs (OR 14.78, 95% CI 1.43 to 152.43), access to toilet facilities (OR 3.89, 95% CI 1.31 to 11.57), rehabilitation (OR 6.83, 95% CI 2.4 to 19.42) and Government social welfare services (OR 4.82, 95% CI 2.35 to 9.91) in intervention when compared to the control. People who were part of a DPO had an improvement in having their opinion heard (OR 1.94, 95% CI 1.16 to 3.24) and being able to make friends (OR 1.63, 95% CI 1 to 2.65) compared to those who were not part of a DPO. All other well-being variables had little evidence despite greater improvement in the DPO intervention group.
CONCLUSIONS


This is the first randomised control trial to demonstrate that DPOs in LMICs are effective at improving participation, access and well-being. This study supports the ongoing role of DPOs in activities related to disability inclusion and disability services. This study also suggests that supporting the establishment, facilitation and strengthening of DPOs is a cost-effective intervention and role that non-governmental organisations (NGOs) can play.
TRIAL REGISTRATION


ISRCTN36867362, 9th Oct 2019 (retrospectively registered).",2020,"RESULTS


DPO formation had improved participation in community consultations (OR 2.57, 95% CI 1.4 to 4.72), social activities (OR 2.46, 95% CI 1.38 to 4.38), DPOs (OR 14.78, 95% CI 1.43 to 152.43), access to toilet facilities (OR 3.89, 95% CI 1.31 to 11.57), rehabilitation (OR 6.83, 95% CI 2.4 to 19.42) and Government social welfare services (OR 4.82, 95% CI 2.35 to 9.91) in intervention when compared to the control.","['302 people from 20 villages were assigned to the intervention arm and 225 from 19 villages', 'people with disabilities', ""Disabled People's Organisations (DPOs"", '39 distinct rural villages in Uttarakhand State, North India', 'A total of 527 participants were included from 39 villages']",[],"['DPOs', 'access to toilet facilities', 'Government social welfare services', 'social activities', 'participation in community consultations']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0040364', 'cui_str': 'Lavatories'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",527.0,0.178846,"RESULTS


DPO formation had improved participation in community consultations (OR 2.57, 95% CI 1.4 to 4.72), social activities (OR 2.46, 95% CI 1.38 to 4.38), DPOs (OR 14.78, 95% CI 1.43 to 152.43), access to toilet facilities (OR 3.89, 95% CI 1.31 to 11.57), rehabilitation (OR 6.83, 95% CI 2.4 to 19.42) and Government social welfare services (OR 4.82, 95% CI 2.35 to 9.91) in intervention when compared to the control.","[{'ForeName': 'Nathan John', 'Initials': 'NJ', 'LastName': 'Grills', 'Affiliation': 'Nossal Institute for Global Health and Australia-India Institute, University of Melbourne, Level 5, 333 Exhibition Street, Melbourne, 3000, Australia. ngrills@unimelb.edu.au.'}, {'ForeName': 'Monsurul', 'Initials': 'M', 'LastName': 'Hoq', 'Affiliation': ""Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, 3052, Australia.""}, {'ForeName': 'Chun-Ping Pam', 'Initials': 'CP', 'LastName': 'Wong', 'Affiliation': 'Nossal Institute for Global Health, University of Melbourne, Level 5, 333 Exhibition Street, Melbourne, 3000, Australia.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Allagh', 'Affiliation': 'Indian Institute of Public Health-Hyderabad, Plot\xa0# 1, A.N.V.Arcade, Amar Co-op Society, Kavuri Hills, Madhapur, Hyderabad, 500 033, India.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Singh', 'Affiliation': ""'Pari Mahal' D-55 Aman Vihar, Lane no.10, Chidowali, P.O:Kandoli, Sahastradhara Road, Dehra dun, Uttarakhand, India.""}, {'ForeName': 'Fairlene', 'Initials': 'F', 'LastName': 'Soji', 'Affiliation': 'CBM, #140, ""Commerce Cube"", 5th Main, Puttannachetty Road, Chamarajpet, Bengaluru, Karnataka, 560 018, India.'}, {'ForeName': 'G V S', 'Initials': 'GVS', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health-Hyderabad, Plot\xa0# 1, A.N.V.Arcade, Amar Co-op Society, Kavuri Hills, Madhapur, Hyderabad, 500 033, India.'}]",BMC public health,['10.1186/s12889-020-8192-0']
1936,32005202,Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol.,"BACKGROUND


Cervical cancer is almost entirely preventable through vaccination and screening, yet remains one of the 'gravest threats to women's lives' according to the World Health Organization. Specific high-risk subtypes of human papillomavirus (HR-HPV) are well-established as the primary cause of cervical cancer. Uganda has one of the highest cervical cancer incidence rates in the world (54.8 per 100,000) as a result of limited screening access and infrastructure. The integration of a self-collected cervical cancer screening program using HPV testing within existing community-based primary health care services could increase access to screening and reduce cervical cancer rates among Ugandan women.
METHODS


Using a pragmatic, sequential, cluster randomized trial design; we will compare the effectiveness of two cervical cancer screening models for self-collected HPV testing: 1) community health worker recruitment (door-to-door); and 2) community health meetings. In Mayuge district, Uganda, 31 villages are randomized to one of two treatment arms. Due to the nature of this trial, blinding is not possible. Women are eligible to participate if they have no previous history of hysterectomy or treatment for cervical cancer or pre-cancer and are aged 25-49 years old. All participants receive an integrated package of cervical cancer screening and education. Samples are tested for HPV using GeneXpert point of care testing. All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation. The primary outcome for the trial is the number of women who attend follow-up for VIA screening at a designated Health Centre after a positive HR-HPV test out of all women screened per arm. Secondary outcomes include: cervical cancer screening knowledge; patient-reported experience measures for self-collected cervical cancer screening; and HPV incidence.
DISCUSSION


Results from this study will inform the national scale-up of cervical cancer screening in Uganda, aligning with the World Health Organization's target of achieving cervical cancer elimination through the pillar of increased HPV screening coverage.
TRIAL REGISTRATION


ISRCTN, ISRCTN12767014. Registered 14 May 2019, https://doi.org/10.1186/ISRCTN12767014; clinicaltrials.gov, NCT04000503; Registered 27 June 2019, https://clinicaltrials.gov/ct2/show/NCT04000503 PROTOCOL VERSION: January 8, 2020, version 1.",2020,All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation.,"['Mayuge District Uganda (ASPIRE Mayuge', 'Ugandan women', 'Women are eligible to participate if they have no previous history of hysterectomy or treatment for cervical cancer or pre-cancer and are aged 25-49\u2009years old', 'All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation']","['Integrated cervical cancer screening', 'integrated package of cervical cancer screening and education']","['cervical cancer rates', 'number of women who attend follow-up for VIA screening at a designated Health Centre', 'cervical cancer screening knowledge; patient-reported experience measures for self-collected cervical cancer screening; and HPV incidence', 'cervical cancer incidence rates']","[{'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0438065', 'cui_str': 'H/O: hysterectomy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201679', 'cui_str': 'Human papillomavirus typing (procedure)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.148029,All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation.,"[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Nakisige', 'Affiliation': 'Uganda Cancer Institute, Kampala, Uganda.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Trawin', 'Affiliation': ""Women's Health Research Institute, Vancouver, Canada.""}, {'ForeName': 'Sheona', 'Initials': 'S', 'LastName': 'Mitchell-Foster', 'Affiliation': ""Women's Health Research Institute, Vancouver, Canada.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': ""Women's Health Research Institute, Vancouver, Canada.""}, {'ForeName': 'Angeli', 'Initials': 'A', 'LastName': 'Rawat', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Mithani', 'Affiliation': ""Women's Health Research Institute, Vancouver, Canada.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Amuge', 'Affiliation': 'Uganda Cancer Institute, Kampala, Uganda.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'BC Centre for Disease Control, Vancouver, Canada.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Orem', 'Affiliation': 'Uganda Cancer Institute, Kampala, Uganda.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': ""Women's Health Research Institute, Vancouver, Canada.""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Ogilvie', 'Affiliation': ""Women's Health Research Institute, Vancouver, Canada. gina.ogilvie@bccdc.ca.""}]",BMC public health,['10.1186/s12889-020-8216-9']
1937,31036503,Morbidity and mortality after lifestyle intervention for people with impaired glucose tolerance: 30-year results of the Da Qing Diabetes Prevention Outcome Study.,"BACKGROUND


Lifestyle interventions can delay the onset of type 2 diabetes in people with impaired glucose tolerance, but whether this leads subsequently to fewer complications or to increased longevity is uncertain. We aimed to assess the long-term effects of lifestyle interventions in people with impaired glucose tolerance on the incidence of diabetes, its complications, and mortality.
METHODS


The original study was a cluster randomised trial, started in 1986, in which 33 clinics in Da Qing, China, were randomly assigned to either be a control clinic or provide one of three interventions (diet, exercise, or diet plus exercise) for 6 years for 577 adults with impaired glucose tolerance who usually receive their medical care from the clinics. Subsequently, participants were followed for up to 30 years to assess the effects of intervention on the incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy.
FINDINGS


Of the 577 participants, 438 were assigned to an intervention group and 138 to the control group (one refused baseline examination). After 30 years of follow-up, 540 (94%) of 576 participants were assessed for outcomes (135 in the control group, 405 in the intervention group). During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
INTERPRETATION


Lifestyle intervention in people with impaired glucose tolerance delayed the onset of type 2 diabetes and reduced the incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy. These findings provide strong justification to continue to implement and expand the use of such interventions to curb the global epidemic of type 2 diabetes and its consequences.
FUNDING


US Centers for Disease Control and Prevention, WHO, Chinese Center for Disease Control and Prevention, World Bank, Ministry of Public Health of the People's Republic of China, Da Qing First Hospital, China-Japan Friendship Hospital, and National Center for Cardiovascular Diseases & Fuwai Hospital.",2019,"During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
","['1986, in which 33 clinics in Da Qing, China', '577 participants', '577 adults with impaired glucose tolerance who usually receive their medical care from the clinics', 'people with impaired glucose tolerance']","['lifestyle interventions', 'control clinic or provide one of three interventions (diet, exercise, or diet plus exercise', 'lifestyle intervention']","['cardiovascular disease events', 'incidence of cardiovascular events, microvascular complications, and cardiovascular and all-cause mortality, and increased life expectancy', 'life expectancy', 'incidence of diabetes, cardiovascular disease events, composite microvascular complications, cardiovascular disease death, all-cause mortality, and life expectancy', 'median delay in diabetes onset of 3·96 years', 'cardiovascular disease deaths', 'incidence of diabetes, its complications, and mortality', 'microvascular complications', 'Morbidity and mortality']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",576.0,0.0715643,"During the 30-year follow-up, compared with control, the combined intervention group had a median delay in diabetes onset of 3·96 years (95% CI 1·25 to 6·67; p=0·0042), fewer cardiovascular disease events (hazard ratio 0·74, 95% CI 0·59-0·92; p=0·0060), a lower incidence of microvascular complications (0·65, 0·45-0·95; p=0·025), fewer cardiovascular disease deaths (0·67, 0·48-0·94; p=0·022), fewer all-cause deaths (0·74, 0·61-0·89; p=0·0015), and an average increase in life expectancy of 1·44 years (95% CI 0·20-2·68; p=0·023).
","[{'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Non-Communicable Disease Control and Community Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yiling J', 'Initials': 'YJ', 'LastName': 'Cheng', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Yinghua', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiology, Da Qing First Hospital, Da Qing, China.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bennett', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Endocrinology and Cardiovascular Disease Centre, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China; China-Japan Friendship Hospital, Beijing, China. Electronic address: guangwei_li45@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30093-2']
1938,31923341,Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL).,"Although supplemental vitamin D is used to promote bone health in the general population, data from randomized controlled trials (RCTs) have been inconsistent. We determined whether daily, vitamin D 3  supplementation improves bone mineral density (BMD) and/or structure. VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT of supplemental vitamin D 3  (2000 IU/d) and/or omega-3 fatty acids (1 g/d) in 25,871 adults nationwide. This ancillary study included a subcohort of 771 participants (men ≥50 and women ≥55 years; not taking bone active medications) evaluated at baseline and at 2-year follow-up (89% retention). Total 25(OH)D levels were measured by liquid chromatography tandem mass spectrometry (Quest Diagnostics, San Juan Capistrano, CA, USA). Free 25(OH)D (FVD) levels were measured using the ELISA assay by Future Diagnostics Solutions BV (Wijchen, Netherlands). Primary endpoints were 2-year changes in areal (a) BMD at the spine, hip, and whole body determined by dual-energy X-ray absorptiometry (DXA). Secondary endpoints were 2-year changes in volumetric (v) BMD and cortical thickness at the radius and tibia assessed by peripheral quantitative computed tomography. Supplemental vitamin D 3  versus placebo had no effect on 2-year changes in aBMD at the spine (0.33% versus 0.17%; p = 0.55), femoral neck (-0.27% versus -0.68%; p = 0.16), total hip (-0.76% versus -0.95%; p = 0.23), or whole body (-0.22% versus -0.15%; p = 0.60), or on measures of bone structure. Effects did not vary by sex, race/ethnicity, body mass index, or 25(OH)D levels. Among participants with baseline FVD levels below the median (<14.2 pmol/L), there was a slight increase in spine aBMD (0.75% versus 0%; p = 0.043) and attenuation in loss of total hip aBMD (-0.42% versus -0.98%; p = 0.044) with vitamin D 3  . Whether baseline FVD levels help to identify those more likely to benefit from supplementation warrants further study. Supplemental vitamin D 3  versus placebo for 2 years in general healthy adults not selected for vitamin D insufficiency did not improve BMD or structure. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,Supplemental vitamin D 3  vs. placebo had no effect on 2-year changes in aBMD at the spine (0.33% vs. 0.17%;,"['771 participants (men ≥50 and women ≥55\u2009years; not taking bone active medications) evaluated at baseline and 2-years follow-up (89% retention', '25,871 adults nationwide', 'general healthy adults', 'Women and Men in the VITamin D and OmegA-3 TriaL (VITAL']","['VITamin D and OmegA-3 TriaL', 'omega-3 fatty acids', 'supplemental vitamin D', 'vitamin D 3  supplementation', 'Supplemental Vitamin D', 'placebo', 'Supplemental vitamin D 3  vs. placebo']","['femoral neck', '2-year changes in volumetric (v)BMD and cortical thickness at the radius and tibia assessed by peripheral quantitative computed tomography', 'sex, race/ethnicity, BMI, or 25(OH)D levels', 'BMD or structure', 'bone mineral density (BMD) and/or structure', '2-year changes in aBMD', 'Total 25(OH)D levels', 'Bone Health Outcomes', 'spine aBMD', 'total hip', '2-year changes in areal (a)BMD at the spine, hip, and whole body determined by dual-energy X-ray absorptiometry', 'attenuation in loss of total hip aBMD', 'Free 25(OH)D (FVD) levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]",771.0,0.308404,Supplemental vitamin D 3  vs. placebo had no effect on 2-year changes in aBMD at the spine (0.33% vs. 0.17%;,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Donlon', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3958']
1939,31269409,Use of consumer monitors for estimating energy expenditure in youth.,"The purpose of this study was to compare energy expenditure (EE) estimates from 5 consumer physical activity monitors (PAMs) to indirect calorimetry in a sample of youth. Eighty-nine youth (mean (SD); age, 12.3 (3.4) years; 50% female) performed 16 semi-structured activities. Activities were performed in duplicate across 2 visits. Participants wore a Cosmed K4b 2  (criterion for EE), an Apple Watch 2 (left wrist), Mymo Tracker (right hip), and Misfit Shine 2 devices (right hip; right shoe). Participants were randomized to wear a Samsung Gear Fit 2 or a Fitbit Charge 2 on the right wrist. Oxygen consumption was converted to EE by subtracting estimated basal EE (Schofield's equation) from the measured gross EE. EE from each visit was summed across the 2 visit days for comparison with the total EE recorded from the PAMs. All consumer PAMs estimated gross EE, except for the Apple Watch 2 (net Active EE). Paired  t  tests were used to assess differences between estimated (PAM) and measured (K4b 2 ) EE. Mean absolute percent error (MAPE) was used to assess individual-level error. The Mymo Tracker was not significantly different from measured EE and was within 15.9 kcal of measured kilocalories ( p  = 0.764). Mean percent errors ranged from 3.5% (Mymo Tracker) to 48.2% (Apple Watch 2). MAPE ranged from 16.8% (Misfit Shine 2 - right hip) to 49.9% (Mymo Tracker).  Novelty  Only the Mymo Tracker was not significantly different from measured EE but had the greatest individual error. The Misfit Shine 2 - right hip had the lowest individual error. Caution is warranted when using consumer PAMs in youth for tracking EE.",2020,Mean percent errors ranged from 3.5% (MT) to 48.2% (AW).,"['Youth', 'Eighty-nine youth (mean(SD); age, 12.3(3.4']","['Consumer Monitors', 'wear a Samsung Gear Fit 2 (SG) or a Fitbit Charge 2 (FC']","['Oxygen consumption', 'Mean absolute percent error (MAPE']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",89.0,0.0344607,Mean percent errors ranged from 3.5% (MT) to 48.2% (AW).,"[{'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'LaMunion', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Blythe', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Hibbing', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kaplan', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53211, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Clendenin', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, The University of Tennessee, Knoxville, TN 37996, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0129']
1940,32005642,Mindfulness-Based Cognitive Therapy for Improving Subjective Well-Being Among Healthy Individuals: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Previous studies have indicated that higher subjective well-being works as a protective factor for health. Some studies have already shown the effects of mindfulness-based interventions on improving subjective well-being. However, these studies targeted specific populations rather than the general public. Furthermore, they assessed either life evaluation or affective aspects of subjective well-being rather than the concept as a whole, including the eudemonic aspect of well-being.
OBJECTIVE


This study aims to investigate the effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) for improving the wholistic aspects of subjective well-being in healthy individuals.
METHODS


This study was an 8-week, randomized, parallel-group, superiority trial with a 2-month follow-up. Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale (SWLS) were eligible to participate and randomly allocated to the MBCT group or the wait-list control group. The intervention program was developed by modifying an MBCT program to improve the well-being of a nonclinical population. The primary outcome was the difference between the two groups in mean change scores from the baseline on the SWLS. The secondary outcomes included scores on the Flourishing Scale and the Scale of Positive and Negative Experience as well as the incremental cost-effectiveness ratio.
RESULTS


This study began recruiting participants in July 2018 and recruitment was completed at the end of September 2019. Data collection and dataset construction was completed by the end of March 2020.
CONCLUSIONS


This study is unique in that it investigates MBCT's effects on the three different aspects of subjective well-being: life evaluation, affect, and eudemonia. It is limited, as the specific effect attributable to MBCT cannot be detected because of the lack of an active control group.
TRIAL REGISTRATION


University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000031885; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15892.",2020,"Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale will be eligible participants and randomly allocated to MBCT, or wait-list control.","['healthy individuals', 'Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale will be eligible participants', 'participants in July 2018']","['Mindfulness-Based Cognitive Therapy', 'Mindfulness Based Cognitive Therapy (MBCT', 'MBCT, or wait-list control']","['Flourishing Scale, Scale of Positive and Negative Experience, Incremental Cost Effectiveness Ratio etc', 'Effectiveness and cost effectiveness', 'mean change scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0222045'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0485996,"Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale will be eligible participants and randomly allocated to MBCT, or wait-list control.","[{'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Sado', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Kosugi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Nagaoka', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Sunre', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Faculty of Nursing and Medicine Care, Keio University, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Joichiro', 'Initials': 'J', 'LastName': 'Shirahase', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",JMIR research protocols,['10.2196/15892']
1941,32014538,Effects of the Mother-Child Education Program on Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon: A Pilot Randomized Controlled Trial.,"OBJECTIVE


Few randomized controlled trials (RCTs) have explored the implementation and impact of early childhood parenting education programs in very fragile contexts and humanitarian settings. We tested the effects of a group-based intervention, the Mother-Child Education Program (MOCEP), on parenting stress and practices among two refugee communities and one other marginalized community in Beirut, Lebanon.
METHOD


A pilot wait-list RCT was conducted to assess the program's impact on maternal, child (average age: 4 years), and dyadic outcomes. A total of 106 mother-child dyads were randomly assigned to either the intervention group (n = 53) or the wait-list control group (n = 53). Analysis was conducted by modified intention-to-treat and supplemental analyses through multiple imputation of missing post-intervention data.
RESULTS


Forty families (38%) withdrew early from the study. After completing the program, mothers in the intervention group showed a reduction in their harsh parenting practices, as indexed by the Disciplinary Style Questionnaire (Cohen's d = -0.76, 95% CI = -1.24, -0.27) and in their level of parenting stress, as indexed by the Parenting Stress Index-Short Form (PSI-SF; Cohen's d = -0.90, 95% CI = -1.39, -0.40). Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention. However, we did not detect any positive impact on behavioral or emotional outcomes among the children.
CONCLUSION


Our analyses suggest that MOCEP had a positive impact on disciplinary practices and parenting stress in a context of high fragility, but that broader effects on maternal and child outcomes may be dependent on program attendance and the availability of other services. We discuss implications of this pilot study for practice and research of a largely unexplored area of program evaluation.
CLINICAL TRIAL REGISTRATION INFORMATION


Mother and Child Education Program in Palestinian Refugee Camps; https://clinicaltrials.gov; NCT02402556.",2020,Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention.,"['106 mother-child dyads', 'Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon', 'Forty families (38%) withdrew early from the study']","['wait-list control group', 'Mother-Child Education Program', 'MOCEP', 'group-based intervention, the Mother-Child Education Program (MOCEP']","['reduction in their harsh parenting', 'Disciplinary Style Questionnaire', 'behavioral and emotional status']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023190', 'cui_str': 'Lebanese Republic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",106.0,0.128697,Exploratory but underpowered analyses of dyadic interactions revealed reductions in the PSI were associated with a reduction in harsh parenting after the intervention.,"[{'ForeName': 'Liliana A', 'Initials': 'LA', 'LastName': 'Ponguta', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, CT. Electronic address: angelica.ponguta@yale.edu.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Issa', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aoudeh', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Cosette', 'Initials': 'C', 'LastName': 'Maalouf', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sascha D', 'Initials': 'SD', 'LastName': 'Hein', 'Affiliation': 'Dr. Hein is with Freie Universität Berlin, Germany.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Zonderman', 'Affiliation': 'Ms. Zonderman is with the Section of Hospital Medicine, Biological Sciences Division, The University of Chicago, IL.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Katsovich', 'Affiliation': 'Dr. Khoshnood and Ms. Katsovich are with the School of Public Health, Yale University, New Haven, CT.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Khoshnood', 'Affiliation': 'Dr. Khoshnood and Ms. Katsovich are with the School of Public Health, Yale University, New Haven, CT.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bick', 'Affiliation': 'Dr. Bick is with The University of Houston, TX.'}, {'ForeName': 'Abir', 'Initials': 'A', 'LastName': 'Awar', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Nourallah', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Householder', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Moore', 'Affiliation': 'Ms. Moore is with the University of Delaware, Newark.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Salah', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Pia R', 'Initials': 'PR', 'LastName': 'Britto', 'Affiliation': 'Dr. Britto is with UNICEF, New York, NY.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, CT.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.010']
1942,32006484,Baseline Characteristics of Participants in the Treatment of Advanced Glaucoma Study: A Multicenter Randomized Controlled Trial.,"PURPOSE


To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study).
DESIGN


Pragmatic randomized control trial (RCT).
METHODS


Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI).
RESULTS


A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA ""severe"" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3.
CONCLUSIONS


TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.",2020,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","['Four hundred and fifty-three patients were recruited', 'patients presenting with advanced open angle glaucoma in a publicly funded health service', 'Participants with newly diagnosed advanced glaucoma in at least one eye were recruited', 'participants in the Treatment of Advanced Glaucoma Study (TAGS', 'participants enrolled in the Treatment of Advanced Glaucoma Study (TAGS) DESIGN', 'Patients with open angle glaucoma presenting with advanced glaucoma in at least one eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria of severe defect']","['primary augmented trabeculectomy or primary medical management', 'TAGS']","['severe visual field mean deviation (MD', 'mean LogMAR visual acuity of the index eye', 'mean visual field MD', 'Visual field profile defined by the HPA classification, clinical characteristics, Quality of life measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3) and Glaucoma Profile Instrument (GPI']","[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",453.0,0.352301,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Nottingham University Hospital, Nottingham, United Kingdom. Electronic address: anthony.king@nottingham.ac.uk.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fernie', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burr', 'Affiliation': 'University of St. Andrews, St. Andrews, Fife, United Kingdom.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Sparrow', 'Affiliation': 'University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Kernohan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.01.026']
1943,31322039,The effect of literacy and culture on cognitive effort test performance: An examination of the Test of Memory Malingering in Colombia.,"Introduction : Cognitive efforts tests, such as the Test of Memory Malingering (TOMM), are widely used internationally, yet emerging research suggests that performance on the TOMM can be affected by culture and education. This study examined the specificity of the TOMM and performance differences among Colombian adults, contrasting those with varying levels of literacy in order to evaluate the impact of these variables on error rates. It was hypothesized that literacy would be positively correlated with TOMM scores.  Method : The sample consisted of 256 participants: the  Absolute Illiterate  participants had no formal education and no ability to read or write ( n =  58),  Functional Illiterate  participants had no formal education and only basic reading and writing skills ( n =  66),  Literate  participants had up to 12-years of education ( n =  66), and  Highly Literate  participants had some post-secondary education ( n =  66). Group differences for Trial 1 (T1) and Trial 2 (T2) were analyzed using ANOVAs and chi-square tests, along with post-hoc comparisons.  Results : Mean T2 scores for the four groups were all above the suggested cutoff score of 45: the  Highly Literate  group had the highest mean score (49.3, range 41 to 50), and the  Absolute Illiterate  group had the lowest mean score (45.5, range 30 to 50). The  Absolute  and  Functional Illiterate  groups performed significantly worse on the TOMM trials than the literate participants. Cognitive performance as measured by indicators of verbal fluency and executive control significantly correlated with TOMM performance. However, when evaluated together in hierarchical logistic regressions, only age and literacy significantly predicted TOMM scores.  Conclusions : Although the performance of Colombian adults suggests that the TOMM can be used cross-culturally with literate individuals, Colombian adults with poorer literacy skills performed significantly worse, raising concerns regarding the use of this measure with educationally-diverse samples. Research and clinical implications are discussed.",2019,"Mean T2 scores for the four groups were all above the suggested cutoff score of 45: the  Highly Literate  group had the highest mean score (49.3, range 41 to 50), and the  Absolute Illiterate  group had the lowest mean score (45.5, range 30 to 50).","['Colombian adults', '256 participants: the', 'Colombia']","['Absolute Illiterate  participants had no formal education and no ability to read or write ( n =\xa0 58),  Functional Illiterate  participants had no formal education and only basic reading and writing skills ( n =\xa0 66),  Literate  participants had up to 12-years of education ( n =\xa0 66), and  Highly Literate  participants had some post-secondary education', 'TOMM']","['TOMM scores', 'Mean T2 scores', 'Cognitive performance', 'TOMM performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0557286', 'cui_str': 'No formal education (finding)'}, {'cui': 'C0586739', 'cui_str': 'Ability to read (observable entity)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",256.0,0.038443,"Mean T2 scores for the four groups were all above the suggested cutoff score of 45: the  Highly Literate  group had the highest mean score (49.3, range 41 to 50), and the  Absolute Illiterate  group had the lowest mean score (45.5, range 30 to 50).","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Nijdam-Jones', 'Affiliation': 'Department of Psychology, Fordham University , Bronx , NY , USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Rivera', 'Affiliation': 'Biocruces Bizkaia Health Research Institute , Barakaldo , Spain.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rosenfeld', 'Affiliation': 'Department of Psychology, Fordham University , Bronx , NY , USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Arango-Lasprilla', 'Affiliation': 'Biocruces Bizkaia Health Research Institute , Barakaldo , Spain.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1644294']
1944,32139486,Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial.,"INTRODUCTION


Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive-behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.
METHODS AND ANALYSIS


This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.
ETHICS AND DISSEMINATION


This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.
TRIAL REGISTRATION NUMBER


ChiCTR1900023473; Pre-results.",2020,Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group.,"['Eligible patients', '152 participants']","['acupuncture', 'Acupuncture', 'treatment group (acupuncture) and the control group (placebo acupuncture', 'placebo acupuncture', 'normal sleep duration group and insomnia with short sleep duration group']","['actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale', 'efficacy and safety', 'Pittsburgh Sleep Quality Index and the Insomnia Severity Index', 'objective total sleep time: insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",152.0,0.14388,Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen-Jia', 'Initials': 'WJ', 'LastName': 'Yang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xin-Tong', 'Initials': 'XT', 'LastName': 'Yu', 'Affiliation': 'Laboratory Center of Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jin-Jin', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wen-Lin', 'Initials': 'WL', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yi-Xin', 'Initials': 'YX', 'LastName': 'Zheng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China icyf1968@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-033731']
1945,31994918,Examining the Relationships between Cumulative Childhood Adversity and the Risk of Criminal Justice Involvement and Victimization among Homeless Adults with Mental Illnesses after Receiving Housing First Intervention.,"OBJECTIVES


Exposure to adverse childhood experiences (ACEs) is associated with increased risk of criminal justice involvement and repeated victimization among homeless individuals. This study aimed to (1) examine whether the relationship between cumulative ACE score and odds of experiencing criminal justice involvement and victimization remains significant over time after receiving the Housing First (HF) intervention and (2) investigate the moderating effect of cumulative ACE score on the effectiveness of the HF intervention on the likelihood of experiencing these outcomes among homeless individuals with mental illnesses.
METHODS


We used longitudinal data over the 2-year follow-up period from the At Home/ Chez Soi  demonstration project that provided HF versus treatment as usual (TAU) to homeless adults with mental illness in five Canadian cities (N = 1,888).
RESULTS


In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors. However, cumulative ACE score did not moderate intervention effects on odds of experiencing either outcome, suggesting that the effectiveness of HF versus TAU, with regard to the odds of being victimized or criminal justice involvement, did not differ by cumulative ACE scores over the course of study.
CONCLUSIONS


Findings suggest that providing services for homeless individuals with mental illness should be trauma informed and include specialized treatment strategies targeting the experience of ACEs and trauma to improve their treatment outcomes. An intensive approach is required to directly address the problem of criminal justice involvement and victimization in these individuals.",2020,"In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors.","['homeless adults with mental illness in five Canadian cities (N = 1,888', 'homeless individuals with mental illnesses', 'Homeless Adults with Mental Illnesses after Receiving Housing First Intervention', 'homeless individuals', 'homeless individuals with mental illness']","['HF versus treatment as usual (TAU', 'Housing First (HF) intervention', 'HF intervention']","['cumulative ACE scores', 'cumulative ACE score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1888.0,0.0419138,"In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors.","[{'ForeName': 'Hanie', 'Initials': 'H', 'LastName': 'Edalati', 'Affiliation': 'Department of Psychiatry, University of Montreal, Quebec, Canada.'}, {'ForeName': 'Tonia L', 'Initials': 'TL', 'LastName': 'Nicholls', 'Affiliation': 'British Columbia Mental Health and Substance Use Services, Provincial Health Services Authority, Vancouver, Canada.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Schütz', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': 'Faculty of Health Sciences, Somers Research Group, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Jino', 'Initials': 'J', 'LastName': 'Distasio', 'Affiliation': 'Institute of Urban Studies, University of Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Aubry', 'Affiliation': 'School of Psychology, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Department of Psychiatry, University of Montreal, Quebec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720902616']
1946,31995262,Family-based treatment for adolescent anorexia nervosa: What happens to rates of comorbid diagnoses?,"OBJECTIVE


Rates of psychiatric comorbidity are elevated in adolescents with anorexia nervosa, but little is known about how psychiatric comorbidity changes following family-based treatment (FBT).
METHODS


Adolescents with anorexia nervosa (N = 107) enrolled in a randomized controlled trial comparing two forms of FBT completed the Mini International Neuropsychiatric Interview for Children and Adolescents at baseline and end of treatment. Analyses tested whether baseline comorbid diagnoses predicted the presence of comorbid diagnoses at end of treatment and if baseline eating disorder psychopathology impacted this association.
RESULTS


Rates of comorbid diagnoses decreased from 54% at baseline to 26% at end of treatment. Logistic regression analyses indicated that individuals with multiple comorbid diagnoses at baseline were more likely to meet criteria for a comorbid condition at end of treatment (b = 2.00, p < .05). Individuals with reported psychotropic medication use were less likely to meet criteria for a comorbid condition at end of treatment (b = -1.63, p = .04). Diagnostic rates for major depressive disorder, generalized anxiety disorder, and panic disorder/agoraphobia decreased following FBT.
CONCLUSIONS


Findings suggest that FBT for adolescent anorexia nervosa may aid in the resolution of some co-occurring psychiatric diagnoses. Continued research is needed to understand factors contributing to comorbid symptom improvement throughout treatment.",2020,"Diagnostic rates for major depressive disorder, generalized anxiety disorder, and panic disorder/agoraphobia decreased following FBT.
","['adolescent anorexia nervosa', 'Adolescents with anorexia nervosa (N = 107', 'adolescents with anorexia nervosa']","['FBT', 'FBT completed the Mini International Neuropsychiatric Interview']","['Diagnostic rates', 'Rates of comorbid diagnoses', 'generalized anxiety disorder, and panic disorder/agoraphobia']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}]",107.0,0.102058,"Diagnostic rates for major depressive disorder, generalized anxiety disorder, and panic disorder/agoraphobia decreased following FBT.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Trainor', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Gorrell', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Hughes', 'Affiliation': ""The University of Melbourne, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sawyer', 'Affiliation': ""The University of Melbourne, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Burton', 'Affiliation': ""The University of Melbourne, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le  Grange', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2725']
1947,32199006,Minute ventilation stabilization during all pressure-control / support mechanical ventilation modes.,"The main goal of our prospective randomized study was comparing compare the effectiveness of ventilation control method ""Automatic proportional minute ventilation (APMV) ""versus manually set pressure control ventilation modes in relationship to lung mechanics and gas exchange. 80 patients undergoing coronary artery bypass grafting (CABG) were randomized into 2 groups. 40 patients in the first group No.1 (APMV group) were ventilated with pressure control (PCV) or pressure support ventilation (PSV) mode with APMV control. The other 40 patients (control group No.2) were ventilated with synchronized intermittent mandatory ventilation (SIMV-p) or pressure control modes (PCV) without APMV. Ventilation control with APMV was able to maintain minute ventilation more precisely in comparison with manual control (p<0.01), similarly deviations of ETCO(2) were significantly lower (p<0.01). The number of manual corrections of ventilation settings was significantly lower when APMV was used (p<0.01). The differences in lung mechanics and hemodynamics were not statistically significant. Ventilation using APMV is more precise in maintaining minute ventilation and gas exchange compared with manual settings. It required less staff intervention, while respiratory system mechanics and hemodynamics are comparable. APMV showed as effective and safe method applicable on top of all pressure control ventilation modes.",2020,The number of manual corrections of ventilation settings was significantly lower when APMV was used (p<0.01).,"['40 patients in the first group No.1 (APMV group) were', '80 patients undergoing', '40 patients (control group No.2) were ventilated with']","['APMV', 'synchronized intermittent mandatory ventilation (SIMV-p) or pressure control modes (PCV) without APMV', 'ventilated with pressure control (PCV) or pressure support ventilation (PSV) mode with APMV control', 'coronary artery bypass grafting (CABG', 'ventilation control method ""Automatic proportional minute ventilation (APMV) ""versus manually set pressure control ventilation modes']","['lung mechanics and hemodynamics', 'Minute ventilation stabilization', 'number of manual corrections of ventilation settings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0278335', 'cui_str': 'Synchronized intermittent mandatory ventilation (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]",80.0,0.0194448,The number of manual corrections of ventilation settings was significantly lower when APMV was used (p<0.01).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Candík', 'Affiliation': 'Department of Human Physiology, Faculty of Medicine, Safarik University, Kosice, Slovak Republic. viliam.donic@upjs.sk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Depta', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Imrecze', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sabol', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kolesar', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jankajova', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paulíny', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benova', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Galková', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Donic', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Török', 'Affiliation': ''}]",Physiological research,[]
1948,32186122,Effect of the medication injection site on treatment efficacy in pediatric cerebral palsy: conventional sites vs acupoints.,"OBJECTIVE


To analyze treatment effectiveness in terms of the medication injection site.
METHODS


The medical records of 423 patients with cerebral palsy who were admitted to Maternal and Child Health Hospital between January 2009 and December 2016 were collected. All cases were divided into T1, T2, T3, and T4 groups based on the use of conventional medication sites and acupoints for administering injectable medicines.
RESULTS


In the T1 group, patients received injections at conventional medication sites between 2009 and 2010. In the T2 group, patients received injections at conventional medication sites combined with acupoint injection therapy I from 2011 to 2012. In the T3 group, injection at conventional medication sites plus acupoint injection II was applied between 2013 and 2014. Acupoint injection only was used in the T4 group from 2015 to 2016. Therapeutic effects were statistically compared among the different injection procedures. The overall Gross Motor Function Measure (GMFM) and Fine Motor Function Measure (FMFM) scores were significantly improved after hospital discharge. The GMFM score was considerably higher in the T4 group than in the other groups (all P = 0.001 < 0.05). The GMFM scores were significantly higher in the T2 groups than in the T1 group (P = 0.001< 0.05), but no significant difference was observed between the other paired comparions (P > 0.05). Meanwhile, the FMFM scores were significantly higher in the T2 and T4 groups than in the T1 and T3 groups (all P = 0.001 < 0.05).Site injection therapy can significantly improve gross and fine motor function in children with cerebral palsy.
CONCLUSION


It is feasible to administer injectable medicines at acupoints instead of convention sites to enhance the therapeutic effect of treatment in patients with cerebral palsy.",2019,The overall Gross Motor Function Measure (GMFM) and Fine Motor Function Measure (FMFM) scores were significantly improved after hospital discharge.,"['patients with cerebral palsy', 'children with cerebral palsy', '423 patients with cerebral palsy who were admitted to Maternal and Child Health Hospital between January 2009 and December 2016 were collected', 'pediatric cerebral palsy']","['conventional medication sites and acupoints for administering injectable medicines', 'Acupoint injection', 'medication injection site', 'acupoint injection therapy']","['Therapeutic effects', 'FMFM scores', 'overall Gross Motor Function Measure (GMFM) and Fine Motor Function Measure (FMFM) scores', 'GMFM score', 'GMFM scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1527144'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions (observable entity)'}]",423.0,0.0168295,The overall Gross Motor Function Measure (GMFM) and Fine Motor Function Measure (FMFM) scores were significantly improved after hospital discharge.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Teaching Office, School of Rehabilitation Medicine, Henan University of Chinese Medicine, Zhengzhou 450058, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Children's Rehabilitation, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.""}, {'ForeName': 'Chengyan', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Prescription Traching and Research Section, Institute of Literature in Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing 210046, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
1949,31739856,Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea.,"STUDY OBJECTIVES


Comparable health effects of mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy have been attributed to higher adherence with MAD compared with CPAP therapy. The objective of this study was to make a direct comparison of the objective adherence between MAD and CPAP in patients with moderate obstructive sleep apnea (OSA).
METHODS


Adherence was monitored for 12 months in 59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h) as part of a randomized controlled trial. Objective adherence with MAD was assessed using the TheraMon microsensor. Objective adherence with CPAP was assessed using the built-in registration software with readout on SD card. Self-reported adherence with both therapies was assessed using a questionnaire.
RESULTS


Forty patients (68%) completed the study with the therapy to which they were randomly assigned. Median (interquartile range) objective adherence (h/night) in the 3rd month was 7.4 (5.2-8.2) for MAD and 6.8 (5.7-7.6) for CPAP (P = .41), compared to 6.9 (3.5-7.9) with MAD and 6.8 (5.2-7.6) with CPAP (P = .85) in the 12th month. There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46). Changes in adherence were not significantly different between MAD and CPAP (P = .51). Self-reported adherence was significantly higher with MAD than CPAP at all follow-ups. Self-reported adherence with CPAP was lower than objective CPAP adherence at the 6th and 12th month (P = .02).
CONCLUSIONS


Objective adherence with MAD and CPAP is comparable and consistent over time. Self-reported adherence is higher with MAD than with CPAP giving rise to interesting discrepancy between objective and self-reported adherence with CPAP.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01588275.",2019,There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46).,"['patients with moderate obstructive sleep apnea (OSA', 'Patients With Moderate Obstructive Sleep Apnea', '59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h', 'Forty patients (68%) completed the study with the therapy to which they were randomly assigned']","['Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure', 'mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy', 'CPAP therapy', 'MAD and CPAP']","['Objective adherence with MAD', 'Median (interquartile range) objective adherence', 'CPAP', 'Self-reported adherence', 'objective CPAP adherence', 'Objective adherence with CPAP', 'Changes in adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C1504335', 'cui_str': 'Device therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0671759', 'cui_str': 'MAD'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",40.0,0.0685954,There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46).,"[{'ForeName': 'Grietje E', 'Initials': 'GE', 'LastName': 'de Vries', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aarnoud', 'Initials': 'A', 'LastName': 'Hoekema', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johannes Q P J', 'Initials': 'JQPJ', 'LastName': 'Claessen', 'Affiliation': 'Department of Ear, Nose and Throat Surgery, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Stellingsma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Stegenga', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8034']
1950,32176862,"The Effect of Exercise Training on Total Daily Energy Expenditure and Body Composition in Weight-Stable Adults: A Randomized, Controlled Trial.","BACKGROUND


The present study examined, among weight-stable overweight or obese adults, the effect of increasing doses of exercise energy expenditure (EEex) on changes in total daily energy expenditure (TDEE), total body energy stores, and body composition.
METHODS


Healthy, sedentary overweight/obese young adults were randomized to one of 3 groups for a period of 26 weeks: moderate-exercise (EEex goal of 17.5 kcal/kg/wk), high-exercise (EEex goal of 35 kcal/kg/wk), or observation group. Individuals maintained body weight within 3% of baseline. Pre/postphysical activity between-group measurements included body composition, calculated energy intake, TDEE, energy stores, and resting metabolic rate.
RESULTS


Sixty weight-stable individuals completed the protocols. Exercise groups increased EEex in a stepwise manner compared with the observation group (P < .001). There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate. Fat mass and energy stores decreased among the females in the high-exercise group (P = .007).
CONCLUSIONS


The increase in EEex did not result in an equivalent increase in TDEE. There was a sex difference in the relationship among energy balance components. These results suggest a weight-independent compensatory response to exercise training with potentially a sex-specific adjustment in body composition.",2020,"There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate.","['Healthy, sedentary overweight/obese young adults', 'Weight-Stable Adults', 'Sixty weight-stable individuals completed the protocols', 'weight-stable overweight or obese adults']","['Exercise Training', 'exercise energy expenditure (EEex', 'moderate-exercise (EEex goal of 17.5\xa0kcal/kg/wk), high-exercise (EEex goal of 35\xa0kcal/kg/wk), or observation group']","['Pre/postphysical activity', 'body composition, calculated energy intake, TDEE, energy stores, and resting metabolic rate', 'total daily energy expenditure (TDEE), total body energy stores, and body composition', 'EEex', 'changes in TDEE, energy intake, fat-free mass, or resting metabolic rate', 'Individuals maintained body weight', 'Fat mass and energy stores', 'TDEE', 'Total Daily Energy Expenditure and Body Composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0733661,"There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Hand', 'Affiliation': ''}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Shook', 'Affiliation': ''}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Kindred', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Drenowatz', 'Affiliation': ''}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Paluch', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': ''}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0415']
1951,32186014,Effect of Jiawei Shenfu decoction on tumor necrosis factor-alpha and nuclear factor-kappa B in patients who have chronic heart failure with syndromes of deficiency of heart Yang.,"OBJECTIVE


To examine the clinical efficacy of Jiawei Shenfu decoction on tumor necrosis factor-al- pha (TNF-α) and nuclear factor-kappa B (NF-κB) levels in patients who have chronic heart failure with syndromes of deficiency of heart Yang.
METHODS


A total of 63 patients with syndromes of deficiency of heart Yang (chronic heart failure) were enrolled. Patients were randomly divided into the control group and Jiawei Shenfu group. All patients received standard medications for treatment of chronic heart failure. Patients in the Jiawei Shenfu group were additionally provided Jiawei Shenfu decoction one dose daily. Treatments continued for 4 consecutive weeks. The primary endpoint was the change in plasma B-type natriuretic peptide (BNP), NF-κB, and TNF-α levels during 4 weeks of treatment.
RESULTS


At the 4-week follow-up, a significant reduction in BNP levels compared with baseline was observed in both groups, but the Jiawei Shenfu decoction group showed a significantly greater reduction than did the control group. The Jiawei Shenfu group also showed superior performance regarding the Minnesota Living with Heart Failure Questionnaire score, the Chinese medicine syndrome score, heart rate, left ventricular ejection fraction, and 6-min walking distance compared with the control group. The degree of changes in NF-κB and TNF-α levels in the Jiawei Shenfu group was more significant than that in the control group.
CONCLUSION


Routine medicine combined with Jiawei Shenfu decoction for patients with heart Yang deficiency syndrome in chronic heart failure can improve the left ventricular ejection fraction and cardiac function, and reduce BNP levels. The mechanism may be related to inhibition of pro-inflamma- tory cytokines and the NF-κB-induced kinase pathway, leading to amelioration of the inflammatory response.",2019,"The degree of changes in NF-κB and TNF-α levels in the Jiawei Shenfu group was more significant than that in the control group.
","['63 patients with syndromes of deficiency of heart Yang (chronic heart failure', 'patients who have chronic heart failure with syndromes of deficiency of heart Yang', 'patients with heart Yang deficiency syndrome in chronic heart failure']","['control group and Jiawei Shenfu group', 'standard medications', 'Routine medicine combined with Jiawei Shenfu decoction', 'Jiawei Shenfu decoction']","['Minnesota Living with Heart Failure Questionnaire score, the Chinese medicine syndrome score, heart rate, left ventricular ejection fraction, and 6-min walking distance', 'tumor necrosis factor-al- pha (TNF-α) and nuclear factor-kappa B (NF-κB) levels', 'BNP levels', 'tumor necrosis factor-alpha and nuclear factor-kappa B', 'change in plasma B-type natriuretic peptide (BNP), NF-κB, and TNF-α levels', 'NF-κB and TNF-α levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0085258', 'cui_str': 'Yang Xu'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1528398', 'cui_str': 'Shen-Fu'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079904', 'cui_str': 'Nuclear Factor-Kappab'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",63.0,0.0184632,"The degree of changes in NF-κB and TNF-α levels in the Jiawei Shenfu group was more significant than that in the control group.
","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Shaoxing Traditional Chinese Medicine Hospital, The Affiliated Shaoxing Hospital of Zhejiang Chinese Medical University, Shaoxing 312000, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, Shaoxing Traditional Chinese Medicine Hospital, The Affiliated Shaoxing Hospital of Zhejiang Chinese Medical University, Shaoxing 312000, China.'}, {'ForeName': 'Jiaping', 'Initials': 'J', 'LastName': 'Bian', 'Affiliation': 'Department of Cardiology, Shaoxing Traditional Chinese Medicine Hospital, The Affiliated Shaoxing Hospital of Zhejiang Chinese Medical University, Shaoxing 312000, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Shaoxing Traditional Chinese Medicine Hospital, The Affiliated Shaoxing Hospital of Zhejiang Chinese Medical University, Shaoxing 312000, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, Shaoxing Traditional Chinese Medicine Hospital, The Affiliated Shaoxing Hospital of Zhejiang Chinese Medical University, Shaoxing 312000, China.'}, {'ForeName': 'Hangyuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Shaoxing People's Hospital, Shaoxing Hospital, Zhejiang University School of Medicine, Shaoxing 312000, China.""}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
1952,32122177,"Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration.","Importance:  Consumers have reported skin rash/irritation and hair loss/breakage with Wen by Chaz Dean Sweet Almond Mint Cleansing Conditioner (WCDSAMCC), however epidemiologic, toxicologic and clinical hair loss studies have not provided an explanation. Contact dermatitis has been hypothesized. Objective:  To assess the tolerability of six products: WCDSAMCC, three other hair cleansing conditioners, and two controls [salicylic acid shampoo (SAS) and baby shampoo (BS)]. Design:  Double-blind, randomized, controlled trial. Setting:  Single-site study. Population:  General population volunteers. Intervention:  Standard semi-open patch tests (SOPTs) and duration-escalation repeat open application tests (ROATs) over 5 weeks. Main Outcome Measures:  Primary outcome measure was ""stopping point"" [ROAT total component score ≥6 (maximum 10) or global ≥4 (maximum 5)]. Secondary outcomes included ""any reaction"" (ROAT component score ≥1) and SOPT ≥ doubtful. Results:  Two hundred of 298 volunteers were enrolled. There were no significant differences in the tolerability of WCDSAMCC and any of the other three hair cleansing conditioners as assessed by SOPT or ROAT. WCDSAMCC was significantly better tolerated than SAS (""stopping point"", or ""any reaction"",  p  values<0.0001) as well as BS ( p  = 0.01). The frequency of doubtful SOPT reactions was lowest for WCD (2.2%) and highest for SAS (7.1%,  p  = 0.04). Conclusions:  As assessed by both ROAT and SOPTs, WCDSAMCC was similar in tolerability to three other hair cleansing conditioners and significantly better tolerated than both controls (SAS and BS). Summary:  This double-blind, randomized, controlled study found that WCDSAMCC was similar in tolerability to three other HCCs and was significantly better tolerated than both SAS and BS. This study provides critical clinical evidence on the comparative lack of cutaneous effects with use of WCDSAMCC. Trial Registration:  NCT03483025 ClinicalTrials.gov.",2020,There were no significant differences in the tolerability of WCDSAMCC and any of the other three hair cleansing conditioners as assessed by SOPT or ROAT.,"['Population:  General population volunteers', 'Two hundred of 298 volunteers were enrolled']","['WCDSAMCC', 'Intervention:  Standard semi-open patch tests (SOPTs) and duration-escalation repeat open application tests (ROATs', 'hair cleansing conditioners']","['tolerated', 'SOPT or ROAT', 'stopping point"" [ROAT total component score ≥6 (maximum 10) or global ≥4 (maximum 5', 'tolerability of WCDSAMCC', 'any reaction"" (ROAT component score ≥1) and SOPT\u2009≥\u2009doubtful', 'Tolerability', 'controls [salicylic acid shampoo (SAS) and baby shampoo (BS', 'frequency of doubtful SOPT reactions']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0430576', 'cui_str': 'Open patch test (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036080', 'cui_str': 'Salicylic Acids'}, {'cui': 'C1554936', 'cui_str': 'Shampoo - dosing instruction imperative'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",298.0,0.484916,There were no significant differences in the tolerability of WCDSAMCC and any of the other three hair cleansing conditioners as assessed by SOPT or ROAT.,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Warshaw', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Schlarbaum', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}, {'ForeName': 'Yujie L', 'Initials': 'YL', 'LastName': 'Liou', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Kimyon', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Zhang', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Nikle', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Monnot', 'Affiliation': 'Cardno ChemRisk, San Francisco, CA, USA.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hylwa', 'Affiliation': 'Park Nicollet Contact Dermatitis Clinic, Minneapolis, MN, USA.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2020.1722154']
1953,32152202,Outcome-Related Signatures Identified by Whole Transcriptome Sequencing of Resectable Stage III/IV Melanoma Evaluated after Starting Hu14.18-IL2.,"PURPOSE


We analyzed whole transcriptome sequencing in tumors from 23 patients with stage III or IV melanoma from a pilot trial of the anti-GD2 immunocytokine, hu14.18-IL2, to identify predictive immune and/or tumor biomarkers in patients with melanoma at high risk for recurrence.
EXPERIMENTAL DESIGN


Patients were randomly assigned to receive the first of three monthly courses of hu14.18-IL2 immunotherapy either before (Group A) or after (Group B) complete surgical resection of all known diseases. Tumors were evaluated by histology and whole transcriptome sequencing.
RESULTS


Tumor-infiltrating lymphocyte (TIL) levels directly associated with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed. TIL levels directly associated with a previously reported immune signature, which associated with RFS and OS, particularly in Group A tumors. In Group A tumors, there were decreased cell-cycling gene RNA transcripts, but increased RNA transcripts for repair and growth genes. We found that outcome (RFS and OS) was directly associated with several immune signatures and immune-related RNA transcripts and inversely associated with several tumor growth-associated transcripts, particularly in Group A tumors. Most of these associations were not seen in Group B tumors.
CONCLUSIONS


We interpret these data to signify that both immunologic and tumoral cell processes, as measured by RNA-sequencing analyses detected shortly after initiation of hu14.18-IL2 therapy, are associated with long-term survival and could potentially be used as prognostic biomarkers in tumor resection specimens obtained after initiating neoadjuvant immunotherapy.",2020,"RESULTS


Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed.","['23 patients with stage III or IV melanoma', 'Patients', 'melanoma patients at high risk for recurrence']",['hu14.18-IL2 immunotherapy either before (Group A) or after (Group B) complete surgical resection of all known disease'],"['Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS', 'cell cycling gene RNA transcripts', 'Outcome-related signatures identified by Whole Transcriptome Sequencing of Resectable Stage III', 'RNA transcripts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C1529682', 'cui_str': 'EMD 273063'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0079722', 'cui_str': 'Lymphocytes, Tumor-Infiltrating'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]",23.0,0.0462348,"RESULTS


Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed.","[{'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Igor B', 'Initials': 'IB', 'LastName': 'Kuznetsov', 'Affiliation': 'Cancer Research Center and Department of Epidemiology and Biostatistics, University at Albany, Rensselaer, New York.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jun S', 'Initials': 'JS', 'LastName': 'Wei', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Sivasish', 'Initials': 'S', 'LastName': 'Sindiri', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Berkley E', 'Initials': 'BE', 'LastName': 'Gryder', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Vineela', 'Initials': 'V', 'LastName': 'Gangalapudi', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Viharkumar', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Zuleger', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Erbe', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Morris', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Quale', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Albertini', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland. pmsondel@humonc.wisc.edu khanjav@mail.nih.gov.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin. pmsondel@humonc.wisc.edu khanjav@mail.nih.gov.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3294']
1954,32154636,The European Medicines Agency Review of Gilteritinib (Xospata) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation.,"On October 24, 2019, a marketing authorization valid through the European Union (EU) was issued for gilteritinib monotherapy for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation. Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD. The recommended starting dose of gilteritinib is 120 mg (three 40 mg tablets) once daily. Gilteritinib was evaluated in one, phase III, open-label, multicenter, randomized study of gilteritinib (n = 247, gilteritinib arm) versus salvage chemotherapy (n = 124, salvage chemotherapy arm) in patients with relapsed or refractory AML with FLT3 mutation. Overall survival (OS) was statistically significantly different between the two groups with a median OS of 9.3 months in the gilteritinib arm compared with 5.6 months for salvage chemotherapy (hazard ratio, 0.637; 95% confidence interval, 0.490-0.830; p = .0004 one-sided log-rank test). The most common adverse reactions with gilteritinib treatment were blood creatine phosphokinase increase, alanine aminotransferase increase, aspartate aminotransferase increase, blood alkaline phosphatase increase, diarrhea, fatigue, nausea, constipation, cough, peripheral edema, dyspnea, dizziness, hypotension, pain in extremity, asthenia, arthralgia, and myalgia. The objective of this article is to summarize the scientific review of the application leading to regulatory approval in the EU. IMPLICATIONS FOR PRACTICE: Xospata was approved in the European Union as monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation. Gilteritinib resulted in a clinically meaningful and statistically significant improvement of overall survival compared with salvage chemotherapy. At the time of the marketing authorization of gilteritinib, there were no approved standard therapies specifically for adult patients diagnosed with relapsed or refractory AML with FLT3 mutation. In terms of safety, the overall accepted safety profile was considered manageable.",2020,"Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD.","['adult patients with relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation', 'adult patients diagnosed with relapsed or refractory AML with FLT3 mutation', 'Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an FLT3 Mutation', 'adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an Fms-like tyrosine kinase 3 (FLT3) mutation', 'patients with relapsed or refractory AML with FLT3 mutation']","['salvage chemotherapy', 'gilteritinib']","['overall survival', 'blood creatine phosphokinase increase, alanine aminotransferase increase, aspartate aminotransferase increase, blood alkaline phosphatase increase, diarrhea, fatigue, nausea, constipation, cough, peripheral edema, dyspnea, dizziness, hypotension, pain in extremity, asthenia, arthralgia, and myalgia', 'Overall survival (OS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0287186', 'cui_str': 'fms-Like Tyrosine Kinase 3'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3896940', 'cui_str': 'gilteritinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0853034', 'cui_str': 'Blood creatine phosphokinase increased'}, {'cui': 'C0151905', 'cui_str': 'SGPT increased'}, {'cui': 'C0151904', 'cui_str': 'Serum glutamic-oxaloacetic transaminase increased'}, {'cui': 'C0852911', 'cui_str': 'Blood alkaline phosphatase increased'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb (finding)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",,0.100296,"Gilteritinib inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3 internal tandem duplication (ITD), FLT3 D835Y, and FLT3 ITD D835Y, and it induced apoptosis in leukemic cells expressing FLT3 ITD.","[{'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Tzogani', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Røshol', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Helga Haugom', 'Initials': 'HH', 'LastName': 'Olsen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Ida B', 'Initials': 'IB', 'LastName': 'Aas', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Marianne Løiten', 'Initials': 'ML', 'LastName': 'Dalhus', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Gro Dahlseng', 'Initials': 'GD', 'LastName': 'Håkonsen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Laila Sortvik', 'Initials': 'LS', 'LastName': 'Nilssen', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Lindberg', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Økvist', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Bjørg', 'Initials': 'B', 'LastName': 'Bolstad', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Irēna', 'Initials': 'I', 'LastName': 'Rogovska', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Natalja', 'Initials': 'N', 'LastName': 'Karpova', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Enzmann', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gisselbrecht', 'Affiliation': 'Hospital Saint Louis, Paris, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0976']
1955,31345049,The effect of breastfeeding training on exclusive breastfeeding: a randomized controlled trial.,"Introduction:  Although exclusive breastfeeding is very beneficial for children's and mothers' health, a limited number of infants are exclusively breastfed for 6 months.  Aim:  This randomized controlled intervention study aims to determine the effect of breastfeeding training on mothers' knowledge, behaviors, and exclusive breastfeeding for 6 months.  Materials and methods:  The participants were selected randomly for training ( n  = 60) and control groups ( n  = 60) among the pregnant women admitted to the obstetrics and gynecology polyclinics of a baby-friendly hospital. The training group received breastfeeding training during the prenatal and postnatal periods. The data were collected using a questionnaire during admission and at the postpartum 1st and 24th weeks through face-to-face interviews. The study was completed with 34 and 30 mother-infant pairs in the training and control groups, respectively. Analyzed using the chi-square, Student  t,  Mann-Whitney  U , and Wilcoxon  t -tests.  Results:  The difference between the number of correct answers in pre- and posttest was higher in the training group (four questions) than in the control group (two questions) ( p  < .001). The number of mothers exclusively breastfeeding for 6 months was significantly higher in the training group (26.5%) than in the control group (3.3%) ( p  = .015). The median of the exclusive breastfeeding period was longer in the training group (5 months) than in the control group (4 months) ( p  = .013).  Conclusion:  Training and supporting pregnant women and breastfeeding mothers on breastfeeding increased their knowledge, the period of exclusive breastfeeding, and the rate of 6-month exclusive breastfeeding.",2019,The difference between the number of correct answers in pre- and posttest was higher in the training group (four questions) than in the control group (two questions) ( p  < .001).,"[""mothers' knowledge, behaviors, and exclusive breastfeeding for 6\u2009months"", 'pregnant women and breastfeeding mothers on breastfeeding', 'pregnant women admitted to the obstetrics and gynecology polyclinics of a baby-friendly hospital']",['breastfeeding training'],"['median of the exclusive breastfeeding period', 'number of mothers exclusively breastfeeding']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]",,0.0324425,The difference between the number of correct answers in pre- and posttest was higher in the training group (four questions) than in the control group (two questions) ( p  < .001).,"[{'ForeName': 'Müge', 'Initials': 'M', 'LastName': 'Yılmaz', 'Affiliation': 'a Department of Nutrition and Dietetics, Faculty of Health Science, Erciyes University , Kayseri , Turkey.'}, {'ForeName': 'Mualla', 'Initials': 'M', 'LastName': 'Aykut', 'Affiliation': 'b Department of Public Health, Erciyes University, Faculty of Medicine , Kayseri , Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1622672']
1956,32186160,"Acupuncture treatment of lung-spleen Qi deficiency in stable chronic obstructive pulmonary disease: a randomized, open-label, controlled trial.","OBJECTIVE


To evaluate the effectiveness and safety of acupuncture that reinforces the spleen to strengthen the lung in patients with stable chronic obstructive pulmonary disease (COPD).
METHODS


This was a randomized, open-controlled trial in which the acupuncturist and the participants were not blinded, but the outcome evaluators and data analysts were blinded. One-hundred-and-two patients with stable COPD were randomly divided into two groups in a 1∶1 ratio. The acupuncture group received 30-minute sessions of acupuncture therapy at the same acupoints three times weekly for 6 weeks in addition to routine conventional Western Medicine treatment; the control group received routine conventional Western Medicine treatment alone. The primary outcome was the Borg scale score, which was assessed immediately after the 6-minute walk test. The secondary outcomes were the 6-minute walk distance, lung function, and oxygen saturation. Measurements were obtained at baseline and after 6 weeks of treatment.
RESULTS


After 6 weeks of treatment, the Borg scale score in the acupuncture group was significantly better than that in the control group (2.02 ± 0.71 versus 5.01 ± 0.34, P < 0.05). Furthermore, the post-treatment improvements in the 6-minute walk distance, lung function, and oxygen saturation were significantly greater in the acupuncture group than in the control group, showing that the acupuncture group had better exercise tolerance.
CONCLUSION


The findings suggest that acupuncture that aims to reinforce the spleen to strengthen the lung is a safe and effective adjuvant therapy that effectively improves the exercise capacity of patients with stable COPD.",2019,"After 6 weeks of treatment, the Borg scale score in the acupuncture group was significantly better than that in the control group (2.02 ± 0.71 versus 5.01 ± 0.34, P < 0.05).","['patients with stable chronic obstructive pulmonary disease (COPD', 'patients with stable COPD', 'One-hundred-and-two patients with stable COPD', 'stable chronic obstructive pulmonary disease']","['acupuncture', 'acupuncture therapy', 'Acupuncture', 'routine conventional Western Medicine treatment alone']","['Borg scale score', '6-minute walk distance, lung function, and oxygen saturation', 'effectiveness and safety', 'exercise tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",102.0,0.0806866,"After 6 weeks of treatment, the Borg scale score in the acupuncture group was significantly better than that in the control group (2.02 ± 0.71 versus 5.01 ± 0.34, P < 0.05).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Guangtong', 'Initials': 'G', 'LastName': 'Zhuang', 'Affiliation': 'Cardiovascular Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Chenyi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Research, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Erqi', 'Initials': 'E', 'LastName': 'Qin', 'Affiliation': 'Department of Research, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Research, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
1957,31294137,Efficacy and safety of an herbal formula (KBMSI-2) in the treatment of erectile dysfunction: A preliminary clinical study.,"Purpose


To investigate the efficacy and safety of KBMSI-2, an herbal formula consisting of Ginseng Radix Rubra,  Dioscorea tenuipes ,  Cornus officinalis  Sieb. et Zucc.,  Lycium chinense  Mill, and  Curcuma longa  Linn, for the treatment of erectile dysfunction (ED).
Materials and Methods


Patients were instructed to take placebo or 6 g of KBMSI-2 twice per day for 8 weeks, at least 1 hour after food intake. The primary outcome was a change from baseline in erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcome included changes from baseline in all domain scores of the IIEF, scores on the Aging Males' Symptoms scale, and serum total testosterone levels, as well as changes in questions 2 and 3 of the Sexual Encounter Profile, responses to the Global Assessment Question, and changes in the number of 'yes' responses on the Androgen Deficiency in Aging Males questionnaire.
Results


Patients receiving KBMSI-2 had a statistically significant improvement in baseline IIEF-EF domain scores at 8 weeks compared to the placebo group. Intercourse satisfaction domain and the total IIEF scores also increased in the KBMSI-2 group. However, we could not find any significant differences in other efficacy variables between the groups. Only one patient had an adverse event, which was mild in severity.
Conclusions


This preliminary clinical study of KBMSI-2 shows significant improvements in EF and intercourse satisfaction, as measured by the IIEF in patients with ED. Further studies using a larger number of patients in the long term should follow.",2019,"Secondary outcome included changes from baseline in all domain scores of the IIEF, scores on the Aging Males' Symptoms scale, and serum total testosterone levels, as well as changes in questions 2 and 3 of the Sexual Encounter Profile, responses to the Global Assessment Question, and changes in the number of 'yes' responses on the Androgen Deficiency in Aging Males questionnaire.
","['erectile dysfunction', 'patients with ED']","['placebo or 6 g of KBMSI-2', 'herbal formula (KBMSI-2', 'placebo', 'KBMSI-2']","['erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire', ""changes from baseline in all domain scores of the IIEF, scores on the Aging Males' Symptoms scale, and serum total testosterone levels, as well as changes in questions 2 and 3 of the Sexual Encounter Profile, responses to the Global Assessment Question, and changes in the number of 'yes' responses on the Androgen Deficiency in Aging Males questionnaire"", 'EF and intercourse satisfaction', 'adverse event', 'Intercourse satisfaction domain and the total IIEF scores', 'Efficacy and safety', 'baseline IIEF-EF domain scores']","[{'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0342527', 'cui_str': 'Deficiency of testosterone biosynthesis'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0842602,"Secondary outcome included changes from baseline in all domain scores of the IIEF, scores on the Aging Males' Symptoms scale, and serum total testosterone levels, as well as changes in questions 2 and 3 of the Sexual Encounter Profile, responses to the Global Assessment Question, and changes in the number of 'yes' responses on the Androgen Deficiency in Aging Males questionnaire.
","[{'ForeName': 'Nam Cheol', 'Initials': 'NC', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Sae Woong', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Catholic Integrative Medicine Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Sung Yeoun', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Korea Bio Medical Science Institute, Seoul, Korea.'}, {'ForeName': 'Hyun Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Pusan National University School of Medicine, Busan, Korea.'}]",Investigative and clinical urology,['10.4111/icu.2019.60.4.275']
1958,32002593,Intraosseous versus intravenous administration of adrenaline in patients with out-of-hospital cardiac arrest: a secondary analysis of the PARAMEDIC2 placebo-controlled trial.,"PURPOSE


To compare the effectiveness of the intravenous (IV) and intraosseous (IO) routes for drug administration in adults with a cardiac arrest enrolled in the Pre-Hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest (PARAMEDIC2) randomised, controlled trial.
METHODS


Patients were recruited from five National Health Service Ambulance Services in England and Wales from December 2014 through October 2017. Patients with an out-of-hospital cardiac arrest who were unresponsive to initial resuscitation attempts were randomly assigned to 1 mg adrenaline or matching placebo. Intravascular access was established as soon as possible, and IO access was considered if IV access was not possible after two attempts.
RESULTS


Among patients with out-of-hospital cardiac arrest, 3631 received adrenaline and 3686 received placebo. Amongst these, 1116 (30.1%) and 1121 (30.4%) received the study drug via the IO route. The odds ratios were similar in the IV and IO groups for return of spontaneous circulation (ROSC) at hospital handover [adjusted odds ratio (aOR) 4.07 (95% CI 3.42-4.85) and (aOR 3.98 (95% CI 2.86-5.53), P value for interaction 0.90]; survival to 30 days [aOR 1.67 (1.18-2.35) versus 0.9 (0.4-2.05), P = 0.18]; and favourable neurological outcome [aOR 1.39 (0.93-2.06) versus 0.62 (0.23-1.67), P = 0.14].
CONCLUSION


There was no significant difference in treatment effect (adrenaline versus placebo) on ROSC at hospital handover between drugs administered by the intraosseous route or by the intravenous route. We could not detect any difference in the treatment effect between the IV and IO routes on the longer term outcomes of 30-day survival or favourable neurological outcome at discharge (ISRCTN73485024).",2020,We could not detect any difference in the treatment effect between the IV and IO routes on the longer term outcomes of 30-day survival or favourable neurological outcome at discharge (ISRCTN73485024).,"['patients with out-of-hospital cardiac arrest, 3631 received', 'patients with out-of-hospital cardiac arrest', 'adults with a cardiac arrest enrolled in the Pre-Hospital Assessment of the Role of', 'Patients with an out-of-hospital cardiac arrest who were unresponsive to initial resuscitation attempts', 'Patients were recruited from five National Health Service Ambulance Services in England and Wales from December 2014 through October 2017']","['Adrenaline', 'placebo', 'intravenous (IV) and intraosseous (IO) routes', 'adrenaline or matching placebo', 'adrenaline', 'adrenaline versus placebo']","['favourable neurological outcome', 'odds ratios', 'survival', 'return of spontaneous circulation (ROSC', '30-day survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0595613', 'cui_str': 'Intraosseous route'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.243338,We could not detect any difference in the treatment effect between the IV and IO routes on the longer term outcomes of 30-day survival or favourable neurological outcome at discharge (ISRCTN73485024).,"[{'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. paramedictrial@warwick.ac.uk.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, DY5 1LX, West Midlands, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}]",Intensive care medicine,['10.1007/s00134-019-05920-7']
1959,31143842,A nested randomised trial of the effect of tranexamic acid on intracranial haemorrhage and infarction in traumatic brain injury (CRASH-3 trial intracranial bleeding mechanistic study): Statistical analysis plan.,"Background:  The CRASH-3 trial is a randomised trial on the effect of tranexamic acid (TXA) versus placebo on death and disability in traumatic brain injury (TBI). The CRASH-3 intracranial bleeding mechanistic study (IBMS) is a randomised trial nested within the CRASH-3 trial to examine the effect of TXA versus placebo on intracranial bleeding and infarction.  Methods:  Patients eligible for the CRASH-3 trial, with a GCS of 12 or less or intracranial bleeding on a pre-randomisation CT scan are eligible for the IBMS. The occurrence of intracranial bleeding, infarction, haemorrhagic oedematous lesions, mass effect and haemorrhage evacuation is examined within 28 days of randomisation using routinely collected brain scans. The primary outcome is the volume of intra-parenchymal bleeding in patients randomised within three hours of injury (adjusted for prognostic covariates). Secondary outcomes include a composite ""poor"" outcome, progressive and new intracranial bleeding, intracranial bleeding after neurosurgery and cerebral infarcts seen up to 28 days post-randomisation. All outcomes will be compared between treatment groups.  Statistical analyses:  The primary outcome will be analysed using a covariate adjusted linear mixed model. The same analysis will be done separately for patients who undergo haemorrhage evacuation post-randomisation. We will express the effect of TXA on the composite outcome, new and progressive bleeding using relative risks and 95% CIs, and on cerebral infarcts using hazard ratios and 95% CIs. We will conduct sensitivity analyses assuming missing data are MCAR or MNAR.  Conclusion : The IBMS will provide information on the mechanism of action of TXA in TBI. This pre-specified statistical analysis plan is a technical extension of the published protocol.  Trial registration:  The CRASH-3 trial was prospectively registered at the International Standard Randomised Controlled Trials registry (19 July 2011) and ClinicalTrials.gov (25 July 2011). The registries were updated with details for the IBMS on 20 December 2016.",2018,The CRASH-3 trial is a randomised trial on the effect of tranexamic acid (TXA) on death and disability in traumatic brain injury (TBI).,"['traumatic brain injury (CRASH-3 trial intracranial bleeding mechanistic study', 'patients who undergo haemorrhage evacuation post-randomisation', 'Methods:  Patients eligible for the CRASH-3 trial, with a GCS of 12 or less or intracranial bleeding on a pre-randomisation CT scan are eligible for the IBMS', 'traumatic brain injury (TBI']","['TXA', 'tranexamic acid (TXA', 'tranexamic acid']","['occurrence of intracranial bleeding, infarction, haemorrhagic oedematous lesions, mass effect and haemorrhage evacuation', 'intracranial haemorrhage and infarction', 'composite ""poor"" outcome, progressive and new intracranial bleeding, intracranial bleeding after neurosurgery and cerebral infarcts seen', 'volume of intra-parenchymal bleeding', 'death and disability']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.402503,The CRASH-3 trial is a randomised trial on the effect of tranexamic acid (TXA) on death and disability in traumatic brain injury (TBI).,"[{'ForeName': 'Abda', 'Initials': 'A', 'LastName': 'Mahmood', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, WC1E7HT, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, WC1E7HT, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, Department of Population Health, London School of Hygiene & Tropical Medicine, London, WC1E7HT, UK.'}]",Wellcome open research,['10.12688/wellcomeopenres.14731.3']
1960,30892641,Web-Based Program Exposure and Retention in the Families Improving Together for Weight Loss Trial.,"BACKGROUND


Interventions that incorporate behavioral skills training and parental involvement have been effective for promoting weight loss among middle and upper class youth; however, few studies have produced similar weight loss effects in underserved ethnic minority youth.
PURPOSE


This study examined whether online program exposure (in both an online tailored intervention and an online health education comparison program) predicted greater retention among African American youth and their parents in the Families Improving Together (FIT) for Weight Loss trial.
METHODS


Parent-adolescent dyads (N = 125) were randomized to either an online tailored intervention program (n = 63) or an online health education comparison program (n = 62). Paradata including login data were used to determine the number of sessions viewed (0-8) and the number of minutes spent online per session. Study retention, defined as collection of adolescent anthropometric measures at 6 months postintervention, was the outcome.
RESULTS


Logistic regression analyses showed a significant effect for login rate on retention (OR = 1.21, 95% CI [1.04, 1.39]). Total number of sessions viewed, child age, child sex, parent age, and parent sex accounted for 11% of the variance in retention at 6 months post- intervention. Participants who were retained spent a significantly greater number of minutes during each session (M = 12.99, SD = 11.63) than participants who were not retained (M = 7.77, SD = 11.19), t(123) = 2.24, p = .027, d = 0.45.
CONCLUSIONS


The use of paradata from online interventions is a novel and feasible approach for examining exposure in web-based interventions and program retention in underserved ethnic minority families.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01796067. Registered January 23, 2013.",2019,"RESULTS


Logistic regression analyses showed a significant effect for login rate on retention (OR = 1.21, 95% CI [1.04, 1.39]).","['African American youth and their parents in the Families Improving Together (FIT) for Weight Loss trial', 'Parent-adolescent dyads (N = 125', 'underserved ethnic minority families']","['online tailored intervention program (n = 63) or an online health education comparison program', 'online program exposure (in both an online tailored intervention and an online health education comparison program']",['login rate on retention'],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018701'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",125.0,0.0824196,"RESULTS


Logistic regression analyses showed a significant effect for login rate on retention (OR = 1.21, 95% CI [1.04, 1.39]).","[{'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Sweeney', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Law', 'Affiliation': 'Department of Psychology, Barnwell College, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman-Ulrich', 'Affiliation': 'Diabetes Health and Wellness Institute, Baylor Scott and White Health, Dallas, TX, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay047']
1961,30913165,Pain coping skills training for African Americans with osteoarthritis: results of a randomized controlled trial.,"African Americans bear a disproportionate burden of osteoarthritis (OA), but they have been underrepresented in trials of behavioral interventions for pain. This trial examined a culturally tailored pain coping skills training (CST) program, compared to a wait list control group, among 248 African Americans with knee or hip OA. The pain CST program involved 11 telephone-based sessions over 3 months. Outcomes were assessed at baseline, 3 months (primary), and 9 months, and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (primary outcome), WOMAC total score and function subscale, PROMIS Pain Interference, Short-Form 12 Mental and Physical Composite Subscales, Coping Strategies Questionnaire-Total Coping Attempts, Pain Catastrophizing Scale, Patient Health Questionnaire-8, Arthritis Self-Efficacy Scale, and Patient Global Impression of Arthritis Symptom Change. Linear mixed models were fit for all outcomes. There were no significant between-group differences in WOMAC pain score at 3 months (-0.63 [95% confidence interval -1.45, 0.18]; P = 0.128) or 9 months (-0.84 [95% confidence interval -1.73, 0.06]; P = 0.068). Among secondary outcomes, at 3 months, there were significant differences, in favor of the CST group, for Coping Strategies Questionnaire Total Coping Attempts, Pain Catastrophizing Scale, Arthritis Self-Efficacy, and Patient Global Impression of Arthritis Symptom Change (P < 0.01). Coping Strategies Questionnaire Total Coping Attempts, Arthritis Self-Efficacy, and Patient Global Assessment Change were also significantly improved at 9 months in the CST group, compared with wait list (P < 0.01). The culturally tailored pain CST program did not significantly reduce pain severity but did improve key measures of pain coping and perceived ability to manage pain among African Americans with OA.",2019,The culturally tailored pain CST program did not significantly reduce pain severity but did improve key measures of pain coping and perceived ability to manage pain among African Americans with OA.,"['African Americans with osteoarthritis', 'African Americans with OA', 'African Americans', '248 African Americans with knee or hip OA']","['Pain coping skills training', 'CST', 'culturally tailored pain coping skills training (CST) program']","['pain coping and perceived ability to manage pain', 'Coping Strategies Questionnaire Total Coping Attempts, Arthritis Self-Efficacy, and Patient Global Assessment Change', 'Coping Strategies Questionnaire Total Coping Attempts, Pain Catastrophizing Scale, Arthritis Self-Efficacy, and Patient Global Impression of Arthritis Symptom Change', 'pain severity', 'WOMAC pain score', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (primary outcome), WOMAC total score and function subscale, PROMIS Pain Interference, Short-Form 12 Mental and Physical Composite Subscales, Coping Strategies Questionnaire-Total Coping Attempts, Pain Catastrophizing Scale, Patient Health Questionnaire-8, Arthritis Self-Efficacy Scale, and Patient Global Impression of Arthritis Symptom Change']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}]",248.0,0.0836271,The culturally tailored pain CST program did not significantly reduce pain severity but did improve key measures of pain coping and perceived ability to manage pain among African Americans with OA.,"[{'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, United States.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, United States.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, United States.'}, {'ForeName': 'Crystal W', 'Initials': 'CW', 'LastName': 'Cené', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Health Services Research and Development Service, Durham VA Medical Center, Durham, NC, United States.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, United States.'}]",Pain,['10.1097/j.pain.0000000000001525']
1962,30816637,"Sorafenib in Hepatopulmonary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.","The tyrosine kinase inhibitor sorafenib improves hepatopulmonary syndrome (HPS) in an experimental model. However, the efficacy and adverse effect profile in patients with HPS are unknown. We aimed to determine the effect of sorafenib on the alveolar-arterial oxygen gradient (AaPO 2  ) at 3 months in patients with HPS. We performed a randomized, double-blind, placebo-controlled parallel trial of sorafenib in patients with HPS at 7 centers. A total of 28 patients with HPS were randomized to sorafenib 400 mg by mouth daily or a matching placebo in a 1:1 ratio. We found no statistically significant difference in the median change in AaPO 2  from baseline to 12 weeks between the patients allocated to sorafenib (4.5 mm Hg; IQR, -3.8 to 7.0 mm Hg) and those allocated to placebo (-2.4 mm Hg; IQR, -4.8 to 8.2 mm Hg; P = 0.70). There was also no difference between the groups in terms of degree of intrapulmonary shunting by contrast echocardiography. Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life. In conclusion, sorafenib did not change the AaPO 2  or other disease markers at 3 months in patients with HPS. Alternative antiangiogenic therapies or treatments targeting other pathways should be investigated.",2019,"Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life.","['patients with HPS', '28 patients with HPS', 'Hepatopulmonary Syndrome', 'patients with HPS at 7\xa0centers']","['placebo', 'Sorafenib', 'Placebo', 'sorafenib 400\xa0mg by mouth daily or a matching placebo', 'sorafenib']","['median change in AaPO', 'degree of intrapulmonary shunting', 'circulating levels of angiogenic markers, including vascular endothelial growth factor receptors', 'quality of life', 'TIE2-expressing M2 monocytes', 'mental component scores', 'hepatopulmonary syndrome (HPS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600452', 'cui_str': 'Hepato-Pulmonary Syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1527415', 'cui_str': 'Per oral route'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0442121', 'cui_str': 'Intrapulmonary (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0034380'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600452', 'cui_str': 'Hepato-Pulmonary Syndrome'}]",28.0,0.566468,"Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life.","[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kawut', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Krowka', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vargas', 'Affiliation': 'Department of Medicine, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koch', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Sharkoski', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Al-Naamani', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Fox', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Levitsky', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Jae K', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nianfu', 'Initials': 'N', 'LastName': 'Song', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Mottram', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Department of Laboratory Medicine, University of Vermont School of Medicine, Burlington, VT.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kaplan', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Fallon', 'Affiliation': 'Department of Medicine, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25438']
1963,30583732,Correction to: Assessing dengue transmission risk and a vector control intervention using entomological and immunological indices in Thailand: study protocol for a cluster-randomized controlled trial.,"In the original publication [1], the first of two objectives was to ""Assess the effect of periodically treating water storage containers with a pyriproxyfen/spinosad combination on entomological and epidemiological outcomes"".",2018,"In the original publication [1], the first of two objectives was to ""Assess the effect of periodically treating water storage containers with a pyriproxyfen/spinosad combination on entomological and epidemiological outcomes"".",['Thailand'],"['vector control intervention', 'pyriproxyfen/spinosad combination']",[],"[{'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0139497', 'cui_str': '4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether'}, {'cui': 'C0961781', 'cui_str': 'spinosad'}]",[],2.0,0.0917359,"In the original publication [1], the first of two objectives was to ""Assess the effect of periodically treating water storage containers with a pyriproxyfen/spinosad combination on entomological and epidemiological outcomes"".","[{'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Overgaard', 'Affiliation': 'Norwegian University of Life Sciences, Ås, Norway. hans.overgaard@nmbu.no.'}, {'ForeName': 'Chamsai', 'Initials': 'C', 'LastName': 'Pientong', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kesorn', 'Initials': 'K', 'LastName': 'Thaewnongiew', 'Affiliation': 'Office of Disease Prevention and Control, Region 7, Khon Kaen, Thailand.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bangs', 'Affiliation': 'PT Freeport Indonesia/International SOS Indonesia, Kuala Kencana, Indonesia.'}, {'ForeName': 'Tipaya', 'Initials': 'T', 'LastName': 'Ekalaksananan', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sirinart', 'Initials': 'S', 'LastName': 'Aromseree', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thipruethai', 'Initials': 'T', 'LastName': 'Phanitchat', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Supranee', 'Initials': 'S', 'LastName': 'Phanthanawiboon', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Fustec', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Corbel', 'Affiliation': 'Institut de Recherche pour le Développement (IRD), Maladies Infectieuses et Vecteurs, Ecologie, Génétique, Evolution et Contrôle (MIVEGEC, UM1-CNRS 5290-IRD 224), Montpellier, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Cerqueira', 'Affiliation': 'Kasetsart University, Bangkok, Thailand.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, London, UK.'}]",Trials,['10.1186/s13063-018-3110-9']
1964,32089356,Strategies to Improve Recruitment to a De-escalation Trial: A Mixed-Methods Study of the OPTIMA Prelim Trial in Early Breast Cancer.,"AIMS


De-escalation trials are challenging and sometimes may fail due to poor recruitment. The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice. Despite encountering challenges, OPTIMA Prelim reached its recruitment target ahead of schedule. This study reports the root causes of recruitment challenges and the strategies used to successfully overcome them.
MATERIALS AND METHODS


A mixed-methods recruitment intervention (QuinteT Recruitment Intervention) was used to investigate the recruitment difficulties and feedback findings to inform interventions and optimise ongoing recruitment. Quantitative site-level recruitment data, audio-recorded recruitment appointments (n = 46), qualitative interviews (n = 22) with trialists/recruiting staff (oncologists/nurses) and patient-facing documentation were analysed using descriptive, thematic and conversation analyses. Findings were triangulated to inform a 'plan of action' to optimise recruitment.
RESULTS


Despite best intentions, oncologists' routine practices complicated recruitment. Discomfort about deviating from the usual practice of recommending chemotherapy according to tumour clinicopathological features meant that not all eligible patients were approached. Audio-recorded recruitment appointments revealed how routine practices undermined recruitment. A tendency to justify chemotherapy provision before presenting the randomised controlled trial and subtly indicating that chemotherapy would be more/less beneficial undermined equipoise and made it difficult for patients to engage with OPTIMA Prelim. To tackle these challenges, individual and group recruiter feedback focussed on communication issues and vignettes of eligible patients were discussed to address discomforts around approaching patients. 'Tips' documents concerning structuring discussions and conveying equipoise were disseminated across sites, together with revisions to the Patient Information Sheet.
CONCLUSIONS


This is the first study illuminating the tension between oncologists' routine practices and recruitment to de-escalation trials. Although time and resources are required, these challenges can be addressed through specific feedback and training as the trial is underway.",2020,"The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice.","['Early Breast Cancer', 'patients with early stage breast cancer to']","[""chemotherapy versus 'test-directed' chemotherapy"", 'mixed-methods recruitment intervention (QuinteT Recruitment Intervention']",[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",[],,0.0681037,"The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Conefrey', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK. Electronic address: carmel.conefrey@bristol.ac.uk.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Stein', 'Affiliation': 'National Institute for Health Research, University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paramasivan', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bartlett', 'Affiliation': 'Ontario Institute for Cancer Research, Toronto, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Earl', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Harmer', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hughes-Davies', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Macpherson', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pinder', 'Affiliation': ""King's College London, Comprehensive Cancer Centre at Guy's Hospital, London, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Arden Cancer Centre, University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'School of Cancer Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rooshenas', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.01.029']
1965,32154610,EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Children with Lymphoma or Malignant Solid Tumors.,"On March 28, 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending the marketing authorization for the medicinal product plerixafor. The marketing authorization holder for this medicinal product is Genzyme Europe B.Th. The adoption was for an extension of the existing adult indication in combination with granulocyte colony-stimulating factor (G-CSF) to pediatric patients (aged 1 year to <18 years) to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumors. This treatment is indicated either preemptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regard to desired hematopoietic stem cells yield, or in children who previously failed to collect sufficient hematopoietic stem cells. The efficacy and safety of plerixafor were evaluated in an open label, multicenter, phase I/II, dose-ranging, and randomized controlled study (DFI12860) in pediatric patients with solid tumors, including neuroblastoma, sarcoma, Ewing sarcoma, or lymphoma, who were eligible for autologous hematopoietic stem cell transplantation. Forty-five patients (aged 1 year to <18 years) were randomized, 2:1, using 0.24 mg/kg of plerixafor plus standard mobilization (G-CSF with or without chemotherapy) versus control (standard mobilization alone). The primary analysis showed that 80% of patients in the plerixafor arm experienced at least a doubling of the peripheral blood (PB) CD34+ count, observed from the morning of the day preceding the first planned apheresis to the morning prior to apheresis, versus 28.6% of patients in the control arm (p = .0019). The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm. The observed safety profile in the pediatric population was consistent with that in adults, with adverse events mainly related to injection site reactions, hypokalemia, and increased blood bicarbonate. Importantly, plerixafor exposure did not seem to negatively affect transplant efficiency. This article summarizes the scientific review of the application leading to regulatory approval in the European Union. IMPLICATIONS FOR PRACTICE: This review of the marketing authorization of plerixafor will raise awareness of pediatric indication granted for this medicinal product.",2020,The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm.,"['children with lymphoma or solid malignant tumors', 'Children with Lymphoma or Malignant Solid Tumors', 'Forty-five patients (aged 1 year to <18\u2009years', 'pediatric patients with solid tumors, including neuroblastoma, sarcoma, Ewing sarcoma, or lymphoma, who were eligible for autologous hematopoietic stem cell transplantation', 'pediatric patients (aged 1 year to <18\u2009years']","['plerixafor', 'plerixafor plus standard mobilization (G-CSF with or without chemotherapy) versus control (standard mobilization alone', 'granulocyte colony-stimulating factor (G-CSF', 'Plerixafor (Mozobil']","['blood bicarbonate', 'peripheral blood (PB) CD34+ count', 'transplant efficiency', 'efficacy and safety', 'PB CD34+ cell counts']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}, {'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1879513', 'cui_str': 'Mozobil'}]","[{'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}]",,0.0430409,The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm.,"[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Karres', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Sahra', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Paula B', 'Initials': 'PB', 'LastName': 'van Hennik', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Straus', 'Affiliation': 'Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Josephson', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Geanne', 'Initials': 'G', 'LastName': 'Thole', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Glerum', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Herberts', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Babae', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Herold', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Papadouli', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0898']
1966,30541622,Correction to: The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital 'informed choice' intervention to improve attitudes towards uptake and implementation of CBT for psychosis.,"Following publication of the original article [1], the authors reported a typing mistake in the spelling of author Iain O'Leary. The original article has been corrected.",2018,"Following publication of the original article [1], the authors reported a typing mistake in the spelling of author Iain O'Leary.",[],['pre-cognitive behavioural therapy digital '],[],[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]",[],,0.0619631,"Following publication of the original article [1], the authors reported a typing mistake in the spelling of author Iain O'Leary.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Greenwood', 'Affiliation': 'R&D Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Millview Hospital Site, Nevill Avenue, Hove, BN3 7HZ, UK. k.e.greenwood@sussex.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Alford', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RP, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': ""O'Leary"", 'Affiliation': 'R&D Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Millview Hospital Site, Nevill Avenue, Hove, BN3 7HZ, UK.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hardy', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cavanagh', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, East Sussex, BN1 9RP, UK.'}, {'ForeName': 'Andy P', 'Initials': 'AP', 'LastName': 'Field', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, East Sussex, BN1 9RP, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'de Visser', 'Affiliation': 'School of Psychology, University of Sussex, Pevensey Building, Falmer, Brighton, East Sussex, BN1 9RP, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'R&D Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Millview Hospital Site, Nevill Avenue, Hove, BN3 7HZ, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'R&D Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Millview Hospital Site, Nevill Avenue, Hove, BN3 7HZ, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Papamichail', 'Affiliation': 'R&D Department, Sussex Partnership NHS Foundation Trust, Sussex Education Centre, Millview Hospital Site, Nevill Avenue, Hove, BN3 7HZ, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Garety', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.'}]",Trials,['10.1186/s13063-018-3085-6']
1967,31838217,Immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in children and adolescents: A phase III randomized study.,"OBJECTIVES


To analyse the immunogenicity and safety of inactivated subunit quadrivalent influenza vaccine (QIV) versus trivalent influenza vaccine (TIV) in children and adolescents 3-17 years of age.
METHODS


In this phase III, multicentre, double-blind study, 1200 subjects were randomized to receive QIV (n=402), TIV with the B-strain of the Victoria lineage (n=404), or TIV with the B-strain of the Yamagata lineage (n=394). The primary objective was to demonstrate non-inferiority of QIV to TIV for immunogenicity against shared influenza strains, based on post-vaccination hemagglutinin inhibition (HI) titres. Secondary objectives were to show superiority of QIV to TIV for immunogenicity against alternate-lineage B-strains, and to further characterize the immune response by analysing virus neutralization and neuraminidase inhibition titres. Reactogenicity and safety were also compared post-vaccination.
RESULTS


QIV elicited a non-inferior response for shared strains (upper limits of the 95% confidence intervals for the HI geometric mean ratios (GMRs) of TIV/QIV<1.5) and a superior response for alternate-lineage B-strains (HI GMRs of TIV/QIV<1.0; p<0.0001) versus TIV. Reporting rates of local and systemic adverse reactions were similar between vaccine arms.
CONCLUSIONS


QIV had comparable immunogenicity to TIV for shared strains and superior immunogenicity to the alternate-lineage B-strains in TIV. Safety and tolerability profiles were comparable.",2020,"RESULTS


QIV elicited a non-inferior response for shared strains (upper limits of the 95% confidence intervals for the HI geometric mean ratios [GMRs] of TIV/QIV < 1.5) and a superior response for alternate-lineage B-strains (HI GMRs of TIV/QIV < 1.0; p < 0.0001) versus TIV.","['children and adolescents', '1200 subjects', 'children and adolescents 3-17 years of age']","['inactivated subunit quadrivalent influenza vaccine (QIV) versus trivalent influenza vaccine (TIV', 'QIV', 'quadrivalent versus trivalent inactivated subunit influenza vaccine', 'TIV with the B-strain of the Victoria lineage (n\u2009=\u2009404) or Yamagata lineage']","['Immunogenicity and safety', 'Reporting rates of local and systemic adverse reactions', 'Reactogenicity and safety', 'Safety and tolerability profiles']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0770694'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",1200.0,0.0883642,"RESULTS


QIV elicited a non-inferior response for shared strains (upper limits of the 95% confidence intervals for the HI geometric mean ratios [GMRs] of TIV/QIV < 1.5) and a superior response for alternate-lineage B-strains (HI GMRs of TIV/QIV < 1.0; p < 0.0001) versus TIV.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Nordic Research Network Ltd, Biokatu 10, 33520 Tampere, Finland.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Nauta', 'Affiliation': 'Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Lapini', 'Affiliation': 'VisMederi Srl, Strada del Petriccio e Belriguardo 35, 53100 Siena, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Montomoli', 'Affiliation': 'VisMederi Srl, Strada del Petriccio e Belriguardo 35, 53100 Siena, Italy; Department of Molecular and Developmental Medicine, University of Siena, 53100 Siena, Italy.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'van de Witte', 'Affiliation': 'Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands. Electronic address: serge.vandewitte@abbott.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2019.12.010']
1968,31888565,The impact of depression and anxiety treatment on biological aging and metabolic stress: study protocol of the MOod treatment with antidepressants or running (MOTAR) study.,"BACKGROUND


Depressive and anxiety disorders have shown to be associated to premature or advanced biological aging and consequently to adversely impact somatic health. Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders. These interventions may, however, work through different pathophysiological mechanisms and could differ in their impact on biological aging and somatic health. This study protocol describes the design of an unique intervention study that examines whether both treatments are similarly effective in reducing or reversing biological aging (primary outcome), psychiatric status, metabolic stress and neurobiological indicators (secondary outcomes).
METHODS


The MOod Treatment with Antidepressants or Running (MOTAR) study will recruit a total of 160 patients with a current major depressive and/or anxiety disorder in a mental health care setting. Patients will receive a 16-week treatment with either antidepressant medication or running therapy (3 times/week). Patients will undergo the treatment of their preference and a subsample will be randomized (1:1) to overcome preference bias. An additional no-disease-no-treatment group of 60 healthy controls without lifetime psychopathology, will be included as comparison group for primary and secondary outcomes at baseline. Assessments are done at week 0 for patients and controls, and at week 16 and week 52 for patients only, including written questionnaires, a psychiatric and medical examination, blood, urine and saliva collection and a cycle ergometer test, to gather information about biological aging (telomere length and telomerase activity), mental health (depression and anxiety disorder characteristics), general fitness, metabolic stress-related biomarkers (inflammation, metabolic syndrome, cortisol) and genetic determinants. In addition, neurobiological alterations in brain processes will be assessed using structural and functional Magnetic Resonance Imaging (MRI) in a subsample of at least 25 patients per treatment arm and in all controls.
DISCUSSION


This intervention study aims to provide a better understanding of the impact of antidepressant medication and running therapy on biological aging, metabolic stress and neurobiological indicators in patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment.
TRIAL REGISTRATION


Trialregister.nl Number of identification: NTR3460, May 2012.",2019,Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders.,"['160 patients with a current major depressive and/or anxiety disorder in a mental health care setting', 'patients with mood and anxiety disorders', '60 healthy controls without lifetime psychopathology', 'patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment']","['antidepressant medication or running therapy', 'Antidepressants or Running (MOTAR', 'antidepressant medication and running therapy', 'MOod treatment with antidepressants or running (MOTAR']","['biological aging (telomere length and telomerase activity), mental health (depression and anxiety disorder characteristics), general fitness, metabolic stress-related biomarkers (inflammation, metabolic syndrome, cortisol) and genetic determinants', 'biological aging, metabolic stress and neurobiological indicators', 'reversing biological aging (primary outcome), psychiatric status, metabolic stress and neurobiological indicators (secondary outcomes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2718059', 'cui_str': 'Personalized Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0085759', 'cui_str': 'Biological Aging'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",60.0,0.0499851,Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders.,"[{'ForeName': 'Bianca A', 'Initials': 'BA', 'LastName': 'Lever-van Milligen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. b.lever@ggzingeest.nl.'}, {'ForeName': 'Josine E', 'Initials': 'JE', 'LastName': 'Verhoeven', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Schmaal', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'van Velzen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Révész', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Catherine N', 'Initials': 'CN', 'LastName': 'Black', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Laura K M', 'Initials': 'LKM', 'LastName': 'Han', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Melany', 'Initials': 'M', 'LastName': 'Horsfall', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Neeltje M', 'Initials': 'NM', 'LastName': 'Batelaan', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Digna J F', 'Initials': 'DJF', 'LastName': 'van Schaik', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2404-0']
1969,30662958,The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial.,"Background:  Incentives play a role in introducing health-related benefits, but no interventions using mixed incentives, i.e. a combination of individual and group incentives, have been tested in individuals with type 2 diabetes mellitus (T2DM). We evaluated the feasibility of implementing individual- and mixed-incentives, with and without a supportive partner, on glycated haemoglobin (HbA1c) control and weight loss among patients with T2DM.  Methods:  This is a feasibility, sex-stratified, single-blinded, randomized controlled study in individuals with T2DM. All participants received diabetes education and tailored goal setting for weight and glycated haemoglobin (HbA1c). Participants were randomly assigned into three arms: individual incentives (Arm 1), mixed incentives-altruism (Arm 2), and mixed incentives-cooperation (Arm 3). Participants were accompanied by a diabetes educator every other week to monitor targets, and the intervention period lasted 3 months. The primary outcome was the change in HbA1c at 3 months from baseline. Weight and change body mass index (BMI) were considered as secondary outcomes.  Results:  Out of 783 patients screened, a total of 54 participants, 18 per study arm, were enrolled and 44 (82%) completed the 3-month follow-up. Mean baseline HbA1c values were 8.5%, 7.9% and 8.2% in Arm 1, Arm 2, and Arm 3, respectively. At 3 months, participants in all three study arms showed reductions in HbA1c ranging from -0.9% in Arm 2 to -1.4% in Arm 1. Weight and BMI also showed reductions.  Conclusions:  Individual and mixed cash incentives show important reductions in HbA1c, weight and BMI in patients with type 2 diabetes mellitus after 3 months.  Recruitment and uptake of the intervention were successfully accomplished demonstrating feasibility to conduct larger effectiveness studies to test individual and mixed economic incentives for diabetes management. Registration: ClinicalTrials.gov Identifier NCT02891382.",2018,"At 3 months, participants in all three study arms showed reductions in HbA1c ranging from -0.9% in Arm 2 to -1.4% in Arm 1.","['patients with type 2 diabetes mellitus after 3 months', 'individuals with type 2 diabetes mellitus (T2DM', 'individuals with T2DM', '783 patients screened, a total of 54 participants, 18 per study arm, were enrolled and 44 (82%) completed the 3-month follow-up', 'patients with T2DM']","['individual incentives (Arm 1), mixed incentives-altruism (Arm 2), and mixed incentives-cooperation', 'individual and mixed rewards', 'diabetes education and tailored goal setting for weight and glycated haemoglobin (HbA1c']","['Weight and BMI', 'Mean baseline HbA1c values', 'reductions in HbA1c ranging', 'change in HbA1c', 'glycated haemoglobin (HbA1c) control and weight loss', 'Weight and change body mass index (BMI', 'HbA1c, weight and BMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0002357', 'cui_str': 'Altruism'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",54.0,0.104369,"At 3 months, participants in all three study arms showed reductions in HbA1c ranging from -0.9% in Arm 2 to -1.4% in Arm 1.","[{'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Lazo-Porras', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'M Amalia', 'Initials': 'MA', 'LastName': 'Pesantes', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Diez-Canseco', 'Affiliation': 'CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Socorro Del Pilar', 'Initials': 'SDP', 'LastName': 'Cornejo', 'Affiliation': 'Department of Endocrinology, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Trujillo', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Wellcome open research,['10.12688/wellcomeopenres.14824.3']
1970,31326135,The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial.,"BACKGROUND


Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years.
METHODS


Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247).
FINDINGS


Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI -0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (-£910, 95% CI -1503 to -317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR.
INTERPRETATION


Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2019,The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups.,"['patients with medial compartment osteoarthritis (TOPKAT', 'Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45', 'patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients', 'patients with medial compartment osteoarthritis of the knee', 'patients with late-stage isolated medial compartment osteoarthritis', 'patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR']","['TKR versus PKR', 'total knee replacement (TKR) or partial knee replacement (PKR', 'combined expertise-based and equipoise-based approach', 'partial knee replacement', 'PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure']","['OKS', 'Health-care costs', 'Oxford Knee Score (OKS', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0864243', 'cui_str': 'Partial Knee Replacement'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",962.0,0.148873,The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK. Electronic address: david.beard@ndorms.ox.ac.uk.'}, {'ForeName': 'Loretta J', 'Initials': 'LJ', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kent', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Murray', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marion K', 'Initials': 'MK', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31281-4']
1971,31198477,A New Device Improves Signs and Symptoms of TMD.,"Background


Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Herein, we propose a new neuromuscular lingual device able to reduce signs and symptoms of TMD in female patients with chronic orofacial pain.
Methods


50 females with myofascial TMD according to RDC/TMD were randomly assigned to study ( n  = 25) and control groups ( n  = 25). At T0, both groups received sEMG/KNG and pain evaluation by the VAS scale. The study group received the ELIBA device (lingual elevator by Balercia) constructed under ULF-TENS (ultra-low-frequency transcoutaneous electrical nervous stimulation). Subjects were instructed to use ELIBA at least for 16 h/day. After 6 months (T1), both groups underwent to sEMG/KNG and VAS revaluation.
Results


T1 study group compared to controls showed a significant reduction in total ( p  < 0.0001) and mean ( p  < 0.0001) sEMG values, as well as a significant increase in both maximum vertical mouth opening ( p =0.003) and maximum velocity in mouth opening ( p =0.003) and closing ( p  < 0.0001). Interestingly, a significant reduction in pain measured by VAS ( p  < 0.0001) was reported.
Conclusions


After 6 months, the ELIBA device is able to significantly reduce TMD-associated myogenous pain and to promote the enhancement of sEMG/KNG values.
Practical Implications


ELIBA can be considered as a new device, potentially useful for head-neck pain relief in patients suffering from chronic TMD. In addition, its use promotes a muscles relaxation inducing freeway space increase. This characteristic makes it particularly useful for rehabilitation of patients with not enough space for construction of conventional orthotics or neuromuscular bites.",2019,"Results


T1 study group compared to controls showed a significant reduction in total ( p  < 0.0001) and mean ( p  < 0.0001) sEMG values, as well as a significant increase in both maximum vertical mouth opening ( p =0.003) and maximum velocity in mouth opening ( p =0.003) and closing ( p  < 0.0001).","['patients suffering from chronic TMD', '50 females with myofascial TMD according to RDC/TMD', 'female patients with chronic orofacial pain', 'patients with not enough space for construction of conventional orthotics or neuromuscular bites']","['\n\n\nTemporomandibular joint dysfunction (TMD) therapy', 'ELIBA device (lingual elevator by Balercia) constructed under ULF-TENS (ultra-low-frequency transcoutaneous electrical nervous stimulation']","['maximum vertical mouth opening', 'TMD-associated myogenous pain', 'maximum velocity in mouth opening', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain (finding)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0005658', 'cui_str': 'Bites'}]","[{'cui': 'C0039496', 'cui_str': 'Temporomandibular Joint Syndrome'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2349948', 'cui_str': 'Lingual (qualifier value)'}, {'cui': 'C0013890', 'cui_str': 'Elevator'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",50.0,0.0435285,"Results


T1 study group compared to controls showed a significant reduction in total ( p  < 0.0001) and mean ( p  < 0.0001) sEMG values, as well as a significant increase in both maximum vertical mouth opening ( p =0.003) and maximum velocity in mouth opening ( p =0.003) and closing ( p  < 0.0001).","[{'ForeName': 'Ruggero', 'Initials': 'R', 'LastName': 'Cattaneo', 'Affiliation': ""University of L'Aquila, Department of Life, Health and Environmental Sciences, San Salvatore Hospital, Building Delta 6-Unit of Dentistry, V.le San Salvatore, L'Aquila 67100, Italy.""}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Pietropaoli', 'Affiliation': ""University of L'Aquila, Department of Life, Health and Environmental Sciences, San Salvatore Hospital, Building Delta 6-Unit of Dentistry, V.le San Salvatore, L'Aquila 67100, Italy.""}, {'ForeName': 'Barry C', 'Initials': 'BC', 'LastName': 'Cooper', 'Affiliation': 'Division of Translational Oral Biology, School of Dental Medicine, State University of New York, Stony Brook, New York, NY 14214, USA.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Capparè', 'Affiliation': 'Private Dental Technician, Dental Laboratory, Via Sallustio 4, 63074 San Benedetto Del Tronto (AP), Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Ortu', 'Affiliation': ""University of L'Aquila, Department of Life, Health and Environmental Sciences, San Salvatore Hospital, Building Delta 6-Unit of Dentistry, V.le San Salvatore, L'Aquila 67100, Italy.""}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Monaco', 'Affiliation': ""University of L'Aquila, Department of Life, Health and Environmental Sciences, San Salvatore Hospital, Building Delta 6-Unit of Dentistry, V.le San Salvatore, L'Aquila 67100, Italy.""}]",Pain research & management,['10.1155/2019/5646143']
1972,30218818,"Putting patients at the center of kidney care transitions: PREPARE NOW, a cluster randomized controlled trial.","Care for patients transitioning from chronic kidney disease to kidney failure often falls short of meeting patients' needs. The PREPARE NOW study is a cluster randomized controlled trial studying the effectiveness of a pragmatic health system intervention, 'Patient Centered Kidney Transition Care,' a multi-component health system intervention designed to improve patients' preparation for kidney failure treatment. Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and risk prediction tools) to help providers recognize patients in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences. Patient-Centered Kidney Transition Care also adds a 'Kidney Transitions Specialist' to the nephrology health care team to facilitate patients' self-management empowerment, shared-decision making, psychosocial support, care navigation, and health care team communication. The PREPARE NOW study is conducted among eight [8] outpatient nephrology clinics at Geisinger, a large integrated health system in rural Pennsylvania. Four randomly selected nephrology clinics employ the Patient Centered Kidney Transitions Care intervention while four clinics employ usual nephrology care. To assess intervention effectiveness, patient reported, biomedical, and health system outcomes are collected annually over a period of 36 months via telephone questionnaires and electronic health records. The PREPARE NOW Study may provide needed evidence on the effectiveness of patient-centered health system interventions to improve nephrology patients' experiences, capabilities, and clinical outcomes, and it will guide the implementation of similar interventions elsewhere.
TRIAL REGISTRATION


NCT02722382.",2018,Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and risk prediction tools) to help providers recognize patients in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences.,"[""patients' preparation for kidney failure treatment"", 'Putting patients at the center of kidney care transitions', 'eight [8] outpatient nephrology clinics at Geisinger, a large integrated health system in rural Pennsylvania']","['pragmatic health system intervention', 'Patient Centered Kidney Transitions Care intervention while four clinics employ usual nephrology care']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3814531', 'cui_str': 'Nephrology clinic'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}]",[],4.0,0.0278836,Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and risk prediction tools) to help providers recognize patients in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences.,"[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Green', 'Affiliation': 'Department of Nephrology, Geisinger Commonwealth School of Medicine, Danville, PA, USA; Kidney Health Research Institute, Geisinger, Danville, PA, USA. Electronic address: jgreen1@geisinger.edu.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Ephraim', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD, USA. Electronic address: pephraim@jhu.edu.'}, {'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Hill-Briggs', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: fbriggs3@jhmi.edu.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'College of Social Work, University of South Carolina, Columbia, SC, USA. Electronic address: browne@sc.edu.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Strigo', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: tara.strigo@duke.edu.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hauer', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: clhauer@geisinger.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Stametz', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: rastametz@geisinger.edu.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Darer', 'Affiliation': 'Decision Support Siemens Healthineers Malvern, PA, USA. Electronic address: jon.darer@medicalis.com.'}, {'ForeName': 'U D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Division of Nephrology, Duke University School of Medicine, Durham, NC, USA; Gilead Sciences, Inc., Foster City, CA, USA. Electronic address: uptal.patel@duke.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lang-Lindsey', 'Affiliation': 'Department of Social Work, Alabama State University, Montgomery, AL, USA. Electronic address: kllindsey@alasu.edu.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Bankes', 'Affiliation': 'Patient stakeholder co-author, Bloomsburg, PA, USA.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Bolden', 'Affiliation': 'Patient stakeholder co-author, Jacksonville, FL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Danielson', 'Affiliation': 'Patient stakeholder co-author, Portland, OR, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ruff', 'Affiliation': 'Patient stakeholder co-author, Mooresville, NC, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schmidt', 'Affiliation': 'Patient stakeholder co-author, Liberty, Illinois, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Swoboda', 'Affiliation': 'Patient stakeholder co-author, Edgewater, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Woods', 'Affiliation': 'Patient stakeholder co-author, Hartsdale, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vinson', 'Affiliation': 'Quality Insights Renal Network 5, Richmond, VA, USA. Electronic address: BVinson@nw5.esrd.net.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Littlewood', 'Affiliation': 'The Care Centered Collaborative, Pennsylvania Medical Society, Harrisburg, PA, USA. Electronic address: dlittlewood@patientccc.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: george.l.jackson@duke.edu.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Pendergast', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC, USA. Electronic address: jane.pendergast@duke.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'St Clair Russell', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: jennifer.st.clair.russell@duke.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Collins', 'Affiliation': 'Patient Services, National Kidney Foundation, New York, NY, USA. Electronic address: Kelli.Collins@kidney.org.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Norfolk', 'Affiliation': 'Department of Nephrology, Geisinger Commonwealth School of Medicine, Danville, PA, USA. Electronic address: ernorfolk@geisinger.edu.'}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Bucaloiu', 'Affiliation': 'Department of Nephrology, Geisinger Medical Center, Danville, PA, USA. Electronic address: idbucaloiu@geisinger.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kethireddy', 'Affiliation': 'Critical Care Medicine, Northeast Georgia Health System, Gainesville, GA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'Adult Psychology and Behavioral Medicine, Department of Psychiatry, Geisinger, Danville, PA, USA. Electronic address: cacollins1@geisinger.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger, Danville, PA, USA. Electronic address: ddavis1@geisinger.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'dePrisco', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: jjdeprisco@geisinger.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Malloy', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: dtmalloy1@geisinger.edu.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA; Division of Nephrology, Duke University School of Medicine, Durham, NC, USA. Electronic address: clarissa.j.diamantidis@duke.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fulmer', 'Affiliation': 'Geisinger Health Plan, Danville, PA, USA. Electronic address: slfulmer@thehealthplan.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Program Development, National Kidney Foundation, New York, NY, USA. Electronic address: jenniferm@kidney.org.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schatell', 'Affiliation': 'Medical Education Institute, Madison, WI, USA. Electronic address: schatell@meiresearch.org.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Department of Medicine, Section of Nephrology, University of Manitoba, 66 Chancellors Cir, Winnipeg, MB R3T 2N2, Canada; Chronic Disease Innovation Center, Seven Oaks General Hospital, 2300 Mcphillips St, Winnipeg, MB R2V 3M3, Canada. Electronic address: ntangri@sogh.mb.ca.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sees', 'Affiliation': 'Anthem, Inc., Indianapolis, IN, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Siegrist', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: cnsiegrist@geisinger.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Breed', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: jmbreed@geisinger.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Medley', 'Affiliation': 'Geisinger Health Plan, Danville, PA, USA. Electronic address: ammedley@thehealthplan.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Graboski', 'Affiliation': 'Kidney Health Research Institute, Geisinger, Danville, PA, USA. Electronic address: emgraboski@geisinger.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Billet', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: jabillet@geisinger.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hackenberg', 'Affiliation': 'Center for Clinical Innovation, Institute for Advanced Application, Geisinger, Danville, PA, USA. Electronic address: mrhackenberg@geisinger.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Singer', 'Affiliation': 'Renal Physicians Association, Rockville, MD, USA. Electronic address: dsinger@renalmd.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stewart', 'Affiliation': 'Council of Nephrology Social Workers, National Kidney Foundation, New York, NY, USA. Electronic address: Stewart.Stephanie@mayo.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alkon', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: aviel.alkon@duke.edu.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Bhavsar', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: nrupen.bhavsar@dm.duke.edu.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lewis-Boyer', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD, USA; Division of General Internal Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: llewis3@jhmi.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martz', 'Affiliation': 'Geisinger Health Plan, Danville, PA, USA. Electronic address: cmartz2@thehealthplan.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yule', 'Affiliation': 'Kidney Health Research Institute, Geisinger, Danville, PA, USA. Electronic address: cmyule@geisinger.edu.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD, USA; Division of General Internal Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: rgreer@jhmi.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA. Electronic address: msaunder@bsd.uchicago.edu.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cameron', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: blake.cameron@duke.edu.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Boulware', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: ebony.boulware@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.09.004']
1973,30728950,Relative effectiveness of a full versus reduced version of the 'Smoke Free' mobile application for smoking cessation: an exploratory randomised controlled trial.,"Background:  Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version.  Methods:   This was a two-arm exploratory randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual 'badges' and daily 'missions' with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users': device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses.  Results:  The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively.  Conclusions:  Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.",2018,"The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control.","['Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included', 'smoking cessation']","[""full versus reduced version of the 'Smoke Free' mobile application""]","['intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses', 'self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",28112.0,0.11149,"The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, WC1E 6BT, UK.'}, {'ForeName': 'Harveen Kaur', 'Initials': 'HK', 'LastName': 'Ubhi', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, WC1E 6BT, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, WC1E 6BT, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, WC1E 6BT, UK.'}]",F1000Research,['10.12688/f1000research.16148.2']
1974,29720202,Optimization of late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar: a cross-over study.,"BACKGROUND


Cardiovascular magnetic resonance (CMR) imaging may be used to visualize post-ablation atrial scar (PAAS), and three-dimensional late gadolinium enhancement (3D LGE) is the most widely employed technique for imaging of chronic scar. Detection of PAAS provides a unique non-invasive insight into the effects of the ablation and may help guide further ablation procedures. However, there is evidence that PAAS is often not detected by CMR, implying a significant sensitivity problem, and imaging parameters vary between leading centres. Therefore, there is a need to establish the optimal imaging parameters to detect PAAS.
METHODS


Forty subjects undergoing their first pulmonary vein isolation procedure for AF had detailed CMR assessment of atrial scar: one scan pre-ablation, and two scans post-ablation at 3 months (separated by 48 h). Each scan session included ECG- and respiratory-navigated 3D LGE acquisition at 10, 20 and 30 min post injection of a gadolinium-based contrast agent (GBCA). The first post-procedural scan was performed on a 1.5 T scanner with standard acquisition parameters, including double dose (0.2 mmol/kg) Gadovist and 4 mm slice thickness. Ten patients subsequently underwent identical scan as controls, and the other 30 underwent imaging with a reduced, single, dose GBCA (n = 10), half slice thickness (n = 10) or on a 3 T scanner (n = 10). Apparent signal-to-noise (aSNR), contrast-to-noise (aCNR) and imaging quality (Likert Scale, 3 independent observers) were assessed. PAAS location and area (%PAAS scar) were assessed following manual segmentation. Atrial shells with standardised %PAAS at each timepoint were then compared to ablation lesion locations to assess quality of scar delineation.
RESULTS


A total of 271 3D acquisitions (out of maximum 280, 96.7%) were acquired. Likert scale of imaging quality had high interobserver and intraobserver intraclass correlation coefficients (0.89 and 0.96 respectively), and showed lower overall imaging quality on 3 T and at half-slice thickness. aCNR, and quality of scar delineation increased significantly with time. aCNR was higher with reduced, single, dose of GBCA (p = 0.005).
CONCLUSION


3D LGE CMR atrial scar imaging, as assessed qualitatively and quantitatively, improves with time from GBCA administration, with some indices continuing to improve from 20 to 30 min. Imaging should be performed at least 20 min post-GBCA injection, and a single dose of contrast should be considered.
TRIAL REGISTRATION


Trial registry- United Kingdom National Research Ethics Service 08/H0802/68 - 30th September 2008.",2018,"aCNR was higher with reduced, single, dose of GBCA (p = 0.005).
","['Forty subjects undergoing their first pulmonary vein isolation procedure for AF had detailed CMR assessment of atrial scar: one scan pre-ablation, and two scans post-ablation at 3 months (separated by 48\xa0h']","['PAAS', 'late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar', 'gadolinium-based contrast agent (GBCA']","['aCNR', 'PAAS location and area (%PAAS scar', 'ECG- and respiratory-navigated 3D LGE acquisition', 'Apparent signal-to-noise (aSNR), contrast-to-noise (aCNR) and imaging quality (Likert Scale', 'aCNR, and quality of scar delineation', 'overall imaging quality']","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}]","[{'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",40.0,0.0543896,"aCNR was higher with reduced, single, dose of GBCA (p = 0.005).
","[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Chubb', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK. henry.chubb@kcl.ac.uk.""}, {'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Rashed', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sohns', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Orod', 'Initials': 'O', 'LastName': 'Razeghi', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Whitaker', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Harrison', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Chiribiri', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schaeffter', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""O'Neill"", 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razavi', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}]",Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance,['10.1186/s12968-018-0449-8']
1975,29800080,Early Weight Loss in Behavioral Treatment Predicts Later Rate of Weight Loss and Response to Pharmacotherapy.,"BACKGROUND


Early weight loss (EWL) in the first 1-2 months of behavioral treatment is a strong predictor of later total weight loss. It is not clear whether participants with lower early losses lose less in ongoing treatment or simply fail to overcome the smaller initial loss. Furthermore, no study has tested whether EWL in behavioral treatment predicts response to a different treatment modality, such as pharmacotherapy.
METHODS


Data were from 170 participants with obesity (baseline BMI = 40.8 ± 5.8 kg/m2, 87.6% female; 71.3% Black) enrolled in a two-phase trial. Data from the weight loss phase, which provided weekly lifestyle counseling and a meal replacement diet, were used to examine the relationship between 4-week EWL and subsequent rate of weight loss in behavioral treatment. Data from the maintenance phase, in which 137 participants who had lost ≥5% of initial weight were randomized to 52 weeks of maintenance counseling with lorcaserin or placebo, were used to determine whether EWL with behavioral treatment affects the benefit of pharmacotherapy.
RESULTS


EWL in the first 4 weeks of behavioral treatment (3.6 ± 1.7%) predicted greater total losses at Week 14 (r2 = 0.61, p < .001) and a faster rate of weight loss in the subsequent 9 weeks of the program (p < .001). During the maintenance phase, lower EWL in behavioral treatment predicted a greater benefit of lorcaserin, in comparison with placebo, for the maintenance of a ≥5% loss at Weeks 24 and 52.
CONCLUSIONS


These findings support recommendations to modify treatment for individuals with low EWL.",2019,"During the maintenance phase, lower EWL in behavioral treatment predicted a greater benefit of lorcaserin, in comparison with placebo, for the maintenance of a ≥5% loss at Weeks 24 and 52.
","['individuals with low EWL', 'Data were from 170 participants with obesity (baseline BMI = 40.8 ± 5.8 kg/m2, 87.6% female; 71.3% Black) enrolled in a two-phase trial', '137 participants who had lost ≥5% of initial weight']","['lorcaserin or placebo', 'EWL', 'placebo']","['total losses', 'weight loss', 'Early Weight Loss']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",170.0,0.0498746,"During the maintenance phase, lower EWL in behavioral treatment predicted a greater benefit of lorcaserin, in comparison with placebo, for the maintenance of a ≥5% loss at Weeks 24 and 52.
","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Suite, Philadelphia, PA, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Suite, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Suite, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Suite, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Suite, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Suite, Philadelphia, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay036']
1976,31092654,Kanuka honey versus aciclovir for the topical treatment of herpes simplex labialis: a randomised controlled trial.,"OBJECTIVE


To compare New Zealand medical grade kanuka honey with topical aciclovir for the treatment of herpes simplex labialis.
DESIGN


Prospective parallel randomised controlled open-label superiority trial.
SETTING


76 community pharmacies across New Zealand between 10 September 2015 and 13 December 2017.
PARTICIPANTS


952 adults randomised within the first 72 hours of a herpes simplex labialis episode.
INTERVENTIONS


Random assignment 1:1 to either 5% aciclovir cream or medical grade kanuka honey (90%)/glycerine (10%) cream, both applied five times daily.
OUTCOME MEASURES


The primary outcome was time from randomisation to return to normal skin (stage 7). Secondary outcomes included time from randomisation to stage 4 (open wound), time from stage 4 to 7, maximal pain, time to pain resolution and treatment acceptability.
RESULTS


Primary outcome variable: Kaplan-Meier-based estimates (95% CI) for the median time in days for return to normal skin were 8 (8 to 9) days for aciclovir and 9 (8 to 9) for honey; HR (95% CI) 1.06 (0.92 to 1.22), p=0.56. There were no statistically significant differences between treatments for all secondary outcome variables. No related serious adverse events were reported.
CONCLUSION


There was no evidence of a difference in efficacy between topical medical grade kanuka honey and 5% aciclovir in the pharmacy-based treatment of herpes simplex labialis.
TRIAL REGISTRATION NUMBER


ACTRN12615000648527;Post-results.",2019,"There was no evidence of a difference in efficacy between topical medical grade kanuka honey and 5% aciclovir in the pharmacy-based treatment of herpes simplex labialis.
","['herpes simplex labialis', '952 adults randomised within the first 72\u2009hours of a herpes simplex labialis episode', '76 community pharmacies across New Zealand between 10 September 2015 and 13 December 2017']","['topical aciclovir', 'Kanuka honey versus aciclovir', 'aciclovir cream or medical grade kanuka honey (90%)/glycerine (10%) cream, both applied five times daily']","['serious adverse events', 'time from randomisation to return to normal skin (stage 7', 'time from randomisation to stage 4 (open wound), time from stage 4 to 7, maximal pain, time to pain resolution and treatment acceptability', 'Kaplan-Meier-based estimates (95%\u2009CI) for the median time in days for return to normal skin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C1049346', 'cui_str': 'Kanuka'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0585292', 'cui_str': 'Five times daily (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0332798', 'cui_str': 'Open wound (morphologic abnormality)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",952.0,0.255931,"There was no evidence of a difference in efficacy between topical medical grade kanuka honey and 5% aciclovir in the pharmacy-based treatment of herpes simplex labialis.
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Semprini', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Shortt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Darmiga', 'Initials': 'D', 'LastName': 'Thayabaran', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2018-026201']
1977,30986795,Self-Collection of Vaginal Swabs Among Adolescent Girls in a School-Setting in East Africa.,"BACKGROUND


Few studies have evaluated the acceptability of self-collected vaginal swabs among young women in sub-Saharan Africa, including in school settings. We evaluated the acceptability of 2 conditions for the self-collection of swabs in secondary schools in Entebbe, Uganda.
METHODS


Assenting girls with parental consent from 3 secondary schools were provided instructions for sampling, and randomly allocated to self-collection of vaginal swabs with or without nurse assistance to help with correct placement of the swab. Swabs were tested for bacterial vaginosis by Gram stain. Participants were followed up after 1 to 2 days and 1 to 2 weeks and invited for a qualitative interview.
RESULTS


Overall 96 girls were enrolled (median age, 16 years; interquartile range, 15-17 years). At the first follow-up visit, participants in both arms reported that instructions for sample collection were easy to understand, and they felt comfortable with self-collection. Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04). About half (47%) of participants agreed that self-sampling was painful, but almost all (94%) would participate in a similar study again. Qualitative data showed that participants preferred self-collection without nurse assistance to preserve privacy. Bacterial vaginosis prevalence was 14% (95% confidence interval, 8-22).
CONCLUSIONS


In this setting, self-collection of vaginal swabs in secondary schools was acceptable and feasible, and girls preferred self-collection without nurse assistance. Self-collection of swabs is an important tool for the detection, treatment and control of reproductive tract infections in girls and young women.",2019,"Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04).","['young women in sub-Saharan Africa, including in school settings', 'Adolescent Girls in a School-Setting in East Africa', 'Overall 96 girls were enrolled (median age, 16 years; interquartile range, 15-17 years', 'girls and young women', 'Assenting girls with parental consent from 3 secondary schools']",['self-collection of vaginal swabs with or without nurse assistance to help with correct placement of the swab'],"['Bacterial vaginosis prevalence', 'Self-Collection of Vaginal Swabs']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001741', 'cui_str': 'East Africa'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab (specimen)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0444207', 'cui_str': 'Vaginal swab (specimen)'}]",96.0,0.0398205,"Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04).","[{'ForeName': 'Suzanna C', 'Initials': 'SC', 'LastName': 'Francis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Miiro', 'Affiliation': 'Uganda Virus Research Institute.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nakuya', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Rwamahe', 'Initials': 'R', 'LastName': 'Rutakumwa', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Nakiyingi-Miiro', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Nabaggala', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Saidat', 'Initials': 'S', 'LastName': 'Musoke', 'Affiliation': 'Uganda Virus Research Institute.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Namakula', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Tanton', 'Affiliation': ''}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Torondel', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ross', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000000990']
1978,30302543,"Correction to: An open-label, randomized, placebo-controlled study on the effectiveness of a novel probiotics administration protocol (ProbiotiCKD) in patients with mild renal insufficiency (stage 3a of CKD).","In the original publication of the article, few of the authors were missed in the author group.",2019,"In the original publication of the article, few of the authors were missed in the author group.",['patients with mild renal insufficiency (stage 3a of CKD'],"['novel probiotics administration protocol (ProbiotiCKD', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0552753,"In the original publication of the article, few of the authors were missed in the author group.","[{'ForeName': 'Mariadelina', 'Initials': 'M', 'LastName': 'Simeoni', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy. adelina.simeoni@unicz.it.""}, {'ForeName': 'Maria Lucia', 'Initials': 'ML', 'LastName': 'Citraro', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Cerantonio', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Deodato', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Provenzano', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cianfrone', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Capria', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Corrado', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Libri', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comi', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Pujia', 'Affiliation': ""Clinical Nutrition Unit, 'Magna Graecia' University Hospital, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Abenavoli', 'Affiliation': ""Digestive Physiopathology Unit, 'Magna Graecia' University Hospital, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Andreucci', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cocchi', 'Affiliation': '""Paolo Sotgiu"" Institute for Research in Quantitative and Quantum Psychiatry and Cardiology, LUdeS, Lugano, Switzerland.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Montalcini', 'Affiliation': ""Clinical Nutrition Unit, 'Magna Graecia' University Hospital, 88100, Catanzaro, CZ, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Fuiano', 'Affiliation': ""Nephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.""}]",European journal of nutrition,['10.1007/s00394-018-1831-x']
1979,30026931,Study protocol for the Anesthesiology Control Tower-Feedback Alerts to Supplement Treatments (ACTFAST-3) trial: a pilot randomized controlled trial in intraoperative telemedicine.,"Background : Each year, over 300 million people undergo surgical procedures worldwide. Despite efforts to improve outcomes, postoperative morbidity and mortality are common. Many patients experience complications as a result of either medical error or failure to adhere to established clinical practice guidelines. This protocol describes a clinical trial comparing a telemedicine-based decision support system, the Anesthesiology Control Tower (ACT), with enhanced standard intraoperative care.  Methods : This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs. Primary outcomes include blood glucose management and temperature management. Secondary outcomes will include surrogate, clinical, and economic outcomes, such as incidence of intraoperative hypotension, postoperative respiratory compromise, acute kidney injury, delirium, and volatile anesthetic utilization.  Ethics and dissemination : The ACTFAST-3 study has been approved by the Human Resource Protection Office (HRPO) at Washington University in St. Louis and is registered at clinicaltrials.gov ( NCT02830126). Recruitment for this protocol began in April 2017 and will end in December 2018. Dissemination of the findings of this study will occur via presentations at academic conferences, journal publications, and educational materials.",2018,"This protocol describes a clinical trial comparing a telemedicine-based decision support system, the Anesthesiology Control Tower (ACT), with enhanced standard intraoperative care.  ","['12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group', '300 million people undergo surgical procedures worldwide']","['telemedicine-based decision support system, the Anesthesiology Control Tower (ACT', 'intraoperative telemedicine', ' ']","['blood glucose management and temperature management', 'surrogate, clinical, and economic outcomes, such as incidence of intraoperative hypotension, postoperative respiratory compromise, acute kidney injury, delirium, and volatile anesthetic utilization']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]","[{'cui': 'C1638311', 'cui_str': 'Blood sugar management (procedure)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0042153', 'cui_str': 'use'}]",12000.0,0.138067,"This protocol describes a clinical trial comparing a telemedicine-based decision support system, the Anesthesiology Control Tower (ACT), with enhanced standard intraoperative care.  ","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gregory', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Murray-Torres', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Helsten', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Troy S', 'Initials': 'TS', 'LastName': 'Wildes', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Anshuman', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, 63110, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",F1000Research,['10.12688/f1000research.14897.2']
1980,30146493,Training models for implementing evidence-based psychological treatment for college mental health: A cluster randomized trial study protocol.,"Mental disorders often emerge in adolescence and young adulthood, and these disorders can have lasting effects on students' health, social functioning, and education. Although evidence-based treatments have been established for many mental disorders, few community therapists use such treatments. What is needed is a practical, economically feasible means of training clinicians to implement evidence-based treatments suitable for widespread use. This cluster randomized trial will randomize 26 college counseling centers to one of two implementation strategies for training counselors to use interpersonal psychotherapy (IPT), an evidence-based treatment for depression and eating disorders: 1) an external expert consultation model comprising a workshop, therapy manual, and expert follow-up consultation (n = 13); or 2) a train-the-trainer model in which a staff member from the counseling center is coached to train other staff members to implement IPT (n = 13). The primary outcome is therapist adherence to IPT, with secondary outcomes of therapist competence in IPT and client outcomes for depression and eating disorders. Therapist and organizational characteristics will be explored as potential moderators and mediators of implementation outcomes. Implementation costs for each of the training methods will also be assessed. The present study involves partnering with college counseling centers to determine the most effective method to implement IPT for depression and eating disorders in these settings. The results of this study will inform future large-scale dissemination of clinical interventions to mental health service providers by providing evidence for the selection of training methods when an agency chooses to adopt new interventions.",2018,"This cluster randomized trial will randomize 26 college counseling centers to one of two implementation strategies for training counselors to use interpersonal psychotherapy (IPT), an evidence-based treatment for depression and eating disorders: 1) an external expert consultation model comprising a workshop, therapy manual, and expert follow-up consultation (n = 13); or 2) a train-the-trainer model in which a staff member from the counseling center is coached to train other staff members to implement IPT (n = 13).","['college mental health', 'partnering with college counseling centers', '26 college counseling centers']","['external expert consultation model comprising a workshop, therapy manual, and expert follow-up consultation (n\u202f=\u202f13); or 2) a train-the-trainer model in which a staff member from the counseling center is coached to train other staff members to implement IPT', 'training counselors to use interpersonal psychotherapy (IPT']","['therapist adherence to IPT, with secondary outcomes of therapist competence in IPT and client outcomes for depression and eating disorders']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation (procedure)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]",,0.0921508,"This cluster randomized trial will randomize 26 college counseling centers to one of two implementation strategies for training counselors to use interpersonal psychotherapy (IPT), an evidence-based treatment for depression and eating disorders: 1) an external expert consultation model comprising a workshop, therapy manual, and expert follow-up consultation (n = 13); or 2) a train-the-trainer model in which a staff member from the counseling center is coached to train other staff members to implement IPT (n = 13).","[{'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: wilfleyd@psychiatry.wustl.edu.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: fitzsimmonscrafte@psychiatry.wustl.edu.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, 8950 Villa La Jolla Dr., Suite C-203, San Diego, CA 92037, USA. Electronic address: deichen@ucsd.edu.'}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Van Buren', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: vanbured@psychiatry.wustl.edu.'}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: welchr@psychiatry.wustl.edu.'}, {'ForeName': 'Athena H', 'Initials': 'AH', 'LastName': 'Robinson', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 401 Quarry Rd., Stanford, CA 94305, USA. Electronic address: athenar@stanford.edu.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 401 Quarry Rd., Stanford, CA 94305, USA. Electronic address: booil@stanford.edu.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Raghavan', 'Affiliation': 'School of Social Work, Rutgers, The State University of New Jersey, 536 George St., New Brunswick, NJ 08901, USA. Electronic address: ramesh.raghavan@rutgers.edu.'}, {'ForeName': 'Enola K', 'Initials': 'EK', 'LastName': 'Proctor', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, CB 1196, One Brookings Drive, St. Louis, MO 63130, USA. Electronic address: ekp@wustl.edu.'}, {'ForeName': 'G Terence', 'Initials': 'GT', 'LastName': 'Wilson', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers, The State University of New Jersey, 152 Frelinghuysen Rd., Piscataway, NJ 08854, USA. Electronic address: tewilson@rci.rutgers.edu.'}, {'ForeName': 'W Stewart', 'Initials': 'WS', 'LastName': 'Agras', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, CB 1196, One Brookings Drive, St. Louis, MO 63130, USA. Electronic address: sagras@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.002']
1981,30689757,Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial.,"BACKGROUND


The population effects of influenza vaccination in children have not been extensively studied, especially in tropical, developing countries. In rural Senegal, we assessed the total (primary objective) and indirect effectiveness of a trivalent inactivated influenza vaccine (IIV3).
METHODS


In this double-blind, cluster-randomized trial, villages were randomly allocated (1:1) for the high-coverage vaccination of children aged 6 months through 10 years with either the 2008-09 northern hemisphere IIV3 or an inactivated polio vaccine (IPV). Vaccinees were monitored for serious adverse events. All village residents, vaccinated and unvaccinated, were monitored for signs and symptoms of influenza illness using weekly home visits and surveillance in designated clinics. The primary outcome was all laboratory-confirmed symptomatic influenza.
RESULTS


Between 23 May and 11 July 2009, 20 villages were randomized, and 66.5% of age-eligible children were enrolled (3918 in IIV3 villages and 3848 in IPV villages). Follow-up continued until 28 May 2010. There were 4 unrelated serious adverse events identified. Among vaccinees, the total effectiveness against illness caused by the seasonal influenza virus (presumed to all be drifted A/H3N2, based on antigenic characterization data) circulating at high rates among children was 43.6% (95% confidence interval [CI] 18.6-60.9%). The indirect effectiveness against seasonal A/H3N2 was 15.4% (95% CI -22.0 to 41.3%). The total effectiveness against illness caused by the pandemic influenza virus (A/H1N1pdm09) was -52.1% (95% CI -177.2 to 16.6%).
CONCLUSIONS


IIV3 provided statistically significant, moderate protection to children in Senegal against circulating, pre-2010 seasonal influenza strains, but not against A/H1N1pdm09, which was not included in the vaccine. No indirect effects were measured. Further study in low-resource populations is warranted.
CLINICAL TRIALS REGISTRATION


NCT00893906.",2019,"IIV3 provided statistically significant, moderate protection to children in Senegal against circulating pre-2010 seasonal influenza strains but not against A/H1N1pdm09 not included in the vaccine.","['Between May 23 and July 11, 2009, 20 villages were randomized, and 66.5% of age-eligible children were enrolled (3918 in IIV3 villages and 3848 in IPV villages', 'children aged 6 months through 10 years with 2008-09 northern hemisphere IIV3 or', 'children in Senegal during a year of vaccine mismatch']","['seasonal influenza vaccination', 'inactivated polio vaccine (IPV', 'inactivated influenza vaccine, trivalent (IIV3']","['laboratory-confirmed symptomatic influenza', 'Indirect effectiveness against seasonal A/H3N2', 'Total effectiveness against illness']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",20.0,0.338471,"IIV3 provided statistically significant, moderate protection to children in Senegal against circulating pre-2010 seasonal influenza strains but not against A/H1N1pdm09 not included in the vaccine.","[{'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Ousmane M', 'Initials': 'OM', 'LastName': 'Diop', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Diop', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Mbayame Nd', 'Initials': 'MN', 'LastName': 'Niang', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Sugimoto', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development, University of Maryland, Baltimore.'}, {'ForeName': 'El Hadji Abdourahmane', 'Initials': 'EHA', 'LastName': 'Faye', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Bou', 'Initials': 'B', 'LastName': 'Diarra', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Goudiaby', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, Washington.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Emery', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Sahar Z', 'Initials': 'SZ', 'LastName': 'Zangeneh', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Cheikh', 'Initials': 'C', 'LastName': 'Sokhna', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development, University of Maryland, Baltimore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, Washington.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz066']
1982,30521673,Inhaled steroids with and without regular salmeterol for asthma: serious adverse events.,"BACKGROUND


Epidemiological evidence has suggested a link between use of beta₂-agonists and increased asthma mortality. Much debate has surrounded possible causal links for this association, and whether regular (daily) long-acting beta₂-agonists (LABAs) are safe, particularly when used in combination with inhaled corticosteroids (ICSs). This is an update of a Cochrane Review that now includes data from two large trials including 11,679 adults and 6208 children; both were mandated by the US Food and Drug Administration (FDA).  OBJECTIVES: To assess risks of mortality and non-fatal serious adverse events (SAEs) in trials that randomised participants with chronic asthma to regular salmeterol and ICS versus the same dose of ICS.
SEARCH METHODS


We identified randomised trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trials registers for unpublished trial data. We also checked FDA submissions in relation to salmeterol. The date of the most recent search was 10 October 2018.
SELECTION CRITERIA


We included parallel-design randomised trials involving adults, children, or both with asthma of any severity who were randomised to treatment with regular salmeterol and ICS (in separate or combined inhalers) versus the same dose of ICS of at least 12 weeks in duration.
DATA COLLECTION AND ANALYSIS


We conducted the review according to standard procedures expected by Cochrane. We obtained unpublished data on mortality and SAEs from the sponsors, from ClinicalTrials.gov, and from FDA submissions. We assessed our confidence in the evidence according to current GRADE recommendations.
MAIN RESULTS


We have included in this review 41 studies (27,951 participants) in adults and adolescents, along with eight studies (8453 participants) in children. We judged that the overall risk of bias was low for all-cause events, and we obtained data on SAEs from all study authors. All except 542 adults (and none of the children) were given salmeterol and fluticasone in the same (combination) inhaler.DeathsEleven of a total of 14,233 adults taking regular salmeterol and ICS died, as did 13 of 13,718 taking regular ICS at the same dose. The pooled Peto odds ratio (OR) was 0.80 (95% confidence interval (CI) 0.36 to 1.78; participants = 27,951; studies = 41; I² = 0%; moderate-certainty evidence). In other words, for every 1000 adults treated for 25 weeks, one death occurred among those on ICS alone, and the corresponding risk among those taking salmeterol and ICS was also one death (95% CI 0 to 2 deaths).No children died, and no adults or children died of asthma, so we remain uncertain about mortality in children and about asthma mortality in any age group.Non-fatal serious adverse eventsA total of 332 adults receiving regular salmeterol with ICS experienced a non-fatal SAE of any cause, compared to 282 adults receiving regular ICS. The pooled Peto OR was 1.14 (95% CI 0.97 to 1.33; participants = 27,951; studies = 41; I² = 0%; moderate-certainty evidence). For every 1000 adults treated for 25 weeks, 21 adults on ICS alone had an SAE, and the corresponding risk for those on salmeterol and ICS was 23 adults (95% CI 20 to 27).Sixty-five of 4229 children given regular salmeterol with ICS suffered an SAE of any cause, compared to 62 of 4224 children given regular ICS. The pooled Peto OR was 1.04 (95% CI 0.73 to 1.48; participants = 8453; studies = 8; I² = 0%; moderate-certainty evidence). For every 1000 children treated for 23 weeks, 15 children on ICS alone had an SAE, and the corresponding risk for those on salmeterol and ICS was 15 children (95% CI 11 to 22).Asthma-related serious adverse eventsEighty and 67 adults in each group, respectively, experienced an asthma-related non-fatal SAE. The pooled Peto OR was 1.15 (95% CI 0.83 to 1.59; participants = 27,951; studies = 41; I² = 0%; low-certainty evidence). For every 1000 adults treated for 25 weeks, five receiving ICS alone had an asthma-related SAE, and the corresponding risk among those on salmeterol and ICS was six adults (95% CI 4 to 8).Twenty-nine children taking salmeterol and ICS and 23 children taking ICS alone reported asthma-related events. The pooled Peto OR was 1.25 (95% CI 0.72 to 2.16; participants = 8453; studies = 8; I² = 0%; moderate-certainty evidence). For every 1000 children treated for 23 weeks, five receiving an ICS alone had an asthma-related SAE, and the corresponding risk among those receiving salmeterol and ICS was seven children (95% CI 4 to 12).
AUTHORS' CONCLUSIONS


We did not find a difference in the risk of death or serious adverse events in either adults or children. However, trial authors reported no asthma deaths among 27,951 adults or 8453 children randomised to regular salmeterol and ICS or ICS alone over an average of six months. Therefore, the risk of dying from asthma on either treatment was very low, but we remain uncertain about whether the risk of dying from asthma is altered by adding salmeterol to ICS.Inclusion of new trials has increased the precision of the estimates for non-fatal SAEs of any cause. We can now say that the worst-case estimate is that at least 152 adults and 139 children must be treated with combination salmeterol and ICS for six months for one additional person to be admitted to the hospital (compared to treatment with ICS alone). These possible risks still have to be weighed against the benefits experienced by people who take combination treatment.However more than 90% of prescribed treatment was taken in the new trials, so the effects observed may be different from those seen with salmeterol in combination with ICS in daily practice.",2018,The pooled Peto odds ratio (OR) was 0.80,"['1000 adults treated for 25 weeks, 21 adults on ICS alone had an SAE, and the corresponding risk for those on', '152 adults and 139 children', 'All except 542 adults (and none of the children', '27,951 adults or 8453 children randomised to', 'participants = 27,951; studies = 41; I² = 0%; moderate-certainty evidence', '332 adults receiving regular', '282 adults receiving regular ICS', 'participants with chronic asthma to regular', '41 studies (27,951 participants) in adults and adolescents, along with eight studies (8453 participants) in children', '14,233 adults taking regular salmeterol and ICS died, as did 13 of 13,718 taking regular ICS at the same dose', '11,679 adults and 6208 children', 'adults, children, or both with asthma of any severity who were randomised to treatment with']","['salmeterol', 'ICS', 'Inhaled steroids with and without regular salmeterol', 'regular salmeterol and ICS or ICS', 'salmeterol and fluticasone', 'combination salmeterol and ICS', 'regular salmeterol and ICS', 'salmeterol and ICS', 'salmeterol with ICS']","['death', 'pooled Peto OR', 'pooled Peto odds ratio (OR', 'risk of death or serious adverse events', 'asthma-related non-fatal SAE']","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0939232', 'cui_str': 'fluticasone / salmeterol'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",332.0,0.40879,The pooled Peto odds ratio (OR) was 0.80,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cates', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, UK, SW17 0RE.""}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Ferrer', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Sayer', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Waterson', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006922.pub4']
1983,31995406,Clinic Versus Ambulatory Blood Pressure in Resistant Hypertension: Impact of Antihypertensive Medication Nonadherence: A Post Hoc Analysis the DENERHTN Study.,"Clinic-ambulatory blood pressure (BP) difference is influenced by patients- and device-related factors and inadequate clinic-BP measurement. We investigated whether nonadherence to antihypertensive medications may also influence this difference in a post hoc analysis of the DENERHTN trial (Renal Denervation for Hypertension). We pooled the data of 77 out of 106 evaluable patients with apparent resistant hypertension who received a standardized antihypertensive treatment and had both ambulatory BP and drug-screening results available at baseline after 1 month of standardized triple therapy and at 6 months on a median of 5 antihypertensive drugs. After drug assay samplings on study visits, patients took their antihypertensive treatment under supervision immediately after the start of the ambulatory BP recording, and supine clinic BP was measured 24 hours post-dosing; both allowed to calculate the clinic minus daytime ambulatory systolic BP (SBP) difference (clinic-SBP-day-SBP). A total of 29 (37.7%) were found nonadherent to medications at baseline and 38 (49.4%) at 6 months. At baseline, the mean clinic-SBP-day-SBP difference in the nonadherent group was 12.7 mm Hg (95% CI, 7.8-17.7 mm Hg,  P <0.001). In contrast, clinic SBP was almost identical to day-SBP in the adherent group (clinic-SBP-day-SBP difference, 0.1 mm Hg; 95% CI, -3.3 to 3.5 mm Hg;  P =0.947). Similar observations were made at 6 months. Using receiver operating characteristics curves, we found that a 6 mm Hg cutoff of clinic-SBP-day-SBP difference had 67% sensitivity and 69% specificity to predict nonadherence to the triple therapy at baseline. In conclusion, a large clinic-SBP-day-SBP difference may help discriminating between adherence and nonadherence to treatment in patients with resistant hypertension. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01570777.",2019,"At baseline, the mean clinic-SBP-day-SBP difference in the nonadherent group was 12.7 mm Hg (95% CI, 7.8-17.7 mm Hg,  P <0.001).","['patients with resistant hypertension', '106 evaluable patients with apparent resistant hypertension who received a standardized antihypertensive treatment and had both ambulatory BP and drug-screening results available at baseline after 1 month of standardized triple therapy and at 6 months on a median of 5 antihypertensive drugs']",['Clinic Versus Ambulatory Blood Pressure'],"['daytime ambulatory systolic BP (SBP) difference (clinic-SBP-day-SBP', 'mean clinic-SBP-day-SBP difference', 'Clinic-ambulatory blood pressure (BP) difference', 'clinic SBP', 'ambulatory BP recording, and supine clinic BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0013206', 'cui_str': 'Drug Screening'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",106.0,0.0834692,"At baseline, the mean clinic-SBP-day-SBP difference in the nonadherent group was 12.7 mm Hg (95% CI, 7.8-17.7 mm Hg,  P <0.001).","[{'ForeName': 'Idir', 'Initials': 'I', 'LastName': 'Hamdidouche', 'Affiliation': ""From the INSERM, Centre d'Investigations Cliniques- Plurithématique 1418, Paris, France (I.H., H.P., M.A.).""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gosse', 'Affiliation': 'ESH Hypertension excellence center, Hopital Saint André, University hospital of Bordeaux, France (P.G., A.C.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Cremer', 'Affiliation': ''}, {'ForeName': 'Aurelien', 'Initials': 'A', 'LastName': 'Lorthioir', 'Affiliation': 'AP-HP, Hypertension unit and DMU CARTE, Hôpital Européen Georges-Pompidou, Paris, France (A.L., H.P., M.A.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Delsart', 'Affiliation': 'CHU Lille, Institut Cœur Poumon, Bd Pr Leclercq, France (P.D.).'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Courand', 'Affiliation': 'Cardiology department, European Society of Hypertension Excellence Center, Hôpital de la Croix-Rousse et Hôpital Lyon Sud, Hospices Civils de Lyon, France (P.-Y.C.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Denolle', 'Affiliation': ""Hĉpital Arthur Gardiner, Centre d'Excellence en HTA Rennes- Dinard, France (T.D.).""}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Halimi', 'Affiliation': 'Service de nephrologie-immunologie clinique, Hopital universitaire de Tours, et EA4245 Université Francois Rabelais, France (J.-M.H.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Girerd', 'Affiliation': 'Unité de Prévention Cardio Vasculaire, Groupe Hospitalier Universitaire Pitié-Salpêtrière-Institut IE3M, Paris, France (X.G).'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ormezzano', 'Affiliation': 'Department of Cardiology, University Hospital and INSERM U1039, Bioclinic Radiopharmaceutics Laboratory, Grenoble, France (O.O.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations Cliniques- Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (P.R.).""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pereira', 'Affiliation': ""From the INSERM, Centre d'Investigations Cliniques- Plurithématique 1418, Paris, France (I.H., H.P., M.A.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Azizi', 'Affiliation': ""From the INSERM, Centre d'Investigations Cliniques- Plurithématique 1418, Paris, France (I.H., H.P., M.A.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13520']
1984,30724035,Efficacy and safety of bivalirudin during percutaneous coronary intervention in high-bleeding-risk elderly patients with chronic total occlusion: A prospective randomized controlled trial.,"OBJECTIVES


To assess the efficacy and safety of bivalirudin during percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in high-bleeding-risk elderly patients.
BACKGROUND


Bivalirudin reduces PCI-related bleeding; however, its efficacy and safety in patients with CTO, especially elderly patients with a high bleeding risk, remain unclear.
METHODS


This single-center prospective randomized controlled trial assigned 123 high-bleeding-risk elderly patients with CTO to either the unfractionated heparin (UFH) group (n = 55) or the bivalirudin group (n = 68). The primary efficacy endpoint was the incidence of major adverse cardiac events (MACEs) during hospitalization and at the 6-month follow-up. The safety endpoint was bleeding or procedure (access)-related complications after PCI.
RESULTS


MACE incidence was 17.6% and 20.0% in the bivalirudin and UFH groups, respectively (P = 0.82). Bleeding Academic Research Consortium (BARC) type 1-2 bleeding events during hospitalization were comparable between the groups (UFH: 10.9% vs. bivalirudin: 8.8%, P = 0.77). No BARC type 3-5 bleeding events or severe procedure (access)-related complications (subcutaneous hematoma >5 cm) occurred in either group. At the 6-month follow-up, MACE incidence was comparable between the groups (UFH: 3.6% vs. bivalirudin: 1.5%, P = 0.59). The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43). One case of BARC type 3-5 bleeding (fatal intracranial hemorrhage) was observed in the UFH group at the 6-month follow-up.
CONCLUSIONS


Bivalirudin and UFH showed comparable efficacy and safety in elderly patients with a high bleeding risk, undergoing PCI for CTO lesions.",2019,The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43).,"['high-bleeding-risk elderly patients', 'high-bleeding-risk elderly patients with chronic total occlusion', 'elderly patients with a high bleeding risk, undergoing PCI for CTO lesions', 'patients with CTO, especially elderly patients with a high bleeding risk', '123 high-bleeding-risk elderly patients with CTO to either the']","['bivalirudin', 'Bivalirudin', 'percutaneous coronary intervention (PCI', 'percutaneous coronary intervention', 'Bivalirudin and UFH', 'unfractionated heparin (UFH']","['BARC type 3-5 bleeding (fatal intracranial hemorrhage', 'BARC type 3-5 bleeding events or severe procedure (access)-related complications', 'Efficacy and safety', 'MACE incidence', 'incidence of major adverse cardiac events (MACEs', 'efficacy and safety', 'MACE-free survival rates']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",123.0,0.0407001,The Kaplan-Meier analysis revealed that MACE-free survival rates were comparable between the groups (P = 0.43).,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Cheng-Fu', 'Initials': 'CF', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Fan', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Xiao-Jiao', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'De-Feng', 'Initials': 'DF', 'LastName': 'Luo', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Guo-Ning', 'Initials': 'GN', 'LastName': 'Yu', 'Affiliation': ""Department of Science and Education, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Ai-Jie', 'Initials': 'AJ', 'LastName': 'Hou', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Luan', 'Affiliation': ""Department of Cardiology, The People's Hospital of China Medical University, The People's Hospital of Liaoning Province, Shenyang, Liaoning, People's Republic of China.""}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28087']
1985,32037783,Effects of a 30-week combined training program in normoxia and in hypoxia on exercise performance and health-related parameters in obese adolescents: a pilot study.,"BACKGROUND


A light but regular combined training program is sufficient to improve health in obese adolescents. Hypoxia is known to potentiate the effects of a high intensity period of combined training on exercise performance and glucose metabolism in this population. Here, we tested the effects of a less intensive hypoxic combined training program on exercise performance and health-related markers in obese adolescents.
METHODS


Fourteen adolescents volunteered to participate to a 30-week combined training protocol whether in normoxia (FiO2 21%, NE, N.=7) or in hypoxia (FiO2 15%, HE, N.=7). Once a week, adolescents exercised for 50-60min including 12min on a cycloergometer and strength training of the abdominal, quadriceps and biceps muscles.
RESULTS


Combined training reduced body mass (NE: -12%; HE: -8%), mainly due to a loss in fat mass (NE: -26%; HE: -15%), similarly in both the hypoxic and normoxic groups. After training, maximal O2 consumption (VO2max) (NE: +30%; HE: +25%,), maximal aerobic power (MAP) (NE: +20%; HE: +36%), work capacity and one-repetition maximum (1RM) for the quadriceps (NE: +26%; HE: +12%), abdominal (NE: +48%; HE: +36%) and biceps muscles (NE: +26%; HE: +16%) were increased similarly in both groups but insulin sensitivity markers were not modified.
CONCLUSIONS


Except for insulin sensitivity, 1h a week of combined training for 30 weeks improved morphological and health-related markers as well as exercise performance in obese adolescents in both normoxic and hypoxic conditions. This is of particular importance for motivating those adolescents, who often are reluctant to exercise. Even a low dose of exercise per week can induce positive health outcomes.",2020,"RESULTS


Combined training reduced body mass","['obese adolescents', 'Fourteen adolescents volunteered to participate to a 30-week']","['HE', 'intensive hypoxic combined training program', '30-week combined training program in normoxia and in hypoxia', 'combined training protocol whether in normoxia (FiO2 21%, NE, n=7) or in hypoxia', 'adolescents exercised for 50-60min including 12min on a cycloergometer and strength training of the abdominal, quadriceps and biceps muscles']","['work capacity and one-repetition maximum (1RM', 'maximal aerobic power (MAP', 'body mass']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.05537,"RESULTS


Combined training reduced body mass","[{'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Britto', 'Affiliation': 'Institute of Neuroscience, Catholic University of Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'De Groote', 'Affiliation': 'Institute of Neuroscience, Catholic University of Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Aranda', 'Affiliation': 'Institute of Neuroscience, Catholic University of Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Bullock', 'Affiliation': 'Clairs Vallons Pediatric Medical Center, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Nielens', 'Affiliation': 'Institute of Neuroscience, Catholic University of Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Institute of Neuroscience, Catholic University of Louvain, Louvain-la-Neuve, Belgium - louise.deldicque@uclouvain.be.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10190-7']
1986,31227472,Identifying Patient Readmissions: Are Our Data Sources Misleading?,"BACKGROUND


The accuracy of data is vital to identifying hospitalization outcomes for clinical trials. Patient attrition and recall bias affects the validity of patient-reported outcomes, and the growing prevalence of Medicare Advantage (MA) could mean Fee-for-Service (FFS) claims are less reliable for ascertaining hospital utilization. Statewide health information exchanges (HIEs) may be a more complete data source but have not been frequently used for research.
DESIGN


Secondary analysis comparing identification of readmissions using 3 different acquisition approaches.
SETTING


Randomized controlled trial of heart failure (HF) disease management in 37 skilled nursing facilities (SNFs).
PARTICIPANTS


Patients with HF discharged from the hospital to SNF.
MEASURES


Readmissions up to 60 days post-SNF admission collected by patient self-report, recorded by nursing home (NH) staff during the SNF stay, or recorded in the state HIE.
RESULTS


Among 657 participants (mean age 79 ± 10 years, 49% with FFS), 295 unique readmissions within 60 days of SNF admission were identified. These readmissions occurred among 221 patients. Twenty percent of all readmissions were found using only patient self-report, 28% were only recorded by NH staff during the SNF stay, and 52% were identified only using the HIE. The readmission rate (first readmission only) based only on patient self-report and direct observation was 18% rather than 34% with the addition of the enhanced HIE method.
CONCLUSIONS AND IMPLICATIONS


More than one-quarter (34%) of HF patients were rehospitalized within 60 days post SNF admission. Use of a statewide HIE resulted in identifying an additional 153 admissions, 52% of all the readmissions seen in this study. Without use of an HIE, nearly half of readmissions would have been missed as a result of incomplete patient self-report or loss to follow-up. Thus, HIEs serve as an important resource for researchers to ensure accurate outcomes data.",2019,"The readmission rate (first readmission only) based only on patient self-report and direct observation was 18% rather than 34% with the addition of the enhanced HIE method.
","['37 skilled nursing facilities (SNFs', '657 participants (mean age 79 ± 10\xa0years, 49% with FFS), 295 unique readmissions within 60\xa0days of SNF admission were identified', 'Patients with HF discharged from the hospital to SNF']",[],"['readmission rate (first readmission only) based only on patient self-report and direct observation', 'nursing home (NH) staff during the SNF stay, or recorded in the state HIE']","[{'cui': 'C0037265', 'cui_str': 'Extended Care Facilities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1301808', 'cui_str': 'State'}]",28.0,0.0432695,"The readmission rate (first readmission only) based only on patient self-report and direct observation was 18% rather than 34% with the addition of the enhanced HIE method.
","[{'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado School of Medicine, Aurora, CO. Electronic address: Andrea.Daddato@ucdenver.edu.'}, {'ForeName': 'Blythe', 'Initials': 'B', 'LastName': 'Dollar', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Lum', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado School of Medicine, Aurora, CO; Veterans Affairs Eastern Colorado Geriatric Research Education and Clinical Center, Aurora, CO.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Burke', 'Affiliation': 'Center for Health Equity Research and Promotion, Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Boxer', 'Affiliation': 'Institute for Health Research, Kaiser Permanente, Aurora, CO.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.04.028']
1987,31366275,Effects of acute pain and pain-related fear on risky decision-making and effort during cognitive tests.,"Introduction : The experience of acute pain and pain-related fear negatively impact cognition and behavior; however, little research has examined their impacts on risky decision-making and effort. The present study investigated the effects of acute pain and pain-related fear on risky decision-making and effort during cognitive tests.  Method : Levels of pain-related fear were assessed. Healthy participants ( n  = 146) experienced acute pain induced via cold pressor task, and then were randomly assigned to one of the four conditions to induce pain-related fear: Pain Threat ( n  = 36), Pain Threat with Control ( n  = 39), Cognitive Threat with Control ( n  = 34), and Control ( n  = 36). Participants then completed measures of effort (Word Memory Test [WMT], self-reported effort) and risky decision-making (Iowa Gambling Task [IGT], Balloon Analogue Risk Task [BART]).  Results : Collapsed across condition, participants did not learn to decide advantageously on the IGT following an acute pain experience. During the early trials (1-40) on the IGT, participants in the Pain Threat condition made riskier decisions. Higher levels of pain during the cold pressor task predicted less risky decisions on the BART, and participants in the Cognitive Threat with Control condition made less risky decisions. Participants in the Pain Threat with Control condition self-reported lower effort on cognitive tests, yet no group-based differences were seen in WMT performance. Greater pain-related fear predicted greater self-reported effort and better WMT performance, but no effects were seen on decision-making task performance.  Conclusions : The experience of pain and the threat of additional pain can lead to changes in risky decision-making and effort on cognitive tasks. This threat of additional pain could activate underlying pain-related fear, creating hypervigilance to and avoidance of pain that affects subsequent task performance. Implications for research and clinical evaluation of acute pain and pain-related fear are discussed.",2019,"Participants in the Pain Threat with Control condition self-reported lower effort on cognitive tests, yet no group-based differences were seen in WMT performance.",['Healthy participants ( n  = 146) experienced acute pain induced via cold pressor task'],"['pain-related fear: Pain Threat ( n  = 36), Pain Threat with Control ( n  = 39), Cognitive Threat with Control', 'IGT']","['effort (Word Memory Test [WMT], self-reported effort) and risky decision-making (Iowa Gambling Task [IGT], Balloon Analogue Risk Task [BART', 'risky decisions', 'pain', 'pain-related fear', 'cognitive tests', 'decision-making task performance', 'acute pain and pain-related fear on risky decision-making and effort during cognitive tests', 'WMT performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]",,0.0371482,"Participants in the Pain Threat with Control condition self-reported lower effort on cognitive tests, yet no group-based differences were seen in WMT performance.","[{'ForeName': 'Wesley R', 'Initials': 'WR', 'LastName': 'Barnhart', 'Affiliation': 'Nisonger Center, The Ohio State University , Columbus , Ohio , USA.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': 'Buelow', 'Affiliation': 'Department of Psychology, The Ohio State University Newark , Newark , Ohio , USA.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Trost', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham , Birmingham , Alabama , USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1646711']
1988,31289040,Immunologic Correlates of Pathologic Complete Response to Preoperative Immunotherapy in Hepatocellular Carcinoma.,"In hepatocellular carcinoma (HCC), surgical resection is associated with high recurrence rate, and no effective adjuvant therapy currently exists. We initiated a pilot randomized trial of perioperative immunotherapy with nivolumab and ipilimumab for resectable HCC. Here, we provide an illustrative report of a case that achieved a complete response and report immunologic correlates of this complete pathologic response to perioperative immunotherapy. Clinical response was correlated with an increase in CD8 +  T-cell infiltration, with an increase in two effector T-cell clusters. This study is ongoing, and the final results may contribute to a paradigm shift in the perioperative treatment of HCC, leading to the incorporation of immunotherapy in the curative setting.",2019,"Clinical response was correlated with an increase in CD8+ T-cell infiltration, with an increase in two effector T-cell clusters.",['Hepatocellular Carcinoma'],"['Preoperative Immunotherapy', 'peri-operative immunotherapy with nivolumab and ipilimumab']","['CD8+ T-cell infiltration', 'Clinical response']","[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0246268,"Clinical response was correlated with an increase in CD8+ T-cell infiltration, with an increase in two effector T-cell clusters.","[{'ForeName': 'Ahmed Omar', 'Initials': 'AO', 'LastName': 'Kaseb', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. akaseb@mdanderson.org padsharma@mdanderson.org.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Vence', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Blando', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Shalini S', 'Initials': 'SS', 'LastName': 'Yadav', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Naruhiko', 'Initials': 'N', 'LastName': 'Ikoma', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Roberto Carmagnani', 'Initials': 'RC', 'LastName': 'Pestana', 'Affiliation': 'Department of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jean Nicolas', 'Initials': 'JN', 'LastName': 'Vauthey', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allison', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Immunology, The University of Texas MD Anderson Cancer Center, Houston, Texas. akaseb@mdanderson.org padsharma@mdanderson.org.'}]",Cancer immunology research,['10.1158/2326-6066.CIR-18-0605']
1989,31707634,Acupoint dependence of depressor and bradycardic responses elicited by manual acupuncture stimulation in humans.,"The cardiovascular effects of the autonomic nervous system (ANS) are modulated by inputs from peripheral sensors and other brain regions. However, it currently remains unknown whether the manual acupuncture (MA) stimulation of different acupuncture points evokes different responses by the heart and vasculature, a phenomenon known as ""site specificity"". Sixty healthy subjects were randomly divided into a control group and MA stimulation groups at the lower leg, ear, abdomen, and forearm. MA was performed at 1 Hz for 2 min. A depressor response was observed only in the lower leg stimulation group, in which mean blood pressure significantly decreased from 83.4 ± 10.1 to 80.9 ± 11.7 mmHg (p < 0.003). A bradycardic response was elicited in all MA stimulation groups. There was no significant differences in the magnitude of the bradycardic response between groups. MA-induced cardiovascular responses, which may be mediated by the modulation of ANS, differ depending on acupuncture points.",2019,"A depressor response was observed only in the lower leg stimulation group, in which mean blood pressure significantly decreased from 83.4 ± 10.1 to 80.9 ± 11.7 mmHg (p < 0.003).","['Sixty healthy subjects', 'humans']","['MA', 'manual acupuncture stimulation', 'control group and MA stimulation']","['depressor response', 'bradycardic response', 'mean blood pressure', 'MA-induced cardiovascular responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0180377', 'cui_str': 'Depressor (physical object)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",60.0,0.0354952,"A depressor response was observed only in the lower leg stimulation group, in which mean blood pressure significantly decreased from 83.4 ± 10.1 to 80.9 ± 11.7 mmHg (p < 0.003).","[{'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Nakahara', 'Affiliation': 'Graduate School of Health Sciences, Morinomiya University of Medical Sciences, 1-26-16 Nankokita, Suminoe, Osaka, 559-8611, Japan. nakahara@morinomiya-u.ac.jp.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kawada', 'Affiliation': 'Department of Cardiovascular Dynamics, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan.'}, {'ForeName': 'Shin-Ya', 'Initials': 'SY', 'LastName': 'Ueda', 'Affiliation': 'Department of Physical Education, Faculty of Education, Gifu University, 1-1 Yanagido, Gifu, 501-1193, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Kawai', 'Affiliation': 'Osaka City University Graduate School of Medicine, 3-3-138 Sugimoto Sumiyoshi, Osaka, 558-8585, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiology, Department of Medicine, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Sugimachi', 'Affiliation': 'Department of Cardiovascular Dynamics, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan.'}, {'ForeName': 'Tadayoshi', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Sport and Health Sciences, Faculty of Sport and Health Sciences, Osaka Sangyo University, Wellness 2008, 3-1-1, Nakagaito, Daito, Osaka, 573-1004, Japan.'}]",The journal of physiological sciences : JPS,['10.1007/s12576-019-00728-y']
1990,32087257,The influence of prolonged temperature management on acute kidney injury after out-of-hospital cardiac arrest: A post hoc analysis of the TTH48 trial.,"BACKGROUND


Acute kidney injury (AKI) is common after cardiac arrest and targeted temperature management (TTM). The impact of different lengths of cooling on the development of AKI has not been well studied. In this study of patients included in a randomised controlled trial of TTM at 33 °C for 24 versus 48 h after cardiac arrest (TTH48 trial), we examined the influence of prolonged TTM on AKI and the incidence and factors associated with the development of AKI. We also examined the impact of AKI on survival.
METHODS


This study was a sub-study of the TTH48 trial, which included patients cooled to 33 ± 1 °C after out-of-hospital cardiac arrest for 24 versus 48 h. AKI was classified according to the KDIGO AKI criteria based on serum creatinine and urine output collected until ICU discharge for a maximum of seven days. Survival was followed for up to six months. The association of admission factors on AKI was analysed with multivariate analysis and the association of AKI on mortality was analysed with Cox regression using the time to AKI as a time-dependent covariate.
RESULTS


Of the 349 patients included in the study, 159 (45.5%) developed AKI. There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-h groups. Serum creatinine values had significantly different trajectories for the two groups with a sharp rise occurring during rewarming. Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index were independent predictors of AKI. Patients with AKI had a higher mortality than patients without AKI (hospital mortality 36.5% vs 12.5%, p < 0.001), but only AKI stages 2 and 3 were independently associated with mortality.
CONCLUSIONS


We did not find any association between prolonged TTM at 33 °C and the risk of AKI during the first seven days in the ICU. AKI is prevalent after cardiac arrest and TTM and occurs in almost half of all ICU admitted patients and more commonly in the elderly, with an increasing BMI and longer arrest duration. AKI after cardiac arrest is an independent predictor of time to death.",2020,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","['TTH48 trial, which included patients cooled to 33±1˚C after out-of-hospital cardiac arrest for 24 versus 48hours', '349 patients included in the study, 159 (45.5%) developed AKI', 'acute kidney injury after out-of-hospital cardiac arrest']","['prolonged temperature management', 'TTM']","['higher mortality', 'mortality', 'Serum creatinine values', 'Survival', 'incidence, severity or time to AKI', 'Age, time to return of spontaneous circulation, serum creatinine at admission and body mass index']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",349.0,0.11476,"There was no significant difference in the incidence, severity or time to AKI between the 24- and 48-hour groups.","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Intensive Care, Stavanger University Hospital, Norway. Electronic address: kristian.strand@sus.no.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Critical Care and Anaesthesiology Research Group, Stavanger University Hospital, Stavanger, Norway; Department Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Belgium.'}, {'ForeName': 'Anders Morten', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Centre for Emergency Medicine and Emergency Department, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anni Nørgaard', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-University, Berlin, Germany.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Aalborg University Hospital, and Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet and Dept of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Valdo', 'Initials': 'V', 'LastName': 'Toome', 'Affiliation': 'Department of Intensive Cardiac Care, North Estonia Medical Centre, Tallinn, Estonia.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Paine Medicine, University of Helsinki and Helsinki University Hospital, Finland.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, Helsinki University Hospital, Finland.'}]",Resuscitation,['10.1016/j.resuscitation.2020.01.039']
1991,31878199,Stress Recovery of Campus Street Trees as Visual Stimuli on Graduate Students in Autumn.,"Human stress recovery response to landscapes is under discussion in Chinese settings. The present study aimed to clarify the stress recovery effects of campus street trees on graduate students in autumn. A total of 150 participants (23.75 ± 1.01 years old) completed the Trier Social Stress Test (TSST) and were then randomly assigned to view one of five virtual environments, including the street trees  Sophora japonica ,  Ginkgo biloba ,  Platanus acerifolia ,  Koelreuteria paniculata , and the indoor environment (control). Physiological responses were measured by R-R interval and electroencephalography (EEG). Psychological responses were examined through the state version of the State-Trait Anxiety Inventory (STAI-S) and the Perceived Restorativeness Scale (PRS). Results showed that R-R intervals significantly increased while viewing all street trees. Both alpha and beta brainwave activities while viewing  S. japonica  and  G. biloba  were remarkably higher than those while viewing  P. acerifolia  and  K. paniculata . The STAI-S scores significantly decreased, and the positive PRS scores were registered after viewing street trees. We concluded that a brief virtual visual experience of campus street trees in autumn has stress recovery effects on graduate students, and the different levels of stress recovery are associated with different types of street trees.",2019,Both alpha and beta brainwave activities while viewing  S. japonica  and  G. biloba  were remarkably higher than those while viewing  P. acerifolia  and  K. paniculata .,"['Graduate Students in Autumn', 'A total of 150 participants (23.75 ± 1.01 years old) completed the', 'graduate students in autumn']",['Trier Social Stress Test (TSST'],"['R-R intervals', 'positive PRS scores', 'R-R interval and electroencephalography (EEG', 'Psychological responses', 'Physiological responses', 'state version of the State-Trait Anxiety Inventory (STAI-S) and the Perceived Restorativeness Scale (PRS', 'STAI-S scores']","[{'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}]",150.0,0.020667,Both alpha and beta brainwave activities while viewing  S. japonica  and  G. biloba  were remarkably higher than those while viewing  P. acerifolia  and  K. paniculata .,"[{'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Ren-Lin', 'Initials': 'RL', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Ai-Hua', 'Initials': 'AH', 'LastName': 'Ren', 'Affiliation': 'College of Landscape Architecture and Arts, Northwest A&F University, Shaanxi 712100, China.'}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'Niu', 'Affiliation': 'College of Landscape Architecture and Arts, Northwest A&F University, Shaanxi 712100, China.'}, {'ForeName': 'Yan-Long', 'Initials': 'YL', 'LastName': 'Zhang', 'Affiliation': 'College of Landscape Architecture and Arts, Northwest A&F University, Shaanxi 712100, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17010148']
1992,29546732,Folate supplementation in people with sickle cell disease.,"BACKGROUND


Sickle cell disease (SCD) is a group of disorders that affects haemoglobin, which causes distorted sickle- or crescent-shaped red blood cells. It is characterized by anaemia, increased susceptibility to infections and episodes of pain. The disease is acquired by inheriting abnormal genes from both parents, the combination giving rise to different forms of the disease. Due to increased erythropoiesis in people with SCD, it is hypothesized that they are at an increased risk for folate deficiency. For this reason, children and adults with SCD, particularly those with sickle cell anaemia, commonly take 1 mg of folic acid orally every day on the premise that this will replace depleted folate stores and reduce the symptoms of anaemia. It is thus important to evaluate the role of folate supplementation in treating SCD.
OBJECTIVES


To analyse the efficacy and possible adverse effects of folate supplementation (folate occurring naturally in foods, provided as fortified foods or additional supplements such as tablets) in people with SCD.
SEARCH METHODS


We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also conducted additional searches in both electronic databases and clinical trial registries.Date of last search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register: 17 November 2017.
SELECTION CRITERIA


Randomised, placebo-controlled trials of folate supplementation for SCD.
DATA COLLECTION AND ANALYSIS


Four review authors assessed We used the standard Cochrane-defined methodological procedures.Four review authors independently assessed the eligibility and risk of bias of the included trials and extracted and analysed the data included in the review. The quality of the evidence was assessed using GRADE.
MAIN RESULTS


One trial, undertaken in 1983, was eligible for inclusion in the review. This was a double-blind placebo-controlled quasi-randomised triaI of supplementation of folic acid in people with SCD. A total of 117 children with homozygous sickle cell (SS) disease aged six months to four years of age participated over a one-year period (analysis was restricted to 115 children).Serum folate measures, obtained after trial entry at six and 12 months, were available in 80 of 115 (70%) participants. There were significant differences between the folic acid and placebo groups with regards to serum folate values above 18 µg/L and values below 5 µg/L (low-quality evidence). In the folic acid group, values above 18 µg/L were observed in 33 of 41 (81%) compared to six of 39 (15%) participants in the placebo (calcium lactate) group. Additionally, there were no participants in the folic acid group with serum folate levels below 5 µg/L, whereas in the placebo group, 15 of 39 (39%) participants had levels below this threshold. Haematological indices were measured in 100 of 115 (87%) participants at baseline and at one year. After adjusting for sex and age group, the investigators reported no significant differences between the trial groups with regards to total haemoglobin concentrations, either at baseline or at one year (low-quality evidence). It is important to note that none of the raw data for the outcomes listed above were available for analysis.The proportions of participants who experienced certain clinical events were analysed in all 115 participants, for which raw data were available. There were no statistically significant differences noted; however, the trial was not powered to investigate differences between the folic acid and placebo groups with regards to: minor infections, risk ratio (RR) 0.99 (95% confidence interval (CI) 0.85 to 1.15) (low-quality evidence); major infections, RR 0.89 (95% CI 0.47 to 1.66) (low-quality evidence); dactylitis, RR 0.67 (95% CI 0.35 to 1.27) (low-quality evidence); acute splenic sequestration, RR 1.07 (95% CI 0.44 to 2.57) (low-quality evidence); or episodes of pain, RR 1.16 (95% CI 0.70 to 1.92) (low-quality evidence). However, the investigators reported a higher proportion of repeat dactylitis episodes in the placebo group, with two or more attacks occurring in 10 of 56 participants compared to two of 59 in the folic acid group (P < 0.05).Growth, determined by height-for-age and weight-for-age, as well as height and growth velocity, was measured in 103 of the 115 participants (90%), for which raw data were not available. The investigators reported no significant differences in growth between the two groups.The trial had a high risk of bias with regards to random sequence generation and incomplete outcome data. There was an unclear risk of bias in relation to allocation concealment, outcome assessment, and selective reporting. Finally, There was a low risk of bias with regards to blinding of participants and personnel. Overall the quality of the evidence in the review was low.There were no trials identified for other eligible comparisons, namely: folate supplementation (fortified foods and physical supplementation with tablets) versus placebo; folate supplementation (naturally occurring in diet) versus placebo; folate supplementation (fortified foods and physical supplementation with tablets) versus folate supplementation (naturally occurring in diet).
AUTHORS' CONCLUSIONS


One doubIe-blind, placebo-controlled triaI on folic acid supplementation in children with SCD was included in the review. Overall, the trial presented mixed evidence on the review's outcomes. No trials in adults were identified. With the limited evidence provided, we conclude that, while it is possible that folic acid supplementation may increase serum folate levels, the effect of supplementation on anaemia and any symptoms of anaemia remains unclear.If further trials were conducted, these may add evidence regarding the efficacy of folate supplementation. Future trials should assess clinical outcomes such as folate concentration, haemoglobin concentration, adverse effects and benefits of the intervention, especially with regards to SCD-related morbidity. Such trials should include people with SCD of all ages and both sexes, in any setting. To investigate the effects of folate supplementation, trials should recruit more participants and be of longer duration, with long-term follow-up, than the trial currently included in this review. However, we do not envisage further trials of this intervention will be conducted, and hence the review will no longer be regularly updated.",2018,There were significant differences between the folic acid and placebo groups with regards to serum folate values above 18 µg/L and values below 5 µg/L (low-quality evidence).,"['children with SCD', 'people with sickle cell disease', 'children and adults with SCD, particularly those with sickle cell anaemia', 'people with SCD', '117 children with homozygous sickle cell (SS) disease aged six months to four years of age participated over a one-year period (analysis was restricted to 115 children).Serum folate measures, obtained after trial entry at six and 12 months, were available in 80 of 115 (70%) participants']","['Folate supplementation', 'folic acid supplementation', 'placebo', 'placebo-controlled triaI on folic acid supplementation', 'placebo; folate supplementation', 'SCD', 'folate supplementation', 'placebo; folate supplementation (fortified foods and physical supplementation with tablets) versus folate supplementation', 'placebo (calcium lactate', 'folic acid', 'folic acid and placebo', 'folate supplementation (folate occurring naturally in foods']","['total haemoglobin concentrations', 'serum folate values', 'minor infections, risk ratio (RR) 0.99', 'Haematological indices', 'episodes of pain', 'serum folate levels', 'repeat dactylitis episodes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0076769', 'cui_str': 'TO 115'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0556110', 'cui_str': 'Folic acid supplementation (product)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0016498', 'cui_str': 'Enriched Food'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0108121', 'cui_str': 'calcium 2-hydroxypropanoate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C4517488', 'cui_str': '0.99'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis (disorder)'}]",117.0,0.614977,There were significant differences between the folic acid and placebo groups with regards to serum folate values above 18 µg/L and values below 5 µg/L (low-quality evidence).,"[{'ForeName': 'Ruchita', 'Initials': 'R', 'LastName': 'Dixit', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College, Jalan Batu Hampar, Bukit Baru, Melaka, Malaysia, 75150.'}, {'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Nettem', 'Affiliation': ''}, {'ForeName': 'Simerjit S', 'Initials': 'SS', 'LastName': 'Madan', 'Affiliation': ''}, {'ForeName': 'Htoo Htoo Kyaw', 'Initials': 'HHK', 'LastName': 'Soe', 'Affiliation': ''}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': ''}, {'ForeName': 'Leah D', 'Initials': 'LD', 'LastName': 'Vance', 'Affiliation': ''}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Stover', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011130.pub3']
1993,31553946,Effectiveness of the 5A's Model for Changing Physical Activity Behaviors in Rural Adults Recruited From Primary Care Clinics.,"BACKGROUND


Most rural adults do not meet current guidelines for physical activity (PA). A 12-week feasibility study tested the effectiveness of using the 5A's model for PA counseling on rural adults' PA behaviors.
METHODS


Inactive rural adults recruited from a primary care clinic were randomized to an intervention (n = 30) or control (n = 29) group. All subjects wore a Fitbit to track steps and active minutes. The intervention group completed action plans to improve self-regulatory PA strategies and received weekly motivational text messages to improve PA behaviors. Theory of planned behavior constructs and self-regulatory strategies of planning, goal setting, and tracking (steps and active minutes) were measured with both groups. The control group received the Fitbit only.
RESULTS


All individuals became more physically active; however, no significant differences between groups in active minutes or steps were found. All subjects, regardless of group, increased steps (P > .05). There were no statistically significant differences between groups on any of the theoretical variables.
CONCLUSIONS


It is vitally important to continue to find ways to make PA a priority to improve the overall health and well-being of rural adults. Future research warrants adjusting the intervention dose and strategies to increase PA that can be maintained long term.",2019,"All subjects, regardless of group, increased steps (P > .05).","[""rural adults' PA behaviors"", 'Inactive rural adults recruited from a primary care clinic', 'Rural Adults Recruited From Primary Care Clinics', 'rural adults']","[""5A's model for PA counseling"", 'action plans to improve self-regulatory PA strategies and received weekly motivational text messages', ""5A's Model""]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0202682,"All subjects, regardless of group, increased steps (P > .05).","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Reed', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Estabrooks', 'Affiliation': ''}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Heelan', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wichman', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0477']
1994,31856749,Modified regional citrate anticoagulation is optimal for hemodialysis in patients at high risk of bleeding: a prospective randomized study of three anticoagulation strategies.,"BACKGROUND


Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca 2+  containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk.
METHOD


In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-2 and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-2 and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded.
RESULTS


Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively). The median circuit survival time was 240 min (IQR 240 to 240) in the RCA-two group, was significantly longer than 230 min (IQR 155 to 240, P < 0.001) in the RCA-one group and 210 min (IQR 135 to 240, P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P > 0.05.
CONCLUSIONS


Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding.
TRIAL REGISTRATION


GDREC, GDREC2017250H. Registered February 2, 2018; retrospectively registered.",2019,"RESULTS


Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively).","['patients at high risk of bleeding', '52 HD patients (77 sessions', 'HD patients with a high bleeding risk', 'hemodialysis in patients at high risk of bleeding', 'hemodialysis (HD) patients at high risk of bleeding with heparin contraindication', 'group in part one of the trial, and 45 patients (64 sessions']","['RCA-2 and RCA-one', 'saline flushing or RCA', 'RCA', 'Regional citrate anticoagulation (RCA', 'Modified regional citrate anticoagulation', 'RCA-2 and saline']","['Serious clotting events, adverse events and blood analyses', 'efficacy and safety', 'hypotension, hypoglycemia and chest tightness', 'median circuit survival time', 'Serious clotting events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4039184', 'cui_str': 'High risk of hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0610301', 'cui_str': 'RCA II'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005768'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0232292', 'cui_str': 'Tight chest (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",52.0,0.0396148,"RESULTS


Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P < 0.001, respectively).","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Renwei', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shuifu', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qizhan', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Hemodialysis, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xingbo', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Department of Hemodialysis, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yuchi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Hemodialysis, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yuanhan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Huaban', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Jianchao', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhonglin', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shuangxin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. 13543456446@163.com.""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. xinlingliang_ggh@163.com.""}]",BMC nephrology,['10.1186/s12882-019-1661-y']
1995,31665610,The effects of aerobic exercise intensity on memory in older adults.,"Aerobic exercise may enhance memory in older adults. However, the optimal intensity and underlying mechanism are unclear. This community-based study examined the effect of aerobic exercise intensity on memory and general cognitive abilities. Brain-derived neurotrophic factor (BDNF) was examined as a potential mechanism. Sixty-four sedentary older adults participated in 1 of 3 groups: ( i ) high-intensity interval training (HIIT); ( ii ) moderate continuous training (MCT); or ( iii ) stretching control (CON). Prior to and following the intervention, high-interference memory was assessed using a Mnemonic Similarity task and executive functions were assessed using Go Nogo and Flanker tasks. HIIT led to the greatest memory performance compared with MCT and CON ( F [2,55]  = 6.04,  p  = 0.004) and greater improvements in memory correlated with greater increases in fitness ( r s  (46) = 0.27,  p  = 0.03). Exercise intensity seemed to matter less for executive functioning, as positive trends were observed for both HIIT and MCT. No significant differences in BDNF were found between groups. Overall, these results suggest that aerobic exercise may enhance memory in older adults, with the potential for higher intensity exercise to yield the greatest benefit. While our findings suggest that BDNF does not regulate these adaptations, the mechanisms remain to be determined.  Novelty  High-intensity interval training results in the greatest memory performance in inactive older adults compared with moderate continuous training or stretching. Improvement in fitness correlates with improvement in memory performance.",2019,"HIIT led to the greatest memory performance compared to MCT and CON [F(2, 55) =","['Sixty-four sedentary older adults participated in one of three groups: 1', 'older adults', 'inactive older adults']","['BDNF', 'moderate continuous training or stretching •', 'high-intensity interval training (HIIT); 2) moderate continuous training (MCT); or 3) stretching control (CON', 'Novelty bullets: • High-intensity interval training', 'Aerobic exercise', 'aerobic exercise', 'aerobic exercise intensity']","['Mnemonic Similarity task and executive functions', 'memory and general cognitive abilities', 'memory performance', 'BDNF']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",64.0,0.0408448,"HIIT led to the greatest memory performance compared to MCT and CON [F(2, 55) =","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Fenesi', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Paolucci', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Heisz', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON L8S 4K1, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0495']
1996,31150063,Quantification of the Capacity for Cold-Induced Thermogenesis in Young Men With and Without Obesity.,"OBJECTIVE


Cold exposure increases energy expenditure (EE) and could have a role in combating obesity. To understand this potential, we determined the capacity for cold-induced thermogenesis (CIT), the EE increase above the basal metabolic rate at the individualized coldest tolerable temperature before overt shivering.
DESIGN


During a 13-day inpatient protocol, we quantitated the EE of 12 lean men and 9 men with obesity at various randomly ordered ambient temperatures in a room calorimeter. Subjects underwent brown fat imaging after exposure to their coldest tolerable temperature.
RESULTS


CIT capacity was 300 ± 218 kcal/d (mean ± SD) or 17 ± 11% in lean men and 125 ± 146 kcal/d or 6 ± 7% in men with obesity (P = 0.01). The temperature below which EE increased, lower critical temperature (Tlc), was warmer in lean men than men with obesity (22.9 ± 1.2 vs 21.1 ± 1.7°C, P = 0.03), but both had similar skin temperature (Tskin) changes and coldest tolerable temperatures. Whereas lean subjects had higher brown fat activity, skeletal muscle activity increased synchronously with CIT beginning at the Tlc in both groups, indicating that muscle is recruited for CIT in parallel with brown fat, not sequentially after nonshivering thermogenesis is maximal.
CONCLUSIONS


Despite greater insulation from fat, men with obesity had a narrower range of tolerable cool temperatures available for increasing EE and less capacity for CIT than lean men, likely as a result of greater basal heat production and similar perception to Tskin cooling. Further study of the reduced CIT capacity in men with obesity may inform treatment opportunities for obesity.",2019,"While lean subjects had higher brown fat activity, skeletal muscle activity increased synchronously with CIT beginning at the lower critical temperature in both groups, indicating that muscle is recruited for CIT in parallel with brown fat, not sequentially after non-shivering thermogenesis is maximal.
","['young men with and without obesity', '12 lean men and 9 men with obesity at various randomly ordered ambient temperatures in a room calorimeter', 'men with obesity']",[],"['skin temperature changes and coldest tolerable temperatures', 'CIT capacity', 'temperature below which energy expenditure', 'brown fat activity, skeletal muscle activity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0542496', 'cui_str': 'Ambient temperature (observable entity)'}]",[],"[{'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0006298', 'cui_str': 'Brown Fat'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]",12.0,0.0209791,"While lean subjects had higher brown fat activity, skeletal muscle activity increased synchronously with CIT beginning at the lower critical temperature in both groups, indicating that muscle is recruited for CIT in parallel with brown fat, not sequentially after non-shivering thermogenesis is maximal.
","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brychta', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Brooks P', 'Initials': 'BP', 'LastName': 'Leitner', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jacob D', 'Initials': 'JD', 'LastName': 'Hattenbach', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Bell', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fletcher', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Perron Wood', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Idelson', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Duckworth', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGehee', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Courville', 'Affiliation': 'Nutrition Department, Hatfield Clinical Research Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shanna B', 'Initials': 'SB', 'LastName': 'Bernstein', 'Affiliation': 'Nutrition Department, Hatfield Clinical Research Center, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Reitman', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Cypess', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00728']
1997,30898323,Cost-effectiveness of individual versus group female-specific cognitive behavioral therapy for alcohol use disorder.,"OBJECTIVE


To determine the relative cost-effectiveness of individual female-specific cognitive behavioral therapy (I-FS-CBT) versus group female-specific cognitive behavioral therapy (G-FS-CBT).
METHODS


This cost-effectiveness study is based on a randomized controlled trial in which 155 women seeking treatment for alcohol use disorder at an academic outpatient clinic were randomized to 12 manual-guided sessions of I-FS-CBT (n = 75) or G-FS-CBT (n = 80). The primary patient outcomes were the number of drinking days and the number of heavy drinking days during the 12-week treatment and 1-year follow-up periods. All cost data (including resource utilizations) were collected prospectively alongside the trial. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were used to determine the cost-effectiveness of I-FS-CBT relative to G-FS-CBT. Results are presented from the provider perspective.
RESULTS


During the 12-week treatment period, G-FS-CBT is likely to be cost-effective when the threshold value to decision-makers of one fewer drinking day (or one fewer day of heavy drinking) is less than $141 (or $258), and I-FS-CBT is likely to be cost-effective if the threshold is greater than $141 (or $258). During the 1-year follow-up period, G-FS-CBT is likely to be cost-effective when the threshold value to decision-makers of one fewer drinking day (or one fewer day of heavy drinking) is less than $54 (or $169), and I-FS-CBT is likely to be cost-effective if the threshold is greater than $54 (or $169). The results are robust to sensitivity analyses on several key cost parameters.
CONCLUSIONS


Compared to I-FS-CBT, G-FS-CBT holds promise as a cost-effective approach, in both the short run and the long run, for improving drinking outcomes of women with alcohol use disorder.",2019,The primary patient outcomes were the number of drinking days and the number of heavy drinking days during the 12-week treatment and 1-year follow-up periods.,"['women with alcohol use disorder', '155 women seeking treatment for alcohol use disorder at an academic outpatient clinic']","['12 manual-guided sessions of I-FS-CBT (n\u202f=\u202f75) or G-FS-CBT', 'individual versus group female-specific cognitive behavioral therapy', 'individual female-specific cognitive behavioral therapy (I-FS-CBT) versus group female-specific cognitive behavioral therapy (G-FS-CBT']","['number of drinking days and the number of heavy drinking days', 'Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves', 'Cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",155.0,0.0217427,The primary patient outcomes were the number of drinking days and the number of heavy drinking days during the 12-week treatment and 1-year follow-up periods.,"[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'Lyndon B. Johnson School of Public Affairs, The University of Texas at Austin, 2300 Red River Street, Austin, TX 78713, United States of America. Electronic address: tolmstead@austin.utexas.edu.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Graff', 'Affiliation': 'War Related Illness and Injury Study Center, VA NJ Healthcare System, 385 Tremont Ave., East Orange, NJ 07018, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Ames-Sikora', 'Affiliation': 'Department of Psychology, Georgia State University, 140 Decatur Street SE, Atlanta, GA 30302, United States of America. Electronic address: aames3@gsu.edu.'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'McCrady', 'Affiliation': 'Center of Alcohol Studies, Rutgers University, 607 Allison Road, Piscataway, NJ 08854, United States of America; Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America. Electronic address: bmccrady@unm.edu.'}, {'ForeName': 'Ayorkor', 'Initials': 'A', 'LastName': 'Gaba', 'Affiliation': 'Center of Alcohol Studies, Rutgers University, 607 Allison Road, Piscataway, NJ 08854, United States of America; Department of Psychiatry, University of Massachusetts Medical School, 365 Plantation Street, Worcester, MA 01605, United States of America. Electronic address: ayorkor.gaba@umassmed.edu.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Center of Alcohol Studies, Rutgers University, 607 Allison Road, Piscataway, NJ 08854, United States of America; Department of Psychiatry, University of Massachusetts Medical School, 365 Plantation Street, Worcester, MA 01605, United States of America. Electronic address: Elizabeth.Epstein@umassmed.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.02.001']
1998,31146022,The Trials within Cohorts design faced methodological advantages and disadvantages in the exercise oncology setting.,"OBJECTIVES


The Trials within Cohorts (TwiCs) design is an alternative for pragmatic randomized controlled trials (RCTs) and might overcome disadvantages such as difficult recruitment, dropout after randomization to control, and contamination. We investigated the applicability of the TwiCs design in an exercise oncology study regarding the recruitment process, representativeness of the study sample, contamination, participation, and dropout.
METHODS


The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA) Fit TwiCs evaluates an exercise intervention in inactive breast cancer patients. Eligible patients participating in the prospective UMBRELLA were identified and randomized. Patients randomized to the intervention (n = 130) were offered the intervention, whereas controls (n = 130) were not informed.
RESULTS


Fifty-two percent (n = 68) accepted the intervention. Because this rate was lower than expected, a larger sample size was required than initially estimated (n = 166). However, recruitment of 260 patients was still completed by one researcher within 30 months. Unselective eligibility screening and randomization before invitation improved representativeness. Disadvantage of the design might be inclusion of ineligible patients when cohort information is limited. Furthermore, the design faced higher noncompliance in the intervention group, but prevention of contamination.
CONCLUSION


The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.",2019,"The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.","['260 patients was still completed by one researcher within 30\xa0months', 'Eligible patients participating in the prospective', 'inactive breast cancer patients']",['exercise intervention'],[],"[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],260.0,0.0542404,"The TwiCs design improved logistics in recruitment and prevented contamination, but noncompliance due to refusal of the intervention was higher compared with conventional pragmatic exercise oncology RCTs, which may dilute the estimated intervention effect.","[{'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Carla H', 'Initials': 'CH', 'LastName': 'van Gils', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rolf H H', 'Initials': 'RHH', 'LastName': 'Groenwold', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Desirée H J G', 'Initials': 'DHJG', 'LastName': 'van den Bongard', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Petra H M', 'Initials': 'PHM', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Department of Clinical Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: A.M.May@umcutrecht.nl.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.05.017']
1999,31477359,Normal Saline Trigger Point Injections vs Conventional Active Drug Mix for Myofascial Pain Syndromes.,"BACKGROUND


Myofascial pain syndrome (MPS) originates in the muscle and fascia. MPS presents with referred pain specific for each muscle and a trigger point that reproduces the symptoms. Trigger-point-injection (TPI) is an effective approach to treating MPS. Some TPI agents, however, are associated with systemic and local side effects.
OBJECTIVE


The aim of this study was to evaluate the effectiveness of TPI with a conventional active drug mixture (CADM) vs. that with normal saline solution (NS) alone in patients with MPS presenting to the emergency department (ED).
METHODS


Adults with MPS diagnosed in the ED, participants were randomly assigned to receive TPI with NS or with CADM. Pain intensity was scored using a 0-10 numeric rating scale prior to and after TPI, before discharge and 2 weeks after TPI.
RESULTS


Among 48 patients analyzed, 23 received TPI with NS. The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM). At 2-week follow up, the mean pain scores were 4.29 (NS) and 4.14 (CADM). Pain was significantly reduced after TPI in both groups. At 2 weeks, the mean pain scores were similar between the groups. No adverse events were reported.
CONCLUSION


In cases of MPS in the ED, pain can be controlled with TPI independent of the injectate. TPI with NS may be preferred over CADM because of its lower cost and more favorable side effect profile.",2020,"The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM).","['patients with MPS presenting to the emergency department (ED', '48 patients analyzed, 23 received TPI with NS', 'patients with myofascial pain syndromes', 'Adults with MPS diagnosed in the ED, participants']","['normal saline (NS) and conventional active drug mix (CADM', 'TPI with a conventional active drug mixture (CADM) vs. that with normal saline solution (NS) alone', 'Trigger-point-injection (TPI', 'MPS', 'TPI with NS or with CADM']","['Pain intensity', 'Pain', 'adverse events', 'mean pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0027073', 'cui_str': 'Myofascial Pain Syndromes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points (procedure)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",48.0,0.111465,"The mean pain scores were as follows: immediately before TPI, 7.59 (NS) and 7.44 (CADM); immediately after TPI, 2.22 (NS) and 1.76 (CADM); prior to discharge, 1.52 (NS) and 1.76 (CADM).","[{'ForeName': 'Carlos J', 'Initials': 'CJ', 'LastName': 'Roldan', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA. Electronic address: croldan@mdanderson.org.'}, {'ForeName': 'Uzondu', 'Initials': 'U', 'LastName': 'Osuagwu', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marylou', 'Initials': 'M', 'LastName': 'Cardenas-Turanzas', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Billy K', 'Initials': 'BK', 'LastName': 'Huh', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158410']
2000,30775818,A walk on water: comparing the influence of Ai Chi and Tai Chi on fall risk and verbal working memory in ageing people with intellectual disabilities - a randomised controlled trial.,"BACKGROUND


Aquatic motor intervention has been found to be effective in reducing falls and improving verbal working memory among the general population. However, effects among older adults with intellectual disabilities (ID) have never been explored. The aim of this study was to examine the effects of aquatic motor intervention on fall risk and verbal working memory among older adults with ID.
METHODS


Forty-one older adults with mild to moderate ID (age: 50-66 years) were randomly assigned to 14 weeks of aquatic motor intervention (Ai Chi: N = 19) or identical on-land motor intervention (Tai Chi: N = 22). Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory, measured with the digit span forward test, were assessed pre-intervention, after 7 weeks of intervention and post-intervention.
RESULTS


Study results indicate positive effects of both aquatic and on-land motor intervention on TBAT fall risk score, while the aquatic motor intervention group improved TBAT fall risk score quicker as compared with the on-land motor intervention group. Moreover, the lower the pre-intervention TBAT score was, the higher the improvement. In addition, study findings support the positive effects of aquatic motor intervention on verbal working memory ability as measured with the digit span forward test.
CONCLUSIONS


Motor intervention, and particularly in an aquatic environment, can potentially reduce fall risk. Aquatic motor intervention may help to improve verbal working memory among older adults with ID.",2019,"Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory, measured with the digit span forward test, were assessed pre-intervention, after 7 weeks of intervention and post-intervention.
","['older adults with intellectual disabilities (ID', 'older adults with ID', 'ageing people with intellectual disabilities ', 'Forty-one older adults with mild to moderate ID (age: 50-66\xa0years']","['aquatic motor intervention', 'Aquatic motor intervention', 'Ai Chi and Tai Chi', 'aquatic motor intervention (Ai Chi: N\xa0=\xa019) or identical on-land motor intervention (Tai Chi: N\xa0=\xa022']","['fall risk and verbal working memory', 'verbal working memory', 'pre-intervention TBAT score', 'Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory', 'TBAT fall risk score', 'TBAT fall risk score quicker', 'verbal working memory ability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1960377', 'cui_str': 'Assessment of sense of balance (procedure)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",41.0,0.0265963,"Fall risk, measured with the Tinetti balance assessment tool (TBAT), and verbal working memory, measured with the digit span forward test, were assessed pre-intervention, after 7 weeks of intervention and post-intervention.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nissim', 'Affiliation': 'The Gonda Multidisciplinary Brain Research Center, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hutzler', 'Affiliation': 'The Academic College at Wingate, Netanya, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'The Gonda Multidisciplinary Brain Research Center, Bar-Ilan University, Ramat-Gan, Israel.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12602']
2001,30958543,Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial.,"BACKGROUND


The Sabin strain-based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries.
METHODS


The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60-90 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively.
RESULTS


A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P < .01); 94.8% and 84.0%, respectively, for type 2 (P < .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P < .01).
CONCLUSIONS


The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
CLINICAL TRIALS REGISTRATION


NCT03526978.",2019,"The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
","['A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population', 'A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population', '1200 healthy infants aged 60-90 days']","['Sabin strain-based inactivated polio vaccine (sIPV', 'Sabin Strain-Based Inactivated Polio Vaccine', 'IPV', 'sIPV']","['Immunogenicity and Safety', 'Seroconversion rates', 'Immunogenicity and safety outcomes']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",1200.0,0.508302,"The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
","[{'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Vaccine Evaluation, Nanjing.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Research, Sinovac Biotech, Beijing.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Vaccine Evaluation, Nanjing.'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Center of Research and Development, Sinovac Biotech, Beijing.'}, {'ForeName': 'Fengdong', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Guanyun County Center for Disease Control and Prevention, Guanyun.'}, {'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'Ying', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Pizhou County Center for Disease Control and Prevention, Pizhou, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Office of the Deputy Director, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Office of the General Manager, Sinovac Biotech, Beijing.'}]",The Journal of infectious diseases,['10.1093/infdis/jiy736']
2002,31868916,Fine-Needle Aspiration for the Evaluation of Hepatic Pharmacokinetics of Vaniprevir: A Randomized Trial in Patients With Hepatitis C Virus Infection.,"Fine-needle aspiration (FNA) for serial hepatic sampling may be an efficient and less invasive alternative to core needle biopsy (CNB), the current standard for liver tissue sampling. In this randomized, open-label trial in 31 participants with hepatitis C virus genotype 1 infection (NCT01678131/Merck protocol PN048), we evaluated the feasibility of using FNA to obtain human liver tissue samples appropriate for measuring hepatic pharmacokinetics (PK), using vaniprevir as a tool compound. The primary end point was successful retrieval of liver tissue specimens with measurable vaniprevir concentrations at two of three specified FNA time points. Twenty-nine patients met the primary end point and, therefore, were included in the PK analyses. Hepatic vaniprevir concentrations obtained with FNA were consistent with known vaniprevir PK properties. The shape of liver FNA and CNB concentration-time profiles were comparable. In conclusion, FNA may be effective for serial tissue sampling to assess hepatic drug exposure in patients with liver disease.",2020,The shape of liver FNA and CNB concentration-time profiles were comparable.,"['31 participants with hepatitis C virus genotype 1 infection (NCT01678131/Merck protocol PN048', 'Patients With Hepatitis C Virus Infection', 'patients with liver disease', 'Twenty-nine patients met the primary endpoint and therefore were included in the PK analyses']","['Fine-needle aspiration (FNA', 'Fine-Needle Aspiration', 'FNA']","['shape of liver FNA and CNB concentration-time profiles', 'Hepatic vaniprevir concentrations', 'successful retrieval of liver tissue specimens with measurable vaniprevir concentrations']","[{'cui': 'C3532919', 'cui_str': 'Hepatitis C virus genotype 1'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}]","[{'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2931927'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0736268', 'cui_str': 'Structure of parenchyma of liver'}]",31.0,0.0303212,The shape of liver FNA and CNB concentration-time profiles were comparable.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Webber', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Maxwell', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Luzelena', 'Initials': 'L', 'LastName': 'Caro', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'André M M', 'Initials': 'AMM', 'LastName': 'Miltenburg', 'Affiliation': 'Merck Sharp & Dohme, Oss, The Netherlands.'}, {'ForeName': 'Serghei', 'Initials': 'S', 'LastName': 'Popa', 'Affiliation': 'Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Republic of Moldova.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Van Dyck', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Wenning', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mangin', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fandozzi', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Railkar', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Norah J', 'Initials': 'NJ', 'LastName': 'Shire', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Fraser', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Howell', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Talal', 'Affiliation': 'University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, New Jersey, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1737']
2003,31148196,Altered erythroid-related miRNA levels as a possible novel biomarker for detection of autologous blood transfusion misuse in sport.,"BACKGROUND


Autologous blood transfusion (ABT) is a performance-enhancing method prohibited in sport; its detection is a key issue in the field of anti-doping. Among novel markers enabling ABT detection, microRNAs (miRNAs) might be considered a promising analytical tool.
STUDY DESIGN AND METHODS


We studied the changes of erythroid-related microRNAs following ABT, to identify novel biomarkers. Fifteen healthy trained males were studied from a population of 24 subjects, enrolled and randomized into a Transfusion (T) and a Control (C) group. Seriated blood samples were obtained in the T group before and after the two ABT procedures (withdrawal, with blood refrigerated or cryopreserved, and reinfusion), and in the C group at the same time points. Traditional hematological parameters were assessed. Samples were tested by microarray analysis of a pre-identified set of erythroid-related miRNAs.
RESULTS


Hematological parameters showed moderate changes only in the T group, particularly following blood withdrawal. Among erythroid-related miRNAs tested, following ABT a pool of 7 miRNAs associated with fetal hemoglobin and regulating transcriptional repressors of gamma-globin gene was found stable in C and differently expressed in three out of six T subjects in the completed phase of ABT, independently from blood conservation. Particularly, two or more erythropoiesis-related miRNAs within the shortlist constituted of miR-126-3p, miR-144-3p, miR-191-3p, miR-197-3p, miR-486-3p, miR-486-5p, and miR-92a-3p were significantly upregulated in T subjects after reinfusion, with a person-to-person variability but with congruent changes.
CONCLUSIONS


This study describes a signature of potential interest for ABT detection in sports, based on the analysis of miRNAs associated with erythroid features.",2019,"RESULTS


Hematological parameters showed moderate changes only in the T group, particularly following blood withdrawal.","['Fifteen healthy trained males were studied from a population of 24 subjects, enrolled and randomized into a Transfusion (T) and a Control (C) group']",['Autologous blood transfusion (ABT'],"['fetal hemoglobin and regulating transcriptional repressors of gamma-globin gene', 'Seriated blood samples']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005842', 'cui_str': 'Autotransfusion'}]","[{'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0017033', 'cui_str': 'gamma-Globins'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",15.0,0.0355977,"RESULTS


Hematological parameters showed moderate changes only in the T group, particularly following blood withdrawal.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gasparello', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, Section of Sport Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Papi', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Lampronti', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Lucia Carmela', 'Initials': 'LC', 'LastName': 'Cosenza', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Fabbri', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Bianchi', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Zambon', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, Section of Sport Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Dalla Corte', 'Affiliation': 'Immunohematological and Transfusional Service, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Govoni', 'Affiliation': 'Immunohematological and Transfusional Service, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Reverberi', 'Affiliation': 'Immunohematological and Transfusional Service, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, Section of Sport Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gambari', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Finotti', 'Affiliation': 'Department of Life Sciences and Biotechnologies, Section of Biochemistry and Molecular Biology, University of Ferrara, Ferrara, Italy.'}]",Transfusion,['10.1111/trf.15383']
2004,31703570,Paris MEM: a study protocol for an effectiveness and efficiency trial on the treatment of traumatic stress in France after the 2015-16 terrorist attacks.,"BACKGROUND


The Paris and Nice terrorist attacks affected a thousand of trauma victims and first-line responders. Because there were concerns that this might represent the first of several attacks, there was a need to quickly enhance the local capacities to treat a large number of individuals suffering from trauma-related disorders. Since Reconsolidation Therapy (RT) is brief, relatively easy to learn, well tolerated and effective, it appeared as the ideal first-line treatment to teach to clinicians in this context.
METHODS


This study protocol is a two-arm non-randomized, multicenter controlled trial, comparing RT to treatment as usual for the treatment of trauma-related disorders. RT consists of actively recalling one's traumatic event under the influence of the ß-blocker propranolol, once a week, for 10-25 min with a therapist, over 6 consecutive weeks. This protocol evaluates the feasibility, effectiveness, and cost-utility of implementing RT as part of a large multi-center (N = 400) pragmatic trial with a one-year follow-up.
DISCUSSION


Paris MEM is the largest trial to date assessing the efficiency of RT in the aftermath of a large-scale man-made disaster. RT could possibly reinforce the therapeutic arsenal for the treatment of patients suffering from trauma-related disorders, not only for communities in western countries but also worldwide for terror- or disaster-stricken communities.
TRIAL REGISTRATION


Clinical Trials (ClinicalTrials.gov). June 3, 2016. NCT02789982.",2019,"RT could possibly reinforce the therapeutic arsenal for the treatment of patients suffering from trauma-related disorders, not only for communities in western countries but also worldwide for terror- or disaster-stricken communities.
","['trauma-related disorders', 'traumatic stress in France after the 2015-16 terrorist attacks']","['Paris MEM', 'RT', 'Reconsolidation Therapy (RT']","['feasibility, effectiveness, and cost-utility']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]","[{'cui': 'C0331677', 'cui_str': 'Paris (organism)'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0375986,"RT could possibly reinforce the therapeutic arsenal for the treatment of patients suffering from trauma-related disorders, not only for communities in western countries but also worldwide for terror- or disaster-stricken communities.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brunet', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ayrolles', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gambotti', 'Affiliation': ""Département de Psychiatrie adulte, Hôpital Universitaire de la Pitié Salpêtrière, Assistance Publique - Hôpitaux de Paris, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maatoug', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Estellat', 'Affiliation': ""Département de Psychiatrie adulte, Hôpital Universitaire de la Pitié Salpêtrière, Assistance Publique - Hôpitaux de Paris, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Descamps', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Girault', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kalalou', 'Affiliation': 'Unité de recherche clinique, EPS de Ville Evrard, G03, 5 rue du Dr Delafontaine, 93200, Saint-Denis, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Abgrall', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris -, Hôtel-Dieu, 75004, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ducrocq', 'Affiliation': 'France CHRU de Lille, Pôle de Psychiatrie Médecine Légale et Santé en milieu Pénitentiaire, SCA-Lab CNRS UMR 9193, 59037 cedex, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vaiva', 'Affiliation': 'France CHRU de Lille, Pôle de Psychiatrie Médecine Légale et Santé en milieu Pénitentiaire, SCA-Lab CNRS UMR 9193, 59037 cedex, Lille, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jaafari', 'Affiliation': 'CIC INSERM U802, CHU de Poitiers, Unité de recherche clinique intersectorielle en psychiatrie du Centre Hospitalier Henri Laborit, 86022, Poitiers, France.'}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': 'Krebs', 'Affiliation': 'Centre Hospitalier Sainte Anne, Service Hospitalo-Universitaire, Faculté de Médecine Paris Descartes, Université Paris Descartes, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castaigne', 'Affiliation': 'Service de Psychiatrie, CHU de Bicêtre, HUPS, APHP 78, rue du général Leclerc, 94270, Le Kremlin Bicêtre, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hanafy', 'Affiliation': 'CH Marne La Vallée, Service de Médecine Légale, 77420, Marne-La-Vallée, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Benoit', 'Affiliation': ""Clinical Neuroscience Department Hospital Pasteur 1, France University of Côte d'Azur, 30 avenue de la voie, 06002 NICE cedex 1, Romaine, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mouchabac', 'Affiliation': ""Département de psychiatrie et de psychologie médicale de l'adulte, Hôpital universitaire Saint-Antoine, Université Pierre et Marie Curie, Paris VI - AP-HP, 184 rue du Faubourg-Saint-Antoine, 75012, Paris, France.""}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Cabié', 'Affiliation': ""Pôle Paris 11 Les Hôpitaux de Saint Maurice, 12-14 rue Val d'Osne, 94410, St Maurice, France.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Guillin', 'Affiliation': 'Service Hospitalo-universitaire, CH du Rouvray, 4 rue Paul Eluard, 76300, Sotteville-lès-Rouen, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hodeib', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'ECEVE, UMR 1123 URCEco Ile de France Hôtel Dieu, 1 place du Parvis de Notre Dame, 75004, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Millet', 'Affiliation': ""Département de Psychiatrie adulte, boulevard de l'Hôpital, 75013, Paris, France. b.millet@aphp.fr.""}]",BMC psychiatry,['10.1186/s12888-019-2283-4']
2005,30861061,"Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial.","BACKGROUND


ZTI-01 (fosfomycin for injection) is an epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has broad in vitro spectrum of activity, including multidrug-resistant Gram-negative pathogens, and is being developed for treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) in the United States.
METHODS


Hospitalized adults with suspected or microbiologically confirmed cUTI/AP were randomized 1:1 to 6 g ZTI-01 q8h or 4.5 g intravenous (IV) piperacillin-tazobactam (PIP-TAZ) q8h for a fixed 7-day course (no oral switch); patients with concomitant bacteremia could receive up to 14 days.
RESULTS


Of 465 randomized patients, 233 and 231 were treated with ZTI-01 and PIP-TAZ, respectively. In the microbiologic modified intent-to-treat (m-MITT) population, ZTI-01 met the primary objective of noninferiority compared with PIP-TAZ with overall success rates of 64.7% (119/184 patients) vs 54.5% (97/178 patients), respectively; treatment difference was 10.2% (95% confidence interval [CI]: -0.4, 20.8). Clinical cure rates at test of cure (TOC, day 19-21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively). In post hoc analysis using unique pathogens typed by pulsed-field gel electrophoresis, overall success rates at TOC in m-MITT were 69.0% (127/184) for ZTI-01 versus 57.3% (102/178) for PIP-TAZ (difference 11.7% 95% CI: 1.3, 22.1). ZTI-01 was well tolerated. Most treatment-emergent adverse events, including hypokalemia and elevated serum aminotransferases, were mild and transient.
CONCLUSIONS


ZTI-01 was effective for treatment of cUTI including AP and offers a new IV therapeutic option with a differentiated MOA for patients with serious Gram-negative infections.
CLINICAL TRIAL REGISTRATION


NCT02753946.",2019,"Clinical cure rates at test-of-cure (TOC, Day 19-21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively).","['Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP', 'Hospitalized adults with suspected or microbiologically confirmed cUTI/AP', 'patients with serious Gramnegative infections', 'Of 465 randomized patients, 233 and 231 were treated with ZTI-01 and PIP-TAZ, respectively']","['ZEUS', 'PIP-TAZ', 'ZTI-01 q8h or 4.5 g IV piperacillin-tazobactam (PIP-TAZ', 'Fosfomycin for injection (ZTI-01) vs Piperacillin-Tazobactam (PIP-TAZ']","['overall success rates', 'Clinical cure rates', 'hypokalemia and elevated serum aminotransferases', 'tolerated']","[{'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin / tazobactam'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",465.0,0.178605,"Clinical cure rates at test-of-cure (TOC, Day 19-21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively).","[{'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Louis B', 'Initials': 'LB', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Warren Alpert Medical School of Brown University and Rhode Island Hospital and The Miriam Hospital, Providence.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Dane', 'Affiliation': 'DaneStat Consulting, Alderly Edge, United Kingdom.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Stus', 'Affiliation': 'Municipal Institution Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine, Dnipro.'}, {'ForeName': 'Olexiy', 'Initials': 'O', 'LastName': 'Sagan', 'Affiliation': 'Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia, Regional Council Department of Urology, State Institution Zaporizhzhia Medical Academy of Postgraduate Education under the Ministry of Health of Ukraine.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fedosiuk', 'Affiliation': 'Brest Regional Hospital, Belarus.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'Das Statistical Consulting, Guerneville.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skarinsky', 'Affiliation': 'Zavante Therapeutics, Inc., San Diego, California.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Zavante Therapeutics, Inc., San Diego, California.'}, {'ForeName': 'Evelyn J', 'Initials': 'EJ', 'LastName': 'Ellis-Grosse', 'Affiliation': 'Zavante Therapeutics, Inc., San Diego, California.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz181']
2006,31269427,Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake.,,2019,,[],"['Ad Libitum Food Intake', 'Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain']",[],[],"[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",[],,0.173456,,"[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ayuketah', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brychta', 'Affiliation': ''}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cassimatis', 'Affiliation': ''}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Courville', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Darcey', 'Affiliation': ''}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Ciaran G', 'Initials': 'CG', 'LastName': 'Forde', 'Affiliation': ''}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Gharib', 'Affiliation': ''}, {'ForeName': 'Juen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'Paule V', 'Initials': 'PV', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGehee', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ouwerkerk', 'Affiliation': ''}, {'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Raisinger', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Rozga', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stagliano', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ''}]",Cell metabolism,['10.1016/j.cmet.2019.05.020']
2007,31236874,Improvement in 6-min Walk Test Distance Following Treatment for Behavioral Weight Loss and Disinhibited Eating: an Exploratory Secondary Analysis.,"BACKGROUND


Poor functional exercise capacity is common among those with obesity; however, objective measures of exercise capacity are rarely examined in behavioral treatments targeting obese individuals. We examined whether a 4-week acceptance and commitment therapy (ACT) intervention for disinhibited eating or a behavioral weight loss (BWL) intervention improved exercise capacity and explored demographic and disinhibited eating variables related to exercise capacity.
METHODS


Veterans (n = 61), randomized to receive ACT or BWL, completed an assessment of exercise capacity via the 6-min walk test (6MWT) at baseline and 6-month follow-up. Measures of disinhibited eating patterns and body mass index (BMI), at baseline and post-treatment, were also collected. Change in 6MWT distance and treatment group differences were examined using mixed ANOVAs. Characteristics related to baseline 6MWT and predictors of improvement in 6MWT at 6 months were examined with hierarchical multiple regression.
RESULTS


There were overall significant improvements on the 6MWT from baseline to 6-month follow-up (F(1,59) = 11.14, p = .001, η p 2  = .159) but no differences between the ACT and BWL groups. Baseline BMI (β = - .33, p = .005) was the only variable related to baseline 6MWT. Improvements on the 6MWT were related to younger age (β = - .41, p = 0.001), female gender (β = .36, p = .001), and treatment-related increases in dietary restraint behaviors (β = .42, p = .001).
CONCLUSIONS


Functional exercise capacity improved among participants completing behavioral interventions for weight and disinhibited eating. Improvements in dietary behavior regulatory skills may have generalized to improved regulation in other behavioral domains associated with exercise capacity.",2019,Improvements on the 6MWT were related to younger age (β ,"['Veterans (n\u2009=\u200961', 'participants completing behavioral interventions for weight and disinhibited eating']","['ACT or BWL, completed an assessment of exercise capacity via the 6-min walk test (6MWT', '4-week acceptance and commitment therapy (ACT) intervention for disinhibited eating or a behavioral weight loss (BWL) intervention']","['Baseline BMI', 'Behavioral Weight Loss and Disinhibited Eating', 'disinhibited eating patterns and body mass index (BMI', '6MWT', 'female gender (β', 'dietary restraint behaviors (β\u2009']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0492712,Improvements on the 6MWT were related to younger age (β ,"[{'ForeName': 'Jennalee S', 'Initials': 'JS', 'LastName': 'Wooldridge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Herbert', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hernandez', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Dochat', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Center for Weight, Eating and Lifestyle Science (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Gasperi', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Afari', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA. nafari@ucsd.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09796-1']
2008,31274827,Missing expectations: Windlass tourniquet use without formal training yields poor results.,"BACKGROUND


Despite significant attempts to educate civilians in hemorrhage control, the majority remain untrained. We sought to determine if laypersons can successfully apply one of three commercially available tourniquets; including those endorsed by the United States Military and the American College of Surgeons.
METHODS


Preclinical graduate health science students were randomly assigned a commercially available windless tourniquet: SAM XT, Combat Application Tourniquet (CAT), or Special Operation Forces Tactical Tourniquet (SOFT-T). Each was given up to 1 minute to read package instructions and asked to apply it to the HapMed Leg Tourniquet Trainer. Estimated blood loss was measured until successful hemostatic pressure was achieved or simulated death occurred from exsanguination. Simulation survival, time to read instructions and stop bleeding, tourniquet pressure, and blood loss were analyzed.
RESULTS


Of the 150 students recruited, 55, 46, and 49 were randomized to the SAM XT, CAT, SOFT-T, respectively. Mean overall simulation survival was less than 66% (65%, 72%, 61%; p = 0.55). Of survivors, all three tourniquets performed similarly in median pressure applied (319, 315, and 329 mm Hg; p = 0.54) and median time to stop bleeding (91, 70, 77 seconds; p = 0.28). There was a statistical difference in median blood loss volume favoring SOFT-T (SAM XT, 686 mL; CAT, 624 mL; SOFT-T, 433 mL; p = 0.03). All 16 participants with previous experience were able to successfully place the tourniquet compared with 81 (62%) of 131 first-time users (p = 0.008).
CONCLUSION


No one should die of extremity hemorrhage, and civilians are our first line of defense. We demonstrate that when an untrained layperson is handed a commonly accepted tourniquet, failure is unacceptably high. Current devices are not intuitive and require training beyond the enclosed instructions. Plans to further evaluate this cohort after formal ""Stop the Bleed"" training are underway.",2019,"There was a statistical difference in median blood loss volume favoring SOFT-T (SAM XT 686 ml, CAT 624 ml, SOFT-T 433 ml; p=0.03).","['those endorsed by the United States Military and the American College of Surgeons', 'Pre-clinical graduate health science students', 'Of the 150 students recruited, 55, 46, and 49']","['commercially-available windless tourniquet: SAM® XT, Combat Application Tourniquet® (CAT), or Special Operation Forces® Tactical Tourniquet (SOFT-T']","['Estimated blood loss', 'Simulation survival, time to read instructions and stop bleeding, tourniquet pressure, and blood loss', 'median pressure', 'median time to stop bleeding', 'median blood loss volume', 'Mean overall simulation survival']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0599022,"There was a statistical difference in median blood loss volume favoring SOFT-T (SAM XT 686 ml, CAT 624 ml, SOFT-T 433 ml; p=0.03).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dennis', 'Affiliation': 'From the Department of Trauma and Burn Surgery, Cook County Health (A.D., F.Ba., V.S., L.C.T., C.B., M.K., T.M., F.S., J.M., F.Bo.); Department of Surgery, Rush University (A.D., V.S., L.C.T., C.B., T.M., F.S. F.Bo.), Chicago; Department of Surgery, Midwestern University (A.D., V.S., L.C.T., A.I., K.I., A.L., T.P., F.S., J.M.), Downers Grove, Illinois.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bajani', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Schlanser', 'Affiliation': ''}, {'ForeName': 'Leah C', 'Initials': 'LC', 'LastName': 'Tatebe', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Impens', 'Affiliation': ''}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Ivkovic', 'Affiliation': ''}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pickett', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kaminsky', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Messer', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Starr', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Mis', 'Affiliation': ''}, {'ForeName': 'Faran', 'Initials': 'F', 'LastName': 'Bokhari', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002431']
2009,31189517,"Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial.","BACKGROUND


Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment.
METHODS


This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1·73 m 2 , and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo for 26 weeks, in addition to background medication. Participants and site staff were masked to assignment. Two efficacy-related estimands were defined: treatment policy (regardless of treatment discontinuation or rescue medication) and trial product (on treatment without rescue medication) in all participants randomly assigned. Endpoints were change from baseline to week 26 in HbA 1c  (primary endpoint) and bodyweight (confirmatory secondary endpoint), assessed in all participants with sufficient data. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered on ClinicalTrials.gov, number NCT02827708, and the European Clinical Trials Registry, number EudraCT 2015-005326-19, and is now complete.
FINDINGS


Between Sept 20, 2016, and Sept 29, 2017, of 721 patients screened, 324 were eligible and randomly assigned to oral semaglutide (n=163) or placebo (n=161). Mean age at baseline was 70 years (SD 8), and 168 (52%) of participants were female. 133 (82%) participants in the oral semaglutide group and 141 (88%) in the placebo group completed 26 weeks on treatment. At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA 1c  (estimated mean change of -1·0 percentage point (SE 0·1; -11 mmol/mol [SE 0·8]) vs -0·2 percentage points (SE 0·1; -2 mmol/mol [SE 0·8]); estimated treatment difference [ETD]: -0·8 percentage points, 95% CI -1·0 to -0·6; p<0·0001) and bodyweight (estimated mean change of -3·4 kg [SE 0·3] vs -0·9 kg [SE 0·3]; ETD, -2·5, 95% CI -3·2 to -1·8; p<0·0001) by the treatment policy estimand. Significant differences were seen for the trial product estimand: mean change in HbA 1c  -1·1 percentage points (SE 0·1; -12 mmol/mol [SE 0·8] versus -0·1 percentage points (SE 0·1; -1 mmol/mol [SE 0·8]; ETD -1·0 percentage points, 95% CI -1·2 to -0·8; p<0·0001); mean change in bodyweight -3·7 kg (SE 0·3) versus -1·1 kg (SE 0·3; ETD -2·7 kg, 95% CI -3·5 to -1·9; p<0·0001). More patients taking oral semaglutide than placebo had adverse events (120 [74%] of 163 vs 105 [65%] of 161), and discontinued treatment as a result (24 [15%] vs eight [5%]). Gastrointestinal events, mainly mild-to-moderate nausea, were more common with oral semaglutide than with placebo. Three deaths occurred during the treatment period that were not condsidered to be treatment related, one in the semaglutide group and two in the placebo group.
INTERPRETATION


Oral semaglutide was effective in patients with type 2 diabetes and moderate renal impairment, potentially providing a new treatment option for this population. Safety, including renal safety, was consistent with the GLP-1 receptor agonist class.
FUNDING


Novo Nordisk A/S.",2019,"At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA 1c  (estimated mean change of -1·0 percentage point (SE 0·1; -11 mmol/mol [SE 0·8])","['patients with type 2 diabetes and moderate renal impairment', 'Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1·73 m 2 , and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible', 'Between Sept 20, 2016, and Sept 29, 2017, of 721 patients screened, 324 were eligible and randomly assigned to', 'participants who received at least one dose of study drug', 'Mean age at baseline was 70 years (SD 8), and 168 (52%) of participants were female', '88 sites in eight countries', 'patients with type 2 diabetes']","['GLP-1) receptor agonist', 'oral semaglutide', 'placebo', 'interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo']","['Gastrointestinal events, mainly mild-to-moderate nausea', 'renal safety', 'adverse events', 'Efficacy and safety', 'efficacy and safety', 'deaths', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",324.0,0.63011,"At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA 1c  (estimated mean change of -1·0 percentage point (SE 0·1; -11 mmol/mol [SE 0·8])","[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel. Electronic address: ofrim@hadassah.org.il.'}, {'ForeName': 'Thalia Marie', 'Initials': 'TM', 'LastName': 'Blicher', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Rosenlund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Clinical Diabetology and Metabolism, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ole Holm', 'Initials': 'OH', 'LastName': 'Hels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL, USA.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Academic Diabetes, Endocrinology and Metabolism Research Group, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Desouza', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30192-5']
2010,31799782,"Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide may be beneficial in the regression of diabetic cardiomyopathy. South Asian ethnic groups in particular are at risk of developing type 2 diabetes.
PURPOSE


To assess the effects of liraglutide on left ventricular (LV) diastolic and systolic function in South Asian type 2 diabetes patients.
STUDY TYPE


Prospective, double-blind, randomized, placebo-controlled trial.
POPULATION


Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease, who were randomly assigned to 26-week treatment with liraglutide (1.8 mg/day) or placebo.
FIELD STRENGTH/SEQUENCE


3T (balanced steady-state free precession cine MRI, 2D and 4D velocity-encoded MRI,  1  H-MRS, T 1  mapping).
ASSESSMENT


Primary endpoints were changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction). Secondary endpoints were changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV]).
STATISTICAL TESTS


Data were analyzed according to intention-to-treat. Between-group differences were reported as mean (95% confidence interval [CI]) and were assessed using analysis of covariance (ANCOVA).
RESULTS


Liraglutide (n = 22) compared with placebo (n = 25) did not change Edec (+0.2 mL/s 2  × 10 -3  (-0.3;0.6)), E/A (-0.09 (-0.23;0.05)), E/Ea (+0.1 (-1.2;1.3)) and ejection fraction (0% (-3;2)), but decreased stroke volume (-9 mL (-14;-5)) and increased heart rate (+10 bpm (4;15)). Aortic PWV (+0.5 m/s (-0.6;1.6)), myocardial triglyceride content (+0.21% (-0.09;0.51)), and ECV (-0.2% (-1.4;1.0)) were unaltered.
DATA CONCLUSION


Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.
LEVEL OF EVIDENCE


1 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;51:1679-1688.",2020,"Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.
","['South Asian type 2 diabetes patients', 'Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease', 'Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands', 'Dutch South Asian type 2 diabetes patients with or without coronary artery disease']","['Placebo', 'glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide', 'Liraglutide', 'placebo', 'liraglutide']","['myocardial triglyceride content', 'left ventricular (LV) diastolic and systolic function', 'stroke volume', 'changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction', 'Aortic PWV', 'ejection fraction', 'Cardiovascular Function and Myocardial Tissue Characteristics', 'LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume', 'heart rate', 'changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429481', 'cui_str': 'Early fetal heart deceleration (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C1265984', 'cui_str': 'Diffuse fibrosis'}]",47.0,0.355122,"Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.
","[{'ForeName': 'Elisabeth H M', 'Initials': 'EHM', 'LastName': 'Paiman', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Minke M A', 'Initials': 'MMA', 'LastName': 'van Aalst', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'van der Geest', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jos J M', 'Initials': 'JJM', 'LastName': 'Westenberg', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Petronella H', 'Initials': 'PH', 'LastName': 'Geelhoed-Duijvestijn', 'Affiliation': 'Department of Medicine, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Aan V', 'Initials': 'AV', 'LastName': 'Kharagjitsingh', 'Affiliation': 'Department of Diabetology and Endocrinology, University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department of Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27009']
2011,30882751,Single versus Split Dose of Iron Optimizes Hemoglobin Mass Gains at 2106 m Altitude.,"PURPOSE


To determine if a single versus a split equivalent daily dose of elemental iron was superior for hemoglobin mass (Hbmass) gains at altitude while minimizing gastrointestinal (GI) discomfort.
METHODS


Twenty-four elite runners attended a 3.1 ± 0.3 wk training camp (Flagstaff, AZ; 2106 m). A two-group design, randomized and stratified to baseline Hbmass, sex, and ferritin (>30 μ·L), was implemented daily as: 1) single dose of 1 × 200 mg (PM only, SINGLE) versus 2) split dose of 2 × 100 mg (AM and PM; SPLIT) elemental iron (ferrous fumarate). The Hbmass and venipuncture assessments were completed upon arrival and departure (±2 d) from camp for ferritin, hepcidin, and erythroferrone (ERFE) concentrations. Validated food frequency, GI distress, menstrual blood loss (MBL) and training questionnaires were implemented throughout. Univariate analysis was used to compare Hbmass, with baseline ferritin, dietary iron intake, MBL, and training volume used as covariates.
RESULTS


Both conditions increased Hbmass from baseline (P < 0.05), with SINGLE (867.3 ± 47.9 g) significantly higher than SPLIT (828.9 ± 48.9 g) (P = 0.048). The GI scores were worse in SINGLE for weeks 1 and 2 combined (SINGLE, 18.0 ± 6.7 points; SPLIT, 11.3 ± 6.9 points; P = 0.025); however, GI scores improved by week 3, resulting in no between-group differences (P = 0.335). Hepcidin significantly decreased over time (P = 0.043) in SINGLE, with a nonsignificant decrease evident in SPLIT (~22%). ERFE significantly decreased in both groups (~28.5%; P < 0.05). No between-group differences existed for ERFE, hepcidin, food frequency, MBL, or daily training outcomes (P > 0.05).
CONCLUSIONS


A single nightly 200-mg dose of elemental iron was superior to a split dose for optimizing Hbmass changes at altitude in runners over an approximately 3-wk training camp.",2019,"No between-group differences existed for ERFE, hepcidin, food frequency, MBL, or daily training outcomes (P > 0.05).
","['Twenty-four elite runners attended a 3.1 ± 0.3 wk training camp (Flagstaff, AZ; 2106 m']","['single dose of 1 × 200 mg (PM only, SINGLE) versus 2) split dose of 2 × 100 mg (AM and PM; SPLIT) elemental iron (ferrous fumarate']","['hemoglobin mass (Hbmass) gains at altitude while minimizing gastrointestinal (GI) discomfort', 'Validated food frequency, GI distress, menstrual blood loss (MBL) and training questionnaires', 'GI scores', 'ERFE', 'baseline ferritin, dietary iron intake, MBL, and training volume used as covariates', 'ERFE, hepcidin, food frequency, MBL, or daily training outcomes', 'ferritin, hepcidin, and erythroferrone (ERFE) concentrations']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0060276', 'cui_str': 'Ferrous fumarate'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood (substance)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0376520', 'cui_str': 'Dietary Iron'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0612011,"No between-group differences existed for ERFE, hepcidin, food frequency, MBL, or daily training outcomes (P > 0.05).
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Canadian Sport Institute Pacific, Vancouver & Victoria, British Columbia, CANADA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peeling', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Crawley, Western Australia, AUSTRALIA.'}, {'ForeName': 'Elizabeta', 'Initials': 'E', 'LastName': 'Nemeth', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bergland', 'Affiliation': 'Hypo2 High Performance Sport Center, Flagstaff, AZ.'}, {'ForeName': 'Walter T P', 'Initials': 'WTP', 'LastName': 'McCluskey', 'Affiliation': 'Canadian Sport Institute Pacific, Vancouver & Victoria, British Columbia, CANADA.'}, {'ForeName': 'Trent', 'Initials': 'T', 'LastName': 'Stellingwerff', 'Affiliation': 'Canadian Sport Institute Pacific, Vancouver & Victoria, British Columbia, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000001847']
2012,30505459,"Correction to: The help for people with money, employment or housing problems (HOPE) intervention: pilot randomised trial with mixed methods feasibility research.",[This corrects the article DOI: 10.1186/s40814-018-0365-6.].,2018,[This corrects the article DOI: 10.1186/s40814-018-0365-6.].,"['people with money, employment or housing problems (HOPE) intervention']",[],[],"[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0587170', 'cui_str': 'Housing unsatisfactory (finding)'}]",[],[],,0.113137,[This corrects the article DOI: 10.1186/s40814-018-0365-6.].,"[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Barnes', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Haase', 'Affiliation': '3School of Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': '2National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West, UH Bristol NHS Trust, UK/Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Linton', 'Affiliation': '2National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West, UH Bristol NHS Trust, UK/Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Bard', 'Affiliation': '4School of Veterinary Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': '2National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West, UH Bristol NHS Trust, UK/Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Davies', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dursley', 'Affiliation': 'Psychiatric Liaison Team, UH Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Psychiatric Liaison Team, UH Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Potokar', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kapur', 'Affiliation': '7Centre for Suicide Prevention, University of Manchester, Manchester, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hawton', 'Affiliation': '8Centre for Suicide Research, University of Oxford, Oxford, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': ""O'Connor"", 'Affiliation': '9Suicidal Behaviour Research Laboratory, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gunnell', 'Affiliation': '1Population Health Sciences, University of Bristol, Canynge Hall, Bristol, BS8 PS UK.'}]",Pilot and feasibility studies,['10.1186/s40814-018-0374-5']
2013,31285751,Correction to: BPSM-D-19-00022R2 Subjective well-being and problem-solving skills for alleviating the stress of elderly men attending a randomized controlled trial of shogi-assisted cognitive behavioral therapy.,[This corrects the article DOI: 10.1186/s13030-019-0153-4.].,2019,[This corrects the article DOI: 10.1186/s13030-019-0153-4.].,['elderly men attending'],"['BPSM-D-19-00022R2 Subjective well-being and problem-solving skills', 'shogi-assisted cognitive behavioral therapy']",[],"[{'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],,0.0329389,[This corrects the article DOI: 10.1186/s13030-019-0153-4.].,"[{'ForeName': 'Mutsuhiro', 'Initials': 'M', 'LastName': 'Nakao', 'Affiliation': '1Department of Psychosomatic Medicine, School of Medicine, International University of Health and Welfare, 4-3, Kozunomo, Narita-shi, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Furukawa', 'Affiliation': '2School of Basic Research and Improvement of Practice for Education, Naruto University of Education, Tokushima, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Kitashima', 'Affiliation': '3Graduate School of System Design and Management, Keio University, Tokyo, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Noda', 'Affiliation': '4Graduate School of Human and Social Sciences, Musashino University, Tokyo, Japan.'}]",BioPsychoSocial medicine,['10.1186/s13030-019-0157-0']
2014,30617139,"Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study.","PURPOSE


This phase III study compared clinical efficacy and safety of the biosimilar ABP 215 with bevacizumab reference product (RP) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).
PATIENTS AND METHODS


Patients were randomized 1:1 to ABP 215 or bevacizumab 15 mg/kg every three weeks for 6 cycles. All patients received carboplatin and paclitaxel every three weeks for ≥4 and ≤6 cycles. The primary efficacy endpoint was risk ratio of objective response rate (ORR); clinical equivalence was confirmed if the 2-sided 90% confidence interval (CI) of the risk ratio was within the margin of 0.67 to 1.5. Secondary endpoints included risk difference of ORR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS); pharmacokinetics, adverse events (AEs), and incidence of antidrug antibodies (ADAs) were monitored.
RESULTS


A total of 820 patients were screened; 642 were randomized to ABP 215 ( n  = 328) and bevacizumab ( n  = 314). Overall, 128 (39.0%) and 131 (41.7%) patients in the ABP 215 and bevacizumab groups, respectively, had objective responses [ORR risk ratio: 0.93 (90% CI, 0.80-1.09)]. In the ABP 215 and bevacizumab group, 308 (95.1%) and 289 (93.5%) patients, respectively, had at least 1 AE; 13 (4.0%) and 11 (3.6%) experienced a fatal AE. Anti-VEGF toxicity was low and comparable between treatment groups. At week 19, median trough serum drug concentration was 132 μg/mL (ABP 215 group) and 129 μg/mL (bevacizumab group). No patient tested positive for neutralizing antibodies.
CONCLUSIONS


ABP 215 is similar to bevacizumab RP with respect to clinical efficacy, safety, immunogenicity, and pharmacokinetics. The totality of evidence supports clinical equivalence of ABP 215 and bevacizumab.",2019,Anti-VEGF toxicity was low and comparable between treatment groups.,"['A total of 820 patients were screened; 642 were randomized to', 'patients with advanced nonsquamous non-small cell lung cancer (NSCLC', 'Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE', 'Patients']","['bevacizumab', 'ABP', 'carboplatin and paclitaxel', 'ABP 215 or bevacizumab', 'Bevacizumab', 'biosimilar ABP 215 with bevacizumab reference product (RP', 'Biosimilar ABP 215']","['median trough serum drug concentration', 'risk ratio of objective response rate (ORR); clinical equivalence', 'fatal AE', 'clinical efficacy, safety, immunogenicity, and pharmacokinetics', 'risk difference of ORR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS); pharmacokinetics, adverse events (AEs), and incidence of antidrug antibodies (ADAs', 'Anti-VEGF toxicity', 'Efficacy and Safety']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0330996', 'cui_str': 'Maple'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",820.0,0.485391,Anti-VEGF toxicity was low and comparable between treatment groups.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Thatcher', 'Affiliation': 'The Christie Hospital, Manchester, United Kingdom. Nick.Thatcher@christie.nhs.uk.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Goldschmidt', 'Affiliation': 'Oncology and Hematology Associates of Southwest Virginia, US Oncology Research, McKesson Specialty Health, Blacksburg, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitatsklinikum, Heidelberg, Translational Lung Research Center, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Centrul de Oncologie Sf Nectarie, Craiova, Romania.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares Rodriguez', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': 'Department of Clinical Biotechnologies, N. N. Blokhin National Medical Research Center of Oncology, Russia.'}, {'ForeName': 'Gyula', 'Initials': 'G', 'LastName': 'Ostoros', 'Affiliation': 'Koranyi National Institute for TB and Pulmonology, Budapest, Hungary.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2702']
2015,31830962,"Influence of psychiatric or social backgrounds on clinical decision making: a randomized, controlled multi-centre study.","BACKGROUND


Frequent and repeated visits from patients with mental illness or free medical care recipients may elicit physicians' negative emotions and influence their clinical decision making. This study investigated the impact of the psychiatric or social background of such patients on physicians' decision making about whether to offer recommendations for further examinations and whether they expressed an appropriate disposition toward the patient.
METHODS


A randomized, controlled multi-centre study of residents in transitional, internal medicine, or emergency medicine was conducted in five hospitals. Upon randomization, participants were stratified by gender and postgraduate year, and they were allocated to scenario set 1 or 2. They answered questions pertaining to decision-making based on eight clinical vignettes. Half of the eight vignettes presented to scenario set 1 included additional patient information, such as that the patient had a past medical history of schizophrenia or that the patient was a recipient of free care who made frequent visits to the doctor (biased vignettes). The other half included no additional information (neutral vignettes). For scenario set 2, the four biased vignettes presented to scenario set 1 were neutralized, and the four neutral vignettes were rendered biased by providing additional information. After reading, participants answered decision-making questions regarding diagnostic examination, interventions, or patient disposition. The primary analysis was a repeated-measures ANOVA on the mean management accuracy score, with patient background information as a within-subject factor (no bias, free care recipients, or history of schizophrenia).
RESULTS


A total of 207 questionnaires were collected. Repeated-measures ANOVA showed that additional background information had influence on mean accuracy score (F(7, 206) = 13.84, p <  0.001 partial η2 = 0.063). Post hoc pairwise multiple comparison test, Sidak test, showed a significant difference between schizophrenia and no bias condition (p <  0.05). The ratings for patient likability were lower in the biased vignettes compared to the neutral vignettes, which was associated with the lower utilization of medical resources by the physicians.
CONCLUSIONS


Additional background information on past medical history of schizophrenia increased physicians' mistakes in decision making. Patients' psychiatric backgrounds should not bias physicians' decision-making. Based on these findings, physicians are recommended to avoid being influenced by medically unrelated information.",2019,"The ratings for patient likability were lower in the biased vignettes compared to the neutral vignettes, which was associated with the lower utilization of medical resources by the physicians.
","['patients with mental illness or free medical care recipients', 'residents in transitional, internal medicine, or emergency medicine was conducted in five hospitals']",[],"['ratings for patient likability', 'mean management accuracy score, with patient background information as a within-subject factor (no bias, free care recipients, or history of schizophrenia', 'mean accuracy score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0455502', 'cui_str': 'H/O: schizophrenia'}]",207.0,0.0628089,"The ratings for patient likability were lower in the biased vignettes compared to the neutral vignettes, which was associated with the lower utilization of medical resources by the physicians.
","[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Tokyo Bay Urayasu/Ichikawa Medical Centre, 3-4-32 Todaijima, Urayasu, Chiba, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shiga', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Tokyo Bay Urayasu/Ichikawa Medical Centre, 3-4-32 Todaijima, Urayasu, Chiba, Japan. tshiga@iuhw.ac.jp.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Shikino', 'Affiliation': 'Department of General Medicine, University of Chiba Hospital, 1-8-1 Inohana, Chuo, Chiba, Chiba, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Uechi', 'Affiliation': 'Department of General Medicine, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Koyama', 'Affiliation': 'Department of Emergency and Critical Care Medicine, University of Tsukuba Hospital, 2-1-1 Tenkubo, Tsukuba, Ibaragi, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Shimozawa', 'Affiliation': 'Department of Emergency and Critical Care Medicine, St. Marianna University School of Medicine Hospital, 2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Hiraoka', 'Affiliation': 'Department of General Internal Medicine, Tokyo Bay Urayasu/Ichikawa Medical Centre, 3-4-32 Todaijima, Urayasu, Chiba, Japan.'}, {'ForeName': 'Hiraku', 'Initials': 'H', 'LastName': 'Funakoshi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Tokyo Bay Urayasu/Ichikawa Medical Centre, 3-4-32 Todaijima, Urayasu, Chiba, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Mizobe', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Tokyo Bay Urayasu/Ichikawa Medical Centre, 3-4-32 Todaijima, Urayasu, Chiba, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Imaizumi', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan.'}, {'ForeName': 'Masatomi', 'Initials': 'M', 'LastName': 'Ikusaka', 'Affiliation': 'Department of General Medicine, University of Chiba Hospital, 1-8-1 Inohana, Chuo, Chiba, Chiba, Japan.'}]",BMC medical education,['10.1186/s12909-019-1897-z']
2016,31958772,Kinetic and Kinematic Changes in Vertical Jump in Prepubescent Girls After 10 Weeks of Plyometric Training.,"PURPOSE


To examine the effect of a 10-week plyometric training (PT) on the kinematic and kinetic properties of prepubescent girls during squat jump, countermovement jump, and drop jumps.
METHODS


Twenty-four untrained girls (aged 9-11 y) were assigned to a training group (TG) and a control group. The TG followed twice a week PT for 10 weeks. Squat jump, countermovement jump, and drop jumps performed from heights of 20, 35, and 50 cm were tested before and after PT. Jump height, kinematic, and kinetic parameters were evaluated using a motion analysis system and a force plate.
RESULTS


Jumping height in all jump types increased significantly after PT for the TG (P < .001). After training, the TG presented increased power (P < .001) and knee angular velocity (P < .001), higher knee flexion at the deepest point during the braking phase (P < .001), longer contact time (P < .001), and unchanged stiffness and reaction strength index (P > .05). No differences were observed in the control group (P > .05).
CONCLUSION


These findings indicate that a 10-week PT positively affected jumping performance in prepubescent girls who improved their drop jump performance after training not by adopting a stiff/bouncing jumping style of short contact time and increased stiffness, but a compliant/absorbing style of prolonged contact time.",2020,"After training, the TG presented increased power (P < .001) and knee angular velocity (P < .001), higher knee flexion at the deepest point during the braking phase (P < .001), longer contact time (P < .001), and unchanged stiffness and reaction strength index (P > .05).","['Prepubescent Girls', 'Twenty-four untrained girls (aged 9-11\xa0y']","['training group (TG', 'Plyometric Training', '10-week plyometric training (PT']","['longer contact time', 'Kinetic and Kinematic Changes in Vertical Jump', 'higher knee flexion', 'unchanged stiffness and reaction strength index', 'knee angular velocity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",24.0,0.0185251,"After training, the TG presented increased power (P < .001) and knee angular velocity (P < .001), higher knee flexion at the deepest point during the braking phase (P < .001), longer contact time (P < .001), and unchanged stiffness and reaction strength index (P > .05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Katsikari', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Bassa', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Skoufas', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Savvas', 'Initials': 'S', 'LastName': 'Lazaridis', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Kotzamanidis', 'Affiliation': 'Aristotle University of Thessaloniki.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Patikas', 'Affiliation': 'Aristotle University of Thessaloniki.'}]",Pediatric exercise science,['10.1123/pes.2019-0188']
2017,31272931,Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial.,"BACKGROUND


After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4-1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes.
METHODS


ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65-1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA 1c  or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials.gov, number NCT01663402.
FINDINGS


At study baseline, 5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2·20-2·28 mmol/L), after 4 months' treatment with alirocumab (0·80 mmol/L), or after 4 months' treatment with placebo (2·25-2·28 mmol/L). In the placebo group, the incidence of the primary endpoint over a median of 2·8 years was greater in patients with diabetes (16·4%) than in those with prediabetes (9·2%) or normoglycaemia (8·5%); hazard ratio (HR) for diabetes versus normoglycaemia 2·09 (95% CI 1·78-2·46, p<0·0001) and for diabetes versus prediabetes 1·90 (1·65-2·17, p<0·0001). Alirocumab resulted in similar relative reductions in the incidence of the primary endpoint in each glycaemic category, but a greater absolute reduction in the incidence of the primary endpoint in patients with diabetes (2·3%, 95% CI 0·4 to 4·2) than in those with prediabetes (1·2%, 0·0 to 2·4) or normoglycaemia (1·2%, -0·3 to 2·7; absolute risk reduction p interaction =0·0019). Among patients without diabetes at baseline, 676 (10·1%) developed diabetes in the placebo group, compared with 648 (9·6%) in the alirocumab group; alirocumab did not increase the risk of new-onset diabetes (HR 1·00, 95% CI 0·89-1·11). HRs were 0·97 (95% CI 0·87-1·09) for patients with prediabetes and 1·30 (95% CI 0·93-1·81) for those with normoglycaemia (p interaction =0·11).
INTERPRETATION


After a recent acute coronary syndrome, alirocumab treatment targeting an LDL cholesterol concentration of 0·65-1·30 mmol/L produced about twice the absolute reduction in cardiovascular events among patients with diabetes as in those without diabetes. Alirocumab treatment did not increase the risk of new-onset diabetes.
FUNDING


Sanofi and Regeneron Pharmaceuticals.",2019,HRs were 0·97,"['patients with diabetes', 'acute coronary syndrome in patients with or without diabetes', 'patients with an acute coronary syndrome and diabetes', 'patients with prediabetes and 1·30', '5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia', 'patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins']","['alirocumab', 'ezetimibe or statins', 'alirocumab with placebo', 'placebo', 'alirocumab or placebo', 'Alirocumab']","['glycaemic categories in median LDL cholesterol', 'diabetes', 'risk of new-onset diabetes', 'composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission', 'mean LDL cholesterol', 'normoglycaemia', 'efficacy and safety', 'cardiovascular events', 'cardiovascular and metabolic outcomes', 'median of 2·8 years']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.567059,HRs were 0·97,"[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London, UK. Electronic address: k.ray@imperial.ac.uk.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi, Montpellier, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Heart & Vascular Center, Brigham and Women's Hospital Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andrzej J', 'Initials': 'AJ', 'LastName': 'Budaj', 'Affiliation': 'Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada; St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Loizeau', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Duke University, Durham, NC, USA.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Murin', 'Affiliation': '1st Internal Department, Comenius University, University Hospital, Bratislava, Slovakia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Arsen D', 'Initials': 'AD', 'LastName': 'Ristic', 'Affiliation': 'Department of Cardiology, Clinical Center of Serbia, Belgrade University School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Tuñón', 'Affiliation': 'Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30158-5']
2018,31881956,Comparing sensitivity to change using the 6-item versus the 17-item Hamilton depression rating scale in the GUIDED randomized controlled trial.,"BACKGROUND


Previous research suggests that the 17-item Hamilton Depression Rating Scale (HAM-D17) is less sensitive in detecting differences between active treatment and placebo for major depressive disorder (MDD) than is the HAM-D6 scale, which focuses on six core depression symptoms. Whether HAM-D6 shows greater sensitivity when comparing two active MDD treatment arms is unknown.
METHODS


This post hoc analysis used data from the intent-to-treat (ITT) cohort (N = 1541) of the Genomics Used to Improve DEpression Decisions (GUIDED) trial, a rater- and patient-blinded randomized controlled trial. GUIDED compared combinatorial pharmacogenomics-guided care with treatment as usual (TAU) in patients with MDD. Percent of symptom improvement, response rate and remission rate from baseline to week 8 were evaluated using both scales. Analyses were performed for the full cohort and for the subset of patients who at baseline were taking medications predicted by the test to have moderate or significant gene-drug interactions. A Mokken scale analysis was conducted to compare the homogeneity of HAM-D17 with that of HAM-D6.
RESULTS


At week 8, the guided-care arm demonstrated statistically significant benefit over TAU when the HAM-D6 (∆ = 4.4%, p = 0.023) was used as the continuous measure of symptom improvement, but not when using the HAM-D17 (∆ = 3.2%, p = 0.069). Response rates increased significantly for guided-care compared with TAU when evaluated using both HAM-D6 (∆ = 7.0%, p = 0.004) and HAM-D17 (∆ = 6.3%, p = 0.007). Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 ∆ = 4.6%, p = 0.031; HAM-D17 ∆ = 5.5%, p = 0.005). Patients in the guided-care arm who at baseline were taking medications predicted to have gene-drug interactions showed further increased benefit over TAU at week 8 for symptom improvement (∆ = 7.3%, p = 0.004) response (∆ = 10.0%, p = 0.001) and remission (∆ = 7.9%, p = 0.005) using HAM-D6. All outcomes showed continued improvement through week 24. Mokken scale analysis demonstrated the homogeneity and unidimensionality of HAM-D6, but not of HAM-D17, across treatment arms.
CONCLUSIONS


The HAM-D6 scale identified a statistically significant difference in symptom improvement between combinatorial pharmacogenomics-guided care and TAU, whereas the HAM-D17 did not. The demonstrated utility of pharmacogenomics-guided treatment over TAU as detected by the HAM-D6 highlights its value for future biomarker-guided trials comparing active treatment arms.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT02109939. Registered 10 April 2014.",2019,"Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 ∆ = 4.6%, p = 0.031; HAM-D17 ∆ = 5.5%, p = 0.005).",['patients with MDD'],"['placebo', 'HAM-D6', 'combinatorial pharmacogenomics-guided care with treatment as usual (TAU']","['HAM-D6 scale', 'remission', 'Remission rates', '17-item Hamilton depression rating scale', 'symptom improvement, response rate and remission rate', 'Response rates', '17-item Hamilton Depression Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomics'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0222045'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0421053,"Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 ∆ = 4.6%, p = 0.031; HAM-D17 ∆ = 5.5%, p = 0.005).","[{'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 12 Executive Park Dr. NE, 3rd Floor, Atlanta, GA, 30329, USA. bdunlop@emory.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'Department of Psychiatry, and National Network of Depression Centers, University of Michigan Comprehensive Depression Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'UMass Memorial Healthcare, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'The Corporal Michael Crescenz VAMC, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Department of Psychiatry, and the John Cochran Veteran's Administration Hospital, Washington University School of Medicine, St. Louis, MO, USA.""}, {'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'McLean Hospital, Division of Geriatric Psychiatry, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Mondimore', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and School of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine-Wichita, Wichita, KS, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'Myriad Genetics, Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Traxler', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience, Mason, OH, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience, Mason, OH, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience, Mason, OH, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'Department of Psychiatry, and National Network of Depression Centers, University of Michigan Comprehensive Depression Center, Ann Arbor, MI, USA.'}]",BMC psychiatry,['10.1186/s12888-019-2410-2']
2019,31125423,"The Effect of Using Pazopanib With Food vs. Fasted on Pharmacokinetics, Patient Safety, and Preference (DIET Study).","Pazopanib is taken fasted in a fixed oral daily dose of 800 mg. We hypothesized that ingesting pazopanib with food may improve patients' comfort and reduce gastrointestinal (GI) adverse events. Therefore, we investigated the bioequivalent dose of pazopanib when taken with food compared with 800 mg pazopanib taken fasted. In addition, we investigated the differences in GI toxicity, patient satisfaction, and patient's preference for either intake. The intake of 600 mg pazopanib with food resulted in a bioequivalent exposure and was preferred over a standard pazopanib dose without food. No differences were seen in GI toxicities under both intake regimens. Patients seem to be more positive about their feelings about side effects and satisfaction with their therapy when pazopanib was taken with food. Forty-one of the patients (68%) preferred the intake with a continental breakfast.",2019,No differences were seen in GI toxicities under both intake regimens.,[],"['pazopanib', 'Pazopanib']","[""patients' comfort and reduce gastrointestinal (GI) adverse events"", ""GI toxicity, patient satisfaction, and patient's preference for either intake"", 'GI toxicities']",[],"[{'cui': 'C1831796', 'cui_str': 'pazopanib'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]",,0.0886014,No differences were seen in GI toxicities under both intake regimens.,"[{'ForeName': 'Floor J E', 'Initials': 'FJE', 'LastName': 'Lubberman', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hamberg', 'Affiliation': 'Department of Medical Oncology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Walter L', 'Initials': 'WL', 'LastName': 'Vervenne', 'Affiliation': 'Department of Medical Oncology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Sasja F', 'Initials': 'SF', 'LastName': 'Mulder', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Frank G A', 'Initials': 'FGA', 'LastName': 'Jansman', 'Affiliation': 'Department of Clinical Pharmacy, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T A', 'Initials': 'WTA', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Luelmo', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Dirk Jan A R', 'Initials': 'DJAR', 'LastName': 'Moes', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Carla M L', 'Initials': 'CML', 'LastName': 'van Herpen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nielka P', 'Initials': 'NP', 'LastName': 'van Erp', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1515']
2020,31328876,Angiotensin II receptor blocker attenuates stress pressor response in young adult African Americans.,"African Americans (AAs) are susceptible to hypertension (HTN) and its associated organ damage leading to adverse cardiovascular (CV) outcomes. Psychological stress is proposed to contribute to the development of HTN; however, the potential role of the renin-angiotensin system (RAS) in stress-related HTN in AAs is largely unknown. In this study, we tested the hypothesis that activation of RAS is a potential contributing factor for altered CV responses to stress, and suppression of angiotensin II (Ang II) activity will improve hemodynamic responses to a prolonged mental stressor in healthy young AAs. Utilizing a double-blind, randomized, crossover study design, 132 normotensive AAs (25 ± 7 years) were treated with either a placebo (PLC) or 150 mg/d irbesartan (an Ang II type 1 receptor blocker; ARB) for 1 week. On the final day of each treatment, hemodynamic measures and urinary sodium excretion (UNaV) were collected before, during and after a 45 minute-mental stress. The magnitude of stress-induced increase in blood pressure with ARB was blunted and delayed compared to PLC. Systolic blood pressure at the end of recovery on ARB was significantly lower compared to either PLC (110 ± 13 vs 117 ± 12 mm Hg respectively; P < 0.001) or the prestress level on ARB (P = 0.02). ARB treatment reduced overall vasoconstriction and improved poststress UNaV. ARB attenuated blood pressure responses to mental stress and improved the poststress BP recovery process which were partly linked to reduced overall vasoconstriction and improved stress-induced UNaV in young adult AAs prior to the development of disease conditions. These results suggest that treatment approaches that inhibit RAS action could have significant relevance to potentially lower susceptibility to stress responses and eventually the premature development of HTN in AAs.",2019,ARB treatment reduced overall vasoconstriction and improved poststress UNaV. ARB attenuated blood pressure responses to mental stress and improved the poststress BP recovery process which were partly linked to reduced overall vasoconstriction and improved stress-induced UNaV in young adult AAs prior to the development of disease conditions.,"['African Americans (AAs', 'young adult African Americans', 'healthy young AAs', '132 normotensive AAs (25\xa0±\xa07\xa0years']","['PLC', 'Angiotensin II receptor blocker', 'placebo (PLC) or 150\xa0mg/d irbesartan (an Ang II type 1 receptor blocker; ARB', 'ARB']","['Systolic blood pressure', 'hemodynamic measures and urinary sodium excretion (UNaV', 'overall vasoconstriction', 'stress pressor response', 'blood pressure with ARB', 'overall vasoconstriction and improved stress-induced UNaV', 'ARB']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",132.0,0.0239157,ARB treatment reduced overall vasoconstriction and improved poststress UNaV. ARB attenuated blood pressure responses to mental stress and improved the poststress BP recovery process which were partly linked to reduced overall vasoconstriction and improved stress-induced UNaV in young adult AAs prior to the development of disease conditions.,"[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Hanevold', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pollock', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Harshfield', 'Affiliation': 'Department of Population Health Sciences, Georgia Prevention Institute, Augusta University, Augusta, Georgia.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13625']
2021,30973998,Effects of the P-Glycoprotein Inhibitor Clarithromycin on the Pharmacokinetics of Intravenous and Oral Trospium Chloride: A 4-Way Crossover Drug-Drug Interaction Study in Healthy Subjects.,"The quaternary ammonium compound trospium chloride is poorly absorbed from 2 ""absorption windows"" in the jejunum and cecum/ascending colon, respectively. To confirm whether intestinal P-glycoprotein (P-gp) is involved, a 4-period, crossover drug interaction study with trospium chloride after intravenous (2 mg) and oral administration (30 mg) without and after comedication of clarithromycin (500 mg), an inhibitor for P-gp, was initiated in 12 healthy subjects. Pharmacokinetics of trospium was evaluated using gas chromatography-mass spectrometry, noncompartmental evaluation, and pharmacokinetic modeling. Trospium chloride was poorly absorbed after oral administration (absolute bioavailability, ∼8%-10%). About 30% of the bioavailable dose fraction was absorbed from the ""narrow window"". Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01). Bioavailability was not increased as hypothesized. The geometric mean ratios (90% confidence interval) for area under the plasma concentration-time curve, maximum concentration, and renal clearance accounted for 0.75 (0.56-1.01), 0.64 (0.45-0.89), and 1.00 (0.90-1.13), respectively. The amount of trospium absorbed from the ""narrow window"" was reduced in all subjects but from the ""wider window"" in only 9 of them. Bioavailability was strongly predicted by the maximum absorption rate of trospium in the distal ""window"" (rs 2   = 0.910, P < .0001). In conclusion, the P-gp inhibitor clarithromycin significantly increases distribution volumes but not oral absorption of trospium. The amount absorbed from the ""narrow window"" was lowered in all subjects. However, the extent of all influences seems not to be of clinical relevance.",2019,Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01).,"['Healthy Subjects', '12 healthy subjects']","['intestinal P-glycoprotein (P-gp', 'clarithromycin', 'Oral Trospium Chloride', 'P-Glycoprotein Inhibitor Clarithromycin', 'Trospium chloride']","['maximum absorption rate of trospium', 'geometric mean ratios', 'plasma concentration-time curve, maximum concentration, and renal clearance', 'steady-state distribution volumes', 'Bioavailability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0077408', 'cui_str': 'trospium chloride'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0772089', 'cui_str': 'Trospium'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",12.0,0.0224912,Comedication with clarithromycin increased steady-state distribution volumes by ∼27% (P < .01).,"[{'ForeName': 'Bayew Tsega', 'Initials': 'BT', 'LastName': 'Abebe', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Pharmacology, Martin Luther University Halle-Wittenberg, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Modess', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Roustom', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Tadken', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Wegner', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schwantes', 'Affiliation': 'Department Medical Science/Clinical Research, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Neumeister', 'Affiliation': 'Department Medical Science/Clinical Research, Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Schulz', 'Affiliation': 'LAFAA, Laboratory for Contract Research in Clinical Pharmacology and Biopharmaceutical Analytics GmbH, Bad Schwartau, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Scheuch', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Siegmund', 'Affiliation': 'Department of Clinical Pharmacology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Greifswald, Germany.'}]",Journal of clinical pharmacology,['10.1002/jcph.1421']